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Background: Transplantation using hearts obtained through donation after circulatory death (DCD) is increasing, but data on recipient renal outcomes are limited., Methods and Results: Patients at a single institution who underwent heart transplantation using organs procured through DCD or donation after brain death (DBD) from April 2016 to August 2022 were included in this retrospective cohort study. Hemodynamic measures were collected via right heart catheterization performed 1 week after transplantation. Posttransplantation renal outcomes included estimated glomerular filtration rate at 1 week, 4 weeks, and 16 weeks, and the incidence of acute kidney injury (AKI) and renal replacement therapy within 1 week. The analysis included 225 patients (55 recipients of DCD). Baseline characteristics were comparable between recipients of DCD and DBD. Renal outcomes within 1 week posttransplantation in recipients of DCD were similar to recipients of DBD, including percent change in estimated glomerular filtration rate (-37.9% [-58.6 to -6.2] versus -31.9% [-52.4 to -9.9]; P =0.91), incidence of AKI (47.3% versus 46.5%; P >0.99) and incidence of renal replacement therapy (3.6% versus 4.7%; P >0.99). Recipients of DCD with AKI within 1 week ("early AKI") did not recover to baseline estimated glomerular filtration rate (75.8 [60.2-91.3] mL/min per 1.73 m 2 ) by week 16 (59.3 [46.9-73.6] mL/min per 1.73 m 2 ; P =0.002), whereas recipients without early AKI exhibited comparable estimated glomerular filtration rate to baseline by week 4 (84.5 [70.8-98.5] mL/min per 1.73 m 2 ; P =0.084). Similar trends were observed in recipients of DBD., Conclusions: Recipients of DCD demonstrated similar renal outcomes compared with recipients of DBD, supporting the ongoing use of DCD transplantation. Early AKI was associated with persistent renal dysfunction for recipients of both DCD and DBD.

Background: Low donor heart availability underscores the need to identify all potentially transplantable organs. We sought to determine whether pre-emptive administration of pangenotypic direct-acting antiviral therapy can safely prevent the development of chronic hepatitis C virus (HCV) infection in uninfected recipients of HCV-infected donor hearts., Methods: Patients were recruited for this an open-label, single-centre, proof-of-concept study from Nov 1, 2017, to Nov 30, 2018. Following enrolment, the recipient's status on the heart transplantation waiting list was updated to reflect a willingness to accept either an HCV-positive or HCV-negative heart donor. Patients who underwent transplantation with a viraemic donor heart, as determined by nucleic acid testing (NAT), received pre-emptive oral glecaprevir-pibrentasvir before transport to the operating room followed by an 8-week course of glecaprevir-pibrentasvir after transplantation. Patients receiving HCV antibody-positive donor hearts without detectable circulating HCV RNA were followed using a reactive approach and started glecaprevir-pibrentasvir only if they developed viraemia. The primary outcome was achievement of sustained virological response 12 weeks after completion of glecaprevir-pibrentasvir therapy (SVR12). Patients were followed from study enrolment to 1 year after transplantation. This is an interim analysis, initiated after all enrolled patients reached the primary outcome. Results reflect data from Nov 1, 2017, to May 30, 2019. This trial is registered with ClinicalTrials.gov, number NCT03208244., Findings: 55 patients were assessed for eligibility and 52 consented to enrolment. 25 patients underwent heart transplantation with HCV-positive donor hearts (20 NAT-positive, five NAT-negative), three of whom underwent simultaneous heart-kidney transplantation. All 20 recipients of NAT-positive hearts tolerated glecaprevir-pibrentasvir and showed rapid viral suppression (median time to clearance 3·5 days, IQR 0·0-8·3), with the subsequent achievement of SVR12 by all 20. The five recipients of NAT-negative grafts did not become viraemic. Median pre-transplant waiting time for patients following enrolment in the HCV protocol was 20 days (IQR 8-57). Patient and allograft survival were 100% at a median follow-up of 10·7 months (range 6·5-18·0)., Interpretation: Pre-emptive administration of glecaprevir-pibrentasvir therapy results in expedited organ transplantation, rapid HCV suppression, prevention of chronic HCV infection, and excellent early allograft function in patients receiving HCV-infected donor hearts. Long-term outcomes are not yet known., Funding: American Association for the Study of Liver Diseases, National Institutes of Health, and the Massachusetts General Hospital., (Copyright © 2019 Elsevier Ltd. All rights reserved.)

Patients in end stage heart failure with a BMI >35 are considered unacceptable candidates for heart transplantation due to increased morbidity and mortality after transplant. Those with a left ventricular assist device (LVAD) may struggle losing weight (and often gain weight) and may be inactivated on the waiting list (or denied listing) until weight loss is achieved. To assist these patients in weight loss with a goal of reactivation on the transplant list, we created clinical guidelines for laparoscopic bariatric surgery. A multidisciplinary collaboration to develop clinical guidelines was conducted with members from cardiology, cardiac surgery, bariatric surgery, nutrition, nursing, anesthesia, perfusion and anticoagulation management. Patients were admitted preoperatively for Heparin bridge (aspirin was not held) and to adjust antihypertensives and diuretics to prevent post-operative complications. Postoperatively antihypertensives were resumed based on MAP, diuretics were held, intravenous fluids given until patient was euvolemic on exam, and warfarin was resumed 24 hours after surgery. A clinical protocol was implemented, and 4 male patients underwent successful bariatric surgery between April 1, 2019 and September 30, 2019. The median age was 47 (range 31-61) with a median BMI of 40.27 (range 36.03 to 50.09). Patients were scheduled for laparoscopic sleeve gastrectomy with 3 successful surgeries performed. One surgery was aborted secondary to the HeartMate II (HMII) obstructing the gastrosplenic ligament, however, the patient successfully underwent laparoscopic magenstrassa mill procedure days later. The median preoperative length of stay was 3 days with a median post-operative length of stay of 7 days. There were no complications or re-admissions associated with the bariatric surgery and all patients lost weight after surgery (median 12.5kg; range 4.9 to 25.3kg at 1-5 months). Two of the four patients were able to be reactivated on the heart transplant waiting list at 1 and 4 months after surgery. Our experience demonstrates that bariatric surgery can be safely performed on patients with an LVAD. Consideration may be required for patients with a HeartMate II related to device positioning. Multidisciplinary collaboration in establishing a clinical protocol ensures that VAD management strategies are addressed. [ABSTRACT FROM AUTHOR]

Routine surveillance endomyocardial biopsy (EMB) following heart transplantation (HT) is considered an important tool for early detection of allograft rejection. However, the recommended frequency of EMB is not defined by societal guidelines and scheduling practices are widely variable between transplant centers. We sought to identify whether there were differences in hemodynamic, echocardiographic or outcome parameters between patients categorized by rejection grade on surveillance EMB. We examined LVEF by echocardiography and right heart catheterization (RHC) hemodynamic parameters obtained at the time of routine surveillance EMB in 222 patients who underwent HT between January 2015 - January 2021 at a single center. On the first four post-transplant paired EMBs and RHCs, similar hemodynamic measurements and LVEFs were observed regardless of corresponding cellular rejection grade (P > 0.5) (Table 1). Patients were then grouped by if they ever had a biopsy with significant rejection (SR) defined as ≥ grade 2R (n=119, 54%) or no significant rejection (NSR) defined as grade 0 or 1R (n=103, 46%). Kaplan-Meier survival analysis showed no significant difference in post-transplant survival (HR 0.56, p=0.14) in SR vs NSR (Figure 1). A total of 26 deaths were observed (16 NSR and 10 SR). For those that died in the SR group, only one may have been related to allograft rejection with the cause of death being outside hospital sudden death. In a SR sub-group of 39 patients with ≥3 episodes of grade 2R mortality was low (n=3, 8%). We observed minimal hemodynamic, echocardiographic or prognostic implications of cellular rejection detected by routine surveillance EMB. These findings lend support to the practice of limiting high frequency routine surveillance EMB in post-HT patients, even in the early period when non-invasive diagnostics are not applicable. [ABSTRACT FROM AUTHOR]

The purpose of this study was to determine the difference in survival, adverse event frequency, and overall outcomes in diabetic (DM) versus non-diabetic (non-DM) patients following the implant of a left-ventricular assist device (LVAD). We hypothesized that the DM population would have a higher mortality rate, greater frequency of renal injury or failure, and a greater frequency of post-operative infections. We performed a retrospective analysis of 176 LVAD patients (100 non-DM and 76 DM) from our institution from 2016 to 2021. Descriptive statistics and Kaplan-Meier survival functions were employed to examine the differences in 1-year survival, renal outcomes, adverse events, and time to heart transplantation between the groups. Both cohorts were evenly matched for sex, race, age, heart failure etiology, and baseline functional status. Severe acute kidney injuries (as defined by a 300% increase in serum creatinine, serum creatinine > 4.0 mg/dl, urine output <0.3 ml/kg/h for >24 hours, anuria for >12 hours, or need for renal replacement therapy) occurred at a greater frequency (6 vs. 11 patients, p=0.049) in the DM VAD population than the non-DM population during support. Discharge status, change in Hgb-A1c and creatinine, occurrence of infection, duration of LVAD support, bleeding events, neurological events, time to transplant, hospital and ICU length of stay, and overall outcome did not differ significantly between groups. 1-year survival and the length of time to a heart transplant as plotted by Kaplan-Meier curves both did not differ significantly between the DM and non-DM groups (p=0.8171, p=0.4385). Although severe acute kidney injury events occurred at a greater frequency in the DM population, other important outcomes (including survival, adverse event frequency, and time to heart transplant) were equivalent between DM and non-DM groups. This preliminary data suggests that DM status in heart failure patients may not be a predictor of a worse outcomes for LVAD patients. [ABSTRACT FROM AUTHOR]

Demand for donor hearts persistently outstrips supply. To expand the donor pool, in the past four years, US centers have transplanted hearts procured from donors after circulatory death (DCD). DCD heart recipients frequently exhibit early, clinically significant, but reversible right ventricular dysfunction (RVD), but little is known about how this impacts post-transplant renal function. We evaluated whether DCD transplantation is associated with early renal dysfunction as compared to recipients receiving standard of care (SOC) hearts donated after brain death (DBD). All patients at a single center who were not on dialysis and underwent single-organ cardiac transplantation from April 2016 to August 2022 were included. Renal metrics collected included final pre-transplantation creatinine and peak creatinine within seven days after transplantation; these were converted to eGFR using the CKD-Epi 2021 Race-Free GFR equation. Acute kidney injury (AKI) was defined as a 1.5-fold rise in creatinine within seven days. RA pressure was measured via right heart catheterization on day seven after transplant. Data were statistically analyzed with two-tailed t-tests, chi-squared tests, and Pearson's correlation coefficients, as appropriate. 228 patients (171 SOC and 57 DCD) were included. Baseline characteristics were similar between groups. Nadir eGFR in the first week post-transplantation was similar between DCD and SOC (50.4 ± 28.0 mL/min vs 48.1 ± 25.8 mL/min; p=0.58), as were rates of AKI (49.1% vs 46.2%; p=0.92) and use of CVVH (7.0% vs 5.3%; p=0.89). DCD patients had higher RA pressures on day seven post-transplant (10.0 ± 4.2 mmHg vs 8.2 ± 4.7 mmHg for SOC; p=0.01); the inverse relationship between RA pressures and nadir post-transplantation eGFR in DCD patients was not significant (r=-0.25; p=0.07). While transplantation using DCD hearts is associated with early RVD, no adverse impact on early renal outcomes compared to SOC recipients was observed. [ABSTRACT FROM AUTHOR]

The United Network for Organ Sharing (UNOS) policy governing heart transplantation priority changed in October 2018 and is now less favorable to patients with durable left ventricular assist devices (LVADs). This study endeavored to assess differences in demographics and outcomes between patients with durable LVAD undergoing orthotopic heart transplant (OHT) before and after this change in the priority system. A retrospective analysis of 129 patients with durable LVAD who underwent OHT at Massachusetts General Hospital between 2016 and 2022 was performed using site-specific databases for heart transplant and durable LVAD. Patients listed before but transplanted after this policy change were excluded from analysis. 58 patients listed for transplant and transplanted before the policy change 10/18/18 were compared to 71 patients listed and transplanted after 10/18/18. Standard statistical analysis was used to examine baseline characteristics, organ donor characteristics, and post-transplant outcomes. Kaplan-Meier survival curves were generated then compared by log-rank test. 58 patients were included in the Old Listing Criteria group, and 71 patients were included in the New Listing Criteria group. There were no significant differences in gender (74.14% male vs 76.06% male, p=0.306), age (55.1 vs 57.4, p=0.802), or race (p=0.402). More patients in the New Listing Criteria group were implanted with an LVAD as destination therapy then listed for OHT afterwards compared to the Old Listing Criteria group (92.96% vs 53.45%, p=0.000). There was no significant difference in 1-year mortality. There were no significant differences in ejection fraction, cardiac index, or pulmonary capillary wedge pressure in the near-term post-operative period between the two groups. Patients with LVAD who underwent OHT before and after the decreased prioritization of LVAD patients 10/18/18 were similar demographically and did not have clinically significant differences in outcomes suggesting that LVAD therapy remains a reasonable consideration as a bridge to transplant. [ABSTRACT FROM AUTHOR]

We assessed the dual impact of the heart allocation policy change and DCD heart transplantation on recipient waiting time and post-transplant outcomes in VAD patients. 129 VAD patients transplanted at our center between 2016 and 2022 were analyzed. Patients listed and transplanted pre-policy change were compared to patients listed and transplanted post-policy change. Patients who crossed over eras were excluded. 58 patients comprised the pre-change group (74.1% male, mean age 55.1yrs) and 71 patients comprised the post-change group (76.1% male, mean age 57.4yrs). Post-change patients were more likely to be listed for OHT after implant (93.0% vs 53.5% pre-change, p<0.0001). The pre-change group had shorter mean time from implant to listing (8.4d vs 274.4d, p<0.0001). Median time on support pre-change was 223 days and post-change was 275 days (p=0.377). Despite concerns that durable VAD support leads to longer wait times in the current era, the post-change group had shorter median time on the waitlist (41d vs 180.5d, p=0.0001). As expected, lower waitlist status correlated with shorter wait times (β=55.13 d, p=0.006), however this did not seem to be mediated by the introduction of DCD heart utilization at our center in 2020 (p=0.191). To better understand the effect of DCD transplantation, the post-change cohort was divided into two groups: patients who received a DBD heart (N=40) and those who received a DCD heart (N=31). Mean ICU (9.3d DBD vs 7.9d DCD) and hospital length of stays (20.6d DBD vs 19.2d DCD), need for post-transplant renal replacement therapy (12.5% DBD vs 3.2% DCD), and occurrence of severe primary graft dysfunction (7.5% DBD vs 9.7% DCD) did not significantly differ between the two groups. Survival was similar across eras and DCD vs DBD transplant (Figure 1). Allocation policy changes and DCD heart transplant has led to changes in practice patterns and wait times for durable VAD supported patients. Reassuringly, survival remains unchanged for these patients. [ABSTRACT FROM AUTHOR]

Hepatitis C (HCV) has become readily treatable in the modern era. The use of HCV+ organs for transplant has shown promising results and increases donor availability. This study is an updated analysis of outcomes after HCV+ heart transplantation in the United States. The United Network for Organ Sharing registry was queried for adult patients who received heart transplants from 2015-2018. Excluded multiorgan transplants, incomplete HCV data, and loss to follow-up. HCV status was classified by serology (Ab+ vs Ab-). Median follow-up was 24 months. During the study period, 7529 patients received heart transplants: 136 from HCV Ab+ donors and 7393 from HCV Ab- donors. Seven recipients (5.1%) of HCV Ab+ hearts had HCV+ serology prior to transplant, compared to 129 recipients (1.7%) of HCV Ab- organs (p=0.018). There was no difference in donor age (p=0.489), ejection fraction (p=0.221), gender mismatch (p=0.341), or ABO compatibility (p=0.707). HCV Ab+ transplants involved further travel (mean: 323 vs 149 miles, p<0.001) with longer ischemic times (mean: 3.55 vs 3.03 hours, p<0.001) due to regional variation in use of HCV+ organs. Kaplan Meier analysis showed no effect of HCV status on overall survival (p=0.960), and no difference in graft failure (p=0.700). On multivariate Cox regression, HCV status was not a significant predictor of mortality (HR 0.85, 95% CI 0.47-1.56, p=0.601), while overall mortality was affected by HLA mismatch (HR 1.07, 95% CI 1.00-1.14, p= 0.037), donor age (HR 1.01, 95% CI 1.00-1.02, p=0.002), recipient creatinine (HR 1.07, 95% CI 1.04-1.12, p<0.001), and use of ECMO (HR 3.27, 95% CI 2.08-5.12, p<0.001) or a ventricular assist device (HR 1.23, 95% 1.08-1.41, p=0.003) at the time of transplant. Transplantation of HCV+ donor hearts has demonstrated promising outcomes thus far, with comparable overall survival and graft outcomes. Ongoing investigation is warranted to observe long-term outcomes. [ABSTRACT FROM AUTHOR]

Purpose Donor availability has continued to be a major issue limiting the number of cardiac transplantations in the United States. Given this shortage, it is necessary to consider strategies aimed at increasing the donor pool. We sought to evaluate the expanded use of hepatitis C virus (HCV) donor hearts, and characterize early allograft function in HCV-negative patients receiving pre-emptive anti-viral therapy following receipt of an HCV-infected donor heart. Methods Patients who underwent heart transplantation with HCV-positive donors at our institution between November 2017 and October 2018 were studied. Invasive hemodynamic and echocardiographic data were collected from routine scheduled post-transplant procedures. Intensive care unit (ICU) time, time on inotropes and time until discharge were evaluated from the index hospitalization for heart transplantation and compared to data from our center in patients receiving non-HCV hearts between January 2016 and June 2018. Results In total, there have been 23 recipients of donor HCV-positive heart transplants. Cardiac allograft and patient survival has been 100% at a median of 114 (IQR 81-190) days post-transplant. The average time on inotropes was 4.7±3.3 days in recipients of donor HCV-positive heart transplants, average time spent in the ICU was 7.2±4 days in the study group compared with 7.8±7.8 days in patients receiving non-HCV hearts and the average time to discharge was 19 ± 9 days in the study group compared with 21±22 days in patients receiving non-HCV hearts (both p>0.05). Among 80 echocardiograms done on or after post-operative day 2 in recipients of HCV-positive donor hearts, the ejection fraction (EF) was 65±9% with a single value falling below 50% (45%) that normalized 6 days later. One and 8-week hemodynamic values, respectively, were as follows: right atrial pressure of 7±5 and 5±3 mmHg, mean pulmonary arterial pressure of 20±7 and 20±6 mmHg, mean pulmonary capillary wedge pressure of 14±6 and 11±5 mmHg, and cardiac index of 2.8±0.8 and 2.9±0.4 L/min/m2. Conclusion In this single-center prospective study, patients who received preemptive direct-acting antiviral therapy following receipt of an HCV-positive donor heart demonstrated preserved early allograft function post-transplant. [ABSTRACT FROM AUTHOR]