Advanced heart disease trials and studies at Brigham and Women’s Hospital include new ventricular assist devices, medical therapy for diastolic heart failure, and strategies to prevent advanced heart disease.
Directed by Kenneth L. Baughman, MD, the Advanced Heart Disease Program – part of the Cardiovascular Center – is comprised of a multidisciplinary team of leading specialists dedicated to the care of patients with congestive heart failure and other severe cardiac conditions. Tailoring therapy. The Program offers a full complement of therapeutic modalities including optimization of medications and exercise prescription; implantable devices such as pacemakers, implantable cardiac defibrillators (ICDs), and biventricular pacing; percutaneous valve therapies; high-risk revascularization, valve repair, and ventricular reconstruction; mechanical circulatory support; and cardiac transplantation. Lynne Warner Stevenson, MD, Co-Director of BWH’s Cardiomyopathy and Heart Failure Program, says, “Our goals are to understand and treat each patient as a unique individual. Our first priority is to relieve symptoms for those suffering from heart failure. Looking to the future, we tailor therapy to achieve the best function for each heart, and to help our patients perform and enjoy those activities that are most important to them for quality-of-life.”
Promising trials. In addition to conventional therapies, patients have the opportunity to participate in clinical trials of new medications and innovative strategies for managing advanced heart disease. • CHRONICLE – Dr. Stevenson is principal investigator at BWH for the trials assessing the efficacy of an implantable hemodynamic monitor (the CHRONICLE) that can be linked to an ICD. Information from inside the heart can be downlinked from home by telephone to the heart failure team. This information provides an early warning system of changes in time to adjust medications to prevent hospitalizations. Dr. Stevenson observes, “This strategy has the potential to revolutionize the management of heart failure outside the hospital.”
Jarvik 2000 Heart Assist System – Gregory S. Couper, MD, and James Fang, MD, are directing this trial assessing a new ventricular assist device (VAD) that is quieter, smaller, and more durable compared with older generation VADs. Patients with end-stage congestive heart failure who are failing medical therapy and considered appropriate candidates for cardiac transplantation may qualify for this clinical trial.
TOPCAT – For patients with diastolic heart failure, this National Heart, Lung, and Blood Institute (NHLBI) – sponsored, international multicenter trial is testing the efficacy of an aldosterone antagonist in the treatment of heart failure patients with preserved ejection fraction. Patients 50 years of age or younger with a left ventricular ejection fraction of less than or equal to 45 percent and signs and symptoms of heart failure with either a heart failure hospitalization in the past 12 months or elevated brain natriuretic peptide levels are eligible for the study. TOPCAT is led internationally by Marc A. Pfeffer, MD, PhD, and locally at Brigham and Women’s Hospital by Dr. Fang, along with Brigham and Women’s Hospital specialists Eldrin F. Lewis, MD, MPH, Scott D. Solomon, MD, and Akshay S. Desai, MD. This trial is only the second major Cardiovascular Center: Innovative Trials and Screening for Patients with Advanced Heart Disease The compact size of the Jarvik 2000 FlowMaker® device (left) is beneficial for patients, including many women with advanced heart disease, whose body size is too small to qualify for the currently approved devices (right).
Advanced heart disease trials and studies at Brigham and Women’s Hospital include new ventricular assist devices, medical therapy for diastolic heart failure, and strategies to prevent advanced heart disease trial that has offered a medical therapeutic option for patients with diastolic heart failure;
HF-ACTION (Heart Failure – A Controlled Trial Investigating Outcomes of Exercise Training) – Sponsored by the NHLBI, this randomized, controlled, multicenter trial is designed to evaluate the impact of exercise on patients with heart failure, including its effects on mortality, morbidity, hospitalizations, and overall quality-of-life. Class II, III, and IV systolic heart failure patients with ejection fraction less than or equal to 35 percent may qualify for participation in this trial, which is overseen locally in three locations by Brigham and Women’s Hospital specialist Daniel E. Forman, MD. (For more information, call 617-525-7638 or visit www.hfaction.org).
Indications for Referral
Patients with the following conditions may be referred to the Advanced Heart Disease Program:
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New onset cardiomyopathy for evaluation and therapy;
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Asymptomatic ventricular dysfunction;
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Symptoms of heart failure with depressed or normal ventricular systolic function;
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Evaluation for advanced pacing and defibrillation devices, in conjunction with the Electrophysiology Program;
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Evaluation for cardiac transplantation or ventricular assist devices;
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Evaluation for high-risk cardiac surgery in the presence
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of depressed left ventricular function (in conjunction with the Division of Cardiac Surgery);
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Other severe, life-threatening cardiac conditions.
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