Department of Cardiology and Angiology I, University Heart Center Freiburg, Medical Faculty, University of Freiburg, Freiburg, Germany.
Institute of Medical Biometry and Statistics, Faculty of Medicine and Medical Center, University of Freiburg, Freiburg, Germany.
Heart. 2020 Oct;106(20):1604-1608. doi: 10.1136/heartjnl-2019-316058. Epub 2020 Feb 18.
Transcatheter aortic valve implantation (TAVI) is the most common aortic valve replacement in Germany. Since 2015, to ensure high-quality procedures, hospitals in Germany and other countries that meet the minimum requirement of 50 interventions per centre are being certified to perform TAVI. This study analyses the impact of these requirements on case number and in-hospital outcomes.
All isolated TAVI procedures and in-hospital outcomes between 2008 and 2016 were identified by International Classification of Diseases (ICD) and the German Operation and Procedure Classification codes.
73 467 isolated transfemoral and transapical TAVI procedures were performed in Germany between 2008 and 2016. During this period, the number of TAVI procedures per year rose steeply, whereas the overall rates of hospital mortality and complications declined. In 2008, the majority of procedures were performed in hospitals with fewer than 50 cases per year (54.63%). Until 2014, the share of patients treated in low-volume centres constantly decreased to 5.35%. After the revision of recommendations, it further declined to 1.99%. In the 2 years after the introduction of the minimum requirements on case numbers, patients were at decreased risk for in-hospital mortality when treated in a high-volume centre (risk-adjusted OR 0.62, p=0.012). The risk for other in-hospital outcomes (stroke, permanent pacemaker implantation and bleeding events) did not differ after risk adjustment (p=0.346, p=0.142 and p=0.633).
A minimum volume of 50 procedures per centre and year appears suitable to allow for sufficient routine and thus better in-hospital outcomes, while ensuring nationwide coverage of TAVI procedures.
经导管主动脉瓣植入术（TAVI）是德国最常见的主动脉瓣置换术。自 2015 年以来，为确保高质量的手术，德国和其他符合中心每年至少进行 50 例手术的最低要求的医院都获得了进行 TAVI 的认证。本研究分析了这些要求对手术数量和住院治疗结果的影响。
通过国际疾病分类（ICD）和德国手术和操作分类代码，确定了 2008 年至 2016 年间所有孤立的 TAVI 手术和住院治疗结果。
2008 年至 2016 年间，德国共进行了 73467 例经股动脉和经心尖 TAVI 手术。在此期间，每年 TAVI 手术数量急剧增加，而医院死亡率和并发症的总体发生率则有所下降。2008 年，大多数手术是在每年手术量少于 50 例的医院（54.63%）进行的。直到 2014 年，低容量中心的患者比例一直持续下降至 5.35%。在推荐修订后，这一比例进一步下降至 1.99%。在实施病例数量最低要求的 2 年内，在高容量中心治疗的患者住院死亡率风险降低（风险调整后 OR 0.62，p=0.012）。风险调整后，其他住院治疗结果（中风、永久性心脏起搏器植入和出血事件）无差异（p=0.346，p=0.142，p=0.633）。
中心每年至少进行 50 例手术似乎适合保证足够的常规手术量，从而获得更好的住院治疗结果，同时确保 TAVI 手术在全国范围内得到覆盖。
