Jawad H Butt, Johan Skovgaard Bundgaard, Morten Schou, Adelina Yafasova, Seiko N Doi, Jesper H Svendsen, Dan E Høfsten, Christian Hassager, Hans Eiskjær, Jens C Nielsen, Niels E Bruun, Lars Videbæk, Axel Brandes, Jens Jakob Thune, Steen Pehrson, Lars Køber
{"title":"非缺血性心力衰竭伴射血分数降低的植入式心律转复除颤器和衰弱：丹麦试验的延长随访。","authors":"Jawad H Butt, Johan Skovgaard Bundgaard, Morten Schou, Adelina Yafasova, Seiko N Doi, Jesper H Svendsen, Dan E Høfsten, Christian Hassager, Hans Eiskjær, Jens C Nielsen, Niels E Bruun, Lars Videbæk, Axel Brandes, Jens Jakob Thune, Steen Pehrson, Lars Køber","doi":"10.1016/j.amjcard.2025.08.068","DOIUrl":null,"url":null,"abstract":"<p><p>Patients with frailty are often perceived to have a less favorable risk/benefit profile for pharmacological and device-based therapies. We examined the long-term effects of a primary prevention implantable cardioverter-defibrillator (ICD), compared with usual care, according to frailty status in an extended follow-up study of the DANISH trial. The DANISH trial randomized 1,116 patients with non-ischemic HFrEF to ICD implantation or usual care. Frailty was measured using the Rockwood cumulative deficit approach. The primary outcome was all-cause death, and secondary outcomes were cardiovascular death and sudden cardiovascular death. A frailty index (FI) was calculable in 1,109 patients. In total, 618 (55.7%) patients were in frailty class 1 (FI <0.210, i.e., not frail), 361 (32.6%) in frailty class 2 (FI 0.211-0.310, i.e., more frail), and 130 (11.7%) in frailty class 3 (FI >0.311, i.e., most frail). Compared with patients in FI class 1, those in FI class 2 and 3 had a higher rate of all outcomes. The effect of ICD implantation on all-cause death did not vary significantly by frailty class (class 1, HR 0.92 [95% CI, 0.68-1.24]; class 2-3, 0.93 [0.73-1.19]; P<sub>interaction</sub>=0.99). Consistent effects were observed for cardiovascular death (P<sub>interaction</sub>=0.94), but not for sudden cardiovascular death (P<sub>interaction</sub>=0.03); the beneficial effect of ICD implantation on this outcome appeared to be greater in patients who were more frail. However, when the FI was analyzed as a continuous variable, frailty no longer significantly modified the effects of ICD implantation on any outcome. In conclusion, in patients with non-ischemic HFrEF, frailty did not significantly modify the effects of ICD implantation compared with usual care. However, the need for a primary prevention ICD in frail patients with HFrEF receiving contemporary guideline-directed medical therapy remains uncertain Clinical Trial Registration Number: NCT00542945.</p>","PeriodicalId":7705,"journal":{"name":"American Journal of Cardiology","volume":" ","pages":""},"PeriodicalIF":2.1000,"publicationDate":"2025-09-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Implantable Cardioverter-Defibrillator And Frailty In Non-ischemic Heart Failure With Reduced Ejection Fraction: Extended Follow-Up Of The DANISH Trial.\",\"authors\":\"Jawad H Butt, Johan Skovgaard Bundgaard, Morten Schou, Adelina Yafasova, Seiko N Doi, Jesper H Svendsen, Dan E Høfsten, Christian Hassager, Hans Eiskjær, Jens C Nielsen, Niels E Bruun, Lars Videbæk, Axel Brandes, Jens Jakob Thune, Steen Pehrson, Lars Køber\",\"doi\":\"10.1016/j.amjcard.2025.08.068\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p>Patients with frailty are often perceived to have a less favorable risk/benefit profile for pharmacological and device-based therapies. We examined the long-term effects of a primary prevention implantable cardioverter-defibrillator (ICD), compared with usual care, according to frailty status in an extended follow-up study of the DANISH trial. The DANISH trial randomized 1,116 patients with non-ischemic HFrEF to ICD implantation or usual care. Frailty was measured using the Rockwood cumulative deficit approach. The primary outcome was all-cause death, and secondary outcomes were cardiovascular death and sudden cardiovascular death. A frailty index (FI) was calculable in 1,109 patients. In total, 618 (55.7%) patients were in frailty class 1 (FI <0.210, i.e., not frail), 361 (32.6%) in frailty class 2 (FI 0.211-0.310, i.e., more frail), and 130 (11.7%) in frailty class 3 (FI >0.311, i.e., most frail). Compared with patients in FI class 1, those in FI class 2 and 3 had a higher rate of all outcomes. The effect of ICD implantation on all-cause death did not vary significantly by frailty class (class 1, HR 0.92 [95% CI, 0.68-1.24]; class 2-3, 0.93 [0.73-1.19]; P<sub>interaction</sub>=0.99). Consistent effects were observed for cardiovascular death (P<sub>interaction</sub>=0.94), but not for sudden cardiovascular death (P<sub>interaction</sub>=0.03); the beneficial effect of ICD implantation on this outcome appeared to be greater in patients who were more frail. However, when the FI was analyzed as a continuous variable, frailty no longer significantly modified the effects of ICD implantation on any outcome. In conclusion, in patients with non-ischemic HFrEF, frailty did not significantly modify the effects of ICD implantation compared with usual care. However, the need for a primary prevention ICD in frail patients with HFrEF receiving contemporary guideline-directed medical therapy remains uncertain Clinical Trial Registration Number: NCT00542945.</p>\",\"PeriodicalId\":7705,\"journal\":{\"name\":\"American Journal of Cardiology\",\"volume\":\" \",\"pages\":\"\"},\"PeriodicalIF\":2.1000,\"publicationDate\":\"2025-09-23\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"American Journal of Cardiology\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1016/j.amjcard.2025.08.068\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"CARDIAC & CARDIOVASCULAR SYSTEMS\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"American Journal of Cardiology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1016/j.amjcard.2025.08.068","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"CARDIAC & CARDIOVASCULAR SYSTEMS","Score":null,"Total":0}
Implantable Cardioverter-Defibrillator And Frailty In Non-ischemic Heart Failure With Reduced Ejection Fraction: Extended Follow-Up Of The DANISH Trial.
Patients with frailty are often perceived to have a less favorable risk/benefit profile for pharmacological and device-based therapies. We examined the long-term effects of a primary prevention implantable cardioverter-defibrillator (ICD), compared with usual care, according to frailty status in an extended follow-up study of the DANISH trial. The DANISH trial randomized 1,116 patients with non-ischemic HFrEF to ICD implantation or usual care. Frailty was measured using the Rockwood cumulative deficit approach. The primary outcome was all-cause death, and secondary outcomes were cardiovascular death and sudden cardiovascular death. A frailty index (FI) was calculable in 1,109 patients. In total, 618 (55.7%) patients were in frailty class 1 (FI <0.210, i.e., not frail), 361 (32.6%) in frailty class 2 (FI 0.211-0.310, i.e., more frail), and 130 (11.7%) in frailty class 3 (FI >0.311, i.e., most frail). Compared with patients in FI class 1, those in FI class 2 and 3 had a higher rate of all outcomes. The effect of ICD implantation on all-cause death did not vary significantly by frailty class (class 1, HR 0.92 [95% CI, 0.68-1.24]; class 2-3, 0.93 [0.73-1.19]; Pinteraction=0.99). Consistent effects were observed for cardiovascular death (Pinteraction=0.94), but not for sudden cardiovascular death (Pinteraction=0.03); the beneficial effect of ICD implantation on this outcome appeared to be greater in patients who were more frail. However, when the FI was analyzed as a continuous variable, frailty no longer significantly modified the effects of ICD implantation on any outcome. In conclusion, in patients with non-ischemic HFrEF, frailty did not significantly modify the effects of ICD implantation compared with usual care. However, the need for a primary prevention ICD in frail patients with HFrEF receiving contemporary guideline-directed medical therapy remains uncertain Clinical Trial Registration Number: NCT00542945.
期刊介绍：
Published 24 times a year, The American Journal of Cardiology® is an independent journal designed for cardiovascular disease specialists and internists with a subspecialty in cardiology throughout the world. AJC is an independent, scientific, peer-reviewed journal of original articles that focus on the practical, clinical approach to the diagnosis and treatment of cardiovascular disease. AJC has one of the fastest acceptance to publication times in Cardiology. Features report on systemic hypertension, methodology, drugs, pacing, arrhythmia, preventive cardiology, congestive heart failure, valvular heart disease, congenital heart disease, and cardiomyopathy. Also included are editorials, readers'' comments, and symposia.
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