German Heart Center, Lazarette Strasse 36, Munich, Germany.
J Am Coll Cardiol. 2012 Jan 17;59(3):280-7. doi: 10.1016/j.jacc.2011.10.868. Epub 2011 Dec 21.
The purpose of this study was to investigate the evolution of patient selection criteria for transcatheter aortic valve implantation (TAVI) and its impact on clinical outcomes.
Anecdotal evidence suggests that patient selection for TAVI is shifting toward lower surgical risk patients. The extent of this shift and its impact on clinical outcomes, however, are currently unknown.
We conducted a single-center study that subcategorized TAVI patients into quartiles (Q1 to Q4) defined by enrollment date. These subgroups were subsequently examined for differences in baseline characteristics and 30-day and 6-month mortality rate. The relationship between quartiles and mortality rate was examined using unadjusted and adjusted (for baseline characteristics) Cox proportional hazard models.
Each quartile included 105 patients (n = 420). Compared with Q4 patients, Q1 patients had higher logistic EuroSCORES (25.4 ± 16.1% vs. 17.8 ± 12.0%, p < 0.001), higher Society of Thoracic Surgeons scores (7.1 ± 5.5% vs. 4.8 ± 2.6%, p > 0.001), and higher median N-terminal pro-B-type natriuretic peptide levels (3,495 vs. 1,730 ng/dl, p < 0.046). From Q1 to Q4, the crude 30-day and 6-month mortality rate decreased significantly from 11.4% to 3.8% (unadjusted hazard ratio [HR]: 0.33; 95% confidence interval [CI]: 0.11 to 1.01; p = 0.053) and from 23.5% to 12.4% (unadjusted HR: 0.49; 95 CI: 0.25 to 0.95; p = 0.07), respectively. After adjustment for baseline characteristics, there were no significant differences between Q1 and Q4 in 30-day mortality rate (adjusted HR ratio: 0.29; 95% CI: 0.08 to 1.08; p = 0.07) and 6-month mortality rate (HR: 0.67; 95% CI: 0.25 to 1.77; p = 0.42).
The results of this study demonstrate an important paradigm shift toward the selection of lower surgical risk patients for TAVI. Significantly better clinical outcomes can be expected in lower than in higher surgical risk patients undergoing TAVI.
本研究旨在探讨经导管主动脉瓣置换术（TAVI）患者选择标准的演变及其对临床结局的影响。
有传闻证据表明，TAVI 的患者选择正在向手术风险较低的患者转移。然而，这种转移的程度及其对临床结局的影响目前尚不清楚。
我们进行了一项单中心研究，根据入组日期将 TAVI 患者分为四分位组（Q1 至 Q4）。随后比较了这些亚组之间的基线特征和 30 天及 6 个月死亡率的差异。使用未调整和（根据基线特征）调整后的 Cox 比例风险模型检查四分位与死亡率之间的关系。
每个四分位组包括 105 名患者（n=420）。与 Q4 患者相比，Q1 患者的 logistic EuroSCORES 更高（25.4±16.1% vs. 17.8±12.0%，p<0.001），胸外科医生协会评分更高（7.1±5.5% vs. 4.8±2.6%，p>0.001），中位 N-末端 pro-B 型利钠肽水平更高（3495 vs. 1730ng/dl，p<0.046）。从 Q1 到 Q4，30 天和 6 个月的粗死亡率从 11.4%显著下降至 3.8%（未调整的风险比[HR]：0.33；95%置信区间[CI]：0.11 至 1.01；p=0.053）和从 23.5%下降至 12.4%（未调整的 HR：0.49；95%CI：0.25 至 0.95；p=0.07）。调整基线特征后，Q1 和 Q4 之间 30 天死亡率（调整后 HR 比：0.29；95%CI：0.08 至 1.08；p=0.07）和 6 个月死亡率（HR：0.67；95%CI：0.25 至 1.77；p=0.42）无显著差异。
本研究结果表明，TAVI 患者的选择正朝着选择手术风险较低的患者的重要模式转变。接受 TAVI 的手术风险较低的患者的临床结局显著优于手术风险较高的患者。
