Tartaglia Francesco, Gitto Mauro, Kim Won-Keun, Leone Pier Pasquale, Fabris Tommaso, De Biase Chiara, Costa Giuliano, Montarello Nicholas, Scotti Andrea, Bellamoli Michele, Alfadhel Mesfer, Koren Ofir, Fezzi Simone, Bellini Barbara, Massussi Mauro, Costa Giulia, Fraccaro Chiara, Mazzapicchi Alessandro, Giacomin Enrico, Burzotta Francesco, Zito Andrea, Gorla Riccardo, Angelillis Marco, Hug Karsten, Briguori Carlo, Bettari Luca, Messina Antonio, Galasso Michele, Regazzoli Damiano, Cattaneo Greta, Boiago Mauro, Calamita Gianmaria, Laterra Giulia, Renker Matthias, Garcia Gomez Mario, Ielasi Alfonso, Landes Uri, Rheude Tobias, Bedogni Francesco, Amat Santos Ignacio, Saia Francesco, Bai Lin, Chen Mao, Adamo Marianna, De Carlo Marco, Montorfano Matteo, Makkar Raj R, Mylotte Darren, Blackman Daniel J, Barbanti Marco, Tchetche Didier, Tarantini Giuseppe, Latib Azeem, Maffeo Diego, De Backer Ole, Buono Andrea, Mangieri Antonio
Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, MI, Italy.
IRCCS Humanitas Research Hospital, Via Alessandro Manzoni, 56, 20089, Milan, Rozzano, Italy.
Clin Res Cardiol. 2025 Aug 6. doi: 10.1007/s00392-025-02726-0.
Bicuspid aortic valve (BAV) stenosis poses several challenges when transcatheter aortic valve implantation (TAVI) is performed, including the risk of high residual gradients (HRG).
To identify incidence, predictors and outcomes of HRG after TAVI in Sievers type 1 BAV stenosis.
Consecutive patients with Sievers type 1 BAV stenosis undergoing TAVI at 24 international centers from 2016 to 2023 were enrolled. HRG were defined as a mean transvalvular gradient ≥ 20 mmHg at 30 days, according to Valve Academic Research Consortium-3 (VARC-3) criteria. The primary endpoint was major adverse cardiovascular events (MACE), defined as a composite of all-cause death, neurologic events or hospitalization for heart failure, assessed at 3 years after TAVI. Secondary endpoints included the single components of the primary outcome. Endpoints were assessed according to the presence of HRG, before and after covariate adjustment for clinically relevant confounders.
A total of 972 patients were enrolled. HRG post-TAVI were found in 35 patients (3.6%). Patients with HRG had a higher preprocedural aortic valve gradient (57.0 [interquartile range: 49.0-69.0] mmHg vs 48.0 [40.0-58.0] mmHg, p < 0.001) and received smaller transcatheter heart valve (THV) (26.0 [23.0-29.0] mm vs 29.0 [26.0-29.0] mm, p < 0.001) when compared to patients with normal residual gradients (NRG). The only independent predictor of HRG was a bioprosthesis size ≤ 23 mm. At 3 years, MACE occurred in 35.0% of HRG patients and 22.3% of NRG patients (adjusted hazard ratio [HR]: 2.41, 95% confidence interval [CI]: 1.15-5.04; p = 0.019). HRG patients had a higher risk of neurologic events as compared to NRG patients (13.3% versus 4.5%, adjusted HR: 4.50, 95% CI: 1.52-13.30, p = 0.007).
After TAVI in Sievers type 1 BAV stenosis, HRG occurred in around 4% of cases and were associated with an increased risk of MACE and neurologic events.
在进行经导管主动脉瓣植入术(TAVI)时,二叶式主动脉瓣(BAV)狭窄带来了诸多挑战,包括高残余梯度(HRG)风险。
确定1型BAV狭窄患者TAVI术后HRG的发生率、预测因素和结局。
纳入2016年至2023年在24个国际中心接受TAVI的连续1型BAV狭窄患者。根据瓣膜学术研究联盟-3(VARC-3)标准,HRG定义为术后30天平均跨瓣压差≥20 mmHg。主要终点是主要不良心血管事件(MACE),定义为全因死亡、神经系统事件或因心力衰竭住院的综合指标,在TAVI术后3年进行评估。次要终点包括主要结局的单个组成部分。根据HRG的存在情况,在对临床相关混杂因素进行协变量调整前后评估终点。
共纳入972例患者。TAVI术后发现35例患者(3.6%)存在HRG。与残余梯度正常(NRG)的患者相比,HRG患者术前主动脉瓣压差更高(57.0[四分位间距:49.0 - 69.0]mmHg对48.0[40.0 - 58.0]mmHg,p < 0.001),且接受的经导管心脏瓣膜(THV)更小(26.0[23.0 - 29.0]mm对29.0[26.0 - 29.0]mm,p < 0.001)。HRG的唯一独立预测因素是生物瓣膜尺寸≤23 mm。3年时,HRG患者中35.0%发生MACE,NRG患者中为22.3%(调整后风险比[HR]:2.41,95%置信区间[CI]:1.15 - 5.04;p = 0.019)。与NRG患者相比,HRG患者发生神经系统事件的风险更高(13.3%对4.5%,调整后HR:4.50,95%CI:1.52 - 13.30,p = 0.007)。
在1型BAV狭窄患者TAVI术后,约4%的病例出现HRG,且与MACE和神经系统事件风险增加相关。