Okuno Taishi, Heg Dik, Lanz Jonas, Praz Fabien, Gräni Christoph, Langhammer Bettina, Reineke David, Räber Lorenz, Wenaweser Peter, Pilgrim Thomas, Windecker Stephan, Stortecky Stefan
Department of Cardiology, Inselspital, University of Bern, Bern, Switzerland.
Clinical Trials Unit, University of Bern, Bern, Switzerland.
Catheter Cardiovasc Interv. 2021 Nov 1;98(5):E768-E779. doi: 10.1002/ccd.29700. Epub 2021 Apr 15.
To investigate the impact of transcatheter heart valve (THV) sizing on procedural results and clinical outcomes following transcatheter aortic valve implantation (TAVI).
The impact of individual THV sizing for patients with borderline aortic annulus anatomy remains unclear.
In the prospective BernTAVI registry, THV sizing conditions were retrospectively evaluated, and patients were categorized into three groups based on the recommendations and the sizing chart of the manufacturers: optimal sizing, borderline sizing (THV size located within 5% to each border of the optimal sizing recommendation), and suboptimal sizing (THV size outside the recommended range). The latter two groups were further subcategorized into THV-oversizing and THV-undersizing. The primary endpoint was a composite of all-cause death and unplanned repeat intervention at 1 year.
Out of a total of 1,638 patients who underwent TAVI, 9.5 and 15.6% of patients were categorized into the borderline and suboptimal sizing group, respectively. Device success was achieved in 87.4, 88.9, and 83.6% of patients with optimal, borderline, and suboptimal sizing, respectively. The primary endpoint occurred in 12.3% of patients with optimal sizing, 14.9% of patients with borderline sizing (HR 1.35, 95%CI 0.87-2.09), and in 17.4% of patients with suboptimal sizing (HR 1.42, 95%CI 1.01-1.99). Within the suboptimal sizing cohort, unfavorable outcomes were mainly associated with THV undersizing (device success: 76.4%, primary endpoint: 23.9%, HR 1.98, 95%CI 1.36-2.87).
Suboptimal TAVI prosthesis sizing is associated with an increased risk of all-cause death and unplanned repeat intervention within 1 year largely attributable to undersized THV prostheses.
研究经导管心脏瓣膜(THV)尺寸对经导管主动脉瓣植入术(TAVI)术后手术结果及临床结局的影响。
对于主动脉瓣环解剖结构临界的患者,个体化THV尺寸的影响尚不清楚。
在前瞻性伯尔尼TAVI注册研究中,对THV尺寸情况进行回顾性评估,并根据制造商的建议和尺寸图表将患者分为三组:最佳尺寸组、临界尺寸组(THV尺寸位于最佳尺寸建议范围各边界的5%以内)和非最佳尺寸组(THV尺寸超出推荐范围)。后两组再进一步细分为THV尺寸过大组和THV尺寸过小组。主要终点为1年时全因死亡和非计划再次干预的复合终点。
在总共1638例行TAVI的患者中,分别有9.5%和15.6%的患者被归入临界尺寸组和非最佳尺寸组。最佳尺寸组、临界尺寸组和非最佳尺寸组患者的手术成功率分别为87.4%、88.9%和83.6%。主要终点在最佳尺寸组患者中的发生率为12.3%,临界尺寸组患者中的发生率为14.9%(风险比1.35,95%置信区间0.87 - 2.09),非最佳尺寸组患者中的发生率为17.4%(风险比1.42,95%置信区间1.01 - 1.99)。在非最佳尺寸队列中,不良结局主要与THV尺寸过小有关(手术成功率:76.4%,主要终点发生率:23.9%,风险比1.98,95%置信区间1.36 - 2.87)。
TAVI假体尺寸非最佳与1年内全因死亡和非计划再次干预风险增加相关,这在很大程度上归因于THV假体尺寸过小。