Learning Curve in Left Ventricular Assist Device Implantation: Low Volumes Do Not Equate Bad Outcomes

Braz J Cardiovasc Surg. 2022 Oct 8;37(5):628-638. doi: 10.21470/1678-9741-2021-0498.

Abstract

Introduction: Most implantations of left ventricular assist devices (LVAD) are performed in low-volume centers. This study aimed to evaluate the procedural learning curve of HeartMate II (HM2) implantations by comparing outcomes between two time periods in a low-volume center.

Methods: All 51 consecutive patients undergoing HM2 implantation between January 2009 and December 2017 were reviewed and allocated into 2 groups: early-era group (from 2009 to 2014; n=25) and late-era group (from 2015 to 2017; n=26). The primary outcome was the 90-day mortality rate, and the secondary outcome was a composite of mortality, neurological event, reoperation for bleeding, need for temporary right ventricular assist device, and pump thrombosis at 90 days. Median follow-up time was 51 months (0-136). A cumulative sum (CUSUM) control analysis was used to establish a threshold of implantations that optimizes outcomes.

Results: Patients in the early era had a higher rate of diabetes, previous stroke, and inotrope support before HM2 implantation. The 90-day mortality rate was not significantly higher in the early era (24% vs. 15%, P=0.43), but the composite endpoint was significantly higher (76% vs. 42%, P=0.01). The CUSUM analysis found a threshold of 23 operations after which the composite endpoint was optimized.

Conclusion: Patients undergoing HM2 implantation in a low-volume center have improving outcomes with number of cases and optimized results after a threshold of 23 cases. Significant changes in patient selection, surgical techniques, and patient management might lead to improved outcomes after LVAD implantation.

Keywords: Circulatory Support Devices (LVAD, RVAD, BVAD, TAH); Heart Failure (Incl Diagnosis, Assessment, Treatment); Outcomes (Incl Mortality, Morbidity, Survival, Etc.); Postoperative Care.

MeSH terms

  • Heart Failure* / surgery
  • Heart-Assist Devices* / adverse effects
  • Humans
  • Learning Curve
  • Retrospective Studies
  • Treatment Outcome