C-Pulse Heart Assist Device Improved Ventricular Remodeling, HF Symptoms

SAN FRANCISCO, CALIF.—Results from a prospective feasibility study demonstrate that the C-Pulse Heart Assist System is both safe and effective in patients with moderate to severe heart failure.

The device, which is a non-blood contacting extra-aortic counterpulsation system, was associated with improved NYHA class and ventricular remodeling, as evidenced by improved LVEF.

At baseline, the 20 patients enrolled in the study were in NYHA class III or IV. Significant improvements were observed at both 3 months (P=.0008) and 6 months (P=.0001), with an average NYHA class improvement from 3.1 to 2.2 at 6 months. Using a responder definition of improvement of at least one NYHA class, there were 12 responders, 8 unchanged and none who worsened.

The researchers also observed a significant improvement in quality of life as measured by the Minnesota Living with Heart Failure questionnaire: at baseline, the quality of life score was 64 and at 3 and 6 months the score was substantially improved to 49 (P=.0099).

 “The average in this same quality of life [scoring system] with ACE inhibitors or beta blockers is 5 points; with cardiac resynchronization it’s 9 points,” William T. Abraham, MD, of Ohio State University, Columbus, said during his presentation. “The magnitude seen here is not only statistically significant but quite clinically meaningful when compared to other therapies; this was seen on top of other evidence-based and guideline-recommended therapies,” he said.

The purpose of the pilot study was to demonstrate feasibility and safety of the device (manufactured by Sunshine Heart) and the procedure; explore preliminary efficacy signals and provide support for a subsequent pivotal trial.

The mean age of patients was 56 years. All patients were on optimal medical therapy and had an implantable cardioverter-defibrillator, and 45% had cardiac resynchronization therapy.

There were no deaths at 30 days. At 137 days post-implant, one patient experienced aortic disruption after a sternal wound infection post-surgery. Aortic rupture occurred at the time of the third surgical intervention in this patient and resulted in death. There were no cases of neurological dysfunction or MI. However, there were nine infections, eight of which were related to exit site.

There was a nonsignificant trend for improved 6MWT distance at 3 months, which was sustained at 6 months, with a difference of almost 30 meters, according to Abraham. “This is about what we see with cardiac resynchronization therapy. Though it did not reach statistical significance, it’s an encouraging trend favoring improvement with the C-Pulse device,” he said.

Peak VO₂ did not improve significantly, but there was a significant improvement in remodeling, as indicated by improvement in LVEF. From baseline to 3 and 6 months, there was progressive improvement in LVEF (P=.0432).

“A prospective, randomized controlled trial to confirm and extend these observations is warranted,” Abraham said.