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Background Concerns regarding long-term durability of surgical repair for functional mitral regurgitation are based on short-term data, with few comparisons of ischemic (IMR) versus non-ischemic (NIFMR) etiology. Methods 788 consecutive patients receiving mitral repair for functional mitral regurgitation were evaluated from a prospectively maintained database. Patients with other surgical procedures were included. Propensity score matching was used to compare outcomes in IMR versus NIFMR. Results Unmatched IMR patients tended to be older men with greater comorbidities. 198 matched pairs of IMR versus NIFMR patients had similar demographics with relatively preserved ejection fraction 40±13% and end-systolic diameter 4.3±1.1cm. Concomitant coronary revascularization occurred in 70% of matched IMR patients. All patients received an annuloplasty ring, usually 24-26 mm. Heart failure class improved from 2.8 preop to 1.5 at 5 years (P =2+) mitral regurgitation (27±4% v 26±4%, P=0.4), severe regurgitation (10±3% v 8±2%, P=0.5), and mitral reoperation (3±1% v 3±1%, P=0.4) were not different between IMR v NIFMR. Recurrent moderate regurgitation was associated with heart failure readmission but not with mortality. Conclusions In propensity-matched patients, IMR versus NIFMR had worse survival but similar repair durability, with moderate regurgitation in 27% at 10 years and rare severe regurgitation or mitral reoperation. In selected patients with relatively preserved function, mitral repair for IMR or NIFMR can improve symptoms with durable mild regurgitation in most patients out to 10 years.

The prediction of right heart failure (RHF) after left ventricular assist device (LVAD) implantation remains a challenge. Recently, risk scores were derived from analysis of the European Registry for Patients with Mechanical Circulatory Support (EUROMACS) data, the EUROMACS-RHF, and the modified postoperative EUROMACS-RHF. The authors assessed the performance characteristics of these 2 risk score formulations in a continuous-flow LVAD cohort at their institution.A retrospective, observational study.At a tertiary-care academic medical center.Adult patients who underwent durable LVAD implantation between 2015 and 2018.None MEASUREMENTS AND MAIN RESULTS: Early post-LVAD RHF was defined as follows: (1) need for right ventricular assist device, or (2) inotropic or inhaled pulmonary vasodilator support for ≥14 postoperative days. The authors used logistic regression and examined receiver operating characteristic (ROC) curves to evaluate the ability of the 2 risk scores to distinguish between outcome groups. A total of 207 patients met the inclusion criteria. Of the patients, 16% developed RHF (33/207). The EUROMACS-RHF score was not predictive of RHF in the authors' cohort (odds ratio [OR] 1.25; 95% CI [0.99-1.60]; p = 0.06), but the postoperative EUROMACS-RHF CPB score was significantly associated (OR 1.38; 95% CI [1.03-1.89]; p = 0.03). The scores had similar ROC curves, with weak discriminatory performance: 0.601 (95% CI [0.509-0.692]) and 0.599 (95% CI [0.505-0.693]) for EUROMACS-RHF and postoperative EUROMACS-RHF, respectively.In the authors' single-center retrospective analysis, the EUROMACS-RHF risk score did not predict early RHF. An optimized risk score for the prediction of RHF after LVAD implantation remains an urgent unmet need.

The "2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure" replaces the "2013 ACCF/AHA Guideline for the Management of Heart Failure" and the "2017 ACC/AHA/HFSA Focused Update of the 2013 ACCF/AHA Guideline for the Management of Heart Failure." The 2022 guideline is intended to provide patient-centric recommendations for clinicians to prevent, diagnose, and manage patients with heart failure.A comprehensive literature search was conducted from May 2020 to December 2020, encompassing studies, reviews, and other evidence conducted on human subjects that were published in English from MEDLINE (PubMed), EMBASE, the Cochrane Collaboration, the Agency for Healthcare Research and Quality, and other relevant databases. Additional relevant clinical trials and research studies, published through September 2021, were also considered. This guideline was harmonized with other American Heart Association/American College of Cardiology guidelines published through December 2021.Heart failure remains a leading cause of morbidity and mortality globally. The 2022 heart failure guideline provides recommendations based on contemporary evidence for the treatment of these patients. The recommendations present an evidence-based approach to managing patients with heart failure, with the intent to improve quality of care and align with patients' interests. Many recommendations from the earlier heart failure guidelines have been updated with new evidence, and new recommendations have been created when supported by published data. Value statements are provided for certain treatments with high-quality published economic analyses.

PURPOSE: Clinical models to identify patients at high risk of primary graft dysfunction (PGD) after heart transplantation (HT) are limited, and the underlying pathophysiology of this common post-transplant complication remains poorly understood. We sought to identify whether pre-transplant levels of circulating proteins reporting on immune activation and inflammation are associated with incident PGD. METHODS: The study population consisted of 219 adult heart transplant recipients identified between 2016 and 2020 at Duke University Medical Center, randomly divided into derivation (n = 131) and validation (n = 88) sets. PGD was defined using modified ISHLT criteria. Proteomic profiling was performed using Olink panels (n = 354 proteins) with serum samples collected immediately prior to transplantation. Association between normalized relative protein expression and PGD was tested using univariate and multivariable (recipient age, creatinine, mechanical circulatory support, and sex; donor age; ischemic time) models. Significant proteins identified in the derivation set (p < 0.05 in univariate models), were then tested in the validation set. Pathway enrichment analysis was used to test candidate biological processes. The predictive performance of proteins was compared to that of the RADIAL score. RESULTS: Nine proteins were associated with PGD in univariate models in the derivation set. Of these, only CLEC4C remained associated with PGD in the validation set after Bonferroni correction (OR [95% CI] = 3.04 [1.74,5.82], p = 2.8×10(−4)). Patterns of association were consistent for CLEC4C in analyses stratified by biventricular/left ventricular and isolated right ventricular PGD. Pathway analysis identified interferon-alpha response and C-type lectin signaling as significantly enriched biologic processes. The RADIAL score was a poor predictor of PGD (AUC = 0.55). CLEC4C alone (AUC = 0.66, p = 0.048) and in combination with the clinical covariates from the multivariable model (AUC = 0.69, p = 0.018) improved discrimination for the primary outcome. CONCLUSIONS: Pre-transplantation circulating levels of CLEC4C, a protein marker of plasmacytoid dendritic cells (pDCs), may identify HT recipients at risk for PGD. Further studies are needed to better understand the potential role pDCs and the innate immune response in PGD.

Background Left ventricular assist devices (LVAD) are increasingly used for durable mechanical circulatory support in advanced heart failure. While LVAD therapy provides substantial improvement in mortality and quality of life, long-term therapy confers increased risk for device complications. We evaluated if cardiac computed tomography (CCT) improves the detection of cardiomechanical complications among patients with LVAD and suspected device malfunction. Methods In this study, we compared the diagnostic performance of CCT and transthoracic echocardiography (TTE) for the identification of cardiomechanical LVAD complications, including thrombus or neointimal hyperplasia, inflow cannula malposition with dynamic obstruction, fixed outflow obstruction, device infection, and severe aortic regurgitation. Complications were confirmed with surgical evaluation, pathologic assessment, or response to therapeutic intervention. Results Among 58 LVAD patients, who underwent CCT and TTE for suspected LVAD dysfunction, there were 49 confirmed cardiomechanical LVAD complications among 43 (74.1%) patients. The most common LVAD complication was thrombus or neointimal hyperplasia (65.3%), followed by dynamic obstruction (26.5%). Individually, CCT identified 29 of the 49 (59.2%) confirmed LVAD cardiomechanical complications, whereas TTE alone identified a complication in 11 cases (22.4%). However, diagnostic performance was greatest when the two modalities were used in combination, yielding a sensitivity of 67%, specificity of 93%, PPV of 97%, NPV of 47% and diagnostic accuracy of 73%. Conclusion The novel and complementary use of CCT with TTE for the evaluation of suspected device malfunction improves the accurate identification of cardiomechanical LVAD complication compared to either modality alone.

BACKGROUND: In the era of antiretroviral therapy, HIV-positive patients have reduced mortality from HIV infection and increased morbidity from end stage heart failure. The number of HIV-positive heart transplantation recipients remains scant. Long-term survival has not been rigorously studied. We compared survival outcomes of heart transplantation in HIV-positive recipients to HIV-negative recipients. METHODS: Clinical data from all adult heart transplantations were extracted from the UNOS Dataset. The impact of recipient HIV status was analyzed with Cox proportional hazards modeling, 1:3 propensity score matching and Kaplan-Meier survival analysis. RESULTS: Seventy-five HIV-positive recipients and 29,848 HIV-negative recipients were identified. Race distributions differed between the recipient groups, with Blacks comprising a larger proportion of the HIV-positive recipient group (46.7% versus 20.9%, p

OBJECTIVE: Conventional ultrafiltration (CUF) during cardiopulmonary bypass (CPB) serves to hemoconcentrate blood volume to avoid allogeneic blood transfusions. Previous studies have determined weight-indexed CUF volumes as a continuous variable are associated with postoperative AKI after cardiac surgery but optimal weight-indexed volumes that predict AKI have not been described. DESIGN: Retrospective cohort SETTING: Single-center university hospital PARTICIPANTS: 1,641 consecutive patients that underwent elective cardiac surgery between June 2013-December 2015. INTERVENTIONS: CUF volume was removed during CPB in all participants as part of our routine practice. We investigated the association of dichotomized weight indexed CUF volume removal with postoperative AKI development to provide pragmatic guidance for clinical practice at our institution. MEASUREMENTS AND MAIN RESULTS: Primary outcomes of postoperative AKI was defined by the KDIGO staging criteria and dichotomized, weight indexed CUF volumes (ml/kg) were defined by (i) extreme quartiles (Q3) and by (ii) Youden’s criterion that best predicted AKI development. Multivariable logistic regression models were developed to test the association of these dichotomized indices with AKI status. Postoperative AKI occurred in 827 patients (50.4%). Higher CUF volumes were associated with AKI development by quartiles (CUF >Q(3)=32.6 vs. CUF 32 mL/kg increased the risk for postoperative AKI development. Importantly, CUF volume removal of any amount did not mitigate allogeneic blood transfusion during elective cardiac surgery. Prospective studies are needed to validate these findings.

Whether to repair nonsevere tricuspid regurgitation (TR) during surgery for ischemic mitral valve regurgitation (IMR) remains uncertain.The goal of this study was to investigate the incidence, predictors, and clinical significance of TR progression and presence of ≥moderate TR after IMR surgery.Patients (n = 492) with untreated nonsevere TR within 2 prospectively randomized IMR trials were included. Key outcomes were TR progression (either progression by ≥2 grades, surgery for TR, or severe TR at 2 years) and presence of ≥moderate TR at 2 years.Patients' mean age was 66 ± 10 years (67% male), and TR distribution was 60% ≤trace, 31% mild, and 9% moderate. Among 2-year survivors, TR progression occurred in 20 (6%) of 325 patients. Baseline tricuspid annular diameter (TAD) was not predictive of TR progression. At 2 years, 37 (11%) of 323 patients had ≥moderate TR. Baseline TR grade, indexed TAD, and surgical ablation for atrial fibrillation were independent predictors of ≥moderate TR. However, TAD alone had poor discrimination (area under the curve, ≤0.65). Presence of ≥moderate TR at 2 years was higher in patients with MR recurrence (20% vs. 9%; p = 0.02) and a permanent pacemaker/defibrillator (19% vs. 9%; p = 0.01). Clinical event rates (composite of ≥1 New York Heart Association functional class increase, heart failure hospitalization, mitral valve surgery, and stroke) were higher in patients with TR progression (55% vs. 23%; p = 0.003) and ≥moderate TR at 2 years (38% vs. 22%; p = 0.04).After IMR surgery, progression of unrepaired nonsevere TR is uncommon. Baseline TAD is not predictive of TR progression and is poorly discriminative of ≥moderate TR at 2 years. TR progression and presence of ≥moderate TR are associated with clinical events. (Comparing the Effectiveness of a Mitral Valve Repair Procedure in Combination With Coronary Artery Bypass Grafting [CABG] Versus CABG Alone in People With Moderate Ischemic Mitral Regurgitation, NCT00806988; Comparing the Effectiveness of Repairing Versus Replacing the Heart's Mitral Valve in People With Severe Chronic Ischemic Mitral Regurgitation, NCT00807040).

The effects of stroke and delirium on postdischarge cognition and patient-centered health outcomes after surgical aortic valve replacement (SAVR) are not well characterized. Here, we assess the impact of postoperative stroke and delirium on these health outcomes in SAVR patients at 90 days.Patients (N = 383) undergoing SAVR (41% received concomitant coronary artery bypass graft) enrolled in a randomized trial of embolic protection devices underwent serial neurologic and delirium evaluations at postoperative days 1, 3, and 7 and magnetic resonance imaging at day 7. Outcomes included 90-day functional status, neurocognitive decline from presurgical baseline, and quality of life.By postoperative day 7, 25 (6.6%) patients experienced clinical stroke and 103 (28.5%) manifested delirium. During index hospitalization, time to discharge was longer in patients experiencing stroke (hazard ratio, 0.62; 95% confidence interval [CI], 0.42-0.94; P = .02) and patients experiencing delirium (hazard ratio, 0.68; 95% CI, 0.54-0.86; P = .001). At day 90, patients experiencing stroke were more likely to have a modified Rankin score2 (odds ratio [OR], 5.9; 95% CI, 1.7-20.1; P = .01), depression (OR, 5.3; 95% CI, 1.6-17.3; P = .006), a lower 12-Item Short Form Survey physical health score (adjusted mean difference -3.3 ± 1.9; P = .08), and neurocognitive decline (OR, 7.8; 95% CI, 2.3-26.4; P = .001). Delirium was associated with depression (OR, 2.2; 95% CI, 0.9-5.3; P = .08), lower 12-Item Short Form Survey physical health (adjusted mean difference -2.3 ± 1.1; P = .03), and neurocognitive decline (OR, 2.2; 95% CI, 1.2-4.0; P = .01).Stroke and delirium occur more frequently after SAVR than is commonly recognized, and these events are associated with disability, depression, cognitive decline, and poorer quality of life at 90 days postoperatively. These findings support the need for new interventions to reduce these events and improve patient-centered outcomes.

Many patients die while waiting for a heart transplant. Therefore, it is vital that all suitable organs are used for transplantation. We present a case of an allograft that was transplanted twice and outline considerations regarding tissue typing, the impact of repeated ischemic time, and ethical considerations with allograft retransplantation. (Level of Difficulty: Intermediate.), Central Illustration

This study sought to determine the indications, characteristics, and outcomes of cardiovascular implantable electronic device (CIED) surgery in patients with LVAD.Many patients with a left ventricular assist device (LVAD) will require implantable cardioverter-defibrillator generator change or device revision or are candidates for de novo implantable cardioverter-defibrillator implantation following LVAD implantation.We performed an observational retrospective study of all LVAD recipients who subsequently underwent CIED surgery at Duke University Hospital from 2009 to 2019.A total of 159 patients underwent CIED surgery following LVAD implantation, including generator change (n = 93), device revision (n = 38), and de novo implant (n = 28). The median (interquartile range) time from LVAD implantation to CIED surgery was 18.1 months (5.5 to 35.1 months). Pre-operative risk for infection was elevated in the overall cohort with a median (interquartile range) Prevention of Arrhythmia Device Infection Trial (PADIT) score of 7.0 (5.0 to 9.0). Pocket hematoma occurred in 21 patients (13.2%) following CIED surgery. Antimicrobial envelops were used in 43 patients (27%). Device infection due to CIED surgery occurred in 5 (3.1%) patients and occurred only in patients who developed post-operative pocket hematoma (p 0.001). Mortality at 1 year following CIED surgery was 20% (n = 32).CIED surgery following LVAD implantation is associated with an increased risk for pocket hematoma and CIED infection. Further studies are needed to determine the risk-benefit ratio of CIED surgery in patients with LVADs.

Background Sensitized candidates with unacceptable antigens are a group that demands special attention in organ transplantation. Calculated panel reactive antigen (cPRA) is not used to modify allocation priorities in lung transplantation. The impact of cPRA on waiting list time and mortality is unknown. Methods We performed a retrospective review of candidates for lung transplantation listed from May 2005 to 2018. Data from the Organ Procurement and Transplantation Network/United Network for Organ Sharing STAR (Standard Analysis and Research) dataset was paired with additional unacceptable human leukocyte antigen (UA-HLA) data, which were used to calculate the listing cPRA. Candidates were stratified based on the lack of UA-HLAs or cPRA level for candidates with unacceptable antigens reported. Unadjusted competing risks and adjusted subdistribution hazard models were fit. Results A total of 29,085 candidates met inclusion criteria for analysis. Of these, 23,562 (81%) with no UA-HLAs, 3472 (11.9%) with a cPRA less than 50, and 2051 with a cPRA greater than or equal to 50 (7.1%). On adjusted analysis, a cPRA greater than or equal to 50 was independently associated with increased waitlist mortality at 1 year (hazard ratio, 1.71; 95% confidence interval, 1.55-1.88; P Conclusions Further evaluation of organ allocation with consideration of a candidate's cPRA may be warranted in order to optimize equity in access to transplants.

Background An early report of recipient heart transplantation outcomes under the new U.S. heart allocation system introduced in late 2018 found a lower post-transplant survival rate compared with that of the prior system. Objectives The aim of this study was to examine recipient survival under the new system by using an updated dataset. Methods The 2015 to 2019 United Network for Organ Sharing registry was queried for adult heart transplant recipients, stratified according to whether the subjects were listed and underwent transplant before or after October 18, 2018, when the new allocation system was implemented. The association between allocation system and recipient mortality was analyzed by using the Kaplan-Meier method and multivariable Cox proportional hazards regression. Results A total of 7,119 recipients met inclusion criteria: 6,004 (84%) and 1,115 (16%) listed and undergoing transplant in the old and new allocation systems, respectively. This registry update included 576 new-system recipients, more than double the amount previously analyzed. Recipients from the new system were more likely to be bridged to transplant with temporary mechanical circulatory support devices instead of durable left ventricular assist devices and had longer graft ischemic times. After adjustment, the new system was not associated with poorer survival on Kaplan-Meier survival analysis (log-rank test; p = 0.075) or multivariable Cox proportional hazards modeling (adjusted hazard ratio: 1.18; 95% confidence interval: 0.90 to 1.55). Conclusions The short-term survival of recipients listed and receiving a transplant under the old and new allocation systems seems to be comparable. The modification to the allocation system has resulted in several changes to the clinical profiles of patients undergoing transplants that must be closely monitored in the coming years.

Objectives The goal of this study was to assess the utility of transvenous lead extraction for cardiovascular implantable electronic device (CIED) infection in patients with a left ventricular assist device (LVAD). Background The utility of transvenous lead extraction for the management CIED infection in patients with a durable LVAD has not been well described. Methods Clinical and outcomes data were collected retrospectively among patients who underwent lead extraction for CIED infection after LVAD implantation at Duke University Hospital. Results Overall, 27 patients (n = 6 HVAD; n = 15 HeartMate II; n = 6 Heartmate III) underwent lead extraction for infection. Median (interquartile range) time from LVAD implantation to infection was 6.1 (2.5, 14.9) months. Indications included endocarditis (n = 16), bacteremia (n = 9), and pocket infection (n = 2). Common pathogens were Staphylococcus aureus (n = 10), coagulase-negative staphylococci (n = 7), and Enterococcus faecalis (n = 3). Sixty-eight leads were removed, with a median lead implant time of 5.7 (3.6, 9.2) years. Laser sheaths were used in all procedures, with a median laser time of 35.0 (17.5, 85.5) s. Mechanical cutting tools were required in 11 (40.7%) and femoral snaring in 4 (14.8%). Complete procedural success was achieved in 25 (93.6%) patients and clinical success in 27 (100%). No procedural failures or major adverse events occurred. Twenty-one patients (77.8%) were alive without persistent endovascular infection 1 year after lead extraction. Most were treated with oral suppressive antibiotics after extraction (n = 23 [82.5%]). Persistent infection after extraction occurred in 4 patients and was associated with 50% 1-year mortality. Conclusions Transvenous lead extraction for LVAD-associated CIED infection can be performed safely with low rates of persistent infection and 1-year mortality.

Background Postoperative atrial fibrillation (POAF) frequently complicates cardiac surgery and is associated with worse outcomes. The cardiac autonomic nervous system is implicated in the pathogenesis of POAF. Objective The purpose of this study was to determine the efficacy and safety of selective cardiac autonomic modulation in preventing POAF. Methods In this randomized, double-blind, placebo-controlled trial, adults undergoing cardiac surgery were randomized 1:1 to intraoperative injection of 250 units onabotulinumtoxinA (botulinum toxin type A [BoNTA]) or placebo into epicardial fat pads. The study was powered to detect a 40% reduction in relative risk of POAF. Time to first episode of in-hospital POAF was the primary outcome, evaluated in patients receiving injection. Additionally, incidence of POAF, length of stay (LOS), and adverse events were examined. Results The trial assigned 145 patients to injection, 15 of whom were dropped before treatment, leaving 130 patients for analysis. Overall, 36.5% (23/63) of BoNTA-treated patients developed POAF compared with 47.8% (32/67) of placebo-treated patients. The time-to-event analysis revealed a hazard ratio of 0.69 (95% confidence interval 0.41–1.19; P = .18) for the BoNTA vs placebo arm. There were no significant differences in postoperative hospital LOS (median [interquartile range] 6.0 [3.4] vs 6.2 [3.7] days; P = .51) or adverse events prolonging LOS (27/63 [42.9%] vs 30/67 [44.8%]; P = .83) in patients receiving BoNTA vs placebo. Conclusion Epicardial injection of onabotulinumtoxinA was without discernible adverse effects, but we failed to detect a significant difference in risk of POAF. Future large-scale studies of epicardial onabotulinumtoxinA injection as a potential POAF prevention strategy should be designed to study smaller, but clinically meaningful, treatment effects.

Utilization of extracorporeal membrane oxygenation (ECMO) has increased dramatically over the last decade. Despite this trend, many medical centers have limited, if any, access to this technology or the resources necessary to manage these complex patients. In an effort to improve the current infrastructure of regional ECMO care, ECMO centers of excellence have an obligation to partner with facilities within their communities and regions to increase access to this potentially life-saving technology. While the need for this infrastructure is widely acknowledged in the ECMO community, few reports describe the actual mechanisms by which a successful interfacility transport program can operate. As such, the purpose of this document is to describe the elements of and methods for providing safe and efficient mobile ECMO services from the perspective of an experienced, high-volume tertiary ECMO center of excellence in the Southeastern United States.

Objectives The aim of this study was to prospectively evaluate the impact of blood pressure management on stroke rates in patients receiving the HeartWare HVAD System. Background The ENDURANCE trial demonstrated noninferiority of the HeartWare HVAD System versus control (HeartMate II) in patients with advanced heart failure ineligible for heart transplantation. However, stroke was more common in HVAD subjects. Post hoc analyses demonstrated increased mean arterial blood pressure as a significant independent risk factor for stroke. Methods The ENDURANCE Supplemental Trial was a prospective, multicenter evaluation of 465 patients with advanced heart failure ineligible for transplantation, randomized 2:1 to HVAD (n = 308) or control (n = 157). The primary endpoint was the 12-month incidence of transient ischemic attack or stroke with residual deficit 24 weeks post-event. Secondary endpoints included the composite of freedom from death, disabling stroke, and need for device replacement or urgent transplantation, as well as comparisons of stroke or transient ischemic attack rates in HVAD cohorts in ENDURANCE Supplemental and ENDURANCE. Results The enhanced blood pressure protocol significantly reduced mean arterial blood pressure. The primary endpoint was not achieved (14.7% with HVAD vs. 12.1% with control, noninferiority [margin 6%] p = 0.14). However, the secondary composite endpoint demonstrated superiority of HVAD (76.1%) versus control (66.9%) (p = 0.04). The incidence of stroke in HVAD subjects was reduced 24.2% in ENDURANCE Supplemental compared with ENDURANCE (p = 0.10), and hemorrhagic cerebrovascular accident was reduced by 50.5% (p = 0.02). Conclusions The ENDURANCE Supplemental Trial failed to demonstrate noninferiority of HVAD versus control regarding the pre-specified primary endpoint. However, the trial confirmed that BP management is associated with reduced stroke rates in HVAD subjects. HVAD subjects, relative to control subjects, more commonly achieved the composite endpoint (freedom from death, disabling stroke, and device replacement or urgent transplantation). (A Clinical Trial to Evaluate the HeartWare™ Ventricular Assist System [ENDURANCE SUPPLEMENTAL TRIAL] [DT2]; NCT01966458)

Purpose An increasing number of patients with end-stage heart failure are supported with left ventricular assist device (LVAD) implantation and must be maintained on a consistent anticoagulation regimen. Pre-emptive extraction of carious teeth in these patients is necessary to prevent seeding of the implanted device and endocarditis. Thus, the objective of this study was to evaluate bleeding complications after minor oral surgery, specifically teeth extractions, in this unique patient population requiring long-term anticoagulation. Materials and Methods This study was a retrospective single-center review. Adult patients supported on an implanted continuous-flow LVAD from January 1, 2007 to December 31, 2016 were included. Baseline characteristics were collected by retrospective chart review and the institutional LVAD registry. All extractions were performed in the operating room under local anesthesia with moderate sedation or general anesthesia with nasal intubation, and LVAD settings were monitored by a trained perfusionist. Preoperative and postoperative hematology laboratory values, such as hemoglobin and international normalized ratio (INR), were collected by chart review. Continuous variables were presented as mean ± standard deviation and compared using the Student t test. Categorical variables were presented as proportion and percentage and compared using the χ2 test or Fisher exact test as appropriate. Statistical significance was established at a P value less than .05. Results After screening 798 patients, 32 (4%) were found to have undergone dental extractions after LVAD implantation. The sample was composed of 32 patients with a mean age of 60.13 years and 81.25% were men. The average time from LVAD implantation to extraction was 445.19 ± 1,108.53 days. Average preoperative INR was 1.76 ± 0.47. Preoperative fresh frozen plasma was not administered to any patients. Twenty-eight patients (87.5%) were on Coumadin (warfarin) preoperatively. In 11 of these 28 patients (39.3%), Coumadin was held preoperatively. The average postoperative change in hemoglobin level was −0.79 ± 1.45. Only 1 patient (3%) required postoperative blood transfusion for a hemoglobin level of 7.6 that responded appropriately. There were no reoperations for bleeding. Conclusions Minor oral surgical procedures can be performed safely for patients being supported on LVAD therapy. With primary closure of the gingiva at the site of extraction, dental extractions can be performed without the full reversal of anticoagulation.

Changes in heart transplantation (HT) donor and recipient demographics may influence the incidence of primary graft dysfunction (PGD). We conducted a retrospective study to evaluate PGD incidence, trends, and associated risk factors by analyzing consecutive adult patients who underwent HT between January 2009 and December 2014 at our institution. Patients were categorized as having PGD using the International Society for Heart & Lung Transplantation (ISHLT)–defined criteria. Variables, including clinical and demographic characteristics of donors and recipients, were selected to assess their independent association with PGD. A time-trend analysis was performed over the study period. Three-hundred seventeen patients met inclusion criteria. Left ventricular PGD, right ventricular PGD, or both, were observed in 99 patients (31%). Risk factors independently associated with PGD included ischemic time, recipient African American race, and recipient amiodarone treatment. Over the study period, there was no change in the PGD incidence; however, there was an increase in the recipient pretransplantation use of amiodarone. The rate of 30-day mortality was significantly elevated in those with PGD versus those without PGD (6.06% vs 0.92%, P = .01). Despite recent advancements, incidence of PGD remains high. Understanding associated risk factors may allow for implementation of targeted therapeutic interventions.

Background Outcome of mitral valve replacement in extreme scenarios of small mitral annulus with the use of the Regent mechanical aortic valve is not well documented. Methods Records were examined in 31 consecutive patients who underwent mitral valve replacement with the use of the aortic Regent valve because of a small mitral annulus. Results Mean age was 60 ± 14 years. Mitral stenosis or mitral annulus calcification was present in 30 of 31 patients (97%). Concurrent procedures were performed in 17 of 31 patients (55%). Median valve size was 23 mm. Mean mitral gradient coming out of the operating room was 4.2 ± 1.5 mm Hg and at follow-up echocardiogram performed at a median of 32 months after the procedure was 5.8 ± 2.4 mm Hg. Conclusions A Regent aortic mechanical valve can be a viable option with a larger orifice area than the regular mechanical mitral valve in a problematic situation of a small mitral valve annulus. Moreover, the pressure gradients over the valve are acceptable intraoperatively and over time.

Background Primary outcomes analysis of the Multicenter Study of MagLev Technology in Patients Undergoing MCS Therapy With HeartMate 3 (MOMENTUM 3) trial short-term cohort demonstrated a higher survival rate free of debilitating stroke and reoperation to replace/remove the device (primary end-point) in patients receiving the HeartMate 3 (HM3) compared with the HeartMate (HMII). In this study we sought to evaluate the individual and interactive effects of pre-specified patient subgroups (age, sex, race, therapeutic intent [bridge to transplant/bridge to candidacy/destination therapy] and severity of illness) on primary end-point outcomes in MOMENTUM 3 patients implanted with HM3 and HMII devices. Methods Cox proportional hazard models were used to analyze patients enrolled in the “as-treated cohort” ( n = 289) of the MOMENTUM 3 trial to: (1) determine interaction of various subgroups on primary end-point outcomes; and (2) identify independent variables associated with primary end-point success. Results Baseline characteristics were well balanced among HM3 ( n = 151) and HMII ( n = 138) cohorts. No significant interaction between the sub-groups on primary end-point outcomes was observed. Cox multivariable modeling identified age (≤65 years vs >65 years, hazard ratio 0.42 [95% confidence interval 0.22 to 0.78], p = 0.006]) and pump type (HM3 vs HMII, hazard ratio 0.53 [95% confidence interval 0.30 to 0.96], p = 0.034) to be independent predictors of primary outcomes success. After adjusting for age, no significant impact of sex, race, therapeutic intent and INTERMACS profiles on primary outcomes were observed. Conclusions This analysis of MOMENTUM 3 suggests that younger age (≤65 years) at implant and pump choice are associated with a greater likelihood of primary end-point success. These findings further suggest that characterization of therapeutic intent into discrete bridge-to-transplant and destination therapy categories offers no clear clinical advantage, and should ideally be abandoned.

To determine the frequency and risk factors for non-home discharge (NHD) and its association with clinical outcomes and quality of life (QOL) at 1 year following cardiac surgery in patients with ischemic mitral regurgitation (IMR).Discharge disposition was evaluated in 552 patients enrolled in trials of severe or moderate IMR. Patient and in-hospital factors associated with NHD were identified using logistic regression. Subsequently, association of NHD with 1-year mortality, serious adverse events (SAEs), and QOL was assessed.NHD was observed in 30% (154/522) with 25% (n = 71/289) in moderate and 36% (n = 83/233) in patients with severe IMR (unadjusted P = .006), a difference not significant after including age (5-year change: adjusted odds ratio [adjOR], 1.52; 95% confidence interval [CI], 1.35-1.72; P .001), diabetes (adjOR, 1.94; 95% CI, 1.27-2.94; P = .002), and previous heart failure (adjOR, 1.64; 95% CI, 1.06-2.52; P = .03). Odds of NHD were increased for patients with postoperative SAEs (adjOR, 1.85; 95% CI, 1.19-2.86; P = .01) but not based on type of cardiac surgery. Greater rates of death and SAEs were observed in NHD patients at 1 year: adjusted hazard ratio, 4.29 (95% CI, 2.14-8.59; P .001) and adjusted rate ratio, 1.45 (95% CI, 1.03-2.02; P = .03), respectively. QOL did not differ significantly between groups.NHD is common following surgery for IMR, influenced by older age, diabetes, previous heart failure, and postoperative SAEs. These patients may be at greater risk of death and subsequent SAEs after discharge. Discussion of NHD with patients may have important implications for decision-making and guiding expectations following cardiac surgery.

Purpose Survival and the relative impact of adverse events after mechanical circulatory support may be different amongst white males (WM), black males (BM), white females (WF) and black females (BF). Methods Patients implanted with the HeartWareTM HVADTM System in the BTT/CAP, ENDURANCE and ENDURANCE Supplemental trials were assessed. Baseline characteristics, survival and adverse events were investigated and compared between WM, BM, WF and BF. Results There were 947 patients included: 60% WM, 16% BM, 15% WF and 9% BF. There were no differences in INTERMACS profile at implant. WM were more likely to be older, with more ischemic risk factors (smoking 70.0%, diabetes 46.7%, carotid disease 15.8%, ischemic HF 64.0%, MI 51.6%, CABG 32.9%). BM had a higher mean body mass index (29.2 kg/m2) and renal insufficiency (mean 1.5 mg/dL), while WF were least likely to be hypertensive (48.2%). Implant as DT was highest in WM 66.3% and lowest in WF 51.1%. According to 4-year adverse event rates per patient year (Figure 1A), WM had highest rates of gastrointestinal bleeds, ischemic stroke, and pump thrombosis, but lowest risk of right heart failure. WF had the lowest risk for driveline infection. Mean duration of support (months) was longest in BF 31.7 compared to WM 24.8, BM 29.4, and WF 25.8, p=0.007. However, BF had the best survival at two years and overall; WM had the worst survival. (Figure 1B) Conclusion In a large cohort of HVAD recipients, white men had the highest rates of gastrointestinal bleeding, pump thrombus, ischemic stroke and the worst survival. Black women had a significantly longer duration of support, but the highest survival, particularly in the first two years post-implant.

Programmed death-ligand 1 (PD-L1), a transmembrane protein and member of the CD28 T cell family is associated with lymphocyte activation.1 PD-L1 expression is upregulated on activated antigen presenting cells such as monocytes, myeloid and dendritic cells.2 When bound to its cognate receptor programmed cell death (PD-1), inhibition of immune responses including downregulation of T cell proliferation occurs.3 Mechanistically, such inhibition would be hypothetically favorable in the setting of a transplanted organ undergoing allograft rejection. However, there is a paucity of data addressing the role of PD-L1 and PD-1 expression in the human transplanted heart.

Objectives The authors sought to provide the pre-specified primary endpoint of the ROADMAP (Risk Assessment and Comparative Effectiveness of Left Ventricular Assist Device and Medical Management in Ambulatory Heart Failure Patients) trial at 2 years. Background The ROADMAP trial was a prospective nonrandomized observational study of 200 patients (97 with a left ventricular assist device [LVAD], 103 on optimal medical management [OMM]) that showed that survival with improved functional status at 1 year was better with LVADs compared with OMM in a patient population of ambulatory New York Heart Association functional class IIIb/IV patients. Methods The primary composite endpoint was survival on original therapy with improvement in 6-min walk distance ≥75 m. Results Patients receiving LVAD versus OMM had lower baseline health-related quality of life, reduced Seattle Heart Failure Model 1-year survival (78% vs. 84%; p = 0.012), and were predominantly INTERMACS (Interagency Registry for Mechanically Assisted Circulatory Support) profile 4 (65% vs. 34%; p Conclusions Survival on original therapy with improvement in 6-min walk distance was superior with LVAD compared with OMM at 2 years. Reduction in key adverse events beyond 1 year was observed in the LVAD group. The ROADMAP trial provides risk-benefit information to guide patient- and physician-shared decision making for elective LVAD therapy as a treatment for heart failure. (Risk Assessment and Comparative Effectiveness of Left Ventricular Assist Device and Medical Management in Ambulatory Heart Failure Patients [ROADMAP]; NCT01452802 )

Systemic right ventricle failure often develops in patients with dextro-transposition of the great arteries who have undergone atrial-level switch procedures. An adult with dextro-transposition of the great arteries with Mustard repair in childhood presented with end-stage heart failure due to systemic right ventricle failure, Mustard baffle leak, and unrepaired partial anomalous pulmonary venous return. She underwent device closure of the baffle leak by catheterization, followed by baffle revision and concomitant systemic ventricular assist device placement by adult and pediatric heart surgeons. This case demonstrates the importance of multidisciplinary collaboration between pediatric and adult heart failure specialists in caring for complex adult congenital heart patients.

Summary of Objectives This is a single-arm, non-randomized study designed to assess the preliminary safety and clinical performance of a novel ambulatory counterpulsation device. The device is an intra-aortic, counterpulsation blood pump delivered via axillary artery. The system includes a skin interface device facilitating patient ambulation and an external, portable drive unit allowing increased mobility and independence. This study will assess potential benefits to patients who have advanced heart failure and require additional circulatory support. This study will evaluate human factors, the clinical safety of the device, device failures, whether the device performs its intended purpose, patient characteristics that may impact device performance, and device use outside of the hospital. Methods Following a First-in-Human study of 14 patients, this feasibility study will enroll up to 86 implanted patients in up to 20 investigational sites for a total of 100 patients on device. To date, 71 of 100 patients have been implanted across 14 of 16 participating institutions. Endpoints The primary endpoint of this study is to assess survival to transplant or stroke-free survival at 30 days. The following secondary endpoints will also be evaluated at 30 days: number of patients who deteriorate requiring escalation of inotropic support and/or additional mechanical circulatory support; incidence of serious device-related adverse events; incidence of procedure-related adverse events; incidence of all adverse events; change in NYHA class from baseline; change in quality of life from baseline as measured by Kansas City Cardiomyopathy Questionnaire (KCCQ) - global assessment; change in Seattle Heart Failure Model Prognosis Score; change in six minute walk test and two minute step test from baseline. Subjects supported with the device past 30 days will continue to be followed and evaluated in the study until transplantation, device explant, alternative mechanical circulatory support or death. A Pivotal Trial with this device is expected to begin by the second quarter of 2020.

Purpose Cardiac gene therapy remains limited by inefficient transgene delivery with currently available methods (intravenous infusion, transcatheter coronary artery infusion, direct myocardial injection). We previously demonstrated in a porcine heterotopic heart transplant model that cardiac allograft gene transfer can be achieved using ex vivo perfusion with adenovirus (Ad). Adeno-associated viral (AAV) vectors generally achieve lower transgene expression compared to Ad. However, AAV vectors also achieve a significantly longer duration of expression, and thus are more suitable for therapies with genes that are effective even at lower levels but require prolonged expression. The purpose of this study is to evaluate whether ex vivo perfusion can also be used as a platform for cardiac allograft gene therapy using AAV. Methods Heart transplantation was performed using blood type-matched and swine leukocyte antigen-matched Yucatan mini pigs (n=2 transplants). Donor hearts received ex vivo perfusion for two hours with a perfusate including AAV vector bearing the firefly luciferase gene (dosed at 2 × 10^13 and 1 × 10^14 genome-containing vectors for transplants 1 and 2, respectively). The allograft was implanted heterotopically into the recipient abdomen. Recipients were survived for 30 days on oral immunosuppression and then euthanized. Transgene expression in allograft and native recipient tissues was assessed using a luciferase enzymatic assay, and transgene detection was performed using qPCR on DNA extracted using a modified Hirt protocol. Results Luciferase activity was detected in the allograft in both experiments. While luciferase activity was undetectable in the right and left atria and coronary arteries from the allograft exposed to the lower dose, the higher dose of AAV resulted in detectable luciferase activity throughout the entire heart and at high levels. Luciferase activity was undetectable in all recipient tissues (heart, lung, liver, spleen, and psoas muscle). Additionally, luciferase DNA was detectable on qPCR in allograft specimens (1.5-1.9 × 10^3 transgene copies per 100 ng of DNA). Conclusion Ex vivo perfusion can be used as a platform for cardiac allograft gene therapy using AAV vectors, with robust transgene expression detectable 30 days following transplant.

Purpose Inhaled pulmonary vasodilators (iPVD) are commonly used to lower PVR to modify the risk of acute RV failure in durable LVAD implantation or orthotopic heart transplantation (OHT). While inhaled nitric oxide (iNO) is the iPVD gold standard, inhaled epoprostenol (Veletri®) has been introduced as a cost-conscious alternative without high-grade evidence. Thus, we conducted an investigation to primarily determine if inhaled epoprostenol is equivalent to iNO in the ability to modify acute RVF after advanced heart failure therapies. Methods Our group has enrolled 232 patients (LVAD, N=100; OHT, N=132) in a triple-blinded (clinician, subject, statistician) randomized controlled trial conducted between May 2017-October 2020 (NCT03081052). Participants were grouped into strata according to key clinical prognostic features. Within each stratum, subjects were assigned either iNO or inhaled epoprostenol via 1:1 randomization. To assess equivalency between the two treatment arms for our primary outcome analysis, we will calculate absolute and relative risk estimates and corresponding confidence intervals (CI). If the CI do not contain the margin of difference (15%), then we will conclude there is sufficient evidence that the risk of the primary outcome in each treatment arm is similar. For each secondary outcome, we will construct univariable effect estimates and corresponding CI, which will allow for assessment of difference between treatment arms. In the case that patients have switched to the other treatment arm, we will perform an intent-to-treat (ITT) analysis without reclassifying treatment assignment. To verify ITT results, we will perform a per-protocol analysis. Endpoints Primary. LVAD: Moderate or Severe RVF (defined by INTERMACS, up to 21-days after surgery); OHT: PGD-RV treated with RVAD or VA-ECMO, up to 30-days after surgery. Secondary. Duration of postoperative mechanical ventilation, iPVD duration/cost, ICU and hospital lengths-of-stay, postoperative acute kidney injury, and 30-day mortality.

Purpose Models to identify those at high risk of primary graft dysfunction (PGD) after heart transplantation (HT) are lacking and the pathophysiology remains poorly understood. We sought to identify whether proteins reporting on immune activation and inflammation were associated with incident PGD. Methods Using the Olink platform, we performed proteomic profiling of pre-transplant serum samples from HT recipients. PGD was defined using modified ISHLT criteria. We tested the association between PGD and protein levels using logistic regression with adjustment for clinical covariates (recipient age, creatinine, MCS, and sex; donor age; ischemic time). Significant proteins (p Results The derivation cohort consisted of 157 adult HT recipients, among whom 47 had PGD. Eleven of 368 proteins were associated with PGD in unadjusted and adjusted models and were tested in a validation cohort of 62 patients. The strongest association in the derivation cohort was with CLEC4C (OR [95%CI] = 2.0 [1.4,3.1], p=5.4 × 10−4), which remained the most significant tested protein in the validation set (OR [95%CI] = 1.8 [0.9,3.8], p=0.10; p Conclusion CLEC4C, a marker of plasmacytoid dendritic cells (PDC) which play a pro-inflammatory role via IFN-α signaling, may identify HT recipients at the highest risk for PGD. Further studies are needed to better understand the potential role of PDCs in PGD.

Background Although primary graft dysfunction (PGD) is a leading cause of mortality and morbidity early post-heart transplant, relatively little is known regarding mechanisms involved in PGD development. Methods and Results We examined the relationship between cardiac troponin I (cTnI) concentrations in the preservation solution from 43 heart transplant procedures and the development of PGD. Donor hearts were flushed with cold preservation solution (University of Wisconsin [UW] or Custodiol) and stored in the same solution. cTnI concentrations were measured utilizing the i-STAT System and normalized to left ventricular mass. Recipient medical records were reviewed to determine PGD according to the 2014 ISHLT consensus conference. Nineteen patients developed PGD following cardiac transplantation. For both UW and Custodiol, normalized cTnI levels were significantly increased ( P = .031 and .034, respectively) for those cases that developed PGD versus no PGD. cTnI levels correlated with duration of ischemic time in the UW group, but not for the Custodiol group. Donor age and donor cTnI (obtained prior to organ procurement) did not correlate with preservation cTnI levels in either UW or Custodiol. Conclusions Increased preservation solution cTnI is associated with the development of PGD suggesting preservation injury may be a dominant mechanism for the development of PGD.

Background Heart failure (HF) is characterized by perturbations in energy homeostasis and metabolism. The reversibility and prognostic value of circulating markers associated with these changes remain unclear. Objectives This study sought to describe the metabolomic profiles of patients along the spectrum of systolic HF, determine their association with adverse outcomes in a clinical trial of HF, and evaluate whether identified metabolites change with treatment for end-stage systolic HF. Methods To assess association of metabolites with clinical outcomes, we evaluated a population of 453 chronic systolic HF patients who had been randomized to exercise training versus usual care. To assess change in metabolites with mechanical circulatory support, 41 patients with end-stage HF who underwent left ventricular assist device (LVAD) placement were studied. Targeted, quantitative profiling of 60 metabolites using tandem flow injection mass spectrometry was performed on frozen plasma samples obtained prior to randomization, as well as prior to and ≥90 days post-placement in the LVAD group. Principal components analysis was used for data reduction. Results Five principal components analysis–derived factors were significantly associated with peak V o 2 levels at baseline in fully adjusted models. Of these, factor 5 (composed of long-chain acylcarnitines) was associated with increased risk of all 3 pre-specified clinical trial outcomes: all-cause mortality/all-cause hospitalization, all cause-hospitalization, and cardiovascular death or cardiovascular hospitalization. Individual components of factor 5 were significantly higher in patients with end-stage HF prior to LVAD placement and decreased significantly post-implantation. Conclusions In chronic HF patients, circulating long-chain acylcarnitine metabolite levels were independently associated with adverse clinical outcomes and decreased after long-term mechanical circulatory support. These metabolites may serve as potential targets for new diagnostics or therapeutic interventions. (Exercise Training Program to Improve Clinical Outcomes in Individuals With Congestive Heart Failure; NCT00047437 )

Purpose We previously reported that heart transplant (HTx) recipients with pre-formed, anti-HLA antibodies at low titer had one-year survival that was comparable to patients without any anti-HLA antibodies. As a result, we defined unacceptable HLA antigens by MFI>1000 in serum at 1:16 dilution. The current study evaluates how pre-formed, low-titer, donor-specific antibodies (DSA) and positive crossmatch affect long term survival of HTx recipients. Methods Total 495 adult recipients transplanted at our center between Jan. 2007 and Dec. 2016 were studied. Prior to HTx, recipients had HLA antibody screening (FlowPRA) and specificity testing (LABScreen). Unacceptable HLA antigens were defined by MFI>1000 in serum at 1:16 dilution. Acceptable donors were selected by virtual crossmatch using the criteria above, and flow cytometry crossmatch (FCXM) was performed peri- or post-HTx. Recipients transplanted across low titer DSA, positive in undiluted serum but negative at 1:16 dilution, received peri-operative plasmapheresis. We used log-rank testing to evaluate survival in the following groups compared to their controls: (1) presence of any pre-formed HLA antibodies; (2) presence of pre-formed DSA; and (3) positive FCXM. Results Of 495 HTx recipients, 179 (36%) had pre-existing HLA antibodies, and their overall survival was not different from patients without HLA antibodies (p=0.883). However, median survival time was reduced in patients with pre-formed DSA (n=62), compared to DSA-negative recipients (n=117): 9.1 years (95% CI 3.52 to 14.65) vs. 10.9 years (95% CI 6.13 to 15.70); p=0.02. The survival rates for 1-, 3-, 5-year of DSA-negative recipients were 91.5%, 85.4% and 79.5%, and the DSA-positive recipients were 83.9%, 66.1% and 61.7%, respectively. Total 62 recipients had pre-HTx DSA. Among them, 26 had a positive FCXM (46%). The survival rates of FCXM-positive cases were lower than FCXM-negative cases (n=36) at 1, 3, and 5 years: 80.8%, 57.9%, 52.1% vs. 86.1%, 71.4%, 67.6%. Conclusion Our findings suggest that pre-formed DSA, even at low titer, negatively impacted HTx survival. Cases with positive FXCM had the worst outcomes. Avoiding all pre-formed DSA may improve survival for HTx patients, but may increase waitlist mortality. To improve the HTx survival, close post-transplant monitoring and proactive immunological management may be required when pre-formed DSA are present.

Purpose Significant tricuspid regurgitation (TR) in patients undergoing durable left ventricular assist device (LVAD) implantation has been associated with increased incidence of right heart failure (RHF). There is great surgical practice variability related to moderate TR repair at the time of LVAD implantation. In this single-center study, we investigated whether moderate TR repair concurrent with LVAD implantation has impact on late RHF occurrence. Methods We gathered data on adult patients undergoing durable LVAD implantation between 2009 and 2017. Only patients with moderate TR at the time of LVAD implantation constituted the study cohort. Patients were separated in two groups, concurrent tricuspid valve repair (TVr group) and no-TVr group. LateRHF was defined as any readmission for HF, requiring treatment with diuretics or inotropes or implantation of a right ventricular assist device. Unrepaired TR was categorized as improved if it was persistently graded as mild or less on post-operative echocardiographic studies. TVr failure was defined as moderate or severe TR on any post-operative echocardiographic study. Kaplan-Meier curves were used to analyze freedom from late RHF between the two groups. Results Out of 140 patients, 92 (65%) were in the TVr group. TVr failure was present in 35 (38%) of these patients. Out of the 48 patients in the no-TVr group, 22 (45%) experienced improvement of TR. Late RHF occurred in 12 (25%) patients in the no-TVr group and 35 (38%) patients in the TVr group. There was no event-free survival difference between the two groups (log rank p=0.678)(Figure). Conclusion In our study cohort, we found no benefit in concurrent TVr for moderate TR at LVAD implantation on late RHF occurrence. Moreover, 45% of the patients with unrepaired moderate TR experienced improvement of TR, while 38% of patients with TVr experienced repair failure. Future randomized studies should address and confirm these results.

Constrictive pericarditis occurs in less than 2% of patients after an episode of acute pericarditis. Up to 26% of patients with constrictive pericarditis are found to have an underlying malignancy. A 75 y/o male with recent acute pericarditis and pericardial window presented in cardiogenic shock.

Purpose Constrictive pericarditis has become an increasingly recognized long-term post-operative complication of lung transplantation. Heightened clinical suspicion, improved diagnostic imaging and effective surgical treatment of the disease have led to progressive awareness of the pathology. We present our institutional experience with constrictive pericarditis in an effort to investigate the etiology and natural history of the disease. Methods From October 2005 to October 2018, 1,234 patients underwent orthotopic lung transplantation at Duke University Hospital. A prospectively maintained institutional database was queried to identify incident patients and determine baseline clinical data. At a median of 13.8 months (IQR 4.6-124 months), 10 patients (0.8%) developed constrictive pericarditis. Simple descriptive statistics were used to describe cohort characteristics and identify variables associated with constrictive pericarditis after lung transplantation. Results The indication for transplantation at index operation was idiopathic pulmonary fibrosis in 9 of 10 patients (1.2% of the 760 restrictive lung disease patients transplanted in the same time period). All ten patients presented with worsening dyspnea and pleural effusions. Right heart catheterization confirmed constrictive physiology in all cases. Nine patients underwent pericardiectomy with improvement in cardiovascular hemodynamics and resolution of symptoms with no 30-day perioperative mortality. Conclusion Diagnosis of constrictive pericarditis should be considered in patients with new onset heart failure symptoms and/or recurrent pleural effusions within 2 years of lung transplantation. Idiopathic pulmonary fibrosis may be associated with increased risk for constrictive pericarditis. Pericardiectomy is a safe and effective treatment for post-transplant constrictive pericarditis.