Abstract

Objectives: We aimed to summarize the current evidence on outcomes of continuous-flow left ventricular assist devices (CF LVAD). Background: Conveying the complex trade-offs of LVAD is challenging, and made more difficult by absence of an evidence summary for the full range of possible outcomes. This absence of accurate and easily accessible information from which to anchor risk-benefit communication leads to a potentially non-standardized and variable informed consent and decision-making process around LVADs that may be incomplete, confusing, or biased. Methods: 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. Results: The electronic search identified 465 abstracts, of which 50 met inclusion criteria; manual review added 2 articles in press and 3 focused on medical therapy. Evidence was generally of low-strength, with 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 (see Table 1). 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. Conclusion: 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.

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