eISSN 2325-4416

Logo



Preliminary Results From the C-Pulse® OPTIONS HF European Multicenter Post-Market Study

Antonia Schulz, Thomas Krabatsch, Jan D. Schmitto, Roland Hetzer, Mirko Seidel, Pascal M. Dohmen, Holger Hotz

(Cardio Centrum Berlin, Academic Teaching Institution of Charité, Medical University Berlin, Berlin, Germany)

Med Sci Monit Basic Res 2016; 22:14-19

DOI: 10.12659/MSMBR.896959

Published: 2016-02-18


BACKGROUND: The C-Pulse® System is an extra-aortic balloon counterpulsation device. It is used to treat patients with heart failure disease in NYHA functional class III or ambulatory class IV.
MATERIAL AND METHODS: We present preliminary site-reported 6-month data from 3 centers in Germany as part of the prospective observational post-market OPTIONS HF study.
RESULTS: Between May 2013 and March 2014, the C-Pulse System was implanted in 8 patients (7 male) with a mean age of 61.6±9.3 years. Four had ischemic and 4 had non-ischemic cardiomyopathy. No stroke, myocardial infarction, major bleeding, or major infection due to the device were reported. One patient developed non-device-related refractory tachycardia with worsening heart failure 12 h after surgery and underwent left ventricular assist device implantation. Within 6 months of observation, functional status improved from NYHA III to II in 5 patients, and 2 remained in NYHA III. Mean left ventricular ejection fraction increased from 24.3±7.9% to 44.5±4.5% (p<0.0001). Mean Kansas City Cardiomyopathy Questionnaire overall score improved from 28.6±19.1 to 59.1±22.5 (p=0.0183). Six-minute walk test was performed in 6 out of 7 patients at follow-up. The mean distance improved from 252.0±85.1 m to 279.2±87.5 m (p>0.05). One patient was weaned off the device after 6 months of support.
CONCLUSIONS: The C-Pulse System provides a therapeutic option for patients with moderate-to-severe heart failure and seems to improve quality of life and cardiac function over time.

Keywords: Counterpulsation - instrumentation, Cardiomyopathies - therapy, Female, Germany, Heart Failure - therapy, Humans, Male, Middle Aged, Product Surveillance, Postmarketing, Prospective Studies, Treatment Outcome



Back