Impact of new allocation policy on waitlist and transplant outcomes of adult congenital heart patients supported with ECMO.

BACKGROUND: The use of ECMO as a bridge to heart transplantation has been growing rapidly in all heart transplant recipients since the implementation of the new UNOS allocation policy; however, the impact on adult congenital heart disease (ACHD) patients is not known. METHODS: We analyzed the UNOS data (2015-2021) for ACHD patients supported with extracorporeal membrane oxygenation (ECMO) during the waitlist, before and after October 2018, to assess the impact on the waitlist and posttransplant outcomes. We compared the characteristics and outcomes of ACHD patients with or without ECMO use during the waitlist and pre- and postpolicy changes. RESULTS: A total of 23 821 patients underwent heart transplantation, and only 918 (4%) had ACHD. Out of all ACHD patients undergoing heart transplants, 6% of patients in the prepolicy era and 7.6% in the postpolicy era were on ECMO at the time of listing. Those on ECMO were younger and sicker compared to the rest of the ACHD cohort. Those on ECMO had similar profiles pre- and postpolicy change; however, there was a very significant decrease in the waitlist time [136 days (IQR 29-384) vs. 38 days (IQR 11-108), p = 0.01]. There was no difference in waitlist mortality; however, competing risk analyses showed a higher likelihood of transplantation (51% vs. 29%) and a lower likelihood of death or deterioration (31% vs. 42%) postpolicy change. Long-term outcomes posttransplant for those supported with ECMO compared to the non-ECMO cohort are similar for ACHD patients, although there was higher attrition in the first year for the ECMO cohort. CONCLUSION: The new allocation policy has resulted in shorter waitlist times and a higher likelihood of transplantation for ACHD patients supported by ECMO. However, the appropriate use of ECMO and the underuse of durable circulatory support devices in this population need further exploration.

Identification of risk factors and prediction models for secondary malignant neoplasms (SMNs)-free survival and SMNs-specific survival in testicular cancer survivors.

OBJECTIVE: This research endeavored to determine the key demographic and pathological factors tied to secondary malignant neoplasms (SMNs) in survivors of testicular cancer and to develop a predictive model. METHOD: A total of 53,309 testicular cancer patients from the SEER national database (1975-2016) were included in our analysis. The primary outcome measured was SMNs-free survival, defined as the duration from testicular cancer diagnosis to the detection of a non-testicular malignancy. The secondary outcome was SMN-specific survival, defined as the period from testicular cancer diagnosis until the patient's death due to SMNs. FINDINGS: Of the patients in the SEER cohort, 2978 (5.6%) developed non-testicular cancer SMNs. Higher age, receipt of chemotherapy, and radiation treatment were all significantly associated with the development of SMNs in survivors of testicular cancer (all p < 0.001). Kaplan-Meier analysis revealed a worse SMNs-free survival and poor SMN-specific survival in patients who underwent radiation therapy (both p < 0.001). Multivariable Cox regression analysis found non-Hispanic Black ethnicity, higher age, chemotherapy, and radiation therapy to be significantly associated with worse SMNs-free survival (p = 0.002, p < 0.001, p < 0.001, and p < 0.001, respectively), while lymphoma histology was associated with better SMNs-free survival (p < 0.001). The most common SMN types in patients receiving radiation therapy were prostate, lung, and bladder cancers. Predictive nomograms for SMNs-free survival and SMNs-specific survival were developed, with a C-index of 0.776 and 0.824, respectively. CONCLUSION: The age of diagnosis, non-Hispanic Black ethnicity, lymphoma histology, and treatment history with chemotherapy and radiation therapy were identified as prognostic factors for SMNs-free survival.

Contemporary outcomes of durable ventricular assist devices in adults with congenital heart disease as a bridge to heart transplantation.

OBJECTIVES: This study aimed to compare the clinical characteristics, risk factors, and overall survival outcomes in adults with congenital heart disease (ACHD) bridged to transplantation with a ventricular assist device (VAD) versus no-VAD. METHODS: The study included 894 ACHD patients aged ≥18 years listed for primary heart transplantation between 2010 and 2019 from the United Network for Organ Sharing database. Primary outcomes were waitlist and 1-year post-transplant mortality between VAD and no-VAD ACHD patients. RESULTS: Of 894 ACHD patients included in the study, 91(10.1%) had VAD support at the time of listing. Patients who needed VAD support were mostly males, heavier, and had higher pulmonary artery pressure than the no-VAD group at the listing. The overall waitlist mortality was 38% in the VAD group than 17% in the no-VAD group (p < 0.01). ECMO use was associated with significantly higher mortality than either group. There was no significant difference in 1-year post-transplant mortality between VAD versus no-VAD at the time of transplant (15% vs. 17%; p = 0.66). Multivariate regression analysis found that BMI <20 kg/m2 (hazard ratio (HR) 1.1; p = 0.01), bilirubin >2 mg/dl (HR 1.1; p = 0.03), creatinine >2 mg/dl (HR 1.3; p = 0.04) and ECMO at transplant (HR 1.4; p = 0.03) increased early post-transplant mortality. CONCLUSIONS: The one-year post-transplant mortality rate was no different for ACHD patients that received VAD versus no-VAD. These findings suggest that a VAD should be considered an option to support ACHD patients as a bridge to heart transplantation.

Prospective Multicenter Study of Myocardial Recovery Using Left Ventricular Assist Devices (RESTAGE-HF [Remission from Stage D Heart Failure]): Medium-Term and Primary End Point Results.

BACKGROUND: Left ventricular assist device (LVAD) unloading and hemodynamic support in patients with advanced chronic heart failure can result in significant improvement in cardiac function allowing LVAD removal; however, the rate of this is generally considered to be low. This prospective multicenter nonrandomized study (RESTAGE-HF [Remission from Stage D Heart Failure]) investigated whether a protocol of optimized LVAD mechanical unloading, combined with standardized specific pharmacological therapy to induce reverse remodeling and regular testing of underlying myocardial function, could produce a higher incidence of LVAD explantation. METHODS: Forty patients with chronic advanced heart failure from nonischemic cardiomyopathy receiving the Heartmate II LVAD were enrolled from 6 centers. LVAD speed was optimized with an aggressive pharmacological regimen, and regular echocardiograms were performed at reduced LVAD speed (6000 rpm, no net flow) to test underlying myocardial function. The primary end point was the proportion of patients with sufficient improvement of myocardial function to reach criteria for explantation within 18 months with sustained remission from heart failure (freedom from transplant/ventricular assist device/death) at 12 months. RESULTS: Before LVAD, age was 35.1±10.8 years, 67.5% were men, heart failure mean duration was 20.8±20.6 months, 95% required inotropic and 20% temporary mechanical support, left ventricular ejection fraction was 14.5±5.3%, end-diastolic diameter was 7.33±0.89 cm, end-systolic diameter was 6.74±0.88 cm, pulmonary artery saturations were 46.7±9.2%, and pulmonary capillary wedge pressure was 26.2±7.6 mm Hg. Four enrolled patients did not undergo the protocol because of medical complications unrelated to the study procedures. Overall, 40% of all enrolled (16/40) patients achieved the primary end point, P<0.0001, with 50% (18/36) of patients receiving the protocol being explanted within 18 months (pre-explant left ventricular ejection fraction, 57±8%; end-diastolic diameter, 4.81±0.58 cm; end-systolic diameter, 3.53±0.51 cm; pulmonary capillary wedge pressure, 8.1±3.1 mm Hg; pulmonary artery saturations 63.6±6.8% at 6000 rpm). Overall, 19 patients were explanted (19/36, 52.3% of those receiving the protocol). The 15 ongoing explanted patients are now 2.26±0.97 years after explant. After explantation survival free from LVAD or transplantation was 90% at 1-year and 77% at 2 and 3 years. CONCLUSIONS: In this multicenter prospective study, this strategy of LVAD support combined with a standardized pharmacological and cardiac function monitoring protocol resulted in a high rate of LVAD explantation and was feasible and reproducible with explants occurring in all 6 participating sites. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01774656.

Interplay between donor and recipient factors impacts outcomes after pediatric heart transplantation: An analysis from the united network for organ sharing database.

BACKGROUND: Donor utilization rates continue to be low for pHT, however, efforts to expand the donor acceptance criteria have shown mixed results in single-institution studies in pediatric and adult transplantation. Purpose of this study is to assess impact of individual and cumulative donor risk factors on transplant outcomes as well as the interplay between donor and recipient risk factors as it relates to transplant outcomes. METHOD: We analyzed pHT UNOS data (2008-2018) to compare the recipient characteristics, donor characteristics, and outcomes based on donor ejection fraction of less than 50% (low EF) and or ischemic time of greater than 4 hours (prolonged IT). RESULTS: A total of 4345 pHT were performed of which 1309 (30.1%) were with prolonged IT and 122 (2.8%) in low EF. Additionally, 58 (1.3%) were performed with both low EF and prolonged IT (combined risk). Rest (2856 patients, 65.7%) was considered low risk. Recipients of combined risk were more likely to be younger, have post-surgical congenital heart disease, be on ECMO or ventilator but less likely on VAD (all P < .01) compared with any other group. Waitlist time was significantly lower for low EF (mean 39 days, 15-109) or combined risk group (36 days, range 15-80) compared with other groups (60 days, range 23-125) (P = .01). 1-year mortality was 8% in low-risk group, 12% in prolonged IT, 14% in reduced EF, and 28% in combined risk patients (P < .01). Number of treated rejections in one year were significantly higher in prolonged IT and combined risk group compared to other groups (P < .01). When stratified by recipient risk, there was no difference in outcomes for low risk, prolonged IT, or low EF groups; however, there were significant survival differences for high-risk recipient versus low-risk recipient in each donor group. CONCLUSION: Lower EF donors performed similar to prolonged IT donor, but were uncommonly used. Acceptance of risk was common in recipients deemed higher risk for waitlist mortality and led to shorter wait times. Caution should be used in accepting combined risk transplants. The recipient risk factors have significant impact on outcomes across all donor risk groups and further analysis will help balance the waitlist mortality with post-transplant outcomes.

Role of implantable cardioverter-defibrillator in patients awaiting heart transplant in the continuous-flow left ventricular assist device era.

Implantable cardioverter-defibrillators (ICDs) have been shown to have survival advantage in advanced heart failure patients. Few studies have evaluated the role of ICDs in patients supported with continuous-flow left ventricular assist devices (CFVADs). We aimed to evaluate the impact of ICD and CFVAD on heart transplant (HTx) waiting list survival. We queried the United Network for Organ Sharing (UNOS) thoracic transplant database between years 2007 and 2016 for patients aged ≥ 18 years listed for HTx. Patients receiving devices other than CFVAD were excluded. Patients were divided into groups-with and without CFVAD and further subdivided into groups-with and without ICD use. Kaplan-Meier curves were used to evaluate the survival outcomes. There were 34 860 patients listed for HTx during study period of which 11 481 (32%) had a CFVAD and 26 139 (75%) had an ICD. Within CFVAD group, patients with ICD were older, more likely male, with higher creatinine and listed as UNOS status 1A. In the No-CFVAD group, 1-year waitlist survival was significantly better with ICD use (81% vs. 73%, P < .0001); however, in CFVAD patients, 1-year survival with ICD use was comparable to No-ICD use (95% vs. 94%, P = .1). Use of ICD is associated with significantly better heart transplant waitlist survival in patients not supported by CFVAD. In patients supported with CFVAD, the ICD does not offer additional survival benefit.

Association of temporal trends in neutrophil lymphocyte ratio on left ventricular assist device patient outcomes.

Neutrophil to lymphocyte ratio (NLR) can predict mortality/complications in left ventricular assist device (LVAD) patients; however, the prognostic value of longitudinal NLR measurements has not been well studied. Here, we examine the mortality/complication incidence in patients with chronically increased NLR verses patients with acutely elevated NLR as a predictor of patient outcomes. This retrospective analysis included 102 patients who underwent LVAD implantation from 2016 to 2018 at a single center. The NLR was calculated at the time of surgery, and at 30 and 90 days after surgery. The NLR values were grouped into categorical data: low, normal (put in range), and high. Patients were classified in 2 groups based on change in their NLR values from surgery to 90 days; the H90 group had sustained increase of NLR over 90-days and the N90 group had normalization of NLR at 90-days. Actuarial survival the between study groups was measured using Kaplan-Meier curves. The N90 group had 50 patients (median age 58 (48-66) years, 21% female) at the time of LVAD placement. Group H90 had 52 patients (median age 64 (52-68) years, 16% female). Median age, body mass index (BMI), bilirubin, creatinine, and BNP at time of implant as well as type of device and implant strategy were comparable between the study groups. The post implant survival for N90 group was significantly better than the H90 group at 1 year (93% vs. 80%) and 2 years (90% vs. 67%) (log-rank P = .001). Early post LVAD survival in patients with elevated NLR over 90 days postoperatively was significantly worse compared to patients who normalized the NLR at 90 days.

Aortic root replacement with Medtronic Freestyle bioprosthesis: 25-year experience.

BACKGROUND: Stentless porcine bioprothesis is a surgical strategy to treat aortic root disease. Use has been limited due to the concern for long-term valve degeneration. This study evaluated the perioperative and late outcomes of patients with aortic root disease requiring root replacement. METHODS: A total of 409 patients underwent aortic root replacement by a single surgeon using a stentless porcine bioroot between February 1996 and May 2020. The cohort was divided into two groups (age ≤65 and >65 years). Descriptive statistics were used to analyze the data and Kaplan-Meier curves used to evaluate long-term outcomes. RESULTS: Patients age >65 years were more likely to be female (p = .01), have hypertension (p = .01), require circulatory arrest (p = .01), and have concomitant coronary artery bypass grafting (CABG) (p = .04). Baseline creatinine >1.8 (p = .20), diabetes (p = .06), and ejection fraction (p = .20) were similar between groups. The 1-, 5-, and 10-year survival for patients age ≤65 years were 92%, 87%, and 69%, respectively, significantly better than patients age >65 (88%, 73%, and 43%, respectively) (p < .01, Figure 1). The 1-, 5-, and 10-year freedom from reoperation for patients ≤65 years were 99%, 97%, and 93% versus 99%, 98%, and 96% in patients age >65 years, respectively (p = .24). CONCLUSION: Patients with aortic root disease can be treated with acceptable perioperative outcomes, long-term survival, and low reoperation rates using a stentless porcine bioprothesis. It should be considered irrespective of age due to its excellent durability and freedom from anti-coagulation requirement.

Combined Heart-Kidney Transplant Versus Sequential Kidney Transplant in Heart Transplant Recipients.

OBJECTIVES: In patients with reduced kidney function there are no established guidelines to suggest combined heart-kidney transplant (HKTx) versus sequential kidney transplant (SKTx) using preoperative value of estimated glomerular filtration (eGFR). METHODS: The United Network for Organ Sharing database was queried from 2000 to 2015 to evaluate survival of HKTx and SKTx population stratified by preoperative eGFR rate <45 mL/min. Aim of the study was to assess the eGFR rate that is most beneficial to perform a concomitant or a SKTx at time of transplant evaluation. RESULTS: In our analysis, patients who required SKTx are recipients that, after heart transplantation, developed or worsened kidney insufficiency due to calcineurin inhibitor nephrotoxicity. In recipients with eGFR <30 or dialysis, a total of 545 received HKTx and 80 received SKTx. The median waiting time between heart and kidney transplant in SKTx group was 6 years. The overall post-transplant survival was 81% and 80% and 75% and 59% at 5 and 1 years for the HKTx and SKTx groups, respectively (P = .04). In recipients with eGFR from 30 to 44, a total of 107 received HKTx and 112 received SKTx. The median waiting time between heart and kidney transplant in SKTx group was 4 years. Overall post-transplant survival showed no statistically significant differences in HKTx group (n=107) compared with SKTx group (n=112) and was 90% and 95% at 1 year and 74% and 52% at 5 years, respectively (P = .4) . CONCLUSIONS: To optimize organ and patient survival, eGFR value can be utilized to discern between HKTx versus SKTx in patients with decreased renal function at the time of heart transplantation. Patients with eGFR<30 or in dialysis presented better survival with HKTx, while both SKTx and HKTx are suitable for patients with eGFR between 30 and 45.

Risk Factors and Outcomes in Redo Coronary Artery Bypass Grafting.

BACKGROUND: Reoperative coronary artery bypass grafting (redo-CABG) has declined during the last decade, while use of percutaneous coronary intervention (PCI) has increased. The aim of this retrospective study was to evaluate risk factors, in-hospital mortality, and long-term survival between first-time CABG and redo-CABG. METHODS: From January 2009 to December 2015, 2,581 patients underwent first-time CABG procedures while 132 underwent isolated redo-CABG. Logistic regression was used to identify risk factors predictive of redo-CABG and after propensity matching the in-hospital morbidity and long-term all-cause mortality were compared. RESULTS: Risk factors for redo-CABG were prior PCI, dyslipidaemia, diabetes and hypertension. After propensity matching there were no significant differences between the redo-CABG (n = 126) and first-time CABG groups (n = 232) in baseline characteristics. The adjusted in-hospital mortality was 3.1% for redo-CABG and 2.1% for first-time CABG (p = 0.55). Redo-CABG required significantly more intraoperative red blood cells (p = 0.03), platelets (p < 0.001), cryoprecipitate (p < 0.007) and fresh frozen plasma (p < 0.001) than first-time CABG. There was no significant difference in reoperation for bleeding (p = 0.72), prolonged ventilation (p = 0.98), postoperative stroke (p = 0.92) or dialysis (p = 0.44). The survival at 1, 3 and 5 years for redo-CABG was 93.5%, 90%, and 85% respectively, and 95.5%, 94.5%, 93% for first-time CABG, respectively (p = 0.2). CONCLUSIONS: Prior PCI after first time CABG and the risk factors for atherosclerotic disease are predictive for redo-CABG. An increased use of blood products is required during redo-CABG. After propensity matching, in-hospital mortality and long-term survival for redo-CABG is comparable to first-time operation. Re-sternotomy does not impact the survival in redo-CABG.

Impact of QRS Duration and Ventricular Pacing on Clinical and Arrhythmic Outcomes in Continuous Flow Left Ventricular Assist Device Recipients: A Multicenter Study.

OBJECTIVES: Wide QRS duration and ventricular pacing are common in recipients of continuous-flow left ventricular assist devices (CF-LVADs) but their impact on outcomes remains unclear. We assessed the clinical and arrhythmic outcomes of CF-LVAD patients with wide QRS or right ventricular (RV) pacing at baseline, compared with those with narrow QRS and those with continued cardiac resynchronization therapy (CRT). METHODS AND RESULTS: A total of 520 patients (57 ± 13 years) with an implantable cardioverter-defibrillator (ICD) (n = 240) or CRT-defibrillator (n = 280) who underwent CF-LVAD implantation at 5 centers in 2007-2015 were studied. Patients were divided into 3 groups: ICD-N (QRS ≤120 ms; n = 134), ICD-W (QRS >120 ms; n = 106), and CRT (n = 280). Mortality, hospitalization, and ventricular arrhythmia (VA) incidence were compared among the groups. Baseline QRS duration was different among the groups (100 ± 13 [ICD-N] vs 155 ± 26 [ICD-W] vs 159 ± 29 ms [CRT]; P < .0001). In the ICD-W group, 37 (35%) had >80% RV pacing at baseline. Median biventricular pacing in the CRT group was 96%. Over 523 days of CF-LVAD support, Kaplan-Meier analysis showed no difference in survival among groups (log rank P = .9). According to multivariate Cox regression, wide QRS duration and RV pacing were not associated with survival. QRS narrowed during CF-LVAD support in the ICD-W and CRT groups but was not associated with improved survival (P = .9). No differences were noted among the groups in hospitalizations (P = .9), VA (P = .2), or ICD shocks (P = .06). CONCLUSIONS: In this large CF-LVAD cohort, a wide QRS duration, high percentage of RV pacing at baseline, and changes in QRS duration after LVAD implantation were not associated with survival. Continued CRT after CF-LVAD implantation also was not associated with improved survival or HF hospitalizations.

Myocardial protection with complementary dose of modified Del Nido cardioplegia during heart transplantation.

Myocardial protection during heart transplantation is achieved by a first dose of heart preservation solution during donor heart harvesting, while there is no consensus about the management of complementary doses during implantation in the recipient. We describe a preliminary case series where modified Del Nido Cardioplegia was used as complementary dose at the time of donor heart implantation.

Changing demographics of heart donors: The impact of donor drug intoxication on posttransplant survival.

Recent reports have shown an increase in the number of organ donors from drug intoxication. The impact of donor drug use on survival after cardiac transplant remains unclear. The aim of our study was to illustrate changes in donor death mechanisms and assess the impact on posttransplant survival. We queried United Network of Organ Sharing thoracic transplant and deceased donor databases to identify patients undergoing heart transplantation between 2005 and 2015. We evaluated annual trends in donor death mechanisms. Recipients were propensity matched (drug-intoxicated-non-drug-intoxicated = 1:2) and posttransplant survival was compared using Kaplan-Meier curves. In total, 19 384 donor hearts were used for transplant during the period (donor age 31.6 ± 11.8 years, 72% male). Use of drug-intoxicated donors increased from 2% (2005) to 13% (2015) and decreased from blunt injury (40%-30%) and intracranial hemorrhage (29%-25%). After propensity matching, posttransplant survival of drug-intoxicated donor hearts was 90%, 82%, and 76% at 1, 3, and 5 years, which was similar to non-drug-intoxicated. Heart transplants using drug-intoxicated donors have significantly increased; however, they have not adversely affected posttransplant survival. Hearts from drug-intoxicated donors should be carefully evaluated and considered for transplant.

Use of drug intoxicated donors for lung transplant: Impact on survival outcomes.

INTRODUCTION: The number of increasing deaths due to the opioid epidemic has led to a potential greater supply of organ donors. There is hesitancy to use drug intoxicated donors, and we evaluated their impact on post-transplant survival. BACKGROUND: Patients ≥18 years of age undergoing lung transplantation and donors from whom at least one organ was donated between January 2005 and March 2015 were selected from the United Network of Organ Sharing database. Baseline characteristics and post-transplant survival were compared between drug intoxicated and all other donors. RESULTS: The utilization of drug intoxicated donors increased from 1.86% in 2005 to 6.23% in 2014. The 2 study groups had similar characteristics including age, gender, and Lung Allocation Score. As compared to all other donors, drug intoxicated donors were younger (29.1 ± 9.4 vs 34.6 ± 13.4 years, P < .0001), less likely to be male (52% vs 61%, P < .0001), and had a greater smoking history (14% vs 11%, P .04). There was no difference in post-lung transplant survival at 1, 3, and 5 years between drug intoxicated donors (85%, 64%, and 47%) and non-drug intoxicated donors (83%, 65%, and 51%). CONCLUSION: Transplantation utilizing drug intoxicated donor lungs has significantly increased over the past decade without significantly impacting post-transplant survival.

Regional Cerebral Oxygen Saturation Level Predicts 30-Day Mortality Rate After Left Ventricular Assist Device Surgery.

OBJECTIVE: Left ventricular assist device (LVAD) surgery is complex, high risk, and expensive. The authors' hypothesis is baseline regional cerebral oxygen saturation (rSO2) might be a predictor of postoperative clinical outcomes. DESIGN: Retrospective review of 210 consecutive continuous flow LVAD patients between 2008 and 2014. The primary measure is 30-day mortality rate and secondary measures include modified major adverse cardiocerebral events (MACE), length of stay (LOS), and intensive care unit (ICU) stay. Multiple logistic regression models were applied to examine if a binary outcome variable, such as 30-day mortality and MACE, is associated with rSO2 at baseline. Log-linear model was used to examine whether LOS or ICU stay hours is associated with rSO2 at baseline. SETTING: Single institution, academic hospital. PARTICIPANTS: Patients who received LVAD surgery ​at Jewish Hospital, Louisville, KY. INTERVENTIONS: All patients received LVAD surgery. Cerebral oximetry monitoring was used in both the preoperative and intraoperative periods. MEASUREMENTS AND MAIN RESULTS: The authors found that higher rSO2 at baseline is associated with lower 30-day mortality with an odds ratio of 0.94 and 95% confidence interval (0.888, 0.995) for every 1% increase of rSO2. For secondary outcomes, baseline rSO2 was not significantly associated with MACE, requirement for postoperative renal failure/dialysis, reoperation for bleeding, and LOS or ICU hours. CONCLUSIONS: Regional cerebral oxygen saturation levels at baseline are significantly associated with 30-day mortality after LVAD surgeries.

Comparison of total artificial heart and biventricular assist device support as bridge-to-transplantation.

BACKGROUND: The use of left ventricular assist devices (LVAD) has increased significantly in the last decade. However, right heart dysfunction remains a problem despite the improved outcomes with continuous-flow LVADs. Surgical options for bridge to transplantation (BTT) in patients with biventricular failure are total artificial heart (TAH) or biventricular support (BiVAD). This study examines the differences in pre- and post-transplantation outcomes and survival in patients with TAH or BiVAD support as BTT. METHODS: The United Network of Organ Sharing database was retrospectively queried from January 2005 to December 2014 to identify adult patients undergoing heart transplantation (n = 17,022). Patients supported with either TAH (n = 212) or BiVAD (n = 366) at the time of transplantation were evaluated. Pre- and post-transplantation Kaplan-Meier survival curves were examined. Cox regression model was used to study the hazard ratios of the association between TAH versus BiVAD support and post-transplant survival. RESULTS: The median age of the study groups was 49.8 ± 12.9 (TAH) and 47.2 ± 13.9 (BiVAD) years (range 18-74 years). There were more men, 87% versus 74%, in the TAH group (p < 0.0001) with greater body mass index, 27.3 ± 5.2 versus 25.6 ± 4.7 (p < 0.0001), compared to those with BiVADs. Creatinine was higher, 1.7 + 1.2 versus 1.3 + 0.8 mg/dL (p < 0.0001), in the TAH group before transplant. The 30-day, one-, and three-year post-transplantation survival was 88%, 78%, and 67%, respectively, for patients with TAH support versus 93%, 83%, and 73% (p = 0.06) for patients with BiVAD support. Cox regression model shows pre-transplant creatinine (HR = 1.21, p = 0.008) is associated with a lower post-transplant survival. TAH is not associated with a worse post-transplant survival (p = 0.1). There was no difference in wait-list survival in patients supported with TAH or BiVAD (p = 0.8). CONCLUSION: Although there has been a recent increase in the use of the TAH as BTT, BiVAD support remains a viable option with similar post-transplant survival.

Impact of cardiac resynchronization therapy on clinical outcomes in patients with continuous-flow left ventricular assist devices.

BACKGROUND: Implantable cardioverter-defibrillators (ICDs) can improve survival in left ventricular assist device (LVAD) recipients. However, the impact of cardiac resynchronization therapy (CRT-D) on outcomes in continuous-flow left ventricular assist device (CF-LVAD) patients is not known. We sought to determine if CRT-D improved clinical outcomes in CF-LVAD patients compared with ICDs alone. METHODS AND RESULTS: Sixty-one consecutive CF-LVAD patients with an ICD or CRT-D were evaluated. Impacts of CRT-D on mortality, all-cause hospitalization, and incidence of atrial (AA) and ventricular (VA) arrhythmias after LVAD implantation was compared with patients with ICD alone. Of the 61 LVAD patients, 31 (age 59.8 ± 16 years, 84% male) had CRT-D and 30 (age 57.2 ± 13 years, 74% male) had ICD. Before LVAD implantation, no significant differences were noted between the groups in demographic and clinical characteristics, LVAD indications, and incidence of AA and VA. Over 682 ± 45 days of LVAD support, 8 patients (25.8%) died in the CRT-D arm versus 5 (16.7%) in the ICD arm (P = .35). No differences were noted between the CRT-D and ICD groups in all-cause (96.8 vs 93.3%; P = .63) and HF (19.4 vs 26.7%; P = .78) hospitalizations, left ventricular (LV) end-diastolic diameter (6.4 ± 1.5 vs 6.2 ± 1.1 cm, P = .47), and incidence of AA (35.4% vs 33.3%; P = .80), VA (29% vs 26.6%; P = .86), and ICD shocks (22.6% vs 16.7%; P = .93). Beta-blocker and antiarrhythmic drug use after LVAD implantation was similar in both groups. CONCLUSIONS: In patients with refractory HF who received CF-LVADs, CRT-D, compared with ICD, did not significantly improve mortality, all-cause hospitalization, LV dimensions, and incidence of AA and VA.

Associated Factors and Impact of Persistent Renal Dysfunction in Pediatric Heart Transplantation.

BACKGROUND: We evaluated the impact of significant renal dysfunction (SRD) on listing and pediatric heart transplantation (PHT) outcomes. METHODS: The United Network of Organ Sharing registry was queried. Our cohort included 11,625 children listed for PHT (2000-2020). At listing, 1494 (13%) had SRD, defined as an estimated glomerular filtration rate of <45 mL/min/1.73 m2 and/or dialysis requirement. Characteristics of children with and without SRD were compared. SRD impact on outcomes was examined. Factors associated with waiting list mortality, persistent SRD at PHT, and post-PHT survival with and without simultaneous heart-kidney transplantation were assessed. RESULTS: Compared with children with an estimated glomerular filtration rate >45 mL/min/1.73 m2, those with SRD had higher waiting list death (37% vs 14%, P < .01) and lower transplantation rate (51% vs 71%, P < .01). On multivariable analysis, SRD was associated with waiting list death (hazard ratio, 3.016; P < .0001). Among 767 children with SRD who received PHT, 361 (47%) had persistent SRD at the time of PHT. On multivariable analysis, factors associated with persistent SRD were older age (odds ratio [OR], 1.147 per year; 95% CI, 1.046-1.258 per year; P = .0035), bilirubin (OR, 1.127 per 1-mg/dL; 95% CI, 1.061-1.197 per 1-mg/dL; P < .0001), dialysis (OR, 1.839; 95% CI, 1.017-3.326; P = .0115), mechanical ventilation (OR, 1.972; 95% CI, 1.336-2.911; P = .0006), extracorporeal membrane oxygenation (OR, 1.747; 95% CI, 1.074-2.842; P = .0247), and not using a ventricular assist device (VAD) (OR, 0.498 [VAD use]; 95% CI, 0.277-0.895 VAD use; P = .0198). Post-PHT survival was 72%, 70%, and 56% (P < .01) at 8 years for PHT alone with improved renal function, simultaneous heart-kidney transplantation (n = 69), and PHT alone with persistent SRD, respectively. CONCLUSIONS: SRD is associated with high waiting list death and decreased transplantation rate. Timely proper pre-PHT support with VAD could enhance kidney recovery. Simultaneous heart-kidney transplantation neutralized persistent SRD effect on survival and might be considered in high-risk patients such as those on dialysis, mechanical ventilation, or extracorporeal membrane oxygenation support.

Predictors of Survival After Heart Transplant in the New Allocation System: A UNOS Database Analysis.

Clinical predictors of posttransplant graft loss since the United Network for Organ Sharing (UNOS) heart allocation system change have not been well characterized. Single organ adult heart transplants from the UNOS database were identified (n = 10,252) and divided into a test cohort (n = 6,869, 67%) and validation cohort (n = 3,383, 33%). A Cox regression analysis was performed on the test cohort to identify recipient and donor risk factors for posttransplant graft loss. Based on the risk factors, a score (max 16) was developed to classify patients in the validation cohort into risk groups of low (≤1), mid (2-3), high (≥4) risk. Recipient factors of advanced age, Black race, recipient blood group O, diabetes, etiology of heart failure, renal dysfunction, elevated bilirubin, redo-transplantation, elevated pulmonary artery pressure, transplant with a durable ventricular assist device, or transplant on extracorporeal membrane oxygenation (ECMO) or ventilator were associated with more posttransplant graft loss. Donor factors of ischemic time and donor age were also associated with outcomes. One year graft survival for the low-, mid-, high-risk groups was 94%, 91%, and 85%, respectively. In conclusion, easily obtainable clinical characteristics at time of heart transplant can predict posttransplant outcomes in the current era.

Perioperative Morbidity and Outcomes in Pediatric Patients Transitioned From Extracorporeal Membrane Oxygenation to Ventricular Assist Device Support: A Study of the Society of Thoracic Surgeons Congenital Heart Surgery Database.

As a bridge to transplant strategy, children transitioned from extracorporeal membrane oxygenation (ECMO) to ventricular assist device (VAD) have higher waitlist mortality compared with those who receive de novo VAD. However, the contribution of the immediate perioperative period and differences in the two groups are not well studied. We performed a nested case-control study between children receiving de novo VAD (group 1) and those transitioned from ECMO to VAD (group 2) between 2014 and 2019 using The Society of Thoracic Surgeons (STS) database. A total of 735 children underwent VAD placement with 498 in group 1 and 237 in group 2. Patients in group 2 were significantly younger, smaller, and significantly sicker, were twice as likely to transition to biventricular VAD and need unplanned reoperations. Overall mortality was 16% for group 1 and 34% for group 2 ( p < 0.01). Regression analysis showed that ECMO use (odds ratio [OR], 2.17 [1.3-3.4]), ventilator need (OR, 2.2 [1.3-3.9]), and cardiogenic shock (OR, 1.8 [1.2-2.8]) were all independent preoperative predictors of VAD mortality while dialysis need (OR, 25.5 [8.6-75.3]), stroke (OR, 6.2 [3.1-12.6]), and bleeding (OR, 1.9 [1.1-3.4]) were independent postoperative predictors of VAD mortality within 30 days (all p < 0.05). The study demonstrated significant baseline differences between the two cohorts, warranting avoidance of comparison. Early elective VAD placement in this cohort of patients should be sought to avoid interim ECMO and high post-VAD mortality.