High recurrence of device-related adverse events following transvenous lead extraction procedure in patients with cardiac resynchronization devices
High recurrence of device-related adverse events following transvenous lead extraction procedure in patients with cardiac resynchronization devices
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DOI：
10.1002/ejhf.558
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发表时间：
2016-10-01
影响因子：
18.2
通讯作者：
Auricchio, Angelo
中科院分区：
文献类型：
--
作者：
Regoli, Francois;Bongiorni, Maria Grazia;Auricchio, Angelo
介绍心脏起搏治疗（CRT）患者经静脉电极导线拔除（TLE）后的临床结局和复发性系统相关不良事件（SAE）知之甚少。（平均年龄68.3 ± 11.6岁，216名男性，88%为纽约心脏协会II-IV级，射血分数35.1 ± 10.8%）在四家欧洲机构治疗TLE。TLE的适应症包括全身（18%）或局部（45%）感染、系统故障（34%）或其他（3%）。回顾性收集人口统计学、临床、TLE手术和随访数据。不良事件（AE）被视为全因死亡、心血管住院和SAE（SAE包括囊袋和/或全身感染、电极导线故障或需要翻修的囊袋血肿）。614根电极导线中有609根（99.2%）通过手动牵引（28%）、机械（52%）或激光（20%）鞘管完全取出。中位随访21个月（四分位距12-29），任何AE和SAE的累积发生率分别为53.9%和21.1%。23例患者（9.0%）发生复发性系统故障，16例患者（6.2%）发生感染，15例患者（5.9%）发生囊袋血肿需要翻修。口服抗凝治疗是任何AE [风险比（HR）2.09，95%置信区间（CI）1.35-3.22，P = 0.001]和SAE的独立预测因子（HR 2.38，95%CI 1.21-4.68，P = 0.012）。结论TLE治疗CRT患者安全有效，在中期随访时观察到TLE后复发SAE的高负担。当CRT患者出现TLE时，建议仔细评估患者特征和植入策略，尤其是接受口服抗凝治疗的患者。
IntroductionLittle is known about the clinical outcome and recurring system-related adverse events (SAE) in cardiac resynchronization therapy (CRT) patients after transvenous lead extraction (TLE).Methods and resultsFrom January 2009 to June 2014, 256 consecutive CRT patients (mean age 68.3 11.6 years, 216 male, 88% in New York Heart Association class II-IV, ejection fraction 35.1 +/- 10.8%) were treated at four European institutions with TLE. Indications for TLE included systemic (18%) or local (45%) infection, system malfunction (34%), or other (3%). Demographic, clinical, TLE procedural, and follow-up data were collected retrospectively. Adverse events (AE) were considered as death from any cause, cardiovascular hospitalization, and SAE (SAE included pocket and/or systemic infection, lead malfunction, or pocket haematoma requiring revision). Complete removal was achieved for 609 out of 614 leads (99.2%) by using either manual traction (28%), mechanical (52%) or laser (20%) sheaths. Over a median follow-up of 21 (interquartile range 12-29) months, cumulative incidences of any AE and SAE were 53.9% and 21.1%, respectively. Recurring system malfunction occurred in 23 patients (9.0%), infection in 16 patients (6.2%), and pocket haematoma requiring revision in 15 patients (5.9%). Oral anticoagulation therapy was an independent predictor of both any AE [hazard ratio (HR) 2.09, 95% confidence interval (CI) 1.35-3.22, P = 0.001] and SAE (HR 2.38, 95% CI 1.21-4.68, P = 0.012) after TLE.ConclusionsEven though TLE is safe and effective to treat CRT patients, a high burden of recurring SAE after TLE was observed at mid-term follow-up. Careful evaluation of both patient characteristics as well as implantation strategy is suggested when indicating TLE in a CRT patient, particularly in patients receiving oral anticoagulation therapy.