URMC Heart Researchers Launch $27M ICD Study

Heart researchers at University of Rochester Medical Center (URMC) will launch a $27 million study that may substantially decrease the use of implantable cardioverter defibrillators (ICD) for patients with heart failure, because of advances in medical therapies.

“Our current analysis suggests that at least 50 percent of the patients who receive an ICD today do not derive a survival benefit from it,” said Ilan Goldenberg, MD, who is leading the North American study. “I believe the whole paradigm of heart failure treatment will change.”

This funding, from the Patient-Centered Outcomes Research Institute (PCORI), will support Rochester scientists conducting a head-to-head comparison of patient outcomes using medications alone or with an ICD.

“This study has the potential to fill an important evidence gap relevant to a range of health care decision-makers and help them better assess their care options,” said PCORI Executive Director Nakela L. Cook, MD, MPH. “We look forward to following the study’s progress and working with URMC to share its results.”

“This funding underscores URMC’s pivotal role in reshaping cardiac care standards through innovative research,” said David C. Linehan, MD, URMC CEO and dean of the School of Medicine and Dentistry. “It speaks to our strength as a research institution and our history of powerful work in the field of cardiac care. Our clinician-scientists’ commitment to advancing scientific understanding to improve patients’ lives is an inspiration for the entire community.”

ICDs are standard therapy for the treatment of deadly arrhythmias, which can cause cardiac arrest.  

Goldenberg, director of the Clinical Cardiovascular Research Center at URMC, hopes this study will result in a change in practice guidelines to provide physicians greater autonomy in selection for device therapy. “This study aims to improve the quality of life for people with heart failure by saving them from unnecessary procedures,” he said.  

“Our internationally recognized heart research team is tackling some of the big questions that impact how we practice medicine, and the care patients will receive tomorrow,” said Spencer Z. Rosero, MD, chief of Cardiology.

Goldenberg outlined four medical therapies that have made strides for heart failure patients: beta-blockers, two medications that improve heart function and reduce blood pressure, and a new class of diabetes drug that reduces fluid retention, a symptom that plagues many patients with heart failure.  

When patients receive a personalized and optimized regimen of these drug therapies, he suggests they are less likely to require an ICD. Contemporary data shows that of all patients with an ICD, only 1 percent of them receive appropriate device shocks per year.

More than 3,000 patients will be enrolled in the study at 115 sites across the U.S. and Canada. URMC expects to enroll participants, in addition to performing analysis of all data.

“Sometimes we have these clinical quandaries where our personal observation of the patient says they might not benefit from an ICD, but as clinicians, we feel we can’t go against guidelines,” said David Huang, MD, director of Cardiac Electrophysiology at URMC, which implants more than 300 ICDs a year.

“This study will likely provide much-needed data that could potentially result in a change in the guidelines for ICD use, and greater opportunity to make informed decisions about whether our patient truly needs the device,” Huang said, “From medical, physical, emotional, and psychological standpoints, it would be a great relief for patients who may not have a lifelong device implanted in their bodies.”

Global Leaders

URMC has a long history of leadership in heart rhythm research. Internationally renowned scientist, the late Arthur J Moss, MD, completed groundbreaking research that led to the existing ICD guidelines. Moss was at the forefront of research into sudden cardiac death, Long QT Syndrome, arrhythmias, and implantable devices.

“That was more than 20 years ago, and it’s time to address their use in today’s clinical practices, which include more therapies than ever before,” said Goldenberg, principal investigator for the clinical coordinating center.

In the early 1990s, Moss led the landmark MADIT trials (Multicenter Automatic Defibrillator Implantation Trial), demonstrating the significant risk reduction of sudden death with ICDs in patients following a heart attack.

This led to setting ICD guidelines worldwide in the early 2000s. The MADIT family of trials continued to explore the effectiveness of heart devices and other cardiac therapies. The 2012 MADIT-RIT trial explored the optimization of device use, starting the conversation about reducing unnecessary therapies (but not yet changing those guidelines). 

Several URMC researchers join Goldenberg in the study: Wojciech Zareba, MD, PhD, and Robert Strawderman, ScD are principal and co-principal investigators for the data coordinating center; Valentina Kutyifa, MD, PhD, co-chair of the recruitment and retention core; Leway Chen, MD, MPH, chair of the cardiovascular and death events adjudication core; David Huang, MD, chair of the arrhythmia and ICD events adjudication core; Christopher Beck, MA, PhD, co-chair of the statistical core; with support from the Biostatistics team.

The Rochester team is working with scientists across the country and in Canada, including: co-PI Javed Butler, MD, MPH, MBA, from Baim Institute for Clinical Research, Samuel Sears, Jr, PhD, from East Carolina University, Christine Albert, MD, from Cedars Sinai Medical Center, Eileen Hsich, MD, from Cleveland Clinic, and Justin Ezekowitz, MBBCh, MSc, from University of Alberta.

URMC is collaborating with global institutions that contribute to the development of practice guidelines, such as the Heart Rhythm Society, the American Heart Association, Women Heart, and the Association of Black Cardiologists. The study also received global support and endorsement from the European Heart Rhythm Society, and the European Heart Failure Society.

U.S. Senator Charles Schumer said, “This $27 million federal investment will not only bolster Rochester and it’s world-class workforce as a leading center in health care research, but promises to advance clinical care practices across the health care field to save lives and improve patient outcomes for patients and families dealing with cardiovascular disease.” 

“Today’s announcement further cements URMC’s position as a national leader in medical research,” said Congressman Joe Morelle. “This award will help ensure patients in our community and around the world are receiving the best cardiovascular care possible by strengthening treatment and diagnostic methods. I’m grateful to URMC for all they do to deliver quality health care, and I look forward to our continued work together to improve patient outcomes and support the future of medicine.”

*This award has been approved pending completion of a business and programmatic review by PCORI staff and issuance of a formal award contract.