Pub Date : 2025-02-01DOI: 10.1016/j.jchf.2024.11.011
Pablo Garcia-Pavia MD, PhD , Ozlem Bilen MD , Melissa Burroughs MD , Juan Pablo Costabel MD , Edileide de Barros Correia MD , Anne M. Dybro MD, PhD , Perry Elliott MBBS, MD , Neal K. Lakdawala MD , Amy Mann BA , Ajith Nair MD , Michael E. Nassif MD , Steen H. Poulsen MD , Patricia Reant MD, PhD , P. Christian Schulze MD , Andrew Wang MD , Indrias Berhane PhD , Stephen B. Heitner MD , Daniel L. Jacoby MD , Stuart Kupfer MD , Fady I. Malik MD, PhD , Michael A. Fifer MD
Beta-blockers and nondihydropyridine calcium-channel blockers have been standard-of-care (SOC) medications for patients with symptomatic obstructive hypertrophic cardiomyopathy (oHCM), even though these agents do not directly affect the underlying pathophysiology of the disease. Cardiac myosin inhibitors act by decreasing the number of myosin heads binding to actin, reducing the pathologic hypercontractility of HCM, and have been shown to improve exercise capacity and alleviate symptoms in oHCM when added to SOC medications. Cardiac myosin inhibitors are currently considered as second-line therapy in the absence of head-to-head comparison studies vs SOC medications. The aim of the ongoing phase 3 study MAPLE-HCM (Metoprolol vs Aficamten in Patients With LVOT Obstruction on Exercise Capacity in HCM) is to fill this evidence gap by evaluating aficamten as both first-line therapy for newly diagnosed oHCM and as a monotherapy alternative for patients currently on SOC drugs. The authors describe the rationale, design, and baseline characteristics of patients in this study. (Phase 3 Trial to Evaluate the Efficacy and Safety of Aficamten Compared to Metoprolol Succinate in Adults With Symptomatic oHCM [MAPLE-HCM]; NCT05767346)
{"title":"Aficamten vs Metoprolol for Obstructive Hypertrophic Cardiomyopathy","authors":"Pablo Garcia-Pavia MD, PhD , Ozlem Bilen MD , Melissa Burroughs MD , Juan Pablo Costabel MD , Edileide de Barros Correia MD , Anne M. Dybro MD, PhD , Perry Elliott MBBS, MD , Neal K. Lakdawala MD , Amy Mann BA , Ajith Nair MD , Michael E. Nassif MD , Steen H. Poulsen MD , Patricia Reant MD, PhD , P. Christian Schulze MD , Andrew Wang MD , Indrias Berhane PhD , Stephen B. Heitner MD , Daniel L. Jacoby MD , Stuart Kupfer MD , Fady I. Malik MD, PhD , Michael A. Fifer MD","doi":"10.1016/j.jchf.2024.11.011","DOIUrl":"10.1016/j.jchf.2024.11.011","url":null,"abstract":"<div><div>Beta-blockers and nondihydropyridine calcium-channel blockers have been standard-of-care (SOC) medications for patients with symptomatic obstructive hypertrophic cardiomyopathy (oHCM), even though these agents do not directly affect the underlying pathophysiology of the disease. Cardiac myosin inhibitors act by decreasing the number of myosin heads binding to actin, reducing the pathologic hypercontractility of HCM, and have been shown to improve exercise capacity and alleviate symptoms in oHCM when added to SOC medications. Cardiac myosin inhibitors are currently considered as second-line therapy in the absence of head-to-head comparison studies vs SOC medications. The aim of the ongoing phase 3 study MAPLE-HCM (Metoprolol vs Aficamten in Patients With LVOT Obstruction on Exercise Capacity in HCM) is to fill this evidence gap by evaluating aficamten as both first-line therapy for newly diagnosed oHCM and as a monotherapy alternative for patients currently on SOC drugs. The authors describe the rationale, design, and baseline characteristics of patients in this study. (Phase 3 Trial to Evaluate the Efficacy and Safety of Aficamten Compared to Metoprolol Succinate in Adults With Symptomatic oHCM [MAPLE-HCM]; <span><span>NCT05767346</span><svg><path></path></svg></span>)</div></div>","PeriodicalId":14687,"journal":{"name":"JACC. Heart failure","volume":"13 2","pages":"Pages 346-357"},"PeriodicalIF":10.3,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143180875","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}
Pub Date : 2025-02-01DOI: 10.1016/j.jchf.2024.08.018
Onyedika J. Ilonze MD, MPH , Daniel E. Forman MD , Lisa LeMond MD , Jonathan Myers PhD , Scott Hummel MD , Amanda R. Vest MBBS MPH , Ersilia M. DeFilippis MD , Eiad Habib MBBS , Sarah J. Goodlin MD
Heart failure (HF) is a leading cause of cardiovascular morbidity, mortality, and health care expenditure. Guideline-directed medical therapy and device-based therapy in HF are well established. However, the role of nonpharmacologic modalities to improve HF care remains underappreciated, is underused, and requires multimodal approaches to care. Diet, exercise and cardiac rehabilitation, sleep-disordered breathing, mood disorders, and substance use disorders are potential targets to reduce morbidity and improve function of patients with HF. Addressing these factors may improve symptoms and quality of life, reduce hospitalizations, and improve mortality in heart failure. This state-of-the-art review discusses dietary interventions, exercise programs, and the management of sleep-disordered breathing, mood disorders, and substance use in individuals with heart failure. The authors review the latest data and provide optimal lifestyle recommendations and recommended prescriptions for nonpharmacologic therapies.
{"title":"Beyond Guideline-Directed Medical Therapy","authors":"Onyedika J. Ilonze MD, MPH , Daniel E. Forman MD , Lisa LeMond MD , Jonathan Myers PhD , Scott Hummel MD , Amanda R. Vest MBBS MPH , Ersilia M. DeFilippis MD , Eiad Habib MBBS , Sarah J. Goodlin MD","doi":"10.1016/j.jchf.2024.08.018","DOIUrl":"10.1016/j.jchf.2024.08.018","url":null,"abstract":"<div><div>Heart failure (HF) is a leading cause of cardiovascular morbidity, mortality, and health care expenditure. Guideline-directed medical therapy and device-based therapy in HF are well established. However, the role of nonpharmacologic modalities to improve HF care remains underappreciated, is underused, and requires multimodal approaches to care. Diet, exercise and cardiac rehabilitation, sleep-disordered breathing, mood disorders, and substance use disorders are potential targets to reduce morbidity and improve function of patients with HF. Addressing these factors may improve symptoms and quality of life, reduce hospitalizations, and improve mortality in heart failure. This state-of-the-art review discusses dietary interventions, exercise programs, and the management of sleep-disordered breathing, mood disorders, and substance use in individuals with heart failure. The authors review the latest data and provide optimal lifestyle recommendations and recommended prescriptions for nonpharmacologic therapies.</div></div>","PeriodicalId":14687,"journal":{"name":"JACC. Heart failure","volume":"13 2","pages":"Pages 185-199"},"PeriodicalIF":10.3,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142500653","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}
Pub Date : 2025-02-01DOI: 10.1016/j.jchf.2024.09.008
Monica Ahluwalia MD , Jiankang Liu PhD , Iacopo Olivotto MD , Victoria Parikh MD , Euan A. Ashley MRCP, DPhil , Michelle Michels MD, PhD , Jodie Ingles MPH, PhD , Rachel Lampert MD , John C. Stendahl MD, PhD , Steven D. Colan MD , Dominic Abrams MD , Alexandre C. Pereira MD, PhD , Joseph W. Rossano MD , Thomas D. Ryan MD, PhD , Anjali T. Owens MD , James S. Ware PhD, MRCP , Sara Saberi MD, MS , Adam S. Helms MD , Sharlene Day MD , Brian Claggett PhD , Neal K. Lakdawala MD
Background
An improved understanding of the natural history in NYHA functional class I patients with obstructive hypertrophic cardiomyopathy (oHCM) is needed.
Objectives
Using a multicenter registry (SHaRe [Sarcomeric Human Cardiomyopathy Registry]), this study described the natural history in patients with oHCM who were classified as NYHA functional class I at the initial visit compared with patients classified as NYHA functional class II and reported baseline characteristics associated with incident clinical events.
Methods
Incident events assessed included a composite of NYHA functional class III to IV symptoms, left ventricular ejection fraction <50%, atrial fibrillation, stroke, ventricular arrhythmias, septal reduction therapy, ventricular assist device or transplantation, or death. Factors associated with incident events were determined using Kaplan-Meier, Cox proportional hazards, and restricted cubic spline models.
Results
Of 7,964 patients with HCM in SHaRe, 1,239 patients with oHCM met inclusion criteria; 598 were in NYHA functional class I at the initial visit (age 48 ± 17 years; 31.1% female; peak gradient, 75 ± 40 mm Hg). At 5-year follow-up, the composite event rate of NYHA functional class I patients was 28% compared with 44% (P < 0.001) in 641 NYHA functional class II patients with oHCM (age 54 ± 16 years; 46.5% female; peak gradient, 83 ± 39 mm Hg). Left atrial (LA) diameter ≥45 mm (HR: 1.56 [95% CI: 1.14-2.12]; P = 0.005), female sex (HR: 1.61 [95% CI: 1.16-2.24]; P = 0.003), and older age (HR: 1.21 per 10 years [95% CI: 1.09-1.34]; P < 0.001), but not the magnitude of left ventricular outflow tract obstruction, were associated with a higher risk of the composite outcome in NYHA functional class I patients.
Conclusions
Although NYHA functional class I patients with oHCM fared better than NYHA functional class II patients, more than one-fourth experienced adverse events over 5-year follow-up, especially if they were older, female, and/or had LA enlargement. Strategies to reduce the rate of clinical outcomes in NYHA functional class I patients warrant further study.
背景：需要进一步了解 NYHA 功能分级 I 型阻塞性肥厚型心肌病（oHCM）患者的自然病史：需要进一步了解 NYHA 功能分级为 I 级的阻塞性肥厚型心肌病（oHCM）患者的自然病史：本研究通过多中心登记（SHaRe [Sarcomeric Human Cardiomyopathy Registry]），描述了初次就诊时被归为 NYHA 功能分级 I 级的阻塞性肥厚型心肌病患者与被归为 NYHA 功能分级 II 级的患者的自然病史，并报告了与临床事件相关的基线特征：评估的事件包括NYHA功能分级III级至IV级症状、左室射血分数结果：在 SHaRe 的 7964 名 HCM 患者中，1239 名 oHCM 患者符合纳入标准；598 名患者在首次就诊时处于 NYHA 功能分级 I 级（年龄 48 ± 17 岁；31.1% 为女性；峰值梯度 75 ± 40 mm Hg）。随访5年时，NYHA功能分级I级患者的综合事件发生率为28%，而641名NYHA功能分级II级的oHCM患者（年龄为54±16岁；46.5%为女性；峰值梯度为83±39毫米汞柱）的综合事件发生率为44%（P<0.001）。左心房（LA）直径≥45 mm（HR：1.56 [95% CI：1.14-2.12]；P = 0.005）、性别为女性（HR：1.61 [95% CI：1.16-2.24]；P = 0.003）、年龄较大（HR：每 10 年 1.21 [95% CI：1.09-1.34]；P < 0.003）。34]；P < 0.001），但与左心室流出道梗阻的程度无关，与 NYHA 功能分级 I 患者较高的综合结局风险相关：尽管NYHA功能分级I级的oHCM患者比NYHA功能分级II级的患者情况要好，但超过四分之一的患者在5年的随访中出现了不良事件，尤其是年龄较大、女性和/或LA增大的患者。降低 NYHA 功能分级 I 患者临床结局发生率的策略值得进一步研究。
{"title":"The Clinical Trajectory of NYHA Functional Class I Patients With Obstructive Hypertrophic Cardiomyopathy","authors":"Monica Ahluwalia MD , Jiankang Liu PhD , Iacopo Olivotto MD , Victoria Parikh MD , Euan A. Ashley MRCP, DPhil , Michelle Michels MD, PhD , Jodie Ingles MPH, PhD , Rachel Lampert MD , John C. Stendahl MD, PhD , Steven D. Colan MD , Dominic Abrams MD , Alexandre C. Pereira MD, PhD , Joseph W. Rossano MD , Thomas D. Ryan MD, PhD , Anjali T. Owens MD , James S. Ware PhD, MRCP , Sara Saberi MD, MS , Adam S. Helms MD , Sharlene Day MD , Brian Claggett PhD , Neal K. Lakdawala MD","doi":"10.1016/j.jchf.2024.09.008","DOIUrl":"10.1016/j.jchf.2024.09.008","url":null,"abstract":"<div><h3>Background</h3><div>An improved understanding of the natural history in NYHA functional class I patients with obstructive hypertrophic cardiomyopathy (oHCM) is needed.</div></div><div><h3>Objectives</h3><div>Using a multicenter registry (SHaRe [Sarcomeric Human Cardiomyopathy Registry]), this study described the natural history in patients with oHCM who were classified as NYHA functional class I at the initial visit compared with patients classified as NYHA functional class II and reported baseline characteristics associated with incident clinical events.</div></div><div><h3>Methods</h3><div>Incident events assessed included a composite of NYHA functional class III to IV symptoms, left ventricular ejection fraction <50%, atrial fibrillation, stroke, ventricular arrhythmias, septal reduction therapy, ventricular assist device or transplantation, or death. Factors associated with incident events were determined using Kaplan-Meier, Cox proportional hazards, and restricted cubic spline models.</div></div><div><h3>Results</h3><div>Of 7,964 patients with HCM in SHaRe, 1,239 patients with oHCM met inclusion criteria; 598 were in NYHA functional class I at the initial visit (age 48 ± 17 years; 31.1% female; peak gradient, 75 ± 40 mm Hg). At 5-year follow-up, the composite event rate of NYHA functional class I patients was 28% compared with 44% (<em>P <</em> 0.001) in 641 NYHA functional class II patients with oHCM (age 54 ± 16 years; 46.5% female; peak gradient, 83 ± 39 mm Hg). Left atrial (LA) diameter ≥45 mm (HR: 1.56 [95% CI: 1.14-2.12]; <em>P =</em> 0.005), female sex (HR: 1.61 [95% CI: 1.16-2.24]; <em>P =</em> 0.003), and older age (HR: 1.21 per 10 years [95% CI: 1.09-1.34]; <em>P <</em> 0.001), but not the magnitude of left ventricular outflow tract obstruction, were associated with a higher risk of the composite outcome in NYHA functional class I patients.</div></div><div><h3>Conclusions</h3><div>Although NYHA functional class I patients with oHCM fared better than NYHA functional class II patients, more than one-fourth experienced adverse events over 5-year follow-up, especially if they were older, female, and/or had LA enlargement. Strategies to reduce the rate of clinical outcomes in NYHA functional class I patients warrant further study.</div></div>","PeriodicalId":14687,"journal":{"name":"JACC. Heart failure","volume":"13 2","pages":"Pages 332-343"},"PeriodicalIF":10.3,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142620762","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}
Pub Date : 2025-02-01DOI: 10.1016/j.jchf.2024.08.001
Anita W. Asgar MD , Gilbert H.L. Tang MD , Jason H. Rogers MD , Wolfgang Rottbauer MD , M. Andrew Morse MD , Paolo Denti MD , Paul Mahoney MD , Michael J. Rinaldi MD , Federico M. Asch MD , Jose L. Zamorano MD , Melody Dong PhD , Rong Huang MS , Joann Lindenfeld MD , Francesco Maisano MD , Ralph Stephan von Bardeleben MD , Saibal Kar MD , Evelio Rodriguez MD
Background
Moderate secondary mitral regurgitation (SMR) represents a subgroup of heart failure (HF) patients with treatment restricted to medical therapy. Outcomes in patients with moderate SMR treated with mitral transcatheter edge-to-edge repair (M-TEER) are less well known.
Objectives
The aim of this study was to assess the safety and effectiveness of M-TEER in subjects with moderate SMR using the EXPANDed studies.
Methods
One-year outcomes in subjects from the EXPANDed studies (EXPAND [A Contemporary, Prospective Study Evaluating Real-world Experience of Performance and Safety for the Next Generation of MitraClip Devices] and EXPAND G4 [A Post-Market Study Assessment of the Safety and Performance of the MitraClip G4 System] MitraClip studies) with baseline moderate SMR (2+), per echocardiographic core laboratory (ECL) assessment, were compared with subjects with baseline severe SMR (≥3+).
Results
There were 335 subjects with moderate SMR and 525 with severe SMR at baseline per ECL review. Baseline characteristics were similar between the 2 subgroups. After treatment with M-TEER, significant MR reduction was achieved in both groups. Significant left ventricular (LV) reverse remodeling was observed through 1 year, with a >20 mL decrease in LV end-diastolic and end-systolic volumes on average in the moderate SMR group. Significant 1-year improvements in NYHA functional class (>78% NYHA functional class I or II) and quality of life (>20 points on the Kansas City Cardiomyopathy Questionnaire–Overall Summary) were observed in subjects with moderate SMR. Similarly, low rates of major adverse events, all-cause mortality, and HF hospitalizations were observed between the 2 subgroups through 1 year.
Conclusions
In the EXPANDed studies, subjects with moderate SMR treated with M-TEER had improvements similar to subjects with severe SMR in quality of life and positive LV remodeling at 1 year. Future studies are needed to evaluate if M-TEER would be beneficial for HF patients with moderate SMR.
{"title":"Evaluating Mitral TEER in the Management of Moderate Secondary Mitral Regurgitation Among Heart Failure Patients","authors":"Anita W. Asgar MD , Gilbert H.L. Tang MD , Jason H. Rogers MD , Wolfgang Rottbauer MD , M. Andrew Morse MD , Paolo Denti MD , Paul Mahoney MD , Michael J. Rinaldi MD , Federico M. Asch MD , Jose L. Zamorano MD , Melody Dong PhD , Rong Huang MS , Joann Lindenfeld MD , Francesco Maisano MD , Ralph Stephan von Bardeleben MD , Saibal Kar MD , Evelio Rodriguez MD","doi":"10.1016/j.jchf.2024.08.001","DOIUrl":"10.1016/j.jchf.2024.08.001","url":null,"abstract":"<div><h3>Background</h3><div>Moderate secondary mitral regurgitation (SMR) represents a subgroup of heart failure (HF) patients with treatment restricted to medical therapy. Outcomes in patients with moderate SMR treated with mitral transcatheter edge-to-edge repair (M-TEER) are less well known.</div></div><div><h3>Objectives</h3><div>The aim of this study was to assess the safety and effectiveness of M-TEER in subjects with moderate SMR using the EXPANDed studies.</div></div><div><h3>Methods</h3><div>One-year outcomes in subjects from the EXPANDed studies (EXPAND [A Contemporary, Prospective Study Evaluating Real-world Experience of Performance and Safety for the Next Generation of MitraClip Devices] and EXPAND G4 [A Post-Market Study Assessment of the Safety and Performance of the MitraClip G4 System] MitraClip studies) with baseline moderate SMR (2+), per echocardiographic core laboratory (ECL) assessment, were compared with subjects with baseline severe SMR (≥3+).</div></div><div><h3>Results</h3><div>There were 335 subjects with moderate SMR and 525 with severe SMR at baseline per ECL review. Baseline characteristics were similar between the 2 subgroups. After treatment with M-TEER, significant MR reduction was achieved in both groups. Significant left ventricular (LV) reverse remodeling was observed through 1 year, with a >20 mL decrease in LV end-diastolic and end-systolic volumes on average in the moderate SMR group. Significant 1-year improvements in NYHA functional class (>78% NYHA functional class I or II) and quality of life (>20 points on the Kansas City Cardiomyopathy Questionnaire–Overall Summary) were observed in subjects with moderate SMR. Similarly, low rates of major adverse events, all-cause mortality, and HF hospitalizations were observed between the 2 subgroups through 1 year.</div></div><div><h3>Conclusions</h3><div>In the EXPANDed studies, subjects with moderate SMR treated with M-TEER had improvements similar to subjects with severe SMR in quality of life and positive LV remodeling at 1 year. Future studies are needed to evaluate if M-TEER would be beneficial for HF patients with moderate SMR.</div></div>","PeriodicalId":14687,"journal":{"name":"JACC. Heart failure","volume":"13 2","pages":"Pages 213-225"},"PeriodicalIF":10.3,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142269281","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}
Pub Date : 2025-02-01DOI: 10.1016/j.jchf.2024.10.007
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}
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.
Objectives
This study sought to analyze characteristics of hospitalized advanced HF patients across LVEF spectrum, world regions, and country income.
Methods
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.
Results
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%; P = 0.018). Adjusted 1-year mortality risk did not differ among LVEF subgroups (all P > 0.05), nor did 1-year HF hospitalization rate (P = 0.56).
Conclusions
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.
{"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}
Pub Date : 2025-02-01DOI: 10.1016/j.jchf.2024.09.023
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
Background
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.
Objectives
The purpose of this study was to examine the safety and efficacy of the Revivent TC® anchor system in patients with HF.
Methods
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/m2, 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.
Results
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%; P < 0.0001). There was no significant difference in the primary 12-month hierarchical composite efficacy endpoint (win ratio 1.13; P = 0.32). In post hoc analysis, the surgical only approach (23 treated patients) had more favorable outcomes than the hybrid approach (60 treated patients).
Conclusions
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; NCT02931240)
{"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}
Pub Date : 2025-02-01DOI: 10.1016/j.jchf.2024.10.025
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}
Pub Date : 2025-02-01DOI: 10.1016/j.jchf.2024.11.013
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
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 (pVO2) 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 pVO2 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); NCT05582395)
{"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}
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