Area del Corazon, Hospital Universitario Central de Asturias, Oviedo, Spain.
Rev Esp Cardiol. 2010 Feb;63(2):141-8. doi: 10.1016/s1885-5857(10)70031-1.
The aim of the study was to describe early experience and medium-term follow-up with the CoreValve self-expanding aortic prosthesis at three Spanish hospitals.
The study included patients with severe symptomatic aortic stenosis. Other inclusion criteria were: aortic valve area <1 cm(2) (<0.6 cm(2)/m(2)); aortic valve annulus diameter in the range 20-27 mm; diameter of the ascending aorta at the level of the sinotubular junction < or = 40 mm (small prosthesis) or < or = 43 mm (large prosthesis), and femoral artery diameter >6 mm.
The study included 108 patients with a mean age of 78.6 + or - 6.7 years, a mean aortic valve area of 0.63 + or - 0.2 cm(2) and a mean logistic EuroSCORE of 16% + or - 13.9% (range, 2.27%-86.4%). After valve implantation, the maximum echocardiographic transaortic valve gradient decreased from 83.8 + or - 23 to 12.6 + or - 6 mmHg. No patient presented with greater than grade-2 residual aortic regurgitation on angiography. The procedural success rate was 98.1%. No patient died during the procedure. Definitive pacemaker implantation was carried out for atrioventricular block in 38 patients (35.2%). At 30 days, all-cause mortality and the rate of the combined endpoint of death, stroke, myocardial infarction or referral for surgery were 7.4% and 8.3%, respectively. The estimated 1-year survival rate calculated using the Kaplan-Meier method was 82.3% (for a median follow-up period of 7.6 months).
Our early experience indicates that percutaneous aortic valve replacement is a safe and practical therapeutic option for patients with severe aortic stenosis who are at a high surgical risk.
本研究的目的在于描述在西班牙的三家医院中，应用 CoreValve 自膨式主动脉瓣的早期经验和中期随访结果。
本研究纳入了患有严重症状性主动脉瓣狭窄的患者。其他纳入标准包括：主动脉瓣瓣口面积<1cm2（<0.6cm2/m2）；主动脉瓣环直径在 20-27mm 范围内；窦管交界上方升主动脉直径<或=40mm（小瓣口）或<或=43mm（大瓣口），股动脉直径>6mm。
本研究共纳入 108 例患者，平均年龄 78.6+/-6.7 岁，平均主动脉瓣瓣口面积 0.63+/-0.2cm2，平均 logisticEuroSCORE 为 16%+/-13.9%（范围：2.27%-86.4%）。瓣膜植入后，最大经主动脉瓣跨瓣压差从 83.8+/-23mmHg 降至 12.6+/-6mmHg。在血管造影中，无患者存在大于 2 级的残余主动脉瓣反流。手术成功率为 98.1%。术中无患者死亡。38 例（35.2%）患者因房室传导阻滞行永久性起搏器植入。30 天时，全因死亡率和死亡、卒中和心肌梗死或手术转诊复合终点发生率分别为 7.4%和 8.3%。Kaplan-Meier 方法计算的 1 年生存率为 82.3%（中位随访时间为 7.6 个月）。
我们的早期经验表明，经皮主动脉瓣置换术对于高危外科手术风险的严重主动脉瓣狭窄患者而言是一种安全实用的治疗选择。
