Trejeeve Martyn MD, MSc , Harsh Patolia MD , Nicholas Platek DO , Ryan Tang MD , Nancy M. Albert PhD , Danielle Crow MSN , Amanda R. Vest MBBS, MPH , Samir Kapadia MD , Raed Dweik MD , Lars G. Svensson MD, PhD , Jerry D. Estep MD , Conor P. Delaney MD, PhD , Richard D. Rothman MD , Jessica Hohman MD, MSc, MSc
{"title":"Early Heart Failure Outcomes and Medical Therapy Use in a Virtually Managed Hospital at Home Setting","authors":"Trejeeve Martyn MD, MSc , Harsh Patolia MD , Nicholas Platek DO , Ryan Tang MD , Nancy M. Albert PhD , Danielle Crow MSN , Amanda R. Vest MBBS, MPH , Samir Kapadia MD , Raed Dweik MD , Lars G. Svensson MD, PhD , Jerry D. Estep MD , Conor P. Delaney MD, PhD , Richard D. Rothman MD , Jessica Hohman MD, MSc, MSc","doi":"10.1016/j.jchf.2024.10.007","DOIUrl":"10.1016/j.jchf.2024.10.007","url":null,"abstract":"","PeriodicalId":14687,"journal":{"name":"JACC. Heart failure","volume":"13 2","pages":"Pages 381-385"},"PeriodicalIF":10.3,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142647905","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Hospitalized Advanced Heart Failure With Preserved vs Reduced Left Ventricular Ejection Fraction","authors":"Vasiliki Bistola MD, PhD , Dimitrios Farmakis MD, PhD , Jasper Tromp MD, PhD , Wan Ting Tay MApp STAT , Wouter Ouwerkerk PhD , Christiane E. Angermann MD , John G.F. Cleland MD , Ulf Dahlström MD, PhD , Kenneth Dickstein MD, PhD , Georg Ertl MD , Mahmoud Hassanein MD , Sotiria Liori MD , Petros Nikolopoulos MD , Sergio V. Perrone MD , Mathieu Ghadanfar MD , Anja Schweizer PhD , Achim Obergfell MD , Sean P. Collins MD , Carolyn S.P. Lam MBBS, PhD , Gerasimos Filippatos MD","doi":"10.1016/j.jchf.2024.09.009","DOIUrl":"10.1016/j.jchf.2024.09.009","url":null,"abstract":"<div><h3>Background</h3><div>Outcomes of hospitalized patients with heart failure (HF) and characteristics of advanced HF stage may vary across left ventricular ejection fraction (LVEF) and world regions.</div></div><div><h3>Objectives</h3><div>This study sought to analyze characteristics of hospitalized advanced HF patients across LVEF spectrum, world regions, and country income.</div></div><div><h3>Methods</h3><div>Among 18,553 hospitalized patients with acute HF (7,902 new-onset HF and 10,651 decompensated chronic HF) enrolled in the global registry REPORT-HF (International Registry to Assess Medical Practice With Longitudinal Observation for Treatment of Heart Failure), the authors analyzed characteristics and outcomes of patients with advanced HF, defined as previously diagnosed HF; severe symptoms before current admission (NYHA functional class III/IV); and ≥1 HF-related hospitalization in the preceding 12 months, excluding the current. Differences among hospitalized advanced HF subgroups stratified by LVEF, world region, and country income were examined.</div></div><div><h3>Results</h3><div>Among 6,999 patients with decompensated chronic HF and available previous NYHA functional class and HF hospitalization status, 3,397 (48.5%; 18.3% of the total population) had advanced HF. Of these, 44.5% had severely reduced (≤30%), 34.9% mildly/moderately reduced (31%-49%), and 20.7% preserved (≥50%) LVEF. Patients from Eastern Europe had the lowest 1-year mortality (23%), whereas those from Southeast Asia had the highest (37%). Patients from lower-middle-income countries were younger, with shorter HF duration and lower comorbidity prevalence, received fewer beta-blockers and HF-devices, and had higher 1-year mortality (34%) than upper-middle-income (26%) or high-income countries (27%; <em>P</em> = 0.018). Adjusted 1-year mortality risk did not differ among LVEF subgroups (all <em>P</em> > 0.05), nor did 1-year HF hospitalization rate (<em>P</em> = 0.56).</div></div><div><h3>Conclusions</h3><div>Hospitalized patients with advanced HF and preserved LVEF had similarly adverse outcomes as those with reduced LVEF. Patients from lower-middle-income countries had less implementation of HF therapies and higher 1-year mortality.</div></div>","PeriodicalId":14687,"journal":{"name":"JACC. Heart failure","volume":"13 2","pages":"Pages 229-247"},"PeriodicalIF":10.3,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142620685","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Jerry D. Estep MD , Ori Ben-Yehuda MD , Andrew S. Wechsler MD , Rishi Puri MD, PhD , Andrew C. Kao MD , Jessica K. Heimes DO , Michael P. Pfeiffer MD , John P. Boehmer MD , Vlasis Ninios MD , Azfar Zaman MD , Gregg W. Stone MD
{"title":"Transcatheter Left Ventricular Reconstruction in Heart Failure Patients With Prior Anterior Myocardial Infarction","authors":"Jerry D. Estep MD , Ori Ben-Yehuda MD , Andrew S. Wechsler MD , Rishi Puri MD, PhD , Andrew C. Kao MD , Jessica K. Heimes DO , Michael P. Pfeiffer MD , John P. Boehmer MD , Vlasis Ninios MD , Azfar Zaman MD , Gregg W. Stone MD","doi":"10.1016/j.jchf.2024.09.023","DOIUrl":"10.1016/j.jchf.2024.09.023","url":null,"abstract":"<div><h3>Background</h3><div>Left ventricular (LV) dilatation and extensive scar portend a poor prognosis in heart failure (HF). The Revivent TC system (BioVentrix Inc) is used either during a hybrid transcatheter-surgical or a surgical-only procedure to exclude transmural scar and reduce LV dimensions.</div></div><div><h3>Objectives</h3><div>The purpose of this study was to examine the safety and efficacy of the Revivent TC® anchor system in patients with HF.</div></div><div><h3>Methods</h3><div>The authors conducted a prospective, multicenter, nonrandomized (2:1 device vs control) trial in patients with NYHA functional class III-IV symptoms, LV ejection fraction ≤45%, LV end-systolic volume index ≥50 mL/m<sup>2</sup>, and transmural anterior LV scar. Patients with inadequate scar or previous sternotomy served as the control group. The primary safety endpoint was the composite of major adverse events in the device arm compared with a performance goal of 40.5%. The primary effectiveness endpoint was the hierarchical composite of cardiovascular mortality, HF hospitalization, change in 6-minute walk test, change in Minnesota Living With Heart Failure questionnaire score, and change in NYHA functional classification assessed at 12 months as the win ratio in the device group compared with the control group.</div></div><div><h3>Results</h3><div>In total, 126 patients (84 device; 42 control) were enrolled at 28 sites. Mean LV ejection fraction was 29.6% ± 7.2%, and mean LV end-systolic volume index was 93.9 ± 35.5 mm. The primary 30-day safety performance goal endpoint was met (major adverse events 15 of 84 [17.9%]; 1-sided 97.5% upper confidence limit 27.7%; <em>P <</em> 0.0001). There was no significant difference in the primary 12-month hierarchical composite efficacy endpoint (win ratio 1.13; <em>P =</em> 0.32). In post hoc analysis, the surgical only approach (23 treated patients) had more favorable outcomes than the hybrid approach (60 treated patients).</div></div><div><h3>Conclusions</h3><div>The Revivent TC® system safely reduced LV dimensions in HF patients caused by extensive anterior scar but did not improve clinical effectiveness outcomes at 1 year. A randomized trial is warranted to further define the risks and benefits of the surgical only approach. (BioVentrix Revivent TC™ System Clinical Study; <span><span>NCT02931240</span><svg><path></path></svg></span>)</div></div>","PeriodicalId":14687,"journal":{"name":"JACC. Heart failure","volume":"13 2","pages":"Pages 296-308"},"PeriodicalIF":10.3,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142965053","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
João Pedro Ferreira MD, PhD , Faiez Zannad MD, PhD
{"title":"We Need Simpler and More Integrated Guidelines in Cardio-Kidney-Metabolic Diseases","authors":"João Pedro Ferreira MD, PhD , Faiez Zannad MD, PhD","doi":"10.1016/j.jchf.2024.10.025","DOIUrl":"10.1016/j.jchf.2024.10.025","url":null,"abstract":"","PeriodicalId":14687,"journal":{"name":"JACC. Heart failure","volume":"13 2","pages":"Pages 371-374"},"PeriodicalIF":10.3,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142965054","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Milind Y. Desai MD, MBA , Steve E. Nissen MD , Theodore Abraham MD , Iacopo Olivotto MD , Pablo Garcia-Pavia MD, PhD , Renato D. Lopes MD, PhD , Nicolas Verheyen MD , Omar Wever-Pinzon MD , Kathy Wolski MPH , Wael Jaber MD , Lisa Mitchell RN , Deborah Davey RN , Jonathan Myers PhD , Thomas Rano PhD , Vandana Bhatia PhD , Yue Zhong PhD , Suzanne Carter-Bonanza RN , Victoria Florea MD , Ron Aronson MD , Anjali T. Owens MD
{"title":"Mavacamten in Symptomatic Nonobstructive Hypertrophic Cardiomyopathy","authors":"Milind Y. Desai MD, MBA , Steve E. Nissen MD , Theodore Abraham MD , Iacopo Olivotto MD , Pablo Garcia-Pavia MD, PhD , Renato D. Lopes MD, PhD , Nicolas Verheyen MD , Omar Wever-Pinzon MD , Kathy Wolski MPH , Wael Jaber MD , Lisa Mitchell RN , Deborah Davey RN , Jonathan Myers PhD , Thomas Rano PhD , Vandana Bhatia PhD , Yue Zhong PhD , Suzanne Carter-Bonanza RN , Victoria Florea MD , Ron Aronson MD , Anjali T. Owens MD","doi":"10.1016/j.jchf.2024.11.013","DOIUrl":"10.1016/j.jchf.2024.11.013","url":null,"abstract":"<div><div>There are no approved therapies for patients with symptomatic nonobstructive hypertrophic cardiomyopathy (nHCM). The authors describe the baseline characteristics of ODYSSEY-HCM (A Study of Mavacamten in Non-Obstructive Hypertrophic Cardiomyopathy), a phase 3, randomized, double-blind, placebo-controlled trial conducted worldwide at 201 sites evaluating mavacamten in symptomatic adult patients with nHCM. The 2 primary endpoints are the changes from baseline to week 48 in: 1) Kansas City Cardiomyopathy Questionnaire 23-item Clinical Summary Score; and 2) peak oxygen consumption (pVO<sub>2</sub>) on cardiopulmonary exercise testing. Dose titrations are made on blinded core laboratory assessments. Of 1,088 patients screened, 580 are randomized (mean age 56 ± 15 years, 46% women, 43% with family histories). All patients are nonobstructive and symptomatic (70% in NYHA functional class II and 30% class III), with a mean Kansas City Cardiomyopathy Questionnaire 23-item Clinical Summary Score of 58 ± 20, and 77% are on beta-blockers. The mean left ventricular ejection fraction and pVO<sub>2</sub> are 66% ± 4% and 18 ± 6 mL/kg/min, respectively. ODYSSEY-HCM will report if mavacamten improves patient-reported health status and exercise capacity in patients with symptomatic nHCM. (A Study of Mavacamten in Non-Obstructive Hypertrophic Cardiomyopathy (ODYSSEY-HCM); <span><span>NCT05582395</span><svg><path></path></svg></span>)</div></div>","PeriodicalId":14687,"journal":{"name":"JACC. Heart failure","volume":"13 2","pages":"Pages 358-370"},"PeriodicalIF":10.3,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143180876","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Alberto Aimo MD, PhD , Iacopo Olivotto MD , Giancarlo Todiere MD, PhD , Andrea Barison MD, PhD , Giorgia Panichella MD , Mona Fiuzat PharmD , Cecilia Linde MD, PhD , Neal K. Lakdawala MD, MSc , Milind Desai MD, MBA , Faiez Zannad MD, PhD , Martin S. Maron MD
{"title":"Endpoint Selection in Randomized Clinical Trials for Hypertrophic Cardiomyopathy","authors":"Alberto Aimo MD, PhD , Iacopo Olivotto MD , Giancarlo Todiere MD, PhD , Andrea Barison MD, PhD , Giorgia Panichella MD , Mona Fiuzat PharmD , Cecilia Linde MD, PhD , Neal K. Lakdawala MD, MSc , Milind Desai MD, MBA , Faiez Zannad MD, PhD , Martin S. Maron MD","doi":"10.1016/j.jchf.2024.10.016","DOIUrl":"10.1016/j.jchf.2024.10.016","url":null,"abstract":"<div><div>Randomized clinical trials (RCTs) for hypertrophic cardiomyopathy (HCM) have long been challenging caused by the condition’s rarity, low event rates, and diverse clinical presentations. However, recent advances in targeted therapies have sparked increased interest in HCM research. Despite this, designing effective RCTs remains complex, particularly in identifying clinically meaningful endpoints. HCM, often linked to sequence variation in sarcomeric protein genes like <em>MYH7</em> and <em>MYBPC3</em>, exhibits varied phenotypic expressions that influence disease progression and treatment responses. This genetic variability underscores the need for personalized approaches in clinical trials. Emerging gene therapies, such as CRISPR/Cas9, show promise in addressing these genetic factors. A major challenge in HCM RCTs is ensuring that endpoints are both statistically and clinically significant, given issues like test-retest variability and missing data. Primary endpoints often focus on symptom relief and functional improvement, while secondary and exploratory endpoints provide broader insights into treatment effects. Regulatory authorities are increasingly open to a wider range of endpoints, including patient-reported outcomes and functional measures, although the cost-risk balance is crucial, especially for high-risk interventions. Future HCM RCTs may incorporate hard clinical endpoints such as heart failure hospitalization, atrial fibrillation recurrence, and all-cause mortality, offering a more comprehensive evaluation of treatment efficacy. Integrating genetic insights and advanced technologies will be essential to improving trial design and enhancing patient outcomes in HCM.</div></div>","PeriodicalId":14687,"journal":{"name":"JACC. Heart failure","volume":"13 2","pages":"Pages 200-212"},"PeriodicalIF":10.3,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142872112","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Mingming Yang MD, PhD , Toru Kondo MD, PhD , Atefeh Talebi PhD , Pardeep S. Jhund MBChB, MSc, PhD , Kieran F. Docherty MBChB, MD , Brian L. Claggett PhD , Muthiah Vaduganathan MD, MPH , Erasmus Bachus MD, PhD , Adrian F. Hernandez MD , Carolyn S.P. Lam MBBS, PhD , Felipe A. Martinez MD , Rudolf A. de Boer MD, PhD , Mikhail N. Kosiborod MD , Akshay S. Desai MD, MPH , Lars Køber MD, DMSc , Piotr Ponikowski MD, PhD , Marc S. Sabatine MD, MPH , Scott D. Solomon MD , John J.V. McMurray MD
{"title":"EuroQol 5-Dimension Questionnaire in Heart Failure With Reduced, Mildly Reduced, and Preserved Ejection Fraction","authors":"Mingming Yang MD, PhD , Toru Kondo MD, PhD , Atefeh Talebi PhD , Pardeep S. Jhund MBChB, MSc, PhD , Kieran F. Docherty MBChB, MD , Brian L. Claggett PhD , Muthiah Vaduganathan MD, MPH , Erasmus Bachus MD, PhD , Adrian F. Hernandez MD , Carolyn S.P. Lam MBBS, PhD , Felipe A. Martinez MD , Rudolf A. de Boer MD, PhD , Mikhail N. Kosiborod MD , Akshay S. Desai MD, MPH , Lars Køber MD, DMSc , Piotr Ponikowski MD, PhD , Marc S. Sabatine MD, MPH , Scott D. Solomon MD , John J.V. McMurray MD","doi":"10.1016/j.jchf.2024.10.020","DOIUrl":"10.1016/j.jchf.2024.10.020","url":null,"abstract":"<div><h3>Background</h3><div>The value of generic quality of life (QoL) instruments in heart failure (HF) is uncertain.</div></div><div><h3>Objectives</h3><div>In this study, the authors sought to quantify individual dimension scores and the EuroQol 5-Dimension questionnaire (EQ-5D) Level Sum Score (LSS) in patients with HF with reduced, mildly reduced, or preserved ejection fraction, the association between those scores and outcomes, and the impact of treatment with dapagliflozin on the scores.</div></div><div><h3>Methods</h3><div>Analyses were conducted using patient-level data from DAPA-HF and DELIVER trials. Cox proportional hazards regression models were used to assess the association between EQ-5D scores (each dimension and LSS) and clinical outcomes. Sankey diagrams were used to illustrate changes in individual patient EQ-5D dimensions from baseline to 8 months’ follow-up.</div></div><div><h3>Results</h3><div>Of the 11,007 patients randomized in DAPA-HF and DELIVER, 10,135 (92.1%) completed the instrument at baseline. Scores varied markedly by question with 37%, 30%, and 33% of patients reporting no, slight, or moderate or greater problem, respectively for mobility; 67%, 20%, and 13% for self-care; 40%, 33%, and 27% for usual activities; 45%, 32%, and 23% for pain/discomfort; and 57%, 27%, and 16% for anxiety/depression. Patients with higher (worse) EQ-5D-LSS were more frequently female, had more comorbidities, and had worse HF status. Compared with patients free from any problem across all dimensions (ie, an EQ-5D-LSS of 5), the HRs for the composite outcome of time to first cardiovascular death or worsening HF were 1.27 (95% CI: 1.10-1.47), 1.70 (95% CI: 1.46-1.98), and 2.31 (95% CI: 1.88-2.85) in patients with EQ-5D-LSS of 6-10, 11-15, and 16-25 points, respectively. Dapagliflozin led to greater improvement and less worsening in mobility (OR: 1.13 [95% CI: 1.04-1.23]; <em>P =</em> 0.004), self-care (OR: 1.13 [95% CI: 1.02-1.24]; <em>P =</em> 0.016), usual activities (OR: 1.11 [95% CI: 1.02-1.21]; <em>P =</em> 0.015), and anxiety/depression (OR: 1.10 [95% CI: 1.01-1.21]; <em>P =</em> 0.034) after 8 months. The number needed to treat for 1 patient to report improvement in EQ-5D-LSS was 31 (95% CI: 20-72).</div></div><div><h3>Conclusions</h3><div>The EQ-5D revealed problems not often associated (eg, pain) with HF or commonly quantified in HF (eg, anxiety/depression). Dapagliflozin improved multiple QoL dimensions, and possibly anxiety/depression. (Study to Evaluate the Effect of Dapagliflozin on the Incidence of Worsening Heart Failure or Cardiovascular Death in Patients With Chronic Heart Failure [DAPA-HF]; <span><span>NCT03036124</span><svg><path></path></svg></span>; Dapagliflozin Evaluation to Improve the Lives of Patients With Preserved Ejection Fraction Heart Failure [DELIVER]; <span><span>NCT03619213</span><svg><path></path></svg></span>)</div></div>","PeriodicalId":14687,"journal":{"name":"JACC. Heart failure","volume":"13 2","pages":"Pages 277-292"},"PeriodicalIF":10.3,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143179804","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Not All Hospitalized Heart Failure Patients Are the Same","authors":"Garrick C. Stewart MD, MPH","doi":"10.1016/j.jchf.2024.11.014","DOIUrl":"10.1016/j.jchf.2024.11.014","url":null,"abstract":"","PeriodicalId":14687,"journal":{"name":"JACC. Heart failure","volume":"13 2","pages":"Pages 260-264"},"PeriodicalIF":10.3,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143179837","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}