Russo Andrea M, Desai Milind Y, Do Monika M, Butler Javed, Chung Mina K, Epstein Andrew E, Guglin Maya E, Levy Wayne C, Piccini Jonathan P, Bhave Nicole M, Russo Andrea M, Desai Milind Y, Do Monika M, Ambardekar Amrut V, Berg Nancy C, Bilchick Kenneth C, Dec G William, Gopinathannair Rakesh, Han Janet K, Klein Liviu, Lampert Rachel J, Panjrath Gurusher S, Reeves Ryan R, Yoerger Sanborn Danita Marie, Stevenson Lynne W, Truong Quynh A, Varosy Paul D, Villines Todd C, Volgman Annabelle S, Zareba Karolina M
J Am Coll Cardiol. 2025 Mar 25;85(11):1213-1285. doi: 10.1016/j.jacc.2024.11.023. Epub 2025 Jan 13.
This appropriate use criteria (AUC) document is developed by the American College of Cardiology along with key specialty and subspecialty societies. It provides a comprehensive review of common clinical scenarios where implantable cardioverter-defibrillator (ICD), cardiac resynchronization therapy (CRT), cardiac contractility modulation, leadless pacing, and conduction system pacing therapies are frequently considered. The 335 clinical scenarios covered in this document address ICD indications including those related to secondary prevention, primary prevention, comorbidities, generator replacement at elective replacement indicator, dual-chamber, and totally subcutaneous ICDs, as well as device indications related to CRT, conduction system pacing, leadless pacing, cardiac contractility modulation, and ICD therapy in the setting of left ventricular assist devices (LVADs). The indications (clinical scenarios) were derived from common applications or anticipated uses, as well as from current clinical practice guidelines and results of studies examining device implantation. The indications in this document were developed by a multidisciplinary writing group and scored by a separate independent rating panel on a scale of 1 to 9 to designate care that is considered “Appropriate” (median 7 to 9), “May Be Appropriate” (median 4 to 6), and “Rarely Appropriate” (median 1 to 3). The final ratings reflect the median score of the 17 rating panel members. In general, Appropriate designations were assigned to scenarios for which clinical trial evidence and/or clinical experience was available that supported device implantation. In contrast, scenarios for which clinical trial evidence was limited or device implantation seemed reasonable for extenuating or practical reasons were categorized as May Be Appropriate. Scenarios for which there were data showing harm, or no data were available, and medical judgment deemed device therapy was illadvised were categorized as Rarely Appropriate. For example, comorbidities including reduced life expectancy related to noncardiac conditions or severe cognitive dysfunction would negatively impact appropriateness ratings. The appropriate use criteria for ICD, CRT, and pacing have the potential to enhance clinician decision making, healthcare delivery, and payment policy. Furthermore, recognition of clinical scenarios rated as May Be Appropriate facilitates the identification of areas where there may be gaps in evidence that would benefit from future research.
这份合理使用标准(AUC)文件由美国心脏病学会联合主要专科和亚专科协会共同制定。它全面回顾了常见临床情况,在这些情况下,植入式心脏复律除颤器(ICD)、心脏再同步治疗(CRT)、心脏收缩力调制、无导线起搏和传导系统起搏治疗常被纳入考虑。本文件涵盖的335种临床情况涉及ICD的适应证,包括与二级预防、一级预防、合并症、择期更换指标时的发生器更换、双腔以及完全皮下ICD相关的适应证,以及与CRT、传导系统起搏、无导线起搏、心脏收缩力调制和左心室辅助装置(LVAD)情况下的ICD治疗相关的装置适应证。这些适应证(临床情况)源自常见应用或预期用途,以及当前临床实践指南和研究装置植入的研究结果。本文件中的适应证由一个多学科写作小组制定,并由一个独立的评级小组以1至9分的尺度进行评分,以指定被认为“合适”(中位数为7至9)、“可能合适”(中位数为4至6)和“很少合适”(中位数为1至3)的治疗。最终评级反映了17名评级小组成员的中位数得分。一般来说,对于有临床试验证据和/或临床经验支持装置植入的情况,指定为“合适”。相比之下,临床试验证据有限或因情有可原或实际原因装置植入似乎合理的情况被归类为“可能合适”。有数据显示有害或无数据可用且医学判断认为装置治疗不合适的情况被归类为“很少合适”。例如,包括与非心脏疾病相关的预期寿命缩短或严重认知功能障碍在内的合并症会对合适性评级产生负面影响。ICD、CRT和起搏的合理使用标准有可能改善临床医生的决策、医疗服务提供和支付政策。此外,识别被评为“可能合适”的临床情况有助于确定证据可能存在差距且将从未来研究中受益的领域。