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On June 3, 2021 Medtronic, Inc announced discontinuation of the HVAD left ventricular assist device. The purpose of this analysis was to provide summary data on surgical risks of HVAD to HeartMate 3 exchange and compare survival after HVAD to HeartMate 3 exchange to survival after primary HVAD implantation.Three cohorts within The Society of Thoracic Surgeons Intermacs database were identified: primary HVAD implant cohort (January 2017 to March 2021, n = 3797), HVAD to HeartMate 3 exchange cohort (December 2017 to March 2021, n = 45), and HVAD to HVAD exchange cohort (January 2017 to March 2021, n = 234). Mortality after HVAD to HeartMate 3 exchange was modeled and compared with the constant hazard phase for risk of mortality while on continued HVAD support. As a secondary analysis outcomes and survival were compared between patients who underwent HVAD to HeartMate 3 and HVAD to HVAD exchange.HVAD to HeartMate 3 exchange was associated with significantly reduced survival compared with survival while remaining on HVAD support (6 months after exchange, 73.8% [70% confidence interval, 68.6-77.8] vs 79.0% [70% confidence interval, 78.3-79] for continued HVAD support). Compared with HVAD to HVAD exchange, survival was higher after replacement with HeartMate 3 (1 year: 85.9% [70% confidence interval, 79.5-90.5] vs 66.6% [70% confidence interval, 63.0-70.0], P = .009).Compared with continued support on HVAD, an exchange to HeartMate 3 was found to be associated with a significant increase in mortality. For patients who required pump exchange on HVAD support, exchange to HeartMate 3 demonstrated superior survival. Currently there is insufficient evidence to support elective exchange from an HVAD to HeartMate 3.

Continuous-flow left ventricular assist devices (CF-LVAD) have been shown to enhance reverse remodeling and myocardial recovery in certain patients allowing for device removal. We sought to analyze the characteristics and describe outcomes of patients who underwent CF-LVAD explantation at a large academic center. We retrospectively identified all patients who underwent CF-LVAD explants due to recovery from 2006 to 2019. Patient baseline characteristics and data on pre- and postexplant evaluation were collected and analyzed. Of 421 patients who underwent CF-LVAD implantation, 13 underwent explantation (3.1%). Twelve HeartMate II and one HeartWare LVAD were explanted. All patients had nonischemic cardiomyopathy. Median time from heart failure diagnosis to LVAD implant was 12 months (interquartile range [IQR], 2-44) and the median time supported on LVAD was 22 months (IQR, 11-28). Two patients died within 30 days of explant. Three additional patients died during the follow-up period and all were noted to be nonadherent to medical therapy. After a mean follow-up duration of 5 years, overall survival was 52%. Mean pre-explant ejection fraction was 49%, which decreased at most recent follow-up to 32%. Mean pre-explant left ventricular internal diameter in diastole (LVIDD) was 4.37 cm and increased to 5.52 cm at most recent follow-up. Continuous-flow left ventricular assist device explantation is feasible and safe in select patients.

BACKGROUND The Society of Thoracic Surgeons (STS) Intermacs Registry represents a real-world data source of durable, left ventricular assist devices that can address knowledge gaps not informed through randomized clinical trials. We sought to compare survival with contemporary left ventricular assist device technologies using multiple analytic approaches to assess concordance of treatment effects and to validate prior STS Intermacs observations. METHODS Patients (≥19 years of age) enrolled into STS Intermacs between August 2017 and June 2019 were stratified by device type (continuous flow, centrifugal left ventricular assist device with hybrid levitation [CF-HL] or full magnetic levitation [CF-FML]). The primary outcome was 1-year survival assessed by 3 statistical methodologies (multivariable regression, propensity score matching, and instrumental variable analysis). RESULTS Of 4448 patients, 2012 (45.2%) received the CF-HL and 2436 (54.8%) received the CF-FML. One-year survival for the CF-FML was 88% vs 79% for the CF-HL (overall P < .001), with a hazard ratio for mortality of 3.18 for the CF-HL (P < .0001) after risk adjustment. With propensity score matching (n = 1400 each cohort), 1-year survival was 87% for the CF-FML vs 80% for the CF-HL, with a hazard ratio of 3.20 for mortality with the CF-HL (P < .0001) after risk adjustment. With an instrumental variable analysis, the probability of receiving the CF-HL was associated with a hazard ratio of 3.11 (P < .0001). CONCLUSIONS Statistical methodology using propensity score matching and instrumental variable analysis increased the robustness of observations derived from real-world data and demonstrates the feasibility of performing comparative effectiveness research using STS Intermacs. These analyses provide additional evidence supporting a survival benefit of the CF-FML vs CF-HL.

BACKGROUND: We hypothesized that long-term clinical and echocardiographic recovery of the impaired ventricle from pressure (aortic stenosis [AS]) and volume (aortic regurgitation [AR]) overload would be different after aortic valve replacement (AVR). METHODS: We compared the results of AVR in patients with a preoperative ejection fraction (EF) of 0.35 or less due to AS, AR, or mixed disease. We constructed a mixed-effects model of EF and left ventricular (LV) end-diastolic diameter (LVEDD) to understand ventricular recovery over the short- (in-hospital), intermediate- (3–6 months), and longer- (>24 months) terms. We sought to identify factors associated with clinical and echocardiographic recovery using multivariable analysis. RESULTS: Between July 2011 and 2017, 136 patients with a preoperative EF of 0.35 or less and severe AS (n = 83), severe AR (n = 18), or mixed AS and AR (n = 35) underwent AVR. There were 2 (1.5%) early deaths in the AS group. Survival at 1, 2, and 5 years did not differ between groups. Baseline EF did not differ between the groups but improved with markedly different trajectory and time course in the AS, AR, and mixed groups over time. LVEDD regressed in all patient cohorts, following a different pattern for AS and AR. Baseline EF and LVEDD predicted the long-term fate of the LV but did not determine survival. We identify factors associated with long-term survival. CONCLUSIONS: The pattern of LV recovery appears to be early in AS and delayed in AR. Baseline clinical factors, rather than echocardiographic status of the LV, appear to determine late survival.

In the setting of chronic primary mitral regurgitation, the benefit of mitral valve repair over replacement is well established. However, data comparing outcomes for mitral valve surgery for endocarditis is limited. We sought to determine whether mitral valve repair offers traditional advantages over replacement in the endocarditis population. Retrospective review of our institutional mitral valve database (N = 8,181) was performed between 1998 and 2019 for all adult patients undergoing isolated mitral valve surgery for endocarditis. Patients were stratified by mitral valve repair or replacement and propensity score matching was performed to adjust for differences in baseline characteristics and degree of valve damage. Overall, 267 surgeries (124 repair, 153 replacement) met inclusion criteria during the study period. Following propensity matching, the repair cohort was associated with shorter initial ventilator times (5.6 vs 7.9 hours, p = 0.05), shorter ICU (28 vs 52 hours, p = 0.03), and hospital lengths of stays (7 vs 11 days, p0.01). Thirty-day mortality (0% vs 2.1%, p = 0.01) and 10-year survival (88% vs 86%, p = 0.55) were similar between cohorts. Patients in the repair cohort were less likely to require repeat mitral valve intervention at our institution for recurrent endocarditis than those in the replacement cohort (0% vs 10.6%, p = 0.03). Mitral valve repair is safe, when feasible, in the setting of isolated native valve endocarditis and may provide patients faster recovery. Experienced mitral surgeons should approach this patient population with a "repair if feasible" methodology.

Background Because of ongoing shortages of donors for heart transplantation, the use of donor candidates whose availabilities are the result of drug overdoses (ODs) has become increasingly prevalent, even though these donors carry a high preponderance of the now curable hepatitis C virus (HCV). This study investigated temporal trends and regional variabilities in HVC-positive (HCV+) allograft use in heart transplantation and assessed the relationship between the use of HCV+ graft donors and the use of OD donors as well as assessing waitlist and post-transplant outcomes. Methods and Results A retrospective review of the United Network for Organ Sharing database assessed adults listed for heart transplantation. Patients were stratified both temporally into pre-HCV and HCV eras related to HCV+ graft use trends and regionally by degree of HCV+ allograft use. Regions of high HCV+ donor use were associated with an increase in OD donor access by 7.8% across eras compared to 0.4% in low HCV+ donor-use regions. One-year waitlist mortality decreased from 4.7% to 2.5% across eras in high HCV+ donor-use regions (P= 0.001) and remained roughly the same as before in low HCV+ donor-use regions (3.0% vs 2.4%; P= 0.244.). Post-transplant survival at 1 year remained similar across eras. Conclusions HCV+ donor allograft use can help to optimize donor use, decreasing waitlist mortality without compromising early survival. Ongoing assessment is essential to ensure long-term safety and efficacy of using HCV+ donors.

BACKGROUND Predicted heart mass (PHM) is currently the most reliable metric for donor-recipient size matching in heart transplantation. Undersizing PHM donor-recipient match more than 20% independently predicts reduced survival. However, it is unclear if this is the case in obese recipients, in whom size matching can be challenging. We examined the use of PHM undersized hearts in obese recipients and assessed its impact on survival. METHODS The United Network for Organ Sharing database was queried for adult patients undergoing heart transplantation from 1995 to 2020. Obese recipients (BMI ≥ 30) were categorized based on donor-recipient PHM match ≤-20% (undersized) or >-20% (size-matched). Nearest-neighbor propensity score matching was performed to adjust for baseline differences between cohorts. Temporal outcomes were compared by Kaplan-Meier survival analysis. RESULTS A total of 13,668 obese recipients met inclusion criteria, with 9.6% receiving undersized and 90.4% receiving size-matched hearts. The proportion of undersized donor hearts in obese recipients significantly decreased over the study period (16.2% [1995] to 7.4% [2019], NP-trend < 0.001). Propensity-score matching resulted in 984 well-matched pairs of undersized and size-matched obese recipients. Recipients of undersized hearts saw similar 30-day mortality (5.5% vs 6.0%, p= 0.11) and re-transplantation rates (1.2% vs 1.2%, p = 1.00) as size-matched recipients. Survival at 1 year (88.4% vs 87.9%, p = 0.14), and 15 years (35.1% vs 31.0%, p = 0.12) was similar across cohorts. CONCLUSIONS A decreasing proportion of PHM undersized hearts are being utilized in obese recipients. However, utilizing PHM undersized hearts in obese recipients was not associated with a detriment in survival.

Cardiogenic shock represents a very challenging patient population due to the undifferentiated pathologies presenting as cardiogenic shock, difficult decision-making, prognostication, and ever-expanding support options. The role of cardiac surgeons on this team is evolving. The implementation of a shock team is associated with improved outcomes in patients with cardiogenic shock. Early deployment of mechanical circulatory support devices may allow an opportunity to rescue these patients. Cardiothoracic surgeons are a critical component of the shock team who can deploy timely mechanical support and surgical intervention in selected patients for optimal outcomes.

PURPOSE OF REVIEW There is a critical shortage of organs in cardiac transplantation. Recent advancements in both organ allocation and donor utilization have intended to address this shortage and optimally allocate allografts. This review evaluates several important aspects of recipient and donor management. For recipients, the focus is placed on the evolving mechanical circulatory support population and its bidirectional impact on organ allocation. From the donor standpoint, organ utilization is assessed with respect to increasing access to previously unused allografts. RECENT FINDINGS Implementation of the new heart allocation system in the United States has better stratified waitlist candidates by illness acuity. Compared to the prior system, those requiring venoarterial extracorporeal membrane oxygenation support are less likely to die on the waitlist, although conflicting data exists whether this has improved their posttransplant survival. The use of pretransplant intra-aortic balloon pumps has markedly increased, whereas transplantation of patients with dischargeable left ventricular assist devices has decreased. Although some studies have reported inferior short- to mid-term posttransplant survival in the new system compared to its predecessor, others report similar outcomes.Several recent advancements in donor utilization have also been noted. Coinciding with the global increase in drug overdose deaths, efforts have been made to increase use of these donors who are frequently considered 'increased risk' and are hepatitis C-positive. Grafts from these donors appear safe to use. These, alongside donation after circulatory death donors, represent potentially underutilized populations that may effectively expand the donor pool. SUMMARY Recent changes in organ allocation, alongside efforts to expand the donor pool, have attempted to improve cardiac allograft utilization and reduce the imbalance between organ supply and demand. Ongoing monitoring and continuous re-evaluation of these efforts will help guide future practice.

Extracellular vesicles (EV) that are derived from endothelial progenitor cells (EPC) have been determined to be a novel therapy for acute myocardial infarction, with a promise for immediate “off-the-shelf” delivery. Early experience suggests delivery of EVs from allogeneic sources is safe. Yet, clinical translation of this therapy requires assurances of both EV stability following cryopreservation and absence of an adverse immunologic response to EVs from allogeneic donors. Thus, more bioactivity studies on allogeneic EVs after cold storage are necessary to establish quality standards for its widespread clinical use. Thus, in this study, we aimed to demonstrate the safety and efficacy in delivering cryopreserved EVs in allogeneic recipients as a therapy for acute myocardial infarction. In this present study, we have analyzed the cardioprotective effects of allogeneic EPC-derived EVs after storage at −80°C for 2 months, using a shear-thinning gel (STG) as an in vivo delivery vehicle. EV size, proteome, and nucleic acid cargo were observed to remain steady through extended cryopreservation via nanoparticle tracking analysis, mass spectrometry, and nanodrop analysis, respectively. Fresh and previously frozen EVs in STG were delivered intramyocardially in a rat model of myocardial infarction (MI), with both showing improvements in contractility, angiogenesis, and scar thickness in comparison to phosphate-buffered saline (PBS) and STG controls at 4 weeks post-MI. Pathologic analyses and flow cytometry revealed minimal inflammatory and immune upregulation upon exposure of tissue to EVs pooled from allogeneic donor cells. Allogeneic EPC-EVs have been known to elicit minimal immune activity and retain therapeutic efficacy after at least 2 months of cryopreservation in a post-MI model.

The use of ventricular assist devices (VADs) as a bridge to heart transplant (HT) is increasing, while HT volume remains stagnant. This may portend longer waiting times and an otherwise more competitive environment for all patients on the HT waiting list. A retrospective analysis of patients who were listed for HT in the United Network for Organ Sharing (UNOS) database from 2000 to 2015 was conducted. Mean waiting time, proportion of HT reception (%HT), proportion of death (%death), and proportion of waiting list removal (%removal) were calculated across three eras: Era 1 (2000-2007), Era 2 (2008-2011), and Era 3 (2012-2015). During the study period, 29 728 patients successfully underwent HT. 19 127 (64.3%) were directly transplanted (direct HT); 4491 (15.1%) received VADs prior to listing as a bridge to decision (BTD); and 4593 (15.5%) received VADs after listing as a bridge to transplant (BTT). Across the three eras, the average number of registrants per year grew. Among all groups, waiting time increased across the eras. %HT generally decreased in the BTD and BTT groups but remained constant in the direct HT group. %removal increased, while %death decreased in all group across the eras. Waiting time for HT increased from 2000 to 2015. Patients with VADs as a bridge strategy experienced decreasing %HT and increasing %removal but stable survival. Improvements in VAD safety and durability will ensure their success as part of a bridge strategy to HT under the new UNOS allocation policy.

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).

Many single ventricle patients palliated with the Fontan operation suffer from Fontan failure and progressive liver disease. Combined heart-liver transplantation is a rarely utilized and complex transplant strategy available for select Fontan patients. At the Hospital of the University of Pennsylvania, all Fontan patients deemed eligible for a heart transplantation undergo a combined sequential dual organ transplantation with same-donor organs. This article describes the techniques utilized as well as current results.

Aims Perioperative blood transfusions are common among patients undergoing left ventricular assist device (LVAD) implantation. The association between blood product transfusion at the time of LVAD implantation and mortality has not been described. Methods and results This was a retrospective cohort study of all patients who underwent continuous flow LVAD implantation at a single, large, tertiary care, academic centre, from 2008 to 2014. We assessed used of packed red blood cells (pRBCs), platelets, and fresh frozen plasma (FFP). Outcomes of interest included all‐cause mortality and acute right ventricular (RV) failure. Standard regression techniques were used to examine the association between blood product exposure and outcomes of interest. A total of 170 patients were included in this study (mean age: 56.5 ± 15.5 years, 79.4% men). Over a median follow‐up period of 11.2 months, for every unit of pRBC transfused, the hazard for mortality increased by 4% [hazard ratio (HR) 1.04; 95% CI 1.02–1.07] and odds for acute RV failure increased by 10% (odds ratio 1.10; 95% CI 1.05–1.16). This association persisted for other blood products including platelets (HR for mortality per unit 1.20; 95% CI 1.08–1.32) and FFP (HR for mortality per unit 1.08; 95% CI 1.04–1.12). The most significant predictor of perioperative blood product exposure was a lower pre‐implant haemoglobin. Conclusions Perioperative blood transfusions among patients undergoing LVAD implantation were associated with a higher risk for all‐cause mortality and acute RV failure. Of all blood products, FFP use was associated with worst outcomes. Future studies are needed to evaluate whether pre‐implant interventions, such as intravenous iron supplementation, will improve the outcomes of LVAD candidates by decreasing need for transfusions.

Background Impella (Abiomed Inc, Danvers, MA) is a temporary mechanical support device positioned across the aortic valve, and can be used to support patient before LVAD implantation. There are no data on the incidence of aortic insufficiency (AI) in patients supported with Impella as a bridge to durable LVAD implantation. We sought to assess the incidence of AI in patients with Impella support as a bridge to durable left ventricular assist device (LVAD) implantation. Methods We reviewed all patients undergoing primary LVAD implantation at the University of Pennsylvania from January 2015 onward, comparing those supported with Impella as temporary mechanical support with those supported by either venoarterial extracorporeal life support or an intra-aortic balloon pump. We reviewed transthoracic echocardiography preoperatively, as well as at 1 week, 1, 3, 6, 9, and 12 months after LVAD implantation. Results A total of 215 echocardiograms were analyzed in 41 patients. Eleven patients were supported with Impella before LVAD implant—6 patients with Impella alone (5 with Impella CP, 1 with Impella 5.0) and 5 with Impella in conjunction with venoarterial extracorporeal life support (2 with Impella 2.5, 2 with Impella CP, and 1 with Impella 5.0). After LVAD implant, mild or moderate AI developed in 82% of patients supported with Impella (9 of 11) compared with 43% of those without Impella (13 of 30) (P = .038). Conclusions Patients supported by Impella as a bridge to durable LVAD have a higher risk of developing AI. Further studies are needed to assess this risk as the use of the Impella increases.

Purpose: We sought to assess the relationship of intraoperative perfusion parameters while on cardiopulmonary bypass, including oxygen delivery (DO2), to the need for ECMO following orthotopic heart transplantation (OHT). Methods: We included all adult (>18 years old) OHTs performed at our institution since implementation of an electronic perfusion record (March 2019-February 2020). Multi-organ transplants were excluded. The primary outcome was the need for immediate venoarterial ECMO in the OR following OHT. Univariable statistics were computed across demographic, clinical, operative, and perfusion variables, including oxygen delivery (DO2) measured each minute. Results: Fifty-three OHT were included with a median age of 54 years (interquartile range, 45-61). The primary outcome occurred in eight patients (15.1%). A significantly greater proportion of patients requiring ECMO had ischemic cardiomyopathy (50.0% (4/8) vs. 15.6% (7/45), p = 0.02) and had preoperative ventricular assist devices (37.5% (3/8) vs. 8.9% (4/45), p = 0.03). Median bypass times were longer in the ECMO group (217 vs. 147 minutes, p = 0.001). Phenylephrine doses were nonsignificantly higher in ECMO patients (4.1 vs. 1.9 mg, p = 0.10). No significant differences were observed in single-point median DO2 (275 vs. 294 mL O2/min/m2 BSA, p = 0.17) and nadir DO2 (226 vs. 222, p = 0.94), but increasing time and depth of DO2 below a threshold of 300 mL O2/min/m2 BSA (i.e. area over the DO2 curve (AOC) but below threshold) was significantly associated with the need for postoperative ECMO (p = 0.04). Conclusion: This is the first study to examine the relationship of perfusion parameters, including oxygen delivery, to outcomes following heart transplantation. We note that DO2 2 differences in patients who require post-OHT ECMO reflect vasoplegia, or a more causative relationship which might be leveraged to improve outcomes.

In the setting of the current novel coronavirus pandemic, this document has been generated to provide guiding statements for the adult cardiac surgeon to consider in a rapidly evolving national landscape. Acknowledging the risk for a potentially prolonged need for cardiac surgery procedure deferral, we have created this proposed template for physicians and interdisciplinary teams to consider in protecting their patients, institution, and their highly specialized cardiac surgery team. In addition, recommendations on the transition from traditional in-person patient assessments and outpatient follow-up are provided. Lastly, we advocate that cardiac surgeons must continue to serve as leaders, experts, and relevant members of our medical community, shifting our role as necessary in this time of need.

Background Heart transplant volume varies significantly among centers. We hypothesized that centers where the transplant team routinely accepts organs previously declined by other centers and where operating room availability is unrestricted have higher transplant volumes. Methods and Results We used the potential transplant recipient sequence number in the United Network for Organ Sharing database as a surrogate for graft acceptance threshold and the number of transplantations occurring on weekends and 8 major holidays as a marker of center resource availability. Centers were classified as low-, medium-, or high-volume if the average annual number of transplants were, respectively, 30 over a 10-year period. From July 12, 2006, to December 31, 2015, 19,054 transplants were performed by 142 centers. There were 59 low-volume centers, 69 medium-volume centers, and 14 high-volume centers with median potential transplant recipient sequence numbers for transplanted candidates of 7 (interquartile range 3–11), 7 (5–10), and 15 (7–40), respectively (P = .002). The median proportion of off-hours transplantations performed by medium-volume centers was 28% (25%–31%) compared with 32% (29%–33%) by high-volume centers (P = .009). Five-year survival was equivalent among all centers (P = .053). Conclusions Transplants for candidates with high sequence numbers and unrestricted operating room availability are associated with increased center volume without sacrificing post-transplantation survival.

Postsurgical readmissions are an increasingly scrutinized marker of health care quality. We sought to estimate the risk factors and costs associated with readmissions after mitral valve (MV) surgery in a large, nationally representative cohort.Adult patients undergoing MV repair or replacement were queried from the National Readmissions Database from 2010 to 2014. Data were collected on the prevalence and indications for readmission within 30 days as well as the hospital-, procedure, and patient-level risk factors as determined by multivariable logistic regression.Among 76,342 patients undergoing MV surgery, the rate of 30-day readmission was 17.0%. Those undergoing replacement procedures had significantly higher readmission rates (20.7% vs 13.1%; P.001) compared with repair. Significant independent predictors of readmission after both MV repair and replacement included length of stay ≥8 days, chronic lung disease, chronic renal disease, and low hospital procedural volume for MV surgery. Readmissions to nonindex hospitals accounted for 26.6% of all readmissions. The most common indications for readmission were heart failure (21.4%), arrhythmia (17.0%) and respiratory diagnoses (15.0%), and infections (10.2%). The mean cost per readmission was $15,397, and among readmitted patients, the cost of readmission accounted for 17.8% of the total cost of the episode of care.Nearly 1 in 5 patients undergoing MV surgery are readmitted within 30 days. Treatment at a low-volume center was strongly associated with readmission, and much of the readmission burden falls on nonindex hospitals. Further characterization of readmissions may improve the quality of care associated with MV surgery.

The topic of extracorporeal life support (ECLS) for COVID-19 patients was also heavily addressed by a panel of experts including Dr Daniel Brodie and Dr Cara Agerstrand from Columbia University, Dr Amy Hackmann from UT Southwestern, Dr Jacob Klapper from Duke University, and Dr Asif Mustafa from Rush University This study found that post-October 2018 significantly more transplant patients received temporary MCS (31 1% vs 11 5%) and that these patients were more likely to be transplanted during their listing window than prior to the policy change (87% vs 64%) Of the nearly 5000 patients in the STS INTERMACS database who received HM3 with a median follow-up of 9 months, patients were stratified by MOMENTUM 3 trial eligibility criteria [Extracted from the article] Copyright of Artificial Organs is the property of Wiley-Blackwell and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission However, users may print, download, or email articles for individual use This abstract may be abridged No warranty is given about the accuracy of the copy Users should refer to the original published version of the material for the full abstract (Copyright applies to all Abstracts )

BACKGROUND: There is limited data to inform minimum case requirements for training in robotically assisted coronary artery bypass grafting (RA-CABG). Current recommendations rely on nonclinical endpoints and expert opinion. OBJECTIVES: To determine the minimum number of RA-CABG procedures required to achieve stable clinical outcomes. METHODS: We included isolated RA-CABG in the Society of Thoracic Surgeons (STS) registry performed between 2014 and 2019 by surgeons without prior RA-CABG experience. Outcomes were approach conversion, reoperation, major morbidity or mortality, and procedural success. Case sequence number was used as a continuous variable in logistic regression with restricted cubic splines with fixed effects. Outcomes were compared between operations performed earlier versus later in case sequences using unadjusted and adjusted metrics. RESULTS: There were 1195 cases performed by 114 surgeons. A visual inflection point occurs by a surgeon’s 10th procedure for approach conversion, major morbidity or mortality, and overall procedural success after which outcomes stabilize. There was a significant decrease in the rate of approach conversion (7.7% and 2.5%), reoperation (18.9% and 10.8%), and major morbidity or mortality (21.7% and 12.9%), as well as an increase in the rate of procedural success (72.9% and 85.3%) with increasing experience between groups. In a multivariable logistic regression model, case sequences of >10 were an independent predictor of decreased approach conversion (odds ratio [OR]: 0.27; 95% confidence interval [CI]: 0.09-0.84) and increased rate procedural success (OR: 1.96; 95% CI: 1.00-3.84). CONCLUSIONS: The learning curve for RA-CABG is initially steep, but stable clinical outcomes are achieved after the 10th procedure.

Older patients (aged 60 years or more) awaiting heart transplant often have comorbidities that may limit overall survival independent of cardiac status. We hypothesized that these comorbidities have a more-limiting impact on survival than age of donor heart and that older allografts might be utilized in these patients without compromising outcomes.We identified all transplant recipients aged more than 60 years in the United Network for Organ Sharing database. Local regression analysis detected the point above which increasing donor age incurred increasing risk of mortality, above and below which two cohorts were defined. Kaplan-Meier analysis compared cumulative 5-year survival between groups. Cox proportional hazard modeling was then used to determine the hazards of death in the two groups.An inflection point in posttransplant survival was detected near donor age 50 years. Of 14,113 older recipients studied, 86% received younger donor hearts (less than 50 years of age), and 14% received advanced age allografts (50 years of age or more). Baseline characteristics were comparable between groups except more recipients had left ventricular assist devices at time of transplant in the younger donor group (15% versus 9%, p 0.001). Five-year survival was significantly lower among recipients receiving advanced age hearts compared with those receiving younger hearts (67% versus 73%, log rank p0.001). Adjusting for relevant recipient baseline characteristics, patients receiving advanced age hearts were 30% more likely to die by 5 years compared with patients receiving younger hearts.Transplant recipients aged 60 years and more who receive advanced age donor hearts (50 years or more) have a significantly increased risk of mortality. With careful allograft selection, use of donor hearts to age 50 may be acceptable among older transplant recipients.

Ventricular assist device has rapidly emerged as a durable and safe therapy for end-stage heart failure patients with >22 000 implantations to date. Though originally conceived for bridge-to-transplant indication, significant advancements in medical management as well as technology with arrivals of newer generation devices have improved patient outcomes, leading to increasing use as destination therapy. Despite such improvement, however, the burden of adverse events remains significant and defines the most pressing issue in the current state of ventricular assist device therapy. Eventual use of ventricular assist device technology as a comparable alternative to heart transplantation will ultimately rely on our ability to mitigate these risks. Therefore, this review article provides the narrative surrounding the rapid integration of this technology into the heart failure paradigm, specifically in the context of the most recent data on its outcomes and adverse event profiles. It describes ongoing investigations and general trends that may have significant implications for future improvements in device-related outcomes, as the field continues to grow as the epitome of synergy between advancements in engineering and clinical medicine.

Background COVID-19 continues to inflict significant morbidity and mortality, particularly on patients with preexisting health conditions. The clinical course, outcomes, and significance of immunosuppression regimen in heart transplant recipients with COVID-19 remains unclear. Methods We included the first 99 heart transplant recipients at participating centers with COVID-19 and followed patients until resolution. We collected baseline information, symptoms, laboratory studies, vital signs, and outcomes for included patients. The association of immunosuppression regimens at baseline with severe disease were compared using logistic regression , adjusting for age and time since transplant. Results The median age was 60 years, 25% were female, and 44% were white. The median time post-transplant to infection was 5.6 years. Overall, 15% died, 64% required hospital admission, and 7% remained asymptomatic. During the course of illness, only 57% of patients had a fever, and gastrointestinal symptoms were common. Tachypnea , oxygen requirement, elevated creatinine and inflammatory markers were predictive of severe course. Age ≥ 60 was associated with higher risk of death and the use of the combination of calcineurin inhibitor , antimetabolite , and prednisone was associated with more severe disease compared to the combination of calcineurin inhibitor and antimetabolite alone (adjusted OR = 7.3, 95% CI 1.8-36.2). Among hospitalized patients, 30% were treated for secondary infection, acute kidney injury was common and 17% required new renal replacement therapy . Conclusions We present the largest study to date of heart transplant patients with COVID-19 showing common atypical presentations and a high case fatality rate of 24% among hospitalized patients and 16% among symptomatic patients.

Durable left ventricular assist devices (LVAD) are frequently complicated by driveline infection. The objective of this case series was to examine whether an association exists between driveline infection and intracranial hemorrhage. This retrospective case series included patients at a single tertiary care hospital on durable LVAD support who developed intracranial hemorrhage. Physical examination data, vital signs, and laboratory markers of sepsis including blood cultures and imaging of driveline sites were reviewed. A total of nine patients were included in the case series. At the time of hemorrhagic event, five patients had active driveline infection, and five patients were found to be bacteremic. All bacteremic patients were found to have supratherapeutic INR at the time of presentation. Although five patients experienced subarachnoid hemorrhage, only one patient was found to have a cerebral aneurysm. This case series highlights a possible association between LVAD driveline infection and intracranial hemorrhage, and the need for further research to better understand the pathophysiology driving this association.

Background The opioid epidemic has seen a drastic increase in the incidence of drug-associated infective endocarditis (IE). No clinical tool exists to predict operative morbidity and mortality in patients undergoing surgery. Methods A multi-institutional database was reviewed between 2011 and 2018. Multivariate logistic regression was fitted in an automated stepwise fashion. The STratification risk analysis in OPerative management of drug-associated IE (STOP) score was constructed. Morbidity was defined as reintubation, prolonged ventilation, pneumonia, renal failure, dialysis, stroke, reoperation for bleeding, and a permanent pacemaker. Cross-validation provided an unbiased estimate of out-of-sample performance. Results A total of 1181 patients underwent surgery for drug-associated IE (median age, 39; interquartile range [IQR], 30-54, 386 women [32.7%], 341 reoperations for prosthetic valve endocarditis [28.9%], 316 patients with multivalve disease [26.8%]). Operative morbidity and mortality were 41.1% and 5.9%, respectively. Predictors of morbidity were dialysis (95% confidence interval [CI], 1.16-2.82), emergent intervention (1.83-4.73), multivalve procedure (1.01-1.98), causative organisms other than Streptococcus (1.09-2.02), and type of valve procedure performed [aortic valve procedure (1.07-2.15), mitral valve replacement (1.03-2.05), tricuspid valve replacement (1.21-2.60)]. Predictors of mortality were dialysis (1.29-5.74), active endocarditis (1.32-83), lung disease (1.25-5.43), emergent intervention (1.69-6.60), prosthetic valve endocarditis (1.24-3.69), aortic valve procedure (1.49-5.92) and multivalve disease (1.00-2.95). Variables maximizing explanatory power were translated into a scoring system. Each point increased odds of morbidity and mortality by 22.0% and 22.4% with an accuracy of 94.0% and 94.1%, respectively. Conclusion Drug-related IE is associated with significant morbidity and mortality. An easily-applied risk stratification score may aid in clinical decision-making.

There are limited data describing the prevalence of mental health disorders (MHDOs) in patients with ventricular assist devices (VADs), or associations between MHDOs and resource use or outcomes. We used the Nationwide Emergency Department Sample administrative database to analyze 44,041 ED encounters for VAD-supported adults from 2010 to 2017, to assess the relationship between MHDOs and outcomes in this population. MHDO diagnoses were present for 23% of encounters, and were associated with higher charges and rates of admission, but lower mortality.

Background With a growing population of patients supported by ventricular assist devices (VADs) and the improvement in survival of this patient population, understanding the healthcare system burden is critical to improving outcomes. Thus, we sought to examine national estimates of VAD‐related emergency department (ED) visits and characterize their demographic, clinical, and outcomes profile. Additionally, we tested the hypotheses that resource use increased and mortality improved over time. Methods and Results This retrospective database analysis uses encounter‐level data from the 2010 to 2017 Nationwide Emergency Department Sample. The primary outcome was mortality. From 2010 to 2017, >880 million ED visits were evaluated, with 44 042 VAD‐related ED visits identified. The annual mean visits were 5505 (SD 4258), but increased 16‐fold from 2010 to 2017 (824 versus 13 155). VAD‐related ED visits frequently resulted in admission (72%) and/or death (3.0%). Median inflation‐adjusted charges were $25 679 (interquartile range, $7450, $63 119) per encounter. The most common primary diagnoses were cardiac (22%), and almost 30% of encounters were because of bleeding, stroke, or device complications. From 2010 to 2017, admission and mortality decreased from 82% to 71% and 3.4% to 2.4%, respectively ( P for trends Conclusions We present the first study using national‐level data to characterize the growing ED resource use and financial burden of patients supported by VAD. During the past decade, admission and mortality rates decreased but remain substantial; in 2017 ≈1 in every 40 VAD ED encounters resulted in death, making it critical that clinical decision–making be optimized for patients with VAD to maximize good outcomes.

Comprehensive information on the characteristics of surgical heart valves (SHVs) is essential for optimal valve selection. Such information is also important in assessing SHV function after valve replacement. Despite the existing regulatory framework for SHV sizing and labelling, this information is challenging to obtain in a uniform manner for various SHVs. To ensure that clinicians are adequately informed, the European Association for Cardio-Thoracic Surgery (EACTS), The Society of Thoracic Surgeons (STS) and American Association for Thoracic Surgery (AATS) set up a Task Force comprised of cardiac surgeons, cardiologists, engineers, regulatory bodies, representatives of the International Organization for Standardization and major valve manufacturers. Previously, the EACTS–STS–AATS Valve Labelling Task Force identified the most important problems around SHV sizing and labelling. This Expert Consensus Document formulates recommendations for providing SHV physical dimensions, intended implant position and hemodynamic performance in a transparent, uniform manner. Furthermore, the Task Force advocates for the introduction and use of a standardized chart to assess the probability of prosthesis–patient mismatch and calls valve manufacturers to provide essential information required for SHV choice on standardized Valve Charts, uniformly for all SHV models.

BACKGROUND On October 18, 2018, the US heart allocation policy was restructured to improve transplant waitlist outcomes. Previously, hypertrophic cardiomyopathy (HCM) patients experienced significant waitlist mortality and functional decline, often requiring status exemptions to be transplanted. This study aims to examine changes in waitlist mortality and transplant rates of HCM patients in the new system. METHODS Retrospective analysis was performed of the United Network for Organ Sharing Transplant Database for all isolated adult single-organ first-time heart transplant patients with HCM listed between October 17, 2013 and September 4, 2020. Patients were divided by listing date into eras based on allocation system. Era 1 spanned October 17, 2013 to October 17th, 2018 and Era 2 spanned October 18th, 2018 to September 4, 2020. RESULTS During the study period, 436 and 212 HCM patients were listed in Eras 1 and 2, respectively. Across eras, no differences in gender, ethnicity, BMI or functional status were noted (p>0.05). LVAD utilization remained low (Era 1: 3.7% vs Era 2: 3.3%, p = 0.297). Status upgrades decreased from 49.1% to 31.6% across eras (p = 0.001). There was no statistically significant difference in waitlist mortality across eras (p = 0.332). Transplant rates were improved in Era 2 (p = 0.005). Waitlist time among transplanted patients decreased in Era 2 from 97.1 to 63.9 days (p

This study evaluates the Area Deprivation Index (ADI) as a novel prognostic metric of socioeconomic status for patients with a left ventricular assist device.A retrospective analysis of patients with a left ventricular assist device at a high-volume institution from 2007 to 2018 was conducted. Socioeconomic status was determined using the ADI, a multifactorial neighborhood-based metric where higher ADI denotes worse socioeconomic status. Patients were stratified into 4 ADI cohorts. Long-term survival was compared with multivariate analysis. Of the 380 patients stratified by ADI, 35 were in the 10th percentile or lower, 218 were in the 11th-50th percentile, 104 were in the 51st-89th percentile, and 23 were in the 90th percentile or higher. Baseline characteristics were comparable. On multivariate analysis, being male (hazard ratio [HR], 0.14; P = .01), bridge-to-transplant (HR, 0.14; P = .03), and not requiring biventricular support (HR, 0.02; P.01) were protective, whereas chronic kidney disease (HR, 9.07; P.01) and an elevated total bilirubin (HR, 3.56; P = .02) were harmful. The ADI as a continuous variable did not affect survival; however, categorically, a higher ADI was protective (ADI 90-100: HR, 0.07; P = .04).Socioeconomically disadvantaged patients had noninferior outcomes given appropriate pre-implant optimization and workup.

BACKGROUND Several distinctly engineered left ventricular assist devices (LVADs) are in clinical use. However, contemporaneous real world comparisons have not been conducted, and clinical trials were not powered to evaluate differential survival outcomes across devices. OBJECTIVES Determine real world survival outcomes and healthcare expenditures for commercially available durable LVADs. METHODS Using a retrospective observational cohort design, Medicare claims files were linked to manufacturer device registration data to identify de-novo, durable LVAD implants performed between January 2014 and December 2018, with follow-up through December 2019. Survival outcomes were compared using a Cox proportional hazards model stratified by LVAD type and validated using propensity score matching. Healthcare resource utilization was analyzed across device types by using nonparametric bootstrap analysis methodology. Primary outcome was survival at 1-year and total Part A Medicare payments. RESULTS A total of 4,195 de-novo LVAD implants were identified in fee-for-service Medicare beneficiaries (821 HeartMate 3; 1,840 HeartMate II; and 1,534 Other-VADs). The adjusted hazard ratio for mortality at 1-year (confirmed in a propensity score matched analysis) for the HeartMate 3 vs HeartMate II was 0.64 (95% CI; 0.52-0.79, p< 0.001) and for the HeartMate 3 vs Other-VADs was 0.51 (95% CI; 0.42-0.63, p < 0.001). The HeartMate 3 cohort experienced fewer hospitalizations per patient-year vs Other-VADs (respectively, 2.8 vs 3.2 EPPY hospitalizations, p < 0.01) and 6.1 fewer hospital days on average (respectively, 25.2 vs 31.3 days, p < 0.01). The difference in Medicare expenditures, conditional on survival, for HeartMate 3 vs HeartMate II was -$10,722, p < 0.001 (17.4% reduction) and for HeartMate 3 vs Other-VADs was -$17,947, p < 0.001 (26.1% reduction). CONCLUSIONS In this analysis of a large, real world, United States. administrative dataset of durable LVADs, we observed that the HeartMate 3 had superior survival, reduced healthcare resource use, and lower healthcare expenditure compared to other contemporary commercially available LVADs.

Background: Non-citizens of the United States face complex social and economic issues, which may impact their post-transplant outcomes compared to US citizens. To this end, we utilized the United Network for Organ Sharing (UNOS) database to examine post-heart transplant (OHT) outcomes, stratified by citizenship status. Methods: UNOS was queried to identify OHT recipients from 03/01/12 (start of new schema for citizenship categorization) through 10/18/18 (start of new heart allocation algorithm). Groups for analysis, were as follows: US Citizen, Non-US Citizen/Resident (NC-R) and Non-US Citizen/Non-US Resident (NC-NR). Post-transplant survival and rate of post-transplant rejection were assessed via Kaplan-Meier analysis and tests of proportions. Results: Of the 16,211 OHT recipients identified, 15,677 (96.7%) were US citizens and 534 (3.3%) were Non-Citizens. Among Non-Citizens, 430 were NC-R and 104 were NC-NR, representing 2.7% and 0.6% of the total transplants. Notably, NC-NR were younger than either Citizens or NC-R, and had the shortest median time from listing to transplant (NC-R 80 days vs. Citizens 107 days vs. NC-NR 76 days, p=0.001). The proportion of transplants received by non-citizens varied widely by region, ranging from 0.59% in region 8 (6/1018) to 8.31% (84/1011) in region 9. There was no significant difference in post-transplant survival estimates in citizens vs. non-citizens (logrank p = 0.542), nor in the proportion of patients treated for rejection by one year (15.0% vs. 16.1%, p= 0.504) Conclusion: Non-US Citizens receive three percent of heart transplants performed in the US each year. Post-heart transplant survival and rate of rejection are similar in US citizens and non-citizens. These data may be relevant in the context of evolving UNOS policies. Additional studies are needed are to further inform organ allocation policy.

Introduction: Revascularization relieves myocardial ischemia but induces additional reperfusion injury by oxidative stress. Superoxide dismutase (SOD) is a potent antioxidant with preclinical promise in reducing reperfusion injury but is not well retained within the myocardium. Hypothesis: Use of SOD-encapsulated nanoparticles (NP-SOD) will improve SOD retention and preserve cardiac function in a rat model of myocardial ischemia-reperfusion (I/R) injury. Methods: Ischemia was maintained for 60 minutes via occlusion of the left anterior descending artery (LAD). Immediately prior to reperfusion, intramyocardial injections of NP-SOD, free SOD or phosphate buffered saline (PBS) were administered along the border of ischemic myocardium. Acute injury was assessed 3 hours post-reperfusion (n=8 per group), and chronic injury at 4 weeks (n=12). Hemodynamics were measured by echocardiography and pressure-volume loops. Acute and chronic injury were examined histologically. Protein isolates at 3 hours measured mediators of cell-death. Intramyocardial enzyme retention analysis was performed by injecting NP or free fluorescent-tagged SOD and explanting hearts for imaging at 0, 24 and 72 hours (n=4 per group). Results: Intramyocardial SOD retention was 25% greater in NP-SOD than free SOD at 24 hours (p Conclusions: NP-SOD provides prolonged enzyme retention within the myocardium. Intramyocardial NP-SOD administration prior to reperfusion attenuates acute myocardial injury and protects against chronic adverse ventricular remodeling. SOD acts by downregulating necrosis. These findings suggest potential for NP-SOD based therapy in mitigating myocardial I/R injury.