Division of Cardiology, DRK Kliniken Berlin I Köpenick, Medizinische Klinik I, Salvador-Allende-Str. 2-8, D-12559 Berlin, Germany.
Europace. 2011 Mar;13(3):416-20. doi: 10.1093/europace/euq394. Epub 2010 Nov 11.
Wound healing is a major determent in the post-surgical course of patients (pts) after pacemaker (PM) and implantable cardioverter defibrillator (ICD) implantation. Insufficient closure may lead to serious complications with pocket infections leading to the device's explantation as the worst case scenario. In addition to the different types of suture and suture clips, a novel topical skin adhesive containing 2-octyl-cyanoacrylate is commercially available.
Over a period of 18 months, we prospectively assigned all cases of PM, ICD, and loop recorder implants either to skin adhesive (Group 1) or to absorbable intracutaneous polydioxanon suture (Group 2). Data were analysed with respect to operation time, wound infections, and healing disorders. One hundred and eighty-three pts were randomized into Group 1 [71 PMs, 60 ICD, 15 cardiac resynchronization therapy (CRT), 11 loop recorders, and 26 generator replacements]. One hundred and eighty-five pts were assigned to Group 2 (62 PMs, 70 ICD, 30 CRT, 7 loop recorders, and 16 generator replacements). There were no differences regarding sex, diabetes, renal insufficiency, corticosteroid therapy, oral anticoagulants, and acetylsalicylic asa/clopidogrel (P = n.s.). For the significantly higher amount of CRT devices (P < 0.05) in Group 2, the procedure times are given for surgeries except CRT. It was 49.1 ± 27.7 min for Group 1 and 53.4 ± 31.9 min for Group 2 (P = n.s.). Adverse events as insufficient closure, major and minor bleeding, pocket haematoma, erythema, incrustation, dehiscence, keloid, and explantation due to infection occurred significantly more often in the adhesive group (P = 0.02). The greatest impact on this result had early adverse events as insufficient closure, wound incrustation, and inflammation (9.3 vs. 6.0%; P = 0.02). We did not find any difference in long-term adverse events, infections in particular (2.7 vs. 1.6%; P = 0.47).
This study shows no benefit using skin adhesive in comparison to absorbable intracutaneous suture regarding surgery times for the implantation of cardiac rhythm devices. The rate of early adverse events after wound closure is higher after skin adhesive but no difference in long-term adverse events occurred.
心脏起搏器 (PM) 和植入式心脏复律除颤器 (ICD) 植入后，患者 (pts) 的术后过程中主要取决于伤口愈合。如果闭合不充分，可能会导致严重的并发症，包括口袋感染，最坏的情况是导致设备取出。除了不同类型的缝线和缝线夹外，还可商购一种含有 2-辛基氰基丙烯酸酯的新型局部皮肤粘合剂。
在 18 个月的时间里，我们前瞻性地将所有 PM、ICD 和环路记录器植入病例分配到皮肤粘合剂组 (第 1 组) 或可吸收皮下聚二恶烷缝线组 (第 2 组)。根据手术时间、伤口感染和愈合障碍分析数据。183 名 pts 被随机分配到第 1 组 [71 例 PM、60 例 ICD、15 例心脏再同步治疗 (CRT)、11 例环路记录器和 26 例发生器更换]。185 名 pts 被分配到第 2 组 (62 例 PM、70 例 ICD、30 例 CRT、7 例环路记录器和 16 例发生器更换)。两组间在性别、糖尿病、肾功能不全、皮质类固醇治疗、口服抗凝剂、乙酰水杨酸/氯吡格雷方面无差异 (P = 无显著性)。由于第 2 组 CRT 设备数量明显较高 (P < 0.05)，因此手术时间仅适用于除 CRT 以外的手术。第 1 组为 49.1 ± 27.7 分钟，第 2 组为 53.4 ± 31.9 分钟 (P = 无显著性)。在粘合组中，闭合不良、大出血和小出血、口袋血肿、红斑、结痂、裂开、瘢痕疙瘩和感染导致的设备取出等不良事件的发生率显著更高 (P = 0.02)。这一结果的最大影响是早期不良事件，如闭合不良、伤口结痂和炎症 (9.3%比 6.0%；P = 0.02)。我们没有发现长期不良事件，特别是感染方面的差异 (2.7%比 1.6%；P = 0.47)。
与可吸收皮下缝线相比，在心脏节律装置植入手术时间方面，皮肤粘合剂没有优势。在伤口闭合后，使用皮肤粘合剂的早期不良事件发生率较高，但长期不良事件无差异。
