Institut Hospitalier Jacques Cartier, 6 avenue du Noyer Lambert, Massy, France.
Eur Heart J. 2011 Jan;32(2):148-57. doi: 10.1093/eurheartj/ehq427. Epub 2010 Nov 12.
Transcatheter aortic valve implantation (TAVI) has emerged as a new therapeutic option in high-risk patients with severe aortic stenosis.
PARTNER EU is the first study to evaluate prospectively the procedural and mid-term outcomes of transfemoral (TF) or transapical (TA) implantation of the Edwards SAPIEN® valve involving a multi-disciplinary approach.
Primary safety endpoints were 30 days and 6 months mortality. Primary efficacy endpoints were haemodynamic and functional improvement at 12 months. One hundred and thirty patients (61 TF, 69 TA), aged 82.1 ± 5.5 years were included. TA patients had higher logistic EuroSCORE (33.8 vs. 25.7%, P = 0.0005) and more peripheral disease (49.3 vs. 16.4%, P< 0.0001). Procedures were aborted in four TA (5.8%) and six TF cases (9.8%). Valve implantation was successful in the remaining patients in 95.4 and 96.4%, respectively. Thirty days and 6 months survival were 81.2 and 58.0% (TA) and 91.8 and 90.2% (TF). In both groups, mean aortic gradient decreased from 46.9 ± 18.1 to 10.9 ± 5.4 mmHg 6 months post-TAVI. In total, 78.1 and 84.8% of patients experienced significant improvement in New York Heart Association (NYHA) class, whereas 73.9 and 72.7% had improved Kansas City Cardiomyopathy Questionnaire (KCCQ) scores in TA and TF cohorts, respectively.
This first team-based multi-centre European TAVI registry shows promising results in high-risk patients treated by TF or TA delivery. Survival rates differ significantly between TF and TA groups and probably reflect the higher risk profile of the TA cohort. Optimal patient screening, approach selection, and device refinement may improve outcomes.
经导管主动脉瓣植入术（TAVI）已成为高危重度主动脉瓣狭窄患者的一种新的治疗选择。
PARTNER EU 是第一项前瞻性评估经股（TF）或经心尖（TA）植入 Edwards SAPIEN®瓣膜的多学科方法的程序和中期结果的研究。
主要安全性终点为 30 天和 6 个月死亡率。主要疗效终点为 12 个月时血液动力学和功能改善。共纳入 130 例患者（61 例 TF，69 例 TA），年龄 82.1±5.5 岁。TA 患者的 logistic EuroSCORE 更高（33.8%比 25.7%，P=0.0005），外周血管疾病更多（49.3%比 16.4%，P<0.0001）。4 例 TA（5.8%）和 6 例 TF 病例（9.8%）的手术被取消。其余患者的瓣膜植入均成功，成功率分别为 95.4%和 96.4%。30 天和 6 个月的存活率分别为 TA 组的 81.2%和 58.0%和 TF 组的 91.8%和 90.2%。在两组中，主动脉瓣平均梯度从 TAVI 后 6 个月的 46.9±18.1mmHg 降至 10.9±5.4mmHg。共有 78.1%和 84.8%的患者纽约心脏协会（NYHA）分级显著改善，TA 和 TF 队列分别有 73.9%和 72.7%的患者堪萨斯城心肌病问卷（KCCQ）评分改善。
这是第一项基于团队的多中心欧洲 TAVI 登记研究，结果显示高危患者经 TF 或 TA 输送治疗有良好的效果。TF 和 TA 组之间的生存率有显著差异，这可能反映了 TA 组的风险较高。优化患者筛选、方法选择和器械改进可能会改善结果。
