Migliore Federico, Pittorru Raimondo, Dall'Aglio Pietro Bernardo, De Lazzari Manuel, Rovaris Giovanni, Piazzi Elena, Dentico Alessia, Ferrieri Alessandra, D'Angelo Giuseppe, Marzi Alessandra, Sawaf Basma El, Bertaglia Emanuele, Iliceto Sabino, Gerosa Gino, Tarzia Vincenzo, Carretta Domenico, Mazzone Patrizio
Department of Cardiac, Thoracic, Vascular Sciences and Public Health, University of Padova, Padova, Italy.
Department of Cardiology, San Gerardo Hospital, Monza, Italy.
J Cardiovasc Electrophysiol. 2023 Mar;34(3):728-737. doi: 10.1111/jce.15767. Epub 2022 Dec 21.
Lead dwell time >10 years is a recognized predictor for transvenous lead extraction (TLE) failure and complications. Data on the efficacy and safety of TLE using the bidirectional rotational mechanical sheaths in patients with very old leads are lacking. In this multicenter study, we reported the outcomes of transvenous rotational mechanical lead extraction in patients with leads implanted for ≥10 years.
A total of 441 leads (median: 159 months [135-197]; range: 120-487) in 189 consecutive patients were removed with the Evolution RL sheaths (Cook Medical, Bloomingtom, IN, USA) and mechanical ancillary tools supporting the procedures.
The main indication for TLE was infection in 74% of cases. Complete procedural success rate, clinical success rate, per lead were 94.8% and 98.2%, respectively. Failure of lead extraction was seen in 1.8% of leads. The additional use of a snare via the femoral approach was required in 9% of patients. Lead dwell time was the only predictor of incomplete led removal (odds ratio: 1.009; 95% confidence interval [CI]: 1.003-1.014; p = .002). Four major complication (2%) were encountered. During a mean time follow-up of 31 ± 27 months, 21 patients (11%) died. No procedure-related mortality occurred. Predictors of mortality included severe left ventricular systolic dysfunction (hazard ratio [HR]: 8.06; 95% CI: 2.99-21.73; p = .001), TLE for infection (HR: 8.0; 95% CI: 1.04-62.5; p = .045), diabetes (HR: 3.7; 95% CI: 1.48-9.5; p = .005), and previous systemic infection (HR: 3.1; 95% CI: 1.17-8.24; p = .022). Incomplete lead removal or failure lead extraction did not impact on survival during follow-up.
Our findings demonstrated that the use of bidirectional rotational TLE mechanical sheaths combined with different mechanical tools and femoral approach allows reasonable success and safety in patients with very old leads at experienced specialized centers.
导线植入时间>10年是经静脉导线拔除术(TLE)失败及并发症的公认预测因素。目前缺乏关于在导线植入时间很长的患者中使用双向旋转机械鞘进行TLE的有效性和安全性的数据。在这项多中心研究中,我们报告了导线植入≥10年患者经静脉旋转机械导线拔除术的结果。
使用Evolution RL鞘(美国印第安纳州布卢明顿市库克医疗公司)及辅助机械工具,为189例连续患者拔除了总共441根导线(中位数:159个月[135 - 197];范围:120 - 487)。
TLE的主要指征在74%的病例中为感染。手术成功率、临床成功率分别为94.8%和98.2%。1.8%的导线拔除失败。9%的患者需要经股动脉途径额外使用圈套器。导线植入时间是导线拔除不完全的唯一预测因素(比值比:1.009;95%置信区间[CI]:1.003 - 1.014;p = 0.002)。发生了4例严重并发症(2%)。在平均31±27个月的随访期间,21例患者(11%)死亡。未发生与手术相关的死亡。死亡的预测因素包括严重左心室收缩功能障碍(风险比[HR]:8.06;95%CI:2.99 - 21.73;p = 0.001)、因感染进行TLE(HR:8.0;95%CI:1.04 - 62.5;p = 0.045)、糖尿病(HR:3.7;95%CI:1.48 - 9.5;p = 0.005)以及既往全身感染(HR:3.1;95%CI:1.17 - 8.24;p = 0.022)。导线拔除不完全或失败对随访期间的生存无影响。
我们的研究结果表明,在经验丰富的专业中心,对于导线植入时间很长的患者,使用双向旋转TLE机械鞘结合不同机械工具及经股动脉途径可取得合理的成功率和安全性。