JAMA cardiology最新文献

{"title":"Rates of Sudden Death After Myocardial Infarction-Insights From the VALIANT and PARADISE-MI Trials.","authors":"James P Curtain, Marc A Pfeffer, Eugene Braunwald, Brian L Claggett, Christopher B Granger, Lars Køber, Eldrin F Lewis, Aldo P Maggioni, Doug L Mann, Jean L Rouleau, Scott D Solomon, Philippe Gabriel Steg, Peter V Finn, Alberto Fernandez, Karola S Jering, John J V McMurray","doi":"10.1001/jamacardio.2024.2356","DOIUrl":"10.1001/jamacardio.2024.2356","url":null,"abstract":"<p><strong>Importance: </strong>Sudden death is a leading cause of death after acute myocardial infarction (AMI). The Prospective ARNi vs ACE Inhibitor Trial to Determine Superiority in Reducing Heart Failure Events After MI (PARADISE-MI) and Valsartan in Acute Myocardial Infarction (VALIANT) trials enrolled patients with pulmonary congestion and/or left ventricular dysfunction after AMI. Whether the prognosis in such patients has changed over time has not been examined.</p><p><strong>Objective: </strong>To compare the rate of sudden death/resuscitated cardiac arrest (RCA) after AMI in the PARADISE-MI and VALIANT trials.</p><p><strong>Design, setting, and participants: </strong>This was a secondary analysis of multicenter randomized clinical trials enrolling patients after AMI. In the primary analysis, the VALIANT cohort was restricted to patients with \"PARADISE-MI-like\" characteristics (eg, at least 1 augmenting risk factor and no history of heart failure). The baseline characteristics of people in both trials were compared. The VALIANT trial enrolled from December 1998 to June 2001, and the PARADISE-MI trial enrolled between December 2016, and March 2020. The median follow-up in the VALIANT and PARADISE-MI trials was 24.7 and 22 months, respectively. People with AMI, complicated by pulmonary congestion and/or left ventricular dysfunction, were included in the analysis.</p><p><strong>Exposure: </strong>Sudden death after AMI.</p><p><strong>Results: </strong>A total of 5661 patients were included in the PARADISE-MI cohort (mean [SD] age, 63.7 [11.5] years; 4298 male [75.9%]), 9617 were included in the VALIANT (PARADISE-MI-like) cohort (mean [SD] age, 66.1 [11.5] years; 6504 male [67.6%]), and 14 703 patients were included in the VALIANT (total) cohort (mean [SD] age, 64.8 [11.8] years; 10 133 male [68.9%]). In the PARADISE-MI-like cohort of the VALIANT trial, 707 of 9617 participants (7.4%) experienced sudden death/RCA. A total of 148 of 5661 people (2.6%) in the PARADISE-MI trial experienced sudden death/RCA. Sudden death rates were highest in the first month after infarction in both trials: 19.3 (95% CI, 16.4-22.6) per 100 person-years in the VALIANT trial and 9.5 (95% CI, 7.0-12.7) per 100 person-years in the PARADISE-MI trial, and these rates declined steadily thereafter. Compared with the VALIANT cohort, people in the PARADISE-MI trial were more often treated with percutaneous coronary intervention for their qualifying AMI and received a β-blocker, statin, and mineralocorticoid receptor antagonist more frequently.</p><p><strong>Conclusions and relevance: </strong>After AMI, the risk of sudden death/RCA was highest in the first month, declining rapidly thereafter. Results revealed that compared with counterparts from 20 years ago, the rate of sudden death/RCA in patients with a reduced left ventricular ejection fraction and/or pulmonary congestion was 2- to 3-fold lower in people receiving contemporary management. Interventions to further pro","PeriodicalId":14657,"journal":{"name":"JAMA cardiology","volume":" ","pages":"928-933"},"PeriodicalIF":14.8,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11307160/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141897447","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":"Routine Protamine Administration for Bleeding in Transcatheter Aortic Valve Implantation: The ACE-PROTAVI Randomized Clinical Trial.","authors":"Pieter A Vriesendorp, Shane Nanayakkara, Samuel Heuts, Jocasta Ball, Jaya Chandrasekar, Ronald Dick, Kawa Haji, Nay Min Htun, David McGaw, Samer Noaman, Sonny Palmer, Sesto Cairo, Mark Shulman, Enjarn Lin, Stuart Hastings, Benedict Waldron, George Proimos, Kean H Soon, Matias B Yudi, Adam Zimmet, Dion Stub, Antony S Walton","doi":"10.1001/jamacardio.2024.2454","DOIUrl":"10.1001/jamacardio.2024.2454","url":null,"abstract":"<p><strong>Importance: </strong>Vascular complications after transfemoral transcatheter aortic valve implantation (TAVI) remain an important cause of procedure-related morbidity. Routine reversal of anticoagulation with protamine at the conclusion of transfemoral TAVI could reduce complications, but data remain scarce.</p><p><strong>Objective: </strong>To evaluate the efficacy and safety of routine protamine administration after transfemoral TAVI.</p><p><strong>Design, setting, and participants: </strong>The ACE-PROTAVI trial was an investigator-initiated, double-blind, placebo-controlled randomized clinical trial performed at 3 Australian hospitals between December 2021 and June 2023 with a 1-year follow-up period. All patients accepted for transfemoral TAVI by a multidisciplinary heart team were eligible for enrollment.</p><p><strong>Interventions: </strong>Eligible patients were randomized 1:1 between routine protamine administration and placebo.</p><p><strong>Main outcomes and measures: </strong>The coprimary outcomes were the rate of hemostasis success and time to hemostasis (TTH), presented as categorical variables and compared with a χ2 test or as continuous variables as mean (SD) or median (IQR), depending on distribution. The major secondary outcome was a composite of all-cause death, major and minor bleeding complications, and major and minor vascular complications after 30 days, reported in odds ratios (ORs) with 95% CIs and P values.</p><p><strong>Results: </strong>The study population consisted of 410 patients: 199 patients in the protamine group and 211 in the placebo group. The median (IQR) patient age in the protamine group was 82 (77-85) years, and 68 of 199 patients receiving protamine (34.2%) were female. The median (IQR) patient age in the placebo group was 80 (75-85) years, and 89 of 211 patients receiving the placebo (42.2%) were female. Patients receiving up-front protamine administration had a higher rate of hemostasis success (188 of 192 patients [97.9%]) than patients in the placebo group (186 of 203 patients [91.6%]; absolute risk difference, 6.3%; 95% CI, 2.0%-10.6%; P = .006); in addition, patients receiving up-front protamine had a shorter median (IQR) TTH (181 [120-420] seconds vs 279 [122-600] seconds; P = .002). Routine protamine administration resulted in a reduced risk of the composite outcome in the protamine group (10 of 192 [5.2%]) vs the placebo group (26 of 203 [12.8%]; OR, 0.37; 95% CI, 0.1-0.8; P = .01). This difference was predominantly driven by the difference in the prevalence of minor vascular complications. There were no adverse events associated with protamine use.</p><p><strong>Conclusions and relevance: </strong>In the ACE-PROTAVI randomized clinical trial, routine administration of protamine increased the rate of hemostasis success and decreased TTH. The beneficial effect of protamine was reflected in a reduction in minor vascular complications, procedural time, and postprocedural hospital stay d","PeriodicalId":14657,"journal":{"name":"JAMA cardiology","volume":" ","pages":"901-908"},"PeriodicalIF":14.8,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11325237/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141975711","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":"Verinurad Plus Allopurinol for Heart Failure With Preserved Ejection Fraction: The AMETHYST Randomized Clinical Trial.","authors":"Dalane W Kitzman, Adriaan A Voors, Robert J Mentz, Gregory D Lewis, Shira Perl, Robin Myte, Grace Kaguthi, C David Sjöström, Christian Källgren, Sanjiv J Shah","doi":"10.1001/jamacardio.2024.2435","DOIUrl":"10.1001/jamacardio.2024.2435","url":null,"abstract":"<p><strong>Importance: </strong>Elevated serum uric acid (SUA) level may contribute to endothelial dysfunction; therefore, SUA is an attractive target for heart failure with preserved ejection fraction (HFpEF). However, to the authors' knowledge, no prior randomized clinical trials have evaluated SUA lowering in HFpEF.</p><p><strong>Objective: </strong>To investigate the efficacy and safety of the novel urate transporter-1 inhibitor, verinurad, in patients with HFpEF and elevated SUA level.</p><p><strong>Design, setting, and participants: </strong>This was a phase 2, double-blind, randomized clinical trial (32-week duration) conducted from May 2020 to April 2022. The study took place at 59 centers in 12 countries and included patients 40 years and older with HFpEF and SUA level greater than 6 mg/dL. Data were analyzed from August 2022 to May 2024.</p><p><strong>Interventions: </strong>Eligible patients were randomized 1:1:1 to once-daily, oral verinurad, 12 mg, plus allopurinol, 300 mg; allopurinol, 300 mg, monotherapy; or placebo for 24 weeks after an 8-week titration period. Allopurinol was combined with verinurad to prevent verinurad-induced urate nephropathy, and the allopurinol monotherapy group was included to account for allopurinol effects in the combination therapy group. All patients received oral colchicine, 0.5 to 0.6 mg, daily for the first 12 weeks after randomization.</p><p><strong>Main outcomes and measures: </strong>Key end points included changes from baseline to week 32 in peak oxygen uptake (VO2), Kansas City Cardiomyopathy Questionnaire total symptom score (KCCQ-TSS), and SUA level; and safety/tolerability (including adjudicated cardiovascular events).</p><p><strong>Results: </strong>Among 159 randomized patients (53 per treatment group; median [IQR] age, 71 [40-86] years; 103 male [65%]) with median (IQR) N-terminal pro-brain natriuretic peptide level of 527 (239-1044) pg/mL and SUA level of 7.5 (6.6-8.4) mg/dL, verinurad plus allopurinol (mean change, -59.6%; 95% CI, -64.4% to -54.2%) lowered SUA level to a greater extent than allopurinol (mean change, -37.6%; 95% CI, -45.3% to -28.9%) or placebo (mean change, 0.8%; 95% CI, -11.8% to 15.2%; P < .001). Changes in peak VO2 (verinurad plus allopurinol, 0.27 mL/kg/min; 95% CI, -0.56 to 1.10 mL/kg/min; allopurinol, -0.17 mL/kg/min; 95% CI, -1.03 to 0.69 mL/kg/min; placebo, 0.37 mL/kg/min; 95% CI, -0.45 to 1.19 mL/kg/min) and KCCQ-TSS (verinurad plus allopurinol, 4.3; 95% CI, 0.3-8.3; allopurinol, 4.5; 95% CI, 0.3-8.6; placebo, 1.2; 95% CI, -3.0 to 5.3) were similar across groups. There were no adverse safety signals. Deaths or cardiovascular events occurred in 3 patients (5.7%) in the verinurad plus allopurinol group, 8 patients (15.1%) in the allopurinol monotherapy group, and 6 patients (11.3%) in the placebo group.</p><p><strong>Conclusions and relevance: </strong>Results of this randomized clinical trial show that despite substantial SUA lowering, verinurad plus allopurinol ","PeriodicalId":14657,"journal":{"name":"JAMA cardiology","volume":" ","pages":"892-900"},"PeriodicalIF":14.8,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11325246/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141975712","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":"Reporting Primary Language in Cardiology Clinical Trials.","authors":"Zara Latif, Vanessa Blumer, Ersilia M DeFilippis","doi":"10.1001/jamacardio.2024.2483","DOIUrl":"10.1001/jamacardio.2024.2483","url":null,"abstract":"","PeriodicalId":14657,"journal":{"name":"JAMA cardiology","volume":" ","pages":"867-868"},"PeriodicalIF":14.8,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142017452","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":"Tombstone Pattern Electrocardiogram in a Young Woman.","authors":"Yun Chen, Ping Ge, Xiao-Feng Zhuang","doi":"10.1001/jamacardio.2024.2537","DOIUrl":"10.1001/jamacardio.2024.2537","url":null,"abstract":"","PeriodicalId":14657,"journal":{"name":"JAMA cardiology","volume":" ","pages":"944-945"},"PeriodicalIF":14.8,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142017453","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":"JAMA Cardiology.","authors":"","doi":"10.1001/jamacardio.2023.3679","DOIUrl":"https://doi.org/10.1001/jamacardio.2023.3679","url":null,"abstract":"","PeriodicalId":14657,"journal":{"name":"JAMA cardiology","volume":"9 10","pages":"866"},"PeriodicalIF":14.8,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142390601","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":"Factors Underlying Reduced Hospitalizations for Myocardial Infarction During the COVID-19 Pandemic.","authors":"Andrew D Wilcock, Jose R Zubizarreta, Rishi K Wadhera, Robert W Yeh, Kori S Zachrison, Lee H Schwamm, Ateev Mehrotra","doi":"10.1001/jamacardio.2024.2031","DOIUrl":"10.1001/jamacardio.2024.2031","url":null,"abstract":"<p><strong>Importance: </strong>The incidence of hospital encounters for acute myocardial infarction (AMI) decreased sharply early in the COVID-19 pandemic and has not returned to prepandemic levels. There has been an ongoing debate about what mechanism may underlie this decline, including patients avoiding the hospital for treatment, excess mortality from COVID-19 among patients who would otherwise have had an AMI, a reduction in the incidence or severity of AMIs due to pandemic-related changes in behavior, or a preexisting temporal trend of lower AMI incidence.</p><p><strong>Objective: </strong>To describe drivers of changing incidence in AMI hospital encounters during the COVID-19 pandemic.</p><p><strong>Design, setting, and participants: </strong>This cross-sectional study used traditional Medicare claims from all patients enrolled in traditional Medicare from January 2016 to June 2023 (total of 2.85 billion patient-months) to calculate the rate of AMI hospital encounters (emergency department visits, observation stays, or inpatient admissions) per capita at all short-term acute care and critical access hospitals in the United States overall and by patient characteristics. Observed rates were compared with expected rates that accounted for shifts in population characteristics and the prepandemic temporal trend (as estimated over 2016-2019). Data were analyzed in November 2023.</p><p><strong>Main outcomes and measures: </strong>Hospital encounters for AMI.</p><p><strong>Results: </strong>On average, the study sample included 31 623 928 patients each month from January 2016 through June 2023, for a total of 2 846 153 487 patient-months during the 90-month study period. In June 2023, there were 0.044 AMI hospital encounters per 100 patients, which was 20% lower than in June 2019 (0.055 encounters per 100 patients). Early in the pandemic, AMI rates moved inversely with COVID-19 death rates and tracked patterns seen for other painful acute conditions, such as nephrolithiasis, suggesting these changes were associated with care avoidance. Changes in patient characteristics driven by excess deaths during the pandemic explained little of the decline. Later in the pandemic, the decline may be explained by the long-standing downward trend in AMI incidence; by April 2022, the observed rate of encounters matched the expected rate that accounted for this trend. During the full pandemic period, from March 2020 to June 2023, there were an estimated 5% (95% prediction interval, 1%-9%) fewer AMI hospital encounters than expected.</p><p><strong>Conclusions and relevance: </strong>The early reduction in AMI encounters was likely driven by care avoidance, while ongoing reductions through June 2023 likely reflect long-standing temporal trends. During the pandemic, there were 5% fewer AMI encounters than expected.</p>","PeriodicalId":14657,"journal":{"name":"JAMA cardiology","volume":" ","pages":"914-920"},"PeriodicalIF":14.8,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11292572/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141855517","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":"Evaluating Pregnancy Safety During Cardiology Training.","authors":"Leila Haghighat, Shadi Kalantarian, Jacqueline T DesJardin, Cara N Pellegrini","doi":"10.1001/jamacardio.2024.2294","DOIUrl":"10.1001/jamacardio.2024.2294","url":null,"abstract":"","PeriodicalId":14657,"journal":{"name":"JAMA cardiology","volume":" ","pages":"946-947"},"PeriodicalIF":14.8,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11307157/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141897444","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":"Racial Disparities in Sports Cardiology: A Review.","authors":"Sheela Krishnan, James Sawalla Guseh, Merije Chukumerije, Aubrey J Grant, Peter N Dean, Jeffrey J Hsu, Mustafa Husaini, Dermot M Phelan, Ankit B Shah, Katie Stewart, Meagan M Wasfy, Quinn Capers, Utibe R Essien, Amber E Johnson, Benjamin D Levine, Jonathan H Kim","doi":"10.1001/jamacardio.2024.1899","DOIUrl":"10.1001/jamacardio.2024.1899","url":null,"abstract":"<p><strong>Importance: </strong>Racial disparities in cardiovascular health, including sudden cardiac death (SCD), exist among both the general and athlete populations. Among competitive athletes, disparities in health outcomes potentially influenced by social determinants of health (SDOH) and structural racism remain inadequately understood. This narrative review centers on race in sports cardiology, addressing racial disparities in SCD risk, false-positive cardiac screening rates among athletes, and the prevalence of left ventricular hypertrophy, and encourages a reexamination of race-based practices in sports cardiology, such as the interpretation of screening 12-lead electrocardiogram findings.</p><p><strong>Observations: </strong>Drawing from an array of sources, including epidemiological data and broader medical literature, this narrative review discusses racial disparities in sports cardiology and calls for a paradigm shift in approach that encompasses 3 key principles: race-conscious awareness, clinical inclusivity, and research-driven refinement of clinical practice. These proposed principles call for a shift away from race-based assumptions towards individualized, health-focused care in sports cardiology. This shift would include fostering awareness of sociopolitical constructs, diversifying the medical team workforce, and conducting diverse, evidence-based research to better understand disparities and address inequities in sports cardiology care.</p><p><strong>Conclusions and relevance: </strong>In sports cardiology, inadequate consideration of the impact of structural racism and SDOH on racial disparities in health outcomes among athletes has resulted in potential biases in current normative standards and in the clinical approach to the cardiovascular care of athletes. An evidence-based approach to successfully address disparities requires pivoting from outdated race-based practices to a race-conscious framework to better understand and improve health care outcomes for diverse athletic populations.</p>","PeriodicalId":14657,"journal":{"name":"JAMA cardiology","volume":" ","pages":"935-943"},"PeriodicalIF":14.8,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141626781","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":"Leadless Ultrasound-Based Cardiac Resynchronization System in Heart Failure.","authors":"Jagmeet P Singh, Christopher A Rinaldi, Prashanthan Sanders, Spencer H Kubo, Simon James, Imran K Niazi, Timothy Betts, Christian Butter, Toshimasa Okabe, Ryan Cunnane, Emad Aziz, Mauro Biffi, Amir Zaidi, Jeffrey Alison, Pascal Defaye, Angelo Aurrichio, Michael R Gold, JoAnn Lindenfeld, Tyson Rogers, Mary Norine Walsh","doi":"10.1001/jamacardio.2024.2050","DOIUrl":"10.1001/jamacardio.2024.2050","url":null,"abstract":"<p><strong>Importance: </strong>Approximately 40% of patients with heart failure (HF) who are eligible for cardiac resynchronization therapy (CRT) either fail to respond or are untreatable due to anatomical constraints.</p><p><strong>Objective: </strong>To assess the safety and efficacy of a novel, leadless, left ventricular (LV) endocardial pacing system for patients at high risk for a CRT upgrade or whose coronary sinus (CS) lead placement/pacing with a conventional CRT system failed.</p><p><strong>Design, setting, and participants: </strong>The SOLVE-CRT study was a prospective multicenter trial enrolling January 2018 through July 2022, with follow-up at 6 months. Data were analyzed from January 17, 2018, through February 15, 2023. The trial combined data from an initial randomized, double-blind study (n = 108) and a subsequent single-arm part (n = 75). It took place at 36 centers across Australia, Europe, and the US. Participants were nonresponders, previously untreatable (PU), or high-risk upgrades (HRU). All participants contributed to the safety analysis. The primary efficacy analysis (n = 100) included 75 PU-HRU patients from the single-arm part and 25 PU-HRU patients from the randomized treatment arm.</p><p><strong>Interventions: </strong>Patients were implanted with the WiSE CRT System (EBR Systems) consisting of a leadless LV endocardial pacing electrode stimulated with ultrasound energy delivered by a subcutaneously implanted transmitter and battery.</p><p><strong>Main outcomes and measures: </strong>The primary safety end point was freedom from type I complications. The primary efficacy end point was a reduction in mean LV end systolic volume (LVESV).</p><p><strong>Results: </strong>The study included 183 participants; mean age was 68.1 (SD, 10.3) years and 141 were male (77%). The trial was terminated at an interim analysis for meeting prespecified stopping criteria. In the safety population, patients were either New York Heart Association Class II (34.6%) or III (65.4%). The primary efficacy end point was met with a 16.4% (95% CI, -21.0% to -11.7%) reduction in mean LVESV (P = .003). The primary safety end point was met with an 80.9% rate of freedom from type I complications (P < .001), which included 12 study device system events (6.6%), 5 vascular events (2.7%), 3 strokes (1.6%), and 7 cardiac perforations which mostly occurred early in the study (3.8%).</p><p><strong>Conclusions and relevance: </strong>The SOLVE-CRT study has demonstrated that leadless LV endocardial pacing with the WiSE CRT system is associated with a reduction in LVESV in patients with HF. This novel system may represent an alternative to conventional CRT implants in some HF patient populations.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov Identifier: NCT0292203.</p>","PeriodicalId":14657,"journal":{"name":"JAMA cardiology","volume":" ","pages":"871-879"},"PeriodicalIF":14.8,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11292567/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141855520","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}