Study Raises Questions About Heart Devices

A new meta-analysis by a physician research team from University Hospitals (UH) Case Medical Center and Case Western Reserve University School of Medicine, reveals that certain <"">pacemakers implanted in heart failure patients were of no help to 40 percent of those implanted, said Science Daily. The report appears in the Archives of Internal Medicine.

“These findings have significant clinical implications and impact tens of thousands of patients in the U.S.,” said Ilke Sipahi, MD, Associate Director of Heart Failure and Transplantation at UH Case Medical Center and Assistant Professor at Case Western Reserve University School of Medicine, quoted Science Daily. “In this in-depth analysis, we found that pacemaker patients with less severe electrical disturbance in their hearts did not receive any benefit whatsoever from these expensive and potentially risky implants. Given the abundance of data showing lack of efficacy in this patient population, current treatment guidelines should be changed,” added Sipahi, MD.

Cardiac resynchronization therapy (CRT)—also known as biventricular pacing—the treatment involved, was reviewed by both Sipahi, MD and James Fang, MD, Director, Clinical Cardiovascular Services at UH Case Medical Center and Professor at Case Western Reserve University School of Medicine.

This “highly sophisticated treatment,” said Science Daily, is meant to correct disorders between the electrical synchronization of the heart’s left and right ventricles, added The Wall Street Journal. Congestive heart failure patients suffering from impaired cardiac synchronicity experienced minimized heart efficacy and reduced strength.

The meta-analysis looked at five randomized CRT studies, involved about 6,000 patients, and reviewed prevailing medical criteria and patient selection, explained Science Daily. “CRT with current devices doesn’t help patients with a QRS below 150,” Dr. Sipahi added, quoted The Journal.

Generally, these devices are sanctioned for people suffering from the symptoms of heart failure because of weakened heart muscles and that very specifically show with a QRS prolongation of more than 0.12 seconds (120 milliseconds) on an electrocardiogram (EKG) test, said Science Daily. The new data proves these devices to not provide increased benefits or reduced hospitalizations when their QRS is prolonged to more than 0.15 seconds, significantly greater than the suggested guideline of 0.12 seconds, noted Science Daily.

“This study can have profound impact on minimizing unnecessary procedures” added Dr. Sipahi. “Revising the criteria for implantation of these devices will help avoid thousands of unnecessary implants and will also lead to cutting down on unwarranted costs,” he added. “This study may help to better select patients who are most likely to benefit from this effective but costly procedure,” said Fang, quoted Science Daily.

At a price tag of $25,000 per CRT and implanted in about 60,000 patients annually, the high-cost treatment comes with high risks, noted The Wall Street Journal.

In an accompanying editorial, Lynne Warner Stevenson, a heart-failure expert at Brigham and Women’s Hospital in Boston, wrote that the new analysis challenges “us to re-evaluate our approach to CRT,” quoted the Journal, which noted that Medtronic Inc., Boston Scientific Corp., and St. Jude Medical Inc. are three of the key makers of CRT devices.

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