Multicenter Automatic Defibrillator Implantation Trial II

Since 1997 cardiologists at Deborah Heart and Lung Center have been participating in an exciting research project which involves 80 clinical centers worldwide. MADIT II (Multicenter Automatic Defibrillator Implantation Trial) is the second phase of a randomized, FDA-approved trial examining the use of ICDs (Implantable Cardioverter Defibrillators) in high-risk coronary artery disease patients with advanced left ventricular dysfunction or ventricular tachycardia. According to Raffaele Corbisiero, MD, Attending Electrophysiologist at Deborah Heart and Lung Center, "The study is designed to determine if prophylactic ICD therapy will improve survival and reduce mortality in the high-risk population above or sudden cardiac death (SCD)." It is estimated that 50 percent of the deaths in patients with advanced LV dysfunction is due to ventricular fibrillation (VF) - the survival rate is only five percent for the first cardiac episode. The MADIT II trial recognizes that in patients who have a history of severe heart rhythm problems and have had prior events, the likelihood of it happening again is very high.

The original MADIT I trial started in 1994, justified the efficacy of ICDs to save lives in a high-risk population. It was found that the ICD group had a 54 percent better survival rate over the group treated medically. An extension of this groundbreaking study is the MADIT II trial, which broadens the earlier MADIT I research by acknowledging that a large population of patients who have a history of severe left ventricular dysfunction and are at great risk for ventricular arrhythmias, is not accounted for and/or identified, and should be treated before sudden cardiac death occurs.

Sudden cardiac death remains a major unresolved public health problem in the US and throughout the world. An estimated 450,000 Americans succumb to sudden cardiac death annually. Ventricular tachyarrythmias account for 80-90 percent of these deaths and without treatment, VF can cause the heart to stop and deplete the brain and body tissue of oxygen-rich blood resulting in damage or possible death.

The MADIT II trial is an example of preventative medicine that has the potential to help a large population of high risk patients that, to date, nothing can be done for. As the MADIT II Trial is ongoing, no conclusive findings have been reported as of yet. However, if the trial proves the success of ICDs, all high-risk patients will be identified and will receive ICDs as a preventive measure.

Clinical Research Continues at Deborah

It is of vital importance to conduct clinical research studies so that improvements may be made on existing techniques, medical devices and procedures which will have even more favorable, long-term results for the patients as well as for national replication. To be a leader in modern medicine, it is essential to search for new and effective ways to diagnose and treat patients. Deborah is confident that information gathered through clinical research will provide the basis for new treatment options for patients, as well as help to establish the standards for the medical community.

"Research is integral to accomplishing the Center's mission of delivering the highest quality inpatient and outpatient services for the diagnosis and treatment of cardiovascular and pulmonary disease within our service area," said Lynn B. McGrath, MD, Vice President of Medical Affairs and Chair, Department of Surgery, Deborah Heart and Lung Center. "Research is important both directly and indirectly. Directly, patients with cardiac or lung disease benefit from participation in cutting-edge technological advances, improved phamacologic therapies and developments in nonsurgical interventional strategies." Dr. McGrath continued, "Patients indirectly benefit from the Center-wide support for applied research through its impact on physician recruitment and retention. Many of the highest quality physicians expect the opportunity to participate in multi-center clinical trials, have the ability to offer cutting-edge therapeutic modalities to their patients and pursue individual clinical research interests."

With over 40 research investigations currently in progress at the Center, Deborah's physician staff is contributing heavily to the body of science surrounding cardiac, pulmonary and vascular care. According to Dr. McGrath, Deborah's Department of Surgery participates in the database for the Society of Thoracic Surgery; this database serves as a professional benchmark for prevailing standards of care, and is a resource to the Healthcare Financing Administration in establishing standard of care expectations.

More than one-third of the physician staff in the Center's Department of Cardiology is connected to at least one research investigation. Members of the Department of Cardiology are heavily involved in both single- and multi-center clinical trials. Because Deborah's physicians are active in the clinical research arena, our patients are able to garner the maximum benefit from the latest technology and treatments available.

The majority of research projects conducted at Deborah Heart and Lung Center are multi-center clinical trials, investigating benefits of new drugs, devices or procedures. Many are industry sponsored; some are partially or entirely underwritten by a combination of grants from the National Institute of Health (NIH) and organizations like the American Heart Association, while others receive family, organizational or corporate funding through Deborah Hospital Foundation.

Whether single- or multi-center, all patient-related investigations conducted at Deborah Heart and Lung Center are governed by Deborah's Institutional Review Board (IRB). Deborah's IRB was established in the early 1970s, and functions as an arm of the Federal Government's Food and Drug Administration (FDA). The IRB, chaired by Betsy Schloo, MD, Chair, Department of Pathology, Deborah Heart and Lung Center, regularly monitors all aspects of Deborah research investigations, and operates with the primary goals of patient information and safety.

"The IRB was established to ensure that all patient safety and ethical guidelines are met during clinical research at Deborah," said Dr. Schloo. "As a committee, the members govern the projects to protect the rights and welfare of the patients who have volunteered to be a part of the research investigation, in accordance with the Belmont Report, Declaration of Helsinki, American Medical Association Principles of Ethics, Hippocratic Oath and all other established principles of medical ethics."

"As a Deborah Heart and Lung Center physician and Chairman of the Center's IRB, I believe the benefits of clinical research are numerous, for both the institution and its patients," said Dr. Schloo.

"Not only are Deborah physicians able to immediately offer new treatments to patients, but they are also directly involved in setting the standards for the use of these new drugs, devices and procedures. Patients treated at Deborah Heart and Lung Center should feel confident that they are receiving the most advanced treatments available, and that those treatments are administered by high-quality physicians heavily involved in the advancement of heart, lung anad vascular care."

Lynn B. McGrath, MD., Vice President of Medical Affairs and Chair, Department of Surgery