Department of Cardiothoracic Surgery, The University of Sydney, Royal Prince Alfred Hospital, Sydney 2050, Australia.
J Thorac Cardiovasc Surg. 2010 Jun;139(6):1519-28. doi: 10.1016/j.jtcvs.2009.08.037. Epub 2009 Oct 28.
The present systematic review objectively assessed the safety and clinical effectiveness of transcatheter aortic valve implantation for patients at high surgical risk with severe aortic stenosis.
Electronic searches were performed in 6 databases from January 2000 to March 2009. The end points included feasibility, safety, efficacy, and durability. Clinical effectiveness was synthesized through a narrative review with full tabulation of results of all included studies.
The current evidence on transcatheter aortic valve implantation for aortic stenosis is limited to short-term observational studies. The overall procedural success rates ranged from 74% to 100%. The incidence of major adverse events included 30-day mortality (0%-25%), major ventricular tachyarrhythmia (0%-4%), myocardial infarction (0%-15%), cardiac tamponade (2%-10%), stroke (0%-10%), conversion to surgery (0%-8%), moderate to major paravalvular leak (4%-35%), vascular complication (8%-17%), valve-in-valve procedure (2%-12%), and aortic dissection/perforation (0%-4%). The overall 30-day major adverse cardiovascular and cerebral events ranged from 3% to 35%. The mean aortic valve area ranged from 0.5 to 0.8 cm(2) before and 1.3 to 2.0 cm(2) after transcatheter aortic valve implantation. The mean pressure gradient ranged from 34 to 58 mm Hg before and 3 to 12 mm Hg after transcatheter aortic valve implantation. There was no significant deterioration in echocardiography measurements during the assessment period. Death rate at 6 months postprocedure ranged from 18% to 48%. No studies had adequate follow-up to reliably evaluate long-term outcomes.
The procedure has a potential for serious complications. Although short-term efficacy based on echocardiography measurements is good, there is little evidence on long-term outcomes. The use of transcatheter aortic valve implantation should be considered only within the boundaries of clinical trials.
本系统评价客观评估了经导管主动脉瓣植入术在高危外科手术严重主动脉瓣狭窄患者中的安全性和临床疗效。
电子检索 2000 年 1 月至 2009 年 3 月的 6 个数据库。终点包括可行性、安全性、疗效和耐久性。通过叙述性综述综合临床疗效，并详细列出所有纳入研究的结果。
目前关于经导管主动脉瓣植入术治疗主动脉瓣狭窄的证据仅限于短期观察性研究。总体手术成功率为 74%至 100%。主要不良事件的发生率包括 30 天死亡率（0%-25%）、严重室性心律失常（0%-4%）、心肌梗死（0%-15%）、心脏压塞（2%-10%）、中风（0%-10%）、转为手术（0%-8%）、中重度瓣周漏（4%-35%）、血管并发症（8%-17%）、瓣中瓣手术（2%-12%）和主动脉夹层/穿孔（0%-4%）。30 天主要不良心血管和脑事件的总发生率为 3%至 35%。经导管主动脉瓣植入术前平均主动脉瓣面积为 0.5 至 0.8cm²，术后为 1.3 至 2.0cm²。经导管主动脉瓣植入术前平均压力梯度为 34 至 58mmHg，术后为 3 至 12mmHg。评估期间超声心动图测量值无明显恶化。术后 6 个月死亡率为 18%至 48%。没有研究有足够的随访来可靠地评估长期结果。
该手术有发生严重并发症的潜在风险。虽然基于超声心动图测量的短期疗效良好，但长期结果的证据很少。经导管主动脉瓣植入术的应用应仅在临床试验范围内考虑。
