1. Between May 2013 and June 2014, we implanted the C-Pulse device in 7 male and 1 female patients with a mean age ± SD of 61.1 ± 9.4 years. Four had ischemic cardiomyopathy, and four had non-ischemic cardiomyopathy. Seven patients were NYHA class III and one was ambulatory NYHA class IV. All were on optimal medical therapy. Five had a CRT/ICD and six had an ICD. Surgical implantation was successful in all patients and does not require cardiopulmonary bypass (CPB). CPB was used in one case for concomitant coronary artery bypass surgery. 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. Four patients had reached their 6 month follow-up visit and were evaluable for analysis. Functional status improved from NYHA III to II in three patients; one patient remained NYHA III (Fig 2). Paired mean 6MWT ± SD improved by 28% from 203.3 ± 25m to 260.5 ± 77m (Fig 3). Paired mean LVEF ± SD improved from 26.3 ± 8.5% to 43.1 ± 5.6%, a 64% relative improvement from baseline (Fig 4). Paired mean KCCQ score ± SD improved from 29.4 ± 17.9 to 47.9 ± 21.2 (Fig 5). Data presented in this interim report are un-adjudicated and site-reported. Preliminary Results from the C-Pulse ® System European Multicenter Study Holger Hotz 1, Jan Schmitto 2, Mirko Seidel 3, Thomas Krabatsch 4 1. Cardio Centrum Berlin, Germany; 2. Medizinische Hochschule Hannover, Germany; 3. Unfallkrankenhaus Berlin, Germany; 4. Deutsches Herzzentrum Berlin, Germany Preliminary Results from the C-Pulse ® System European Multicenter Study Holger Hotz 1, Jan Schmitto 2, Mirko Seidel 3, Thomas Krabatsch 4 1. Cardio Centrum Berlin, Germany; 2. Medizinische Hochschule Hannover, Germany; 3. Unfallkrankenhaus Berlin, Germany; 4. Deutsches Herzzentrum Berlin, Germany 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 first implantations in Europe, as part of the OPTIONS HF post-market study, a multi-center, prospective, single arm study designed to evaluate the clinical performance and safety of the device in the population of patients who meet the approved clinical conditions provided in the indications and contraindications. Methods We are reporting on preliminary site reported and un-adjudicated 6 months follow up data from three centers in Germany where the first implants in Europe took place. The study will enroll up to 50 patients at up to 15 sites in Europe. Patients will be followed for up to 5 years to collect performance and safety data. Patients can be included who are 18 years or older, have moderate to severe heart failure (ACC/AHA stage C, NYHA class III/IV ambulatory), are refractory to optimal medical therapy and non-responders to CRT. Patients with evidence of significant ascending aortic calcification, 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 mmHg are excluded. Disclosure: H. Hotz provides consulting services for Sunshine Heart and received travel expenses. M. Seidel, J. Schmitto and T. Krabatsch declare no conflict of interest. Results 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. Caution: Investigational device, limited by United States Law to investigational use. Figure 1. The balloon around the ascending aorta inflates during diastole and starts deflating shortly before ejection, thereby potentially increasing coronary blood flow and decreasing afterload. All Patients (N=8) Mean ±SD (range) Age (in years)61.1 ± 9.4 (51, 79) Gender Male87.5% (7/8) Co-morbidities Arrhythmia50% (4/8) Diabetes Mellitus62.5% (5/8) Smoking history87.5% (7/8) Cardiomyopathy100% (8/8) - Ischemic50% (4/8) - Non-Ischemic50% (4/8) INTERMACS Profile 4: Resting symptoms37.5% (3/8) 5: Exertion Intolerant37.5% (3/8) 6: Exertion Limited25% (2/8) NYHA Class III87.5% (7/8) IV12.5% (1/8) CRT62.5% (5/8) ICD Therapy75.0% (6/8) Table 1. Demographics Figure 2. Improvement in NYHA Figure 3. Improvement in 6MWT Figure 4. Improvement in LVEF Poster presented at the Heart Failure Society of America (HFSA) 18 th Annual Scientific Meeting, 2014 September 14–17, Las Vegas, Nevada, USA. Baseline N=4 6 months N=4 Baseline N=4 6 months N=4 Baseline N=4 6 months N=4 Percent Meters Score Figure 5. Improvement in KCCQ-OS