van Ginkel D J, Brouwer J, van Hemert N D, Kraaijeveld A O, Rensing B J W M, Swaans M J, Timmers L, Voskuil M, Stella P R, Ten Berg J M
Department of Cardiology, St. Antonius Hospital, Nieuwegein, The Netherlands.
Department of Cardiology, University Medical Centre Utrecht, Utrecht, The Netherlands.
Neth Heart J. 2021 Dec;29(12):632-642. doi: 10.1007/s12471-021-01638-8. Epub 2021 Nov 1.
Despite considerable advances in the last decade, major adverse events remain a concern after transcatheter aortic valve implantation (TAVI). The aim of this study was to provide a detailed overview of their underlying causes and contributing factors in order to identify key domains for quality improvement.
This observational, prospective registry included all patients undergoing TAVI between 31 December 2015 and 1 January 2020 at the St. Antonius Hospital in Nieuwegein and the University Medical Centre in Utrecht. Outcomes of interest were all-cause mortality, stroke, major bleeding, life-threatening or disabling bleeding, major vascular complications, myocardial infarction, severe acute kidney injury and conduction disturbances requiring permanent pacemaker implantation within 30 days after TAVI, according to the Valve Academic Research Consortium‑2 criteria.
Of the 1250 patients who underwent TAVI in the evaluated period, 146 (11.7%) developed a major complication. In 54 (4.3%) patients a thromboembolic event occurred, leading to stroke in 36 (2.9%), myocardial infarction in 13 (1.0%) and lower limb ischaemia in 11 (0.9%). Major bleeding occurred in 65 (5.2%) patients, most frequently consisting of acute cardiac tamponade (n = 25; 2.0%) and major access-site bleeding (n = 21; 1.7%). Most complications occurred within 1 day of the procedure. Within 30 days a total of 54 (4.3%) patients died, the cause being directly TAVI-related in 30 (2.4%). Of the patients who died from causes that were not directly TAVI-related, 14 (1.1%) had multiple hospital-acquired complications.
A variety of underlying mechanisms and causes form a wide spectrum of major threats affecting early safety in 11.7% of patients undergoing TAVI in a contemporary cohort of real-world patients.
尽管在过去十年中取得了相当大的进展，但经导管主动脉瓣植入术（TAVI）后主要不良事件仍是一个令人担忧的问题。本研究的目的是详细概述其潜在原因和促成因素，以便确定质量改进的关键领域。
这项观察性前瞻性登记研究纳入了2015年12月31日至2020年1月1日期间在荷兰新韦根的圣安东尼乌斯医院和乌得勒支大学医学中心接受TAVI的所有患者。根据瓣膜学术研究联盟-2标准，感兴趣的结局包括全因死亡率、中风、大出血、危及生命或致残性出血、主要血管并发症、心肌梗死、严重急性肾损伤以及TAVI后30天内需要植入永久性起搏器的传导障碍。
在评估期间接受TAVI的1250例患者中，146例（11.7%）发生了主要并发症。54例（4.3%）患者发生血栓栓塞事件，导致36例（2.9%）中风、13例（1.0%）心肌梗死和11例（0.9%）下肢缺血。65例（5.2%）患者发生大出血，最常见的是急性心脏压塞（n = 25；2.0%）和主要穿刺部位出血（n = 21；1.7%）。大多数并发症发生在手术当天。30天内共有54例（4.3%）患者死亡，其中直接与TAVI相关的原因导致30例（2.4%）死亡。在因与TAVI无直接关系的原因死亡的患者中，14例（1.1%）有多种医院获得性并发症。
在当代真实世界患者队列中，11.7%接受TAVI的患者中，多种潜在机制和原因构成了影响早期安全性的广泛主要威胁。
