Brignole Michele, Sutton Richard, Menozzi Carlo, Garcia-Civera Roberto, Moya Angel, Wieling Wouter, Andresen Dietrich, Benditt David G, Vardas Panos
Department of Cardiology, Arrhythmologic Centre, Ospedali del Tigullio, Lavagna, Italy.
Eur Heart J. 2006 May;27(9):1085-92. doi: 10.1093/eurheartj/ehi842. Epub 2006 Mar 28.
This prospective multicentre observational study assessed the efficacy of specific therapy based on implantable loop recorder (ILR) diagnostic observations in patients with recurrent suspected neurally mediated syncope (NMS).
Patients with three or more clinically severe syncopal episodes in the last 2 years without significant electrocardiographic and cardiac abnormalities were included. Orthostatic hypotension and carotid sinus syncope were excluded. After ILR implantation, patients were followed until the first documented syncope (Phase I). The ILR documentation of this episode determined the subsequent therapy and commenced Phase II follow-up. Among 392 patients, the 1-year recurrence rate of syncope during Phase I was 33%. One hundred and three patients had a documented episode and entered Phase II: 53 patients received specific therapy [47 a pacemaker because of asystole of a median 11.5 s duration and six anti-tachyarrhythmia therapy (catheter ablation: four, implantable defibrillator: one, anti-arrhythmic drug: one)] and the remaining 50 patients did not receive specific therapy. The 1-year recurrence rate in 53 patients assigned to a specific therapy was 10% (burden 0.07 +/- 0.2 episodes per patient/year) compared with 41% (burden 0.83 +/- 1.57 episodes per patient/year) in the patients without specific therapy (80% relative risk reduction for patients, P = 0.002, and 92% for burden, P = 0.002). The 1-year recurrence rate in patients with pacemakers was 5% (burden 0.05 +/- 0.15 episodes per patient/year). Severe trauma secondary to syncope relapse occurred in 2% and mild trauma in 4% of the patients.
A strategy based on early diagnostic ILR application, with therapy delayed until documentation of syncope allows a safe, specific, and effective therapy in patients with NMS.
这项前瞻性多中心观察性研究评估了基于植入式循环记录仪(ILR)诊断结果的特异性治疗对复发性疑似神经介导性晕厥(NMS)患者的疗效。
纳入过去2年中有3次或更多次临床严重晕厥发作且无明显心电图和心脏异常的患者,排除体位性低血压和颈动脉窦晕厥患者。植入ILR后,对患者进行随访直至首次记录到晕厥(第一阶段)。该发作的ILR记录决定后续治疗并开始第二阶段随访。在392例患者中,第一阶段晕厥的1年复发率为33%。103例患者有记录发作并进入第二阶段:53例患者接受特异性治疗[47例因中位时长11.5秒的心脏停搏植入起搏器,6例接受抗快速心律失常治疗(导管消融:4例,植入式心脏除颤器:1例,抗心律失常药物:1例)],其余50例患者未接受特异性治疗。接受特异性治疗的53例患者的1年复发率为10%(每位患者每年发作负担0.07±0.2次),而未接受特异性治疗的患者为41%(每位患者每年发作负担0.83±1.57次)(患者相对风险降低80%,P = 0.002;发作负担降低92%,P = 0.002)。植入起搏器患者的1年复发率为5%(每位患者每年发作负担0.05±0.15次)。晕厥复发导致的严重创伤发生在2%的患者中,轻度创伤发生在4%的患者中。
基于早期应用诊断性ILR的策略,治疗延迟至记录到晕厥后进行,可为NMS患者提供安全、特异且有效的治疗。