Houston Methodist - Heart Annual Report 2014-15

LEADING HEART & VASCULAR CARE 2014-2015 YEAR IN REVIEW

Our commitment to advancing medicine with global impact begins in Houston, Texas, where we pioneer a better tomorrow through research, innovation and breakthroughs to rewrite the future of health.

THAT’S THE DIFFERENCE BETWEEN PRACTICING MEDICINE AND LEADING IT.

26 CONTENTS LEADING MEDICINE: AN OVERVIEW

02

3-D PRINTING: A GLIMPSE INTO THE FUTURE

04

REINVENTING CARE FOR ADULT PATIENTS WITH CONGENITAL HEART DISEASE

06

WIRELESSLY MONITORING THE FAILING HEART

08

A REVOLUTIONARY PLATFORM OF ROBOTIC TECHNOLOGY FOR CARDIAC ARRHYTHMIAS

09

NOVEL APPROACHES FOR TREATING ATRIAL FIBRILLATION

10

PURSUING MEDICAL DISCOVERIES THROUGH RESEARCH

12

NEW THERAPEUTIC PATHWAYS FOR COMPLEX ANEURYSM REPAIR

ACHIEVING OPTIMAL OUTCOMES IN VALVE THERAPIES

16 18

SAFE VASCULAR IMAGING FOR RENAL FAILURE PATIENTS

25

BLOODLESS THERAPIES GIVE PATIENTS NEW OPTIONS

26

PIONEERING GLOBAL CARDIOVASCULAR EDUCATION

30

INTERNATIONAL PUMPS & PIPES SYMPOSIUM

32

21

29

22

02 HOUSTON METHODIST LEADING HEART & VASCULAR CARE

LEADING MEDICINE: AN OVERVIEW DEBAKEY HEART & VASCULAR CENTER Houston Methodist DeBakey Heart & Vascular Center provides an interdisciplinary approach to patient care and research. Patients have access to a highly trained and integrated group of cardiologists, cardiovascular surgeons, cardiovascular anesthesiologists, intensivists and a team of specialized health care professionals who deliver the most advanced medical and surgical solutions, individualized for each patient.

As one of the top cardiovascular hospitals in the United States, we offer the most effective, efficient and compassionate cardiovascular care available. In addition, we have a rich legacy of participation in national and international clinical trials and research. What we learn and achieve here, we pass along to the future generation of heart and vascular specialists through our dedicated training, residency and fellowship programs.

Our broad areas of expertise and array of resources offer comprehensive care and treatment for the world’s most complex cardiac disorders.

Houston Methodist DeBakey Heart & Vascular Center offers: More than 125 heart specialists 1,000 employees 10 operating rooms 2 hybrid operating rooms 9 catheterization labs 176 acute-care beds 58 ICU beds 43 transplant beds More than $3 million in research support annually* Ranked No. 21 by U.S. News & World Report**

• • • • • • • • • •

*Sources: National Institutes of Health, the American Heart Association and others **Ranked among 694 hospitals in the United States for cardiology and heart surgery

$40,285,610

43,816

total given for patient care, education, research and training

patient visits from across the United States and 48 countries

2003-2015

2014-2015

CARDIOVASCULAR SURGERY CASES CARDIOVASCULAR SURGERY CASES 2014-2015 Total Cases: 4,739 2014-2015 Total Cases: 4,739 Mortality Rates Mortality 2014 Rates

2014

2015 2015

Expected Observed

Expected*3.09% 3.52% Observed*

2.14%

3.52% 3.09% 3.59% 3.59% 2.14%

Expected Observed Expected* Observed* *Data represents mortality Jan.-Oct. 2015 *Data represents mortality Jan.-Oct. 2015

4,739

total cases 2014-2015

CORONARY INTERVENTION VOLUMES CORONARY INTERVENTION VOLUMES 2014 2015 Total2014 Cases Total Cases

2015 5,410 5,529 5,410 5,529

MESSAGE FROM THE DIRECTOR As medical director of Houston Methodist DeBakey Heart & Vascular Center, I am pleased to share some of our achievements throughout 2014 and 2015.

Our physicians and health care teams continue to be recognized for our excellence in clinical care, innovative research and advanced education. Our superior patient care is well demonstrated by the large volume of national and international patients and our record of outstanding outcomes in all cardiac diseases and disorders.

In 2015, we were the first institution in Houston to implant the CardioMEMS system, which is the only monitoring device for heart failure approved by the FDA. We are one of the few medical centers in Texas currently implanting custom fenestrated endovascular grafting stents for complex aneurysm repair. Due to sophisticated technology and strict adherence to protocols, our rate of blood transfusion during cardiac surgery ranks as one of the lowest in the country. Our Valve Clinic is a globally recognized leader in the use of technologies for transcatheter aortic valve replacement (TAVR). Houston Methodist also stands at the forefront of catheterbased mitral valve correction with the MitraClip system.

Houston Methodist DeBakey Heart & Vascular Center continues to lead medicine in our development of advanced pharmacology, technology and procedural techniques. A number of our clinical trials research the efficacy of ventricular assist devices (VADs) and other types of valvular repair. In the field of atrial fibrillation, we seek to demonstrate success in a National Institutes of Healthsponsored phase III trial of alcohol-infused ablation, a technique that was conceived and developed by Houston Methodist investigators.

We are consistently broadening the DeBakey Institute for Cardiovascular Education & Training (DICET) to provide instruction for cardiovascular professionals at all stages of their medical careers and to further our goal of being the premier cardiovascular training environment in the world. The didactic college offers practical instruction in invigorating symposia, while the DICET Skills Academy provides a forum in which health care providers learn technical and manual skills. Furthermore, DICET employs a hybrid operating room suite that is used solely for educational purposes and is a first-of-its-kind training venue.

We are expanding our cross-industry collaborations. Our annual Pumps & Pipes Symposium may well be broadcast from an international platform next year. The idea of technology transfer and the exchange of competencies between global industries is a high priority. Pumps & Pipes has proven an extremely effective mechanism for the sharing of ideas and technological strengths.

Continuing the legacy of education and training, the Cardiovascular Nanomedicine International Meeting, funded by the George and Angelina Kostas Center, was held successfully for the first time in 2014. In addition, for the third year, we hosted the Southwest Valve Summit, which focused on imaging innovation and percutaneous valve interventions. In 2015, the conference explored the interface between regenerative cardiology and nanodelivery.

I invite you to read further about our innovations and developments in cardiovascular care. We welcome your feedback on how we can continue to support you and your patients.

Alan B. Lumsden, MD Walter W. Fondren III Distinguished Endowed Chair Medical Director, Houston Methodist DeBakey Heart & Vascular Center Chair, Department of Cardiovascular Surgery Houston Methodist Hospital

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04 HOUSTON METHODIST LEADING HEART & VASCULAR CARE

3 -D PRINTING OF THE COMPROMISED HEART: A GLIMPSE INTO THE FUTURE Houston Methodist DeBakey Heart & Vascular Center is one of the first centers in the United States to use 3-D cardiac printing to provide vital structural insight into diseased hearts prior to complex cardiac procedures.

For example, the presence of branched arteries can pose problems for the endovascular treatment of aneurysms. Flow models printed in 3-D have been excellent tools for training on branch endografts.

“We take a patient’s clinical imaging — a CT scan, an MRI or an echocardiogram — and use a special software to segment out various parts of the anatomy,” said Stephen H. Little, MD, director of the Valve Clinic at the heart center. “We take this digitized, patient-specific anatomy and create a very accurate 3-D model of the patient’s heart.”

Michael J. Reardon, MD, cardiac surgeon at the center, used 3-D cardiac printing to determine the best approach for a patient with a recurrent renal cell carcinoma.

The tumor presented as a mass at the junction of the right atrium and inferior vena cava.

“The problem was I needed to know exactly how far the tumor extended into the inferior vena cava behind the liver, and whether or not I would be able to resect it from above without dissecting out the abdomen,” Reardon said. The exact 3-D replica of the patient’s heart and tumor location enabled Reardon to definitively plan an operation that was less invasive than an abdominal approach.

“This particular surgery demonstrated that the 3-D modeling was very accurate both in identifying the tumor as well as indicating where it was attached within the heart,” Little said. “This proved enormously helpful in deciding the extent of the surgery.”

Funding and expertise for the cardiac printing was provided by William J. Doré Jr., philanthropist and owner of the 3-D Print Bureau of Houston, LLC.

“ We take this digitized, patient-specific anatomy and create a very accurate 3-D model of the patient’s heart.”

MICHAEL J. REARDON, MD

06 HOUSTON METHODIST LEADING HEART & VASCULAR CARE

REINVENTING CARE FOR ADULT PATIENTS WITH CONGENITAL HEART DISEASE Revolutionary surgical advancements during the second half of the 20th century have allowed patients with congenital heart disease to survive into their fifth and sixth decades for the first time in history. Unfortunately, it is a success story for which the medical community was unprepared.

“Adult cardiology and congenital cardiology are actually quite distinct,” said C. Huie Lin, MD, PhD, adult congenital cardiologist at Houston Methodist DeBakey Heart & Vascular Center. “Adult congenital heart disease is a completely different type of physiology and almost a different language.” As a result, many patients continue to see their pediatric congenital cardiologists well into adulthood.

To provide specialized patient-centered care for this rapidly growing population of adult patients, the heart center formed the Adult Congenital Heart Program in 2012. “Although many of these patients had surgery as children, they continue to require regular specialized care throughout adulthood,” Lin said. As a result, advances in transcatheter interventions have become an important aspect in maintaining the quality of life for these individuals.

One important advance in catheter interventions is the Melody Transcatheter Pulmonary Valve. “In the past, some of my patients with lesions such as Tetralogy of Fallot may have required three or even four open heart surgeries during a lifetime.

But transcatheter valve technology has brought a completely new optimism to the conversation I can have with my patients,” Lin said.

An additional innovation at Houston Methodist is the recent ability to create a 3-D printing of a patient-specific, congenitally malformed adult heart. Modeling the diseased heart allows physicians to simulate the precise placement of a valve.

“I think having the 3-D model will help tremendously with patients with Tetralogy of Fallot,” Lin said.

One such case involved a 27-year-old Tetralogy of Fallot patient who posed several medical dilemmas: she lived on the East Coast, was a Jehovah’s Witness who would not accept blood products, and her right ventricular outflow tract (RVOT) was too large for conventional transcatheter valve replacement.

Based on the patient’s CT scan, performed locally and sent to Houston Methodist Hospital, Lin and his team were able to take her dataset and print a 3-D model of her heart.

“We took this 3-D replica to the hybrid operating room at MITIE (Houston Methodist Institute for Technology, Innovation & EducationSM) and were able to simulate the surgery before we even met the patient in person,” Lin explained. “In this simulated procedure, we confirmed that conventional transcatheter valve deployment was not feasible. But, we were able to devise a novel strategy of modifying the patient’s RVOT to create a landing zone for the new valve. We then deployed this strategy, and the patient was able to leave the hospital just a few days later with a new valve without the use of the heart-lung machine or blood transfusion.

“Being able to simulate procedures in these individuals prior to surgery is one of the directions that will drive the field of 3-D printing,” Lin said.

“ Being able to simulate procedures in individuals prior to surgery is one of the directions that will drive the field of 3-D printing.”

C. HUIE LIN, MD, PHD

08 HOUSTON METHODIST LEADING HEART & VASCULAR CARE

WIRELESSLY MONITORING THE FAILING HEART Houston Methodist Hospital is one of the first hospitals in the country to adopt the CardioMEMS heart failure system to wirelessly monitor patients with compromised heart function. Use of the CardioMEMS monitor significantly reduces hospital admissions for patients with heart failure who continue to struggle with symptoms. In addition, research has documented a significant reduction in 30-day readmissions with the use of this device.

The small wireless sensor is placed percutaneously into the patient’s pulmonary artery (PA) where it proactively measures PA pressure, an indirect measurement of fluid buildup in the heart. The monitor measures pressure in patients with either systolic or diastolic heart failure.

A heart failure exacerbation results when there is too much pressure (due to fluid buildup) in the lungs because the heart cannot pump efficiently. Such fluid buildup progresses over a period of several days and is frequently preceded by increased PA pressures in patients who are otherwise asymptomatic. The CardioMEMS system transmits PA pressure data to clinicians from the comfort of patients’ homes, allowing physicians to treat compromised heart function more quickly and reducing the need for hospitalization.

“If we see that the patient’s blood pressure is consistently high, we call in an alert,” said Arvind Bhimaraj, MD, MPH, heart failure cardiologist at Houston Methodist. “We explain to the patient that we see an irregularity and we adjust either medication or fluid intake.”

Studies show that one hospitalization for heart failure places that patient at a 35-percent risk of dying within a few years. Wireless monitoring will help clinicians and patients drastically lower this statistic.

The system doesn’t use batteries or power. Instead, the patient reclines on a pillow containing an antenna that translates the levels of blood flow and pressure into signals. With a press of a button, the antenna picks up the pressure and transmits it into the portal, which can be accessed on the Internet.

Through the DeBakey Institute for Cardiovascular Education & Training (DICET), Houston Methodist Hospital is one of the few hospitals that serves as a national training site for physicians to observe and learn implantation of the CardioMEMS system.

A REVOLUTIONARY PLATFORM OF ROBOTIC TECHNOLOGY FOR CARDIAC ARRHYTHMIAS Houston Methodist Hospital houses two laboratories with Hansen Medical’s robotic system for application and development of advanced, catheter-based cardiovascular procedures. “We have one of the largest — if not the largest — experiences using robotic ablation both for atrial fibrillation and ventricular tachycardia,” said Miguel Valderrábano, MD, chief of the division of cardiac electrophysiology at Houston Methodist DeBakey Heart & Vascular Center. “We were the first to report successful treatment of ventricular tachycardia with the robot.”

These advanced imaging and navigation laboratories use an electrophysiological approach to cardiac ablation with robotics. One is located in the Houston Methodist Institute for Technology, Innovation & EducationSM (MITIE). Our physicians are pioneering work with robotics in the non-electrophysiology realm. “Now we can navigate catheters remotely using robotics, without turning on the X-ray machine.

And it is highly accurate. It has unprecedented stability and navigation capability,” said Alan B. Lumsden, MD, medical director of the heart center.

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10 HOUSTON METHODIST LEADING HEART & VASCULAR CARE

ALCOHOL ABLATION IMPROVES OUTCOMES FOR ATRIAL FIBRILLATION Atrial fibrillation occurs in 1-2 percent of the general population and is the most common clinically significant cardiac arrhythmia. It also carries a five times greater risk of stroke and is responsible for 15 percent of all strokes in people under age 65 in the United States. Current pharmacologic and surgical treatments for atrial fibrillation are suboptimal. At Houston Methodist DeBakey Heart & Vascular Center, cardiologists actively seek to demonstrate significant improvement in outcomes in a National Institutes of Health (NIH)-sponsored phase III trial of alcohol-infused ablation, a technique conceived, developed and validated by Houston Methodist investigators.

“ In some patients with atrial fibrillation, alcohol ablation is truly a life-changer.”

MIGUEL VALDERRÁBANO, MD

“Traditional ablation with radiofrequency is an aggressive procedure where we ablate a fair amount of the left upper chamber of the heart,” said Miguel Valderrábano, MD, chief of cardiac electrophysiology at the heart center. “The alcohol infusion targets a cluster of nerves around the vein of Marshall. This technique allows us to ablate in an area that cannot be reached with conventional catheters.”

Use of this front-line research protocol will potentially benefit a significant number of atrial fibrillation patients who are refractory to conventional treatment.

Cardiologists at the center frequently see patients who are persistently symptomatic despite one or more conventional ablations. “I recently had a patient who was ablated twice in another institution,” Valderrábano said. “He was having recurrent symptoms and was hospitalized every few weeks for shortness of breath. We did a single alcohol ablation, and he has been free from symptoms for nine months.

In some patients with atrial fibrillation, alcohol ablation is truly a life-changer.”

NEW TECHNIQUES IN STROKE PREVENTION WITH THE WATCHMAN DEVICE Houston Methodist DeBakey Heart & Vascular Center is one of a limited number of medical centers in the United States currently implanting the newly approved WATCHMAN left atrial appendage closure (LAAC) device.

The WATCHMAN provides stroke risk reduction for high-risk patients with nonvalvular atrial fibrillation who cannot tolerate warfarin therapy. In addition, according to the PINNACLE Registry, up to 40 percent of patients who are eligible for warfarin or other anticoagulation therapies choose not to take it.

The WATCHMAN LAAC device requires minimally invasive placement close to the left atrial appendage, which is believed to be the source of more than 90 percent of the emboli that can cause stroke in patients with non-valvular atrial fibrillation.

Houston Methodist Hospital is one of the select locations that Boston Scientific, the manufacturer of the WATCHMAN LAAC, will use as a national training site to educate clinicians on the implantation of the device through live cases and at the Houston Methodist Institute for Technology, Innovation & EducationSM (MITIE).

The WATCHMAN provides stroke risk reduction for high-risk patients with non-valvular atrial fibrillation who cannot tolerate warfarin therapy.

GROUNDBREAKING TRIAL: USING ATRICLIP TO PREVENT AFIB STROKE Houston Methodist is the largest enroller for the AtriCure AtriClip trial, led by Mahesh Ramchandani, MD. The AtriClip is the first left atrial appendage device to be approved in the United States. The trial is a feasibility study to assess the safety and efficacy of the AtriClip when placed

via minimally invasive surgical deployment to the left atrial appendage. The purpose is for evaluation of stroke prevention in patients with non-valvular atrial fibrillation who are not able to take oral anticoagulants.

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12 HOUSTON METHODIST LEADING HEART & VASCULAR CARE

INNOVATIONS THAT IMPACT THE FUTURE OF CARDIAC CARE The Center for Cardiovascular Regeneration at Houston Methodist has made great strides in 2015 toward transforming cardiovascular care.

Directed by John Cooke, MD, PhD, professor and chair of the Department of Cardiovascular Sciences, the center’s 54 scientists, technicians and administrative personnel are focused on understanding the mechanisms of cardiovascular senescence and disease, as well as developing and testing useful products for cardiovascular health.

Others in the center are working to understand the mechanisms by which the heart and blood vessels repair themselves. Prasanna Krishnamurthy, MVSc, PhD, has discovered specific microRNA and RNA binding proteins that are critical for the regeneration of heart cells. Jack Wong, PhD, is also studying beneficial microRNA, focusing on those that are expressed during blood flow. And Kaifu Chen, PhD, is a skilled bioinformatician who helps interpret the huge volume of molecular data that is pouring out of the center.

The center is the first academic unit in the country to generate cGMP RNA that can be used in clinical trials. Ivone Bruno, PhD, and her colleagues in the RNAcore at Houston Methodist Research Institute have developed methods and procedures to create therapeutic RNA. These specifically designed RNA molecules can enter cells and generate proteins that cause beneficial modifications or provide the cells with new, useful functions. In 2015, the team published some of its research that demonstrated the use of RNA encoding telomerase to markedly extend the lifespan of human cells. Currently, the center is working with a regenerative medicine company to improve their cell therapy using therapeutic RNA.

Working together, this center’s scientists, technicians and other staff are generating fundamental insights that will lead to transformative changes in cardiovascular care.

Shu Meng, MD, PhD, and colleagues have developed methods to transform scar cells into vascular cells using small molecules and proteins. Meng has improved the technology and is testing the approach now in murine models. This technology may be useful for diseases characterized by scarring. During a myocardial infarction, for example, fibroblasts migrate into the area of injury where they proliferate and make a matrix to form a scar. If these cells can be transformed into vascular cells, they may self-assemble to form the capillaries that will provide blood flow to permit true tissue regeneration rather than a scar.

Henry Pownall, PhD, is studying the role of lipoproteins in atherosclerosis, the major cause of vascular senescence and death (from heart attack or stroke). Pownall has detected a protein that markedly reduces cholesterol by 30 percent with a single treatment. Longhou Fang, PhD, has discovered a protein that removes cholesterol from cell membranes. And Zheng-Zheng Shi, MD, PhD, has identified a protein important in cell metabolism. New therapies based on these findings could be used to reduce obesity, the progression of atherosclerosis, and/or pathological vessel formation (as in tumors).

John Cooke, MD, PhD, director of the Center for Cardiovascular Regeneration

PERFORMING TOMORROW’S RESEARCH TODAY: THE KOSTAS CENTER FOR CARDIOVASCULAR NANOMEDICINE

The George and Angelina Kostas Research Center for Cardiovascular Nanomedicine at the Houston Methodist Research Institute began operations in 2014 after the receipt of a generous gift from George J. and Angelina P. Kostas, the largest philanthropic gift ever donated in support of cardiovascular nanomedicine. The Kostas’ ultimate purpose is to revolutionize the treatment of cardiovascular disease.

The Kostas Center fosters international collaboration and integrates top laboratory and physician scientists from Houston Methodist DeBakey Heart & Vascular Center and the research institute’s Department of Nanomedicine to investigate the emerging realm of nanomedicine and its application to damaged cardiovascular systems.

The Kostas Center is directed by Mauro Ferrari, PhD, president and CEO of the research institute, and Alan B. Lumsden, MD, medical director of the heart center.

Group leaders within the Kostas Center include some of the best nanotechnology researchers and cardiovascular physicians and surgeons in the country. The Kostas Center’s groups are designed to work sequentially to best translate discoveries quickly into technologies that can be tested in human clinical trials.

One current medical advance made possible by the Kostas Center involves a study on magnetic nanoparticles that could transport tissue plasminogen activator (tPA) directly to blood clots, improving outcomes from life-threatening emboli. Findings from this research were published in Advanced Functional Materials.

The Kostas’ gift will also fund the annual Cardiovascular Nanomedicine International Meeting, which convened for the first time in October 2014 at the Research Institute.

The 2015 meeting explored the interface between regenerative cardiology and nanodelivery systems. The meeting preceded the National Heart, Lung, and Blood Institute Progenitor Cell Biology Consortium (PCBC) meeting. The RNAcore at the Houston Methodist Research Institute is a leader in RNA synthesis and serves as the RNAcore for the PCBC. Scientists from the RNAcore recently received $4.8 million from the Cancer Prevention and Research Institute of Texas for the pursuit of RNA-based therapeutics and research.

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14 HOUSTON METHODIST LEADING HEART & VASCULAR CARE

NATIONAL LEADERS IN LVAD RESEARCH Houston Methodist’s left ventricular assist device (LVAD) program has distinction as one of the largest in the country. Under the wide umbrella of cardiovascular and transplant medicine, physicians and surgeons from both the Houston Methodist DeBakey Heart & Vascular Center and the Houston Methodist J.C. Walter Jr. Transplant Center work together to pursue the most current and advanced clinical trials in LVAD therapy.

“We offer cutting-edge trials for several ventricular assist devices, such as HeartWare’s ENDURANCE Supplemental Trial,” said Brian Bruckner, MD, director of mechanical circulatory support and surgical director of the LVAD and extracorporeal membrane oxygenation (ECMO) programs at Houston Methodist. “We’re also doing the ReliantHeart’s HeartAssist device, a prospective, randomized, multicenter, clinical trial to evaluate the safety and efficacy of 96 patients implanted with the ReliantHeart HeartAssist5® VAD system compared to 96 patients implanted with either a Thoratec HeartMate II® LVAD or HeartWare HVAD® for left ventricular support while awaiting cardiac transplantation.”

Houston Methodist is participating in Thoratec’s MOMENTUM 3 clinical trial, which will enroll more than 1,000 participants in up to 60 centers across the nation to evaluate the HeartMate 3 for use as long-term support for individuals who are not candidates for heart transplantation (known as destination therapy). The device will also be evaluated for short-term use in patients awaiting transplantation. “Houston Methodist is the first center in Texas to implant the HeartMate 3 device, which is the newest assist device out in trial,” Bruckner said.

The Houston Methodist left ventricular assist device (LVAD) program has distinction as one of the largest in the country.

Recently, Houston Methodist was the largest enroller in Thoratec’s pivotal ROADMAP (Risk Assessment and Comparative Effectiveness of Left Ventricular Assist Device and Medical Management in Ambulatory Heart Failure Patients) trial. Led by Jerry Estep, MD, medical director of the heart transplant and LVAD program, the trial included 200 patients and compared the HeartMate II LVAD therapy with optimal medical management in ambulatory heart failure patients who were not dependent on intravenous inotropic support but met the FDA-approved indication for destination

therapy. The primary endpoint measurement was a composite of survival with improvement in the Six Minute Walk Test distance from a baseline of ≥ 75 meters at 12 months. “This study gives us, for the first time, data that carefully allows us to weigh the benefits and risks of using current LVAD therapy in this patient population.

This clarity of projected benefit versus risk allows us to tailor our treatment decision more accurately and appropriately,” Estep said. The study findings were published in the October 2015 issue of the Journal of the American College of Cardiology and Estep was the first author of the paper. The two-year follow-up study of patients is currently in progress.

The VAD program at Houston Methodist has a rich history. The first assist device was implanted by Michael E. DeBakey, MD, in the 1960s. DeBakey continued to develop assist devices with George P. Noon, MD, also at Houston Methodist, and together they designed the first continuous flow pump, called the DeBakey VAD.

2015 Waitlist Mortality Rate 10.1% 9.5% National SRTR Benchmark

Houston Methodist Hospital

HEART TRANSPLANTS 2014

24

2015

38

116 TOTAL LVAD IMPLANTS 2014-2015

AASTROM (VERICEL) IXCELL DCM TRIAL Barry H. Trachtenberg, MD, was the principal investigator of a clinical study investigating the use of Ixmyelocel-T administered via transendocardial catheterbased injections for patients with heart failure due to ischemic dilated cardiomyopathy (IDCM). Ixmyelocel-T is a patient-specific, expanded multicellular therapy manufactured from the patient’s own bone marrow with a proven range of activities, including repair and regeneration of ischemic tissue. Ixmeylocel-T selectively expands the population of mesenchymal stromal cells and alternatively activated macrophages, which are responsible for the production of anti-inflammatory and pro-angiogenic factors known to be important for repair of damaged tissue.

16

HOUSTON METHODIST LEADING HEART & VASCULAR CARE

NEW THERAPEUTIC PATHWAYS FOR COMPLEX ANEURYSM REPAIR At Houston Methodist DeBakey Heart & Vascular Center, cardiologists and cardiovascular surgeons are currently helping pioneer a wider therapeutic path for complex aneurysm treatment. The unique procedures are made possible by the combination of three leading-edge medical developments. First is the ability to create an intricate model of an aneurysm that provides a detailed evaluation of the pathogenesis of the aneurysm’s progression. Second is capitalizing on sophisticated, state-of-the-art imaging technology that allows for detailed visualization of the area of injury. And third is using custom-made fenestrated stents.

Houston Methodist is one of the few medical centers in Texas currently implanting fenestrated endovascular grafting stents for complex aneurysm repair. The most common site of aortic aneurysms is the abdominal aorta, a location that can be problematic for repair. Short-necked aneurysms, or those proximal to the renal arteries, or complex aneurysms, are often refractory to surgical treatment with standard endovascular stents.

“When the aneurysm is at the renal artery, the traditional covered stent is inadequate because there is no healthy area in the aorta for stent placement. If you implant the stent higher, the patient will go into renal failure,” said Carlos Bechara, MD, a vascular surgeon with the heart center.

Initially, the patient’s internal vasculature and central line flow is measured and documented through CT scans of the chest, abdomen and pelvis. These anatomical specifications are molded by Cook® Medical into a custom-made stent with fenestrations that will accommodate blood flow to the renal arteries, superior mesenteric artery and celiac axis.

Modeling of the aneurysm is accomplished at the Houston Methodist Institute for Technology, Innovation & EducationSM (MITIE℠), which provides physicians and researchers with a detailed replica of an aneurysm from a patient’s dataset.

Physicians receive training through DeBakey Institute for Cardiovascular Education & Training (DICET) at MITIE that entails printing a 3-D aortic model, connecting it to a hose and watching the flow. This modeling means interventional cardiologists can now

practice patient-specific implantation techniques prior to the live procedures where the stent is percutaneously deployed via the groin, without any type of open surgery.

“Aneurysm repair used to require extensive surgery — we often had to open both the abdomen and the chest — and many patients were not good candidates for surgery,” Bechara said. “Many of these patients can now benefit from this minimally invasive alternative that results in a shorter recovery time, fewer complications and a return to normal activity in a week or two, as compared to a significantly longer period required with an open procedure.”

Other avenues of aortic aneurysm repair are currently under study with Jean Bismuth, MD, a Houston Methodist cardiovascular surgeon who is principal investigator (PI) on an arch branch graft trial, and the national PI for a trial on ascending aortic dissection.

NEW GRAFT OPTION STUDIED FOR PERIPHERAL ARTERY DISEASE The purpose of FINEST (MAQUET Protocol MCV-00001506, Comparison of Safety and Primary Patency Between FUSION™ Vascular Graft, FUSION™ Vascular Graft with BiolinE, and EXXCEL Soft ePTFE), headed by Alan B. Lumsden, MD, is to demonstrate the efficacy of a new synthetic hybrid vascular graft made of Dacron and ePTFE (Teflon) with an interior coated with heparin. Results were published in the March 2015 issue of Journal of Vascular Surgery . Investigators found that primary patency rates with the FUSION BIOLINE were superior (86.4 percent) to the standard ePTFE group (70.0 percent).

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18 HOUSTON METHODIST LEADING HEART & VASCULAR CARE

LOTUS: TESTING A REPOSITIONABLE, REDEPLOYABLE AORTIC VALVE The Valve Clinic at Houston Methodist DeBakey Heart & Vascular Center is a globally recognized leader in the use of technologies for transcatheter aortic valve replacement (TAVR). Clinical trials at Houston Methodist and other institutions show that percutaneous valve replacement can achieve optimal results without the high risk of mortality and morbidity typically associated with major surgery for valve replacement in patients at risk.

Michael J. Reardon, MD, the Allison Family Distinguished Chair in cardiovascular research and professor of cardiothoracic surgery, is currently the international surgical principal investigator for REPRISE III: Repositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus™ Valve System – Randomized Clinical Evaluation trial, funded by Boston Scientific. The objective of this study is to evaluate the safety and efficacy of the Lotus™ Valve System for TAVR in symptomatic subjects with calcific, severe native aortic stenosis who are considered at extreme or high risk for surgical valve replacement.

“The Lotus™ valve is recapturable, repositionable and redeployable,” Reardon said.

“When we position these valves, if we get it in the right place the right way, that’s great.

But nothing is 100 percent, so being able to reposition and redeploy a valve if required is extremely beneficial.”

Currently, the Lotus™ valve is undergoing clinical investigation in the United States.

In an FDA-Investigation Device Event (IDE) for potential approval, the trial is randomized 2:1 between the Lotus™ valve and the CoreValve, a commercially available valve in use today.

In 2014, data from the REPRISE II clinical trial confirmed safety and effectiveness of the Lotus™ valve at one year, with more than 86 percent of patients exhibiting no paravalvular aortic regurgitation and no patients with moderate or severe paravalvular aortic regurgitation.

Currently, Boston Scientific is conducting Lotus™ training in the Houston Methodist Institute for Technology, Innovation & EducationSM (MITIE). The Lotus™ valve has already been approved for use in Canada, Europe and Australia.

In 2014, data from the REPRISE II clinical trial confirmed safety and effectiveness of the Lotus™ valve at one year, with more than 86 percent of patients exhibiting no paravalvular aortic regurgitation and no patients with moderate or severe paravalvular aortic regurgitation.

Image courtesy of Boston Scientific

PIONEERING RESEARCH IN AORTIC VALVE REPLACEMENT Beginning with the unparalleled research of Michael E. DeBakey, MD, the cardiovascular physicians, surgeons and scientists of the Houston Methodist DeBakey Heart & Vascular Center continue to lead the medical vanguard in their pursuit of cutting-edge pharmacology, technology and procedural techniques. This is accomplished through numerous clinical trials, a few of which are highlighted below.

treatment option than is currently available. The study is known as the Surgical Replacement and Transcatheter Aortic Valve Implantation, or SURTAVI, trial. It is designed to evaluate the safety and efficacy of the Medtronic CoreValve System in the treatment of symptomatic, severe aortic stenosis for patients who are intermediate-risk candidates for the open heart procedure that traditional aortic valve replacement requires.

MEDTRONIC COREVALVE US PIVOTAL TRIAL (HIGH-RISK SURGICAL PATIENTS)

SURTAVI is a follow-up trial to the CoreValve US Pivotal Trial High-Risk Study, the first and only trial that showed significant survival rates for a transcatheter aortic valve over a surgical aortic valve in a randomized study. Results of that study, “Transcatheter Aortic-Valve Replacement with a Self-Expanding Prosthesis,” were published in the May 2014 issue of The New England Journal of Medicine.

Michael J. Reardon, MD, principal investigator, recently presented two-year findings for the Medtronic CoreValve US Pivotal Trial High-Risk Study, a randomized trial that compared treatment for high-risk surgery patients with a traditional surgical valve versus transcatheter placement of the self-expanding CoreValve aortic valve.

Reardon presented data at the American College of Cardiology conference that showed superiority at two years for the CoreValve in major adverse cardiac and cerebrovascular events. The findings for this study may warrant a change in the guidelines to reflect the efficacy of transcatheter aortic valve replacement (TAVR) over traditional surgery.

THE MEDTRONIC COREVALVE EVOLUT R US CLINICAL STUDY Neal Kleiman, MD, principal investigator, and Reardon, co-principal investigator, lead this prospective, single-arm, historical-controlled, multicenter study. The clinical trial will assess procedural as well as 30-day safety and efficacy of TAVR through comparison of the Medtronic next-generation CoreValve Evolut R US System to appropriate historical control for the Medtronic CoreValve System.

Within the SURTAVI trial, the minimally invasive CoreValve implantation can be performed by way of transfemoral, subclavian or direct aortic access. Approximately 2,500 patients will be enrolled from national and international sites. SURTAVI is a controlled study that will randomize patients to either receive a transcatheter aortic valve or undergo standard open heart surgery. All patients will be followed for five years.

“This trial gives us a chance to look at a group of aortic stenosis patients who are searching for a less invasive way to treat their disease,” Reardon said. “Less invasive means a shorter hospital stay and a shorter recovery time for these patients who had few, if any, options before.”

SURTAVI CLINICAL TRIAL: A TRANSCATHETER ALTERNATIVE FOR AORTIC VALVE REPLACEMENT Of the 1.5 million Americans diagnosed with aortic stenosis, more than 500,000 have severe aortic stenosis and 250,000 are symptomatic. Reardon is the national surgical principal investigator for a clinical trial that is testing a less invasive

Total Clinical Trials

2014 2014

207

71

2015

182

2015

93

Peer-Reviewed Articles

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20 HOUSTON METHODIST LEADING HEART & VASCULAR CARE

TESTING TEE FLUORO FUSION IN INTRACARDIAC REPAIR Because Houston Methodist embraces state-of-the-art technology that propels medical discovery and development, cardiologists are able to conceptualize and test new procedures that will ultimately improve patient care. One such innovation unites the latest fluoroscopy systems with a prototype software that fuses live, 3-D transesophageal echocardiographic (TEE) images with fluoroscopic images to increase the accuracy of intracardiac interventions.

Colin M. Barker, MD, cardiologist at Houston Methodist DeBakey Heart & Vascular Center, and Stephen H. Little, MD, medical director of the heart center’s Valve Clinic,

are co-principal investigators on a preclinical study that tests the efficacy of the fused 3-D images to guide structural interventions in the heart.

“We are using three-dimensional echo to guide our catheter as we tag spots around the mitral valve annulus with methylene blue, which is a less expensive surrogate for a mitral valve clip,” Little said. “The challenge of the clip is getting it positioned correctly. Using the images to guide us, we’re injecting dye into the heart tissues in the area where we would place an actual clip.”

Once the dye has been injected into a murine model, the heart can be removed and accuracy determined. “The goal is to validate that fusion imaging leads to more accurate placement of catheters within the heart, shorter procedures and less fluoroscopic time,” Little said.

In addition, studies have shown that intraoperative fusion imaging using aortic wall calcifications over the boney landmarks of the spine may provide a more accurate method of 3-D imaging for endovascular aneurysm repair. Researchers in the angiography division of Siemens Medical Solutions are working with Houston Methodist physicians to further develop and refine methods to enhance this unique form of image fusion. The technique uses preoperative computed tomography angiography (CTA) and intraoperative, non-contrast C-arm CT to align patientspecific calcifications of the aortic wall. Results thus far have shown an improved accuracy of image fusion through decreased error due to table differences and intraoperative patient positioning.

CARDIAC CATHETERIZATION CASES

A TRAINING CENTER FOR THE MEDICAL INDUSTRY As a center of excellence for several medical industry companies, Houston Methodist is able to individualize partnerships with the leading innovators of medical research and development. We are ideally positioned to provide unique training and educational opportunities on a global basis for staff and physicians who are actively pioneering the frontiers of medical science.

THIRD ANNUAL SOUTHWEST VALVE SUMMIT

7,695 7,964

2014

2015

In a wide-ranging presentation on heart valve disorders, the DeBakey Institute for Cardiovascular Education & Training (DICET) hosted the third annual Southwest Valve Summit in May 2015. The one-day conference focused on functional anatomy, imaging innovation and percutaneous valve interventions.

Live cases, presented by Michael J. Reardon, MD, and the Houston Methodist valve team, highlighted the day’s activities, including the preparation for a transcatheter aortic valve replacement (TAVR) from the hybrid OR at the Houston Methodist Institute for Training, Innovation & Education (MITIESM), as well as a live MitraClip implantation by the valve team performed in the catheterization laboratory. Participants gained experience in state-of-the-art imaging platforms with hands-on simulations led by Neal S. Kleiman, MD, Colin M. Barker, MD, and Paul A. Grayburn, MD. Stephen H. Little, MD, together with co-directors Barker, Kleiman, Reardon and Miguel A. Quiñones, MD, led the summit. houstonmethodist.org/debakeyheart

22 HOUSTON METHODIST LEADING HEART & VASCULAR CARE

“ We performed two transcatheter procedures and dramatically changed the structure and function of the patient’s heart…

It is a spectacular outcome.”

STEPHEN H. LITTLE, MD

OPTIMAL RESULTS WITH TRANSCATHETER CARDIAC VALVE REPAIR Historically, open heart surgery was required for any type of cardiac valve repair or replacement. Today, scientists, physicians and surgeons at Houston Methodist DeBakey Heart & Vascular Center are major contributors in the research and development of transcatheter cardiac valve procedures. Clinical trials at Houston Methodist and elsewhere show that percutaneous valve replacement can achieve optimal results without the high risk of mortality and morbidity typically associated with major surgery for valve repair.

The Valve Clinic at the heart center is a globally recognized leader in the use of technologies for transcatheter aortic valve replacement (TAVR). Houston Methodist is also at the forefront of catheter-based mitral valve repair with the MitraClip system. When percutaneously placed, the MitraClip restores leaflet coaptation for degenerative mitral valve disease. Ongoing clinical trials are evaluating the role of the MitraClip for repair of functional (secondary) mitral valve regurgitation.

Cardiac endovascular procedures are performed by a dedicated team of structural heart interventionalists, surgeons, anesthesiologists and imaging cardiologists.

For patients, transcatheter cardiac procedures offer an enormous advantage.

Recently, the valve team at Houston Methodist successfully performed both a transcatheter mitral valve repair with the MitraClip as well as TAVR in a patient with severe aortic valve stenosis, severe mitral valve regurgitation and severe impairment of left ventricular function — the worst combination of pathologies. “In one patient, we performed two transcatheter procedures and dramatically changed the structure and function of the patient’s heart. He is now off oxygen, out of the wheelchair, and walking laps up and down the clinic hallways,” said Stephen H. Little, MD, director of the Valve Clinic. “He feels fantastic, and he still can’t believe he didn’t have surgery. It is a spectacular outcome.”

For patients with kidney dysfunction, liver dysfunction, too much heart failure or very advanced age, the risks of open heart surgery are too high. For such high-risk patients, the valve team at Houston Methodist now has other treatment options such as MitraClip and TAVR. “For some patients, our transcatheter procedures offer the opportunity to live a longer, fuller life,” Little said.

MITRACLIP TESTED AS NONSURGICAL TREATMENT IN VALVE REPAIR Neal Kleiman, MD, principal investigator, and Michael J. Reardon, MD, cardiac surgeon and co-investigator, head up the Coapt trial, a prospective, randomized, parallel-controlled, multicenter clinical evaluation.

The trial will assess the efficacy of the MitraClip

device for the treatment of clinically significant, functional mitral regurgitation in symptomatic subjects who are considered inappropriate for surgery. Eligible subjects will be randomized in a 1:1 ratio to the MitraClip device or to no MitraClip device.

houstonmethodist.org/debakeyheart

24 HOUSTON METHODIST LEADING HEART & VASCULAR CARE

TOTAL REPAIR OF DEGENERATIVE MITRAL REGURGITATION Through a better understanding of the dynamics of mitral valve function, cardiovascular surgeons at Houston Methodist DeBakey Heart & Vascular Center have developed the most successful repair technique for degenerative mitral regurgitation thus far in the United States. Sophisticated data sets reveal the critical interaction of the mitral valve with adjacent structures. Most recently, the critical impact of aortic root and ascending aorta motion on the mitral valve within the aortic-mitral coupling has been demonstrated.

With this knowledge, physicians at Houston Methodist have been testing a new approach for mitral valve repair. “We used a nonresectional technique designed to preserve and restore normal mitral valve function, as well as the left ventricular outflow tract and aortic-mitral coupling function,” said Gerald M. Lawrie, MD, cardiovascular surgeon and Michael E. DeBakey Distinguished Chair in cardiovascular surgery.

Cardiovascular surgeons at Houston Methodist have developed the most successful repair technique for degenerative mitral regurgitation thus far in the United States.

Surgeons use pressurized saline to inflate the left ventricle and ascending aorta, thereby locking the diastolic mitral valve and causing early isovolumic systole. With the left ventricle at maximum dilation, the aorta and root distend and mitral leaflets oppose, surgeons adjust the artificial chordae and size the flexible annuloplasty ring for precise leaflet coaptation.

“I’m pleased to say we demonstrated 100 percent reparability in a large group of patients with this nonresectional dynamic approach,” Lawrie said. “No other medical center in the United States has reported a 100-percent success rate with this type of mitral valve repair.”

This study was presented at the Fifty-first Annual Meeting of The Society of Thoracic Surgeons in San Diego, California, in January 2015. It was also published in The Annals of Thoracic Surgery in February 2016.

SAFE VASCULAR IMAGING FOR RENAL FAILURE PATIENTS Houston Methodist DeBakey Heart & Vascular Center is one of only two medical centers in the country where cardiac physicians and surgeons have aggressively pioneered the use of a contrast medium that is free of gadolinium.

Gadolinium has been contraindicated for patients with compromised renal systems since 2006, creating an unmet need in vascular patients with impaired kidney function.

Gadolinium is a paramagnetic metal ion that is frequently used as a contrast agent for magnetic resonance imaging (MRI) and magnetic resonance angiography (MRA). Individuals with a glomerular filtration rate (GFR) of less than 30 have an increased incidence of gadolinium-associated nephrogenic systemic fibrosis.

“We are working with a non-gadolinium, iron-based agent for vascular imaging to use in patients with renal failure,” said Dipan J. Shah, MD, cardiologist at Houston Methodist. “We have found it useful in the thoracic and abdominal aorta as well as lower extremity vascular anatomy.”

Shah and his team are in the process of preparing a paper that will further elaborate on their clinical work with this alternative contrast agent.

VASCULAR SURGERY CASES

Total Cases 789 846

Patients evaluated and diagnosed in the department of CV Imaging

2014 2015

86,144

Mortality Rates

79,386

2.36%

Expected

1.27%

Observed

2.45%

Expected* Observed*

.71%

*Data represents mortality Jan.-Oct. 2015

2014

2015

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26

HOUSTON METHODIST LEADING HEART & VASCULAR CARE

BLOODLESS THERAPIES GIVE PATIENTS NEW OPTIONS

BLOOD UTILIZATION (2014-2015)

According to The Society of Thoracic Surgeons (STS), approximately 20 percent of cardiac surgery patients will consume more than 80 percent of blood transfused perioperatively*. Randomized trials support the finding of increased adverse events in transfused patients. In a rigorous attempt to conserve blood and diminish the need for transfusion during cardiac surgery, the blood management team at Houston Methodist Hospital spearheaded a blood conservation program with strict adherence to STS guidelines and exemplary patient care. The result of these efforts is currently a 30-percent patient transfusion rate for heart surgery, which is continuing to trend even lower and is one of the lowest in the country.

70.0%

Blood conservation begins preoperatively with optimization of the blood system in cardiac patients. This allows for better intraoperative management of the patient’s circulatory system.

Perioperatively, surgeons use several strategies to decrease the risk of transfusion, including normovolemic hemodilution, retrograde autologous priming (RAP) techniques and decreased blood sampling, along with judicious use of the Sorin XL cell-saver machine. Sorin XL returns washed and filtered red blood cells to the patient with a hematocrit of between 55 and 60 percent. Coupled with the American Association of Blood Banks’ recommendations for sponge rinsing and the Sorin XL cell salvage technology, blood can be captured and recycled to the patient.

% Intraoperative Blood Use 80.0% 74.3%

60.0%

59.4% 56.4%

53.3% 50.7%

50.0% 42.9%

43.5%

40.0%

47.2% 38.9%

30.0% 26.7%

26.0%

2013

2014

20.0% 2012

24.2%

2015

CABG+Valve Surgeries Valve Surgeries CABG Surgeries

In addition, Houston Methodist is the only center in Texas to incorporate a new technology to calculate blood lost through the use of sponges and canisters. The Triton, from Gauss Surgical, is the first FDA-cleared device that helps estimate this volume loss and thereby helps the surgical team make better decisions intraoperatively about the timing and need for blood transfusions.

With effective patient blood management teamwork and coordination, surgeons are able to operate on individuals such as Jehovah’s Witness patients who may require heart surgeries, aortic-arch dissections and other complicated cardiovascular procedures. *Ann Thorac Surg 2007;83:S27-86 houstonmethodist.org/debakeyheart

28 HOUSTON METHODIST LEADING HEART & VASCULAR CARE

MYUNG H. PARK, MD: MULTIFACETED APPROACHES TO HEART FAILURE AND PULMONARY HYPERTENSION Houston Methodist Hospital is pleased to welcome Myung H. Park, MD, in her new role as division chief of heart failure and transplant. Park is nationally and internationally known for her contributions in the fields of pulmonary hypertension, heart failure and cardiac transplant. Park’s professional path has taken her from a fellowship in advanced heart failure and transplant at the Cleveland Clinic Foundation to the Ochsner Clinic in New Orleans as director of heart failure and transplant, and, most recently, to the University of Maryland Medical Center in Baltimore, where she served as director of the pulmonary vascular diseases program and director of the cardiac care unit/cardiology inpatient services.

In her new role at Houston Methodist, Park sees an opportunity to create and oversee an optimal patient care model for individuals with advanced heart failure. “We have a dedicated team of advanced heart failure specialists with expertise in cutting-edge treatment modalities such as heart transplant and mechanical circulatory support devices. We treat the full spectrum of cardiomyopathies, including the uncommon forms like amyloidosis and chemotherapy-induced heart failure,” Park said. “Our mission is to create a network approach in heart failure care delivery. By partnering with our colleagues in the community, my goal is to establish patient care models that will expand the delivery of heart failure treatments into the areas where our patients live.”

Park is working closely with colleagues in the pulmonary division to build a multidisciplinary program for pulmonary hypertension. “Pulmonary hypertension is a condition with abnormalities in pathophysiology that involve both the heart and lungs. My goal is to integrate expertise from both cardiology and pulmonology, offering our patients a complete array of expertise that is so crucial in the management and care of this complex disease state,” Park said.

Park has initiated another ambitious endeavor that will foster a unique treatment program for patients with chronic thromboembolic pulmonary hypertension (CTEPH). “This is a complex condition that is under-recognized and often misdiagnosed,” she said. “When accurately diagnosed, the condition can be completely cured with a surgical procedure called thromboendarterectomy.”

Currently, there are no CTEPH centers in the southwest region. “With the collaboration of our cardiothoracic surgeons and anesthesiologists, pulmonary and critical care services, we will be able to create a lifesaving service,” she said.

Park and Alan B. Lumsden, MD, medical director of Houston Methodist DeBakey Heart & Vascular Center, are planning a 2016 symposium that will address the management of acute and chronic pulmonary emboli.

Park said she also looks forward to working closely with the Houston Methodist Institute for Technology, Innovation & Education (MITIESM) in continuing her studies in the mechanism and treatment of heart failure and pulmonary hypertension. “By focusing in both left- and right-sided heart failure, as well as the pulmonary vascular bed, we’re creating a one-stop shop for all forms of heart failure,” she said.

“ The nanoparticle also allows us to use smaller amounts of tPA, which could make hemorrhage less likely.”

ALAN B. LUMSDEN, MD

TARGETED CLOT BUSTING FOR ISCHEMIC EVENTS In an unparalleled study at the Houston Methodist Research Institute, scientists and physicians report that blood clots can be destroyed up to 1,000 times faster than is possible with conventional thrombolytic treatment. Early phase murine testing targets blood clots with heated, albumincoated iron oxide nanoparticles that deliver tissue plasminogen activator, or tPA, directly to the clot.

“We have designed the nanoparticles so that they trap themselves at the site of the clot, which means they can quickly deliver a burst of tPA where it is most needed,” said Paolo Decuzzi, PhD, interim chair of Houston Methodist’s Department of Translational Imaging and the study’s co-principal investigator. “Studies suggest that tPA is most effective at higher temperatures — 40˚ ⁰C or about 104˚ ⁰F. Through exposure to external, alternating magnetic fields, the researchers created friction and heat, which would increase clot dissolution.”

Tissue plasminogen activator is rapidly broken down by the blood. Current therapy for myocardial infarction or ischemic stroke requires a high dose of tPA to be clinically effective, though this carries a risk of intracranial hemorrhage.

“The nanoparticle protects the drug from the body’s defenses, and allows us to use smaller amounts of tPA, which could make hemorrhage less likely,” said Alan B. Lumsden, MD, medical director of the Houston Methodist DeBakey Heart & Vascular Center.

A full report of this study, titled “tPA Immobilization on Iron Oxide Nanocubes and Localized Magnetic Hyperthermia Accelerate Blood Clot Lysis,” is published online in Advanced Functional Materials.

houstonmethodist.org/debakeyheart

30 HOUSTON METHODIST LEADING HEART & VASCULAR CARE

PIONEERING GLOBAL CARDIOVASCULAR EDUCATION In addition to the coordination of care for thousands of international patients each year, Houston Methodist Global Health Care Services stands as a single point of contact for international partners who seek to broaden and invigorate their health care organizations. Incorporating the extraordinary experience and knowledge of our physicians and health care personnel at Houston Methodist, we are committed to the extension of our medical expertise throughout the international community.

INFORMATION SHARING SOUTH OF THE BORDER In June 2014, cardiologists from Houston Methodist traveled to Monterrey, Mexico, to discuss state-of-the-art cardiac treatments, procedures and outcomes at the Houston Methodist DeBakey Heart & Vascular Center with affiliate hospital Zambrano Hellion and TecSalud of Sistema Tecnológico. Houston Methodist cardiologists Miguel Quiñones, MD, and Colin Barker, MD, participated in teaching rounds with cardiology residents and fellows followed by a panel discussion.

A luncheon held for approximately 100 women provided the cardiologists an excellent platform to discuss the importance of understanding and managing the specific risk factors for heart disease in females. This same event was also held at TecSalud in Guadalajara. According to Quiñones, women are much better informed about breast cancer than heart disease, yet heart disease in women is more prevalent.

REACHING ACROSS BORDERS Alan B. Lumsden, MD, medical director of the Houston Methodist DeBakey Heart & Vascular Center, and Mahesh Ramchandani, MD, a Houston Methodist cardiovascular surgeon, gave a joint presentation on minimally invasive cardiac surgery to the staff and residents of the American British Cowdray (ABC) Medical Center in Mexico City. The event was sponsored by ABC and introduced the physicians and staff of ABC to cardiologists from Houston Methodist with the goal of fostering referrals to Houston Methodist.

HOUSTON METHODIST GLOBAL COLLABORATION WITH MAQUET To expand our international footprint, Houston Methodist Global reached out to MAQUET, a biomedical engineering company located in China, in 2014. The aim of this endeavor was to provide five cardiovascular surgeons from China with approximately six weeks of mentorship by surgeons such as Ramchandani.

In addition to exposure to the most advanced cardiovascular procedures and treatments available, the international visitors benefited from several of the continuing medical education courses that Houston Methodist offers.

As an outgrowth of this collaboration, Houston Methodist hired a patient liaison/ business development representative fluent in both Mandarin and Cantonese to interact with patients referred from China.

901 INTERNATIONAL INPATIENT AND OUTPATIENT ENCOUNTERS 2014-2015

WORLD-RENOWNED ADVANCED TRAINING OPPORTUNITIES The DeBakey Institute for Cardiovascular Education & Training (DICET) provides learners with hands-on training in the most advanced cardiovascular medicine in development today.

Working in conjunction with Siemens, a world leader in providing health care products for image-guided procedures, the new hybrid suite in the Houston Methodist Institute for Technology, Innovation & EducationSM (MITIE) has opened up numerous training and research possibilities that could only be imagined a short while ago.

DICET SKILLS ACADEMY The DICET Skills Academy is a forum that offers training in technical and manual skills.

Education programs are customized to the skill level and specialty of the individual learner.

Examples of DICET’s offerings at the Skills Academy include the Total Endovascular Series, a symposium designed to outline current approaches to limb salvage, and the Cardiovascular MRI (CMR) Workshop, a week-long program that covers the practical applications of CMR. HYBRID ROOMS AND HYBRID PROCEDURES

SIXTH ANNUAL RE-EVOLUTION SUMMIT This DICET-hosted symposium, subtitled Minimally Invasive Cardiac Surgery: The Ultimate Hands-On Summit, convened in May 2015. The program overview acknowledged the paradigm shift in cardiac surgery toward minimal access surgery, including cardiac valve repair, coronary revascularization, ablation of atrial fibrillation, aortic pathology and heart failure. The goal of the conference was to provide current, evidence-based didactic lectures in conjunction with expertinstructed hands-on exposure to the most current aspects of minimal access cardiac surgery with an emphasis on hybrid approaches.

Participants at the summit were invited to perform procedures on cadavers, sophisticated beating heart platforms and advanced simulators.

DICET employs a hybrid operating room suite at MITIE that provides a unique training experience.

Students can practice real-time, image-guided procedures using an array of imaging equipment, as well as master new minimally invasive and percutaneous techniques. Radiation safety is taught using a Raysafe electronic radiation sensor.

SEMINARS DICET-hosted seminars provide an additional venue for cardiology training. The Annual Southwest Valve Summit is a one-day conference on heart valve disorders. In 2015, the hybrid suite at MITIE was used to demonstrate preparation for a transcatheter aortic valve replacement (TAVR). The Re-Evolution Summit in May focused on minimally invasive cardiac surgery and provided hands-on exposure to the most advanced hybrid approaches to specific cardiovascular dysfunctions. Attendees were invited to use MITIE’s sophisticated beating heart platforms and advanced simulators.

DICET AT A GLANCE 2014-2015

113

9,574

79

7,200

COURSES

LEARNERS

COUNTRIES

CLINICAL STAFF

REPRESENTED

EDUCATED

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32 HOUSTON METHODIST LEADING HEART & VASCULAR CARE

THE INTERNATIONAL PUMPS & PIPES SYMPOSIUM: GLOBAL INDUSTRIES COMPARE NOTES At the annual Pumps & Pipes symposium, Houston professionals from the health care, aerospace and energy arenas come together to examine current industry challenges. For the past nine years, the Pumps & Pipes symposium has taken participants from inner space to outer space with stops in between.

“Pumps & Pipes is about the transfer of knowledge between the energy world, the cardiovascular world and, more recently, the aerospace world,” said Alan B. Lumsden, MD, medical director of Houston Methodist DeBakey Heart & Vascular Center.

“The other guy’s toolkit is something we emphasize because that’s where the solution often resides. We just need the opportunity to network, bring people together, and explore that.”

Discovery Pathways was the theme for Pumps & Pipes, held in December 2015.

The symposium kicked off with a presentation from NASA on Getting to Mars. Other presentations included Cracks: What Simulating Hearts and Hydraulic Fractures Have in Common, by Dassault Systemes; Making Sense of Drilling Data, by ExxonMobil; and Pumps & Pipes Norway: Stavanger Session, from the International Research Institute of Stavanger, Norway. A live transcatheter aortic valve replacement was broadcast from the hybrid operating room in the Houston Methodist Institute for Technology, Innovation & EducationSM (MITIE). This was followed by a live presentation from Keele University

Observatory in England on the newly discovered Jupiter-sized exoplanet, WASP-142B. Afternoon presentations included Hearts, Lungs and Rocket Scientists; Living in a Radiation Field; Clips and Plugs: An Interventionalist’s Toolkit; and Why Mars is Hard.

Pumps & Pipes is not just for industry professionals. The symposium offers a community outreach program for science, technology, engineering and math (STEM) students.

The Houston Independent School District (HISD) estimates that hundreds of students watched the symposium webcast in classrooms around the city.

“We realized how important this platform can be for encouraging students to enter these fields, which can sometimes be thought of as dry subjects,” Lumsden said.

“When you see what these engineers and researchers can do, it’s magical.” At a uniquely convened Mentors for Mentors symposium in 2015, 15 educators from seven HISD campuses attended a Pumps & Pipes externship to learn how to apply concepts from engineering to medicine, and vice-versa.

The Pumps & Pipes symposium continues to grow every year. “Technology and competence transfer is a high priority, and there is a strong drive to explore an international interactive platform between sectors to foster the sharing of knowledge and innovation,” said Stephen R. Igo, director of the Houston Methodist Entrepreneurial Institute and executive director of the Pumps & Pipes program. “We have established a Pumps & Pipes affiliate in Europe to be headquartered in Stavanger, Norway. We now have a Euro Pumps & Pipes advisory board in place that helped launch the two live feeds from Europe in 2015.”

852,052,830

TOTAL WORLDWIDE AUDIENCE FOR 2014 PUMPS & PIPES SYMPOSIUM

EXPLORE THE LATEST BREAKTHROUGHS AND DISCOVERIES IN CARDIOVASCULAR CARE METHODIST DEBAKEY CARDIOVASCULAR JOURNAL Founded in 2005, the peer-reviewed Methodist DeBakey Cardiovascular Journal features leading-edge research, diagnoses and treatments in cardiovascular disease.

In 2009, the journal became a citable source on MEDLINE. • Each issue offers at least one article for continuing medical education (CME) credit.

• Readers take a short quiz about the article to earn one hour of CME credit.

VISIT houstonmethodist.org/debakey-cardiovascular-journal to subscribe.

HOUSTON METHODIST @HEART, ―THE HOUSTON METHODIST DEBAKEY HEART & VASCULAR CENTER’S PHYSICIAN ENEWSLETTER More than 5,000 heart and vascular surgeons in the United States read Houston Methodist @Heart. Earn CME credit while accessing the work of leading clinicians and researchers and learn about cutting-edge discoveries, innovations, procedures and treatments for cardiac and vascular disorders.

VISIT houstonmethodist.org/ physician-subscribe to subscribe.

HOUSTON HEARTS: A HISTORY OF CARDIOVASCULAR SURGERY AND MEDICINE AND THE METHODIST DEBAKEY HEART & VASCULAR CENTER

by William J. Winters Jr., MD, MACC, with Betsy Parrish Houston has been referred to as the “heart capital of the world” with good reason. The 1948 arrival of Michael E. DeBakey, MD, at Houston Methodist changed the direction of modern cardiology. Houston Hearts tells the story of this legendary physician and the events that helped shape cardiovascular care over a 70-year period. Houston Hearts was written from the perspective of William J. Winters Jr., MD, MACC, who was an eyewitness and key player in this trajectory of medical history.

PURCHASE online at amazon.com. houstonmethodist.org/debakeyheart

34

HOUSTON METHODIST LEADING HEART & VASCULAR CARE

EXPANDING DELIVERY OF COMPREHENSIVE, INTEGRATED CARE

HOUSTON METHODIST DEBAKEY HEART & VASCULAR CENTER MEMBERS

In 1951, Houston Methodist Hospital relocated to the Texas Medical Center from downtown Houston. Since that time, the hospital’s footprint has expanded exponentially. New construction has begun on the campus that will help us continue to grow and meet our mission of providing comprehensive, integrated and multidisciplinary care to the people we serve.

CARDIOLOGISTS

This new facility will function as an epicenter of care and will house all services for heart and vascular diagnosis, treatment and rehabilitation. The health professionals working within this new structure will collaborate across the Houston Methodist system and complement the Houston Methodist Research Institute and Houston Methodist Institute for Technology, Innovation & EducationSM (MITIE℠), one of the largest and most comprehensive education and research facilities in the world.

Phase I of new construction is located on our north campus and is slated for completion in 2017. The new North Tower will account for 745,000 to 923,000 square feet and will include: ·

EXPANDED OR SUITE WITH FOUR HYBRIDS AND I-MRI

·

ICU/UNIVERSAL BED FLOORS (102 BEDS)

·

SIX ACUTE BED FLOORS (216 BEDS)

·

TWO SHELLED BED FLOORS (72 BEDS)

·

24-BED VIP UNIT

·

HELIPAD

·

CONFERENCE FACILITIES

Specific to heart and vascular care, our new building will offer: ·

66 ICU BEDS

·

72 ACUTE CARE BEDS

·

16 OPERATING ROOMS

·

14 INTERVENTIONAL CATHETERIZATION/EP LABS

At Houston Methodist, we have the flexibility, skill, technology and vision to provide exemplary cardiovascular care to meet the needs of our community while we continue to lead medicine.

Ashrith Guha Mohammed M. Attar Christie Ballantyne Nabil Baradhi Colin Barker Arvind M. Bhimaraj Douglas Bree John M. Buergler Sarma Challa Su-Min M. Chang Amish S. Dave Clement A. Defelice Timothy Doyle Stanley Duchman Jerry D. Estep Zsolt Garami Mark J. Hausknect Thomas E. Hong Robert G. Hust John Isaac Mateethra C. Jacob Sonia Jacob Amin H. Karim Masroor Khan Neal S. Kleiman Sanjay M. Kunapuli Karla M. Kurrelmeyer George Li C. Huie Lin Kevin A. Lisman Stephen H. Little John Mahmarian Faisal M. Nabi Sherif Nagueh Vijay Nambi Nadim J. Nasir Myung H. Park Craig M. Pratt Miguel A. Quinones Albert E. Raizner Michael E. Raizner Tapan G. Rami Manuel M. Reyes

Howard S. Rubin Monica Sanchez-Ross George M. Schroth Alpesh Shah Dipan J. Shah Gopi Shah Hue-The M. Shih Stuart L. Solomon Cyril Tawa Guillermo M. Torre Barry Trachtenberg Valentina M. Ugolini Miguel Valderrabano Brian L. Walton Htut K. Win William L. Winters David M. Yao Nadim M. Zacca William Zoghbi CARDIOVASCULAR SURGEONS Ulises Baltazar Carlos Bechara Jean M. Bismuth Brian A. Bruckner Javier A. Lafuente Gerald M. Lawrie Linda Le Richard Lee Alan B. Lumsden Imran Mohiuddin George P. Noon Jacobo Nurko Walter O’hara Eric K. Peden Mahesh K. Ramchandani Michael J. Reardon Ross Reul Scott A. Scheinin Erik E. Suarez Michael M. Sweeney Uttam M. Tripathy Houssam K. Younes

INTENSIVISTS John Fetter Faisal Masud Iqbal Ratnani Kamlesh Thaker Divina Tuazon Faisal Uddin Saleem Zaidi Asma Zainab CV ANESTHESIOLOGISTS Mohamad Abdalla Nidal Abdel-Rahman Nicolas Athanassiou Jessica Brown Ghazala Butt Jane Carter James Carter Diane Gibson Elizabeth Herrera Saras Karri Gary Monteiro Joseph Naples Hany Samir Karanbir Singh Luis Velez-Pestana Zbigniew Wojciechowski INVESTIGATORS IN BASIC OR CLINICAL RESEARCH

Lloyd Michael Joel Morrisett Ryan Neal Scott Parazynski Henry Pownall Anilkumar Reddy Nazish Sayed Daryl Schulz George Taffet Joann Trial Wing Tak Jack Wong ADMINISTRATION Michael Garcia Senior Vice President Scott Flowers Vice President Annie Thornhill Director Susmitha Gadde Director of Research Sarah Homer Director of Clinical Operations Melanie Lazarus Program Director of Education Tammy Plumb Administrator, Cardiology/ Cardiovascular Services

Gerd Brunner Su Min Chang John Cooke Mark Entman Nikolaos Frangogiannis Yohannes Ghebremariam Dale Hamilton Craig Hartley Sandra Haudek Ron Hoogeveen Peter Jones Dirar Khoury

houstonmethodist.org/debakeyheart

36 HOUSTON METHODIST LEADING HEART & VASCULAR CARE

HOUSTON METHODIST HOSPITAL: BUILDING A LEGACY OF INGENUITY From humble beginnings as a 30-bed hospital more than 90 years ago, Houston Methodist Hospital has evolved into one of the nation’s largest private nonprofit hospitals, an academic medical center and a center for visionary medical research.

Our reputation for excellence in patient care and commitment to improving outcomes represent a significant motivation in the development of six multidisciplinary centers of excellence.

• Houston Methodist Cancer Center • Houston Methodist DeBakey Heart & Vascular Center • Houston Methodist J.C. Walter Jr. Transplant Center • Houston Methodist Lynda K. and David M. Underwood Center for Digestive Disorders • Houston Methodist Neurological Institute • Houston Methodist Orthopedics & Sports Medicine

Primary academic affiliates of Houston Methodist are top-ranked Weill Cornell Medicine and NewYork-Presbyterian Hospital. Houston Methodist also has affiliations with The Texas A&M University System and the University of Houston.

Together, we collaborate to advance clinical medical research and train the next generation of physicians and researchers.

For Houston Methodist clinicians and researchers, leading medicine is a call for excellence in every aspect of patient care. We consistently rank in U.S. News & World Report’s “Best Hospitals” list. The 2015 issue named Houston Methodist among the country’s top hospitals in 11 specialties, No. 1 in the metro area and No. 1 hospital in Texas. Additionally, Houston Methodist unfailingly achieves Magnet distinction for exceptional nursing. Our research ranks in the top 20 for federal funding, and supports early phase clinical trials and FDA-certified manufacturing for research. Because of this commitment to excellence, the finest researchers and clinicians are joining us to accelerate the discovery and delivery of better care and better cures. That’s the difference between practicing medicine and leading it.

2015 HOUSTON METHODIST HOSPITAL STATISTICS

830 OPERATING BEDS

36,720

326,534

12,406

72,399

INPATIENTS

OUTPATIENT

INTERNATIONAL PATIENT ENCOUNTERS (from 84 foreign countries)

EMERGENCY ROOM VISITS

VISITS

1,479

603

36

AFFILIATED PHYSICIANS

FACULTY

RESIDENCY

44 GME

PROGRAMS

PROGRAMS

MORE THAN 790 clinical studies and trials $130 MILLION total research portfolio FORTUNE is a registered trademark of Time Inc. and is used under license. From FORTUNE Magazine, February 3, 2014 (c)2014 Time Inc. FORTUNE and Time Inc. are not affiliated with, and do not endorse products or services of, Licensee.

The heart center leadership team, from left to right: Miguel A. QuiĂąones, MD, John Cooke, MD, Joseph Naples, MD, and Alan B. Lumsden, MD

Houston Methodist Hospital 6565 Fannin St., Houston, TX 77030 713.DEBAKEY

houstonmethodist.org/debakeyheart

LEADING MEDICINE YESTERDAY, TODAY AND TOMORROW

At Houston Methodist, we have a proud tradition of revolutionizing medicine. Our past achievements have built a legacy that spans multiple decades and disciplines, and that same culture of excellence inspires us to be the pioneers of tomorrow.