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Background: Heart transplantation (HT) survival and waitlist times are established outcome metrics. Patient-centered HT outcomes are insufficiently characterized. This study evaluates the role of days alive and outside the hospital (DAOH) as a candidate patient-centered HT performance measure., Methods: The study cohort included Medicare beneficiaries undergoing HT (July 2008-December 2017). The percent of days outside of hospital (%DOH) 6 months before (%DOH-BF) and percent of days alive outside of hospital 12 months after HT (%DAOH-AF) were evaluated along with adverse events (AEs, early: ≤3 months; late: 4-12 months). Patients were stratified by patient %DAOH-AF terciles. Risk-adjusted %DAOH was evaluated across hospitals., Results: A total of 5,104 beneficiaries underwent HT across 108 hospitals. Median [interquartile range (IQR)] age was 62 [53-67] years, 23.9% were female, and 21.4% were African-American. The overall median %DOAH-AF was 92.9% [83.8%, 95.9%], varying by tercile: low 71.8% [4.9%, 83.6%], intermediate 92.9% [91%, 94%]; high 96.4% [95.9%, 97.3%]. The lowest (vs highest) tercile %DAOH-AF had a lower median %DOH-BF (88% [73%-97%] vs 92% [81%-98%]) and longer post-HT inpatient stay (54 [36-81] vs 13 [10-15] days). After HT, the lowest versus highest tercile had greater AEs burden in the early (allograft failure [16.1% vs 1.6%], stroke [12.1% vs 2.3%]) and late (stroke [5.1% vs 1.9%], sternal wound infection [5.0% vs 0.8%]) phases post-HT. The mean hospital %DAOH adj was 80.5% (min:max 57.7%-96.7%)., Conclusions: Post-HT %DAOH varies across beneficiaries and hospitals and is associated with AEs. Further research is warranted to assess the role and validity of %DAOH as an HT quality metric., (Copyright © 2024 International Society for the Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.)

Of the 5 randomized controlled trials (RCTs) included, chronic thromboembolic pulmonary hypertension (CTEPH) patients constituted 20% of the overall pulmonary hypertension (PH) patient population. We did not find any RCTs that evaluated the role of exercise training in patients with CTEPH. The results of this study indicate that exercise training may be effective at improving exercise capacity, as measured by 6-min walk distance, in patients with PH. Another notable finding from this analysis is the lack of adverse events associated with exercise training, suggesting that contrary to widespread perception, exercise training is safe in CTEPH and PAH patients., Competing Interests: Disclosure The authors have nothing to disclose., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Despite increasing therapeutic options and evolving treatment strategies, including targeting 3 therapeutic pathways, in the management of pulmonary arterial hypertension (PAH), morbidity and mortality have remained unacceptably high. Sotatercept is a first-in-class, novel activin signaling inhibitor approved for treating PAH based on evolving efficacy and safety evidence. This state-of-the-art review summarizes the current understanding of the mechanism of action, the impact on outcomes that improve how patients feel, function, and survive, and the safety and adverse event profile to inform readers of this breakthrough novel therapy., (Copyright © 2024 International Society for the Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.)

Patients 65 years of age or older represent the fastest-growing demographic group added to the U.S. heart transplant (HT) list. While post-HT outcomes appear acceptable, immortal time bias is introduced if adverse outcomes that occur while waiting for HT are not considered. Recent durable left ventricular assist device (dLVAD) technological innovations have engendered the question of whether this patient subgroup would achieve equivalent survival from a strategy of primary dLVAD implant as opposed to HT listing. We identified adults ≥65 years of age listed for HT between 2018 and 2021, excluding persons with dLVAD support and/or multiorgan listing. Among 1,176 patients, 2-year survival from HT listing was 78.4% ± 1.2%, similar to the 71% to 75% reported in The Society of Thoracic Surgeons (STS) Intermacs National Database for older adults. Linkage of the Scientific Registry of Transplant Recipients with STS Intermacs would enable comparative effectiveness analyses of surgical heart failure therapeutic strategies in high-risk patient cohorts., (Copyright © 2025 International Society for the Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.)

Clinical trials in pulmonary arterial hypertension (PAH) have led to the approval of several effective treatments that improve symptoms, exercise capacity and clinical outcomes. In phase 3 clinical trials, primary end-points must reflect how a patient "feels, functions or survives". In a rare disease like PAH, with an ever-growing number of treatment options and numerous candidate therapies being studied, future clinical trials are now faced with challenges related to sample size requirements, efficiency and demonstration of incremental benefit on traditional end-points in patients receiving background therapy with multiple drugs. Novel clinical trial end-points, innovative trial designs and statistical approaches and new technologies may be potential solutions to tackle the challenges facing future PAH trials, but these must be acceptable to patients and regulatory bodies while preserving methodological rigour. In this World Symposium on Pulmonary Hypertension task force article, we address emerging trial end-points and designs, biomarkers and surrogate end-point validation, the concept of disease modification, challenges and opportunities to address diversity and representativeness, and the use of new technologies such as artificial intelligence in PAH clinical trials., Competing Interests: Conflict of interest: J. Weatherald declares grants or contracts to their institution from Janssen, Bayer, Merck, AstraZeneca and Sanofi; consulting fees, payment or honoraria to themselves, travel support and paid membership of an Advisory Board from Janssen and Merck; payment for expert testimony from Sprigings Intellectual Property Law; unpaid membership of a Data Safety Monitoring Board drom Université Laval; and unpaid membership of the medical advisory committee of the Pulmonary Hypertension Association of Canada and the scientific medical advisory committee of the Pulmonary Vascular Research Institute. T.R. Fleming declares no competing interests. M.R. Wilkins declares grants or contracts from the British Heart Foundation (RE/18/4/34215 centre support); consulting fees from MorphogenIX (advisory committee), VIVUS (study protocol advisory meeting), Janssen and Kinaset (study advisory boards) and Chiesi, Aerami and Benevolent AI (consultancy); payment for expert testimony from Pennington Marches and Sprigings; support for travel to scientific meetings from Apollo Therapeutics; patents planned, issued or pending (Imperial Innovations: patent submitted for prognostic protein model presented in this manuscript; patent for ZIP12 as a drug target; patent for TSPO as a drug target); membership of an adjudication committee for three clinical trials for Acceleron; membership of study safety committees for GSK and Novartis; a role as a trustee of the Pulmonary Vascular Research Institute; and stock options in W12 Therapeutics. T.M. Cascino delares grants from NHLBI (K12 HL138039) and Johnson & Johnson Innovative Medicine; consulting fees from and participation on a Data Safety Monitoring Board or Advisory Board for Merck; and payment or honoraria from Total CME. M.A. Psotka declares no competing interests. R. Zamanian declares grants to their institution from Gossamer Bio, Merck, United Therapeutics and Janssen; consulting fees from Gossamer Bio, Morphogen IX, Merck and Aerovate; patents planned, issued or pending for FK506 for treatment of pulmonary hypertension; participation on a Data Safety Monitoring Board or Advisory Board for Aerovate; and stock options in REVIVA. W. Seeger declares consulting fees from United Therapeutics, Abivax, Tiakis Biotech AG, Pfizer, Liquidia, Medspray BV and Pieris Pharmaceuticals. N. Galiè declares grants or contracts from Janssen, Actelion and Merck; consulting fees from Janssen, Actelion, Chiesi and Ferrer; payment or honoraria from Janssen, Actelion and Chiesi; support for attending meetings and/or travel from Dompe; and participation on a Data Safety Monitoring Board or Advisory Board from Janssen, Actelion and Ferrer. M. Gomberg-Maitland declares consulting fees from Acceleron/Merck (steering committee), Aerami (until 2023), Janssen (consultancy), JucaBio (steering committee), Keros (steering committee) and United Therapeutics (Jenesis Young Investigator Grant Chairman); support for attending the ERS Congress from Merck; participation on a Data Safety Monitoring board for Acceleron/Merck (until 2023) and Janssen (until 2023); and unpaid roles as Treasurer of ISHLT and a member of the United Therapeutics Scientific Advisory Board., (Copyright ©The authors 2024.)

Background: Patients with heart failure (HF) overestimate survival compared with model-predicted estimates, but the reasons for this discrepancy are poorly understood. We characterized how patients with end-stage HF and their care partners understand prognosis and elicited their preferences around prognosis communication., Methods: We conducted in-depth, semistructured interviews with patients with end-stage HF and their care partners between 2021 and 2022 at a tertiary care center in Michigan. Participants were asked to describe barriers they faced to understanding prognosis. All interviews were coded and analyzed using an iterative content analysis approach., Results: Fifteen patients with end-stage HF and 15 care partners participated, including 7 dyads. The median patient age was 66.5 years (range, 31-80) and included 9 of 15 (60%) White participants and 9 of 15 (60%) were males. Care partners included 10 of 15 (67%) White participants and 6 of 15 (40%) were males. Care partners were partners (n=7, 47%), siblings (n=4, 27%), parents (n=2, 13%), and children (n=2, 13%). Most patients demonstrated a poor understanding of their prognosis. In contrast, care partners commonly identified the patient's rapidly declining trajectory. Patients and care partners described ineffective prognosis communication with clinicians, common barriers to understanding prognosis, and similar suggestions on improving prognosis communication. Barriers to understanding prognosis included (1) conversation avoidance by physicians, (2) information inconsistency across different physicians, (3) distractions during prognosis communication due to emphasis on other conditions, and (4) confusion related to the use of medical jargon. Most patients and care partners wanted discussions around prognosis to begin early in the course of the disease, repeated routinely using layperson's terms, incorporating both quality of life and survival assessments, and involving care partners. Both patients and care partners did not expect precise survival estimates., Conclusions: Patients with end-stage HF demonstrate a poor understanding of their prognosis compared with their care partners. Patients and care partners are open to discussing prognosis early, using direct and patient-centered language., Competing Interests: Disclosures None.

Background: Gastrointestinal bleeding (GIB) results in frequent hospitalizations and impairs quality of life in durable left ventricular assist device (LVAD) recipients. Anticipation of these events before implantation could have important implications for patient selection and management., Methods: The study population included all adult HeartMate 3 (HM3) primary LVAD recipients enrolled in the STS Intermacs registry from January 2017 to December 2020. Using multivariable modeling methodologies, we investigated the relationships between preimplantation characteristics and postimplant bleeding, bleeding and death, and additional bleeding episodes on subsequent bleeding episodes and created a risk score to predict the likelihood of post-LVAD GIB based solely on preimplantation factors., Results: Of 6,425 patients who received an HM3 LVAD, 1,010 (15.7%) patients experienced GIB. Thirteen preimplantation factors were independent predictors of post-LVAD GIB. A risk score was created from these factors and calculated for each patient. By 3 years postimplant, GIB occurred in 11%, 26%, and 43% of low-, medium- and high-risk patients, respectively. Experiencing 1 post-LVAD GIB event was associated with an increased risk for further GIB events, with 33.9% of patients experiencing at least 1 recurrence. While post-LVAD GIB was associated with mortality, there was no relationship between number of GIB events and death., Conclusions: The Michigan Bleeding Risk Model is a simple tool, which facilitates the prediction of post-LVAD GIB in HM3 recipients using 13 preimplant variables. The implementation of this tool may help in the risk stratification process and may have therapeutic and clinical implications in HM3 LVAD recipients., Competing Interests: Disclosure statement F.DP reports the following disclosures: Noncompensated ad-hoc scientific advisor for Abbott, CH Biomedical, FineHeart, and Medtronic; Noncompensated medical monitor for Abiomed; Member, Data Safety Monitoring Board for Carmat and the National Heart, Lung, and Blood Institute PumpKIN Study; Receives grant funding from the National Heart, Lung, and Blood Institute and the Agency for Healthcare Research and Quality; Receives partial salary support from Blue Cross/Blue Shield of Michigan as Associate Director of the Michigan Society of Thoracic and Cardiovascular Surgeons Quality Collaborative. Outside of this work, Dr. Likosky (1) receives research funding from the Agency for Healthcare Research and Quality and the National Institutes of Health, (2) receives partial salary support from Blue Cross Blue Shield of Michigan to advance quality in Michigan in conjunction with the Michigan Society of Thoracic and Cardiovascular Surgeons Quality Collaborative, and (3) serves as a consultant for the American Society of Extracorporeal Technology. Other authors have no conflicts of interest to disclose. This manuscript received no funding., (Copyright © 2023 International Society for the Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.)

Background: Clinical trials in heart transplantation (HT) recipients have largely focused on objective outcomes such as survival; however, there is a paucity of data regarding the use of patient-reported outcome measures (PROMs) in these studies. We aimed to characterize the use of PROMs in registered clinical studies of HT recipients., Methods: All clinical studies of adult HT recipients were queried from ClinicalTrials.gov and stratified by inclusion of PROMs. Studies reporting PROMs were identified via specific search terms using the "outcomes measures" field. Summary statistics compared characteristics of studies with and without PROMs., Results: Between November 1999 and August 2022, 227 studies of HT recipients were registered on ClinicalTrials.gov. PROMs were included in 11% ( n = 24/227) of studies. Studies reporting PROMs were more likely to be conducted outside of the United States (91.7% vs 54.2%, p < 0.001) and report a greater number of primary/secondary outcomes (PROMs: median 7 [interquartile ranges (IQR): 4, 9] vs no PROMs: median 3 [IQR: 2, 6]; p < 0.001). The majority of studies reporting PROMs (58.3%) were initiated after 2020. Twenty-one distinct PROM tools/domains were reported as outcome measures, with the Short Form Health Survey 36 being most frequently used ( n = 10/24). Thirteen of the 21 PROMs included questions assessing mental health, whereas only 3 PROM tools were cardiac-specific., Conclusions: About 1 in 10 registered clinical trials of HT recipients includes PROMs, and mental health is the most commonly assessed PROM domain. Development and validation of PROM tools is needed to fully assess health-related quality of life in HT recipients.

Competing Interests: Declaration of Competing Interest Dr. Cascino reports the University of Michigan has received research funding from Actelion Pharmaceuticals United States. Dr. McLaughlin reports serving as a consultant and/or advisor for Actelion Pharmaceuticals United States, Inc., Bayer, Gilead Sciences, Inc., Medtronic, Merck, St. Jude Medical, and United Therapeutics Corporation and the University of Michigan has received research funding from Actelion Pharmaceuticals United States, Inc., Arena, Bayer, and Sonovie. Dr. Jackson reports research funding from NIH, AHRQ, VA; editorial board membership: Circulation. Cardiovascular Quality and Outcomes; consulting: American College of Cardiology and McKesson, Inc.; and royalties for UpToDate. Dr. Barnes reports research funding from Boston Scientific; and consulting fees from Pfizer, Bristol-Myers Squibb, Janssen, Bayer, AstraZeneca, Sanofi, Anthos, Abbott Vascular, Boston Scientific. The remaining authors have no competing interests to declare.

Background: Despite the known benefits of pulmonary rehabilitation (PR) for patients with chronic respiratory disease, this treatment is underused. Evidence-based guidelines should lead to greater knowledge of the proven benefits of PR, highlight the role of PR in evidence-based health care, and in turn foster referrals to and more effective delivery of PR for people with chronic respiratory disease. Methods: The multidisciplinary panel formulated six research questions addressing PR for specific patient groups (chronic obstructive pulmonary disease [COPD], interstitial lung disease, and pulmonary hypertension) and models for PR delivery (telerehabilitation, maintenance PR). Treatment effects were quantified using systematic reviews. The Grading of Recommendations, Assessment, Development and Evaluation approach was used to formulate clinical recommendations. Recommendations: The panel made the following judgments: strong recommendations for PR for adults with stable COPD (moderate-quality evidence) and after hospitalization for COPD exacerbation (moderate-quality evidence), strong recommendation for PR for adults with interstitial lung disease (moderate-quality evidence), conditional recommendation for PR for adults with pulmonary hypertension (low-quality evidence), strong recommendation for offering the choice of center-based PR or telerehabilitation for patients with chronic respiratory disease (moderate-quality evidence), and conditional recommendation for offering either supervised maintenance PR or usual care after initial PR for adults with COPD (low-quality evidence). Conclusions: These guidelines provide the basis for evidence-based delivery of PR for people with chronic respiratory disease.

Background: Catheter-based interventions have emerged for both acute and chronic pulmonary thromboembolic disease. With this development and the need for segmental cannulation, anatomic understanding of pulmonary arterial segmental branch origination is important. We aim to describe the prevalence of different pulmonary arterial segmental branch origination patterns., Methods: This study included 179 consecutive patients who underwent bilateral nonselective invasive pulmonary angiography for the evaluation of chronic thromboembolic pulmonary hypertension., Results: In our study population (age, 59.0 ± 14.8 years, 55.3% female, 71% White), we found several anatomic variations of branches to the different lobes. These included 7 branching patterns in the right upper lobe, 3 in the right middle lobe, and 10 in the right lower lobe (4 patterns for the origin of the superior segmental artery and 6 for the origin of the basilar segmental arteries). On the left side, we found 8 patterns in the left upper lobe, with 5 involving lingular branches, and 9 in the left lower lobe (5 for the origin of the superior segmental artery and 4 for the basilar segmental pulmonary arteries). Although there were many variations, only 2-3 variations for each individual lobe accounted for >90% of the angiograms., Conclusions: Up to 3 anatomic branching patterns per lobe were noted to account for >90% of pulmonary artery branching variations in this study. This knowledge is not only useful for the interventionalist performing catheter-directed therapies but also for future research efforts that aim to standardize reporting of pulmonary angiographic findings., (© 2023 The Author(s).)

Background: In 2018, a new heart allocation policy was introduced to reduce variability in access to and outcomes after transplantation, in part, through attempts at broader geographic sharing of donor hearts. We evaluated how this policy affected geographic sharing and waitlist outcomes by donation service area (DSA)., Methods: This retrospective study of the Scientific Registry of Transplant Recipients database included adult patients waitlisted between October 2016 and October 2020, stratified by policy period. Our primary outcomes were mean proportion of imported and exported hearts aggregated by DSA as well as time to transplant., Results: Following the policy change, there was substantial evidence of sharing across DSAs. The mean proportion of imported hearts transplanted by a DSA increased from 32% (95% CI: 27%-36%) to 74% (95% CI: 71%-78%; p < 0.001), and the mean proportion of exported hearts increased from 37% (95% CI: 33%-42%) to 75% (95% CI: 71%-79%; p < 0.001). The mean sharing ratio, defined as the log-transformed ratio of imported to exported hearts per DSA, shifted from 1.15 (95% CI: 0.88-1.42) to 1.02 (95% CI: 0.96-1.07), with a 76% decline in the variance across DSAs. As sharing increased, time to transplant per DSA declined from 153.9 days (95% CI, 143.4-164.4 days) pre-policy to 89.6 days (95% CI, 83.1-96.1 days) post-policy (p < 0.001). A larger decrease in waitlist time was associated with a higher proportion of exported hearts., Conclusions: The 2018 heart allocation policy was associated with more uniform access to heart transplantation and improved waitlist outcomes., (Copyright © 2023 International Society for Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.)

Objective: Failure to rescue (FTR), defined as death after a complication, is recognized as a principal driver of variation in mortality among hospitals. We evaluated FTR as a quality metric in patients who received durable left ventricular assist devices (LVADs) using the Society of Thoracic Surgeons Interagency Registry for Mechanically Assisted Circulatory Support., Methods: Data on 13,617 patients who received primary durable LVADs from April 2012 to October 2017 at 131 hospitals that performed at least 20 implants were analyzed from the Society of Thoracic Surgeons Interagency Registry for Mechanically Assisted Circulatory Support. Rates of major complications and FTR were compared across risk-adjusted in-hospital mortality terciles (low, medium, high) and hospital volume. Logistic regression was used to estimate expected FTR rates on the basis of patient factors for each major complication., Results: The overall unadjusted in-hospital mortality rate was 6.96%. Risk-adjusted in-hospital mortality rates varied 3.1-fold across terciles (low, 3.3%; high, 10.3%; P trend <.001). Rates of major complications varied 1.1-fold (low, 34.0%; high, 38.8%; P < .0001). Among patients with a major complication, 854 died in-hospital for an FTR rate of 17.7%, with 2.8-fold variation across mortality terciles (low, 8.5%; high, 23.9%; P < .0001). FTR rates were highest for renal dysfunction requiring dialysis (45.3%) and stroke (36.5%). Higher average annual LVAD volume was associated with higher rates of major complications (<10 per year, 26.7%; 10-20 per year, 34.0%; 20-30 per year, 34.0%; >30 per year, 40.1%; P trend <.0001) whereas hospitals implanting <10 per year had the highest FTR rate (<10 per year, 23.5%; 10-20 per year, 16.5%; 20-30 per year, 17.0%; >30 per year, 17.9%; P = .03)., Conclusions: FTR might serve as an important quality metric for durable LVAD implant procedures, and identifying strategies for successful rescue after complications might reduce hospital variations in mortality., (Copyright © 2021 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.)

Background: Balloon pulmonary angioplasty (BPA) was introduced as a treatment modality for patients with inoperable, medically refractory chronic thromboembolic pulmonary hypertension decades ago; however, reports of high rates of pulmonary vascular injury have led to considerable refinement in procedural technique., Objectives: The authors sought to better understand the evolution of BPA procedure-related complications over time., Methods: The authors conducted a systematic review of original articles published by pulmonary hypertension centers globally and performed a pooled cohort analysis of procedure-related outcomes with BPA., Results: This systematic review identified 26 published articles from 18 countries worldwide from 2013 to 2022. A total of 1,714 patients underwent 7,561 total BPA procedures with an average follow up of 7.3 months. From the first period (2013-2017) to the second period (2018-2022), the cumulative incidence of hemoptysis/vascular injury decreased from 14.1% (474/3,351) to 7.7% (233/3,029) (P < 0.01); lung injury/reperfusion edema decreased from 11.3% (377/3,351) to 1.4% (57/3,943) (P < 0.01); invasive mechanical ventilation decreased from 0.7% (23/3,195) to 0.1% (4/3,062) (P < 0.01); and mortality decreased from 2.0% (13/636) to 0.8% (8/1,071) (P < 0.01)., Conclusions: Procedure-related complications with BPA, including hemoptysis/vascular injury, lung injury/reperfusion edema, mechanical ventilation, and death, were less common in the second period (2018-2022), compared with first period (2013-2017), likely from refinement in patient and lesion selection and procedural technique over time., Competing Interests: Funding Support and Author Disclosures Dr Krasuski has been a consultant to Actelion/Janssen Pharmaceuticals, Bayer Pharmaceuticals, Gore Medical and Medtronic; and has received research funding from the Adult Congenital Heart Association, Actelion, Corvia, CryoLife, Edwards Lifesciences, and Medtronic. Dr Rosenfield has been a consultant to or served on scientific advisory boards for Abbott Vascular, Althea Medical, Angiodynamics, Auxetics, Becton-Dickinson, Boston Scientific, Contego, Crossliner, Innova Vascular, Inspire MD, Janssen/Johnson and Johnson, Magneto, Mayo Clinic, MedAlliance, Neptune Medical, Penumbra, Philips, Surmodics, Terumo, Thrombolex, Truvic, Vasorum, and Vumedi; has received institutional research grants from the NIH, Abiomed, Boston Scientific, Novo Nordisk, Penumbra, and Gettinge-Atrium; has equity interest in Accolade, Access Vascular, Aerami, Althea Medical, Auxetics, Contego, Crossliner, Cruzar Systems, Embolitech, Endospan, Imperative Care/Truvic, Innova Vascular, InspireMD, JanaCare, Magneto, MedAlliance, Neptune Medical, Orchestra, PQ Bypass, Prosomnus, Shockwave, Skydance, Summa Therapeutics, Thrombolex, Valcare, Vasorum, and Vumedi; and is a board member and founder of the National PERT Consortium. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Published by Elsevier Inc.)

Background: Racial disparities in access to advanced therapies for heart failure (HF) patients are well documented, although the reasons remain uncertain. We sought to determine the association of race on utilization of ventricular assist device (VAD) and transplant among patients with access to care at VAD centers and if patient preferences impact the effect., Methods: We performed an observational cohort study of ambulatory chronic systolic HF patients with high-risk features and no contraindication to VAD enrolled at 21 VAD centers and followed for 2 years in the REVIVAL study (Registry Evaluation of Vital Information for VADs in Ambulatory Life). We used competing events cause-specific proportional hazard methodology with multiple imputation for missing data. The primary outcomes were (1) VAD/transplant and (2) death. The exposures of interest included race (Black or White), additional demographics, captured social determinants of health, clinician-assessed HF severity, patient-reported quality of life, preference for VAD, and desire for therapies., Results: The study included 377 participants, of whom 100 (26.5%) identified as Black. VAD or transplant was performed in 11 (11%) Black and 62 (22%) White participants, although death occurred in 18 (18%) Black and 36 (13%) White participants. Black race was associated with reduced utilization of VAD and transplant (adjusted hazard ratio, 0.45 [95% CI, 0.23-0.85]) without an increase in death. Preferences for VAD or life-sustaining therapies were similar by race and did not explain racial disparities., Conclusions: Among patients receiving care by advanced HF cardiologists at VAD centers, there is less utilization of VAD and transplant for Black patients even after adjusting for HF severity, quality of life, and social determinants of health, despite similar care preferences. This residual inequity may be a consequence of structural racism and discrimination or provider bias impacting decision-making., Registration: URL: https://www., Clinicaltrials: gov; Unique identifier: NCT01369407.

Importance: In 2020, the Centers for Medicare & Medicaid Services revised its national coverage determination, removing the requirement to obtain review from a Medicare-approved heart transplant center to implant a durable left ventricular assist device (LVAD) for bridge-to-transplant (BTT) intent at an LVAD-only center. The association between center-level transplant availability and access to heart transplant, the gold-standard therapy for advanced heart failure (HF), is unknown., Objective: To investigate the association of center transplant availability with LVAD implant strategies and subsequent heart transplant following LVAD implant before the Centers for Medicare & Medicaid Services policy change., Design, Setting, and Participants: A retrospective cohort study of the Society of Thoracic Surgeons Intermacs multicenter US registry database was conducted from April 1, 2012, to June 30, 2020. The population included patients with HF receiving a primary durable LVAD., Exposures: LVAD center transplant availability (LVAD/transplant vs LVAD only)., Main Outcomes and Measures: The primary outcomes were implant strategy as BTT and subsequent transplant by 2 years. Covariates that might affect listing strategy and outcomes were included (eg, patient demographic characteristics, comorbidities) in multivariable models. Parameters for BTT listing were estimated using logistic regression with center-level random effects and for receipt of a transplant using a Cox proportional hazards regression model with death as a competing event., Results: The sample included 22 221 LVAD recipients with a median age of 59.0 (IQR, 50.0-67.0) years, of whom 17 420 (78.4%) were male and 3156 (14.2%) received implants at LVAD-only centers. Receiving an LVAD at an LVAD/transplant center was associated with a 79% increased adjusted odds of BTT LVAD designation (odds ratio, 1.79; 95% CI, 1.35-2.38; P < .001). The 2-year transplant rate following LVAD implant was 25.6% at LVAD/transplant centers and 11.9% at LVAD-only centers. There was an associated 33% increased rate of transplant at LVAD/transplant centers compared with LVAD-only centers (adjusted hazard ratio, 1.33; 95% CI, 1.17-1.51) with a similar hazard for death at 2 years (adjusted hazard ratio, 0.99; 95% CI, 0.90-1.08)., Conclusions and Relevance: Receiving an LVAD at an LVAD-transplant center was associated with increased odds of BTT intent at implant and subsequent transplant receipt for patients at 2 years. The findings of this study suggest that Centers for Medicare & Medicaid Services policy change may have the unintended consequence of further increasing inequities in access to transplant among patients at LVAD-only centers.

Functional mitral regurgitation (MR) in the setting of heart failure results from progressive dilatation of the left ventricle (LV) and mitral annulus. This leads to leaflet tethering with posterior displacement. Contrary to common assumptions, MR often does not resolve with LVAD decompression of the LV alone. The negative impact of significant (moderate-severe) mitral regurgitation in the LVAD setting is becoming better recognized in terms of its harmful effect on right heart function, pulmonary vascular resistance and hospital readmissions. However, controversies remain regarding the threshold for intervention and management. At present, there are no consensus indications for the repair of significant mitral regurgitation at the time of LVAD implantation due to the conflicting data regarding potential adverse effects of MR on clinical outcomes. In this review, we summarize the current understanding of MR pathophysiology in patients supported with LVAD and potential future management strategies., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2022 Noly, Duggal, Jiang, Nordsletten, Bonini, Lei, Ela, Haft, Pagani, Cascino and Tang.)

Background: Although the current wide-scale adoption of the HeartMate 3 left ventricular assist device can be attributed to favorable clinical trial outcomes, restrictive clinical trial eligibility criteria may result in lack of generalizability to real-world populations. We assessed the generalizability of left ventricular assist device clinical trial outcomes and evaluated the prognostic value of specific inclusion and exclusion criteria., Methods: The Multicenter Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Therapy With HeartMate 3 (MOMENTUM 3) eligibility criteria were applied to patients identified in The Society of Thoracic Surgeons Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs) who underwent HeartMate 3 implantation (n = 4610) between August 2017 and March 2020. Patients were categorized as trial-eligible or trial-ineligible and by number of ineligibility criteria. The effect of trial eligibility on mortality was estimated using Cox models., Results: Indications for HeartMate 3 implant included destination therapy (n = 2827, 61%), bridge to candidacy (n = 969, 21%), and bridge to transplant (n = 702, 15%). A total of 1941 recipients (42%) were trial-ineligible, with 1245 (27%) meeting one ineligibility criterion, 470 (10%) meeting two, and 226 (5%) meeting three or more. Estimated 1-year mortality for trial-ineligible recipients was higher than for trial-eligible recipients (17% ± 1% vs 10% ± 1%, P < .001). Compared with trial-eligible patients, 1-year mortality was incrementally higher for patients meeting one ineligibility criterion (15% ± 1%), two criteria (16% ± 2%), and three or more criteria (30% ± 3%). Thrombocytopenia and elevated creatinine, bilirubin, and international normalized ratio in trial-ineligible patients were independently associated with increased mortality., Conclusions: Despite differences in mortality, both trial-eligible and trial-ineligible HeartMate 3 recipients had excellent outcomes in real-world practice, suggesting future trial eligibility criteria could be expanded., (Copyright © 2022 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Balloon pulmonary angioplasty (BPA) is an evolving treatment modality for patients with chronic thromboembolic pulmonary hypertension (CTEPH) who are not candidates for pulmonary endarterectomy. Although several imaging modalities currently exist for evaluating CTEPH, their individual use, specifically in the clinical practice of BPA, has not been well described. In this article, we provide a preprocedural, intraprocedural, and postprocedural interventional imaging roadmap for safe and effective BPA performance in routine clinical practice. Preprocedural assessment includes transthoracic echocardiography for right ventricular assessment, ventilation/perfusion scan to identify pulmonary segments with the highest degree of hypoperfusion, cross-sectional chest imaging excluding alternative causes of mismatched defects and providing anatomic and perfusion imaging concurrently, and nonselective invasive pulmonary angiography for risk stratification of individual lesion subtypes. Intraprocedural assessment includes subselective segmental angiography (SSA) for delineating segmental and subsegmental branch anatomy, lesion identification, and vessel sizing. Intravascular ultrasound and optical coherence tomography serve as adjunctive intraprocedural tools for more accurate vessel sizing and lesion characterization when SSA alone is insufficient. Postprocedural considerations include chest radiography to monitor for immediate postprocedure complications and echocardiography for the interval assessment of the right ventricle on longer-term follow-up., (© 2022 The Authors.)

Importance: While left ventricular assist devices (LVADs) increase survival for patients with advanced heart failure (HF), racial and sex access and outcome inequities remain and are poorly understood., Objectives: To assess risk-adjusted inequities in access and outcomes for both Black and female patients and to examine heterogeneity in treatment decisions among patients for whom clinician discretion has a more prominent role., Design, Setting, and Participants: This retrospective cohort study of 12 310 Medicare beneficiaries used 100% Medicare Fee-for-Service administrative claims. Included patients had been admitted for heart failure from 2008 to 2014. Data were collected from July 2007 to December 2015 and analyzed from August 23, 2020, to May 15, 2022., Exposures: Beneficiary race and sex., Main Outcomes and Measures: The propensity for LVAD implantation was based on clinical risk factors from the 6 months preceding HF admission using XGBoost and the synthetic minority oversampling technique. Beneficiaries with a 5% or greater probability of receiving an LVAD were included. Logistic regression models were estimated to measure associations of race and sex with LVAD receipt adjusting for clinical characteristics and social determinants of health (eg, distance from LVAD center, Medicare low-income subsidy, neighborhood deprivation). Next, 1-year mortality after LVAD was examined., Results: The analytic sample included 12 310 beneficiaries, of whom 22.9% (n = 2819) were Black and 23.7% (n = 2920) were women. In multivariable models, Black beneficiaries were 3.0% (0.2% to 5.8%) less likely to receive LVAD than White beneficiaries, and women were 7.9% (5.6% to 10.2%) less likely to receive LVAD than men. Individual poverty and worse neighborhood deprivation were associated with reduced use, 2.9% (0.4% to 5.3%) and 6.7% (2.9% to 10.5%), respectively, but these measures did little to explain observed disparities. The racial disparity was concentrated among patients with a low propensity score (propensity score <0.52). One-year survival by race and sex were similar on average, but Black patients with a low propensity score experienced improved survival (7.2% [95% CI, 0.9% to 13.5%])., Conclusions and Relevance: In this cohort study of Medicare beneficiaries hospitalized for HF, disparities in LVAD use by race and sex existed and were not explained by clinical characteristics or social determinants of health. The treatment and post-LVAD survival by race were equivalent among the most obvious LVAD candidates. However, there was differential use and outcomes among less clear-cut LVAD candidates, with lower use but improved survival among Black patients. Inequity in LVAD access may have resulted from differences in clinician decision-making because of systemic racism and discrimination, implicit bias, or patient preference.

Background: Patients undergoing left ventricular assist device (LVAD) implantation are at risk for death and postoperative adverse outcomes. Interhospital variability and concordance of quality metrics were assessed using the Society of Thoracic Surgeons Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs)., Methods: A total of 22 173 patients underwent primary, durable LVAD implantation across 160 hospitals from 2012 to 2020, excluding hospitals performing <10 implant procedures. Observed and risk-adjusted operative mortality rates were calculated for each hospital. Outcomes included operative and 90-day mortality, a composite of adverse events (operative mortality, bleeding, stroke, device malfunction, renal dysfunction, respiratory failure), and secondarily failure to rescue. Rates are presented as median (interquartile range [IQR]). Hospital performance was evaluated using observed-to-expected (O/E) ratios for mortality and the composite outcome., Results: Interhospital variability existed in observed (median, 7.2% [IQR, 5.1%-9.6%]) mortality. The rates of adverse events varied across hospitals: major bleeding, 15.6% (IQR, 11.4%-22.4%); stroke, 3.1% (IQR, 1.6%-4.7%); device malfunction, 2.4% (IQR, 0.8%-3.7%); respiratory failure, 10.5% (IQR, 4.6%-15.7%); and renal dysfunction, 6.4% (IQR, 3.2%-9.6%). The O/E ratio for operative mortality varied from 0.0 to 6.1, whereas the O/E ratio for the composite outcome varied from 0.28 to 1.99. Hospital operative mortality O/E ratios were more closely correlated with the 90-day mortality O/E ratio (r = 0.74) than with the composite O/E ratio (r = 0.12)., Conclusions: This study reported substantial interhospital variability in performance for hospitals implanting durable LVADs. These findings support the need to (1) report hospital-level performance (mortality, composite) and (2) undertake benchmarking activities to reduce unwarranted variability in outcomes., (Copyright © 2022 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Introduction: Cardiac resynchronization therapy (CRT) and left ventricular assist devices (LVAD) improve outcomes in heart failure patients. Early ventricular arrhythmias (VA) are common after LVAD and are associated with increased mortality. The association between left ventricular pacing (LVP) with CRT and VAs in the early post-LVAD period remains unclear., Methods: This was a retrospective study of all patients undergoing LVAD implantation from 1/2016 to 12/2019. Patients were divided into those with CRT and active LVP (CRT-LVP) immediately post-LVAD implant versus those without CRT-LVP. Implantable cardiac defibrillator electrograms were reviewed and early VAs were defined as sustained ventricular tachycardia (VT)/ventricular fibrillation occurring within 30 days of LVAD implantation., Results: Of 186 included patients (mean age 53 years, 75% male, mean body mass index 28), 72 had CRT devices, 63 of whom had LV pacing enabled after LVAD implant (CRT-LVP group). Patients with CRT-LVP were more likely to have VA in the early postoperative period (21% vs. 4%; p = .0001). All 9 patients with CRT in whom LVP was disabled had no early VA. Among those with early VA, patients with CRT-LVP were more likely to have monomorphic VT (77% vs. 40%; p = .07). In multiple logistic regression, CRT-LVP pacing remained an independent predictor of early VA after adjustment for history of VA and AF., Conclusions: Patients with CRT-LVP after LVAD implant had a higher incidence of early VA (specifically monomorphic VT). Epicardial LV pacing may be proarrhythmic in the early postoperative period after LVAD., (© 2022 Wiley Periodicals LLC.)

Introduction: Patients with ambulatory advanced heart failure (HF) are increasingly considered for durable mechanical circulatory support (MCS) and heart transplantation and their effective triage requires careful assessment of the clinical trajectory., Methods: REVIVAL, a prospective, observational study, enrolled 400 ambulatory advanced HF patients from 21 MCS/transplant centers in 2015-2016. Study design included a clinical re-assessment of Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) profile within 120 days after enrollment. The prognostic impact of a worsening INTERMACS Profile assigned by the treating physician was assessed at 1 year after the Early Relook., Results: Early Relook was done in 325 of 400 patients (81%), of whom 24% had a worsened INTERMACS Profile, associated with longer HF history and worse baseline INTERMACS profile, but no difference in baseline LVEF (median 0.20), 6-minute walk, quality of life, or other baseline parameters. Early worsening predicted higher rate of the combined primary endpoint of death, urgent MCS, or urgent transplant by 1 year after Early Relook, (28% vs 15%), with hazard ratio 2.2 (95% CI 1.2- 3.8; p = .006) even after adjusting for baseline INTERMACS Profile and Seattle HF Model score. Deterioration to urgent MCS occurred in 14% vs 5% (p = .006) during the year after Early Relook., Conclusions: Early Relook identifies worsening of INTERMACS Profile in a significant population of ambulatory advanced HF, who had worse outcomes over the subsequent year. Early reassessment of ambulatory advanced HF patients should be performed to better define the trajectory of illness and inform triage to advanced therapies., Competing Interests: Disclosure P.S. reports the following grant support: American Heart Association/Enduring Hearts Scientist Development Grant, Merck, Haemonetrics, and Medtronic. Consulting: NuPulse CV and Ortho Clinical Diagnostics. K.D.A. reports the following related to the submitted work: the National Institutes of Health/National Heart, Lung, and Blood Institute (contract) and outside the submitted work: Medtronic (research support and consultant [Independent Physician Quality Panel member]), Abbott (research support), Procyrion (consultant), NuPulseCV (consultant), Bioventrix (research support). M.K., A.V.A., S.P., J.T., N.A.G., G.A.E., J.S., M.P., J.D.E., J.T.B., W.T.P., T.M.C., N.J., L.W.S., D.L.M., G.C.S., M.Y., B.R., and S.K have no conflicts of interest to disclose., (Copyright © 2021 International Society for Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.)

Background: The United States National Organ Procurement Transplant Network (OPTN) implemented changes to the adult heart allocation system to reduce waitlist mortality by improving access for those at greater risk of pre-transplant death, including patients on short-term mechanical circulatory support (sMCS). While sMCS increased, it is unknown whether the increase occurred equitably across centers., Methods: The OPTN database was used to assess changes in use of sMCS at time of transplant in the 12 months before (pre-change) and after (post-change) implementation of the allocation system in October 2018 among 5,477 heart transplant recipients. An interrupted time series analysis comparing use of bridging therapies pre- and post-change was performed. Variability in the proportion of sMCS use at the center level pre- and post-change was determined., Results: In the month pre-change, 9.7% of patients were transplanted with sMCS. There was an immediate increase in sMCS transplant the following month to 32.4% - an absolute and relative increase of 22.7% and 312% (p < 0.001). While sMCS use was stable pre-change (monthly change 0.0%, 95% CI [-0.1%,0.1%]), there was a continuous 1.2%/month increase post-change ([0.6%,1.8%], p < 0.001). Center-level variation in sMCS use increased substantially after implementation, from a median (interquartile range) of 3.85% (10%) pre-change to 35.7% (30.6%) post-change (p < 0.001)., Conclusions: Use of sMCS at time of transplant increased immediately and continued to expand following heart allocation policy changes. Center-level variation in use of sMCS at the time of transplant increased compared to pre-change, which may have negatively impacted equitable access to heart transplantation., (Copyright © 2021 International Society for Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.)

Purpose of Review: The coronavirus disease 2019 (COVID-19) pandemic has led to almost 3,000,000 deaths across 139 million people infected worldwide. Involvement of the pulmonary vasculature is considered a major driving force for morbidity and mortality. We set out to summarize current knowledge on the acute manifestations of pulmonary vascular disease (PVD) resulting from COVID-19 and prioritize long-term complications that may result in pulmonary hypertension (PH)., Recent Findings: Acute COVID-19 infection can result in widespread involvement of the pulmonary vasculature, myocardial injury, evidence of persistent lung disease, and venous thromboembolism. Post COVID-19 survivors frequently report ongoing symptoms and may be at risk for the spectrum of PH, including group 1 pulmonary arterial hypertension, group 2 PH due to left heart disease, group 3 PH due to lung disease and/or hypoxia, and group 4 chronic thromboembolic PH., Summary: The impact of COVID-19 on the pulmonary vasculature is central to determining disease severity. Although the long-term PVD manifestations of COVID-19 are currently uncertain, optimizing the care of risk factors for PH and monitoring for the development of PVD will be critical to reducing long-term morbidity and improving the health of survivors., (Copyright © 2021 Wolters Kluwer Health, Inc. All rights reserved.)

Background: Obesity is common in heart failure with preserved ejection fraction (HFpEF), and a hypocaloric diet can improve functional capacity. Malnutrition, sarcopenia, and frailty are also frequently present, and calorie restriction could harm some patients. Resting metabolic rate (RMR) is an essential determinant of caloric needs; however, it is rarely measured in clinical practice. The accuracy of commonly used predictive equations in HFpEF is unknown., Methods: RMR was measured with indirect calorimetry in 43 patients with HFpEF undergoing right heart catheterization at the University of Michigan, and among 49 participants in the SECRET trial (Study of the Effects of Caloric Restriction and Exercise Training in Patients With Heart Failure and a Normal Ejection Fraction); SECRET patients also had dual-energy X-ray absorptiometry body composition measures. Measured RMR was compared with RMR estimated using the Harris Benedict, Mifflin-St Jeor, World Health Organization, and Academy for Nutrition and Dietetics equations., Results: All predictive equations overestimated RMR (by >10%, P <0.001 for all), with mean (95% CI) differences Harris Benedict equation +250 (186-313), Mifflin-St. Jeor equation +169 (110-229), World Health Organization equation +300 (239-361), and Academy for Nutrition and Dietetics equation +794 (890-697) kcal/day. Results were similar across both patient groups, and the discrepancy between measured and estimated RMR tended to increase with body mass index. In SECRET, measured RMR was closely associated with lean body mass (ρ=0.74; by linear regression adjusted for age and sex: β=27 [95% CI, 18-36] kcal/day per kg, P <0.001; r 2 =0.56)., Conclusions: Commonly used predictive equations systematically overestimate measured RMR in patients with HFpEF. Direct measurement of RMR may be needed to effectively tailor dietary guidance in this population. Registration: URL: https://www.clinicaltrials.gov; Unique Identifier: NCT00959660.

Purpose: The objective of this study was to review randomized controlled trials (RCT), which included a wearable activity tracker in an intervention to promote physical activity among cardiac rehabilitation (CR) participants, and to conduct a meta-analysis for the outcomes of step counts and aerobic capacity (V˙o2max)., Methods: Eight databases were searched for RCTs that included an activity tracker, enrolled adults eligible for CR, and reported outcomes of step count or aerobic capacity. Mean differences were calculated for outcomes in the meta-analyses., Results: Nineteen RCTs with 2429 participants were included in the systematic review and 10 RCTs with 891 participants were included in the meta-analysis. Meta-analysis of three RCTs using a pedometer or accelerometer demonstrated a significant increase in daily step count compared with controls (n = 211, 2587 steps/d [95% CI, 916-5257]; I2 = 74.6% and P = .002). Meta-analysis of three RCTs using a pedometer or accelerometer intervention demonstrated a significant increase in V˙o2max compared with controls (n = 260, 2.6 mL/min/kg [95% CI, 1.6-3.6]; I2 = 0.0% and P < .0001). Meta-analysis of four RCTs using a heart rate monitor demonstrated a significant increase in V˙o2max compared with controls (n = 420, 1.4 mL/min/kg [95% CI, 0.4-2.3]; I2 = 0.0% and P = .006)., Conclusions: Use of activity trackers among CR participants was associated with significant increases in daily step count and aerobic capacity when compared with controls. However, study size was small and variability in intervention supports the need for larger trials to assess use of activity trackers in CR., Competing Interests: The authors declare no conflicts of interest., (Copyright © 2021 Wolters Kluwer Health, Inc. All rights reserved.)

Importance: While wide-scale adoption of durable left ventricular assist devices (LVADs) can be attributed to favorable randomized clinical trial outcomes, restrictive selection criteria may be associated with a lack of generalizability to real-world experience., Objective: To estimate the proportion of LVAD recipients who are eligible for clinical trials and to assess whether an association exists between trial eligibility and mortality., Design, Setting, and Participants: This cohort study examined 14 679 patients undergoing primary, intracorporeal continuous-flow LVAD implantation (with or without a right ventricular assist device) in 181 North American centers from January 1, 2012, to June 30, 2017, identified in the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS). To simulate a trial population, trial criteria from the Multicenter Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Therapy With HeartMate 3 (MOMENTUM 3) were mapped to INTERMACS variables. Patients were categorized as eligible for trial inclusion or ineligible for trial inclusion and by number of ineligibility criteria met. Follow-up in INTERMACS was complete for all patients through October 31, 2017. Data were analyzed from July 2019 through November 2020., Exposures: Undergoing durable LVAD implantation., Main Outcomes and Measures: Trial eligibility and postimplant mortality were analyzed using Kaplan-Meier estimates and Cox proportional hazards models., Results: Among 14 679 recipients, mean (SD) age was 57 (13) years, 11 503 individuals (78.4%) were men, and 11 406 individuals (77.7%) presented with New York Heart Association class IV heart failure. A total of 6429 recipients (43.8%) were ineligible for trial inclusion, of whom 4226 individuals (65.7%) met 1 ineligibility criterion, 1442 individuals (22.4%) met 2 criteria, and 761 individuals (11.8%) met 3 or more criteria. Estimated mortality for recipients who were trial-ineligible was higher than for recipients who were trial-eligible (1-year mortality: 25.3% [95% CI, 24.2%-26.5%] vs 16.2% [95% CI, 15.4%-17.1%]; 3-year mortality: 42.8% [95% CI, 41.3%-44.4%] vs 36.4% [95% CI, 35.0%-37.8%]; log-rank P < .001 for both). Patients who were trial-ineligible had increased risk of mortality compared with patients who were trial-eligible if they met 1 trial ineligibility criterion (hazard ratio [HR], 1.16 [95% CI, 1.08-1.24]; P < .001), 2 trial ineligibility criteria (HR, 1.51 [95% CI, 1.36-1.67]; P < .001), or 3 or more trial ineligibility criteria (HR, 2.09 [95% CI, 1.84-2.39]; P < .001). Among patients meeting only 1 ineligibility criterion, 4 criteria were independently associated with mortality: prior or ongoing mechanical circulatory support (HR, 1.63 [95% CI, 1.23-2.16]; P = .001), elevated creatinine level (HR, 1.42 [95% CI, 1.17-1.72]; P < .001), elevated bilirubin level (HR, 1.39 [95% CI, 1.17-1.66]; P < .001), and low albumin or prealbumin level (HR, 1.18 [95% CI, 1.05-1.33]; P = .007)., Conclusions and Relevance: These findings suggest that while treatment for patients who are ineligible for LVAD trial inclusion should be weighed against medical management, more consideration could be given to designing trials with eligibility criteria that reflect real-world experience.

Exercise rehabilitation is underutilized in patients with pulmonary arterial hypertension despite improving exercise capacity and quality of life. We sought to understand the association between (1) patient characteristics and (2) patient-perceived barriers and referral to exercise rehabilitation. We performed a cross-sectional survey of patients with pulmonary arterial hypertension or chronic thromboembolic pulmonary hypertension attending an International PAH meeting. Predictors of referral considered included gender, body mass index, subjective socioeconomic status, insurance type, age, and World Health Organization functional class and perceived barriers assessed using the Cardiac Rehabilitation Barriers Scale. Among 65 participants, those in the lowest subjective socioeconomic status tertile had reduced odds of referral compared to the highest tertile participants (odds ratio 0.22, 95% confidence interval: 0.05-0.98, p  = 0.047). Several patient-perceived barriers were associated with reduced odds of referral. For every 1-unit increase in a reported barrier on a five-point Likert scale, odds of referral were reduced by 85% for my doctor did not feel it was necessary; 85% for prefer to take care of my health alone, not in a group; 78% many people with heart and lung problems don't go, and they are fine; and 78% for I didn't know about exercise therapy. The lack of perceived need subscale and overall barriers score were associated with a 92% and 77% reduced odds of referral, respectively. These data suggest the need to explore interventions to promote referral among low socioeconomic status patients and address perceived need for the therapy., (© The Author(s) 2020.)

Background: Resting oxygen consumption (VO 2 ) is often estimated and frequently used to guide therapeutic decisions in symptomatic heart failure (HF) patients. The relationship between resting VO 2 and symptomatic HF and the accuracy of estimations of VO 2 in this population are unknown., Methods and Results: We performed a cross-sectional study of HF patients (n = 691) and healthy control subjects (n = 77). VO 2 was measured with the use of a metabolic cart, and estimated VO 2 was calculated with the use of the Dehmer, LaFarge, and Bergstra formulas and the thermodilution method. The measured and estimated VO 2 were compared and the potential impact of estimations determined. In the multivariable model, resting VO 2 decreased with increasing New York Heart Association (NYHA) functional class in a stepwise fashion (β NYHA functional class IV vs control = -36 mL O 2 /min; P < .001). Estimations of VO 2 with the use of derived equations diverged from measured values, particularly for patients with NYHA functional class IV limitations. The percentage difference of measured VO 2 versus estimated VO 2 was >25% in 39% (n = 271), 25% (n = 170), 82% (n = 566), and 39% (n = 271) of HF patients when using the Dehmer, LaFarge, Bergstra, and thermodilution-derived estimations of VO 2 respectively., Conclusions: Resting VO 2 decreases with increasing NYHA functional class and is lower than in control subjects. Using estimations of VO 2 to calculate CO may introduce clinically important error., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Background: Patients with heart failure (HF) often have multiple chronic conditions that may impact health-related quality of life (HRQOL) despite HF therapy. We sought to determine the association between noncardiac comorbidities and HRQOL in ambulatory patients with advanced HF., Methods: Baseline data from 373 subjects in REVIVAL (Registry Evaluation of Vital Information for Ventricular Assist Devices in Ambulatory Life) were analyzed using multivariable general linear models to evaluate the relationship between comorbidities and HRQOL (EuroQol Visual Analogue Scale, EQ-5D-3L Index Score, and Kansas City Cardiomyopathy Questionnaire). The primary independent variables were a comorbidity index (sum of 14 noncardiac conditions), a residual comorbidity index (without depression), and depression alone. The median (25th to 75th percentile) number of comorbidities was 3 (2-4)., Results: Increasing comorbidity burden was associated with a reduction in generic (EQ-5D Index, P =0.005) and HF-specific (Kansas City Cardiomyopathy Questionnaire, P =0.001) HRQOL. The residual comorbidity index was not associated with HRQOL when depression included in the model independently, while depression was associated with HRQOL across all measures. Participants with depression (versus without) scored on average 13 points (95% CI, 8-17) lower on the EuroQol Visual Analogue Scale, 0.15 points (95% CI, 0.12-0.18) lower on the EQ-5D Index, and 24.9 points (95% CI, 21.2-28.5) lower on the Kansas City Cardiomyopathy Questionnaire overall summary score., Conclusions: While noncardiac comorbidities were prevalent in ambulatory advanced HF patients, only depression was associated with decreased generic and HF-specific HRQOL. Other than depression, the presence of noncardiac comorbidities should not impact expected gains in HRQOL following ventricular assist device implantation, provided the conditions are not a contraindication to implant. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01369407.

Background: Worsening heart failure (HF) and health-related quality of life (HRQOL) have been shown to impact the decision to proceed with left ventricular assist device (LVAD) implantation, but little is known about how socioeconomic factors influence expressed patient preference for LVAD., Methods and Results: Ambulatory patients with advanced systolic HF (n=353) reviewed written information about LVAD therapy and completed a brief survey to indicate whether they would want an LVAD to treat their current level of HF. Ordinal logistic regression analyses identified clinical and demographic predictors of LVAD preference. Higher New York Heart Association (NYHA) class, worse HRQOL measured by Kansas City Cardiomyopathy Questionnaire, lower education level, and lower income were significant univariable predictors of patients wanting an LVAD. In the multivariable model, higher NYHA class (OR [odds ratio]: 1.43, CI [confidence interval]: 1.08-1.90, P = .013) and lower income level (OR: 2.10, CI: 1.18 - 3.76, P = .012 for <$40,000 vs >$80,000) remained significantly associated with wanting an LVAD., Conclusion: Among ambulatory patients with advanced systolic HF, treatment preference for LVAD was influenced by level of income independent of HF severity. Understanding the impact of socioeconomic factors on willingness to consider LVAD therapy may help tailor counseling towards individual needs., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Background: Ambulatory patients with advanced heart failure (HF) are often considered for advanced therapies, including durable mechanical circulatory support (MCS). The Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) profiles are a commonly used descriptor of disease severity in patients receiving MCS devices, but their role in defining the prognosis of ambulatory patients is less well established, especially for Profiles 6 and 7., Methods: Registry Evaluation of Vital Information on Ventricular Assist Devices in Ambulatory Life is a prospective observational study of 400 outpatients from 21 MCS and cardiac transplant centers. Eligible patients had New York Heart Association Class II to IV symptoms despite optimal medical and electrical therapies with a recent HF hospitalization, heart transplant listing, or evidence of high neurohormonal activation., Results: The cohort included 33 INTERMACS Profile 4 (8%), 83 Profile 5 (21%), 155 Profile 6 (39%), and 129 Profile 7 (32%). Across INTERMACS profiles, there were no differences in age, gender, ejection fraction, blood pressure, or use of guideline-directed medical therapy. A lower INTERMACS profile was associated with more hospitalizations, greater frailty, and more impaired functional capacity and quality of life. The composite end point of death, durable MCS, or urgent transplant at 12 months occurred in 39%, 27%, 24%, and 14% subjects with INTERMACS Profiles 4, 5, 6, and 7, respectively (p = 0.004)., Conclusions: Among ambulatory patients with advanced HF, a lower INTERMACS profile was associated with a greater burden of HF across multiple dimensions and a higher composite risk of durable MCS, urgent transplant, or death. These profiles may assist in risk assessment and triaging ambulatory patients to advanced therapies., (Copyright © 2019 International Society for Heart and Lung Transplantation. All rights reserved.)

Purpose of Review: Improving outcomes with durable mechanical circulatory support have led to expanding interest in the earlier recognition of patients destined to develop refractory heart failure (HF). The recognition of advanced HF has received increasing attention., Recent Findings: The Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) registry developed patient profiles of advanced HF to describe the spectrum of patients with refractory HF undergoing mechanical circulatory support. These patient profiles have been extended to advanced HF patients on medical therapy and used to align outcomes with medical and device therapy in the Medical Arm of Mechanically Assisted Circulatory Support (MedaMACS) registries and the ROADMAP study. Shared decision-making about treatment options for advanced HF requires individualized consideration of risks and benefits beyond survival. Future studies, including the ongoing Registry for Vital Information for VADs in Ambulatory Life (REVIVAL) study, will provide prognostic information for patients transitioning from stage C to stage D HF to help patients, caregivers, and physicians navigate the increasingly complex terrain of HF care.

Patients with pulmonary arterial hypertension (PAH) and chronic thromboembolic pulmonary hypertension (CTEPH) have low levels of physical activity (PA). Increased PA has health benefits including improved quality of life. This study aimed to identify patient-perceived barriers to PA that correlate with objectively measured PA in this population. We performed a cross-sectional survey of 40 patients with PAH and CTEPH. Participants rated how often 15 barriers interfere with being physically active on a 5-point Likert Scale. The primary outcome measure was PA quantified using the Fitbit Zip activity tracker for two weeks. The primary independent variables were the 15 barriers and a summary score (total average barriers). Separate multivariable linear regressions were performed to assess the association between the 15 barriers and the summary score and PA adjusting for age, sex, and PAH etiology. Of the participants, 85% (34/40) had valid step counts and were included. Of these 34, 85% (n = 29) were female and 91% (n = 31) had PAH. The median (interquartile range [IQR]) number of daily steps was 3913 (2309-6313). The barriers endorsed most strongly were lack of self-discipline, lack of energy, and lack of interest. In the multivariable analysis, a 1-unit increase in perceived lack of interest, lack of enjoyment, and lack of skills was associated with a significant decrease in step counts of -1414 steps (95% confidence interval [CI] = (-2580 - -248), -1458 steps (-2404 - -511), and -1533 steps (-2910 - -156), respectively. Counseling and interventions aimed at increasing PA in patients with PAH should address interest, enjoyment, and skill development.

Heart failure with preserved ejection fraction (HFpEF) is a prevalent but incompletely understood syndrome. Traditional models of HFpEF pathophysiology revolve around systemic HTN and other causes of increased left ventricular afterload leading to left ventricular hypertrophy (LVH) and diastolic dysfunction. However, emerging models attribute the development of HFpEF to systemic proinflammatory changes secondary to common comorbidities which include HTN. Alterations in passive ventricular stiffness, ventricular-arterial coupling, peripheral microvascular function, systolic reserve, and chronotropic response occur. As a result, HFpEF is heterogeneous in nature, making it difficult to prescribe uniform therapies to all patients. Nonetheless, treating systemic HTN remains a cornerstone of HFpEF management. Antihypertensive therapies have been linked to LVH regression and improvement in diastolic dysfunction. However, to date, no therapies have definitive mortality benefit in HFpEF. Non-pharmacologic management for HTN, including dietary modification, exercise, and treating sleep disordered breathing, may provide some morbidity benefit in the HFpEF population. Future research is need to identify effective treatments, perhaps in more specific subgroups, and focus may need to shift from reducing mortality to improving exercise capacity and symptoms. Tailoring antihypertensive therapies to specific phenotypes of HFpEF may be an important component of this strategy.