JACC. Heart failure最新文献

{"title":"Endpoint Selection in Randomized Clinical Trials for Hypertrophic Cardiomyopathy.","authors":"Alberto Aimo, Iacopo Olivotto, Giancarlo Todiere, Andrea Barison, Giorgia Panichella, Mona Fiuzat, Cecilia Linde, Neal K Lakdawala, Milind Desai, Faiez Zannad, Martin S Maron","doi":"10.1016/j.jchf.2024.10.016","DOIUrl":"https://doi.org/10.1016/j.jchf.2024.10.016","url":null,"abstract":"<p><p>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 MYH7 and MYBPC3, 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.</p>","PeriodicalId":14687,"journal":{"name":"JACC. Heart failure","volume":" ","pages":""},"PeriodicalIF":10.3,"publicationDate":"2024-12-07","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}

{"title":"Left Ventricular Dimensions and Clinical Outcomes With a Fully Magnetically Levitated Left Ventricular Assist Device.","authors":"Ezequiel J Molina, Mustafa M Ahmed, Farooq H Sheikh, Joseph C Cleveland, Daniel J Goldstein, Nir Y Uriel, AiJia Wang, Jordan J Revis, Mandeep R Mehra","doi":"10.1016/j.jchf.2024.09.019","DOIUrl":"https://doi.org/10.1016/j.jchf.2024.09.019","url":null,"abstract":"<p><strong>Background: </strong>Prior analyses have suggested that a smaller left ventricular end-diastolic diameter (LVEDD) is associated with reduced survival following HeartMate 3 left ventricular assist device implantation.</p><p><strong>Objectives: </strong>In this trial-based comprehensive analysis, the authors sought to examine clinical characteristics and association with the outcome of this specific relationship.</p><p><strong>Methods: </strong>The authors analyzed the presence of LVEDD <55 mm among 1,921 analyzable HeartMate 3 patients within the MOMENTUM 3 (Multicenter Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Support Therapy With HeartMate 3) trial portfolio, on endpoints of overall survival and adverse events at 2 years. Adverse events included hemocompatibility-related (stroke, bleeding, and pump thrombosis) and non-hemocompatibility-related (right heart failure, infection) outcomes.</p><p><strong>Results: </strong>Those with a smaller LVEDD (<55 mm) (n = 108) were older (age 63 ± 11 years vs 60 ± 12 years; P = 0.005), were more often female (31% vs 20%; P = 0.096), and had more ischemic cardiomyopathy (60.2% vs 42.6%; P = 0.0004) compared with the LVEDD ≥55 mm group (n = 1,813). Death during implant hospitalization was higher (14.8 vs 5.7%; P = 0.0007) and survival at 2 years was lower (63.3% vs 81.8%; HR: 1.97 [95% CI: 1.39-2.79]; P = 0.0002) in the LVEDD <55 mm group. The LVEDD <55 mm group experienced more deaths due to hemocompatibility-related adverse events (2.8% vs 0.6%; HR: 4.61 [95% CI: 1.29-16.45]; P = 0.018) and right heart failure, both early (0-30 days; 7.4% vs 2.0%; HR: 3.70 [95% CI: 1.73-7.91]; P = 0.001) and late (>30 days; 12.0 vs 4.8%; HR: 2.58 [95% CI: 1.37-4.84]; P = 0.003). Low-flow alarms rehospitalizations were higher in the LVEDD <55 mm cohort (17.4 vs 8.3%; HR: 2.39 [95% CI: 1.59-3.59]; P < 0.001).</p><p><strong>Conclusions: </strong>Although infrequent in occurrence, smaller LVEDD (<55 mm) is associated with increased risk for early and late mortality, a consequence of hemocompatibility-related and right heart failure-related deaths. Rehospitalizations due to low-flow alarms are also more frequent. (MOMENTUM 3 IDE Clinical Study Protocol [HM3™]; NCT02224755; MOMENTUM 3 Continued Access Protocol [MOMENTUM 3 CAP]; NCT02892955).</p>","PeriodicalId":14687,"journal":{"name":"JACC. Heart failure","volume":" ","pages":""},"PeriodicalIF":10.3,"publicationDate":"2024-12-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142872113","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":"Clinical and Proteomic Risk Profiles of New-Onset Heart Failure in Men and Women.","authors":"Hailun Qin, Jasper Tromp, Jozine M Ter Maaten, Geert H D Voordes, Bart J van Essen, Mark André de la Rambelje, Camilla C S van der Hoef, Bernadet T Santema, Carolyn S P Lam, Adriaan A Voors","doi":"10.1016/j.jchf.2024.09.022","DOIUrl":"https://doi.org/10.1016/j.jchf.2024.09.022","url":null,"abstract":"<p><strong>Background: </strong>Previous studies have examined clinical predictors of incident heart failure (HF) in men and women. However, potential mechanisms through which these clinical predictors relate to the onset of HF remain to be established.</p><p><strong>Objectives: </strong>The authors studied the association between clinical and proteomic risk profiles of new-onset HF in men and women.</p><p><strong>Methods: </strong>Incident HF was studied in 478,479 participants from the UK Biobank. The association between new-onset HF and 8 common modifiable traditional risk factors, including obesity, smoking status, socioeconomic status, atrial fibrillation, type 2 diabetes, hypertension, hyperlipidemia, and history of myocardial infarction, was assessed in men and women. Proteomics data (2,923 unique proteins, Olink) was available in 22,695 men and 27,421 women. Pathway over-representation analyses were performed to identify biological pathways in men and women with and without new-onset HF. Principal component analyses were performed to extract weighted scores for each pathway. Subsequently, weighted scores were used in mediation analyses to investigate how the pathways mediated the association between risk factors and new-onset HF.</p><p><strong>Results: </strong>During a median follow-up time of 12 years, HF incident rate was 3.60 per 1,000 person-years in men and 1.72 per 1,000 person-years in women (P < 0.001). The strongest risk factor for future HF was a history of myocardial infarction (HR: 2.61; 95% CI: 2.46-2.77) in men and atrial fibrillation (HR: 4.10; 95% CI: 3.58-4.71) in women. When a risk factor was present in women, it conferred a higher risk of new-onset HF compared with the presence of the same risk factor in men. Both in men and women, the population-attributable risk was highest for hypertension (25% in men, 29% in women) and obesity (16% in men, 21% in women). Pathway analyses of protein profiles indicated several inflammatory pathways, and neutrophil degranulation in particular, to be activated both in men and women who developed HF. These inflammatory pathways modestly (22% in men and 24% in women) contributed to the association between hypertension and new-onset HF, but showed a stronger contribution (33% in men and 47% in women) to the association between obesity and new-onset HF.</p><p><strong>Conclusions: </strong>In men and women, the most prominent risk factors for new-onset HF were hypertension and obesity, but they conferred a greater risk of new-onset HF in women. New-onset HF in both men and women was associated with pathophysiological pathways related to neutrophil degranulation and immunomodulation and these pathways partly mediated the association between hypertension, obesity, and new-onset HF.</p>","PeriodicalId":14687,"journal":{"name":"JACC. Heart failure","volume":" ","pages":""},"PeriodicalIF":10.3,"publicationDate":"2024-12-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142872111","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":"Revisiting ICD Therapy for Primary Prevention in Patients With Heart Failure and Reduced Ejection Fraction.","authors":"Amin Yehya, Jose Lopez, Andrew J Sauer, Jonathan D Davis, Nasrien E Ibrahim, Roderick Tung, Biykem Bozkurt, Gregg C Fonarow, Sana M Al-Khatib","doi":"10.1016/j.jchf.2024.09.014","DOIUrl":"10.1016/j.jchf.2024.09.014","url":null,"abstract":"<p><p>Implantable cardioverter-defibrillators (ICDs) are recommended to reduce the risk of sudden cardiac death (SCD) in patients with heart failure with reduced ejection fraction (HFrEF). The landmark studies leading to the current guideline recommendations preceded the 4 pillars of guideline-directed medical therapies (GDMTs). Therefore, some have questioned the role of ICDs for primary prevention in current clinical practice. In this paper, the authors provide an overview of the current ICD recommendations, including the instrumental clinical trials, the risk of SCD as observed in clinical trials vs real-world scenarios, disparities in ICD use among different patient populations, the impact of contemporary GDMT on outcomes, and ongoing and future trials and methodologies to help identify patients who are at an increased risk of SCD and who may benefit from an ICD. The authors also propose a pragmatic guidance for clinicians when they engage in the shared decision-making discussions for primary ICD implantation.</p>","PeriodicalId":14687,"journal":{"name":"JACC. Heart failure","volume":" ","pages":""},"PeriodicalIF":10.3,"publicationDate":"2024-12-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142785426","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":"Choosing the Appropriate Combination of Diuretics for Patients With Heart Failure and Congestion","authors":"Edgar Francisco Carrizales-Sepúlveda MD,&nbsp;Alejandro Ordaz-Farías MD,&nbsp;Raymundo Vera-Pineda MD,&nbsp;Ramiro Flores-Ramírez MD, PhD","doi":"10.1016/j.jchf.2024.09.015","DOIUrl":"10.1016/j.jchf.2024.09.015","url":null,"abstract":"","PeriodicalId":14687,"journal":{"name":"JACC. Heart failure","volume":"12 12","pages":"Pages 2123-2124"},"PeriodicalIF":10.3,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142759095","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":"Association of Multiple Nonhypertrophic Cardiomyopathy–Related Genetic Variants and Outcomes in Patients With Hypertrophic Cardiomyopathy","authors":"Takashi Hiruma MD ,&nbsp;Shunsuke Inoue MD, PhD ,&nbsp;Zhehao Dai MD, PhD, MPH ,&nbsp;Seitaro Nomura MD, PhD ,&nbsp;Toru Kubo MD, PhD ,&nbsp;Kenta Sugiura MD, PhD ,&nbsp;Atsushi Suzuki MD, PhD ,&nbsp;Takeshi Kashimura MD, PhD ,&nbsp;Shouji Matsushima MD, PhD ,&nbsp;Takanobu Yamada MD, PhD ,&nbsp;Takashige Tobita MD, PhD ,&nbsp;Manami Katoh MD, PhD ,&nbsp;Toshiyuki Ko MD, PhD ,&nbsp;Masamichi Ito MD, PhD ,&nbsp;Junichi Ishida MD, PhD ,&nbsp;Eisuke Amiya MD, PhD ,&nbsp;Masaru Hatano MD, PhD ,&nbsp;Norifumi Takeda MD, PhD ,&nbsp;Eiki Takimoto MD, PhD ,&nbsp;Hiroshi Akazawa MD, PhD ,&nbsp;Issei Komuro MD, PhD","doi":"10.1016/j.jchf.2024.08.005","DOIUrl":"10.1016/j.jchf.2024.08.005","url":null,"abstract":"<div><h3>Background</h3><div>Approximately 10% of hypertrophic cardiomyopathy (HCM) patients have left ventricular systolic dysfunction (end-stage HCM) leading to severe heart-failure; however, risk stratification to identify patients at risk of progressing to end-stage HCM remains insufficient.</div></div><div><h3>Objectives</h3><div>In this study, the authors sought to elucidate whether the coexistence of other cardiovascular disease (CVD)–related variants is associated with progression to end-stage HCM in patients with HCM harboring pathogenic or likely pathogenic (P/LP) sarcomeric variants.</div></div><div><h3>Methods</h3><div>The authors performed genetic analysis of 83 CVD-related genes in HCM patients from a Japanese multicenter cohort. P/LP variants in 8 major sarcomeric genes (<em>MYBPC3</em>, <em>MYH7</em>, <em>TNNT2</em>, <em>TNNI3</em>, <em>TPM1</em>, <em>MYL2</em>, <em>MYL3</em>, and <em>ACTC1</em>) definitive for HCM were defined as “sarcomeric variants.” In addition, P/LP variants associated with other CVDs, such as dilated cardiomyopathy and arrhythmogenic cardiomyopathy, were referred to as “other CVD-related variants.”</div></div><div><h3>Results</h3><div>Among 394 HCM patients, 139 carried P/LP sarcomeric variants: 11 (7.9%) carried other CVD-related variants, 6 (4.3%) multiple sarcomeric variants, and 122 (87.8%) single sarcomeric variants. In a multivariable Cox regression analysis, presence of multiple sarcomeric variants (adjusted HR [aHR]: 3.35 [95% CI: 1.25-8.95]; <em>P =</em> 0.016) and coexistence of other CVD-related variants (aHR: 2.80 [95% CI: 1.16-6.78]; <em>P =</em> 0.022) were independently associated with progression to end-stage HCM. Coexisting other CVD-related variants were also associated with heart failure events (aHR: 2.75 [95% CI: 1.27-5.94]; <em>P =</em> 0.010).</div></div><div><h3>Conclusions</h3><div>Approximately 8% of sarcomeric HCM patients carried other CVD-related variants, which were associated with progression to end-stage HCM and heart failure events. Comprehensive surveillance of CVD-related variants within sarcomeric HCM patients contributes to risk stratification and understanding of mechanisms underlying end-stage HCM.</div></div>","PeriodicalId":14687,"journal":{"name":"JACC. Heart failure","volume":"12 12","pages":"Pages 2041-2052"},"PeriodicalIF":10.3,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142346901","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":"Refining a Stratified Medicine Approach to Heart Failure","authors":"W.H. Wilson Tang MD","doi":"10.1016/j.jchf.2024.10.003","DOIUrl":"10.1016/j.jchf.2024.10.003","url":null,"abstract":"","PeriodicalId":14687,"journal":{"name":"JACC. Heart failure","volume":"12 12","pages":"Pages 2071-2072"},"PeriodicalIF":10.3,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142759139","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":"Management of Iron Deficiency in Heart Failure","authors":"Kazuhiko Kido PharmD ,&nbsp;Craig J. Beavers PharmD ,&nbsp;Kenneth Dulnuan MD ,&nbsp;Nadia Fida MD ,&nbsp;Maya Guglin MD, PhD ,&nbsp;Onyedika J. Ilonze MD ,&nbsp;Robert J. Mentz MD ,&nbsp;Nikhil Narang MD ,&nbsp;Navin Rajagopalan MD ,&nbsp;Bhavadharini Ramu MD ,&nbsp;Yasar Sattar MD ,&nbsp;George Sokos DO ,&nbsp;Ewa A. Jankowska MSc, MD, PhD","doi":"10.1016/j.jchf.2024.05.014","DOIUrl":"10.1016/j.jchf.2024.05.014","url":null,"abstract":"<div><div><span><span>Iron deficiency (ID) is present in approximately 50% of patients with heart failure (HF) and even higher prevalence rate up to 80% in post-acute HF setting. The current guidelines for HF recommend intravenous (IV) iron replacement in HF with reduced or mildly reduced </span>ejection fraction<span><span> and ID based on clinical trials showing improvements in </span>quality of life and exercise capacity, and an overall treatment benefit for recurrent HF hospitalization. However, several barriers cause challenges in implementing IV iron supplementation in practice due, in part, to clinician knowledge gaps and limited resource availability to protocolize routine utilization in appropriate patients. Thus, the current review will discuss practical considerations in ID treatment, implementation of evidence-based ID treatment to improve regional </span></span>health disparities with toolkits, inclusion/exclusion criteria of IV iron supplementation, and clinical controversies in ID treatment, as well as gaps in evidence and questions to be answered.</div></div>","PeriodicalId":14687,"journal":{"name":"JACC. Heart failure","volume":"12 12","pages":"Pages 1961-1978"},"PeriodicalIF":10.3,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141603654","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":"Early U.S. Heart Transplant Experience With Normothermic Regional Perfusion Following Donation After Circulatory Death","authors":"Abigail R. Benkert MD ,&nbsp;Jeffrey E. Keenan MD ,&nbsp;Jacob N. Schroder MD ,&nbsp;Adam D. DeVore MD, MHS ,&nbsp;Chetan B. Patel MD ,&nbsp;Carmelo A. Milano MD ,&nbsp;Oliver K. Jawitz MD, MHS","doi":"10.1016/j.jchf.2024.06.007","DOIUrl":"10.1016/j.jchf.2024.06.007","url":null,"abstract":"<div><h3>Background</h3><div>Heart transplantation following donation after circulatory death (DCD HT) has short-term survival outcomes comparable to donation after brain death and has led to a significant increase in transplantation volume. The U.S. experience with the normothermic regional perfusion (NRP) DCD HT procurement method has not been evaluated.</div></div><div><h3>Objectives</h3><div>The aim of this study was to examine short-term outcomes associated with NRP vs direct procurement and perfusion (DPP) methods used during DCD HT in the United States.</div></div><div><h3>Methods</h3><div>The UNOS (United Network for Organ Sharing) registry was queried for all adult (age ≥18 years) heart recipients and corresponding donors of controlled DCD HT from January 2019-December 2023. Transplantations were stratified by NRP or DPP reperfusion methods. The primary outcome was overall survival.</div></div><div><h3>Results</h3><div>A total of 918 heart donors and recipients met inclusion criteria, including 622 (68%) DPP and 296 (32%) NRP transplantations. Unadjusted Kaplan-Meier survival analysis demonstrated improved short-term survival associated with NRP (log-rank <em>P =</em> 0.005). After adjustment, DCD HT with NRP was independently associated with improved survival (HR: 0.39 [95% CI: 0.22-0.70]; <em>P =</em> 0.002). A propensity-matched analysis similarly demonstrated a cumulative survival benefit to NRP (log-rank <em>P =</em> 0.006).</div></div><div><h3>Conclusions</h3><div>In this largest national series of DCD HT procurement perfusion strategies, NRP is associated with improved short-term survival as compared with DPP. This study evaluates the U.S. early experience with DCD HT, and longer-term follow-up data are needed to further assess the impact of DPP and NRP methods on post-heart transplantation outcomes.</div></div>","PeriodicalId":14687,"journal":{"name":"JACC. Heart failure","volume":"12 12","pages":"Pages 2073-2083"},"PeriodicalIF":10.3,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141874823","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":"Impact of a Novel Wearable Sensor on Heart Failure Rehospitalization","authors":"John P. Boehmer MD ,&nbsp;Sebastian Cremer MD ,&nbsp;Wael S. Abo-Auda MD ,&nbsp;Donny R. Stokes MD ,&nbsp;Azam Hadi MD ,&nbsp;Patrick J. McCann MD ,&nbsp;Ashley E. Burch PhD ,&nbsp;Diana Bonderman MD","doi":"10.1016/j.jchf.2024.07.022","DOIUrl":"10.1016/j.jchf.2024.07.022","url":null,"abstract":"<div><h3>Background</h3><div>There is an unmet need for early detection of heart failure decompensation, allowing patients to be managed remotely and avoid hospitalization.</div></div><div><h3>Objectives</h3><div>The purpose of this study was to compare a strategy utilizing data from a wearable HF sensor for management following a HF hospitalization to usual care.</div></div><div><h3>Methods</h3><div>Eligible subjects were discharged from the hospital within the previous 10 days and had a HF event in the previous 6 months. The concurrent control study was divided into 2 arms; a control arm, BMAD-HF and an open-label intervention arm, BMAD-TX. The HFMS (Heart Failure Monitoring System) was worn by subjects for up to 90 days. Device data was blinded to investigators and subjects in the BMAD-HF control arm but provided proactively in the BMAD-TX intervention arm. The impact of HF management with the HFMS was evaluated by Kaplan-Meier analysis of time to first HF hospitalization.</div></div><div><h3>Results</h3><div>A total of 522 subjects were enrolled in the study at 93 sites. A total of 245 subjects in BMAD-HF and 249 in BMAD-TX were eligible for intention-to-treat analysis. There were 276 hospitalizations in 189 subjects at 90 days, of which 108 events were determined to be heart failure related in 82 subjects. The subjects in the arm managed using HFMS data to direct HF therapy had a 38% lower HF hospitalization rate during the 90 days following a HF hospitalization compared to subjects in the control arm (HR: 0.62; <em>P =</em> 0.03).</div></div><div><h3>Conclusions</h3><div>In patients with a recent HF hospitalization, a strategy of using HFMS data for HF management is associated with a 38% relative risk reduction in 90-day HF rehospitalization. (Benefits of Microcor in Ambulatory Decompensated Heart Failure [BMAD-TX]; <span><span>NCT04096040</span><svg><path></path></svg></span>; Benefits of Microcor in Ambulatory Decompensated Heart Failure [BMAD-HF]; <span><span>NCT03476187</span><svg><path></path></svg></span>)</div></div>","PeriodicalId":14687,"journal":{"name":"JACC. Heart failure","volume":"12 12","pages":"Pages 2011-2022"},"PeriodicalIF":10.3,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142465734","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}