Abstract
s S221 system (Berlin Heart) is a third generation axial continuous flow pump with active magnetic levitation, thus avoiding the potential downsides of mechanical bearings. Implemented software algorithms allow for a more physiologic operation mode including pulsatility. Methods: The aim of this study was to review the Italian experience with the INCOR LVAD and to determine the prevalence of GI bleeding and pump thrombosis. All patients implanted from January 2006 to May 2012, in centers with at least 5 implants were considered eligible. All AE, meeting the INTERMACS classification, were evaluated. Results: The total population consisted of 42 patients. LVAD indication was BTT in 36 (86%) patients and DT in 6 (14%) patients. 31 patients (74%) were in class 1 or 2 INTERMACS at time of implantation, among them 22 (52%) requiring inotropic therapy and 10 (24%) extracorporeal membrane oxygenation support. The mean support time was 525 ± 570 days, median 372 days (5 to 2704) days. The 30-day post-operative mortality was 7 %. The 1-year and 2-year survival rates were 74% and 60%, respectively. At last follow-up (July 2014), 17 (41%) of the 42 patients were transplanted, one (2%) patient regained myocardial function and had the device removed, 5 (12%) are still on support , 19 (45%) of the 42 patients died . The most frequently observed AE was driveline infection in 19 patients (0.33 events PPY). Stroke with consequence occurred in 10 patients (0.17 events PPY), followed by sepsis in 4 patients (0.07 events PPY), right heart failure in 3 patients (0.05 events PPY), and device malfunction in 2 patients (0.03 events PPY). No episodes of pump thrombosis or GI bleeding were observed during the long term follow-up. Conclusion: In this cohort of mainly high-risk HF patients INCOR LVAD seems to be effective in support patients. Moreover, absence of GI bleeding and pump thrombosis seem to demonstrate a favorable device characteristic. Further prospective studies are needed to confirm these data.
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