Donor Age More Than 20 Years Greater Than Recipient Age Is Associated With Worse 5 Year Survival in Young Adult Heart Transplantation.

Prior studies indicate donor age-recipient age (DA-RA) difference may be of prognostic value in adolescents, although not adults. We aim to analyze the relationship between DA-RA difference and long-term survival of young adult heart transplantation (HTx) recipients. First-time, single-organ HTx recipients aged 18-30 who underwent HTx between 2010 and 2020 were analyzed from the United Network for Organ Sharing (UNOS) registry. Four cohorts were created based on DA-RA difference. The primary outcome was 5 year post-HTx survival. Secondary outcome was post-HTx complications. One thousand eight hundred three donor-recipient pairs were divided into four groups: DA-RA < 0, 0 ≤ DA-RA < 10, 10 ≤ DA-RA < 20, and DA-RA ≥ 20 with 682 (37.8%), 651 (36.1%), 356 (19.7%), 114 (6.3%) pairs in each cohort, respectively. The estimated 5 year survival of the DA-RA ≥ 20 cohort was 66.5% compared to the other three groups at ~75%. After adjustment, DA-RA ≥ 20 was independently associated with worse survival compared to DA-RA < 0 (adjusted hazard ratio [HR] = 1.55; 95% confidence interval [CI] = 1.06-2.27; log-rank p = 0.008). There was no significant difference in complication incidence across cohorts. Among young adults, accepting a donor heart more than 20 years older than the recipient was associated with worse 5 year survival. We did not detect a significant difference up to 20 years. This information may help guide appropriate donor selection in the young adult population.

The Impact of Pre-Heart Transplantation Blood Transfusion Varies Based on Recipient MELD-XI Score.

Prior studies reveal adverse effects of transfusion on cardiac surgery, but little is known of transfusion impact on heart transplantation. First-time, single-organ adult heart transplant recipients between January 1, 2010, and December 31, 2020, were included, stratified above or below a model for end-stage liver disease excluding international normalized ratio (MELD-XI) score of 9.4, and propensity score matched to their nearest neighbor. A 90 day landmark analysis within each cohort was also performed. Unadjusted analysis showed transfusion recipients, MELD-XI ≥9.4, were more likely to experience post-heart transplantation mortality (Hazard Ratio (HR), 1.352 [95% Confidence Interval (CI), 1.239-1.477], p < 0.001), persisting after adjustment for potential confounders (adjusted HR, 1.211 [95% CI, 1.100-1.335], p < 0.001) and after propensity-score matching (HR, 1.174 [95% CI, 1.045-1.319], p = 0.007). Post-transplant length of stay was longer (25.9 vs. 23.2 days, p < 0.001). Post-transplant dialysis was more common (18.7 vs. 15.9%, p = 0.009). There was no survival difference on 90 day landmarked analysis (p = 0.108). With MELD-XI <9.4, there was slight survival detriment among transfusion recipients on univariable analysis (HR, 1.111 [95% CI, 1.001-1.234], p = 0.049) but not on multivariable analysis (adjusted HR, 1.061 [95% CI, 0.952-1.181], p = 0.285). There was similar survival after propensity-score matching (HR, 1.032 [95% CI, 0.903-1.180], p = 0.642) and on landmark analysis (p = 0.581). Ultimately, transfusion was associated with worse post-heart transplantation outcomes among recipients with a MELD-XI ≥9.4.

Ventricular assist device using a thoracotomy-based implant technique: Multi-Center Implantation of the HeartMate 3 in Subjects With Heart Failure Using Surgical Techniques Other Than Full Median Sternotomy (HM3 SWIFT).

OBJECTIVES: The HeartMate 3 (Abbott) left ventricular assist device provides substantial improvement in long-term morbidity and mortality in patients with advanced heart failure. The Implantation of the HeartMate 3 in Subjects With Heart Failure Using Surgical Techniques Other Than Full Median Sternotomy study compares thoracotomy-based implantation clinical outcomes with standard median sternotomy. METHODS: We conducted a prospective, multicenter, single-arm study in patients eligible for HeartMate 3 implantation with thoracotomy-based surgical technique (bilateral thoracotomy or partial upper sternotomy with left thoracotomy). The composite primary end point was survival free of disabling stroke (modified Rankin score >3), or reoperation to remove or replace a malfunctioning device, or conversion to median sternotomy at 6-months postimplant (elective transplants were treated as a success). The primary end point (noninferiority, -15% margin) was assessed with >90% power compared with a propensity score-matched cohort (ratio 1:2) derived from the Multi-Center Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Support Therapy With HeartMate 3 continued access protocol. RESULTS: The study enrolled 102 patients between December 2020 and July 2022 in the thoracotomy-based arm at 23 North American centers. Follow-up concluded in December 2022. In the Implantation of the HeartMate 3 in Subjects With Heart Failure Using Surgical Techniques Other Than Full Median Sternotomy study group, noninferiority criteria was met (absolute between-group difference, -1.2%; Farrington Manning lower 1-sided 95% CI, -9.3%; P < .0025) and event-free survival was not different (85.0% vs 86.2%; hazard ratio, 1.01; 95% CI, 0.58-2.10). Length of stay with thoracotomy-based implant was longer (median, 20 vs 17 days; P = .03). No differences were observed for blood product utilization, adverse events (including right heart failure), functional status, and quality of life between cohorts. CONCLUSIONS: Thoracotomy-based implantation of the HeartMate 3 left ventricular assist device is noninferior to implantation via standard full sternotomy. This study supports thoracotomy-based implantation as an additional standard for surgical implantation of the HeartMate 3 left ventricular assist device.

Blood type O heart transplant candidates have longer waitlist time and higher delisting under the new allocation system.

OBJECTIVE: Prior studies have examined the effect of blood type on heart transplantation (HTx) waitlist outcomes in cohorts through 2015. We aim to analyze the effect of blood type on contemporary waitlist outcomes with a new allocation system focus. METHODS: Adults listed for HTx between April 2015 and December 2020 were included. Survival to HTx and waitlist death/deterioration was compared between type O and non-type O candidates using competing risks regression. Donor/recipient ABO compatibility trends were further investigated. RESULTS: Candidates with blood type O (n = 7509) underwent HTx less frequently than candidates with blood type other than type O (n = 9699) (subhazard ratio [sHR], 0.56; 95% CI, 0.53-0.58) with higher rates of waitlist death/deterioration (sHR, 1.18; 95% CI, 1.04-1.34). Subgroup analyses demonstrated persistence of this trend under the new donor heart allocation system (HTx: sHR, 0.58; 95% CI, 0.54-0.62; death/clinical deterioration: sHR, 1.27; 95% CI, 1.02-1.60), especially among those listed at high status (1, 2, or 3) (HTx: sHR, 0.69; 95% CI, 0.63-0.75; death/deterioration: sHR, 1.61; 95% CI, 1.16-2.22). Among those listed at status 3, waitlist death/deterioration was modified by presence of a durable left ventricular assist device (left ventricular assist device: sHR, 1.57; 95% CI, 0.58-4.29; no left ventricular assist device: sHR, 3.79; 95% CI, 1.28-11.2). Type O donor heart allocation to secondary ABO candidates increased in the new system (14.5% vs 12.0%; P < .01); post-HTx survival remained comparable between recipients with blood type O and non-type O (log-rank P = .07). CONCLUSIONS: Further logistical considerations are warranted to minimize allocation inequity regarding blood type under the new allocation system.

Design and characteristics of the prophylactic intra-operative ventricular arrhythmia ablation in high-risk LVAD candidates (PIVATAL) trial.

BACKGROUND: The use of a Left Ventricular Assist Device (LVAD) in patients with advanced heart failure refractory to optimal medical management has progressed steadily over the past two decades. Data have demonstrated reduced LVAD efficacy, worse clinical outcome, and higher mortality for patients who experience significant ventricular tachyarrhythmia (VTA). We hypothesize that a novel prophylactic intra-operative VTA ablation protocol at the time of LVAD implantation may reduce the recurrent VTA and adverse events postimplant. METHODS: We designed a prospective, multicenter, open-label, randomized-controlled clinical trial enrolling 100 patients who are LVAD candidates with a history of VTA in the previous 5 years. Enrolled patients will be randomized in a 1:1 fashion to intra-operative VTA ablation (n = 50) versus conventional medical management (n = 50) with LVAD implant. Arrhythmia outcomes data will be captured by an implantable cardioverter defibrillator (ICD) to monitor VTA events, with a uniform ICD programming protocol. Patients will be followed prospectively over a mean of 18 months (with a minimum of 9 months) after LVAD implantation to evaluate recurrent VTA, adverse events, and procedural outcomes. Secondary endpoints include right heart function/hemodynamics, healthcare utilization, and quality of life. CONCLUSION: The primary aim of this first-ever randomized trial is to assess the efficacy of intra-operative ablation during LVAD surgery in reducing VTA recurrence and improving clinical outcomes for patients with a history of VTA.

The Use of Impella 5.5 for Donor-Heart Hemodynamic Support in Heart Transplantation.

Primary graft dysfunction is a feared complication and cause of mortality post-heart transplant. Primary graft dysfunction may require mechanical circulatory support, such as venoarterial extracorporeal membrane oxygenation, which carries its own risk for complications. We developed a new mechanical circulatory support method for patients who underwent heart transplant bridged with Impella 5.5, which was then placed into the donor heart. Among 12 heart transplants, four required Impella 5.5 support. The average age was 55.8 years. The mean duration for postoperative mechanical circulatory support was 3.8 days, ranging from 2 to 5 days. No patients developed severe right ventricular dysfunction. In our limited study, complications and mortality associated with the replanted Impella 5.5 were both 0%.

Transplantation Outcomes with Donor Hearts after Circulatory Death.

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.).

Cardiac Cachexia in Left Ventricular Assist Device Recipients and the Implications of Weight Gain Early After Implantation.

Background Severe cardiac cachexia or malnutrition are commonly considered relative contraindications to left ventricular assist device (LVAD) implantation, but post-LVAD prognosis for patients with cachexia is uncertain. Methods and Results Intermacs (Interagency Registry for Mechanically Assisted Circulatory Support) 2006 to 2017 was queried for the preimplantation variable cachexia/malnutrition. Cox proportional hazards modeling examined the relationship between cachexia and LVAD outcomes. Of 20 332 primary LVAD recipients with available data, 516 (2.54%) were reported to have baseline cachexia and had higher risk baseline characteristics. Cachexia was associated with higher mortality during LVAD support (unadjusted hazard ratio [HR], 1.36 [95% CI, 1.18-1.56]; P<0.0001), persisting after adjustment for baseline characteristics (adjusted HR, 1.23 [95% CI, 1.0-1.42]; P=0.005). Mean weight change at 12 months was +3.9±9.4 kg. Across the cohort, weight gain ≥5% during the first 3 months of LVAD support was associated with lower mortality (unadjusted HR, 0.90 [95% CI, 0.84-0.98]; P=0.012; adjusted HR, 0.89 [95% CI, 0.82-0.97]; P=0.006). Conclusions The proportion of LVAD recipients recognized to have cachexia preimplantation was low at 2.5%. Recognized cachexia was independently associated with higher mortality during LVAD support. Early weight gain ≥5% was independently associated with lower mortality during subsequent LVAD support.

Heart Transplant Waitlist Outcomes and Wait Time by Center Volume in the Pre-2018 Allocation Change Era.

Although the transplant outcomes of centers are heavily monitored and compared, with a particular link between posttransplant outcomes and center volume demonstrated, little data exist comparing waitlist outcomes. Here, we explored waitlist outcomes by transplant center volume. We performed a retrospective analysis of adults listed for primary heart transplantation (HTx) from 2008 to 2018 using the United Network for Organ Sharing database. Transplant centers were split into low (<10 HTx/year), medium (10-30 HTx/year), and high (>30 HTx/year) volume, and waitlist outcomes were compared. Of the 35,190 patients included in our study, 23,726 (67.4%) underwent HTx, 4,915 (14.0%) died or deteriorated before receiving HTx, 1,356 (3.9%) were delisted due to recovery, and 1,336 (3.8%) underwent left ventricular assist device (LVAD) implantation. High-volume centers had higher rates of survival to transplant (71.3% vs. 60.6% for low-volume centers and 64.9% for medium-volume centers), and low rates of death or deterioration (12.6% vs. 14.6% for low-volume centers and 15.1% for medium-volume centers). Listing at a low-volume center was independently associated with death or delisting before HTx (HR 1.18, p = 0.007), whereas listing at a high-volume center (HR 0.86; p < 0.001) and prelisting LVAD (HR 0.67, p < 0.001) were protective. Death or delisting before HTx was lowest for patients listed in higher volume centers.

Improved 3 Year Heart Transplant Survival in Black Recipients Following the Affordable Care Act.

To improve healthcare access, the US government implemented the Affordable Care Act (ACA) in 2014. Previous studies investigating its impact on healthcare inequities showed significant improvement in Black transplant recipient outcomes. Our objective is to determine the ACA's impact on Black heart transplant (HTx) recipients. Using the United Network for Organ Sharing database, we analyzed 3,462 Black HTx recipients pre- and post-ACA (January 2009 to December 2012, and January 2014 to December 2017). Black recipient numbers and rates of overall HTx, insurance effects on survival, geographic changes in HTx, and post-HTx survival were compared pre- and post-ACA. Black recipients increased from 1,046 (15.3%) to 2,056 (22.2%) post-ACA ( p < 0.001). Three year survival increased among Black recipients (85.8-91.9%, p = 0.01; 79.4-87.7%, p < 0.01; 78.3-84.6%, p < 0.01). Affordable Care Act implementation was protective for survival (hazard ratio [HR] = 0.64 [95% confidence interval [CI], 0.51-0.81], p < 0.01). Publicly insured patient survival increased post-ACA to match that of privately insured (87.3-91.8%, p = 0.001). United Network for Organ Sharing (UNOS) Regions 2, 8, and 11 experienced improved survival post-ACA ( p = 0.047, p = 0.02, and p < 0.01, respectively). The post-ACA era showed improved HTx access and survival in Black recipients, indicating that national medical policy may play a strong role in eliminating racial disparities. Further attention is required to improve inequities in medical care. http://links.lww.com/ASAIO/B2.

Total ventricular mass oversizing +50% or greater was a predictor of worse 1-year survival after heart transplantation.

OBJECTIVES: Current donor-recipient size matching guidelines rely primarily on body weight, with no specified oversizing cutoff values. Recent literature has explored predicted total ventricular mass matching over body weight matching. We aim to explore the impact of total ventricular mass oversizing on heart transplant outcomes. METHODS: The United Network for Organ Sharing database was queried for adults who underwent primary heart transplant from 1997 to 2017. By using validated equations, donor-recipient total ventricular mass mismatch was calculated. Donor-recipient pairs were divided into 3 groups by total ventricular mass mismatch. Post-heart transplant 1-year survival was analyzed using the Kaplan-Meier method and Cox proportional hazards models. We also investigated post-heart transplant complications, independent predictors for mortality, donor-recipient sex mismatch, and donor-recipient body habitus in total ventricular mass mismatch greater than +50%. RESULTS: A total of 34,455 donor-recipient pairs were included. Fractional polynomial regression demonstrated increased the risk of mortality with higher total ventricular mass mismatch. Total ventricular mass mismatch of +48.3% maximized the Youden Index. Donor-recipient pairs were subsequently grouped by total ventricular mass mismatch as -20% to +30%, +30% to +50%, and greater than +50%. Total ventricular mass mismatch greater than +50% was an independent risk factor for 1-year mortality (hazard ratio, 1.40, P = .004) and was associated with increased postoperative stroke (P = .002). Some 80.3% of these recipients were smaller female patients with male donors. Total ventricular mass mismatch from +30% to +50% was not associated with worse survival (P = .17). CONCLUSIONS: Total ventricular mass mismatch greater than +50% is associated with worse 1-year survival, although this group comprises a small portion of heart transplant. total ventricular mass mismatch from +30% to +50% is not associated with worse survival. These outcomes should be considered in selecting donors and in efforts to expand the potential donor pool.

Impella 5.5 Support Beyond 50 Days as Bridge to Heart Transplant in End-Stage Heart Failure Patients.

Prolonged mechanical circulatory support (MCS) for severe left ventricular dysfunction in cardiogenic shock as a bridge to heart transplantation (HTx) generally requires a surgical procedure. Typically, a surgically implanted temporary extracorporeal left ventricular assist device (LVAD) is chosen because of superior flow and durability compared with a percutaneously delivered endovascular LVAD (pVAD). However, compared with its predecessors, the Impella 5.5 trans-valvular pVAD provides higher hemodynamic support and features improved durability. Here, we present four successful cases with prolonged Impella 5.5 support as a bridge to HTx, with a mean support duration of 70 days (maximum 83 days). These cases highlight several potential benefits of Impella 5.5. The minimally invasive implantation procedure of the device reduces bleeding, decreases the postoperative recovery period, and enables early patient ambulation to reduce physical deconditioning before HTx surgery. Furthermore, Impella 5.5 adequately unloads the left ventricle and provides hemodynamic support to maintain end-organ function to further optimize hemodynamics before HTx. The evolution of Impella 5.5 technology may provide an alternative bridging strategy to traditional surgically implanted temporary MCS in select cases.

Use of Mechanical Circulatory Support to Demonstrate Pulmonary Hypertension Reversibility in Mitral Stenosis.

A 56 year old female with a history of rheumatic mitral stenosis (MS) presented with severe pulmonary edema. Transthoracic echocardiogram demonstrated severe MS (mean valve area 0.5 cm 2 , mean gradient of 16 mm Hg) with preserved left ventricular ejection fraction. Right heart catheterization demonstrated elevated pulmonary artery (PA) pressures of 110/80 mm Hg and a wedge pressure of 40 mm Hg. Mechanical circulatory support (MCS) was initiated with extracorporeal left atrial to femoral artery bypass. MCS allowed preoperative unloading of the left atrium. The volume status and lung congestion were optimized before surgery. In addition, pulmonary hypertension reversibility was demonstrated with significantly lower PA pressures after initiation of MCS. Intraoperatively, the MCS left atrial inflow cannula was pulled back into the right heart and used as a venous cannula for cardiopulmonary bypass. Successful mitral valve replacement was performed. Postoperatively, the mitral valve mean gradient was 3 mm Hg.

Trends in Outcomes of Heart Transplants Using Extended Criteria Donors: A United Network for Organ Sharing Database Analysis.

BACKGROUND: Although the use of extended criteria donors (ECDs) is traditionally avoided because of poorer outcomes, management of heart transplant (HTx) recipients has evolved over the past decades. We sought to examine the temporal trends in outcomes of ECDs in HTx. METHODS: We queried the United Network for Organ Sharing database for adult HTx recipients who fit the EXPAND Trial criteria for ECDs: ischemic time ≥ 4 hours, ejection fraction < 50%, age > 55 years, and history of coronary artery disease. Transplant years were stratified into the following 4 periods: (1) 2000 to 2004, (2) 2005 to 2009, (3) 2010 to 2014, and (4) 2014 to 2018. The 2-sample t test, Kaplan-Meier survival analysis, log-rank test, analysis of variance, multivariable Cox proportional hazards, and multinomial logistic regression were used to compare data between periods. RESULTS: Through periods 1 to 4, 39,028 patients were stratified as follows: 9217 (2942 ECDs, 31.9%), 9224 (2730 ECDs, 29.6%), 10,309 (2762 ECDs, 26.8%), and 10,278 (2190 ECDs, 21.3%). Transplants using ECDs in periods 1 and 2 had increased 1-year mortality compared with periods 3 and 4 (16.9% and 15.6% vs 11.9% and 10.9% respectively, P < .001). Later periods also demonstrated improved Karnofsky scores (P < .001). CONCLUSIONS: Although use of ECDs decreased across the periods, we noted significant improvement in 1-year survival rates and postoperative functional status.

The impact of temporary mechanical circulatory support strategies on thrombocytopenia.

One common but not well-understood phenomenon of temporary mechanical circulatory support (MCS) use is thrombocytopenia. This clinical issue increases the risk of bleeding and the need for platelet transfusion. Additionally, heparin-induced thrombocytopenia must be considered as part of the differential diagnosis, which complicates patient management. In what follows, we analyze the degree and relative rate of platelet count drop with various temporary MCS strategies - Impella 5.5; Veno-venous Extracorporeal Membrane Oxygenation (VV ECMO); Veno-arterial ECMO (VA ECMO); Intra-aortic Balloon Pump (IABP) and Centrimag Biventricular Assist Device (BIVAD). A total of 337 cohort was investigated. 77 was included for analysis after strict exclusion criteria were utilized (platelet transfusions, bleeding complications, etc.). Repeated measure mixed effect and linear regression models were used to assess the percent platelet drop on implantation of MCS and recovery after explantation of MCS. A statistically significant mean percent drop occurred in MCS types - VA ECMO(-69.6%, p < 0.001), VV ECMO(-40.9%, p < 0.001), Impella 5.5(-20.9%, p = 0.01) and IABP(-28.3%, p = 0.01), except Centrimag BIVAD(-6.5%, p = 0.61). Platelet recovery to or above baseline occurred in VA ECMO(+107.0%, p = 0.42), Impella 5.5(+117.2%, p = 0.28), IABP(+108.3%, p = 0.37), VV-ECMO(163.3%, p = 0.01*) and Centrimag BIVAD(+100.1%, p = 0.99). These results show that the degree of thrombocytopenia depends on MCS device type and is reversible.

A Simple Technique for Reliable Donor Organ Temperature Management With the SherpaPak System.

Here, we present our technique for thermoregulation of cardiac preservation solution with the SherpaPak device before heart transplantation. If it is above the ideal range (5-10°C) to avoid organ injury and ensure proper function, the cardiac preservation solution bag should be placed in ice water to bring down temperature until the ideal range is achieved. SherpaPak has limitation in immediately correcting initial temperatures outside of the normal range, so we believe this simple step should be included into standard SherpaPak procedure to ensure its effectiveness and to preserve the best organ function.

Percutaneous Decommissioning of a Left Ventricular Assist Device in a Patient With Myocardial Recovery.

A 37-year-old man was referred for consideration of percutaneous decommissioning of a left ventricular assist device (LVAD). Following careful hemodynamic monitoring during pump turn-down and temporary outflow graft occlusion, the LVAD was permanently decommissioned by using a vascular plug to induce thrombosis of the outflow graft. (Level of Difficulty: Advanced.).