Comparative Outcomes of Surgical and Transcatheter Aortic Valve Replacement: A Meta-analysis and Parametric Extrapolation of Clinical Trials.

INTRODUCTION: We aimed to pool randomized clinical trials (RCTs) comparing surgical aortic valve replacement (SAVR) with transcatheter aortic valve replacement (TAVR) and extrapolate pooled time-to-event data to compare long-term outcomes. METHODS: An electronic database search was performed for RCTs comparing SAVR with TAVR. The most current longest follow-up data for each RCT were included. Data were pooled using a random-effects model. Survival data were pooled for Kaplan-Meier analysis as well as parametric modeling with extrapolation. RESULTS: Seven RCTs comprising 7774 patients were included. Mean valve gradient at 5 y was comparable between SAVR [11 mmHg (3.7; 18.3)] and TAVR [8.1 mmHg (1.9; 14.3)] (P = 0.38). TAVR had a higher mean valve area at 30 d, 1 y, and 2 y [1.68 cm2 (1.22; 2.13) versus 1.8 cm2 (1.35; 2.25), P = 0.02]. SAVR had a higher freedom from any paravalvular leak at 30 d and 1 y [86% (81; 90) versus 39% (36; 41), P < 0.01]. All-cause death was lower in the SAVR group at 5 y [39% (29; 50) versus 43% (31; 57), P < 0.01]. Although no differences were seen between SAVR and TAVR in the pooled Kaplan-Meier analysis of all-cause mortality and composite of all-cause mortality or stroke, parametric modeling with extrapolation showed significant divergence for both outcomes. CONCLUSIONS: Pooled all-cause mortality as well as pooled composite of all-cause mortality or stroke indicated better survival with SAVR at 5 y. Long-term parametric extrapolation also indicated superior survival with SAVR.

Outcomes of outflow graft stenting in HeartMate 3 left ventricular assist devices: A systematic review and individual patient data meta-analysis.

PURPOSE: LVAD outflow graft stenosis continues to remain prevalent with a high complication rate. We sought to pool the existing evidence on indications, utilization patterns, and outcomes of transcatheter interventions for outflow graft stenosis in the HeartMate 3 LVAD. METHODS: An electronic search was performed to identify all studies in the English literature reporting on HeartMate 3 LVAD outflow graft stenting. Patient-level data were extracted for analysis. RESULTS: Thirteen published reports and one unpublished case comprising a total of 28 patients were included. Median patient age was 68.5 years [Interquartile range: 58, 71] and 25.9% (7/27) were female. Dyspnea [60.7% (17/28)] was the most common presenting symptom. Low flow alarms were present in 60% (15/25) of patients. Findings included external compression [35.7% (10/28)], graft twist [21.4% (6/28)], graft twist and external compression [14.3% (4.28)], intraluminal thrombus [10.7% (3/28)], graft twist and intraluminal thrombus [3.6% (1/28)], and pseudoaneurysm of outflow graft [3.6% (1/28)]. Median time from LVAD implantation to stenting was 2.1 years [1.4, 3]. Immediate flow normalization after stenting was observed in 85.7% (24/28). The 30-day mortality was 12% (3/25). Overall mortality was 12% (3/25) at a median follow-up of 3.9 months [1, 17]. CONCLUSION: Outflow graft stenting in the HeartMate 3 LVAD appears to be a reasonable treatment option for outflow graft stenosis, with low overall rates of complications and mortality. Further refinement of indications and approaches may improve outcomes.

Organ Donation by the Imminently Dead: Addressing the Organ Shortage and the Dead Donor Rule.

The dead donor rule (DDR) has facilitated the saving of hundreds of thousands of lives. Recent advances in heart donation, however, have exposed how DDR has limited donation of all organs. We propose advancing the moment in the dying process at which death can be determined to increase substantially the supply of organs for transplantation. We justify this approach by identifying certain flaws in the Uniform Determination of Death Act and proposing a modification of that law that permits earlier procurement of healthier organs in greater numbers.

Characterizing Adaptive Changes and Patient Survival After 2018 Donor Allocation Restructuring: A UNOS Database Analysis.

PURPOSE: We sought to characterize adaptive changes to the revised United Network for Organ Sharing donor heart allocation policy and estimate long-term survival trends for heart transplant (HTx) recipients. METHODS: Patients listed for HTx between October 17, 2013 and September 30, 2021 were identified from the United Network for Organ Sharing database, and stratified into pre- and postpolicy revision groups. Subanalyses were performed to examine trends in device utilization for extracorporeal membranous oxygenation (ECMO), durable left ventricular assist device (LVAD), intra-aortic balloon pump (IABP), microaxial support (Impella), and no mechanical circulatory support (non-MCS). Survival data post-HTx were fitted to parametric distributions and extrapolated to 5 years. RESULTS: We identified 27,523 HTx waitlist candidates during the study period, most of whom (n = 16,376) were waitlisted in the prepolicy change period. Overall, 19,554 patients underwent HTx during the study period (pre: 12,037 and post: 7517). Listings increased after the policy change for ECMO ( P < 0.01), Impella ( P < 0.01), and IABP ( P < 0.01) patients. Listings for LVAD ( P < 0.01) and non-MCS ( P < 0.01) patients decreased. HTx increased for ECMO ( P < 0.01), Impella ( P < 0.01), and IABP ( P < 0.01) patients after the policy change and decreased for LVAD ( P < 0.01) and non-MCS ( P < 0.01) patients. Waitlist survival increased for the overall ( P < 0.01), ECMO ( P < 0.01), IABP ( P < 0.01), and non-MCS ( P < 0.01) groups. Waitlist survival did not differ for the LVAD ( P = 0.8) and Impella ( P = 0.1) groups. Post-transplant survival decreased for the overall ( P < 0.01), LVAD ( P < 0.01), and non-MCS ( P < 0.01) populations. CONCLUSIONS: Allocation policy revisions have contributed to greater utilization of ECMO, Impella, and IABP, decreased utilization of LVADs and non-MCS, increased waitlist survival, and decreased post-HTx survival.