HospiMedica International November 2016

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Vol.34 No.7 • 11/2016

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L E A D E R DAILY CLINICAL NEWS

ISSN 0898-7270

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Novel SLN Tracer Maps Breast Cancer Metastasis new study describes how a novel sentinel lymph node (SLN) radiotracer helps determine breast cancer spread by targeting a specific antigen. Researchers at Beijing Cancer Hospital (BJC; Beijing, China; www. bjcancer.org) and Peking University Cancer Hospital & Institute (Beijing, China) conducted a retrospective

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Innovative Magnetic Platform Expedites Gallbladder Removal novel magnetic surgery system grasps and retracts tissue and organs in laparoscopic cholecystectomy procedures, facilitating access and visualization of the surgical site.

The Levita Magnetic Surgical System is comprised of a magnetic grasper device with a detachable tip and a magnetic controller. The

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grasper is inserted into the abdominal cavity via a small incision; once the magnetic tip reaches the gallbladder, the surgeon deploys it, attaching it to the body and the fundus of the gallbladder, and removes the grasper. The surgeon then uses the magnetic controller to maneuver and lift the gallbladder via a magnetic field, without Cont’d on page 2

Intraventricular Assist Device Measures Blood Flow Directly

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Image: Courtesy of ReliantHeart

novel hand and wrist imaging system has received CE Mark (Conformité Européenne) approval for the European market, and is now on sale in the European Economic Area (EEA).

The novel hand and wrist Magnetic Resonance Imaging (MRI) imaging system was developed by a life-science startup company, and previously received U.S. Food and Drug Administration (FDA) approval.

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Health IT . . . . . . . . . . . . . . . . 42 Industry News . . . . . . . . . . . . 49 International Calendar . . . . . 50

n innovative device uses magnetic resonance imaging (MRI) guidance to deliver focused ultrasound into the thalamus, the area of the brain thought to be responsible for tremor.

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News Update . . . . . . . . . . . . . 6 Product News . . . . . . . . . .6-14

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New Standards Released for Digital Projection Radiography

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ext generation ultrasonic shears provide optimal efficiency for easier dissection, faster transection, and more secure sealing. The Harmonic HD 1000i shears offer a seamless combination of precision, strength, and efficiency in numerous surgical specialties, including hepato-pancreato-biliary, thoracic, colorectal, gynecologic oncology, and other complex laparoscopic and open procedures. The device hand piece is integrated into the

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Focused Ultrasound Device Helps Treat Essential Tremor

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Ultrasonic Shears Help Complex Procedures

Hand & Wrist MRI System Gets Market Approval

Image: The aVAD intraventricular, axial flow LVAD

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new left ventricular assist device (LVAD) provides direct flow measurement, which may give clinicians the ability to detect potential patient problems earlier. The aVAD is surgically implanted in proximity to the heart, with one end attached to the left ventricle, while the other end is attached to the aorta.

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he US NEMA standards organization has published a new standard for medical imaging device manufacturers designing and manufacturing X-Ray equipment for projection radiography.

This new standard presents the minimum equipment requirements to facilitate quality control of Computed Tomography (CR) and Digital Tomography

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(DR) equipment at the facility level.

The new US National Electrical Manufacturers Association (NEMA; Arlington, VA, USA; www.nema.org) NEMA/MITA XR 30-2016 standard is intended for medical digital radiography, and medical X-Ray diagnostic imaging radiography. The standard was Cont’d on page 5

News Update . . . . . . . . . . . . 18 Product News . . . . . . . . 18-26

News Update . . . . . . . . . . . . 30 Product News . . . . . . . . .30-38

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Innovative Magnetic Platform Expedites Gallbladder Removal cont’d from cover

damaging the abdominal wall. Once near the opening, the grasper is re-inserted to retrieve the magnetic tip and attached gallbladder.

The system reduces complications during surgery – such as organ injuries, bleeding, or pain – and also provides a better procedure for the surgeon, with less instrument crowding and less scarring for the patient. The Levita Magnetic Surgical System is a product of Levita Magnetics (San Mateo, CA, USA; www.levita.com), and has been approved by the U.S. Food and Drug Administration (FDA) for laparoscopic cholecystectomy in patients within a body mass index (BMI) range of 20- 34 kg/m2.

“We are proud to be the pioneers of magnetic surgery. Having been a minimally invasive surgeon

for over 10 years, I understand the complexity my peers face when trying to gain proper access to organs,” said surgeon Alberto Rodriguez-Navarro, MD, founder and CEO of Levita Magnetics. “Our goal at Levita is to equip surgeons with the technology they need to make surgery easier and less invasive, while enabling improved patient outcomes.”

In traditional laparoscopic cholecystectomy, four incisions are made in the abdomen: one on the rim of the navel, one beneath the navel, and two be-

neath the navel and to the right. A laparoscope and surgical instruments are passed into the interior of the abdomen to aid the surgeon in removal of the gallbladder. The new magnetic system reduces the number of incisions needed.

Image: Levita Magnetic Surgical System (Photo courtesy of Levita Magnetics).

Focused Ultrasound Device Helps Treat Essential Tremor cont’d from cover

The ExAblate Neuro device is designed to deliver precise high-intensity focused ultrasound (HIFU) waves to target a focal point in the Vim nucleus of the thalamus, a part of the brain thought to be responsible for causing tremors. The proprietary ultrasound transducer consists of 1,024 beams that generate heat at a focal point of up to 85 C to ablate targeted tissue the frequencies used for therapeutic ultrasound are in the range of 220-680 MHz. The result is an immediate and significant reduction of tremor for patients.

During planning and treatment for essential tremor, the patient is fully conscious and lying on the treatment bed in a proprietary MR guided focused ultrasound (MRgFUS) system. The MRI provides highresolution visualization, patient-specific treatment planning, and continuous monitoring of the procedure. Real-time thermal feedback allows the physician to control and adjust the treatment, ensuring that the targeted tissue is completely ablated without impacting adjacent healthy tissue. The ExAblate Neuro device is a product of InSightec (Dallas, TX, USA; www.insightec.com), and has been approved by the U.S. Food and Drug Administration (FDA).

“I am confident that we have arrived at a tipping point for non-invasive medical treatment,” said Maurice Ferré, MD, CEO and chairman of the board of InSightec. “Focused ultrasound has the unique ability to precisely ablate target tissue deep within the body.

With Exablate Neuro, InSightec expands its Exablate product line with a system that signifies a new era for functional neurosurgery.” HIFU technology is based on nonlinear acoustic mathematical optimization methods to analyze and simulate the propagation of sound in material. The information is then used to enhance the shape of an acoustic lens in such a way that that ultrasound pressure is focused precisely on the location of the tissue to be ablated, while the surrounding tissue retains as little damage as possible.

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Intraventricular Assist Device Measures Blood Flow Directly new left ventricular assist device (LVAD) provides direct flow measurement, which may give clinicians the ability to detect potential patient problems earlier.

The aVAD is an intraventricular, axial flow LVAD that while only 2.5 centimeters in diameter, provides a 1.2 cm main channel that rests outside the ventricle. A second component inserted into the heart contains an adjustable pump depth mechanism to provide optimal action. Deep linear channels help transport blood through the pump, away from the dangerous forces of radial shear. The aVAD also features direct flow measurement and 3G cellular-powered remote monitoring, allowing clinical teams to notice problems and make corrections sooner.

Additional features include active magnetic stabilization, which pulls the pump’s impeller precisely between the front and rear retention cups, and directional retention. A FastConnect system provides for adjustable pump depth inside the ventricle, and the entire aVAD driveline is disconnectable just below the diaphragm, so that in the event of driveline infection, it can be removed and replaced with a new one. The aVAD is a product of ReliantHeart (Houston, TX, USA; www.reliantheart.com), and has received the European Community CE mark of approval.

“Other LVADs have a calculated flow measurement, as opposed to the flow sensor aVAD uses; the first thing [physicians] need to do is trust the flow,” said Rodger Ford, CEO of ReliantHeart. “In addition, clinicians will need to gain experience with remote monitoring. Physicians will need to set the alarms properly so that the thresholds for low flow or high power provide an advance warning of something that could be a bad outcome.”

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25%, respectively). The authors acknowledged that they failed to totally exclude patients with biventricular assist devices (17%) and right ventricular assist devices (4%). The study was published in the July 2016 issue of JACC: Heart Failure.

“The evidence supporting ICD use in patients with LVADs is limited to a few, relatively small studies. Current practice guidelines supporting ICD use in LVAD patients are therefore predominantly based on expert consensus and observational studies,” wrote lead author Kairav Vakil, MD, and colleagues, adding that, “this cohort was enriched with patients that received an LVAD as bridge-totransplantation. As such, these results cannot be generalized to patients receiving destination thera-

py LVADs, who are known to be relatively sicker than those awaiting transplantation.”

An LVAD is intended to complement a weakened heart by providing circulatory support. Surgically implanted in proximity to the heart, one end is attached to the left ventricle, while the other is attached to the aorta. Blood flows from the ventricles into the pump and is then ejected out of the device and into the aorta. Although the mechanism of survival benefit from ICDs in LVAD patients remains unclear, a possible explanation is that it may contribute to a reduction in harmful effects of ventricular arrhythmias on right ventricular function, thereby leading to reduction of heart failure deaths.

LVAD Survival Improved When Combined with ICD In a related development, researchers at the Minneapolis Veterans Affairs (VA) Health Care System (MN, USA; www.minneapolis.va.gov) conducted a systematic review and meta-analysis of studies published in PubMed and Ovid databases from January 2000 through October 2015 in order to evaluate the impact of implantable cardioverter defibrillators (ICD) on mortality in patients with left ventricular assist devices (LVAD). In all, six relevant studies were identified, which included 937 patients (mean age 53 years, 80% male). A continuous-flow LVAD was present in 39% of the patients, and an ICD was present in 38%.

The results showed that among LVAD patients, all-cause mortality rates were 16% with an ICD, versus 32% without one, over a mean follow-up period of 7 months. Patients with newer, continuous flow LVADs showed a similar, but non-significant trend for better survival with an ICD (14% versus

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HospiMedica International

Ultrasonic Shears Help Complex Procedures

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device, driving clinical performance, and energy activation is controlled via one button, thus providing reliable sealing for vessels of up to 5 mm in diameter.

A unique blade design mimics a mechanical dissector, with a tapered jaw that enables more precise access to tissue planes. The curved, tapered geometry of the blade also delivers superior dissection. An added benefit of the blade design is exceptional sealing burst pressures, which allow for more secure seals, even in challenging hemostasis conditions.

The strong tip grasping is designed to minimize tissue slippage and aid tissue manipulation and control. The Harmonic HD 1000i shears are a product of Ethicon Endo-Surgery (Ethicon, Cincinnati, OH, USA; www.ethicon.com), and have been approved by the U.S. Food and Drug Administration (FDA).

“Harmonic HD 1000i is the latest example of our commitment to developing meaningful innovations that can help improve outcomes in critical, complex procedures,” said Grace Chung, vice president of energy global strategic marketing at Ethicon. “As we move toward the future, Harmonic HD 1000i will

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www.hospimedica.com A G L O B E T E C H P U B L I C AT I O N Publishers of: HospiMedica International • HospiMedica en Español HospiMedica China • Medical Imaging International • LabMedica International LabMedica en Español • LabMedica China • Bio Research International HospiMedica.com • MedImaging.net • LabMedica.com • BiotechDaily.com

Image: Harmonic HD 1000i shears (Photo courtesy of Ethicon Endo-Surgery).

Dan Gueron Publisher Daniel Beris, DDS News Director Joseph Ciprut Managing Editor

serve as a platform for developing a portfolio of Harmonic devices focused on trying to meet surgical needs through our in-depth knowledge of tissue and energy sciences to enable surgeons to reach more patients and restore more lives.”

Ultrasonic dissectors use two types of energy; low power which cleaves water containing tissues by cavitations, leaving organized structures with low water content intact, such blood vessels, bile ducts, etc.; and high power systems which cleave loose areolar tissues by frictional heating and thus cut and coagulate the edges at the same time. High power ultrasonic dissection may cause collateral damage by excessive heating.

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ISSN 0898-7270 Vol.34 No.7 • Published, under license, by Globetech Media LLC Copyright © 2016. All rights reserved. Reproduction in any form is forbidden without express permission.

Teknopress Yayıncılık ve Ticaret Ltd. S¸ti. adına ˙Imtiyaz Sahibi: M. Geren • Yazı is¸leri Müdürü: Ersin Köklü Müs¸ ir Dervis¸ ˙Ibrahim Sok. 5/4, Esentepe, 34394 S ¸ is¸ li, ˙Istanbul P. K. 1, AVPIM, 34001 ˙Istanbul • E-mail: Teknopress@yahoo.com Baskı: Promat Web Ofset Tesisi • Orhangazi Mahallesi 1673. Sokak, No: 34 • 34510 Esenyurt, B. Çekmece • ˙Istanbul Yerel süreli yayındır. Yılda sekiz kere yayınlanır, ücretsiz dag˘ıtılır.

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Novel SLN Tracer Maps Breast Cancer Metastasis cont’d from cover

study of 2,317 patients with primary breast cancer who underwent lymphoscintigraphy and sentinel lymph node biopsy (SLNB). Before imaging, all patients were administered a preoperative peritumoral injection of 37 MBq of 99mTc-rituximab, a new SLN radiotracer that binds to the antigen CD20, which is expressed extensively in lymph nodes.

Initial results in 100 randomly selected patients showed that the detection rate for SLN by injection of Tc-99m-rituximab, as verified by lymphoscintigraphy, was 100%. SLNs from the 100 patients were then harvested, guided by a hand-held gamma-detecting probe, and biopsied with a similar success rate of 100%. When examining results of the other 2,217 patients in the study, the detection rate was 98.8% percent for lymphoscintigraphy and 99.9 % for SLN biopsy. The study was published in the August 2016 issue of The Journal of Nuclear Medicine.

“The advantage of Tc-99m-rituximab is its uniform molecular weight and molecular size. It does not escape easily from SLNs to the second echelon lymph nodes,” said senior author Zhi Yang, PhD, chair of the department of nuclear medicine at BJC. “This results in clear SLN imaging in patients and the high success rate of lymphoscintigraphy. In addition, technical factors, such as the injection dose, injection volume and injection site, can be well controlled.”

Lymph nodes serve as biologic filters that contain immune cells to fight infection and clean the blood.

When cancer cells break away from a tumor, they can travel through the lymph system; sentinel node surgery allows the surgeon to remove the nodes to determine cancer spread. Since human lymph nodes are only a half-centimeter in size, they are difficult to discern among the surrounding tissue during surgery.

Furthermore, even when surgeons are able to map the location of the nodes, there is no current technique that indicates whether or not the lymph nodes contain cancer, requiring removal of more lymph nodes than necessary.

Image: A sentinel node biopsy for breast cancer diagnosis (Photo courtesy of CancerQuest).

New Standards Released for Digital Projection Radiography cont’d from cover

developed by the Medical Imaging & Technology Alliance (MITA; Arlington, VA, USA; www. medicalimaging.org) Computed Radiography-Digital Radiography Group, in the X-Ray Imaging division of NEMA, and can be downloaded for free.

The NEMA/MITA XR 30-2016 standard includes methods to identify image-processing settings and validate the consistency of image processing settings over time, and image quality analysis. When using CR/DR equipment some image processing is needed for optimization of the characteristics of specific detectors and to provide enhanced image quality. Image processing methods and settings are often unique for each vendor and associated customization parameters are proprietary to each vendor. The standard is intended to help clinicians verify image processing settings that can be adjusted by them, or check what are the expected processing outcomes following software upgrades. The standard is also intended to help users meet safety and regulatory compliance requirements, and validated the performance of equipment performance cost-effectively.

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PRODUCT NEWS RESPIRATORY MASKS

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Tetherless Monitor Continuously Measures Hemoglobin Concentration novel wearable device enables non-invasive monitoring of more than 10 parameters, including continuous total hemoglobin concentration (SpHb).

The Masimo (Irvine, CA, USA; www.masimo. com) Radius-7 with Root is a lightweight device that provides rainbow SET noninvasive sensor technology, which uses more than seven wavelengths of light to acquire blood constituent data based on light absorption. Indices measured include blood oxygen saturation (SpO2), pulse rate, and perfusion index (PI). Advanced signal processing algorithms and unique adaptive filters work together to isolate, identify and quantify various hemoglobin species, including SpHb. The Radius-7 with Root attaches to the arm, allowing untethered monitoring whether a patient is in or out of bed, thus reducing the need for nursing assistance to disconnect from or reconnect to a bedside monitor. The Radius-7 communicates to Root at the bedside, and thereon to the Masimo Patient SafetyNet in order to alert clinicians of critical changes in oxygen saturation, pulse rate, respiration, and hemoglobin, among other parameters. Each Radius-7 comes with two “hot-swappable” rechargeable bat-

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tery modules, each with a battery life of 12 hours, to minimize monitoring interruption.

“Never before could patients be monitored for such key parameters as continuous SpHb, which can help clinicians make more timely and informed blood management decisions, while patients are fully mobile,” said Joe Kiani, founder and CEO of Masimo. “Root with Radius-7 with rainbow SET, coupled with Patient SafetyNet for mobile clinician notification, is now an even more versatile and powerful monitoring system, all while promoting freedom of patient movement and quicker recovery times.”

“We are monitoring SpHb for selected postsurgical patients, which can be extremely beneficial because it can provide insight into hemoglobin trends between invasive blood samplings,” said professor of anesthesiology and intensive care Christer Svensen, MD, of Karolinska Institute (Stockholm, Sweden). “Such insight may lead clinicians to confirm trends by performing blood draws sooner than they might otherwise have done, which may then suggest the need to intervene.”

SpHb monitoring may provide insight to the directional trend of hemoglobin between invasive blood samplings. For example, when SpHb trend is stable, and the clinician may otherwise think hemoglobin is decreasing; when SpHb trend is rising, and the clinician may otherwise think hemoglobin is not rising fast enough; or when the SpHb trend is decreasing, and the clinician may otherwise think hemoglobin is stable.

Image: The Radius-7 with Root (Photo courtesy of Masimo).

New ICU Treatment Room Designed for Future Hospitals new project employed evidence based design (EBD) to create a blueprint for a new treatment room in the intensive care unit (ICU) and intermediate care facilities.

Called EVICURES, the futuristic treatment room project is being designed at the Technical Research Centre of Finland (VTT; Espoo; www.vttresearch. com), based on input from hospital staff, management, doctors and nurses, patients and their families, the hospital district, and other cooperation partners. The data was collected via questionnaires that surveyed participant views on such issues as architecture, indoor conditions, durability, functionality, safety, accessibility, and usability.

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An additional goal was to improve the quality and effectiveness of operations, and to increase both patient and staff satisfaction. The design team therefore employed a human thermal model tool to evaluate the individual thermal comfort of both the staff and patients, resulting in setting new limits for ideal temperature. These were implemented in the heating, ventilating, and air conditioning (HVAC) systems to adjust the thermal conditions to an optimal level, with a view to job and patient satisfaction.

Computer-aided drafting (CAD) methods were used to model a virtual space in accordance with the architectural drawing, which VTT utilized for

improving user-friendliness. From this three dimensional (3D) model, VTT developed a videogame that allowed the staff to move around in the ICU facilities virtually and to experience realistic interactive care situations in the new working area. This helped in designing suitable facilities to support actual working practices and increase job satisfaction.

The EVICURES project will be realized when the first single-patient intensive and intermediate care and cardiac unit in Finland will be built at Seinäjoki Central Hospital (Finland; www.seinajoki. fi). In accordance with the model, 24 single patient rooms will becomes operational in 2018.

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Implantable Nerve Stimulator Helps Alleviate Sleep Apnea nnovative hypoglossal nerve stimulation (HGNS) implants offers promise for patients with moderate to severe obstructive sleep apnea (OSA). Researchers at the University of Pennsylvania (Penn; Philadelphia, USA; www.upenn.edu) conducted a study involving 20 patients who were implanted with the Inspire Upper Airway Stimulation device, as they were unable to tolerate continuous positive airway pressure (CPAP) treatment for OSA. All patients had information from a baseline polysomnography (PSG) recording prior to HGNS implant and again approximately two months after HGNS in order to assess the severity of their apnea and any change after treatment. Those who received the implant were typically overweight, middle aged, and had severe OSA. The results showed that total apnea-hypopnea index (AHI) – which measures severity of sleep apnea by counting the number of pauses in breathing during sleep – for all patients significantly decreased an average of 35 events per hour after the device was planted, which correVisit us at sponds to an average reduction of 84%. Additionally, the lowest oxygen level measMEDICA ured in the blood during the night signifi2016 cantly increased by 11%, from 79% to 90%.

Hall 11-B40 The study was presented at the 30th annual meeting of the Associated Professional Sleep Societies (SLEEP), held during June 2016 in Denver (CO, USA).

“Considering that sleep apnea can lead to high blood pressure, heart attack, stroke, and other serious health problems, it is critically important that we study devices that may serve as another option instead of CPAP to treat patients with sleep apnea,” said lead author Richard Schwab, MD, comedical director of the Penn Sleep Center.

“There is no perfect treatment option for obstructive sleep apnea, but our preliminary data suggest that hypoglossal nerve stimulation can effectively treat patients with sleep apnea who are unable to tolerate CPAP.” The Inspire Upper Airway Stimulation device, a product of Inspire Medical Systems (Maple Grove, MN, USA; www.inspiresleep. com), is a pacemaker with a tiny generator and a sensing lead to stimulate the tongue. Patients use a remote control to turn on the device before going to sleep and turn it off upon waking up. A delay allows the user to fall asleep before the pulse generator begins stimulation. After detecting the user’s breathing pattern, the machine stimulates the hypoglossal nerve, which controls tongue motion to enlarge the upper airway.

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Image: The Inspire upper airway stimulation device (Photo courtesy of Inspire Medical Systems).

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Critical Care

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New Material Kills E. Coli in 30 Seconds novel oligomer can kill 99.7% of E. coli bacteria within 30 seconds aided by its chain-like structure, which helps it penetrate the cell membrane and destroy the bacteria.

Researchers at The Agency for Science, Technology and Research (A*STAR; Singapore; www. research.a-star.edu.sg) developed the imidazolium oligomers, which come in the form of a white, water-soluble powder. Molecular dynamic simulations of the oligomer revealed a delicate effect manifested by structural changes in the translocation motion across the microbial cell membrane, which suggest that the spontaneous penetration requires a very short timescale, killing over 99.7% of the bacteria within 30 seconds.

Additionally, when dissolved in alcohol, the imidazolium oligomers gel spontaneously, thanks to the hydrophobicity of the end-group chain. The material could thus be incorporated in alcoholic sprays used for sterilization in hospitals or homes, providing superior activity and excellent selectivity by targeting the cell membrane. In contrast, antibiotics only kill the bacteria, without destroying the cell

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membrane, thus leaving the cell structure intact, allowing new antibiotic-resistant bacteria to grow. A study describing the new imidazolium oligomers was published on April 14, 2016, in Small.

“The global threat of drug-resistant bacteria has given rise to the urgent need for new materials that can kill and prevent the growth of harmful bacteria,” said lead author Prof. Jackie Ying, PhD, executive director of the A*STAR Institute of Bioengineering and Nanotechnology (IBN). “Our new antimicrobial material could be used in consumer and personal care products to support good personal hygiene practices and prevent the spread of infectious diseases.”

“Our unique material can kill bacteria rapidly and inhibit the development of antibiotic-resistant bacteria. Computational chemistry studies supported our experimental findings that the chain-like compound works by attacking the cell membrane,” concluded corresponding author Yugen Zhang, PHD. “This material is also safe for use because it carries a positive charge that targets the more negatively charged bacteria, without destroying red blood cells.”

Image: A microscopic image of the E. coli bacteria after it has been destroyed by the antimicrobial material (Photo courtesy of the Institute of Bioengineering and Nanotechnology).

Kinematic Technology Helps Treat Patients with Tremors combination of wearable movement sensors and computer software can help clinicians precisely plan where to place botox injections to reduce upper limb tremors at the source.

Developed by researchers at the Lawson Health Research Institute (LHRI; London, ON, Canada; www. lawsonresearch.ca), the University of Bonab (Iran; www.en.bonabu.ac.ir), and other institutions, TremorTek is a kinematic tremor assessment system that helps determine exactly which muscles and what biomechanics are at play for each individual patient’s tremor symptoms. The data helps alleviate functional disability caused by essential tremor by objectively individualizing and personalizing injection parameters for botulinum toxin type A (BoNT-A).

The researchers conducted a 38week open label study of 24 people injected with BoNT-A. The participants performed two postural and two weight-bearing scripted tasks with TremorTek motion sensors placed over the wrist, elbow, and shoulder joints. The sensors captured angular tremor amplitude and acceleration joint motion that was segmented into directional components: flexion-extension (F/E) at the elbow, F/E and adduction-abduction at the shoulder, pronation-supination, and radial-ulnar F/E at the wrist.

The multi-joint biomechanical recordings allowed individualized se-

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Image: Research shows TremorTek offers new hybrid therapy for treatment of tremors (Photo courtesy of the Lawson Health Research Institute).

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lection and determination of which muscles would contribute to specific upper limb tremor biomechanics and subsequent dosing per participant.

The results showed that by week 38, the patients showed a significant decrease in tremor amplitude in the wrist and shoulder joints; 40% participants self-reported mild weakness in injected muscles, but had no interference in arm function. The study was published on April 21, 2016, in PLOS One. “Very few clinicians inject for tremor because before now, it just didn’t work. The injections would only cause weakness,” said senior author Prof. Mandar Jog, PhD, of the LHRI department of clinical neurological sciences. “We realize now that was because they didn’t know where to inject. The uniqueness of our development is the simplicity of it. It records from multiple joints in a straightforward way.”

BoNT-A intramuscular injections are commonly used to treat various movement disorders, such as focal dystonias, and may provide modest beneficial effects in essential tremor patients who are unresponsive to conventional drugs. The therapy has not been widely adopted due to risk of significant hand and wrist weakness causing functional limb impairment, and therefore proper identification of the dynamics of the tremulous joints is necessary to optimize injection pattern and outcomes.

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PRODUCT NEWS RESPIRATORY SYSTEM

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ANESTHESIA MACHINE

TEMP MANAGEMENT SYSTEM

Hans Rudolph

Drager Medical

Zoll Medical

The SmartLab is a flexible system for measurement/analysis of respiratory signals in research applications. The base module can accept up to 3 sensor modules for measuring flow and pressures.

Optional inputs include an oximeter, CO2 sensor, temperature and humidity and digital I/O.

The Perseus A500 features a new breathing system design to facilitate fast gas concentration changes, and provides seamless monitoring and IT integration. It features airway pressure release ventilation for continued protective ventilation therapy, and is ideal for use with all patients.

The Thermogard XP allows patients to quickly reach and maintain target temperature, with a change as small as 0.1°C triggering an immediate adjustment in temperature. It offers a variety of standard CVCs and control regardless of target temperature to enable individual treatment.

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Novel Vital Signs Monitor Delivers Digital Connectivity new spot-check vital signs device provides accurate and reliable automated measurements of blood pressure (BP), temperature, and pulse oximetry (SpO2).

The SunTech CT40 is a modular, affordable solution for clinical grade spot-checks measurement of blood pressure (BP) and other vital signs in hospitals and clinics. The modular design allows clinicians to easily make adaptations to the device, enabling them to add thermometry, blood SpO2, and Wi-Fi while in the field, based solely on patient needs. Another feature of the CT40 is customizable BP averaging, a key component to accurate blood pressure measurement, which automatically takes and averages multiple BP measurements base on an individual averaging protocol.

The device also allows users to verify automated readings using a stethoscope without remov-

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ing the cuff, for consistent patient BP measurements. Network connection is via built-in ethernet or optional Wi-Fi, and uses standard profiles to facilitate communication of patient and measurement data with the electronic medical record (EMR) system. A barcode reader is also available for easy data entry, as well as a thermal printer for hard copies of vital signs measurements. The built-in memory can store up to 99 vital signs charting sessions.

Optional accessories include touchless infrared (IR) thermometry, the Covidien (Dublin, Ireland; www.covidien.com) Filac 3000 thermometry module, the Masimo (Irvine, CA, USA; www.masimo. com) SET SpO2 module, and the Corscience (Erlangen, Germany; www.corscience.de) ChipOx Nellcor-compatible SpO2 module. A robust mobile stand is also available to facilitate room-to-room relocation. The SunTech CT40 is a product of Sun-

Tech Medical (Morrisville, NC, USA; www. suntechmed.com), and has been approved by the U.S. Food and Drug Administration (FDA).

Image: The CT40 vital signs monitor (Photo courtesy of SunTech Medical).

Novel Electroporation Technique Could Prevent Scar Formation new study suggests that short, pulsed, electric fields could be used to damage collagen cells, the proliferation of which causes permanent scarring at a burn injury site.

Developed by researchers at Tel Aviv University (Israel; www.tau.ac.il) and Harvard University (Cambridge, MA, USA; www.harvard.edu), the non-invasive partial irreversible electroporation (pIRE) technique is intended to try and control this natural response to trauma. By harnessing microsecond-pulsed, high-voltage, non-thermal electric fields, pIRE causes irreversible damage to the collagen cells. But the researchers had to find a delicate balance between creating a new wound and over-healing the existing wound, because scarring is the body’s natural way of healing.

They therefor conducted an experimental study that involved treating contact burn injuries in rats during five therapy sessions over a six month peri-

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od, with varying treatment parameters assessed in order to optimize the treatment protocol. Scar surface area and structural properties of the scar were assessed with histology and with non-invasive, longitudinal imaging using polarization-sensitive optical coherence tomography (OCT).

The results showed that pIRE using 200 pulses of 250 Volts and 70 s duration, delivered at 3 Hz every 20 days during a total of five therapy sessions resulted in a 57.9% reduction of the scar area, compared with untreated scars, resulting in structural features approaching those of normal skin. The researchers cautioned, however, that unlike humans, rats do not develop hypertrophic scars, and that the use of a rat animal model is thus a limiting factor for future research. The study was published on July 5, 2016, in the Journal of Investigative Dermatology.

“Surgical excision, laser therapy, electron-beam irradiation, mechanical compression dressing, sili-

cone sheet application and other techniques have been tested to treat scars over the years,” said lead author Alexander Golberg, PhD, of the TAU Center for Engineering in Medicine. “But there have been only modest improvements in the healing outcomes among all these treatments. We believe that the technology we developed, called partial irreversible electroporation, can be used to prevent debilitating burn scars from forming.”

Hypertrophic scars are characterized by deposits of excessive amounts of collagen, which gives rise to a raised scar. They generally develop after thermal or traumatic injury that involves the deeper layers of the dermis and express high levels of TGF- .

Hypertrophic scars are red and thick and may be itchy or painful. While they do not extend beyond the boundary of the original wound, they can continue to thicken for up to six months, and often contain nerves and blood vessels.

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Critical Care

Electric Forehead Patch Could Help Treat PTSD n unobtrusive patch on the forehead that induces trigeminal nerve stimulation (TNS) could provide relief from chronic post-traumatic stress disorder (PTSD), according to a new study.

Researchers the University of California Los Angeles (UCLA; USA; www.ucla.edu) conducted a study in 12 adults (average age 52.8, eight females) with PTSD and comorbid unipolar major depressive disorder (MDD) to study TNS therapy for these commonly co-occurring conditions. The eight-week outpatient trial involved stimulation to cranial nerves for eight hours each night as an adjunct to pharmacotherapy via an external TNS (eTNS) patch placed on the user’s forehead and powered using the NeuroSigma (Los Angeles, CA, USA; www.neurosigma.com) TNS stimulator.

While the person sleeps, the NeuroSigma powered patch sends a low-level electrical current to the supraorbital and supratrochlear nerves that run through the forehead, branches of trigeminal nerve that conducts the signals to areas of the brain that help to regulate mood, behavior, and cognition. These include the amygdala, the medial prefrontal cortex, and the autonomic nervous system. Changes in the participant’s symptoms were monitored using the PTSD Patient Checklist (PCL), as well as three other questionnaires.

The results showed significant improvements in PTSD and depression severity, with eTNS associated with an average drop of more than 30% in symptoms, and with the severity of their depression dropping by an average of more than 50%. In fact, for one-quarter of the study subjects, PTSD symptoms went into remission. In addition, study subjects generally said they felt more able to participate in their daily activities, and reported that the treatment itself was well tolerated, with few emergent adverse events. The study was published on January 28, 2016, in Neuromodulation.

“Most patients with PTSD do get some benefit from existing treatments, but the great majority still have symptoms and suffer for years from those symptoms,” said senior author Professor of Psychiatry Andrew Leuchter, MD, director of the neuromodulation division at UCLA. “This could be a breakthrough for patients who have not been helped adequately by existing treatments.”

“PTSD is one of the invisible wounds of war. The chance to have an impact on debilitating diseases with this elegant and simple technology is very satisfying,” said lead author Ian Cook, MD. “The scars are inside but they can be just as debilitating as visible scars. So it’s tremendous to be working on a contribution that could improve the lives of so many brave and courageous people who have made sacrifices for the good of our country.”

Neuroanatomical projections of the trigeminal system suggest that eTNS may alter activity in structures regulating mood, anxiety, and sleep. It is currently being tested as an emerging therapy for epilepsy and depression, with preliminary studies suggesting it has an excellent safety profile and is associated with significant improvements in seizures and mood.

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Image: PTSD sufferer Ron Ramirez wearing the patch (Photo courtesy of Reed Hutchinson/ UCLA).

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PRODUCT NEWS SYRINGE VALIDATOR

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PORTABLE DEFIBRILLATOR

VITAL SIGNS MONITOR

Hans Rudolph

Primedic

Infinium Medical

The Syringe Volumetric Validator is designed to check the displacement volume of calibration syringes used in testing, and checking respiratory spirometers and pulmonary function testing devices. The Validator also stores test data, and provides a report showing the test results.

The HeartSave AS delivers an electric shock preceded by an audible warning if it detects lifethreatening fibrillation eliminating the need to press the shock button. Its easy-to-understand voice feature prompts and guides first aid personnel step-by-step through the rescue procedure.

The CLEO measures pulse oximetry, pulse, NIV blood pressure and oral temperature, and features a touch screen display. It operates by a rechargeable lithium battery or AC power, making it well suited for both continuous bedside monitoring and spot check monitoring.

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Home PT/ INR Device Enables Remote Care of Anticoagulated Patients novel Bluetooth-enabled home health device helps healthcare providers (HCPs) have greater control over their patient’s coagulation status and Vitamin K Antagonist (VKA) therapy.

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The CoaguChek INRange system requires just a single drop of blood from a lancet prick. Within 60 seconds, prothrombin time (PT), along with its derived measures of prothrombin ratio (PR) and international

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normalized ratio (INR), are presented on the color display. The device also provides on screen trend report functionality, providing both patients and their HCP with an overview of the stability of their INR anticoagulation levels and time in therapeutic range (TTR).

The results and trend reports are clearly displayed in colorcoded results and graphs, with up to six patient comments available. The built-in Bluetooth wireless technology transmits the results from the meter to the HCPs, allowing them to keep patients on track and in range, anytime, anywhere. The CoaguChek INRange meter, a product of Roche (Basel, Switzerland; www. oche.com), is supplied with the proprietary CoaguChek Softclix lancing device (for single patient use only), and a set of 10 lancets.

“As healthcare systems face continued pressure to deliver improved access to care at a lower cost, increased connectivity between HCPs and patients becomes even more important,” said Roland Diggelmann, COO of Roche. “This innovative technology continues the CoaguChek legacy of setting the standard in coagulation monitoring by providing high quality, convenient care, while optimizing outcomes for patients. This is another proof point towards our aim to position patient self-testing as the standard of care to monitor VKA therapy.”

“In a clinical environment, we need to establish a model of care that empowers patients, helping them to understand their health condition and allowing them to take responsi-

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bility of their own health care needs,” said Juan Carlos Souto, MD, of Hospital de Sant Pau (Barcelona, Spain).

“The new technology will enable us to access the test results in the clinic’s database, to keep track of the individual patient’s status and to measure the quality of care provided by our clinic.”

Vitamin K antagonists modify blood clotting by reducing the action of vitamin K. They are used as anticoagulants for the prevention of thrombosis, and in pest control, as rodenticides. They work by depleting the active form of the vitamin by inhibiting vitamin K epoxide reductase, recycling inactive vitamin K epoxide back to the active reduced form of vitamin K. Vitamin K is required for the carboxylation of specific glutamic acid residues on prothrombin, which are needed to produce the fibrin monomers that are polymerized to form blood clots.

Image: The CoaguChek INRange system (Photo courtesy of Roche Diagnostics).

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Critical Care

Root Cause of Thyroid Cancer Epidemic Due to Overdiagnosis new study concludes that the growing epidemic of thyroid cancer reported in several high-income countries is largely due to overdiagnosis. Researchers at the International Agency for Research on Cancer (IARC, Lyon, France; www.iarc.fr) and the Aviano National Cancer Institute (CRO; Italy; www.cro.it) used highquality cancer registry data to estimate the number of overdiagnosed cases of thyroid cancer in 12 countries (Australia, Denmark, England, Finland, France, Italy, Japan, Norway, Republic of Korea, Scotland, Sweden, and the USA). In all, they estimated that more than 470,000 women and 90,000 men may have been overdiagnosed with thyroid cancer during the last two decades.

The estimated fraction of overdiagnosis cases in women was 70-80% in Australia, France, Italy, and the USA, approximately 50% in Japan, the Nordic countries, England, and Scotland, and approximately 90% in South Korea. In men, the incidences reported were similar but less pronounced, with an estimated overdiagnosis of approximately 70% in France, Italy, and the Republic of Korea, 45% in Australia and the USA, and less than 25% in all other countries exam-

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ined. The study was published on August 18, 2016, in The New England Journal of Medicine.

“Countries such as the USA, Italy, and France have been most severely affected by overdiagnosis of thyroid cancer since the 1980’s, after the introduction of ultrasonography, but the most recent and striking example is the Republic of Korea,” said lead author Salvatore Vaccarella, PhD, of the IARC. “A few years after ultrasonography of the thyroid gland started being widely offered in the framework of a population-based multi-cancer screening, thyroid cancer has become the most commonly diagnosed cancer in women in the Republic of Korea.”

Increasing medical surveillance and new diagnostic techniques, such as neck ultrasonography, computed tomography (CT) scanning, and magnetic resonance imaging (MRI), have led to the detec-

tion of a large number of indolent, non-lethal diseases that exist in abundance in the thyroid gland of healthy people of any age. Most of these tumors are very unlikely to cause symptoms or death during the lifetime of the patient.

Image: An ultrasound scan of the thyroid (Photo courtesy of ShutterStock).

Ring-Shaped Pump Supports Weakened Hearts n innovative cardiac support system uses peristaltic motion to help the heart pump and transport blood. Developed by researchers at Ecole Polytechnique Fédérale de Lausanne (EPFL; Switzerland; www.epfl.ch), the miniature pump is made of three tiny rings placed around the aorta at the exact spot where it exits the left ventricle. The rings are made of a dielectric electro active polymer (DEAP) with special electrical properties.

Each ring has two electrodes that are drawn together by an electrostatic force whenever the electric pulse, provided by magnetic induction, is activated.

Each of the three rings contracts in sequence, in a movement reminiscent of an earthworm. The series of contractions, called peristalsis, creates a wave that moves the blood inside the artery. The double action, both vertical and horizontal, occurs simultaneously and immediately, creating a back-and-forth movement that can be controlled in real time. And since the pump ring does not come into direct contact with the blood, it avoids problems of hemolysis and the subsequent need for regular blood transfusions to replenish the damaged red blood cells (RBCs).

“This method does not require us to enter the heart; this means it is significantly less invasive than other cardiac support systems, which work by implanting valves or screw pumps inside the ventricle,” said Yves Perriard, director of the EPFL Integrated Actuators Laboratory (LAI).

The DEAP peristaltic pump is currently in prototype stage. The researchers plan to improve the device’s performance before testing it on a liquid with similar fluidic properties to those of the blood, such as glycerol. The researchers are also in contact with the University Hospital of Bern (Switzerland), where clinical trials could be conducted.

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PRODUCT NEWS TRANSPORT MONITOR

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EEG MONITOR

ECG SYSTEM

Comen Medical

Compumedics

Infinium Medical

The C30 features a waterproof, shockproof and fireproof body, an anti-scratch high-luminance LCD screen and Linux operating system. It comes with lithium batteries and weighs 1.2kg, making it ideal for monitoring during rescue, emergency treatment, first aid and ambulance transportation.

The Grael HD-EEG system blends digital amplifier technology with recording, trending, and reviewing software for improved efficiency and productivity. It is network-linked, supports secure remote access, and is built on a small footprint cart system.

The QRS-12 allows displayed patient information and vital sign settings to be quickly modified in order to meet the needs of changing conditions.

Featuring a high-resolution, 7-inch touch screen and alphanumeric keypad, it offers multiple print and data transfer options.

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Leadless Pacemaker Offers New Option for Bradycardia he world’s smallest pacemaker is placed directly on the heart to stimulate a normal heart rhythm, and does not require the use of leads.

The miniaturized Micra transcatheter pacing system (TPS) is de-

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livered via a percutaneous catheter to the inside wall of the right ventricle, with small nitinol tines used to hold the device and the electrodes in place. The device can be repeatedly repositioned in the ventricle to make sure heart activity and low electrical

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thresholds are optimal.

Once in position, the device responds to patients’ activity levels by automatically adjusting electrical impulses to regulate heartbeats, in the same fashion as traditional single chamber pacemakers. The device consists of a bipolar pacing anode and a steroideluting cathode that is separated from the tines to provide optimal contact with the myocardium.

Less than one tenth the size of a conventional pacemaker, The Micra TPS does not require a surgical pocket under the skin or future extraction once the battery is depleted, eliminating potential sources of complications. Despite its miniaturized size, the device has an estimated 12-year battery life, and is also approved for both 1.5 and 3 Tesla full body magnetic resonance imaging (MRI) scans.

The Micra TPS is a product of Medtronic (Dublin, Ireland; www. medtronic.com), and has been approved by the U.S. Food and Drug Administration (FDA).

“Dating back to the development of the first external battery operated pacemaker more than 60 years ago, Medtronic has a long history of collaborating with clinicians to better understand the needs of patients, and then innovating new products to meet those needs,” said John Liddicoat, MD, senior vice president of Medtronic. “We are thrilled to be the first to introduce a transcatheter pacemaker to patients in the U.S., and we’re looking forward to working with physicians and educating

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implanters to extend the positive results of our global clinical trial experience to even more patients.”

“For many years we’ve been hopeful that a transcatheter pacing solution, with a safety and effectiveness profile on par with conventional devices, would become available, and today Micra has achieved this milestone,” said Prof. Dwight Reynolds, MD, of the University of Oklahoma Health Sciences Center (Oklahoma City, USA), and principal investigator in the Micra TPS global clinical trial.

“In the clinical trial, the Micra was successfully implanted in nearly all patients, and met its safety and effectiveness endpoints by wide margins.

This gives us great confidence that this miniaturized device will bring patients the most advanced pacing technology, combined with the lessinvasive nature of the new technology.”

Image: The miniaturized Micra transcatheter pacing system (Photo courtesy of Medtronic).

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Medication Automation Solution Streamlines Patient Care utomated medication dispensing cabinets enable nurses to queue up medication orders at the patients’ bedside, instead of waiting in line at the cabinet.

The Omnicell G4 Unity automated dispensing cabinet (ADC) provides high capacity storage to accommodate oral tablets and capsules, ampules, vials, oral solutions, bulk stock, and other medications, in a wide array of drawer styles to meet patient care needs. Medications and supplies can be combined in a single cabinet, adding convenience and saving space. The cabinets are also fitted with single-dose dispensing system, which improves security and reduces the need for manual narcotic count-backs.

The Omnicell ADC is linked via a shared database with the controlled substance manager and other solutions on the proprietary Unity integrated platform, which allows a more automated chain of custody, providing greater visibility and helping to reduce time spent resolving discrepancies. The specialized cabinets are expected to enhance the secu-

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rity and eliminate drug diversion risk, which is considered important in an area, which deals with powerful narcotics.

Other features of the ADC cabinet include a large, high resolution display that is easy to see and read; guiding lights technology to quickly direct the user to the desired location in the cabinet; an advanced biometric ID system to provide fast yet secure access; an integrated online medication reference library; dispensing alerts that provide additional safety checks; and a bar code scanner for enhanced safety and efficiency. The Omnicell ADC is a product of Omnicell (Mountain View, CA, USA; www.omnicell.com).

Image: The Omnicell G4 Unity automated dispensing cabinet (Photo courtesy of Omnicell).

Patient-Level Model Predicts In-Hospital Cardiac Mortality esearchers at Yale University School of Medicine (Yale; New Haven, CT, USA; www.medicine.yale.edu), Duke University (Durham, NC, USA; www.duke.edu), and other institutions reviewed patient admittance characteristics in the Acute Coronary Treatment and Intervention Outcomes Network (ACTION) registry database from January 2012 through December 2013, in order to develop a multivariate hierarchical logistic regression model to predict in-hospital mortality.

The study population, which included 243,440 patients from 655 hospitals, was divided into a 60% sample for model derivation, with the remaining 40% used for model validation.

The researchers found that in-hospital mortality was 4.6%, with independent associations for age, heart rate, systolic blood pressure, presentation after cardiac arrest, cardiogenic shock, and heart failure, presentation with ST-segment elevation myocardial infarction (STEMI), creatinine clearance, and troponin ratio. Upon model validation, the researchers found that it performed well in subgroups based on age, sex, race, transfer status, and presence of diabetes mellitus, renal dysfunction, cardiac arrest, cardiogenic shock, and STEMI. The study was published in the August 9, 2016, issue of the Journal of the American College of Cardiology (JACC).

MI occurs following an ischemia that causes damage to heart muscle. The most common symptom is chest pain or discomfort, which may travel into the shoulder, arm, back, neck, or jaw. Other symptoms may include shortness of breath, nausea, feeling faint, a cold sweat, or fatigue. Most MIs occur as a result of coronary artery disease (CAD), with risk factors including high blood pressure, smoking, diabetes, lack of exercise, obesity, high blood cholesterol, poor diet, and excessive alcohol intake.

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Critical Care

PRODUCT NEWS WEARABLE MONITOR

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ECG SYSTEM

PULSE OXIMETER

Masimo

SonoScape

Charmcare

The Radius-7 is designed to allow patient mobility along with continuous monitoring of SpO2, pulse rate, and respiration rate. It offers parameter and waveform views for on-the-spot assessment of patient status, configurable display shut-off for minimizing patient distraction, and 12-hour battery life.

The IE12 is uses an acquisition box to filter noise generated by the human body before transforming to increase the signal-to-noise ratio. It displays the ECG and patient data on an LCD touch screen and can be used with adults, children, and newborns in hospitals, clinics, and ambulances.

The ACCURO II pulse oximeter features a 4.3-inch color TFT LCD screen, and uses the latest RT-SAT patented technology for enhanced SpO2 measuring. It provides a connection lock for safer operator use, and can be used as a desktop or a handheld device.

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Painless Microneedle System Helps Monitor Drug Levels novel microneedle monitoring system measures drug levels in the skin, without the need for drawing blood for analysis.

Developed by researchers at the University of British Columbia (UBC, Vancouver, Canada; www.ubc.ca) and the Paul Scherrer Institut (PSI; Villigen, Switzerland; www.psi.ch), the new system consists of a small patch pressed against a patient’s arm for therapeutic drug monitoring (TDM) during medical treatment. The patch contains an integrated, hollow microneedle-optofluidic biosensor with needle-like projections less than half a millimeter long, which extract extremely small volumes – less than one nanoliter – of interstitial fluid (ISF).

The inner lumen of the microneedle is functionalized to be used as a micro-reactor during sample collection, trapping and binding target drug candidates during extraction, without the requirement of a sample transfer. An optofluidic device is integrated with-

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in the microneedle to rapidly quantify drug analytes with high sensitivity, using a straightforward absorbance scheme. In a clinical study, the antibiotic vancomycin was detected using ISF volumes that ranged between 50–100 L. The study was published on July 6, 2106, in Scientific Reports.

“The microneedles resemble hollow cones and are less than half a millimeter in length; they are designed to puncture only the outer layer of skin, which acts as a protective barrier, but not the epidermis or dermis, which comprise nerves, blood vessels, and active immune cells,” said senior author Victor Cadarso, PhD, of PSI. “The combination of knowhow from UBC and PSI, bringing together microneedles, microfluidics, optics, and biotechnology, allowed us to create a device capable of both collecting the fluid and performing the analysis.”

ISF surrounds all tissue cells. It is advantageous in biosensing applications, since it does not contain

any particulates such as red blood cells or platelets, and contains at least 5–10 times less protein than blood serum. But only extremely low volumes are found in human skin, making the process of ISF extraction rather difficult.

Image: The microneedle-optofluidic biosensor drug monitoring system (Photo courtesy of UBC).

New Blood Test Predicts Sepsis in Burn Patients new study suggests that measuring three biomarkers of neutrophil function could help determine which burn victims are likely to develop sepsis during their treatment.

Researchers at the University of Birmingham (UB; United Kingdom; www.birmingham.ac.uk) and Queen Elizabeth Hospital Birmingham (QEHB; United Kingdom; www.uhb.nhs.uk), conducted a study in 62 patients admitted to the QEHB Burns Centre with 39% burns (on average), who were recruited within 24 hours of their injury. The researchers measured peripheral blood neutrophil function and biomarkers of neutrophil phagocytosis, oxidative burst capacity, and neutrophil extracellular trap (NET). The patients where then monitored in the weeks following for development of sepsis.

In addition, three potential biomarkers of sepsis were tracked – immature granulocyte (IG) count, plasma citrullinated histone H3 (Cit H3), and plasma cell-free DNA (cfDNA). The researchers found

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that neutrophil function was reduced in a greater degree in patients who developed sepsis, which was also characterized by elevated IG, Plasma cfDNA, and Cit-H3 during septic episodes. The researchers concluded that measurement of the three markers at the first post-injury day gave good discriminatory power for the identifying potentially septic patients. The study was published on May 26, 2016, in Annals of Surgery.

“The researchers have shown that burn patients who may suffer life threatening systemic infections, which occur in 30% of major burns at around day six following their injury, could be identified with a 98.6% certainty,” said study co-author Mr Naiem Moiemen, burns and plastics consultant at QEHB. “Burn patients who suffer systemic infection have a high probability of non-surviving their injury. This discovery will enable the clinicians to stratify the care of these patients and improve their outcomes.”

“Major burn injuries result in a systemic inflam-

matory response syndrome (SIRS) and reduced immune function, which increases the risk of patients developing sepsis or infections in hospitals. Administration of antibiotics within three hours after sepsis recognition is recommended, but only when positive blood cultures are present,” said senior author Prof. Janet Lord, PhD, director of the UB institute of inflammation and ageing. “However, the majority of clinical studies report negative cultures in as many as 40% of severe sepsis patients, so many cases will be missed. As such, the identification of novel, accurate biomarkers is crucial.”

Neutrophils are the most abundant (40-75 %) type of white blood cells (WBCs) in mammals, and form an essential part of the innate immune system.

Normally found in the bloodstream, they are shortlived and highly motile, recruited to the site of an injury by chemotaxis within minutes following trauma. They are also the predominant cells in pus, accounting for its whitish/yellowish appearance.

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Critical Care

Warfarin Use Can Increase Dementia Risk in AF Patients new study shows that atrial fibrillation (AF) patients treated over a long period of time with Warfarin experience higher rates of dementia than their counterparts.

Researchers at Intermountain Medical Center (IMC; Salt Lake City, UT, USA; https://intermountainhealthcare. org) enrolled 10,537 patients with no prior history of dementia who were treated with warfarin for both AF and other, non-AF conditions (such as valvular heart disease and thromboembolism) on a long-term basis. The researchers also examined other variables, such as age, hypertension, diabetes, hyperlipidemia, renal failure, smoking history, prior myocardial infarction (MI) or cerebral vascular accident, and heart failure. Participants were aged 18 years and older.

The results showed that during a follow-up of approximately seven years, dementia was more prevalent in

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the AF group (5.8%) than the non-AF group (1.6%). In both groups the risk of dementia increased as time in therapeutic range decreased, or became erratic; when warfarin levels were consistently too high or too low, dementia rates increased. Regardless of the adequacy of anticoagulation, the AF patients consistently experienced higher rates of all forms of dementia.

The study was presented at the 37th annual scientific sessions of the Heart Rhythm Society, held during May 2016 in San Francisco (CA, USA).

“As physicians we have to understand that although we need to use anticoagulants for many reasons, including to prevent stroke in AF patients, at that same time there are risks that need to be considered, some of which we are only right now beginning to understand,” said lead author T. Jared Bunch, MD, director of heart rhythm research at IMC. “In

Single-Wavelength UV Light Reduces Surgical Site Infections new study suggests that ultraviolet (UV) light in the farUVC 207 nm wavelength kills bacteria without apparent harm to human skin tissue.

Researchers at Columbia University Medical Center (CUMC; New York, NY, USA; www.cumc.columbia.edu) conducted a study in hairless mice to test the hypothesis that 207 nm UVC light is not cytotoxic to exposed mammalian skin. The mice were exposed to a fluence of 157 mJ/cm2 of UVC, delivered by a krypton-bromine (Kr-Br) excimer lamp that produces high-intensity light at 207 nm. Similar mice were exposed to a conventional 254-nm UV germicidal lamp. Study controls involved mice unexposed to UVC light.

The researchers characterized eight relevant cellular and molecular damage endpoints, including epidermal hyperplasia, pre-mutagenic DNA lesions, skin inflammation, and normal cell proliferation and differentiation. The results showed that while conventional 254 nm germicidal UV exposure produced significant effects for all the studied skin damage endpoints, the same fluence delivered by 207 nm UVC light produced results that were not statistically distinguishable from zero exposure controls. The study was published on June 8, 2016, in PLOS One. “The mechanistic background is that far UVC light in the wavelength

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Image: Warfarin may increase the risk of dementia in certain populations (Photo courtesy of Fotolia).

this regard, only those that absolutely need blood thinners should be placed on them long-term. In people that are on warfarin in which the levels are erratic or difficult to control, switching to newer agents that are more predictable may lower risk.”

Warfarin decrease blood coagulation by inhibiting vitamin K epoxide reductase, an enzyme that recycles oxidized vitamin K to its reduced form after it has participated in the

carboxylation of several blood coagulation proteins, mainly prothrombin and factor VII. It was initially introduced in 1948 as a pesticide against rats and mice and is still popular for this purpose. In the early 1950’s warfarin was found to be effective and relatively safe for preventing thrombosis and embolism in many disorders. It is the most widely prescribed oral anticoagulant drug in North America.

range of around 200 to 220 nm is strongly absorbed by essentially all proteins, and so its ability to penetrate biological material is very limited,” concluded lead author Manuela Buonanno, PhD, of the CUMC Center for Radiological Research (CRR). “The very short half value distance of 207 nm UV light in biological material means that, while it can penetrate bacteria and viruses that are typically smaller than 1 m in size, it cannot penetrate the human stratum corneum, nor the ocular cornea, nor the cytoplasm of individual human cells.”

“We’ve known for a long time that UV light has the potential to reduce surgical site infections, because UV can efficiently kill all bacteria, including drug-resistant bacteria and even so-called superbugs,” added senior author Prof. David Brenner, PhD, director of the CRR. “Unfortunately, it’s not possible to use conventional germicidal UV light when people are around, because it’s a health hazard to patients and medical personnel.”

SSIs is most frequent healthcareassociated infection (HAI) after asymptomatic bacteriuria, representing a high burden on patients and hospitals in terms of morbidity, mortality, prolonged length of hospital stay, and additional costs. Each year, approximately 500,000 surgical patients develop SSIs. LINKXPRESS COM

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The Dual Tier desk enables the user to arrange monitors to maximize visibility and reach advantages. The independent electronic height adjustment capabilities of each surface allow the user to change the height of the equipment within seconds at the touch of a button.

The MR1510 fixed-height trolley features a patient weight capacity 220 kilos (490 lb), and a backrest adjustable to 85 degrees. Other benefits include four 150mm lockable castors, front/rear handlebars, and available IV pole, oxygen cylinder holder, and patient restraining straps.

The OsCare Sono provides a reliable and cost-effective means for osteoporosis screening. It measures the speed of low frequency ultrasound in the forearm using many ultrasonic heads. The speed correlates with bone porosity, thickness, and elasticity providing information on bone strength.

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Hand & Wrist MRI System Gets Market Approval cont’d from cover

Image: The WristView MRI system (Photo courtesy of Aspect Imaging).

Smallest Mobile PET/CT System Introduced iemens Healthineers (Erlangen, Germany; www.healthcare.siemens.com) has introduced a mobile configuration of the Biograph Horizon positron emission tomography/computed tomography (PET/CT) system, which delivers high-end functionality at an attractive total cost of ownership.

The mobile-ready version of the Biograph Horizon is intended for cost-conscious healthcare facilities that do not yet possess the patient volume to support installation of a fixed PET/CT, and is also suitable for consolidated health systems looking to tailor their imaging delivery strategy in diverse service areas, with clinical indications in oncology, neurology, and cardiology. With the addition of the mobile version of the Biograph Horizon, the entire line of Biograph PET/CT systems from Siemens Healthineers is now available in both mobile and fixed configurations.

The system’s 4 mm lutetium orthosilicate (LSO) crystals scintillate faster and boast a higher light

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The WristView imaging was developed by Aspect Imaging (Tel Aviv, Israel; www. aspectimaging.com). The company designs and develops compact MR imaging and Nuclear Magnetic Resonance (NMR) systems for preclinical and medical applications.

WristView does not require cooling systems, or a special shielding room, costs less, and requires less training than a full-body MRI scanner. WristView uses a 1-T permanent magnet, and is optimized for hand and wrist applications, in terms of its design and bore size. The system requires very little maintenance, and has an extremely low-level external magnetic field, allowing it to be used anywhere in a hospital or research center. The CE Mark now enables the company to sell the scanner in Australia, New Zealand, Eastern Europe, and some Asian countries.

Founder and CEO of Aspect Imaging, Uri Rapoport, said, “We are thrilled to bring our MR imaging solutions to a wider international audience. Europe makes up a large percentage of the global market for this product in particular, and we’re extremely excited to now have the ability to introduce our system there. We encourage all people suffering from rheumatoid arthritis and carpal tunnel syndrome to demand that their condition be diagnosed with MRI.”

Image: The Biograph Horizon PET/CT (Photo courtesy of Siemens Healthineers).

output than commonly used bismuth germanate oxide (BGO) crystals, yielding high image resolution and better image quality, thus enabling physicians to visualize small lesions earlier and contributing to a more accurate disease staging and a more accurate evaluation of therapy response. The system also enables Time-of-Flight (ToF) acquisition and offers built-in capabilities to automate routine tasks in order to increase productivity and streamline workflows.

The Biograph Horizon utilizes the new iteration of the Siemens Healthineers syngo.via molecular imaging workplace image processing solution, which offers – for the first time – single photon emission computed tomography (SPECT).

The new iteration offers four new features; for SPECT, organ processing for nuclear medicine helps physicians visualize and quantify the physi-

ological characteristics of organs such as the lungs, kidneys, and stomach; For PET, tMolecular Tumor Volume (MTV) and Total Lesion Glycolysis (TLG) features enable physicians to measure the standardized metabolic activity of the entire tumor mass; and hybrid gating four-dimensional (4D) visualization of PET and CT supports therapy planning and delivery.

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Mobile System Combines OCT Imaging with Angiography new diagnostic system couples state-of-the-art optical coherence tomography (OCT) and angiography co-registration into one portable system for hospitals with multiple catheterization labs. The OPTIS Mobile System uses the combination technology to help physicians make improved stenting decisions based on high-resolution and three-dimensional (3D) OCT views of coronary anatomy, while simultaneously mapping their exact location via an angiogram. By using OCT technology, the system provides anatomical images of disease morphology and automated measurements that help physicians to visualize and measure important vessel characteristics that are otherwise not visible or difficult to assess with older imaging technology.

As a result, the automated, highly accurate measurements can guide stent selection, deployment, and placement ensuring successful procedures, and helping to minimize repeat revascularizations. The system also integrates proprietary fractional flow reserve (FFR) technology to offer detailed coronary hemodynamic circulatory information during percutaneous coronary intervention (PCI). The OPTIS Mobile System is a product of St. Jude Medical (SJM; St. Paul, MN, USA; www.sjm.com), and has been approved for sale in Europe and Japan.

“The OPTIS Mobile System represents the ongoing commitment of St. Jude Medical to develop products that provide physicians with more options for improved OCT and angiography co-registration guidance in their daily practice,” said Eric Fain, MD, Group President of St. Jude Medical. “In contrast with intravascular ultrasound, OCT offers increased resolution and highly-detailed intracoronary arterial views, which can improve PCI procedures, especially in complex cases.”

“As the interventional cardiology landscape continues to expand, there is a real need for more portable intravascular imaging systems to ensure hospitals with multiple catheterization labs have the right technology available for physicians to make more informed treatment decisions during PCI,” said Nick West, MD, of Papworth Hospital (Cambridge, United Kingdom). “The imaging advancements offered with the OPTIS Mobile System provide the same benefits of the OPTIS Integrated System, and allow physicians to clearly visualize complex cardiac anatomy and evaluate how to best proceed during PCI.” FFR is a physiological index used to determine the hemodynamic severity of atherosclerotic narrowing of the coronary arteries, and is measured using proprietary SJM PressureWire Aeris and Certus systems.

FFR specifically identifies which coronary narrowing is responsible for the ischemic obstruction of the flow of blood to a patient’s heart muscle and helps guide the interventional cardiologist in determining which lesions warrant stenting, resulting in improved patient outcomes and reduced health care costs.

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Image: The OPTIS mobile imaging system (Photo courtesy of St. Jude Medical) V

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Medical Imaging

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MRI Helps Identify High-Risk Heart Disease Patients new study concludes that magnetic resonance imaging (MRI) scans are the safest and most effective way to identify patients with suspected coronary heart disease (CHD).

Researchers at the University of Leeds (United Kingdom; www.leeds. ac.uk) conducted a study involving 752 patients being investigated for suspected CHD to establish the ability of cardiovascular magnetic resonance (CMR) and single-photon emission computed tomography (SPECT) to predict major adverse cardiovascular events (MACEs), which include cardiovascular death, acute coronary syndrome, unscheduled revascularization, or hospital admission for cardiovascular cause. The patients were followed for a minimum of five years.

The results showed that 99% of the recruited patients had complete follow-up. Of 628 patients who underwent CMR, SPECT, and a standard X-ray angiography, 16.6% had at least one MACE. The researchers

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found that abnormal findings on CMR and SPECT were both strong and independent predictors of MACE, but after adjustment, only CMR remained a significant predictor for MACE. The study was published on May 10, 2016, in Annals of Internal Medicine.

“The benefits of cardiac MRI are not limited to reducing exposure to ionizing radiation. The non-invasive cardiac MRI test, which is not only more diagnostically accurate and cost effective for the NHS than SPECT, is also potentially better at forecasting the outcome of the disease,” said lead author Prof. John Greenwood, MB ChB, PhD. “Although SPECT is currently more widely available than MRI, the use of MRI across a wide spectrum of diseases means that it will be much

more readily available for heart disease investigation in coming years.”

“This research shows that MRI is the best non-invasive way to diagnose significant coronary heart disease in people with chest pain,” commented Prof. Peter Weissberg, MD, medical director at the British Heart Foundation (Birmingham, United Kingdom; www.bhf.org.uk). “Having an MRI

scan does not involve radiation and the scanners are already widely available in heart centers across the UK, which should aid its rapid adoption in UK diagnostic guidelines.”

Image: The results of MRI scans are expected to inform future clinical guidelines for heart disease (Photo courtesy of the University of Leeds).

Longer Breath-Holds Allow Targeted Radiotherapy in a Single Session esearchers in the UK have demonstrated that by training breast cancer patients to hold their breath for over five minutes, targeted radiotherapy can be administered in one single dose in a daily session.

It takes two minutes to deliver a typical shaped radiation beam that is used to treat cancerous tumors. Currently most radiotherapy treatments are delivered while patients are breathing and their chests are moving, increasing the risk of damage to healthy tissues surrounding the tumor.

The research was carried out by clinical teams from the University of Birmingham (Birmingham, UK; www.birmingham.ac.uk) and the UK National Health Service (NHS) Foundation Trust, and published in the May 2016, issue of the British Journal of Radiology.

The trial included 15 patients all of whom were undergoing radiotherapy. Thirteen of the patients also underwent chemotherapy, and two patients were taking Herceptin. The patients were trained how to maintain a relaxed posture, practice inhaling and exhaling to maximum effect, and nat-

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urally raise blood oxygen levels, and reduce blood carbon dioxide levels, using mechanically induced hypocapnia, and pre-oxygenation techniques.

The training enabled the patients to hold their breath for 5.3 minutes on average. According to the researchers assisting patients to achieve a single breath-hold could significantly improve long-term survival, and improve the quality of life of patients with breast cancer.

Dr Mike Parkes, from the University of Birmingham, said, “The physiology of breath holding is well understood on the whole, but has been somewhat overlooked in medical research because until now it hadn’t any obvious clinical application. Following on from our preliminary work on healthy subjects, we wanted to see if we could help patients with breast cancer to achieve a breath hold of over two minutes to allow a radiotherapy treatment to be delivered in a single breath-hold. Being able to hit the cancerous tumor accurately is essential to avoid damage to other areas, including the heart muscle. Having a stable chest that we can target in one dose could be invaluable in protecting the surrounding tissue.”

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The Discovery NM/CT 670 CZT is equipped with a new digital detector that uses cadmium zinc telluride (CZT) technology for converting photons into digital signals. It offers a contrast-to-noise ratio and spatial resolution of 2.5 mm, and allows for exams of specific organs or the whole-body.

The DRX Plus 4343 DXR detectors are available in gadolinium (GOS) scintillators for general radiology and cesium (CsI) scintillators for pediatric and dose-sensitive applications. They are suited for chest x-rays, extremity exams, and general studies, and can be used for bariatric patients.

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Next-Generation Echocardiography Features Advanced Reporting Modules next-generation cardiology image management and reporting solution offers new echocardiography module enhancements.

The redesigned reporting modules were designed according to American

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Society of Echocardiography (ASE) standards, and showcased at the annual ASE Annual Scientific Sessions, June 2016, in Seattle, Washington, USA. The Synapse Cardiovascular cardiology image management and report-

ing solution was developed by FUJIFILM Medical Systems (Stamford, CT, USA; www.fujifilmusa.com). The company is promoting integration of ultrasound solutions, such as the SonoSite iViz, with medical Internet Technology (IT). The iViz is the first such system on the market that can accept patient demographics from and send reports too an Electronic Medical Record (EMR) using the FUJIFILM Synapse EMR gateway.

Updates to the Synapse Cardiovascular solution include an enhanced workflow, image review, cardiology reporting, and redesigned Echocardiography Advanced Reporting (EAR) mod-

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ules. Additional features include autosummary statements, configurable macros, Z-scores, an updated measurement package, and data trending. The modules were redesigned using ASE standards for adult, pediatric, fetal, and stress studies.

Bill Lacy, VP, Medical Informatics, FUJIFILM Medical Systems U.S.A, said, “Recent research shows that from 2001 to 2011, approximately 7,669,000 echos were performed nationwide on hospital inpatients alone, representing an average annual rate of increase of echocardiography of 3.41%. With Synapse Cardiovascular, clinicians and sonographers can expect a streamlined and efficient clinical experience – leaving them more time and energy to do what they do best, which is care for patients.”

Image: The Synapse Cardiovascular cardiology image management and reporting solution (Photo courtesy of Fujifilm Medical Systems).

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Medical Imaging

Brain Research Facility Set to Become Top Neuro-Imaging Research Center in Europe new brain research imaging center in Wales, UK, that will employ MRI systems to improve neurology and psychiatric treatments for the human brain, has been officially opened.

Researchers will use the new neuro-imaging research hub to try to find the causes of various neurological and psychiatric conditions, including dementia, multiple sclerosis, and schizophrenia, and also perform general brain research.

Researchers at the Cardiff University Brain Research Imaging Centre (CUBRIC; Cardiff, Wales, UK; http://sites.cardiff.ac.uk/cubric) will use four Siemens Healthineers (Erlangen, Germany; www. healthcare.siemens.com) Magnetic Resonance Imaging (MRI) systems to help find new insights into the structure, chemical composition, and function of living brain tissue. The research will include both imaging and cognitive techniques, including microstructural imaging, functional MRI (fMRI), and brain stimulation, and is expected to improve scientists’ understanding of neurological and psychiatric conditions.

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The MRI systems at the hub include Siemens’ Magnetom Skyra Connectom 3T1, the only system of this kind in Europe, a Magnetom 7T2 scanner with ultra-high spatial resolution and more than double the field strength of other MRI scanners, and two Magnetom Prisma 3T systems.

Prof. Derek Jones, Director of CUBRIC, comments, “The Cardiff University Brain Research Imaging Centre is unique in Europe and the equal of any facility of its kind in the world. This is the most exciting development in this field in the past decade and the start of a new era in neuro-imaging.

The technology will allow us to establish a much better picture of the make-up of the brain, includ-

ing detailed measurements of the fiber bundles that interconnect different parts of the brain. Ultimately we hope that this will help provide new targets for treatment.”

Image: The new Cardiff University Brain Research Imaging Centre is expected to become one of the top neuroimaging facilities in Europe (Photo courtesy of CUBRIC).

Structural MRI Can Help Predict Outcomes of Electroconvulsive Therapy esults from a non-randomized prospective study have shown that neuro-imaging techniques can be used to predict the therapeutic effectiveness of ElectroConvulsive Therapy (ECT) in individuals.

ECT therapy treatment involves intentionally triggering a short seizure in the brain using small electric currents, and is performed under general anesthesia.

The procedure can be used to treat certain mental illnesses, including acute major depressive disorder.

The research was published online in the May 4, 2016, issue of the journal JAMA Psychiatry. The goal of the researchers from the University of Muenster (Muenster, Germany; www.uni-muenster.de/en) was to find out whether structural Magnetic Resonance Imaging (MRI) could identify biomarkers that could accurately predict the response to ECT treatment.

In the study, the structure of grey matter of inpatients from Department of Psychiatry at the University of Muenster was assessed twice using a 3-T MRI scanner and voxel-based morphometry, at intervals of approximately 6 weeks. The study took place between March 11, 2010, and March 27, 2015. The patients included two groups with acute major depressive disorder, one of which received a series of ECT treatments and antidepressants (n = 24). The second group was treated with antidepressants (n = 23) alone. The researchers then compared both groups with a healthy control group (n = 21).

The researchers found that successful treatment with ECT therapy could be linked to a relatively small degree of structural impairment in the sub-genual cingulate cortex observed in neuroimaging before treatment.

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Metasurface Grid Boosts Sensitivity of MRI Machines new study claims that ultrathin metasurface resonators could reduce magnetic resonance imaging (MRI) scanning times by more than 50%.

Researchers at ITMO University (St. Petersburg, Russia; www.ifmo. ru), Australian National University (ANU; Canberra; www.anu.edu.au), and other institutions demonstrated that when a specially designed metasurface (formed by an array of metallic wires) is placed under an object inside a MRI scanner, a substantial enhancement of the radiofrequency (RF) magnetic field is achieved by means of subwavelength manipulation with the metasurface, increasing the signal-to-noise ratio in the scanned area.

The result of this increase is that either a higher resolution image can be obtained over the same time slot, or that a faster examination can be performed with the same resolution as in an ordinary MRI scanner. In addition, the metasurface suppresses the electric field responsible for tissue

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heating, a phenomenon has recently become even more relevant with the arrival of high-field and ultra-highfield MRI scanners that provide better image resolution, but also cause an increase in RF energy absorption.

The study describing the technology was published on January 11, 2016, in Advanced Materials.

“In the future we see even more potential in the concept of special smart clothing for MRI scanning; stripes of our metamaterial can be sewn in the clothes,” said lead author Alexey Slobozhanyuk, a PhD student from ITMO University at ANU. “The examination of patients, wearing such clothes, would lead to higher resolution MRI images, while the special design will enable a homogeneous enhancement of the signal-tonoise ratio, which does not pose any risk to the patients’ health.”

The metasurface solution does not require any intervention in the hardware of the MRI scanner, but rather represents an inexpensive functional add-on device that can be used with

any existing MRI scanner. The patent-pending technology is currently being co-developed by MediWise (London, United Kingdom; www. mediwise.co.uk), a company that specializes in commercializing metamaterials for medical applications.

“Metamaterials have been proven to add value through their ability to process electromagnetic and sound waves in ways that no natural material can do,” said George Palikaras, Founder and CEO of Mediwise. “The

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Image: An artist’s view of a biological object placed on a metasurface resonator (Photo courtesy of Advanced Materials).

Ultrasound Guidance Lowers Surgical Risks Following Mastectomy ltrasound guidance reduces the chances of causing a pneumothorax during thoracic paravertebral block (TPVB) for pain control following surgery for breast cancer, according to a new study.

Researchers at Massachusetts General Hospital (MGH; Boston, MA, USA; www.massgeneral.org) conducted a retrospective study involving 856 patients with a total of 1,427 TPVB injections between January 1, 2010, and December 3, 2013; all TPVB injections were placed for postoperative analgesia after unilateral or bilateral mastectomy with immediate breast reconstruction. Ultrasound guidance was used to perform TPVB, allowing visualization of the exact location of the thoracic spinal nerve roots.

Ultrasound guidance was used in addition to the conventional approach of using anatomical landmarks to guide the injection. The researchers then reviewed medical records for reports on accidental pleural puncture, symptomatic pneumothorax, hypotension, bradycardia, and other signs and symptoms of toxicity or effects of local anesthetic outside of the paravertebral space were reviewed. The results showed that there were only six complications that developed, representing a risk factor of 0.7%.

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The complications included symptomatic bradycardia and hypotension, a vasovagal episode, and evidence of possible local anesthetic toxicity. There was no incidence of suspected accidental pleural puncture or symptomatic pneumothorax identified in the study population. The researchers said that they hope their experience will encourage other hospitals to use their anesthesia technique to reduce the common and difficult-to-treat problem of chronic pain after mastectomy. The study was published on January 11, 2016, in Anesthesia & Analgesia.

“Pleural puncture resulting in pneumothorax is a serious complication associated with traditional approaches using guidance from anatomic landmarks and nerve stimulation, and may contribute to the low utilization of this block,” concluded senior author Peter Stefanovich, MD, and colleagues. “An ultrasound-guided technique has the potential to reduce complications by providing direct visualization of the paravertebral space during needle manipulation.”

TPVB involves injecting a small amount of local anesthetic around the thoracic nerve roots as they emerge from the spinal cord. This numbs the entire area of the chest, and provides excellent control of pain after breast cancer surgery.

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Medical Imaging

Functional Imaging Technique Measures Brain Resting State new study suggests that functional magnetic resonance imaging (fMRI) could be a cost-effective alternative for estimating relative levels of activity in a cerebral metabolic map.

Researchers at Western University (WU; London, Canada; www.uwo.ca) and the University Hospital of Liège (Belgium; www.chuliege.be) conducted a study to gauge the possibility of using fMRI instead of 18F-fluorodeoxyglucose positron emission tomography (FDG-PET) for generating the metabolic maps that are used to asses changes in brain activity in clinical applications, such as during the study of se-

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MR Techniques Find Link Between NAFLD and Heart Failure in Obese People he results of a new study published online in the journal Radiology, has found that fatty liver is independently associated with subclinical heart failure in people who are obese.

Non-Alcoholic Fatty Liver Disease (NAFLD) occurs when large droplets of fat are deposited in the liver (hepatic steatosis). The disease is related to insulin resistance, and includes risk factors such as obesity and diabetes. The disease is common in children in the United States and the Western World and can lead to hepatitis, cirrhosis, scars in liver tissue, and liver cancer. Up to 30% of the general population in the US suffer from NAFLD. The prevalence of NAFLD in obese people or people suffering from type 2 diabetes is between 70% to 90%. NAFLD is a manifestation of risk factors such as high blood pressure, unhealthy cholesterol levels, and excess abdominal fat that increase the risk of strokes, heart attacks, and diseases.

The researchers from the Leiden University Medical Center (LUMC; Leiden, The Netherlands; www.lumc.nl) studied 714 men and women aged between 45 and 65 years, 47% of which were classified as overweight, and 13% as obese. The researchers used proton Magnetic Resonance Spectroscopy (MRS) to measure hepatic triglyceride content, noninvasively, and cardiac Magnetic Resonance Imaging (MRI) to assess left ventricular diastolic function.

Lead author of the study, Ralph L. Widya, MD, said, “One of the unique aspects of our study is that we took all of the individual components of the metabolic syndrome into account as possible confounders in this association, as the metabolic syndrome is associated with NAFLD and with cardiovascular disease.

Our results may be of importance in cardiovascular risk stratification in obesity, because there is a large variation in the degree of hepatic steatosis in obesity.

Also, more emphasis should be put on dietary interventions to reduce or prevent hepatic steatosis. The reasons for the link between fatty liver and heart function are unknown, but could be related to several factors, including the presence of infection-fighting white bloods cells called macrophages or increased expression in the liver of small proteins known as cytokines.

Future research is required to study the effect of NAFLD on cardiovascular events, and further study is needed to investigate to what extent the association exists and differs among normal weight, overweight and obese persons.”

vere brain injury and disorders of consciousness.

To do so, the researchers first extracted resting state fMRI functional connectivity maps using independent component analysis, and combined only components of neuronal origin. They then compared the generated maps with the FDG-PET maps in 16 healthy controls, 11 vegetative state/unresponsive wakefulness syndrome patients, and in four locked-in patients.

The results showed a significant similarity for healthy controls and for vegetative state/unresponsive wakefulness syndrome patients between the FDG-PET and the fMRI based maps, with conjunction analysis showing decreased frontoparietal and medial regions in vegetative patients with respect to controls. Subsequent analysis in locked-in syndrome patients, which are known to be conscious, also produced consistent neuronal maps with healthy controls. The study was published on December 29,

2015, in Brain and Behavior.

“Many hospitals in developing countries have access to functional MRI technology or FDG-PET, but not both. By developing new fMRI techniques, hospitals that already have the expensive scanning equipment or wish to purchase a unit effectively get ‘more bang for their buck’,” said lead author Andrea Soddu, PhD, of the WU department of physics and astronomy. “If no metabolic absolute measures can be extracted, our approach may still be of clinical use in centers without access to FDG-PET.” PET scans are widely used to diagnose and track a variety of diseases, including cancer, because they show how organs and tissues function in the body, in contrast to MRI or CT scans, which mostly show anatomy. Using radioactive tracers that produce a signal from within the body, PET scanners produce a 3D image that is constructed by computers using sophisticated mathematical techniques.

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The UF-760AG features PW Doppler, Color Doppler, stress echo, spatial compounding, speckle reduction, tissue harmonic and tissue specific imaging. It has an on-board archive for more than 150,000 images, and comes with a 15-inch LCD flat monitor and battery.

The KUB 250 offers high resolution to enable clear visualization of PICC line placements down to 1.0 French. It comes with an extending arm and rotating collimator to enable easy and accurate positioning for AP and lateral views, and fits conveniently between cots and Isolettes in a busy NICU.

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Successful Scan with Novel 3T MRI Scanner leading manufacturer of electrical and electronic products, and systems, and two Japanese universities have successfully imaged a mouse fetus using a small model of a new 3T Magnetic Resonance Imaging (MRI) scanner that uses hightemperature superconducting coils. Most MRI scanners in use today have magnets that are cooled by liquid helium, a gas that is becoming increasingly scarce.

The new technology uses high-temperature superconducting coils that do not require cooling. The company expects to develop a half-size MRI scanner by 2020, and to be able to commercialize a full-size scanner within five years, in 2021.

Mitsubishi Electric (Tokyo, Japan; www.mitsubishielectric.com), Kyoto University and Tohoku

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University, successfully developed the 3T magnetic field by increasing the precision of the coil winding.

The company used laser displacement meters to measure the coil height and then adjusted it with correction sheets. The researchers succeeded in developing a pancake coil with a winding accuracy of 0.1 mm and an outer diameter of approximately 400 mm, and were able to achieve sufficient magnetic field homogeneity for use in commercial imaging. The model scanner has an imaging space with a diameter of 25 mm – the same level as that in a 230-mm diameter and 650-mm cylinder commercial-sized MRI scanner. Mitsubishi Electric used the 3T scanner model to successfully image a 25millimeter mouse fetus.

Image: The model of the first 3T MRI scanner with high-temperature coils (Photo courtesy of Mitsubishi Electric).

Exclusive Research Partnership To Bring MR Fingerprinting to Clinical Application Stage new partnership between a major medical imaging provider and a leading university in the US aims to bring a new Magnetic Resonance (MR) quantitative tissue analysis technique that can identify individual disease tissues, to clinical application.

The goal of the researchers is to provide software that can reliably distinguish between healthy and diseased tissue and help identify disease tissues earlier and faster than existing techniques. The MR Fingerprinting (MRF) software package has already been evaluated successfully by several research facilities.

The partnership between Siemens Healthcare (Erlangen, Germany; www.healthcare.siemens. com) and Case Western Reserve University (CWRU; Cleveland, OH, USA; www.case.edu) was announced in Singapore at the Annual Meeting of the International Society for Magnetic Resonance in Medicine (ISMRM).

MRF provides a non-invasive quantification of

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tissue properties and can be used to measure multiple parameters simultaneously. The technique provides a unique fingerprint for each type of tissue, disease, or material in the body. MRF can provide a low level of variance across many exam types, different MR scanners, and institutions, and could help clinicians monitor and evaluate patient treatments with greater accuracy.

MRF has previously been used for cardiac examinations and for multiple sclerosis patients. The CWRU research team has successfully used the technique for patients with brain tumors, prostate tumors, and breast cancer patients with liver metastases.

Prof. Siegfried Trattnig from the Medical University of Vienna, who has done initial research with brain tumor and glioma patients, said, “The MR Fingerprint technique lets us see more details than

the standard imaging process, and has the potential to redefine MRI. In this way, MRF could help us, as radiologists, to make the paradigm shift from qualitative to quantitative imaging and to incorporate quantitative data into our daily routine.”

Image: MR Fingerprinting (MRF) can be used to identify individual tissues and diseases quantitatively (Photo courtesy of Siemens Healthcare).

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Medical Imaging

New 3D Tool Predicts Patients at Higher Risk from Lethal Arrhythmias esearchers in an interdisciplinary team have developed a non-invasive 3D assessment tool to help clinicians find patients most at risk from lethal arrhythmias, and those who need a defibrillator implant.

The proof-of-concept study was published online in the May 10, 2016, issue of the journal Nature Communications. The researchers reported that the new digital technique provided a more accurate assessment of which patients were most at risk, and needed a defibrillator, than current blood pumping measurements.

The landmark study was carried out by researchers at the John Hopkins University (Balti-

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PET Imaging Can Detect and Diagnose Early Alzheimer’s novel tracer called Pittsburgh Compound B (PiB) binds to the amyloid plaques in the brain that are a characteristic cause of Alzheimer’s disease (AD), according to a new study.

Prof. Ann Cohen, MD, PhD, of the department of psychiatry at the University of Pittsburgh (Pitt, PA, USA; www.pitt.edu) has presented a review that focuses on the use of PiB-PET across the spectrum of AD pathogenesis. PiB, a radioactive analog of thioflavin-T (ThT) known to bind to amyloid beta (A )proteins, can be used to image the brains of AD patients using positron emission tomography (PET) scans in order to image the accumulation of A plaques in neuronal tissue.

The review found that PiB can provide early, perhaps even preclinical, detection of disease, and accurately distinguishes AD from dementias of other etiologies in which the diagnostic distinction is difficult to make clinically. According to the study author, using imaging agents can be used to study the relationships between A pathology and changes in cognition, brain structure, and function across the continuum from normal aging to mild cognitive impairment (MCI), and on to AD. The review was published in the June 2016 issue of Technology & Innovation.

“PiB retention in AD patients was generally most prominent in cortical areas and lower in white matter areas of the brain, consistent with post-mortem studies of A plaques in the AD brain,” said study author Prof. Cohen. “Major challenges ahead include finding ways to determine the earliest signs of amyloid accumulation, associating amyloid accumulation with cognitive impairments, and determining whether early amyloid deposition will lead to clinical dementia.”

“These challenges will likely require us to continue to focus on cognitively normal elderly and the detection of the earliest signs of amyloid deposition, along with markers of neurodegeneration...to determine the clinical significance of pre-symptomatic pathology,” concluded Prof. Cohen. “As anti-amyloid clinical trials begin in asymptomatic people, it will be critical to effectively identify the earliest changes in amyloid deposition and the significance of such changes on downstream neurodegenerative processes.”

more, MD, USA; www.jhu.edu). The researchers used Magnetic Resonance Imaging (MRI) scans and computer-modeling techniques to build a personalized geometrical replica of each patient’s heart. The researchers then added representations of the electrical processes, and were able to discover which virtual heart developed an arrhythmia, and which did not. The technique, called Virtual-heart Arrhythmia Risk Predictor (VARP), enabled the researchers to take account of the specific geometry of the heart of each patient, the electrical impulses, and the impact of scar tissue left by a previous heart attack.

The VARP technique was able to predict arrhythmia occurrence in patients four-to-five times better than current ejection fraction techniques, and other non-invasive and invasive clinical risk predictors.

The technique was able to eliminate unnecessary

implantations of defibrillators, and could also be used to save the lives of a much larger number of at-risk patients.

Prof. Natalia Trayanova, John Hopkins University, said, “Our virtual heart test significantly outperformed several existing clinical metrics in predicting future arrhythmic events. This non-invasive and personalized virtual heart-risk assessment could help prevent sudden cardiac deaths and allow patients who are not at risk to avoid unnecessary defibrillator implantations. We demonstrated that VARP is better than any other arrhythmia prediction method that is out there. By accurately predicting which patients are at risk of sudden cardiac death, the VARP approach will provide the doctors with a tool to identify those patients who truly need the costly implantable device, and those for whom the device would not provide any life-saving benefits.”

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Medical Imaging

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Predicting Long-Term Effects of Combat Induced Mild Traumatic Brain Injury esearchers in the US have found that MRIDTI measurements correlate with clinical outcomes such as symptom severity and healthcare utilization in veterans with Mild Traumatic Brain Injury (MTBI).

Diffusion Tensor Imaging (DTI) is a Magnetic Resonance Imaging (MRI) technique that can be used to measure the integrity of white matter in the brain’s signal-transmitting nerve fibers.

The researchers studied 57 military veterans, diagnosed with MTBI after their return from combat, and with an average period of 3.8 years between injury and post-deployment evaluation. The average follow-up duration was 1.4 years.

The study was published in the March issue of the journal Radiology and was carried out by re-

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searchers at the Philadelphia VA Medical Center (Philadelphia, USA; www.philadelphia.va.gov).

There has been a dramatic rise in the number of cases of combat-related MTBI in US service members. According to the US Armed Forces Health Surveillance Center more than 300,000 soldiers were diagnosed with MTBI between 2000 and 2015. The diagnosis of MTBI remains challenging, and it can be confused with other conditions such as Post-Traumatic Stress Disorder (PTSD).

The results of the study show significant correlations between initial post-deployment DTI measurements and neuro-behavioral symptoms. The measurements also correlated with the timing of injury, subsequent functional outcomes, and the frequency of healthcare visits made by veterans with

MTBI. According to the researchers, loss of white matter integrity is directly related to clinical outcomes in veterans who suffered concussion or Mild Traumatic Brain Injury (MTBI) during combat.

Jeffrey B. Ware, MD at the Philadelphia VA Medical Center, said, “All conventional MR images were interpreted as normal. We retrospectively analyzed the data from the DTI sequence to derive measures of white matter integrity, which we compared to clinical measures and subsequent outcome measures 6 months to 2.5 years after the initial evaluation. Our findings suggest that differences in white matter microstructure may partially account for the variance in functional outcomes among this population. In particular, loss of white matter integrity has a direct, measurable effect. It was illuminating to see the association between measures of white matter integrity and important outcomes occurring months to years down the road in our study population.”

Nanostim Leadless Pacemakers Approved for MRI ll European patients with a Nanostim leadless pacemaker, as well as new patients implanted with the device, can now safely undergo full body magnetic resonance imaging (MRI) scans.

The St. Jude Medical (SJM; St. Paul, MN, USA; www.sjm.com) Nanostim leadless pacemaker is just 10% the size of a conventional pacemaker, and is designed to be implanted directly in the heart, reducing or eliminating common complications associated with leads, chest incisions, and surgical pockets. It is implanted via a percutaneous coronary intervention (PCI) through the femoral vein into the heart, using a miniature delivery system, and is designed to be

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fully retrievable for repositioning throughout the procedure, and later retrieved if necessary.

The device is supported via the proprietary Merlin Programmer, which is also used to interrogate and program the company’s other pacemakers and implantable cardioverter defibrillators (ICDs). Eliminating the visible lump and scar at a conventional pacemaker’s implant site, in addition to the removal of patient activity restrictions that may prevent the dislodgement or damage to a conventional lead, could potentially improve the quality of life for patients and allow most to continue living active, uninhibited lifestyles.

“The Nanostim leadless pacemak-

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er is one of the most important advances in the history of pacemaker technology,” said Mark Carlson, MD, vice president of global clinical affairs and chief medical officer of St. Jude Medical. “The freedom from leads and now the ability for patients with the Nanostim leadless pacemaker to undergo MRI scans are important factors for physicians as they consider treatment options.”

“It’s important that my patients in need of pacemakers also have the freedom to undergo MRI diagnostic scans for other conditions, if needed,” commented cardiologist and electrophysiologist Tom Wong, MD, of Royal Brompton Hospital (London, United Kingdom). “This new labeling provides that flexibility and will be of great benefit to patients to ensure peace of mind for the future.”

MRI of the Cervix More Accurate Than Ultrasound at Predicting Preterm Birth he results of a new study have shown that MRI of the cervix is more accurate at predicting preterm birth, for some women, than ultrasound.

The study, published in the March, 2016, online edition of Radiology, investigated early dilation of the cervix, during pregnancy, which can lead to premature delivery.

Women with a cervix measuring 15 mm or less, as measured using an ultrasound exam in the second trimester of pregnancy, are considered to have an increased risk of preterm birth.

The researchers used DiffusionWeighted Imaging Magnetic Resonance Imaging (DWI-MRI) to examine pregnant women with suspected fetal or placental abnormality. The thirty pregnant women that took part in the study all had a short cervix, and underwent a positive fetal fibronectin test between the 23rd and 28th weeks of gestation. Eight of the women delivered within one week of the MRI examination, and

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the other 22 delivered 55 days later on average.

The researchers compared ADC values, using MRI data, between the inner, sub-glandular zone and the outer, stromal area of the cervix and found that the sub-glandular ADC was higher in patients with impending delivery. This suggested increased mobility of water molecules in that area, consistent with cervical ripening.

Lead author of the study, Gabriele Masselli, MD, Radiology Department, Sapienza University (Rome, Italy; http://en.uniroma1.it), said, “Our results indicate that a high ADC value recorded at the level of the subglandular area of the cervix is associated with the imminent delivery of asymptomatic patients with a short cervix. In detail, the subglandular ADC was inversely correlated to the time interval between MRI and delivery and therefore emerged as a powerful imaging biomarker in evaluating patients with impending delivery.”

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PRODUCT NEWS ASPIRATION DEVICE

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The Silver Scope series for gastroenterology provides pure white light endoscopy. It also offers display options in other defined spectral ranges and new visualization options for diagnostics even under difficult lighting conditions.

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Rapid Deployment Device Streamlines Aortic Valve Replacement n innovative rapid deployment system facilitates minimally invasive aortic valve replacement (AVR) procedures.

The Edwards Intuity Elite Valve System is a bovine pericardial heart valve based on the Carpentier-Edwards Perimount design, and features an innovative, balloon-expandable frame designed to facilitate rapid annular placement and a rapid deployment delivery system for easier access and visibility through smaller incisions. The system can also reduce the time it takes to cross-clamp the aorta, as well as the amount of time

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spent under cardiopulmonary bypass, thus improving patient safety and outcomes and leading to shorter recovery times.

The replacement valve is constructed with an Elgiloy stent at the orifice and commissures for flexibility, and has an incomplete supra-annular configuration with an intra-annular component. The pericardium tissue is fixed by a stress-free process using glutaraldehyde. Data from an 839-patient trial that took place in 29 centers across the United States showed that one year post-procedure, the system was safe and effective.

The Edwards Intuity Elite Valve System is a product of Edwards Lifesciences (Irvine, CA, USA; www. edwards.com), and has been approved by the U.S. Food and Drug Administration (FDA).

“Many patients with aortic stenosis have more than one type of heart disease, most commonly coronary artery disease,” said Kevin Accola, MD, program director at the Florida Hospital Cardiovascular Institute Valve Center for Excellence (Orlando, FL, USA). “The Edwards Intuity Elite valve system enables surgeons to streamline concomitant procedures, which can be beneficial for patients undergoing these longer, more complex surgeries.”

“Patients request less invasive surgical options, and the Edwards Intuity Elite valve system meets this need by facilitating multiple ap-

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proaches to minimally invasive operations, which can mean less trauma, early recovery, and decreased need for blood transfusions for many patients,” said Mubashir Mumtaz, MD, chief of cardiothoracic surgery and surgical director of the structural heart program at Pinnacle Health (Harrisburg, PA, USA).

The Carpentier-Edwards Perimount heart valve design mounts matched leaflets under the flexible stent, thus minimizing commissural stress points. The leaflets are produced by computer-aided design (CAD) for optimal leaflet to stent matching, using tissue deflection testing that enables the leaflets to be matched accurately.

Image: The Edwards Intuity Elite valve system (Photo courtesy of Edwards Lifesciences).

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Surgery Comes to the Big Screen in 4K Color n ultra-high definition (UHD) display unites state-of-the-art electronics with advanced optics for unparalleled vision inside the human body. The Olympus (Tokyo, Japan; www.olympus-global.com) VISERA 4K 55-inch primary operative display transforms minimally invasive surgery into an immersive experience by bringing the entire surgical team into the operation. With an integrated 4K imaging chain delivering four times the resolution of regular high definition (HD), a brighter image, and wider color spectrum, the display allows operating room (OR) personnel to view cases live on the 55-inch operative display, magnifying anatomical features and delivering immersive visual information.

Benefits of the Integrated VISERA 4K UHD system include enhancing visualization in advanced multi-quadrant procedures, in procedures with challenging access, and in deep surgical cavities when using a 5-mm telescope. Structure enhancement allows clearer recognition of human tissue and compatibility with narrow band imaging, while intraoperative color enhancement reproduces more vivid shades of red and yellow and higher contrast levels for better visualization of anatomical structures and precise tissue delineation.

“With the introduction of the VISERA 4K UHD System, we launch a new chapter in the evolution of minimally invasive surgery – the era of big screen surgery,” said Todd Usen, President of Olympus Medical Systems Group. “By working closely with OR teams around the world, and our partner Sony who brings the most advanced electronics, Olympus is proud to provide our US customers with the VISERA 4K UHD system for the ultimate visibility and clarity during surgery.”

“The color and contrast in the Olympus 4K image provides superb clarity, unlike any operative video image I have seen before,” said Prof. Ninh Nguyen, MD, of the department of surgery at the University of California (UIC) Irvine Medical Center. “The image is so clear that I was able to see down to the capillary level. [Seeing the capillary level] is important for improved dissection of tissue and evaluating the perfusion of the tissue.”

The Olympus VISERA 4K system, which includes the display and a camera, is the first product of Sony Olympus Medical Solutions (Tokyo, Japan; www.sony-olympus-medical. com), a joint venture between Olympus and the Sony Corporation founded in 2013. The system incorporates the Sony Exmor R CMOS image sensor in the camera head, and also includes an ultra-telescope with an extra-low dispersion lens that reduces chromatic aberration, ensuring that the system will consistently provide extremely sharp images in true colors, even on the fringes of the visible edge.

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Image: The VISERA 4K 55-inch primary operative display (Photo courtesy of Olympus Medical Solutions).

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Surgical Techniques

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Robot-Supported Angiography System Advances Hybrid ORs novel angiography system offers personalized, minimally invasive surgery for multimorbid patients with changing disease patterns. The Siemens Healthineers (Erlangen, Germany; www.healthcare.siemens.com) Artis pheno provides patients with multiple health issues the option to undergo MIS and interventional radiology and interventional cardiology procedures, despite the additional risks associated with chronic disease.

Artis can scan the body up to 15% faster (compared to prior systems Siemens Healthineers systems), and produce three-dimensional (3D) images that need less contrast agent; if the patient is sensitive to the contrast agent, Artis pheno can also support CO2 imaging of the extremities.

The C-arm is 13 centimeters wider and has a free inner diameter of 95.5 centimeters, offering more space for handling adipose patients and longer instrument use that can be used without added difficulty.

The multi-tilt table is designed to accommodate patients weighing up to 280 kilograms, with edge of the table capable of tilting to stabilize the patient's blood pressure, for example, or to make breathing easier when necessary. The system can be fitted with a comprehensive range of optional software applications to deal with complex cases.

The robotic construction of the Siemens Healthineers table gives it a flexible isocenter, so that the angiography system can follow all table positions and provide imaging support for the patient's treat-

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ment, while representing the target area of the body from virtually any angle. Artis pheno recognizes the position of the tabletop at all times, and automatically aligns itself. Memory positions let the system move the C-arm out of the operating area quickly if necessary, giving the surgeon and team free access to the patient, and then move it back to exactly the same position again for further imaging.

A dedicated hygiene approach combines several factors: an antimicrobial coating prevents bacteria and viruses from multiplying on the system; the wiring is routed inside the system to prevent cables from becoming dirty and potentially transmitting bacteria; and seamless surfaces with no recesses, and spaces that are easy to access, make the system easier to clean. And because the system is floormounted, it is easier to install in the OR, and the sterile airflow from the ceiling is interrupted during imaging only by the flat-panel detector.

“We see a high number of multimorbid patients with impaired kidney function in the angio suite,” said Prof. Frank Wacker, MD, director of the institute for diagnostic and interventional radiology at Hanover Medical School (Germany; www. mh-hannover.de). “Shorter scan times help reduce the amount of iodinated contrast agent during 3D angiography in the thorax and abdomen by up to fifteen percent.”

Additional optional application packages include software for extensive spinal fusion procedures us-

ing screws or needles; screw paths can be precisely planned, and an automatic path alignment function automatically aligns the C-arm to follow them. A laser integrated in the image detector shows the surgeon the planned path, which helps improve both accuracy and speed in the OR. A number of applications support tumor transarterial chemoembolization (TACE), rendering arterial vessels visible, with graphic overlaying of the selected vessel paths with the real-time X-ray images.

Image: The Artis Pheno robot-supported angiography system (Photo courtesy of Siemens Healthineers).

Symptoms Prevalent Following Bariatric Surgery new study reveals that the prevalence of symptoms such as abdominal pain and fatigue are high after Roux-en-Y gastric bypass (RYGB) surgery, with nearly one-third of patients admitted to hospital.

Researchers at Aarhus University Hospital (Denmark; www.au.dk) surveyed 2,238 patients who underwent RYGB surgery between January 1, 2006, and December 31, 2011, in the central Denmark region to examine overall wellbeing and the prevalence and predictors of medical, nutritional, and surgical symptoms after RYGB surgery, and their association with quality of life. The 1,429 (63.7%) patients who responded to the survey were compared to a control cohort of 89 individuals matched according to sex and body mass index (BMI), but who did not undergo RYGB surgery.

The results showed that 87.4% of the patients reported that their wellbeing was improved following surgery, with 88.6% reporting symptoms; 67.6% of the patients contacted the health care system about their symptoms, and 29.1% were hospitalized. The symptoms most commonly

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reported were abdominal pain (34%), fatigue (34%), anemia (28%), and gallstones (16%). Risk of symptoms was higher among women, patients younger than 35 years, smokers, the unemployed, and in those with surgical symptoms before RYGB surgery.

The study was published online on January 6, 2016, in JAMA Surgery.

“Most patients reported improved well-being after RYGB surgery, but the prevalence of symptoms was high and nearly one-third of patients were hospitalized, 4- to 5-fold more than among the comparison group,” concluded lead author Sigrid Bjerge Gribsholt, MD, and colleagues. “Predictors of symptoms included young age, female sex, smoking, and experiencing symptoms before RYGB surgery. Development of weight loss procedures with fewer subsequent symptoms should be a high priority.”

For patients with morbid obesity, bariatric surgery (including RYGB surgery) is an effective treatment for weight loss and associated diseases.

Various medical, nutritional, and surgical symptoms that require treatment may occur after RYGB surgery and may impair patients’ quality of life.

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Surgical Techniques

Robotic Surgery Reduces Blood Loss Risk in Obese Patients esearchers at the Loyola University Health System (Chicago, IL, ISA; www.loyola medicine.org) identified 9,108 obese patients from the 2009-2010 Nationwide Inpatient Sample (NIS) who underwent radical prostatectomy. Of these, 60.4% underwent RARP, and 39.6% underwent open radical prostatectomy (ORP). The primary outcome was the presence of peri-operative adverse events, such as surgical complications, blood transfusion, and prolonged length of stay.

The results showed that when compared with patients who underwent ORP, patients undergoing RARP were 83% less likely to require blood transfusions, and 72% less likely to require prolonged hospital stays.

RARP did not, however, reduce the risk of infections, and both approaches were associated with similar odds of developing a complication. The study was published in the May 2016 issue of Current Urology.

“For urologists, the finding that robotic and open surgery have similar complication rates implies that both

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techniques remain interchangeable.

The surgeon’s comfort level should dictate which surgical approach is used,” concluded lead author Gopal Gupta, MD, an assistant professor in the department of urology. “For obese prostate cancer patients, the broad findings suggest that both surgical approaches are feasible and safe.”

RARP uses the Intuitive Surgical (Sunnyvale, CA, USA; www.intuitivesurgical.com) da Vinci minimally invasive surgery system. The advantages of RARP include improved cosmetic result, less blood loss, briefer and less intense post-operative convalescence, and reduced hospitalization costs. It is also the basis of a “nervesparing” procedure called the Veil of Aphrodite, developed to minimize the erectile dysfunction common in men after undergoing traditional radical prostatectomy.

Image: A new study shows obese patients undergoing robotic-assisted radical prostatectomy (RARP) have a lower risk of blood loss risk and prolonged hospital stays (Photo courtesy of Loyola University Health System).

Laparoscopic Surgery Beneficial for Gastric Reflux aparoscopic antireflux surgery (LARS) is beneficial for patients with chronic gastroesophageal reflux disease (GERD), according to a new study.

Researchers at Haukeland University Hospital (Bergen, Norway; www. helse-bergen.no), Karolinska Institutet (Stockholm, Sweden; www.ki. se), and other institutions conducted a prospective, randomized, open-label trial comparing the efficacy and safety of LARS (116 patients) and esomeprazole (151 patients) in patients with chronic GERD. The researchers analyzed data derived from ambulatory intraesophageal and intragastric 24-hour pH monitoring data before treatment, and six months and five years afterward.

The results showed that the median 24-hour esophageal acid exposure was 8.6% at baseline and 0.7% after six months and five years in the LARS group. The corresponding values were 8.8%, 2.1%, and 1.9% in the esomeprazole group; in both groups, gastric acidity was consistently stable.

More severe supine reflux at baseline was seen in the patients who required a dose increase of esomeprazole, who also demonstrated decreased eso-

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phageal acid exposure and gastric acidity. The study was published in the May 2016 issue of Clinical Gastroenterology and Hepatology.

“Esophageal acid reflux was reduced greatly by LARS or esomeprazole therapy. However, patients receiving LARS had significantly greater reductions in 24-hour esophageal acid exposure after six months and five years,” concluded lead author Jan Hatlebakk, MD, PhD, of Haukeland University Hospital, and colleagues. “Esophageal and gastric pH, off and on therapy, did not predict long-term outcomes of patients.”

In most GERD patients, the esophageal sphincter is weakened and does not close tightly, allowing digestive juices to return and irritate the esophageal lining. LARS, also known as laparoscopic Nissen fundoplication, involves reinforcing the annulus between the esophagus and the stomach by wrapping the upper portion of the stomach around the lowest portion of the esophagus, much the way a bun wraps around a hot dog. Carbon dioxide gas is used to temporarily expand the abdomen, giving the surgeon room to see and work the laparoscope.

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PRODUCT NEWS ENDOSCOPY SYSTEM

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HD MONITORS

COLONOSCOPES

Richard Wolf

ACEM

PENTAX Medical

The Endocam Flex HD offers universal connectivity and allows the use of flexible sensor and rigid endoscopes. Its plug-and-play feature does away with the need for white balancing or focusing as it automatically regulates brightness controls for excellent image quality and illumination.

The HD monitors ensure sharpness and accuracy of details during surgical and endoscopic interventions. They can be connected to surgical lamps, and come with sterilizable, interchangeable handles for wide operating ranges, as well as height adjustment and ease of positioning.

The i10 Series HD+ colonoscopes are equipped with second-generation HD+ Megapixel Resolution CCDs for exceptional image clarity and detail resolution. They provide enhanced views of the mucosal surface and blood vessels, making them ideal for screening/treatment in lower GI tracts.

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HD Pulmonology System Provides Sharp Image Quality

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new endoscopy system delivers high-definition (HD) image quality, supporting clinical outcomes across a range of diagnostic and therapeutic applications.

The DEFINA system in Pulmonology combines the state-of-the art PENTAX EPK-3000 HD processor technology and two highly maneuverable HD bronchoscopes to deliver sharp, clear images, enabling rapid and highly detailed visualization for improved evaluation of anatomical details in the bronchial mucosa. When combined with i-scan technology, precise detection and demarcation of suspicious areas is facilitated, assisting clinicians in the characterization of various abnormalities to support therapeutic decisions.

The two J10 HD bronchoscopes (EB15-J10 and EB19-J10) of the DEFINA system are designed for ease of operation, with a lightweight body and ergonomically positioned suction valve control, angulation levers, and remote control buttons. Effortless maneuverability within the bronchus, with easy access even to the right upper lobe of the lung, is made possible due to the bronchoscopes’ 210˚ distal tip deflection and insertion tube flexibility. The DEFINA system in Pulmonology system is a product of PENTAX Medical (Tokyo, Japan; www. pentaxmedical.com).

“Through our close relations with practicing endoscopists worldwide,

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we have looked to develop a highdefinition video endoscope system that delivers the optimum in visualization, providing crystal clarity,” said Rainer Burkard, president of EMEA at PENTAX Medical. “We have produced a system that also offers high standards of hygiene and ergonomics for the full range of diagnostic and therapeutic applications in the pulmonology field. Our new DEFINA system in Pulmonology is engineered to support the delivery of best clinical outcomes and image quality.”

In compliance with strict hygiene requirements, the new system uses disposable accessories to reduce risk of cross-contamination. It is also compatible with the Sterrad Sterilization System, ensuring that it is clear of multidrug resistant and extreme drug resistant mycobacterium. To further add to patient safety, a disposable suction valve is attached to the endoscope via a click mechanism, and cannot be dislodged.

Image: The DEFINA system in Pulmonology (Photo courtesy of PENTAX Medical).

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Surgical Techniques

Miniaturized Implantable VAD Alleviates Pediatric Heart Failure minute axial-flow ventricular assist device (VAD) offers hope in the management of severe heart failure (HF) in small children.

The Infant Jarvik 2015 is an implantable VAD that offers up to three liters per minute flow rate. To test the VAD, researchers at Texas Children’s Hospital (Houston, USA; www.texas childrens.org), implanted it in ten sheep, with the outflow graft attached to the proximal descending aorta. Results showed that eight of the ten sheep completed the study and remained in good health, as indicated by appropriate weight gain over a period of one to two months. The remaining two animals did not complete the study due to complications that were not directly related to the pump.

The most significant finding was very minimal red blood cell (RBC) hemolysis, despite the high pump speed of up to 18,000 revolutions per minute (RPM). The entire VAD pathway was clean, without thrombi or fibrin deposits, except in one sheep.

In six animals, there were small kid-

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ney infarcts. The study was presented at the 96th annual meeting of the American Association for Thoracic Surgery (AATS), held during May 2016 in Baltimore (MD, USA).

“This preclinical study not only demonstrates the clinical feasibility of the new device, it also provides important insights into how this device may be managed when used clinically in pediatric patients,” said lead investigator Iki Adachi, MD. “ This study will be an important milestone in the new era of pediatric heart failure management with implantable VADs.” VADs have become the standard of care in the management of severe HF. But while in adults, implantable VADs, usually axial, are used exclusively no implantable VADs until now have been designed specifically for small children. The result is that the vast majority of pediatric patients with severe HF are managed with paracorporeal (external) VADs, which in general are associated with higher risk profiles and require hospital management.

Image: The Infant Jarvik 2015, used in the chronic sheep model (Photo courtesy of Texas Children’s Hospital).

Uncertainty Continues on Role of Dressings in Infection Protection here is insufficient evidence to know whether dressings reduce the risk of surgical site infection (SSI) in closed primary surgical wounds, claims a new study.

Researchers at the University of Bristol (United Kingdom; www. bristol.ac.uk) searched a 2014 Cochrane systematic review of 20 randomized, controlled trials that summarized the evidence for the use of dressings to prevent SSI in people with closed primary surgical wounds.

All were at an unclear or high risk of bias, and only two studies compared leaving wounds exposed with applying a dressing.

To supplement the Cochrane review, the researchers systematically searched for further randomized controlled trials evaluating application of tissue adhesive as a dressing on closed primary surgical wounds, screening 319 abstracts, 19 full papers, and two trials. They also searched the Cochrane Wounds Group Specialized Register, Medline, Embase, and other databases for trials that compared immediate postoperative application of wound dressings with tissue adhesive as a dressing to closed primary surgical wounds.

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The results showed there is insufficient evidence to know whether dressings reduce the risk of SSI wound infection; and that there is insufficient evidence to conclude which type of dressing reduced infection, or whether dressings were needed at all. Because of the lack of evidence, the researchers recommend that current decision making about dressings may need to be led by practical issues, such as wound symptom management and costs, rather than SSI. The study was published on May 24, 2016, in BMJ. “Without evidence of the superiority of more expensive dressings, and with anecdotal reports of the convenience of dressings for patients and health care staff, the use of basic adhesive (with minimal absorbency) dressings at a cost of a few pence per dressing on a closed primary surgical wounds is pragmatic,” concluded study author Prof. Jane Blazeby, MD. “An exception to this recommendation would be settings in which it is standard practice not to use dressings, and pediatric surgery may constitute such an exception, if the removal of dressings causes undue distress to children.”

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PRODUCT NEWS SMOKE EVACUATION PENCIL

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HD CAMERA SYSTEM

ENDOSCOPIC VIDEO SYSTEM

Buffalo Filter

Enova Ilumination

NDS Surgical Imaging

The PlumePen Pro features an easy to remove Xray detectable capture port for effortless electrode replacement. It is smaller size makes it a cost-effective and suitable alternative for surgeries where a pencil adapter is less optimal.

The Futudent HD offers perfect focus with excellent depth-of-view, very high resolution, and 2-8X magnification. It can be attached to Enova LED surgical headlights or any brand of loupes, and captures crisp HD video recordings, stills, and audio for documenting surgeries.

The Radiance Ultra TruColor enables consistent image quality and more accurate color reproduction for a more true-to-life viewing experience. It provides visualization that more accurately resembles anatomy the human eye would visualize during an open surgical procedure.

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Artificial Cervical Disc Preserves Neck Motion next-generation artificial disc for adult patients with pain or spinal cord injuries allows motion in the neck following an operation. The Medtronic (Dublin, Ireland; www. medtronic.com) Prestige LP Cervical Disc is approved to treat skeletally mature patients with cervical disc disease caused by nerve or spinal cord compression at two neighboring levels between the C3C7 segments of the neck, as an alternative to anterior cervical discectomy with fusion (ACDF). Indications include intractable arm pain and/or a neurological deficit with or without neck pain; myelopathy due to abnormality localized to the level of the disc space; and at least one of the following conditions: nucleus pulposus, spondylosis, and visible loss of disc height as compared to adjacent levels.

The Prestige LP Disc is implanted using an anterior approach following discectomy at one level or two contiguous levels. The low profile disc has a ball-and-trough design that allows it to move in a range of motions, including bending, rotation, and translation. It is made of a titanium ceramic composite which provides improved wear resistance while retaining the mechanical, biocompatible, and imaging benefits of the base titanium alloy. The Medtronic Prestige LP Cervical Disc has been approved by the U.S. Food and Drug Administration

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(FDA), and is magnetic resonance imaging (MRI) conditional at 1.5 and 3 Tesla.

“Medtronic is committed to elevating spine care by combining innovative new technologies with clinical evidence,” said Doug King, senior vice president and president of Medtronic’s spine division.

“The Prestige LP Disc is a superior alternative to ACDF and an important motion-preserving option for physicians treating certain patients suffering from two-level cervical disc disease.”

“For my active patients with cervical disc disease at two adjacent levels, I want to preserve motion in their necks,” said orthopedic surgeon Jeff McConnell, MD, of Lehigh Valley Hospital (Allentown, PA, USA). “I choose to use the Prestige LP Disc at two levels because it provides superior clinical outcomes at 24 months and the titanium ceramic composite material allows post-op assessment and visualization by MRI.” ACDF involves the removal of a cervical disc herniation (discectomy) through an anterior approach with concomitant surgical decompression, thus relieving spinal cord or nerve root pressure and alleviating corresponding pain, weakness, numbness and tingling. Fusion surgery is done at the same time as the discectomy in order to stabilize the cervical segment.

Image: The Prestige LP cervical disc (Photo courtesy of Medtronic).

Percutaneous Coronary Intervention Feasible Even in Very Elderly Patients ercutaneous coronary intervention (PCI) can be safely and successfully performed in patients 90 years of age or older presenting with ST-segment elevation myocardial infarction (STEMI), according to a new study.

Researchers at Pitie-Salpetriere Hospital (Paris, France; pitiesalpetriere.aphp.fr), Sheba Medical Center (Tel Hashomer, Israel; https://eng.sheba.co.il), and other institutions conducted a retrospective study of 145 consecutive all-comer nonagenarians treated with primary PCI for STEMI in five international high-volume centers between 2006 and 2013, in order to assess clinical events and mortality outcomes, which were assessed at six months and one

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year after the procedure.

The results showed that failed PCI occurred in 11% of patients due to distal embolization, coronary dissection, or inability to pass the wire through the thrombus. Overall, 60% of the procedures were performed through the transradial approach, with successful revascularization of the culprit vessel obtained in 86% of the cases. Major or clinically relevant bleeding was observed in 4% of patients, and inhospital mortality was 24%. The six-month and one year survival rates were 61% and 53%, respectively.

The study was published on July 13, 2016, in Heart.

“Despite intensive antiplatelet and anticoagulant therapy, major or clinically relevant bleeding events

were recorded in only six patients during in-hospital follow-up,” concluded lead author Gérard Helft, MD, PhD, of Pitie-Salpetriere Hospital, and colleagues. “The high rate of procedures conducted through the transradial approach may explain the low rate of access site bleeding complications.”

STEMI, a more precise term for heart attack, is caused by a prolonged period of ischemia that affects large areas of the heart. It refers to an identifiable pattern as seen on an electrocardiogram (ECG). Thousands of patients with STEMI fail to receive critical therapy in a timely fashion, and nearly 30% of patients with STEMI do not receive reperfusion treatment at all.

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Surgical Techniques

Novel Therapeutic Solution for Aortic Aneurysms n innovative solution facilitates the endovascular aneurysm repair (EVAR) of abdominal aortic aneurysms (AAA) in patients with challenging anatomies.

The Gore Excluder Conformable AAA endoprosthesis is made of expanded polytetrafluoroethylene (ePTFE) graft material and a nitinol stent, and relies on an active control system (ACS) which allows physicians to angle the device for optimal conformability and maximal seal in the proximal aortic neck. The Excluder is characterized by its low profile, flexible on and off catheter characteristics, and active infrarenal fixation, which provides the physician with a proven and durable option to better treat a broader range of patients diagnosed with abdominal aortic aneurysms.

Other features include proprietary low profile sleeve technology, a repositionable delivery system, and a simple three-stage deployment procedure.

The Gore Excluder Conformable AAA endoprosthesis is a product of Gore Medical Products (Flagstaff, AZ, USA; www.goremedical.com), and is intended for patients with proximal aortic neck angles of up to 90 degrees with a minimum aortic neck length of 15 mm, and in patients with proximal aortic neck angles of up to 60 degrees with a minimum aortic neck length of 10 mm.

“In order to qualify for EVAR, the patient had to fit a fairly narrow subset of anatomical criteria,” said Robert Rhee, MD, chief of vascular and endovascular surgery at Maimonides Medical Center (New York,

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Image: The Gore Excluder conformable AAA endoprosthesis (Photo courtesy of Gore Medical Products).

NY, USA). “The Gore Excluder Conformable AAA endoprosthesis will expand the applicability of EVAR to patients traditionally considered to have anatomy too challenging for endovascular treatment.”

“With the Gore Excluder conformable device, our EVAR solutions will offer the broadest treatment range of any supplier in the market,” said Ryan Takeuchi, aortic business unit leader at Gore. “The feedback received on this new product suggests a high level of interest from physicians seeking to treat challenging AAA anatomies.

As we scale up operations to meet this demand,

we look forward to bringing this valuable product to patients and physicians.”

AAA is the localized dilatation of the abdominal aorta exceeding the normal diameter by more than 50%, and is the most common form of aortic aneurysm; approximately 90% occur below the kidneys. The aneurysms can extend to include one or both of the pelvic iliac arteries. The major complication of AAA is rupture, which is life-threatening, as large amounts of blood spill into the abdominal cavity, and can lead to death within minutes. Mortality during rupture repair in the hospital is 60-90%.

External Stenting Relieves Pediatric Chronic Airway Obstruction novel technique known as external stenting (ES) expands and stabilizes the airway in children by suspending it on a rigid prosthesis placed around the bronchus or trachea.

Developed by researchers at Sakakibara Heart Institute (Tokyo (Japan; www.hospital.heart.or.jp), the ES technique suspends the airway on two separate oversized ring-reinforced polytetrafluoroethylene prosthesis in order to both expand and stabilize the airway in small children suffering from chronic airway obstruction. The technique avoids the common problem of granulation formation that results from endolumenal corrective approaches, such as endoscopic stent placement.

From April 1997 to July 2015, 98 children (43 female and 55 male, median birth weight 2.7kg) underwent ES at Sakakibara Heart Institute, with the median age at the first operation being 7.2 months, and cardiovascular anomalies were noted in 82 children, with 18 having aortic arch obstruction, while 14 children had functional single ventricular hearts and were expecting future Fontan operations. Eight of the patients had previously undergone an unsuccessful aortopexy.

In all, the patients underwent a total of 127 ES procedures, with 14 mortalities. Of the 84 survivors, 88.1% were successfully weaned from the ventilator at a median of five days. The negative pressure threshold to induce airway collapse was measured for 58 procedures for congenital malacia, and showed improved stability of the airway. A follow-up computerized tomography (CT) in 23 patients two years after intervention showed the di-

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ameter of the stented area was almost equal to that of the age-matched control. The study was presented at the 96th AATS annual meeting, held during May 2016 in Baltimore (MD, USA).

“Our ES technique may provide an alternative or adjunct to established practices for relieving airway obstruction, such as aortopexy,” said lead author and study presenter Makoto Ando, MD, of the department of pediatric cardiac surgery. “ES is less invasive and more reliable, and is effective equally

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for tracheobronchomalacia with or without vascular compression. It also has the potential of allowing age proportional growth of the airway.”

An airway obstruction manifested during early childhood can be life threatening, and is also frequently associated with congenital cardiovascular anomalies. Incomplete relief of the obstruction may lead to obstructive pulmonary vascular disease, which is unfavorable for patients with congenital heart disease (CHD).

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PRODUCT NEWS VIDEO NASOLARYNGOSCOPE

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OR SYSTEMS INTEGRATION

SURGICAL LIGHT

Henke Sass Wolf

Olympus

Trumpf

The HSW video nasolaryngoscope is based on CMOS chip-on-the-tip technology, and features integrated LED for optimal illumination. Its ultra-slim ergonomic design allows for gentle insertion, easy handling, and perfect control, making it suitable for all ENT applications.

The ENDOALPHA increases efficiency and improves the ergonomics, communication, and information systems for medical teams in endoscopy suites and ORs. The SmartGuide navigation is designed to revolutionize the way surgeons and nurses interact with technology in the OR.

The iLED 7 uses 3D sensor technology to ensure its light field size and intensity remain consistent regardless of the distance between it and the surgical site. It can be operated using a touch screen wall panel, wireless tablet, or from the sterile light handle, including acoustic feedback.

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LED Surgical Lamp Illuminates Operating Field n innovative surgical lamp grants a homogeneous and shadowless light thanks to next generation light emitting diode (LED) technology.

The STARLED3 NX surgical lamp is composed of three reflectors that produce a well-blended and intense cone of light that can be focused through automatic adjustment of the light spot diameter. The resulting visual area is perfectly illuminated with a well-blended and intense (130.000 lux) cone of light with a color temperature (CCT) of 4.500 °K and a color rendering index (CRI) of 95. Despite the intensity, the lamp maintains a low energy consumption of just 69W, and is thus suitable for countless applications, including dentistry, gynecology, dermatology, general medicine, and surgery.

The LED’s maintain a life cycle of about 50,000 hours.

All functions are managed via the digital I–SENSE control panel, including power, light intensity, light spot diameter dimension (focus), and depth of field (DoF) adjustment for a full visualization of the operating field and deep cavities. The ISENSE panel can also be used to synchronize the controls of combined lamps, such as a double STARLED3 NX (twin dome) configuration, or the

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STARLED3 NX combined together with a STARLED5 NX or a STARLED7 NX surgical lamp. An ENDO function gives the possibility to use the STARLED3 NX for minimal-invasive endoscopic surgery.

The slim, practical, and compact design provides ergonomic handling, making it easy to move and position.

The lamp has also been designed taking in consideration laminar air flow in the operating room, resulting in a smooth and resistant material composition that makes cleaning quick, easy, and complete. The STARLED3 NX is a product of ACEM Medical Company Image: The STARLED3 NX (Bologna, Italy; www.acem.it), and is surgical lamp by ACEM available in a ceiling mounted version tal parameters, including residual charge, type of (single, double, or together with other STARLED power supply, recharge status, and electrical power NX lamps); a wall mounted version; and a trolley supply presence. The battery is recharged by an aumounted version powered by the proprietary tomatic charger with a maximum charging time of rechargeable ACEM battery powered system about 8 hours. An electronic control allows for au(ABPS). tomatic switching from electric power supply to The ABPS battery system is wholly contained battery power supply, so that STARLED3 NX can be within the trolley base, with a control panel on the used as a high performance mobile unit. structure that allows management of all fundamen-

Nasoalveolar Molding Reduces Need for Cleft Lip Surgery esearchers at the Loyola University Health System (Chicago, IL, ISA; www.loyola medicine.org) conducted a retrospective cohort study of 276 patients with complete unilateral and bilateral cleft lip and palate (U/BCLP) to compare the risk of early secondary nasal revision surgery following NAM and surgery – which consisted of cleft lip repair and primary surgical nasal reconstruction – versus surgery alone. The NAM treatment group consisted of 172 patients with UCLP and 71 patients with BCLP, whereas the nonNAM-prepared group consisted of 28 patients with UCLP and 5 with BCLP. The results showed that the risk of secondary

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nasal revision for patients with UCLP was 3% in the NAM group and 21% in the non-NAM group. The risk of secondary nasal revision for patients with BCLP was 7% in the NAM group compared with 40% in the non-NAM group. Using multicenter averages, the researchers found that overall non-NAM revision rates were 37.8% for UCLP and 48.5% for BCLP. The study was published in the June 2016 issue of The Journal of Craniofacial Surgery.

“NAM is a technique that molds the patient’s lip, nose and gums, decreasing the width of the cleft and contouring the nose before surgery is performed. This makes the surgery easier to perform and now has been shown to improve outcomes and

reduce cost,” said lead author plastic and reconstructive surgeon Parit Patel, MD. “Surgery always has a certain element of risk and the use of NAM reduces complications and the overall number of surgeries. This results in a potentially healthier child, which is really the ultimate goal.”

Cleft lip and palate are two of the most common major birth defects, resulting from incomplete closure of tissues of the face during development; the cause is unknown in most cases. NAM is based on an oral plate similar to a dental retainer that is typically implanted in a baby’s mouth four to five weeks after delivery, helping to correct the deformity by reducing the size of the cleft before surgery is performed.

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Surgical Techniques

Vaginal Insert Offers Alternative Treatment for Fecal Incontinence novel vaginal insert for bowel control eliminates the need for surgery or an in-office procedure for the treatment of female fecal incontinence (FI). The second-generation Eclipse System is comprised of a vaginal insert in the form of an inflatable balloon that is placed in the same location as a tampon or a diaphragm. The insert is composed of a base portion, an inflatable balloon portion, an inflation tube, and a self-closing Luer valve connection. The base portion positions the balloon and helps maintain the placement of the insert in the vagina. The balloon itself is made of thin walled silicone, with an enclosed, non-body contacting polyurethane liner to minimize air loss. The silicone inflation tube terminates in the self-closing Luer valve that connects to the patient pump.

The pump itself is fitted with a removable regulating valve that controls the amount of air introduced to the inflatable balloon. During inflation, the pump is squeezed seven to ten times to adequately fill the balloon, with any excess air vented out by the regulator. When inflated, the balloon exerts pressure

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through the vaginal wall, occluding the rectal area and providing immediate bowel control. The patient can inflate and deflate the device at home when needed, thus reducing the number of FI episodes and protecting from unwanted stool passage. The device is removed periodically for cleaning.

The insert is initially fitted using a sizing tool to assist with customizing insert size, and is inflated to the correct volume by a clinician to determine the correct regulator valve. A trial insert is available to allow patients to evaluate the therapy before deciding whether it works for them. The system is available in three base sizes and two balloon sizes, and is intended for women 18–75 years old who have had four or more FI episodes during a two-week period. The Eclipse System is a product of Pelvalon (Sunnyvale, CA, USA; www.pelvalon.com), and has been approved by the US Food and Drug Administration (FDA).

“With this FDA clearance for our next-generation Eclipse, we are excited to initiate the first phase of our commercial launch in select centers of

excellence,” said Miles Rosen, CEO and co-founder of Pelvalon. “We believe that this early phase of partnership with thought and practice leaders in the field of pelvic floor disorders will ensure a smooth expansion down the road.”

“Eclipse is a nonsurgical therapy offering immediate bowel control that can be used early in the treatment pathway,” said Holly Richter, MD, director of the division of urogynecology and pelvic reconstructive surgery at the University of Alabama (Birmingham, USA).

FI is the inability to control bowel movements and is a common problem, especially among older adults. It affects women about twice as often as men, most probably due to childbirth, nerve or muscle damage in the pelvic region, or gastrointestinal disorders such as irritable bowel syndrome (IBS). First-line treatments include dietary changes, exercise, and medication; if the issue persists, patients may need to move on to more invasive and costly treatments, such as surgery, surgical implants or injections.

Next-Generation Cervical Disc Treats Degenerative Disease new artificial disc system is designed to provide a long term, flexible alternative for cervical disk replacement procedures.

The Rhine cervical disc system features a one-piece compressible elastomeric polymer core with dome-shaped, plasma-coated endplates and a central-split keel that are intended to minimize wear and tear between the polymer core and metal endplates. Fabricated

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using a proprietary molding technology, the monolithic compressible polymer core design was shown to be comparable to the natural cervical disc when subjected to biomechanical testing.

The system also feature a streamlined instrumentation kit that simplifies the surgical technique by integrating both disc trialing and keel cutting into a single instrument, and also includes a built-in adjustable stop that

Heart Disease Etiology Impacts Catheter Ablation Outcomes new study reveals that cardiomyopathy etiology impacts the long-term outcomes of catheter ablation procedures. Researchers at Alfred Hospital (Melbourne, Australia; www.alfred. org.au), St Bartholomew’s Hospital (London, United Kingdom; www. bartshealth.nhs.uk), and other institutions conducted a study to examine the impact of cardiomyopathy etiology on long-term outcomes of catheter ablation in 101 patients between 2002 and 2014. The patients suffered from known heart disease (KHD; 77 patients) and idiopathic dilated cardiomyopathy (IDCM; 24 patients). All patients had a left ventricular ejection fraction (LVEF) lower than 45%.

The results showed that at threeyear follow-up, the IDCM group showed less functional impairment and improved LVEF than the KHD group. Super responders, with an ejection fraction improvement of more than 15%, were overwhelming-

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ly found in the IDCM group, and demonstrated greater AF control. The IDCM group also had significantly less all-cause mortality (1.3%) than the KHD group (17%). The study was published online on December 28, 2015, in the Journal of Cardiovascular Electrophysiology.

“Idiopathic dilated cardiomyopathy was associated with greater AF control and improvement in symptoms and LVEF, compared to patients with known heart disease post AF ablation,” concluded lead author Sandeep Prabhu, MD, MBBS, of the Alfred Hospital, and colleagues.

AF is a medical condition that can lead to serious adverse events, such as thrombi travelling from the heart to obstruct arteries supplying the brain, causing stroke, or other parts of the body causing tissue damage. AF affects an estimated one percent of the population, with nearly three million AF patients in the United States and six million AF patients in Europe.

allows for customized anterior or posterior positioning of the disc, based on surgeon preference. The Rhine cervical disc system is a product of K2M (Leesburg, VA, USA; www.k2m.com), and has received the European Community CE marking of approval.

“We are excited to receive a CE mark for our Rhine cervical disc technology, as it represents an important regulatory milestone event for K2M as we continue to build our product portfolio and penetrate the global spine market with innovative techniques and technologies,” said Eric Major, President and CEO of K2M. “We look forward to further expanding our international product offer-

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ing, and will remain focused on the complex spine category across all of our international markets.”

“The Rhine cervical disc system is manufactured through a proprietary over-molding process of elastomeric polymer that differentiates the system from the competitive offering,” said principal inventor of the Rhine, orthopedic surgeon Casey Lee, MD. “The first single and multi-level surgical procedures using the Rhine system were recently completed in Belgium and Germany. We are committed to showing successful clinical results and are initiating a prospective observational clinical study in multiple sites throughout Europe.”

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Surgical Techniques

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Endoscopic Device Streamlines Gastrointestinal Exams new rotatory resection tool facilitates the removal of mucosal lesions, such as polyps, along the entire gastrointestinal (GI) tract.

The Interscope EndoRotor System provides a streamlined means to resect flat lesions in the alimentary and gastrointestinal tract via a catheter inserted into the working channel of an endoscope. The device can resect 3–5 mm lesions in a single tap, once the vacuum function is engaged. As the rotating resecting blade cuts the tissue, it is drawn into the device via suction; the sample is then transported via suction to a specimen trap. Specimen collection is not influenced by tissue morphology (flat/sessile/depressed).

Once the operator resects the specimen, the need may arrive to isolate the specimen, obtain a lateral margin resection, or to remove specimens from a secondary site. To do so, the two halves of the specimen trap are separated, and the filter is removed and replaced with a new filter and resealed before the next procedure. The specimens in the used filter

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are then removed and can then be sent to pathology. The EndoRotor System is a product of Interscope (Worcester, MA, USA; http://interscopemed. com) and has received the European Community marking of approval.

“The EndoRotor is an exciting invention that would be easier and safer than hot biopsy or snare for flat polyp removal when piecemeal removal is necessary,” said associate Prof. Norio Fukami, MD, of the University of Colorado. “This may be useful for clean up after piecemeal polypectomy or in replacement for cold snare polypectomy.”

Gastrointestinal endoscopic mucosal resection (EMR) is a procedure to remove cancerous or other abnormal lesions from the GI digestive tract. During EMR of the upper digestive tract, an endoscope is passed down the throat into the esophagus, stomach, or upper part of the duodenum. To remove lesions from the colon, the tube is guided up through the anus. If cancer is

present, EMR can help determine if the cancer has invaded tissues beneath the digestive tract lining.

First Use of Miniaturized Robots in Human Surgery miniaturized robotically assisted surgical device (RASD) has been used successfully for the first time in humans for colon resection.

The Virtual Incision (Pleasanton, CA, USA; www.virtualincision.com) RASD robotic platform features a small, self-contained surgical device that is inserted through a single midline umbilical incision in the patient’s abdomen. The technology is designed to utilize existing tools and techniques familiar to surgeons, and does not require a dedicated operating room or specialized infrastructure. The robot is also expected to be significantly less expensive than existing robotic alternatives for laparoscopic surgery, and will enable a minimally invasive approach to surgeries that are performed today using a large open incision.

The primary indication of the platform is currently colon resection procedures in patients with diverticulitis, Crohn’s disease, inflammatory bowel disease (IBD), and colon cancer. Approximately two-thirds of the two million resection procedures performed annually at this time involve an open surgical procedure with up to six weeks of recovery time. Because of the complicated nature of the procedure, existing robotically as-

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Image: The Interscope EndoRotor system (Photo courtesy of Interscope).

sisted surgical devices are rarely used, and manual laparoscopic approaches are only used in one-third of cases due to their difficulty and complexity.

“To the best of our knowledge, this is the first time an active miniaturized robot has performed complex surgical tasks with the robot inside a living human, which is a significant milestone in robotics and in surgery,” said Shane Farritor, co-founder and chief technical officer of Virtual Incision. “The robotically assisted colon resection procedures were completed in Asunción, Paraguay, as part of the safety and feasibility trial for the technology. The surgeries were successful and the patients are recovering well.”

“Virtual Incision’s robotically assisted surgical device achieved proof-of-concept in highly complex abdominal procedures,” said head surgeon Dmitry Oleynikov, DM, chief of minimally invasive surgery at the University of Nebraska Medical Center (Omaha, USA; www. unmc.edu), and co-founder of Virtual Incision. “Additionally, we verified that our extensive regimen of bench, animal, cadaver, biocompatibility, sterilization, electrical safety, software, human factors and other testing enabled the safe use of this innovative technology.”

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Surgical Techniques

Wireless Probe Detects Cancer Cells During Surgery ovel wireless probes inserted into the surgical wound identify cancer cells and suspicious lymph nodes by emitting an auditory alarm that directs the surgeon.

Developed by researchers at Ecole Polytechnique Fédérale de Lausanne (EPFL; Switzerland; www.epfl.ch), the Gamma and Beta probes are 20 centimeters long each and weigh around 100 grams, resembling a large pen. While the Gamma probe is an upgrade to similar devices already used, the Beta probe is a completely new device that is able to detect extremely small specimens of cancerous tissue by searching for positrons emitted by a tracer substance, which attaches to the cancer cells. Since positrons can only travel through a millimeter of tissue, when detected they pinpoint the tumor cells.

The Gamma probe does not directly detect cancer cells; instead, it finds a sentinel lymph node – the lymph node cancer cells reach before they make their way to the rest of the body – near the main tumor site. The lymph node can then be removed by the surgeons and used to stage the disease. If the sentinel lymph node is free of cancer cells, it means that the tumor has not spread. Both probes were tested at University Hospital Lausanne (CHUV; Switzerland; www.chuv.ch), after earning the European CE mark in early 2015.

“The probe has a little window at one end that picks up the gamma rays or positrons given off by the substance injected into the patient,” said Edoardo Charbon, director of the Advanced Quantum Architecture Lab (AQUA) at EPFL. “A scintillator converts the energy of the rays into photons, which are then detected by a highly sensitive sensor.”

The positron is the antimatter counterpart of the electron; it has an electric charge of +1 e, a spin of ½, and has the same mass as an electron. When a lowenergy positron collides with a low-energy electron, annihilation occurs, resulting in the production of two or more gamma ray photons. Positrons may be generated by positron emission radioactive decay (through weak interactions), or by pair production from a sufficiently energetic photon, which is interacting with an atom in a material.

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Image: The EPFL Beta probe (Photo courtesy of EPFL).

Sacral Neuromodulation System Treats Urinary and Fecal Dysfunction novel rechargeable, implantable, sacral neuromodulation (SNM) system helps in the treatment of overactive bladder (OAB), fecal incontinence, and urinary retention.

The Axonics SNM System helps in the management of urinary and fecal dysfunction by modulating the sacral nerve, which controls everyday function of the pelvic floor, urethral sphincter, bladder, and bowel. The system includes a miniaturized implantable pulse generator that promises to last 15 years, more than three times longer than currently marketed non-rechargeable SNM devices. In addition, the system features a patient-friendly remote control and an intuitive clinician programmer that guides and supports physician implanters throughout the procedure, from lead placement to programming.

The system works by imitating a signal sent via the central nervous system (CNS) when the nerves in the sacral area and the brain no longer communicate effectively, resulting in a bowel/bladder disorder. By stimulating the sacral nerve, a signal is sent that manipulates a contraction within the pelvic floor. Over time these contractions rebuild the strength of the organs and muscles, alleviating or eliminating symptoms of the urinary/fecal disorder. The Axonics SNM System is a product of Axonics Modulation Technologies (Irvine, CA, USA; www.axonicsmodulation.com), and has received the European Community CE mark of approval.

“Axonics has successfully developed a unique product to deliver SNM therapy that we believe will greatly improve the patient and clinician experience,” said Raymond Cohen, CEO of Axonics.

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“We look forward to treating patients in our upcoming post-market clinical follow up (PMCF) study.”

“The Axonics device promises increased patient comfort given its small size and moreover, the fact that it is rechargeable and can function three times longer in patients will eliminate the need for repeat surgeries to replace non-rechargeable devices that currently require replacement every four or five years,” said Prof. Karen Noblett, MD, of the Univer-

sity of California Riverside (UCR; USA; www.ucr.edu) School of Medicine.

OAB affects more than 37 million people in the United States alone, with a significant impact on the quality of life of suffers by affecting social activities, disrupting exercise, and causing disruptive nighttime voiding. Despite this, only 33% of those suffering seek treatment, and as many as 70% stop using their medication within six months, due to intolerable side effects or unsatisfying results.

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PRODUCT NEWS CENTRAL STATION MONITOR

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MEDICAL TABLET

MEDICAL TERMINAL

Fukuda Denshi

IEI Technology

Advantech

The DS-8900 features a 26-inch full HD touch display with dual screen capability, and enables continuous visual monitoring of up to 32 patients. It provides clear patient data and alarm identifications, with up to 120 hours of full disclosure storage.

The ICEFIRE 2 tablet features an LCD screen and is powered by the Intel Atom N2800 processor, with 8GB of storage. It offers a 1.3/3.0 MP front/rear camera, along with 1D/2D barcode reader and RFID reader, and offers Bluetooth, Wi-Fi, and 3.75G wireless connectivity options.

The HIT-W121B infotainment terminal features an 11.6-inch touch screen and is powered by an Intel Celeron Quad core processor. It is available in various modules such as bedside info terminal, nurse/emergency call, pharmacy info system, mobile nurse cart and self-serve hospital kiosks.

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Smart Printed Sensors Monitor Movement Sequences novel motion sensor material can be printed onto different textiles, enabling smart garments that can track activity. Developed by researchers at the Fraunhofer Institute for Silicate Research (ISC, Würzburg, Germany; www.isc.fraunhofer.de), the sensor materials are thinner than a human hair, and so hardly noticeable when embedded in a garment; they are also flexible and transparent. The manufacturing process includes two steps: first, the sensor pattern is printed; then, the sensors are subjected to an electric field that aligns the piezolectric polymers so as to adopt the targeted pressure sensitivity.

The sensors do not require any power source, but harvest energy to power themselves.

According to ISC, the cost-efficient screenprinting process of the piezoelectric polymer sensor is key to the mass production of printed sensors on textiles, with freedom of design in color and form for the garments. And since they register pressure and deformation, they are also suitable for a range of applications besides integration into smart textiles, such as in touch or motion sensors. Their thermal sensitivity also enables monitoring of temperature variations or noncontact interaction, such as in proximity sensors.

ISC and the Fraunhofer Institute for Silicon Technology (ISIT; Itzehoe, Germany; www.isit.fraunhofer.de), together with several industry partners, will incorporate the sensors into a prototype shirt that will feature a number of functions, including monitoring movement sequences. The next development steps will include field testing on several types of textiles and applications, further optimization of the electronics, and wear and washability tests. The innovative textile was presented at IDTechEX Europe, held in Berlin (Germany) during April 2016.

Smart textiles can be used in healthcare or assisted living settings to monitor

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everyday life. Additionally, it would be possible to monitor vital signs such as temperature or respiration, which could be especially beneficial for bedridden patients or babies. Last but not least, functional sensor clothing could achieve cost reductions in the health care system by promoting preventive health care.

Image: Non-transparent printed sensors (Photo courtesy of K. Selsam-Geißler, Fraunhofer ISC).

University Hospital in Finland to Install First Fully Digital Pathology Department university hospital in Finland plans to extend its existing PACS to include pathology images significantly improving hospital workflow and diagnostics by facilitating cooperation between radiologists and pathologists in the hospital.

The inclusion of digital pathology in the hospital workflow is a critical step towards improving patient care because it brings improved efficiency in pathology image storage, image review, and sharing.

Sectra’s (Linköping, Sweden; www.sectra.com) digital pathology solution will be installed at the Diagnostic Imaging Center at Kuopio University Hos-

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pital (Kuopio, Finland; www.psshp.fi/web/en).

The pathology department of the Kuopio University Hospital has a staff of eight pathologists, and currently processes approximately 100,000 glass slides, and 27,000 histological, and cytological exams every year.

The Sectra digital pathology solution provides a complete primary diagnostics solution including image archiving, image storage and review workstations. The solution is based on the same platform as Sectra’s radiology Picture Archiving and Communications System (PACS), enabling images from both diagnostic specialties to be stored and displayed on one system, and facilitating multidisciplinary

rounds for integrated diagnostics. The solution will also be integrated with the hospital’s Laboratory Information Management System (LIMS).

Other hospitals in Europe and Scandinavia are also in the process of digitizing their pathology departments. Digital pathology for primary diagnostics is still pending US FDA approval in the US. Vesa Kärjä, adjunct professor and chief of Clinical Pathology, Kuopio University Hospital, said, ”With this enterprise imaging solution, we will increase efficiency in pathology as well as improve overall patient care. The investment is a crucial step in our strategy to improve workflow and diagnostics for better patient care.”

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California Hospital Pays Ransom to Computer Hackers

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Image: The Hollywood Presbyterian Medical Center (Photo courtesy of HPMC).

ollywood Presbyterian Medical Center (HPMC; Los Angeles, CA, USA; www.hollywoodpresbyterian.com) has paid ransom to regain control of its data, after its computer system was taken hostage by hackers. HPMC staff had problems accessing the hospital’s computer network for several days, following which the information technology staff (IT) staff discovered malware that encrypted certain network files that prevented user access to the hospital electronic medical record (EMR) system. Unnamed hospital sources said that he locked-down computer systems were also used for the sharing of lab work, X-rays, and computerized tomography (CT) scans.

The hospital notified law enforcement agencies and hired computer experts to try and bring the system back online, but their recommendations proved ineffectual, and the hospital then decided to pay the ransom. The ransomware was paid using 40 bitcoins, which equals to roughly USD 17,000, following which the hackers gave the hospital the necessary decryption keys to unlock the files and gain back access. The hospital denied rumors that the ransom demanded was 9,000 Bitcoins, equal to USD 3.4 million. HPMC is cooperating fully with the Los Angeles police department (LAPD) and the FBI to attempt to discover the identity of the hackers.

“The quickest and most efficient way to restore our systems and administrative functions was to pay the ransom and obtain the decryption key. In the best interest of restoring normal operations, we did this,” said Allen Stefanek, CEO of HPMC. “HPMC has restored its EMR on Monday, February 15th. All clinical operations are utilizing the EMR system; all systems currently in use were cleared of the malware and thoroughly tested. We continue to work with our team of experts to understand more about this event.”

Ransomware can be spread to computer networks through phishing campaigns, in which unwitting users click on emails that appear to be legitimate correspondence. By clicking on a link on a fraudulent email, a user can potentially download malware that locks down the computer and then asks for a ransom to unlock the machine.

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3D VISUALIZATION SOLUTION

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The InteleViewer provides customizable toolsets and a flexible interface that allow radiologists to customize their reading and reporting workflow. It also helps maximize efficiency through its embedded critical results management, reporting templates, and communication tools.

The PROcedure Rehearsal Studio creates a patient-specific 3D model based on CT images, and a segmentation process to help clinicians prepare for upcoming procedures. It allows files to be exported to a virtual environment or printed on 3D printers for pre-operative treatment options.

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Neuroimaging May Help Track Brain Volume in MS Patients new software tool could enable the accurate identification and quantification of ventricular volume in multiple sclerosis (MS), despite variability in brain shapes and scanning technology used.

Developed by researchers at the University at Buffalo (NY, USA; www.buffalo.edu), the Neurological Software Tool for Reliable Atrophy Measurement in MS (NeuroSTREAM) tool estimates brain atrophy by measuring lateral ventricular volume (LVV), one of the brain structures that contain cerebrospinal fluid (CSF); when atrophy occurs, the LVV expands. Since the LVV is anatomically distinctive and strategically located in the center of the brain, focusing on it provides a metric that is relatively immune to the adverse impacts of imprecise positioning, gradient distortions, incomplete head coverage, and other motion and wraparound artifacts.

The new tool simplifies the calculation of brain atrophy based on data from routine magnetic resonance imaging (MRI) scans, by comparing them to a database bank of 20,000 brain scans taken from of MS patients. The software runs on a user-friend-

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ly, cloud-based platform that is easily available from workstations, laptops, tablets, iPads, and smartphones. The software is specifically designed to work with low-resolution MRI scanners, such as those normally found in clinical practice.

Preliminary results presented at the American Academy of Neurology (AAN) meeting, held during April 2016 in Vancouver (Canada), show that NeuroSTREAM can provide a feasible, accurate, reliable, and clinically relevant method of measuring brain atrophy in MS patients. The researchers ultimate goal is to develop a user-friendly website to which clinicians can upload anonymous scans and receive real-time feedback on what the scans reveal. The study describing NeuroSTREAM was published in the July 2016 issue of Expert Review of Neurotherapeutics.

“Without measuring brain atrophy, clinicians cannot obtain a complete picture of how a patient’s disease is progressing. Measuring brain atrophy on an annual basis will allow clinicians to identify

which of their patients is at highest risk for physical and cognitive decline,” said lead author professor of neurology Robert Zivadinov, MD, PhD, of the Buffalo Neuroimaging Analysis Center. “Physicians and radiologists can easily count the number of new lesions on an MRI scan; but lesions are only part of the story related to development of disability in MS patients.”

Image: Brain scans of patients with the LVV highlighted in red (Photo courtesy of the University at Buffalo).

Cloud-Based Medical Imaging Suite Improves Access large Internet cloud-based, medical image management suite is being used to power the exchange of images for non-profit organizations, and improve access to high-quality healthcare and second opinions for underserved communities around the globe.

According to the World Health Organization (WHO; Geneva, Switzerland; www.who.int), around four billion people are in urgent need of radiology services. Access to medical imaging is an important part of patient care and such tests are being made available to underserved communities worldwide by non-profit organizations.

The DICOM Grid (Phoenix, AZ, USA; www.di-

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comgrid.com) – a Software as a Service (SaaS) – provides one of the largest cloud-based medical image management suites available. DICOM Grid is donating part of the subscription fees and implementation services of the image management suite used by RAD-AID (Chevy Chase, MD, USA; www.rad-aid.org), Partners In Health (Boston, MA, USA; www.pih.org), and thesecondopinion (San Francisco, CA, USA; http://thesecondopinion.org).

RAD-AID is using DICOM Grid in Nepal to provide cloud Picture Archiving and Communications System (PACS) services, and performs around 100150 exams every day in the country. Partners In Health is using DICOM Grid to providing modern

medical imaging services to underserved communities in Haiti by sending imaging studies from a Mirebalais hospital in Haiti to volunteer radiologists in the US. Thesecondopinion uses DICOM Grid to provide improved imaging services for cancer patients with limited medical resources in the US. According to Louise Secordel, program coordinator of the Medical Informatics Team of Partners In Health, said, “Since moving to DICOM Grid, the image transfer success rate has dramatically improved to 100%. As our hospital volume continues to grow with over 1,000 patient visits a day, fewer technological issues give us more time to focus upon education and preventive care.”

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Wearable System Helps Predict Asthma Attacks new study describes an integrated, wearable system that monitors the user’s environment and other physical attributes, with the goal of predicting and preventing asthma attacks.

Developed at North Carolina State University (NC State, Raleigh, USA; www.ncsu.edu) and the University of North Carolina (UNC, Chapel Hill, USA; www.unc.edu), the Health and Environmental Tracker (HET) system incorporates a host of novel sensing devices integrated into a wristband, as well as an adhesive patch that is placed on the chest which includes sensors that track the patient’s movement, heart rate, respiratory rate, amount of oxygen in the blood, skin impedance, and wheezing.

The wristband focuses largely on environmental factors, monitoring volatile organic compounds and ozone in the air, as well as ambient humidity and temperature. The wristband also includes sensors to monitor motion, heart rate, and the amount of oxygen in the blood. The system also includes one non-wearable compo-

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nent – a spirometer, which patients breathe into several times a day to measure lung function. Data from all of the sensors is transmitted wirelessly to a computer, where custom software collects and records the data.

The study was published on May 26, 2016, in IEEE Journal of Biomedical and Health Informatics.

“Right now, people with asthma are asked to use a peak flow meter to measure lung function on a day-today basis. That information is used to inform the dosage of prescription drugs used in their inhalers,” said lead author James Dieffenderfer, a PhD student in the joint biomedical engineering program at NC State and UNC. “For HET, we developed a customized self-powered spirometer, which collects more accurate information on lung function and feeds that data into the system.”

“Our goal was to design a wearable system that could track the wellness of the subjects, and in particular provide the infrastructure to predict asthma attacks so that the users could take steps to prevent them by

changing their activities or environment,” said senior author assistant professor of electrical and computer engineering Alper Bozkurt, PhD, of NC State. “Once we have that data, the center can begin developing software that will track user data automatically and give users advance warning of asthma attacks.”

In asthmatics, the latent inflammation of the bronchial tubes generally spreads long before the patients actually feel anything. If the inflammation is intense, the air passages constrict and the patient has an asth-

ma attack. The attacks can be so serious that the patient has to be hospitalized, which is why many asthma sufferers regularly take anti-inflammatory medication. Previously, the only way to detect impending asthma attacks was to conduct pulmonary examinations to determine if the patient’s breath contained heightened levels of nitrous monoxide (NO), which signal such an attack.

Image: Researchers work with the HET system wristband (Photo courtesy of NC State University).

Vendor Selected for Implementation of Cloud-Based Image Sharing Project in France medical imaging systems and Information Technology (IT) solutions provider has been selected to implement the Shared Regional Medical Imaging Services (S-PRIM) project in the large Île-de-France region in France.

The S-PRIM project follows on from the Region Without Film (RSF) project and will enable rapid implementation of a shared medical imaging infrastructure in the Île-de-France region. The project will include migration of archiving and Picture Archiving and Communication System (PACS) systems, and innovative new services for public and private organizations in the region.

Groupement de Coopération Sanitaire (GCS) Service Numérique de Santé (GCS Sesan; Paris, France; www.sesan.fr) awarded the tender to Carestream (Rochester, NY, USA; http://www.carestream.com). The award includes Carestream’s Software as a Service (SaaS) Vue Cloud platform. The cloud-based services will include secure medical imaging data sharing and exchange to facilitate collaboration in the Île-de-France

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region. The services will also include creation of a unique and holistic patient folder, the ability to create integrated clinical pathways and treatment plans, and results sharing with prescribing doctors and patients using a secure portal. Dynamic multimedia enhanced reporting and advanced post-processing tools natively integrated in the diagnostic viewer are also included in the project.

Patrick Koch, managing director, Carestream France and Benelux, said, “We are proud to welcome GCS Sesan, with the S-PRIM project, into the community of partners putting their confidence in Carestream. This includes the hospitals in the AP-HP hospital group (the Greater Paris University Hospitals – the largest hospital group in Europe), the Midi-Pyrenees, Central, Pays de la Loire and Provence-Alpes-Côte d’Azur. Subscribing hospitals will be connected gradually to our Vue Cloud platform, which is already being used by more than 100 healthcare establishments in France and for which we have accreditation from the French government to host personal medical data.”

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Skanska Wins Bid to Overhaul Medical Center in Western Florida

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kanska (Stockholm, Sweden; www.group.skanska.com) has been awarded a USD 178 million contract for the expansion and overhauling of the Lee Memorial Health System (www.leememorial.org) Gulf Coast Medical Center (GCMC) in Fort Myers (FL, USA).

The project consists of the consolidation of two hospitals, Southwest Florida Regional Medical Center (Fort Myers, FL, USA) and GCMC to one campus, and includes a new, 34,000m² building, and overhauling of 4,500m² of existing area, adding additional floors along with numerous horizontal expansions. The new 229 bed hospital will include an emergency department (ED), laboratory, radiology department, a combined med-surg department, a surgery department with 22 operating rooms, a new central energy plant, a kitchen space, a new dining facility and atrium, a pharmacy, and a 1,300 space parking structure.

The existing GCMC is a 218-bed acute-care hospital manned with 460-member medical staff and more than 1,000 employees and caters to the residents in Fort Myers and surrounding Bay County (FL, USA). The hospital also features a 42-bed critical care unit, which includes a 20-bed adult-level Intensive Care Unit (ICU), the region’s only four-bed Pediatric ICU, and an 18-bed Level III neonatal ICU. GCMC also offers a cancer program accredited by the American College of Surgeons (ACS) commission on cancer.

Skanska will claim a 89% share of the total contract value of USD 200 million, through a joint venture company that will be formed with Gates Construction (Bonita Springs, FL, USA; www.gatesinc. com), which will hold the remaining 11%. Skanska will begin construction work in July 2016, and the project is scheduled to be completed in 2021.

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Korean Hospital Inaugurates Proton Therapy Facility amsung Medical Center (SMC; Seoul, South Korea; www.samsunghospital.com) has opened a new proton therapy facility for cancer treatment, equipped with a cyclotron and two rotating gantries.

The SMC proton therapy facility will provide two different irradiation nozzle systems, including a multi-purpose nozzle in the first treatment room that can offer both conventional broad beam irradiation and advanced pencil beam scanning (PBS); irradiation modes can be switched on demand, depending on the target diseases. The second treatment room provides a dedicated scanning nozzle that offers PBS for larger fields (maximum 40x30 cm). A future, third treatment room is planned with a rotating gantry.

PBS delivers narrow proton beams to the targeted cancer tissue conforming to the shape of tumor, enabling complex tumors to be irradiated precisely with concentrated high doses, while minimizing side effects for surrounding healthy tissues. In comparison with broad beam irradiation, preparation prior to treatment is easier, and the consumable cost for patient’s specific compensators and collimators can be decreased by PBS. The broad beam treatment room (G1) opened in December 2015, and the large field PBS treatment room (G2) was launched in March 2016.

SMC is one of the leading hospitals in Korea, with almost 2,000 patient beds, a staff of 8,000, and over 150,000 patients treated annually. It is composed of Samsung Seoul Hospital Kangbook Samsung Hospital, Samsung Changwon hospital, and the Samsung Life Sciences Research Center. SMC was founded in 1994 under the philosophy of “contributing to improving the nation’s health through the best medical service, advanced medical research, and development of outstanding medical personnel.”

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Image: The Gulf Coast Medical Center (Photo courtesy of GCMC).

Hospital News

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IBM’s Watson Healthcare Platform to Improve Cancer Treatment in China wenty-one hospitals in China will adopt the IBM (Armonk, NY, USA; www. ibm.com) Watson Healthcare platform as part of a multiyear push toward personalized and evidencebased cancer treatment.

IBM will work with healthcare services organization Hangzhou Cognitive Care (Beijing, China) to introduce Watson for Oncology, a cognitive computing platform for physicians developed by Memorial Sloan Kettering Cancer Center (MSKCC, New York, NY, USA; www.mskcc. org) to deliver personalized, evidence-based cancer treatment options. The initial 21-hospital introduction is part of a far-reaching, multi-year partnership through which Hangzhou Cognitive Care will introduce Watson for Oncology to hospitals across China.

Watson for Oncology will help doctors customize treatments by analyzing massive volumes of medical literature to select individualized treatments by quickly summarizing patient records and scoring and ranking them. It works from a bank of more

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than 300 medical journals, more than 200 textbooks, and close to 15 million pages of text, as well as peerreviewed studies and clinical guidelines to offer recommendations on possible treatment options. And its machine learning capacity means that it will only improve over time.

Hangzhou Cognitive Care will support the Watson rollout in China by localizing Watson for Oncology, offering translation support so that insights, such as drug labels and treatment guidelines, will be available to customers and patients in Chinese. Cognitive Care will also localize dosing based on Chinese medical guidelines, and will build on its regional network of teleconsultation system service providers tapping into their knowledge of the region, the medical community, and the health needs of the population.

“IBM is committed to working with Cognitive Care as the first mover in China to bring Watson Health technologies into this market,” said Deborah DiSanzo, general manager for IBM Watson Health.

“Health leaders in Asia-Pacific are leading the way globally in advancing

cancer care. The 21 hospitals in China that will adopt the Watson for Oncology offering join world-class facilities that are offering the power of Watson to their physicians and the adoption of Watson in China is indicative of the momentum we are seeing among health professionals worldwide for IBM’s unique cognitive computing platform.”

“Hangzhou Cognitive Care is eager to bring IBM’s Watson for Oncology to reach every oncologist in China we possibly can,” said Zhen Tu,

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Image: The IBM Watson healthcare platform (Photo courtesy of IBM).

One-Third of Developing World Hospitals Lack Running Water new study reveals that more than one-third of hospitals in low- and middle-income countries (LMICs) lack running water, a deficiency that can lead to unsanitary conditions for patients in general and dangerous conditions for those who need surgery.

Researchers at Stellenbosch University (SU, South Africa; www.sun. ac.za), Johns Hopkins University (JHU, Baltimore, MD, USA; www. jhu.edu), Komfo Anokye Teaching Hospital (Kumasi, Ghana; www. kathhsp.org), and other institutions conducted a search for surgical capacity assessments in LMICs. They also extracted data regarding water availability from MEDLINE, PubMed, and the World Health Organization (WHO) global health library. National indicator data from the World Bank (Washington DC, USA; www.worldbank.org) was used to create a predictive model for water availability in LMICs globally.

The researchers successfully identified 19 surgical capacity studies undertaken between 2009 and 2015 that included information on water availability, covering 430 hospitals in 19 nations. They found that 147 of the 430 hospitals lacked continuous running water (34%), ranging from less than 20% of hospitals with running

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CEO of Hangzhou Cognitive Care.

IBM has established a number of partnerships around its Watson Health division, notably teaming up with the American Diabetes Association to apply cognitive computing to clinical and research data, and deploying the Watson Genomic Analysis cloud-based service to help 14 hospitals across the United States provide personalized cancer treatment.

water in Liberia to more than 90% in Bangladesh and Ghana. The study was published on June 17, 2016, in The Journal of Surgical Research.

“Running water is something we so take for granted, and it doesn’t exist in a third of hospitals in these countries,” said study co-author Adam Kushner, MD, MPH, of the JHU Bloomberg School of Public Health. “Instead of water just being there, some hospitals truck in water or collect it in rain barrels, with no guarantee of its cleanliness. Without clean water, there is no way to clean surgeons’ hands or instruments, wash gowns and sheets, or clean wounds to prevent or reduce infections.”

“Hopefully, people aren’t operating in those conditions, but what do you do if a woman shows up in obstructed labor and needs an emergency C-section, and it’s the dry season and the rain barrel is empty,” concluded Dr. Kushner. “You can’t operate with dirty instruments, but if you don’t she’s going to die. This is the sort of dilemma that surgeons in these hospitals face. In order to provide basic health care, you need a functioning system and running water is part of that. It shows the deficiencies in the health systems in general in those countries.”

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Industry News

Boston Scientific to Acquire EndoChoice oston Scientific Corporation (Marlborough, MA, USA; www.bostonscientific.com) has agreed to acquire EndoChoice Holdings, Inc. (Alpharetta, GA, USA; www.endochoice.com), which will become part of its endoscopy business after completion of the transaction.

Boston Scientific develops, manufactures and markets medical devices used in a range of interventional medical specialties, including interventional radiology, interventional cardiology, peripheral interventions, neuromodulation, neurovascular intervention, electrophysiology, cardiac surgery, vascular surgery, endoscopy, oncology, urology and gynecology.

EndoChoice focuses on the manu-

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facturing and commercialization of platform technologies including endoscopic imaging systems, as well as devices, infection control products and pathology services for gastrointestinal specialists. The company’s portfolio includes single-use devices, such as resection and retrieval devices, needles, graspers and infection control kits.

Both the companies have entered into a definitive agreement under which Boston Scientific will launch a tender offer for all of EndoChoice’s outstanding shares at a cash price of USD 8 per share. The total equity value of the deal is approximately USD 210 million and the transaction is expected to close in the fourth quarter.

Siemens and IBM in Global Alliance For Public Health Management iemens Healthineers (Erlangen, Germany; www.healthcare. siemens.com) and IBM Watson Health (Armonk, New York, USA; www.ibm.com/watson/health) have entered into a five-year, global strategic alliance in Population Health Management (PHM). The alliance will assist hospitals, health systems, integrated delivery networks, and other providers in delivering valuebased care to patients with complex, chronic and costly conditions, like heart disease and cancer.

Both the companies plan to assist healthcare professionals in navigating unprecedented changes driven

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by a growing volume and diversity of health data, an aging global population, increasing prevalence of chronic diseases, changes in healthcare payment models, and the digitization and consumerization of healthcare.

Siemens Healthineers will offer PHM solutions and services from IBM Watson Health that are designed to help meet hospital and healthcare systems' demands for value-based care analytics and reporting, and patient engagement. The company will also provide consulting services to support providers in their transition to value-based care.

Global Digital Imaging Systems Market To Reach USD 38 Billion by 2024 he global medical digital imaging systems market is expected to record a CAGR of around 4.5% over the period 20142024 to reach USD 37.9 billion by 2024, driven by increasing awareness about the benefits of early diagnosis, rising prevalence of chronic diseases, such as cancer and cardiovascular diseases, and availability of digital screens with higher resolution and three-dimensional views in diagnostic devices.

These are the findings of Grand View Research, Inc. (San Francisco, CA, USA; www.grandviewresearch. com), a market research and consulting company.

Product-wise, the medical digital imaging systems market is segmented into X-ray devices, ultrasound systems, computed tomography (CT) scanners, magnetic resonance imaging equipment and nuclear imaging equipment.

By technology, the market is segmented into 2D, which includes black & white and color, and 3D and 4D. In 2015, the X-ray imaging devices segment held the largest share of the vertical and was valued at

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around USD 6.9 billion, driven by a large number of applications and increasing incidences of orthopedic injuries and diseases. 2D technology dominated the global market in 2015 due to the high awareness and low cost of these devices. North America held the largest market share during the year, led by a well-established healthcare infrastructure and high adoption of advanced diagnostic technology. Moreover, the rising adoption of routine screening due to government recommendations for routine checkups is pushing the demand for advanced image visualization devices in North America.

The integration of digital screens with diagnostic devices has led to a significant increase in their incorporation in screening procedures, as they help doctors in faster decision making by delivering higher image clarity and accuracy, and offering expanded capabilities. The huge scope for further development of digital screens and introduction of software that enable data digitalization are expected to drive innovation in the medical digital imaging systems market in the future.

Bruker to Acquire Preclinical PET Imaging Business ruker Corporation (Billerica, MA, USA; www.bruker. com) will acquire the preclinical imaging business of Oncovision (Valencia, Spain; www.oncovision. com), which will retain its clinical human imaging business, including the MAMMI PET, a breast cancer diagnostic device based on PET imaging.

Oncovision’s medical imaging devices are used by surgeons, radiologists, oncologists and nuclear physicians for the diagnosis and treatment of cancer, while Bruker provides scientific research instruments and analytical solutions in the areas of life science molecular research, applied and pharma applications,

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microscopy, nano-analysis and industrial applications, as well as cell biology, preclinical imaging, clinical research, microbiology and molecular diagnostics.

For the past five years, Bruker and Oncovision have been enjoying an exclusive marketing agreement for Albira PET/SPECT/CT systems, and have jointly developed the next-generation Albira Si with advanced Silicon photomultiplier (SiPM) technology, which boasts of the highest full field-of-view PET resolution and sensitivity. Both the companies have also worked together on a high-performance preclinical 3 Tesla SiPM-PET/ MRI system.

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International Calendar For a free listing of your event, or a paid advertisement in this section, contact:

International Calendar, HospiMedica International P.O.Box 802214, Miami, FL 33280-2214, USA Fax: 1-954-893-0038 • E-mail: info@globetech.net

DECEMBER 2016 MEDEXPO AFRICA 2016. Dec 1-3; Dar-es-Salaam, Tanzania; Web: www. expogr.com Euro Echo Imgaing 2016. Dec 7-10; Leipzig, Germany; Web: www.escardio. org/EACVI JANUARY 2017 2017 Gastrointestinal Cancers Symposium. Jan-19-21; San Francisco, CA, USA; Web: http://gicasym.asco.org Controversies & Updates in Vascular Surgery (CACVS 2017). Jan 19-21; Paris, France; Web: www.cacvs.org/en Arab Health 2017. Jan 30-Feb 2; Dubai, UAE; Web: www.arabhealth online.com 46th Annual Meeting of the Society for Critical Care Medicine (SCCM).

Jan 21-25; Honolulu, HI, USA; Web: www.sccm.org FEBRUARY 2017 ISET 2017 – International Symposium on Endovascular Therapy. Feb 4-8; Hollywood, FL, USA; Web: http://iset.org HIMSS Annual Meeting 2017 - Health IT Conference and Exhibition. Feb 923; Orlando, FL, USA; Web: www. himssconference.org MEDICAL JAPAN 2017. Feb 15-17; Osaka, Japan; Web www.medical-jpn.jp

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