Haut Lévèque University Hospital, Pessac, France.
Hôpital Privé du Confluent, Nantes, France.
Heart Rhythm. 2018 Jun;15(6):870-876. doi: 10.1016/j.hrthm.2017.12.028. Epub 2017 Dec 26.
Cardiac resynchronization therapy (CRT) is an effective treatment of heart failure (HF), but is limited by a substantial proportion of nonresponders. We hypothesized that adding a second left ventricular (LV) lead to deliver a triple-site CRT (V CRT) may improve clinical status of CRT nonresponders.
We assessed the feasibility and safety of adding a second LV lead to CRT nonresponders and its clinical impact.
Eighty-four recipients of a CRT system and considered as nonresponders as per clinical composite score (CCS) were enrolled in this multicenter study. They were randomized to the V arm (implantation of an additional LV lead; n = 43) or control arm (no change; n = 41). Implant success rate, incidence of severe adverse events, CCS, and secondary clinical and echocardiographic end points were evaluated at 12 and 24 months.
Positioning of a second LV lead was successful at first (40 of 44 - 90.9%) or second (4 of 44 - 9.09%) attempt. The perioperative complication rate (infection, system explant, pneumothorax, and hematoma) was high (procedures or system-related complications for 9 patients- 20.4%). After 24 months, 35 systems (79.5%) were working properly. The multinomial logistic regression model showed that V treatment had no significant influence (P = .27) on the CCS, number of HF hospitalizations, time to first HF hospitalization, New York Heart Association class, and LV ejection fraction at 12 and 24 months.
Although addition of a second LV lead in CRT nonresponders is feasible with a high success rate, this approach is associated with a significant rate of severe adverse events and does not provide significant long-term clinical benefits (ClinicalTrials.gov Identifier No. NCT01059175).
心脏再同步治疗（CRT）是心力衰竭（HF）的有效治疗方法，但很大一部分患者对此无反应。我们假设，在 CRT 无反应者中增加第二个左心室（LV）导联以提供三部位 CRT（V CRT）可能会改善 CRT 无反应者的临床状态。
我们评估了在 CRT 无反应者中增加第二个 LV 导联的可行性、安全性及其临床影响。
本多中心研究纳入了 84 例接受 CRT 系统治疗且根据临床综合评分（CCS）被认为是无反应者的患者。他们被随机分配到 V 组（植入额外的 LV 导联；n = 43）或对照组（无变化；n = 41）。在 12 个月和 24 个月时评估植入成功率、严重不良事件发生率、CCS 和次要临床及超声心动图终点。
在首次（44 例中的 40 例，90.9%）或第二次尝试（44 例中的 4 例，9.09%）中，成功放置第二个 LV 导联。围手术期并发症发生率（感染、系统取出、气胸和血肿）较高（9 例患者发生手术或系统相关并发症-20.4%）。24 个月后，有 35 个系统（79.5%）正常工作。多项逻辑回归模型显示，V 治疗对 CCS、HF 住院次数、首次 HF 住院时间、纽约心脏协会（NYHA）心功能分级和 12 个月和 24 个月时的 LV 射血分数均无显著影响（P =.27）。
尽管 CRT 无反应者中增加第二个 LV 导联是可行的，成功率较高，但这种方法与严重不良事件发生率高相关，并且不能提供显著的长期临床益处（ClinicalTrials.gov 标识符：NCT01059175）。
