Page 1

January / February 200

Issue 10 UNITED KINGDOM

IRELAND

Special Feature

coronaryheart.com

Inventory Management

Site Visit

Freeman Hospital, Newcastle

Education

• Heart Failure • Removing Knotted Catheters

Interview

Courage Trial Opinion -with Dr Chester, Dr Ludman, and Dr Gershlick

EMP

Hot Topic

LO

Dr Azfar Zaman - Freeman Hospital

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NT E M “Subscribe online for FREE!!”


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For further information please contact:

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CONTENTS

January / February 200

CORONARY HEART THIS EDITION 04

Editorial

0

Latest News

0

Hot Topic

Contents Freeman Hospital Site Visit

Page: 34

‘The COURAGE Trial Debate’

10

Interview ‘Dr Asfar Zaman Freeman Hospital’

14

Equipment Review ‘Ultra-Portable Ultrasound’

1

Special Feature

43

‘Integration of Inventory Control Systems’

21

Special Feature ‘Should hospitals adopt RFID for critical supply management’

24

Home Monitoring ‘For Pacemakers and ICD’s’

2

Education

‘Management of Knotted Intravascular Catheters and Foreign Body Removal’

4

Journal Trawl

4

Events Diary

4

Next Issue

47

Employment

Page: 43

Education ‘Heart Failiure’

34

Cardiac Site Visit ‘Freeman Hospital, Newcastle, UK’

3

Cardiac Site Visit ‘Main Line Health, PA, USA’

Page: 21 CORONARY HEART ™ 3


EDITORIAL

From the Editor Dear Reader

Coronary Heart Publishing Ltd 145 - 157 St John Street London, EC1V 4PY United Kingdom Email: admin@coronaryheart.com Phone: +44 (0) 207 788 7967 Fax: +44 (0) 207 160 9334

Visit us online at

www.coronaryheart.com Director / Chief Editor Tim Larner Clinical Editor Dr Simon Redwood Senior Consulting Editors Dr Richard Edwards Dr Rodney Foale Mr Ian Wright Mr Stuart Allen

ADVERTISING Wendy Rose Rose Media Ltd Email: sales@rose-media.co.uk CIRCULATION 2050 Cardiac Professionals (+800 for Advanced Angioplasty) Copyright 2006 by Coronary Heart Publishing Ltd. All rights reserved. Material may only be reproduced by prior arrangement and with due acknowledgment of Coronary Heart Publishing. The publication of an advertisement or product review does not imply that a product is recommended by Coronary Heart Publishing Ltd.

Disclaimer:

Welcome to the next generation of Coronary Heart. As promised from the last edition we have included several new sections designed with cardiologists in mind. We have steered away from the traditional journals full of cardiac studies to bring you a publication full of the right blend of easy to read advice. New sections include a Hot Topic, whereby we speak with various leading cardiologists about an issue affecting their practice. In this issue we look at the COURAGE trial (page 8). We have also added interesting interviews with Cardiologists around the UK, finding out about their work history, opinions on various topics, as well as what they do for fun. Dr Asfar Zaman from the Freeman Hospital kicks it all off (page 10).

Tim Larner Director

Further through you will find a factual comparison on ultra-portable ultrasound (page 14). This section is perfect for decision making in your practice when you are looking to upgrade or make a first purchase, to give you some knowledge before meeting with company representatives. For registrars we have included a section on how to problem solve various situations in the lab. On page 43 we have an interesting article written by the radiologists at Guy’s and St Thomas’ Hospital about removing knotted catheters and foreign bodies. Naturally this article will also be of interest to consultants. As you would have noticed though the main flavour of our publication heads towards the managers in cardiology, with Inventory Management featuring in this edition. Whilst many cardiologists may believe management doesn’t affect them, an increasing number are being asked to be involved, through attending regular management meetings, discussing a variety of topics from staffing levels to equipment purchases. Topics affecting you here are usually affecting other departments around the world, which is why we have writers from the United States regularly submitting articles. Finally for cardiac staff we have our education pages. Our education partners in the USA have again written another great topic, this time on Heart Failure (page 28). In regards to the ECG Problem Solving. It will be back in Edition 11. I am sure you will enjoy this issue, and if you have picked this up for the first time remember it is free, and you can get a regular copy sent to you just by subscribing online at www.coronaryheart.com.

- Tim Larner

COVER PHOTO (courtesy of Wavemark: Raul Navarro, Inventory Technician at UMass Memorial Medical Center in Worcester, MA.

Coronary Heart should never be regarded as an authoritative peer reviewed medical journal. Coronary Heart has been designed as a guide only, to inform readers who work in the cardiology environment about latest news stories and the different techniques used by others around the world. Whilst all care is taken in reviewing articles obtained from various companies and contributors, it is not possible to confirm the accuracy of all statements. Therefore it is the reader’s responsibility that any advice provided in this publication should be carefully checked themselves, by either contacting the companies involved or speaking to those with skills in the specific area. Readers should always re check claims made in this publication before employing them in their own work environment. Opinions expressed by contributors are their own and not necessarily those of their institution, Coronary Heart Publishing Ltd or the editorial staff.

4

CORONARY HEART ™


LATEST NEWS

CAUTION: Some products within this magazine may be restricted to specific regional usage, and may not be available in your region. Always check with the manufacturer to determine availability.

What’s New? Images courtesy Siemens Medical

Siemens New Robotic Artis zeego Imaging System

I

n late November 2007 at the 93rd Scientific Assembly and Annual Meeting of the Radiological Society of North America (RSNA), Siemens unveiled their new Artis zee® family of interventional imaging systems. The stand-out system though in the range is the revolutionary new Artis zeego®, which utilises robotic technology. The result is a multi-axis c-arm which gives advanced crosssectional imaging not achievable with traditional C-arm systems. Siemens claim “the Artis zeego makes it possible for the position of the isocenter to be adjusted according to the procedural needs or the height of the physician, which is particularly beneficial to a physician during lengthy procedures while wearing a heavy leadshielded apron. This adjustable isocenter also allows for off-center rotational angiography, supporting 3D imaging techniques and the Siemens syngo® DynaCT. “With the Artis zeego you can go from one position to another within a

Toshiba’s New Infinix System

interventional procedures. The new floor-mounted, single plane system features a multi-axis positioner for head-to-toe coverage. Combine this with a high-resolution 12”x16” flat panel detector for detailed cardiac images, and you have the perfect universal workhorse.

The rest of the zee family has enhanced image acquisition and processing to give sharply detailed images in both 2D and 3D. For more information email us at news@coronaryheart.com and reference: 1001

For more information email us at news@coronaryheart.com and reference: 1002

Image courtesy Toshiba

T

oshiba recently released their new Infinix™ VF-i/SP X-ray system, described as a universal cardiovascular system designed to accommodate diagnostic and

fraction of a second, which enables you to reproduce exact angulations during the same procedure without having to reinject contrast,” stated Michel E. Mawad, M.D., chief, Neurovascular Service, St. Luke’s Episcopal Health Hospital in Houston, Texas.

CORONARY HEART ™  


LATEST NEWS

What’s New? Siemens New Adaptive CT

Philips Unveil New CT & Xper Table

GE Innova + IVUS = Less Time

A

n late October 2007, results of a time-motion study of approximately 50 interventional coronary cases conducted at Providence Heart Institute in Columbia, SC, found the Innova IVUS cuts procedure time by up to 40%. The study was performed on the GE Innova 2100IQ with Innova IVUS and compared with another GE Healthcare Innova using Volcano’s S5 standalone IVUS system.

t RSNA, Philips released their new flagship product, the 256slice Brilliance iCT scanner. In just two beats Philips claim it can image the entire heart providing a highquality image with an up to 80% dose reduction compared with other scanners.

M

any smaller hospitals can’t justify the costs of a top of the range cardiac scanner which is good at some things and not others. Siemens though have come to the rescue with their new Somatom Definition AS system. Siemens claim it can adapt to virtually any patient or exam on the fly and with very low dose. Perfect for departments that need a scanner shared between cardiology, radiology, and emergency. Images courtesy Siemens Medical

The Definition AS will be available in 40-slice, 64-slice and 128-slice configurations. However for cardiac work you would primarily choose the 64 or 128. Email us at news@coronaryheart.com and reference: 1007 for information.   CORONARY HEART ™

Philips have also recently released their new Xper table specially designed for Cardiologists and Hybrid Surgery procedures. Whilst we have only seen the videos it seems to feature unique tilting mechanisms especially the side tilt which Philips claim gives easier access to the left femoral artery. Email us at news@coronaryheart. com and reference: 1008 for info.

I

Although the average time saved was only 2.5 minutes, in a lab whereby IVUS is used a lot the compound effect would be significant time savings, making for a more efficient department. Email us at news@coronaryheart.com and reference: 1009 for information.

Radi Focuses on HD Femoral Compression

been used on over 5 million patients worldwide, however when used in conjunction with a haemostatic dressing both deep and topical haemostasis can be achieved in one, easy to use, clinically validated and widely accepted product.

At TCT 2007, Radi Medical Systems Inc showcased the Femostop HD Femoral Compression System, and demonstrated that with the addition of a haemostatic dressing, it promotes dual-action hemostasis, reportedly reducing the need for stocking multiple haemostasis products.

How is this achieved?

The Femostop Plus Femoral Compression System has been on the market for over 10 years and has

For more information email us at news@coronaryheart.com and reference: 1004

The haemostatic dressing achieves topical haemostasis that facilitates clotting at the skin incision, while the Femostop provides external compression to facilitate clotting of the arterial puncture wound, thereby achieving deep haemostasis.


LATEST NEWS

What’s New? COOK Launches an EVOLUTION® for Lead Extraction

New Cardiac Technology

A

company in Israel called MediGuide Ltd have just received a CE Mark by European regulators for their new Guided Measurement Catheter (GMC). Used in conjunction with a Medical Position System (MPS). The company claim that the MPS is equipped on an X-ray imaging Cath Lab system and is intended for intravascular evaluation of coronary anatomy.

A

t the XIII World Congress on Cardiac Pacing and Electrophysiology in Rome, COOK Medical showcased their new EVOLUTION® Mechanical Dilator Sheath Set. The set is designed to easily remove pacemaker and ICD leads which may have become damaged, or caused infection or through the inability to implant new leads due to the presence of existing ones. At present leads can only be removed by laser extraction or the use of snares with the patient under local or general anaesthetic, which may have disadvantages in terms of cost, time and or potential patient adverse events. So how does the new COOK system work?

New Heart Test

A

For more information email us at news@coronaryheart.com and reference: 1003 The new test searches for a hearttype fatty acid-binding protein (H-FABP) which is released into the circulation following heart injury (myocardial ischemia). Alistair Hall, Professor of Clinical Cardiology at Leeds, stated “The H-FABP test is a major advance on what we had before. It appears to be able to detect milder and earlier degrees of heart injury than do current tests which detect heart cell death.” The study has been recently published in the American Journal of Cardiology and was funded by the British Heart Foundation.

The system enables real-time tip positioning and navigation, quantitative length measurement, 3D lumen reconstruction, qualitative 3D foreshortening indication and landmarking, in patients who are candidates for coronary angiography and/or Percutaneous Coronary Intervention (PCI). Visit www.mediguide.co.il for info.

Flexible Wireless ECG Patch

A

Belgium/Netherlands research center in nanoelectronics has developed a wireless ECG patch for the continuous monitoring of cardiac activity and heart rate. The electronics are placed on a flexible Polyimide substrate and textile integration, allowing flexibility and stretchability.

Image courtesy IMEC

new test has been developed at the University of Leeds which has the potential to reduce the number of patients needlessly admitted to hospital. If a patient admits with chest pain and doesn’t fit into a high or low risk category they are usually given a troponin test. However this can give both false negative and false positive results, meaning a patient could be wrongly admitted.

According to COOK the set comes in variable sizes and comprises a threaded barrel distal tip design. It consists of a flexible rotating sheath that succinctly separates fibrous binding sites from the leads that need extracting. A mechanical trigger rotates the sheath and the physician can easily feel the progress and is in total control.

CORONARY HEART ™ 7


The Cardiology Expert Panel

HOT TOPIC

The COURAGE Trial Debate Have the results from the COURAGE Trial influenced your decision making for aggressive drug therapy versus PCI in the treatment of patients with stable angina? Prof Anthony Gershlick Professor of Interventional Cardiology University Hospitals of Leicester

What is the COURAGE Trial? Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation The randomisation of 2,287 patients with stable Coronary Artery Disease (CAD) to be treated with aggressive drug therapy alone, or aggressive drug therapy along with stents. Over a period of seven years patients were followed up with a tabulation of results from the incidence of subsequent heart attacks and deaths.

Results? Basically there was no difference of outcomes between the two groups. Therefore stents did not improve the ability of aggressive drug therapy in preventing heart attacks and death in patients with stable CAD, however they did have better control of their symptoms.

Debate? Naturally this trial has divided some in the cardiology community, so we have brought together three well known physicians to present their points of view.

  CORONARY HEART ™

C

OURAGE was an important albeit mechistically flawed and therefore difficult to interpret trial. Accepting the failings of the study which have been well documented (Heart. 2007 Oct;93(10):1188-90. PCI or CABG: which patients and at what cost Gershlick T, Thomas M) the fundamental question is – who should get coronary angiography and percutaneous coronary angioplasty and when (ie at what stage in the natural history of their disease). The sequence is very simple and has been part of my practice for long before COURAGE was conceived. Patients present with chest discomfort/ pain/ shortness of breath on exertion. Public education should promote early presentation. There is some evidence that this has been the case but only since the cardiologist has encouraged (for example through “Rapid Access Chest Pain Clinics”) a low threshold for seeing and investigating such patients. COURAGE should not discourage primary care physicians or patients from presenting early through the misconception that medication only is “ok” and is all that is going to be offered. Such patients should have a good history taken and then be investigated non-invasively. Patients in

my practice are treated medically and if they fail to settle on relatively simple therapy (2 anti-anginal medications) or if the risk of significant coronary disease is high (multiple risk factors) or if they are young and the noninvasive test positive, then coronary angiography is mandated. It is a low risk investigation that provides important prognostic information. We spent too many years overcoming the hoops patients had to jump through to get coronary angiography to return to those dark days. If the angiogram shows prognostic disease (proximal disease in the LAD or in > two coronary arteries) then intervention should be considered. The choice between PCI and CABG is a mechanistic one depending on the likelihood of optimal success for that particular patient with those particular lesion(s). If the lesions are intermediate in severity (using a pressure wire if necessary), distally located or in side branches then the patient will be managed with optimal medical therapy. What COURAGE confirmed is that many such patients do not remain minimally symptomatic and what COURAGE tells us is that as such all patients should be monitored (by the patient or the primary care physician) and undergo PCI (or CABG) if they become symptomatic (nb the large crossover in COURAGE). This has always been my practice… appropriate assessment… appropriate non-invasive tests… low threshold for angiography and optimal medical therapy for those with low risk lesions- intervention for all others. Personally I am not sure what all the COURAGE fuss is about other than its failings as a trial to address an appropriate clinical question.


HOT TOPIC

Professor Michael R Chester Consultant Cardiologist & Director National Refractory Angina Centre, Royal Liverpool and Broadgreen University Hospital NHS Trust. Professor of Rehabilitation and Preventive health Education, Liverpool Hope University email chester@angina.org

Y

es, because COURAGE gives patients, and critics of the overuse of PCI in stable angina, the confidence to defer PCI until genuine conservative management has failed. For the past decade stable angina

Dr Peter F Ludman Consultant Cardiologist Queen Elizabeth Hospital University Hospital Birmingham Trust Birmingham No, the courage trial has not altered my management of patients with stable angina. It has simply reinforced my current treatment patterns. For the majority of patients with stable angina who are not at high risk (determined either non-invasively or at angiography) I have always reserved mechanical revascularisation (PCI or CABG) to treat patients who remain symptomatic despite good medical therapy, or who get side effects from

management guidelines have consistently emphasised the importance of optimal medical management (patient education, optimal antianginal medication and aggressive risk factor modification) prior to palliative revascularisation. Evidence shows that these elements of the guidelines are poorly implemented and consequently patient education is haphazard, compliance is poor, and harmful misconceptions are normal among angina sufferers and their carers.1 In my experience, many patients consent to PCI because of a mistaken belief that PCI is necessary to improve an otherwise bleak prognosis.2 Yet, as with RITA-2, COURAGE confirms that we should tell our patients that while, overall, PCI seems marginally superior to conservative management in terms of symptom improvement, it does not reduce major adverse cardiovascular events. This marginal advantage must be offset against a much more significant profile of PCIrelated risks. Patients should also be interested to learn that more than 70% of patients who were randomised to

anti-angina therapy. The courage trial confirms that PCI is not only extremely effective at relieving symptoms in such patients, but that it is also extremely safe compared with optimal medical therapy used alone. However, patients in the courage trial represent a minority of my practice, which is dominated by patients presenting with acute coronary syndromes, and also those at high risk. For many of these patients we have good evidence that they gain most benefit from a strategy of mechanical revascularisation combined with medical therapy at the outset.

optimal medical therapy were free of angina at three years compared to 13% who were angina-free at outset. Most importantly, COURAGE is just the encouragement patients and patient-centred healthcare professionals need to develop the therapeutic alliance that is recommended by the ESC and the General Medical Council and which is central to optimal rehabilitation and risk reduction. 3,4 1.

Heart patient survey shows too many people are leaving hospital without aftercare and advice June 2005. http://www.healthcarecommission. org.uk/newsandevents/pressreleases. cfm/widCall1/customWidgets. content_view_1/cit_id/1998 (accessed 10 Dec 2007)

2.

Bridson J, Hammond C, Leach A, Chester MR. Making consent patient centred BMJ 2003;327;1159-1161

3.

http://www.gmc-uk.org/guidance/ good_medical_practice/index.asp (accessed 10 Dec 2007)

4.

European Guidelines on cardiovascular disease prevention in clinical practice. Eur J Cardiovascular Prev 2007; vol 14 (suppl 2:S1-S113 http://www.escardio. org/knowledge/guidelines/CVD_ Prevention_in_Clinical_Practice.htm (accessed 10 dec 2007)

Next Issue: The results from the NICE Trial relating to Drug Eluting Stent usage should be in. We will speak with leading UK cardiologists on whether the results will affect their decisions in the cath lab. You can subscribe free for this publication online at www.coronaryheart.com

CORONARY HEART â„˘â€ƒ 


INTERVIEW

UNITED KINGDOM

Cardiologist Interview: Dr Asfar Zaman

Dr Azfar Zaman BSc, MB ChB, MD, FRCP Director, Interventional Cardiology Newcastle Upon Tyne Hospitals NHS Foundation Trust

Why did you decide to become an interventional cardiologist? Difficult question. Life rarely goes according to plan. As a medical student and a junior trainee my mission was to be a surgeon. I spent 3 months of my elective period with a really progressive unit at Johns Hopkins in Baltimore doing plastic surgery for 2 months, and a month at the Maryland Trauma Centre. When I came back to the UK plastics was what I wanted to do. Somewhere along the line, after house jobs, I decided that surgery wasn’t for me and chose medicine. In my first SHO job I worked with Alan Mackintosh at St. James’s in Leeds, an interventional cardiologist, and that was really my first exposure to a procedure based medical specialty and I decided to make this a career. To date, not too many regrets!

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CORONARY HEART ™

Where did you train?

Career Highlights?

I started with Dr Mackintosh for six months as an SHO A further 2 years in General Medicine with Drs Walker and Simmons was followed by research with Professor Ball and Dr Campbell Cowan in Leeds. After I completed my thesis I headed to London where I worked at the Royal London, Barts, and the London Chest working with Drs Dawson, MacDonald, Mills, Rothman, Dymond, Nathan, Spurrel and Hogan. My immediate supervisor was my senior registrar at the time, John Dean (now in Exeter) who was instrumental in guiding me through the chicanes of invasive cardiology. Two years in London was hard work which I really enjoyed and was the springboard for my cardiology career. I then moved to Cardiff as senior registrar to the University Hospital of Wales working with Drs Penny, Stephens, Buchalter, and Groves. After 2 years I was fortunate to get a Fulbright scholarship and an international scholarship from the BHF to spend time at Mount Sinai in Manhattan under Valentin Fuster. After 18 months I returned to Swansea then back to Cardiff and then to Newcastle.

I guess, breaking of the “umbilicalcord” when I left Leeds, because I trained there as a medical student, and did my initial cardiology training there. And to move from Leeds where I was established to London was a big change. However when I look back on my career it was the best thing that could have happened. It was a major decision, but what it taught me was that when you go to different units you learn different skills and learn to interact with different people. After that I moved around approximately every 2 years and have lived in several places. Newcastle is now the longest I have stayed in one cardiology institution.

Your position at the Freeman? I started here in April 2001 and the senior interventionist who was the director of the cath lab was Douglas Reid who I had enormous respect for. Six months after my appointment though, he retired. So it was around November of that year that responsibility for the catheter labs and PCI was handed to me.

The move to Mount Sinai in Manhattan was undoubtedly a career highlight, and the 18 months I spent there was probably the longest and best holiday of my career!!! It was hard work, but Manhattan is just so full of energy. It either energises you, or gets you down. And for me it was the former. When I think back on the long hours that I endured in the experimental labs it was so enjoyable because there were people from all over the world with a similar attitude and work ethic. The department worked you hard but the end result justified the means. In between the experiments and writing there was plenty of time to enjoy the city and its peoples.


INTERVIEW

Was London similar to Manhattan? Yes it was in that the experience of living in an energetic, cosmopolitan city was exciting. With respect to my roles they were of course, very different. In New York I was doing a research based job, which meant that I could do experiments when I wanted and the hours were decided by me. Weekends were largely free and I was able to explore much of the city in my time there. The pressures in London as a junior registrar in clinical cardiology were very different. A request for a late start or early finish from John Dean would usually be met by the sound of boot leather on gonad!!! The learning curve was steep!

Do you think that working overseas would increase a Registrars potential to gain employment in the UK in a higher role? The very first physician I worked for used to say that one of the most important qualifications in this country was a BTA - “Been To America”. Whether that is still the case today where there appears to be a balance between training and consultant jobs, I am not sure. I guess we still look for people today who have spent time out of their host institution as it reflects an individual’s ambition. I think it enhances the person and allows one to learn much faster- not necessarily in your subspeciality skills but in your interaction with other people.

If one has been abroad then it doesn’t do any harm - I wouldn’t wish to put it more strongly than that.

What do you think will be the next change in Cardiology in the next 5-10 years? That is a difficult question. The last 5-10 years have seen remarkable change in delivery of service to patients with coronary artery disease. My feeling is that over the next 5 years we will see a tapering off in demand for coronary intervention. There are mitigating factors such as obesity and diabetes, but I think as interventional cardiologists we now need to expand our repertoire. I think the biggest change we are seeing in this area is percutaneous valves. I believe we will go from performing

CORONARY HEART ™ 11


INTERVIEW

Dr Azfar Zaman (cont...) percutaneous coronary interventions to percutaneous cardiac interventions.

If you were on the table would you prefer a DES or Bare metal stent?

Secondly, we will be performing procedures on an increasingly elderly population and I think we will become interventionists of the elderly, both coronary and extra coronary. This will require a reappraisal of the risk profile of certain procedures for an increasingly elderly population.

You have asked this question at an important time! If you had asked 1 year ago I may have tossed a coin. Today, I can say with a degree of confidence that I would go for a DES. We now have very robust data from trials and registries showing DES to be safe and effective. Even with the small added risk of stent thrombosis, the overall benefits including target vessel revascularisation rates and mortality are in favour of DES. Of course, all members of the NICE committee would receive a bare metal stent!!

What is your position on Cardiac CT? This is an addendum to the above question. This is one area where we will see growth and there will be, over a period of time, diminution of the role of invasive diagnostic procedures as this is replaced by cardiac CT and MR. We are at a very early stage of cardiac imaging. Look at the rate of progress in echocardiography from the 1970’s when we were doing simple M-mode echo’s to where we are now. I would suspect we are in the early phase of growth with respect to CT and MR imaging. I can’t even begin to predict where we will be in 5-10 years’ time. Suffice to say I believe invasive diagnostic coronary angiography by that time will have been exceeded by non-invasive cardiac imaging.

PET scanning is a technique on the periphery of cardiology. What is your opinion on this area? I have very little experience of PET scans. My prediction would be, and this is from an ignorance of PET, that I think MR scans looking at myocardial function with novel contrast agents may fill the need that PET scans currently provide. But I certainly don’t know enough about the scope of PET scans to answer that question accurately. 12  CORONARY HEART ™

If the NICE results show it is best not to be using it will you change your opinion? It will definitely make life a lot more difficult for coronary interventionists having had the luxury of being able to make that decision in the best interest of the patient. I think to have that independence taken away, we would find it very difficult as a body to cope with. I will not change my opinion but may have to change my practice.

What can cardiologists benefit from coming to Newcastle rather than staying in London? A Life!!! With respect to cardiology, Newcastle offers a full range of services ranging from secondary cardiology to cardiac transplantation. Within percutaneous coronary intervention we provide a full range of adjunctive therapies, IVUS, rotablation, laser atherectomy, thrombectomy devices, filter wires. We have 5 dedicated catheter labs and one additional lab for device implantation. We have a large department that is very

sub specialty focussed. We have five cardiologists dedicated to secondary cardiology and based at the Royal Victoria Infirmary. Within Freeman we have: •

• • • •

5 NHS interventionists and 1 academic interventionist (1 new post to start April 2008). 6 EP and devices doctors (2 vacant posts at time of writing). 1 echocardiologists. 1 heart failure consultant. 1 cardiac transplant consultant.

So we offer a full range of invasive and non-invasive cardiology training and I think that is the big strength of cardiology training in Newcastle. Our percutaneous valve programme is intended to start next year. Academic cardiology in Newcastle received a boost with Professor Keavney being awarded the BHF chair of cardiology this year. For core training there is little difference from London, so clearly it is a lifestyle choice.

Hobbies and Passions outside of work? For my sins I am a fan of Leeds United. Up until this year I was a season ticket holder which I had been for 24 years until their relegation last year. I still go to most home games. In Newcastle I go to watch the Falcons (rugby union). I used to play a lot of sports, but due to knee injuries (and age) restrict myself to cricket over the summer months. I guess should mention my family here, in case my wife reads the article!!.


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Agfa and the Agfa rhombus are trademarks of Agfa-Gevaert N.V. or its affiliates. All rights reserved.


EQUIPMENT REVIEW

CARDIAC

Ultra-Portable Ult

Dimensions and Weight Depth: Width: Height: Weight:

Siemens Acuson P50

279mm 350mm 63.5mm 5 kg

Target Users + Studies • •

Cardiac and Vascular Scanning Able to perform all studies.

Siemens P10 Dimensions and Weight Lenght: Width: Height:

142mm 97mm 54mm

Weight:

0.73kg

Different modalities

Target Users + Studies

• • • • • • •

Cardiac and Vascular Scanning

2D fundamental and harmonic imaging Color Doppler Velocity Color Doppler Energy M-mode and Anatomical M-mode PW spectral Doppler CW spectral Doppler Duplex and Triplex PW and CW Doppler

Different modalities •

2D fundamental and harmonic imaging

Color Doppler Energy (Next Release)

Special Features (some optional) • • • • • • • • •

SieVision Imaging Stress Echo Package syngo® USWP License syngo® Arterial Health Package License (Intima-Media Thickness) syngo® Auto Left Heart License syngo® VVI License Intracardiac Echo (ICE) TOE with V5M Custom Cart

Special Features • • • • • •

Worlds First pocket ultrasound 10 Second Boot up TGO tissue grayscale optimization software 3.7inch diagonal LCD Screen Clip and Store Facilities with export via USB or SD card Docking station with dual battery charger

Compatibility with other units Digital connectivity with DICOM standard output to PACS and DICOM Modality Worklist

Cost £23,000 14

CORONARY HEART ™

Compatibility with other units Network connectivity with P10 Viewer software

Cost £5,600.00


EQUIPMENT REVIEW

trasound Systems GE Vivid i

Sonosite M-Turbo Dimensions and Weight Length: Width: Height: Weight:

302mm 274mm 79mm 3.04 kg (without battery)

Target Users + Studies •

Hospital Cardiologists ( portable/clinic studies), Community Screening Clinics, Cardiac Nurse Specialists, Cardiac Physiologists.

Full studies for target markets and screening services

Dimensions and Weight Depth: Width: Height: Weight:

313mm 358mm 59mm 4.9kg (with battery)

Target Users + Studies Cardiac and Vascular Scanning Able to perform all studies.

Different modalities

• • • • • • •

Imaging Modes and Processing: Broadband, multifrequency imaging: 2D / Tissue Harmonic Imaging / M-mode Velocity Color Doppler / Color Power Doppler PW, PW Tissue Doppler and CW SonoADAPT™ Tissue Optimization SonoHD™ Imaging Technology SonoMB™ Multi-beam Imaging Dual imaging, Duplex imaging

2x pan/zoom capability, Dynamic range and gain

Different modalities Phased-array transducer technology for 2D, color and Doppler imaging, & Live Anatomical M-Mode

Special Features (some optional) • • • • •

Smart Stress (stress echo protocol) Tissue Velocity Imaging & Tissue Tracking (for LV) Speckle Reduce Imaging Coded Phase Inversion Automatic Spectrum Optimization

Special Features 8GB internal Flash memory storage capability.

Compatibility with other units Can support additional transducers for other modalitiesTOE release expected March 2008, integrates with DICOM and Hospital PACS systems.

Compatibility: Comprehensive connectivity options include wireless DICOM, DVD, USB, VCR, printers and MPEGvue.

Cost Price On Application

Cost: £25,000 to £35,000

CORONARY HEART ™ 1


EQUIPMENT REVIEW

Ultra-Portable Ultrasound Systems

Zonare Z.One

ALOKA T3000

Dimensions and Weight Depth: Width: Height: Weight:

250mm 250mm 73mm 2.49kg

Dimensions and Weight Depth: Width: Height: Weight:

244mm 358mm 63.5mm 4.4kg

Target users + Studies Target users + Studies Basic Cardiac, Vascular, Radiology and Ob/Gyn examinations without compromising diagnostic quality

Different modalities Unique capabilites such as Zone Speed Technology automatically adjusting the focus velocity to match the patient thus reducing the effects of obesity on performance.

• •

Transthoracic cardiac imaging and Vascular imaging Suitable for general imaging including transabdominal and endocavity applications

Different modalities • • •

Full Doppler modes including Colour, Power, Directional Power, PW & CW Doppler Tissue Doppler Imaging Cardiovascular analysis package including LV function with advanced cardiovascular reporting Vascular analysis package

Special Features (some optional)

Comes with a range of carts to allow users to perform full studies or instantly convert to portable usage.

Special Features (some optional)

Compatibility with other units Fully Dicom compatible

Cost £25,000 - £65,000

• • • •

Tissue Harmonic Imaging Teravision Image Enhancement mode Open PC architecture Retractable SuperGlide ultrasound control panel

Compatibility with other units • •

Optional DICOM Store Optional DICOM Modality Worklist

Cost Price On Application 1

CORONARY HEART ™


EQUIPMENT REVIEW

More Information Siemens Medical Solutions Newton House, Sir William Siemens Square Frimley, Camberley, Surrey, GU16 8QD General Enquiries (ask for Medical Solutions) Tel: +44 (0) 1276 696000 Web: www.medical.siemens.com

Esoate MyLab 30CV Dimensions and Weight Depth: Width: Height: Weight:

490mm 355mm 140mm <9kg

Target Users + Studies • • •

Cardiologists and Cardiac Physiologists for hospital based Cardiac departments and private sectors. ITU and Emergency Departments. Primary Care Trusts for community echo.

Different modalities • • • • • • • • • •

Tissue Enhancement Imaging (Harmonic Modality). High Frame rate Colour and Power Doppler M-Mode, Anatomical M- Mode Pulsed Wave Doppler Continuous Wave Doppler Tissue Doppler Strain/Strain Rate Stress Echo TOE compatible

Compatibility:

SonoSite UK Alexander House, 40A Wilbury Way Hitchin, Herts, SG4 0AP Tel: Web:

+44 (0) 1462 444800 www.sonosite.com

GE Healthcare (Clinical Systems Ultrasound) 2 Napier Road, Bedford, MK41 0JW Web: www.gehealthcare.com

Esaote Europe BV, UK Branch Office. 400, Thames Valley Park Drive, Reading, Berkshire. RG6 1PT Tel:

+44 (0) 118 965 3500

KeyMed (Medical & Industrial Equipment) Ltd KeyMed House, Stock Road Southend-on-Sea, Essex SS2 5QH Tel: +44 (0) 1702 616333 E-mail: keymed@keymed.co.uk Web: www.keymed.co.uk

Data export can be done in a number of formats including DICOM allowing easy connection to any PACS system.

Cost Under £30,000

David Thomas (Managing Director) Zonare Medical Systems UK Ltd Tel: +44 (0) 8448 711814 Web: www.zonare.com

CORONARY HEART ™ 17


INVENTORY

Integration of Inventory Control Systems

Jan Carr (Regional Director) & Gregg A. Cohen, Ph.D (Director, Medical Technology) Abrio Healthcare Solutions, Inc.

W

here are you today with your inventory control system? Where would you like to be? Inventory control systems (ICS) are in place in all hospitals in a wide variety of applications. This discussion will focus on high-end dollar use items that are typically managed by a self-made manual system, a bar-coded system or a facility-wide hardware cabinet, all with varying degrees of success. Inventory problems continue to challenge the best and brightest in healthcare. While there’s a plethora of products, ideas, software and hardware, solving these problems still comes down to how well they’re managed at the end-user level. Hospitals have reached some common ground with just-in-time inventory of highly disposable products like tape, gauze and 4 x 4’s, etc. Areas that are drawing a lot of attention are high-dollar specialty products, with products in catheterization labs, cardiovascular and operating room suites representing the largest portion of highend items in any hospital inventory. 1

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Hospitals continue to look at the best inventory systems to track, account and re-order very high-dollar expendable items like pacemakers, implantable defibrillators, stents and heart valves. There’s a wide variety of ways to track and account for these items. They may be expensed when received and then moved to a specialty cost center. Many hospitals have gone to a perpetual inventory of high-end specialty items to try to capture inventory costs and identify what’s invested in inventory at any given time, which may vary from $1 to 4 million.

Why an inventory system? There are many reasons to track high-dollar items, but the most important are to ensure that supply items are available when the next patient arrives, and that the items are appropriately charged. The FDA and other regulatory agencies also require health systems and physicians track their use of medical devices, particularly implantable devices such as coils, pacemakers, defibrillators, stents, shunts and valves.

Operating suites, cardiac catheterization labs and vascular suites are just a few of the areas that must be able to track, account for items for reimbursement, and re-stock with minimal or no delays. Ownership of the system often falls to a manager close to the end user of the product. More often than not, a selfmade manual system is used. What follows is a look at the pros and cons of the most commonly available systems.

Manual inventory processes Most operating room suites, cath labs and endoscopy suites use a manual process for tracking device use and the materiels management associated with that device. There’s a continuing need to monitor devices by personnel who are familiar with the products and how they’re used. Staff monitoring can improve the accuracy of the appropriate charge and where the item was used. In fact staff record-keeping is integral to the success of any inventory system. This type of record-keeping can be tedious and time-consuming, however. It requires high vigilance on the part of personnel and is sometimes prone to error due to the flow of work in the laboratory. This is very much a silo-type system and provides limited access to all the required information. In this case, the information would be available to only this department, and other pertinent information, residing in other systems, would not be accessible unless shared through a manual process. Data for device use is logged in several places, but only accessible


INVENTORY

manually and not electronically.

database of items.

There are two big challenges here: to ensure that all information resides in a database for ease of reference by hospital personnel, and to provide an accurate record to device manufacturers for their patient reference databases.

A less-costly option is a silo-driven system. The issues around this type of implementation are those of interprocess communication. The information is in an isolated environment that does not interact or provide context with any of the other patient information that is available within the enterprise. Investment can be minimal but still provide you with some electronic process when other options are far too costly: the estimated cost for a department specific silo-driven system will vary between $150,000 -250,000. This silo, low-cost option will also require a staff member to monitor, maintain and modify the inventory of items to keep it current. It will allow the department specific use levels for monitoring and tracking of high dollar inventory device items.

All managers want to improve tracking systems for the cost, use, inventory control, security, and regulatory tracking perspectives. A more automated and integrated system can be the first step. Here are three possible options: Inventory control software is offered in a variety of systems. Cardiology inventory systems are an option package in all hemodynamic systems. These systems may offer a bar code option that can be integrated into the hospital information system (HIS)/ materiels management inventory system. For these systems to be reliable, an ongoing audit trail must be kept by staff closest to the use of the product. This ensures that appropriate charges are made and inappropriate charges are corrected before they impact patient billing and inventory supply orders, particularly if just-intime ordering is in place. These systems have limitations. The fact that there are no industry wide standards in healthcare devices limits all inventory systems. Adopting a bar code system also requires an investment of time and resources at either the department and/or hospital materiels management level. At either level, an inventory system supported with bar codes can be a giant leap in implementing an inventory management system. Instead of expecting staff to track and manually input data, the system provides an audit trail and improves the capture of used items. Again, a continued investment of time and maintenance is necessary to build and maintain the ever changing

Self-made inventory systems: A second option is to develop a selfmade inventory system to monitor, maintain and keep the order supply chain moving. This is a silo-type arrangement that limits access to the system, and daily maintenance is necessary to keep the supply chain full. This option is often less than ideal but is used in more specialty areas than most facilities like to admit. It requires the least amount of materiels and resources to develop a tracking system. It may be appropriate for sites with lower volume. It works well in managing specialty products but can be limiting as volume increases. It does provide an audit trail but may require at least 1.0 Full Time Employee (FTE), if not more, to maintain. This system often fills daily needs and requires minimal investment. Itâ&#x20AC;&#x2122;s usually maintained in or near the source of use. It can be a cost-effective system if assigned personnel have a strong familiarity with the products,

since personnel can be used in other needed roles. Investment is minimal, and the system provides you with a tracking system for high-end dollar specialty items.

Cabinet inventory systems: The third option is a cabinet/ATM-type inventory system that offers security with a password requiring a time-out feature, which is now mandated by HIPAA. As hospitals plan for the integration of systems across their enterprise, some facilities see these systems as an option. Several years ago cabinet inventory systems were a hot item for high-end products. Pharmaceuticals are the key area in which these systems have been adapted and are most successful. Often the features and functionality of these systems are applied to management reporting to ensure patient safety. But interest has lately moved away from adapting these systems for highend specialty products. Adapting an enterprise inventory system to specialty areas outside materiels management requires a significant investment of money. The amount is contingent on the cost of cabinets that support the shapes of the products used. This can be a problem with catheters that may be 100 to 110 cm in length. Making space to support inventory in areas adjacent to the end-user is the next big stumbling block.

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INVENTORY

These systems can be fully integrated with other inventory systems requiring a password and security timeout as mandated by HIPAA. This can be cumbersome for end-users who may need to change products frequently based on patient needs in catheterization lab suites or cardiovascular OR suites. The systems also require personnel to consistently monitor specialty products as requirements change. The cost associated with these highly integrated systems is significant with a conservative range $500,000 to 900,000, and facilities that have invested in them rarely have applied all the features and functionality of cabinet or ATM systems. They do remain an alternative for some facilities. Of course, inventory management systems are not, and should not, be isolated systems. They should be integrated into the rest of the facility management systems. For hospitals, this means integration into the hospital information system (HIS). Order sets should be developed to include the basic load-out of materiels required to perform the procedure under consideration. This allows materiels management to verify that supplies are available for the procedure. If the procedure is scheduled 24 hours in advance, this may allow “just-intime’ delivery of the materiels required. In addition to prior knowledge, interfaces back to HIS allow materiels use to be traced and accounted for in the master inventory. For this to be possible, interfaces must be instantiated between the inventory control system and HIS. This involves network connections and HL7 coding to transmit Admissions Discharge and Transfer messages (ADT) orders and results between ICS and HIS. For HIS that do not do materiels management, the interfaces between ICS and materiels management may be direct. 20  CORONARY HEART ™

In addition, these systems may not use standards-based HL7 messaging schema.

More and more hospitals and health systems are reviewing new software and tools offered through information systems to drive down costs and improve supply chain efficiency and patient care.

Develop an integrated and collaborative plan for clinical services and ultimately for the enterprise.

Research all systems that offer integration of services and compatibility with installed systems.

Ensure that the upgrade and/ or selection of an inventory control system and/or related software specific to cardiology or operating room services presents an opportunity to implement a system across multiple departments.

Don’t make a decision specific to a single department unless there’s an ongoing strategy to incorporate these systems into enterprise planning.

Selection across a service line can be beneficial in terms of cost savings and end results for largedollar ticket items.

For the past nine years, Hospitals and Health Networks, an AHA publication, has identified the 100 Most Wired Hospitals and Health Systems. The most-wired list is based on a comprehensive survey tool that asks hospitals to report how information technology is applied to five key areas: safety and quality, customer service, business processes, workforce and public health and safety. This year’s survey collected responses from 568 hospitals and health systems representing 1284 hospitals. The survey notes that Radio Frequency Identification Device (RFID) technology and bar code technology are being used efficiently, and costs are diminishing. Survey results also point to the use of automation of medical, surgical and pharmaceutical supplier activities through better adoption of electronic purchase orders and the application of both automatic and semi-automatic online systems. Some health systems have adopted RFID to minimize scanning inventory materiels at the point of use in order to reduce lost charges for these products. A department-based or enterprisewide system to support purchase of an affordable system for inventory can pay for itself within two to three years. While there’s no concrete evidence, hospitals seem to be carrying fewer high-end inventory products than they were five years ago in these specialty areas. Here are some considerations for selecting an inventory control system:

In conclusion: Inventory Control Systems are becoming a requirement for the smooth running of any materiels-dependent service. These systems should be part of an integrated strategy for materiels management for the enterprise. The systems should also be integrated into systems used for patient management, materiels management, resource management, billing and scheduling. Adherence to standards or the ability to use standards-based practices is also necessary. When this is taken into account, your facility can manage its inventory in a manner that’s financially, legally and medically sound.

Reference

2007 Most Wired Survey and Benchmarking Study, Hospitals and Health Networks.


INVENTORY

Should hospitals adopt RFID for critical supply management? However, beyond the ordering, receiving, and tracking of supplies, there is a more urgent need to evaluate the current inventory practices: patient safety. What if a technology solution could remove any uncertainty that the right product is available at the right time; that the patient actually received the right product in the procedure; and that the right product was documented on the patient bill?

By, Dan Scharbach, Regional Director, Invasive Cardiovascular Services, Providence Health System, Portland, OR, with technical contribution from Carola Endicott, VP Hospital Services, WaveMark, Inc.

M

ost hospitals, consumed with financial constraints and pressing patient care requirements, are laggards in supply chain innovation. Healthcare is also known to invest less in new technology adoption than other industries. Combined, these factors would predict a slow uptake of automated inventory management in the healthcare arena.

When it comes to items that are implanted in a patient, a pacemaker for example, there is tremendous peace of mind associated with knowing that the right model is on hand, the serial number from that pacemaker was accurately captured and that no similar models with recalls are sitting on the shelf. Does a technology that can do all this merit a fast-track to adoption in hospital procedure areas? As specialty procedure areas begin to evaluate the possible solutions to managing the growing supply of critical care products, several factors must be considered. 1. Is the new technology better than the status quo? 2. Does the promise of the new technology match actual results? 3. Does the new technology streamline workflow? 4. Is the technology user-friendly?

5. Does the cost of the new technology create an insurmountable barrier to adoption in cash-strapped hospitals? Currently, there are 2 technologies that dominate how labs control and manage inventory levels. 1. Manual - counting each individual box by hand and recording the information, generally in a spreadsheet. Unfortunately, not a technology at all, but the most widely used method of managing inventory, including high-value consumables. 2. Bar Code - a bar code reader captures the information on the product packaging and stores it for further manipulation. Although this automates the process a step further, it is still a manual process requiring line of sight to capture dataâ&#x20AC;&#x201D;forcing the inventory manager, or other cardiovascular department staff to manually participate in the capture of information. The common thread in the current methods is that they generate information that is time-specific, not real-time, thus putting patient safety at risk. Although the current methods can be fairly accurate, when dealing with implantable medical devices and other critical patient care supplies, fairly accurate can be a problem. To improve patient safety and provide peace of mind RFID, or radio frequency identification is the technology of CORONARY HEART â&#x201E;˘â&#x20AC;&#x192; 21


INVENTORY

Should Hospitals Adopt RFID (cont...) choice for many forward-thinking labs. What does RFID offer that changes the current landscape? For tracking inventory, as opposed to movable, capital assets like wheelchairs and IV pumps, the most common approach is to place a small, inexpensive RFID tag on the box and make that tag the “license plate” linked to the specific item, including that box’s product description, expiration date, lot number, serial number, its price upon receipt, its status as consigned or owned, and so on. When the tag is “seen” by a RFID reader, the information is immediately available to the user. While smart cabinets continually read their contents, the removal of an item is automatically recorded and reported to the user. The user now has the completely new experience of having a physical count being done automatically, including the crucial information about where the item is located. This real-time inventory is both 99.9% accurate, much higher than the typical human counted inventory which tends to be about 95% accurate, and it includes the expiration date and lot number of each item

Above and Below: Cath lab staff at Providence Portland Hospital with their new Wavemark RFID cabinets

sitting on the shelf. In addition, the question of what was used is no longer left to the manual recording of each item because the cabinets record items coming and going. In the case of an open cabinet design,

product usage can be captured with an RFID reader at the point of care inside the procedure room by simply waving the tagged box in front of the reader. The user can now track down “missing” items quickly and efficiently, including finding product that was used by another department. In some RFID systems, usage is captured at the time of item removal from the cabinet through the use of a closed cabinet system. The user must wave their RFID-enabled ID badge or use a thumbprint to open the cabinet and then assign the item to a patient for billing purposes. This real-time visibility is available today and has been proven over the last couple of years in hospital clinical settings, but remains in the early phases of adoption by hospital procedure areas. There are several companies aiming at the development of cardiovascular department specific RFID inventory management. The company I have been most impressed

22  CORONARY HEART ™


INVENTORY

with is WaveMark, Inc., which is currently in a trial period within one of our cardiovascular departments. WaveMark, Inc. has achieved critical acclaim for providing an RFID inventory management solution. By engineering the hardware to ensure 99.996% read rates and software to accept the flood of tag reads, their approach seems to have achieved the goal of tracking inventory where it makes sense: at the last step in the high-expense supply chain of medical devices – the hospital procedure area.

OR Region. He is a member of SICP; served as the past chair of the Novation Cardiovascular Council; the current Director of the Northwest Cardiovascular Management Association and also participates in several other advisory boards/leadership councils.

With WaveMark CIMS, the act of putting an item on the shelf (it is received automatically) and taking the item off the shelf (it is noted as missing automatically) is meant to closely parallel the existing workflow. By following current processes, nurses and techs are more likely to embrace this technology because, unlike many inventory systems, this approach is largely invisible to the front line clinical user. In addition to smooth workflow, WaveMark CIMS uses a web-based user interface making it easy to use and very cost effective, as there is no hardware expense. There remains the question of total cost of ownership. The argument in favor of existing methods is that they are low cost and make use of the ubiquitous barcodes already on these products. Very few medical device manufacturers are placing RFID tags on their products as of today, although the trend towards this is accelerating. So, why spend money on a system when the current one is adequate? The answer may reside in asking a few last questions: What if the cost of a largely hands-free solution was equivalent to not losing a stent a month? Would it be worth it? What if the cost was recovered two-fold in charge capture improvements alone? What if concerns about critical supply availability, managing expiring product, and responding to recalls were eliminated? What is peace of mind worth? In the case of WaveMark, a business model of a low monthly service fee, which becomes an operational expense, and minimal IT resource requirements makes this technology accessible to almost any size procedure area.

chm

Thus, we come back to the question of whether it is worth accelerating the generally slow rate of adoption for the use of RFID in medical device inventory management. We believe that the certainty of inventory availability at the item level (not catalogue number level) is an invaluable tool for managers and clinicians as they simultaneously strive to improve patient safety, streamline work processes, and increase nurse and staff satisfaction. About the author: Dan is the Regional Director of Invasive Cardiovascular Services in the Providence Health System – Portland,

CORONARY HEART ™  23


CRM

Home Monitoring for ICD’s and Pacemakers

Mr Nolan Stain MSc, NASPExam (Pacing) Chief Physiologist: Pacing and ICDs Imperial College NHS Trust

P

atients with implantable devices including pacemakers and implantable defibrillators (ICD) require regular clinical and technical assessment of their devices. In the UK, these patients are currently followed-up in the pacing and ICD clinic. Patients usually, attend in person for annual or bi-annual visits. In some exceptional cases, for example where a battery is ageing, technical reasons or the device is under Medical Health Regulatory Agency (MHRA) advisories, they are seen more regularly. The manufacturers recommend follow-up for ICDs at 3 monthly intervals, irrespective of MHRA advisory advice. There are also clinical situations that may require clinic visits, including patients who have frequent arrhythmic episodes, patients who may have had an episode (ICD shocks), and the involvement of cardiac resynchronization therapy (CRT) algorithms in predications of heart failure. Home monitoring, which offers an alterative approach to device management, is now available in the UK from most of the device companies,. Home monitoring enables 24

CORONARY HEART ™

pacemakers and ICDs patients to be remotely ‘followed-up’ via wireless or telephone technology, and could enhance patient safety and reduce pacing clinic visits. Home monitoring has been widely used in the US for several years but in the UK and Europe it has not been well subscribed. This is primarily due to two main reasons: the size of the market and the various data protection acts in each European country that have to be met. However, due to the increasing pressure on UK device follow-up clinics, home monitoring has started to make an increasing appearance in the UK market. Medtronic CareLink has been evaluated at various UK centres over the last 12 months. “We have 400 patients on active follow-up at present. A large percentage of them have had their devices implanted years ago” says Neil Stevens, Market Development Manager, Medtronic Ltd. The Medtronic CareLink services was officially launched in Europe at last year’s Europace conference and is now available in 14 European countries, with 1,300 patients on active followup. In the US, Medtronic Carelink is well established with over 150,000 patients being followed up remotely. Biotronik cardio-messenger was first used in 2001 and now there are over 60,000 Biotronik devices with homemonitoring implanted worldwide. “More than 50% of all home monitored devices are in the US, 40% are implanted in Europe and 10% for the rest of the world” says Mandy Hall, Territory Manager, Biotronik Ltd. It is expected that by 2010 the uptake of home monitoring of Biotronik devices will increase to 40% of pacemakers and 70% of ICDs.

Guidant/Boston Scientific Latitude home-monitoring system is currently not available in UK or Europe. “There are over 20,000 devices on active follow-up in the US” says Matt Powell, Cardiac Rhythm Manager, Guidant/ Boston Scientific. St Jude Medical’s Home-call was launched in City Hospital Belfast about six months ago. “We have about a thousand devices active in Europe and we plan to roll out in the UK in 2008” says Nigel Hylands-White, Marketing Manager, St Jude Medical, UK.

Home monitoring and how the companies compare Home monitoring provides limited information with respect to battery status, lead impedance, parameters and diagnostic data. Pacemaker lead testing, which still remains the mainstay of device follow-up, cannot be performed via this technology.

Home-monitoring - device programming and optimization “Patients will still need to be seen in pacing clinic for reprogramming and clinical assessment” says Mr Stevens. Home monitoring provides an opportunity to remotely monitor patients for arrhythmias, ICD therapies, heart failure therapies and other technical problems. It would be particularly useful for the monitoring of patients who are immobile, have travel issues or for MHRA advisories who requiring intensified follow-up. “Home monitoring enables cardiac physiologists to prioritise patient follow-up” says Ms Hall. The data provided will enable the physiologists


CRM

Medtronic

Biotronik

Guidant

St Jude

Yes – device data using cardio messenger via wireless telemetry at pre- programmed time up to each 24 hours, + if outside uniquely set patient parameters. Yes – via GSM SMS network – mobile therefore no interruption for travelling client / working away. No, GSM, SMS network. Yes

Yes – device data via telephone line (wireless link to ICD / pacemaker).

Yes - via telephone line, from patient’s transmitter to dedicated PC in cardiac dept.

Yes – requires phone line.

Yes - requires phone line.

Yes

Yes As often as you want.

Remote Monitoring

Yes – device data via telephone line.

Sent from home

Yes – requires phone line.

Via phone line

Yes

Daily?

No – after instruction from hospital. As often as required Yes Yes

Yes

No. Patient required to Yes plug the monitor into an analogue phone line. Model dependant. Clinical assessment, Clinical assessment, reprogramming. reprogramming, device optimisation. Carelink evaluation has Patient satisfaction been completed and questionnaires were indicated that patients administered at the prefer Carelink to out- end of each home patient appointments. monitoring trial, with positive feedback. Yes - if used within set Yes - if used within set parameters. parameters.

Yes, if within contact Yes - application of of wireless link / phone transmitter wand. line.

Access to Medtronic programme required – generally cardiac physiologist.

Alert generated if activity outside client specific parameters? Passive system (user involvement requirement?) Visit to clinic required for: Patient feedback

Compliant with EU regulation Who can review data? Data on : Battery status Pacing Threshold Lead impedance Intra-cardiac electrograms showing events. Mode switching data showing AF

Yes – if within contact No of wireless link / phone line.

Clinical assessment, reprogramming – any physical intervention. US patient experience has had positive feedback.

Clinical assessment, full follow-up, device function changes. Positive.

Yes – if used within set parameters.

Yes

Anyone authorised to access site, generally cardiac physiologists.

Anyone authorised to access site, generally cardiac physiologists.

Anyone with access to PC in cardiac dept.

Yes Yes Yes Yes

Yes Yes Yes Yes

Yes Yes Yes Yes

Yes Yes Yes Yes

Yes

Yes

Yes

Yes CORONARY HEART ™  25


CRM

Home Monitoring (cont...) to triage device patients effectively, ensuring the patient is treated promptly. Patients can be brought into device clinic for re-programming, optimisation, clinical assessment, or if they have technical problems and not simply to be checked.

Home-monitoring and integration with current device follow-up In many UK centres, Pacing and ICD clinics form part of the patient’s total follow-up care package. Many patients’ only contact with the hospital is through their pacing or ICD clinic appointment. Pacing clinic staff very often detect both cardiac and non-cardiac problems, and ensure patients are reviewed by the appropriate medical team. “Remote follow-up is usual for routine patients without complications. Patients with symptoms, changes in clinical status and requiring reprogramming and optimisation need to be seen in pacing clinic. Home-monitoring enables cardiac physiologists to focus on more complicated and symptomatic patients” says Ms Hall. Home monitoring is designed to supplement device clinics, which face increasing pressure due to the rise is the number of implants, increases in the complexity of devices, and MHRA advisories. “Cardiac Physiologists would be key to the success of home monitoring, and it would require their active involvement. Given the lack of cardiac physiologists in the labour force, home monitoring would help to make them more efficient at managing increasing caseloads” says Mr Powell

Home monitoring and the law Home monitoring will raise concerns over legal liability among many health professionals. For example, if a serious 26  CORONARY HEART ™

complication was detected out of hours and not reviewed by staff until it was too late to intervene. Some devices provide for automatic downloads on a daily basis. “Any legal considerations must be weighed up by the physician and healthcare provider. However, if we look at the current situation, most patients are followed-up 3, 6 or 12 monthly. If a complication arose, for example a lead displacement, it would only be detected at the next followup or if the patient presented with symptoms. Home monitoring provides daily lead impedance measurements and would enable that patient to be treated much faster than patients without home monitoring” says Ms Hall. “Home monitoring is part of the patient follow-up process and this context would be an overall improvement to patient care and safety” Mr Powell. “St Jude Medical’s Home-call works on demand. It is not permanently activated and therefore cannot be accessed 24 hours. The device clinic makes contacted with the patient at the times and intervals decided by them. On contact with the patient, they activate and access the system” says Mr Hyland-White.

Home monitoring and public opinion “Home-monitoring will have an important impact on the future role of device clinics. The follow-up intervals for lead integrity and battery checks are currently arbitrarily assigned according to technician capacity and historical data on battery longevity. Daily electronic checks with preset warning levels are clearly the safest and most cost-efficient method to perform these tasks. This is the reason for the rapid take-up of this technology in the US, and no doubt Europe will follow

this trend. It will have a positive effect on device clinics, which will evolve to focus on ensuring that implanted devices are working optimally, with the best settings for biventricular devices, and reducing unnecessary ICD therapies, rather than performing routine safety checks.” Dr Prapa Kanagaratnum, Consultant Cardiologist, London “Remote follow-up has the potential to completely revolutionise the way patients have their implantable devices followed up. Ultimately, device clinics should be more efficient and patients can benefit from a reduction in unnecessary clinic visits. Remote follow-up is not about saving staff costs. However, with device follow up expected to rise by 150% over the next few years, remote follow up can help offset some of the device clinic staffing issues that will arise from this increase. Remote follow-up is about managing your patients more effectively and not about replacing in-hospital visits entirely. With the ever increasing amount of automaticity within devices, the need for performing tests during in-hospital visit is becoming less, and therefore the number of times a patient needs to visit the hospital can be reduced. A number of our follow up patients still want to attend clinic every 3 or 6 months as they always have done, and we expect that remote follow-up is more useful for reducing unscheduled clinic visits. When a patient calls on Friday afternoon reporting they have passed out and they might have had a shock, our normal practice would to be book the patient an in-hospital visit the following week, which often means overbooking the clinic (some of our clinics may have up to 5 or 6 unscheduled patients). Remote follow-up allows you to prioritise the management of that patient and reduce any worry the patient might have had waiting for a clinic visit. In some patients I have arranged a remote follow up once a week to check the effectiveness of a recent drug change; this may be impossible to


CRM

do by in-hospital visits if the patient has to travel long distances, or without overbooking your clinic. With the increase in CRT implants, we are finding remote follow-up can be very useful if you wish to utilise heart failure algorithms such as Medtronic’s Optivol, or the Boston Scientific weight and blood pressure monitors designed to prevent admissions due to heart failure. Not all of our patients will immediately be able to have access to remote follow-up due to the model and age of their device. There is also often an extra cost associated with the model of device needed for remote monitoring or the use of the device company’s website, and this can be a limiting factor. The aim at Southampton is to have 500 patients on remote follow-up by the end of this year; this will be about fifth of our device population (in the US some hospitals have over 10,000 patients on remote follow up). New remote follow up patients will be assessed on a prescriptive basis, i.e. distance to clinic or frequency of episodes.” Stuart Allen, Technical Head, Cardiology Department, Southampton “Although home monitoring, seems very convenient from a patient perspective, caution must be applied to ensure patient follow-up from a clinical cardiac perspective is not lost . In my experience many patients, who have been discharged from cardiac outpatients, return to the cardiac outpatient clinic via the pacing clinic, where cardiac-related problems are often detected.” Dr Bhavesh Sanchdev, Specialist Registrar: Cardiology, London “Home monitoring has interesting potential for improving demand on pacing services, particularly at a time

where demand is ever increasing. My concern is that often pacing clinics are the first port of call for a patient’s cardiology needs, and the loss of direct contact with patients may be to their detriment. However, by using home monitoring for straight forward cases, there will be more time in clinic for complex devices, which is an important prospective development.” Sophie Blackman, Chief Cardiac Physiologist, London “I think this is a good idea in principle, especially for patients who have to travel a great distance to their nearest device follow-up center. However, many patients benefit from the visit to a device clinic and not just the mechanical follow-up. Patients benefit from the input and advice provided by cardiac physiologists and other health workers. There is also the opportunity to discuss any problems, and have medications reviewed. Just having contact with a health professional is beneficial to some patients, especially those with diminished quality of life. This technology would be suitable for certain patient groups. Patients will have to be evaluated individually.” Diane Snowdon, Arrhythmia Nurse Specialist, London “Yes, I think it’s a good idea because many patients have far to travel. But I would prefer to be seen in ICD clinic.” A BIV ICD Patient, 63 years, London “I am positive and would welcome home monitoring. Travelling to London for device follow-ups is not always easy. Train fares, congestions charges and car parking can make ICD follow-up expensive for patients. Home monitoring will allow the team to concentrate on and prioritise the patients in need of urgent care.” ICD patient, 41, Bedfordshire

Medtronic Virtuoso™ ICD Courtesy Medtronic, Inc.

“Interesting, but I wish to continue with attending the pacing clinic in person.” A Pacemaker Patient, 69 years, London “In principle I think home monitoring is a good idea, but in the early stages of having a pacemaker I think it is important for a patient to go to the clinic and be able to talk about any problems or queries they may have.” Pacemaker Patient, 67 years, Windsor

Home monitoring and the future NICE guidelines indicate that implanting rates in the UK are below European averages. It is envisaged that implants will increase over the next few years, as will the complexity of device therapies. Many UK device clinics are under increasing pressure to meet the current follow-up burden. Home monitoring will enable cardiac physiologists to triage patients, freeing up clinic visits for more problematic or complex patients. It is estimated that up to 80% of routine follow-ups do not require reprogramming, making home monitoring a suitable alternative for this cohort. Home monitoring could also have a positive effect on the environment “by reducing the carbon footprint associated with the patient hospitals visits” say Ms Hall. CORONARY HEART ™ 27


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Heart Failure: Types and Treatments care for this patient population. In addition, every year over 11 million patients with heart failure will visit their family doctor and a record 3.5 million will become hospitalized. Of the hospitalized group, one third will be readmitted within three months. This makes the cost of heart failure hospitalizations twice the amount spent in treating patients with cancer. By Dawn Provost-Larmond, AS, BS, M. Ed, RCIS Healthworks, Inc.

Introduction: Although cardiac catheterization and electrophysiology labs treat many different patient populations, one patient population that has shown an overwhelming increase in recent years is that of patients with heart failure. These patients normally have chronic heart failure and have had procedures such as pacemakers or defibrillators implanted in the EP labs or SwanGanz catheters inserted in the cardiac cath lab to evaluate cardiac function. In either case, despite maximal everyday treatment options, some heart failure patients may need an orthotopic heart transplantation (OHT).

Heart Failure Statistics: An estimated 4.8 million Americans have been diagnosed with heart failure. This is equivalent to about 1 in every 56 Americans. Every year a record 500,000 new cases are being reported. Heart failure is more prevalent in the elderly. An alarming 10% of all elderly patients over the age of 75 are affected by some type of heart failure. The United States spends approximately $25-$40 billion dollars each year to 2

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Types of Heart Failure There are a wide variety and many types of heart failure, including failures that are related to the structure of the heartâ&#x20AC;&#x2122;s valves or breakdown in function due to changes and weakening of the heart muscle. Heart failure can also be attributed to various diseases. The following are brief descriptions of the most common forms of failure.

1. Valvular a. Regurgitation - Leaking of valves, causing the heart to pump blood twice. As a result, the heart has to compensate for this added workload. The heart dilates and eventually the heart muscle weakens.

common in men with heart failure affecting 2 in 100. b. Ischemic Cardiomyopathy It is caused by coronary artery disease (CAD). This is the most common type of heart failure in the U.S., affecting 1 in 100 people with heart failure. Most common in middle age elderly men. c. Hypertensive Cardiomyopathy - Longstanding, untreated hypertension causes thickening of the heart muscle and eventual dilation. d. Peripartum Cardiomyopathy - Occurs during last trimester of pregnancy or within 5 months of delivery. e. Alcoholic Cardiomyopathy - A form of dilated cardiomyopathy that occurs as a result of longstanding alcohol abuse and is usually associated with rhythm problems. f.

Infectious Cardiomyopathy - Associated with HIV, Viral Myocarditis, Lyme disease and Chagas Disease.

b. Stenosis - Narrowing of valves. The heart chamber behind the narrowed valve has to work harder. The heart muscle of this chamber weakens as a result.

2. Cardiomyopathy - Weakening

of the heart muscle or a change in the muscle structure. a. Dilated Cardiomyopathy Usually Idiopathic. The heart becomes weakened and enlarged. This is the most common form of cardiomyopathy. It is most

CRT Device Courtesy of Medtronic


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most common causes of CHF in the U.S. are coronary artery disease (CAD), hypertension, alcohol abuse, valvular disease, viral infection of the myocardium, rhythm disorders, and drug induced. Right Heart Failure The right side of the heart is unable to pump blood efficiently. This normally occurs as a result of tricuspid regurgitation (TR), right- ventricular (RV) infarct, pulmonic stenosis (PS) and pulmonary hypertension. Left Ventricular Assist Device (LVAD) Courtesy of Thoratec Corporation

Restrictive Cardiomyopathy Also referred to as Infiltrative Cardiomyopathy. Affects heart muscle and its ability to relax between contractions. Myocardium becomes fibrous. The heart tends to be normal in size or only slightly enlarged. Hypertrophic Cardiomyopathy - also referred to as Asymmetric Septal Hypertrophy (ASH), hypertrophic obstructive cardiomyopathy (HOCM), and idiopathic hypertrophic subaortic stenosis (IHSS). Tends to be familial. Causes asymmetry in the ventricular chambers usually affecting the left ventricle and the septum. Occurs in young adults.

Left Heart Failure The left side of the heart cannot pump enough blood to the body. This condition can be life threatening and normally occurs as a result of left ventricular (LV) dysfunction or aortic stenosis.

Classification of Heart Failure: According to the New York Heart Association (NYHA), heart failure patients can be classified into 4 groups based on symptoms. Class I - Patients have risk factors but no symptoms. Class II - Patients may have some underlying cardiac history and may have symptoms with very moderate exertion. Class III - Patients have known cardiac history and previous heart failure symptoms with medication. Patients have symptoms with very minimal exertion. Class IV - Patients require bridge devices like left ventricular assist devices (LVADs), heart transplant or palliative treatment. Patients have symptoms at rest.

Systolic Heart Failure Difficulty pumping. Diastolic Heart failure Difficulty with expansion and inadequate filling due to stiffness of the heart muscle.

4. Coronary Artery disease (CAD) Also known as coronary heart disease (CHD). The narrowing of the coronary arteries as a result of fatty material and plaque build up.

3. Congestive heart Failure (CHF) -

5. Congenital Heart Disease -

Failure of the heart to perform effectively and adequately. As the heart fails, other organs are affected, especially the kidneys which lose their ability to excrete salt and water. The lungs eventually become fluid overloaded as in pulmonary edema. The liver can also lose its ability to excrete toxins. Over time, all organs become affected in some way. The

6. Family History -

An abnormality in heart structure and function. This abnormality occurs during the heart development before birth but is present at birth.

A family history of enlarged hearts

Treatment of Heart Failure: I. Medical Therapy a. Positive Inotropes - Increase myocardial contraction. b. Diuretics - achieve a euvolemic state by removing more sodium and water from the body in the form of urine. Examples include Lasix and Spironolactone. c. Vasodilators - relax blood vessels allowing for increase in flow d. Angiotensin -converting enzyme (ACE) inhibitors and Angiotensin Receptor Blockers (ARB) prevent the body from making angiotensin which causes vessels to tighten, thus increasing blood pressure. These medications cause vessels to dilate, allowing increased flow, decreasing blood pressure and ultimately decreasing the heart’s workload. e. Aldosterone Blockers - work on CORONARY HEART ™  29


EDUCATION

Heart Failure (cont...) hormones in the blood stream like aldosterone, causing an increase in salt and water excretion. The drugs also lower blood pressure and thus decrease the heart’s workload. f.

Beta Blockers - decrease heart rate, primarily block beta receptors and sometimes can block alpha and beta receptors (mixed antagonism) allowing arteries to expand, decreasing resistance, lowering blood pressure and reducing arrhythmias. Heart failure causes an increase in levels of norepinephrine, which causes heart remodeling. Beta blockers act on these beta receptors reducing this effect.

g. Digoxin - increases muscle strength and slows heart rate. The most common indication for Digoxin is to treat atrial fibrillation and atrial flutter with fast ventricular response h. Other Medications, including blood thinners and antiarrhythmics. Blood thinners decrease the risk of stroke and antiarrhytmics treat arrhythmias

II. Device Therapy a. Biventricular Pacemaker with Defibrillation – Cardiac resynchronization therapy (CRT) is a proven treatment option for patients with heart failure. It maintains heart rate and allows the left and right ventricle to contract at the same time. If combined with defibrillation, it also terminates deadly arrhythmias. A pacemaker (Medtronic Corporation) is shown on page 28. b. Left ventricular assist device (LVAD) Used as a bridge to transplant. It assists the weakened ventricle by pulling blood from the left ventricle and sending it to the aorta 30

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via the pump. LVADs are portable and patients can be discharged to home (Also known as destination therapy). An implantable LVAD, the Heart Mate II (Thoratec Corporation) is shown on page 29. The HeartMate II is implanted in the chest to support the heart’s pumping function. An external, belt-worn system controller and battery are attached to the implanted pump via a thin, flexible percutaneous cable. c. temporary Total Artificial Heart (TAH-t) The modern version of the Jarvik7 artificial heart, which was first implanted in 1982. The first temporary Total Artificial Heart manufactured by CardioWest (SynCardia Systems, Inc.) was recently transplanted at the University of Pennsylvania Hospital. Research studies suggest that patients receiving the TAH-t have almost twice the survival rate of patients receiving the ventricular assist devices.

Temporary Artificial Heart (t-TAH) Images above and below courtesy of SynCardia Systems, Inc., www.syncardia.com

To implant the TAH-t the patient’s heart is removed and replaced with the artificial heart. The TAH-t is the only total artificial heart currently approved by the U.S. FDA, Health Canada, and Communite Europeenne as a bridge device to transplant. Refer to images on this pages for examples of a temporary artificial heart, and on page 31 for a patient recovering after surgery.

Total Implantable artificial heart The AbioCor device, a total implantable artificial heart manufactured by ABIOMED was first implanted in 2001. It was approved by the FDA in 2006 as a humanitarian device. A disadvantage is its size, which is presently compatible only with

males with larger frames. The current device has a life expectancy of about 18 months. An AbioCor II device is schedule for human trials in 2008. The new model will be smaller in size, making it more universal for both men and women. There also has been modification to decrease the risk of stroke which is a concern of the FDA. Life expectancy of the AbioCor II is projected to be about 5 years.


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the patient before proceeding with any elective procedures. It is important to remember that treating the underlying cause can sometimes make heart transplantation a future treatment option and not an immediate choice.

CardioWest™ temporary Total Artificial Heart patient Vanessa Cirillo, 28, works on getting healthier for her human heart transplant with trainer Robert Bailey at University Medical Center in Tucson, Ariz. Vanessa received her human heart transplant Nov. 24, 2007.

CardioWest™ temporary Total Artificial Heart patient Vanessa Cirillo, 28, works out with her trainers Robert Bailey and Krista Mundt at University Medical Center in Tucson, Ariz. She was implanted with her artificial heart on Aug. 10, 2007.

Heart Failure Patients As noted earlier, patients with heart failure are a growing part of the patient population in electrophysiology and cardiac catheterization labs. These patients usually present with symptoms that include but are not limited to shortness of breath (SOB), edema, hypotension, orthopnea, arrhythmias, and ascites. In a cath lab setting patients sometimes undergo a right and left heart catheterization. Hemodynamic analysis and coronary angiography are especially important in diagnosis and treatment. From a hemodynamic standpoint, right heart pressures, left ventricular end diastolic pressure (LVEDP), cardiac output and cardiac index are used along with a pulmonary artery oxygen saturation as guides in determining, classifying and treating these patients.

For example: if the pulmonary capillary wedge pressure (PCWP) is greater than 18 mmHg, the physician may choose to leave an indwelling Swan-Ganz catheter for monitoring. If the catheter is left in, the patient is normally transferred to a unit with nursing staff trained to care for these patients. Physicians may choose not to do an elective left heart cath with coronary angiography in a patient in severe failure, primarily because heart failure patients often suffer from renal failure. In an effort to minimize any further damage to the kidneys from contrast agents, elective procedures are often avoided in these patients. Coronary angiography gives the interventional cardiologist the option to treat any blockages s/he concludes are culprits. Once again, the physician may opt to “tune up”

In the electrophysiology lab setting, heart failure patients are often referred for biventricular cardiac resynchronization therapy (CRT)/ implantable cardioverter defibrillator (ICD) insertions. CRT is often recommended in patients with an ejection fraction < 35%, QRS>120msec, NYHA Class III or Class IV despite maximum medical therapy. Patients present with the same symptoms described earlier.

Heart Transplantation Definition: A surgical transplant procedure in which a damaged or failing heart is removed and replaced with a donor heart. This is usually performed on patients with end- stage heart failure or severe coronary artery disease. Heart transplantation has become the treatment of choice for many patients with severe heart failure who have failed maximum medical therapy. Survival rates have improved over the last 30 years, due primarily to advancements in the treatment of post transplant infections, and drug therapy with immunosuppressants. Heart transplant patients are generally under the age of 70 and do not have irreversible damage to other organs. A major problem facing patients in need of heart transplantation today is the shortage of donor hearts. History: The first human heart transplant was performed in 1967 in South Africa by Christian Barnard. CORONARY HEART ™  31


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Heart Failure (cont...) In 1968 the first heart transplant was performed in the U.S. by Norman Shumway. However, the survival rate during the first year post-transplant was documented to be approximately 15%. This low survival rate was primarily due to the inability to treat rejection with the immunosuppresion drugs available at that time. In 1981 Robert Jarvic developed the first artificial heart. In 1982 the first artificial heart implant procedure was performed by Dr. William Devieres. The patient survived only 112 days. In 1984 a new born baby known as Baby Fae was transplanted using a baboon heart. Baby Fae only survived for a few days.

Statistics: Heart transplant survival results as of August 2006 are as follows: •

1 year: Males—86.1% Females—83.9%

Biopsy Forceps Courtesy of COOK Medical Inc

There are four types of transplant procedures: 1. Orthotopic: The left atrium and pulmonary vein of patient’s original heart are left in place. 2. Heterotropic: The patient’s original heart is not removed resulting in what is referred to as a “double heart”. The original heart is in a state of rest, with hopes of healing and overcoming heart failure.

3 years: Males—78.3% Females—74.9%

5 years: Males—71.2% Females—66.9%

Two to three episodes of rejection occur in the first year.

Acute rejection occurs in the first three to six months.

Most deaths in the first year are due to acute rejection (18%) or infections (22%).

3. Xenograft: A heart from another species. This procedure was performed on Baby Fae with a baboon heart. Recent research has shown advancements, with porcine (pig) transplant possible for humans in the future.

Four thousand patients each are in need of cardiac transplantation every year, but only about 2,000 organs become available.

4. Artificial Heart: A man made heart. As noted above, there have been some technological advancements with the Jarvic heart (1981).

Heart transplantation is the fourth most common transplant surgery in the U.S.

Treatment post-transplant: The body sees the transplanted heart as foreign tissue. Without

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immunosupressants, the body attacks the organ as it would an infection. Cardiac endomyocardial biopsies are performed frequently to check for rejection. Rejections are known to occur in the first weeks and months after transplant. The frequency of biopsy decreases over time. Drug therapy continues, even though fewer antisuppressants may be needed over time. The patient’s immune system activity is suppressed, making him/her more prone to infections. Patients are sometimes prescribed antibacterial, antiviral and antifungal drugs to help prevent infections. The transplanted organ can also experience heart failure due to rejection, valvular disease or coronary artery disease. If this occurs, the patient could possibly be retransplanted or the drug therapy modified. Endomyocardial Biopsy: The risk of developing rejection is


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usually highest immediately after transplant. About 40% of new transplant patients will have at least one rejection during the first year post transplant with 85% of all rejections classified as “cellular rejection”. An endomyocardial biopsy is normally performed post transplantation, although it is sometimes performed on patients who have not undergone transplant. For non transplant patients, a biopsy is done in order to help with clinical diagnoses. A biopsy is done by placing a sheath in the internal jugular vein or femoral vein. A bioptome is then used to remove small pieces of heart tissue from the right ventricle for analysis. Tissue analysis is used to check for rejection post transplant. Rejection: The International Heart and Lung Transplantation Society (IHLTS) grading scale is used to measure rejection of transplanted hearts. 1. Grade 1A and 1B: mild rejection. Heart tissues usually show signs of interstitial inflammation. There is no myocyte necrosis. Mild rejection is often not treated with immunosuppressant. Patients are usually stable and their medications adjusted. 2. Grade 2: Patients are also stable. Drug doses are normally increased and steroids added (100 mg prednisone). 3. Grade 3 and 4: Moderate/severe rejection. Patients are treated with augmented immunosuppressant. Grade 3A/3B rejection normally shows increase in central venous pressure (CVP) and pulmonary capillary wedge pressure (PCWP), a decrease in ejection fraction (EF) and an increase in arrhythmias. Patients are usually given more steroids and anti-rejection treatment, such as ORTHOCLONE OKT®3 (muromonab-CD3). This type

of aggressive treatment is normally used for a grade 3B or grade 4 rejections.

The Future of Heart Transplant: Heart transplant and treatment continue to evolve. Currently, the only way to monitor and treat rejection is by doing an endomyocardial biopsy. With technological advancements and research studies, other alternatives are being investigated. The CARGO (Cardio Allograft Rejection Gene Expression Observational) trial, for example, is investigating the use of blood tests as the tool to monitor rejection. A test called AlloMap looks for the activation of genes proven to be associated with rejection. The Tailored Immunosuppressant Therapy study is protocol based and makes use of tissue typing and individual risk profiles. The current treatment protocol is one in which every patient gets the standard immunosuppressant treatment. Tailored Immunosuppressant Therapy takes an in-depth look at each patient and generates a specific treatment regimen. Groups identified as high risk prior to transplantation should continue to be monitored closely post transplant and be considered for this type of treatment.

Immunosuppressant therapy should be tailored so that patients in a high risk group receive higher doses and more intensive treatment.

Conclusion Although research and technological advancements continue in the heart failure /heart transplantation arena, healthcare workers must continue to be patients’ advocates. Education should be made available to patients on the severity of heart failure, and the potential problems and end results if the condition is left untreated. Continuous and close monitoring is recommended for patients diagnosed with heart failure. Patients should be referred to a heart failure group where they can be evaluated and early treatment options utilized to minimize progression of the condition. As noted earlier, early diagnosis and treatment can postpone and even prevent the need for the least favored treatment option of heart transplantation.

References •

Billingham ME. Diagnosis of cardiac rejection by endomyocardial biopsy. J Heart Transplant 1982; 1:25-30.

Cattaneo, Dario; Perico, Norberto; Remuzzi, Giuseppe. From Pharmacokinetics to Pharmacogenomics: A New Approach to Tailor Immunosuppressive Therapy. American Journal of Transplantation, Volume 7, Number 9.

Dressler, Diane K., RN, MSN, CCRN, CCTC Organ Transplantation: Concepts, Issues, Practice, and Outcomes. Organ Transplant 2002

Tuma, Rabiya S., PhD Molecular Test Supports Weaning From Immunosuppressants. Medscape Medical News 2007.

These high risk groups include: •

Younger females of African American race

Donors older than 50

www.americanheart.org

Re-transplants

www.Wikipedia.org

Patients with high levels of preformed antibodies (PRA).

Patients with delayed graft function. CORONARY HEART ™  33


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UNITED KINGDOM

Freeman Hospital ADDRESS The Newcastle upon Tyne Hospitals NHS Trust Freeman Hospital Freeman Road High Heaton Newcastle upon Tyne NE7 7DN Think you would like to work at the Freeman Hospital? Contact: Amanda Hill Email: Amanda.Hill@nuth.nhs.uk

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he following questions have been answered by consultant cardiologist and Coronary Heart Consulting Editor Dr Richard Edwards.

Size of the Department: We are a regional tertiary centre providing a full range of adult and paediatric cardiac procedures including transplantation. 34

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From November 2007 we have 5 fully operational catheter labs and one dedicated devices lab with a mobile screening unit. Additionally there is ongoing refurbishment of a dedicated EP lab. Each subspecialty has its own recovery area adjacent to the catheter labs. Freeman cardiology has • 8 CCU beds for acute regional transfers •

21 cardiology beds for regional transfers

28 protected elective beds

Additionally, the Royal Victoria Infirmary (RVI) provides a secondary care service for cardiology (52 beds) and serves the population of the city of Newcastle.

Staff Numbers: Consultants: 14 NHS and 2 Academic appointments at Freeman. 5 NHS at RVI Registrar: 9 plus 2 at RVI Cath lab nurses: 16.6 (Whole time equivalent) Radiographers: 7 full time, 1 part time Cardiac physiologists: 9 Admin and waiting list team: 2 Store person

1


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Procedures: PCI, angiograms, EP, RFA, simple and complex pacing, septal ablation, valvuloplasty. ASD/PFO and other device closures. Cardiac biopsies. Pacing lead extraction using laser.

Procedures performed per year: For the financial year 2006/2007: 5273 procedures in total of these •

PCI = 1986

EP = 516

Angiograms = 1539

Pacing x 607

Biventricular pacing

ICD = 190

Device closure (ASD/PFO/VSD) = 21

Other = 414

By the end of this financial year we expect a significant increase in throughput due to the 5th lab being formally established in November.

Equipment: Siemens Axiom Artis Labs Above: Cardiology Staff 1st row from left to right Saritha, Grace Diploma, Jude Belford, Samantha Clint, Charlene Booth, Jessica Seal, Johnson Mukanganiki, Allison Simpson. 2nd row right to left Mandy Hill, Unknown, David, Ian Purcell, Christine Hedley, Judith Curtis, Donald Greenhalgh, Claire McGinty, John Crompton, Guiseppe DiNicola 3rd row Right to left Dr Richard Edwards, James Pierce, Dr Wazzif Razzaq

Agfa Heartlab Cardiovascular Image and Information Management Solution IVUS, rotablation, atherectomy, pressure wire, excimer laser, baylis

Day Procedures: All angiography and 5% of PCI performed as day cases. The majority of patients are in patients transfers from around our network.

New procedures implemented:

From Left: Claire McGinty (Radiographer), Dr Wasif Razziq (Registrar), and Dr Richard Edwards (Consultant)

a full range of adjunctive devices for coronary intervention. On the electrical side lead extractions using laser has become established practice. We are presently exploring the possibility of converting one lab to a permanent hybrid theatre to undertake combined cardiology/surgical procedures and we are excited by the prospect of percutaneous valve treatments and hope to adopt an aortic valve programme soon.

Cross-Training of staff: Not at present. Our present practice has no formal cross training although in practice there are a number of areas where the role boundaries have been softened.

Surgical Back-up: There are 4 cardiothoracic theatres on site and cardiac surgery team available 24/7 and a dedicated cardiac ITU.

From April we are rolling out a 24/7 primary PCI service for a tertiary population of 1.8 millions. We have CORONARY HEART ™  35


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Freeman Hospital, UK (cont...) Alliances with other hospitals for the treatment of patients: We form part of the Northern Network of cardiac care and we cooperate closely with hospitals in Tyne and Wear, North Durham, Northumberland and Cumbria. No formal alliance exists.

Training for new employees: New staff undertake a formal induction to the Trust, and a departmental orientation. They are allocated a personal preceptor/mentor to help with the settling- in period and completion of medical device competencies. We are a very friendly department and the day to day environment is conducive to professional development. From Left: Saritha and Camilla

Inventory Management:

Continuing education programs for the staff: Staff have close links with local

We have a dedicated store person for our stock which we are sure saves us time and money. We have installed a Siemens system to manage inventory and this will be operational in 2008.

Hemostasis Management: We are mainly radial operators and use TR bands and Radi stops after most cases. We use Femstops following femoral approaches and sometimes the angioseal. Although there are digital sheath removals performed by operators and the wards.

Measures implemented to cut costs: A comprehensive and collaborative tendering process with a clinical lead with astute negotiating skills! Our trust as a whole is in good financial order. We take care not to be too flagrant with expensive equipment; we monitor our DES usage and keep a close eye on budgetary constraints. 36â&#x20AC;&#x192; CORONARY HEART â&#x201E;˘

Cardiac Physiologist: Jude Belford Notice the live video monitor on the left. The physiologists can control the camera movement around the lab. When busy they can zoom in on the products being used rather than have the nurses constantly coming in and out of the room to tell them.


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universities that can facilitate further and continuing education such as degree programmes or stand alone units eg ECG, teaching and assessing in clinical practice, etc. There are a wide range of short training courses available from the Trust to enhance clinical and managerial skills. Every effort is made to accommodate training requests from individuals through a proactive appraisal system and support for external study requests.

Competency checks for staff: Continuous informal assessment and annual appraisals are undertaken. Medical device competencies are identified for each job description and formally assessed by a formally trained colleague.

Challenges: We are planning to start a primary PCI program in the next few weeks which has involved a great deal of work convincing everyone it’s the right thing for patients and implementing the changes within the Network and ambulance service. The geography of our Network imposes upon us challenges to ensure equity for all. It is a major reason why we have lagged behind full implementation of primary PCI compared to the metropolitan based Networks in the UK.

Training facility for cardiac registrars (fellows): We have 9 registrars who are trained in all aspects of cardiology during their tenure.

What is the best part of working at your facility:

WHY NEWCASTLE? Located on the north bank of the River Tyne in North East England is the city of Newcastle upon Tyne (usually shortened to just Newcastle). Founded in Roman times and now with a population of 20,000 the city has transformed into one of Europe‘s most exciting places. Art: The BALTIC Centre for Contemporary Art is the biggest gallery of its kind in the world. Shopping: The MetroCentre has the biggest shopping and leisure complex in Europe. Sporting: Rugby, Football, Golf, Cycling, Cricket, Horse Racing, etc. Nightlife: World class restaurants, theatres, and of course pubs and clubs makes Newcastle the place for a guaranteed good time!!

The coffee machine (would be if we had one!)

What’s Nearby: •

Lake District National Park: A couple of hours drive west you arrive at this famous park. Climb Scafell Pike, the highest mountain in England or just relax by the many lakes.

Hadrian’s Wall: Starting in Newcastle and originally 117km long, this wall was built over 2000 years ago by the Romans to prevent military raids by the ancient tribes of Scotland in the north. Large sections of this UNESCO site remain as it stretches across the entire width of England.

A view of Newcastle quayside at twilight from the Tyne bridge

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UNITED STATES OF AMERICA

Main Line Health ADDRESS Paoli Hospital 2 W Lancaster Ave Paoli PA 1301 United States of America

Invasive Cardiology Services

Cardiology Manager Contact Information Paoli Hospital Elizabeth Marasco Kennedy, RN, Assoc., Degree + 1 (610) 648 1287 Bryn Mawr Hospital Mark Miller, RN, BSN +1 (610) 526 4197 Lankenau Hospital Chris Dearing, RN, BSN +1 (610) 645 3590

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his issue we head back to Pennsylvania to have a look at the Main Line Health Invasive Cardiology Service. The following questions have been answered by Elizabeth Kennedy whom you may remember wrote the article on Creating Motivated and Loyal Staff in Edition 8. 3

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Dr. Todd Rudo and Debbie Beckley do a device implantation case at Paoli Memorial Hospital. Dr. Rudo is an electrophysiologist and Debbie is a Registered Tech trained both in EP and Cath. Debbie works across the system doing Electrophysiology.

Size of the department and staff numbers:

be converted to holding areas for the hospital when in a divert situation.

Main Line Health’s Invasive Cardiology Services consist of three campuses, Lankenau, Bryn Mawr and Paoli Hospitals. Lankenau being the largest, consists of (7) invasive labs for both cath and ep, (1) noninvasive lab and (1) procedure room for myocardial biopsies and right heart caths for our heart failure program. There is also a 13 bed holding area used for admitting, recovering and discharging patients. Bryn Mawr consist of (2) invasive labs, (1) noninvasive lab and a 3 bed holding area. Paoli consists of (3) invasive labs and some noninvasive testing is done in the holding area that has 10 beds for holding patients. All of the labs are considered critical care beds and can

At Lankenau there are 60 staff members on payroll, consisting of a nurse manager, 2 charge nurses, one being an electrophysiology lead, nurses, CVT’s, some registered and some on the job trained, 2 unit secretaries, nurse practitioners, a physician’s assistant, an inventory control coordinator and cardiology aids that assist with ancillary issues; transporting, stocking and turning over procedure rooms. Bryn Mawr and Paoli have smaller staffs but the same type of personnel mix exists in these labs as well.

Procedures: Throughout the Main Line Health


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Invasive Cardiology system we perform Invasive and Non Invasive procedures of all types ranging from complicated Invasive Cath, diagnostic and interventional, Invasive complicated Electrophysiology procedures including complicated atrial fibrillation and ventricular tachycardia ablations, biventricular device implantation for heart failure as well as diagnostic electrophysiology and simple pacemaker and AICD implantation. We also perform noninvasive cardiac procedures such as Tilt Testing, NIPS procedures and cardioversions. We perform right heart cath and myocardial biopsies to support our heart failure/transplant program. Lastly, the labs are responsible for complicated peripheral vascular procedures including limb angioplasty and laser procedures. Main Line Health Invasive Cardiology is also very involved in up and coming research protocols and many of our physicians are primary investigators for these protocols. Main Line Health is one of the largest and busiest invasive cardiology programs in the area.

Procedures performed on an outpatient basis: We perform diagnostic cath procedures, noninvasive cardiology procedures, diagnostic electrophysiology procedures, pacemaker implantation, generator change outs, device pocket and lead revisions, diagnostic peripheral procedures and simple, uncomplicated catheter ablation procedures.

Surgical Back-up: Our facilities normally opt to perform procedures during the day hours when surgeons are in the house and the operating room is available but often our day lasts much longer than the

Paoli Hospital cardiac surgeons. It is not mandatory that surgical backup be in the house. If a patient needs emergency surgery they are mobilized immediately to the OR and the team arrive within an acceptable amount of time. We’ve not had an issue with an OR team not being available in an emergency situation.

Department Management: Our management is lead by a System Chief of Invasive Cardiology and three physician lab directors; one for each hospital, Lankenau, Bryn Mawr and Paoli. There is also a physician chief of electrophysiology for the system. At Lankenau, there is a manager and 2 charge nurses, one being a clinical lead for electrophysiology. There is a manager at Bryn Mawr and Paoli; they run the everyday operations as their programs are smaller. The charge nurses at Lankenau function independently as the manger at this campus is involved across the campuses as the role of the Affinity Liaison for Main Line Health Invasive Cardiology.

The managers are able to cross cover each other when one is on vacation etc. The manager is ultimately responsible for everything that happens in the lab. Major responsibilities are the budgetary process, staffing and quality performance. It is the manager’s responsibility to engage the staff enough to follow the vision and purpose of Main Line Health. We promote the ultimate patient satisfactory experience, being financially responsible and promoting quality and excellent patient care to all patients coming through our system. The scheduling coordinator and clinical lead are responsible for daily staff scheduling, staff schedules, procedure schedules, facilitating movement of cases through the lab and being resource staff members for the rest of the staff with regards to procedures performed in our facilities. They participate in annual evaluations of the staff; they are in charge when the manger is off campus. CORONARY HEART ™  39


CARDIAC SITE VISIT

Main Line Health (cont...) sooner from the hospital and also it allows the patients that have had interventions to be able to mobilize themselves much sooner and they don’t have to be on bed rest for 24 hours like in the past. They are much more comfortable than laying flat on their backs. This promotes patient satisfaction overall and allows them to feel they are more control of their treatment and not hat the mercy of the hospital staff.

Inventory Management:

Paoli Memorial Hospital’s Invasive Cardiology Staff; Chris Torretti, Helen Cockerham and Rebecca Hay reviewing Electrophysiology with Steve Harding, RN who is crosstrained in both Electrophysiology and Cath; and works at all campuses.

We report to nursing as well as our physician directors; it is a very cohesive group.

Cross-Training: The staff at all three campuses are cross trained to cardiac cath and electrophysiology procedures within their own labs as well as the labs across the system. We standardize across our system so staff can move freely from one campus to another. This allows us to move staff to a campus when one lab needs someone or one lab needs to down staff; it works well and we have not had to use agency for some time. This proved to be most valuable when recently Paoli Hospital launched their electrophysiology program; the highly skilled staff from electrophysiology at Lankenau cross covered the lab at Paoli. Since the managers and physicians work so closely together; this was a smooth process.

40  CORONARY HEART ™

Clinical Ladder: The nursing department at Main Line Health participates in the clinical ladder program. The managers decided to implement a modified clinical ladder for CVT’s in the lab; there are two different job grades for CVT’s, one that is for a RCIS and then a second for on the job trained CVT’s. The registered CVT’s are a higher grade and can make more money; those that are on the job trained have the opportunity to advance in their career.

Haemostasis Management: We use closure devices on many of our patients; AngioSeal, Perclose and Starclose. We also utilize closure pads and on some of our cases we use c-clamps and manual pressure. Many of our patients that have interventions receive closure devices as well as diagnostic procedures. This enables them to be either discharged much

The labs have inventory control managers. They are in charge of working with the managers and charge nurses setting par levels on all equipment in the labs. Everyday par levels are checked and orders are placed by the ICC through a computerized system so electronic tracking can be performed.

Measures implemented to cut costs: Our invasive cardiology department meets monthly at an Equipment Committee Meeting. This group includes the physician directors from each lab, the physician director of Invasive Cardiology for the System, the clinical coordinators, the inventory control coordinators and the contracts department. Here all new technology is introduced to the group as well as any new or different product that a physician feels would benefit the care of a patient. Costs analysis is done and we weigh the pros and cons of the product. It is decided after all of these issues are discussed whether it is beneficial for the product to come into the labs. We request consignment for all products and those that cannot be consigned are contracted at a system approach so all three labs benefit. Pricing for all products is contracted for the system.


CARDIAC SITE VISIT

Quality control / quality assurance measures: We practice many quality measures; our most important for the cath side is our core measure for door to balloon time of < 90 min. We do very well in this area and we continually look for improvement areas. We found that review of each case within 24 hours is most beneficial. In the EP areas, we track antibiotic timing for device implantation. Other areas that we track for quality are: Patient Identification by two measures, Time Outs for all procedures, Groin Complications as well as other complications, First case on time starts, Patient Falls, Room Turnover Times. This data is collected monthly and presented at the quarterly QA meeting for Invasive Cardiology. All three campuses, Lankenau, Bryn Mawr and Paoli are represented.

Electrophysiology staff at Lankenau reviewing a case with Joan Capoferri, RN. Joan has been at Lankenau for a long time; experienced both in cath and ep. Working with nurses, Geri Riehl, Torrie Lee, also the scheduling coordinator for Lankenau, Denise Bucci and Beth Kennedy, manager of PMH Invasive Cardiology, Cath and EP.

Competing for patients: Our physicians that perform procedures are very well known to our patients as well as very involved in front line research in invasive cardiology procedures. We are reputable for our excellent care provided to our patients. We are one of the largest Invasive Cardiology Departments in the area; Main Line Health includes Lankenau, Bryn Mawr and Paoli hospitals. We provide cardiovascular services to the area of Philadelphia out to Chester County and beyond. We have a great marketing department that promotes all of our specialties and continually look for areas where business can be derived from. Our best marketing agent is our cardiologists; they are well known for their talent and the care they provide in the Main Line Health System. We have a dedicated and highly skilled Invasive Cardiology Staff that moves

across the Main Line allowing them to be trained in many different areas.

Training for new employees: New staff members are assigned to a preceptor for 12 weeks. They are trained in all areas of the lab ranging from our busy holding area, cardiac cath suites, non invasive EP rooms, invasive procedure room, device implantation and EP. Roles of the individual may vary in each of these areas for example; we have core staff for EP that also advance to the level of learning mapping systems and the EP recording systems. This person will orient to cath but not the recording system; they will be able to circulate the procedure. There is also a difference in the role for nurses in the device room; they normally are providing conscious sedation when anesthesia is not available.

Each orientation is individualized and we work closely with the new employee; we want to retain them after we invest the time into training. We interview very closely; we don’t want to pick the wrong people for our department.

Continuing education programs for the staff: We value continuing education at all levels. One morning a week is dedicated to an in-service for the staff with the exception of one Tuesday a month; this is reserved for a staff meeting. We provide educational days and we look for educational opportunities within our department and outside conferences as well; this is a little more difficult due to costs, etc. We have an educational committee for our department that consists of four staff members; they are responsible CORONARY HEART ™  41


CARDIAC SITE VISIT

Main Line Health (cont...) for tracking all education for the department; we’ve just expanded this committee to Paoli hospital. Now there is a staff member from that site who ensures the staff at Paoli is being provided with the same opportunities. We keep lists and rotate all staff so everyone gets an opportunity to do this.

Vendor Management: Vendors are scheduled by appointment for a day in the lab or a meeting with the manager; no one shows up in the lab unannounced. They must sign in at security and with the Inventory Control Coordinator. They are expected to present PPD testing results for TB on their first visit to the lab or they will not be admitted. They are also expected to read our vendor policy and we have to have a signed copy on record in our department. A vendor is expected to act professionally at all times; no new products are to be introduced unless the product has gone through our new products committee for approval. If this happens, payment should NOT be expected for any product. Failure on the vendor’s part to comply can jeopardize his/her admittance into the lab. This is strictly enforced.

Competency checks for staff: Staff competency is evaluated by computer based training programs, annual competencies for the hospital and unit based competencies through our educational committee. ACLS and BLS are required. The staff is responsible for tracking their education throughout the year and this is reviewed in their annual evaluation.

Late cases and staff call time management:

This is done differently at two of our campuses. Paoli hospital has a smaller staff and does not have a fellowship program. They do self scheduling for on call; their call staff is the staff that stays late to finish the cases at the end of the day. This does get complicated when an emergency comes in but maneuvering of the schedule happens at the time this occurs. Lankenau has a much larger staff and is lucky to have several staff members that like to take call; call is almost always covered and assignment for a week night is rare unless a person is on vacation. Weekend and holiday call is assigned; approximately every 8 weekends; staff may switch amongst themselves if a need arises. The late case coverage is assigned every day; the call team leaves at 5:30 so they are readily available for an emergency. The late staff finishes the day.

Trends emerging within Invasive Cardiology? I see cath volumes remaining flat for some labs; there are many labs that are arising in the communities and there is a fight for Invasive Cardiology Business. I see a trend in the slight decrease of implantation of DES for some time until the recent controversy is settled. I see a definite increase in atrial fibrillation ad ventricular tachycardia ablations and I see a leveling out of ICD implantation; most of these patients have had their ICD’s implanted over the past two years. I do see a growth in the peripheral vascular area; this is certainly an area for growth. I also see more OR type procedures and a collaboration of surgeons working with invasive cardiologists in more percutaneous procedures for example, valve replacement.

Challenges: One of our biggest issues within

42  CORONARY HEART ™

our department is the scheduling of electrophysiology case. The timeframe for these procedures as we know is a moving target. Ablation procedures can run anywhere from 2 to 6 hours. It is hard to give an accurate case time other than “to follow”. This is extremely frustrating to patients and their families. This is important to us for our patient satisfaction goal. There is a smaller impact with coronary cases except when peripherals are thrown into the mix. Every day we are challenged to pull together and give a team effort in finishing our cases while providing excellent and professional care to our patients. We need to meet the needs of everyone, patients, their families, physicians and the staff. We need to work collaboratively with many departments and each other.

Lab uniqueness & best part of working at your facility: Our Invasive Cardiology staff is completely cross trained both to cath and EP. Along with this, they are cross trained across the Main Line Health Invasive Cardiology System. We don’t use agency and the managers across this system work very closely together. We have dedicated electrophysiology staff that function at such a high skill level; they are often sought out by industry and other hospitals. With our dedicated staff we are able to maintain two busy electrophysiology departments at Lankenau and Paoli. We also provide excellent care in the peripheral vascular arena, sponsoring teaching summits for both physician and staff. As a manager, I am extremely lucky to have the opportunity to work with my staff; they are excellent and it is because of them the department is so successful.


EDUCATION

The management of knotted intravascular catheters and foreign body retrieval Dr. Farhan Ahmad Interventional Fellow St Thomas’ Hospital, London Dr. Ashish Saini Interventional Fellow Guy’s Hospital, London Dr. Tarun Sabharwal Consultant Interventional Radiologist St Thomas’ Hospital, London

K

notted catheters, guide wires and electrodes are rare but serious complications of angiographic procedures and line insertions. The percutaneous techniques and materials used in releasing knots are similar to those used in foreign body retrieval. The aim of this review is to provide an overview of both of these important skills.

Managing knotted catheters Knotting can occur when curved catheters are reformed in the aorta or when excessive manipulation is used to engage a branch vessel such the right coronary artery (1). Head hunter shaped catheters are thought to be particularly prone to knotting (2) as are pulmonary arterial Swan Ganz catheters due their length and flexibility. In all cases manipulating the knotted catheter at the level of visceral branches should be avoided, as should loosening the knot by fixing the distal tip of the catheter within a branch vessel. Both risk intimal damage and embolisation

(2). Almost all methods can be performed in the lower abdominal aorta. Where catheters have more than one knot they should be corrected in sequence starting with the most distal first. Simple measures The following may be tried initially: • Gentle catheter traction and rotation. • Withdrawing the catheter over a stiff guide wire. • Advancing the catheter with a stiff wire to fix the loop against the superior aspect of the aortic arch. Gentle to and fro motion of the catheter enlarges the loop and loosens the knot allowing a wire to be advanced (3). This is most effective with a large loop. These methods may in fact tighten the knot and more challenging cases require counter traction to loosen the knot (2). Methods requiring a contralateral femoral artery puncture or puncture of a common femoral vein •

Hooking the loop of a knot with a secondary catheter

A guide wire and pigtail catheter may be passed through the loop of a knot from the contralateral groin. The pigtail can then “lock” in position and traction applied to it while advancing the knotted catheter with a guide

wire to loosen it (2). The knot may also be withdrawn to the level of the aortic bifurcation and gentle to and fro traction applied (4). A similar method describes snaring the loop with a side winder catheter. Both catheters are then withdrawn to the aortic bifurcation where the secondary catheter is then closed within the iliac artery making opening of its curve less likely. Traction is then maintained on the secondary catheter while advancing and loosening the knotted catheter (5). Similarly a hooked catheter and deflecting guide wire from the groin may be used to snare the knot of a venous catheter allowing both catheters to be pulled in opposite directions (6). When small the knot loop may be enlarged by inflating an angioplasty balloon through the loop (7). Alternatively a stiff guide (such as a Lunderquist) passed through the loop of a knot and positioned well CORONARY HEART ™  43


EDUCATION

above the level of the knot, to provide adequate support, may then allow a knotted catheter to be manipulated and loosened. (6). •

Tightening the loop of a knot

Tightening the knot makes it smaller. This may be achieved by forcing the knot against a catheter sheath (6) or with venous catheters by snaring the knotted catheter from the groin and pulling on both ends. The tightened knot may then be pulled down to the groin after cutting its hub at the insertion site and removed through an introducer sheath (8). •

Grabbing the knotted catheter with forceps or snare

Above: During embolisation of an arteriovenous malformation at the left shoulder a coil has migrated to the right common femoral artery (arrow).

Grabbing forceps have been used to fix guiding catheters above the level of the knot. The proximal end of the catheter is then manipulated to free the knot with anticlockwise rotation being most successful (1). Snare devices can be used in a similar manner by fixing the end of central venous catheters •

Combined percutaneous and surgical removal

Appropriate for large or multiple knots. After pulling down a knotted catheter to a superficial vein, venotomy is performed under local anaesthetic.

Foreign body retrieval Foreign body retrieval should be undertaken promptly to avoid life threatening complications such as thromboembolism, infection, perforation and arrhythmia (9). Foreign bodies include filters, valves, pacemaker transducers, stents and embolised coils as well as more familiar catheter and guide wire fragments. Retrieval methods are highly effective 44  CORONARY HEART ™

(10) and the same principles apply for venous and arterial retrieval. The loop snare is the most effective and commonly used method (10). Baskets and forceps have also been used but are both relatively rigid making tortuous vessels difficult to negotiate (10). Loop snares are directed using a curved guiding catheter such as a cobra or multipurpose catheter (11). Once the fragment is encircled the catheter is advanced to close the loop. The fragment is then fixed firmly against the catheter and ideally withdrawn into the catheter. A larger 9F catheter and / or long sheath is therefore used (11). Fragments that do not present a free end to the snare first require manipulation or extraction to a larger vessel. Double curve or pigtail catheters, deflecting guide wires with fixed hooks (9), grasping forceps, baskets and balloon catheters have all been used (10,12). A Judkins left coronary artery catheter can be used to hook trapped coronary electrodes, which commonly lies with its tips in the left subclavian vein and right ventricle. The catheter is then pulled to release one end of the electrode which can then be snared (10). A technically demanding co-axial catheter pass over technique has also been described. A guide wire is passed through the catheter fragment. A larger catheter is then passed over the fragment and then withdrawn through the sheath (10). In conclusion knotted catheters and retained intravascular foreign bodies are important clinical situations which all angiographers will face. Familiarity with the percutaneous management options are essential for a successful outcome and avoidance of surgery.

References Above: The coil was retrieved by puncturing the contralateral femoral artery and using a snare device passed across the aortic bifurcation.

1.

Tanner MA, Ward D. Percutaneous technique for the reduction of knotted coronary catheters. Heart 2003; 89: 11323.


JOURNALS

Journal Trawl 2.

Thomas HA, Sievers RE. Nonsurgical reduction of arterial catheter knots. Am J Roentgenol 1979; 132: 1018-9.

3.

Young DA, Maurer RM. Successful manipulation of a knotted intravascular catheter allowing non-surgical removal. Radiology 1970; 94: 155-6.

4.

Bierman HR. On the intravascular knotting of catheters. Vasc Surg 1972; 6: 155-8.

5.

Cohen HR, Deutsch AM, Ryvicker MJ, et al. Reduction of catheter knots. Radiology 1980; 134: 243-5.

6.

Cho S, Tisnado, Beachley MC, Vines FS, Alford WL. Percutaneous unknotting of intravascular catheters and retrieval of catheter fragments. Am J Roentgenol 1983; 141: 397-402.

7.

Tan C, Bristow PJ, Segal P, et al. A technique to remove pulmonary arterial catheters. Anaesth Intensive Care 1997; 25: 160-2.

8.

Ismail KM, Deckmyn TJ, Vandermeersch E, et al. Non-surgical extraction of intracardiac double knotted pulmonary artery catheter. J Clin Anaesth 1997; 10: 160-2.

9.

Fisher RG, Ferreyro R. Evaluation of current techniques for non-surgical removal of intravascular iatrogenic foreign bodies. Am J Roentgenol 1978; 130: 541-8.

10. Uflacker R, Lima S, Melichar AC. Intravascular foreign bodies: percutaneous retrieval. Radiology 1986; 160: 731-5. 11. Gabelmann A, Kramer S, Gorich J. Percutaneous retrieval of lost or misplaced intravascular objects. Am J Roentgenol 2001; 176: 1509-13. 12. Dagdalen S, Yuce M, Caglar N. Percutaneous removal of two intracardiac and pulmonary trunkal catheter fragment by using a snare-loop catheter. Int J Cardiol 2007; 116: 413-5.

Dr John Paisley brings you the lastest news from cardiology journals around the world. Comments, criticism and suggestions to johnpaisey@doctors.org.uk The trend to ever larger trials proving ever smaller statistically (if not clinically) significant endpoint improvements with Statins finally bottomed out with the publication of the CORONA trial. Elderly folk with heart failure but no known coronary disease were randomised to statin or placebo with no difference in the primary endpoint of Cardiovascular death, stroke or MI. Kjekshus and others Circulation 357:2248-2261November 29, 2007Number 22. RethinQ - a smallish trial of CRT in narrow QRS patients with LV impairment, NYHA III and echo assessed aynchrony cast more darkness on this murky area with some conflicting findings. NYHA class improved but the primary endpoint of VO2 max only increased in 120-130 ms but not <120 ms QRSd patients. A bit late now but the primary endpoint, power calculations and echo protocol used could do with rethinQing. Beshai and others, epub ahead of print www.nejm.org. The proverbial pendulum is swinging with full force as the backlash against the one sided rubbishing of drug eluting stents takes off. Following on from favourable registry data for DES an examination of bare metal stents has shown in stent restenosis is not the benign phenomenon often portrayed. A 10 year in stent restenosis driven thrombosis incidence of 2.1% was observed in BMS. Doyle and others Circulation 2007 116: 2359.

Compelling evidence of the contribution of PFO to cryptogenic stroke was provided by a case control study comparing TOEs of patients with known cause and cryptogenic stroke. Particularly striking was the odds ratio of 7.36 for PFO and atrial septal aneurysm in younger patients with cryptogenic vs. known cause CVA. Handke and others N Engl J Med. 2007 Nov 29;357(22):2262-8 Yet another study examining the beneficial effects of chocolate on spurious surrogate CV endpoints this time in transplant recipients; apparently eating dark chocolate induces coronary vasodilation and decreased platelet aggregation. Fascinatingly this was positively correlated with a change in epicatechin levels. Flammer and others Circulation. 2007;116:2376-2382. More evidence that paroxysmal and permanent AF carry the same high risk of stoke disease arises form an Active W substudy. Patients treated with aspirin and clopidogrel but not warfarin had an annual serious cerebral/systemic embolism risk of about 2% regardless of pattern of AF. Hohnloser and others JACC Vol. 50, No. 22, 2007 November 27, 2007:2156–61. I have always found the capacity of the BMJ to publish anything other than a normal scientific study perplexing. They surpassed themselves with a Bayesian Network Meta-analysis of combined CRT-ICD…………..the results were inconclusive. Lam and Owen BMJ 2007;335;925 Is there an association between venous and arterial thrombosis? A cohort study from Denmark reveals an early doubling of MI and trebling of CVA in the first year after a PE. Similar though less marked effects were seen after DVT and over longer term follow up. Sørensen and others Lancet 2007; 370: 1773–79

CORONARY HEART ™  45


DIARY

Events Diary To list an event please contact Tim Larner by Email: tim@coronaryheart.com or Fax: +44 (0) 20 7160 9334.

January Advanced Angioplasty

23-25 January, 2008 London, UK Web: www. advancedangioplasty.co.uk

February 4th Cardiff Freeman Echocardiography Course

5-7 February, 2008 Cardiff, UK Email: info@ millbrookconferences.co.uk

March ACC 2008 + i2 Summit 29 March - 1 April, 2008 Chicago, IL, USA Web: www.acc08.acc.org

XVI World Congress of Cardiology

18-21 May, 2008 Buenos Aires, Argentina Web: www.worldheart.org

June BCS Annual Scientific Conference

O

ur next issue will be a bumper edition and will be of major interest to all of our readers. We have several of the best writers in the cardiac industry submitting articles for us on the topic of:

The Future of Cardiology We will investigate how leading departments are managing for the future and how to prosper in the face of rapidly changing technology? Hot Topic:

Do the results from the NICE Study influence your decision for drug eluting stents?

Reviews:

Contrast Media

Site Visit:

Kings College Hospital, London

9-15 June, 2008 Email: aaaw@stars.org.uk

Education:

Stem Cell Research Overview

Heart Failure 2008 Congress

Conferences:

Advanced Angioplasty Wrap-up

2-5 June, 2008 Manchester, UK Web: www.bcs.com

Arrhythmia Awareness Week 2008

14-17 June, 2008 Milan, Italy Web: www.escardio.org

Cardiostim 2008

May

Next Issue

The Future of Cardiology

18-21 June, 2008 Nice, France Web: www.cardiostim.fr

EuroPRevent 2008

1-3 May, 2008 Paris, France Web: www.escardio.org

EuroPCR

13-16 May, 2008 Barcelona, Spain Web: www.europcr.com

Heart Rhythm 2008 - 29th Annual Scientific Sessions 14-17 May, 2008 San Francisco, CA, USA Web: www.hrsonline.org

4

CORONARY HEART â&#x201E;˘

August ESC Congress 2008

30 August - 3 September, 2008 Munich, Germany Web: www.escardio.org

October Acute Cardiac Care 2008

11-14 October, 2008 Versailles, France Web: www.escardio.org

Edition 11 Mar/Apr 2008


United Kingdom

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Thinking of a move into the Industry? Need some advice? With unsurpassed knowledge of the cardiology industry sector, we are able to offer all the pro’s and con’s of making that move, and the different benefits offered by various companies. So, if you are even just thinking about making that move and need some ‘no-pressure’, balanced, informed and free advice, please call us on 01223 550 860. Go on! How will you know if you don’t ask? Remtec Selection - the specialists in medical device industry recruitment

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CORONARY HEART ™ 47


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Coronary Heart January / February 2008

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