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Objectives: The HeartMate 3 (Abbott) left ventricular assist device provides substantial improvement in long-term morbidity and mortality in patients with advanced heart failure. The Implantation of the HeartMate 3 in Subjects With Heart Failure Using Surgical Techniques Other Than Full Median Sternotomy study compares thoracotomy-based implantation clinical outcomes with standard median sternotomy., Methods: We conducted a prospective, multicenter, single-arm study in patients eligible for HeartMate 3 implantation with thoracotomy-based surgical technique (bilateral thoracotomy or partial upper sternotomy with left thoracotomy). The composite primary end point was survival free of disabling stroke (modified Rankin score >3), or reoperation to remove or replace a malfunctioning device, or conversion to median sternotomy at 6-months postimplant (elective transplants were treated as a success). The primary end point (noninferiority, -15% margin) was assessed with >90% power compared with a propensity score-matched cohort (ratio 1:2) derived from the Multi-Center Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Support Therapy With HeartMate 3 continued access protocol., Results: The study enrolled 102 patients between December 2020 and July 2022 in the thoracotomy-based arm at 23 North American centers. Follow-up concluded in December 2022. In the Implantation of the HeartMate 3 in Subjects With Heart Failure Using Surgical Techniques Other Than Full Median Sternotomy study group, noninferiority criteria was met (absolute between-group difference, -1.2%; Farrington Manning lower 1-sided 95% CI, -9.3%; P < .0025) and event-free survival was not different (85.0% vs 86.2%; hazard ratio, 1.01; 95% CI, 0.58-2.10). Length of stay with thoracotomy-based implant was longer (median, 20 vs 17 days; P = .03). No differences were observed for blood product utilization, adverse events (including right heart failure), functional status, and quality of life between cohorts., Conclusions: Thoracotomy-based implantation of the HeartMate 3 left ventricular assist device is noninferior to implantation via standard full sternotomy. This study supports thoracotomy-based implantation as an additional standard for surgical implantation of the HeartMate 3 left ventricular assist device., Competing Interests: Conflict of Interest Statement Dr Gosev reports consulting for Abbott. Dr Pham reports consulting for Abbott, Abiomed, and Medtronic. Dr Itoh reports speaker honoraria from Abbott and Abiomed. Dr Kotkar is a speaker (nonfinancial) for Abiomed and 3M. Dr Naka reports consulting for Abbott, Biomet-Zimmer, Cryolife, and receiving speaker’s fees for Nipro Co. Dr Peltz reports research support from Bridge to Life Ltd and Paragonix Inc. Dr Silvestry reports consulting for Abbott, Abiomed, Medtronic, and data and safety monitoring board participation for Carmat. Dr Leacche reports consulting for Abbott and advisory board participation for Abiomed. Dr Rao reports consulting for Abbott, Medtronic, and Gore. Dr Sun reports consulting for Abbott. Dr Tedford reports consulting for Abbott, Medtronic, Aria CV Inc, Alleviant, Acorai, Acceleron, Cytokinetics, Itamar, Edwards LifeSciences, Eidos Therapeutics, Lexicon Pharmaceuticals, Gradient, and United Therapeutics. He is the national co-principal investigator for the RIGHT-FLOW clinical trial (Edwards), serves on steering committees for Merck, and a research advisory board for Abiomed. He also does hemodynamic core lab work for Merck. Dr Mokadam reports consulting for Abbott, Medtronic, SynCardia, Carmat, and Xylocor. Drs McNutt and Crandall are employees of Abbott. Dr Mehra reports payment made to institution from Abbott for consulting; consulting fees from Mesoblast, Janssen, Moderna, and Paragonix, and Baim Institute for clinical research; he is an advisory board member for Transmedics, NuPulseCV, Leviticus, and FineHeart. Dr Salerno reports consulting for Abbott. All other authors reported no conflicts of interest. The Journal policy requires editors and reviewers to disclose conflicts of interest and to decline handling manuscripts for which they may have a conflict of interest. The editors and reviewers of this article reported no conflicts of interest., (Copyright © 2024 The Author(s). Published by Elsevier Inc. All rights reserved.)

Objective: Donation after circulatory death heart transplantation potentially increases donor allografts, especially for patients with lower listing status. We assessed the outcomes of donation after circulatory death heart transplantation in patients bridged with durable left ventricular assist devices., Methods: The United Network for Organ Sharing database was queried for adult heart transplants using donation after circulatory death donors from 2019 to 2022. Patients were stratified between those with durable left ventricular assist devices and those with intra-aortic balloon pump, inotropic, or no bridging support (control group). Primary outcome was 1-year mortality. Secondary end points were hospital length of stay, stroke, pacemaker implantation, dialysis, and acute rejection before discharge., Results: A total of 160 left ventricular assist device recipients and 311 control recipients met study inclusion criteria. Recipients bridged with left ventricular assist devices were younger (55 vs 58 years, P < .001) with lower body mass index (28.3 vs 30.3, P < .001), longer waitlist times (112 vs 34 days, P < .001), longer out of body times (5.7 vs 4.6 hours, P < .001), and less frequent normothermic regional perfusion (31% vs 40%, P = .049). Patients with left ventricular assist devices commonly underwent transplantation at United Network for Organ Sharing status 3 and 4 (92%), whereas control patients underwent transplantation at status 2 (27%), status 3 (10%), status 4 (30%), or status 6 (30%). Kaplan-Meier analysis showed no difference in 1-year mortality between groups (P = .34). However, acute rejection was higher in the unadjusted left ventricular assist device cohort (26% vs 13%, P < .001). On multivariable logistic regression, left ventricular assist device was an independent predictor of acute rejection (odds ratio, 2.21, 95% CI, 1.32-3.69, P = .002)., Conclusions: Durable left ventricular assist devices may be associated with a higher risk of developing an early inflammatory response in donation after circulatory death heart transplantation; however, 1-year survival was similar between groups., Competing Interests: Conflict of Interest Statement G.T.S. receives consulting fees from Abbott and Medtronic. N.U. receives grant support from and serves as a consultant for Abbott and Medtronic. All other authors reported no conflicts of interest. The Journal policy requires editors and reviewers to disclose conflicts of interest and to decline handling or reviewing manuscripts for which they may have a conflict of interest. The editors and reviewers of this article have no conflicts of interest., (Copyright © 2024 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.)

Objective: The HeartMate 3 survival risk score was recently validated in the Multicenter study Of MagLev Technology in Patients Undergoing Mechanical Circulatory Support Therapy with HeartMate 3 to predict patient-specific survival in HeartMate 3 left ventricular assist device candidates. The HeartMate 3 survival risk score stratifies individuals into tertiles according to survival probability., Methods: We performed a single-center retrospective review of all HeartMate 3 left ventricular assist device recipients between September 2017 and August 2022. Baseline characteristics were collected from the electronic medical records. HeartMate 3 survival risk scores were calculated for all eligible patients. One- and 2-year Kaplan-Meier survival analyses were conducted. A univariate and multivariable Cox regression model was used to identify predictors., Results: A total of 181 patients were included in this final analysis. The median age was 62 years, 83% were male, and 26% were Interagency Registry for Mechanically Assisted Circulatory Support Profile 1. The mean HeartMate 3 survival risk score for the entire cohort was 2.66 ± 0.66. Two-year survivals in the high, average, and low survival groups were 93.5% ± 3.2%, 81.6% ± 7.4%, and 82.0% ± 6.6%, respectively. As a continuous variable, the unadjusted HeartMate 3 survival risk score was a significant predictor of mortality (hazard ratio, 2.20; 95% CI, 1.08-4.45; P = .029). The areas under the curve were 0.70 and 0.66 at 1 and 2 years, respectively. We were unable to demonstrate the discriminatory ability of the HeartMate 3 survival risk score using the original stratification, but we found significantly increased survival in the high survival group using a binary cutoff (hazard ratio, 4.8; 95% CI, 1.01-20.9; P = .038)., Conclusions: The unadjusted HeartMate 3 survival risk score was associated with postimplant survival in patients outside of the Multicenter study Of MagLev Technology in Patients Undergoing Mechanical Circulatory Support Therapy with HeartMate 3 but did not remain an independent predictor after adjusting for ischemic etiology and severe diabetes. The HeartMate 3 survival risk score was able to identify patients at high survival using a binary cutoff, but we were unable to demonstrate its discriminatory ability among the previously published risk tertiles., Competing Interests: Conflict of Interest Statement Dr Uriel is on the medical advisory board for Livemetric, Revamp, and Leviticus. Center for Advanced Cardiac Care at Columbia University Irving Medical Center receives grant support from CareDx and Abbott. Dr Sayer has been a consultant for Abbott and is on the medical advisory board for CareDx. Dr Clerkin receives National Institutes of Health grant support K23 HL148528 and the Nelson Family Grant. Dr Topkara receives National Institutes of Health grant support (HL146964). Dr Moeller receives a grant from ISHLT and CareDx. All other authors reported no conflicts of interest. The Journal policy requires editors and reviewers to disclose conflicts of interest and to decline handling or reviewing manuscripts for which they may have a conflict of interest. The editors and reviewers of this article have no conflicts of interest., (Published by Elsevier Inc.)

Objective: Our objective was to analyze the development of aortic insufficiency in patients who received central aortic valve repair when undergoing continuous-flow left ventricular assist device implantation., Methods: We conducted a retrospective review of patients who underwent HeartMate II or 3 (Abbott Lab) implantation between 2004 and 2022. Ninety-four patients were excluded from analysis for history of aortic valve procedures, a bicuspid aortic valve, baseline trace aortic insufficiency, or other concomitant aortic valve procedure. Patients who had ≥ mild aortic insufficiency had concomitant aortic valve repair. Clinical characteristics, serial echocardiograms, and outcomes were determined., Results: Of the 656 patients who underwent HeartMate II or 3 implantation, 105 patients (59 HeartMate II and 46 HeartMate 3) met study criteria. Median age was 68 years [60-74 years], 91.4% [n=96] were male, 54.4% [n=56] were white, and 68.6% [n=72] received support as destination therapy. Preoperative aortic insufficiency degree was 54.3% (n=57) mild, 23.8% (n=25) mild-to-moderate, 20.0% (n=21) moderate, 1.0% (n=1) moderate-to-severe, 1.0% (n=1) severe. In hospital mortality was 5.7% [n=6]. Freedom from ≥ moderate aortic insufficiency was 96.4% (95%CI: 92.5%-100%), 93.3% (95%CI: 87.6%-99.2%), and 91.0% (95%CI: 84.1%-98.5%) at 1-year, 2-year, and 3-year post-implantation, respectively. One HeartMate II patient experienced severe aortic insufficiency and was treated with a heart transplant. Three-year survival was 63.4% [95%CI: 52.9%-75.9%]., Conclusions: Central aortic valve repair may be an effective technique to mitigate aortic insufficiency in HeartMate II and 3. A larger cohort study with longer duration of follow up is warranted to further investigate the clinical impact., (Copyright © 2024. Published by Elsevier Inc.)

Objective: Among left ventricular assist device patients, the most commonly infected component is the drive line, which can be managed with antibiotics and local debridement. Infection of intrathoracic device components is less common but more difficult to manage. Herein we describe the incidence of deep device infection (DDI) at our center as well as management and outcomes., Methods: We retrospectively reviewed 658 patients who underwent implantable left ventricular assist device insertion with HeartMate 2 (Abbott) or HeartMate 3 (Abbott) devices between January 2004 and June 2021. DDI was defined according to radiographic and clinical criteria. Cumulative incidence was calculated using a Fine-Gray subdistribution model; survival analysis was performed using the method of Kaplan and Meier., Results: There were 32 (4.8%) DDIs during this study period. Drive line infection and re-exploration for bleeding were associated with development of DDI. Cumulative incidence of DDI increased over time, affecting 11% (7%-18%) at 5 years. The dominant microbes involved in DDI were Pseudomonas aeruginosa (19%) and methicillin-resistant Staphylococcus aureus (13%). Nineteen patients (59%) with device infection underwent device exchange, 6 (19%) underwent initial transplant, and 7 (22%) were treated solely with debridement and antibiotics. Of those who underwent device exchange, 12 (63%) developed reinfection of their new device and 6 underwent subsequent heart transplant. Patients who underwent transplantation for management of device infection had improved 5-year survival (80% vs 11%; P = .01) but 3 patients (25%) developed deep sternal wound infection after transplant., Conclusions: DDI is a rare but challenging complication in this destination era. Heart transplantation is the preferred management strategy for eligible patients but infectious complication is common., (Copyright © 2022 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.)

Objective: Our objective was to compare outcomes after left ventricular assist device implantation performed via median sternotomy or lateral thoracotomy., Methods: We retrospectively analyzed 222 adult patients with the HeartMate3 (Abbott Lab) left ventricular assist device implanted between November 2014 and November 2021. Outcomes stratified by surgical approach were evaluated in propensity score-matched groups. The primary outcome was 1-year survival. Secondary outcomes included in-hospital morbidity and mortality, readmissions, and significant valvular regurgitation., Results: Our cohort consisted of 60 patients (27%) who underwent lateral thoracotomy and 162 patients (73%) who underwent median sternotomy. Propensity score matching compared 45 patients who underwent lateral thoracotomy with 68 patients who underwent median sternotomy. There were no differences in intensive care unit or hospital stay duration (median, 10 vs 11 days, P = .58; 46 vs 40 days, P = .279), time to extubation (median, 2 days, P = .627), vasoactive-inotropic scores at intensive care unit arrival (18.20 vs 16.60, P = .654), or in-hospital mortality (2 [5%] vs 4 [6.1%] patients, P = 1). One-year survival (95.56% vs 90.61%, P = .48) and all-cause hospital readmission rate (Gray's test: P = .532) were also comparable. Patients who underwent lateral thoracotomy had significantly less early right ventricular failure (24.4% vs 53.7%, P = .004), although they had more follow-up tricuspid regurgitation (17.6% vs 0%, P = .030) and volume overload readmissions (Gray's test: P = .0005)., Conclusions: Our data suggest that lateral thoracotomy is a safe although not necessarily superior alternative to median sternotomy for HeartMate 3 implantation in the perioperative and postoperative periods, because it precludes concomitant tricuspid valve repairs and may be associated with increased risk of late tricuspid regurgitation and volume overload readmissions., (Copyright © 2022 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.)

Objective: To compare 3-year survival and readmissions of patients who received the HeartMate 3 (HM3) left ventricular assist device (LVAD) or underwent orthotopic heart transplantation (OHT) as primary treatment for advanced heart failure., Methods: We retrospectively analyzed 381 adult patients who received an HM3 LVAD or were listed for OHT between January 2014 and March 2021 at our center. To minimize crossover bias, OHT recipients with a prior LVAD were excluded, and HM3 patients were censored at the time of transplant. Cohorts were propensity score-matched to reduce confounding variables. The primary outcome was 3-year survival, and the secondary outcome was mean cumulative all-cause unplanned readmission., Results: The study population comprised 185 HM3 patients (49%) and 196 OHT patients (51%), with 104 propensity score-matched patients in each group. After propensity score matching, there was no statistical difference in 3-year survival (83.7% for HM3 vs 87.0% for OHT; P = .91; relative risk [RR], 1.00; 95% confidence interval [CI], 0.45-2.20). In the unmatched cohorts, patients age 18 to 49 years had comparable survival with HM3 and OHT (96.9% vs 95.9%; N = 91; P = 1.00; RR, 0.92; 95% CI, 0.09-9.78). Patients age 50+ years had slightly inferior survival with HM3 (75.0% vs 83.9%; N = 290; P = .60; RR, 1.51; 95% CI, 0.85-2.68). The mean number of readmissions at 3 years was higher in the HM3 group (3.89 vs 2.05; P < .001)., Conclusions: This exploratory analysis suggests that for similar patients, HM3 may provide comparable 3-year survival to OHT as a primary treatment for heart failure but may result in more readmissions., Competing Interests: Conflict of Interest Statement The HeartMate 3 left ventricular assist system is manufactured by Abbott. P.C. serves as an Abbott consultant without honoraria and has received an Abbott research grant. G.S. receives consulting fees from Abbott and Medtronic. N.U. receives grant support from and serves as a consultant for Abbott and Medtronic. Y.N. serves as consultant for Abbott. The other authors have no conflicts of interest to report. The Journal policy requires editors and reviewers to disclose conflicts of interest and to decline handling or reviewing manuscripts for which they may have a conflict of interest. The editors and reviewers of this article have no conflicts of interest., (Copyright © 2023 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.)

Background: Correction of valvular disease is often undertaken during left ventricular assist device (LVAD) implantation with uncertain benefit. We analyzed clinical outcomes with HeartMate 3 (HM3; Abbott) LVAD implantation in those with various concurrent valve procedures (HM3+VP) with those with an isolated LVAD implant (HM3 alone)., Methods: The study included 2200 patients with HM3 implanted within the Multicenter Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Support Therapy with HeartMate 3 (MOMENTUM 3) trial portfolio who underwent 820 concurrent procedures among which 466 (21.8%) were HM3+VP. VPs included 101 aortic, 61 mitral, 163 tricuspid; 85 patients had multiple VPs. Perioperative complications, major adverse events, and survival were analyzed., Results: Patients who underwent HM3+VP had higher-acuity Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) profiles (1-2: 41% vs 31%) compared with no VPs (P < .05). The cardiopulmonary bypass time (124 vs 76 minutes; P < .0001) and hospital length of stay (20 vs 18 days; P < .0001) were longer in HM3+VP. A higher incidence of stroke (4.9% vs 2.4%), bleeding (33.9% vs 23.8%), and right heart failure (41.5% vs 29.6%) was noted in HM3+VP at 0 to 30 days (P < .01), with no difference in 30-day mortality (3.9% vs 3.3%) or 2-year survival (81.7% vs 80.8%). Analysis of individual VP showed no differences in survival compared to HM3 alone. No differences were noted among patients with either significant mitral (moderate or worse) or tricuspid (moderate or worse) regurgitation with or without corrective surgery., Conclusions: Concurrent VPs, commonly performed during LVAD implantation, are associated with increased morbidity during the index hospitalization, with no effect on short- and long-term survival. There is sufficient equipoise to consider a randomized trial on the benefit of commonly performed VPs (such as mitral or tricuspid regurgitation correction), during LVAD implantation., (Copyright © 2022 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.)

Background: Little is known regarding the profile of patients with multiorgan failure listed for simultaneous cardiac transplantation and secondary organ. In addition, few studies have reported how these patients are bridged with mechanical circulatory support (MCS). In this study, we examined national data of patients listed for multiorgan transplantation and their outcomes after bridging with or without MCS., Methods: United Network for Organ Sharing data were reviewed for adult multiorgan transplantations from 1986 to 2019. Post-transplant patients and total waitlist listings were examined and stratified according to MCS status. Survival was assessed via Cox regression in the post-transplant cohort and Fine-Gray competing risk regression with transplantation as a competing risk in the waitlist cohort., Results: There were 4534 waitlist patients for multiorgan transplant during the study period, of whom 2117 received multiorgan transplants. There was no significant difference in post-transplant survival between the MCS types and those without MCS in the whole cohort and heart-kidney subgroup. Fine-Gray competing risk regression showed that patients bridged with extracorporeal membrane oxygenation had significantly greater waitlist mortality compared with those without MCS when controlling for preoperative characteristics (subdistribution hazard ratio, 2.27; 95% confidence interval, 1.48-3.47; P < .001), whereas those bridged with a ventricular assist device had a decreased incidence of death compared with those without MCS (subdistribution hazard ratio, 0.78; 95% confidence interval, 0.63-0.96; P = .017)., Conclusions: MCS, as currently applied, does not appear to compromise the survival of multiorgan heart transplant patients. Waitlist data show that extracorporeal membrane oxygenation patients have profoundly worse survival irrespective of preoperative factors including organ type listed. Survival on the waitlist for multiorgan transplant has improved across device eras., (Copyright © 2021 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.)

Objective: Our study assesses differences between male and female patients placed on venoarterial extracorporeal membrane oxygenation for cardiogenic shock., Method: We retrospectively analyzed 574 adult patients placed on venoarterial extracorporeal membrane oxygenation for cardiogenic shock at our institution between January 2007 and December 2018. Baseline characteristics and outcomes were assessed. Propensity score matching was used to compare outcomes. The primary end point was in-hospital mortality. Secondary outcomes include limb ischemia, limb ischemia interventions, distal perfusion cannula placement, stroke, bleeding, and continuous venovenous hemofiltration initiation., Results: There were 394 male patients (69%) and 180 female patients (31%). After adjusting for baseline differences, propensity score matching compared 171 male patients with 171 female patients. No difference was seen between men and women in in-hospital mortality (60.2% vs 56.7%; P = .59), limb ischemia (47.4% vs 45.6%; P = .83), limb ischemia surgery (15.2% vs 12.9%; P = .64), bleeding (49.7% vs 49.1%; P = 1), continuous venovenous hemofiltration initiation (39.2% vs 32.7%; P = .26), and stroke (8.2% vs 9.4%; P = .85). Multivariable logistic regression showed that female patients who died were more likely to have had chronic kidney disease (odds ratio [OR], 2.67; 95% confidence interval [CI], 1.09-6.53; P = .032) than surviving women. Male patients who died were more likely to have had coronary artery disease (OR, 2.25; 95% CI, 1.34-3.78; P = .002) and higher lactate levels (OR, 1.14; 95% CI, 1.08-1.21; P < .001) than surviving men. Women with cardiac transplant primary graft dysfunction were more likely to survive (OR, 0.04; 95% CI, 0.01-0.27; P = .001), whereas men with cardiac transplant primary graft dysfunction were less likely to survive (OR, 0.28; 95% CI, 0.11-0.71; P = .007), than patients with other shock etiologies., Conclusions: After adjusting for baseline difference, there was no difference in outcomes between male and female patients despite differing risk profiles for in-hospital mortality., (Copyright © 2020 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.)

Objective: The objective of this study was to describe the profiles and outcomes of a cohort of advanced heart failure patients on ambulatory inotropic therapy (AIT)., Background: With the growing burden of patients with end-stage heart failure, AIT is an increasingly common short or long-term option, for use as bridge to heart transplant (BTT), bridge to ventricular assist device (BTVAD), bridge to decision regarding advanced therapies (BTD) or as palliative care. AIT may be preferred by some patients and physicians to facilitate hospital discharge. However, counseling patients on risks and benefits is critically important in the modern era of defibrillators, durable mechanical support and palliative care., Methods: We retrospectively studied a cohort of 241 patients on AIT. End points included transplant, VAD implantation, weaning of inotropes, or death. The primary outcomes were survival on AIT and ability to reach intended goal if planned as BTT or BTVAD. We also evaluated recurrent heart failure hospitalizations, incidence of ventricular arrhythmias (VT/VF) and indwelling line infections. Unintended consequences of AIT, such reaching unintended end point (e.g. VAD implantation in BTT patient) or worse than expected outcome after LVAD or HT, were recorded., Results: Mean age of the cohort was 60.7 ± 13.2 years, 71% male, with Class III-IV heart failure (56% non-ischemic). Average ejection fraction was 19.4 ± 10.2%, pre-AIT cardiac index was 1.5 ± 0.4 L/min/m 2 and 24% had prior ventricular arrhythmias. Overall on-AIT 1-year survival was 83%. Hospitalizations occurred in 51.9% (125) of patients a total of 174 times for worsening heart failure, line complication or ventricular arrhythmia. In the BTT cohort, only 42% were transplanted by the end of follow-up, with a 14.8% risk of death or delisting for clinical deterioration. For the patients who were transplanted, 1-year post HT survival was 96.7%. In the BTVAD cohort, 1-year survival after LVAD was 90%, but with 61.7% of patients undergoing LVAD as INTERMACS 1-2. In the palliative care cohort, only 24.5% of patients had a formal palliative care consult prior to AIT., Conclusions: AIT is a strategy to discharge advanced heart failure patients from the hospital. It may be useful as bridge to transplant or ventricular assist device, but may be limited by complications such as hospitalizations, infections, and ventricular arrhythmias. Of particular note, it appears more challenging to bridge to transplant on AIT in the new allocation system. It is important to clarify the goals of AIT therapy upfront and continue to counsel patients on risks and benefits of the therapy itself and potential unintended consequences. Formalized, multi-disciplinary care planning is essential to clearly define individualized patient, as well as programmatic goals of AIT., (Copyright © 2021. Published by Elsevier Inc.)

Background: The onset of the coronavirus disease 2019 (COVID-19) pandemic has forced our cardiac surgery program and hospital to enact drastic measures that has forced us to change how we care for cardiac surgery patients, assist with COVID-19 care, and enable support for the hospital in terms of physical resources, providers, and resident training., Methods: In this review, we review the cardiovascular manifestations of COVID-19 and describe our system-wide adaptations to the pandemic, including the use of telemedicine, how a severe reduction in operative volume affected our program, the process of redeployment of staff, repurposing of residents into specific task teams, the creation of operation room intensive care units, and the challenges that we faced in this process., Results: We offer a revised set of definitions of surgical priority during this pandemic and how this was applied to our system, followed by specific considerations in coronary/valve, aortic, heart failure and transplant surgery. Finally, we outline a path forward for cardiac surgery for the near future., Conclusions: We recognize that individual programs around the world will eventually face COVID-19 with varying levels of infection burden and different resources, and we hope this document can assist programs to plan for the future., (Copyright © 2020 Jointly between The American Association for Thoracic Surgery, The Society of Thoracic Surgeons, and the European Association for Cardio-Thoracic Surgery. Published by Elsevier Inc. Published by Elsevier Inc. All rights reserved.)

Objective: Venoarterial extracorporeal membrane oxygenation is a useful treatment for severe primary graft dysfunction after heart transplant. The ideal timing of initiation is unknown., Methods: We retrospectively reviewed 362 adult heart transplant recipients at our center between January 2011 and December 2017. Thirty-eight patients (10.5%) experienced severe primary graft dysfunction treated with venoarterial extracorporeal membrane oxygenation. As our institution adopted a prompt venoarterial extracorporeal membrane oxygenation policy in 2015, patients were stratified into pre-2015 (conservative extracorporeal membrane oxygenation: n = 18) and post-2015 (prompt extracorporeal membrane oxygenation: n = 20) cohorts. Clinical outcomes were compared., Results: Baseline characteristics were similar (conservative vs prompt) except for age (51.82 vs 59.96 years, P = .036), aspartate transaminase (32 vs 21.5 U/L, P = .038), male donor (44.4 vs 80%, P = .042), and donor ejection fraction (60 vs 65%, P = .047). Median ischemic time was significantly longer in the conservative extracorporeal membrane oxygenation cohort (210 vs 148 minutes, P = .005). Median time to initiation of extracorporeal membrane oxygenation was significantly shorter in the prompt extracorporeal membrane oxygenation cohort (7.26 vs 1.95 hours, P < .0001). There was no difference in intensive care unit stay or major complications. In-hospital mortality improved from 28% (conservative) to 5% (prompt, P = .083). Post-transplant survival at 1 year was 67% in the conservative extracorporeal membrane oxygenation cohort and 90% in the prompt extracorporeal membrane oxygenation cohort (P = .117). There was no difference in the Kaplan-Meier survival curves (P = .071), although Cox regression suggested, but certainly did not prove, a 74.6% lower risk of mortality in the prompt extracorporeal membrane oxygenation group (P = .094)., Conclusions: Prompt venoarterial extracorporeal membrane oxygenation use for primary graft dysfunction after heart transplant results in excellent myocardial recovery and a possible decrease in mortality without increased risk of complications., (Copyright © 2019 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.)

Background: Outcomes have improved in patients bridged to heart transplant on contemporary continuous-flow ventricular assist devices over the past decade. We evaluated mechanical circulatory support as a means to bridge patients to cardiac retransplantation., Methods: We retrospectively reviewed 464 patients who underwent cardiac retransplant from the United Network for Organ Sharing database between January 2006 and November 2016. Pre- and post-transplant data were compared between patients bridged to retransplant with mechanical circulatory support (n = 81) and those without mechanical circulatory support (n = 383)., Results: The mean ages for the patients in the mechanical circulatory support and nonmechanical circulatory support cohorts were 41.2 ± 16 years and 42.1 ± 15.7 years, respectively (P = .64). Patients bridged with mechanical circulatory support were placed on extracorporeal membrane oxygenation (n = 29, 35.8%), a total artificial heart (n = 13, 16.0%), or a temporary or durable ventricular assist device (n = 39, 48.1%). Twelve patients (14.8%) were placed on a second device before retransplant. Thirty-nine percent of the mechanical circulatory support group were indicated for listing because of primary graft dysfunction or acute rejection versus 6% of the nonmechanical circulatory support group (P < .01). Likewise, 30% of patients in the mechanical circulatory support group were listed for cardiac allograft vasculopathy compared with 59% of the nonmechanical circulatory support group (P < .01). Thirty-day mortality was significantly higher in the mechanical circulatory support group (17.8% vs 4.8%, P < .01). However, patients who were bridged with a ventricular assist device or total artificial heart had comparable midterm outcomes to the nonmechanical circulatory support group., Conclusions: Patients who require mechanical circulatory support bridge to retransplantation belong to a high-risk cohort. Comparable midterm outcomes to the nonmechanical circulatory support cohort were demonstrated when patients' conditions allow for bridge with a ventricular assist device or total artificial heart. Bridging to retransplantation with extracorporeal membrane oxygenation remains a relative contraindication., (Published by Elsevier Inc.)

Background: The use of percutaneous mechanical circulatory support (MCS) in the treatment of cardiogenic shock has increased. However, limitations in flow capability, ventricular unloading effect, durability, and mobility remain. We reviewed our single-center experience with continuous-flow external ventricular assist devices (VADs) to determine the role of temporary VADs for cardiogenic shock in the contemporary MCS era., Methods: We retrospectively reviewed 252 patients who underwent continuous-flow external VAD insertion between January 2007 and December 2016. To investigate the change in indications, device configurations, and outcomes, we divided the cohort into 2 groups-2007 to 2011 (Era 1; n = 127) and 2012 to 2016 (Era 2; n = 125)-and compared early and late outcomes., Results: Indications and device configurations changed significantly over time. The use of preoperative percutaneous MCS (53% vs 23%; P < .01) and use of minimally invasive VAD configurations (23% vs 6.7%; P < .01) were greater in Era 2 compared with Era 1. The rate of bridge to the next destinations, including myocardial recovery, transplantation, and durable VAD, was similar in the 2 groups. In-hospital mortality was significantly better in Era 2 (50% vs 37%; P = .04). Overall survival at 1 year was 57% in Era 2 versus 43% in Era 1 (P = .04)., Conclusions: Better outcomes in the recent era could be associated with the changes in practice patterns using continuous-flow external VAD in patients with refractory cardiogenic shock., (Copyright © 2018 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.)

Objectives: Venoarterial extracorporeal membrane oxygenation (ECMO) use as a bridge to transplant is extremely infrequent in adults. We investigated patient outcomes of the use of ECMO as bridge to transplant., Methods: United Network of Organ Sharing provided de-identified patient-level data. Between 2003 and 2016, 25,168 adult recipients were identified. Of these, 107 (0.4%) were bridged with ECMO and 6148 (24.4%) were bridged with a continuous-flow left ventricular assist device., Results: Patients in ECMO group were younger, more likely to have severely disabled functional status, shorter waitlist time, and were more frequently mechanically ventilated than were patients in the continuous-flow left ventricular assist device group. Kaplan-Meier analysis demonstrated estimated posttransplant survival of 73.1% versus 93.1% at 90 days (P < .001) and 67.4% versus 82.4% at 3 years (P < .001) in ECMO and continuous-flow left ventricular assist device groups, respectively. Analysis of a propensity-matched cohort still demonstrated a lower survival in ECMO group at 90 days (74.8% vs 88.8%; P = .025) and 3 years (69.3% vs 82.2%; P = .054). Among the ECMO patients, multivariable logistic and Cox regression analyses showed model for end-stage liver disease excluding international normalized ratio (MELD-XI) score to be the sole contributor to both 90-day (odds ratio, 1.94; 95% confidence interval, 1.00-3.76; P = .050) and 3-year mortality (hazard ratio, 1.47; 95% confidence interval, 1.16-1.88; P = .002). ECMO-supported patients with a high MELD-XI score (>17) were associated with poor posttransplant survival compared with those with a low MELD-XI score (<13) (90 day, 54.4% vs 85.0% [P < .001] and 3 year, 49.5% vs 73.5% [P < .001])., Conclusions: Bridge to transplant with ECMO was associated with increased early/mid-term mortality, especially in patients with a high MELD-XI score who demonstrated > 50% 3-year mortality. These findings may help to inform future organ allocation policies., (Copyright © 2017 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.)

Background: Pre-existing mitral pathology is common in patients undergoing continuous-flow left ventricular assist device implantation. We sought to investigate whether concurrent mitral repair confers any advantage., Methods: From March 2004 to October 2014, 374 patients received a continuous-flow left ventricular assist device. Of these, a total of 115 patients with pre-existing mitral regurgitation (MR) greater than moderate were identified and included in the analysis. Outcomes were compared between patients with concurrent mitral repair (n = 52 [45.2%]; Group A) and without repair (n = 63 [54.8%]; Group B)., Results: The mean age was 56.8 years and 25 (21.5%) were women. Patients in Group A were more likely to have undergone destination therapy (48.1% vs 11.1%; P < .001) and had a greater cardiopulmonary bypass time (125 vs 89 minutes; P < .001) than did patients in Group B. Longitudinal analysis using a generalized mixed-effects model demonstrated the odds of developing moderate or severe MR during device support were 86% lower for Group A patients (P < .001). Among those who were discharged alive, 9 (8.6%)-consisting of 1 (2.2%) in Group A and 8 (13.6%) in Group B (P = .039)-developed late right heart failure requiring a total of 13 readmissions (0.03 vs 0.15 readmissions per patient-year; P = .011). Multivariable competing risks regression revealed mitral repair to be a protective factor (hazard ratio, 0.16; 95% confidence interval, 0.03-0.94; P = .042) for late right heart failure occurrence., Conclusions: Concurrent mitral repair appears to be efficacious in controlling MR after device implant. The fact that repaired patients developed late right heart failure less frequently than did patients without repair challenges the notion that concurrent mitral repair is unwarranted., (Copyright © 2017. Published by Elsevier Inc.)

Objective: Although the outcomes of patients with cardiogenic shock remain poor, short-term mechanical circulatory support has become an increasingly popular modality for hemodynamic assistance and organ preservation. Because the kidney is exquisitely sensitive to poor perfusion, acute kidney injury is a common sequela of cardiogenic shock. This study examines the incidence and clinical impact of acute kidney injury in patients with short-term mechanical circulatory support for cardiogenic shock., Methods: Retrospective review was performed of 293 consecutive patients with cardiogenic shock who were treated with short-term mechanical circulatory support. The well-validated 2014 Kidney Disease Improving Global Outcomes criteria were used to stage acute kidney injury. Outcomes of interest were long-term mortality and renal recovery., Results: Acute kidney injury developed in 177 of 293 patients (60.4%), of whom 113 (38.6%) were classified with stage 3 (severe). Kaplan-Meier survival estimates indicated a 1-year survival of 49.2% in the nonsevere (stages 0-2) acute kidney injury cohort versus 27.3% in the severe acute kidney injury cohort (P < .001). Multivariable Cox regression demonstrated that severe acute kidney injury was a predictor of long-term mortality (hazard ratio, 1.54; confidence interval, 1.10-2.14; P = .011). Among hospital survivors, renal recovery occurred more frequently (82.4% vs 63.2%, P = .069) and more quickly (5.6 vs 24.5 days, P < .0001) in the nonsevere than in the severe acute kidney injury group., Conclusions: Acute kidney injury is common and frequently severe in patients in cardiogenic shock treated with short-term mechanical circulatory support. Milder acute kidney injury resolves with survival comparable to patients without acute kidney injury. Severe acute kidney injury is an independent predictor of long-term mortality. Nonetheless, many surviving patients with acute kidney injury do experience gradual renal recovery., (Copyright © 2017 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.)

Objective: The role of short-term mechanical circulatory support has increased in patients with refractory cardiogenic shock. However, limited data exist on the outcomes of a bridge to a durable left ventricular assist device strategy using short-term mechanical circulatory support., Methods: We retrospectively reviewed 382 patients who underwent continuous-flow left ventricular assist device insertion between 2004 and 2014. Of these, 45 (12%) were bridged with short-term mechanical circulatory support devices for refractory cardiogenic shock. We analyzed early and midterm outcomes in this bridged cohort. Multivariate Cox proportional hazards modeling was performed to evaluate the predictor of overall death in the entire cohort., Results: The mean age of the bridged cohort was 53 ± 10 years, and 87% were male. The types of initial support included percutaneous devices in 24 patients (53%) and external continuous-flow ventricular assist device in 21 patients (47%). The median duration of short-term mechanical circulatory support was 14.0 (interquartile range, 7.5-29.5) days. The short-term mechanical circulatory support significantly improved end-organ function and hemodynamics. After conversion to durable left ventricular assist device insertion, in-hospital mortality was 18%. The incidence of right ventricular assist device use was high at 27%. The overall survival was 70% and 62% at 1 and 2 years, respectively. Cox multivariate hazard analysis in the entire cohort demonstrated that the use of a postoperative right ventricular assist device was a significant predictor of overall death (hazard ratio, 4.04; P < .001; 95% confidence interval, 1.97-7.94), but the use of a short-term mechanical circulatory support was not (P = .937)., Conclusions: Short-term mechanical circulatory support can optimize patients in refractory cardiogenic shock and serve as a bridge to implantation of a durable left ventricular assist device. However, the early mortality rate after durable left ventricular assist device implantation is high because of unrecognized right ventricular failure., (Copyright © 2016 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.)

Objective: To evaluate sternal healing, complications, and costs after sternotomy closure with rigid plate fixation or wire cerclage., Methods: This prospective, single-blinded, multicenter trial randomized 236 patients at 12 US centers at the time of sternal closure to either rigid plate fixation (n = 116) or wire cerclage (n = 120). The primary endpoint, sternal healing at 6 months, was evaluated by a core laboratory using computed tomography and a 6-point scale (greater scores represent greater healing). Secondary endpoints included sternal complications and costs from the time of sternal closure through 6 months., Results: Rigid plate fixation resulted in better sternal healing scores at 3 (2.6 ± 1.1 vs 1.8 ± 1.0; P < .0001) and 6 months (3.8 ± 1.0 vs 3.3 ± 1.1; P = .0007) and greater sternal union rates at 3 (41% [42/103] vs 16% [16/102]; P < .0001) and 6 months (80% [81/101] vs 67% [67/100]; P = .03) compared with wire cerclage. There were fewer sternal complications through 6 months with rigid plate fixation (0% [0/116] vs 5% [6/120]; P = .03) and a trend towards fewer sternal wound infections (0% [0/116] vs 4.2% [5/120]; P = .06) compared with wire cerclage. Although rigid plate fixation was associated with a trend toward greater index hospitalization costs ($23,437 vs $20,574; P = .11), 6-month follow-up costs tended to be lower ($9002 vs $13,511; P = .14). As a result, total costs from randomization through 6 months were similar between groups ($32,439 vs $34,085; P = .61)., Conclusions: Sternotomy closure with rigid plate fixation resulted in significantly better sternal healing, fewer sternal complications, and no additional cost compared with wire cerclage at 6 months after surgery., (Copyright © 2016 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.)

Objective: To assess outcomes after cardiac transplantation in patients receiving long-term continuous-flow left ventricular assist device (CF-LVAD) support., Methods: The United Network of Organ Sharing Database was used to identify 7808 heart transplant recipients between January 2011 and March 2014, 2456 (31.5%) of whom were bridged with CF-LVAD. Recipients were stratified by CF-LVAD duration: group 1, <1 year (n = 1590; 64.7%); group 2, 1 to 2 years (n = 599; 24.4%); and group 3, >2 years (n = 267; 10.9%)., Results: Compared with patients in groups 1 and 2, patients in group 3 spent more time as status 1A, had a greater body mass index and higher serum creatinine level, more often received blood transfusions and antibiotics, and more often developed device-related infection and life-threatening arrhythmia before transplantation. Kaplan-Meier analysis revealed statistically significant lower survival rates in group 3 compared with groups 1 and 2, at both 30 days (92.9% vs 96.4% vs 95.5%; group 1 vs group 3, P = .009) and 2 years (78.9% vs 88.2% vs 86.3%; group 1 vs group 3, P = .001) posttransplantation. Multivariable analyses identified duration of CF-LVAD support as a significant factor for 2-year posttransplantation mortality (hazard ratio, 1.16; 95% confidence interval, 1.01-1.34; P = .040)., Conclusions: A bridge-to-transplant (BTT) strategy with a CF-LVAD has become standard care for patients with advanced heart failure. Duration of CF-LVAD support is associated with increased midterm mortality, warranting early transplantation in the modern BTT era., (Copyright © 2016. Published by Elsevier Inc.)

Objectives: Severe right ventricular failure often is considered a contraindication for left ventricular assist device (LVAD) therapy and necessitates use of biventricular assist devices (BiVADs). Available options for BiVADs are limited, and comparative outcomes are largely unknown., Methods: Heart transplant candidates who were registered on the United Network for Organ Sharing waitlist and underwent long-term contemporary LVAD (n = 3195) or BiVAD (n = 408) implantation, from January 2010 through June 2014, were retrospectively analyzed. We evaluated clinical characteristics and outcomes of patients requiring a BiVAD, as well as regional differences in utilization of this technology., Results: Patients requiring a BiVAD were younger (48.9 vs 53.3 years), had a higher proportion of nonischemic disease (69.1% vs 58.2%), a higher bilirubin level (0.9 vs 0.7 mg/dL), and a lower 6-month survival rate (68.1% vs 92.7%) after device implantation (all P < .05). Postimplantation and posttransplantation survival was comparable for commonly used BiVAD configurations, including total artificial heart, continuous flow BiVAD, a continuous-flow LVAD coupled with a right-sided device, and pulsatile flow. Significant variation was found in regional utilization of these devices, regardless of differences in transplantation waitlist times. A large body surface area was an independent predictor of mortality on a BiVAD (hazard ratio = 2.12, P = .017)., Conclusions: Outcomes of patients requiring a BiVAD remain poor in the contemporary device era, regardless of the configuration used. Among other clinical factors, body surface area should be incorporated into decision making for device selection in these patients., (Copyright © 2016 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.)

Objective: Patients evaluated for a continuous-flow left ventricular assist device frequently present with severe right ventricular dysfunction with tricuspid regurgitation. Long-term outcomes of concurrent tricuspid valve procedures in continuous-flow left ventricular assist device implantation are unclear., Methods: From May 2004 to December 2013, 336 patients received continuous-flow left ventricular assist devices. Among these, 8 patients with prior tricuspid valve procedures were excluded. At continuous-flow left ventricular assist device implantation, 76 patients underwent tricuspid valve procedures (group A), including 68 repairs and 8 replacements. The remaining 252 patients did not receive concurrent tricuspid valve procedures (group B)., Results: Preoperatively, group A had higher central venous pressure/pulmonary capillary wedge pressure (P = .032), total bilirubin (P = .009), and percentage of moderate or greater tricuspid regurgitation (98.7% vs 18.8%; P < .001). In group A, cardiopulmonary bypass time (136 ± 52.0 minutes vs 83.9 ± 38.8 minutes; P < .001), intraoperative platelet use (13.6 ± 6.70 units vs 11.7 ± 5.92 units; P = .042), and bleeding requiring reoperation (27.5% vs 16.7%; P = .046) were significantly increased. In-hospital mortality was similar (10.5% vs 6.4%; P = .22). On-device 2-year survival was 73.9% in group A and 74.2% in group B (P = .24). At 2 years, mean cumulative readmissions for right heart failure was 0.21 in group A and 0.27 in group B (P = .95). A generalized linear mixed-effects model showed that tricuspid valve procedures are protective for developing future significant tricuspid regurgitation (odds ratio, 0.38; 95% confidence interval, 0.19-0.76; P = .006)., Conclusions: Concomitant tricuspid valve procedures at continuous-flow left ventricular assist device implantation can be performed safely and are protective against worsening tricuspid regurgitation during the first 2 years of support., (Copyright © 2016. Published by Elsevier Inc.)

Objectives: Aortic insufficiency (AI) after continuous-flow left ventricular assist device implantation can affect patient outcomes. Central aortic valve closure (CAVC) is a strategy commonly practiced; however, its efficacy has not been extensively investigated., Methods: From March 2004 to May 2014, a total of 340 patients received a continuous-flow left ventricular assist device (89; 26.2%) as destination therapy (DT). Outcomes were compared between patients with CAVC (n = 57 [16.8%]; group A) versus without repair (n = 283 [83.2%]; group B)., Results: Patients in group A were older, were more likely to be having DT, had a greater cardiopulmonary bypass and aortic crossclamp time, and more often received intraoperative transfusions than did patients in group B. Twenty-three (40.4%) patients in group A had significant pre-existing AI, defined as >mild AI, whereas none did in group B. Kaplan-Meier analysis revealed that freedom from significant AI was 66.7% and 59.9% at 2 years (P = .77) in groups A and B, respectively. In the DT cohort, freedom from significant AI was 78.1% and 41.8% at 2 years (P = .077). A generalized mixed-effects model demonstrated a 57% and 69% decrease in the odds of significant AI progression among repaired patients in the entire and DT cohort, respectively, after adjusting for time effect and degree of baseline pre-existing AI., Conclusions: Despite pre-existing AI, the prevalence of significant AI in patients with CAVC was comparable to the AI in those without pre-existing AI/CAVC. The efficacy of this technique was more evident in DT patients. Thus, CAVC may be an effective and durable strategy, especially in patients who require lengthy device support., (Copyright © 2016 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.)

Objectives: Pulmonary hypertension is often considered a contraindication to orthotopic heart transplantation. Left ventricular assist device support may improve pulmonary hypertension by unloading the left ventricle, making patients eligible for transplantation. We sought to investigate the effect of continuous-flow left ventricular assist device support on pulmonary hypertension and compare post-transplantation outcomes in patients with preexisting pulmonary hypertension., Methods: Between March 2004 and December 2013, 256 potential orthotopic heart transplantation candidates underwent continuous-flow left ventricular assist device implantation at Columbia University. Preimplantation right heart catheterization data were available for 227 patients. Patients were divided into 2 groups on the basis of preimplantation pulmonary vascular resistance: low (<5 Wood units) (n = 182) and high (≥5 Wood units) (n = 45). Postimplantation and post-transplantation outcomes were compared between the groups., Results: Pulmonary vascular resistance in the high resistance group decreased significantly during left ventricular assist device support (P < .001). Post-transplantation in-hospital mortality was significantly higher in patients with high vascular resistance (P < .05). However, 3-year survival after transplantation was similar between groups (85.0% and 79.0% for low and high vascular resistance, respectively; P = .45)., Conclusions: Continuous-flow left ventricular assist device therapy reduced pulmonary vascular resistance. Subsequent orthotopic heart transplantation in patients with significantly elevated pulmonary vascular resistance resulted in higher in-hospital mortality but similar 3-year survival., (Copyright © 2015 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.)

Objectives: To facilitate venoarterial extracorporeal membrane oxygenation (ECMO) insertion for cardiogenic shock, we recently adopted a strategy of using a 15F arterial cannula in all patients, rather than 1 designed to maximize flow. We aimed to compare the clinical outcomes of these 2 strategies., Methods: In this retrospective study, 101 consecutive patients supported with ECMO via femoral cannulation between March 2007 and March 2013 were divided into 2 groups: Group L (17F-24F arterial cannula to accommodate full flow [ie, cardiac index of 2.5 L/m(2)/min]; n = 51) and Group S (15F arterial cannula; n = 50). The primary outcomes of interest were patients' overall status at 24 hours of support and cannulation-related adverse events., Results: There were no significant differences in patient demographics, etiology of cardiogenic shock, or severity of illness before ECMO initiation between the 2 groups. Group L had significantly higher ECMO flow than Group S (flow index at 24 hours: 2.2 ± 0.7 vs 1.7 ± 0.3 L/m(2)/min; P < .001). However, there was no significant difference in use of vasoactive medication/hemodynamic parameters/laboratory parameters. Group L had higher incidence of cannulation-related adverse events (35% vs 22% in Group S [P = .14]), particularly in cannulation site bleeding (28% vs 10% [P = .03]). Thirty-day survival was 55% in Group L versus 52% in Group S (P = .77). Bleeding complication occurred in 53% in Group L versus 32% in Group S (P = .03)., Conclusions: Compared with the use of larger cannulas, ECMO with a 15F arterial cannula appears to provide comparable clinical support with reduced bleeding complications., (Copyright © 2015 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.)

Objectives: Recent advances in technology and improved patient management have enabled the use of mechanical circulatory support for unexpected long-term periods. Improved long-term outcomes may facilitate the use of device therapy as an alternative to heart transplantation. However, there are scarce data about the long-term outcomes of continuous-flow left ventricular assist devices. This study sought to evaluate the long-term outcomes in patients receiving continuous-flow left ventricular assist devices., Methods: Between March 2004 and June 2010, 140 patients underwent continuous-flow left ventricular assist device insertion as a bridge to transplantation or a destination therapy. These patients' charts were retrospectively reviewed., Results: The initial strategy for continuous-flow left ventricular assist device therapy was bridge to transplantation in 115 patients (82%) and destination therapy in 25 patients (18%). Of those, 24 (17%) died on left ventricular assist device support, 94 (67%) were successfully bridged to transplantation, and 1 (0.71%) showed native heart recovery. Twenty-four patients (17%) had been on continuous-flow left ventricular assist device support for more than 3 years (mean, 3.9 years; range, 3.0-7.5 years). Estimated on-device survival at 1, 3, and 5 years was 83%, 75%, and 61%, respectively. Rehospitalizations due to bleeding, cardiac events, and device-related issues were common. The freedom from rehospitalization rates at 1 and 3 years was 31% and 6.9%, respectively. A total of 14 patients (10%) required device exchange., Conclusions: Current continuous-flow left ventricular assist devices can provide satisfactory long-term survival. However, rehospitalization is frequently required., (Copyright © 2014 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.)

Background: Preexisting valve pathology is common in patients with end-stage heart failure undergoing left ventricular assist device (LVAD) placement. The indications and subsequent benefits of performing valvular procedures in these patients are unclear. The objective of this study was to determine the impact of performing concurrent surgical valve procedures in a large cohort of patients receiving LVADs., Methods: One thousand one hundred six patients received the HeartMate II (HMII) LVAD in the bridge to transplant (n = 470) and destination therapy (n = 636) clinical trials. Of these, 374 patients (34%) had concurrent cardiac surgery procedures as follows: 242 patients (21%) with 281 concurrent valve procedures (VP) (aortic 80, mitral 45, and tricuspid 156), and 641 patients had only HMII LVAD. The focus of this study was to determine the clinical outcomes of patients undergoing HMII + VP compared with those who received HMII alone., Results: Patients undergoing HMII + VP were significantly older, had higher blood urea nitrogen levels and central venous pressure, and decreased right ventricular stroke work index; intraoperatively, the median cardiopulmonary bypass times were also longer. The unadjusted 30-day mortality was significantly higher in patients undergoing HMII + VP (10.3% vs 4.8% for LVAD alone, P = .005). Subgroup analysis of individual VPs showed that higher mortality occurred in patients with HMII plus 2 or more VPs (13.5%, P = .04) followed by trends for increased mortality with HMII plus mitral alone (11.5%, P = NS), HMII plus aortic alone (10.9%, P = NS), and HMII plus tricuspid (8.9%, P = NS) procedures. Of these various groups, only patients undergoing HMII + isolated aortic VP (P = .001) and HMII + multiple VPs (P = .046) had significantly worse long-term survival compared with patients undergoing HMII alone. Right heart failure and right ventricular assist device use was increased in patients undergoing VPs, but there was no difference in the incidence of bleeding or stroke., Conclusions: Patients frequently require concurrent VPs at the time of LVAD placement; these patients are sicker and have higher early mortality. Furthermore, right ventricular dysfunction is increased in these patients. Further studies to develop selection criteria for concurrent valve interventions are important to further improve clinical outcomes., (Copyright © 2014 The American Association for Thoracic Surgery. Published by Mosby, Inc. All rights reserved.)

Objectives: Cardiogenic shock after cardiac surgery is accompanied by a high mortality rate. Early institution of hemodynamic support with a versatile, easy to insert left ventricular assist device might help bridge patients to recovery or to the next therapy, and improve the outcomes., Methods: Patients developing cardiogenic shock or low cardiac output syndrome after being weaned off cardiopulmonary bypass were enrolled in a prospective single-arm feasibility study (RECOVER I). The primary safety endpoint was the frequency of major adverse events (death, stroke) at 30 days or discharge, whichever was longer. The primary efficacy endpoint was survival of the patient to implementation of the next therapy, which included recovery at 30 days after device removal and bridge-to-other-therapy., Results: Sixteen patients provided informed consent and were enrolled in the study. Hemodynamics improved immediately after the initiation of mechanical support: cardiac index, 1.65 versus 2.7 L/min/m(2) (P = .0001); mean arterial pressure, 71.4 versus 83.1 mm Hg (P = .01); and pulmonary artery diastolic pressure, 28.0 versus 19.8 mm Hg (P < .0001). The pump provided an average of 4.0 ± 0.6 L/min of flow for an average duration of 3.7 ± 2.9 days (range, 1.7-12.6). The primary safety endpoint occurred in 2 patients (13%; 1 stroke and 1 death). For the primary efficacy endpoint, recovery of the native heart function was obtained in 93% of the patients discharged, with bridge-to-other-therapy in 7%. Survival to 30 days, 3 months, and 1 year was 94%, 81%, and 75%, respectively., Conclusions: The use of the Impella 5.0/left direct device is safe and feasible in patients presenting with postcardiotomy cardiogenic shock. The device was rapidly inserted, enabled early support, and yielded favorable outcomes., (Copyright © 2013. Published by Mosby, Inc.)

Cardiogenic shock remains a deadly complication of acute myocardial infarction (MI). Early revascularization, inotropic support, and intraaortic balloon counterpulsation are the mainstays of treatment, but these are not always sufficient. New mechanical approaches, both percutaneous and surgical, are available in this high-risk population. We present a case of a young woman with a massive anterior wall MI and subsequent cardiogenic shock who was treated with advanced mechanical circulatory support. This case serves as an illustration of the stepwise escalation of mechanical support that can be applied in a patient with an acute MI complicated by refractory cardiogenic shock. We also review the literature with regard to the use of percutaneous left ventricular assist devices in the setting of cardiogenic shock., (Copyright © 2012 Elsevier Inc. All rights reserved.)

Objective: Most studies of anastomotic technique have been underpowered to detect subtle differences in survival. We analyzed the United Network for Organ Sharing database for trends in use and outcomes after either bicaval or traditional (biatrial) anastomoses for heart implantation., Methods: Review of United Network for Organ Sharing data identified 20,999 recipients of heart transplants from 1997 to 2007. Patients were stratified based on the technique of atrial anastomosis: standard biatrial (atrial group, n = 11,919, 59.3%), bicaval (caval group, n = 7661, 38.1%), or total orthotopic (total group, n = 519, 2.6%)., Results: The use of the bicaval anastomosis is increasing, but many transplantations continue to use a biatrial anastomosis (1997, 0.2% vs 97.6%; 2007, 62.0% vs 34.7%; P < .0001). Atrial group patients required permanent pacemaker implantation more often (odds ratio, 2.6; 95% confidence interval, 2.2-3.1). Caval group patients had a significant advantage in 30-day mortality (odds ratio, 0.83; 95% confidence interval, 0.75-0.93), and Cox regression analysis confirmed the decreased long-term survival in the atrial group (hazard ratio, 1.11; 95% confidence interval, 1.04-1.19)., Conclusions: Heart transplantations performed with bicaval anastomoses require postoperative permanent pacemaker implantation at lower frequency and have a small but significant survival advantage compared with biatrial anastomoses. We recommend that except where technical considerations require a biatrial technique, bicaval anastomoses should be performed for heart transplantation., (2010 The American Association for Thoracic Surgery. Published by Mosby, Inc. All rights reserved.)

Objective: Although left ventricular assist devices (LVADs) are associated with excellent outcomes in patients with end-stage heart failure, there are conflicting reports on posttransplant survival in these patients. Furthermore, prior studies with pulsatile LVADs have shown that transplantation, either early (<6 weeks) or late (>6 months) after LVAD implantation, adversely affected post-cardiac transplant survival. We sought to determine factors related to posttransplant survival in patients supported with continuous-flow LVADs., Methods: The HeartMate II LVAD (Thoratec Corporation, Pleasanton, Calif) was implanted in 468 patients as a bridge to transplant at 36 centers in a multicenter trial. Patients who underwent transplantation after support were stratified by demographics: gender, age, etiology, body mass index, duration of device support, and by adverse events during support. The median age was 54 years (range 18-73 years); 43% had ischemic etiology, and 18% were women. Survival was determined at the specific intervals of 30 days and 1 year after transplantation., Results: Of 468 patients, 250 (53%) underwent cardiac transplant after a median duration of LVAD support of 151 days (longest: 3.2 years), 106 (23%) died, 12 (2.6%) recovered ventricular function and the device was removed, and 100 (21%) were still receiving LVAD support. The overall 30-day and 1-year posttransplant survivals were 97% and 87%. There were no significant differences in survival based on demographic factors or LVAD duration of less than 30 days, 30 to 90 days, 90 to 180 days, and more than 180 days. Patients requiring more than 2 units of packed red blood cells in 24 hours during LVAD support had a statistically significant decreased 1-year survival (82% vs 94%) when compared with patients who did not require more than 2 units of packed red blood cells in 24 hours during LVAD support (P = .03). There was a trend for slightly lower survival at 1 year in patients with percutaneous lead infections during LVAD support versus no infection (75% vs 89%; P = .07)., Conclusions: Post-cardiac transplant survival in patients supported with continuous-flow devices such as the HeartMate II LVAD is equivalent to that with conventional transplantation. Furthermore, posttransplant survival is not influenced by the duration of LVAD support. The improved durability and reduced short- and long-term morbidity associated with the HeartMate II LVAD has reduced the need for urgent cardiac transplantation, which may have adversely influenced survival in the pulsatile LVAD era. This information may have significant implications for changing the current United Network for Organ Sharing criteria regarding listing of heart transplant candidates., (2010 The American Association for Thoracic Surgery. Published by Mosby, Inc. All rights reserved.)

Background: The purpose of this study was to compare posttransplantation morbidity and mortality in orthotopic heart transplant recipients bridged to transplant with a left ventricular assist device with nonbridged recipients. To account for potential differences across device types, we stratified bridge-to-transplant recipients by type of ventricular assist device: extracorporeal (EXTRA), paracorporeal (PARA), and intracorporeal (INTRA)., Methods: The United Network for Organ Sharing provided de-identified patient-level data. The study population included 10,668 orthotopic heart transplant recipients aged 18 years old or older and undergoing transplantation between January 1, 2001, and December 31, 2006. Follow-up data were provided through August 3, 2008, with a mean follow-up time of 3.17 +/- 2.15 years (range, 0-8.11 years). The primary outcome was actuarial posttransplant graft survival. Other outcomes of interest included infection, stroke, and dialysis during the transplant hospitalization; primary graft failure at 30 days; transplant hospitalization length of stay; and long-term complications including diabetes mellitus, transplant coronary artery disease, and chronic dialysis. Multivariable Cox proportional hazards regression (backward, P < .15) was used to determine the relationship between groups and overall graft survival, and multivariable logistic regression analysis (backward, P < .15) was used to determine the relationship between groups and secondary outcome measures., Results: In multivariable Cox regression analysis, when compared with the nonbridged group, risk-adjusted greater than 90-day graft survival was diminished among the EXTRA group (hazard ratio = 3.54, 2.28-5.51, P < .001), but not the INTRA group (1.04, 0.719-1.51, P = .834) or the PARA group (1.06, 0.642-1.76, P = .809). There were no significant differences in risk-adjusted graft survival across the 4 groups during the 90-days to 1-year or 1- to 5-year intervals. However, at more than 5 years, risk-adjusted graft survival in the INTRA group (0.389, 0.205-0.738, P = .004) was better than in the nonbridged group. The EXTRA, PARA, and INTRA groups all experienced increased risks of infection. The EXTRA group had increased risks of dialysis, stroke, and primary graft failure at 30 days, whereas neither the PARA nor the INTRA group differed from the nonbridged group. Long-term complications did not differ by group., Conclusion: The use of implantable left ventricular assist devices as bridges to transplantation, including both intracorporeal and paracorporeal devices, is not associated with diminished posttransplant survival. However, 90-day survival was diminished in recipients bridged with extracorporeal devices.

Objective: Biomaterials and textured surfaces in early pulsatile left ventricular assist devices (HeartMate I; Thoratec Corporation, Pleasanton, Calif) may increase immunologic risk through allosensitization. We hypothesized that axial-flow devices without biologic membranes or textured surfaces (HeartMate II; Thoratec; and DeBakey; MicroMed Cardiovascular, Inc, Houston, Tex) would cause less allosensitization than devices with such membranes and surfaces., Methods: HeartMate II and DeBakey (n = 24) and HeartMate I (n = 36) devices were implanted from 1999 to 2006 in patients with severe heart failure cohort-matched for age, etiology, and support duration. Serum samples reacting with more than 10% of the HLA reference panel were considered positive for anti-HLA antibodies. Endomyocardial biopsy samples were collected after transplant., Results: There were no significant cohort differences in age, etiology, sex, blood transfusion, or support duration. Anti-HLA antibodies were not detected at implantation of either HeartMate II and DeBakey or HeartMate I devices; however, significant increases in anti-HLA antibodies were present within 1 and 3 months of support with HeartMate I but not HeartMate II and DeBakey devices. Overall, fewer patients with HeartMate II and DeBakey devices demonstrated positive anti-HLA antibodies during support (8% vs 28%, P = .02), and fewer episodes of acute rejection per patient were seen within the first 9 posttransplant months(0.31 vs 0.69, P = .052). Long-term posttransplant survival was not different between groups., Conclusion: Hemodynamic support with HeartMate II and DeBakey devices produced less allosensitization than did HeartMate I devices. Device selection may improve clinical outcomes for high-risk patients.

Objective: Infections are among the most common and serious complications of ventricular assist device implantation. These infections generally occur within the first 2 months after surgery. The basis for this high incidence of infection is not well established, so a murine intravascular infection model was developed with aortic implantation of the textured polyurethane patch material currently used in HeartMate ventricular assist devices (Thoratec Corporation Pleasanton, Calif)., Methods: Polyurethane patch material was placed in the wall of the mouse descending aorta. Mice were then infected with Staphylococcus aureus 1 or 14 days after implantation. In vitro adhesion studies were conducted with polyurethane membranes coated with endothelial cells and membranes coated with fibrinogen., Results: Mice were susceptible to infection in both dose- and time-dependent fashions. The patch material was significantly more susceptible to infection at day 1 than day 14. Immunohistologic and morphologic studies demonstrated that the CD31+ cells deposited on the membrane surface phenotypically appeared to be endothelial cells. In vitro adhesion studies of polyurethane membranes coated with endothelial cells showed them to be less susceptible to S. aureus binding than were membranes coated with fibrinogen., Conclusion: Textured polyurethane membranes are less susceptible to infection as cellular deposition occurs. The time frame within which these membranes become populated with cellular material is consistent with the time-dependent clinical incidence of infection. Cellular coating of polyurethane may provide a strategy for reducing the risk of infection.

Objectives: (1) To examine the interaction of donor age with ischemic time and their effect on survival and (2) to define ranges of ischemic time associated with differences in survival., Methods: The United Network for Organ Sharing provided de-identified patient-level data. The study population included 33,640 recipients undergoing heart transplantation between October 1, 1987, and December 31, 2004. Recipients were divided by donor age into terciles: 0 to 19 years (n = 10,814; 32.1%), 20 to 33 years (11,410, 33.9%), and 34 years or more (11,416, 33.9%). Kaplan-Meier survival functions and Cox regression were used for time-to-event analysis. Receiver operating characteristic curves and stratum-specific likelihood ratios were generated to compare 5-year survival at various thresholds for ischemic time., Results: In univariate Cox proportional hazards regression, the effect of ischemic time on survival varied by donor age tercile: 0 to 19 years (P = .141), 20 to 33 years (P < .001), and 34 years or more (P < .001). These relationships persisted in multivariable regression. Threshold analysis generated a single stratum (0.37-12.00 hours) in the 0- to 19-year-old group with a median survival of 11.4 years. However, in the 20- to 33-year-old-group, 3 strata were generated: 0.00 to 3.49 hours (limited), 3.50 to 6.24 hours (prolonged), and 6.25 hours or more (extended), with median survivals of 10.6, 9.9, and 7.3 years, respectively. Likewise, 3 strata were generated in the group aged 34 years or more: 0.00 to 3.49 (limited), 3.50 to 5.49 (prolonged), and 5.50 or more (extended), with median survivals of 9.1, 8.5, and 6.3 years, respectively., Conclusions: The effect of ischemic time on survival after heart transplantation is dependent on donor age, with greater tolerance for prolonged ischemic times among grafts from younger donors. Both donor age and anticipated ischemic time must be considered when assessing a potential donor.

Objective: The use of left ventricular assist devices as a bridge to transplantation for patients with chronic congestive heart failure is well accepted. However, few studies have examined outcomes solely for these patients. This study details one center's left ventricular assist device experience with this population., Methods: Two hundred one patients received HeartMate left ventricular assist devices (Thoratec Corp, Pleasanton, Calif) from January 1, 1996, to April 30, 2004. Of these, 119 (59.2%) had chronic congestive heart failure (diagnosis >6 months) as the primary indication. Outcome parameters included early mortality after left ventricular assist device placement (<30 days), bridge-to-transplantation rate, and posttransplantation survival. Variables examined included patient demographic data; preoperative pacemaker, internal defibrillator, and balloon pump use; and preoperative laboratory values., Results: Advanced age, female sex, and diabetes were independent predictors of early death (P = .048, odds ratio 1.879 per 10 years of age, 95% confidence interval 1.005-3.515; P = .002, odds ratio 10.029, 95% confidence interval 2.256-44.583; P = .040, odds ratio 3.974, 95% confidence interval 1.063-14.861). Advanced age, female sex, and low preoperative albumin were independent predictors of poor bridge-to-transplantation rate (P = .029, odds ratio 0.135 per 10 years of age, 95% confidence interval 0.022-0.819; P = .002, odds ratio 0.013, 95% confidence interval 0.001-0.197; P = .023, odds ratio 19.178 per 1 g/dL albumin, 95% confidence interval 1.504-244.598). There were no independent predictors of poor posttransplantation survival and prolonged intensive care unit stay. Overall bridge-to-transplantation rate was 81.5%. The 1-, 3-, 5-, and 7-year posttransplantation survivals were 88.4%, 84.5%, 78.4%, and 76.0%., Conclusion: Among patients with chronic congestive heart failure, advanced age, female sex, diabetes, and low preoperative albumin predict poor clinical course. Careful risk stratification and comprehensive evaluation by care providers should be performed for candidates who are female, are elderly, and have diabetes, and preoperative nutritional optimization should be encouraged to enhance patient outcomes.