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Background Primary graft dysfunction (PGD) is a major cause of early mortality following heart transplant (HT). The International Society for Heart and Lung Transplantation (ISHLT) subdivides PGD into 3 grades of increasing severity. Most studies have assessed risk factors for PGD without distinguishing between PGD severity grade. We sought to identify recipient, donor and surgical risk factors specifically associated with mild/moderate or severe PGD. Methods We identified 734 heart transplant recipients at our institution transplanted between January 1, 2012 and December 31, 2018. PGD was defined according to modified ISHLT criteria. Recipient, donor and surgical variables were analyzed by multinomial logistic regression with mild/moderate or severe PGD as the response. Variables significant in single variable modeling were subject to multivariable analysis via penalized logistic regression. Results PGD occurred in 24% of the cohort (n = 178) of whom 6% (n = 44) had severe PGD. One-year survival was reduced in recipients with severe PGD but not in those with mild or moderate PGD. Multivariable analysis identified 3 recipient factors: prior cardiac surgery, recipient treatment with ACEI/ARB/ARNI plus MRA, recipient treatment with amiodarone plus beta-blocker, and 3 surgical factors: longer ischemic time, more red blood cell transfusions, and more platelet transfusions, that were associated with severe PGD. We developed a clinical risk score, ABCE, which provided acceptable discrimination and calibration for severe PGD. Conclusions Risk factors for mild/moderate PGD were largely distinct from those for severe PGD, suggesting a differing pathophysiology involving several biological pathways. Further research into mechanisms underlying the development of PGD is urgently needed.

The COVID-19 pandemic initially brought forth considerable challenges to the field of heart transplantation. To prevent the spread of the virus and protect immunocompromised recipients, our center made the following modifications to post-transplant outpatient management: eliminating early coronary angiograms, video visits for postoperative months 7, 9, and 11, and home blood draws for immunosuppression adjustments. To assess if these changes have impacted patient outcomes, the current study examines 1-year outcomes for patients transplanted during the pandemic. Between March and September 2020, we assessed 50 heart transplant patients transplanted during the pandemic. These patients were compared to patients who were transplanted during the same months between 2011 and 2019 (n = 482). Endpoints included subsequent 1-year survival, freedom from cardiac allograft vasculopathy, any-treated rejection, acute cellular rejection, antibody-mediated rejection, nonfatal major adverse cardiac events (NF-MACE), and hospital and ICU length of stay. Patients transplanted during the pandemic had similar 1-year endpoints compared to those of patients transplanted from years prior apart from 1-year freedom from NF-MACE which was significantly higher for patients transplanted during the pandemic. Despite necessary changes being made to outpatient management of heart transplant recipients, heart transplantation continues to be safe and effective with similar 1-year outcomes to years prior.

Heart transplantation remains limited by donor availability. Currently, only some programs accept older donors, and their use remains contentious. We compared outcomes of heart transplant recipients who received donor hearts ≥55 years with those who received donor hearts55 years.Records of first-time adult heart transplant recipients between 2010 and 2019 were reviewed. Endpoints included 30-day and 1-, 3-, and 5-year survival; freedom from cardiac allograft vasculopathy; freedom from nonfatal major adverse cardiac events; and freedom from any rejections. The effect of donor age ≥55 years was analyzed with Cox proportional hazards modeling, 1:2 propensity score matching, and Kaplan-Meier survival analysis.Sixty-six patients received donor hearts ≥55 years and 766 received donor hearts55 years. In the unmatched cohort, there was no significant difference in survival between the 2 groups at 30 days (93.9% vs 97.3%, P = .127), 1 year (87.9% vs 91.6%, P = .325), 3 years (86.4% vs 86.5%, P = .888), or 5 years (78.8% vs 83.8%, P = .497). The ≥55 years group had a significantly lower freedom from cardiac allograft vasculopathy and fatal major adverse cardiac events. In propensity-matched patients, recipients of donors ≥55 years had similar survival and freedom from cardiac allograft vasculopathy but significantly lower 1-year (76.7% vs 88.3%, P = .026), 3-year (68.3% vs 84.2%, P = .010), and 5-year (63.3% vs 83.3%, P = .002) freedom from nonfatal major adverse cardiac events when compared to recipients of younger donors.Carefully selected older donors can be considered for a carefully selected group of recipients with acceptable outcomes.

As the SARS‐CoV‐2 pandemic continues to unfold, the number of heart transplants completed in the United States has been declining steadily. The current case series examines the immediate short‐term outcomes of 7 heart transplant recipients transplanted during the SARS‐CoV‐2 pandemic. We hope to illustrate that with proper preparation, planning, and testing, heart transplantation can be continued during a pandemic. We assessed 7 patients transplanted from March 4, 2020 to April 15, 2020. The following endpoints were noted: in‐hospital survival, in‐hospital freedom from rejection, in‐hospital non‐fatal major cardiac adverse events (NF‐MACE), severe primary graft dysfunction, hospital length of stay, and ICU length of stay. There were no expirations throughout the hospital admission. In addition, there were no patients with NF‐MACE or treated rejection, and 1 patient developed severe primary graft dysfunction. Average length of stay was 17.2 days with a standard deviation of 5.9 days. ICU length of stay was 7.7 days with a standard deviation of 2.3 days. Despite the decreasing trend in completed heart transplants due to SARS‐CoV‐2, heart transplantation appears to be feasible in the immediate short term. Further follow up is needed, however, to assess the impact of SARS‐CoV‐2 on post‐heart transplant outcomes months after transplantation.

Background Indications for heart transplantation are expanding to include amyloid light chain (AL) and transthyretin-related (TTR) amyloidosis. Previously, AL amyloid had been a contraindication to heart transplantation given inferior outcomes. These patients typically have biventricular failure requiring mechanical circulatory support (MCS). We report the outcomes of patients with end-stage cardiac amyloidosis who underwent cardiac transplantation, including some who were bridged to transplantation with a durable biventricular MCS Methods The records for patients with cardiac amyloidosis who underwent cardiac transplant between 2010 and 2018 were reviewed. Primary endpoint was post-transplant 1-year survival. Secondary endpoints included 1-year freedom from cardiac allograft vasculopathy (as defined by stenosis ≥ 30% by angiography), nonfatal major adverse cardiac events (myocardial infarction, new congestive heart failure, percutaneous coronary intervention, implantable cardioverter defibrillator/pacemaker implant, stroke), and any rejection. Results A total of 46 patients received heart transplantation with a diagnosis of either AL or TTR amyloidosis. Of these, 7 patients were bridged to transplantation with a durable biventricular MCS device (6 AL, 1 TTR) and 39 patients were transplanted without MCS bridging. The MCS group consisted of 5 total artificial hearts and 2 biventricular assist devices. The 1-year survival was 91% for the entire cohort, 83% for those with AL amyloidosis, 94% for those with TTR amyloidosis, and 86% for those who received MCS bridging. Conclusions Cardiac transplantation can be safely performed in selected amyloidosis patients with reasonable short-term outcomes. Those bridged to transplantation with biventricular MCS appear to have short-term outcomes similar to those transplanted without MCS. Larger numbers and longer observation are required to confirm these findings.

Purpose Hypertension after heart transplantation (HTx) is noted in a majority of HTx patients due to the side effects of calcineurin inhibitors (CNI). The use of angiotensin-converting enzyme inhibitors (ACEI) or angiotensin receptor blockers (ARB) are effective anti-hypertensive agents and may have longer term clinical benefits. We assessed our patients on ACEI/ARBs versus others in the first year post-HTx and followed them for 5-year outcomes. Methods Between 2010 and 2015, we assessed 101 HTx patients who were on ACEI/ARBs only in the first year for more than 6 months. Those patients were then followed for 5 years. Likewise, a group of patients who were placed on non-ACEI/ARBs blood pressure medications, such as calcium channel-blockers, beta blockers, and diuretics, in the first year for more than 6 months were the control group. Outcomes included 5-year survival, 5-year freedom from non-fatal major adverse cardiac event (NF-MACE: MI, new CHF, PCI, ICD implant, stroke), freedom from cardiac allograft vasculopathy (CAV: angiographic stenosis >30%), freedom from left ventricular dysfunction (left ventricular ejection fraction ≤40%) and freedom from left ventricular hypertrophy (LVH), defined as intraventricular septum or posterior wall ≥1.3cm. Results The patients treated with ACEI/ARBs in the first year post-HTx compared to those without had significantly lower 5-year survival but a trend for greater 5-year freedom from CAV. There was no significant difference between the two study groups in 5-year freedom from NF-MACE, left ventricular dysfunction and LVH (see table). Baseline demographics between groups were similar for recipient age, % female, pre-transplant diabetes and renal dysfunction (creatinine >1.5mg/dl) (data not shown). Conclusion The use of ACEI/ARBs in the first year post-HTx is associated with lower survival but other factors may be involved. A possible lower development of CAV from ACEI/ARBs may be a benefit to be explored.

Background We report clinical experience with combined heart and kidney transplantation (HKTx) over a 23-year time period. Methods From June 1992 to August 2015, we performed 83 combined HKTx procedures at our institution. We compared the more recent cohort of 53 HKTx recipients (group 2, March 2009 to August 2015) with the initial 30 previously reported HKTx recipients (group 1, June 1992 to February 2009). Pre-operative patient characteristics, peri-operative factors, and post-operative outcomes including survival were examined. Results The baseline characteristics of the two groups were similar, except for a lower incidence of ethanol use and higher pre-operative left-ventricular ejection fraction, cardiac output, and cardiac index in group 2 when compared with group 1 (P = .007, .046, .037, respectively). The pump time was longer in group 2 compared with group 1 (153.30 ± 38.68 vs 129.60 ± 37.60 minutes; P = .007), whereas the graft ischemic time was not significantly different between the groups, with a trend to a longer graft ischemic time in group 2 versus group 1 (195.17 ± 45.06 vs 178.07 ± 52.77 minutes; P = .056, respectively). The lengths of intensive care unit (ICU) and hospital stay were similar between the groups (P = .083 and .39, respectively). In addition, pre-operative and post-operative creatinine levels at peak, discharge, 1 year, and 5 years and the number of people on post-operative dialysis were similar between the groups (P = .37, .75, .54, .87, .56, and P = .139, respectively). Overall survival was not significantly different between groups 2 and 1 for the first 5 years after transplant, with a trend toward higher survival in group 2 (P = .054). Conclusions The most recent cohort of combined heart and kidney transplant recipients had similar ICU and hospital lengths of stay and post-operative creatinine levels at peak, discharge, and 1 and 5 years and a similar number of patients on post-operative dialysis when compared with the initial cohort. Overall survival was not significantly different between the later and earlier groups, with a trend toward higher overall survival at 5 years in the more recent cohort of patients. In selected patients with co-existing heart and kidney failure, combined heart and kidney transplantation is safe to perform and has excellent outcomes.

Purpose In the past, Hepatitis B donors have been declined in patients who have not been vaccinated by the Hepatitis B vaccine. There is concern that these donors would transmit Hepatitis B to the recipient if they are not vaccinated. There is treatment available for these Hepatitis B infections, however, it has not been established as to its efficacy in patients on immunosuppression. In addition, hepatitis viruses have been reported to affect the endothelium of vital organs. Hepatitis B may injure the endothelium of the coronary vascular tree and could potentially result in a greater development of cardiac allograft vasculopathy (CAV) after heart transplantation. Therefore, we sought to assess this possibility by examining our patients who received Hepatitis B donors. Methods Between 2010 and 2016 we assessed 24 heart transplant patients who received a Hepatitis B donor. All of the recipients had received a Hepatitis B vaccine prior to transplantation. Endpoints include 3-year survival, 3-year freedom from CAV, 3-year freedom from non-fatal major adverse cardiac events (NF-MACE), and freedom from first year rejection, including any treated rejection (ATR), acute cellular rejection (ACR), and antibody-mediated rejection (AMR). These study patients were compared with 600 patients without Hepatitis B donors in a contemporaneous era. Results 3-year survival, freedom from NF-MACE, and freedom from first year rejection were similar between the Hepatitis B and control groups. There is numerically a lower incidence of freedom from CAV in the Hepatitis B group compared to the control, but this was not statistically significant. Conclusion Hepatitis B donors appear to have acceptable outcome compared to non-Hepatitis B donors after heart transplantation. Larger numbers of Hepatitis B donors will be needed to assess risk for increased CAV development.

Temporary mechanical circulatory support (MCS) devices are generally used short term to maintain adequate organ perfusion in patients with advanced heart failure and cardiogenic shock. Unacceptably high waitlist mortality in this cohort motivated changes to heart allocation policy, which recognized the severity of illness by prioritization for temporary MCS and broader sharing in the new U.S. donor heart allocation policy. We evaluated the post-heart transplant outcomes for patients bridged with temporary MCS, a control population not bridged with MCS, and a cohort bridged with durable MCS.The heart transplant research database was queried to identify patients bridged with temporary MCS and bridged with durable MCS who went directly to heart transplant in our center. Temporary MCS included Impella, intra-aortic balloon pump, and extracorporeal membrane oxygenation. Post-transplant endpoints were assessed at 30 days, 6 months, and 1 year.From 2010 to 2017, a total of 23 patients were bridged to heart transplant with temporary MCS and 548 were transplanted without MCS bridge. Patients bridged with temporary MCS had younger age, lower body mass index, and higher frequencies of prior blood transfusion and Status 1 (1A/1B) listing at transplant compared to patients not bridged with MCS (all P .001). Despite the severity of illness in patients bridged with temporary MCS, post-transplant outcomes were indistinguishable from those in patients transplanted without MCS bridge, with no difference in 30-day, 6-month, or 1-year survival or 1-year freedom from cardiac allograft vasculopathy, nonfatal major adverse cardiac events, any-treated rejection, acute cellular rejection, or antibody-mediated rejection (P = .23-.97). Similarly, compared to 157 patients bridged with durable MCS, no differences in post-transplant outcomes were identified for the temporary MCS cohort (P = .15-.94).Temporary MCS as a bridge to transplant achieves similar post-transplant outcomes at 1 year compared to no MCS and durable MCS. These encouraging findings support recent changes in the Organ Procurement and Transplantation Network | United Network Organ Sharing (OPTN|UNOS) adult heart allocation policy.

Background Combined heart and kidney transplantation ( HKT x) is performed in patients with severe heart failure and advanced renal insufficiency. We analyzed the long‐term survival after HKT x, the influence of age and dialysis status, the rates of cardiac rejection, and the influence of sensitization. Methods and Results From June 1992 to December 2016, we performed 100 HKT x procedures. We compared older (≥60 years, n=53) with younger (50%, and compared these survival rates with those from the United Network for Organ Sharing database. There was no difference in 15‐year survival between the 2 age groups (35±12.4% and 49±17.3%, ≥60 versus P =0.45). There was no difference in 15‐year survival between the dialysis and nondialysis groups (44±13.4% and 37±15.2%, P =0.95). Actuarial freedom from any cardiac rejection ( acute cellular rejection >0 or antibody‐mediated rejection >0) was 92±2.8% and 84±3.8%, acute cellular rejection (≥2R/3A) 98±1.5% and 94±2.5%, and antibody‐mediated rejection (≥1) 96±2.1% and 93±2.6% at 30 days and 1 year after HKT x. There was no difference in the 5‐year survival among recipients by sensitization status with panel‐reactive antibody levels 50% (82±5.9%, 83±10.8%, and 92±8.0%; P =0.55). There was no difference in 15‐year survival after HKT x between the United Network for Organ Sharing database and our center (38±3.2% and 40±10.1%, respectively; P =0.45). Conclusions HKT x is safe to perform in patients 60 years and older or younger than 60 years and with or without dialysis dependence, with excellent outcomes. The degree of panel‐reactive antibody sensitization did not appear to affect survival after HKT x.

Purpose Right ventricular failure occurs in a variety of clinical settings and is associated with worse survival. We describe our clinical experience with two temporary percutaneous right ventricular assist devices (RVADs): TandemLife Protek Duo (TPD) and Impella RP. Methods A prospectively maintained institutional registry was used to identify patients requiring TPD and Impella RP support. Baseline characteristics, etiology of heart failure, indication for RVAD support, timing of implantation in relation to the onset of right ventricular (RV) failure were characterized. Specific clinical outcomes, including overall survival, time on temporary percutaneous RV support, device explant and device exchange rates were analyzed. Outcomes were further analyzed among the cohort of explanted patients. Results Between January 2015 and December 2018, 19 TPD devices and 10 Impella RP devices were implanted. Indication for RV support included post-left ventricular assist device implantation RV failure, post-cardiotomy cardiogenic shock, and post-transplant RV failure. Mean (median) support duration for TPD was 16 (12) days, and 5 (4) days for Impella RP. Among TPD patients, 11 (57.9%) were explanted, 4 (21.0%) died, and there were no device exchanges. Among Impella RP patients, 5 (50.0%) were explanted, 3 (30.0%) died, and 1 (10.0%) required device exchange. Among TPD patients explanted, 7 (63.6%) recovered and were weaned, 3 (27.2%) died, and 1 (9.1%) required a durable RVAD. Among Impella RP patients explanted, 4 (80.0%) recovered and were weaned, and 1 (20.0%) required a durable RVAD. Conclusion RV failure is associated with reduced survival. Temporary percutaneous RVAD devices provide a suitable strategy for bridging patient to recovery.

Purpose Hemodynamic compromise rejection (HCR) is seen Methods Between 2010-15, among 589 heart transplants, we identified 15 HTx pts (2.5%) who developed HCR. At the time of presentation of HCR, results of EMB were reviewed. Outcomes of these pts included subsequent 1-year survival, freedom from cardiac allograft vasculopathy (CAV, as defined by stenosis ≥30% by angiography), freedom from non-fatal major adverse cardiac event (NF-MACE: myocardial infarction, new congestive heart failure, percutaneous coronary intervention, defibrillator/pacemaker implant, stroke), and freedom from subsequent recurrence of rejection episodes, including any treated rejection (ATR), acute cellular rejection (ACR), and antibody-mediated rejection (AMR). The HCR group was compared to a case-controlled group with similar age, sex, time from transplant (n=39). Results HCR did not consistently show rejection with 64% revealing neither ACR nor AMR on biopsy slides. 27% showed ACR, 9% showed AMR and the remainder showed no rejection. In the HCR group, subsequent 1-year survival and freedom from NF-MACE was significantly compromised compared to the control group. Subsequent 1-year freedom from CAV and recurrent rejections were not significantly different. (table) Conclusion In a majority of HCR cases, EMB findings reveal no rejection which may be due to an atypical immune process. In the current era, outcomes from HCR continue to be compromised which suggest the need for a more aggressive approach to immunosuppression and management.

Purpose As donor criteria expand to meet increasing demand for transplantable hearts, increased focus has fallen on mitigating risk associated with extended criteria donors. It has been postulated that warm ischemic time may be as significant a factor as total ischemic time, and reduction is associated with better outcomes. This study investigates the impact of warm ischemic time on post-operative events and survival in orthotopic heart transplantation patients at a high-volume center. Methods From 2015 to 2020, patients who underwent heart transplantation were identified at a single institution in a prospectively maintained database with long-term clinical outcomes. After excluding heart-lung transplants and those with missing warm ischemic time, 388 patients were identified. Patients were classified in to three groups: Results Between warm ischemic time groups, there were significant differences in recipient sex, age, and body mass index (BMI), all p 0.05, as was 30-day freedom from PGD, 80.2% (85) vs 82.9% (141) vs 76.8% (86), 30-day survival, 98.1% (104) vs 98.2% (167) vs 97.3% (109), and one-year survival, 92.5% (98) vs 93.5% (159) vs 91.1% (102) (all p > 0.05). Warm ischemic time was not a predictor of one-year mortality, odds ratio (OR) 0.99 (95% CI, 0.97-1.02). In subgroup analysis with over 4 hours of total ischemic time, warm ischemic time was not a predictor of PGD, OR 0.94 (95% CI, 0.82-1.07), or one-year survival, OR 0.94 (95% CI, 0.82-1.07). Conclusion Although increased warm ischemic time did not predict increased adverse post-operative outcomes, continued emphasis on reducing total ischemic time is paramount.

Purpose Cyclosporine (CsA) became available in the US in 1983 and improved clinical outcomes. Another calcineurin inhibitor, tacrolimus (TAC), became available in the 1990s and demonstrated benefit in further reducing rejection. In most heart transplant (HTx) programs, TAC is currently the drug of choice for immunosuppression. However, a switch to CsA does occur due to adverse effects from TAC. It is not well-established that this switch to CSA results in subsequent non-inferior outcomes. Therefore, we reviewed our single center experience to assess for real world potential outcomes. Methods Between 2010 and 2017, we identified 58 HTx patients who were administered CsA in place of TAC mostly due to neurologic adverse effects from TAC. For comparison, a TAC group was matched based on age, sex, baseline renal function and time from transplant. The average time of this switch occurred at 6.6 ± 1.1 months post-transplant. Outcomes included subsequent 1-year freedom from any treated rejection (ATR), acute cellular rejection (ACR), and antibody-mediated rejection (AMR) and 3-year subsequent survival, freedom from cardiac allograft vasculopathy (CAV, as defined by stenosis ≥30% by angiography), and freedom non-fatal major adverse cardiac event (NF-MACE: myocardial infarction, new congestive heart failure, percutaneous coronary intervention, implantable cardioverter defibrillator/pacemaker implant, stroke). Results The CsA/MMF group compared to the TAC/MMF group had significantly lower subsequent 3-year survival and worse renal function at 1-year (after the switch to CsA). There was similar subsequent 3-year freedom from CAV and NF-MACE and 1-year rejections between the two groups. (see table) Conclusion In the current era in a large, single center study there are indications that a switch to CsA from TAC may be inferior in heart transplant recipients. Further investigation with larger numbers is needed to confirm these findings.

Purpose The organ care system (OCS) has been found to have comparable 30-day mortality compared to standard of care (SOC) therapy for the donor heart. At our institution, we had previously shown comparable results on 1-year outcome in terms of rejection, antibody development and survival. In this current study, this cohort of patients were followed, and we evaluated long term results. Methods Between 2011 and 2013, we randomized 38 heart transplant (HTx) patients to either OCS or SOC. We assessed total ischemic time (TIT), cold ischemic time (CIT), development of de novo antibodies (abs) and donor specific antibodies (DSA) within 8 year post-HTx, 8-year survival, 8-year freedom from cardiac allograft vasculopathy (CAV), 8-year freedom from non-fatal major cardiac events (NF-MACE: Myocardial Infarction, Heart Failure, angioplasty, pacemaker/ICD, stroke), 8-year freedom from any-treated rejection (ATR), biopsy (bx) proven cellular rejection (ACR >2R), bx proven antibody-mediated rejection (AMR1, 2, or 3). Results OSC group had significant longer TIT but significantly shorter CIT compared to SOC. There was no statistically significant difference in 8-year freedom from CAV, NF-MACE, ATR, ACR and AMR. Moreover, 8-year survival was not statistically significant different between the two groups. There were total of 8 deaths in the OCS group and the cause of death included 3 immediate postoperative cases of hemorrhage and thrombotic event, two died of complications of malignancy, one due to multi-organ failure, one patient died due to complications of CMV infection and last patient died of unknown etiology. In the SOC group, there were 5 deaths. Causes of death included once case of rejection, one case of stroke, one patient died of CMV infection, one due to patient non-compliance, and one patient died of unknown cause at an outside hospital. Conclusion OCS appears to be a valid tool to extend total donor ischemic time without compromising long term outcomes.

Purpose The criteria for combined heart-liver transplant (HLiTx) has not been well established. Liver cirrhosis in a heart failure patient would require consideration for HLiTx. Investigators have used non-invasive testing (NIT) such as abdominal ultrasound and CT scans to assess for liver surface nodularity which suggests cirrhosis. Biopsies are then performed to assess for liver disease. However, pathology findings can be heterogeneous and, therefore, the biopsy may not be reliable to exclude cirrhosis due to sampling error. It is not known whether abnormal NIT suggesting cirrhosis alone renders poor outcome if heart alone transplant (HATx) proceeds. Methods Between 2012 and 2017, we identified 24 patients with an abnormal NIT demonstrating liver surface nodularity suggestive of cirrhosis but with liver biopsies showing no cirrhosis by pathology. Of these 24 patients, most patients had mild-moderate fibrosis with 3 patients who had severe 3-4+ fibrosis. Study endpoints included 3-year survival, freedom from non-fatal major adverse cardiac events (NF-MACE: MI, CHF, PCI, ICD implant, stroke), and freedom from cardiac allograft vasculopathy (CAV, defined by stenosis ≥30%). Freedom from 1-year rejection [acute cellular rejection (ACR), antibody-mediated rejection (AMR)] was also recorded. We compared these 24 patients to patients who underwent HATx without liver disease (n=523) during this same time period. Results Patients who had liver nodularity with HTx had similar 3-year survival, freedom from NF-MACE, and freedom from CAV compared to control patients who had HATx without liver disease. Furthermore, 1-year freedom from rejection was similar between study groups (see table). The 3 patients with 3-4+ fibrosis on liver biopsy had similar outcomes to the rest of the study group. Conclusion In our single center experience, surface nodularity suggesting cirrhosis by NIT but with no evidence of biopsy-proven cirrhosis does not appear to be a contraindication to proceed with HATx.

The upper age limit of heart transplantation remains controversial. The goal of the present study was to investigate the mortality and morbidity of orthotopic heart transplantation (HT) for recipients ≥70 compared with those 70 years of age.Of 704 adults who underwent HT from December 1988 to June 2012 at our institution, 45 were ≥70 years old (older group) and 659 were 70 years old (younger group). Survival, intraoperative blood product usage, intensive care unit (ICU) and hospital stays, and frequency of reoperation for chest bleeding, dialysis, and48 hours ventilation were examined after HT.The older group had 100% 30-day and 60-day survival compared with 96.8 ± 0.7% 30-day and 95.9 ± 0.8% 60-day survival rates in the younger group. The older and younger groups had similar 1-year (93.0 ± 3.9% vs 92.1 ± 1.1%; P = .79), 5-year (84.2 ± 6.0% vs 73.4 ± 1.9%; P = .18), and 10-year (51.2 ± 10.7% vs 50.2 ± 2.5%; P = .43) survival rates. Recipients in the older group had higher preoperative creatinine levels, frequency of coronary artery disease, and more United Network for Organ Sharing status 2 and fewer status 1 designations than recipients in the younger group (P .05 for all). Pump time and intraoperative blood usage were similar between the 2 groups (P = NS); however, donor-heart ischemia time was higher in the older group (P = .002). Older recipients had higher postoperative creatinine levels at peak (P = .003) and at discharge (P = .007). Frequency of postoperative complications, including reoperation for chest bleeding, dialysis,48 hours ventilation, pneumonia, pneumothorax, sepsis, in-hospital and post-discharge infections, were similar between groups (P = NS for all comparisons). ICU and hospital length of stays were similar between groups (P = .35 and P = .87, respectively). In Cox analysis, recipient age ≥70 years was not identified as a predictor of lower long-term survival after HT.HT recipients ≥70 years old had similar 1, 5, and 10-year survival rates compared with younger recipients. Both patient groups had similar intra- and postoperative blood utilization and frequencies of many postoperative complications. Older and younger patients had similar morbidity and mortality rates following HT. Carefully selected older patients (≥70 years) can safely undergo HT and should not be excluded from HT consideration based solely on age.

Purpose Diabetes is common in heart failure patients and almost a quarter of heart transplant (HTx) recipients are diabetic at 1-year post transplant. The effect of diabetes on transplant outcomes is conflicting. The goal of this study was to examine the impact of diabetes on post-transplant outcomes at a large single center. Methods We divided 952 patients at our center transplanted from 2010 to 2018 into those with (n = 274) and without pre-transplant diabetes (n = 578). The diabetic patients were further divided: tight glucose control (HbA1c 7.0; n = 23) Demographic data and outcomes were compared between groups. Results There was no significant difference between groups in 1-year survival, freedom from cardiac allograft vasculopathy, non-fatal major cardiac events, rejection, new-onset dialysis, or infection. There was a trend towards worse 1-year survival in the relaxed glucose control group compared with the tight control group (82.6 v 94.1%; p=0.35). There was no difference in other outcomes between groups. Conclusion While pre-transplant diabetes is often considered an important factor in selecting appropriate heart transplant candidates, this large single-center analysis does not demonstrate an association between pre-transplant diabetes and post-transplant outcomes, regardless of the adequacy of glucose control.

Purpose Severe primary graft dysfunction (PGD) is seen in approximately 5% of all heart transplant recipients per the International Society for Heart and Lung Transplantation (ISHLT) PGD grading scale. These patients suffer endothelial cell damage and are known to have increased risk of early mortality. It is not known whether the survivors of severe PGD develop more donor specific antibody (DSA), have more treated rejections, have increased risk of the development of cardiac allograft vasculopathy (CAV), and have increased mortality at 3 years post transplantation. We sought to assess this potential association. Methods Between 2010-2016 we assessed 24 heart transplant patients who developed severe PGD per the ISHLT PGD grading scale. These patients who developed severe PGD were compared to those without severe PGD in a contemporaneous era. Patients were then followed for 3 years and assessed for the following endpoints: 3-year survival, 3-year freedom from CAV, 3-year freedom from non-fatal major adverse cardiac events (NF-MACE, defined as myocardial infarction, percutaneous coronary intervention/angioplasty, new congestive heart failure, pacemaker/implantable cardioverter-defibrillator placement, and stroke), and 1-year freedom from rejection, including any treated rejection (ATR), acute cellular rejection (ACR), and antibody-mediated rejection (AMR). Results Patients with severe PGD had decreased 3-year survival, 1-year freedom from any treated rejection, and 3-year freedom from NF-MACE compared to those patients who did not have severe PGD. There were no significant differences between the two groups in terms of 3-year freedom from CAV and freedom from DSA. Conclusion Severe PGD appears to have increased mortality and morbidity with more rejection and more NF-MACE. More intense therapies to offset the inflammatory response from severe PGD should be pursued.

Purpose For patients in cardiogenic shock, temporary mechanical circulatory support (MCS) with impella 5.0 as a bridge to decision, durable MCS, or transplantation, is associated with acceptable clinical outcomes. In October 2018, UNOS heart allocation criteria were reclassified, and we sought to determine the impact of bridging with impella 5.0 post-reclassification. Methods A prospectively collected institutional heart failure device registry was mined for clinical data related to the impella 5.0 before and after UNOS re-classification. Basic demographic characteristics, surgical access site, and duration of support (total and after listing) were queried pre and post-reclassification. The proportion of patients who died, received device exchange, were explanted, bridged to durable MCS or transplant were queried. Survival to hospital discharge, and 3 and 6-month survival post-transplant were analyzed. Results Under old and new criteria respectively, 105/24 patients received an impella 5.0, 8(7.6%)/2(8.3%) had device exchange, 23(21.9%)/2(8.3%) expired, 28(26.7%)/4(16.6%) were explanted, 13(12.4%)/2(8.3%) received durable MCS, and 33(31.4%)/14(58.3%) were transplanted. Among those transplanted, duration of support after listing was 14.6(12.1) v 7.1(7.5), p=0.038. There was no significant difference in the proportion of patients supported ≤14d v >14d under old and new criteria (p=0.421). Among transplanted patients, there were no significant demographic differences (gender, age, blood type, length of support). 100% of transplanted patients were alive at discharge under old allocation criteria, whereas only 91.7% of patients were alive at discharge under new criteria, although this was not significant (p=0.094). 3 and 6-month survival were 100% under old allocation criteria, and 88.9% under new criteria (p=0.055). Conclusion A greater proportion of patients supported with impella 5.0 were transplanted under the new allocation criteria, with shorter support duration and no significant difference in mortality. Impella bridging to transplant is associated with excellent survival. Further investigation is required to delineate the relationships between allocation tier and clinical outcomes.

Purpose Patients with muscular dystrophy may have an associated cardiomyopathy, resulting in advanced heart failure requiring transplantation. However, the skeletal muscle dysfunction can result in respiratory impairment, dysphagia, and inability to participate in rehabilitation after heart transplantation. The purpose of this study was to describe the characteristics and outcomes of muscular dystrophy patients undergoing heart transplantation at our center. Methods We reviewed patients at our center status post heart transplantation between 2010 and 2017. Of the 646 patients, we identified 10 with muscular dystrophy. The demographics, clinical characteristics, and outcomes of these 10 patients with muscular dystrophy were compared to the 646patients without muscular dystrophy transplanted during this time period. Results The muscular dystrophy patients were all deemed acceptable to proceed by a neurologist with expertise in muscular dystrophy. They were younger (45 years vs 56 years; p = 0.006); had younger donors (27 years vs 35 years, p = 0.05); had lower creatinine (0.95 mg/dL vs 1.15 mg/dL; P = 0.01); and less pre-transplant diabetes (13% vs 52%; p = 0.03). There was no difference in sensitization, CMV IgG mismatch status, or Status 1A listing. The muscular dystrophy patients had 100% 1- and 5-year survival (Figure) and there was no difference in the incidence of cellular rejection, antibody-mediated rejection, or allograft vasculopathy between groups. Conclusion Patients with muscular dystrophy-associated cardiomyopathy may require heart transplantation. This analysis indicates that carefully selected patients can have excellent outcomes and therefore should be considered candidates for advanced heart failure therapies.

The impact of prior implantation of a ventricular assist device (VAD) on short- and long-term postoperative outcomes of adult heart transplantation (HTx) was investigated.Of the 359 adults with prior cardiac surgery who underwent HTx from December 1988 to June 2012 at our institution, 90 had prior VAD and 269 had other (non-VAD) prior cardiac surgery.The VAD group had a lower 60-day survival when compared with the Non-VAD group (91.1% ± 3.0% vs 96.6% ± 1.1%; P = .03). However, the VAD and Non-VAD groups had similar survivals at 1 year (87.4% ± 3.6% vs 90.5% ± 1.8%; P = .33), 2 years (83.2% ± 4.2% vs 88.1% ± 2.0%; P = .21), 5 years (75.7% ± 5.6% vs 74.6% ± 2.9%; P = .63), 10 years (38.5% ± 10.8% vs 47.6% ± 3.9%; P = .33), and 12 years (28.9% ± 11.6% vs 39.0% ± 4.0%; P = .36). The VAD group had longer pump time and more intraoperative blood use when compared with the Non-VAD group (P.0001 for both). Postoperatively, VAD patients had higher frequencies of48-hour ventilation and in-hospital infections (P = .0007 and .002, respectively). In addition, more VAD patients had sternal wound infections when compared with Non-VAD patients (8/90 [8.9%] vs 5/269 [1.9%]; P = .005). Both groups had similar lengths of intensive care unit (ICU) and hospital stays and no differences in the frequencies of reoperation for chest bleeding, dialysis, and postdischarge infections (P = .19, .70, .34, .67, and .21, respectively). Postoperative creatinine levels at peak and at discharge did not differ between the 2 groups (P = .51 and P = .098, respectively). In a Cox model, only preoperative creatinine ≥1.5 mg/dL (P = .006) and intraoperative pump time ≥210 minutes (P = .022) were individually considered as significant predictors of mortality within 12 years post-HTx. Adjusting for both, pre-HTx VAD implantation was not a predictor of mortality within 12 years post-HTx (hazard ratio [HR], 1.23; 95% confidence interval [CI], 0.77-1.97; P = .38). However, pre-HTx VAD implantation was a risk factor for 60-day mortality (HR, 2.86; 95% CI, 1.07-7.62; P = .036) along with preoperative creatinine level ≥2 mg/dL (P = .0006).HTx patients with prior VAD had lower 60-day survival, higher intraoperative blood use, and greater frequency of postoperative in-hospital infections when compared with HTx patients with prior Non-VAD cardiac surgery. VAD implantation prior to HTx did not have an additional negative impact on long-term morbidity and survival following HTx. Long-term (1-, 2-, 5-, 10-, and 12-year) survival did not differ significantly in HTx patients with prior VAD or non-VAD cardiac surgery.

Purpose Combined heart-liver transplantation is an increasingly accepted treatment for select patients with heart and liver disease. Despite growing optimism, heart-liver transplantation remains an infrequent operation. We report our institutional experience with heart-liver transplantation. Methods All combined heart-liver transplantations at Cedars-Sinai Medical Center from 1998–2014 were analyzed. Primary outcomes were patient and graft survival and secondary outcomes included rejection, infection, reoperation, length of stay, and readmission. Results There were 7 heart-liver transplants: 6 simultaneous (single donor) and 1 staged (2 donors). Median follow-up was 22.1 (IQR 13.2–48.4) months. Mean recipient age was 50.8 ± 19.5 years. Heart failure etiologies included familial amyloidosis, congenital heart disease, hypertrophic cardiomyopathy, systemic lupus erythematosus, and dilated cardiomyopathy. Preoperative left ventricular ejection fraction averaged 32.3 ± 12.9%. Five (71.4%) patients required preoperative inotropic support; 1 required mechanical circulatory support. The most common indications for liver transplant were amyloidosis and cardiac cirrhosis. Median Model for End-stage Liver Disease score was 10.0 (9.3–13.8). Six-month and 1-year actuarial survivals were 100% and 83.3%, with mean survival exceeding 4 years. No patient experienced cardiac allograft rejection, 1 experienced transient liver allograft rejection, and 1 developed progressive liver dysfunction resulting in death. Five developed postoperative infections and 3 (42.9%) required reoperation. Median ICU and hospital stays were 7.0 (7.0–11.5) and 17.0 (13.8–40.5) days. There were 4 (57.1%) readmissions. Conclusions For carefully selected patients with coexisting heart and liver disease, combined heart and liver transplantation offers acceptable patient and graft survival.

This study investigated the effect of prior sternotomy (PS) on the postoperative mortality and morbidity after orthotopic heart transplantation (HTx).Of 704 adults who underwent HTx from December 1988 to June 2012 at a single institution, 345 had no PS (NPS group) and 359 had ≥ 1 PS (PS group). Survival, intraoperative use of blood products, intensive care unit (ICU) and hospital stays, frequency of reoperation for bleeding, dialysis, and48-hour ventilation were examined.The NPS and PS groups had similar 60-day survival rates (97.1 ± 0.9% vs 95.3 ± 1.1%; P = .20). However, the 1-year survival was higher in the NPS group (94.7 ± 1.2% vs 89.7 ± 1.6%; hazard ratio [HR], 1.98; 95% CI, 1.12-3.49; P = .016). The PS group had longer pump time and more intraoperative blood use (P.0001 for both). Postoperatively, the PS group had longer ICU and hospital stays, and higher frequencies of reoperation for bleeding and48-hour ventilation (P.05 for all comparisons). Patients with 1 PS (1PS group) had a higher 60-day survival rate than those with ≥ 2 PS (2+PS group; 96.7 ± 1.1% vs 91.1 ± 3.0%; HR, 2.70; 95% CI, 1.04-7.01; P = .033). The 2+PS group had longer pump time and higher frequency of postoperative dialysis (P.05 for both). Patients with prior VAD had lower 60-day (91.1 ± 3.0% vs 97.1 ± 0.9%; P = .010) and 1-year (87.4 ± 3.6% vs 94.7 ± 1.2%; P = .012) survival rates than NPS group patients. Patients with prior CABG had a lower 1-year survival than NPS group patients (89.0 ± 2.3% vs 94.7 ± 1.2%; P = .018).The PS group had lower 1-year survival and higher intraoperative blood use, postoperative length of ICU and hospital stays, and frequency of reoperation for bleeding than the NPS group. Prior sternotomy increases morbidity and mortality after HTx.

Introduction Orthotopic heart transplantation (OHT) is performed using the bicaval and pulmonary venous anastomoses or the standard (biatrial) anastomoses. The special considerations of endomyocardial biopsy after OHT using the bicaval technique, and after myocardial infarction for harvesting of cardiac stem cells, have not been described. Methods When approached via the right or left internal jugular vein, important technical considerations were ultrasound guidance for vascular access; a soft, 80-cm, 0.035-inch, J-tipped guidewire; a long (23-cm), 7-Fr sheath; and a flexible 7-Fr, 50-cm bioptome. These technical aspects were helpful to avoid disruption of the superior vena cava suture line, avoid entry into the right atrial appendage or coronary sinus, avoid right ventricular free wall perforation, and provide ready access to the right ventricular septal wall. We used the same principles and technical considerations when obtaining the cardiac stem cells after myocardial infarction in patients enrolled in the CADUCEUS trial. Results From January 2002 to December 2005, 754 biopsy procedures were performed in 179 patients after OHT with the bicaval technique, using bioptome A. There was 1 occurrence of ventricular fibrillation requiring cardioversion, and no occurrence of cardiac tamponade during the procedure. From January 2006 to September 2013, 2818 biopsy procedures were performed in 1064 patients using bioptome B. No patient developed ventricular fibrillation or cardiac tamponade during the procedure. In 2010 and 2011, 23 biopsy procedures were performed in 23 patients after acute myocardial infarction, using bioptome B. No immediate complications occurred while performing these biopsies. The late occurrence of tricuspid regurgitation was not evaluated in this study. Conclusions Endomyocardial biopsy procedures can be safely performed after OHT with the bicaval technique and after myocardial infarction for harvesting of cardiac stem cells. Ultrasound guidance for vascular access, a long guidewire and sheath, and a flexible bioptome are important features for the safe conduct of the biopsy procedure.

Purpose Certain donor characteristics after heart transplantation (HTx) may have less optimal outcome post-HTx. One factors leading to worse outcome is female donors to male recipient possibly due to size (height and weight) mismatch relative to male donors. We try to compensate for this size mismatch by using obese female donors into male recipients. However, there have been recent concerns with obese donors, in the sense that there are commonly large fat deposits on the donor heart. It is not known whether short and obese female donors (weight oversizing) results in acceptable outcome after HTx. We sought to assess for this possibility in our large single center. Methods Between 2010 and 2017 we assessed 799 HTx patients and divided them into those male recipients who received female donors (n=246) that were short (≤ 66 inches) and obese (BMI≥30) (n=61) and short and non-obese (BMI major adverse cardiac events (NF-MACE: myocardial infarction , new congestive heart failure , percutaneous coronary intervention, implantable cardioverter defibrillator/pacemaker implant, stroke), and freedom from any-treated rejection, acute cellular rejection , and antibody-mediated rejection . Results There is no significant difference in 1-year outcomes between short and obese female donors, short and non-obese female donors, and male donors of similar heights and weights (see tables). Conclusion Short and stout female donors appear to be acceptable for HTx which increases the donor pool.

Purpose Approximately 30% of patients undergoing heart transplantation (HTx) may have diabetes mellitus type 2 (DM2). More importantly, DM2 may become more prevalent after HTx because of high corticosteroid use. Metformin - an oral anti-hypoglycemic drug for DM2- has also been demonstrated to have immunomodulatory effects. It has been reported that metformin may decrease acute and chronic rejection as well as the development of cardiac allograft vasculopathy (CAV). Therefore, we reviewed our HTx patients placed on metformin pre-HTx and post-HTx to assess potential outcomes and benefits. Methods Between 2010 and 2017, we assessed 229 heart transplant patients with DM2. We divided these diabetic patients in those on metformin post-HTx (n=32) and those not on metformin (n=176). Metformin was continued for at least one-year post-transplant. Endpoints included 1-year survival, 1-year freedom from CAV (as defined by >30% stenosis via angiography), 1-year freedom from non-fatal major adverse cardiac events (NF-MACE: myocardial infarction, new congestive heart failure, percutaneous coronary intervention, implantable cardioverter defibrillator/pacemaker implant, stroke), and 1-year freedom from any-treated rejection (ATR), acute cellular rejection (ACR), and antibody-mediated rejection (AMR). Results There was no significant difference in 1-year survival in DM2 patients on metformin and DM2 patients not on metformin. There was no significant difference in 1-year freedom from CAV, NF-MACE or rejection between the groups (see table). Conclusion The use of metformin does not appear to demonstrate an immunomodulatory benefit. A larger cohort of patients are needed to confirm these findings.

Chagas disease (CD) is becoming an increasingly recognized cause of dilated cardiomyopathy outside of Latin America, where it is endemic, due to population shifts and migration. Heart transplantation (HTx) is a therapeutic option for end-stage cardiomyopathy due to CD, but may be considered a relative contraindication due to potential reactivation of the causative organism with immunosuppression therapy. The total artificial heart (TAH) can provide mechanical circulatory support in decompensated patients with severe biventricular dysfunction until the time of HTx, while avoiding immunosuppressive therapy and removing the organ most affected by the causative organism. We report herein a patient with CD and severe biventricular dysfunction, who had mechanical circulatory support with a TAH for more than 6 months, followed by successful orthotopic HTx and treatment with benznidazole for 3 months. The patient had no evidence of recurrent disease in the transplanted heart based on endomyocardial biopsy up to 1 year post-transplantation, and remains alive more than 30 months after insertion of a TAH and 24 months after HTx.

Introduction. Patients with history of prior sternotomy may have poorer outcomes after heart transplantation. Quantitation of risk from prior sternotomy has not been well established. The United Network for Organ Sharing (UNOS) database was analyzed to assess early and late survival and predictors of outcome in adult heart transplant recipients with and without prior sternotomy. Methods. Of 11,266 adults with first hearteonly transplantation from 1997 to 2011, recipients were divided into 2 groups: those without prior sternotomy (first sternotomy group; n ¼ 6006 or 53.3%) and those with at least 1 prior sternotomy (redo sternotomy group; n ¼ 5260 or 46.7%). A multivariable Cox model was used to identify predictors of mortality. Results. Survival was lower in the redo group at 60 days (92.6% vs 95.9%; hazard ratio [HR] 1.83, 95% confidence interval [CI]: 1.56e2.15; P < .001). Conditional 5-year survival in 60-day survivors was similar in the 2 groups (HR ¼ 1.01, 95% CI 0.90e1.12, P ¼ .90). During the first 60 days post-transplant, the redo group had more cardiac reoperations (12.3% vs 8.8%, P ¼ .0008), a higher frequency of dialysis (8.9% vs 5.2%, P < .0001), a greater percentage of drug-treated infections (23.2% vs 19%, P ¼ .003), and a higher percentage of strokes (2.5% vs 1.4%, P ¼ .0001). A multivariable Cox proportional hazards model identified prior sternotomy as a significant independent predictor of mortality, in addition to age, female gender, congenital cardiomyopathy, need for ventilation, mechanical circulatory support, dialysis prior to transplant, pretransplant serum bilirubin (� 3 mg/dL), and preoperative serum creatinine (� 2 mg/dL). Conclusions. Prior sternotomy is associated with an excess 3.3% mortality and higher morbidity within the first 60 days after heart transplantation, as measured by frequency of dialysis, drug-treated infections, and strokes. Conditional 5-year survival after 60 days is unaffected by prior sternotomy. These findings should be taken into account for risk assessment of patients undergoing heart transplantation.

Introduction An economical animal model to study xenograft tissue degeneration and calcification and the durability of biological vascular patch material and bioprosthetic valve leaflets is desirable. Objective A cost-effective model to analyze xenograft degeneration, calcification, immunologic reaction, and anticalcification treatment was developed. Furthermore, a technique for implant into the vascular lumen of the abdominal aorta in rats is presented. Methods Twelve Lewis rats were used as recipients. The microsurgical procedure was performed using a high-definition optical system. Anesthesia was induced and maintained with isoflurane inhalation. The suprarenal and infrarenal portion of the abdominal aorta was isolated, the abdominal aorta was cross-clamped, and a 4-mm square portion of the abdominal aorta was removed. Subsequently, a complementary-sized piece of porcine or bovine glutaraldehyde-fixed bioprosthetic valve leaflet tissue was sutured as a patch in the abdominal aorta. Results The mean operating time was 45 ± 10 minutes and the mean ischemic time was 25 ± 5 minutes. Early and 3-month survivals were 100%. One rat had intraoperative bleeding. No paralysis or thrombosis was observed. Conclusion Feasibility and reproducibility of removing a portion of the abdominal aorta and replacing it with a patch of xenograft tissue was demonstrated in a rodent model with 100% survival at 3 months. Concomitant dual intravascular and subcutaneous microsurgical implantation of xenograft tissue in a small-animal (rat) model is a cost-effective approach for investigation of xenograft tissue degeneration.

The most common causes of death after heart transplantation (HTx) include acute rejection and multi-organ failure in the early period and malignancy and cardiac allograft vasculopathy (CAV) in the late period. Polyclonal antibody preparations such as rabbit anti-thymocyte globulin (ATG) may reduce early acute rejection and the later occurrence of CAV after HTx. ATG therapy depletes T cells, modulates adhesion and cell-signaling molecules, interferes with dendritic cell function, and induces B-cell apoptosis and regulatory and natural killer T-cell expansion. Evidence from animal studies and from retrospective clinical studies in humans indicates that ATG can be used to delay calcineurin inhibitor (CNI) exposure after HTx, thus benefiting renal function, and to reduce the incidence of CAV and ischemia-reperfusion injury in the transplanted heart. ATG may reduce de novo antibody production after HTx. ATG does not appear to increase cytomegalovirus infection rates with longer prophylaxis (6-12 months). In addition, ATG may reduce the risk of lymphoproliferative disease and does not appear to confer an additive effect on acquiring lymphoma after HTx. Randomized, controlled trials may provide stronger evidence of ATG association with patient survival, graft rejection, renal protection through delayed CNI initiation, as well as other benefits. It can also help establish optimal dosing and patient criteria to maximize treatment benefits.

Heart transplantation (HTx) surgically interrupts the parasympathetic vagal neurons and the intrinsic postganglionic sympathetic nerve fibers traveling from the stellate ganglia to the myocardium, causing axonal Wallerian degeneration and thus extrinsic cardiac denervation.[1][1], [2][2], [3][3], [4

We present the first single-center report of 2 consecutive cases of combined heart and kidney transplantation after insertion of a total artificial heart (TAH). Both patients had advanced heart failure and developed dialysis-dependent renal failure after implantation of the TAH. The 2 patients underwent successful heart and kidney transplantation, with restoration of normal heart and kidney function. On the basis of this limited experience, we consider TAH a safe and feasible option for bridging carefully selected patients with heart and kidney failure to combined heart and kidney transplantation. Recent FDA approval of the Freedom driver may allow outpatient management at substantial cost savings. The TAH, by virtue of its capability of providing pulsatile flow at 6 to 10 L/min, may be the mechanical circulatory support device most likely to recover patients with marginal renal function and advanced heart failure.

The role of solid multiorgan transplantation remains to be determined. We compared our experience with combined heart-kidney transplantation (HKT) and heart transplant alone (HT), and assessed patient survival rates and freedom from allograft rejection in these two patient groups.We reviewed the clinical outcomes of patients undergoing HKT (n=30) or HT (n=440) between June 1992 and March 2009. Baseline patient characteristics, perioperative factors, incidence of rejection, and survival were examined.There were no significant differences between the two groups for age, gender, etiology of heart disease, functional class, preoperative left ventricular ejection fraction, end-diastolic diameter, cardiac output, or transplant waitlist status. Patients with HKT had a higher serum creatinine level (P.001) and a greater incidence of hypertension (P=.04). No differences were found in cardiac allograft ischemic times, including cardiopulmonary bypass or cross-clamp times. Kidney allograft ischemic time was 14.6±9 hours (mean±SD; range, 4 hours to 49 hours). Kaplan-Meier survival estimates were similar for the HKT and HT groups at 30 days (93%±4.6% versus 98%±0.7%), 1 year (87%±6.2% versus 93%±1.2%), 5 years (68%±9.0% versus 76%±2.1%), and 10 years (51%±11% versus 53%±3.0%; P=.54 for all comparisons). Follow-up serum creatinine levels were similar after HKT and HT at 30 days (1.6±1.8 mg/dL versus 1.1±0.4 mg/dL), 1 year (1.4±0.6 mg/dL versus 1.5±0.6 mg/dL), and 5 years (1.8±1.8 mg/dL versus 1.8±1.2 mg/dL; P.05 for all comparisons).HKT offers excellent survival and similar renal function when compared with HT alone. Patients with end-stage cardiac and renal failure can be considered for HKT.

Objective Advanced age has been viewed as a contraindication to orthotopic heart transplantation (OHT). We analyzed the outcome of OHT in patients who were aged 70 years or older and compared the results with those in younger patients during a two-decade period. Methods A total of 519 patients underwent first-time single-organ OHT at our institution from 1988 to 2009. Patients were divided into three groups by age: ≥ 70-years old (group 1, n = 37), 60 to 69-years old (group 2, n = 206), and ≤60-years old (group 3, n = 276). Primary endpoints were 30-days, and 1-, 5-, and 10-years survival. Secondary outcomes included re-operation for bleeding, postoperative need for dialysis, and length of postoperative intubation. Results There was no significant difference in survival between the greater than or equal to 70-year-old group and the two younger age groups for the first 10 years after OHT. Survival rates at 30 days, and 1-, 5-, and 10-years, and median survival in group 1 recipients were 100%, 94.6%, 83.2%, 51.7%, and 10.9 years (CI 7.1–11.0), respectively; in group 2 those numbers were 97.6%, 92.7%, 73.8%, 47.7%, and 9.1 years (CI 6.7–10.9), respectively; and in group 3 those numbers were 96.4%, 92.0%, 74.7%, 57.1%, and 12.2 years (CI 10.7–15.4; P = NS), respectively. There was no significant difference in secondary outcomes of re-operation for bleeding, postoperative need for dialysis, and prolonged intubation among the three age groups. Conclusions Patients who are aged 70 years and older can undergo heart transplantation with similar morbidity and mortality when compared with younger recipients. Advanced heart failure patients who are aged 70 years and older should not be excluded from transplant consideration based solely on an age criterion. Stringent patient selection, however, is necessary.

Background The standard biatrial technique for orthotopic heart transplantation uses a large atrial anastomosis to connect the donor and recipient atria. A modified technique involves bicaval and pulmonary venous anastomoses and is believed to preserve the anatomic configuration and physiological function of the atria. Bicaval heart transplantation reduces postoperative valvular regurgitation and is associated with a lower incidence of pacemaker insertion. Objective The aim of this study was to compare postoperative functional capacity and exercise performance in patients with bicaval and biatrial orthotopic heart transplantation. Methods Patients were selected for the study if they did not have any of the following: obstructive coronary artery disease (>50% stenosis), severe mitral or tricuspid regurgitation, signs of rejection (grade ≥1B-1R) on endomyocardial biopsy during the prior year, respiratory impairment, a permanent pacemaker, orthopedic or muscular impediments, or lived more than 150 miles from the medical center. A total of 27 patients qualified. In 15 patients who received a biatrial heart transplant and 12 patients with a bicaval heart transplant, a stationary bicycle exercise test was performed. Ventilatory gas exchange and maximum oxygen consumption measurements were measured. Results Recipient and donor characteristics, including body surface area, donor/recipient weight mismatch, immunosuppressive regimen, and self-reported weekly exercise activity, did not differ between the biatrial and bicaval groups (P = not significant [NS]). At peak exercise, similar heart rate, workload, oxygen consumption, carbon dioxide production, ventilation, functional capacity, and exercise duration were found between the 2 groups (P = NS). Patients in the biatrial group were studied later than patients in the bicaval group (6.54 ± 0.71 vs 4.68 ± 0.28 years; P Conclusion There were no significant differences in the exercise capacity between patients with biatrial versus bicaval techniques for orthotopic heart transplantation. Factors other than the atrial connection (such as cardiac denervation, immunosuppressive drug effect, or physical deconditioning) may be more important determinants of subnormal exercise capacity after heart transplantation. Nevertheless, the reduction in morbidity and postoperative complications and the simplicity in the bicaval technique suggest that bicaval heart transplantation offers advantages when compared with the standard biatrial technique.

Background. Cytomegalovirus (CMV) is a common cause of infection and morbidity after heart transplantation. Seronegative recipients (R) of seropositive donor hearts (D) are at high risk for CMV disease. We compared three different CMV prophylaxis regimens using combined antiviral and immunoglobulin therapy. Methods. In 99 patients who survived more than 30 days after heart transplant, all received induction with antilymphocytic therapy and triple-drug therapy. In group A, DR patients received one dose of intravenous immunoglobulin (IVIG) followed by one dose of CMV-specific immunoglobulin (CMV-IVIG), and intravenous ganciclovir (GCV) for 4 weeks followed by 11 months of oral acyclovir (ACV). In group B, DR patients received one dose IVIG followed by five doses of CMV-IVIG and intravenous GCV for 14 weeks followed by 9 months of oral ACV. In group C, DR patients were treated with the same regimen as for group B, except oral ACV was replaced with oral GCV. Results. The actuarial freedom from CMV disease for DR patients at 1 month, 1 year, and 2 years after transplantation in group A was 100%, 25% 15%, and 25% 15%, respectively; group B was 100%, 67% 27%, and 67% 27%; group C was 100%, 83% 15%, and 83% 15% (P .01, groups B and C vs group A). By comparison, the actuarial freedom from CMV disease for seropositive recipients (DR or DR )a t 1 month, 1 year, and 2 years in group A was 100%, 87% 7%, and 82% 8%, respectively; group B was 100%, 88% 8%, and 75% 11%; group C was 100%, 72% 9%, and 72% 9% (P NS among groups). Rejection rates did not differ among the three groups. Conclusions. A longer course of intravenous GCV with multiple doses of CMV-IVIG was a more effective prophylaxis regimen against CMV disease for the high-risk group of seronegative recipients of seropositive donor hearts.

Deciding who should receive maximal technological treatment options and who should not represents an ethical, moral, psychological and medico-legal challenge for health care providers. Especially in patients with chronic heart failure, the ethical and medico-legal issues associated with providing maximal possible care or withholding the same are coming to the forefront. Procedures, such as cardiac transplantation, have strict criteria for adequate candidacy. These criteria for subsequent listing are based on clinical outcome data but also reflect the reality of organ shortage. Lack of compliance and non-adherence to lifestyle changes represent relative contraindications to heart transplant candidacy. Mechanical circulatory support therapy using ventricular assist devices is becoming a more prominent therapeutic option for patients with end-stage heart failure who are not candidates for transplantation, which also requires strict criteria to enable beneficial outcome for the patient. Physicians need to critically reflect that in many cases, the patient’s best interest might not always mean pursuing maximal technological options available. This article reflects on the multitude of critical issues that health care providers have to face while caring for patients with end-stage heart failure.