Lydia Hanna, Alexander D Rodway, Puneet Garcha, Luci Maynard, Janane Sivayogi, Oliver Schlager, Juraj Madaric, Vinko Boc, Lucas Busch, Martin B Whyte, Simon S Skene, Jenny Harris, Christian Heiss
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Eligibility-criteria, complications, and patient characteristics were extracted, methodological quality assessed (adapted Newcastle-Ottawa Scale), and meta-analyses of complications and technical success performed to provide pooled estimates. This study is registered with PROSPERO, CRD42022316466.</p><p><strong>Findings: </strong>Thirty observational studies (17 retrospective, 13 prospective) and 1 RCT reported 2427 minor and 653 major complications after 99,600 daycase procedures (93,344 patients). Eighteen studies reported daycase eligibility-criteria including 'responsible adult companion' (78%), 'proximity to hospital', and 'telephone availability' and excluding unstable and severe co-morbidities, offset coagulation, and severe chronic kidney disease. Pooled incidences of minor (4.7% [95% CI 3.8-5.6%], <i>I</i> <sup>2</sup> = 96%) and major (0.64% [95% CI 0.48-0.79%], <i>I</i> <sup><i>2</i></sup> = 46%) complications were low and technical success high (93% [95% CI 91-96%], <i>I</i> <sup>2</sup> = 97%). Most complications were related to the puncture site. Pooled conversion-to-hospitalisation rates and re-admission after discharge were 1.6% (95% CI 1.1-2.2%, <i>I</i> <sup>2</sup> = 82%) and 0.11% (95% CI 0.095-0.23%, <i>I</i> <sup>2</sup> = 97%), respectively. Meta-regression identified that minor complications decreased since 2000. Male sex and coronary artery disease were associated with more frequent, and higher age and closure device use with less minor complications. Diabetes mellitus and chronic kidney disease were associated with less major complications. 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引用次数: 0
摘要
背景:及时、经济地提供血管重建手术是医疗保健的主要需求。我们旨在研究外周动脉疾病患者日间下肢血管内再通手术的安全性和有效性:在这项系统性回顾和荟萃分析中,我们检索了 MEDLINE 和 Embase 中从 2000 年 1 月 1 日到 2024 年 4 月 1 日报道当天出院的下肢血管内再通手术并发症的研究。我们提取了合格标准、并发症和患者特征,评估了方法学质量(改编的纽卡斯尔-渥太华量表),并对并发症和技术成功率进行了荟萃分析,以提供汇总估计值。本研究已在 PROSPERO 注册,编号为 CRD42022316466:30项观察性研究(17项回顾性研究、13项前瞻性研究)和1项研究性试验报告了99,600例日间手术(93,344名患者)后的2427例轻微并发症和653例主要并发症。18 项研究报告了日间病例的资格标准,包括 "有责任心的成人陪伴"(78%)、"靠近医院 "和 "有电话",并排除了不稳定和严重的并发症、凝血功能障碍和严重的慢性肾病。轻微(4.7% [95% CI 3.8-5.6%],I 2 = 96%)和严重(0.64% [95% CI 0.48-0.79%],I 2 = 46%)并发症的汇总发生率较低,技术成功率较高(93% [95% CI 91-96%],I 2 = 97%)。大多数并发症与穿刺部位有关。汇总的转院率和出院后再次入院率分别为 1.6% (95% CI 1.1-2.2%, I 2 = 82%) 和 0.11% (95% CI 0.095-0.23%, I 2 = 97%)。元回归发现,自2000年以来,轻微并发症有所减少。男性和冠状动脉疾病与更频繁的轻微并发症有关,而高年龄和使用闭合器械与较少的轻微并发症有关。糖尿病和慢性肾病与较少的主要并发症有关。六项研究报告了日间病例和住院病人的并发症发生率,两者之间没有显著差异(-0.8% [95% CI -1.9 至 0.3%]):解读:在仔细评估手术资格后,下肢血管成形术可在日间病例环境下安全进行,且技术成功率高。大多数并发症都是由穿刺部位引起的,而非手术本身,这凸显了最佳入路部位管理的重要性。不同研究之间的异质性要求对并发症和结果进行标准化监测:欧洲计量合作组织,由欧盟地平线欧洲研究与创新计划、英国研究与创新以及医学研究理事会共同资助。
Safety and procedural success of daycase-based endovascular procedures in lower extremity arteries of patients with peripheral artery disease: a systematic review and meta-analysis.
Background: Timely and economic provision of revascularisation procedures is a major healthcare need. We aimed to examine the safety and efficacy of daycase-based lower extremity endovascular revascularisation procedures in patients with peripheral artery disease.
Methods: In this systematic review and meta-analysis, we searched MEDLINE and Embase for studies from Jan 01, 2000 through Apr 01, 2024 reporting complications of lower limb endovascular revascularisation procedures with same-day discharge. Eligibility-criteria, complications, and patient characteristics were extracted, methodological quality assessed (adapted Newcastle-Ottawa Scale), and meta-analyses of complications and technical success performed to provide pooled estimates. This study is registered with PROSPERO, CRD42022316466.
Findings: Thirty observational studies (17 retrospective, 13 prospective) and 1 RCT reported 2427 minor and 653 major complications after 99,600 daycase procedures (93,344 patients). Eighteen studies reported daycase eligibility-criteria including 'responsible adult companion' (78%), 'proximity to hospital', and 'telephone availability' and excluding unstable and severe co-morbidities, offset coagulation, and severe chronic kidney disease. Pooled incidences of minor (4.7% [95% CI 3.8-5.6%], I2 = 96%) and major (0.64% [95% CI 0.48-0.79%], I2 = 46%) complications were low and technical success high (93% [95% CI 91-96%], I2 = 97%). Most complications were related to the puncture site. Pooled conversion-to-hospitalisation rates and re-admission after discharge were 1.6% (95% CI 1.1-2.2%, I2 = 82%) and 0.11% (95% CI 0.095-0.23%, I2 = 97%), respectively. Meta-regression identified that minor complications decreased since 2000. Male sex and coronary artery disease were associated with more frequent, and higher age and closure device use with less minor complications. Diabetes mellitus and chronic kidney disease were associated with less major complications. Six studies reported complication rates both in daycases and inpatients and there was no significant difference (-0.8% [95% CI -1.9 to 0.3%]).
Interpretation: After careful evaluation of eligibility, lower limb angioplasty can be performed safely with high technical success in a daycase setting. Most complications arise from the puncture site and not the procedure itself highlighting the importance of optimal access site management. The heterogeneity between studies warrants standardised monitoring of complications and outcomes.
Funding: European Partnership on Metrology, co-financed from European Union's Horizon Europe Research and Innovation Programme and UK Research and Innovation, and Medical Research Council.
期刊介绍:
eClinicalMedicine is a gold open-access clinical journal designed to support frontline health professionals in addressing the complex and rapid health transitions affecting societies globally. The journal aims to assist practitioners in overcoming healthcare challenges across diverse communities, spanning diagnosis, treatment, prevention, and health promotion. Integrating disciplines from various specialties and life stages, it seeks to enhance health systems as fundamental institutions within societies. With a forward-thinking approach, eClinicalMedicine aims to redefine the future of healthcare.