Background Since the United Network for Organ Sharing (UNOS) allocation system change patients listed for orthotopic heart transplant (OHT) are more likely to be on temporary mechanical circulatory support (tMCS). Limited sex specific data exits for use and outcomes of tMCS since the allocation change. Methods We queried the UNOS registry for patients listed for OHT on tMCS from October 1, 2015 to June 28, 2023, comparing baseline characteristics and outcomes between sexes pre- and post- allocation change. Results Women comprised 23% of patients listed for OHT on tMCS before and after the allocation change, despite similar cardiac index (CI) compared with men (pre: 2.03 vs 2.09 L/min m2 p=0.21; post: 1.92 vs 1.92 L/min m2 p=0.89). Women were significantly younger (54 vs 57 years; p<0.001), had lower BMI (26.9 vs 27.2; p 0.006), were more likely to be on intra-aortic balloon pump (IABP) (67% vs 61% p <0.001) and had shorter waitlist times (13 vs 16 days; p <0.001). Waitlist mortality decreased similarly for both sexes (3.6% vs 3.8%; p= 0.7). There was no significant difference in 1-year post-transplant survival between the sexes in either era (HR: 0.9, 95% CI: 0.76, 1.06 p=0.2), however, 1-year post-transplant survival improved overall for patients bridged with tMCS post allocation change independent of sex (HR 0.70 (95% CI: 0.54 to 0.90; p=0.005). Conclusion Despite an increase in the use of tMCS as a bridge to OHT since the UNOS allocation change, women comprise less than a quarter of patients listed on tMCS despite similar CI, suggesting possible underuse in women. Notably, for those bridged to OHT in the post allocation era, waitlist mortality has improved for both sexes and 1-year post-transplant survival has also improved independent of sex. ### Competing Interest Statement The authors have declared no competing interest. ### Funding Statement No funding ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: Atrium Health (IRB #02-21-06E) I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes All data included in the manuscript will be made available.

OBJECTIVE:The United States' experience with heart transplantation following donation after circulatory death (DCD HT) has expanded since clinical adoption in 2019. We aimed to examine a large institution's outcomes associated with DCD HT versus HT following donation after brain death (DBD). METHODS:Adult heart recipients and corresponding donors at a single quaternary academic center from January 2019 to October 2024 were included. Recipient and donor data were extracted from the institution's electronic medical record and the United Network for Organ Sharing registry, respectively. The primary outcome was overall survival. RESULTS:In total, 553 heart donors and recipients met inclusion criteria, including 404 (73%) DBD and 149 (27%) DCD recipients. Recipients of DCD allografts were less likely to have an intra-aortic balloon pump before transplant, but there was no significant difference in waitlist status at the time of transplant between the 2 groups. DCD allografts had increased total ischemic time (defined by United Network for Organ Sharing registry as time between donor explant and re-perfusion in the recipient) (5.7 vs 3.7 hours; P < .001) and distance to travel (381 vs 299 miles; P = .001) compared with DBD allografts. Unadjusted Kaplan-Meier survival analysis demonstrated no significant difference between DCD and DBD recipients' cumulative survival (log-rank P = .14). The rate of severe primary graft dysfunction was not significantly different between groups (12% DCD vs 11% DBD; P = .65). CONCLUSIONS:Cardiac allografts from DCD donors perform similarly to a contemporary population of DBD allografts. The rate of severe primary graft dysfunction and the unadjusted cumulative survival were not significantly different between DCD and DBD cohorts.

Transplantation is one of the few life-saving therapies for patients with end-stage organ disease, yet organ availability remains restrictive. Expanding donors to include those with hepatitis B virus (HBV) infection, incorporating HBV nucleic acid amplification testing (NAT) positive donors, could improve organ access. However, the risk of donor-derived HBV transmission and recipient management of organs transplanted from HBV NAT-positive donors, particularly in thoracic organ recipients, is limited. We conducted a single-center retrospective study to assess the safety and outcomes in recipients of non-hepatic organ transplants from HBV NAT-positive donors. Over a 4.5-year period, 25 transplant recipients, including 16 thoracic organ recipients, received organs from 22 unique, qualitative HBV NAT-positive donors. All recipients were HBV surface antibody-positive prior to transplant. Quantitative NAT was performed in 20/22 (91%) donors with values ranging from 0 to 1 280 000 IU/mL; 8/22 (36%) donors had HBV NAT values that were undetected or below the lower limit of quantification. All recipients were administered HBV immunoglobulin (HBIG) and received HBV active antiviral therapy post-transplant. Recipients were followed post-transplant for a median of 250 days (IQR: 169-467 days). No recipients developed de novo HBV infection characterized by HBV surface antigen (HBsAg) seroconversion, quantifiable HBV NAT detection, or sustained HBV core antibody (HbcAb) seroconversion post-transplant. Similarly, no recipient developed liver dysfunction or died due to HBV infection. Quantifying HBV from NAT-positive donors may better inform the risk of donor-derived infection in recipients, and the use of these organs incorporating a multimodal prevention strategy could safely increase the donor pool.

BACKGROUND:The benefit of implantable cardioverter-defibrillators (ICDs) and cardiovascular resynchronization therapy defibrillators (CRT-Ds) in patients supported with a HeartMate 3 left ventricular assist device (LVAD) remains uncertain. METHODS:An analysis was done of the Multicenter Study of MAGLEV Technology in Patients Undergoing Mechanical Circulatory Support Therapy with HeartMate 3 (MOMENTUM 3) randomized clinical trial and the first 1000 patients in the Continued Access Protocol (CAP) trial. Patients were divided into 3 groups based on the presence of an ICD and/or CRT-D: No device (n = 153, 11%), ICD only (n = 699, 50.4%), and CRT-D (n = 535, 38.6%). We assessed the association of ICDs or CRT-Ds with overall mortality, ventricular arrhythmias (VAs), rehospitalization rates, quality of life, and the 6-minute walk test distance at 2 years' follow-up. RESULTS:Patients with an ICD or CRT-D had similar survival to those without (hazard ratio [HR], 1.3; 95% CI 0.8-2.1, P = .36) with no differences in rehospitalizations, quality of life or 6-minute walk test distance. VA occurred more frequently in patients with an ICD or CRT-D (HR, 2.4; 95% CI 1.3-4.3, P = .006). Compared with an ICD alone, patients with a CRT-D demonstrated similar survival (HR, 1.1; 95% CI 0.9-1.5, P = .36). However, they had increased rates of VA (HR, 1.3; 95% CI 1.0-1.7, P = .03). There were no differences in rate of rehospitalization between those with an ICD or CRT-D and those without (P = .19) or between those with an ICD and those with a CRT-D (P = .32). A propensity-matched sensitivity analysis confirmed these findings. CONCLUSIONS:In this post-hoc analysis of the MOMENTUM 3 trial, the presence of an ICD or CRT-D at the time of HM3 LVAD implantation was associated with an increased incidence of VA but was not associated with survival, quality of life, or functional capacity. TRIAL REGISTRATION:Momentum 3 portfolio, NCT02224755 (Pivotal) and NCT02892955 (CAP).

BACKGROUND:Outcomes for patients living with heart failure (HF) remain poor with high rates of death and hospitalization due to worsening HF. Noninvasive tools may be useful to identify patients at risk for disease progression before these outcomes occur. For example, loss of cell mass and compromised cell membrane integrity throughout the body are associated with chronic disease, mortality, frailty, and malnutrition. As the cell membrane loses its integrity, its electrical capacitance decreases, lowering bioelectrical phase angle. Data collected during the SCALE-HF 1 study (NCT04882449) was used to evaluate bioelectrical phase angle as a marker for heart failure (HF) hospitalization risk. Phase angle was measured by the FDA-cleared Bodyport Cardiac Scale. METHODS:SCALE-HF 1 was a multicenter, prospective, observational study, investigating HF event prediction. Baseline phase angle was measured during the first week in the study with the patient standing barefoot on the Cardiac Scale at home for approximately 20 seconds. HF hospitalizations were independently adjudicated. The analysis was based on univariable and multivariable Cox regression models adjusted for age, sex, race, body mass index (BMI), left ventricular ejection fraction (LVEF), inpatient status at enrollment, and selected comorbidities and laboratory tests. RESULTS:329 participants with HF were enrolled across 8 US sites with 238 patient-years of follow-up. 312 (95%) of the participants had a baseline phase angle, and 57 (18%) of those had a HF hospitalization during the follow-up period. Participants with baseline phase angle in the lowest quartile (suggesting worse cell membrane integrity) were at increased risk for HF hospitalization compared to participants with baseline phase angle in the highest quartile (Hazard ratio: 3.44, 95% CI: 1.55 to 7.63, P = .002). When adjusted for risk factors selected from age, sex, race, BMI, LVEF, laboratory tests and comorbidities in the multivariable model, participants with baseline phase angle in the lowest quartile continued to be at increased risk for HF hospitalization compared to participants with baseline phase angle in the highest quartile (Hazard ratio: 3.51, 95% CI: 1.73 to 7.12, P < .001). CONCLUSIONS:Phase angle was found to be independently associated with HF hospitalization risk. The noninvasive measurement, acquired with a familiar scale form factor, may help guide remote care and triage. TRIAL REGISTRATION:ClinicalTrials.gov NCT04882449. https://clinicaltrials.gov/study/NCT04882449.

Organ allocation guidelines prioritize patients at risk of waitlist mortality. In the United States, both the heart and lung allocation systems were revised within the last ten years. There is no specific allocation system for patients listed for combined heart-lung transplant. With updates to the heart and lung allocation systems, we have observed that combined heart-lung transplant patients can face unnecessarily long wait times. A focused listing pathway to better prioritize potential combined heart-lung transplant recipients could help ensure the appropriate patients are transplanted effectively and efficiently.

Background:Persons with human immunodeficiency virus (PWH) are living longer, leading to increased end-organ disease from chronic illness. Organ transplantation improves survival in patients with end-organ disease yet remains a constrained resource due to limited access. We aimed to better understand barriers to transplantation for thoracic end-organ disease in PWH. Methods:We performed a retrospective study of patients referred to our center for consideration of thoracic organ transplant and assessed the factors associated with transplant eligibility in candidates with human immunodeficiency virus (HIV). We also assessed clinical outcomes in PWH progressing to transplant. Results:Over a 10-year period, 30 HIV-seropositive candidates and 10,905 HIV-seronegative candidates were referred to our center. Of candidates referred, 40% (12 of 30) of HIV-seropositive candidates were waitlisted compared to 20% (2,172 of 10,905) of HIV-seronegative candidates (p = 0.006). The median time from referral to waitlist activation in HIV-seropositive and HIV-seronegative candidates was similar (103 days vs 102 days, respectively; p = 0.92). Eight (27%) HIV-seropositive candidates underwent transplant compared to 1,962 (18%) HIV-seronegative candidates (p = 0.22). The median waitlist time in HIV-seropositive and HIV-seronegative candidates was similar (20 days vs 16 days, respectively; p = 0.98). Of the 8 HIV-seropositive transplant recipients, no recipient developed any HIV-associated complication, and 7 recipients (88%) survived beyond 1 year. Conclusions:HIV-seropositive thoracic transplant candidates were more likely to be waitlisted compared to HIV-seronegative candidates. Progression to transplant and waitlist times were similar between candidates with and without HIV. Our study suggests that HIV alone was not a significant barrier to transplantation in PWH when referred and evaluated for thoracic organ transplantation.

BACKGROUND:Among patients with heart failure (HF), guideline-directed medical therapy (GDMT) remains underutilized. Remote digital interventions may facilitate rapid initiation and uptitration of GDMT; however, potential benefits have not been evaluated in well-powered trials. The VITAL-HF (Virtual Care to Improve Heart Failure Outcomes) trial assessed the safety and efficacy of a remote, digital intervention targeting GDMT optimization versus usual care in participants with HF with reduced ejection fraction (HFrEF). METHODS:VITAL-HF was a multicenter, randomized-controlled trial of 178 participants with HFrEF. Eligibility included smartphone access, English proficiency, and left ventricular ejection fraction ≤40%. Participants were randomized to receive either the remote, digital intervention (Story Health HF GDMT Titration Program) or usual care for 6 months. The primary outcome was change from baseline in GDMT using the HF Collaboratory Score (HFC), an expert-defined score integrating use and dose of prescribed GDMT. Secondary outcomes included healthcare visits related to symptomatic hypotension, hyperkalemia, and angioedema. RESULTS:The median age was 66.4 (Q1-Q3: 56.1-73.1) years and 38.8% were female. Major comorbidities included hypertension (71.3%), coronary artery disease (45.5%), atrial fibrillation/flutter (31.5%), and type 2 diabetes (28.1%). At enrollment, the median HFC score was 5 (Q1-Q3: 4-6) with 84.8% on an evidence-based beta blocker, 48.9% on an angiotensin receptor neprilysin inhibitor, 48.9% on a mineralocorticoid receptor antagonist, and 47.2% on a sodium-glucose cotransporter-2 inhibitor. CONCLUSIONS:The VITAL-HF trial results will provide valuable insights into the safety and efficacy of a remote, digital intervention to improve the use and intensification of GDMT for patients with HFrEF. TRIAL REGISTRATION:ClinicalTrials.gov Identifier: NCT05602454; ClinicalTrials.gov URL: https://clinicaltrials.gov/study/NCT05602454.

BACKGROUND:Tricuspid regurgitation (TR) is common immediately after orthotopic heart transplantation (OHT), though the expected outcomes of TR over time remain undefined. In this study, we examined the natural trajectory of TR in the first 120 days post-transplantation. We observed the clinical phenotypes of trajectories of TR after OHT, and assessed trajectory correlation with 1-year mortality and degree of right ventricular (RV) dysfunction. METHODS:All patients who underwent OHT at a single institution from January 2009 to July 2019 were included, unless death occurred during the index hospitalization. TR and RV dysfunction on follow-up transthoracic echocardiograms were tracked on 4-point scales and latent-class mixed modeling (LCMM) identified classes of TR trajectories. Fisher's exact test was used to compare 1-year mortalities between classes. RESULTS:Based on LCMM, four distinct classes of TR trajectories emerged, characterized as sustained (n = 40), variable (n = 172), stable (n = 175), and recovered (n = 189) TR. Significant differences in mortality rates were found amongst classes at 10.0%, 8.1%, 4.0%, and 2.6%, respectively (p = 0.025). The degree of RV dysfunction mirrored TR severity in all subsets except the sustained TR group. CONCLUSIONS:The trajectory of TR in the first 120 days post-OHT is associated with 1-year mortality. In many subsets, there is a close association with TR grade and RV function improvement. However, in the sustained TR group, RV function improved without subsequent improvement in TR severity. These findings could identify patients with higher mortality risk for whom more frequent follow-up or intervention is warranted.

There is a pressing need to translate evidence for heart failure (HF) therapies into contemporary practice. Medications that improve HF morbidity and mortality remain underused because of complex barriers at multiple levels across the health care ecosystem. High-quality implementation trials demonstrate that specific interventions can increase prescription, intensification, and persistence of HF medication. However, evidence-based interventions have not been widely implemented across health care organizations in the United States. This review explores 5 key strategies—patient activation, audit and feedback, rapid intensive initiation of medical therapy, virtual care teams, and clinical decision support tools—and discusses barriers to their widespread adoption. Although some barriers are specific to an intervention, others stem from systemic limitations among health care organizations and the health policy landscape. Using lessons learned from recent trials, this review also highlights future investigations needed to address these barriers, encourages uptake of successful implementation strategies, and discusses common approaches that should be abandoned.

BACKGROUND:We previously reported that concurrent tricuspid valve surgery (TVS) was not associated with a lower incidence of early right heart failure (RHF) in patients undergoing durable left ventricular assist device (LVAD) implantation. This follow-up analysis aimed to further define the clinical impact of concurrent TVS after 2 months of follow-up. METHODS:Patients with moderate or severe tricuspid regurgitation (TR) on preoperative echocardiography (n = 71) were randomized to LVAD implantation either alone (no TVS group; n = 34) or with concurrent TVS (TVS group; n = 37). Randomization was stratified by preoperative right ventricular dysfunction. The patients were followed for at least 12 months after surgery. The incidence of RHF was determined by an adjudication committee using Interagency Registry for Mechanically Assisted Circulatory Support criteria. Functional studies and repeat echocardiography were performed at 12 months. RESULTS:Demographics were similar in the 2 study arms. At 12 months, the rate of moderate or severe RHF was 50.0% in the no TVS arm versus 51.4% in the TVS arm. No patients developed RHF between 6 and 12 months following the procedure. Death from RHF was 5.4% in the TVS arm versus 8.8% in the no TVS arm. At 12 months, there was no significant difference in TR severity between the 2 arms, owing to improvement in TR severity in the no TVS arm. Cardiopulmonary exercise testing at 12+ months revealed no significant between-group difference in peak oxygen consumption. CONCLUSIONS:In patients with significant preimplantation TR, the severity of TR improved over time in the no TVS arm with LVAD implantation alone. By 12 months, there was no significant difference in TR severity between the 2 arms. This may account for the lack of difference in late clinical or functional parameters.

Outflow graft obstruction (OGO) is an under-reported but severe complication after insertion of magnetically levitated centrifugal-flow left ventricular assist devices (LVADs). The optimal treatment and long-term outcomes have not been well-described. We report a retrospective single high-volume center's experience with surgical exploration for OGO from June 2019 to October 2023. Outflow graft obstruction was identified in 19 LVAD recipients from a total experience of 550 LVAD implants (3.3%). Median time of LVAD support to development of OGO was 32.5 months (interquartile range [IQR], 28-47.5). Low-flow alarms were the most common presentation, followed by dyspnea on exertion, and syncope. Computed tomography angiography (CTA) and echocardiography were the most common diagnostic modalities. Aortic valve opening with every beat and worsened mitral insufficiency were both more common at presentation compared to prior echocardiographic studies. Surgical excision of the bend relief (BR) and evacuation of proteinaceous material between the BR and the outflow graft immediately improved hemodynamics and LVAD function. There were no in-hospital mortalities, and all patients were discharged home after a median length of stay of 9 days (IQR, 10-21). All but four patients were alive at median follow-up 21 months. Thirteen of the 19 patients were readmitted a total of 50 times, none for recurrent OGO.

Despite improvements in managing earlier stage heart disease, the population of patients needing heart transplants continues to increase in the United States. Fortunately, novel methods of procuring and preserving donor hearts, including the use of ex-vivo heart perfusion and controlled hypothermic preservation, have enabled a rise in heart transplantation. In particular, ex-vivo heart perfusion has contributed to increased utilization of donation after circulatory death (DCD), as well as enhanced use of donor hearts from increased geographic distances and extended criteria (marginal) donors. The use of such preservation technologies, however, has coincided with a significant increase in the cost of donor heart procurement and the advent of a donor organ procurement services industry. We aim to provide an overview on the rising costs of heart donation, explore the causes of such increase, and discuss potential solutions to drive both cost savings and increased access to heart transplantation.

BACKGROUND:Out-of-sequence (OOS) allocation is a mechanism by which donor organs are offered outside the standard match run, typically to expedite the placement of hard-to-match or time-sensitive allografts. Rising OOS rates are described in abdominal organ transplantation, but limited data exist regarding OOS practices in heart transplantation. METHODS:The United Network for Organ Sharing (UNOS) was used to identify all adult heart transplant recipients and corresponding donors between January 2015 and March 2024. The Potential Transplant Recipient file was then used to classify each donation as either in-sequence or out-of-sequence. We assessed temporal trends and practice patterns in relation to OOS allocation. Additionally, we evaluated donor and recipient characteristics and post-transplant survival outcomes. RESULTS:Within the study period, there were 25,608 heart transplantations, of which 509 (2%) were from OOS donors. OOS allocation increased 2-fold over the study period (1.4%-3.1%). Use varied across Organ Procurement Organizations (OPOs) (0-5.4%) and transplant centers (0-16.7%), with a small subset of OPOs accounting for the majority of OOS allocations. Recipients of OOS-allocated allografts were more likely to be nonhospitalized older females with type O blood group. There was no significant difference in overall survival rates between OOS and in-sequence recipients at 1 year (93.1% vs 91.6%, respectively). CONCLUSIONS:OOS heart allocation, while rare, is increasing, and varies by geography and OPO. The OOS mechanism may provide an opportunity to improve organ recovery and support transplant access for harder-to-match candidates. However, standardization of OOS practices is needed to ensure equity in transplant access.

BACKGROUND:Patients with heart failure (HF) remain at high risk for hospitalization and death, in part, due to underuse of available HF pharmacological therapy. Digital interventions may facilitate rapid initiation and titration of HF pharmacological therapy, but they have not been systematically evaluated in adequately powered, randomized, control trials. In the AIM-POWER study, we evaluated the safety and efficacy of the BiovitalsHF DTx decision-support platform as a strategy to guide optimal initiation and titration of pharmacological therapy in patients with HF with reduced ejection fraction (HFrEF). METHODS AND RESULTS:We enrolled 122 participants with symptomatic HFrEF (left ventricular ejection fraction ≤ 40%) who had not yet been optimized on HF pharmacological therapy. Participants were randomized 1:1 in an open-label fashion to management; they were supported by BiovitalsHF or usual care. Using wearable home-based monitors and digital scales, the BiovitalsHF platform assembled data regarding patients' status and formulated suggestions regarding initiation and titration of HF pharmacological therapy per published guidelines. These recommendations were provided to site clinicians, but final decisions about prescribing and titration were left to the sites. The primary outcome was the between-group difference in the change in an HF optimal medical therapy score from baseline-90 days. CONCLUSION:The results of the AIM-POWER study will provide important insights into digital interventions for HF management and will evaluate the effectiveness of BiovitalsHF in improving the use and dosing of pharmacological therapy for participants with HFrEF.