Transcatheter aortic valve implantation versus conservative management for severe aortic stenosis in real clinical practice

BackgroundTranscatheter aortic valve implantation (TAVI) is criticized by some as an expensive treatment in super-elder patients with limited life expectancy. However, there is a knowledge gap regarding the magnitude of clinical benefit provided by TAVI in comparison with conservative management in patients with severe aortic stenosis (AS) in real clinical practice, which would be important in the decision making for TAVI.MethodsWe combined two independent registries, namely CURRENT AS and K-TAVI registries. CURRENT AS was a multicenter registry enrolling 3815 consecutive patients with severe AS irrespective to treatment modalities between January 2003 and December 2011. K-TAVI was a multicenter, prospective registry including 449 consecutive patients with severe AS, who underwent TAVI with SAPIEN XT balloon-expandable valves between October 2013 and June 2016. In these 2 registries, 449 patients received TAVI and 894 patients were managed with conservative strategy. We conducted propensity score matching and finally obtained a cohort of 556 patients (278 patients for each group) for the analysis. The primary outcome measures were all-cause death and heart failure (HF) hospitalization at 2-year.ResultsThe cumulative 2-year incidences of all-cause death and HF hospitalization were significantly lower in the TAVI group than in the conservative group (16.8% versus 36.6%, PConclusionsTAVI in the early Japanese experience was associated with striking risk reduction for all-cause death as well as HF hospitalization as compared with the historical cohort of patients with severe AS who were managed conservatively just before introduction of TAVI in Japan.

背景：经导管主动脉瓣置入术（Transcatheter Aortic Valve Implantation, TAVI）在部分观点中被批评为针对预期寿命有限的超高龄患者的昂贵治疗手段。然而，在真实临床实践中，相较于保守治疗，重度主动脉瓣狭窄（Severe Aortic Stenosis, AS）患者接受TAVI所能获得的临床获益程度仍存在认知空白，这对TAVI的临床决策制定至关重要。
方法：本研究整合了两个独立的注册数据库，即CURRENT AS注册研究与K-TAVI注册研究。CURRENT AS为多中心注册研究，于2003年1月至2011年12月期间纳入了3815例无论治疗方式的连续重度主动脉瓣狭窄患者。K-TAVI为多中心前瞻性注册研究，于2013年10月至2016年6月期间纳入了449例接受SAPIEN XT球囊扩张式瓣膜行经导管主动脉瓣置入术的连续重度主动脉瓣狭窄患者。在这两个注册数据库中，共449例患者接受TAVI治疗，894例患者采用保守治疗策略。本研究采用倾向性得分匹配法进行匹配，最终获得556例患者的分析队列（每组各278例）。本研究的主要终点为2年随访时的全因死亡与心力衰竭（Heart Failure, HF）住院率。
结果：TAVI组的2年累积全因死亡与心力衰竭住院发生率均显著低于保守治疗组（16.8% 对比 36.6%，P）
结论：相较于日本经导管主动脉瓣置入术普及前的重度主动脉瓣狭窄保守治疗历史队列，日本早期TAVI临床实践可显著降低全因死亡与心力衰竭住院风险。