Cleveland Clinic Foundation Heart Center - Print version
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CLINICAL RESEARCH
The clinical research activity of the Department of Thoracic and Cardiovascular Surgery consists of approximately 70 individuals devoted to generation of new knowledge in the treatment of thoracic and cardiovascular diseases. The activity is divided somewhat arbitrarily into those related to observational clinical studies (including translational research from basic science to clinical relevance) and those related to clinical trials. At any given time, approximately 200 projects are in various stages of activity. Clinical studies (CS) utilize retrospective and prospective data that is specially gathered on groups of patients undergoing treatment. Short- and long-range patient outcomes are related to patient, disease, and treatment factors. These studies utilize data registries, such as the Cardiovascular Information Registry (CVIR), that contain patient and follow-up data on over 200,000 patients Clinical trials (CT), in contrast, are studies of specific patient groups enrolled in trials of new treatment modalities, such as devices and medicines. Many are multi-site, industry-sponsored trials. The trials are often randomized to make the most reliable comparisons. The research group is a multidisciplinary one that combines expertise and clinical knowledge, information and data analysis technology, data gathering, and the surgical experience of the investigators that include staff, clinical fellows, full-time research fellows, residents, and nurses. The full-time research fellows may elect to participate in a two-year didactic program leading to a Master’s degree. Each resident is involved in a project that leads to a presentation on Residents’ Day. The individuals in these clinical research activities are directed by Dr. Eugene Blackstone. In late 1997, he was recruited from an endowed professorial position at the University of Alabama at Birmingham to lead the cardiovascular surgery clinical research program. He is also a full staff member of the Department of Biostatistics and Epidemiology. His long association as a full-time professional investigator with Dr. John Kirklin has equipped him for this leadership role. He was one of the founders of the field of digital signal processing, is considered a leader in the molecular biology of cardiopulmonary bypass and biocompatibility, and has developed biomathematical models of time-related risks that are used for multivariable modeling of time-related data. METHODOLOGIC RESEARCH In addition to data gathering, analyses pertaining to specific topics, reporting activities, manuscript and presentation preparation, methodologic research is also prominent. This includes further development of Hazard Function Technology embodied as a powerful software package. This package was developed originally by Dr. Blackstone’s group at the University of Alabama at Birmingham and now being maintained and expanded at The Cleveland Clinic Foundation. It is useful for assessment of risk factors for time-related events. Current Cardiovascular Surgery Research The Cleveland Clinic Foundation (CCF) is a not-for-profit, multi-specialty academic medical center that integrates clinical and hospital care with research and education. The founders of the Cleveland Clinic believed research and education were the cornerstones of excellence in patient care. The Cleveland Clinic Foundation puts patients first through improved outcomes, better services and providing a healthier future for all. Based on these guiding principles, you may be approached for participation in research studies during your visit to CCF. Participation in any research is completely voluntary. Your desire not to participate will not affect your care or treatment in any way. If a patient/family has a desire to be involved in a particular research study, they should tell their physician about the interest. The physician will be able to direct the patient and family to a study that is suitable for their particular condition. Below are summaries of ongoing research projects. There are other projects that are not listed due to having stringent criteria for admission to the research study. Ischemic Heart Disease CS: Coronary Artery Bypass Grafting in Patients Having a Variety of Other Important Diseases (Comorbidities) We are studying the long-term fate of patients who have had coronary bypass grafting with accompanying diabetes, radiation therapy and neurologic complications, and mild aortic valve disease. We are also studying effects of cardiopulmonary bypass, atrial fibrillation, and outcomes of tracheostomy. Physicians: Delos Cosgrove MD, Michael K. Banbury MD, A. Marc Gillinov MD, Bruce W. Lytle MD, Joseph Sabik MD, Nicholas G. Smedira MD CS: Surgical Coronary Venous Bypass Grafting (Pilot Study) This study will evaluate the safety and feasibility of Coronary Venous Bypass Grafting as an alternative to medical management for patients with an ischemic region of myocardium that is not amenable to conventional revascularization methods. Patients eligible for this study are those that have viable myocardium in the area of the RCA that can not be grafted. Physician: A. Marc Gillinov MD is Primary Investigator, the rest of cardiothoracic surgery staff are co-investigators. CS: Ischemic Mitral Regurgitation Following some heart attacks, the one-way valve between the left ventricle (main pumping chamber) and its receiving chamber (the left atrium), called the mitral valve, becomes leaky (regurgitation). This may be caused by disruption of the apparatus that normally tethers the valve. It may come from dysfunction of the heart muscle or dilation of the heart. Currently, it is not known which of these valves should be repaired and which should be replaced. In the largest study of its kind to-date, we are ascertaining the durability of repair, possible survival advantage in some patients of valve repair vs. replacement, and the mechanism of regurgitation on the basis of three-dimensional echocardiography. Physician: A. Marc Gillinov MD CS: Minimally Invasive Coronary Artery Surgery We are investigating the possible benefits of less invasive operations for treatment of coronary artery disease. This includes studying the possible beneficial effects of off-pump bypass, differing approaches for reoperation, and other minimally invasive approaches. Physicians: Joseph Sabik MD, A. Marc Gillinov MD, Gosta B. Pettersson MD, Jose L. Navia MD CS: Ventricular PseudoaneurysmWe are studying the outcomes over time of pseudoaneurysm in the left ventricle (small or large area of scarred muscle that becomes thin and out-pouches [like a balloon] with each heartbeat). Physician: Jose L. Navia MD CS: Post Infarction Ventricular Septal Defect A particularly devastating complication of a heart attack is a hole developing between the pumping chambers (postinfarction ventricular septal defect). Over the last 20 years, there has been considerable improvement in results of surgery for postinfarction ventricular septal defect. This difficult and life-threatening condition requires urgent surgery. Analysis of our extensive experience with patients experiencing this event guides current operative strategy. Physicians: A. Marc Gillinov MD CS: Radial artery Bypass Grafts Radial artery grafts are being used for conduits in place of leg veins. These arteries are not as protected from developing their own disease, as is the internal thoracic artery, pioneered by The Cleveland Clinic Foundation. The long-term fate of these grafts is being studied. Physician: Gosta B. Pettersson MD Surgery for Heart Failure CS: Cleveland Clinic Experience in Coronary Artery Bypass Graft plus/minus Mitral Valve Repair and plus/minus Left Ventricular Reconstruction Surgery A retrospective investigation of outcomes of patients after heart attack (myocardial infarction) with systolic heart failure having the above procedures (alone or in combination) to determine if there is a difference in survival and the need for future reoperation or cardiac transplantation among the groups. We hope to learn the optimum method of treating patients with heart failure after myocardial infarction. Physicians: Nicholas G. Smedira MD, Michael Banbury MD, Jose Navia, MD CT: Clinical Investigation of the DeBakey LVAD with Comparison to Performance Goal to Establish Safety and Effectiveness of the Device as Left Ventricular Support in Patients Awaiting Cardiac Transplantation This study will determine the effectiveness and safety of the DeBakey VAD ® in providing circulatory support, as a bridge to transplant, in patients who are awaiting heart transplant. The device, an axial flow pump, provides ventricular assistance using a small, lightweight, and mechanically simple design. Primary Investigator: Nicholas Smedira, M.D. CT: The Evaluation of the HeartMate II LVAS For Use as a Bridge To Transplant and for Destination Therapy in Patients Not Eligible for Heart Transplant The purpose of this multicenter feasibility study is to evaluate the preliminary safety and potential effectiveness of the HeartMate II LVAS device in patients with end-stage heart failure in patients not eligible for heart transplant. Primary Investigator: Nicholas Smedira, M.D. CT: Randomized Clinical Trial of the Safety and Efficacy of the DeBakey VAD® as a Destination Therapy in Patients with End-Stage Heart Failure Cardiac transplantation is the established treatment for patients with end-stage heart failure. Many patients are not candidates for cardiac transplantation. The other alternative to transplantation in this population is mechanical circulatory support. A clinical trial is underway to evaluate the safety and efficacy of the DeBakey VAD® device in providing long-term circulatory support for patients who have NYHA Class IV heart failure and who are not eligible for transplant. Participants will randomly receive either a Debakey VAD® or a HeartMate® XVE LVAD (TC). Primary Investigator: Nicholas Smedira, M.D. CT: A Pivotal, Randomized, Controlled Study to Evaluate the Safety and Effectiveness of the Novacor ® Left Ventricular Assist System ( LVAS) for Patients Who Are Not Eligible for Cardiac Transplantation This study is designed to evaluate the Novacor LVAS to determine safety and effectiveness in patients who are not eligible for cardiac transplantation. Participants must be NYHA Class IV, have end-stage LVF, have received optimal medical therapy for at least 60 of last 90 days, have a life expectance of less that two years, and not eligible for cardiac transplant. Primary Investigator: Nicholas Smedira, M.D. CT: phVEGF 165 Gene Transfer to Promote Angiogenesis in Patients with Advanced Heart Failure Patients who have advanced congestive heart failure (CHF) secondary to idiopathic dilated cardiomyopathy may be eligible for enrollment in a single-center, phase I, double-blind, placebo-controlled, dose escalating study of Intra-Myocardial phVEGF165 Gene transfer. The study will be conducted on 2 groups of participants, those with ischemic and those with non-ischemic heart failure. Primary Investigator Investigator: Nicholas Smedira, M.D. CT: A Prospective , Multi-Center, Randomized, Placebo-Controlled Trial to Assess the Effects of Nitric Oxide for Inhalation during LVAD Implantation This trial will attempt to safely demonstrate if patients undergoing LVAD placement may benefit from treatment with nitric oxide. Primary Investigator: John Pierre Yared M.D. CT: Minimally invasive approaches to lead placement for cardiac resynchronization therapy (CRT) with biventricular pacing CRT leads are usually placed in the heart by an electrophysiologist during a procedure that involves conscious sedation. However, some patients cannot have their left ventricular lead placed in this usual manner due to coronary anatomy or other conditions. The left ventricular lead can be surgically placed in the proper position epicardially (on the outer surface of the heart). This is performed during a routine heart surgery procedure or it can also be performed using small keyhole thoracotomy incisions or through robot-assisted surgery. We are investigating the various approaches to placing the left lateral CRT lead and reviewing clinical outcomes associated with this methodology. Primary Investigator Investigator(s): Nicholas Smedira, M.D., Jose Navia, M.D. CT: Surgical Treatment for Ischemic Heart Failure (STICH) This is a multi-center, international study for patients with coronary artery disease and heart failure. Patients are randomized within three arms of the study based on their condition. Primary Investigator(s): Nicholas Smedira, M.D., Randall Starling, M.D. For more information on heart failure research:go to: Arrhythmia Surgery The heart has its own system of specialized cells that generate the heartbeat conducted to all parts of the heart. Sometimes, for either well-known reasons or less well understood reasons, the heartbeat (rhythm) becomes abnormal. Most disturbances of heart rhythm are managed by various types of artificial pacemakers or devices that can supply electrical energy to the heart to keep it beating. Occasionally, surgery is needed to eliminate the abnormal rhythm. CS: Maze Procedure for Atrial Fibrillation Long-term follow-up of the Maze operation for patients with chronic atrial fibrillation or symptomatic paroxysmal atrial fibrillation has recently been completed. Studies indicate over 90% of patients have been returned to sinus rhythm and there have been no embolic events (blood clots let loose) in follow-up with the clinical experience approaching 200 patients. Ongoing studies are investigating late clinical events. Physician: A. Marc Gillinov, MD CT: Surgical Treatment of Atrial Fibrillation Surgery to eliminate atrial fibrillation has been augmented by the development of new ablation methods. In addition to the conventional method of surgical incisions (maze procedure) , microwaves, radiofrequency waves and cryo-ablation are now available. All of these methods are currently used for specific patient populations. The AtriCure Bipolar Coagulation System has 510K approval from the FDA for soft tissue coagulation. This system coagulates the soft tissue and provides feedback on the electrical property and temperature of the tissues being ablated. A clinical trial is currently evaluating efficacy and safety: Physicians: A. Marc Gillinov, MD Click here to learn more about atrial fibrillation research Valve Surgery The heart contains four one-way valves that make blood flow move in one direction ("forward") when the heart beats. These valves can become leaky, or infected, or partially closed by various disease processes. Ideally, the valve can be repaired. If not, it must be replaced. We are interested in knowing the durability of repair and whether or not it is possible, what device is best in the long-term if it cannot be repaired, and what the consequences are in the long-term of valve repair and replacement. CS: Tricuspid Valve Repair Traditionally the tricuspid valve has been replaced rather than repaired. The durability of tricuspid valve repair, using an annulopasty system, is being tested. Physicians: Joseph Sabik, MD and A. Marc Gillinov, MD CS: Simultaneous Aortic and Mitral Valve Disease Recent data from our institution reveals that patients with combined aortic and mitral valve disease are best served by aortic valve replacement and mitral valve repair rather than double valve replacement. Continued analysis of these patients will help to guide clinical decision making in patients with combined aortic and mitral valve disease. Physician: A. Marc Gillinov, MD CS: Mitral Valve Repair for Rheumatic Heart Disease There is controversy as to the appropriate treatment for patients with rheumatic mitral valve disease with some surgeons advocating repair rather than replacement. Current studies seek to identify the relative merits of mitral valve repair versus replacement in this patient group. Physician: A. Marc Gillinov, MD CS: Aortic Valve Devices Several studies of various replacement devices for the aortic valve (the valve that separates the left ventricle from the aorta) are being conducted to determine not only their long-term outcome, but also to match the right valve to the right patient. Physicians: Eugene H. Blackstone MD, Delos M. Cosgrove MD CS: Ross procedure (pulmonary autograft aortic valve and root replacement) follow-up A follow-up study of the Ross operation performed by a single surgeon at the CCF has been performed. Clinical follow up revealed occurrence of early autograft valve regurgitation and stenosis of the pulmonary allograft. An echocardiographic follow-up is being performed to study pre-, peri- and postoperative factors associated with failure as well as the mode of failure. The Ross operation is presently offered to selected patient with aortic valve disease below the age of 40-50 years. The selection criteria for the Ross operation as well as the surgical technique have been modified. These patients have been entered into a prospective follow up study of clinical outcome and autograft and allograft function. Physicians: Delos Cosgrove MD, Gosta Pettersson MD, Eugene Blackstone MD CS: Aortic Allograft Study Cryopreserved human aortic valves (homografts or allografts) provide optimal hemodynamics while avoiding the need for anticoagulation. The valve's durability needs to be defined. To accomplish this, the 5-10 year freedom from valve-related complications and valve failure in over 500 patients is being evaluated. Physicians: Delos Cosgrove MD, Gosta Pettersson MD CT: New Aortic Bioprosthetic Valve To increase the options available for patients who require aortic valve replacement, a multicenter trial is being conducted to evaluate the safety and efficacy of a new Aortic Stentless Equine Pericardial Bioprosthesic valve. Physicians: Gosta Pettersson, MD, Michael Banbury, MD, Jose Navia, MD, Nicholas Smedira, MD Thoracic Aorta The aorta is the main artery that conducts blood from the left ventricle (main pumping chamber) to the body. It may become enlarged and this is called an aneurysm. Its layers may become separated and this is called a dissection. CS: Ascending Aortic Aneurysms and Dissections We are studying the long-term fate of patients whose ascending aortic aneurysms or dissections have been repaired. More so than at other centers, each operation is tailored to the specific pathology of the aorta, resulting in a number of variations of the repair. These variations are being studied as to their long-term durability and effectiveness. Physician: Joseph Sabik MD CT: Brain Protection During Aortic Arch Replacement Physicians: Lars Svensson MD and Bruce Lytle, MD COMPLICATIONS OF HEART SURGERY No treatment of heart disease is without complications. Thus, a goal of cardiac surgeons at The Cleveland Clinic Foundation is to reduce these complications to a minimum. CT: A Study Comparing Angiomax® (bivalirudin) to Heparin with Protamine Reversal in Patients Undergoing On-Pump Coronary Artery Bypass The purpose of this study is to demonstrate that Angiomax is a safe and effective alternative to heparin in patients undergoing cardiac surgery on coronary artery bypass. Physicians: Nicholas Smedira, MD For a list of recently published articles by our staff:
Copies of publications can be obtained from the National Library of Medicine PubMed or ask your local librarian for assistance. 9/07 revised |
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Original article: http://www.clevelandclinic.org/heartcenter/pub/research/research/cardiothoracic_surgery.asp
This information is provided for education purposes only and is not intended to replace the medical advice of your doctor or health care provider. Please consult your health care provider for advice about a specific medical condition or contact the Cleveland Clinic if you would like an appointment.
