Pub Date : 2024-11-01DOI: 10.1016/j.jchf.2024.05.026
Vishal N. Rao MD, MPH , Anne S. Hellkamp MS , Laine E. Thomas PhD , Gregg C. Fonarow MD , Mona Fiuzat PharmD , Christopher M. O’Connor MD , John A. Spertus MD, MPH , Akshay S. Desai MD, MPH , Nancy M. Albert PhD , Javed Butler MD, MPH, MBA , Adrian F. Hernandez MD, MHS , Adam D. DeVore MD, MHS
Background
Optimal medical therapy (OMT) scoring may stratify clinical risk in real-world chronic heart failure with reduced ejection fraction (HFrEF) by integrating use and dosing of guideline-directed medical therapy (GDMT) for HFrEF.
Objectives
The purpose of this study was to characterize patients and associated long-term clinical outcomes by OMT score-derived treatment groups.
Methods
CHAMP-HF (Change the Management of Patients with Heart Failure) included U.S. outpatients with chronic HFrEF receiving ≥1 GDMT. OMT subgroups were defined as suboptimal (score <3), acceptable (score = 3), and optimal (score ≥4) by baseline use and dose of GDMT, as proposed by the HF Collaboratory consortium. Cox proportional hazard analyses were used to assess for all-cause and cardiovascular death across subgroups, after adjusting for demographic and clinical covariates.
Results
The authors studied 4,582 participants enrolled in CHAMP-HF with available 2-year follow-up. Median age was 68 years, 1,327 (29%) were women, and 2,842 (62%) were White, non-Hispanic. Median OMT score across the population was 4 (Q1-Q3: 2-5), and 1,628 (35%) had suboptimal, 665 (14%) had acceptable, and 2,289 (50%) had optimal therapy. Participants with optimal treatment were younger, had higher annual household income, and were enrolled from practices with dedicated HF clinics (all P < 0.001) than participants with acceptable or suboptimal treatment. Participants with optimal treatment had lower all-cause death (adjusted HR: 0.77; 95% CI: 0.64-0.92) and cardiovascular death (adjusted HR: 0.79; 95% CI: 0.65-0.96) than those with suboptimal treatment.
Conclusions
Across a large cohort of chronic ambulatory HFrEF, OMT scores stratified risk of all-cause and cardiovascular death.
背景：最佳医疗疗法（OMT）评分可通过整合射血分数降低的慢性心力衰竭（HFrEF）指南指导医疗疗法（GDMT）的使用和剂量，对真实世界中的临床风险进行分层：本研究的目的是通过 OMT 评分得出的治疗组别来描述患者的特征和相关的长期临床结果：CHAMP-HF（Change the Management of Patients with Heart Failure，改变心衰患者的管理）纳入了接受≥1次GDMT治疗的美国慢性HFrEF门诊患者。OMT亚组被定义为次优（评分结果：作者研究了 4,582 名参加了 CHAMP-HF 并进行了两年随访的患者。中位年龄为 68 岁，1,327 人（29%）为女性，2,842 人（62%）为非西班牙裔白人。整个人群的 OMT 评分中位数为 4（Q1-Q3：2-5），1628 人（35%）接受了次优治疗，665 人（14%）接受了可接受治疗，2289 人（50%）接受了最佳治疗。与接受可接受治疗或次优治疗的参试者相比，接受最佳治疗的参试者更年轻、家庭年收入更高，且来自设有专门心房颤动诊所的医疗机构（所有 P 均小于 0.001）。与接受次优治疗者相比，接受最优治疗者的全因死亡（调整后HR：0.77；95% CI：0.64-0.92）和心血管死亡（调整后HR：0.79；95% CI：0.65-0.96）更低：结论：在一个大型慢性非卧床 HFrEF 队列中，OMT 评分可对全因死亡和心血管死亡的风险进行分层。
{"title":"Optimal Medical Therapy and Outcomes Among Patients With Chronic Heart Failure With Reduced Ejection Fraction","authors":"Vishal N. Rao MD, MPH , Anne S. Hellkamp MS , Laine E. Thomas PhD , Gregg C. Fonarow MD , Mona Fiuzat PharmD , Christopher M. O’Connor MD , John A. Spertus MD, MPH , Akshay S. Desai MD, MPH , Nancy M. Albert PhD , Javed Butler MD, MPH, MBA , Adrian F. Hernandez MD, MHS , Adam D. DeVore MD, MHS","doi":"10.1016/j.jchf.2024.05.026","DOIUrl":"10.1016/j.jchf.2024.05.026","url":null,"abstract":"<div><h3>Background</h3><div>Optimal medical therapy (OMT) scoring may stratify clinical risk in real-world chronic heart failure with reduced ejection fraction (HFrEF) by integrating use and dosing of guideline-directed medical therapy (GDMT) for HFrEF.</div></div><div><h3>Objectives</h3><div>The purpose of this study was to characterize patients and associated long-term clinical outcomes by OMT score-derived treatment groups.</div></div><div><h3>Methods</h3><div>CHAMP-HF (Change the Management of Patients with Heart Failure) included U.S. outpatients with chronic HFrEF receiving ≥1 GDMT. OMT subgroups were defined as suboptimal (score <3), acceptable (score = 3), and optimal (score ≥4) by baseline use and dose of GDMT, as proposed by the HF Collaboratory consortium. Cox proportional hazard analyses were used to assess for all-cause and cardiovascular death across subgroups, after adjusting for demographic and clinical covariates.</div></div><div><h3>Results</h3><div>The authors studied 4,582 participants enrolled in CHAMP-HF with available 2-year follow-up. Median age was 68 years, 1,327 (29%) were women, and 2,842 (62%) were White, non-Hispanic. Median OMT score across the population was 4 (Q1-Q3: 2-5), and 1,628 (35%) had suboptimal, 665 (14%) had acceptable, and 2,289 (50%) had optimal therapy. Participants with optimal treatment were younger, had higher annual household income, and were enrolled from practices with dedicated HF clinics (all <em>P <</em> 0.001) than participants with acceptable or suboptimal treatment. Participants with optimal treatment had lower all-cause death (adjusted HR: 0.77; 95% CI: 0.64-0.92) and cardiovascular death (adjusted HR: 0.79; 95% CI: 0.65-0.96) than those with suboptimal treatment.</div></div><div><h3>Conclusions</h3><div>Across a large cohort of chronic ambulatory HFrEF, OMT scores stratified risk of all-cause and cardiovascular death.</div></div>","PeriodicalId":14687,"journal":{"name":"JACC. Heart failure","volume":"12 11","pages":"Pages 1862-1875"},"PeriodicalIF":10.3,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141901791","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 : 2024-11-01DOI: 10.1016/j.jchf.2024.07.009
Lisa J. Anderson MD
{"title":"STRONG-HF","authors":"Lisa J. Anderson MD","doi":"10.1016/j.jchf.2024.07.009","DOIUrl":"10.1016/j.jchf.2024.07.009","url":null,"abstract":"","PeriodicalId":14687,"journal":{"name":"JACC. Heart failure","volume":"12 11","pages":"Pages 1859-1861"},"PeriodicalIF":10.3,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142145667","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":"Advances and Challenges in Holistic Treatment of Cardiometabolic Kidney Disease as One Entity","authors":"Biykem Bozkurt MD, PhD (Editor-in-Chief, JACC: Heart Failure)","doi":"10.1016/j.jchf.2024.10.002","DOIUrl":"10.1016/j.jchf.2024.10.002","url":null,"abstract":"","PeriodicalId":14687,"journal":{"name":"JACC. Heart failure","volume":"12 11","pages":"Pages 1949-1951"},"PeriodicalIF":10.3,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142578348","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 : 2024-11-01DOI: 10.1016/j.jchf.2024.05.017
Jason L. Guichard MD, PhD , Eric L. Bonno MD , Michael E. Nassif MD , Taiyeb M. Khumri MD , David Miranda MD , Orvar Jonsson MD , Hirak Shah MD , Tamas Alexy MD, PhD , Gregory P. Macaluso MD , James Sur MD , Gavin Hickey MD , Patrick McCann MD , Jennifer A. Cowger MD, MS , Amit Badiye MD , Wayne D. Old MD , Yasmin Raza MD , Luke Masha MD, MPH , Chandra R. Kunavarapu MD , Mosi Bennett MD, PhD , Faisal Sharif MD, PhD , Liviu Klein MD, MS
Background
Monitoring supine pulmonary artery pressures to guide heart failure (HF) management has reduced HF hospitalizations in select patients.
Objectives
The purpose of this study was to evaluate the effect of managing seated mean pulmonary artery pressure (mPAP) with the Cordella Pulmonary Artery sensor on outcomes in patients with HF.
Methods
Following GUIDE-HF (Hemodynamic-GUIDEd Management of Heart Failure Trial), with U.S. Food and Drug Administration input, PROACTIVE-HF (A Prospective, Multi-Center, Open Label, Single Arm Clinical Trial Evaluating the Safety and Efficacy of the Cordella Pulmonary Artery Sensor System in NYHA Class III Heart Failure Patients trial) was changed from a randomized to a single-arm, open label trial, conducted at 75 centers in the USA and Europe. Eligible patients had chronic HF with NYHA functional class III symptoms, irrespective of the ejection fraction, and recent HF hospitalization and/or elevated natriuretic peptides. The primary effectiveness endpoint at 6 months required the HF hospitalization or all-cause mortality rate to be lower than a performance goal of 0.43 events/patient, established from previous hemodynamic monitoring trials. Primary safety endpoints at 6 months were freedom from device- or system-related complications or pressure sensor failure.
Results
Between February 7, 2020, and March 31, 2023, 456 patients were successfully implanted in modified intent-to-treat cohort. The 6-month event rate was 0.15 (95% CI: 0.12-0.20) which was significantly lower than performance goal (0.15 vs 0.43; P < 0.0001). Freedom from device- or system-related complications was 99.2% and freedom from sensor failure was 99.8% through 6 months.
Conclusions
Remote management of seated mPAP is safe and results in a low rate of HF hospitalizations and mortality. These results support the use of seated mPAP monitoring and extend the growing body of evidence that pulmonary artery pressure–guided management improves outcomes in heart failure. (Multi-Center, Open Label, Single Arm Clinical Trial Evaluating the Safety and Efficacy of the Cordella Pulmonary Artery Sensor System in NYHA Class III Heart Failure Patients trial [PROACTIVE-HF]; NCT04089059)
背景：通过监测仰卧位肺动脉压来指导心力衰竭（HF）的治疗，可以减少部分心力衰竭患者的住院治疗：本研究旨在评估使用 Cordella 肺动脉传感器管理坐位平均肺动脉压（mPAP）对心衰患者预后的影响：继 GUIDE-HF（Hemodynamic-GUIDEd Management of Heart Failure Trial）之后，根据美国食品药品管理局的意见，PROACTIVE-HF（A Prospective, Multi-Center, Open Label, Single Arm Clinical Trial Evaluating the Safety and Efficacy of the Cordella Pulmonary Artery Sensor System in NYHA Class III Heart Failure Patients trial）由随机试验改为单臂、开放标签试验，在美国和欧洲的 75 个中心进行。符合条件的患者均为有 NYHA 功能分级 III 级症状的慢性心力衰竭患者，无论射血分数如何，近期均有心力衰竭住院治疗和/或利钠肽升高。6个月时的主要有效性终点要求心房颤动住院率或全因死亡率低于0.43次/人的绩效目标，该目标是根据以往的血液动力学监测试验确定的。6个月时的主要安全性终点为无设备或系统相关并发症或压力传感器故障：2020年2月7日至2023年3月31日期间，456名患者成功植入了修改后的意向治疗队列。6个月事件发生率为0.15（95% CI：0.12-0.20），明显低于绩效目标（0.15 vs 0.43；P < 0.0001）。6个月内，设备或系统相关并发症发生率为99.2%，传感器故障发生率为99.8%：结论：坐式 mPAP 的远程管理是安全的，且高血压住院率和死亡率较低。这些结果支持使用坐姿 mPAP 监测，并扩展了越来越多的证据，证明肺动脉压力指导下的管理可改善心衰的预后。(评估 NYHA III 级心衰患者使用 Cordella 肺动脉传感器系统的安全性和有效性的多中心、开放标签、单臂临床试验[PROACTIVE-HF]；NCT04089059）。
{"title":"Seated Pulmonary Artery Pressure Monitoring in Patients With Heart Failure","authors":"Jason L. Guichard MD, PhD , Eric L. Bonno MD , Michael E. Nassif MD , Taiyeb M. Khumri MD , David Miranda MD , Orvar Jonsson MD , Hirak Shah MD , Tamas Alexy MD, PhD , Gregory P. Macaluso MD , James Sur MD , Gavin Hickey MD , Patrick McCann MD , Jennifer A. Cowger MD, MS , Amit Badiye MD , Wayne D. Old MD , Yasmin Raza MD , Luke Masha MD, MPH , Chandra R. Kunavarapu MD , Mosi Bennett MD, PhD , Faisal Sharif MD, PhD , Liviu Klein MD, MS","doi":"10.1016/j.jchf.2024.05.017","DOIUrl":"10.1016/j.jchf.2024.05.017","url":null,"abstract":"<div><h3>Background</h3><div>Monitoring supine pulmonary artery pressures to guide heart failure (HF) management has reduced HF hospitalizations in select patients.</div></div><div><h3>Objectives</h3><div>The purpose of this study was to evaluate the effect of managing seated mean pulmonary artery pressure (mPAP) with the Cordella Pulmonary Artery sensor on outcomes in patients with HF.</div></div><div><h3>Methods</h3><div>Following GUIDE-HF (Hemodynamic-GUIDEd Management of Heart Failure Trial), with U.S. Food and Drug Administration input, PROACTIVE-HF (A Prospective, Multi-Center, Open Label, Single Arm Clinical Trial Evaluating the Safety and Efficacy of the Cordella Pulmonary Artery Sensor System in NYHA Class III Heart Failure Patients trial) was changed from a randomized to a single-arm, open label trial, conducted at 75 centers in the USA and Europe. Eligible patients had chronic HF with NYHA functional class III symptoms, irrespective of the ejection fraction, and recent HF hospitalization and/or elevated natriuretic peptides. The primary effectiveness endpoint at 6 months required the HF hospitalization or all-cause mortality rate to be lower than a performance goal of 0.43 events/patient, established from previous hemodynamic monitoring trials. Primary safety endpoints at 6 months were freedom from device- or system-related complications or pressure sensor failure.</div></div><div><h3>Results</h3><div>Between February 7, 2020, and March 31, 2023, 456 patients were successfully implanted in modified intent-to-treat cohort. The 6-month event rate was 0.15 (95% CI: 0.12-0.20) which was significantly lower than performance goal (0.15 vs 0.43; <em>P <</em> 0.0001). Freedom from device- or system-related complications was 99.2% and freedom from sensor failure was 99.8% through 6 months.</div></div><div><h3>Conclusions</h3><div>Remote management of seated mPAP is safe and results in a low rate of HF hospitalizations and mortality. These results support the use of seated mPAP monitoring and extend the growing body of evidence that pulmonary artery pressure–guided management improves outcomes in heart failure. (Multi-Center, Open Label, Single Arm Clinical Trial Evaluating the Safety and Efficacy of the Cordella Pulmonary Artery Sensor System in NYHA Class III Heart Failure Patients trial [PROACTIVE-HF]; <span><span>NCT04089059</span><svg><path></path></svg></span>)</div></div>","PeriodicalId":14687,"journal":{"name":"JACC. Heart failure","volume":"12 11","pages":"Pages 1879-1893"},"PeriodicalIF":10.3,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141995753","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 : 2024-11-01DOI: 10.1016/j.jchf.2024.06.012
Aldo P. Maggioni MD
{"title":"Encouraging Data Encourage More Research on Optimal Medical Therapy for Patients With HFrEF","authors":"Aldo P. Maggioni MD","doi":"10.1016/j.jchf.2024.06.012","DOIUrl":"10.1016/j.jchf.2024.06.012","url":null,"abstract":"","PeriodicalId":14687,"journal":{"name":"JACC. Heart failure","volume":"12 11","pages":"Pages 1876-1878"},"PeriodicalIF":10.3,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141901789","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}
Although the use of glucagon-like peptide-1 receptor agonist (GLP-1 RA) in patients with obesity and heart failure with preserved ejection fraction (HFpEF) has demonstrated improvement in cardiovascular outcomes, the incremental benefits of GLP-1 RA for patients already on sodium-glucose cotransporter 2 inhibitors (SGLT2is) remain underexplored.
Objectives
This study aimed to assess the incremental benefits of GLP-1 RA in patients with type 2 diabetes mellitus, overweight/obesity, and HFpEF receiving SGLT2i therapy.
Methods
The authors conducted a retrospective cohort study using the TriNetX research database including patients ≥18 years with type 2 diabetes mellitus, body mass index ≥27 kg/m2, and HFpEF on SGLT2i. Two cohorts were created based on GLP-1 RA prescription. The outcomes were heart failure exacerbation, all-cause emergency department visits/hospitalizations among others over a 12-month period.
Results
A total of 7,044 patients remained in each cohort after propensity score matching. There was a significantly lower risk of heart failure exacerbations, all-cause emergency department visits/hospitalizations, new-onset atrial arrhythmias, new-onset acute kidney injury, and pulmonary hypertension in the GLP-1 RA plus SGLT2i cohort compared with the SGLT2i-only cohort. The associated benefits persisted across different body mass indexes and ejection fractions as well as in patients with elevated natriuretic peptide. The risk of diabetic retinopathy was higher in the combination therapy group than with SGLT2i-only use.
Conclusions
GLP-1 RA, in addition to SGLT2i, was associated with a significantly lower risk of heart failure hospitalizations in this patient population, suggesting a potential incremental benefit. This highlights the need for prospective studies to confirm the clinical benefits.
{"title":"GLP-1 Receptor Agonists Among Patients With Overweight or Obesity, Diabetes, and HFpEF on SGLT2 Inhibitors","authors":"Rushin Patel MD , Mark Wadid MD , Bhargav Makwana MD , Ashish Kumar MD , Sumanth Khadke MD , Ammar Bhatti MD , Ahan Banker MBBS , Zaid Husami MD , Sherif Labib MD , David Venesy MD , Gregg Fonarow MD , Mikhail Kosiborod MD , Sadeer Al-Kindi MD , Deepak L. Bhatt MD, MPH, MBA , Sourbha Dani MD , Anju Nohria MD , Javed Butler MD, MPH , Sarju Ganatra MD","doi":"10.1016/j.jchf.2024.07.006","DOIUrl":"10.1016/j.jchf.2024.07.006","url":null,"abstract":"<div><h3>Background</h3><div>Although the use of glucagon-like peptide-1 receptor agonist (GLP-1 RA) in patients with obesity and heart failure with preserved ejection fraction (HFpEF) has demonstrated improvement in cardiovascular outcomes, the incremental benefits of GLP-1 RA for patients already on sodium-glucose cotransporter 2 inhibitors (SGLT2is) remain underexplored.</div></div><div><h3>Objectives</h3><div>This study aimed to assess the incremental benefits of GLP-1 RA in patients with type 2 diabetes mellitus, overweight/obesity, and HFpEF receiving SGLT2i therapy.</div></div><div><h3>Methods</h3><div>The authors conducted a retrospective cohort study using the TriNetX research database including patients ≥18 years with type 2 diabetes mellitus, body mass index ≥27 kg/m<sup>2</sup>, and HFpEF on SGLT2i. Two cohorts were created based on GLP-1 RA prescription. The outcomes were heart failure exacerbation, all-cause emergency department visits/hospitalizations among others over a 12-month period.</div></div><div><h3>Results</h3><div>A total of 7,044 patients remained in each cohort after propensity score matching. There was a significantly lower risk of heart failure exacerbations, all-cause emergency department visits/hospitalizations, new-onset atrial arrhythmias, new-onset acute kidney injury, and pulmonary hypertension in the GLP-1 RA plus SGLT2i cohort compared with the SGLT2i-only cohort. The associated benefits persisted across different body mass indexes and ejection fractions as well as in patients with elevated natriuretic peptide. The risk of diabetic retinopathy was higher in the combination therapy group than with SGLT2i-only use.</div></div><div><h3>Conclusions</h3><div>GLP-1 RA, in addition to SGLT2i, was associated with a significantly lower risk of heart failure hospitalizations in this patient population, suggesting a potential incremental benefit. This highlights the need for prospective studies to confirm the clinical benefits.</div></div>","PeriodicalId":14687,"journal":{"name":"JACC. Heart failure","volume":"12 11","pages":"Pages 1814-1826"},"PeriodicalIF":10.3,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142107492","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 : 2024-11-01DOI: 10.1016/j.jchf.2024.07.015
Marvin A. Konstam MD , Joseph Massaro PhD , Ravi Dhingra MD, MPH , Mary Walsh MD , Linda Ordway RN, MS, NP , Michael S. Pursley MD , Dalton S. McLean MD , Sandeep Saha MS , Nicole Close PhD , Jeremy M. Konstam MS , Katherine H. Luepke PharmD, BCPS, CMPP , John F. Mohr PharmD , James E. Udelson MD
Background
Therapies are needed to address worsening congestion, without hospitalization, in patients with chronic heart failure (HF).
Objectives
This pilot study assessed outcomes of a novel subcutaneous (SC) furosemide formulation compared to usual care in outpatients with worsening congestion.
Methods
Participants with chronic HF and worsening congestion were randomized open-label 2:1 to SC furosemide compared to usual care (UC). Decongestion was estimated by tracking body weight. The primary endpoint was a win ratio of a 30-day hierarchical composite of cardiovascular death, HF events, and change in N-terminal pro–B-type natriuretic peptide. Secondary endpoints included dyspnea severity, functional capacity, and quality of life.
Results
Thirty-four participants were randomized to SC furosemide and 17 to UC. SC furosemide caused greater reduction in body weight: between-group difference in least square mean change was −2.02 kg at day 3 (95% CI: −3.9 to −0.14; P = 0.035). SC furosemide-to-UC win ratio was 1.11 (95% CI: 0.48-2.50; P = 0.806). Significant between-group least square mean differences favoring SC furosemide occurred in 7-point dyspnea score (P = 0.017) and 6-minute walk test (P = 0.032), with trend in Kansas City Cardiomyopathy Questionnaire (KCCQ)-12 Overall Summary Score of 9.15 (95% CI: 1.95-20.3; P = 0.106). The most common related adverse event with SC furosemide was mild infusion site pain (11.8%).
Conclusions
SC furosemide augmented weight loss in patients with HF and worsening congestion. The composite primary endpoint was not statistically significant in this pilot investigation. However, findings of improved dyspnea scores and functional capacity, with favorable trend in KCCQ-12 score, warrant additional investigation to further document the clinical value of SC furosemide as an alternative to hospitalization (AT HOME-HF [Avoiding Treatment in the Hospital With Furoscix for the Management of Congestion in Heart Failure—A Pilot Study]; NCT04593823)
{"title":"Avoiding Treatment in Hospital With Subcutaneous Furosemide for Worsening Heart Failure","authors":"Marvin A. Konstam MD , Joseph Massaro PhD , Ravi Dhingra MD, MPH , Mary Walsh MD , Linda Ordway RN, MS, NP , Michael S. Pursley MD , Dalton S. McLean MD , Sandeep Saha MS , Nicole Close PhD , Jeremy M. Konstam MS , Katherine H. Luepke PharmD, BCPS, CMPP , John F. Mohr PharmD , James E. Udelson MD","doi":"10.1016/j.jchf.2024.07.015","DOIUrl":"10.1016/j.jchf.2024.07.015","url":null,"abstract":"<div><h3>Background</h3><div>Therapies are needed to address worsening congestion, without hospitalization, in patients with chronic heart failure (HF).</div></div><div><h3>Objectives</h3><div>This pilot study assessed outcomes of a novel subcutaneous (SC) furosemide formulation compared to usual care in outpatients with worsening congestion.</div></div><div><h3>Methods</h3><div>Participants with chronic HF and worsening congestion were randomized open-label 2:1 to SC furosemide compared to usual care (UC). Decongestion was estimated by tracking body weight. The primary endpoint was a win ratio of a 30-day hierarchical composite of cardiovascular death, HF events, and change in N-terminal pro–B-type natriuretic peptide. Secondary endpoints included dyspnea severity, functional capacity, and quality of life.</div></div><div><h3>Results</h3><div>Thirty-four participants were randomized to SC furosemide and 17 to UC. SC furosemide caused greater reduction in body weight: between-group difference in least square mean change was −2.02 kg at day 3 (95% CI: −3.9 to −0.14; <em>P =</em> 0.035). SC furosemide-to-UC win ratio was 1.11 (95% CI: 0.48-2.50; <em>P =</em> 0.806). Significant between-group least square mean differences favoring SC furosemide occurred in 7-point dyspnea score (<em>P =</em> 0.017) and 6-minute walk test (<em>P =</em> 0.032), with trend in Kansas City Cardiomyopathy Questionnaire (KCCQ)-12 Overall Summary Score of 9.15 (95% CI: 1.95-20.3; <em>P =</em> 0.106). The most common related adverse event with SC furosemide was mild infusion site pain (11.8%).</div></div><div><h3>Conclusions</h3><div>SC furosemide augmented weight loss in patients with HF and worsening congestion. The composite primary endpoint was not statistically significant in this pilot investigation. However, findings of improved dyspnea scores and functional capacity, with favorable trend in KCCQ-12 score, warrant additional investigation to further document the clinical value of SC furosemide as an alternative to hospitalization (AT HOME-HF [Avoiding Treatment in the Hospital With Furoscix for the Management of Congestion in Heart Failure—A Pilot Study]; <span><span>NCT04593823</span><svg><path></path></svg></span>)</div></div>","PeriodicalId":14687,"journal":{"name":"JACC. Heart failure","volume":"12 11","pages":"Pages 1830-1841"},"PeriodicalIF":10.3,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142264099","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 : 2024-11-01DOI: 10.1016/j.jchf.2024.08.021
Juliane Vierecke MD, PhD , Ersilia M. DeFilippis MD , Michael M. Givertz MD
{"title":"Cardiopulmonary Resuscitation in Patients With Left Ventricular Assist Devices","authors":"Juliane Vierecke MD, PhD , Ersilia M. DeFilippis MD , Michael M. Givertz MD","doi":"10.1016/j.jchf.2024.08.021","DOIUrl":"10.1016/j.jchf.2024.08.021","url":null,"abstract":"","PeriodicalId":14687,"journal":{"name":"JACC. Heart failure","volume":"12 11","pages":"Pages 1931-1938"},"PeriodicalIF":10.3,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142465731","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}
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