Stötzel Antonia Katharina, Bhadra Oliver D, Waldschmidt Lara, Demal Till J, Grundmann David, Voigtländer Lisa, Blankenberg Stefan, Reichenspurner Hermann, Schofer Niklas, Schaefer Andreas
Departments of Cardiovascular Surgery, University Heart and Vascular Center Hamburg, University Hospital Hamburg Eppendorf, Hamburg, Germany.
Departments of Cardiology, University Heart and Vascular Center Hamburg, University Hospital Hamburg Eppendorf, Hamburg, Germany.
Catheter Cardiovasc Interv. 2025 Sep;106(3):1873-1882. doi: 10.1002/ccd.70011. Epub 2025 Jul 17.
Valve-in-valve (ViV) procedures are an established therapy. Self-expanding (SE) supra-annular transcatheter heart valves (THV) achieve superior hemodynamics compared to balloon-expandable (BE) intra-annular THV, but influence of stent design versus valve position remains unclear.
This study compares SE intra- and supra-annular THV for aortic ViV procedures to further elucidate this topic.
From 05/2022 to 11/2023, 10 patients underwent ViV procedures with the SE intra-annular Navitor valve. A control group of 22 patients treated with the SE supra-annular Evolut R/PRO valve during the same period was retrieved from our database. Data were retrospectively analyzed according to updated valve academic research consortium (VARC) 3 definitions. A subgroup analysis matched patients for true internal diameter (ID) and body mass index (BMI).
Postprocedural transvalvular gradients were similar between groups. No differences in rates of significant paravalvular leakage (PVL) were seen (p = 0.131). No all-cause mortality occurred in either group. Device success (study group, Navitor: 70 [7] vs. control group, Evolut: 90.1 [20]; p = 0.293), early safety (90 [9] vs. 86.4 [19]; p = 1.000), permanent pacemaker implantation (PPI) (0 [0] vs. 9.1 [2]; p = 1.000), and stroke (0 [0] vs. 4.5 [1]; p = 1.000) were similar between groups. Procedure time was shorter for the study group (65.8 ± 27.9 min vs. 145.7 ± 51.3 min; p < 0.001). After matching for True ID and BMI these results persisted.
Intra- and supra-annular THV showed similar clinical and hemodynamic outcomes in aortic ViV procedures. These findings highlight the applicability of SE intra-annular THV for aortic ViV procedures.
瓣中瓣(ViV)手术是一种成熟的治疗方法。与球囊扩张式(BE)瓣环内经导管心脏瓣膜(THV)相比,自膨胀式(SE)瓣环上THV具有更好的血流动力学效果,但支架设计与瓣膜位置的影响仍不明确。
本研究比较用于主动脉ViV手术的SE瓣环内和瓣环上THV,以进一步阐明该主题。
2022年5月至2023年11月,10例患者接受了使用SE瓣环内Navitor瓣膜的ViV手术。从我们的数据库中检索出同期接受SE瓣环上Evolut R/PRO瓣膜治疗的22例患者作为对照组。根据更新的瓣膜学术研究联盟(VARC)3定义对数据进行回顾性分析。进行亚组分析,使患者的真实内径(ID)和体重指数(BMI)相匹配。
术后跨瓣压差在两组之间相似。两组间显著瓣周漏(PVL)发生率无差异(p = 0.131)。两组均未发生全因死亡。器械成功率(研究组,Navitor:70 [7] vs. 对照组,Evolut:90.1 [20];p = 0.293)、早期安全性(90 [9] vs. 86.4 [19];p = 1.000)、永久性起搏器植入(PPI)(0 [0] vs. 9.1 [2];p = 1.000)和卒中(0 [0] vs. 4.5 [1];p = 1.000)在两组之间相似。研究组的手术时间更短(65.8 ± 27.9分钟 vs. 145.7 ± 51.3分钟;p < 0.001)。在匹配真实ID和BMI后,这些结果仍然成立。
瓣环内和瓣环上THV在主动脉ViV手术中显示出相似的临床和血流动力学结果。这些发现突出了SE瓣环内THV在主动脉ViV手术中的适用性。