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

Abstract

BackgroundThe 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/MethodsWe present preliminary site-reported 6-month data from 3 centers in Germany as part of the prospective observational post-market OPTIONS HF study.ResultsBetween 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.ConclusionsThe 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.

Hemodynamic Impact of the C‐Pulse Cardiac Support Device: A One‐Dimensional Arterial Model Study

“…It is clear that a computer model study has some inherent limitations and does not account for adaptive mechanisms due to autoregulation or sympathetic/parasympathetic modulation. The latter mechanism may be important since the relatively moderate hemodynamic effects predicted from the model and observed in patients has resulted in improved clinical outcomes in terms of improvement in ejection fraction . The results obtained therefore represent a theoretical acute hemodynamic effect of the C‐Pulse.…”

Visit to intensive care of 2050

“…Patients presenting with organ failure nonetheless undergo initial implantation of a bridging device in the ICU and are sent home until a new organ has been created for them [27,28]. This process is automated: once the hospital system is notified of such patient admission, it imports data regarding the pre-damage structure of the patient organs (individual 3-D organ mapping is mandatory at age 18).…”

Design of a Muscle-Powered Extra-Aortic Counterpulsation Device for Long-Term Circulatory Support

“…To calculate these areas, we treated both inflated and deflated shapes as ellipses since they have a major and minor axis. The starting device measures 31.87 mm in the Z-axis and 34.61 mm in the X-axis resulting in a starting area of 866.3 mm 2 . Using the same combinations of materials and pressures described above, we calculated area change as a function of actuation pressure and plotted the results in Figure 4.…”

“…In this context it is important to note that the idea of applying a counterpulsation device around the ascending aorta is not new. Indeed, this approach has been validated by clinical trials recently completed by Sunshine Heart Inc. showing that displacing 20 cc of blood at the aortic root has significant therapeutic benefits [2]. Unfortunately, while the pneumatic 'C-Pulse' device solves the blood-contacting problem, it suffers from the same limitations as traditional VADs-i.e., driveline infections.…”