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While notable improvements in survival, the incidence of hemocompatibility-related adverse events, hospitalizations, and cost have been demonstrated with the only commercially available durable left ventricular assist device, a category of pump malfunctions characterized by outflow graft obstruction has been noted with broader use and clinical follow-up of recipients of this technology. Of particular concern is the accumulation of acellular biodebris between the outflow graft and bend relief covering the outflow graft at its origin with the pump (which we term extrinsic outflow graft obstruction at the bend relief). This process tends to be insidious, occurs late in the postoperative course, can be challenging to diagnose, and can result in significant morbidity and mortality. Herein, we provide a review of this complication and outline diagnostic, treatment, and preventive strategies., (Copyright © 2024 International Society for the Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.)

Background: Utilization of temporary mechanical circulatory support, including veno-arterial extra-corporeal membrane oxygenation as a bridge to heart transplantation (HT) has increased significantly under the revised United Network for Organ Sharing (UNOS) donor heart allocation system. The revised heart allocation system aimed to lower waitlist times and mortality for the most critically ill patients requiring biventricular, nondischargeable, mechanical circulatory support. While previous reports have shown improved 1-year post-HT survival in the current era, 3-year survival and factors associated with mortality among bridge-to-transplant (BTT) extra-corporeal membrane oxygenation (ECMO) patients are not well described., Methods: We queried the UNOS database for all adult (age ≥ 18 years) heart-only transplants performed between 2010 and 2019. Patients were stratified as either pre- (January 2010-September 2018; era 1) or post-allocation change (November 2018-December 2019; era 2) cohort based on their HT date. Baseline recipient characteristics and post-transplant outcomes were compared. A Cox regression analysis was performed to explore risk factors for 3-year mortality among BTT-ECMO patients in era 2. For each era, 3-year mortality was also compared between BTT ECMO patients and those transplanted without ECMO support., Results: During the study period, 116 patients were BTT ECMO during era 1 and 154 patients during era 2. Baseline recipient characteristics were similar in both groups. Median age was 48 (36-58 interquartile range (IQR)) years in era 2, while it was 51 (27-58 IQR) years in era 1. The majority of BTT-ECMO patients were males in both era 2 and era 1 (77.7% vs 71.5%, p = 0.28). Median ECMO run times while listed for HT were significantly shorter (4 days vs 7 days, p < 0.001) in era 2. Waitlist mortality among BTT ECMO patients was also significantly lower in era 2 (6.3% vs 19.3%, p < 0.001). Post-HT survival at 6 months (94.2% vs 75.9%, p < 0.001), 1 year (90.3% vs 74.2%, p < 0.001), and 3 years (87% vs 66.4%, p < 0.001) was significantly improved in era 2 as compared to era 1. Graft failure at 1 year (10.3% vs 25.8%, p = 0.0006) and 3 years (13.6% vs 33.6%, p = 0.0001) was also significantly lower in era 2 compared to era 1. Three-year survival among BTT ECMO patients in era 2 was similar to that of patients transplanted in era 2 without ECMO support (87% vs 85.7%, p = 0.75). In multivariable analysis of BTT-ECMO patients in era 2, every 1 kg/m 2 increase in body mass index was associated with higher mortality at 3 years (hazard ratio (HR) 1.09, 95% CI 1.02-1.15, p = 0.006). Similarly, both post-HT stroke (HR 5.58, 95% CI 2.57-12.14, p < 0.001) and post-HT renal failure requiring hemodialysis (HR 4.36, 95% CI 2.43-7.82, p < 0.001) were also associated with 3-year mortality., Conclusions: Three years post-HT survival in patients bridged with ECMO has significantly improved under the revised donor heart allocation system compared to prior system. BTT ECMO recipients under the revised system have significantly shorter ECMO waitlist run times, lower waitlist mortality and 3-year survival similar to those not bridged with ECMO. Overall, the revised allocation system has allowed more rapid transplantation of the sickest patients without a higher post-HT mortality., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)

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.)

For smaller pediatric patients on ventricular assist devices, the Berlin Heart EXCOR remains the main form of durable support. It requires a connection to the external IKUS, which has limited portability and battery life. The new EXCOR Active mobile driving unit has a battery life of up to 13 hours. We describe the first North American experience with the EXCOR Active in pediatric patients with a Berlin Heart device. A retrospective chart review was undertaken. Between October 2022 and March 2024, 7 patients were on a Berlin Heart and supported with the EXCOR Active. All patients were initially supported with the IKUS with a median time to transition to the EXCOR Active of 12.0 days (interquartile range [IQR] 9.5, 18.5) and a median time of support with the EXCOR Active of 65.0 days (IQR, 32.0, 81.0). The EXCOR Active posed no significant safety issues, and minimal operating issues were noted. Following the transition from IKUS to the EXCOR Active, there was increased patient and caregiver mobility throughout the hospital. Use of the EXCOR Active has the potential to improve the quality of life in pediatric patients waiting for heart transplantation., (Crown Copyright © 2024. 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: 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.)

Background: The current incidence and outcomes of structural transcatheter procedures in heart transplant (HTx) recipients and left-ventricular assist devices (LVAD) carriers is unknown., Aims: To provide insights on structural transcatheter procedures performed across HTx and LVAD patients in Spain., Methods: Multicenter, ambispective, observational nationwide registry., Results: Until May/2023, 36 percutaneous structural interventions were performed (78% for HTx and 22% for LVAD) widely varying among centers (0%-1.4% and 0%-25%, respectively). Percutaneous mitral transcatheter edge-to-edge (TEER) was the most common (n = 12, 33.3%), followed by trancatheter aortic valve replacement (n = 11, 30.5%), and tricuspid procedures (n = 9, 25%). Mitral TEER resulted in mild residual mitral regurgitation in all but one case, mean gradient was <5 mmHg in 75% of them at 1-year, with no mortality and 8.3% re-admission rate. Tricuspid TEER resulted in 100% none/mild residual regurgitation with a 1-year mortality and readmission rates of 22% and 28.5%, respectively. Finally, trancatheter aortic valve replacement procedures (n = 8 in LVADs due to aortic regurgitation and n = 3 in HTx), were successful in all cases with one prosthesis degeneration leading to severe aortic regurgitation at 1-year, 18.2% mortality rate and no re-admissions. Globally, major bleeding rates were 7.9% and 12.5%, thromboembolic events 3.7% and 12.5%, readmissions 37% and 25%, and mortality 22% and 25%, in HTx and LVADs respectively. No death was related to the implanted transcatheter device., Conclusions: Most centers with HTx/LVAD programs perform structural percutaneous procedures but with very inconsistent incidence. They were associated with good safety and efficacy, but larger studies are required to provide formal recommendations., Competing Interests: Declaration of competing interest None., (Copyright © 2024 Elsevier B.V. All rights reserved.)

Competing Interests: Disclosures The author has no conflicts of interest to disclose.

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.)

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.)

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.)

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.)

Since the development of the first heart allocation system in 1988 to the most recent heart allocation system in 2018, the road to heart transplantation has continued to evolve. Policies were shaped with advances in temporary and durable left ventricular assist devices as well as prioritization of patients based on degree of illness. Herein, we review the changes in the heart allocation system over the past several decades and the impact of practice patterns across the United States., Competing Interests: Disclosures The authors have no conflicts of interest to disclose., (Copyright © 2024 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

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.)

Background: The optimal treatment of atrial fibrillation (AF) in patients with heart failure with reduced ejection fraction (HFrEF) remains unsettled., Objective: The purpose of this study was to assess the efficacy of catheter ablation (CA) and medical therapy compared to medical therapy alone in patients with AF and HFrEF., Methods: We performed a systematic review of randomized controlled trials (RCTs) comparing CA with guideline-directed medical therapy for AF in patients with HFrEF (left ventricular ejection fraction [LVEF] ≤ 40%). We systematically searched PubMed, Embase, and Cochrane for eligible trials. A random effects model was used to calculate the risk ratios (RRs) and mean differences (MDs), with 95% confidence intervals (CIs)., Results: Six RCTs comprising 1055 patients were included, of whom 530 (50.2%) were randomized to CA. Compared with medical therapy, CA was associated with a significant reduction in heart failure (HF) hospitalization (RR 0.57; 95% CI 0.45-0.72; P < .01), cardiovascular mortality (RR 0.46; 95% CI 0.31-0.70; P < .01), all-cause mortality (RR 0.53; 95% CI 0.36-0.78; P < .01), and AF burden (MD -29.8%; 95% CI -43.73% to -15.90%; P < .01). Also, there was a significant improvement in LVEF (MD 3.8%; 95% CI 1.6%-6.0%; P < .01) and quality of life (Minnesota Living with Heart Failure Questionnaire; MD -4.92 points; 95% CI -8.61 to -1.22 points; P < .01) in the ablation group., Conclusion: In this meta-analysis of RCTs of patients with AF and HFrEF, CA was associated with a reduction in HF hospitalization, cardiovascular mortality, and all-cause mortality as well as a significant improvement in LVEF and quality of life., Competing Interests: Disclosures The authors have no conflicts of interest to disclose., (Copyright © 2024 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)

Background: Severe lung disease frequently presents with both refractory hypoxemia and right ventricular (RV) failure. Right ventricular assist device with an oxygenator (OxyRVAD) is an extracorporeal membrane oxygenation (ECMO) configuration of RV bypass that also supplements gas exchange. This systematic review summarises the available literature regarding the use of OxyRVAD in the setting of severe lung disease with associated RV failure., Methods: PubMed, Embase, and Google Scholar were queried on September 27, 2023, for articles describing the use of an OxyRVAD configuration. The main outcome of interest was survival to intensive care unit (ICU) discharge. Data on the duration of OxyRVAD support and device-related complications were also recorded., Results: Out of 475 identified articles, 33 were retained for analysis. Twenty-one articles were case reports, and 12 were case series, representing a total of 103 patients. No article provided a comparison group. Most patients (76.4%) were moved to OxyRVAD from another type of mechanical support. OxyRVAD was used as a bridge to transplant or curative surgery in 37.4% and as a bridge to recovery or decision in 62.6%. Thirty-one patients (30.1%) were managed with the dedicated single-access dual-lumen ProtekDuo cannula. Median time on OxyRVAD was 12 days (interquartile range 8-23 days), and survival to ICU discharge was 63.9%. Device-related complications were infrequently reported., Conclusion: OxyRVAD support is a promising alternative for RV support when gas exchange is compromised, with good ICU survival in selected cases. Comparative analyses in patients with RV failure with and without severe lung disease are needed., (Copyright © 2024 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.)

It is unknown whether racial disparities in access to heart transplantation (HT) are amplified when coupled with substance use. We examined patients evaluated for HT over 8 years at an urban transplant center. We evaluated substance use and race/ethnicity as independent and interactive predictors of HT and left ventricular assist device (LVAD) implantation. Of 1,148 patients evaluated for HT, substance use was cited as an ineligibility factor in 151 (13%) patients, 16 (11%) of whom ultimately received HT. Significantly more non-Hispanic Black (NHB) patients were deemed ineligible due to substance use (n = 59, 19%) compared to other races/ethnicities (non-Hispanic white: n = 68, 12%; other race/ethnicity: n = 24, p = 0.002). No racial differences were observed in the likelihood of HT among patients initially excluded for substances, but more NHB patients ultimately received LVAD than the other racial groups. This study encourages greater awareness of the role of substance use and race in the HT evaluation., (Copyright © 2024 International Society for the Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.)

Classic Impella exchange interrupts flow when the old device is pulled into the aorta before advancing the new device across the aortic valve, threatening circulatory collapse and loss of left ventricular access. In "double barrel," uninterrupted Impella exchange, the new device is placed into the ventricle alongside the old, where flow is first transitioned completely. Of 31 consecutive patients undergoing this procedure, none experienced intraoperative cardiac arrest, and 96.8% (30/31) had no new aortic insufficiency. One vascular complication ensued following known preoperative iliac injury. One patient suffered nonembolic stroke; another had subarachnoid hemorrhage. Fifty-five percent (17/31) of patients survived, with 22.6% (7/31) recovering, 25.8% (8/31) undergoing transplant, and 6.5% (2/31) transitioning to durable left ventricular assist device. Impella-only survival (83.3%, 10/12) was significantly higher than Impella-extracorporeal membrane oxygenation survival (36.8%, 7/19; (operating room) OR 14.46, 95% ((confidence interval) CI 1.74-119.93, p = 0.01). We conclude the "double barrel" technique is reliable in device-dependent cardiogenic shock patients, offering significant advantages and minimal risk., (Copyright © 2024 International Society for the Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.)

Background: Continuous-flow left ventricular assist device (cfLVAD) use is effective in supporting patients with end-stage heart failure (ESHF). Reduced flow pulsatility within the systemic circulation in cfLVAD-supported patients may lead to alterations within the microcirculation. Temporal changes in microvasculature in relation to adverse events in cfLVAD-supported patients have not been studied. We aimed to profile changes within retinal microvasculature and its association with adverse events., Methods: Retinal photography was performed using Topcon TRC-NW8 nonmydriatic fundus camera in cfLVAD-supported patients and ESHF control patients. Specific retinal measurements were evaluated using a validated semiautomated program. Demographic and adverse event data were documented., Results: Forty-eight patients were studied (n = 29 cfLVAD, n = 19 ESHF). There were significant trends in retinal arteriolar caliber (B = -0.53 µm, 95% confidence interval [CI]: -0.96 to -0.10, p = 0.016) and retinal fractal dimension parameters (B = 0.014, 95% CI: 0.001-0.002, p = 0.016) in linear mixed model regressions. Among cfLVAD patients, there was a significant association between the incidence of gastrointestinal bleeding and stepwise increases in retinal arteriolar-venular caliber ratio (hazard ratio: 3.03, 95% CI: 2.06-4.45, p = 0.005), a measure of arteriolar narrowing., Conclusions: We have observed for the first time that alterations in retinal microvasculature in cfLVAD-supported patients may be associated with gastrointestinal bleeding. While understanding these temporal changes may predict future adverse events in cfLVAD-supported patients, further multicenter studies are required to confirm the associations observed., (Copyright © 2024 International Society for the Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.)

Up to 20 % of patients presenting with acute heart failure and cardiogenic shock have a structural etiology. Despite efforts in timely management, mortality rates remain alarmingly high, ranging from 50 % to 80 %. Surgical intervention is often the definitive treatment for structural heart disease; however, many patients are considered high risk or unsuitable candidates for such procedures. Consequently, there has been a paradigm shift towards the development of novel percutaneous management strategies and temporizing interventions. This article aims to provide a comprehensive review of the pathophysiology of valvular and structural heart conditions presenting in cardiogenic shock, focusing on the evolving landscape of mechanical circulatory support devices and other management modalities., Competing Interests: Declaration of competing interest The authors do not have any conflicts of interest or relationships to disclose. All authors have read and approved this manuscript and this submission. The paper is not under consideration elsewhere and none of the paper's content have been previously published., (Copyright © 2024. Published by Elsevier Inc.)

Background: The REDUCE LAP-HF II (Reduce Elevated Left Atrial Pressure in Patients With Heart Failure II) trial found that, compared with a sham procedure, the Corvia Atrial Shunt did not improve outcomes in heart failure with preserved or mildly reduced ejection fraction. However, after 12-month follow-up, "responders" (peak-exercise pulmonary vascular resistance <1.74 WU and absence of a cardiac rhythm management device) were identified., Objectives: This study sought to determine: 1) the overall efficacy and safety of the atrial shunt vs sham control after 2 years of follow-up; and 2) whether the benefits of atrial shunting are sustained in responders during longer-term follow-up or are offset by adverse effects of the shunt., Methods: The study analyzed 2-year outcomes in the overall REDUCE LAP-HF II trial, as well as in responder and nonresponder subgroups. The primary endpoint was a hierarchical composite of cardiovascular death or nonfatal ischemic/embolic stroke, total heart failure events, and change in health status., Results: In 621 randomized patients, there was no difference between the shunt (n = 309) and sham (n = 312) groups in the primary endpoint (win ratio: 1.01 [95% CI: 0.82-1.24]) or its individual components at 2 years. Shunt patency at 24 months was 98% in shunt-treated patients. Cardiovascular mortality and nonfatal ischemic stroke were not different between the groups; however, major adverse cardiac events were more common in those patients assigned to the shunt compared with sham (6.9% vs 2.7%; P = 0.018). More patients randomized to the shunt had an increase in right ventricular volume of ≥30% compared with the sham control (39% vs 28%, respectively; P < 0.001), but right ventricular dysfunction was uncommon and not different between the treatment groups. In responders (n = 313), the shunt was superior to sham (win ratio: 1.36 [95% CI: 1.02-1.83]; P = 0.037, with 51% fewer HF events [incidence rate ratio: 0.49 [95% CI: 0.25-0.95]; P = 0.034]). In nonresponders (n = 265), atrial shunting was inferior to sham (win ratio: 0.73 [95% CI: 0.54-0.98])., Conclusions: At 2 years of follow-up in REDUCE LAP-HF II, there was no difference in efficacy between the atrial shunt and sham groups in the overall trial group. The potential clinical benefit identified in the responder group after 1 and 2 years of follow-up is currently being evaluated in the RESPONDER-HF (Re-Evaluation of the Corvia Atrial Shunt Device in a Precision Medicine Trial to Determine Efficacy in Mildly Reduced or Preserved Ejection Fraction Heart Failure) trial. (Reduce Elevated Left Atrial Pressure in Patients With Heart Failure II [REDUCE LAP-HF II]; NCT03088033)., Competing Interests: Funding Support and Author Disclosures The REDUCE LAP-HF II trial was funded by Corvia Medical, Inc. Dr Gustafsson has served as an unpaid advisor to Corvia; has received consulting fees from Bayer, AstraZeneca, Abbott, Ionis, Alnylam, Pfizer, FineHeart, CorWave, and AdjuCor; and has received speaker fees from Novartis. Dr Petrie has received research funding from Boehringer Ingelheim, Roche, SQ Innovations, AstraZeneca, Novartis, Novo Nordisk, Medtronic, Boston Scientific, and Pharmacosmos; and has served as a consultant and on trial committees for Akero, Applied Therapeutics, AnaCardio, Biosensors, Boehringer Ingelheim, Novartis, AstraZeneca, Novo Nordisk, Abbvie, Bayer, Horizon Therapeutics, Takeda, Cardiorentis, Pharmacosmos, Siemens, Lilly, Vifor, New Amsterdam, Moderna, and Teikoku. Dr Komtebedde is an employee of Corvia Medical, Inc. Dr Borlaug has received research support from the National Institutes of Health, and the U.S. Department of Defense; has received research grants from AstraZeneca, Axon, GlaxoSmithKline, Medtronic, Mesoblast, Novo Nordisk, Rivus, and Tenax Therapeutics; has served as a consultant for Actelion, Amgen, Aria, Axon Therapies, BD, Boehringer Ingelheim, Cytokinetics, Edwards Lifesciences, Eli Lilly, Imbria, Janssen, Merck, Novo Nordisk, NGM, NXT, and VADovations; and is a named inventor (US Patent number 10,307,179) for the tools and approach for a minimally invasive pericardial modification procedure to treat heart failure. Dr Mohan has received research funds paid to his institution from Corvia, Alleviant Medical, and V-Wave; has received consulting fees from Corvia, Alleviant Medical, AstraZeneca, Pfizer, and Boston Scientific, and has received speaker honoraria from Bristol-Myers Squibb, Pfizer, and AstraZeneca. Dr Sverdlov has received support from the National Heart Foundation of Australia Future Leader Fellowship (Award ID 106025); has received research grants from the Department of Health and Aged Care (Australia) Medical Research Future Fund (MRF2017053), New South Wales (NSW) Health (Australia), AstraZeneca, Novartis, Biotronik, RACE Oncology, Bristol-Myers Squibb, Roche Diagnostics, and Vifor; and has received personal fees from Novartis, Bayer, Bristol-Myers Squibb, AstraZeneca, Janssen, and Boehringer Ingelheim. Dr Chung has received consulting fees from Abbott, Medtronic, InterShunt, Cardionomic, EBR, CVRx, LivaNova; and has served on the Speakers Bureau for Boehringer Ingelheim. Dr Lurz has received institutional fees and research grants from Abbott Vascular, Edwards Lifesciences, and ReCor; has received honoraria from Edwards Lifesciences, Abbott Medical, Innoventric, ReCor; and Boehringer Ingelheim; and has held stock options with Innoventric. Dr Cikes has received investigator-initiated research grants to her institution from Novartis, Abbott, and Pfizer; has received clinical study contracts for her institution from Novo Nordisk and Corvia; and has served in an advisory role and received speaker honoraria and/or travel grants from Abbott, Abiomed, Amgen, Amicus Therapeutics, AstraZeneca, Bayer, Boehringer Ingelheim, GE Healthcare, Livanova, Krka Pharma, Novartis, Novo Nordisk, Pfizer, Pulsify Medical, Roche, Swixx, Takeda, Teva Pharmaceutical Industries, and Viatris. Dr Shah has received grant support from the National Heart, Lung and Blood Institute (grants U54 HL160273, R01 HL107577, R01 HL127028, R01 HL140731, and R01 HL149423), AstraZeneca, Corvia, and Pfizer; and has received consulting fees from Abbott, Alleviant, AstraZeneca, Amgen, Aria CV, Axon Therapies, Bayer, Boehringer Ingelheim, Boston Scientific, Bristol-Myers Squibb, Cyclerion, Cytokinetics, Edwards Lifesciences, Eidos, Imara, Impulse Dynamics, Intellia, Ionis, Lilly, Merck, MyoKardia, Novartis, Novo Nordisk, Pfizer, Prothena, ReCor, Regeneron, Rivus, Sardocor, Shifamed, Tenax, Tenaya, and Ultromics. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2024 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: The Child Opportunity Index (COI) comprehensively measures children's social determinants of health. We describe association between COI and outcomes after listing for heart transplantation., Methods: We conducted a retrospective review of the United Network for Organ Sharing (UNOS) database for U.S. children listed for heart transplant between 2012 and 2020. ZIP codes were utilized to assign COI. Primary outcome was survival from time of listing. Secondary outcomes included waitlist survival, 1-year post-transplant survival, and conditional 1-year post-transplant survival. Cox regression was performed adjusting for payor, age, race, diagnosis, and support at listing for all outcomes except waitlist survival, for which Fine-Gray competing risk analysis was performed., Results: Of 5,723 children listed, 109 were excluded due to missing ZIP codes. Race/ethnicity and payor were associated with COI (p < 0.001). Patients living in very low COI ZIP codes compared to all others had increased mortality from time of listing (HR 1.16, CI 1.03-1.32, p = 0.02) with 1-, 5-, and 9-year survival of 79.3% vs 82.2%, 66.5% vs 73.0%, and 53.6% vs 64.7% respectively, were more likely to be removed from the waitlist due to death or being too sick (subdistribution HR 1.26, 95% CI 1.10-1.42), and had increased mortality conditional on one-year post-transplant survival (HR 1.38, 1.09-1.74, p = 0.008) with 1-, 3-, and 5- year survival of 94.7% vs 97.3%, 87.0% vs 93.1%, and 78.6% vs 86.9%., Conclusions: Children living in lower opportunity ZIP codes had poorer survival from time of listing, poorer waitlist survival, and poorer conditional one-year post-transplant survival., (Copyright © 2024 International Society for the Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.)

Background: Patient-reported outcome (PRO) measures of distinct concepts are often put together into patient profile assessments. When brief, profile assessments can decrease respondent burden and increase measure completion rates. In this report, we describe the creation of 5 self-reported 4-item short forms and the Mechanical Circulatory Support: Measures of Adjustment and Quality of Life (MCS A-QOL) 20-item profile to assess PROs specific to adjustment and health-related quality of life (HRQOL) among patients who undergo left ventricular assist device (LVAD) implantation., Methods: Using a cross-sectional sample of patients (n = 620) who underwent LVAD implantation at 12 U.S. sites or participated in the MyLVAD.com support group, we created 5 4-item short forms: Satisfaction with Treatment, ventricular assist device (VAD) Team Communication, Being Bothered by VAD Self-care and Limitations, Self-efficacy Regarding VAD self-care, and Stigma, which we combined into a 20-item profile. Analyses included intercorrelations among measures, Cronbach's alpha (i.e., internal consistency reliability)/score-level-specific reliability, and construct validity., Results: The 620 patients were mean age = 57 years, 78% male, 70% White, and 56% on destination therapy LVADs. Intercorrelations among the 5 4-item measures were low to moderate (≤0.50), indicating they are associated yet largely distinct, and correlations with calibrated measures and 6-item short forms were ≥0.76, indicating their ability to reflect full-item bank scores. Internal consistency reliability for the 5 4-item short forms ranged from acceptable (≥0.70) to good (≥0.80). Construct validity was demonstrated for these measures., Conclusions: Our 5 4-item short forms are reliable and valid and may be used individually or together as a 20-item profile to assess adjustment and HRQOL in patients who undergo LVAD implantation., Competing Interests: Disclosure statement Kathleen L. Grady, PhD, RN – NIH Grants (NIA and NHLBI) and payment of room reservation by NIH as faculty at the Ten-day Seminar; lecturer (registration fees paid for meeting: Heart Failure Society of America, American Heart Association, International Society for Heart and Lung Transplantation, and American College of Cardiology); leadership or fiduciary role (ISHLT Board of Directors, Foundation Board, Research Oversight Committee, Governance Committee, Leadership Advisory Forum, and chair, Grants and Awards Committee). Michael Kallen, PhD – Deceased; ICMJE Disclosure Form not completed. Larry A. Allen, MD, MHS – Grant from PCORI and NIH; Consultant for ACI Clinical, Boston Scientific, Cytokinetics, Novartis, UpToDate, and Quidel. JoAnn Lindenfeld, MD –Consulting fees from Abbott, Alleviant, Axon, Astra Zenaca, Boston Scientific, CVRx, Merck, Medtronic, VWave, Edwards Lifesciences, Whiteswell, and Vascular Dynamicx. Colleen K. McIlvennan, PhD, DNP, ANP – Grant from PCORI and Cambia Health Foundation; HFSA Board of Directors. Christopher S. Lee, PhD, RN – DSMB chair: COMBAT-DS; US Department of Health and Human Services: National Advisory Council (member). Josef Stehlik, MD – Grants from Natera and Merck and consulting for Medtronic, Natera, and TransMedics. James K. Kirklin, MD – Intellectual properties for IT software development in registry database design developed at and licensed from the University of Alabama at Birmingham; chair of DSMB for Xeltis cardiac conduit clinical trial, chair of DSMB for Carmat TAH clinical trial, chair XVIVO Clinical Safety Monitoring Board; President World Society for Pediatric and Congenital Heart Surgery; common stock in Kirklin Solutions Co. Database development and analytics (20% ownership; $3.75 per share; current market value $700,000); partial salary support as Director of the Data Center for STS Intermacs/Pedimacs (no payments for any of these roles related to this publication). Jeffrey Teuteberg, MD – Consultant for Abbott, CareDx, Medtronic and Takeda; Lecturer for CareDx, Cytokinetics, Medtronic, and Paragonix. Eric Adler, MD – Grants from Lexeo Therapeutics, Rocket Pharmaceuticals, and California Institute for Regenerative Medicines; Royalties or licenses from Lexeo Therapeutics, Rocket Pharmaceuticals, and Papillion Therapeutics; consulting fees from Abiomed, Norvartis, Abbott, Ionis, Kiniska, Sana, Medtronic, and Cytokinetics; payment for expert testimony on behalf of Astro Zeneca; patents planned, issued or pending: Method for treating Danon disease and other disorders of autophagy and ex vivo genetic modification of hematopoietic cells for the treatment of Danon Disease; participation on DSMB: Edwards Lifesciences, Ancora Heart, and Corstasis Therapeutics; leadership or fiduciary role: Chief Science Officer for Lexeo Therapeutics, Scientific Advisory Board for Sarnoff Foundation, and Board of Directors for Papillion Therapeutics; stock or stock options: Rocket Pharmaceuticals, Lexeo Therapeutics, Corstasis Therapeutics, and Papillion Therapeutics. Michael Kiernan, MD – Steering Committee: Medtronic and Endotronix. The other authors have no conflicts of interest to disclose. Michael Kallen, PhD, MPH, coauthor and statistician/psychometrician for MCS A-QOL and this paper, passed away on July 27, 2023. His contributions to this manuscript were substantial and his passion for the development of patient-reported outcome measures was inspiring. He was a kind and gentle person who is genuinely missed by Beth Hahn, my co-PI on MCS A-QOL, and me. Words cannot adequately express our deep sense of gratitude and loss. This work was sponsored by the National Institutes of Health, National Heart Lung and Blood Institute (NHLBI), Mechanical Circulatory Support: Measures of Adjustment and Quality of Life (MCS A-QOL, [R01HL130502], Grady K.L. and Hahn E.A. [co-PIs])., (Copyright © 2024. Published by Elsevier Inc.)

Background: Gender and racial disparities exist after left ventricular assist device (LVAD) implantation. Compared with older devices, the HeartMate 3 (HM3) (Abbott Cardiovascular) has demonstrated improved survival. Whether HM3 differentially improves outcomes by gender or race and ethnic groups is unknown., Objectives: The purpose of this study is to examine differences by gender and race in the use of HM3 among patients listed for heart transplantation (HT) and associated waitlist and post-transplant outcomes., Methods: The authors examined all patients (20% women, 33% Black) who received LVADs as bridge to transplantation (BTT) between January 2018 and June 2020, in the OPTN (Organ Procurement and Transplantation Network) database. Trends in use of HM3 were evaluated by gender and race. Competing events of death/delisting and transplantation were evaluated using subdistribution hazard models. Post-transplant outcomes were evaluated using multivariate logistic regression adjusted for demographic, clinical, and donor characteristics., Results: Of 11,524 patients listed for HT during the study period, 955 (8.3%) had HM3 implanted as BTT. Use of HM3 increased for all patients, with no difference in use by gender (P = 0.4) or by race (P = 0.2). Competing risk analysis did not demonstrate differences in transplantation or death/delisting in men compared with women (HT: adjusted HR [aHR]: 0.92 [95% CI: 0.70-1.21]; death/delisting: aHR: 0.91 [95% CI: 0.59-1.42]), although Black patients were transplanted fewer times than White patients (HT: aHR: 0.72 [95% CI: 0.57-0.91], death/delisting: aHR: 1.36 [95% CI: 0.98-1.89]). One-year post-transplant survival was comparable by gender (aHR: 0.52 [95% CI: 0.21-1.70]) and race (aHR: 0.76 [95% CI: 0.34-1.70]), with no differences in rates of stroke, acute rejection, or graft failure., Conclusions: Use of HM3 among patients listed for HT has increased over time and by gender and race. Black patients with HM3 were less likely to be transplanted compared with White patients, but there were no differences in post-transplant outcomes between these groups or between men and women., Competing Interests: Funding Support and Author Disclosure Dr Morris is supported by the American Heart Association, AHRQ (HS026081), the Woodruff Foundation, and the Association of Black Cardiologists; and has received consulting fees from Abbott, Acorai, BI Lilly, Cytokinetics, Edwards Lifesciences, Ionis, and Merck. Dr Patel is supported by the Stimulating Access to Research in Residency of the National Institutes of Health under Award Number R38AI140299. Dr Wang is supported by the National Heart, Lung and Blood Institute of the National Institutes of Health under award number 5T32HL007745. Dr Okoh is supported by the National Heart, Lung, and Blood Institute of the National Institutes of Health under Award Number T32HL130025. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2024 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Life expectancy of patients with a durable, continuous-flow left ventricular assist device (CF-LVAD) continues to increase. Despite significant improvements in the delivery of care for patients with these devices, hemocompatability-related adverse events (HRAEs) are still a concern and contribute to significant morbility and mortality when they occur. As such, dissemination of current best evidence and practices is of critical importance. This ISHLT Consensus Statement is a summative assessment of the current literature on prevention and management of HRAEs through optimal management of oral anticoagulant and antiplatelet medications, parenteral anticoagulant medications, management of patients at high risk for HRAEs and those experiencing thrombotic or bleeding events, and device management outside of antithrombotic medications. This document is intended to assist clinicians caring for patients with a CF-LVAD provide the best care possible with respect to prevention and management of these events., (Copyright © 2024 International Society for the Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.)

Background: Disturbance in bodily experience (BE) is a potential adverse consequence of ventricular assist device (VAD) implantation. The concept BE encompasses all cognitive and affective processes related to the subjective experience of one's own body., Methods: A cross-sectional, multicenter study was performed, involving 365 VAD patients (85% male; time postimplant: 3-36 months). Patients completed a BE questionnaire (BE-S, 5-point Likert scale), and the disturbance in BE was analyzed based on sex, time since implantation (in the first, second, or third years postimplant), and patient acuity (elective vs emergent implantation). Subsidiary, patients' gratitude was surveyed., Results: Disturbance in BE was not particularly pronounced (mean = 2.69, standard deviation = 1.17). Eighty-five percent of patients expressed high levels of gratitude. Disturbance in BE decreased (p = 0.04), while gratitude increased (p = 0.02) with time since implantation. Female patients showed more disturbance in BE (p = 0.01) and less gratitude (p = 0.01) compared to male patients. Among patients who underwent emergency implantation, the decrease in disturbance occurred predominantly in the third year, exceeding the level observed in elective implanted patients (p = 0.03)., Conclusions: Disturbance in BE following VAD implantation does generally not reach excessive levels and tends to decrease over time. Our data indicate more disturbance and less gratitude in female patients. In emergently implanted patients, disturbance in BE is prolonged. Screening for disturbance in BE is recommended during follow-up, especially for these at-risk groups, to ensure early and focused psychological support., (Copyright © 2024 International Society for the Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.)

Background: Transplant center report cards are publicly available and used by regulators, insurance payers, and importantly patients and families., Objectives: In this study, the authors sought to evaluate the variability in reported public performance ratings of pediatric and adult heart transplant centers., Methods: Program-specific reports from the Scientific Registry of Transplant Recipients from 2017-2021 were used to evaluate stability, volatility, and reliability of 3 publicly reported ratings: waitlist survival (WS), getting to a faster transplant (FT), and post-transplantation graft failure (GF)., Results: There were 112 adult and 55 pediatric centers. Over the study period, nearly all centers (98%) had at least 1 change in rating in at least 1 of the tiers. The average time to the first rating change of any magnitude was 12-18 months for all tiers and centers. For adult centers, the most volatile rating was WS (SD: 0.77), followed by GF (SD: 0.76) and then FT (SD: 0.57). For pediatric centers, the most volatile rating was WS (SD: 0.79), followed by both GF (SD: 0.66) and FT (SD: 0.68), which were equally volatile. All tiers except adult FT had an estimated Fleiss's kappa <0.20, indicating poor agreement/consistency across the study period. In addition, the intraclass correlation coefficient for all tiers was <0.50, indicating poor reliability., Conclusions: The current 5-tier reporting of transplant center performance is highly volatile and has poor reliability and consistency. Given the unintended and significant negative consequences these reports can have, critical revision of these ratings is warranted., Competing Interests: Funding Support and Author Disclosures The statistical analysis for this study was supported by the Center for Population Health Research, Cleveland Clinic. Dr Amdani is a site primary investigator for a multicenter study led by the University of Michigan (receives no salary support). Dr Schold is vice-chair of the United Network for Organ Sharing data advisory committee. Dr Dewey has reported that she has no relationships relevant to the contents of this paper to disclose., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)

Pediatric heart failure and transplantation carry associated risks for kidney failure and potential need for kidney transplant following pediatric heart transplantation (KT/pHT). This retrospective, United Network of Organ Sharing study of 10,030 pediatric heart transplants (pHTs) from 1987 to 2020 aimed to determine the incidence of waitlisting for and completion of KT/pHT, risk factors for KT/pHT, and risk factors for nonreceipt of a KT/pHT. Among pHT recipients, 3.4% were waitlisted for KT/pHT (median time of 14 years after pHT). Among those waitlisted, 70% received a KT/pHT, and 18% died on the waitlist at a median time of 0.8 years from KT/pHT waitlisting (median age of 20 years). Moderate-high sensitization at KT/pHT waitlisting (calculated panel reactive antibody, ≥ 20%) was associated with a lower likelihood of KT/pHT (adjusted hazard ratio, 0.67; 95% confidence interval, 0.47-0.95). Waitlisting for heart transplantation simultaneously with kidney transplant (adjusted hazard ratio, 3.73; 95% confidence interval, 2.01-6.92) was associated with increased risk of death on the KT/pHT waitlist. While the prevalence of KT/pHT is low, there is substantial mortality among those waitlisted for KT/pHT. These findings suggest a need to consider novel risk factors for nonreceipt of KT/pHT and death on the waitlist in prioritizing criteria/guidelines for simultaneous heart-kidney transplantation., (Copyright © 2024 American Society of Transplantation & American Society of Transplant Surgeons. Published by Elsevier Inc. All rights reserved.)

Background: Aortic root thrombosis(ART) is a complication of continuous-flow left ventricular assist device therapy. However, the incidence and related complications of ART in HeartMate 3 (HM3) patients remain unknown., Methods: Patients who underwent HM3 implantation from November 2014 to August 2020 at a quaternary academic medical center were included. Demographics and outcomes were abstracted from the medical record. Echocardiograms and contrast-enhanced computed tomography studies were reviewed to identify patients who developed ART and/or moderate or greater aortic insufficiency (AI) on HM3 support., Results: The study cohort included 197 HM3 patients with a median postimplant follow-up of 17.5 months. Nineteen patients (9.6%) developed ART during HM3 support, and 15 patients (7.6%) developed moderate or greater AI. Baseline age, gender, race, implantation strategy, and INTERMACS classification were similar between the ART and no-ART groups. ART was associated with an increased risk of death, stroke, or aortic valve (AV) intervention (subhazard ratio [SHR] 3.60 [95% confidence interval (CI) 1.71-7.56]; p = 0.001) and moderate or greater AI (SHR 11.1 [CI 3.60-34.1]; p < 0.001) but was not associated with a statistically significantly increased risk of death or stroke on HM3 support (2.12 [0.86-5.22]; p = 0.10). Of the 19 patients with ART, 6 (31.6%) developed moderate or greater AI, necessitating more frequent AV interventions (ART: 5 AV interventions [3 surgical repairs, 1 surgical replacement, 1 transcatheter replacement; 26.3%]; no-ART: 0)., Conclusions: Nearly 10% of HM3 patients developed ART during device support. ART was associated with increased risk of a composite end-point of death, stroke, or AV intervention as well as moderate or greater AI., (Copyright © 2023. Published by Elsevier Inc.)

Heart failure with preserved ejection fraction (HFpEF) is recognized as an important risk factor for perioperative complications. However, anesthesia management of HFpEF patients remains a considerable challenge without clear guidance. HFpEF is heterogeneous in its pathophysiological processes, diverse clinical presentations, adverse remodeling of cardiovascular and other organs, and clinical outcomes. It is difficult to manage the disease with one fixed approach because of this. This review phenotypes HFpEF patients by combining their clinical features and anesthesia care issues. Five phenotypes of HFpEF patients are identified: A, O, P, C, and Y. The clinical features, anesthesia implications, and anesthesia management for each phenotype are highlighted and discussed. Such an approach to HFpEF patients in the operating room could deliver safe, high-quality perioperative care., Competing Interests: Declaration of competing interest The authors 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.)

Background: There is no FDA-approved left ventricular assist device (LVAD) for smaller children permitting routine hospital discharge. Smaller children supported with LVADs typically remain hospitalized for months awaiting heart transplant-a major burden for families and a challenge for hospitals. We describe the initial outcomes of the Jarvik 2015, a miniaturized implantable continuous flow LVAD, in the NHLBI-funded Pumps for Kids, Infants, and Neonates (PumpKIN) study, for bridge-to-heart transplant., Methods: Children weighing 8 to 30 kg with severe systolic heart failure and failing optimal medical therapy were recruited at 7 centers in the United States. Patients with severe right heart failure and single-ventricle congenital heart disease were excluded. The primary feasibility endpoint was survival to 30 days without severe stroke or non-operational device failure., Results: Of 7 children implanted, the median age was 2.2 (range 0.7, 7.1) years, median weight 10 (8.2 to 20.7) kilograms; 86% had dilated cardiomyopathy; 29% were INTERMACS profile 1. The median duration of Jarvik 2015 support was 149 (range 5 to 188) days where all 7 children survived including 5 to heart transplant, 1 to recovery, and 1 to conversion to a paracorporeal device. One patient experienced an ischemic stroke on day 53 of device support in the setting of myocardial recovery. One patient required ECMO support for intractable ventricular arrhythmias and was eventually transplanted from paracorporeal biventricular VAD support. The median pump speed was 1600 RPM with power ranging from 1-4 Watts. The median plasma free hemoglobin was 19, 30, 19 and 30 mg/dL at 7, 30, 90 and 180 days or time of explant, respectively. All patients reached the primary feasibility endpoint. Patient-reported outcomes with the device were favorable with respect to participation in a full range of activities. Due to financial issues with the manufacturer, the study was suspended after consent of the eighth patient., Conclusion: The Jarvik 2015 LVAD appears to hold important promise as an implantable continuous flow device for smaller children that may support hospital discharge. The FDA has approved the device to proceed to a 22-subject pivotal trial. Whether this device will survive to commercialization remains unclear because of the financial challenges faced by industry seeking to develop pediatric medical devices. (Supported by NIH/NHLBI HHS Contract N268201200001I, clinicaltrials.gov 02954497)., (Copyright © 2024 International Society for the Heart and Lung Transplantation. All rights reserved.)

Heart transplantation remains the gold standard treatment for end-stage heart failure patients without contraindications. However, limited donor availability and long wait times have created a need for left ventricular assist devices (LVAD) to be used as a bridge to transplantation in appropriately selected patients. Improvements in LVAD technology have resulted in improved short- and long-term outcomes, further supporting the use of these devices for a bridge-to-transplant (BTT) indication. LVAD utilization as BTT exhibits notable disparities worldwide, mainly due to variations in organ availability, allocation policies, and financial constraints. Although Europe has experienced a consistent increase in the use of LVAD for this purpose, the United Network for Organ Sharing 2018 policy amendment resulted in a significant reduction in the number of LVADs used for BTT in the US. To overcome this issue, modifications in the US allocation policy to consider factors such as days on device support, age, and type of complications may be necessary to potentially increase implantation rates.The authors provide an overview comparing the current state of heart transplantation in the US and Europe, with a particular focus on how distinct allocation policies and organ availability impact medical practices. Additionally, the review will examine critical aspects ranging from patient selection and pre-implantation optimization to post-transplant outcomes., (Copyright © 2024. Published by Elsevier Inc.)

Background: Myocardial recovery occurs in patients with advanced heart failure on left ventricular assist device (LVAD) support, but there is the premise that it is rare with uncertain results., Objectives: The goal of this study was to investigate the incidence and consequence of LVAD explant after myocardial recovery., Methods: Using the United Network for Organ Sharing registry, LVAD implants in the United States between 2005 and 2020 were tracked until death, transplantation, or explant for myocardial recovery. The cohort undergoing explant was followed up for heart failure relapse (defined as relisting followed by delisting due to death, being too ill, or transplantation; or second durable LVAD implant)., Results: Of 15,728 LVAD implants, 126 patients underwent explant for recovery, which only occurred in 55 (38%) of 145 implanting centers. The crude cumulative incidence was 0.7% at 2 years, whereas the incidence reached 4.7% among designated centers in the selected young nonischemic cohort. Of 126 explanted patients, 76 (60%) were subsequently delisted for sustained recovery. Heart failure relapsing had a relatively higher hazard in the early phase, with a 30-day incidence of 6% (7 of 126) but tapered following with the freedom rate of 72.5% at 4 years., Conclusions: In the United States, LVAD explant for myocardial recovery was underutilized, leading to a very low incidence at the national level despite a realistic rate being achieved in designated centers for selected patients. With follow-up extending up to 4 years after explant, more than one-half were successfully removed and stayed off the waitlist, and approximately 70% were free from heart failure relapse events., Competing Interests: Funding Support and Author Disclosures The authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2024 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

To evaluate outcomes of patients undergoing heart transplants (HTs) using an intra-aortic balloon pump (IABP) under exception status. Adult patients supported by an IABP who underwent HT between November 18, 2018, and December 31, 2020, as documented in the United Network for Organ Sharing, were included. Patients were stratified according to requests for exception status. Kaplan-Meier methodology was used to look for differences in survival between groups. A total of 1284 patients were included; 492 (38.3%) were transplanted with an IABP under exception status. Exception status patients had higher body mass index, were more likely to be Black, and had longer waitlist times. Exception status patients received organs from younger donors, had a shorter ischemic time, and had a higher frequency of sex mismatch. The 1-year posttransplant survival was 93% for the nonexception and 88% for the exception IABP patients (hazard ratio: 1.85 [95% confidence interval: 1.12-2.86, P = .006]). The most common reason for requesting an exception status was inability to meet blood pressure criteria for extension (37% of patients). The most common reason for an extension request for an exception status was right ventricular dysfunction (24%). IABP patients transplanted under exception status have an increased 1-year mortality rate posttransplant compared with those without exception status., (Copyright © 2023 American Society of Transplantation & American Society of Transplant Surgeons. Published by Elsevier Inc. All rights reserved.)