Outcomes after Implantation of Left Ventricular Assist Devices in Patients with Terminal Heart Failure Complicated by Cardiogenic Shock at Time of Device Placement

Background: Presence of cardiogenic shock at time of left ventricular assist device (LVAD) placement for treatment of terminal heart failure diminishes the therapy success. We studied the impact of cardiogenic shock on survival in recipients of new miniaturized rotary blood pumps. Methods: Between 08/2009 and 07/2011 a total of 116 patients with terminal heart failure were treated with the centrifugal blood pump HeartWare HVAD. We divided patients as follows: Group 1, those suffering from cardiogenic shock, n=22; Group 2, those without shock at time of device placement, n=96. Survival rate and clinical course in both groups were analyzed. Results: Cumulative survival rate at 90 days and 1 year was 86% for group 1 and 83% and 81% for group 2, respectively (p=0.7). In Group 1 median support time and cumulative follow-up were 215 days (range 6-665 days) and 15.5 pt./y., with 14 patients with ongoing support and 2 transplanted compared to those in group 2: 234 days (range 1-682 days) and 64.4 pt./y., with 65 patients with ongoing support, 3 transplanted and 1 weaned from the device. Conclusion: A HeartWare HVAD provides good hemodynamic support and end-organ recovery in heart failure patients with and without onset of cardiogenic shock at time of device insertion. After hospital discharge both groups presented good outcomes of long- term circulatory support. ventricular device support of and consisted of heparin, Vitamin K antagonist, aspirin, dipyridamole and clopidogrel. Results: Thirty day, 180 day, and 1 year survival after implantation (excluding transplanted patients) was 95%, 87% and 82% respectively. Nineteen patients (53%) were transplanted, and 9 are ongoing. Mean time on support was 380 days and 39 out of 44 patients with adult-sized pumps were discharged home with a mobile driver. Five patients exceeded 2.5 years of uncomplicated support before they were transplanted. Twenty patients were on support for more than 1 year. One patient with renal failure and dialysis dependence lives at home 3 years after implantation. Complications included infection (n =6), bleeding requiring reexploration (n=5), and thromboembolic events (n =4). Eleven patients died, 1 of an accidentally ruptured cannula (after 365 days), 2 of sepsis, 3 of devastating CVA‘s, 5 of multiorgan system failure. Conclusions: Reliability of components and strict utilization of patient-care protocols leads to excellent survival in this extremely sick population. Meticulous multi-disciplinary management by experienced personnel is essential. Purpose: INTERMACS scale is considered a valid score system to stratify patients´ risk profile in terms of morbidity and mortality after mechanical circulatory support (MCS). This might be a particularly useful tool in destination therapy advanced age patients. We investigated outcomes of patients implanted with Jarvik 2000 (intraventricular-axial- flow pump with novel power delivery system) and enrolled in the Italian Registry. Outcomes were analized according to preoperative conditions, as per INTERMACS scale. Methods and Materials: From June 2006 to September 2011, 65 consecutive end-stage heart failure adult patients (58 males, mean BSA 1.90 m2, 53% ischemic cardiomyopathy) were enrolled in the Jarvik 2000 Italian Registry. Mean age was 63 ± 8 yrs (median 65 yrs), 95% were uneligible to heart transplantation. Relevant pre-operative data and outcomes were analyzed. In particular, two groups of patients were identified: long term survivors (group A, on device >1 yr, N=23) and early deaths (group B, on device < 1 month, N=12). Results: Overall mean time of patients on LVAD was 320 days and mean time of patients discharged out of hospital (72%) was 445 days. Overall survival was mainly impacted by peri-operative mortality. 12 patients died in early post-operative time (< 30 days) due to right ventricular failure (5), sepsis (3), bleeding (3) and HIT (Heparin Induced Throbocytopenia) (1). Late deaths were due to hemorrhagic stroke (5), non device related sepsis (5).