Matsuhiro Yutaka, Mizote Isamu, Nakamura Daisuke, Dohi Tomoharu, Maeda Koichi, Shimamura Kazuo, Kawamura Ai, Yamashita Kizuku, Kosugi Shumpei, Okuno Shota, Sugae Hiroki, Takeda Yasuharu, Sakata Yasushi
Department of Cardiovascular Medicine, Osaka University Graduate School of Medicine, Osaka, Japan.
Department of Cardiovascular Surgery, Osaka University Graduate School of Medicine, Osaka, Japan.
Catheter Cardiovasc Interv. 2025 Apr;105(5):990-997. doi: 10.1002/ccd.31415. Epub 2025 Jan 20.
The long-term valve durability of supra-annular self-expanding valves (SEV) and intra-annular balloon-expandable valves (BEV) in patients with small aortic annuli remains unexplored.
This study aimed to determine the long-term bioprosthetic valve durability with SEV versus BEV in patients with small aortic annuli.
This retrospective study included patients with severe aortic stenosis (AS) and an aortic annulus area of 430 mm or less who underwent transcatheter aortic valve replacement using SEV and BEV between October 2009 and December 2022. Based on the Valve Academic Research Consortium's three definitions, the endpoints were hemodynamic structural valve deterioration (SVD) and bioprosthetic valve failure (BVF). Inverse probability of treatment weighting (IPTW) was used to compare between the two groups and adjust for baseline characteristics. The Fine-Gray subdistribution hazard model accounted for the competing risk of death.
In total, 565 patients (204 treated with SEV and 361 treated with BEV) were included. The median follow-up duration was 3.6 years [2.0 years, 5.7 years], and the maximum was 12.3 years. Hemodynamic SVD and BVF were less frequently identified in the SEV group than in the BEV group (1.1% vs. 9.1% within 5 years, 0.7% vs. 8.1% within 5 years, respectively). On the IPTW adjusted Fine-Gray subdistribution hazard model analysis, hemodynamic SVD was less frequent in SEV compared with BEV (Hazard Ratio [HR]: 0.16; 95% Confidence Interval [CI]: 0.04-0.56, p = 0.004). SEV was also associated with a lower BVF risk than BEV (HR: 0.25; 95% CI: 0.08-0.76, p = 0.015).
SEV appears to be more suitable for long-term valve durability in patients with a small aortic annulus.
小主动脉瓣环患者使用瓣上型自膨式瓣膜(SEV)和瓣环内球囊扩张式瓣膜(BEV)的长期瓣膜耐久性尚未得到研究。
本研究旨在确定小主动脉瓣环患者使用SEV与BEV的长期生物瓣膜耐久性。
这项回顾性研究纳入了2009年10月至2022年12月期间因严重主动脉瓣狭窄(AS)且主动脉瓣环面积小于或等于430mm²而接受经导管主动脉瓣置换术并使用SEV和BEV的患者。根据瓣膜学术研究联盟的三种定义,终点为血流动力学结构性瓣膜退变(SVD)和生物瓣膜失效(BVF)。采用治疗权重逆概率(IPTW)对两组进行比较并调整基线特征。Fine-Gray亚分布风险模型考虑了死亡的竞争风险。
共纳入565例患者(204例接受SEV治疗,361例接受BEV治疗)。中位随访时间为3.6年[2.0年,5.7年],最长为12.3年。SEV组血流动力学SVD和BVF的发生率低于BEV组(5年内分别为1.1%对9.1%,5年内分别为0.7%对8.1%)。在IPTW调整后的Fine-Gray亚分布风险模型分析中,SEV组血流动力学SVD的发生率低于BEV组(风险比[HR]:0.16;95%置信区间[CI]:0.04 - 0.56,p = 0.004)。SEV与BVF风险低于BEV也相关(HR:0.25;95% CI:0.08 - 0.76,p = 0.015)。
对于小主动脉瓣环患者,SEV似乎更适合长期瓣膜耐久性。