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Background Long-term survivors after implantation of left ventricular assist devices (LVADs) are increasing in prevalence. We describe the characteristics and outcomes in patients surviving longer than 4 years on LVAD support. Methods We performed a multicenter, retrospective analysis of patients surviving at least 4 years on continuous-flow LVAD (CF-LVAD) support with a HeartMate II at centers participating in the Evolving Mechanical support Research Group. Results Between 2005 and 2010, 156 long-term survivors were identified with a mean survival of 7.1 years (95% confidence interval: 6.7 to 7.5 years). The mean age was 58.2 ± 15.2 years and 30.1% were women. Readmission rate was low at 1.1 events per patient per year with the most common reasons leading to readmission being infection (0.10 readmissions per patient per year) and gastrointestinal bleeding (0.07 readmissions per patient per year). Two years after implantation, 97% of patients were either New York Heart Association functional class I or II, with 92% at 4 years. Conclusions Patients surviving 4 years on CF-LVAD support can anticipate ongoing long-term survival with sustained improvements in functionality and low rates of rehospitalization. [ABSTRACT FROM AUTHOR]

Background Left ventricular assist devices (LVADs) are increasingly used in patients with heart failure. To study the impact of stroke on clinical outcomes after continuous-flow (CF-) LVAD implantation, we evaluated our single-center experience. Methods From 2006 to 2013, we implanted the HeartMate II CF-LVAD in 230 patients. We used standard statistical methods to evaluate our results. Results Of our study group, 185 patients (80.4%) received the CF-LVAD as a bridge to transplantation. Strokes occurred in a total of 39 patients (17%), an incidence rate of 0.064 strokes per person-year: 19 (48.7%) were embolic, and 20 (51.3%) were hemorrhagic. The stroke-free rate at 6 months after HeartMate II implantation was 92.6%, at 12 months, 89.6%, and at 24 months, 86.1%. Baseline demographic characteristics did not differ significantly, except that stroke patients had a lower incidence of coronary artery disease ( p = 0.004) and prior cardiac surgery ( p = 0.001). We noted a trend toward an increased risk of stroke in patients with CF-LVAD–related infections ( p = 0.053). The survival rate in stroke (versus stroke-free) patients at 6 months was 84.6% (versus 84.2%); at 12 months, 71.8% (versus 81.6%); and at 24 months, 53.9% (versus 74.7%; p = 0.0019). During a median follow-up time of 761 days, mortality risk in stroke patients was 2.01 times that of stroke-free patients (hazard ratio = 2.01; p = 0.004). Conclusions Stroke while on CF-LVAD support was associated with significant mortality. To reduce the risk of stroke, it is essential to further elucidate risk factors, to optimize anticoagulation, and to further understand the impact of LVAD-related infections. [ABSTRACT FROM AUTHOR]

Background. An ongoing challenge in the management of patients with heart failure who receive left ventricular assist devices (LVADs) is achieving optimal anti-coagulation. Adverse prothrombotic events include hemolysis or pump thrombus (H/T) and neurologic events (NEs), and all limit the success of LVAD therapy. Our aim was to study the incidence and clinical outcomes associated with these events in a large single-center cohort. Methods. We retrospectively reviewed our prospectively collected database of all patients receiving a HeartMate II (Thoratec Corp, Pleasanton, CA) LVAD from 2005 to 2012. Demographic, clinical, and outcome data were analyzed using standard statistical methods. All adverse events were recorded. Results. Of 193 patients receiving LVADs, we identified 39 H/T events in 26 (13.4%) patients and 22 NEs in 19 (9.8%) patients. Seventy-four percent of events occurred in the last 3 years of the series, during which time 63% of implants were placed. Of patients with H/T, 8 (31% of those having H/T, 4.1% of total) had more than 1 event and 4 (15.4% of those having H/T, 2.1% of total) underwent pump exchanges. Five (23%) patients had NEs after H/T, and 6 (32%) died as a result of the NE. Of patients with H/T, 27% had preceding episodes of infection, 31% had an international normalized ratio (INR) of less than 1.5, 31% had an INR of 1.5 to 2, 15% had a history of clotting or were hypercoagulable, and 4% had anti-coagulation intentionally withheld. Lactate dehydrogenase (LDH), plasma hemoglobin, INR, and platelet determinations were significantly different at the time of H/T compared with baseline values. The survival at 6 months (alive or having undergone transplantation) for those with a prothrombotic event compared with those without was 70% versus 75.2% (p = 0.5). Conclusions. The incidence of H/T or NEs is significant and results in major morbidity after LVAD placement. Infection and suboptimal anticoagulation are associated with the majority of these events. Identification of patients at higher risk for hemolysis (ie, infection) may allow for modification of anticoagulation regimens to reduce these risks and improve clinical outcomes. [ABSTRACT FROM AUTHOR]

Background: Continuous-flow left ventricular assist devices (LVADs) such as the HeartMate II have become the therapy of choice in patients with end-stage heart failure. The aim of this study is to report the outcomes in patients receiving the HeartMate II LVAD at a single center and review the lessons learned from this experience. Methods: From June 2005 to June 2010, 130 consecutive patients received the HeartMate II LVAD. Of these, 102 were bridge-to-transplant (BTT), 17 destination therapy, and 11 exchanges for failed HeartMate XVE. This study focuses on the 102 BTT patients. The HeartMate II was approved by the US Food and Drug Administration (FDA) as BTT in April 2008 and 64 patients received this device as BTT since that date. We review our experience with the device as BTT and report on patient survival and adverse events as well as the impact of FDA approval on outcomes. Results: Overall, mean age was 52.6 ± 12.8 years; 26 (25.5%) were female. Disease etiology was ischemic in 58, nonischemic in 36, and other in 8. Overall, 30-day, 6-month, and 1-year survival for the BTT patients was 95.1%, 83.5%, and 78.8%, respectively. The 6-month survival in 38 patients in the clinical trial (pre-FDA) was 88.8% and was not statistically significant compared with the 76.2% 6-month survival in the 64 patients in the post-FDA approval period (p value = 0.1). Major adverse events among the 102 BTT patients included right ventricular failure in 5 (4.9%), LVAD driveline infections in 25 (24.5%), neurologic events in 10 (9.8%), and gastrointestinal bleeding in 18 (17.6%) patients. In addition, 1 patient (0.98%) had pump thrombus requiring device replacement. Conclusions: Despite significant morbidity, use of the HeartMate II LVAD as BTT provides excellent hemodynamic support and is associated with excellent survival and low mortality. In addition, there needs to be improvement and focused strategies in the areas of gastrointestinal bleeding, driveline infections, and adverse neurologic events for these devices to be able to provide a real long-term alternative to heart transplantation. [ABSTRACT FROM AUTHOR]

Background: A multicenter clinical trial conducted from 2005 to 2008 of a continuous flow left ventricular assist device (LVAD) resulted in Food and Drug Administration approval for bridge to transplantation. The purpose of this analysis was to determine changes in posttrial outcomes in widespread commercial use since the clinical trial. Methods: We compared outcomes of 486 patients who received a continuous flow LVAD as a bridge to transplantation at 36 centers during the clinical trial (March 2005 to April 2008) with outcomes of 1,496 posttrial patients who received a continuous flow LVAD at 83 centers (April 2008 to September 2010 as reported to the Interagency Registry for Mechanically Assisted Circulatory Support). Results: Baseline data were comparable between groups. Cumulative follow-up was 511 and 1,082 patient-years for trial and posttrial patients, respectively, and average support duration was 12.6 ± 14.0 and 8.7 ± 7.1 months. Kaplan-Meier survival improved at 1 year from 76% (trial) to 85% (posttrial). The percentage of patients undergoing transplantation in the first year decreased from 48% in the trial period to 39% in the posttrial period. Quality of life metrics improved by 3 months in both groups. Conclusions: The survival rate of a large group of continuous flow LVAD patients in a real-world setting after Food and Drug Administration market approval for bridge to transplantation has improved since the clinical trial. These data show that excellent outcomes have been maintained with dissemination of new LVAD technology from a clinical trial phase to more broad based use in the period after market approval. [ABSTRACT FROM AUTHOR]

In the last few years, left ventricular assist devices (LVADs) have moved to the forefront in the management of patients with advanced heart failure. Pumps have gradually become smaller and more efficient and have clearly demonstrated survival benefits and improvement in functional status and quality of life in patients with advanced heart failure. Despite impressive advances in device technology, risk of severe complications remains, such as device thrombosis. A 62-year-old man who underwent HeartWare LVAD implantation as a bridge to cardiac transplant was admitted 18 days after device implantation with severe shortness of breath, fatigue and lethargy; he was found to have increased pump flows with high power demands and evidence of cardiogenic shock. An echocardiogram showed an echo density at the inflow cannula that was suggestive of thrombosis. Laboratory data showed evidence of hemolysis. He was treated successfully with intraventricular tissue plasminogen activator with rapid resolution of his symptoms and return of LVAD flow and power consumption to baseline. The patient was discharged with no complications or recurrence of thrombosis and received a successful transplant 1 month later. [ABSTRACT FROM AUTHOR]