Structural Interventional Cardiology, Department of Clinical & Experimental Medicine, University Hospital Careggi, Florence, Italy.
The Heart Center, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.
EuroIntervention. 2022 Apr 1;17(17):e1397-e1406. doi: 10.4244/EIJ-D-21-00581.
The presence of severe calcific atherosclerosis at the iliofemoral axis may preclude transcatheter aortic valve implantation (TAVI) by the transfemoral (TF) approach. Intravascular lithotripsy (IVL) is a novel technology that fractures intimal/medial calcium and increases vessel compliance allowing TF TAVI in selected patients with peripheral artery disease (PAD).
The aim of this study was to report on the safety and efficacy of IVL-assisted TF TAVI in an all-comers population.
Clinical, imaging and procedural data on all consecutive patients treated by IVL-assisted TF TAVI in six high-volume European centres (2018-2020) were collected in this prospective, real-world, multicentre registry.
IVL-assisted TF TAVI was performed in 108 patients, increasing from 2.4% to 6.5% of all TAVI from 2018 to 2020, respectively. The target lesion was most often localised at the common and/or external iliac artery (93.5% of cases; average TL-MLD 4.6±0.9 mm with 318 degrees of calcium arc). Transfemoral aortic valve delivery was successful in 100% of cases; final procedural success in 98.2% (two conversions to cardiac open surgery for annular rupture and valve migration). Complications of the IVL-treated segments consisted of 1 perforation and 3 major dissections requiring stent implantation (2 covered stents and 2 BMS). Access-site-related complications included 3 major bleedings. Three in-hospital deaths were recorded (2.8%, 1 failed surgical conversion after annular rupture, 1 cardiac arrest after initial valvuloplasty, 1 late hyperkalaemia in renal dysfunction).
IVL-assisted TF TAVI proved to be a safe and effective approach, which helps to expand the indications for TF TAVI in patients with severe calcific PAD. However, these patients continue to have a higher-than-average incidence of periprocedural complications.
在髂股轴严重钙化性动脉粥样硬化的情况下,经股动脉(TF)途径进行经导管主动脉瓣植入术(TAVI)可能不可行。血管内碎石术(IVL)是一种新型技术,可使内膜/中膜钙破裂并增加血管顺应性,从而允许在患有外周动脉疾病(PAD)的选定患者中进行 TF TAVI。
本研究旨在报告在所有患者人群中,使用 IVL 辅助 TF TAVI 的安全性和疗效。
在六个欧洲高容量中心(2018-2020 年),连续收集所有接受 IVL 辅助 TF TAVI 治疗的患者的临床、影像学和手术数据,这是一项前瞻性、真实世界、多中心注册研究。
IVL 辅助 TF TAVI 共进行了 108 例,2018 年至 2020 年分别占所有 TAVI 的 2.4%和 6.5%。靶病变最常位于股总动脉和/或髂外动脉(93.5%的病例;平均 TL-MLD 4.6±0.9mm,钙弧 318 度)。经股主动脉瓣输送在 100%的病例中获得成功;最终手术成功率为 98.2%(因瓣环破裂和瓣膜移位进行 2 例心脏开放手术转换)。IVL 治疗节段的并发症包括 1 例穿孔和 3 例需要支架植入的大夹层(2 例覆盖支架和 2 例 BMS)。与入路相关的并发症包括 3 例大出血。记录了 3 例院内死亡(2.8%,1 例因瓣环破裂导致手术转换失败,1 例初始瓣膜成形术后心脏骤停,1 例肾功能障碍时高钾血症)。
IVL 辅助 TF TAVI 证明是一种安全有效的方法,有助于扩大 TF TAVI 在严重钙化性 PAD 患者中的适应证。然而,这些患者的围手术期并发症发生率仍然高于平均水平。