Pub Date : 2024-09-01DOI: 10.1016/j.jacc.2024.07.006
Background
Lower air temperature and cold spells have been associated with an increased risk of various diseases. However, the short-term effect of lower air temperature and cold spells on myocardial infarction (MI) remains incompletely understood.
Objectives
The purpose of this study was to investigate the short-term effects of lower air temperature and cold spells on the risk of hospitalization for MI in Sweden.
Methods
This population-based nationwide study included 120,380 MI cases admitted to hospitals in Sweden during the cold season (October to March) from 2005 to 2019. Daily mean air temperature (1 km2 resolution) was estimated using machine learning, and percentiles of daily temperatures experienced by individuals in the same municipality were used as individual exposure indicators to account for potential geographic adaptation. Cold spells were defined as periods of at least 2 consecutive days with a daily mean temperature below the 10th percentile of the temperature distribution for each municipality. A time-stratified case-crossover design incorporating conditional logistic regression models with distributed lag nonlinear models using lag 0 to 1 (immediate) and 2 to 6 days (delayed) was used to evaluate the short-term effects of lower air temperature and cold spells on total MI, non–ST-segment elevation myocardial infarction (NSTEMI) and ST-segment elevation myocardial infarction (STEMI).
Results
A decrease of 1-U in percentile temperature at a lag of 2 to 6 days was significantly associated with increased risks of total MI, NSTEMI, and STEMI, with ORs of 1.099 (95% CI: 1.057-1.142), 1.110 (95% CI: 1.060-1.164), and 1.076 (95% CI: 1.004-1.153), respectively. Additionally, cold spells at a lag of 2 to 6 days were significantly associated with increased risks for total MI, NSTEMI, and STEMI, with ORs of 1.077 (95% CI: 1.037-1.120), 1.069 (95% CI: 1.020-1.119), and 1.095 (95% CI: 1.023-1.172), respectively. Conversely, lower air temperature and cold spells at a lag of 0 to 1 days were associated with decreased risks for MI.
Conclusions
This nationwide case-crossover study reveals that short-term exposures to lower air temperature and cold spells are associated with an increased risk of hospitalization for MI at lag 2 to 6 days.
{"title":"Short-Term Effects of Lower Air Temperature and Cold Spells on Myocardial Infarction Hospitalizations in Sweden","authors":"","doi":"10.1016/j.jacc.2024.07.006","DOIUrl":"10.1016/j.jacc.2024.07.006","url":null,"abstract":"<div><h3>Background</h3><p>Lower air temperature and cold spells have been associated with an increased risk of various diseases. However, the short-term effect of lower air temperature and cold spells on myocardial infarction (MI) remains incompletely understood.</p></div><div><h3>Objectives</h3><p>The purpose of this study was to investigate the short-term effects of lower air temperature and cold spells on the risk of hospitalization for MI in Sweden.</p></div><div><h3>Methods</h3><p>This population-based nationwide study included 120,380 MI cases admitted to hospitals in Sweden during the cold season (October to March) from 2005 to 2019. Daily mean air temperature (1 km<sup>2</sup> resolution) was estimated using machine learning, and percentiles of daily temperatures experienced by individuals in the same municipality were used as individual exposure indicators to account for potential geographic adaptation. Cold spells were defined as periods of at least 2 consecutive days with a daily mean temperature below the 10th percentile of the temperature distribution for each municipality. A time-stratified case-crossover design incorporating conditional logistic regression models with distributed lag nonlinear models using lag 0 to 1 (immediate) and 2 to 6 days (delayed) was used to evaluate the short-term effects of lower air temperature and cold spells on total MI, non–ST-segment elevation myocardial infarction (NSTEMI) and ST-segment elevation myocardial infarction (STEMI).</p></div><div><h3>Results</h3><p>A decrease of 1-U in percentile temperature at a lag of 2 to 6 days was significantly associated with increased risks of total MI, NSTEMI, and STEMI, with ORs of 1.099 (95% CI: 1.057-1.142), 1.110 (95% CI: 1.060-1.164), and 1.076 (95% CI: 1.004-1.153), respectively. Additionally, cold spells at a lag of 2 to 6 days were significantly associated with increased risks for total MI, NSTEMI, and STEMI, with ORs of 1.077 (95% CI: 1.037-1.120), 1.069 (95% CI: 1.020-1.119), and 1.095 (95% CI: 1.023-1.172), respectively. Conversely, lower air temperature and cold spells at a lag of 0 to 1 days were associated with decreased risks for MI.</p></div><div><h3>Conclusions</h3><p>This nationwide case-crossover study reveals that short-term exposures to lower air temperature and cold spells are associated with an increased risk of hospitalization for MI at lag 2 to 6 days.</p></div>","PeriodicalId":17187,"journal":{"name":"Journal of the American College of Cardiology","volume":null,"pages":null},"PeriodicalIF":21.7,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142126076","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 : 2024-09-01DOI: 10.1016/j.jacc.2024.07.017
{"title":"Balancing the Climate Equation","authors":"","doi":"10.1016/j.jacc.2024.07.017","DOIUrl":"10.1016/j.jacc.2024.07.017","url":null,"abstract":"","PeriodicalId":17187,"journal":{"name":"Journal of the American College of Cardiology","volume":null,"pages":null},"PeriodicalIF":21.7,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142126071","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 : 2024-09-01DOI: 10.1016/j.jacc.2024.05.076
Background
The perception of takotsubo syndrome (TTS) has evolved significantly over the years, primarily driven by increased recognition of acute complications and mortality.
Objectives
This study aimed to explore temporal trends in demographic patterns, risk factors, clinical presentations, and outcomes in patients with TTS.
Methods
Patients diagnosed with TTS between 2004 and 2021 were enrolled from the InterTAK (International Takotsubo) registry. To assess temporal trends, patients were divided into 6 groups, each corresponding to a 3-year interval within the study period.
Results
Overall, 3,957 patients were included in the study. There was a significant demographic transition, with the proportion of male patients rising from 10% to 15% (P = 0.003). Although apical TTS remained the most common form, the diagnosis of midventricular TTS increased from 18% to 28% (P = 0.018). The prevalence of physical triggers increased from 39% to 58% over the years (P < 0.001). There was a significant increase in 60-day mortality over the years (P < 0.001). However, a landmark analysis excluding patients who died within the first 60 days showed no differences in 1-year mortality (P = 0.150).
Conclusions
This study of temporal trends in TTS highlights a transition in patients demographic with a growing prevalence among men, increasing recognition of midventricular TTS type, and increased short-term mortality and rates of cardiogenic shock in recent years. This transition aligns with the rising prevalence of physical triggers, as expression of increased recognition of TTS in association with acute comorbidities.
{"title":"Temporal Trends in Takotsubo Syndrome","authors":"","doi":"10.1016/j.jacc.2024.05.076","DOIUrl":"10.1016/j.jacc.2024.05.076","url":null,"abstract":"<div><h3>Background</h3><p>The perception of takotsubo syndrome (TTS) has evolved significantly over the years, primarily driven by increased recognition of acute complications and mortality.</p></div><div><h3>Objectives</h3><p>This study aimed to explore temporal trends in demographic patterns, risk factors, clinical presentations, and outcomes in patients with TTS.</p></div><div><h3>Methods</h3><p>Patients diagnosed with TTS between 2004 and 2021 were enrolled from the InterTAK (International Takotsubo) registry. To assess temporal trends, patients were divided into 6 groups, each corresponding to a 3-year interval within the study period.</p></div><div><h3>Results</h3><p>Overall, 3,957 patients were included in the study. There was a significant demographic transition, with the proportion of male patients rising from 10% to 15% (<em>P</em> = 0.003). Although apical TTS remained the most common form, the diagnosis of midventricular TTS increased from 18% to 28% (<em>P =</em> 0.018). The prevalence of physical triggers increased from 39% to 58% over the years (<em>P <</em> 0.001). There was a significant increase in 60-day mortality over the years (<em>P <</em> 0.001). However, a landmark analysis excluding patients who died within the first 60 days showed no differences in 1-year mortality (<em>P =</em> 0.150).</p></div><div><h3>Conclusions</h3><p>This study of temporal trends in TTS highlights a transition in patients demographic with a growing prevalence among men, increasing recognition of midventricular TTS type, and increased short-term mortality and rates of cardiogenic shock in recent years. This transition aligns with the rising prevalence of physical triggers, as expression of increased recognition of TTS in association with acute comorbidities.</p></div>","PeriodicalId":17187,"journal":{"name":"Journal of the American College of Cardiology","volume":null,"pages":null},"PeriodicalIF":21.7,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142108665","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 : 2024-08-31DOI: 10.1016/j.jacc.2024.05.066
{"title":"Serial Shock Severity Assessment","authors":"","doi":"10.1016/j.jacc.2024.05.066","DOIUrl":"10.1016/j.jacc.2024.05.066","url":null,"abstract":"","PeriodicalId":17187,"journal":{"name":"Journal of the American College of Cardiology","volume":null,"pages":null},"PeriodicalIF":21.7,"publicationDate":"2024-08-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142108663","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 : 2024-08-31DOI: 10.1016/j.jacc.2024.05.073
{"title":"Risk Stratification of Recurrent Pericarditis","authors":"","doi":"10.1016/j.jacc.2024.05.073","DOIUrl":"10.1016/j.jacc.2024.05.073","url":null,"abstract":"","PeriodicalId":17187,"journal":{"name":"Journal of the American College of Cardiology","volume":null,"pages":null},"PeriodicalIF":21.7,"publicationDate":"2024-08-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142108659","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 : 2024-08-31DOI: 10.1016/j.jacc.2024.05.072
Background
Recurrent pericarditis (RP) is a complex condition associated with significant morbidity. Prior studies have evaluated which variables are associated with clinical remission. However, there is currently no established risk-stratification model for predicting outcomes in these patients.
Objectives
We developed a risk stratification model that can predict long-term outcomes in patients with RP and enable identification of patients with characteristics that portend poor outcomes.
Methods
We retrospectively studied a total of 365 consecutive patients with RP from 2012 to 2019. The primary outcome was clinical remission (CR), defined as cessation of all anti-inflammatory therapy with complete resolution of symptoms. Five machine learning survival models were used to calculate the likelihood of CR within 5 years and stratify patients into high-risk, intermediate-risk, and low-risk groups.
Results
Among the cohort, the mean age was 46 ± 15 years, and 205 (56%) were women. CR was achieved in 118 (32%) patients. The final model included steroid dependency, total number of recurrences, pericardial late gadolinium enhancement, age, etiology, sex, ejection fraction, and heart rate as the most important parameters. The model predicted the outcome with a C-index of 0.800 on the test set and exhibited a significant ability in stratification of patients into low-risk, intermediate-risk, and high-risk groups (log-rank test; P < 0.0001).
Conclusions
We developed a novel risk-stratification model for predicting CR in RP. Our model can also aid in stratifying patients, with high discriminative ability. The use of an explainable machine learning model can aid physicians in making individualized treatment decision in RP patients.
背景:复发性心包炎(RP)是一种复杂的疾病,发病率很高。之前的研究已经评估了哪些变量与临床缓解相关。然而,目前还没有一个成熟的风险分层模型来预测这些患者的预后:我们建立了一个风险分层模型,该模型可以预测 RP 患者的长期预后,并能识别出预示不良预后的患者特征:方法:我们回顾性研究了2012年至2019年连续接受RP治疗的365名患者。主要结果是临床缓解(CR),即停止所有抗炎治疗且症状完全缓解。研究使用了五个机器学习生存模型来计算5年内出现CR的可能性,并将患者分为高风险组、中风险组和低风险组:组群中,平均年龄为 46 ± 15 岁,205 人(56%)为女性。118名患者(32%)达到 CR。最终模型将类固醇依赖性、复发总数、心包晚期钆增强、年龄、病因、性别、射血分数和心率作为最重要的参数。该模型在测试集上的预测结果C指数为0.800,在将患者分为低危、中危和高危组方面表现出显著的能力(对数秩检验;P < 0.0001):我们建立了一个新的风险分层模型来预测 RP 的 CR。我们的模型还能帮助对患者进行分层,具有很高的鉴别能力。使用可解释的机器学习模型可以帮助医生对 RP 患者做出个体化治疗决策。
{"title":"Predicting Long-Term Clinical Outcomes of Patients With Recurrent Pericarditis","authors":"","doi":"10.1016/j.jacc.2024.05.072","DOIUrl":"10.1016/j.jacc.2024.05.072","url":null,"abstract":"<div><h3>Background</h3><p>Recurrent pericarditis (RP) is a complex condition associated with significant morbidity. Prior studies have evaluated which variables are associated with clinical remission. However, there is currently no established risk-stratification model for predicting outcomes in these patients.</p></div><div><h3>Objectives</h3><p>We developed a risk stratification model that can predict long-term outcomes in patients with RP and enable identification of patients with characteristics that portend poor outcomes.</p></div><div><h3>Methods</h3><p>We retrospectively studied a total of 365 consecutive patients with RP from 2012 to 2019. The primary outcome was clinical remission (CR), defined as cessation of all anti-inflammatory therapy with complete resolution of symptoms. Five machine learning survival models were used to calculate the likelihood of CR within 5 years and stratify patients into high-risk, intermediate-risk, and low-risk groups.</p></div><div><h3>Results</h3><p>Among the cohort, the mean age was 46 ± 15 years, and 205 (56%) were women. CR was achieved in 118 (32%) patients. The final model included steroid dependency, total number of recurrences, pericardial late gadolinium enhancement, age, etiology, sex, ejection fraction, and heart rate as the most important parameters. The model predicted the outcome with a C-index of 0.800 on the test set and exhibited a significant ability in stratification of patients into low-risk, intermediate-risk, and high-risk groups (log-rank test; <em>P <</em> 0.0001).</p></div><div><h3>Conclusions</h3><p>We developed a novel risk-stratification model for predicting CR in RP. Our model can also aid in stratifying patients, with high discriminative ability. The use of an explainable machine learning model can aid physicians in making individualized treatment decision in RP patients.</p></div>","PeriodicalId":17187,"journal":{"name":"Journal of the American College of Cardiology","volume":null,"pages":null},"PeriodicalIF":21.7,"publicationDate":"2024-08-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142108657","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 : 2024-08-31DOI: 10.1016/j.jacc.2024.04.069
Background
The Cardiogenic Shock Working Group–modified Society for Cardiovascular Angiography and Interventions (CSWG-SCAI) staging was developed to risk stratify cardiogenic shock (CS) severity. Data showing progressive changes in SCAI stages and outcomes are limited.
Objectives
We investigated serial changes in CSWG-SCAI stages and outcomes of patients presenting with cardiogenic shock complicating acute myocardial infarction (MI-CS) and heart failure–related CS (HF-CS).
Methods
The multicenter CSWG registry was queried. CSWG-SCAI stages were computed at CS diagnosis and 24, 48, and 72 hours.
Results
A total of 3,268 patients (57% HF-CS; 27% MI-CS) were included. At CS diagnosis, CSWG-SCAI stage breakdown was 593 (18.1%) stage B, 528 (16.2%) stage C, 1,659 (50.8%) stage D, and 488 (14.9%) noncardiac arrest stage E. At 24 hours, >50% of stages B and C patients worsened, but 86% of stage D patients stayed at stage D. Among stage E patients, 54% improved to stage D and 36% stayed at stage E by 24 hours. Minimal SCAI stage changes occurred beyond 24 hours. SCAI stage trajectories were similar between MI-CS and HF-CS groups. Within 24 hours, unadjusted mortality rates of patients with any SCAI stage worsening or improving were 44.6% and 34.2%, respectively. Patients who presented in or progressed to stage E by 24 hours had the worst prognosis. Survivors had lower lactate than nonsurvivors.
Conclusions
Most patients with CS changed SCAI stages within 24 hours from CS diagnosis. Stage B patients were at high risk of worsening shock severity by 24 hours, associated with excess mortality. Early CS recognition and serial assessment may improve risk stratification.
背景:心源性休克工作组修订版心血管造影和介入学会(CSWG-SCAI)分期用于对心源性休克(CS)严重程度进行风险分层。显示 SCAI 分期和预后逐渐变化的数据非常有限:我们调查了急性心肌梗死(MI-CS)和心衰相关 CS(HF-CS)并发心源性休克患者 CSWG-SCAI 分期和预后的连续变化:方法:查询多中心 CSWG 登记。方法:对多中心 CSWG 注册表进行查询,计算 CSWG-SCAI 分级,时间为 CS 诊断时、24、48 和 72 小时:结果:共纳入 3268 名患者(57% 为高频 CS;27% 为心肌梗死 CS)。CS 诊断时,CSWG-SCAI 分期细分为 B 期 593 例(18.1%)、C 期 528 例(16.2%)、D 期 1,659 例(50.8%)和非心脏骤停 E 期 488 例(14.9%)。24 小时后,超过 50% 的 B 期和 C 期患者病情恶化,但 86% 的 D 期患者维持在 D 期。超过 24 小时后,SCAI 分期变化极小。MI-CS 组和 HF-CS 组的 SCAI 分期轨迹相似。在 24 小时内,任何 SCAI 阶段恶化或改善的患者的未调整死亡率分别为 44.6% 和 34.2%。24 小时内出现 E 期或进展至 E 期的患者预后最差。幸存者的乳酸低于非幸存者:大多数CS患者在确诊后24小时内改变了SCAI分期。B期患者在24小时内休克严重程度恶化的风险很高,死亡率也较高。早期 CS 识别和连续评估可改善风险分层。
{"title":"Serial Shock Severity Assessment Within 72 Hours After Diagnosis","authors":"","doi":"10.1016/j.jacc.2024.04.069","DOIUrl":"10.1016/j.jacc.2024.04.069","url":null,"abstract":"<div><h3>Background</h3><p>The Cardiogenic Shock Working Group–modified Society for Cardiovascular Angiography and Interventions (CSWG-SCAI) staging was developed to risk stratify cardiogenic shock (CS) severity. Data showing progressive changes in SCAI stages and outcomes are limited.</p></div><div><h3>Objectives</h3><p>We investigated serial changes in CSWG-SCAI stages and outcomes of patients presenting with cardiogenic shock complicating acute myocardial infarction (MI-CS) and heart failure–related CS (HF-CS).</p></div><div><h3>Methods</h3><p>The multicenter CSWG registry was queried. CSWG-SCAI stages were computed at CS diagnosis and 24, 48, and 72 hours.</p></div><div><h3>Results</h3><p>A total of 3,268 patients (57% HF-CS; 27% MI-CS) were included. At CS diagnosis, CSWG-SCAI stage breakdown was 593 (18.1%) stage B, 528 (16.2%) stage C, 1,659 (50.8%) stage D, and 488 (14.9%) noncardiac arrest stage E. At 24 hours, >50% of stages B and C patients worsened, but 86% of stage D patients stayed at stage D. Among stage E patients, 54% improved to stage D and 36% stayed at stage E by 24 hours. Minimal SCAI stage changes occurred beyond 24 hours. SCAI stage trajectories were similar between MI-CS and HF-CS groups. Within 24 hours, unadjusted mortality rates of patients with any SCAI stage worsening or improving were 44.6% and 34.2%, respectively. Patients who presented in or progressed to stage E by 24 hours had the worst prognosis. Survivors had lower lactate than nonsurvivors.</p></div><div><h3>Conclusions</h3><p>Most patients with CS changed SCAI stages within 24 hours from CS diagnosis. Stage B patients were at high risk of worsening shock severity by 24 hours, associated with excess mortality. Early CS recognition and serial assessment may improve risk stratification.</p></div>","PeriodicalId":17187,"journal":{"name":"Journal of the American College of Cardiology","volume":null,"pages":null},"PeriodicalIF":21.7,"publicationDate":"2024-08-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142108662","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 : 2024-08-30DOI: 10.1016/j.jacc.2024.08.027
Piotr Ponikowski, Tim Friede, Ralph Stephan von Bardeleben, Javed Butler, Muhammad Shahzeb Khan, Monika Diek, Jutta Heinrich, Martin Geyer, Marius Placzek, Roberto Ferrari, William T Abraham, Ottavio Alfieri, Angelo Auricchio, Antoni Bayes-Genis, John G F Cleland, Gerasimos Filippatos, Finn Gustafsson, Wilhelm Haverkamp, Malte Kelm, Karl-Heinz Kuck, Ulf Landmesser, Aldo P Maggioni, Marco Metra, Vlasis Ninios, Mark C Petrie, Tienush Rassaf, Frank Ruschitzka, Ulrich Schäfer, P Christian Schulze, Konstantinos Spargias, Alec Vahanian, Jose Luis Zamorano, Andreas Zeiher, Mahir Karakas, Friedrich Koehler, Mitja Lainscak, Alper Öner, Nikolaos Mezilis, Efstratios K Theofilogiannakos, Ilias Ninios, Michael Chrissoheris, Panagiota Kourkoveli, Konstantinos Papadopoulos, Grzegorz Smolka, Wojciech Wojakowski, Krzysztof Reczuch, Fausto J Pinto, Łukasz Wiewiórka, Witold Streb, Marianna Adamo, Evelyn Santiago-Vacas, Tobias Friedrich Ruf, Michael Gross, Joern Tongers, Gerd Hasenfuß, Wolfgang Schillinger, Stefan D Anker
Background: For patients with functional mitral regurgitation (FMR) and symptomatic heart failure (HF), randomized trials of mitral transcatheter edge-to-edge repair (M-TEER) have produced conflicting results.
Objectives: This study sought to assess the impact of M-TEER on hospitalization rates, and explore the effects of M-TEER on patients who did or did not have a history of recent HF hospitalizations before undergoing M-TEER.
Methods: RESHAPE-HF2 (Randomized Investigation of the MitraClip Device in Heart Failure: 2nd Trial in Patients with Clinically Significant Functional Mitral Regurgitation) included patients with symptomatic HF and moderate to severe FMR (mean effective regurgitant orifice area 0.25 cm2; 14% >0.40 cm2, 23% <0.20 cm2) and showed that M-TEER reduced recurrent HF hospitalizations with and without the addition of cardiovascular (CV) death and improved quality of life. We now report the results of prespecified analyses on hospitalization rates and for the subgroup of patients (n = 333) with a HF hospitalization in the 12 months before randomization.
Results: At 24 months, the time to first event of CV death or HF hospitalization (HR: 0.65; 95% CI: 0.49-0.85; P = 0.002), the rate of recurrent CV hospitalizations (rate ratio [RR]: 0.75; 95% CI: 0.57-0.99; P = 0.046), the composite rate of recurrent CV hospitalizations and all-cause mortality (RR: 0.74; 95% CI: 0.57-0.95; P = 0.017), and of recurrent CV death and CV hospitalizations (RR: 0.76; 95% CI: 0.58-0.99; P = 0.040), were all lower in the M-TEER group. The RR of recurrent hospitalizations for any cause was 0.82 (95% CI: 0.63-1.07; P = 0.15) for patients in the M-TEER group vs control group patients. Patients randomized to M-TEER lost fewer days due to death or HF hospitalization (13.9% [95% CI: 13.0%-14.8%] vs 17.4% [95% CI: 16.4%-18.4%] of follow-up time; P < 0.0001, and 1,067 vs 1,776 total days lost; P < 0.0001). Patients randomized to M-TEER also had better NYHA functional class at 30 days and at 6, 12, and 24 months of follow-up (P < 0.0001). A history of HF hospitalizations before randomization was associated with worse outcomes and greater benefit with M-TEER on the rate of the composite of recurrent HF hospitalizations and CV death (Pinteraction = 0.03) and of recurrent HF hospitalizations within 24 months (Pinteraction = 0.06).
Conclusions: These results indicate that a broader application of M-TEER in addition to optimal guideline-directed medical therapy should be considered among patients with symptomatic HF and moderate to severe FMR, particularly in those with a history of a recent hospitalization for HF.
{"title":"Hospitalization of Symptomatic Patients With Heart Failure and Moderate to Severe Functional Mitral Regurgitation Treated With MitraClip: Insights From RESHAPE-HF2.","authors":"Piotr Ponikowski, Tim Friede, Ralph Stephan von Bardeleben, Javed Butler, Muhammad Shahzeb Khan, Monika Diek, Jutta Heinrich, Martin Geyer, Marius Placzek, Roberto Ferrari, William T Abraham, Ottavio Alfieri, Angelo Auricchio, Antoni Bayes-Genis, John G F Cleland, Gerasimos Filippatos, Finn Gustafsson, Wilhelm Haverkamp, Malte Kelm, Karl-Heinz Kuck, Ulf Landmesser, Aldo P Maggioni, Marco Metra, Vlasis Ninios, Mark C Petrie, Tienush Rassaf, Frank Ruschitzka, Ulrich Schäfer, P Christian Schulze, Konstantinos Spargias, Alec Vahanian, Jose Luis Zamorano, Andreas Zeiher, Mahir Karakas, Friedrich Koehler, Mitja Lainscak, Alper Öner, Nikolaos Mezilis, Efstratios K Theofilogiannakos, Ilias Ninios, Michael Chrissoheris, Panagiota Kourkoveli, Konstantinos Papadopoulos, Grzegorz Smolka, Wojciech Wojakowski, Krzysztof Reczuch, Fausto J Pinto, Łukasz Wiewiórka, Witold Streb, Marianna Adamo, Evelyn Santiago-Vacas, Tobias Friedrich Ruf, Michael Gross, Joern Tongers, Gerd Hasenfuß, Wolfgang Schillinger, Stefan D Anker","doi":"10.1016/j.jacc.2024.08.027","DOIUrl":"https://doi.org/10.1016/j.jacc.2024.08.027","url":null,"abstract":"<p><strong>Background: </strong>For patients with functional mitral regurgitation (FMR) and symptomatic heart failure (HF), randomized trials of mitral transcatheter edge-to-edge repair (M-TEER) have produced conflicting results.</p><p><strong>Objectives: </strong>This study sought to assess the impact of M-TEER on hospitalization rates, and explore the effects of M-TEER on patients who did or did not have a history of recent HF hospitalizations before undergoing M-TEER.</p><p><strong>Methods: </strong>RESHAPE-HF2 (Randomized Investigation of the MitraClip Device in Heart Failure: 2nd Trial in Patients with Clinically Significant Functional Mitral Regurgitation) included patients with symptomatic HF and moderate to severe FMR (mean effective regurgitant orifice area 0.25 cm<sup>2</sup>; 14% >0.40 cm<sup>2</sup>, 23% <0.20 cm<sup>2</sup>) and showed that M-TEER reduced recurrent HF hospitalizations with and without the addition of cardiovascular (CV) death and improved quality of life. We now report the results of prespecified analyses on hospitalization rates and for the subgroup of patients (n = 333) with a HF hospitalization in the 12 months before randomization.</p><p><strong>Results: </strong>At 24 months, the time to first event of CV death or HF hospitalization (HR: 0.65; 95% CI: 0.49-0.85; P = 0.002), the rate of recurrent CV hospitalizations (rate ratio [RR]: 0.75; 95% CI: 0.57-0.99; P = 0.046), the composite rate of recurrent CV hospitalizations and all-cause mortality (RR: 0.74; 95% CI: 0.57-0.95; P = 0.017), and of recurrent CV death and CV hospitalizations (RR: 0.76; 95% CI: 0.58-0.99; P = 0.040), were all lower in the M-TEER group. The RR of recurrent hospitalizations for any cause was 0.82 (95% CI: 0.63-1.07; P = 0.15) for patients in the M-TEER group vs control group patients. Patients randomized to M-TEER lost fewer days due to death or HF hospitalization (13.9% [95% CI: 13.0%-14.8%] vs 17.4% [95% CI: 16.4%-18.4%] of follow-up time; P < 0.0001, and 1,067 vs 1,776 total days lost; P < 0.0001). Patients randomized to M-TEER also had better NYHA functional class at 30 days and at 6, 12, and 24 months of follow-up (P < 0.0001). A history of HF hospitalizations before randomization was associated with worse outcomes and greater benefit with M-TEER on the rate of the composite of recurrent HF hospitalizations and CV death (P<sub>interaction</sub> = 0.03) and of recurrent HF hospitalizations within 24 months (P<sub>interaction</sub> = 0.06).</p><p><strong>Conclusions: </strong>These results indicate that a broader application of M-TEER in addition to optimal guideline-directed medical therapy should be considered among patients with symptomatic HF and moderate to severe FMR, particularly in those with a history of a recent hospitalization for HF.</p>","PeriodicalId":17187,"journal":{"name":"Journal of the American College of Cardiology","volume":null,"pages":null},"PeriodicalIF":21.7,"publicationDate":"2024-08-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142108651","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 : 2024-08-30DOI: 10.1016/j.jacc.2024.08.035
Jeremy Samuel Faust
{"title":"Semaglutide, COVID-19 Mortality, and the Power of Harnessing Ongoing Clinical Trials During Unexpected Outbreaks.","authors":"Jeremy Samuel Faust","doi":"10.1016/j.jacc.2024.08.035","DOIUrl":"10.1016/j.jacc.2024.08.035","url":null,"abstract":"","PeriodicalId":17187,"journal":{"name":"Journal of the American College of Cardiology","volume":null,"pages":null},"PeriodicalIF":21.7,"publicationDate":"2024-08-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142108661","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 : 2024-08-30DOI: 10.1016/j.jacc.2024.08.025
Anthony Rodgers, Abdul Salam, Aletta E Schutte, William C Cushman, H Asita de Silva, Gian Luca Di Tanna, Diederick Grobbee, Krzysztof Narkiewicz, Dike B Ojji, Neil R Poulter, Markus P Schlaich, Suzanne Oparil, Wilko Spiering, Bryan Williams, Jackson T Wright, Alexis Gutierez, Aliu Sanni, Poopalan Lakshman, Deirdre McMullen, Gotabhaya Ranasinghe, Chris Gianacas, Mathangi Shanthakumar, Xiaoqiu Liu, Nelson Wang, Paul Whelton
Background: Single-pill combinations of 3 or more low-dose blood pressure (BP)-lowering drugs hold promise for initial or early treatment of hypertension.
Objectives: We conducted a placebo-controlled trial of a new single-pill combination containing low doses of telmisartan, amlodipine, and indapamide in 2 dose options to assess efficacy and safety.
Methods: This international, randomized, double-blind, placebo-controlled, parallel-group trial enrolled adults with hypertension receiving 0 to 1 BP-lowering drugs. After a 2-week placebo run-in during which any BP-lowering medication was stopped, participants were eligible if home systolic BP (SBP) was 130 to 154 mm Hg. Participants were randomized in a 2:2:1 ratio to GMRx2 ¼ dose (telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg), GMRx2 ½ dose (telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg), or placebo. The primary efficacy outcome was difference in change in home SBP from randomization to week 4, and primary safety outcome was treatment discontinuation due to an adverse event.
Results: From June 14, 2021 to October 18, 2023, a total of 295 participants (mean age: 51 years; 56% female) were randomized and 96% completed the trial. Baseline mean home BP was 139/86 mm Hg and clinic BP was 138/86 mm Hg after placebo run-in. The placebo-corrected least square mean differences in home SBP at Week 4 were -7.3 mm Hg (95% CI: -4.5 to -10.2) for GMRx2 ¼ dose and -8.2 mm Hg (95% CI: -5.2 to -11.3) for GMRx2 ½ dose; reductions for clinic BP were 8.0/4.0 and 9.5/4.9 mm Hg. At Week 4, clinic BP control (<140/90 mm Hg) was 37%, 65%, and 70% for placebo, GMRx2 ¼ dose, and GMRx2 ½ dose, respectively (both doses P < 0.001 vs placebo). Placebo, GMRx2-triple ¼, and GMRx2 ½ treatment discontinuation due to an adverse event occurred in 1 (1.6%), 0, and 6 (5.1%), respectively; out of normal range serum sodium or potassium was observed in 4 (6.3%), 12 (10.6%), and 12 (10.1%), respectively, but no participant had a serum sodium <130/>150 mmol/L or potassium <3.0/>6.0 mmol/L. Serious adverse events were reported by 2 participants in the placebo and GMRx2 ½ groups and none in the GMRx2 ¼ group.
Conclusions: In a population with mild-to-moderate BP elevation, both dose versions of the novel low-dose triple single-pill combination showed good tolerability and clinically relevant BP reductions compared with placebo. (Efficacy and Safety of GRMx2 Compared to Placebo for the Treatment of Hypertension: NCT04518306).
{"title":"Efficacy and Safety of a Novel Low-Dose Triple Single-Pill Combination Compared With Placebo for Initial Treatment of Hypertension.","authors":"Anthony Rodgers, Abdul Salam, Aletta E Schutte, William C Cushman, H Asita de Silva, Gian Luca Di Tanna, Diederick Grobbee, Krzysztof Narkiewicz, Dike B Ojji, Neil R Poulter, Markus P Schlaich, Suzanne Oparil, Wilko Spiering, Bryan Williams, Jackson T Wright, Alexis Gutierez, Aliu Sanni, Poopalan Lakshman, Deirdre McMullen, Gotabhaya Ranasinghe, Chris Gianacas, Mathangi Shanthakumar, Xiaoqiu Liu, Nelson Wang, Paul Whelton","doi":"10.1016/j.jacc.2024.08.025","DOIUrl":"https://doi.org/10.1016/j.jacc.2024.08.025","url":null,"abstract":"<p><strong>Background: </strong>Single-pill combinations of 3 or more low-dose blood pressure (BP)-lowering drugs hold promise for initial or early treatment of hypertension.</p><p><strong>Objectives: </strong>We conducted a placebo-controlled trial of a new single-pill combination containing low doses of telmisartan, amlodipine, and indapamide in 2 dose options to assess efficacy and safety.</p><p><strong>Methods: </strong>This international, randomized, double-blind, placebo-controlled, parallel-group trial enrolled adults with hypertension receiving 0 to 1 BP-lowering drugs. After a 2-week placebo run-in during which any BP-lowering medication was stopped, participants were eligible if home systolic BP (SBP) was 130 to 154 mm Hg. Participants were randomized in a 2:2:1 ratio to GMRx2 ¼ dose (telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg), GMRx2 ½ dose (telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg), or placebo. The primary efficacy outcome was difference in change in home SBP from randomization to week 4, and primary safety outcome was treatment discontinuation due to an adverse event.</p><p><strong>Results: </strong>From June 14, 2021 to October 18, 2023, a total of 295 participants (mean age: 51 years; 56% female) were randomized and 96% completed the trial. Baseline mean home BP was 139/86 mm Hg and clinic BP was 138/86 mm Hg after placebo run-in. The placebo-corrected least square mean differences in home SBP at Week 4 were -7.3 mm Hg (95% CI: -4.5 to -10.2) for GMRx2 ¼ dose and -8.2 mm Hg (95% CI: -5.2 to -11.3) for GMRx2 ½ dose; reductions for clinic BP were 8.0/4.0 and 9.5/4.9 mm Hg. At Week 4, clinic BP control (<140/90 mm Hg) was 37%, 65%, and 70% for placebo, GMRx2 ¼ dose, and GMRx2 ½ dose, respectively (both doses P < 0.001 vs placebo). Placebo, GMRx2-triple ¼, and GMRx2 ½ treatment discontinuation due to an adverse event occurred in 1 (1.6%), 0, and 6 (5.1%), respectively; out of normal range serum sodium or potassium was observed in 4 (6.3%), 12 (10.6%), and 12 (10.1%), respectively, but no participant had a serum sodium <130/>150 mmol/L or potassium <3.0/>6.0 mmol/L. Serious adverse events were reported by 2 participants in the placebo and GMRx2 ½ groups and none in the GMRx2 ¼ group.</p><p><strong>Conclusions: </strong>In a population with mild-to-moderate BP elevation, both dose versions of the novel low-dose triple single-pill combination showed good tolerability and clinically relevant BP reductions compared with placebo. (Efficacy and Safety of GRMx2 Compared to Placebo for the Treatment of Hypertension: NCT04518306).</p>","PeriodicalId":17187,"journal":{"name":"Journal of the American College of Cardiology","volume":null,"pages":null},"PeriodicalIF":21.7,"publicationDate":"2024-08-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142108649","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}