title: Preliminary Results From the C-Pulse OPTIONS HF European Multicenter Post-Market Study.
abstract: 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.
authors.affiliation: Cardio Centrum Berlin, Academic Teaching Institution of Charité, Medical University Berlin, Berlin, Germany.
authors.forename: Antonia
authors.initials: A
authors.lastname: Schulz
authors.affiliation: Department of Cardiac Surgery, German Heart Center Berlin, Berlin, Germany.
authors.forename: Thomas
authors.initials: T
authors.lastname: Krabatsch
authors.affiliation: Department of Cardiac, Thoracic, Transplantation and Vascular Surgery, Hannover Medical School, Hannover, Germany.
authors.forename: Jan D
authors.initials: JD
authors.lastname: Schmitto
authors.affiliation: Cardio Centrum Berlin, Academic Teaching Institution of Charité, Medical University Berlin, Berlin, Germany.
authors.forename: Roland
authors.initials: R
authors.lastname: Hetzer
authors.affiliation: Department of Cardiology, Unfallkrankenhaus Berlin, Academic Teaching Hospital of Charité, Medical University Berlin, Berlin, Germany.
authors.forename: Mirko
authors.initials: M
authors.lastname: Seidel
authors.affiliation: Department of Cardiovascular Surgery, Charité Hospital, Medical University Berlin, Berlin, Germany.
authors.forename: Pascal M
authors.initials: PM
authors.lastname: Dohmen
authors.affiliation: Cardio Centrum Berlin, Academic Teaching Institution of Charité, Medical University Berlin, Berlin, Germany.
authors.forename: Holger
authors.initials: H
authors.lastname: Hotz
mesh_terms: D009202:Cardiomyopathies / Q000628:therapy*; D015908:Counterpulsation / Q000295:instrumentation*; D005260:Female; D005858:Germany; D006333:Heart Failure / Q000628:therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011358:Product Surveillance, Postmarketing; D011446:Prospective Studies; D016896:Treatment Outcome