The Berlin Experience with the C-Pulse® Heart Assist System after 6 Months of Observation

Background: The C-Pulse heart assist system is a balloon counter-pulsation technology used to treat patients with moderate to severe heart failure NYHA class III or ambulatory class IV and refractory to optimal medical therapy. The implantable device is placed outside the bloodstream and gives patients the ability to disconnect from the system. C-Pulse has received CE Mark in July 2012. We wish to report our experience with the device as leading implantation center in Europe.

Methods: We present the 6 month follow-up data of our study center which is part of the OPTIONS-HF trial. Patients can be included in the study who are 18 years or older, have moderate to severe heart failure, are refractory to optimal medical therapy and non-responders to ICD/CRT. Patients with evidence of signicant ascending aortic calcication, moderate or severe atherosclerotic disease, ascending aorto-coronary artery bypass grafts, any history of aortic dissection, severe mitral valve incompetence, moderate to severe aortic valve incompetence or systolic blood pressure less than 90 or greater than 140 mm Hg are excluded.

Results: Between May 2013 and September 2014, we implanted the C-Pulse device in 6 male and 1 female patients with a mean age ± SD of 59 ± 5.6 years. Three had ischemic cardiomyopathy, and four had non-ischemic cardiomyopathy. Six patients were NYHA class III and one was ambulatory NYHA class IV. All were on optimal medical therapy. Five had a CRT/ICD.

Surgical implantation without cardiopulmonary bypass was successful in all patients. It was done in five patients via full sternotomy and in two via partial sternotomy. No stroke, myocardial infarction, major bleeding or major infections were reported due to the device.

One patient developed tachycardia with worsening heart failure 12 hours after surgery without stabilization under medication and underwent left ventricular assist device implantation 5 days post-procedure.

Five patients had reached their 6 month follow-up visit and were evaluable for analysis. Functional status improved from NYHA III to II in all five patients. Paired mean 6MWT ± SD improved by 22.5 ± 18.5% from 259.2 ± 87.7 m to 303.2 ± 52.3 m. Paired mean LVEF ± SD had more than doubled within 6 months of observation from 21 ± 5.8% to 45 ± 2.2%.

Conclusion: These early data 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.