Loughlin Gerard, Datino Tomás, Arenal Ángel, Ruiz-Granell Ricardo, Sánchez-Gómez Juan Miguel, Pérez Luisa, Martínez-Ferrer José, Alzueta Javier, Pérez-Lorente Fernando, Viñolas Xavier, Fidalgo Andrés María Luisa, Fernández de la Concha Joaquín
Servicio de Cardiología, Hospital General Universitario Gregorio Marañón, Madrid, Spain; Unidad de Arritmias, Servicio de Cardiología, Complejo Hospitalario Universitario de Toledo, Toledo, Spain.
Servicio de Cardiología, Hospital General Universitario Gregorio Marañón, Madrid, Spain.
Rev Esp Cardiol (Engl Ed). 2021 Apr;74(4):296-302. doi: 10.1016/j.rec.2020.06.017. Epub 2020 Aug 6.
The ADVANCE III trial showed that a delayed-detection strategy reduces implantable cardioverter-defibrillator (ICD) therapies. Here, we describe the adherence to and predictors of ADVANCE adoption and compare ICD therapy rates between patients with and without ADVANCE programming.
This observational retrospective study analyzed patients implanted with Medtronic ICDs included from 2005 to 2016 in a Spanish national multicenter registry (UMBRELLA database; ClinicalTrials.gov, NCT01561144). Changes in ADVANCE programming adoption were described in relation to a) publication of the ADVANCE trial, b) implementation of an "ADVANCE awareness" campaign, and c) publication of an expert consensus statement. Multivariate logistic regression identified predictors of adoption. Therapy incidence rates were compared between groups by estimating the adjusted incidence rate ratio (aIRR) using negative binomial regression.
A total of 3528 patients were included. An ADVANCE strategy was used in 20% overall and in 44% at the end of the study. ADVANCE III adoption increased after trial publication, with less growth after an "ADVANCE awareness" campaign and after expert consensus statement publication. Predictors of ADVANCE adoption were as follows: ICD device with a nominal number of intervals to detect 30/40 (aOR, 4.4; 95%CI, 3.5-5.4), implantation by an electrophysiologist (aOR, 1.7; 95%CI, 1.4-2.2), and secondary prevention (aOR, 3.2; 95%CI, 2.6-3.9). Dual-chamber ICDs (aOR, 0.6; 95%CI, 0.5-0.8) and cardiac resynchronization-defibrillators (aOR, 0.5; 95%CI, 0.4-0.7) were associated with lower adoption. ADVANCE programming was associated with reduced total therapy burden (aIRR, 0.77; 95%CI, 0.69-0.86) and fewer inappropriate shocks (aIRR, 0.66; 95%CI, 0.52-0.85).
ADVANCE adoption remains modest and can be improved through evidence-driven selection of nominal ICD settings. ADVANCE programming is associated with reduced therapy rates in real-world ICD recipients.
ADVANCE III试验表明,延迟检测策略可减少植入式心脏复律除颤器(ICD)治疗。在此,我们描述了ADVANCE方案的采用情况及其预测因素,并比较了采用和未采用ADVANCE方案的患者之间的ICD治疗率。
这项观察性回顾性研究分析了2005年至2016年纳入西班牙国家多中心注册库(UMBRELLA数据库;ClinicalTrials.gov,NCT01561144)的植入美敦力ICD的患者。根据以下因素描述了ADVANCE方案采用情况的变化:a)ADVANCE试验的发表,b)“ADVANCE认知”活动的开展,以及c)专家共识声明的发表。多因素逻辑回归确定了采用的预测因素。通过使用负二项回归估计调整后的发病率比(aIRR)来比较各组之间的治疗发生率。
共纳入3528例患者。总体上20%的患者采用了ADVANCE策略,研究结束时这一比例为44%。ADVANCE III方案在试验发表后采用率增加,在“ADVANCE认知”活动开展后以及专家共识声明发表后的增长较少。ADVANCE方案采用的预测因素如下:具有30/40个检测间期标称数量的ICD设备(调整后比值比[aOR],4.4;95%置信区间[CI],3.5 - 5.4)、由电生理学家植入(aOR,1.7;95%CI,1.4 - 2.2)以及二级预防(aOR,3.2;95%CI,2.6 - 3.9)。双腔ICD(aOR,0.6;95%CI,0.5 - 0.8)和心脏再同步除颤器(aOR,0.5;95%CI,0.4 - 0.7)与较低的采用率相关。ADVANCE方案与总治疗负担降低相关(aIRR,0.77;95%CI,0.69 - 0.86)以及不适当电击次数减少相关(aIRR,0.66;95%CI,0.52 - 0.85)。
ADVANCE方案的采用率仍然较低,可通过基于证据选择ICD标称设置来提高。在现实世界中,ADVANCE方案与ICD接受者的治疗率降低相关。