Patient Preferences for Features Associated With Leadless Versus Conventional Transvenous Cardiac Pacemakers.

IF 6.2 2区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS
Shelby D Reed, Jui-Chen Yang, Matthew J Wallace, Jessie Sutphin, F Reed Johnson, Semra Ozdemir, Stephanie M Delgado, Scott Goates, Nicole Harbert, Monica Lo, Bharath Rajagopalan, James E Ip, Sana M Al-Khatib
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引用次数: 0

Abstract

Background: Regulatory approval of the first dual-chamber leadless pacemaker system provides patients an alternative to conventional transvenous pacemakers. The study objective was to quantify the preferences of patients for pacemaker features.

Methods: Patients with a de novo (ie, initial) pacemaker indication were recruited from 7 US sites to complete a Web-based discrete-choice experiment survey between May 11, 2022, and May 24, 2023. Patients chose between pairs of experimentally designed, hypothetical pacemakers that varied according to type (removable leadless, nonremovable leadless, or conventional transvenous); battery life (5, 8, 12, or 15 years); time since regulatory approval (2 or 10 years); discomfort for 6 months (none or discomfort); and complication risk and infection risk (1%, 5%, or 10%/20% for each). Patients' choice data were analyzed using random-parameter logit models and latent-class analysis.

Results: Among 117 participants, the mean (SD) age was 67.3 (14.6) years, 94% were white, and 42% were female. On average, patients' survey responses revealed a preference for removable leadless pacemakers (β, 0.340; SE, 0.096) over both nonremovable leadless pacemakers (β, -0.310; SE, 0.131; P=0.001) and conventional transvenous pacemakers (β, -0.030; SE, 0.119; P=0.031). However, latent-class analysis revealed 2 distinct preference classes. One class preferred leadless pacemakers (50.5%), and the other class preferred conventional transvenous pacemakers (49.5%). The conventional pacemaker class prioritized pacemakers with 10 rather than 2 years since regulatory approval (P<0.001), whereas the leadless pacemaker class was insensitive to years since regulatory approval (P=0.83). Complication risks and infection risks were found to be the most influential. All else equal, patients would accept maximum risks of complications or infections ranging about 5% to 18% to receive their preferred pacemaker type.

Conclusions: Latent-class analysis revealed strong patient preferences for the type of pacemaker, with a nearly equal split between recent leadless pacemaker technology and conventional transvenous pacemakers. These findings can inform shared decision-making between health care providers and patients.

Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT05327101.

患者对无引线与传统经静脉心脏起搏器相关功能的偏好。
背景:首个双腔无导线起搏器系统获得监管部门批准,为患者提供了传统经静脉起搏器的替代选择。研究目的是量化患者对起搏器功能的偏好:方法:在 2022 年 5 月 11 日至 2023 年 5 月 24 日期间,从美国 7 个地点招募了具有新起搏器适应症(即初始起搏器适应症)的患者,让他们完成一项基于网络的离散选择实验调查。患者在实验设计的假定起搏器中进行选择,起搏器的类型(可移除无引线、不可移除无引线或传统经静脉);电池寿命(5、8、12 或 15 年);自监管部门批准以来的时间(2 或 10 年);6 个月的不适感(无或不适);以及并发症风险和感染风险(各为 1%、5% 或 10%/20%)。采用随机参数对数模型和潜类分析法对患者的选择数据进行了分析:在 117 名参与者中,平均(标清)年龄为 67.3(14.6)岁,94% 为白人,42% 为女性。平均而言,患者的调查反馈显示他们更倾向于使用可拆卸式无引线起搏器(β,0.340;SE,0.096),而非不可拆卸式无引线起搏器(β,-0.310;SE,0.131;P=0.001)和传统经静脉起搏器(β,-0.030;SE,0.119;P=0.031)。然而,潜类分析显示出两个不同的偏好类别。一类偏好无引线起搏器(50.5%),另一类偏好传统经静脉起搏器(49.5%)。传统起搏器类别优先选择自监管部门批准后 10 年而非 2 年的起搏器(PP=0.83)。并发症风险和感染风险被认为是影响最大的因素。在其他条件相同的情况下,患者愿意接受并发症或感染的最大风险约为5%至18%,以接受其偏好的起搏器类型:潜在类别分析显示,患者对起搏器类型有强烈的偏好,最新的无引线起搏器技术和传统的经静脉起搏器几乎各占一半。这些发现可为医疗服务提供者和患者之间的共同决策提供参考:URL:https://www.clinicaltrials.gov;唯一标识符:NCT05327101。
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来源期刊
Circulation-Cardiovascular Quality and Outcomes
Circulation-Cardiovascular Quality and Outcomes CARDIAC & CARDIOVASCULAR SYSTEMS-
CiteScore
8.50
自引率
2.90%
发文量
357
审稿时长
4-8 weeks
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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