Department of Medicine

University of Pittsburgh

Interventional Cardiology

Faculty

Dr. Conrad Smith is the Director of Cardiac Catheterization Laboratory at Presbyterian Hospital of UPMC. His clinical interests are in the areas or interventional cardiology where he has a very active practice in coronary intervention. He also has extensive experience in the treatment of mitral valve stenosis with mitral valvuloplasty, an alternative to surgical therapy for mitral valve disease in selected patients. With his extensive clinical experience, Dr. Smith travels internationally to share his perspectives on the practice of interventional cardiology. His research interests are primarily in the area of analysis of outcomes after percutaneous coronary intervention. As the Director of the Cardiac Catheterization Laboratory, he is overseeing the development of our cath lab database system which will provide a wealth of research potential to evaluate various aspects in interventional cardiology. He has worked with Dr. Dennis McNamara in developing a database of coronary intervention patients in which we are currently evaluating the potential genetic basis of cardiac disease. Dr. Smith also serves as the Governor of the Western Pennsylvania Chapter of the American College of Cardiology where he has the unique opportunity to directly impact the practice of cardiology in this region.

Dr. Joon Sup Lee is Associate Chief and Clinical Director of the UPMC's Cardiovascular Institute (CVI). His clinical interests are in the area of interventional cardiology. He also serves as the central clinical liaison between the CVI at Presbyterian Hospital and the multiple cardiology divisions in UPMC's affiliated institutions, including St. Margaret's Hospital, Passavant Hospital, and Magee Women's Hospital among others. In this administrative capacity, Dr. Lee has been successful in bringing these many institutions together in forging an environment that promotes collaboration in the clinical and research arenas. Dr. Lee has a specific research interest in the role of gene therapy in cardiovascular disease and has been involved in organizing local and multicenter trials regarding the potential role of this novel therapy in the treatment of coronary disease. Dr. Lee also has an interest in the study of stem cell therapy for cardiovascular disease and is leading efforts along with the Cardiothoracic Surgery division in studying this unique form of treatment.

Dr. William Anderson serves as the Director of Interventional Cardiology. In this capacity he oversees the delivery of interventional cardiac, coronary and peripheral vascular services in the cardiac catheterization laboratories at UPMC Presbyterian Hospital. His clinical interests include interventional cardiology with a focus on coronary and peripheral vascular intervention, including percutaneous approaches to the treatment of carotid artery disease, lower extremity disease, and renal artery stenosis. With his interest and experience in the treatment of carotid artery disease, he sees patients in a combined cardiology/neurology neurovascular clinic to evaluate patients who may benefit from this therapy. He also has an extensive experience in the endovascular treatment of congenital heart disease, including atrial septal defect repair, patent foramen ovale closure and repair of ventricular septal defects and patent ductus arteriosus. With an extensive experience in intravascular ultrasound (IVUS), Dr. Anderson has led UPMC's efforts locally in multicenter trials to evaluate new devices in the treatment of a variety of cardiovascular diseases. Dr. Anderson also serves as the Director of the Interventional Cardiology Fellowship Program and therefore oversees fellows' research programs. These programs currently include projects to develop new ASD closure devices, evaluate the potential role of hormones in limiting the size of heart attacks and investigate the role genes play in determining the clinical outcomes of patients undergoing percutaneous revascularization.

Dr. Peter Counihan's interests include cardiovascular hemodynamics and the assessment of valvular heart disease. He has a particular interest in the evaluation and treatment of patients with hypertrophic cardiomyopathy. Dr. Counihan has treated selected patients with hypertrophic cardiomyopathy with alcohol septal ablation, a newer and less invasive technique in the therapy of these patients. He is also active in interesting in investigating the efficacy and safety of erythropoetin and darbopoetin in animal models of ischemia and reperfusion. This research may lead to further therapies in humans to improve clinical outcomes.

Dr. Vijay Gulati divides his time with three major clinical interests. First, he practices as an interventional cardiologist at UPMC-Presbyterian. He also has an active practice UPMC-St. Margaret's where he practices invasive non-interventional and general cardiology. He has a clinical interest in improving our treatment of patients who present with acute myocardial infarction. Currently, he is developing protocols at UPMC-St.-Margaret to streamline management of acute myocardial infarction at that institution.

Dr. Ashley Lee's primary focus is in the clinical care of patients with coronary artery disease. He has an extremely busy clinical practice at UPMC's Comprehensive Heart Center, and his primary interest is in interventional cardiology and percutaneous coronary intervention.

Dr. Oscar Marroquin divides his time with both clinical and research interests. His research interests are in the study of metabolism and coronary artery disease. To study this, Dr. Marroquin is a member of the investigative team of the Heart Strategies Concentrating on Risk Evaluation (Heart SCORE) study (PI - Dr. Steven Reis) where he studies the role of metabolism in heart disease among different racial/ethnic populations. He has a number of ongoing protocols to help evaluate these issues including a study to assess the correlation between plaque volume and inflammation. He also helps to organize the participation of the CVI in a number of multicenter studies to evaluate the potential benefit of new agents that affect metabolism. He works with Dr. McNamara in the study of genetics behind cardiovascular disease and outcomes after percutaneous coronary intervention. Dr. Marroquin also collaborates with investigators from the Department of Epidemiology/School of Public Health in the National Heart, Lung and Blood Institute's (NHLBI) Dynamic Registry of PCI to study outcomes and changes in practice in interventional cardiology. He is also working to develop the cath lab database at UPMC Presbyterian Hospital to further advance the research in the field of interventional cardiology. Dr. Marroquin's clinical interests include coronary intervention, and intervention in valvular heart disease, including mitral valvuloplasty. He also is interested in the use of intravascular ultrasound and the assessement of the coronary microvasculature. He maintains an active interest in preventative cardiology and heart disease in women.

Dr. Suresh Mulukutla divides his time with both clinical and research pursuits. His overarching clinical research interest is in the study of mechanisms of atherosclerosis. Under the Heart Strategies Concentrating on Risk Evaluation (Heart SCORE) study (PI - Dr. Steven Reis), Dr. Mulukutla studies the role of platelet and endothelial interactions in atherosclerosis. He has also developed a significant collaboration with UPMC's Lupus Center of Excellence in the study of atherosclerosis in this population. He works with Dr. McNamara in the study of genetic underpinnings behind cardiovascular disease and outcomes after percutaneous coronary intervention. Dr. Mulukutla also collaborates with investigators from the Department of Epidemiology/School of Public Health in the National Heart, Lung and Blood Institute's (NHLBI) Dynamic Registry of PCI to study outcomes and changes in practice in interventional cardiology. He is also working to develop the cath lab database at UPMC Presbyterian Hospital to further advance the research in the field of interventional cardiology. Dr. Mulukutla also maintains an interest in the use of newer imaging modalities in cardiovascular disease including MRI and CT to evaluate coronary disease and the coronary microcirculation. Using MRI, Dr. Mulukutla has ongoing studies to investigate cardiac perfusion, function, and viability after acute coronary syndromes. Dr. Mulukutla's clinical interests are in the areas of interventional cardiology with a focus on percutaneous coronary interventions. He also has an interest in preventative cardiology and sees patients clinically at the Comprehensive Heart Center and the Lupus Center of Excellence at Magee Women's Hospital.

Dr. John Schindler's clinical interests are in the treatment of patients with coronary and peripheral vascular disease. In addition, Dr. Schindler is an active member of the Cardiovascular Institute's preventative cardiology team and sees patients in the Comprehensive Heart Center as well as the newly formed Magee Heart Center.

Fellow Research Activities

In addition, the above-mentioned faculty of UPMC's Interventional Cardiology program is committed to providing their interventional fellows with strong clinical and research foundations. In our 2-year interventional fellowship program, one year is devoted to research pursuits and one year is dedicated to clinical ones. Our current fellows are pursuing a wide variety of novel research activities. Many of them collaborate with other investigators in the Cardiovascular Institute. Others are working actively in UPMC's McGowan Institute for Regenerative Medicine, a world renowned organization with expertise in regenerative medicine focused on developing and delivering therapies that reestablish tissue and organ function impaired by disease or congenital abnormalities. Some of the ongoing projects that our fellows are involved in include the following:

  1. Study of safety and efficacy of intramyocardial gene therapy in animal models. Principal Investigators are Drs. Michael Mathier and Barry London.
  2. Investigation of darbopoetin or carbomylated erythropoetin in an animal model of ischemia/reperfusion as a potential adjunctive therapy to improve outcomes in acute coronary syndromes. Principal Investigator is Dr. Peter Counihan.
  3. Investigation of atrial septal defect repair in animal models. Principal Investigators are Drs. William Anderson and Stephen Badylak.
  4. Study of carotid artery replacement with vascular graft material composed of extracellular matrix material in animal models. Principal Investigator is Dr. Stephen Badylak.
  5. Study of right ventricular mechanics and function before and after percutaneous closure of secundum atrial septal defects using tissue Doppler imaging.
  6. The study of drag reducing polymers (DRPs) and their effects on the myocardial blood flow using myocardial contrast echocardiography. This research is being performed in conjunction with Dr. Flordeliza Villanueva and has had provided significant information in coronary microcirculatory flow.

Ongoing Studies in Interventional Cardiology

Advancing the interventional cardiology field is paramount to the mission of the Cardiovascular Institute, and our faculty is at the forefront of many novel areas of cardiovascular medicine. They include the investigation of new devices, the study of mechanisms of cardiovascular disease, and the investigation of new therapies and interventions to treat patients. The following is a partial list of some of current studies being conducted by the Interventional Cardiology Division.

ASD Study - Right Ventricular Mechanics and Function Before and After Percutaneous Transcatheter Closure of Secundum Atrial Septal Defects

PI: William Anderson

The primary goal of this study is to determine the presence and extent of abnormalities in both right ventricular mechanics and function in the adult patient population with secundum atrial septal defects (ASD). The secondary goal of this study is to determine the relationship between these abnormalities in right ventricular function before and after percutaneous transcatheter ASD closure with regards to change in symptoms and functional capacity post procedure.

ATHENA - A Placebo-Controlled, Double-Blind, Parallel Arm Trial to Assess Efficacy of Dronedarone 400mg bid for Prevention of Cardiovascular Hospitalization or Death From Any Cause in Atrial Fibrillation or Atrial Flutter

PI: Peter Counihan

The purpose of this study is to assess the efficacy of dronedarone in preventing cardiovascular hospitalization or death from any cause in a population of high-risk patients with atrial fibrillation/atrial flutter and to assess that dronedarone is well tolerated in this population.

BERLEX - A Multicenter, Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Ad5FGF-4 in Patients with Stable Angina

PI: Joon Sup Lee

This study is on the Follow-Up Only phase. Its objectives include:

  1. To evaluate the short and medium-term effects of Ad5FGF-4 on exercise tolerance and other angina parameters
  2. To evaluate the short-term, medium-term and long-term safety of Ad5FGF-4
  3. To evaluate the dose response of Ad5FGF-4
  4. To evaluate the effects of Ad5FGF-4 on all cause mortality and coronary event (myocardial infarction and myocardial ischemia that results in unplanned hospitalization or revascularization up to one year

DES - D.E.S.cover Registry

PI: Suresh R. Mulukutla

This study is currently in the Follow-Up Only phase. The main objectives for this registry are to assess the following:

  1. Characterize the use of drug-eluting stent (DES) and the outcomes of patients treated with them in the real world
  2. To compare the use of DES among hospitals and practices
  3. To compare DES usage and outcomes to those of balloon angioplasty alone and bare metal stents
  4. To be able to obtain a broad sampling of hospitals and practices that performs angiographic procedures
  5. To obtain important economic, quality of life and clinical information.

EVENT - Evaluation of Drug Eluting Stent Ischemic Events (EVENT) Registry

PI: Conrad Smith

The primary aim of this study is to determine whether the increasing use of drug eluting stents (DES) is associated with an increase in rates of peri-procedural ischemic complications, including myocardial infarction.

Secondary aims of this research include the following:

  1. To determine whether elevations in troponin T or I at 24 hours after percutaneous coronary intervention (PCI) with coronary stent deployment in the combined treatment groups are associated with a higher rate of major adverse events,
  2. To determine how DES are used compared with BMS (bare metal stents)
  3. To determine the unadjusted and risk-adjusted incidence of the combined endpoint of death, new/re-infarction, or urgent target vessel revascularization, and each of the individual components of the combined endpoint during hospitalization, each stratified by administration or lack of administration of a GP IIb-IIIa inhibitor
  4. To characterize temporal changes in the pattern of DES use
  5. To describe patterns of utilization for thienopyridines and temporal changes in these patterns.

Glutol - Evaluation of the Association of Glucose Intolerance-Induced Systemic Inflammation and Diffuse Coronary Atherosclerosis

PI: Oscar C. Marroquin

The objectives of the study include the following:

  1. To assess the relationship between glucose intolerance and plasma levels of pro-inflammatory cytokines (IL-6, TNF-alpha) and nonspecific markers of inflammation (CRP, SAA). We anticipate that the results will demonstrate that glucose intolerance is associated with increased levels of inflammatory markers
  2. To evaluate the hypothesis that plasma levels of pro-inflammatory cytokines (IL-6, TNF-alpha) and nonspecific markers of inflammation (CRP, SAA) correlate with angiographic severity of CAD and atherosclerotic plaque volume as measured by intravascular ultrasound. We anticipate that increased inflammatory markers are associated with greater degrees of atherosclerosis.
  3. To determine whether the association between glucose-intolerance and diffuse coronary atherosclerosis is related to elevated plasma levels of pro-inflammatory cytokines (IL-6, TNF-alpha) and nonspecific markers of inflammation (CRP, SAA). We anticipate that the relationship between glucose intolerance and diffuse coronary atherosclerosis is associated with increased levels of inflammatory markers.

Genetic Blood - Genetic Risk Assessment Of Cardiac Events After PTCA

PI: Conrad Smith

This study is in the Follow-Up Only phase. The study seeks to determine if genetic markers can help to predict the risk of cardiac events after angioplasty. Should the study be positive, it would have important implications in the management and follow-up of future patients undergoing this procedure.

India Study - Subclinical Atherosclerosis In South Asian Populations

PI: Suresh R. Mulukutla

This study is designed to study the following aims:

  1. To determine if Asian Indians, as compared to Caucasian and African-American Americans, have significantly different lipid profiles, especially with regard to the more novel lipid factors, including LDL and HDL subfractionation and lipoprotein(a) analysis
  2. To also determine if there are significant differences among Asian Indians with regard to insulin resistance and markers of platelet-endothelial interactions
  3. To determine if there are significant differences between rural and urban populations within 2 Indian communities with regard to the above-mentioned "novel" risk factors

IVUS - Phase 3 Multi-Center, Double-Blind, Randomized, Parallel Group, Coronary Artery Intravascular Ultrasound Evaluation Of The Anti-Atherosclerotic Efficacy, Safety, And Tolerability Of Fixed Combination CP-529, 414/Atorvastatin, Administered Orally, Once Daily (QD) For 24 Months, Compared With Atorvastatin, In Subjects With Angiographically Documented Coronary Heart Disease

PI: William Anderson

The primary objective of this clinical trial is to demonstrate whether or not the fixed combination CP-529, 414/atorvastatin, titrated to National Cholesterol Education Program (NCEP) Adult Treatment Panel-III (ATP-III) guidelines, can slow the progression of atherosclerosis as measured by the percent change from baseline in atheroma volume, when compared to atorvastatin alone in subjects with angiographically documented CHD, after 24 months of treatment.

Secondary objectives will include:

  1. Assessments of additional measures of atheroma burden from IVUS
  2. Assessments of changes in lipid parameters and biochemical markers of vascular inflammation and insulin resistance
  3. Assessments of safety, including cardiovascular adverse events, and tolerability.

MRI/MI- Assessment Of Myocardial Function And Perfusion By Magnetic Resonance Imaging In Acute Myocardial Infarction

PI: Suresh R. Mulukutla

Specific Aim #1: To demonstrate that regional and global myocardial function and perfusion will be significantly better immediately after PCI in those patients who received a distal protection device during their intervention.

Specific Aim #2: To demonstrate that myocardial function and perfusion will improve to a greater degree and at a faster rate in those patients who received a distal protection device during their intervention.

NHLBI - Dynamic Evaluation of Percutaneous Coronary Intervention - Wave 5

PI: Oscar C. Marroquin

Specific aims:

  1. To evaluate the initial procedural and long-term effectiveness of innovations in catheter-based coronary interventions
  2. To examine potential differences in participant characteristics, disease status, and treatment strategy overall and by gender, race/ethnicity, and socioeconomic status. within and between Waves.
  3. To explore the effects of other participant characteristics, most notably diabetes, on clinical outcome by performing relevant subgroup analyses within and between Waves.
  4. To design and pilot test data collection instruments in a sample of participants from Dynamic Registry clinical sites who will undergo peripheral vascular disease catheter-based interventions.
  5. To coordinate a cost effectiveness analysis of the use of drug-eluting stents in a sample of approximately 150 Wave 4 Dynamic Registry participants.

Periscope - A Double-Blind, Randomized Comparator-Controlled Study in Subjects with Type II Diabetes Mellitus Comparing the Effects of Pioglitazone HCl versus Glimepiride on the Rate of Progression of Atherosclerotic Disease as Measured by Intravascular Ultrasound (PERISCOPE): 01-01-TL-0PI-516

PI: Oscar C. Marroquin

Primary Objective:

To compare the effect of treatment with pioglitazone HCI versus glimepiride on the nominal change in percent atheroma volume of the identified target coronary artery segment in subjects with type 2 diabetes from baseline after 18 months of treatment as measured by intravascular ultrasound (IVUS) imaging of the coronary arteries.

Secondary Objectives:

  1. To compare the effect of pioglitazone HCI versus glimepiride on the occurrence of cardiovascular events as a composite of: cardiovascular mortality, fatal and nonfatal myocardial infarction, fatal and nonfatal stroke, any coronary revascularization, carotid endarterectomy (including carotid stenting) and peripheral vascular intervention
  2. To compare the effect of pioglitazone HCI versus glimepiride on the occurrence of new or exacerbated congestive heart failure (CHF)

Protect Study - WATCHMAN® Left Atrial Appendage System for Embolic Protection in Participants with Atrial Fibrillation

PI: William Anderson

The primary objective of this study is to demonstrate the WATCHMAN implant to be safe and effective in participants with non-valvular paroxysmal, persistent or permanent Atrial Fibrillation (AF) who require anticoagulation therapy for potential thrombus formation and eligible for warfarin therapy. The primary endpoint of this study is Major Adverse Events (MAE) defined as all stroke (ischemic and hemorrhagic), systemic embolism, hard TIA, major bleeding and cardiovascular death.

The secondary objective is to confirm the design and operating specifications of the device with the endpoints for this objective being to report complications associated with the WATCHMAN® system and to confirm location and stability of the device in the left atrial appendage at the 45-day and 6-month follow-up examination through the use of the TEE test and chest x-rays.

Stellar - Prospective Evaluation of the Impact of Stent Deployment Techniques on Clinical Outcomes of Patients treated with the CypherT Stent. The STELLAR Registry PO3-6323

PI: Conrad Smith

The primary endpoint of this study is the incidence of target vessel revascularization at 12 months post-procedure.

The following secondary endpoints will be assessed:

  1. Incidence of geographical miss as defined by the independent angiographic core laboratory
  2. Composite of Major Adverse Cardiac Events (MACE)
  3. Incidence of sub-acute stent thrombosis (SAT)
  4. Incidence of target lesion revascularization (TLR)
  5. Incidence of stent thrombosis 12 months post-procedure
  6. Location of the restenosis obstruction and its relation to the geographic miss area in those patients requiring repeat revascularization procedures.

Stradivarius - Randomized, multicenter, double-blind, placebo-controlled, two-arm parallel group trial of rimonabant 20-mg od, for inhibition of atherosclerosis progression assessed by IVUS (Intra Vascular Ultrasounds), in overweight patients with clustering risk factors - Study Nº EFC5827 - STRADIVARIUS

PI: Oscar C. Marroquin

The primary objective of this study is to evaluate the effect of rimonabant, 20-mg given once daily, in comparison with placebo, on the quantitative progression of coronary atherosclerosis as assessed by IVUS.

The secondary objective of this study is to evaluate the safety and tolerability of the above rimonabant regimen over an 18-month treatment period in the study population of atherosclerotic patients.

Transcendence - A Multicenter, Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Safety of SCH 530348 in Subjects Undergoing Non-Urgent Percutaneous Coronary Intervention (TRANSCENDENCE-PCI)

PI: William Anderson

This study has not begun as yet.

The primary objective is to evaluate the safety of SCH 530348 with respect to the incidence of major and minor bleeding events, as assessed by the TIMI system of classification, in addition to the standard of care in subjects undergoing non-urgent PCI, and as maintenance therapy after the procedure.

Secondary Obejectives will include evaluation of SCH 530348 for the following:

  1. Incidence and tolerability of bleeding
  2. Incidence of "clinically important" bleeding that occurs after discharge from the hospital
  3. Inhibition of platelet aggregation induced by various appropriate agonists, including TRAP as an indicator of the desired pharmacodynamic effect
  4. Incidence of the composite endpoint of death and MACE, ischemia requiring rehospitalization, or coronary revascularization with either CABG or subsequent PCI
  5. Incidence of the individual components of the death/MACE composite, as well as the incidence as cardiovascular death and nonfatal MI, cardiovascular death and stroke and cardiovascular death, nonfatal MI and stroke as measures of potential clinical benefit
  6. Effect on expression of markers of inflammation and of platelet release and activation.

TIME - Pre-Hospital Wireless Transmission of Electrocardiograms to a Cardiologist via a Hand-held Device: The TIME Multicenter Study

PI: Joon Sup Lee

This study is scheduled to start shortly. The primary goals include:

  1. To determine the impact of wireless prehospital ECG transmission to a hand-held computer on reperfusion time, myocardial salvage and clinical outcomes in acute MI patients.
  2. The primary end-point is the time from emergency department entrance time until intervention.
  3. The secondary end-point is Salvaged myocardial tissue