Quebec Heart and Lung Institute, Laval University, Quebec City, Quebec, Canada.
J Am Coll Cardiol. 2010 Mar 16;55(11):1080-90. doi: 10.1016/j.jacc.2009.12.014. Epub 2010 Jan 22.
The aim of this study was: 1) to evaluate the acute and late outcomes of a transcatheter aortic valve implantation (TAVI) program including both the transfemoral (TF) and transapical (TA) approaches; and 2) to determine the results of TAVI in patients deemed inoperable because of either porcelain aorta or frailty.
Very few data exist on the results of a comprehensive TAVI program including both TA and TF approaches for the treatment of severe aortic stenosis in patients at very high or prohibitive surgical risk.
Consecutive patients who underwent TAVI with the Edwards valve (Edwards Lifesciences, Inc., Irvine, California) between January 2005 and June 2009 in 6 Canadian centers were included.
A total of 345 procedures (TF: 168, TA: 177) were performed in 339 patients. The predicted surgical mortality (Society of Thoracic Surgeons risk score) was 9.8 +/- 6.4%. The procedural success rate was 93.3%, and 30-day mortality was 10.4% (TF: 9.5%, TA: 11.3%). After a median follow-up of 8 months (25th to 75th interquartile range: 3 to 14 months) the mortality rate was 22.1%. The predictors of cumulative late mortality were peri-procedural sepsis (hazard ratio [HR]: 3.49, 95% confidence interval [CI]: 1.48 to 8.28) or need for hemodynamic support (HR: 2.58, 95% CI: 1.11 to 6), pulmonary hypertension (PH) (HR: 1.88, 95% CI: 1.17 to 3), chronic kidney disease (CKD) (HR: 2.30, 95% CI: 1.38 to 3.84), and chronic obstructive pulmonary disease (COPD) (HR: 1.75, 95% CI: 1.09 to 2.83). Patients with either porcelain aorta (18%) or frailty (25%) exhibited acute outcomes similar to the rest of the study population, and porcelain aorta patients tended to have a better survival rate at 1-year follow-up.
A TAVI program including both TF and TA approaches was associated with comparable mortality as predicted by surgical risk calculators for the treatment of patients at very high or prohibitive surgical risk, including porcelain aorta and frail patients. Baseline (PH, COPD, CKD) and peri-procedural (hemodynamic support, sepsis) factors but not the approach determined worse outcomes.
本研究的目的是：1）评估经导管主动脉瓣植入术（TAVI）项目的急性和晚期结果，包括经股动脉（TF）和经心尖（TA）两种途径；2）确定在因瓷主动脉或虚弱而被认为无法手术的患者中 TAVI 的结果。
对于极高或禁忌手术风险的严重主动脉瓣狭窄患者，采用经股动脉（TF）和经心尖（TA）两种途径的综合 TAVI 治疗方案的结果，仅有极少数数据。
连续纳入 2005 年 1 月至 2009 年 6 月期间在加拿大 6 个中心接受爱德华瓣膜（爱德华生命科学公司，欧文，加利福尼亚）TAVI 的患者。
在 339 例患者中进行了 345 例手术（TF：168 例，TA：177 例）。预测的手术死亡率（胸外科医生协会风险评分）为 9.8%±6.4%。手术成功率为 93.3%，30 天死亡率为 10.4%（TF：9.5%，TA：11.3%）。中位随访 8 个月（25%至 75%四分位间距：3 至 14 个月）后，死亡率为 22.1%。累积晚期死亡率的预测因素包括围手术期败血症（风险比[HR]：3.49，95%置信区间[CI]：1.48 至 8.28）或需要血流动力学支持（HR：2.58，95%CI：1.11 至 6）、肺动脉高压（PH）（HR：1.88，95%CI：1.17 至 3）、慢性肾脏病（CKD）（HR：2.30，95%CI：1.38 至 3.84）和慢性阻塞性肺疾病（COPD）（HR：1.75，95%CI：1.09 至 2.83）。有瓷主动脉（18%）或虚弱（25%）的患者急性结局与研究人群的其余部分相似，且瓷主动脉患者在 1 年随访时的生存率更高。
包括 TF 和 TA 两种途径的 TAVI 方案与极高或禁忌手术风险患者的手术风险计算器预测的死亡率相当，包括瓷主动脉和虚弱患者。基线（PH、COPD、CKD）和围手术期（血流动力学支持、败血症）因素而非途径决定了较差的结局。
