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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.

Background Transcatheter edge-to-edge (TEER) mitral repair may be complicated by residual or recurrent mitral regurgitation. An increasing need for surgical reintervention has been reported, but operative outcomes are ill defined. Objectives This study evaluated national outcomes of mitral surgery after TEER. Methods The Society of Thoracic Surgeons (STS) Adult Cardiac Surgery Database was used to identify 524 adults who underwent mitral surgery after TEER between July 2014 and June 2020. Emergencies (5.0%; n = 26), previous mitral surgery (5.3%; n = 28), or open implantation of transcatheter prostheses (1.5%; n = 8) were excluded. The primary outcome was 30-day or in-hospital mortality. Results In the study cohort of 463 patients, the median age was 76 years (interquartile range [IQR]: 67 to 81 years), median left ventricular ejection fraction was 57% (IQR: 48% to 62%), and 177 (38.2%) patients had degenerative disease. Major concomitant cardiac surgery was performed in 137 (29.4%) patients: in patients undergoing isolated mitral surgery, the median STS-predicted mortality was 6.5% (IQR: 3.9% to 10.5%), the observed mortality was 10.2% (n = 23 of 225), and the ratio of observed to expected mortality was 1.2 (95% confidence interval [CI]: 0.8 to 1.9). Predictors of mortality included urgent surgery (odds ratio [OR]: 2.4; 95% CI: 1.3 to 4.6), nondegenerative/unknown etiology (OR: 2.2; 95% CI: 1.1 to 4.5), creatinine of >2.0 mg/dl (OR: 3.8; 95% CI: 1.9 to 7.9) and age of >80 years (OR: 2.1; 95% CI: 1.1 to 4.4). In a volume outcomes analysis in an expanded cohort of 591 patients at 227 hospitals, operative mortality was 2.6% (n = 2 of 76) in 4 centers that performed >10 cases versus 12.4% (n = 64 of 515) in centers performing fewer (p = 0.01). The surgical repair rate after failed TEER was 4.8% (n = 22) and was 6.8% (n = 12) in degenerative disease. Conclusions This study indicates that mitral repair is infrequently achieved after failed TEER, which may have implications for treatment choice in lower-risk and younger patients with degenerative disease. These findings should inform patient consent for TEER, clinical trial design, and clinical performance measures.

Mitral valve repair is infrequently performed in patients undergoing corrective surgery for failed mitral transcatheter edge-to-edge repair in current United States practice. This article describes surgical techniques for reconstructive surgery after failed transcatheter edge-to-edge repair. Nine patients underwent robotic-assisted mitral surgery after failed transcatheter edge-to-edge repair between 2008 and 2020 at a single center. Repair was completed in 88.9% (n = 8) patients, and freedom from2+ mitral regurgitation was 87.5% (n = 7) at a median follow-up of 1.9 years.

In advanced heart failure, orthotopic heart transplantation (OHT) remains the standard for definitive treatment. Patients with heart failure and concomitant pulmonary hypertension (PH) represent a challenging subgroup, with poor outcomes following OHT. Recently, Mechanical Circulatory Support (MCS) devices have been utilized as a bridge to OHT for these patients. Patients with MCS devices who underwent OHT were evaluated at a single center. Patients were stratified into three groups, depending on baseline pulmonary vascular resistance (PVR). Groups were analyzed for outcomes. One hundred twenty three patients were identified. Of these, 39 had a PVR ≤1.6, 50 had a PVR >1.6 and ≤ 3, and 34 had a PVR >3. Demographics were generally similar. Tricuspid valve regurgitation (TR) was significantly higher among patients with worse baseline PVR (p=0.016). Survival was similar at both one and three years. On subsequent analysis, moderate/severe TR was associated with worse survival. MCS implantation as a bridge to OHT has good one and three-year outcomes among patients with increasing pre-MCS PVR. However, patients with severe PH prior to MCS have an increased rate of TR. Among these patients, moderate-severe TR after OHT has an associated risk of early death.

Background Subclinical leaflet thrombosis, characterized by hypoattenuated leaflet thickening (HALT) and reduced leaflet motion observed on 4-dimensional computed tomography (CT), may represent a form of bioprosthetic valve dysfunction. Objectives The U.S. Food and Drug Administration mandated CT studies to understand the natural history of this finding, differences between transcatheter and surgical valves, and its association with valve hemodynamics and clinical outcomes. Methods The PARTNER 3 (The Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low-Risk Patients With Aortic Stenosis) CT substudy randomized 435 patients with low–surgical-risk aortic stenosis to undergo transcatheter aortic valve replacement (n = 221) or surgery (n = 214). Serial 4-dimensional CTs were performed at 30 days and 1 year and were analyzed independently by a core laboratory. Results The incidence of HALT increased from 10% at 30 days to 24% at 1 year. Spontaneous resolution of 30-day HALT occurred in 54% of patients at 1 year, whereas new HALT appeared in 21% of patients at 1 year. HALT was more frequent in transcatheter versus surgical valves at 30 days (13% vs. 5%; p = 0.03), but not at 1 year (28% vs. 20%; p = 0.19). The presence of HALT did not significantly affect aortic valve mean gradients at 30 days or 1 year. Patients with HALT at both 30 days and 1 year, compared with those with no HALT at 30 days and 1 year, had significantly increased aortic valve gradients at 1 year (17.8 ± 2.2 mm Hg vs. 12.7. ± 0.3 mm Hg; p = 0.04). Conclusions Subclinical leaflet thrombosis was more frequent in transcatheter compared with surgical valves at 30 days, but not at 1 year. The impact of HALT on thromboembolic complications and structural valve degeneration needs further assessment.

Acutely decompensated heart failure presents a complicated challenge. Established temporary support measures have significant adverse effects. A minimally invasive temporary left ventricular assist device (LVAD), the Impella 5.0 (Abiomed, Danvers, MA), has been developed to support these patients.Patients with acutely decompensated heart failure in whom medical management had failed and who required additional support using an Impella 5.0 device were evaluated from January 2014 to September 2018 at a single center in a retrospective manner using a prospectively maintained database. Patients were treated with the device as a bridge to recovery (BTR; n = 30), bridge to durable device (BTDD; n = 23), or bridge to transplantation (BTT; n = 47). All devices were placed using an axillary artery approach. Demographic features and outcomes were evaluated for each group and compared.A total of 100 patients underwent insertion of an axillary Impella 5.0 LVAD. Patients had an average age of 56.7 ± 13.2 years, were predominantly male (84%), and had a severely depressed left ventricular ejection fraction (average 16%), and most had an Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) profile 1 (57%) or 2 (33%) score. When divided into groups, there was no difference in age or INTERMACS score, but a statistical difference was noted in baseline left ventricular ejection fraction (20%, 14%, 15%) and creatinine level (1.0, 2.0, 1.6), in the BTR, BTDD, or BTT group, respectively (all P.05). Survival was 64% overall, and it was 50%, 48%, and 81% for BTR, BTDD, and BTT, respectively (P = .007). Survival improved during this experience and was 90% overall in the most recent 30 patients.Use of this minimally invasive LVAD system is an attractive strategy to support patients with acute decompensated heart failure to recovery, durable LVAD, or heart transplantation.

Importance There are limited data on outcomes of transcatheter aortic valve replacement (TAVR) for bicuspid aortic stenosis in patients at low surgical risk. Objective To compare the outcomes of TAVR with a balloon-expandable valve for bicuspid vs tricuspid aortic stenosis in patients who are at low surgical risk. Design, setting, and participants Registry-based cohort study of patients undergoing TAVR at 684 US centers. Participants were enrolled in the Society of Thoracic Surgeons (STS)/American College of Cardiology Transcatheter Valve Therapies Registry from June 2015 to October 2020. Among 159 661 patients (7058 bicuspid, 152 603 tricuspid), 37 660 patients (3243 bicuspid and 34 417 tricuspid) who were at low surgical risk (defined as STS risk score Exposures TAVR for bicuspid vs tricuspid aortic stenosis. Main outcomes and measures Coprimary outcomes were 30-day and 1-year mortality and stroke. Secondary outcomes included procedural complications and valve hemodynamics. Results Among 159 661 patients (7058 bicuspid; 152 603 tricuspid), 3168 propensity-matched pairs of patients with bicuspid and tricuspid aortic stenosis at low surgical risk were analyzed (mean age, 69 years; 69.8% men; mean [SD] STS-predicted risk of mortality, 1.7% [0.6%] for bicuspid and 1.7% [0.7%] for tricuspid). There was no significant difference between the bicuspid and tricuspid groups' rates of death at 30 days (0.9% vs 0.8%; hazard ratio [HR], 1.18 [95% CI, 0.68-2.03]; P = .55) and at 1 year (4.6% vs 6.6%; HR, 0.75 [95% CI, 0.55-1.02]; P = .06) or stroke at 30 days (1.4% vs 1.2%; HR, 1.14 [95% CI, 0.73-1.78]; P = .55) and at 1 year (2.0% vs 2.1%; HR 1.03 [95% CI, 0.69-1.53]; P = .89).There were no significant differences between the bicuspid and tricuspid groups in procedural complications, valve hemodynamics (aortic valve gradient: 13.2 mm Hg vs 13.5 mm Hg; absolute risk difference [RD], 0.3 mm Hg [95% CI, -0.9 to 0.3 mm Hg]), and moderate or severe paravalvular leak (3.4% vs 2.1%; absolute RD, 1.3% [95% CI, -0.6% to 3.2%]). Conclusions and relevance In this preliminary, registry-based study of propensity-matched patients at low surgical risk who had undergone TAVR for aortic stenosis, patients treated for bicuspid vs tricuspid aortic stenosis had no significant difference in mortality or stroke at 30 days or 1 year. Because of the potential for selection bias and absence of a control group treated surgically for bicuspid aortic stenosis, randomized trials are needed to adequately assess the efficacy and safety of transcatheter aortic valve replacement for bicuspid aortic stenosis in patients at low surgical risk.

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.

Background Longitudinal motion of the mitral annulus is an index that reflects left ventricular (LV) function. The aim of this study was to evaluate and compare the effects of transcatheter mitral valve (MV) repair and open heart surgery for mitral regurgitation (MR) on mitral annular motion (MAM). Methods We retrospectively analyzed in total 115 patients who underwent isolated transcatheter MV repair using MitraClip (n=50) or surgical MV interventions (n=65, 50 repairs and 15 replacements) for MR. MAM was assessed by two-dimensional B-mode echocardiography in the four- and two-chamber views. MAM was measured before and within 1 month after the mitral procedure. Results Compared with patients undergoing MV surgery, patients undergoing the MitraClip procedure were older and had more comorbidities. MR grade improved significantly in both groups after MV intervention. MAM decreased significantly in the surgery group (12.0±3.1 to 8.1±2.2 mm, P

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.

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.

The most recent American College of Cardiology/American Heart Association heart valve guidelines recommend that prompt surgical correction of severe degenerative mitral valve regurgitation, ideally mitral valve repair, should be performed to decrease the risks of long-term mortality and heart failure risks associated with this condition. Mitral valve repair performed using a minimally invasive robotic approach can now be successfully carried out in nearly all cases of degenerative disease with very low risks of stroke or death. Experienced groups have further shown specific advantages of robotic mitral valve repair compared with conventional approaches, including reduced blood loss, lower risks of infection and atrial fibrillation, shorter hospital length of stay, quicker return to normal activities, and a superior cosmetic result. Herein, we discuss the current status of robotic mitral valve repair including indications, technical advances, safety, effectiveness, and durability.

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 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 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.

Background: In EVEREST II (Endovascular Valve Edge-to-Edge Repair Study), treatment of mitral regurgitation (MR) with a novel percutaneous device showed superior safety compared with surger...

BackgroundA finding of reduced aortic-valve leaflet motion was noted on computed tomography (CT) in a patient who had a stroke after transcatheter aortic-valve replacement (TAVR) during an ongoing clinical trial. This finding raised a concern about possible subclinical leaflet thrombosis and prompted further investigation. MethodsWe analyzed data obtained from 55 patients in a clinical trial of TAVR and from two single-center registries that included 132 patients who were undergoing either TAVR or surgical aortic-valve bioprosthesis implantation. We obtained four-dimensional, volume-rendered CT scans along with data on anticoagulation and clinical outcomes (including strokes and transient ischemic attacks [TIAs]). ResultsReduced leaflet motion was noted on CT in 22 of 55 patients (40%) in the clinical trial and in 17 of 132 patients (13%) in the two registries. Reduced leaflet motion was detected among patients with multiple bioprosthesis types, including transcatheter and surgical bioprostheses. Therapeu...

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.

Thoughtful preparation of the surgical field at the time of initial mechanical circulatory support (MCS) implantation has the potential for decreasing operative time and surgical risk of subsequent heart transplantation. It sets the stage for expeditious, safe sternal reentry, and identification of structures necessary for initiation of cardiopulmonary bypass (CPB).

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.

Background Vasoplegia is characterized as a severe vasodilatory shock after cardiac surgery, and can be associated with substantial morbidity. Increased systemic inflammation and endothelial dysfunction, often related to prolonged cardiopulmonary bypass times, anesthesia, or mechanical circulatory support have been shown to be associated with the development of vasoplegia. We sought to identify risk factors and the impact of various degrees of vasoplegia after heart transplantation. Methods A retrospective review was conducted of 244 consecutive patients who underwent heart transplantation over a 3-year period. Patients were divided into three groups: no vasoplegia, mild vasoplegia (requiring one vasopressor), and moderate/severe vasoplegia (more than two vasopressors). One-year survival, freedom from rejection, and postoperative complication rates were assessed. Risk factors for vasoplegia subgroups were retrospectively identified. Results Vasoplegia syndrome was observed in 34.3% of patients after heart transplantation (mild, 74.1%; moderate/severe, 25.9%). Cardiopulmonary bypass time was significantly longer and pretransplant creatinine was significantly higher in the moderate/severe vasoplegia group. There was a strong trend toward greater use of mechanical circulatory support among moderate/severe vasoplegia patients compared with mild and no vasoplegia patients. After heart transplantation, 1-year survival, freedom from rejection, and need for hemodialysis were not significantly different between groups. Conclusions Vasoplegia syndrome is common after heart transplantation. Risk factors for increased severity include longer cardiopulmonary bypass times and elevated preoperative creatinine. Although higher rates of mortality or graft rejection were not detected, vasoplegia was associated with prolonged intubation, greater blood product usage, and lengthened hospital stay. Further studies involving larger cohorts are warranted.

Subclinical leaflet thrombosis of bioprosthetic aortic valves after transcatheter valve replacement (TAVR) and surgical aortic valve replacement (SAVR) has been found with CT imaging. The objective of this study was to report the prevalence of subclinical leaflet thrombosis in surgical and transcatheter aortic valves and the effect of novel oral anticoagulants (NOACs) on the subclinical leaflet thrombosis and subsequent valve haemodynamics and clinical outcomes on the basis of two registries of patients who had CT imaging done after TAVR or SAVR.Patients enrolled between Dec 22, 2014, and Jan 18, 2017, in the RESOLVE registry, and between June 2, 2014, and Sept 28, 2016, in the SAVORY registry, had CT imaging done with a dedicated four-dimensional volume-rendered imaging protocol at varying intervals after TAVR and SAVR. We defined subclinical leaflet thrombosis as the presence of reduced leaflet motion, along with corresponding hypoattenuating lesions shown with CT. We collected data for baseline demographics, antithrombotic therapy, and clinical outcomes. We analysed all CT scans, echocardiograms, and neurological events in a masked fashion.Of the 931 patients who had CT imaging done (657 [71%] in the RESOLVE registry and 274 [29%] in the SAVORY registry), 890 [96%] had interpretable CT scans (626 [70%] in the RESOLVE registry and 264 [30%] in the SAVORY registry). 106 (12%) of 890 patients had subclinical leaflet thrombosis, including five (4%) of 138 with thrombosis of surgical valves versus 101 (13%) of 752 with thrombosis of transcatheter valves (p=0·001). The median time from aortic valve replacement to CT for the entire cohort was 83 days (IQR 33-281). Subclinical leaflet thrombosis was less frequent among patients receiving anticoagulants (eight [4%] of 224) than among those receiving dual antiplatelet therapy (31 [15%] of 208; p0·0001); NOACs were equally as effective as warfarin (three [3%] of 107 vs five [4%] of 117; p=0·72). Subclinical leaflet thrombosis resolved in 36 (100%) of 36 patients (warfarin 24 [67%]; NOACs 12 [33%]) receiving anticoagulants, whereas it persisted in 20 (91%) of 22 patients not receiving anticoagulants (p0·0001). A greater proportion of patients with subclinical leaflet thrombosis had aortic valve gradients of more than 20 mm Hg and increases in aortic valve gradients of more than 10 mm Hg (12 [14%] of 88) than did those with normal leaflet motion (seven [1%] of 632; p0·0001). Although stroke rates were not different between those with (4·12 strokes per 100 person-years) or without (1·92 strokes per 100 person-years) reduced leaflet motion (p=0·10), subclinical leaflet thrombosis was associated with increased rates of transient ischaemic attacks (TIAs; 4·18 TIAs per 100 person-years vs 0·60 TIAs per 100 person-years; p=0·0005) and all strokes or TIAs (7·85 vs 2·36 per 100 person-years; p=0·001).Subclinical leaflet thrombosis occurred frequently in bioprosthetic aortic valves, more commonly in transcatheter than in surgical valves. Anticoagulation (both NOACs and warfarin), but not dual antiplatelet therapy, was effective in prevention or treatment of subclinical leaflet thrombosis. Subclinical leaflet thrombosis was associated with increased rates of TIAs and strokes or TIAs. Despite excellent outcomes after TAVR with the new-generation valves, prevention and treatment of subclinical leaflet thrombosis might offer a potential opportunity for further improvement in valve haemodynamics and clinical outcomes.RESOLVE (Cedars-Sinai Heart Institute) and SAVORY (Rigshospitalet).

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.

With the evolution of transcatheter valve replacement, an important opportunity has arisen for cardiologists and surgeons to collaborate in identifying the criteria for performing these procedures. Therefore, The Society for Cardiovascular Angiography and Interventions (SCAI), American Association for Thoracic Surgery (AATS), American College of Cardiology (ACC), and The Society of Thoracic Surgeons (STS) have partnered to provide recommendations for institutions to assess their potential for instituting and/or maintaining a transcatheter valve program. This article concerns transcatheter pulmonic valve replacement (tPVR). tPVR procedures are in their infancy with few reports available on which to base an expert consensus statement. Therefore, many of these recommendations are based on expert consensus and the few reports available. As the procedures evolve, technology advances, experience grows, and more data accumulate, there will certainly be a need to update this consensus statement. The writing committee and participating societies believe that the recommendations in this report serve as appropriate requisites. In some ways, these recommendations apply to institutions more than to individuals. There is a strong consensus that these new valve therapies are best performed using a Heart Team approach; thus, these credentialing criteria should be applied at the institutional level. Partnering societies used the ACC's policy on relationships with industry (RWI) and other entities to author this document (http://www.acc.org/guidelines/about-guidelines-and-clinical-documents). To avoid actual, potential, or perceived conflicts of interest due to industry relationships or personal interests, all members of the writing committee, as well as peer reviewers of the document, were asked to disclose all current healthcare-related relationships including those existing 12 months before the initiation of the writing effort. A committee of interventional cardiologists and surgeons was formed to include a majority of members with no relevant RWI and to be led by an interventional cardiology cochair and a surgical cochair with no relevant RWI. Authors with relevant RWI were not permitted to draft or vote on text or recommendations pertaining to their RWI. RWI were reviewed on all conference calls and updated as changes occurred. Author and peer reviewer RWI pertinent to this document are disclosed in the Appendices. In addition, to ensure complete transparency, authors' comprehensive disclosure information (including RWI not pertinent to this document) is available in Appendix AII. The work of the writing committee was supported exclusively by the partnering societies without commercial support. SCAI, AATS, ACC, and STS believe that adherence to these recommendations will maximize the chances that these therapies will become a successful part of the armamentarium for treating valvular heart disease in the United States. In addition, these recommendations will hopefully facilitate optimum quality during the delivery of this therapy, which will be important to the development and successful implementation of future, less invasive approaches to structural heart disease.

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.

Importance Transcatheter aortic valve replacement (TAVR) indications are expanding, leading to an increasing number of patients with bicuspid aortic stenosis undergoing TAVR. Pivotal randomized trials conducted to obtain US Food and Drug Administration approval excluded bicuspid anatomy. Objective To compare the outcomes of TAVR with a balloon-expandable valve for bicuspid vs tricuspid aortic stenosis. Design, Setting, and Participants Registry-based prospective cohort study of patients undergoing TAVR at 552 US centers. Participants were enrolled in the Society of Thoracic Surgeons (STS)/American College of Cardiology (ACC) Transcatheter Valve Therapies Registry from June 2015 to November 2018. Exposures TAVR for bicuspid vs tricuspid aortic stenosis. Main Outcomes and Measures Primary outcomes were 30-day and 1-year mortality and stroke. Secondary outcomes included procedural complications, valve hemodynamics, and quality of life assessment. Results Of 81 822 consecutive patients with aortic stenosis (2726 bicuspid; 79 096 tricuspid), 2691 propensity-score matched pairs of bicuspid and tricuspid aortic stenosis were analyzed (median age, 74 years [interquartile range {IQR}, 66-81 years]; 39.1%, women; mean [SD] STS-predicted risk of mortality, 4.9% [4.0%] and 5.1% [4.2%], respectively). All-cause mortality was not significantly different between patients with bicuspid and tricuspid aortic stenosis at 30 days (2.6% vs 2.5%; hazard ratio [HR], 1.04, [95% CI, 0.74-1.47]) and 1 year (10.5% vs 12.0%; HR, 0.90 [95% CI, 0.73-1.10]). The 30-day stroke rate was significantly higher for bicuspid vs tricuspid aortic stenosis (2.5% vs 1.6%; HR, 1.57 [95% CI, 1.06-2.33]). The risk of procedural complications requiring open heart surgery was significantly higher in the bicuspid vs tricuspid cohort (0.9% vs 0.4%, respectively; absolute risk difference [RD], 0.5% [95% CI, 0%-0.9%]). There were no significant differences in valve hemodynamics. There were no significant differences in moderate or severe paravalvular leak at 30 days (2.0% vs 2.4%; absolute RD, 0.3% [95% CI, −1.3% to 0.7%]) and 1 year (3.2% vs 2.5%; absolute RD, 0.7% [95% CI, −1.3% to 2.7%]). At 1 year there was no significant difference in improvement in quality of life between the groups (difference in improvement in the Kansas City Cardiomyopathy Questionnaire overall summary score, −2.4 [95% CI, −5.1 to 0.3];P = .08). Conclusions and Relevance In this preliminary, registry-based study of propensity-matched patients who had undergone transcatheter aortic valve replacement for aortic stenosis, patients with bicuspid vs tricuspid aortic stenosis had no significant difference in 30-day or 1-year mortality but had increased 30-day risk for stroke. Because of the potential for selection bias and the absence of a control group treated surgically for bicuspid stenosis, randomized trials are needed to adequately assess the efficacy and safety of transcatheter aortic valve replacement for bicuspid aortic stenosis.

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.

Mitral valve regurgitation is associated with significant longterm morbidities including the development of atrial fibrillation, heart failure, and shortened life expectancy. Mitral valve repair improves long-term outcome in patients with mitral regurgitation [1]. Open chest procedures remain the gold standard for mitral repair and remain the context from which to compare durability and outcomes. In the current issue of “Trends in Cardiovascular Medicine”, Khaled Algarni and his team from the Mayo Clinic provide a highly effective, evidence-based analysis of the literature regarding the advantages of minimally invasive mitral repair methods. As Algarni clearly states in his article, minimally invasive mitral valve surgery does not refer to a single procedure, but to a growing inventory of strategies to avert a full sternotomy. However, while it is impressive to note that the use of minimally invasive mitral techniques has increased by 100% over the last few years, such methods still represent merely a small portion of all mitral valve repairs [2]. Currently, minimally invasive mitral valve repairs can be subdivided into three categories. First, are those that utilize a partial sternotomy approach. Second, are the right thoracotomy methods, including the choice between open and robotic. And third, and of the most significance to the future, are the emerging transcatheter techniques of mitral repairs. As stated by Algarni and his Mayo team, minimally invasive surgical mitral valve repair, regardless of the technique, can yield comparable results to conventional open methods in terms of outcome, yet with a substantial reduction in associated morbidities. However, because of the significantly smaller incisions, the technical demands upon the surgeon

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 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

OBJECTIVES Vasoplegia syndrome is a potentially life-threatening condition that can occur following cardiopulmonary bypass. Heart transplantation is a recognized risk factor for developing this vasodilatory state. The objective of this study was to determine the effects of vasoplegia syndrome on 1-year heart transplant outcomes. METHODS A retrospective review of orthotopic heart transplants at a single institution between November 2010 and December 2014 was performed. Of the 347 consecutive adult patients, 107 patients (30.8%) met criteria for vasoplegia syndrome. Preoperative factors and intraoperative variables were collected and compared between vasoplegia and non-vasoplegia cohorts. The incidence of postoperative complications, transplant rejection and patient survival within 1 year were evaluated. RESULTS Demographics and preoperative medication profiles were similar in both groups, while mechanical circulatory support device use was associated with vasoplegia syndrome (30.8% vs 20.0%; P = 0.039). Perioperative characteristics such as longer cardiopulmonary bypass [165.0 (interquartile range [IQR] 74) min vs 140.0 (IQR 42.7) min; P

Previous trials have shown that among high-risk patients with aortic stenosis, survival rates are similar with transcatheter aortic-valve replacement (TAVR) and surgical aortic-valve replacement. We evaluated the two procedures in a randomized trial involving intermediate-risk patients.We randomly assigned 2032 intermediate-risk patients with severe aortic stenosis, at 57 centers, to undergo either TAVR or surgical replacement. The primary end point was death from any cause or disabling stroke at 2 years. The primary hypothesis was that TAVR would not be inferior to surgical replacement. Before randomization, patients were entered into one of two cohorts on the basis of clinical and imaging findings; 76.3% of the patients were included in the transfemoral-access cohort and 23.7% in the transthoracic-access cohort.The rate of death from any cause or disabling stroke was similar in the TAVR group and the surgery group (P=0.001 for noninferiority). At 2 years, the Kaplan-Meier event rates were 19.3% in the TAVR group and 21.1% in the surgery group (hazard ratio in the TAVR group, 0.89; 95% confidence interval [CI], 0.73 to 1.09; P=0.25). In the transfemoral-access cohort, TAVR resulted in a lower rate of death or disabling stroke than surgery (hazard ratio, 0.79; 95% CI, 0.62 to 1.00; P=0.05), whereas in the transthoracic-access cohort, outcomes were similar in the two groups. TAVR resulted in larger aortic-valve areas than did surgery and also resulted in lower rates of acute kidney injury, severe bleeding, and new-onset atrial fibrillation; surgery resulted in fewer major vascular complications and less paravalvular aortic regurgitation.In intermediate-risk patients, TAVR was similar to surgical aortic-valve replacement with respect to the primary end point of death or disabling stroke. (Funded by Edwards Lifesciences; PARTNER 2 ClinicalTrials.gov number, NCT01314313.).

Background Patients with severe mitral regurgitation may be screened for coronary artery disease with the use of cardiac computed tomography before valve surgery. Objective We hypothesized that dual-source multidetector computed tomography (DSCT) could effectively predict the culprit mitral valve scallop identified during surgery among patients with degenerative mitral valve disease undergoing surgical mitral valve repair. Methods Twenty-six patients (7 women) with known severe mitral regurgitation underwent elective mitral valve repair from September 2006 through December 2009 at our institution. An additional 10 patients underwent aortic valve replacement and had no documented history of mitral valve disease. All patients underwent transthoracic echocardiography and had retrospectively gated DSCT performed to evaluate the coronary arteries before surgery. Each mitral scallop was identified as either normal, prolapsed, or flail. CT findings were compared with operative findings, which were guided by intraoperative transesophageal echocardiography (TEE). Results In the 26 patients examined, DSCT identified flail in 23 scallops and prolapse in 48. DSCT agreed with operative findings on identification of the culprit scallop in 25 of 26 patients. On a per-patient and per-scallop basis, the observed κ statistic for agreement between DSCT and operative findings was 0.82. Of the 60 scallops in the aortic valve group, all were judged to be normal by both DSCT and TEE. Conclusions In patients with degenerative mitral valve disease undergoing cardiac surgery, DSCT demonstrates excellent agreement with intraoperative findings. DSCT can be used to identify the affected mitral valve scallop and its structure in patients who are candidates for mitral valve repair.