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Background: The 2018 UNOS allocation policy change deprioritized geographic boundaries to organ distribution, and the effects of this change have been widespread. The aim of this investigation was to analyze changes in donor transplant center distance for organ travel and corresponding outcomes before and after the allocation policy change., Methods: The UNOS database was utilized to identify all adult patients waitlisted for heart transplants from 2016 to 2021. Transplant centers were grouped by average donor heart travel distance based on whether they received more or less than 50% of organs from >250 miles away. Descriptive statistics were provided for waitlisted and transplanted patients. Regression analyses modeled waitlist mortality, incidence of transplant, overall survival, and graft survival., Results: Centers with a longer average travel distance had a higher mean annual transplant volume with a reduction in total days on a waitlist (86.6 vs. 149.2 days), an increased cold ischemic time (3.6 vs. 3.2 h), with no significant difference in post-transplant overall survival or graft survival., Conclusions: The benefits of reducing waitlist time while preserving post-transplant outcomes extend broadly. The trends observed in this investigation will be useful as we revise organ transplant policy in the era of new organ procurement and preservation techniques., (© 2024 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.)

Background: Data showing the efficacy and safety of the transplantation of hearts obtained from donors after circulatory death as compared with hearts obtained from donors after brain death are limited., Methods: We conducted a randomized, noninferiority trial in which adult candidates for heart transplantation were assigned in a 3:1 ratio to receive a heart after the circulatory death of the donor or a heart from a donor after brain death if that heart was available first (circulatory-death group) or to receive only a heart that had been preserved with the use of traditional cold storage after the brain death of the donor (brain-death group). The primary end point was the risk-adjusted survival at 6 months in the as-treated circulatory-death group as compared with the brain-death group. The primary safety end point was serious adverse events associated with the heart graft at 30 days after transplantation., Results: A total of 180 patients underwent transplantation; 90 (assigned to the circulatory-death group) received a heart donated after circulatory death and 90 (regardless of group assignment) received a heart donated after brain death. A total of 166 transplant recipients were included in the as-treated primary analysis (80 who received a heart from a circulatory-death donor and 86 who received a heart from a brain-death donor). The risk-adjusted 6-month survival in the as-treated population was 94% (95% confidence interval [CI], 88 to 99) among recipients of a heart from a circulatory-death donor, as compared with 90% (95% CI, 84 to 97) among recipients of a heart from a brain-death donor (least-squares mean difference, -3 percentage points; 90% CI, -10 to 3; P<0.001 for noninferiority [margin, 20 percentage points]). There were no substantial between-group differences in the mean per-patient number of serious adverse events associated with the heart graft at 30 days after transplantation., Conclusions: In this trial, risk-adjusted survival at 6 months after transplantation with a donor heart that had been reanimated and assessed with the use of extracorporeal nonischemic perfusion after circulatory death was not inferior to that after standard-care transplantation with a donor heart that had been preserved with the use of cold storage after brain death. (Funded by TransMedics; ClinicalTrials.gov number, NCT03831048.)., (Copyright © 2023 Massachusetts Medical Society.)

In donation after circulatory death donors, warm ischemia time is a significant threat to successful cardiac transplantation. The ability to perfuse these organs during the minutes after death, until cardiac evaluation is completed to satisfaction, is crucial in limiting total warm ischemic time. Thoracoabdominal normothermic regional perfusion (TANRP) has emerged as a promising strategy for recovering and monitoring these hearts. We propose a series of clinical practice pearls that we follow for all donation after circulatory death procurements to streamline the process of setting up a TANRP circuit and ensuring all team members present at time procurement are familiar with the procedure. Bicaval cannulation is achieved via the abdomen for aortic cannulation, and via the chest for right atrial cannulation, avoiding deairing maneuvers and providing the shortest possible duration from incision to initiation of cardiopulmonary bypass. Here, we describe a series of practice techniques which we have utilized in our early experience with TANRP., Competing Interests: Disclosure: The authors have no funding and conflicts of interest to report., (Copyright © ASAIO 2022.)

Background: Myocardial recovery following left ventricular assist device (LVAD) implantation has been of interest in transplant candidates with non-ischemic cardiomyopathy but is rare. Evidence suggests that a combination of left ventricular unloading and pharmacologic reverse remodeling is beneficial. Recovery in non-transplant candidates (i.e., destination therapy [DT]) patients is believed to be even rarer., Methods: All DT LVADs between January 1, 2017 and November 23, 2020 were reviewed. All patients were subjected to an institutional protocol consisting of combined pharmacologic remodeling and mechanical unloading with proactive screening for recovery. The primary outcome of interest was the cumulative incidence of myocardial recovery. Baseline characteristics and operative outcomes were compared between recovered and non-recovered DT patients using non-parametric tests to identify predictive factors., Results: A total of 49 patients received DT LVADs. Nine patients were identified as myocardial recovery candidates using the protocol screening criteria. Overall, 11 patients underwent formal confirmatory testing for recovery, of which 10 were deemed recovered and underwent LVAD explant, defunctionalization, or transplantation. 37.5% of patients that had a concomitant coronary artery bypass during LVAD implantation achieved recovery. An equal proportion of ischemic and non-ischemic cardiomyopathy patients achieved recovery. The cumulative incidence of myocardial recovery was 25.1% at 36 months. No factors were identified as being predictive of recovery., Conclusion: Myocardial recovery in DT LVAD patients can be achieved at a higher rate than previously reported. Revascularization at the time of LVAD is safe and may be beneficial. LVAD therapy may not be the final destination in these patients., (© 2022 International Center for Artificial Organ and Transplantation (ICAOT) and Wiley Periodicals LLC.)

Background: Body mass index (BMI) is an important consideration for transplant-eligible left ventricular assist device (LVAD) recipients. LVAD therapy's impact on BMI is unclear. We evaluated BMI changes in patients who underwent LVAD implantation. The association between these patients' BMI and the transplant was studied., Methods: This was a retrospective cohort study of patients who underwent LVAD implantation between January 1, 2012 and December 31, 2018 at our institution. Patients were stratified by preoperative BMI (kg/m 2 ) into four groups: <30, 30-34.9, 34.9-39.9, and ≥40. BMI data were collected at 12 and 6 months prior to implantation, time of implantation, and 3- and 6- months postimplantation., Results: A total of 107 patients underwent LVAD implantation at our institution. Data were available for 80 patients. Baseline characteristics included a mean age of 56.0 years, 69% male, and a mean implant BMI of 29.9 ± 6.8 kg/m 2 . The mean BMI (kg/m 2 ) for each of the BMI (kg/m 2 ) groups <30, 30-34.9, 35-39.9, and ≥40 (n = 60, 25, 12, and 10, respectively) was 25.1, 32.5, 36.8, and 43.8, respectively. There was no consistent pattern with weight change across differing implant BMIs. No patient with a BMI of <30 gained sufficient weight to impact transplant candidacy. Twenty-three percent of patients with a BMI of 30-34.9 kg/m 2 , 60% of patients with a BMI of 35-39.9 kg/m 2 , and 87.5% of patients with a BMI of ≥40 kg/m 2 had a 6-month BMI potentially affecting transplant., Conclusions: Associated weight changes during LVAD support may significantly impact transplant candidacy. Higher BMI groups may benefit from multimodal and multidisciplinary targeted weight-loss interventions., (© 2022 International Center for Artificial Organ and Transplantation (ICAOT) and Wiley Periodicals LLC.)

Despite the widespread belief that donor organ availability varies around holidays and seasons, there is little empirical data supporting this long-held belief. Variations in donor heart availability may be of interest to patients and clinicians. The UNOS/OPTN registry was queried for all heart donations from October 1987 through March 2017. Daily heart donation rates were modeled nationally using Poisson regression including splines for year and day of the year. Seasonality was assessed using a likelihood ratio test for the spine terms for day of the year. The holiday effect was assessed using conditional logistic regression. Seasonal plots suggest a significant, although modest, increase in organ availability during the summer months, except for region 1. The regions with the highest amplitude were region 7 (peak: June 21, amplitude: 16.63%) and region 6 (peak: July 5, amplitude: 11.29%). There was no significant difference in the odds of heart donation when comparing holidays vs. non-holidays using national data (odds ratio [95% CI]: 1.01 [0.98, 1.03], P = 0.560) or any regional subsets. There was no observable correlation between donor heart availability and holidays. However, a significant seasonality effect was observed with higher donation rates occurring during warmer months., (© 2021 Steunstichting ESOT. Published by John Wiley & Sons Ltd.)

We studied whether sustained hemodynamic support (>7 d) with the Impella 5.0 heart pump can be used as a bridge to clinical decisions in patients who present with cardiogenic shock, and whether such support can improve their outcomes. We retrospectively reviewed cases of patients who had Impella 5.0 support at our hospital from August 2017 through May 2019. Thirty-four patients (23 with cardiogenic shock and 11 with severely decompensated heart failure) underwent sustained support for a mean duration of 11.7 ± 9.3 days (range, ≤48 d). Of 29 patients (85.3%) who survived to next therapy, 15 were weaned from the Impella, 8 underwent durable left ventricular assist device placement, 4 were escalated to venoarterial extracorporeal membrane oxygenation support, and 2 underwent heart transplantation. The 30-day survival rate was 76.5% (26 of 34 patients). Only 2 patients had a major adverse event: one each had an ischemic stroke and flail mitral leaflet. None of the devices malfunctioned. Sustained hemodynamic support with the Impella 5.0 not only improved outcomes in patients who presented with cardiogenic shock, but also provided time for multidisciplinary evaluation of potential cardiac recovery, or the need for durable left ventricular assist device implantation or heart transplantation. Our study shows the value of using the Impella 5.0 as a bridge to clinical decisions., (© 2021 by the Texas Heart® Institute, Houston.)

Wait times have increased for patients approved for heart transplants. We reviewed United Network for Organ Sharing (UNOS) data for 14,242 patients listed for isolated heart transplant (2009-2013) to develop a risk score model for timing left ventricular assist device (LVAD) implantation in bridge-to-transplant patients. We used a multivariable Cox proportional hazards regression model with subsequent bootstrap resampling for internal validation to develop a scoring system that combined risk factors, weighted by the corresponding regression coefficients, to define an individual's risk score. Four risk factors were identified (body mass index, blood type, region, and urgency status) to be significantly and independently associated with wait time (p < 0.001), showing adequate model discrimination (C = 0.704) and calibration. Higher risk scores correlated with shorter wait times. Our model corresponded closely with observed transplant rates, predicting longer wait times for lower status, larger size, certain blood groups, and some UNOS regions. This tool has the potential to more accurately describe the wait-time duration for an individual patient, which may influence care decisions. The wait-time discrepancies (blood types/regions) reinforce the need to reevaluate the geographic-allocation policy. The proposed review of the UNOS heart allocation policy may make this model especially relevant.

Objective: Many donor and recipient factors influence 1-year survival of patients after cardiac transplantation. To date, a statistical model has not been developed to assess the interplay of these factors in predicting outcomes, so we developed a risk-assessment tool to enhance decision-making., Methods: We analyzed 29 variables that were reported in the United Network for Organ Sharing database for 24,540 cardiac transplantations performed between January 1, 2000, and June 30, 2015. For one half of the patients (the prediction population), a multivariable Cox regression model and the bootstrap resampling method were used to devise a scoring system predicting 1-year survival. The other half (the validation population) were stratified by score into 3 risk categories: high risk, medium risk, and low risk. One-year survival was compared among the 3 groups., Results: Eleven variables were statistically significant in predicting 1-year survival. One-year survival for patients with risk scores of less than or equal to 8, 9 to 15, and greater than 15 were 91.2%, 81.7%, and 64.6%, respectively (P < .001). The C index of the Cox regression model was calculated at 0.62 when using risk score as a continuous predictor., Conclusions: Donor and recipient risk factors influence patient survival after cardiac transplantation. Long-term outcomes may be optimized with a statistically based risk model to improve donor-recipient matching., (Copyright © 2017. Published by Elsevier Inc.)

Congestive heart failure (HF) remains a serious burden in the Western World. Despite advances in pharmacotherapy and resynchronization, many patients have progression to end-stage HF. These patients may be candidates for heart transplant or left ventricular assist device (LVAD) therapy. Heart transplants are limited by organ shortages and in some cases by patient comorbidities; therefore, LVAD therapy is emerging as a strategy of bridge to transplant or as a destination therapy in patients ineligible for transplant. Patients initially ineligible for a transplant may, in certain cases, become eligible for transplant after physiologic improvement with LVAD therapy, and a small number of patients with an LVAD may have sufficient recovery of myocardial function to allow device explantation. This clinically oriented review will describe (1) the most frequently used pump types and aspects of the continuous-flow physiology and (2) the clinical indications for and the shift toward the use of LVADs in less sick patients with HF. Additionally, we review complications of LVAD therapy and project future directions in this field. We referred to the Interagency Registry for Mechanically Assisted Circulatory Support, landmark trials, and results from recently published studies as major sources in obtaining recent outcomes, and we searched for related published literature via PubMed. This review focuses primarily on clinical practice for primary care physicians and non-HF cardiologists in the United States., (Copyright © 2016 Mayo Foundation for Medical Education and Research. Published by Elsevier Inc. All rights reserved.)

Background: Lung transplantation and heart-lung transplantation represent surgical options for treatment of medically refractory idiopathic pulmonary arterial hypertension. The effect of the lung allocation score on wait-list and transplantation outcomes in patients with idiopathic pulmonary arterial hypertension is poorly described., Methods and Results: Adults diagnosed with idiopathic pulmonary arterial hypertension and listed for transplantation in the 80 months before and after the lung allocation score algorithm was implemented (n=1430) were identified in the United Network for Organ Sharing thoracic registry. Patients were stratified by organ listed and pre- and post-lung allocation score era. The cumulative incidences of transplantation and mortality for wait-listed patients in both eras were appraised with competing outcomes analysis. Posttransplantation survival was assessed with the Kaplan-Meier method. These analyses were repeated in propensity-matched subgroups. Cox proportional hazards analysis evaluated the effect of prelisting and pretransplantation characteristics on mortality. We found that patients in the post-lung allocation score era had significantly worse comorbidities; nevertheless, both lung transplantation and heart-lung transplantation candidates in this era enjoyed lower wait-list mortality and a higher incidence of transplantation in unmatched and propensity-matched analyses. On multivariable analysis, heart-lung transplantation and double-lung transplantation were associated with improved survival from the time of wait-listing, as was being listed at a medium- to high-volume institution. Donor/recipient sex matching predicted posttransplantation survival., Conclusions: The incidence of transplantation has increased while wait-list mortality has decreased in patients with idiopathic pulmonary arterial hypertension wait-listed for transplantation in the post-lung allocation score era. Both heart-lung transplantation and double-lung transplantation are predictive of survival in transplantation candidates with idiopathic pulmonary arterial hypertension, as is being listed at a medium- to high-volume institution. Donor/recipient sex matching is associated with better posttransplantation survival.

Cardiac allotransplantation is subject to a number of chronic complications that may limit graft survival. These include allograft coronary artery disease, renal dysfunction, hypertension, and malignancy, which are largely due to the immuno-modulatory and adverse effects of transplant medications. Reoperation for native allograft disease progression is a rarer phenomenon. We report a case of aortic valve replacement for bicuspid aortic valve stenosis that occurred in a patient more than ten years after cardiac transplantation.

Because no single center has accumulated a large experience with this complex operation, the effectiveness of combined orthotopic heart transplantation (OHT) and orthotopic liver transplantation (OLT) in achieving long-term survival has been unknown. Cases of OHT-OLT were pooled from a U.S. transplant recipient registry and from previously published literature. Aggregate data from these sources was used for survival analysis. Thirty-six patients having undergone OHT-OLT were listed in the national registry; the one- and five-year patient survival rates of these patients were 88% and 78%, respectively. Many patients remain alive at 8+ years after transplantation. An analysis of the pooled results of previously-published cases estimated a one-year patient survival rate of 84%. In selected disease processes, OHT-OLT can correct underlying metabolic deficiencies. While rarely indicated, OHT-OLT is a successful treatment for patients with end-stage heart and liver disease, with survival comparable to that seen after isolated orthotopic heart or orthotopic liver transplantation.

Background: Humoral sensitization, defined as a panel-reactive antibody (PRA) screen of >10%, places heart transplant recipients at a greater risk of acute rejection and mortality. Previous studies have suggested an increased sensitization in left ventricular assist device (LVAD) recipients, although neither the impact of device selection nor the clinical importance of elevated PRA in these patients has been completely described., Methods: Using the registry of the International Society for Heart and Lung Transplantation (ISHLT), we compared PRA levels in 7,686 heart transplant recipients to determine the impact of LVAD therapy on humoral sensitization, acute rejection and mortality. To determine the impact of device selection on sensitization, we compared data from the ISHLT registry as well as from our own institution., Results: Elevated PRA levels were found in 16.6% of LVAD recipients, compared with 7.6% of non-LVAD controls (p < 0.0001). Sensitization differed by device type, being present in 21.9% of Thoratec recipients, 14.4% of HeartMate recipients, and 15.5% of Novacor recipients (p = 0.01). Despite these findings, LVAD use had no impact on rejection rates. LVAD use was associated with a small increase (4.4% and 4.3%, respectively) in 1- and 2-year mortality., Conclusions: These findings support the concept that mechanical circulatory support increases the rate of humoral sensitization. However, these differences in sensitization do not translate to substantial differences in the clinical outcomes of rejection and mortality.