Financial impact of donation after circulatory death heart transplantation: A single-center analysis.

INTRODUCTION: Clinical success of donation after circulatory death (DCD) heart transplantation is leading to growing adoption of this technique. In comparison to procurement from a brain-dead donor, DCD requires additional resources. The economic impact of DCD heart transplantation from the hospital perspective is not well known. METHODS: We compared the financial data of patients who received DCD allografts to those who received a DBD organ at our institution from January 1, 2021 to December 31, 2022. We also compared the cost of ex-situ machine perfusion to in-situ organ perfusion employed during DCD recovery. RESULTS: We performed 58 DBD and 22 DCD heart-alone transplantations during the study period. Out of 22 DCD grafts, 16 were recovered with thoracoabdominal normothermic regional perfusion (TA-NRP) and six with direct procurement followed by normothermic machine perfusion (DP-NMP). The contribution margin per case for DBD versus DCD was $234,362 and $235,440 (P = .72). The direct costs did not significantly differ between the two groups ($171,949 and 186,250; P = .49). In comparing the two methods of procuring hearts from DCD donors, the direct cost of TA-NRP was $155,955 in comparison to $223,399 for DP-NMP (P = .21). This difference translated into a clinically meaningful but not statistically significant greater contribution margin for TA-NRP ($242, 657 vs. $175,768; P = .34). CONCLUSIONS: Our data showed that the adoption of DCD procurement did not have a negative financial impact on the contribution margin in our institution. Programs considering starting DCD heart transplantation, and those who are currently performing DCD procurement should evaluate their own financial situation.

Impact of donation after circulatory death heart transplantation on waitlist outcomes and transplantation activity.

INTRODUCTION: Donation after circulatory death (DCD) heart transplantation has been shown to have comparable outcomes to transplantation using brain death donors (DBDs). This study evaluates the impact of this alternative source of allografts on waitlist mortality and transplant volume. METHODS: We compared waitlist mortality and transplant rates in patients who were registered before (2019 period) and after we adopted DCD heart transplantation (2021 period). RESULTS: We identified 111 patients who were on the waiting list in 2019 and 77 patients who were registered during 2021. Total number of donor organ offers received in 2019 was 385 (178 unique donors) versus 3450 (1145 unique donors) in 2021. More than 40% of all donors in 2021 were DCDs. Waitlist mortality was comparable for patients in 2019 and 2021 (18/100 person-years in 2019 vs. 26/100 person-years in 2021, p = .49). The transplant rate was 67/100 person-years in 2019 versus 207/100 person-years in 2021 (p < .001). After adjusting for acuity status, gender, blood type, and weight, patients listed in 2021 had 2.08 times greater chance of transplantation compared to patients listed in 2019 (HR 2.08, 95% confidence interval [CI] 1.26-3.45, p = .004). CONCLUSIONS: Use of DCD donor hearts significantly increased heart transplant rate in our institution.

Successful lung transplantation with graft recovered after thoracoabdominal normothermic perfusion from donor after circulatory death.

Lung transplantation with lungs procured from donors after circulatory death (DCD) has been established as an alternative technique to traditional donation after brain death (DBD) with comparable outcomes. Recently, in situ thoracoabdominal normothermic regional perfusion (TA-NRP) has emerged as a novel technique employed in the procurement of cardiac allografts after circulatory death. TA-NRP, in contrast to ex situ machine perfusion, has the advantage of allowing in situ assessment of donor organs prior to final acceptance. However, there are some concerns that this technique may adversely impact the quality of lung allografts. Here, we present a case of a successful bilateral sequential lung transplantation in a patient with postinflammatory pulmonary fibrosis due to acute respiratory distress syndrome (ARDS), with lungs procured after normothermic in situ lung perfusion. Apart from the lungs, heart, liver, and kidneys were also successfully transplanted from this donor.

In a large-volume multidisciplinary setting individual surgeon volume does not impact LVAD outcomes.

BACKGROUND: In complex operations surgeon volume may impact outcomes. We sought to understand if individual surgeon volume affects left ventricular assist device (LVAD) outcomes. METHODS: We reviewed primary LVAD implants at an experienced ventricular assist devices (VAD)/transplant center between 2013 and 2019. Cases were dichotomized into a high-volume group (surgeons averaging 11 or more LVAD cases per year), and a low-volume group (10 or less per year). Propensity score matching was performed. Survival to discharge, 1-year survival, and incidence of major adverse events were compared between the low- and high-volume groups. Predictors of survival were identified with multivariate analysis. RESULTS: There were 315 patients who met inclusion criteria-45 in the low-volume group, 270 in the high-volume group. There was no difference in survival to hospital discharge between the low (91.9%) and high (83.3%) volume matched groups (p = .22). Survival at 1-year was also similar (85.4% vs. 80.6%, p = .55). There was no difference in the incidence of major adverse events between the groups. Predictors of mortality in the first year included: age (hazards ratio [HR]: 1.061, p < .001), prior sternotomy (HR: 1.991, p = .01), increasing international normalized ratio (HR: 4.748, p < .001), increasing AST (HR: 1.001, p < .001), increasing bilirubin (HR: 1.081, p = .01), and preoperative mechanical ventilation (HR: 2.662, p = .005). Individual surgeon volume was not an independent predictor of discharge or 1-year survival. CONCLUSION: There was no difference in survival or adverse events between high and low volume surgeons suggesting that, in an experienced multidisciplinary setting, low-volume VAD surgeons can achieve similar outcomes to their high-volume colleagues.

Combination plate and band fixation for primary closure in bilateral lung transplantation.

BACKGROUND: Sternal complications are common following transverse thoracosternotomy in patients undergoing bilateral lung transplantation. We present a single-institution experience using a next generation rigid fixation system for primary sternal closure following transverse sternotomy for bilateral lung transplantation. METHODS: Retrospective review was performed on all patients who had bilateral sequential lung transplants utilizing a transverse thoracosternotomy from 2016 to 2020. Demographics, baseline characteristics, peri-operative data, and outcomes were collected, reviewed and summarized. Two groups of patients were identified: wire cerclage (Group A), combination plate-and-band rigid fixation (Group B). The primary outcome was sternal complications, which were divided into mechanical and non-mechanical. RESULTS: Twenty-two patients met inclusion criteria. Three patients (13.6%) were in Group A, nineteen patients (86.4%) in Group B. Two patients in each Group A (66.6%) and Group B (10.5%) experienced a sternal complication. Sternal complications included sternal dehiscence (2), sternal malunion (1), and surgical site infection (1). One patient with plate-and-band fixation (5.2%) had a mechanical sternal complication. Three patients required reoperation secondary to sternal complication. CONCLUSIONS: The utilization of a combination plate-and-band rigid fixation system for primary closure is safe and may be an effective method to reduce sternal complications following transverse thoracosternotomy for lung transplantation.

Impact of temporary mechanical circulatory support for early graft failure on post-heart transplantation outcomes.

Although temporary mechanical circulatory support (tMCS) for hemodynamic failure following heart transplantation is associated with increased early morbidity and mortality, the impact of etiology of graft dysfunction and long-term clinical implications are less well known. The objective of our study was to evaluate outcomes in patients who required venoarterial extracorporeal membrane oxygenation (VA ECMO) or temporary right ventricular assist device (RVAD) support for either primary or secondary early graft dysfunction. Hospital mortality in 27 patients who required tMCS following heart transplantation at our institution between 2007 and 2017 was 56%, 30% in patients with right ventricular dysfunction secondary to increased afterload, 60% in patients with primary graft dysfunction, and 100% in patients with graft failure secondary to coagulopathy with intraoperative bleeding or overwhelming sepsis. Conditional 1-year and 5-year survival was comparable between patients with, and without, the need for post-transplantation support with tMCS (98% and 89%; 92% and 65% at 1 and 5 years, P = .21). Etiology of early graft failure plays an important part in determining the short-term post-heart transplantation outcome. Although complications associated with tMCS use, such as renal dysfunction and infection, extend beyond index transplant hospitalization, long-term conditional survival is not compromised.

Can we expect improvements in outcomes with centrifugal vs axial flow left ventricular assist devices in patients transitioned from extracorporeal life support?

BACKGROUND: Several patient-related characteristics have been associated with inferior outcomes following durable left ventricular assist device (LVAD) implantation in patients transitioned from venoarterial extracorporeal membrane oxygenation (VA ECMO). The impact of LVAD pump type used is less well-known. METHODS: We compared outcomes between patents who received axial and centrifugal flow LVADs following stabilization with VA ECMO. RESULTS: From January 2011 to December 2018, we implanted 28 LVADs in patients transitioned from VA ECMO. This included 17 axial flow devices (HeartMate II LVAD, Abbott Laboratories, Chicago, IL) and 11 centrifugal flow pumps (eight HeartWare HVADs; Medtronic, Minneapolis, MN and three HeartMate 3 LVAS pumps; Abbott Laboratories, Chicago, IL). There was no difference in hospital mortality (23.5% vs 18.2%, P = .74) or 1-year survival (P = .31) between the devices. There were no differences in adverse event rates between the two pump types, apart from a higher rate of gastrointestinal bleeding in patients who received centrifugal flow pumps (1.44 events per 100 patient-months vs 14.67 events per 100 patient-months, P = .010). Preimplantation levels of alanine aminotransferase (hazard ratio [HR], 1.001; 95% confidence interval [CI], 1.000 to 1.002; P = .004) and elevated serum creatinine level (HR, 3.480; 95% CI, 1.121-10.807; P = .031) emerged as significant predictors of decreased 1-year survival. CONCLUSIONS: Preimplantation optimization of end-organ function is the single most important determinant of successful post-LVAD survival in patients transitioned from extracorporeal life support. There is no association of pump type with LVAD outcomes up to 1-year post implantation.

Donor and recipient risk factor analysis of inferior postheart transplantation outcome in the era of durable mechanical assist devices.

The study objective is to quantify the impact of donor and recipient variables on heart transplant survival in recipients with a significant proportion of implanted continuous-flow left ventricular assist devices (LVADs). This is a prospective cohort study of International Society for Heart and Lung Transplantation (ISHLT) Registry that includes all primary heart-alone transplants in adult recipients (January 2005 and June 2013, N = 15 532, 27% LVADs). Donor and recipient characteristics were assessed for association with death or graft failure within 90 days and between 90 days and 5 years after transplantation. On Cox proportional hazard model donor cause of death other than head trauma (hazard ratio [HR] 1.985, P < 0.0001), recipient congenital (HR 2.7555, P < 0.0001) and ischemic (HR 1.165, P = 0.0383) vs dilated etiology and female donor heart transplanted into male recipient (HR 1.207, P = 0.0354) were predictors of death or graft failure within 90 days. Between 90 days and 5 years, donor cigarette use (HR 1.232, P = 0.0001), recipient cigarette use (HR 1.193, P = 0.0003), diabetes (HR 1.159, P = 0.0050), arterial hypertension (HR 1.129, P = 0.0115), and ischemic vs dilative cardiomyopathy had an increased probability of death or graft failure.

Novel insights into pretransplant allosensitization in heart transplant recipients in the contemporary era of immunosuppression and rejection surveillance.

Solid-phase assays (SPA) have facilitated detection and definition of antibodies to human leukocyte antigens (HLA) and major histocompatibility complex class I chain-related antigen A (MICA). However, clinical consequences of pretransplant SPA results in heart transplantation have been studied insufficiently in the current era of immunosuppression and rejection surveillance. Pretransplant sera, panel-reactive antibodies (PRA), pretransplant crossmatch, and clinical data were retrospectively analyzed in 264 adult heart transplant recipients. The specificity of HLA and MICA antibodies and C1q-binding activity of donor-specific antibodies (DSA) were defined using SPA. Pretransplant HLA antibodies were detected in 57 (22%) individuals, in 28 individuals (11%); these antibodies were DSA after transplant. Preformed DSA and elevated peak PRA were independent predictors of pathologic AMR, which occurred in 19 individuals (7%). The increasing number of DSA and the cumulative mean fluorescence intensity of DSA were associated with AMR. C1q-binding assay was a suboptimal predictor of AMR in our cohort. Pretransplant allosensitization and MICA antibodies were related neither to impaired graft survival nor to other adverse clinical events during a median follow-up of 39 months. Identification of preformed DSA by SPA, in addition to PRA monitoring, may predict AMR in the contemporary era of heart transplantation.

Intracardiac ectopic thyroid (struma cordis).

A 67-year-old male with a history of gastrointestinal malignancy was found to have a tumor in the right ventricular outflow tract. The tumor was surgically removed, and the histological diagnosis was thyroid struma. We review the literature on this rare cardiac tumor.

Does concomitant tricuspid valve intervention at the time of left ventricular assist device placement for patients with significant tricuspid regurgitation lead to improved outcomes compared to isolated left ventricular assist device placement?

A best evidence topic in cardiac surgery was written according to a structured protocol. The question addressed was 'In patients with advanced heart failure (HF) and moderate to severe functional tricuspid regurgitation (TR) undergoing left ventricular assist device (LVAD) placement is concomitant tricuspid valve intervention (TVI) superior for the clinical outcomes of survival, right ventricular failure, rehospitalizations for HF, functional status, and quality of life?' Altogether, 56 papers were found using the reported search, of which 12 papers represented the best evidence to answer the clinical question. The authors, journal, date, country of publication, patient group studied, study type, relevant outcomes and results of these papers are tabulated. Our search found no significant clinical benefit for concomitant TVI at the time of LVAD placement. We conclude that patient with moderate-to-severe TR should not routinely undergo concomitant TVI with LVAD placement.

Improved Early Post-Transplant Outcomes and Organ Use in Kidney Transplant Using Normothermic Regional Perfusion for Donation after Circulatory Death: National Experience in the US.

BACKGROUND: Normothermic regional perfusion (NRP) is a technique that is intended to enhance organ transplant outcomes from donation circulatory death (DCD) donors. STUDY DESIGN: A retrospective analysis of data from the Scientific Registry of Transplant Recipients was performed. DCD donors were screened for inclusion based on date of donation 2020 or later, and whether the heart was also recovered for transplantation. We grouped donors as either donation after brain death or DCD. DCD donors were further divided into groups including those in which the heart was not recovered for transplant (Non-Heart DCD) and those in which it was, based on recovery technique (thoracoabdominal-NRP [TA-NRP] Heart DCD and Super Rapid Recovery Heart DCD). RESULTS: A total of 219 kidney transplant recipients receiving organs from TA-NRP Heart DCD donors were compared to 436 SRR Super Rapid Recovery DCD, 10,630 Super Rapid Recovery non-heart DCD, and 27,820 donations after brain death recipients. Kidney transplant recipients of TA-NRP DCD allografts experienced shorter length of stay, lower rates of delayed graft function, and lower serum creatinine at the time of discharge when compared with recipients of other DCD allografts. CONCLUSIONS: Our analysis demonstrates superior early kidney allograft function when TA-NRP is used for DCD organ recovery.

Considerations for the use of porcine organ donation models in preclinical organ donor intervention research.

Use of animal models in preclinical transplant research is essential to the optimization of human allografts for clinical transplantation. Animal models of organ donation and preservation help to advance and improve technical elements of solid organ recovery and facilitate research of ischemia-reperfusion injury, organ preservation strategies, and future donor-based interventions. Important considerations include cost, public opinion regarding the conduct of animal research, translational value, and relevance of the animal model for clinical practice. We present an overview of two porcine models of organ donation: donation following brain death (DBD) and donation following circulatory death (DCD). The cardiovascular anatomy and physiology of pigs closely resembles those of humans, making this species the most appropriate for pre-clinical research. Pigs are also considered a potential source of organs for human heart and kidney xenotransplantation. It is imperative to minimize animal loss during procedures that are surgically complex. We present our experience with these models and describe in detail the use cases, procedural approach, challenges, alternatives, and limitations of each model.

Consensus Statement: Technical Standards for Thoracoabdominal Normothermic Regional Perfusion.

BACKGROUND: Thoracoabdominal normothermic regional perfusion (TA-NRP) has emerged as a powerful technique for optimizing organ procurement from donation after circulatory death donors. Despite its rapid adoption, standardized guidelines for TA-NRP implementation are lacking, prompting the need for consensus recommendations to ensure safe and effective utilization of this technique. METHODS: A working group composed of members from The American Society of Transplant Surgeons, The International Society of Heart and Lung Transplantation, The Society of Thoracic Surgeons, and The American Association for Thoracic Surgery was convened to develop technical guidelines for TA-NRP. The group systematically reviewed existing literature, consensus statements, and expert opinions to identify key areas requiring standardization, including predonation evaluation, intraoperative management, postdonation procedures, and future research directions. RESULTS: The working group formulated recommendations encompassing donor evaluation and selection criteria, premortem testing and therapeutic interventions, communication protocols, and procedural guidelines for TA-NRP implementation. These recommendations aim to facilitate coordination among transplant teams, minimize variability in practice, and promote transparency and accountability throughout the TA-NRP process. CONCLUSIONS: The consensus guidelines presented herein serve as a comprehensive framework for the successful and ethical implementation of TA-NRP programs in organ procurement from donation after circulatory death donors. By providing standardized recommendations and addressing areas of uncertainty, these guidelines aim to enhance the quality, safety, and efficiency of TA-NRP procedures, ultimately contributing to improved outcomes for transplant recipients.

Consensus Statement: Technical Standards for Thoracoabdominal Normothermic Regional Perfusion.

BACKGROUND: Thoracoabdominal normothermic regional perfusion (TA-NRP) has emerged as a powerful technique for optimizing organ procurement from donation after circulatory death donors. Despite its rapid adoption, standardized guidelines for TA-NRP implementation are lacking, prompting the need for consensus recommendations to ensure safe and effective utilization of this technique. METHODS: A working group composed of members from The American Society of Transplant Surgeons, The International Society of Heart and Lung Transplantation, The Society of Thoracic Surgeons, and The American Association for Thoracic Surgery was convened to develop technical guidelines for TA-NRP. The group systematically reviewed existing literature, consensus statements, and expert opinions to identify key areas requiring standardization, including predonation evaluation, intraoperative management, postdonation procedures, and future research directions. RESULTS: The working group formulated recommendations encompassing donor evaluation and selection criteria, premortem testing and therapeutic interventions, communication protocols, and procedural guidelines for TA-NRP implementation. These recommendations aim to facilitate coordination among transplant teams, minimize variability in practice, and promote transparency and accountability throughout the TA-NRP process. CONCLUSIONS: The consensus guidelines presented herein serve as a comprehensive framework for the successful and ethical implementation of TA-NRP programs in organ procurement from donation after circulatory death donors. By providing standardized recommendations and addressing areas of uncertainty, these guidelines aim to enhance the quality, safety, and efficiency of TA-NRP procedures, ultimately contributing to improved outcomes for transplant recipients.

Mitral valve repair versus replacement in simultaneous aortic and mitral valve surgery.

BACKGROUND: Double valve replacement for concomitant aortic and mitral valve disease is associated with substantial morbidity and mortality. Excellent results with valve repair in isolated mitral valve lesions have been reported; therefore, whether its potential benefits would translate into better outcomes in patients with combined mitral-aortic disease was investigated. METHODS: A retrospective observational study was performed involving 341 patients who underwent aortic valve replacement with either mitral valve repair (n=42) or double valve replacement (n=299). Data were analyzed for early mortality, late valve-related complications and survival. RESULTS: The early mortality rate was 11.9% for valve repair and 11.0% for replacement (P=0.797). Survival (± SD) was 67±11% in mitral valve repair with aortic valve replacement and 81±3% in double valve replacement at five years of follow-up (P=0.187). The percentage of patients who did not experience major adverse valve-related events at five years of follow-up was 83±9% in those who underwent mitral valve repair with aortic valve replacement and 89±2% in patients who underwent double valve replacement (P=0.412). Age >70 years (HR 2.4 [95% CI 1.1 to 4.9]; P=0.023) and renal dysfunction (HR 1.9 [95% CI 1.2 to 3.7]; P=0.01) were independent predictors of decreased survival. CONCLUSIONS: In patients with double valve disease, both mitral valve repair and replacement provided comparable early outcomes. There were no significant differences in valve-related reoperations, anticoagulation-related complications or prosthetic valve endocarditis. Patient-related factors appear to be the major determinant of late survival, irrespective of the type of operation.

Does Tracheostomy Improve Outcomes in Those Receiving Venovenous Extracorporeal Membrane Oxygenation?

Patients receiving venovenous extracorporeal membrane oxygenation (VV-ECMO) often require extended periods of ventilation. We examined the role of tracheostomy on outcomes of patients supported with VV-ECMO. We reviewed all patients at our institution who received VV-ECMO between 2013 and 2019. Patients who received a tracheostomy were compared with VV-ECMO-supported patients without tracheostomy. The primary outcome measure was survival to hospital discharge. Secondary outcome measures included length of intensive care unit (ICU) and hospital stay and adverse events related to the tracheostomy procedure. Multivariable analysis was performed to identify predictors of in-hospital mortality. We dichotomized patients receiving tracheostomy into an "early" and "late" group based on median days to tracheostomy following ECMO cannulation and separate analysis was performed. One hundred and fifty patients met inclusion criteria, 32 received a tracheostomy. Survival to discharge was comparable between the groups (53.1% vs. 57.5%, p = 0.658). Predictors of mortality on multivariable analysis included Respiratory ECMO Survival Prediction (RESP) score (odds ratio [OR] = 0.831, p = .015) and blood urea nitrogen (BUN) (OR = 1.026, p = 0.011). Tracheostomy performance was not predictive of mortality (OR = 0.837, p = 0.658). Bleeding requiring intervention occurred in 18.7% of patients following tracheostomy. Early tracheostomy (<7 days from the initiation of VV-ECMO) was associated with shorter ICU (25 vs. 36 days, p = 0.04) and hospital (33 vs. 47, p = 0.017) length of stay compared with late tracheostomy. We conclude that tracheostomy can be performed safely in patients receiving VV-ECMO. Mortality in these patients is predicted by severity of the underlying disease. Performance of tracheostomy does not impact survival. Early tracheostomy may decrease length of stay.

Utilization of Paragonix Sherpapak Cardiac Transport System for the Preservation of Donor Hearts After Circulatory Death.

BACKGROUND: Donation after circulatory death (DCD) heart transplantation is being increasingly adopted by transplant centers. The optimal method of DCD heart preservation during transport after in situ thoracoabdominal normothermic regional perfusion (TA-NRP) is not known. METHODS: We evaluated our experience with the Paragonix SherpaPak Cardiac Transport System (SCTS) for the transport of DCD cardiac allografts after TA-NRP recovery between January 2021 and December 2022. We collected and evaluated donor characteristics, allograft ischemic intervals, and recipient baseline demographic and clinical variables, and short-term outcomes. RESULTS: Twelve recipients received DCD grafts recovered with TA-NRP and transported in SCTS during the study period. The median age of 10 male and 2 female donors was 32 years (min 15, max 38). The median duration of functional warm ischemia was 12 minutes (min 8, max 22). Hearts were preserved in SCTS for a median of 158 minutes (min 37, max 224). Median recipient age was 61 years (min 28, max 70). Ten recipients (83%) survived to hospital discharge, with one death attributable to graft dysfunction (8%). The median vasoactive-inotropic (VIS) score at 72 hours post-transplantation of the entire cohort was 6 (min 0, max 15). The median length of intensive care unit stay in hospital survivors was 5 days (min 3, max 17) days and hospital stay 17 days (min 9, max 37). CONCLUSIONS: The Paragonix SCTS provides efficacious preservation of DCD grafts for ≥3.5 hours. Organs transported with this device showed satisfactory post-transplantation function.