From the National Centre for Epidemiology, Surveillance and Health Promotion, Istituto Superiore di Sanità, Rome, Italy (S.R., P.D., F. Seccareccia); Division of Cardiac Surgery, IRCCS S Martino, University Hospital, Genova, Italy (F. Santini); Division of Cardiology, Ferrarotto Hospital, University of Catania, Italy (M.B., C.T.); Department of Surgery, Oulu University Hospital, Oulu, Finland (F.B.); Division of Cardiac Surgery, University of Verona Medical School, Verona, Italy (F.O.); Department of Cardiothoracic and Vascular Anesthesia and ICU-IRCCS Policlinico San Donato, San Donato Milanese, Milan, Italy (M.R.); Department of Anesthesia and Intensive Care, Ospedale di Busto Arsizio, Varese, Italy (R.D.C.); Division of Cardiology, Careggi Hospital, Florence, Italy (G.S.); Division of Cardiac Surgery, ASO S. Croce e Carle, Cuneo, Italy (C.G.); and Department of Epidemiology of Lazio Regional Health Service, Rome, Italy (M.V., D.F.).
Circ Cardiovasc Interv. 2016 May;9(5):e003326. doi: 10.1161/CIRCINTERVENTIONS.115.003326.
The proven efficacy of transcatheter aortic valve implantation (TAVI) in high-risk patients is leading to the expansion of its indications toward lower-risk patients. However, this shift is not supported by meaningful evidence of its benefit over surgical aortic valve replacement (SAVR). This analysis aims to describe outcomes of TAVI versus SAVR in low-risk patients.
We compared the outcome after TAVI and SAVR of low-risk patients (European System for Cardiac Operative Risk Evaluation II [EuroSCORE II] <4%) included in the Observational Study of Effectiveness of SAVR-TAVI Procedures for Severe Aortic Stenosis Treatment (OBSERVANT) study. The primary outcome was 3-year survival. Secondary outcomes were early events and major adverse cardiac and cerebrovascular events at 3 years. Propensity score matching resulted in 355 pairs of patients with similar baseline characteristics. Thirty-day survival was 97.1% after SAVR and 97.4% after TAVI (P=0.82). Cardiac tamponade, permanent pacemaker implantation, major vascular damage, and moderate-to-severe paravalvular regurgitation were significantly more frequent after TAVI compared with SAVR. Stroke rates were equal in the study groups. SAVR was associated with higher risk of cardiogenic shock, severe bleeding, and acute kidney injury. At 3 years, survival was 83.4% after SAVR and 72.0% after TAVI (P=0.0015), whereas freedom from major adverse cardiac and cerebrovascular events was 80.9% after SAVR and 67.3% after TAVI (P<0.001).
In patients with low operative risk, significantly better 3-year survival and freedom from major adverse cardiac and cerebrovascular events were observed after SAVR compared with TAVI. Further studies on new-generation valve prostheses are necessary before expanding indications of TAVI toward lower-risk patients.
经导管主动脉瓣植入术(TAVI)在高危患者中的疗效已得到证实,因此其适应证正在向低危患者扩展。然而,目前还没有充分的证据表明 TAVI 比主动脉瓣置换术(SAVR)更具优势。本分析旨在描述 TAVI 与 SAVR 在低危患者中的结局。
我们比较了 Observational Study of Effectiveness of SAVR-TAVI Procedures for Severe Aortic Stenosis Treatment(OBSERVANT)研究中低危患者(欧洲心脏手术风险评估系统Ⅱ[EuroSCORE II]<4%)行经导管主动脉瓣植入术和主动脉瓣置换术的结局。主要结局是 3 年生存率。次要结局为 3 年时的早期事件和主要心脏和脑血管不良事件。倾向评分匹配后得到 355 对基线特征相似的患者。SAVR 术后 30 天生存率为 97.1%,TAVI 术后为 97.4%(P=0.82)。TAVI 术后心脏压塞、永久性心脏起搏器植入、大血管损伤和中重度瓣周漏的发生率明显高于 SAVR。两组的卒中发生率相等。SAVR 与心源性休克、严重出血和急性肾损伤的风险增加相关。3 年时,SAVR 组生存率为 83.4%,TAVI 组为 72.0%(P=0.0015),SAVR 组无主要心脏和脑血管不良事件发生率为 80.9%,TAVI 组为 67.3%(P<0.001)。
在低手术风险患者中,SAVR 组的 3 年生存率和无主要心脏和脑血管不良事件发生率明显优于 TAVI 组。在将 TAVI 的适应证扩展至低危患者之前,需要对新一代瓣膜假体进行进一步研究。