Clinical Outcomes After Continuous-Flow Left Ventricular Assist Device

Abstract

Background Conveying the complex trade-offs of continuous-flow left ventricular assist devices (CF LVAD) is challenging, and made more difficult by absence of an evidence summary for the full range of possible outcomes. We aimed to summarize the current evidence on outcomes of CF LVAD. Methods and Results PubMed and Cochrane Library were searched from January 2007–December 2013, supplemented with manual review. Three reviewers independently assessed each study for saliency regarding patient-centered outcomes. Data were summarized in tabular form. Overall study characteristics encouraged inclusion of all indications (destination therapy and bridge to transplant) and prevented meta-analysis. The electronic search identified 465 abstracts, of which 50 met inclusion criteria; manual review added 2 articles in press. The articles included 10 industry-funded trials and registries, 10 multi-center reports, and the remainder single-center observational experiences. Estimated actuarial survival after CF LVAD ranged from 56–87% at 1-year, 43–84% at 2-years, and 47% at 4-years. Improvements in functional class and quality of life were reported, but missing data complicated interpretation. Adverse events were experienced by the majority of patients, but estimates for bleeding, stroke, infection, right heart failure, arrhythmias, and rehospitalizations varied greatly. Conclusions The totality of data for CF LVADs show consistent improvements in survival and quality of life counterbalanced by a range of common complications. While this summary should provide a practical resource for health care provider-led discussions with patients, it highlights the critical need for high-quality patient-centered data collected with standard definitions.

Survival of HeartMate II Patients Despite Cessation of Anticoagulation ― Outcomes and Hemostatic Analysis ―

“…Despite the low INR target, we demonstrated no increase in the rate of thromboembolic events. The incidence of both PT and IS was lower than the incidences reported by Starling et al, 18 Stulak et al 19 and McIlvennan et al, 3 and comparable to the incidence reported in the PREVENtion study. 4 Data on the safety, risks, and hemostatic profile of HMII patients in whom AT can be safely discontinued are scarce.…”

Left Ventricular Assist Devices

“…9 This is a significant improvement as mortality is about 90% at Year 2 for those with significant heart failure without LVAD therapy. 4 Higher mortality rates occur in people who are older and have cardiogenic shock and progressive cardiac decompensation, right ventricular failure, and renal dysfunction.…”

“…4 Higher mortality rates occur in people who are older and have cardiogenic shock and progressive cardiac decompensation, right ventricular failure, and renal dysfunction. 9 As LVAD DT implantation increases, one may expect a variation in survival rates dependent on the premorbid conditions.…”

Anticoagulation strategies for left ventricular assist devices

“…Short-term and long-term success of these patients arises from appropriate patient selection, surgical technique, type of device, and postimplant care [3]. While many centers around the world have devised unique perioperative anticoagulation strategies, only the International Society for Heart and Lung Transplantation (ISHLT) have put forth recommendations; however, the level of evidence for these guidelines is limited to a handful of observational studies or expert opinion [4 && ].…”