Rogers Toby, Steinvil Arie, Buchanan Kyle, Alraies M Chadi, Koifman Edward, Gai Jiaxiang, Torguson Rebecca, Okubagzi Petros, Ben-Dor Itsik, Pichard Augusto, Satler Lowell, Waksman Ron
Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, District of Columbia.
Cardiovascular and Pulmonary Branch, Division of Intramural Research, National Heart Lung and Blood Institute, National Institutes of Health, Bethesda, Maryland.
J Interv Cardiol. 2017 Aug;30(4):356-361. doi: 10.1111/joic.12389. Epub 2017 May 11.
To evaluate balloon-expandable and self-expanding third-generation transcatheter aortic valve replacement (TAVR) devices according to patient selection criteria and outcomes.
Two competing third-generation TAVR technologies are currently commercially available in the US. There are no published head-to-head comparisons of the relative performance of these two devices.
257 consecutive patients undergoing TAVR with a third-generation balloon-expandable (Edwards Sapien 3) or self-expanding device (Medtronic CoreValve Evolut R) at a single US medical center were included. Choice of TAVR device was at the discretion of the multidisciplinary Heart Team. Baseline clinical characteristics, echocardiographic and CT imaging, procedural and 30-day outcomes were prospectively collected.
74 patients received a self-expanding valve (SEV) and 183 received a balloon-expandable valve (BEV). Patients selected for SEV were more frequently women, with lower body surface area and smaller calcified iliofemoral arteries. Three SEV patients required implantation of a second valve to successfully treat paravalvular leak. Only one BEV patient had moderate paravalvular regurgitation. There was no difference in the rate of stroke, major vascular complication or bleeding. Permanent pacemaker implantation rate was significantly higher with SEV (12.7% vs 4.7%, P = 0.49) and hospital length of stay was longer (8.3% vs 6.5%, P = 0.043), but 30-day mortality was comparable (1.4% vs 1.6%, P = 1.00).
Short-term outcomes were equivalent between the two technologies. Clinically significant paravalvular regurgitation was rare. SEV were more frequently selected in women and patients with challenging transfemoral access, but were associated with higher permanent pacemaker implantation rate and longer hospital length of stay.
根据患者选择标准和治疗结果，评估球囊扩张式和自膨胀式第三代经导管主动脉瓣置换术（TAVR）装置。
目前在美国市场上有两种相互竞争的第三代TAVR技术。尚无关于这两种装置相对性能的直接对比研究发表。
纳入在美国一家医疗中心连续接受第三代球囊扩张式（爱德华兹Sapien 3）或自膨胀式装置（美敦力CoreValve Evolut R）TAVR治疗的257例患者。TAVR装置的选择由多学科心脏团队决定。前瞻性收集患者的基线临床特征、超声心动图和CT成像、手术过程及30天治疗结果。
74例患者接受了自膨胀瓣膜（SEV），183例接受了球囊扩张瓣膜（BEV）。选择SEV的患者中女性更为常见，体表面积较小，髂股动脉钙化程度较轻。3例SEV患者需要植入第二个瓣膜以成功治疗瓣周漏。仅1例BEV患者有中度瓣周反流。两组患者的卒中、主要血管并发症或出血发生率无差异。SEV组的永久起搏器植入率显著更高（12.7%对4.7%，P = 0.49），住院时间更长（8.3%对6.5%，P = 0.043），但30天死亡率相当（1.4%对1.6%，P = 1.00）。
两种技术的短期治疗结果相当。具有临床意义的瓣周反流很少见。女性和经股动脉入路困难的患者更常选择SEV，但SEV与更高的永久起搏器植入率和更长的住院时间相关。
