Svensson Lars G, Dewey Todd, Kapadia Samir, Roselli Eric E, Stewart Alan, Williams Matt, Anderson William N, Brown David, Leon Marty, Lytle Bruce, Moses Jeffrey, Mack Michael, Tuzcu Murat, Smith Craig
Center for Aortic Surgery, Marfan Syndrome and Connective Tissue Disorders Clinic, Department of Thoracic and Cardiovascular Surgery, Cleveland Clinic, Cleveland, OH 44195, USA.
Ann Thorac Surg. 2008 Jul;86(1):46-54; discussion 54-5. doi: 10.1016/j.athoracsur.2008.04.049.
Recent US and European registries have indicated 30% to 60% of patients with critical valvular aortic stenosis (AS) are not treated surgically, usually due to advanced age and comorbidities. We report on a Food and Drug Administration approved feasibility study of a less invasive transcatheter approach to potentially treat these high-risk patients.
Between December 2006 and February 18, 2008, 40 patients underwent transcatheter insertion of a balloon expandable stainless-steel stent with an internally mounted three-leaflet equine pericardial valve (Edwards Sapien Transcatheter Heart Valve; Edwards Lifesciences, Irvine, CA) into the aortic annulus using a transapical left ventricular insertion (TA-AVI). Patients were inoperable by conventional surgery, or extremely high risk based on Society of Thoracic Surgeons score greater than 15% or other documented risk factors.
All 40 valves were successfully delivered and 35 were successfully seated. Two valves embolized and required open aortic valve replacement (AVR), and one case of severe regurgitation later required AVR. In a further two patients placed on cardiopulmonary support, one valve later embolized and one migrated. There were 7 (17.5%) deaths within 30 days, and a further 2 (5%) deaths before discharge at 42 and 72 days. There were no immediate postoperative strokes after successful deployment. Valve area improved from 0.62 cm(2) (SD of 0.13) to 1.61 cm(2) (SD 0.37) at 30 days (p = or<0.0001), with mean perivalvular regurgitation of 1.19 (SD 0.80). Mean follow-up was 143 days (SD 166 days) with 6 further deaths from comorbid disease, none valve or cardiac related. The Kaplan-Meier survival was 81.8% +/- 6.2% at 1 month and 71.7% +/- 7.7% at 3 months.
Transapical insertion of a balloon expandable stented valve is feasible but carries considerable risk and will be further evaluated in the PARTNER (Placement of AoRTic traNscathetER valve) randomized trial.
美国和欧洲最近的登记资料显示，30%至60%的重度主动脉瓣狭窄（AS）患者未接受手术治疗，通常是由于高龄和合并症。我们报告一项经美国食品药品监督管理局批准的可行性研究，该研究采用一种侵入性较小的经导管方法来治疗这些高危患者。
在2006年12月至2008年2月18日期间，40例患者采用经心尖左心室置入法（TA-AVI），经导管将一个球囊扩张式不锈钢支架及内部安装的三叶马心包瓣膜（爱德华兹Sapien经导管心脏瓣膜；爱德华兹生命科学公司，加利福尼亚州欧文市）置入主动脉瓣环。患者因常规手术无法进行，或根据胸外科医师协会评分大于15%或其他记录的危险因素，被判定为极高危患者。
40个瓣膜均成功输送，35个成功定位。2个瓣膜发生栓塞，需要进行主动脉瓣置换术（AVR），1例严重反流患者后来也需要进行AVR。另外2例接受心肺支持的患者，1个瓣膜后来发生栓塞，1个发生移位。30天内有7例（17.5%）死亡，出院前在42天和72天又有2例（5%）死亡。成功置入后无即刻术后卒中发生。30天时瓣膜面积从0.62 cm²（标准差0.13）改善至1.61 cm²（标准差0.37）（p≤0.0001），瓣周平均反流为1.19（标准差0.80）。平均随访143天（标准差166天），又有6例因合并症死亡，均与瓣膜或心脏无关。1个月时Kaplan-Meier生存率为81.8%±6.2%，3个月时为71.7%±7.7%。
经心尖置入球囊扩张式带支架瓣膜是可行的，但风险较大，将在PARTNER（主动脉经导管瓣膜置入）随机试验中进一步评估。
