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Background: Current treatment recommendations for patients with heart failure and secondary mitral regurgitation include transcatheter edge-to-edge repair and mitral-valve surgery. Data from randomized trials comparing these therapies are lacking in this patient population., Methods: In this noninferiority trial conducted in Germany, patients with heart failure and secondary mitral regurgitation who continued to have symptoms despite guideline-directed medical therapy were randomly assigned, in a 1:1 ratio, to undergo either transcatheter edge-to-edge repair (intervention group) or surgical mitral-valve repair or replacement (surgery group). The primary efficacy end point was a composite of death, hospitalization for heart failure, mitral-valve reintervention, implantation of an assist device, or stroke within 1 year after the procedure. The primary safety end point was a composite of major adverse events within 30 days after the procedure., Results: A total of 210 patients underwent randomization. The mean (±SD) age of the patients was 70.5±7.9 years, 39.9% were women, and the mean left ventricular ejection fraction was 43.0±11.7%. Within 1 year, at least one of the components of the primary efficacy end point occurred in 16 of the 96 patients with available data (16.7%) in the intervention group and in 20 of the 89 with available data (22.5%) in the surgery group (estimated mean difference, -6 percentage points; 95% confidence interval [CI], -17 to 6; P<0.001 for noninferiority). A primary safety end-point event occurred in 15 of the 101 patients with available data (14.9%) in the intervention group and in 51 of the 93 patients with available data (54.8%) in the surgery group (estimated mean difference, -40 percentage points; 95% CI, -51 to -27; P<0.001)., Conclusions: Among patients with heart failure and secondary mitral regurgitation, transcatheter edge-to-edge repair was noninferior to mitral-valve surgery with respect to a composite of death, rehospitalization for heart failure, stroke, reintervention, or implantation of an assist device in the left ventricle at 1 year. (Funded by Abbott Vascular; MATTERHORN ClinicalTrials.gov number, NCT02371512.)., (Copyright © 2024 Massachusetts Medical Society.)

Background: The study aimed to evaluate the changes of left ventricular diastolic function and the improvement of clinical symptoms in hypertrophic cardiomyopathy (HCM) patients with heart failure with preserved ejection fraction (HFpEF) after percutaneous intramyocardial septal radiofrequency ablation (PIMSRA)., Methods: This study enrolled 31 adult HCM patients with HFpEF who underwent PIMSRA treatment. Electrocardiogram, imaging, and blood biochemical examinations were performed on these patients during a 6-month follow-up., Results: Compared with the baseline, at 6 months after PIMSRA, patients showed significant reductions in peak left ventricular outflow tract pressure gradients (resting gradient: from a mean of 83.24 to 23.40 mmHg, p < 0.001; postexercise gradient: from a mean of 109.70 to 33.39 mmHg, p< 0.001). The interventricular septal thickness reduced from a mean of 22.90 to 17.48 mm, p < 0.001. The E/e' decreased from a median of 18.67 to 11.54, p < 0.001. The 6-minute walk distance (6MWD) increased from a mean of 359.03 to 435.81 m, p < 0.001. The Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ OS) increased from a mean of 57.57 to 71.93, p < 0.001. The number of HFpEF patients diagnosed according to the European Society of Cardiology's Heart Failure Association HFA-PEFF score decreased from 31 to 23. None of the patients had new-onset bundle branch block or complete heart block after PIMSRA., Conclusion: PIMSRA is a safe and effective treatment. It can improve left ventricular diastolic function and quality of life in HCM patients., (© 2024 Wiley Periodicals LLC.)

Background: In October 2018, the US heart transplant (HT) allocation system was revised giving patients with left ventricular assist device (LVAD) intermediate priority status. Few studies have examined the impact of this policy change on outcomes among patients with LVAD. We sought to determine how the allocation change impacted waitlist and posttransplant mortality in patients with LVAD., Methods: We retrospectively assessed the United Network for Organ Sharing registry for patients with LVAD who were listed for or underwent HT between October 2016 and October 2021. We evaluated waitlist mortality using competing risks analysis and a multivariable Fine-Gray model, and posttransplant mortality using Kaplan-Meier survival analysis and a multivariate proportional hazards model., Results: We analyzed data from 3835 patients with LVAD listed for HT and 3486 patients with LVAD who underwent HT during the study period. Listing for HT preallocation change was significantly associated with an increased risk of waitlist mortality (Gray P =0.0058) compared with postallocation change. After adjustment for covariates, mortality differences by listing era were attenuated, but LVAD brand was significantly associated with waitlist mortality (HM3 versus HMII; hazard ratio, 0.38 [95% CI, 0.21-0.69]; P =0.002; HVAD versus HMII; hazard ratio, 0.79 [95% CI, 0.48-1.30]; P =0.36; overall P =0.004). In contrast, HT postallocation change was associated with increased posttransplant mortality (log-rank P =0.0172) compared with preallocation change. In a multivariable analysis, the association with posttransplant mortality between transplant eras was attenuated, but ischemic time (hazard ratio, 1.16 [95% CI, 1.07-1.26]; P <0.001) and status at time of HT (Status 1-3 versus 4; hazard ratio, 1.29 [95% CI, 1.04-1.61]; P =0.02) were significantly associated with posttransplant mortality., Conclusions: Among patients with LVAD, lower waitlist mortality postallocation change was likely driven by improved LVAD technology. Higher posttransplant mortality following the allocation change was largely attributable to longer ischemic times and patient acuity., Competing Interests: Dr Pham serves as a consultant for Abbott, Abiomed, and Medtronic. Dr Wilcox serves as a consultant for Amgen and Abbott and is on the advisory board of Cytokinetics. The other authors report no conflicts.

Background: The impact of continuous flow resulting from contemporary left ventricular assist devices (LVAD) on renal vascular physiology is unknown. Renal resistive index (RRI) reflects arterial compliance, as well as renal vascular resistance, contributed by afferent and efferent arteriolar tone, the renal interstitium as well as renal venous pressures., Methods: Prospective, single center study with renal Doppler evaluation at baseline (pre-implant) and at 3-months support. Outcomes assessed include need for post-operative renal replacement therapy (RRT), worsening renal function (WRF) defined as persistent increase from pre-implant KDIGO chronic kidney disease stage, right ventricular (RV) failure, and survival to transplantation., Results: Pre-implant RRI did not predict cardiorenal outcomes including right heart failure, need for renal replacement therapy or worsening renal function. Post-implant RRI was significantly lower than pre-implant RRI, with a distinct Doppler waveform characteristic of continuous flow. Post-implant renal end-diastolic velocity, but not RRI, correlated strongly with LVAD flow (Spearman rho -0.99, p < 0.001), with trend toward correlation with mean arterial pressure (Spearman's rho 0.63, p = 0.129). There was a negative correlation between post-implant RRI and mean pulmonary artery pressure (Spearman's rho -0.81, p = 0.049), likely driven by elevated pulmonary capillary wedge pressure (Spearman's rho -0.83, p = 0.058)., Conclusion: The hemodynamic contributors to RRI in LVAD supported patients are complex. Higher mean pulmonary artery and pulmonary capillary wedge pressures seen in lower RRI may reflect a smaller difference in systolic and diastolic flow. Future simultaneous Doppler assessment of the LVAD outflow graft and RRI may help understand the hemodynamic interactions contributing to this index., (© 2024 International Center for Artificial Organ and Transplantation (ICAOT) and Wiley Periodicals LLC.)

Background: Patients have substantial variability in perioperative outcomes after left ventricular assist device (LVAD) implant. A perioperative multidimensional tool integrating mortality, adverse events (AEs), and patient-reported outcomes to assist in quality improvement initiatives is needed., Methods: Patients undergoing HeartMate 3 LVAD implant (January 1, 2017 to January 31, 2024) in the Society of Thoracic Surgeons' Intermacs registry were studied. Cox proportional hazard multivariable analyses incorporating AEs as time-varying covariates for mortality out to 180 days was used to generate the INtermacs Short term composITE quality score (INSITE score derivation), reflecting the adjusted hazard ratio (HR) for mortality contributed by each AE, applying the global ranking methodology. In those alive and on support at 6 months, multivariable logistic regression (odds ratio) was used to examine the impact of AEs on health-related quality of life (QOL) at 180 days, captured through the INSITE-QOL score. Failure to achieve ≥1 point increase in visual analog scale from baseline was the event., Results: Of 13,148 patients, 4,389 (33.4%) suffered at least 1 AE or death through 180 days. Stroke (survival: HR 13.1; QOL: HR 1.7), dialysis (survival: HR 31.4; QOL: HR 4.2), prolonged respiratory failure (survival: HR 5.7; QOL: HR 2.3), reoperation (survival: HR 3.4; QOL: HR 1.6), and right heart failure (survival: 5.0; QOL: HR 1.4), contributed to both mortality and failure to improve QOL at 180 days (all p < 0.05). The median INSITE and INSITE-QOL scores were 0.0 [0.0, 1.6] and 0.0 [0.0, 0.0], respectively. At 9.4% (n = 17) of centers, a high INSITE score (≥13) was present in 15% of patients, while the top 25% of centers had perfect INSITE-QOL scores in at least 75% of patients., Conclusions: AEs after LVAD confer differential impact on mortality and QOL, enabling the development of global rank outcome scores. Given the high mortality hazard conferred by 180-day AEs, center-specific quality interventions aimed at reducing early complications provide the greatest opportunity to improve long-term survival and QOL., (Copyright © 2024 International Society for the Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.)

Introduction and Objectives: Our aim was to describe the characteristics and outcomes of heart transplants in Spain., Methods: We analyzed trends in recipient and donor characteristics, recipient-donor interaction, surgical procedures, immunosuppression, and outcomes of patients included in the Spanish heart transplant registry from 2014 to 2023. Changes in survival were analyzed using the Kaplan-Meier method., Results: In 2023, 325 cardiac transplants were performed (4.5% more than in the previous year), with a total of 2987 procedures from 2014 to 2023. There was a trend toward performing more transplants in women (29.2%), with etiologies other than cardiomyopathy (32.6%), and with better pretransplant status (less hepatic [12.5%], renal [glomerular filtration rate, 81.5mL/min/1.73 m 2 ], and respiratory [8.7%] involvement). In 2023, the number of urgent transplants increased (44% of the total), especially those performed after circulatory support with extracorporeal membrane oxygenation (36% of total assistance), and transplants performed with donation after circulatory death (17.9%). Survival improved in the triennium from 2020 to 2022 compared with 2014 to 2016 (83.0% at 1 year from 2020-2022 vs 79.0% from 2014-2016)., Conclusions: The number of transplants performed in Spain showed an upward trend, with recipients with better clinical status and an increasing use of donation after circulatory death. Survival improved in the last triennium., (Copyright © 2024 Sociedad Española de Cardiología. Published by Elsevier España, S.L.U. All rights reserved.)

Frailty is associated with poor clinical outcomes in heart failure patients. The impact of frailty on outcomes following left ventricular assist device (LVAD) implantation, however, is less clearly defined. We therefore sought to conduct a systematic review to evaluate current frailty assessment strategies and their significance for patients undergoing LVAD implantation. We conducted a comprehensive electronic search of PubMed, Embase, and CINAHL databases from inception until April 2021 for studies examining frailty in patients undergoing LVAD implantation. Study characteristics, patient demographics, type of frailty measurement, and outcomes were extracted. Outcomes were organized into 5 basic categories: implant length of stay (iLOS), 1-year mortality, rehospitalization, adverse events, and quality of life (QOL). Of the 260 records retrieved, 23 studies involving 4935 patients satisfied the inclusion criteria. Approaches to measuring frailty varied, with the 2 most common being sarcopenia determined by computed tomography and Fried's frailty phenotype assessment. Outcomes of interest were also widely variable, with iLOS stay and mortality being the most frequently reported, albeit with differing definitions of both between studies. The heterogeneity among included studies precluded quantitative synthesis. Narrative synthesis showed that frailty by any measure is more likely to be associated with higher mortality, longer iLOS, more adverse events and worse QOL post-LVAD implant. Frailty can be a valuable prognostic indicator in patients undergoing LVAD implantation. Further studies are needed to determine the most sensitive frailty assessment, as well as the ways in which frailty may serve as a modifiable target to improve outcomes following LVAD implantation., Competing Interests: Disclosure: The authors have no conflicts of interest to report., (Copyright © 2023 Wolters Kluwer Health, Inc. All rights reserved.)

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.)

Mechanical circulatory support devices have profoundly transformed the management of severe cardiothoracic disorders. While heart transplantation is the gold standard therapy for end-stage heart disease, long-term mechanical support devices are a viable alternative for those ineligible and/or those awaiting organ availability. Major technological advancements were made over first 5 decades of development, resulting in improved durability and survival with reduced adverse events. However, gains have tapered recently for various complications (e.g., internal bleeding, multisystem organ failure), which collectively represent a significant proportion of disability and/or mortality. Further, in light of mature ventricular assist devices failing during clinical trials or even after clinical approval (class I withdrawals), it is timely to consider: Are our preclinical assessment protocols vital in the design and development of mechanical circulatory support devices, providing a realistic and reliable profile of future clinical performance? This commentary explores this question and analyses development pathways through the lens of the various disciplines involved in the preclinical assessment of mechanical circulatory support technologies: Limitations in approaches to benchtop blood testing, computational design and simulation, and animal testing are discussed as likely contributors to some of the common hemocompatibility-related adverse events (HRAEs). While it is acknowledged that some shortcomings are pragmatic in nature, possible solutions are presented that will only be realized through truly transdisciplinary and open approaches that challenge the current nature of medical device development. We suggest that these can and must be overcome to diminish HRAEs and will potentially demarcate the fourth generation of cardiac assist devices., (Copyright © 2024 International Society for the Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.)

Background: Sarcopenia is underappreciated in advanced heart failure and is not routinely assessed. In patients receiving a left ventricular assist device, preoperative sarcopenia, defined by using computed-tomography (CT)-derived pectoralis muscle-area index (muscle area indexed to body-surface area), is an independent predictor of postoperative mortality. The association between preoperative sarcopenia and outcomes after heart transplant (HT) is unknown., Objectives: The primary aim of this study was to determine whether preoperative sarcopenia, diagnosed using the pectoralis muscle-area index, is an independent predictor of days alive and out of the hospital (DAOHs) post-transplant., Methods: Patients who underwent HT between January, 2018, and June, 2022, with available preoperative chest CT scans were included. Sarcopenia was diagnosed as pectoralis muscle-area index in the lowest sex-specific tertile. The primary endpoint was DAOHs at 1 year post-transplant., Results: The study included 169 patients. Patients with sarcopenia (n = 55) had fewer DAOHs compared to those without sarcopenia, with a median difference of 17 days (320 vs 337 days; P = 0.004). Patients with sarcopenia had longer index hospitalizations and were also more likely to be discharged to a facility other than home. In a Poisson regression model, sarcopenia was a significant univariable and the strongest multivariable predictor of DAOHs at 1 year (parameter estimate = -0.17, 95% CI -0.19 to -14; P = < 0.0001)., Conclusions: Preoperative sarcopenia, diagnosed using the pectoralis muscle-area index, is an independent predictor of poor outcomes after HT. This parameter is easily measurable from commonly obtained preoperative CT scans and may be considered in transplant evaluations., Competing Interests: Disclosures There were no outside sources of funding for this study., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Background: Left ventricular assist devices (LVADs) are well-established for treating end-stage heart failure, but this therapy is only available to Chinese patients in recent years. The CH-VAD is the first used fully magnetically levitated pump in China. This study reports the long-term outcomes of a cohort supported by the CH-VAD for the first time., Methods: From June 2017 to August 2023, 50 consecutive patients received CH-VAD implantation in Fuwai Hospital. Clinical data were collected and retrospectively analyzed., Results: Baseline characteristics included a mean age of 47.9 ± 13.9 years, 90% male, and 26% ischemic etiology. The Interagency Registry for Mechanically Assisted Circulatory Support profile revealed 12% profile 1, 56% profile 2, 26% profile 3, and 6% profile 4. The mean support duration was 868 ± 630 days (range 33 days-6.4 years). Kaplan-Meier survival rate was 93% (95% CI, 79-98) at 1 year, 93% (95% CI, 79-98) at 2 years, and 89% (95% CI, 71-96) at 3 years. Forty patients (80%) currently remain on support, 3 were bridged to recovery, 2 received transplants, and 5 expired during support. Major adverse events (AEs) included right heart failure (10%), surgical-related bleeding (8%), arrhythmia (8%), and driveline infection (16%). Major hemocompatibility-related AEs were limited to 3 nondisabling strokes and 1 gastrointestinal bleeding. No major device malfunction occurred during the follow-up period., Conclusions: The largest single-center experience with the leading LVAD in China shows high survival with low complication rates, demonstrating that CH-VAD is safe and efficient in providing long-term support for patients with end-stage heart failure., (Copyright © 2024 International Society for the Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.)

The development of aortic insufficiency (AI) during HeartMate 3 durable left ventricular assist device (dLVAD) support can lead to ineffective pump output and recurrent heart failure symptoms. Progression of AI often comingles with the occurrence of other hemodynamic-related events encountered during LVAD support, including right heart failure, arrhythmias, and cardiorenal syndrome. While data on AI burdens and clinical impact are still insufficient in patients on HeartMate 3 support, moderate or worse AI occurs in approximately 8% of patients by 1 year and studies suggest AI continues to progress over time and is associated with increased frequency of right heart failure. The first line intervention for AI management is prevention, undertaking surgical intervention on the insufficient valve at the time of dLVAD implant and avoiding excessive device flows and hypertension during long-term support. Device speed augmentation may then be undertaken to try and overcome the insufficient lesion, but the progression of AI should be anticipated over the long term. Surgical or transcatheter aortic valve interventions may be considered in dLVAD patients with significant persistent AI despite medical management, but neither intervention is without risk. It is imperative that future studies of dLVAD support capture AI in clinical end-points using uniform assessment and grading of AI severity by individuals trained in AI assessment during dLVAD support., (Copyright © 2024 International Society for the Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.)

Competing Interests: Dr Sohns received research support and lecture fees from Medtronic, Abbott, Boston Scientific, and Biosense Webster; is a consultant for Medtronic, Boston Scientific, and Biosense Webster; and has received grant support from the Else Kröner-Fresenius-Stiftung and Deutsche Herzstiftung. Dr Sommer is member of the Advisory Board for Abbott, Biosense Webster, Boston Scientific, and Medtronic.

Patients with heart failure (HF) and underlying coronary artery disease (CAD) have a substantially higher risk of mortality compared with those with HF from other causes. However, identifying individuals with HF for whom revascularization is likely to improve prognosis is a complex clinical decision. Revascularization is likely beneficial for patients with CAD-predominant symptoms, such as those with acute myocardial infarction or stable ischemic heart disease with refractory angina. However, for patients with HF-predominant symptoms, characterized by dyspnea without acute myocardial infarction or refractory angina, the benefits of revascularization are less clear. This state-of-the-art review summarizes the outcomes, clinical trials, and therapeutic approaches for patients with both CAD and HF, and proposes a therapeutic algorithm to guide the diagnosis and comprehensive workup of these complex patients., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Objectives: Bridging from a temporary microaxial left ventricular assist device (tLVAD) to a durable left ventricular assist device (dLVAD) is playing an increasing role in the treatment of terminally ill patients with heart failure. Scant data exist about the best implant strategy. The goal of this study was to analyse differences in the dLVAD implant technique and effects on patient outcomes., Methods: Data from 341 patients (19 European centres) who underwent a bridge-to-bridge implant from tLVAD to dLVAD between January 2017 and October 2022 were retrospectively analysed. The outcomes of the different implant techniques with the patient on cardiopulmonary bypass, extracorporeal life support or tLVAD were compared., Results: A durable LVAD implant was performed employing cardiopulmonary bypass in 70% of cases (n = 238, group 1), extracorporeal life support in 11% (n = 38, group 2) and tLVAD in 19% (n = 65, group 3). Baseline characteristics showed no significant differences in age (P = 0.140), body mass index (P = 0.388), creatinine level (P = 0.659), the Model for End-Stage Liver Disease (MELD) score (P = 0.190) and rate of dialysis (P = 0.110). Group 3 had significantly fewer patients with preoperatively invasive ventilation and cardiopulmonary resuscitation before the tLVAD was implanted (P = 0.009 and P < 0.001 respectively). Concomitant procedures were performed more often in groups 1 and 2 compared to group 3 (24%, 37% and 5%, respectively, P < 0.001). The 30-day mortality data showed significantly better survival after an inverse probability of treatment weighting in group 3, but the 1-year mortality showed no significant differences among the groups (P = 0.012 and 0.581, respectively). Postoperative complications like the rate of right ventricular assist device (RVAD) implants or re-thoracotomy due to bleeding, postoperative respiratory failure and renal replacement therapy showed no significant differences among the groups. Freedom from the first adverse event like stroke, driveline infection or pump thrombosis during follow-up was not significantly different among the groups. Postoperative blood transfusions within 24 h were significantly higher in groups 1 and 2 compared to surgery on tLVAD support (P < 0.001 and P = 0.003, respectively)., Conclusions: In our analysis, the transition from tLVAD to dLVAD without further circulatory support did not show a difference in postoperative long-term survival, but a better 30-day survival was reported. The implant using only tLVAD showed a reduction in postoperative transfusion rates, without increasing the risk of postoperative stroke or pump thrombosis. In this small cohort study, our data support the hypothesis that a dLVAD implant on a tLVAD is a safe and feasible technique in selected patients., (© The Author(s) 2024. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)

Objectives: Left ventricular assist device (LVAD) therapy has evolved from a short-term bridge-to-transplant strategy into a long-term and often chronic therapy due to long waiting times for heart transplantation and application as destination therapy. Consequently, patients are at risk of developing complications necessitating LVAD exchange. The aim of this study is to assess patient outcomes after LVAD exchange., Methods: Patients who underwent LVAD exchange between January 2010 and December 2022 were included. Logistic and cox regression analyses were used to identify potential risk factors for short and long-term adverse events, respectively. Survival after exchange was assessed using Kaplan-Meier estimates., Results: Sixty-one patients underwent a total of 80 LVAD exchanges. Most frequently observed short-term complications were pulmonary infections (16.3%) and right heart failure (16.3%). Exit-site infections (34.7%) and device malfunctions (25.3%) were the most often observed long-term complications. HeartWare ventricular assist device as index device was associated with a higher risk of right heart failure [hazard ratio 6.42, 95% confidence interval (CI) 1.80-22.90] and respiratory failure (hazard ratio 7.81, 95% CI 1.95-31.23) compared to HeartMate II and HeartMate 3. Survival was 83% (95% CI 75.5-95.3%) at 1 year and 67% (95% CI 53.9-84.7%) at 6 years after exchange. After 5 years, 25.0% was transplanted, 23.8% had undergone a re-exchange and 32.5% was alive without new intervention., Conclusions: Although LVAD exchange can be performed with a relatively low mortality, other post-operative adverse events are common. Patients with the HeartWare ventricular assist device as index device may be at higher risk of developing right heart failure and respiratory failure after exchange., (© The Author(s) 2024. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery.)

Heart failure (HF) is a progressive disease. It is estimated that more than 250,000 patients suffer from advanced HF with reduced ejection fraction refractory to medical therapy. With limited donor pool for heart transplant, continue flow left ventricle assist device (LVAD) is a lifesaving treatment option for patients with advanced HF. This review will provide an update on indications, contraindications, and associated adverse events for LVAD support with a summary of the current outcomes data., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Left ventricular assist devices (LVADs) improve survival and reduce symptoms in patients with advanced heart failure; however, the longer-term durability of LVADs remains uncertain especially with older-generation devices. In this case report, we describe the clinical course of a patient who has been successfully treated with the same HeartMate II LVAD for 14 years, the longest published and still ongoing LVAD support with the same originally implanted device., Competing Interests: E.N. acknowledges speaker’s honoraria from Novartis, AstraZeneca, Boehringer Ingelheim, and Bayer, with no direct disclosures relevant to the current study. Similarly, L.H.L. has no direct disclosures associated with the present work. However, his unrelated disclosures include research grants from AstraZeneca and Boston Scientific, as well as consulting or speaker’s honoraria from Novartis, AstraZeneca, Bayer, St Jude, Medtronic, Vifor Pharma, and Abbott. The other authors have no conflicts of interest to report., (Copyright © ASAIO 2024.)

Purpose of Review: Mechanical circulatory support is used frequently as a method of stabilizing patients with end stage heart failure who are unable to safely await allograft availability. While this technology has been fundamentally important in supporting patients with normal cardiac anatomy, it is still used infrequently in adult patients with congenital heart disease and end-stage heart failure. Here, we review the data on mechanical circulatory support technology in this small but growing population of patients with chronic heart disease prone to the development of circulatory failure., Recent Findings: Mechanical circulatory support (MCS) has been increasingly employed in adults with congenital heart disease (ACHD) as a bridge to transplant. The new United Network for Organ Sharing listing system favoring temporary MCS use with a higher listing status offers another tool to stabilize ACHD patients and potentially shorten wait times. Both temporary and Durable MCS could help improve transplant candidacy and posttransplant outcomes in select groups of ACHD patients., Summary: Durable and temporary MCS have the potential to significantly improve access to transplant and overall transplant outcomes in ACHD patients., (Copyright © 2024 Wolters Kluwer Health, Inc. All rights reserved.)

Background: Left ventricular assist device (LVAD) recipients report symptom improvement but find adjusting to life with the LVAD challenging. These challenges are unique, and existing patient-reported outcome measures (PROMs) do not reflect their experiences. This study aimed to develop a culturally relevant quality of life PROM for use with LVAD recipients in future research, design evolutions and clinical practice., Methods: A three-stage mixed-methods approach was used to develop a PROM: stage 1 included group concept mapping (GCM); stage 2 semi-structured qualitative interviews were conducted with 11 LVAD recipients and 10 clinicians, and a questionnaire was developed using a conceptual framework; and stage 3 used exploratory psychometric analysis of the PROM data using Rasch measurement theory. This paper presents stages 2 and 3., Results: The conceptual framework consisted of four key concepts, including general health, life with the LVAD, equipment and clothing and emotional impact. Statements from interviews and GCM were used to create items for the LVAD quality of life (LVAD-QoL). Cognitive interviews tested face validity and participant comprehension. Forty-nine participants were recruited from three UK transplant centres. PROM data were collected and analysed using Rasch analysis. Four items displayed misfit; dependency between item sets was the biggest issue (57/485 pairwise differences). After restructuring and dealing with item misfit, the LVAD-QoL conformed to the Rasch model, supporting the psychometric properties and quality of the LVAD-QoL., Conclusions: Using a mixed-methods approach ensured the development of a robust and psychometrically sound tool for research, design evolution and clinical practice with LVAD recipients., (© 2024 The Author(s). ESC Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology.)

Aims: Left ventricular assist device (LVAD) implantation, a therapy for end-stage heart failure, is associated with platelet (PLT) activation. This study aims to evaluate the prognostic impact of PLT count in patients with LVAD implantation., Methods and Results: Data from the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) registry were investigated, and patients were divided into three groups according to tertiles. The dynamic change of PLT counts and its associations with long-term outcomes were analysed. The primary outcome was long-term mortality. A total of 19 517 patients who received the first continuous-flow LVAD were identified from the INTERMACS registry. The PLT count underwent a dynamic change towards normalization after LVAD implantation. Compared with intermediate, both high (hazard ratio [HR], 1.09, 95% confidence interval [CI]: 1.01 to 1.17, P = 0.033) and low (HR, 1.18, 95% CI: 1.10 to 1.27, P < 0.001) pre-implant PLT counts were associated with an increased risk of 2 year mortality. Compared with intermediate, a high post-implant PLT count was associated with an increased risk of 4 year mortality (HR, 1.38, 95% CI: 1.26 to 1.52, P < 0.001). Besides, both pre- and post-implant PLT counts exhibit a U-shaped association with the risk of mortality., Conclusions: LVAD implantation could improve the PLT count towards normalization. Abnormal pre-/post-implant PLT counts were independently associated with increased risks of long-term mortality., (© 2024 The Authors. ESC Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology.)

Aims: Interatrial shunts are under evaluation as a treatment for heart failure (HF); however, their in vivo flow performance has not been quantitatively studied. We aimed to investigate the fluid dynamics properties of the 0.51 cm orifice diameter Ventura shunt and assess its lumen integrity with serial transesophageal echocardiography (TEE)., Methods and Results: Computational fluid dynamics (CFD) and bench flow tests were used to establish the flow-pressure relationship of the shunt. Open-label patients from the RELIEVE-HF trial underwent TEE at shunt implant and at 6 and 12 month follow-up. Shunt effective diameter (D eff ) was derived from the vena contracta, and flow was determined by the continuity equation. CFD and bench studies independently validated that the shunt's discharge coefficient was 0.88 to 0.89. The device was successfully implanted in all 97 enrolled patients; mean age was 70 ± 11 years, 97% were NYHA class III, and 51% had LVEF ≤40%. Patency was confirmed in all instances, except for one stenotic shunt at 6 months. D eff remained unchanged from baseline at 12 months (0.47 ± 0.01 cm, P = 0.376), as did the trans-shunt mean pressure gradient (5.1 ± 3.9 mmHg, P = 0.316) and flow (1137 ± 463 mL/min, P = 0.384). TEE measured flow versus pressure closely correlated (R 2  ≥ 0.98) with a fluid dynamics model. At 12 months, the pulmonary/systemic flow Qp/Qs ratio was 1.22 ± 0.12., Conclusions: When implanted in patients with advanced HF, this small interatrial shunt demonstrated predictable and durable patency and performance., (© 2024 The Authors. ESC Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology.)

Aims: This study aimed to compare the changes in the left ventricle (LV) and right ventricle (RV) geometry and performance after the implantation of HeartMate II (HMII) and HeartMate 3 (HM3). In addition, we investigated whether the echocardiographic parameters LV sphericity index (LVSI) and the novel pressure-dimension index (PDI) can predict post-operative right ventricular failure (RVF)., Methods and Results: Between 2012 and 2020, 46 patients [HMII (n = 22) and HM3 (n = 24)] met the study's criteria and had echocardiography tests pre-operatively, 6 and 12 months post-operatively. The LVSI and PDI were calculated together with the standard LV and RV echocardiographic parameters. The mean follow-up was 24 ± 7 months. In both groups, the LV end-diastolic diameter (LVEDD) significantly decreased 12 months post-operatively compared with the pre-operative values (HMII: 6.4 ± 1.4 cm vs. 5.7 ± 0.9 cm, P = 0.040; HM3: 6.7 ± 1.3 cm vs. 5.5 ± 0.9 cm, P < 0.01, respectively). RV function 12 months post-operatively was better in the HM3 group than in the HMII group, as indicated by a significantly higher RV fractional area change (RVFAC) in the HM3 group than in the HMII group 12 months post-operatively (35 ± 12% vs. 26 ± 16%, P = 0.039), significantly higher tricuspid annular plane systolic excursion (TAPSE) in the HM3 group 12 months post-operatively compared with the HMII group (13.9 ± 1.9 mm vs. 12.0 ± 2.1 mm, P = 0.002), and the tissue Doppler estimated tricuspid annular systolic velocity (TASV) was also significantly higher in the HM3 group 12 months post-operatively compared with the HMII group (11.5 ± 2.7 mm/s vs. 9.9 ± 1.5 mm/s, P = 0.020). The LVSI value was significantly higher 12 months post-operatively in the HMII group than in the HM3 group (1.2 ± 0.4 vs. 0.8 ± 0.2, P = 0.001, respectively), indicating worse geometric changes. The PDI decreased 12 months post-operatively in the HM3-group compared with the baseline (3.4 ± 1.4 mmHg/cm 2 vs. 2.0 ± 0.8 mmHg/cm 2 , P < 0.001). In the univariate and multivariate analyses, only the pre-operative PDI was a predictor of post-operative RVF [odds ratio: 3.84 (95% CI: 1.53-18.16, P = 0.022)]. The area under the curve for pre-operative PDI was 0.912. The 2 year survival was significantly better in the HM3 group (log-rank, P = 0.042)., Conclusions: The design of HM3 offered better geometrical preservation of the LV and enabled normal PDI values, leading to improved RV function, as indicated by better RVFAC, TAPSE, and TASV values. The use of pre-operative PDI as an additional tool for established risk scores might offer a better pre-operative predictor of RVF., (© 2024 The Author(s). ESC Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology.)

With changes in the heart transplant allocation system in the United States, the use of left ventricular device therapy (LVAD) as a bridge to transplant has decreased. Currently, one of the primary reasons to implant a device is for patient support until they can lose weight to qualify for transplant. This paper reviews the outcomes of various weight loss strategies for patients with LVADs including weight reduction surgery and cardiac rehab. Additionally, results of the use of GLP1 agonists on weight loss in general and in heart failure patients is reviewed. Finally, because of the unique issues involving exercise for patients with LVADs, we review safe exercise techniques with instructions for patients., Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Stuart D. Russell reports a relationship with Medtronic Cardiac Rhythm and Heart Failure Management that includes: consulting or advisory. Stuart D. Russell reports a relationship with Abbott that includes: consulting or advisory. If there are other authors, they declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Ventricular assist devices (VADs) are used to assist the heart function of patients with advanced heart failure. Computational fluid dynamics in VADs are widely applied in the development and optimization, for example, to evaluate blood damage. For these simulations, the pulsating operating conditions, in which the VAD operates, should be included accurately. Therefore, this study aims to evaluate the flow in a VAD by interacting with patient-specific cardiovascular systems of heart failure patients. A numeric method will be presented, which includes a patient-specific cardiovascular system model that is bidirectionally coupled with a three-dimensional (3D) flow simulation of the HeartMate 3. The cardiovascular system is represented by a lumped parameter model. Three heart failure patients are considered, based on clinical data from end-stage heart failure patients. Various parameters of the cardiovascular system and the VAD are analyzed, for example, flow rates, pressures, VAD heads, and efficiencies. A further important parameter is the blood damage potential of the VAD, which varies significantly among different patients. Moreover, the predicted blood damage fluctuates within a single heartbeat. The increase in blood damage is evaluated based on the operating conditions. Both, overload and especially partial load conditions during the pulsating operation result in elevated blood damage., Competing Interests: Disclosure: The authors have no conflicts of interest to report., (Copyright © 2024 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the ASAIO.)

Durable left ventricular assist devices (LVADs) are a well-established therapeutic option for patients with advanced heart failure. These devices are often used to "bridge" patients to an orthotopic heart transplantation (HT). Unfortunately, many patients on LVAD support with a body mass index (BMI) above a certain value are not eligible for HT due a lack of suitable donors and the association between obesity and poor outcomes after HT. This case series describes three individuals on LVAD support who were able to successfully lose enough weight to qualify to be listed for an HT. We highlight a systematic, multidisciplinary approach to implementing guideline-driven weight loss strategies, including some aggressive methods ( ie , meal replacements, weight loss medications, and bariatric surgery). In addition to describing the weight loss outcomes, we also discuss barriers and medical challenges during weight loss that are unique to this population., Competing Interests: Disclosure: J.A.C. is serving on the Steering Committee, Advisory Board, and as National PI for HM3, speaker, and DSMB member for HALO-Shock at Abbott. At Medtronic, she is the National PI and part of the Steering Committee for HVAD DT PAS. At Procyrion, she advises and serves as a Steering Committee member with stock options for a pilot trial. At Endotronix, she is an unpaid Steering Committee member for the Proactive HF trial. She is a Steering Committee member for the Restore-HF trial at Nuwellis, an Advisory Board member and consultant at BiVACOR, and both a consultant and speaker at BioVentrix. She also serves as a speaker for fellows conferences at Zoll, a consultant and SC member at CorWave, a DSMB member for the EXCOR pediatric VAD at Berlin Heart, and a consultant and Steering Committee member for BrioVAD at CH Biomedical. The other authors have no conflicts of interest to report., (Copyright © ASAIO 2024.)

There is an evolving role for guideline-directed medical therapy (GDMT) in managing heart failure with reduced ejection fraction after cardiac surgery. GDMT is based on the use of pharmacologic agents from each of 4 distinct drug classes, also known as the 4 pillars of heart failure therapy: β-blockers, renin-angiotensin system inhibitors, often paired with neprilysin inhibitors, mineralocorticoid receptor antagonists, and sodium-glucose cotransporter-2 inhibitors. Despite the demonstrated benefits of GDMT in reducing mortality and hospitalization rates in the nonsurgical literature, there is conspicuous underuse of GDMT after cardiac surgery. The lack of published literature and practical challenges surrounding the timing for initiation of GDMT in the immediate postoperative period has limited standardized implementation strategies. A multidisciplinary approach will be necessary to assist in initiating, titrating, and monitoring the response to these therapies in patients with heart failure with reduced ejection fraction after cardiac surgery., Competing Interests: Disclosures Daniel Engelman reports a relationship with Edwards Lifesciences Corporation, Astellas Pharma US Inc, Alexion Pharmaceuticals Inc, Medela AG, Arthrex Inc, and Renibus Therapeutics Inc that includes: consulting or advisory. Michael Givertz reports a relationship with Merck & Co Inc that includes: consulting or advisory; and with Abbott Vascular Inc, Endtronix, and Natera Inc that includes: institutional research support. Katherine Wood reports a relationship with Abbott Vascular Inc that includes: consulting or advisory. The other authors have no conflicts of interest to disclose., (Copyright © 2024 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Purpose of Review: The number of adult congenital heart disease (ACHD) patients presenting for consideration of heart transplantation continues to grow. Comprehensive pretransplant assessment and thoughtful patient selection are of critical importance to mitigate perioperative and posttransplant morbidity and mortality in this population., Recent Findings: There is increasing evidence that patient outcomes after the onset of heart failure in the ACHD population are poor while overall transplant outcomes for ACHD patients have improved over time. Delineation of factors associated with better versus worse posttransplant outcomes is an area of ongoing research. Several studies have found that delayed patient referral, anatomic complexity and the presence of noncardiac organ dysfunction may increase peri-transplant and posttransplant risk., Summary: Pretransplant assessment and patient selection in ACHD patients should focus on mitigating perioperative and early posttransplant risk. Anatomic complexity, noncardiac organ dysfunction, and referral timing after the onset of heart failure can contribute to poor posttransplant outcomes and should inform patient selection., (Copyright © 2024 Wolters Kluwer Health, Inc. All rights reserved.)

Heart transplant remains the gold standard treatment for patients with end-stage heart failure. However, given the limited availability of donor hearts, alternative approaches and strategies are required. The development of a variety of mechanical circulation support options, including left ventricular assist devices and total artificial heart, have allowed improved quality of life and eventually have facilitated a bridge to heart transplantation strategies for certain patients. However, the presence of an intracorporeal left ventricular assist device poses a technical challenge at the time of heart transplantation. In this video tutorial, we describe the surgical strategy and removal technique for a patient who had received a HeartMate 3 (Abbott, North Chicago, IL, USA) using a classic implantation technique via sternotomy, who underwent concomitant orthotopic heart transplant., (© The Author 2024. Published by MMCTS on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)

Heart failure (HF) and moderate-to-severe mitral regurgitation (MR) with residual elevations in left atrial pressure (LAP) after MitraClip may remain symptomatic and experience subsequent HF readmissions. The V-Wave interatrial shunt system is a permanent interatrial septal implant that shunts blood from the left-to-right atrium and serves to continuously unload the left atrium. Although the V-Wave shunt has previously been studied in patients with HF, the safety and feasibility of its deployment at the time of the MitraClip procedure is unknown. The V-Wave Shunt MitraClip Study (NCT04729933) is an early feasibility study that aims to demonstrate the safety and efficacy of implantation of the V-Wave shunt device at the time of MitraClip procedure. Patients with moderate-to-severe secondary MR with left ventricular ejection fraction 20% to 50% and New York Heart Association functional class III/IV symptoms despite optimal medical therapy, residual mean LAP ≥20 mm Hg after MitraClip, and mean LAP-right atrial pressure difference ≥5 mm Hg are included. The primary safety end point is a composite outcome of all-cause death, stroke, myocardial infarction device embolization, cardiac tamponade, or device-related re-intervention or surgery at 30 days. Patients will be followed up to 5 years. Enrollment is ongoing, with 30-day results expected by the end of 2024. The V-Wave Shunt Mitraclip Study aims to demonstrate the safety and efficacy of the implantation of the V-Wave interatrial shunt device at the time of index MitraClip placement which may serve as an adjunctive method by which continuous left atrial unloading may be achieved., Competing Interests: Declaration of competing interest Dr. Abraham is the Chief Medical Officer of V-Wave Ltd. The remaining authors have no competing interests to declare., (Copyright © 2024. Published by Elsevier Inc.)

Introduction: Heart transplantation is the gold standard for advanced heart failure treatment. This study examines the survival rates and risk factors for early mortality in adult heart transplant recipients at a Brazilian center., Methods: This retrospective cohort study involved 255 adult heart transplant patients from a single center in Brazil. Data were collected from medical records and databases including three defined periods (2012-2015, 2016-2019, and 2020-2022). Statistical analysis employed Kaplan-Meier survival curves, Cox proportional hazards analysis for 30-day mortality risk factors, and Log-rank tests., Results: The recipients were mostly male (74.9%), and the mean age was 46.6 years. Main causes of heart failure were idiopathic dilated cardiomyopathy (33.9%), Chagas cardiomyopathy (18%), and ischemic cardiomyopathy (14.3%). The study revealed an overall survival of 68.1% at one year, 58% at five years, and 40.8% at 10 years after heart transplantation. Survivalimproved significantly over time, combining the most recent periods (2016 to 2022) it was 73.2% in the first year and 63% in five years. The main risk factors for 30-day mortality were longer time on cardiopulmonary bypass, the initial period of transplants (2012 to 2015), older age of the donor, and nutritional status of the donor (overweight or obese). The main causes of death within 30 days post-transplant were infection and primary graft dysfunction., Conclusion: The survival analysis by period demonstrated that the increased surgical volume, coupled with the team's experience and modifications to the immunosuppression protocol, contributed to the improved early and mid-term outcomes.

Left ventricular assist devices (LVADs) are increasingly implanted in patients with advanced heart failure. Currently, LVAD care is predominantly concentrated at specialized tertiary care hospitals. However, the increasing workload and logistical burden for implanting centres pose significant challenges to accessing care for individual patients in remote areas. An emerging approach to LVAD patient management is the use of a shared care model (SCM), which facilitates collaboration between implanting centres and local non-implanting hospitals. This scoping review explores and synthesizes the current scientific evidence on the use of SCMs in LVAD care management. Eligible studies were identified in EMBASE, PubMed MEDLINE, Web of Science, Cochrane and Google Scholar. Findings were synthesized in accordance with PRISMA-ScR guidelines. Of the 950 records screened, five articles met the inclusion criteria. Four review articles focused on the proposed benefits and challenges of using SCMs. Main benefits included improved patient satisfaction and continuity of care. Important challenges were initial education of non-implanting centre staff and maintaining competency. One prospective study showed that absence of LVAD-specific care was associated with impaired survival and higher rates of pump thrombosis and LVAD-related infections. The use of SCMs is a promising approach in the long-term management of LVAD patients. However, sufficient evidence about the impact of SCMs on patients and the healthcare system is not currently available. Standardized protocols based on prospective studies are needed to develop safe and effective shared care for LVAD patients., (© The Author(s) 2024. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery.)

Fusion imaging (FI) technology using EchoNavigator that integrates live transesophageal echocardiogram and overlays on real-time fluoroscopy. We present our experience placing a right ventricular (RV) support device, a ProtekDuo, in our patient with post-operative RV failure using FI to guide the implantation., (© 2024 Wiley Periodicals LLC.)

Background: There are diverse indications for heart transplantation (HTx), often categorized into ischemic (ICM) and nonischemic (NICM) cardiomyopathy. Although there is extensive research comparing the outcomes for these disease processes following certain therapeutic interventions, there are limited data on how recipient etiology impacts post-HTx survival. Our investigation seeks to identify this relationship., Methods: We conducted a retrospective analysis using adult HTx patients from the United Network for Organ Sharing database between 2000 and 2021. Patients with a combined heart-lung transplant or previous HTx were excluded. ICM included coronary artery disease (CAD) and ischemic dilated cardiomyopathy. NICM included nonischemic dilated (NIDCM), hypertrophic (HCM), and restrictive (RCM) cardiomyopathy. Overall survival was analyzed using Kaplan-Meier curves, log-rank tests, and multivariable Cox regression models., Results: A total of 42 268 patients were included in our study. Recipients with ICM were older and more likely to be males, obese, diabetics, and smokers. We found that patients with ICM had an increased incidence of transplant CAD (OR = 1.23, p < 0.001) and risk of mortality (hazard ratio [HR] = 1.22, p < 0.001) compared to NICM. When NICM was expanded, RCM had a similar hazard risk compared to ICM (HR = 1.03, p = 0.650), whereas both NIDCM (HR = 0.81, p < 0.001) and HCM (HR = 0.70, p < 0.001) had improved survival., Conclusion: Our study provides evidence to suggest that ICM has decreased survival when compared to NICM. When NICM was expanded, RCM was found to have an increased mortality risk similar to ICM, whereas NIDCM and HCM both had superior outcomes. The clinical implication of this investigation will allow clinicians to better understand the prognosis of certain patient groups., (© 2024 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.)

A 36 year old woman with history of heart failure and left ventricular assist device (LVAD) implantation, with subsequent explantation after myocardial recovery, presented for management of preconception counseling and subsequent pregnancy. To our knowledge, this case represents the first documented successful pregnancy after LVAD explantation. Management details are provided, and relevant literature is reviewed., Competing Interests: Disclosure: The authors have no conflicts of interest to report., (Copyright © ASAIO 2024.)

Severe right heart failure, often overlooked and challenging to manage, has prompted a growing interest in innovative approaches to provide functional support. This study uses experimentation in large porcine models to introduce a novel prototype of a pulsatile mechanical circulatory support device and document its effects when deployed as a right ventricular assist device (RVAD). The pulsatile ventricular assist platform (pVAP), featuring a membrane pump driven by an intra-aortic balloon pump console, actively generates pulsatile flow to propel right ventricular blood into the pulmonary artery. This novel prototype demonstrates promising potential in addressing the challenges of right heart failure management. After preliminary in vitro assessments, the pVAP was tested on seven porcine models in a healthy state and after the induction of right ventricular failure. During the procedure, a set of standard ( ie , standard-of-care) hemodynamic measurements was obtained. Additionally, invasive pressure-volume loop analysis was employed to examine left ventricular hemodynamics. Results indicated that activation of the pVAP during right ventricular failure significantly improved systemic hemodynamics and enhanced left ventricular function. This study sheds light on the potential of the pVAP in managing right heart failure., Competing Interests: O.M. is the CEO of PulseCath BV. M.B. receives personal fees from PulseCath BV. The other authors have no conflicts of interest to report., (Copyright © ASAIO 2024.)

Background: Patients with cardiogenic shock (CS) or heart failure can develop ischemic cholecystitis from a systemic low-flow state. Cholecystectomy in high-risk patients is controversial. Percutaneous cholecystostomy tube (PCT) is often the chosen intervention; however, data on PCT as definitive treatment are conflicting. Data on cholecystectomy in these patients are limited. This study discusses outcomes following laparoscopic cholecystectomy (LC) in this patient population. Methods: This is a retrospective review of patients who underwent LC from 2015 to 2019 while hospitalized for CS or heart failure. Surgical services are provided by fellowship-trained minimally invasive surgeons at a single, academic, tertiary-care center. Patient characteristics are reported as frequencies' percentages for categorical variables. Odds ratio is used to determine the association between comorbidities and complications. Results: Twenty-four patients underwent LC. Around 83% were white and 79% were male. Many were anticoagulated (88%), with Class IV heart failure (63%), and required vasopressors (46%) at the time of surgery. Fourteen of 24 (58%) had at least one circulatory device at the time of surgery: extracorporeal membrane oxygenation, left ventricular assist device, Impella, tandem heart, and total artificial heart. Four patients (17%) had PCT preoperatively. Fifteen days were the average interval between diagnosis and surgery. Pneumoperitoneum was tolerated by all, and 0% converted to open. Most common complication was bleeding (52%). Nine patients (37.5%) underwent 21 reoperations, one of which (4%) was related to cholecystectomy. Mortality occurred in 5 patients (20.8%); interval between cholecystectomy and mortality ranged 6-30 days. Conclusion: Although high risk, LC is a treatment option in patients with ischemic cholecystitis at risk for death from sepsis.

The patient was diagnosed with perimembranous ventricular septal defect (VSD). She underwent VSD closure and muscle bundle resection across right ventricular outflow tract at the age of 3 months. Since then, she had suffered from severe heart failure and complete heart block. Permanent pacemaker generator was implanted in the left hypochondrium. She was depended on continuous catecholamine administration, so transferred to our hospital for further management. On arrival, her body weight was 5686 g (- 2.7 SD). She underwent Excor pediatric left ventricular assist device implantation at the age of 9 months. Because the position of the left ventricular assist device cannula interfered with the pacemaker, herein, the pacemaker pocket was newly created in the left thoracic cavity. An 1 mm in thickness of expanded polytetrafluoroethylene sheet was trimmed and sutured under the anterolateral wall of left thoracic cavity as a pacemaker pocket. Bipolar ventricular lead was sutured on left ventricular apex and basal wall to face each other, mimicking cardiac regeneration therapy. Even though she unfortunately required right diaphragmatic plication for iatrogenic phrenic nerve palsy, her respiratory function was well maintained; therefore, secondary right heart failure was not observed. Her cardiopulmonary function was quite stable until post-operative day 275 when the patient was transferred to another hospital for heart transplantation., (© 2023. The Japanese Society for Artificial Organs.)

Left ventricular assist devices (LVADs) are excellent therapies for advanced heart failure patients either bridged to transplant or for lifetime use. LVADs also allow for reverse remodeling of the failing heart that is often associated with functional improvement. Indeed, growing enthusiasm exists to better understand this population of patients, whereby the LVAD is used as an adjunct to mediate myocardial recovery. When patients achieve benchmarks suggesting that they no longer need LVAD support, questions related to the discontinuation of LVAD therapy become front and center. The purpose of this review is to provide a surgical perspective on the practical and technical issues surrounding LVAD deactivation., (Copyright © 2024 International Society for the Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.)

Competing Interests: Declaration of competing interest The author declares no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

Background: Left ventricular assist devices (LVAD) improve survival for patients with cardiac failure, but LVAD-specific infection (VSI) remains a challenge with poorly understood predictive risk factors. The indications and use of escalating medical treatment to surgical debridement and potential flap reconstruction are not well characterized., Study Design: A retrospective review of consecutive patients undergoing primary LVAD implantation at a tertiary academic center was performed. The primary outcome measures were 90-day and overall mortality after VSI. Cox proportional hazards regression was used to generate a risk prediction score for mortality., Results: Of the 760 patients undergoing primary LVAD implantation, 255 (34%) developed VSI; of these patients, 91 (36%) were managed medically, 134 (52%) with surgical debridement, and 30 (12%) with surgical debridement and flap reconstruction. One-year survival after infection was 85% with median survival of 2.40 years. Factors independently associated with increased mortality were diabetes (hazard ratio [HR] 1.44, p = 0.04), MRSA infection (HR 1.64, p = 0.03), deep space (pump pocket or outflow cannula) involvement (HR 2.26, p < 0.001), and extracorporeal membrane oxygenation after LVAD (HR 2.52, p < 0.01). Factors independently associated with decreased mortality were flap reconstruction (HR 0.49, p = 0.02) and methicillin-sensitive Staphylococcus aureus infection (HR 0.63, p = 0.03). A clinical risk prediction score was developed using these factors and showed significant differences in median survival, which was 5.67 years for low-risk (score 0 to 1), 3.62 years for intermediate-risk (score 2), and 1.48 years for high-risk (score ≥3; p < 0.001) patients., Conclusions: We developed a clinical risk prediction score to stratify patients with VSI. In selected cases, escalating surgical treatment was associated with increased survival. Future work is needed to determine whether early surgical debridement and flap reconstruction can alter outcomes in select cases of VSI., (Copyright © 2024 by the American College of Surgeons. Published by Wolters Kluwer Health, Inc. All rights reserved.)

Background: The quality-adjusted life year (QALY) measures disease burden and treatment, combining overall survival and health-related quality of life (HRQOL). We estimated QALYs in 3 groups of older patients (60-80 years) with heart failure (HF) who underwent heart transplantation (HT, with pre-transplant mechanical circulatory support [HT MCS] or HT without pre-transplant MCS [HT Non-MCS]) or long-term MCS (destination therapy). We also identified factors associated with gains in QALYs through 24 months follow-up., Methods: Of 393 eligible patients enrolled (10/1/15-12/31/18) at 13 U.S. sites, 161 underwent HT (n = 68 HT MCS, n = 93 HT Non-MCS) and 144 underwent long-term MCS. Survival and HRQOL data were collected through 24 months. QALY health utilities were based on patient self-report of EQ-5D-3L dimensions. Mean-restricted QALYs were compared among groups using generalized linear models., Results: For the entire cohort, mean age in years closest to surgery was 67 (standard deviation, SD: 4.7), 78% were male, and 83% were White. By 18 months post-surgery, sustained significant differences in adjusted average ± SD QALYs emerged across groups, with the HT Non-MCS group having the highest average QALYs (24-month window: HT Non-MCS = 22.58 ± 1.1, HT MCS = 19.53 ± 1.33, Long-term MCS = 19.49 ± 1.3, p = 0.003). At 24 months post-operatively, a lower gain in QALYs was associated with HT MCS, long-term MCS, a lower pre-operative LVEF, NYHA class III or IV before surgery, and an ischemic or other etiology of HF., Conclusions: Determination of QALYs may provide important information for policy makers and clinicians to consider regarding benefits of HT and long-term MCS as treatment options for older patients with HF., (Copyright © 2024 International Society for the Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.)

Background: Catheter ablation (CA) improves clinical outcomes in patients with atrial fibrillation (AF) and heart failure (HF) with reduced ejection fraction (HFrEF). We aimed to evaluate the impact of CA on clinical and quality-of-life outcomes across HF subtypes., Methods: All patients undergoing AF ablation at a tertiary center were enrolled in a prospective registry and included in this study (2013-2021). The primary end point was AF recurrence. Secondary end points included AF-related hospitalizations and quality-of-life outcomes. Patients were categorized according to their HF status: no HF, HFrEF, HF with mildly reduced ejection fraction (HFmrEF), and HF with preserved ejection fraction (HFpEF)., Results: A total of 7020 patients were included (80% no HF, 8% HFrEF, 7% HFmrEF, and 5% HFpEF). Over 3 years, the cumulative incidence of AF recurrence after ablation was as follows: HFpEF (53%), HFmrEF (41%), HFrEF (41%), and no HF (34%); P <0.01. Multivariable Cox analyses confirmed these findings using no HF group as reference (HFpEF: hazard ratio, 1.47 [95% CI, 1.21-1.78]; HFmrEF: hazard ratio, 1.23 [95% CI, 1.04-1.45]; and HFrEF: hazard ratio, 1.17 [95% CI, 1.01-1.37]; P <0.05 for all). In all groups, CA resulted in a significant reduction of AF-related hospitalization (mean rate per 1 patient-years [before and after CA]; HFpEF [1.8 versus 0.3], HFmrEF [1.1 versus 0.2], HFrEF [1.1 versus 0.2], and no HF [1 versus 0.1]; P <0.01 for each comparison) and significant improvement in quality of life as measured by both the AF symptom severity score and the AF burden score ( P <0.01 for the comparison between baseline and follow-up for each score when tested separately)., Conclusions: AF recurrence rates after CA were higher in patients with HF compared with those without HF, with patients with HFpEF being at the highest risk of recurrence. Nonetheless, CA was associated with a significant reduction in AF symptoms, AF-related hospitalization, and HF symptoms in most patients irrespective of HF subtypes., Competing Interests: Dr Hussein receives research grant support from Boston Scientific. The other authors report no conflicts.

In April 2021, destination therapy (DT) was finally approved in Japan. Since DT does not aim at heart transplantation (HT), our goal is to have a patient safely remain on an implantable ventricular assist device (VAD) for the rest of his/her life. To achieve this goal, similarly to bridge-to-transplant (BTT) patients, the authors believe the following six aspects are even more crucial in DT patients: (1) to appropriately assess risks before implantation, (2) to carefully determine the ability to manage the device by multidisciplinary discussions, (3) to prevent complications by improving the quality of care, (4) to expand the number of facilities that can take care of DT patients by improving collaboration among the facilities, (5) to reduce the burden of caregivers by utilizing social resources, and (6) to establish a home palliative care system based on advance care planning. In addition, for elderly DT patients to live happy and long lives, it is essential to help them to find a purpose of life and to keep activities of daily living, such as employment, schooling, and participation in social activities, just like the general elderly population. Our goals are not only to do our best for the patients just in front of us, but also to establish a system to follow up our DT cohort, same as BTT one, by all-Japan manner. In the present review, we discuss the current state of DT in Japan and what we need to focus on to maintain or improve its long-term performance., (© 2024. The Author(s).)

Background: Sarcopenia, characterized by loss of muscle mass and function, is prevalent in heart failure (HF) and predicts poor outcomes. We investigated alterations in sarcopenia index (SI), a surrogate for skeletal muscle mass, in HF, left ventricular assist device (LVAD), and heart transplant (HT), and assessed its relationship with inflammation and digestive tract (gut and oral) microbiota., Methods: We enrolled 460 HF, LVAD, and HT patients. Repeated measures pre/post-procedures were obtained prospectively in a subset of LVAD and HT patients. SI (serum creatinine/cystatin C) and inflammatory biomarkers (C-reactive protein, interleukin-6, tumor necrosis factor-alpha) were measured in 271 and 622 blood samples, respectively. Gut and saliva microbiota were assessed via 16S ribosomal ribonucleic acid sequencing among 335 stool and 341 saliva samples. Multivariable regression assessed the relationship between SI and (1) New York Heart Association class; (2) pre- versus post-LVAD or HT; and (3) biomarkers of inflammation and microbial diversity., Results: Median (interquartile range) natural logarithm (ln)-SI was -0.13 (-0.32, 0.05). Ln-SI decreased across worsening HF class, further declined at 1 month after LVAD and HT, and rebounded over time. Ln-SI was correlated with inflammation (r = -0.28, p < 0.01), gut (r = 0.28, p < 0.01), and oral microbial diversity (r = 0.24, p < 0.01). These associations remained significant after multivariable adjustment in the combined cohort but not for all individual cohorts. The presence of the gut taxa Roseburia inulinivorans was associated with increased SI., Conclusions: SI levels decreased in symptomatic HF and remained decreased long-term after LVAD and HT. In the combined cohort, SI levels covaried with inflammation in a similar fashion and were significantly related to overall microbial (gut and oral) diversity, including specific taxa compositional changes., (Copyright © 2024. Published by Elsevier Inc.)