Reinoud E Knops, Jolien A de Veld, Abdul Ghani, Lucas V A Boersma, Juergen Kuschyk, Mikhael F El Chami, Hendrik Bonnemeier, Elijah R Behr, Tom F Brouwer, Stefan Kääb, Suneet Mittal, Shari Pepplinkhuizen, Anne-Floor B E Quast, Lonneke Smeding, Willeke van der Stuijt, Anouk de Weger, Nick R Bijsterveld, Sergio Richter, Marc A Brouwer, Joris R de Groot, Kirsten M Kooiman, Pier D Lambiase, Petr Neuzil, Kevin Vernooy, Marco Alings, Timothy R Betts, Frank A L E Bracke, Martin C Burke, Jonas S S G de Jong, David J Wright, Ward P J Jansen, Zachary I Whinnett, Peter Nordbeck, Michael Knaut, Berit T Philbert, Jurren M van Opstal, Alexandru B Chicos, Cornelis P Allaart, Alida E Borger van der Burg, Jose M Dizon, Marc A Miller, Dmitry Nemirovksy, Ralf Surber, Gaurav A Upadhyay, Jan G P Tijssen, Arthur A M Wilde, Louise R A Olde Nordkamp
{"title":"皮下或经静脉植入式心律转复除颤器患者的生活质量：PRAETORIAN 试验的二次分析。","authors":"Reinoud E Knops, Jolien A de Veld, Abdul Ghani, Lucas V A Boersma, Juergen Kuschyk, Mikhael F El Chami, Hendrik Bonnemeier, Elijah R Behr, Tom F Brouwer, Stefan Kääb, Suneet Mittal, Shari Pepplinkhuizen, Anne-Floor B E Quast, Lonneke Smeding, Willeke van der Stuijt, Anouk de Weger, Nick R Bijsterveld, Sergio Richter, Marc A Brouwer, Joris R de Groot, Kirsten M Kooiman, Pier D Lambiase, Petr Neuzil, Kevin Vernooy, Marco Alings, Timothy R Betts, Frank A L E Bracke, Martin C Burke, Jonas S S G de Jong, David J Wright, Ward P J Jansen, Zachary I Whinnett, Peter Nordbeck, Michael Knaut, Berit T Philbert, Jurren M van Opstal, Alexandru B Chicos, Cornelis P Allaart, Alida E Borger van der Burg, Jose M Dizon, Marc A Miller, Dmitry Nemirovksy, Ralf Surber, Gaurav A Upadhyay, Jan G P Tijssen, Arthur A M Wilde, Louise R A Olde Nordkamp","doi":"10.1161/CIRCOUTCOMES.124.010822","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>The subcutaneous implantable cardioverter-defibrillator (S-ICD) was developed to overcome the risk of lead-related complications associated with the transvenous implantable cardioverter-defibrillator (TV-ICD). In contrast to the TV-ICD, the S-ICD is a completely extrathoracic device. Subsequently, complications differ between these 2 implantable cardioverter-defibrillators, which might impact patient perceptions of the therapies. This prespecified secondary analysis of the PRAETORIAN trial evaluates differences in quality of life.</p><p><strong>Methods: </strong>The PRAETORIAN trial (A Prospective, Randomized Comparison of Subcutaneous and Transvenous Implantable Cardioverter Defibrillator Therapy) randomized patients with an implantable cardioverter-defibrillator indication, without the need for pacing to S-ICD or TV-ICD therapy. Two questionnaires were collected at baseline, discharge, 12 months, and 30 months. The Duke Activity Status Index measures cardiac-specific physical functioning, and the 36-Item Short Form Health Survey measures physical and mental well-being, with the subscales bodily pain and mental health being of interest in this analysis. Mann-Whitney <i>U</i> tests were used to compare study arms, and a mixed model was used to describe the questionnaire outcomes over time.</p><p><strong>Results: </strong>Patients were randomized to S-ICD (n=426) and TV-ICD (n=423). In the S-ICD group, 20% were women versus 19% in the TV-ICD group. The median age was 63 (interquartile range, 54-69) years in the S-ICD group versus 64 (interquartile range, 56-69) years in the TV-ICD group. There were no significant differences in the Duke Activity Status Index and 36-Item Short Form Health Survey subscales for bodily pain and mental health between the groups at any time point. Patients with a shock in the last 90 days had significantly lower scores for social functioning (<i>P</i>=0.008) and role limitations due to emotional problems (<i>P</i>=0.001) than patients without a shock, but this effect did not differ between treatment arms.</p><p><strong>Conclusions: </strong>In a large randomized cohort of patients with an S-ICD or TV-ICD, no difference in overall quality of life was observed. However, implantable cardioverter-defibrillator shocks resulted in a reduction in quality of life, regardless of the device type or appropriateness.</p><p><strong>Registration: </strong>URL: https://www.clinicaltrials.gov; Unique identifier: NCT01296022.</p>","PeriodicalId":49221,"journal":{"name":"Circulation-Cardiovascular Quality and Outcomes","volume":"17 11","pages":"e010822"},"PeriodicalIF":6.2000,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11575910/pdf/","citationCount":"0","resultStr":"{\"title\":\"Quality of Life in Subcutaneous or Transvenous Implantable Cardioverter-Defibrillator Patients: A Secondary Analysis of the PRAETORIAN Trial.\",\"authors\":\"Reinoud E Knops, Jolien A de Veld, Abdul Ghani, Lucas V A Boersma, Juergen Kuschyk, Mikhael F El Chami, Hendrik Bonnemeier, Elijah R Behr, Tom F Brouwer, Stefan Kääb, Suneet Mittal, Shari Pepplinkhuizen, Anne-Floor B E Quast, Lonneke Smeding, Willeke van der Stuijt, Anouk de Weger, Nick R Bijsterveld, Sergio Richter, Marc A Brouwer, Joris R de Groot, Kirsten M Kooiman, Pier D Lambiase, Petr Neuzil, Kevin Vernooy, Marco Alings, Timothy R Betts, Frank A L E Bracke, Martin C Burke, Jonas S S G de Jong, David J Wright, Ward P J Jansen, Zachary I Whinnett, Peter Nordbeck, Michael Knaut, Berit T Philbert, Jurren M van Opstal, Alexandru B Chicos, Cornelis P Allaart, Alida E Borger van der Burg, Jose M Dizon, Marc A Miller, Dmitry Nemirovksy, Ralf Surber, Gaurav A Upadhyay, Jan G P Tijssen, Arthur A M Wilde, Louise R A Olde Nordkamp\",\"doi\":\"10.1161/CIRCOUTCOMES.124.010822\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>The subcutaneous implantable cardioverter-defibrillator (S-ICD) was developed to overcome the risk of lead-related complications associated with the transvenous implantable cardioverter-defibrillator (TV-ICD). 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引用次数: 0
摘要
背景：开发皮下植入式心律转复除颤器（S-ICD）的目的是为了克服与经静脉植入式心律转复除颤器（TV-ICD）相关的导联并发症风险。与 TV-ICD 不同的是，S-ICD 完全是一种胸外装置。因此，这两种植入式心律转复除颤器的并发症有所不同，这可能会影响患者对疗法的看法。这项 PRAETORIAN 试验的预设二次分析评估了生活质量的差异：PRAETORIAN试验（皮下和经静脉植入式心律转复除颤器治疗的前瞻性随机比较）对具有植入式心律转复除颤器适应症且无需起搏的患者随机进行了S-ICD或TV-ICD治疗。在基线、出院、12 个月和 30 个月时收集了两份问卷。杜克活动状态指数（Duke Activity Status Index）用于测量心脏特异性身体功能，36项简表健康调查（36-Item Short Form Health Survey）用于测量身心健康，其中身体疼痛和心理健康是本次分析的重点。采用曼-惠特尼U检验来比较各研究臂，并采用混合模型来描述随时间变化的问卷结果：患者被随机分为 S-ICD 组（426 人）和 TV-ICD 组（423 人）。S-ICD组中女性占20%，而TV-ICD组中女性占19%。S-ICD组的中位年龄为63岁（四分位间范围为54-69岁），而TV-ICD组为64岁（四分位间范围为56-69岁）。在任何时间点，两组患者的杜克活动状态指数和 36 项简表健康调查中有关身体疼痛和心理健康的分量表均无明显差异。在过去90天内受过电击的患者在社会功能（P=0.008）和因情绪问题导致的角色限制（P=0.001）方面的得分明显低于未受过电击的患者，但这种影响在不同治疗组之间没有差异：结论：在一个大型随机队列中，接受 S-ICD 或 TV-ICD 治疗的患者的总体生活质量没有差异。然而，植入式心律转复除颤器电击导致生活质量下降，与设备类型或适当性无关：URL：https://www.clinicaltrials.gov；唯一标识符：NCT01296022。
Quality of Life in Subcutaneous or Transvenous Implantable Cardioverter-Defibrillator Patients: A Secondary Analysis of the PRAETORIAN Trial.
Background: The subcutaneous implantable cardioverter-defibrillator (S-ICD) was developed to overcome the risk of lead-related complications associated with the transvenous implantable cardioverter-defibrillator (TV-ICD). In contrast to the TV-ICD, the S-ICD is a completely extrathoracic device. Subsequently, complications differ between these 2 implantable cardioverter-defibrillators, which might impact patient perceptions of the therapies. This prespecified secondary analysis of the PRAETORIAN trial evaluates differences in quality of life.
Methods: The PRAETORIAN trial (A Prospective, Randomized Comparison of Subcutaneous and Transvenous Implantable Cardioverter Defibrillator Therapy) randomized patients with an implantable cardioverter-defibrillator indication, without the need for pacing to S-ICD or TV-ICD therapy. Two questionnaires were collected at baseline, discharge, 12 months, and 30 months. The Duke Activity Status Index measures cardiac-specific physical functioning, and the 36-Item Short Form Health Survey measures physical and mental well-being, with the subscales bodily pain and mental health being of interest in this analysis. Mann-Whitney U tests were used to compare study arms, and a mixed model was used to describe the questionnaire outcomes over time.
Results: Patients were randomized to S-ICD (n=426) and TV-ICD (n=423). In the S-ICD group, 20% were women versus 19% in the TV-ICD group. The median age was 63 (interquartile range, 54-69) years in the S-ICD group versus 64 (interquartile range, 56-69) years in the TV-ICD group. There were no significant differences in the Duke Activity Status Index and 36-Item Short Form Health Survey subscales for bodily pain and mental health between the groups at any time point. Patients with a shock in the last 90 days had significantly lower scores for social functioning (P=0.008) and role limitations due to emotional problems (P=0.001) than patients without a shock, but this effect did not differ between treatment arms.
Conclusions: In a large randomized cohort of patients with an S-ICD or TV-ICD, no difference in overall quality of life was observed. However, implantable cardioverter-defibrillator shocks resulted in a reduction in quality of life, regardless of the device type or appropriateness.
期刊介绍：
Circulation: Cardiovascular Quality and Outcomes, an American Heart Association journal, publishes articles related to improving cardiovascular health and health care. Content includes original research, reviews, and case studies relevant to clinical decision-making and healthcare policy. The online-only journal is dedicated to furthering the mission of promoting safe, effective, efficient, equitable, timely, and patient-centered care. Through its articles and contributions, the journal equips you with the knowledge you need to improve clinical care and population health, and allows you to engage in scholarly activities of consequence to the health of the public. Circulation: Cardiovascular Quality and Outcomes considers the following types of articles: Original Research Articles, Data Reports, Methods Papers, Cardiovascular Perspectives, Care Innovations, Novel Statistical Methods, Policy Briefs, Data Visualizations, and Caregiver or Patient Viewpoints.
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