Kini Annapoorna S, Tang Gilbert H L, Yaryura Ricardo, Petrossian George, Roberts David K, Rahman Ayaz, Saltzman Adam, Durkin Raymond, DeVries James T, Stinis Curtiss
Mount Sinai Fuster Heart Hospital, Mount Sinai Health System, New York, New York, USA.
Sarasota Memorial Hospital, Sarasota, Florida, USA.
JACC Cardiovasc Interv. 2025 Mar 24;18(6):785-797. doi: 10.1016/j.jcin.2024.11.015. Epub 2024 Nov 24.
Longer term outcomes of transcatheter aortic valve replacement (TAVR) with the SAPIEN 3 Ultra RESILIA (S3UR) valve over its predecessors have not been reported in a national registry.
The aim of this study was to compare the 1-year clinical and echocardiographic outcomes of the S3UR with those of the SAPIEN 3 (S3) and SAPIEN 3 Ultra (S3U) in the Society of Thoracic Surgeons/American College of Cardiology TVT (Transcatheter Valve Therapy) Registry.
From September 2022 to March 2023, patients who underwent native TAVR with the S3UR or the S3 or S3U valve were propensity matched and compared. Predictors of 1-year outcomes were identified. The median follow-up time was 358 days (Q1-Q3: 47-365 days) for the S3UR and 364 days (Q1-Q3: 80-365 days) for the S3 and S3U.
A total of 4,598 S3UR patients were propensity matched with 4,598 and 32,536 S3 and S3U patients. At discharge, effective orifice areas were larger in the S3UR group (P < 0.0001). The lower discharge mean gradient in the S3UR group was maintained at 30 days and 1 year (P < 0.0001 for all). At 1 year, all-cause mortality (7.6% vs 9.7%; HR: 0.8; 95% CI: 0.67-0.93; P = 0.004), mild or greater paravalvular leak (PVL) (15.6% vs 18.5%; HR: 0.82; 95% CI: 0.69-0.97; P = 0.02), and life-threatening bleeding (2.0% vs 2.7%; HR: 0.7; 95% CI: 0.54-0.94; P = 0.03) were lower in the S3UR group. S3UR and mild or greater PVL were predictive of 1-year mortality in the overall cohort and in low-risk patients. Valve reintervention remained rare at 1 year (0.6% vs 0.4%; HR: 1.46; 95% CI: 0.77-2.78; P = 0.25).
TAVR with the S3UR is associated with superior 1-year clinical outcomes and lower gradients than its predecessors, with less PVL and low valve reintervention. Longer follow-up will determine the durability of the RESILIA technology in the SAPIEN valve platform.
在全国性注册研究中，尚未报道使用SAPIEN 3 Ultra RESILIA（S3UR）瓣膜进行经导管主动脉瓣置换术（TAVR）与其前代产品相比的长期结果。
本研究的目的是在胸外科医师协会/美国心脏病学会经导管瓣膜治疗（TVT）注册研究中，比较S3UR与SAPIEN 3（S3）和SAPIEN 3 Ultra（S3U）的1年临床和超声心动图结果。
2022年9月至2023年3月，对接受S3UR或S3或S3U瓣膜初次TAVR的患者进行倾向评分匹配并比较。确定了1年结果的预测因素。S3UR组的中位随访时间为358天（第一四分位数-第三四分位数：47-365天），S3和S3U组为364天（第一四分位数-第三四分位数：80-365天）。
共有4598例S3UR患者与4598例S3患者和32536例S3U患者进行了倾向评分匹配。出院时，S3UR组的有效瓣口面积更大（P<0.0001）。S3UR组较低的出院平均压差在30天和1年时得以维持（所有比较P<0.0001）。1年时，S3UR组的全因死亡率（7.6%对9.7%；风险比：0.8；95%置信区间：0.67-0.93；P=0.004）、轻度及以上瓣周漏（PVL）（15.6%对18.5%；风险比：0.82；95%置信区间：0.69-0.97；P=0.02）和危及生命的出血（2.0%对2.7%；风险比：0.7；95%置信区间：0.54-0.94；P=0.03）均较低。S3UR和轻度及以上PVL可预测总体队列和低风险患者的1年死亡率。瓣膜再次干预在1年时仍然很少见（0.6%对0.4%；风险比：1.46；95%置信区间：0.77-2.78；P=0.25）。
与前代产品相比，使用S3UR进行TAVR具有更好的1年临床结果和更低的压差，PVL更少，瓣膜再次干预率低。更长时间的随访将确定RESILIA技术在SAPIEN瓣膜平台中的耐久性。
