Presentation and outcomes of women and men undergoing surgery for degenerative mitral regurgitation.

BACKGROUND: Degenerative mitral regurgitation is associated with heart failure, arrhythmia, and mortality. The impact of sex on timing of surgical referral and outcomes has not been reported comprehensively. We examined preoperative status and surgical outcomes of male versus female DMR patients undergoing surgery. METHODS: We reviewed our institutional database for all patients undergoing surgery for degenerative mitral regurgitation between 2013 and 2021. Preoperative clinical and echocardiographic variables, surgical characteristics, and outcomes were compared; and left atrial strain in available images. RESULTS: Of 963 patients, 314 (32.6%) were female. Women were older (67 vs. 64 years, p = 0.031) and more often had bileaflet prolapse (19.4% vs. 13.8%, p = 0.028), mitral annular calcification (12.1% vs. 5.4%, p < 0.001) and tricuspid regurgitation (TR; 31.8% vs. 22.5%, p = 0.001). Indexed left ventricular end-diastolic and end-systolic diameters were higher in women, with 29.4 vs. 26.7 mm/m2 (p < 0.001) and 18.2 vs. 17 mm/m2 (p < 0.001), respectively, and left atrial conduit strain lower (17.6% vs, 21.2%, p = 0.001). Predicted risk of mortality was 0.73% vs. 0.54% in men (p = 0.023). Women required mechanical circulatory support more frequently (1.3% vs 0%, p = 0.011), had longer intensive care unit stay (29 vs. 26 hours, p < 0.001), mechanical ventilation (5.4 vs. 5 hours, p = 0.036), and overall hospitalization (7 vs. 6 days, p < 0.001). There was no difference in long-term re-operation-free survival (p = 0.35). CONCLUSIONS: Women undergoing mitral valve repair are older and show indicators of more advanced disease with long-standing left ventricular impairment. Guidelines may need to be adjusted and address this disparity, to improve postoperative recovery times and outcomes.

The Public Health Service "Increased Risk" 2020 Policy Change Has not Improved Organ Utilization in the United States: A Nationwide Cohort Study.

Objective: To assess the effects of the 2020 United States Public Health Service (PHS) "Increased Risk" Guidelines update. Background: Donors labeled as "Increased Risk" for transmission of infectious diseases have been found to have decreased organ utilization rates despite no significant impact on recipient survival. Recently, the PHS provided an updated guideline focused on "Increased Risk" organ donors, which included the removal of the "Increased Risk" label and the elimination of the separate informed consent form, although the actual increased risk status of donors is still ultimately transmitted to transplant physicians. We sought to analyze the effect of this update on organ utilization rates. Methods: This was a retrospective analysis of the Organ Procurement and Transplantation Network database which compared donor organ utilization in the 2 years before the June 2020 PHS Guideline update for increased-risk donor organs (June 2018-May 2020) versus the 2 years after the update (August 2020-July 2022). The organ utilization rate for each donor was determined by dividing the number of organs transplanted by the total number of organs available for procurement. Student t test and multivariable logistic regression models were used for analysis. Results: There were 17,272 donors in the preupdate cohort and 17,922 donors in the postupdate cohort; of these, 4,977 (28.8%) and 3,893 (21.7%) donors were considered "Increased Risk", respectively. There was a 2% decrease in overall organ utilization rates after the update, driven by a 3% decrease in liver utilization rates and a 2% decrease in lung utilization rates. After multivariable adjustment, donors in the postupdate cohort had 10% decreased odds of having all organs transplanted. Conclusions: The 2020 PHS "Increased Risk" Donor Guideline update was not associated with an increase in organ utilization rates in the first 2 years after its implementation, despite a decrease in the proportion of donors considered to be at higher risk. Further efforts to educate the community on the safe usage of high-risk organs are needed and may increase organ utilization.

Early Outcomes in Patients With LVAD Undergoing Heart Transplant via Use of the SherpaPak Cardiac Transport System.

BACKGROUND: Heart transplant (HT) in recipients with left ventricular assist devices (LVADs) is associated with poor early post-HT outcomes, including primary graft dysfunction (PGD). As complicated heart explants in recipients with LVADs may produce longer ischemic times, innovations in donor heart preservation may yield improved post-HT outcomes. The SherpaPak Cardiac Transport System is an organ preservation technology that maintains donor heart temperatures between 4 °C and 8 °C, which may minimize ischemic and cold-induced graft injuries. This analysis sought to identify whether the use of SherpaPak versus traditional cold storage was associated with differential outcomes among patients with durable LVAD undergoing HT. METHODS: Global Utilization and Registry Database for Improved Heart Preservation-Heart (NCT04141605) is a multicenter registry assessing post-HT outcomes comparing 2 methods of donor heart preservation: SherpaPak versus traditional cold storage. A retrospective review of all patients with durable LVAD who underwent HT was performed. Outcomes assessed included rates of PGD, post-HT mechanical circulatory support use, and 30-day and 1-year survival. RESULTS: SherpaPak (n=149) and traditional cold storage (n=178) patients had similar baseline characteristics. SherpaPak use was associated with reduced PGD (adjusted odds ratio, 0.56 [95% CI, 0.32-0.99]; P=0.045) and severe PGD (adjusted odds ratio, 0.31 [95% CI, 0.13-0.75]; P=0.009), despite an increased total ischemic time in the SherpaPak group. Propensity matched analysis also noted a trend toward reduced intensive care unit (SherpaPak 7.5±6.4 days versus traditional cold storage 11.3±18.8 days; P=0.09) and hospital (SherpaPak 20.5±11.9 days versus traditional cold storage 28.7±37.0 days; P=0.06) lengths of stay. The 30-day and 1-year survival was similar between groups. CONCLUSIONS: SherpaPak use was associated with improved early post-HT outcomes among patients with LVAD undergoing HT. This innovation in preservation technology may be an option for HT candidates at increased risk for PGD. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT04141605.

Increasing Utilization of Extended Criteria Donor Hearts for Transplantation: The OCS Heart EXPAND Trial.

BACKGROUND: Extended criteria donor (ECD) hearts available with donation after brain death (DBD) are underutilized for transplantation due to limitations of cold storage. OBJECTIVES: This study evaluated use of an extracorporeal perfusion system on donor heart utilization and post-transplant outcomes in ECD DBD hearts. METHODS: In this prospective, single-arm, multicenter study, adult heart transplant recipients received ECD hearts using an extracorporeal perfusion system if hearts met study criteria. The primary outcome was a composite of 30-day survival and absence of severe primary graft dysfunction (PGD). Secondary outcomes were donor heart utilization rate, 30-day survival, and incidence of severe PGD. The safety outcome was the mean number of heart graft-related serious adverse events within 30 days. Additional outcomes included survival through 2 years benchmarked to concurrent nonrandomized control subjects. RESULTS: A total of 173 ECD DBD hearts were perfused; 150 (87%) were successfully transplanted; 23 (13%) did not meet study transplantation criteria. At 30 days, 92% of patients had survived and had no severe PGD. The 30-day survival was 97%, and the incidence of severe PGD was 6.7%. The mean number of heart graft-related serious adverse events within 30 days was 0.17 (95% CI: 0.11-0.23). Patient survival was 93%, 89%, and 86% at 6, 12, and 24 months, respectively, and was comparable with concurrent nonrandomized control subjects. CONCLUSIONS: Use of an extracorporeal perfusion system resulted in successfully transplanting 87% of donor hearts with excellent patient survival to 2 years post-transplant and low rates of severe PGD. The ability to safely use ECD DBD hearts could substantially increase the number of heart transplants and expand access to patients in need. (International EXPAND Heart Pivotal Trial [EXPANDHeart]; NCT02323321; Heart EXPAND Continued Access Protocol; NCT03835754).