Itach Tamar, Loewenstein Itamar, Zahler David, Finkelstein Ariel, Barbash Israel, Greener Gabby Elbaz, Assa-Vaknin Hana, Kornowski Ran, Turyan Anna, Steinvil Arie
Cardiology Department, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel.
Affiliated to Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel.
Catheter Cardiovasc Interv. 2025 Feb;105(3):624-632. doi: 10.1002/ccd.31374. Epub 2024 Dec 24.
The management of Transcatheter Aortic Valve Implantation (TAVI) patients with a small aortic annulus (SAA) postures a substantial challenge, increasing the risk of patient- prosthesis mismatch (PPM) and overall mortality.
This study aimed to compare the hemodynamic and clinical outcomes of transcatheter balloon-expandable valve (BEV) versus transcatheter self-expandable valve (SEV) in SAA.
We conducted propensity score matching (PSM) of severe AS patients with SAA who underwent trans-femoral TAVR and enrolled to the Israeli TAVR registry between the years 2008 and 2023. SAA was defined as an aortic-valve annulus area ≤ 430 mm. Since the BEV used have a smaller size cut-off, an additional analysis on very small aortic annulus (vSAA) as defined as aortic-valve annulus area ≤ 345 mm was performed.
The study included 1364 consecutive patients with SAA of (BEV n = 485; SEV n = 879) at a mean age of 82 ± 7 years, of whom the vast majority were female (83%). Propensity-matched groups comprised of 329 and 122 paired for the SAA and vSAA patients, respectively. As compared to BEV in the SAA and vSAA analyses, SEV showed lower rates of postprocedural of LBBB (32% vs. 22% and 41% vs. 22%; both p < 0.01, respectively), however, higher rates of major vascular complications (2% vs. 7% and 2% vs. 12%; both p < 0.01, respectively) and major or life-threatening bleeding but only in vSAA group (17% vs. 9.1%, p = 0.009). One-month mortality was higher in the SEV versus BEV in both SAA and vSAA comparisons (2% vs. 0.6%, p = 0.048 and 3% vs. 0%, p = 0.018; respectively). A nonsignificant trend of higher 5-year mortality was observed in univariate models, noted mainly in vSAA patients (22% vs. 19%, p = 0.385; 24% vs. 15%, p = 0.073).
The present analysis observed higher rates of major vascular complications and 1-month mortality in SAA and vSAA treated with SEV. A similar nonsignificant trend toward long-term mortality for the vSAA group was observed and should be evaluated in larger cohorts.
经导管主动脉瓣植入术（TAVI）治疗主动脉瓣环较小（SAA）的患者面临重大挑战，会增加患者-假体不匹配（PPM）风险和总体死亡率。
本研究旨在比较经导管球囊扩张瓣膜（BEV）与经导管自膨胀瓣膜（SEV）在SAA患者中的血流动力学和临床结局。
我们对2008年至2023年间接受经股动脉TAVR并纳入以色列TAVR注册研究的SAA严重主动脉瓣狭窄（AS）患者进行倾向评分匹配（PSM）。SAA定义为主动脉瓣环面积≤430平方毫米。由于所使用的BEV尺寸下限较小，因此对定义为主动脉瓣环面积≤345平方毫米的极小主动脉瓣环（vSAA）进行了额外分析。
该研究纳入了1364例连续的SAA患者（BEV组n = 485；SEV组n = 879），平均年龄82±7岁，其中绝大多数为女性（83%）。倾向评分匹配组分别包括329例和122例SAA和vSAA患者。在SAA和vSAA分析中，与BEV相比，SEV术后左束支传导阻滞（LBBB）发生率较低（分别为32%对22%和41%对22%；p均<0.01），然而，主要血管并发症发生率较高（分别为2%对7%和2%对12%；p均<0.01），主要或危及生命的出血仅在vSAA组发生率较高（17%对9.1%，p = 0.009）。在SAA和vSAA比较中，SEV组的1个月死亡率均高于BEV组（分别为2%对0.6%，p = 0.048；3%对0%，p = 0.018）。在单变量模型中观察到5年死亡率有升高的非显著趋势，主要见于vSAA患者（22%对19%，p = 0.385；24%对15%，p = 0.073）。
本分析观察到SEV治疗的SAA和vSAA患者主要血管并发症发生率和1个月死亡率较高。vSAA组在长期死亡率方面也观察到类似的非显著趋势，应在更大队列中进行评估。
