FDA approval expected for CCM in heart failure patients

Mitchel L. Zoler/MDedge News

“The investigators are to be complimented for their meticulous measure of exercise. This truly was a well-done trial with an exercise endpoint,” commented designated discussant for the new report Lynne W. Stevenson, MD, a professor of medicine and an advanced heart failure specialist at Vanderbilt University in Nashville, Tenn.

In summing up the trial’s results, Dr. Stevenson noted that “the safety endpoint was met, the primary endpoint and other functional endpoints were met, and functional endpoints are of vital importance to patients. The CCM story is not yet the CRT story,” with CRT having produced even larger effects in its pivotal trial, also led by Dr. Abraham (New Engl J Med. 2002 June 13;346[24]:1845-53), cautioned Dr. Stevenson. But in general she put a positive spin on the CCM device, saying that it “has ingenuity and innovation, and we look forward to a better understanding of which patients benefit from CCM and what we can tell them about the magnitude and duration of the benefit.”

Mitchel L. Zoler/MDedge News

“With CRT, we have a patient phenotype to treat that makes sense – patients with a very wide QRS duration, and [CRT] has stood the test of time. Is CCM truly additive, and does it provide a benefit that nothing else can give you?” asked Clyde Yancy, MD, professor and chief of cardiology at Northwestern University in Chicago. “We can’t give every patient everything. We need to figure out who are the right patients” for CCM treatment, Dr. Yancy said in an interview.

The FIX-HF-5C trial was sponsored by Impulse Dynamics, the company developing the CCM Optimizer device. Dr. Abraham has been a consultant to Impulse Dynamics, as well as to Abbott Vascular, Medtronic, Novartis, and St. Jude Medical. Dr. Singh has been a consultant to Biotronik, Boston Scientific, Liva Nova, Medtronic, and St. Jude. Dr. Stevenson has received research funding from Abbott and Novartis. Dr. Yancy had no disclosures.