Defining Metrics for Short Term Success After LVAD Implant: An Analysis of the Society of Thoracic Surgeons Intermacs Registry

Purpose: While clinical trials evaluating left ventricular assist device (LVAD) technology typically use composite outcomes to assess efficacy, composite outcomes including patient reported outcomes (PROs) have not been utilized as benchmarks for LVAD implant center performance improvement initiatives or quality ranking. The objective of the study was to assess the feasibility of generating a patient composite outcome measure including PROs from a real world registry. Methods: Short term (ST, 180 days) adverse events (AEs) and mortality were tallied for Intermacs patients undergoing LVAD implant between 1/2012 and 12/2019. ST postoperative events included mortality on first device and frequencies of stroke, reoperation (device malfunction/other), right heart failure (RHF), prolonged respiratory failure, and/or dialysis on first device. Logistic regression was used to generate odds ratios for mortality for each AE. Separately, the EuroQOL visual analog scale (VAS) was assessed at baseline and 180 days in ST survivors. Results: Of 20,115 patients, 37% suffered at least one event, most commonly death, reoperation and stroke (Table, column A). Stroke, prolonged respiratory failure, and dialysis attributed the most to ST mortality (Table, column B). Of the 16725 patients alive at 180 days, 43% completed a VAS with 82.0% showing VAS improvement. Renal failure and RHF contributed most to failure to improve VAS (Figure). Conclusion: Assessment of a ST composite outcome metric after LVAD implant from a real world data source is feasible but limited by incomplete PRO reporting. ST adverse events display differential effects on mortality and PROs that can be used in development of global rank outcome scores. While reoperation is common, stroke, prolonged respiratory failure and renal failure conferred highest risks of ST deaths within Intermacs. Assessment of PROs should become a priority for LVAD centers to allow the field to generate a complete assessment of patient-centered outcomes