Doebler Klaus, Boukamp Karin, Mayer Ernst-Dietrich
MDK Baden-Württemberg-KCQ, Stuttgart, Baden-Württemberg, Germany.
Thorac Cardiovasc Surg. 2012 Jul;60(5):309-18. doi: 10.1055/s-0032-1322621. Epub 2012 Aug 28.
Transcatheter aortic valve implantation (TAVI) is a new treatment option for patients with severe symptomatic aortic stenosis. Despite a lack of scientific evidence for a benefit of the procedure compared with surgical valve replacement or repair as the current gold standard and pending questions about safety and long-term results, a continuous and remarkable increase of its application in Germany can be observed.
In a systematic research, publications suitable for the deduction of criteria for indication and structural and process standards were identified.
No appropriate studies exist to define scientifically sound criteria for indication and structural and process standards for TAVI. Two randomized controlled trials give hints for potential patient selection criteria. However, several interdisciplinary position statements of the most relevant scientific societies in Europe and North America provide recommendations for indication criteria and minimum structural and process requirements. TAVI should be used only in patients with contraindications for open surgery or highest perioperative risk. Multidisciplinary heart teams comprising at least one cardiac surgeon and one cardiologist are mandatory for patient selection and performance of TAVI. Structural equipment to carry out immediate open heart surgery is mandatory. Most recommendations require performing TAVI only in hospitals with a cardiac surgery unit. Participation in a registry is recommended.
Currently, TAVI should be restricted to patients with severe symptomatic aortic valve stenosis and contraindications against open heart surgery or maximum perioperative risk. The surgical risk should be assessed by a multidisciplinary team. The procedure should be performed by interdisciplinary heart teams in hospitals with a cardiac surgery unit.
经导管主动脉瓣植入术(TAVI)是重度有症状主动脉瓣狭窄患者的一种新的治疗选择。尽管与作为当前金标准的外科瓣膜置换或修复相比,该手术的益处缺乏科学证据,且在安全性和长期结果方面仍存在疑问,但在德国其应用仍持续显著增加。
在一项系统性研究中,确定了适用于推导适应证标准以及结构和流程标准的出版物。
不存在合适的研究来科学地界定TAVI的适应证标准以及结构和流程标准。两项随机对照试验为潜在的患者选择标准提供了线索。然而,欧洲和北美的几个最相关科学学会的多学科立场声明为适应证标准以及最低结构和流程要求提供了建议。TAVI仅应用于有开胸手术禁忌证或围手术期风险最高的患者。进行TAVI的患者选择和操作必须由至少一名心脏外科医生和一名心脏病专家组成的多学科心脏团队来完成。必须具备能立即进行开胸手术的结构设备。大多数建议要求仅在设有心脏外科科室的医院进行TAVI。建议参与登记。
目前,TAVI应限于重度有症状主动脉瓣狭窄且有开胸手术禁忌证或围手术期风险最大的患者。手术风险应由多学科团队评估。该手术应由多学科心脏团队在设有心脏外科科室的医院进行。