Abstract 16699: Preliminary Results From the C-Pulse OPTIONS HF European Multicenter Post-Market Study
Introduction: The C-Pulse Heart Assist System is an extra-aortic balloon counter-pulsation device used to treat patients with NYHA class III or ambulatory class IV heart failure. The implantable device is surgically placed outside the bloodstream, obviating the need for cardiopulmonary bypass (CPB) and anti-coagulation. C-Pulse affords patients the ability to disconnect from the system. C-Pulse is CE Marked.
Methods: We are reporting on preliminary site reported and un-adjudicated 6 month data from three centers in Germany where the initial implants occurred in Europe as part of the OPTIONS HF post-market study.
Results: Between May 2013 and March 2014 C-Pulse was implanted in one female and seven male patients aged 61.6 ± 9.3 (mean ± SD) years. Four had ischemic and three had non-ischemic cardiomyopathy, while one had mixed alcoholic and ischemic etiology. Seven patients were NYHA class III, one was ambulatory NYHA class IV. All were on optimal medical therapy. Five had a CRT-D, one had an ICD device, and two had neither.
Surgical implantation was successful in all patients. CPB was used in one patient for concomitant CABG. No stroke, myocardial infarction, major bleeding or major infection were reported due to the device through 6 month.
One patient was weaned off the device after 6 months of support and showed an increase in EF from 20% at baseline to 44% at 6-month. One patient developed non-device related refractory tachycardia with worsening heart failure 12 hours after surgery which prevented C-Pulse from supporting the heart properly resulting in subsequent VAD implant 5 days after the index procedure.
Five of eight patients reached the 6 month visit and were evaluable for analysis. Paired mean 6MWD ± SD improved by 28% from 203.3 ± 25m to 260.5 ± 77m. Functional status improved from NYHA III to II in all but one patient who reverted to NYHA III at 6 month. Paired mean LVEF ± SD improved from 25.0 ± 7.9% to 43.3 ± 4.9%, a 73% relative improvement from baseline.
Conclusions: These early 6 month results suggest that the C-Pulse Heart Assist System is a promising therapeutic option for patients with moderate to severe heart failure and may improve cardiac function over time.
Caution: Investigational device, limited by Federal (or United States) Law to Investigational use.
Author Disclosures: H. Hotz: None. A. Schulz: None. J. Schmitto: None. M. Seidel: None. T. Krabatsch: None.
- © 2014 by American Heart Association, Inc.