Deutsches Herzzentrum Berlin, Berlin, Germany.
Ann Thorac Surg. 2013 Jun;95(6):1982-90. doi: 10.1016/j.athoracsur.2013.02.038. Epub 2013 Apr 25.
An important number of patients are considered unsuitable for transcatheter aortic valve implantation because of a large native aortic valve. A new 29-mm balloon-expandable transcatheter valve offers the option to gain a maximal effective orifice area without paravalvular leakage. This study sought to define ranges of safe applicability in terms of device landing zone geometry. A second purpose was to determine performance of the prosthesis and clinical outcome.
Between April 2011 and July 2012, the new 29-mm SAPIEN XT prosthesis was implanted by means of transapical access in 78 patients with large aortic annuli. The study group represents 32.9% of all transapical transcatheter aortic valve implantations performed at our institution during the observation period; 82 patients receiving 26-mm prosthesis served as a control group. Device landing zone morphology was analyzed by echocardiography and computed tomography.
The postimplant effective orifice area (study versus control group) was 2.7 cm(2) (interquartile range, 2.3 to 3.0 cm(2)) and 2.1 cm(2) (interquartile range, 1.7 to 2.4 cm(2)), respectively (p < 0.001), without any severe patient-prosthesis mismatch. Postprocedural regurgitation was similar in both groups (p = 0.892): absent in 56 (71.8%) and 54 (65.9%) patients, trace or mild in 21 (26.9%) and 27 (32.9%), and moderate in 1 (1.3%) and 1 (1.2%), respectively. Including patients in cardiogenic shock, the overall 30-day mortality rate of the study and control groups was 5.1% and 1.2%, respectively. One-year survival was 76.7% ± 8.6% with no difference from control patients (p = 0.743).
The new 29-mm balloon-expandable prosthesis broadens the indication for transcatheter aortic valve implantation to include patients with large annuli. The outcome is very favorable.
由于主动脉瓣较大，许多患者被认为不适合经导管主动脉瓣植入术。一种新的 29mm 球囊扩张式经导管瓣膜提供了在不发生瓣周漏的情况下获得最大有效瓣口面积的选择。本研究旨在根据器械着陆区的几何形状确定安全适用范围。第二个目的是确定假体的性能和临床结果。
2011 年 4 月至 2012 年 7 月，我们通过经心尖途径在 78 例主动脉瓣环较大的患者中植入了新型 29mm SAPIEN XT 瓣膜。该研究组代表了我们机构在观察期内进行的所有经心尖经导管主动脉瓣植入术的 32.9%；82 例接受 26mm 假体的患者作为对照组。通过超声心动图和计算机断层扫描分析器械着陆区形态。
植入后的有效瓣口面积（研究组与对照组）分别为 2.7cm²（四分位距 2.33.0cm²）和 2.1cm²（四分位距 1.72.4cm²）（p<0.001），且无严重的患者-假体不匹配。两组的术后反流程度相似（p=0.892）：无反流分别为 56（71.8%）和 54（65.9%）例，微量或轻度反流分别为 21（26.9%）和 27（32.9%）例，中度反流分别为 1（1.3%）和 1（1.2%）例。包括心源性休克患者在内，研究组和对照组的 30 天死亡率分别为 5.1%和 1.2%。1 年生存率分别为 76.7%±8.6%，与对照组患者无差异（p=0.743）。
新型 29mm 球囊扩张式假体拓宽了经导管主动脉瓣植入术的适应证，包括主动脉瓣环较大的患者。结果非常理想。
