IMPORTANCEThe US heart allocation policy was changed on October 18, 2018. The association of this change with recipient and donor selection and outcomes remains to be elucidated.OBJECTIVE To evaluate changes in patient characteristics, wait list outcomes, and posttransplant outcomes after the recent allocation policy change in heart transplant. DESIGN, SETTING, AND PARTICIPANTSIn this cohort study, all 15 631 adults undergoing heart transplants, excluding multiorgan transplants, in the US as identified by the United Network for Organ Sharing multicenter, national registry were reviewed. Patients were stratified according to prepolicy change (October 1, 2015, to October 1, 2018) and postpolicy change (October 18, 2018 or after). Follow-up data were available through March 31, 2020.EXPOSURES Heart transplants after the policy change. MAIN OUTCOMES AND MEASURESCompeting risk regression for wait list outcomes was performed. Posttransplant survival was compared using the Kaplan-Meier method, and risk adjustment was performed using multivariable Cox proportional hazards regression analysis. RESULTSIn this cohort study, of the 15 631 patients undergoing transplant, 10 671 (mean [SD] age, 53.1 [12.7] years; 7823 [73.3%] male) were wait listed before and 4960 (mean [SD] age, 52.7 [13.0] years; 3610 [72.8%] male) were wait listed after the policy change. Competing risk regression demonstrated reduced likelihood of mortality or deterioration (subhazard ratio [SHR], 0.60; 95% CI, 0.52-0.69; P < .001), increased likelihood of transplant (SHR, 1.38; 95% CI, 1.32-1.45; P < .001), and reduced likelihood of recovery (SHR, 0.54; 95% CI, 0.40-0.73; P < .001) for wait listed patients after the policy change. A total of 6078 patients underwent transplant before and 2801 after the policy change. Notable changes after the policy change included higher frequency of bridging with temporary mechanical circulatory support and lower frequency of bridging with durable left ventricular assist devices. Posttransplant survival was reduced after the policy change (1-year: 92.1% vs 87.5%; log-rank P < .001), a finding that persisted after risk adjustment (HR, 1.29; 95% CI, 1.07-1.55; P = .008).CONCLUSIONS AND RELEVANCE Substantial changes have occurred in adult heart transplant in the US after the policy change in October 2018. Wait list outcomes have improved, although posttransplant survival has decreased. These data confirm findings from earlier preliminary analyses and demonstrate that these trends have persisted to 1-year follow-up, underscoring the importance of continued reevaluation of the new heart allocation policy.

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Background: This study evaluates the impact of the 2018 allocation policy change on outcomes of orthotopic heart transplantation (OHT) in patients bridged with intra-aortic balloon pumps (IABPs). Methods: Adult (≥18 years) patients undergoing OHT between 2013 and 2019 who were bridged with an IABP were stratified based on temporal relation to the policy change. Univariate analysis was used to compare baseline characteristics and postoperative outcomes. Multivariate Cox regression analysis was used to estimate risk-adjusted predictors of post-transplant mortality. Results: A total of 1342 (8.6%) OHT patients were bridged with an IABP during the study period. Rates of bridging with IABP to OHT increased significantly after the policy change (7.0% versus 24.9%, P <0.001). The mean recipient age was 54.1±12.1 years with 981 (73.1%) patients being male. Baseline characteristics were similar between the 2 groups whereas post–policy change patients spent fewer days on the waitlist (15 versus 35 days, P <0.001), had longer ischemic times (3.5 versus 3.0 hours, P <0.001), and received organs from a greater distance (301 versus 105 miles, P <0.001). By multivariable analysis, days on the waitlist (for every 30 days; odds ratio, 1.01 [95% CI, 1.00–1.02], P =0.031) and diabetes mellitus (odds ratio, 1.87 [95% CI, 1.16–3.02], P =0.011) emerged as significant predictors of post-transplant mortality. After the policy change, waitlisted patients requiring IABP support were more likely to survive to transplant (76.4 versus 89.8%, P <0.001). Conclusions: IABP utilization has increased over 3-fold since the 2018 policy change with improved waitlist outcomes and comparable post-OHT survival. Thus, bridging patients to OHT with IABPs appears to be an effective strategy in the current era.

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Background Cardiogenic shock (CS) is a heterogeneous syndrome with varied presentations and outcomes. We used a machine learning approach to test the hypothesis that patients with CS have distinct phenotypes at presentation, which are associated with unique clinical profiles and in‐hospital mortality. Methods and Results We analyzed data from 1959 patients with CS from 2 international cohorts: CSWG (Cardiogenic Shock Working Group Registry) (myocardial infarction [CSWG‐MI; n=410] and acute‐on‐chronic heart failure [CSWG‐HF; n=480]) and the DRR (Danish Retroshock MI Registry) (n=1069). Clusters of patients with CS were identified in CSWG‐MI using the consensus k means algorithm and subsequently validated in CSWG‐HF and DRR. Patients in each phenotype were further categorized by their Society of Cardiovascular Angiography and Interventions staging. The machine learning algorithms revealed 3 distinct clusters in CS: "non‐congested (I)", "cardiorenal (II)," and "cardiometabolic (III)" shock. Among the 3 cohorts (CSWG‐MI versus DDR versus CSWG‐HF), in‐hospital mortality was 21% versus 28% versus 10%, 45% versus 40% versus 32%, and 55% versus 56% versus 52% for clusters I, II, and III, respectively. The "cardiometabolic shock" cluster had the highest risk of developing stage D or E shock as well as in‐hospital mortality among the phenotypes, regardless of cause. Despite baseline differences, each cluster showed reproducible demographic, metabolic, and hemodynamic profiles across the 3 cohorts. Conclusions Using machine learning, we identified and validated 3 distinct CS phenotypes, with specific and reproducible associations with mortality. These phenotypes may allow for targeted patient enrollment in clinical trials and foster development of tailored treatment strategies in subsets of patients with CS.

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Background This study evaluated the impact of hepatitis C–positive ( HCV +) donors on outcomes of heart transplantation in the United States. Methods and Results Adults undergoing isolated heart transplantation in the United States between January 1, 2016, and December 31, 2018, were included. The primary outcome was 1‐year post‐transplant survival. Multivariable Cox regression and 2:1 propensity matching were used to compare outcomes between transplants with HCV + and hepatitis C–negative ( HCV −) donors. A subanalysis was performed to evaluate the impact of nucleic acid amplification test positivity on outcomes. Of 7889 isolated heart transplants performed during the study period, 343 (4.4%) used HCV + donors. Overall unadjusted 1‐year posttransplant survival was not statistically different between HCV − versus HCV + donors (91.1% versus 90.2%; P =0.86), a finding that persisted after risk adjustment (hazard ratio, 1.05; 95% CI, 0.70–1.58; P =0.80). Propensity matching resulted in 675 well‐balanced patients (437 HCV − and 238 HCV +). Overall 1‐year posttransplant survival was not statistically different in propensity‐matched analysis (89.8% HCV − versus 89.2% HCV +; P =0.88). Rates of 1‐year drug‐treated rejection (21.1% versus 22.1%; P =0.84), postoperative dialysis (11.4% versus 14.7%; P =0.22), and stroke (4.6% versus 2.1%; P =0.10) were also not statistically different between HCV − and HCV + groups, respectively. Outcomes were not statistically different between nucleic acid amplification test–negative and nucleic acid amplification test–positive HCV + donors. Conclusions Adult heart transplants using HCV + donors, including those that are nucleic acid amplification test positive, can be performed without an adverse impact on 1‐year survival. Wider implementation of protocols for using HCV + donors and an assessment of longer‐term outcomes including seroconversion rates will be important in maximizing the effect of HCV + donors on national donor shortages.