CAPABILITIES AND SERVICESUPDATED 2020 EDITION

3MCRN MCRN2

MCRN SCIENTIFIC CENTERSMap of MCRN Scientific Centers 3

Message from Stuart Seides, MD 4

Message from Ron Waksman, MD 5

MHVI MCRN Integration Structure 6

MHVI Physician-Scientific Structure (MCRN) 7

About MCRN 8

MCRN at a Glance 9

Academic Clinical Research Organization/Team Members 10MedStar Washington Hospital Center Clinical Trials/Team Members 11

Advanced Heart Failure, Heart Transplantation, and Mechanical Circulatory Support/Team Members 12-13

Critical Care 14

Cardio-Oncology 15

Cardiac Electrophysiology/Team Members 16-17

Interventional Cardiology and Structural Heart Research/ Team Members 18-19

Peripheral Vascular/Team Members 20-21

Baltimore Cardiology/Team Members 22-23

Medstar Franklin Square Medical Center/Team Members 24

MedStar Georgetown University Hospital/Team Members 25

Cardiovascular Research at MedStar Southern Maryland Hospital Center/Team Members 26

Outcomes Research 27

Translational/Team Members 28

Preclinical/Team Members 29

Cardiac Imaging/Team Members 30-33

Invasive Imaging Core Laboratory 34-35

Publications 36-40

MCRN Communications 41

MCRN Directory 42

MedStar Heart & Vascular Institute Directory 43

TABLE OF CONTENTS

MedStar Franklin Square Medical Center

9000 Franklin Square Drive Baltimore, MD 21237https://www.medstarfranklinsquare.org

MedStar Georgetown University Hospital

3800 Reservoir Rd NWWashington, DC 20007https://www.medstargeorgetown.org

MedStar Southern Maryland Hospital Center

7503 Surratts RdClinton, MD 20735https://www.medstarsouthernmaryland.org

MedStar Washington Hospital Center

110 Irving St NW Washington, DC 20010https://www.medstarwashington.org

MedStar Union Memorial Hospital

201 E University PkwyBaltimore, MD 21218https://www.medstarunionmemorial.org

54 MCRN MCRN

RON WAKSMAN, MDSTUART SEIDES, MD

Dear Colleagues,

As the physician executive director of MedStar Heart & Vascular Institute (MHVI), it is with great pleasure that I introduce the “MCRN Research Guide.”

MHVI was founded in 2010 to consolidate and integrate cardiovascular care across the 10 MedStar hospitals and numerous outpatient sites in the Washington-Baltimore corridor. This distributive care delivery network fosters convenience and consistency across our geographic footprint as well as optimizes efficiency and use of resources in our communities. It has also facilitated the development of a broad platform for cardiovascular research under Dr. Ron Waksman’s leadership and direction of the MedStar Cardiovascular Research Network (MCRN), which extends across the full spectrum of our clinical and preclinical settings.

Research is a core mission of MHVI. We feel a clear and vital responsibility to advance scientific knowledge that can ultimately translate into improved patient care. Moreover, there is tremendous synergy between active clinical investigation and excellence in clinical care. The rigor of scientific thinking and ideation along with our positioning on the cutting-edge of technology drives today’s patient care to its highest level while simultaneously developing the critical advances for tomorrow.

I invite all of you to learn more about MCRN and MHVI and to join us by participating in our studies, registries, and conferences.

Best regards,

Stuart F. Seides, MD Physician Executive Director MedStar Heart & Vascular Institute

Dear Colleagues,

It is my honor and privilege to present to you the this report of the MedStar Cardiovascular Research Network (MCRN), which resides within MHVI. MCRN, which includes four hospitals and 10 outpatient clinics, links faculty interested in cardiovascular biology and disease across MedStar facilities, facilitates cutting-edge research, and trains clinicians and scientists to become future leaders in this field.

This brochure describes the wide spectrum of investigations at MCRN, ranging from the most basic science to disease-focused and patient-based research. The structure of the organization is founded on scientific leads across various cardiovascular disciplines, supported by 100 associates who are employed by MedStar Health Research Institute (MHRI).

Over the past four years, we have built a state-of-the-art cardiovascular research organization featuring a brand new cardiac cath lab in our preclinical facilities, six imaging core labs (Echo, CT MRI, Angio, IVUS, OCT, NIRS), and an academic clinical research organization that supports clinical trials conducted by our investigators and external sponsors. In addition, we take pride in the robust activity of our clinical research coordination that facilitates enrollment for more than 100 trials annually across all cardiovascular disciplines. MCRN also collaborates with the National Institutes of Health, the Food and Drug Administration, the Centers for Medicare and Medicaid Services, the Cleveland Clinic and other leading institutions in the USA and globally.

I urge you to read this report and learn more about our accomplishments, research activities, and innovations in cardiovascular research. In addition, I invite you to collaborate with us on innovative research endeavors.

Ron Waksman, MDDirector, MedStar Cardiovascular Research Network and Advanced Education Associate Director, CardiologyMedStar Washington Hospital Center

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MHVI MCRN INTEGRATION STRUCTURE MHVI PHYSICIAN-SCIENTIFIC STRUCTURE MEDSTAR CARDIOVASCULAR RESEARCH NETWORK (MCRN)

MCRN’s accomplishments, beyond providing a wide array of clinical trial opportunities to the patient population of MHVI, include an average of more than 100 peer-reviewed manuscript publications per year, numerous book chapter contributions from its distinguished academic faculty, and a series of research-oriented fellowships for young prospective trainees.

Director, Cardiovascular Research

Electrophysiology(Interim)

S. Lee

Cardiac Critical Care

C. Barnett

Baltimore RegionJ. Wang

Angio Lab

IVUS/VH/ OCT/NIRS Lab

Advanced Heart Failure

S. Najjar

Non-Invasive Imaging F. Asch

CT G. Weigold

G. Weissman

Echo Lead F. Asch

MRI

Invasive ImagingH. Garcia-Garcia

InterventionalR. Waksman

Coronary

Endovascular

Preventive/ LipidsH.B. Brewer

Cardio-OncologyA. Barac

Outcomes Research

W. Weintraub

Pre-Clinical Scientific Lead David Hellinga

Vascular SurgeryE. Woo

TranslationalS. Epstein

Cardiothoracic Surgery

Christian Shults

Structural T. Rogers

MHVI Physician Executive Director

Cardiac Arrhythmia

Advance Cardiac Support

Heart Disease Prevention

Pulmonary Hypertension

Women’s Heart Disease Prevention

Adult Congenital Heart Disease

Aortic Disease Management

Valvular Heart Disease

Cardiac Imaging

Cardiac Cath Lab

Cardiac Surgery

Clinical Research Support Activities

Clinical Research Coordination

Clinical Trial Management

Clinical Research Registries

Grant Writing Support

Research Fellowship/ Internship

Business Development

Regulatory/ Contracts/ Finance

Data Analysis/ Statistical Support

Research Fellows per discipline

Invasive Imaging Core Labs: Angiographic/IVUS VH/OCT

Non-Invasive Core Labs Echo/CT/ MRI Core Lab

Core Labs

IST Trial ManagementElectrophysiology

Heart Failure

Cardiac Imaging

Intervention

Cardiothoracic Surgery

Translational Research

Cardiac Oncology

Vascular Medicine

Cardiac Critical Care

Clinical/Prevention/ Lipids

Database Development

Platelet Center

Animal Lab

Medical Writer/ Publication Submission

Scientific Areas of Research

MHRI

Director, Cardiovascular Research

MCRN

9MCRN MCRN

MCRN AT A GLANCE

8

0

20

5

30

10

40

15

50

60

SouthernMaryland

Baltimore EP Heart Failure Peripheral Interventional

CONTRACTS

0Baltimore Heart Failure Interventional

60

40

Total

20

EP

100

80

ACTIVE STUDIES120

ABOUT MEDSTAR CARDIOVASCULAR RESEARCH NETWORK

The MedStar Cardiovascular Research Network (MCRN), based at MedStar Washington Hospital Center, facilitates cardiovascular research within the MedStar Heart & Vascular Institute (MHVI). MCRN scientists, physicians, nurses, and support staff draw on MHVI’s enormous patient experience, which includes more than 18,000 catheterizations; 5,000 percutaneous interventional procedures; 3,500 electrophysiology procedures; 1,800 open-heart procedures; and thousands of outpatient cardiology and vascular visits per year.

MISSION GOALS VISION

• Improve the survival and quality of life of people with cardiovascular disease

• Advance the development of beneficial cardiovascular treatments

• Investigate early-stage technologies and therapies from bench to bedside

• Educate professionals and the public to enhance patient outcomes

• Define the future of cardiovascular care through research and education

• Establish outstanding cardiovascular research programs

108 ASSOCIATES

175 ONGOING STUDIES

13 SITES

>50 INVESTIGATORS

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MEDSTAR WASHINGTON HOSPITAL CENTER CLINICAL TRIALS ACADEMIC CLINICAL RESEARCH ORGANIZATION

TEAM MEMBERS

Alan MonathProject Lead CRI

Databases

Adrian Margulies Database Programmer

Kathryn Sciandra Research Data Coordinator

Eyerusalem DadiSr. Database

Programmer Analyst

Corey Shea Manager Outcomes

Research

Megan Rowland Project Manager

Temesgen ToreSr. Database

Programmer Analyst

Jonathan Abramowitz Research Data Coordinator

Teshome Deksissa Research Data Coordinator

Joseph SuttonClinical Project Lead

Syed Ali Clinical Project Lead

Cheng ZhangBiostatistician

Established in 2007, the Academic Clinical Research Organization (ACRO) manages both MCRN-sponsored research initiatives and collaborative clinical trials with industry sponsors.

The ACRO team utilizes its own electronic data capture (EDC) system, which is part 11 compliant. The functionalities for this EDC include data collection, enrollment and randomization notification, data management, and seamless adjudication processes. The EDC has been established to ensure fluent communications and, as needed, data safety monitoring board (DSMB) requirements. The ACRO has the capacity to convene and manage DSMBs and clinical event committees.

The ACRO’s publication support team ensures all manuscripts written by our lead investigators are vetted through the rigorous peer-review process of cardiology journals.

ONGOING SPONSORED TRIALS IN• Heart failure

• Electrophysiology

• Structural heart

• Cardiac CCU

• Interventional cardiology

• Outcomes

• Cardiac Surgery

Michelle Deville, RNAssociate Director Clinical TrialsOur clinical research coordinators (CRCs) are the backbone of all MCRN trials—both in-patient and outpatient. More than 25 CRCs, some of whom have up to 20 years of coordinating experience ranging from phase I to phase IV clinical studies, pilot to pivotal trials, support, coordinate, and facilitate the daily clinical trial activities. The CRCs work with the appropriate principal investigators, departments, sponsors, and institutions to support and provide guidance on the administration of the compliance, financial, personnel, and other related aspects of the clinical study. The CRCs are fully trained in good clinical practices (GCPs), are certified through the CITI program, and also have extensive experience with responding to audits by both sponsors and the U.S. FDA.

Rochelle ProctorResearch Admin Asst/

Proj. Coordinator

TEAM MEMBERS

Shreejana PokharelClinical Trials Manager

Caitlin ZiemakRegulatory Affairs

Coordinator

Meseret Deressa Clinical Trials Manager

Suman SinghClinical Trials Manager

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ADVANCED HEART FAILURE, HEART TRANSPLANTATION, AND MECHANICAL CIRCULATORY SUPPORT - TEAM MEMBERS

ADVANCED HEART FAILURE, HEART TRANSPLANTATION, AND MECHANICAL CIRCULATORY SUPPORT

Philip Lam, MD Investigator

ONGOING TRIALS

HELIOS-B Trial: This is a randomized, double blind, placebo-controlled study to Evaluate the Efficacy and Safety of Vutrisiran in Patients with Transthyretin Amyloidosis with Cardiomyopathy (ATTR Amyloidosis with Cardiomyopathy

Farooq H. Sheikh, MDInvestigator

Maria Rodrigo, MD Investigator

Mark R. Hofmeyer, MDInvestigator

Etsubdink Aboye Clinical Research

Coordinator

Ajay Kaddakal, MD Investigator

Hellina T. BirruClinical Research

Coordinator

Princess NzeakoClinical Research Nurse

Coordinator

Samer S. Najjar, MD Ezequiel j. Molina, MDScientific LeadsThe Advanced Heart Failure section is one of the leading mechanical circulatory support programs in the nation. In addition to providing comprehensive care for cardiomyopathies, pulmonary hypertension, and end-stage heart failure, the section is engaged in clinical research focused on novel mechanical circulatory support devices, innovative genomic technologies in heart transplantation, therapeutics for pulmonary hypertension, infiltrative cardiomyopathies, and cardiovascular aging.

The Advanced Heart Failure section has played a pivotal role in landmark clinical trials. For example, it was the leading enroller in the HeartWare HVAD left ventricular assist device bridge-to-transplant clinical trial (ADVANCE), which helped get the device approved by the US Food and Drug Administration. The team’s investigators also led the work that described pump thrombosis in the centrifugal continuous flow left ventricular assist devices.

Under the leadership of Dr. Samer Najjar (medical director), the section includes six advanced heart failure cardiologists and two surgeons and continues to expand.

ARIES-HM3: Prospective, randomized, double-blinded, placebo-controlled clinical investigation of advanced heart failure patients treated with the HM3 with two different antithrombotic regimens: vitamin K antagonist with aspirin versus vitamin K antagonist with placebo.

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CARDIO-ONCOLOGYCRITICAL CARE

CRITICAL CARE TEAM MEMBERS

ONGOING TRIALSCOMPLEXA (CXA-10-301): • To determine the efficacy of oral doses of CXA-10 on stable background

therapy administered for 3 months in subjects with PAH assessed by right ventricular ejection fraction (RVEF) as measured by cardiac MRI.

• To determine the efficacy of oral doses of CXA-10 on stable background therapy administered for 3 months in subjects with PAH assessed by pulmonary vascular resistance (PVR) as measured by right heart catheterization (RHC)

PERFECT (RIN-PH-304) : To demonstrate the efficacy of inhaled Treprostinil compared to placebo in improving exercise ability as measured by change from baseline in 6-Minute Walk Distance (6MWD) following 12 weeks of active treatment in subjects with PH-COPD.

Alexander Papolos, MDInvestigator

Benjamin Kenigsberg, MDInvestigator

Christopher Barnett, MDScientific LeadLed by Christopher Barnett, MD, MPH, research in the Critical Care section is focused on elucidating the mechanism and optimal treatment of pulmonary hypertension. Dr. Barnett, who is the director of the medical cardiac intensive care unit and the director of pulmonary hypertension (PH) program at the MHVI, is working to expand the research activities of the pulmonary hypertension program at MedStar with the goal of providing patients and referring physicians a world-class clinical program as well as the opportunity to contribute to research about this still poorly understood and often fatal disease.

Dr. Barnett is collaborating with the National Institutes of Health (NIH) intramural pulmonary hypertension program on several studies that give patients access to NIH resources for the diagnosis and treatment of pulmonary arterial hypertension. He is also participating in an NIH-funded biobank that investigates the genetic basis of pulmonary hypertension as well as a study to investigate the use of inhaled prostanoids in patients with pulmonary hypertension from interstitial lung disease.

ONGOING TRIALS

SAFE-HEART – The first study investigating cardiac safety of HER2-targeted therapies in patients with HER2+ breast cancer and reduced LV function

PREVENT- (Preventing Anthracycline Cardiovascular Toxicity with Statins) –An NCI-supported study investigating the effect of statins on the risk of anthracycline-induced cardiomyopathy.

Ana Barac, MD, PhDScientific Lead

MedStar’s Cardio-Oncology program focuses on the impact of cancer treatments on cardiovascular health and advances cardiovascular assessment, management, and treatment in patients with cancer. Led by Ana Barac, MD, PhD, a national leader in cardio-oncology and chair of the American College of Cardiology (ACC) Cardio-Oncology Council, this program bridges unique advances in cancer care under Lombardi Comprehensive Cancer Center and MedStar Cancer Network with novel cardiovascular approaches and research throughout MCRN.

17MCRN

CARDIAC ELECTROPHYSIOLOGY - TEAM MEMBERS

MCRN

CARDIAC ELECTROPHYSIOLOGY

16

CLINICAL TRIALS

(EV ICD) Pivotal Study: single-arm, non-randomized, pre-market clinical study. The main purpose of the EV ICD Pivotal study is to demonstrate safety and efficacy of the EV ICD System

ECG Belt: The purpose is to compare ECG Belt Research System managed cardiac resynchronization therapy (CRT) patients and a control CRT group with respect to left ventricular (LV) remodeling

STELLAR: A pivotal, prospective, multicenter, single-arm clinical evaluation of the Multi-Electrode RF Balloon catheter

Seth Worley, MDInvestigator

Manish H. Shah, MDInvestigator

Cyrus Hadadi, MDInvestigator

Susan O’Donoghue, MDInvestigator

Margaret Fischer, MD Investigator

Meseret Deressa Clinical Trials Manager

Nebu Alexander Clinical Research

Coordinator

John Bonilla Clinical Research

Coordinator

Walter Atiga, MD Investigator

Edward V. Platia, MDInvestigator

Zayd Eldadah, MDInvestigator

David A. Strouse, MDInvestigator

Sarfraz A. Durrani, MDInvestigator

Sung W. Lee, MDScientific Lead

The Cardiac Electrophysiology Section at MCRN’s Washington Hospital Center is one of the nation’s most advanced programs for the treatment of heart rhythm disorders. As one of the highest clinical volume centers in the Washington, DC, metropolitan area, the section is developing and testing new and advanced medical and minimally invasive treatments through numerous clinical trials.

The Electrophysiology Section is led by Sung W. Lee, MD, FACC, who is also the director of Cardiac Electrophysiology at MedStar Southern Maryland Hospital Center. Dr. Lee is a recognized specialist in the management of cardiac arrhythmias with special interests in device managements and ablation of complex arrhythmias, including atrial fibrillation and ventricular tachycardia. His main research area is in the management of atrial fibrillation, and he has served as a principal investigator on numerous clinical trials.

19MCRN18 MCRN

INTERVENTIONAL CARDIOLOGY AND STRUCTURAL HEART RESEARCH INTERVENTIONAL CARDIOLOGY AND STRUCTURAL HEART RESEARCH - TEAM MEMBERS

Itsik Ben-Dor, MD Investigator

Hayder Hashim, MD Investigator

Jeffrey Cohen, MDInvestigator

Toby Rogers, MDInvestigator

Christian Shults, MD Investigator

Robert Lager, MD Investigator

Lowell Satler, MD Investigator

Shreejana PokharelClinical Trials Manager

REPRISE IV: designed to evaluate the safety and effectiveness of the LOTUS Edge Valve System for TAVR in symptomatic subjects who have severe native aortic stenosis and are considered at intermediate risk for surgical valve replacement.

APOLLO: Transcatheter Mitral Valve Replacement with the Medtronic Intrepid™ TMVR System in patients with severe symptomatic mitral regurgitation – APOLLO Trial

Donna Whitman, RNClinical Research Nurse

Coordinator

Sandra Griffin, RNClinical Research Nurse

Coordinator

Naima ShaikhClinical Research

Coordinator

Samantha SterbaClinical Research

Assistant

Erin CollinsClinical Research

Coordinator

Aaphtaab DheendsaClinical Research

Coordinator

Hadiya BennClinical Research

Assistant

Ron Waksman, MDChristian Shults, MDScientific LeadsThe Interventional Cardiology section offers a wide array of investigational devices, new pharmaceutical agents, and medication combinations to patients at the Washington Hospital Center in Washington, DC, and MedStar Union Memorial Hospital in Baltimore, Maryland, including new drug-eluting stents, biodegradable drug-eluting stents, and completely bioresorbable scaffolds.

The Structural Heart Research section conducts investigational research with all available aortic valve devices, including Lotus, Portico, Direct Flow, and JenaValve. In addition, the section is engaged in research on valves for aortic insufficiency, mitral valve replacement with the Tendyne device, mitral repair with the MitraClip, and tricuspid repair with the Mitralign system. For left atrial appendage closure, the team is enrolling patients in trials involving the second-generation devices of Watchman with different anticoagulation strategies.

Relay PRO: A Prospective, Multicenter, Non-Blinded, Non-Randomized Study of the RelayPro in Subjects with Acute, Complicated Type B Aortic Dissections

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PERIPHERAL VASCULAR - TEAM MEMBERSPERIPHERAL VASCULAR

Steven Abramowitz, MD Investigator

Nelson L. Bernardo, MD Investigator

Joshua Dearing, MD Investigator

Fatima Javalriah, MD Investigator

Cameron Akbari, MD Investigator

ONGOING TRIALS

CONFIDENCE Trial : Pivotal study of the MicroVention, Inc. carotid artery stent system used in conjunction with the Nanoparasol® embolic protection system for the treatment of carotid artery stenosis in patients at elevated risk for adverse events from carotid endarterectomy.

CLOUT: ClotTriever Thrombectomy System Outcomes (CLOUT) Registry. . The device is indicated for the non-surgical removal of soft thrombi and emboli from peripheral blood vessels.

DETOUR: The Detour Endovascular Technique for long OcclUsive fem-pop Revascularization. The trial is evaluating the safety and effectiveness of the PQ Bypass System to access, deliver guidewires, and implant stent grafts for a percutaneous femoropopliteal (fem-pop) bypass.

Kassaye Sesaba Clinical Research

Coordinator

Misaki Kiguchi, MD Investigator

Abdullah Alfawaz, MD Investigator

Suman SinghClinical Trials Manager

Edward Woo, MDNelson L. Bernardo, MDScientific Leads

Led by Edward Woo, MD, director of the MedStar Vascular Program, the Peripheral Vascular Section of MCRN is at the forefront of international vascular surgery clinical research. The Department of Vascular Surgery performs some of the most complex vascular surgery procedures in the mid-Atlantic region. As part of ongoing clinical research projects and industry-sponsored clinical trials, the group is committed to sharing its expertise as a means of improving outcomes worldwide.

The group presents at almost every major vascular surgery professional society meeting. There are three particular areas of research in the department that continue to garner national attention. First, the group currently has one of the largest international experiences with endovascular iliocaval reconstruction for the treatment of complex, multilevel deep venous occlusive disease. Second, in conjunction with the Limb Salvage Center at MedStar Georgetown University Hospital, there is a continued dedication to improving limb salvage using complex open, hybrid, and endovascular techniques in a multidisciplinary environment. Finally, with the largest aortic volume in the region, the group continues to publish regarding the role of endovascular treatment for complex aortic pathologies, such as Type B Aortic dissection and aneurysmal pathology.

The department also maintains a longstanding close relationship with the medical device community by participating in national clinical trials. Over the past year, it has enrolled in over 15 clinical trials. This exposes patients to the newest technological advancements and allows the group to help mold their use in future care. Current open trials of interest, among others, include: CREST 2, TOBA II, BEST CLI AND VALIANT EVO. With four more clinical trials coming to the MHVI in the next few months, the list will continue to expand as will the group’s international involvement.

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BALTIMORE CARDIOLOGY BALTIMORE CARDIOLOGY TEAM MEMBERS

BALTIMORE CARDIOLOGY - INVESTIGATORS

CLINICAL TRIALSThe inpatient researchteam participates inkey national trials,such as:

• ACURATE IDE

• SUMMIT

• ASAP-TOO

• OPTIMIZE PRO

• DISRUPT CAD III

• BIOFLOW 7

Mary Park Clinical Research

Coordinator

Keith Moyer Regulatory Affairs

Coordinator

Susan Cranford, RNClinical Research Nurse

Coordinator

Rachel Campbell, RNClinical Research Nurse

Coordinator

Colleen KellyClinical Trials Manager

Jennifer Latteri, RNClinical Research Nurse

Coordinator

Cynthia YashinskiClinical Research

Coordinator

Nauman Siddiqi, MDInvestigator

Brian Bethea, MDInvestigator

Michael Fiocco, MD Investigator

Antony Kaliyadan, MD Investigator

Sandeep Jani, MD Investigator

Geetha Jeyabalan, MDInvestigator

Raghuveer Vallabhaneni, MD Investigator

ONGOING TRIALS

OPTIMIZE PRO: The purpose of this study is to collect clinical evidence on valve performance and procedural outcomes associated with an “optimized” TAVR care pathway and using the EvolutTM PRO and EvolutTM PRO+ devices.

DISRUPT CAD III : To assess the safety and effectiveness of the Shockwave Coronary Intravascular Lithotripsy (IVL) System to treat de novo, calcified, stenotic, coronary lesions prior to stenting.

John Wang, MDScientific LeadThe Baltimore section of MCRN conducts and participates in key national trials of cardiovascular medications and devices taking place at MedStar facilities throughout the region including:

• MedStar Union Memorial Hospital (MUMH) • MedStar Franklin Square Medical Center • MedStar Cardiology Associates in Annapolis

The section is led by John Wang, MD, who is also chief of the cardiac catheterization laboratory at MUMH.

SUMMIT: To evaluate the safety and effectiveness of the Tendyne Mitral Valve System for the treatment of patients with symptomatic, moderate-to-severe or severe mitral regurgitation or for patients with symptomatic mitral valve disease due to severe mitral annular calcification.

ACURATE IDE: To evaluate safety and effectiveness of the ACURATE Transfemoral Aortic Valve System for transcatheter aortic valve replacement (TAVR) in subjects with severe native aortic stenosis who are indicated for TAVR.

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MEDSTAR GEORGETOWN UNIVERSITY HOSPITAL

Jose Vargas, MD Investigator

Venkatesh Raman, MD Investigator

MEDSTAR GEORGETOWN UNIVERSITY HOSPITAL - TEAM MEMBERS

MEDSTAR FRANKLIN SQUARE MEDICAL CENTER

MEDSTAR FRANKLIN SQUARE MEDICAL CENTER - TEAM MEMBERS Rafique Ahmed, MD

InvestigatorDavid Schamp, MD

Investigator

Jose Vargas, MD, is one of the leading cardiovascular researchers at MedStar Georgetown University Hospital, which involves a number of collaborative studies. For example, a collaboration with the National Institutes of Health (NIH) focuses on identifying genomic determinants of cardiovascular disease in an African-American cohort by assessing atherosclerosis with state-of-the-art imaging techniques coupled with state-of-the-art genomic sequencing technologies.

Another collaboration with the NIH is designed to assess the correlation between plaque assessment with near infrared spectroscopy (NIRS) and dual energy cardiac computed tomography (CT). As part of this protocol, participants will obtain intravascular ultrasound (IVUS) with NIRS at MedStar Washington Hospital Center and then go to NIH, where they will have dual chamber cardiac CT.

An ongoing collaboration with the Cleveland Clinic aims to assess the presence of genetic mosaicism in hypertrophic cardiomyopathy patients. Patients undergoing clinically indicated myomectomies will have their blood and cardiac tissues sent to the NIH for genotyping.

The Georgetown team has also received grants from the Marriott Foundation and the Charles and Mary Latham Fund to study predictors of cardiovascular events in African-American renal transplant recipients with a particular focus on genetic causes known to disproportionately affect this population (that is, APOL1 genotype status). A Folger grant will be used to study the prevalence of familial hypercholesterolemia within the MedStar system and the rate of cardiovascular events in this population.

Drs. Glenn Meininger, David Schamp, and Rafique Ahmed are active researchinvestigators in electrophysiology for the MedStar Baltimore region. Cynthia Yashinski, CCRC, is the research coordinator for the program.

The program’s current studies are divided primarily between IDE trials and postmarket registries. Additionally, there is one IND trial currently active.

One study examines the optimization of cardiac resynchronization therapy (CRT)in biventricular ICDs using periodic automatic software adjustments to the AV and VV delays (AdaptResponse, Sponsor: Medtronic). This is in contrast to traditional optimization techniques including echocardiograms, which are expensive and often not undertaken unless the patient proves to be a non-responder to therapy at nominal settings.

Another study (Appraise-ATP, Sponsor: Boston Scientific) focuses on the comparing the use of anti-tachycardia pacing versus shock only therapies in primary prevention patients.

The MCRN Baltimore EP research program registries are required postmarket surveillance of newly released leads and generators. Each device manufacturer is required to maintain these registries on newly released devices for five years post market approval.

We are collaborating with Washington Hospital Center on the STOP-AF study(Sponsor: Medtronic), which compares atrial fibrillation ablation as a first line treatment with standard anti-arrhythmic drug therapies.

Finally, we are working on a study which is testing a new drug to treat PSVT(NODE-301/302, Sponsor: Milestone) in outpatient settings instead of emergencyrooms.

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OUTCOMES RESEARCHCARDIOVASCULAR RESEARCH AT MEDSTAR SOUTHERN MARYLAND HOSPITAL CENTER

Sung Lee, MD Investigator

William Suddath, MD Investigator

Srinivas Addala, MD Investigator

CLINICAL TRIALSVOYAGER PAD Study --Vascular Outcomes studY of ASA alonG with rivaroxaban in Endovascular or surgical limb Revascularization for peripheral artery disease (PAD). This international, multi-center, randomized, double-blind, placebo-controlled phase 3 trial is investigating the efficacy and safety of rivaroxaban to reduce the risk of major thrombotic vascular events in patients with symptomatic peripheral artery disease undergoing lower extremity revascularization procedures.

ARTEMIS -- The Affordability and Real-world Antiplatelet Treatment Effectiveness After Myocardial Infarction Study (ARTEMIS) trial is a practical multi-center cluster-randomized clinical trial that will assess whether equalizing the copayments for clopidogrel and ticagrelor leads to improved medication adherence.

CARDIOVASCULAR RESEARCH AT MEDSTAR SOUTHERN MARYLAND HOSPITAL CENTER - TEAM MEMBERS

Alex Ryzhikov, MD Investigator

Athanasios X. Thomaides, MD

Investigator

• Grant preparation• Investigational plan design,

writing and development• Regulatory submission

• FDA submission and discussion

• IRB/EC• Trial management

• Site selection• Study start-up• Site initiation• Interim monitoring• Safety management

• CECs• DSMB

• Master regulatory file maintenance

• Site closure

• Electronic data collection• Data management

• Core labs• Angio (coronary and

peripheral)• CT/ MRI• Echo• IVUS/NIRS

• Biostatistical support• Trial design• Power calculations• Analysis• Methodology

• Data mining of MedStar’s Epidemiological database(s)

• Medical writing• Fellowship

ONGOING CLINICAL TRIALS Multi-site clinical trials managed by ACRO include:

• The Low Risk TAVR IDE Trial 1.0

• EPROMPT

OUTCOMES RESEARCH - TEAM MEMBERS

Paul Kolm Associate Director

Sarahfaye DolmanClinical Proj Lead Data

Mgmt

MedStar Southern Maryland Hospital Center (MSMHC), located in Clinton, Maryland, is involved in numerous clinical trials related to products used for treating various cardiovascular diseases. Those include electrophysiology device, coronary stent, and drug studies.

Sponsors of the studies have included the National Institutes of Health and industry, such as Medtronic, Boston Scientific, St. Jude Medical, InspireMD, STENTYs, Boehringer Ingelheim, Cardinal Health, and Biosensors.

William S. Weintraub, MDScientific LeadWilliam S. Weintraub, MD, is an established outcomes investigator. He is working on large registries and clinical trials. He continues to work in health-care microeconomics and health status assessment. Dr. Weintraub directs the data coordinating center for the Hypertrophic Cardiomyopathy Registry, sponsored by the National Heart, Lung, and Blood Institute (NHLBI), and is a principal investigator of the NHLBI-sponsored Optimize SPRINT study of individualized approaches to intensive therapy for hypertension. He collaborates with and mentors other scientists in the Heart and Vascular Institute on multiple outcomes studies and trials as well as assessing outcomes at MedStar Washington Hospital Center.

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PRECLINICALTRANSLATIONAL

ONGOING TRIALSStem cells – The Translational Section is using preclinical models to develop optimal strategies for delivery of novel mesenchymal stem cells (MSC) that have the potential to treat acute myocardial infarction (AMI) and chronic cardiomyopathy.

Liposomes – The Translational Section demonstrated in mice that pegylated liposomes specifically target ischemic myocardium following AMI. The team is now testing whether the liposomes can be used to deliver a novel agent to ischemic myocardium with the aim of inhibiting the inflammatory response to AMI, thus decreasing ischemic injury.

Dror Luger, PhDVascular Biolab Research

Scientist

TRANSLATIONAL - TEAM MEMBERS

David Hellinga, MSc Associate Director of Pre-Clinical Core Lab Human mesenchymal stem cells

Stephen Epstein, MDScientific LeadThe Translational Section, headed by Stephen Epstein, MD, at Washington Hospital Center, focuses on stem cells as a potential treatment for cardiovascular conditions. With more than 500 publications in peer-reviewed medical journals, Dr. Epstein is a recognized international authority on angiogenesis and on the use of stem cells as a cardiovascular therapeutic. He and his colleagues have also developed, using circulating biomarkers, a strategy that allows detection of individual patients with coronary artery disease who are either at very-high risk of plaque rupture, with attendant myocardial infarction or death, or at very-low risk of plaque rupture.

David Hellinga, MScAssociate Director of Pre-Clinical Core LabThe Preclinical Lab supports and collaborates on research involving interventional devices, cardiac surgery, and drug therapy in preclinical models.

Recent areas of study include: • Biodegradable/bioabsorbable stents • Drug-coated balloons • Neoatherosclerosis studies • Thrombogenicity studies

The majority of the work completed in the lab is for sponsor/client-initiated studies. Industry sponsors include the U.S. Food and Drug Administration, Abbott Vascular, Terumo, Boston Scientific, Medtronic, Johnson & Johnson, and start-up companies.

The lab supports investigators by: • Assisting companies in the development of a study protocol. • Preparing all necessary regulatory documents. • Procuring required supplies to conduct study. • Assisting companies in publicizing their results.

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Federico M. Asch, MD, FACC, FASEScientific Lead

The Cardiac Imaging Section is a very productive team with more than 30 publications a year in top-tier peer-reviewed journals.

Their work includes all imaging modalities:• Core Laboratory services (Echo, CT and MRI) for

multiple industry and NIH-sponsored clinical trials in areas such as structural heart disease, drug and device development, and aortic diseases.

• Innovative techniques in the areas of minimal radiation computed tomography (CT).

• Contributions to national magnetic resonance imaging (MRI) databases.

• Echocardiographic innovations in the areas of cardio-oncology, advanced heart failure, and structural heart diseases.

• Novel technologies that allow for advanced 4D analysis of CT, MRI, echocardiography, and myocardial strain through collaboration with industry partners in their products’ testing and development.

Federico M. Asch, MD, FACC, FASE, director of Cardiac Imaging Research and Director of the Cardiovascular Core Laboratories at MedStar Washington Hospital Center, is principal investigator of National Institutes of Health trials, such as GenTAC, and multiple industry-sponsored studies in the area of structural heart disease with Medtronic, Biotronik, St. Jude Medical, Boston Scientific, JenaValve, Livanova/Sorin, Symetis, Abbott Lifesciences, Mitralign, Guided Delivery Systems, and others.

Diagnostic cardiac catheterization • Immediate• Simultaneous anatomic, functional and hemodynamic assessment for all clinically indicated right heart

catheterizations• Measurement of pulmonary vascular resistance and assessment of ventricular vascular coupling in patients with

pulmonary hypertension• Investigation of patients with unexplained exertional dyspnea

High Resolution Cardiac ImagingWe have access to state-of-the-art cardiac CT & MRI capabilities that enable us to participate in early clinical trials.

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CARDIAC IMAGING - TEAM MEMBERSCARDIAC IMAGING - TEAM MEMBERS

Tamika SamuelClinical Project Lead

Vladimir MasatiEcho Research Technologist

Biruk TeklehaymanotEcho Research Technologist

Kevin ReevesSr. IT Analyst

Lin HanEcho Research Technologist

Devany DeGante CanoResearch Associate

Robin EdelbergEcho Research Technologist

Samuel LegarretaEcho Research Technologist

Alston AndersonEcho Research Technologist

Sangpil LeeEcho Research Technologist

Neil J. Weissman, MDInvestigator

MHRI President

Steven Goldstein, MDInvestigator

W. Guy Weigold, MDInvestigator

Gaby Weissman, MDInvestigator

Andrew Ertel, MDInvestigator

Diego Medvedofsky, MDInvestigator

Ana Barac, MDInvestigator

Preetham Kumar, MD Investigator

Rachel MarcusPhysician

Adriana RosarioPhysician

Tanisha (Nicole) Dickerson Research Assistant

Amir Ali ZohdiEcho Research Technologist

Jin JiEcho Research Technologist

Alton Henry Echo Research Technologist

M. Therese Tupas-HabibMgr. Cardiovascular

Core Lab

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INVASIVE IMAGING CORE LABORATORY INVASIVE IMAGING CORE LABORATORY - TEAM MEMBERS

CLINICAL EVENTS ADJUDICATIONThe Core Lab, through its committee of medical experts, also plays the role of a clinical events committee, which entails the standardized, independent and systematic assessment and/or confirmation of clinical events and protocol-defined study endpoints for a wide variety of single- or multi-center clinical trials in the field of cardiovascular imaging.

Vanessa WilsonCoronary Imag CoreLab

Research Analyst

Yirga Kahsay Coronary Imag CoreLab

Analyst

Solomon BeyeneSr Coron Imag Core Lab

Research Analyst

Echo BrathwaiteProj Lead Coron Imag

Core Lab

Gebremedhin MelakuSr Coron Imag Core Lab

Research Analyst

Kayode KukuSr Coron Imag Core Lab

Research Analyst

Hector M. Garcia-Garcia, MD Scientific Lead

Led by Hector M. Garcia-Garcia, MD, the Invasive Imaging Core Laboratory provides support for a wide range of multi-center preclinical studies and clinical trials that require top-quality quantitative and qualitative invasive coronary and cardiovascular imaging analysis.

The Core Laboratory has extensive experience using:

Quantitative Coronary Analysis (QCA) – The Core Lab uses this in clinical trials to assess coronary artery dimensions, check for restenosis following coronary interventions, and monitor progression of vascular disease.

Intracoronary Imaging – The Core Lab is also involved in stent analysis studies using standard imaging modalities such as intravascular ultrasound (IVUS), virtual histology (VH), near-infrared spectroscopy (NIRS), and optical coherence tomography (OCT).

Independent Clinical Event AdjudicationWith a team of physician adjudicators led by Hector M. Garcia-Garcia, MD, PhD, a seasoned investigator and Scientific lead at MedStar Health, we provide event/endpoint adjudication services for clinical trials through an independent Clinical Events Committee(CEC). The committee performs its functions guided by standard and most-uptodate definitions in NIH and industry-initiated device, pharmaceutical and intervention trials encompassing procedure-, patient-centered and device-oriented endpoints. MCRN has a network of highly experienced physician specialists spread across the MedStar system who are vastly experienced in adjudicating clinical events following established procedures and study protocol/charter specifications. The team presently provides event adjudication services for multiple multicenter and single center trials both locally and globally.

Data Safety and Monitoring BoardThe Data Safety and monitoring team is composed of experienced investigators, specialists and statisticians who provide standardized monitoring of study endpoint data and give recommendations on the continuation, termination or modification of clinical trials towards ensuring the safety of study participants and strict adherence to safety and regulatory standards.

The team also provides standard statistical review of the study data based on the DSMB charter definitions on a study-by-study basis.

The DSMB is usually a team of 3-5 throughly vetted individuals who meet at specific intervals during the course of the clinical trial guided by the study protocol and DSMB charter document.

CEC Workflow

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MCRN PUBLICATIONS IN 2019 MCRN PUBLICATIONS IN 2019Asch FM, Grayburn PA, Siegel RJ, Kar S, Lim DS, Zaroff JG, Mishell JM, Whisenant B, Mack MJ, Lindenfeld J, Abraham WT, Stone GW, Weissman NJ; COAPT Investigators. Echocardiographic Outcomes After Transcatheter Leaflet Approximation in Patients With Secondary Mitral Regurgitation: The COAPT Trial. J Am Coll Cardiol 2019;74(24):2969-2979.

Asch FM, Miyoshi T, Addetia K, Citro R, Daimon M, Desale S, Fajardo PG, Kasliwal RR, Kirkpatrick JN, Monaghan MJ, Muraru D, Ogunyankin KO, Park SW, Ronderos RE, Sadeghpour A, Scalia GM, Takeuchi M, Tsang W, Tucay ES, Tude Rodrigues AC, Vivekanandan A, Zhang Y, Blitz A, Lang RM; WASE Investigators. Similarities and Differences in Left Ventricular Size and Function among Races and Nationalities: Results of the World Alliance Societies of Echocardiography Normal Values Study. J Am Soc Echocardiogr 2019;32(11):1396-1406.e2.

Asch FM, Stone GW, Weissman NJ. Reply: Disproportionate Secondary Mitral Regurgitation: An Exciting Hypothesis Still in Need of Actual Data. J Am Coll Cardiol 2020;75(16):2096-2097.

Axelsson Raja A, Shi L, Day SM, Russell M, Zahka K, Lever H, Colan SD, Margossian R, Hall EK, Becker J, Jefferies JL, Patel AR, Choudhury L, Murphy AM, Canter C, Bach R, Taylor M, Mestroni L, Wheeler MT, Benson L, Owens AT, Rossano J, Lin KY, Pahl E, Pereira AC, Bundgaard H, Lewis GD, Vargas JD, Cirino AL, McMurray JJV, MacRae CA, Solomon SD, Orav EJ, Braunwald E, Ho CY. Baseline Characteristics of the VANISH Cohort. Circ Heart Fail 2019;12(12):e006231.

Ben-Dor I. The Value of Case Reports in Interventional Cardiology. Cardiovasc Revasc Med 2019;20(11S):1-2.

Case BC, Forrestal BJ, Yerasi C, Khan JM, Khalid N, Shlofmitz E, Chen Y, Musallam A, Chezar-Azerrad C, Satler LF, Ben-Dor I, Rogers T, Waksman R. Real-world experience of the Sentinel cerebral protection device: Insights from the FDA Manufacturer and User Facility Device Experience (MAUDE) database. Cardiovasc Revasc Med 2020;21(2):235-238.

Case BC, Waksman R. Coronary Heart Disease: Have We Reached a Plateau in Primary Prevention? J Am Heart Assoc 2020;9(7):e04963.

Case BC, Yang M, Kagan CM, Yerasi C, Forrestal BJ, Tariq MU, Medvedofsky D, Hashim H, Rogers T, Satler LF, Waksman R, Ben-Dor I. Safety and Feasibility of Performing Pericardiocentesis on Patients with Significant Pulmonary Hypertension. Cardiovasc Revasc Med 2019;20(12):1090-1095.

Chen Y, Bernardo NL, Waksman R. Cangrelor for the rescue of intra-procedural stent thrombosis in percutaneous coronary intervention. Cardiovasc Revasc Med 2019;20(7):624-625.

Chen Y, Buchanan KD, Chan RC, Zhang C, Torguson R, Satler LF, Waksman R. Combined Vascular Brachytherapy and Stenting for the Treatment of In-Stent Restenosis. Am J Cardiol 2020;125(5):712-719.

Chen Y, Shlofmitz E, Khalid N, Bernardo NL, Ben-Dor I, Weintraub WS, Waksman R. Right Heart Catheterization-Related Complications: A Review of the Literature and Best Practices. Cardiol Rev 2020;28(1):36-41.

Chlebowski RT, Anderson GL, Manson JE, Prentice RL, Aragaki AK, Snetselaar L, Beresford SAA, Kuller LH, Johnson K, Lane D, Luo J, Rohan TE, Jiao L, Barac A, Womack C, Coday M, Datta M, Thomson CA. Low-Fat Dietary Pattern and Cancer Mortality in the Women’s Health Initiative (WHI) Randomized Controlled Trial. JNCI Cancer Spectr 2019;2(4):pky065.

Crawford TC, Leary PJ, Fraser C 3rd, Suarez-Pierre A, Magruder JT, Baumgartner WA, Zehr KJ, Whitman GJ, Masri SC, Sheikh F, De Marco T, Maron BA, Sharma K, Gilotra NA, Russell SD, Houston BA, Ramu B, Tedford RJ. Impact of the New Pulmonary Hypertension Definition on Heart Transplant Outcomes: Expanding the Hemodynamic Risk Profile. Chest 2020;157(1):151-161.

Dan K, Garcia-Garcia HM, Hideo-Kajita A, Zhang C, Wermers JP, Kolm P, Torguson R, Waksman R. Paclitaxel-coated balloons and stents for the treatment of peripheral artery disease: proceedings from the Cardiovascular Research Technologies (CRT) 2019 Town Hall. EuroIntervention 2019;15(4):e317-e319.

Dan K, Garcia-Garcia HM, Yacob O, Kuku KO, Kolm P, Shah N, Bennett MR, Curzen N, Waksman R, Mahmoudi M. Deoxyribonucleic Acid Repair Activity Is Associated with Healed Coronary Plaque Rupture by Optical Coherence Tomography. J Cardiovasc Transl Res 2019;12(6):608-610.

Dan K, Shlofmitz E, Khalid N, Hideo-Kajita A, Wermers JP, Torguson R, Kolm P, Garcia-Garcia HM, Waksman R. Paclitaxel-related balloons and stents for the treatment of peripheral artery disease: Insights from the Food and Drug Administration 2019 Circulatory System Devices Panel Meeting on late mortality. Am Heart J 2020;222:112-120.

Dauerman HL, Deeb GM, O’Hair DP, Waksman R, Yakubov SJ, Kleiman NS, Chetcuti SJ, Hermiller JB Jr, Bajwa T, Khabbaz K, de Marchena E, Salerno T, Dries-Devlin JL, Li S, Popma JJ, Reardon MJ. Durability and Clinical Outcomes of Transcatheter Aortic Valve Replacement for Failed Surgical Bioprostheses. Circ Cardiovasc Interv 2019;12(10):e008155.

De Maria GL, Garcia-Garcia HM, Scarsini R, Hideo-Kajita A, Gonzalo López N, Leone AM, Sarno G, Daemen J, Shlofmitz E, Jeremias A, Tebaldi M, Bezerra HG, Tu S, Lemos PA, Ozaki Y, Dan K, Collet C, Banning AP, Barbato E, Johnson NP, Waksman R. Novel Indices of Coronary Physiology: Do We Need Alternatives to Fractional Flow Reserve? Circ Cardiovasc Interv 2020;13(4):e008487.

Douglas PS, Carabello BA, Lang RM, Lopez L, Pellikka PA, Picard MH, Thomas JD, Varghese P, Wang TY, Weissman NJ, Wilgus R. 2019 ACC/AHA/ASE Key Data Elements and Definitions for Transthoracic Echocardiography: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Data Standards (Writing Committee to Develop Cardiovascular Endpoints Data Standards) and the American Society of Echocardiography. J Am Coll Cardiol 2019;74(3):403-469.

Edelman JJ, Khan JM, Rogers T, Shults C, Satler LF, Ben-Dor II, Waksman R, Thourani VH. Valve-in-Valve TAVR: State-of-the-Art Review. Innovations (Phila) 2019;14(4):299-310.

Gajanana D, Weintraub WS, Kolm P, Rogers T, Iantorno M, Ben-Dor I, Khalid N, Shlofmitz E, Khan JM, Chen Y, Musallam A, Kajita AH, Hashim H, Satler LF, Torguson R, Waksman R. Trends in Death Rate 2009 to 2018 Following Percutaneous Coronary Intervention Stratified by Acuteness of Presentation. Am J Cardiol 2019;124(9):1349-1356.

Gatti JW, De Araujo Gonçalves P, Garcia-Garcia HM. Computed Tomography Angiography-Based Risk Discrimination: An Established Bright Future for Prognostication. JACC Cardiovasc Imaging 2020;13(4):1097-1098.

Hideo-Kajita A, Garcia-Garcia HM, Kolm P, Azizi V, Ozaki Y, Dan K, Ince H, Kische S, Abizaid A, Töelg R, Lemos PA, Van Mieghem NM, Verheye S, von Birgelen C, Christiansen EH, Wijns W, Lefèvre T, Windecker S, Waksman R, Haude M; BIOFLOW-II, BIOSOLVE-II and BIOSOLVE-III investigators. Comparison of clinical outcomes between Magmaris and Orsiro drug eluting stent at 12 months: Pooled patient level analysis from BIOSOLVE II-III and BIOFLOW II trials. Int J Cardiol 2020;300:60-65.

Hideo-Kajita A, Wopperer S, Beyene SS, Meirovich YF, Melaku GD, Kuku KO, Brathwaite EJ, Ozaki Y, Dan K, Torguson R, Waksman R, Garcia-Garcia HM. Impact of two formulas to calculate percentage diameter stenosis of coronary lesions: from stenosis models (phantom lesion model) to actual clinical lesions. Int J Cardiovasc Imaging 2019;35(12):2139-2146.

Iantorno M, Rogers T, Torguson R, Kolm P, Gajanana D, Khalid N, Shlofmitz E, Khan JM, Chen Y, Musallam A, Weintraub WS, Waksman R. Racial Disparities in Clinical Characteristics and Outcomes of Women Undergoing Percutaneous Coronary Intervention. Cardiovasc Revasc Med 2019;20(12):1039-1042.

Iantorno M, Shlofmitz E, Rogers T, Torguson R, Kolm P, Gajanana D, Khalid N, Chen Y, Weintraub WS, Waksman R. Should Non-ST-Elevation Myocardial Infarction be Treated like ST-Elevation Myocardial Infarction With Shorter Door-to-Balloon Time? Am J Cardiol 2020;125(2):165-168.

Kanwal A, Bustin KM, Delasobera BE, Shah AB. Ischaemia during exercise stress testing in an athlete with Wolff-Parkinson-White pattern. BMJ Case Rep 2020;13(4).

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MCRN

Kenigsberg BB, Barnett CF, Mai JC, Chang JJ. Neurogenic Stunned Myocardium in Severe Neurological Injury. Curr Neurol Neurosci Rep 2019;19(11):90.

Khalid N, Iantorno M, Shlofmitz E, Case BC, Forrestal BJ, Yerasi C, Ben-Dor I, Waksman R. Resolution of massive intracoronary thrombus during percutaneous coronary intervention utilizing intensive pharmacological and aspiration strategies. Cardiovasc Revasc Med 2020;21(2):251-253.

Khalid N, Iantorno M, Shlofmitz E, Hashim H, Waksman R, Bernardo N. Kissing Intravascular Lithotripsy Facilitated Endovascular Repair of a Complex Saccular Abdominal Aortic Aneurysm With Narrowed Distal Aorta: A First-in-Human Report. JACC Cardiovasc Interv 2019;12(12):e97-e99.

Khalid N, Javed H, Ahmad SA, Edelman JJ, Shlofmitz E, Chen Y, Musallam A, Rogers T, Hashim H, Bernardo NL, Waksman R. Analysis of the Food and Drug Administration manufacturer and user facility device experience database for patient- and circuit-related adverse events involving extracorporeal membrane oxygenation. Cardiovasc Revasc Med 2020;21(2):230-234.

Khalid N, Javed H, Rogers T, Hashim H, Shlofmitz E, Chen Y, Khan JM, Musallam A, Torguson R, Bernardo NL, Waksman R. Adverse events and modes of failure related to the FilterWire EZ Embolic Protection System: Lessons learned from an analytic review of the FDA MAUDE database. Catheter Cardiovasc Interv 2019;94(1):157-164.

Khalid N, Rogers T, Shlofmitz E, Chen Y, Dan K, Torguson R, Weintraub WS, Waksman R. Overview of the 2018 US Food and Drug Administration Circulatory System Devices Panel meeting on device-based therapies for hypertension. Cardiovasc Revasc Med 2019;20(10):891-896.

Khan JM, Bruce CG, Babaliaros VC, Greenbaum AB, Rogers T, Lederman RJ. TAVR Roulette: Caution Regarding BASILICA Laceration for TAVR-in-TAVR. JACC Cardiovasc Interv 2020;13(6):787-789.

Khan JM, Rogers T, Greenbaum AB, Babaliaros VC, Yildirim DK, Bruce CG, Herzka DA, Schenke WH, Ratnayaka K, Lederman RJ. Transcatheter Electrosurgery: JACC State-of-the-Art Review. J Am Coll Cardiol 2020;75(12):1455-1470.

Khan JM, Rogers T, Waksman R, Torguson R, Weissman G, Medvedofsky D, Craig PE, Zhang C, Gordon P, Ehsan A, Wilson SR, Goncalves J, Levitt R, Hahn C, Parikh P, Bilfinger T, Butzel D, Buchanan S, Hanna N, Garrett R, Shults C, Garcia-Garcia HM, Kolm P, Satler LF, Buchbinder M, Ben-Dor I, Asch FM. Hemodynamics and Subclinical Leaflet Thrombosis in Low-Risk Patients Undergoing Transcatheter Aortic Valve Replacement. Circ Cardiovasc Imaging 2019;12(12):e009608.

Kiernan MS, Najjar SS, Vest AR, Birks EJ, Uriel N, Ewald GA, Leadley K, Patel CB. Outcomes of Severely Obese Patients Supported by a Centrifugal-Flow Left Ventricular Assist Device. J Card Fail 2020;26(2):120-127.

Koifman E, Medvedofsky D, Didier R, Torguson R, Jerusalem Z, Kiramijyan S, Ben-Dor I, Wang Z, Goldstein SA, Xu L, Pichard AD, Satler LF, Waksman R, Asch FM. Impact of Baseline Left Ventricular Diastolic Dysfunction in Patients With Severe Aortic Stenosis Undergoing Transcatheter Aortic Valve Implantation. Am J Cardiol 2020;125(2):258-263.

Lee HH, Shaw NM, Mohammed S, Kowalczyk KJ, Stamatakis L, Krasnow RE. Prostate Cancer in Men With Treated Advanced Heart Failure: Should we Keep Screening? Urology 2020;136:46-50.

Makkar RR, Thourani VH, Mack MJ, Kodali SK, Kapadia S, Webb JG, Yoon SH, Trento A, Svensson LG, Herrmann HC, Szeto WY, Miller DC, Satler L, Cohen DJ, Dewey TM, Babaliaros V, Williams MR, Kereiakes DJ, Zajarias A, Greason KL, Whisenant BK, Hodson RW, Brown DL, Fearon WF, Russo MJ, Pibarot P, Hahn RT, Jaber WA, Rogers E, Xu K, Wheeler J, Alu MC, Smith CR, Leon MB; PARTNER 2 Investigators. Five-Year Outcomes of Transcatheter or Surgical Aortic-Valve Replacement. N Engl J Med 2020;382(9):799-809.

Medvedofsky D, Koifman E, Jarrett H, Miyoshi T, Rogers T, Ben-Dor I, Satler LF, Torguson R, Waksman R, Asch FM. Association of Right Ventricular Longitudinal Strain with Mortality in Patients Undergoing Transcatheter Aortic Valve Replacement. J Am Soc Echocardiogr 2020;33(4):452-460.

Medvedofsky D, Koifman E, Miyoshi T, Rogers T, Wang Z, Goldstein SA, Ben-Dor I, Satler LF, Torguson R, Waksman R, Asch FM. Usefulness of Longitudinal Strain to Assess Remodeling of Right and Left Cardiac Chambers Following Transcatheter Aortic Valve Implantation. Am J Cardiol 2019;124(2):253-261.

Musallam A, Rogers T, Ben-Dor I, Torguson R, Khan JM, Satler LF, Waksman R. Self-Expanding Transcatheter Aortic Valve-Frame Infolding: A Case Series With a Warning Message. JACC Cardiovasc Interv 2020;13(6):789-790.

Nash MS, Groah SL, Gater DR, Dyson-Hudson TA, Lieberman JA, Myers J, Sabharwal S, Taylor AJ. Identification and Management of Cardiometabolic Risk after Spinal Cord Injury. J Spinal Cord Med 2019;42(5):643-677.

Ozaki Y, Garcia-Garcia HM, Hideo-Kajita A, Kuku KO, Haude M, Ince H, Abizaid A, Tölg R, Lemos PA, von Birgelen C, Christiansen EH, Wijns W, Escaned J, Dijkstra J, Waksman R. Impact of procedural characteristics on coronary vessel wall healing following implantation of second-generation drug-eluting absorbable metal scaffold in patients with de novo coronary artery lesions: an optical coherence tomography analysis. Eur Heart J Cardiovasc Imaging 2019;20(8):916-924.

Ozaki Y, Garcia-Garcia HM, Rogers T, Torguson R, Craig PE, Hideo-Kajita A, Gordon P, Ehsan A, Parikh P, Bilfinger T, Butzel D, Buchanan S, Levitt R, Hahn C, Buchbinder M, Hanna N, Garrett R, Wilson SR, Goncalves JA, Ali S, Asch FM, Weissman G, Shults C, Ben-Dor I, Satler LF, Waksman R. Coronary Artery Disease Assessed by Computed Tomography-Based Leaman Score in Patients With Low-Risk Transcatheter Aortic Valve Implantation. Am J Cardiol 2020;125(8):1216-1221.

Ozaki Y, Garcia-Garcia HM, Shlofmitz E, Hideo-Kajita A, Waksman R. Second-Generation Drug-Eluting Resorbable Magnesium Scaffold: Review of the Clinical Evidence. Cardiovasc Revasc Med 2020;21(1):127-136.

Ozaki Y, Gonzalo N, Salazar CH, Kuku KO, Mejía-Rentería H, Hideo-Kajita A, Núñez-Gil IJ, Escaned J, Waksman R, Garcia-Garcia HM. Comparison of quantitative flow ratio value of left anterior descending and circumflex coronary artery in patients with Takotsubo syndrome. Int J Cardiovasc Imaging 2020;36(1):3-8.

Rogers T, Greenbaum AB, Babaliaros VC, Stine AM, Khan JM, Schenke WH, Eng MH, Paone G, Leshnower BG, Satler LF, Waksman R, Chen MY, Lederman RJ. Dedicated Closure Device for Transcaval Access Closure: From Concept to First-in-Human Testing. JACC Cardiovasc Interv 2019;12(21):2198-2206.

Rogers T, Greenspun BC, Weissman G, Torguson R, Craig P, Shults C, Gordon P, Ehsan A, Wilson SR, Goncalves J, Levitt R, Hahn C, Parikh P, Bilfinger T, Butzel D, Buchanan S, Hanna N, Garrett R, Buchbinder M, Asch F, Garcia-Garcia HM, Okubagzi P, Ben-Dor I, Satler LF, Waksman R. Feasibility of Coronary Access and Aortic Valve Reintervention in Low-Risk TAVR Patients. JACC Cardiovasc Interv 2020;13(6):726-735.

Sandesara PB, O’Neal WT, Tahhan AS, Hayek SS, Lee SK, Khambhati J, Topel ML, Hammadah M, Alkhoder A, Ko YA, Gafeer MM, Beshiri A, Murtagh G, Kim JH, Wilson P, Shaw L, Epstein SE, Sperling LS, Quyyumi AA. Comparison of the Association Between High-Sensitivity Troponin I and Adverse Cardiovascular Outcomes in Patients With Versus Without Chronic Kidney Disease. Am J Cardiol 2018;121(12):1461-1466.2

Shah N, Meira LB, Elliott RM, Hoole SP, West NE, Brown AJ, Bennett MR, Garcia-Garcia HM, Kuku KO, Dan K, Kolm P, Mariathas M, Curzen N, Mahmoudi M. DNA damage and repair in patients with coronary artery disease: Correlation with plaque morphology using optical coherence tomography (DECODE study). Cardiovasc Revasc Med 2019;20(9):812-818.

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MCRN COMMUNICATIONSMCRN PUBLICATIONS IN 2019Shlofmitz E, Ben-Dor I, Khalid N, Kuku KO, Chen Y, Dan K, Garcia-Garcia HM, Waksman R. Intravascular Ultrasound Assessment of the Impact of Intravascular Lithotripsy. Cardiovasc Revasc Med 2019;20(12):1209-1210.

Shlofmitz E, Iantorno M, Waksman R. Restenosis of Drug-Eluting Stents. Circ Cardiovasc Interv 2019;12(8):e007023.

Shlofmitz E, Torguson R, Zhang C, Craig PE, Mintz GS, Khalid N, Chen Y, Rogers T, Hashim H, Ben-Dor I, Garcia-Garcia HM, Satler LF, Waksman R. Impact of Intravascular Ultrasound on Outcomes Following PErcutaneous Coronary InterventioN in Complex Lesions (iOPEN Complex). Am Heart J 2020;221:74-83.

Soud M, Hideo-Kajita A, Ho G, Yacob O, Alahdab F, King F, Waksman R, McFadden EP, Garcia-Garcia HM. Impact of periprocedural biomarker elevation on mortality in stable angina pectoris patients undergoing elective coronary intervention: a systematic review and meta-analysis including 24 666 patients. Coron Artery Dis 2020;31(2):137-146.

Spertus JA, Jones PG, Maron DJ, O’Brien SM, Reynolds HR, Rosenberg Y, Stone GW, Harrell FE Jr, Boden WE, Weintraub WS, Baloch K, Mavromatis K, Diaz A, Gosselin G, Newman JD, Mavromichalis S, Alexander KP, Cohen DJ, Bangalore S, Hochman JS, Mark DB; ISCHEMIA Research Group. Health-Status Outcomes with Invasive or Conservative Care in Coronary Disease. N Engl J Med 2020;382(15):1408-1419.

Waksman R, Di Mario C, Torguson R, Ali ZA, Singh V, Skinner WH, Artis AK, Cate TT, Powers E, Kim C, Regar E, Wong SC, Lewis S, Wykrzykowska J, Dube S, Kazziha S, van der Ent M, Shah P, Craig PE, Zou Q, Kolm P, Brewer HB, Garcia-Garcia HM; LRP Investigators. Identification of patients and plaques vulnerable to future coronary events with near-infrared spectroscopy intravascular ultrasound imaging: a prospective, cohort study. Lancet 2019;394(10209):1629-1637.

Waksman R, Shlofmitz E, Windecker S, Koolen JJ, Saito S, Kandzari D, Kolm P, Lipinski MJ, Torguson R. Efficacy and Safety of Ultrathin, Bioresorbable-Polymer Sirolimus-Eluting Stents Versus Thin, Durable-Polymer Everolimus-Eluting Stents for Coronary Revascularization of Patients With Diabetes Mellitus. Am J Cardiol 2019;124(7):1020-1026.

Yang M, Miller PJ, Case BC, Gilbert AJ, Widell JK, Rogers T, Satler LF, Waksman R, Ben-Dor I. Pre-operative cardiovascular testing and post-renal transplant clinical outcomes. Cardiovasc Revasc Med 2019;20(7):588-593.

Yerasi C, Case BC, Forrestal BJ, Torguson R, Weintraub WS, Garcia-Garcia HM, Waksman R. Drug-Coated Balloon for De Novo Coronary Artery Disease: JACC State-of-the-Art Review. J Am Coll Cardiol 2020;75(9):1061-1073.

Yerasi C, O’Donoghue S, Satler LF, Waksman R. Apple Watch detecting high-grade block after transcatheter aortic valve implantation. Eur Heart J. 2020;41(10):1096.

Yerasi C, Tripathi B, Banga S, McNown C, Jonnalagadda AK, Al-Qaisi S, Miryala V, Nafisi S, Waksman R, Ben-Dor I. Predictors of 90-day readmission and in-hospital mortality in takotsubo cardiomyopathy: An analysis of 28,079 index admissions. Cardiovasc Revasc Med 2019;20(11):973-979.

Publications by MCRN Researchers

• 279 manuscripts published in peer-reviewed journals in FY 2019

• 215 in FY 2020 to date

Comparative Prognostic Value of Low- Density Lipoprotein Cholesterol and C-Reactive Protein in Patients with Stable Coronary Intervention and Chronic Ther-apy

Outcomes among Patients Requiring Un-planned Intra-Aortic Balloon Pump Rein-sertion in Cardiogenic Shock

Type 2 diabetes Impairs Venous, But Not Arterial Smooth Muscle Cell Function: Possible Role of Differential RhoA Ac-tivity

Intra-Stent Tissue Evaluation within Bare Metal and Drug-Eluting Stents > 3 years Since Implantation in Patients With Mind to Moderate Neointimal Proliferation Using Optical Coherence Tomography and Virtual Histology Intravacular Ultra-sound

Aortic Valve ChromaFlo(R): A Feasibili-ty Study of Aortic Regurgitation and Ef-fective Annular Aortic Area Assessment in a Porcine Model

CARDIOVASCULAR REVASCULARIZATION MEDICINECARDIOVASCULAR REVASCULARIZATION MEDICINE

THE CRT MEETING

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VOLUME 15 NUMBER 3APRIL 2014

PUBLISHED 8 TIMES A YEAR

ELSEVIERISSN 1553-8389

WWW.CARDIOVASCMED.COM

INCLUDING VALVE AND STRUCTURAL HEART

CRM02 The Doctor Will Tweet

You Now…

Vital Signs

Reducing the Risk of LVADs

Software Tweaks to Improve CRT Devices

Cardio-Oncology: Bridging the Gap

Dates to RememberNew Hires

Publications

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ZONEISSUE 02 | JUNE 2017

Cardiovascular Revascularization Medicine (CRM), the official journal of CRT Meeting, is an international and multidisciplinary journal that publishes original laboratory and clinical investigations related to revascularization therapies in cardiovascular medicine. MCRN Director Ron Waksman, MD, is the editor-in-chief, and the CRM editorial office is housed at MedStar’s Washington Hospital Center. http://www.cardiorevascmed.com/

MCRN Zone, published quarterly, provides updates on research, clinical trials, and other key events happening within the MedStar Cardiovascular Research Network.

Our publications office is tasked with compiling, submitting and editing manuscripts to peer-review journals, national conferences and meetings. The office also organizes and edits books, book chapters and other texts at the request of our investigators and scientific leads. The publication office also produces monthly newsletters, quarterly MCRN Zones, and annual brochures.

Cardiovascular Revascularization Medicine (CRM) is an international and multidisciplinary journal that publishes original manuscripts on clinical investigations related to revascularization therapies in cardiovascular medicine including valve and structural heart. http://www.cardiorevascmed.com

4342 MCRNMCRN

MCRN DIRECTORY MCRN DIRECTORY

Ron Waksman, MDDirector, MedStar Cardiovascular Research Network and Advanced Education

202.877.5975

CARDIAC ELECTROPHYSIOLOGYSung W. Lee, MD

Meseret Deressa 202.877.0805

CARDIAC IMAGINGFederico M. Asch, MD, FACC, FASE

M. Therese Tupas-Habib 202.877.8130

ADVANCED HEART FAILURE, HEART TRANSPLANTATION, AND MECHANICAL CIRCULATORY SUPPORTSamer S. Najjar, MD

Hellina T. Birru 202.877.9328

HEART FAILURE Hellina T. Birru 202.877.4698

202.877.9328

INTERVENTIONAL CARDIOLOGY AND STRUCTURAL HEART RESEARCHRon Waksman, MDMichelle Deville, RN 202.877.2713

PERIPHERAL VASCULAREdward Woo, MD

Nelson L. Bernardo, MDSuman Singh 202.877.8475

TRANSLATIONAL RESEARCHStephen Epstein, MD 202.877.3321David Hellinga, MSc 202.877.5013

PRECLINICAL RESEARCH

David Hellinga, MSc 202.877.5013

ACADEMIC CLINICAL RESEARCH ORGANIZATIONCorey Shea 202.877.3321

CRITICAL CAREChristopher Barnett, MD 202.877.2339

CARDIO-ONCOLOGYAna Barac, MD, PhD 202.877.6264

INVASIVE IMAGING CORE LABORATORYHector Garcia-Garcia, MD 202.877.3321

CLINICAL TRIALSMichelle Deville, RN 202.877.3321

FRANKLIN SQUARE CARDIOLOGY RESEARCHGlenn Meininger, MD 410.574.1330

Cynthia Yashinski 443.777.2369

BALTIMORE CARDIOLOGYJohn Wang, MD 410.554.2332

Colleen Kelly 410.218.2227

SOUTHERN MARYLANDMeseret Deressa 301.877.5583

MedStar Heart & Vascular InstituteImportant Telephone NumbersMedStar Washington Hospital CenterAdvanced Heart Failure 202.297.9307

Cardiac Surgery 202.877.7464

Electrophysiology 202.877.7685

Interventional Cardiology 202.877.5975

Vascular Surgery 202.877.0275

MedStar Union Memorial HospitalAll physician referrals in all specialties:1.888.529.0200 (toll-free) or 410.554.2332

MedStar Franklin Square HospitalAll physician referrals in all specialties:1.888.529.0200 (toll-free) or 410.554.2332

MedStar Georgetown University HospitalCardiology 202.444.5111

MedStar Southern Maryland Hospital CenterElectrophysiology 301.877.5677

Interventional Cardiology 301.877.5677

Vascular Surgery 301.877.7353

In our virtual classroom, we tackle a variety of interventional cardiology topics led by renown faculty, from the basics to the presentation of complex and interesting cases, while encouraging audience participation.

If it’s a Saturday, it’s the CRT Virtual Fellows Course

This live and interactive classroom meets weekly on Saturdays at 8:00am via Zoom

Introducing CRT’s newest educational offering:The CRT Virtual Fellows Course

FELLOWS COURSE

Register Today!Your education starts with you!

www.crtvirtual.org• Register for the CRT Virtual Fellows Course• Access weekly agendas• Visit our Industry Pavilion• Watch on-demand videos from previous courses• Contact staff for course details or enrollment questions

Take a peek at our new website

www.crtvirtual.org

Define the future of cardiovascular care through Research and EducationResearch and Education

MedStar Cardiovascular Research Network110 Irving Street, NWSuite 4B-1 Washington, DC 20010

FY2020 (July)