Department of Medical Imaging and Division of Cardiology, St. Paul's Hospital, University of British Columbia, Vancouver, British Columbia, Canada; Inje University Busan Paik Hospital, Busan, South Korea.
Department of Medical Imaging and Division of Cardiology, St. Paul's Hospital, University of British Columbia, Vancouver, British Columbia, Canada.
JACC Cardiovasc Interv. 2015 Mar;8(3):462-471. doi: 10.1016/j.jcin.2014.10.014.
This study sought to compare the influence of the extent of multidetector computed tomography (MDCT) area oversizing on the incidence of paravalvular aortic regurgitation (PAR) between the Sapien 3 and the Sapien XT transcatheter heart valve (THV) to define a new MDCT sizing guideline suitable for the Sapien 3 platform.
The inverse relationship of PAR occurrence and oversizing has been demonstrated for the Sapien XT but the incidence of PAR with comparable oversizing with the Sapien 3 is not known.
Sixty-one prospectively enrolled patients who underwent transcatheter aortic valve replacement with the Sapien 3 THV were compared with 92 patients who underwent transcatheter aortic valve replacement with the Sapien XT THV. Patients were categorized depending on the degree of MDCT area oversizing percentage: undersizing (below 0%), 0% to 5%, 5% to 10%, and above 10%. The primary endpoint was mild or greater PAR on transthoracic echocardiography.
Mild or greater PAR was present in 19.7% of patients (12 of 61) in the Sapien 3 group and in 54.3% of patients (50 of 92) in the Sapien XT group (p < 0.01). The Sapien 3 group, compared with the Sapien XT group, consistently demonstrated significantly lower rates of mild or greater PAR except for oversizing >10% (p for interaction = 0.54). Moderate or severe PAR rates were also lower in the Sapien 3 group than in the Sapien XT group (3.3% vs. 13.0%, p = 0.04). In the Sapien 3 group, a MDCT area oversizing percentage value of ≤4.17% was identified as the optimal cutoff value to discriminate patients with or without mild or greater PAR.
Our retrospective analysis suggests that the Sapien 3 THV displays significantly lower rates of PAR than does the Sapien XT THV. A lesser degree of MDCT area oversizing may be employed for this new balloon-expandable THV.
本研究旨在比较多排螺旋 CT（MDCT）面积过度增大对 Sapien 3 与 Sapien XT 经导管心脏瓣膜（THV）植入患者发生瓣周漏（PAR）的影响，以确定适合 Sapien 3 平台的新 MDCT 测量指南。
Sapien XT 中已证实 PAR 发生率与过度增大呈反比关系，但 Sapien 3 中具有可比性的过度增大的 PAR 发生率尚不清楚。
前瞻性纳入 61 例接受 Sapien 3 THV 经导管主动脉瓣置换术的患者，并与 92 例接受 Sapien XT THV 经导管主动脉瓣置换术的患者进行比较。根据 MDCT 面积过度增大百分比将患者分为以下几类：小于 0%（欠扩大）、0%至 5%、5%至 10%、大于 10%。主要终点是经胸超声心动图显示轻度或更严重的 PAR。
Sapien 3 组患者中有 19.7%（61 例中有 12 例）发生轻度或更严重的 PAR，而 Sapien XT 组患者中有 54.3%（92 例中有 50 例）发生轻度或更严重的 PAR（p < 0.01）。与 Sapien XT 组相比，Sapien 3 组除过度增大>10%（p 组间差异=0.54）外，其他各程度的 PAR 发生率均显著降低。Sapien 3 组中中度或重度 PAR 发生率也低于 Sapien XT 组（3.3%比 13.0%，p = 0.04）。在 Sapien 3 组中，确定 MDCT 面积过度增大百分比≤4.17%为鉴别有或无轻度或更严重 PAR 患者的最佳临界值。
本回顾性分析表明，Sapien 3 THV 的 PAR 发生率明显低于 Sapien XT THV。对于这种新型球囊扩张型 THV，可采用较小程度的 MDCT 面积过度增大。
