Masiero Giulia, D'Angelo Livio, Fovino Luca Nai, Fabris Tommaso, Cardaioli Francesco, Rodinò Giulio, Benedetti Alice, Boiago Mauro, Continisio Saverio, Montonati Carolina, Sciarretta Tommaso, Zuccarelli Vittorio, Scotti Andrea, Lorenzoni Giulia, Pavei Andrea, Napodano Massimo, Fraccaro Chiara, Iliceto Sabino, Marchese Alfredo, Esposito Giovanni, Tarantini Giuseppe
Department of Cardiac, Thoracic, Vascular Sciences and Public Health, University of Padua, Padua, Italy.
Unit of Cardiology, GVM Care and Research, Anthea Hospital, Bari, Italy.
Front Cardiovasc Med. 2022 Feb 28;9:832242. doi: 10.3389/fcvm.2022.832242. eCollection 2022.
Among vascular closure devices (VCDs), the novel collagen plug-based MANTA VCD is the first designed for large bore percutaneous access. We aimed to assess the features and predictors of access-site vascular complications in an unselected trans-femoral transcatheter aortic valve replacement (TF-TAVR) population.
Patients undergoing large bore arteriotomy closure with 18F MANTA VCD following TF-TAVR at a large tertiary care center from September 2019 to January 2021 were prospectively analyzed. Primary Outcome was the MANTA VCD access-site-related complications according to Valve Academic Research Consortium-3 (VARC) definitions. Its incidence and predictors were evaluated.
Eighty-eight patients (median age 82 years, 48% male, 3.3 median Society of Thoracic Surgeons score) undergoing TF-TAVR were included, mostly (63%) treated with a self-expandable device and with outer diameter sizes varied from 18F to 24-F. MANTA VCD technical success rate was 98%, while 10 patients (11%) experienced MANTA VCD access-site vascular complications which included 8% of minor complications and only to 2% of major events resulting in VARC type ≥2 bleeding. Vessel occlusion/stenosis (60%), perforation (20%), and pseudoaneurysm/dissection/hematoma (20%) occurred, but all were managed without surgical treatment. Independent predictors of failure were age ( = 0.04), minimum common femoral artery diameter (CFA) ( < 0.01), sheath-to-femoral-artery ratio (SFAR) ( < 0.01), and a lower puncture height ( = 0.03). A CFA diameter <7.1 mm with a SFAR threshold of 1.01 were associated with VCD failure.
In a more comers TF-TAVR population, MANTA VCD was associated with reassuring rates of technical success and major access-site vascular complications. Avoiding lower vessel size and less puncture site distance to CFA bifurcation might further improve outcomes.
在血管闭合装置（VCDs）中，新型基于胶原蛋白塞的MANTA VCD是首个专为大口径经皮穿刺入路设计的装置。我们旨在评估未经选择的经股动脉经导管主动脉瓣置换术（TF-TAVR）人群中穿刺部位血管并发症的特征和预测因素。
对2019年9月至2021年1月在一家大型三级医疗中心接受TF-TAVR后使用18F MANTA VCD进行大口径动脉切开术闭合的患者进行前瞻性分析。主要结局是根据瓣膜学术研究联盟-3（VARC）定义的与MANTA VCD穿刺部位相关的并发症。评估其发生率和预测因素。
纳入了88例接受TF-TAVR的患者（中位年龄82岁，48%为男性，胸外科医师协会评分中位数为3.3），大多数（63%）使用自膨胀装置治疗，外径尺寸从18F到24F不等。MANTA VCD技术成功率为98%，而10例患者（11%）发生了MANTA VCD穿刺部位血管并发症，其中包括8%的轻微并发症，只有2%的严重事件导致VARC≥2型出血。发生了血管闭塞/狭窄（60%）、穿孔（20%）和假性动脉瘤/夹层/血肿（20%），但所有这些均无需手术治疗即可处理。失败的独立预测因素为年龄（P = 0.04）、股总动脉最小直径（CFA）（P < 0.01）、鞘管与股动脉比值（SFAR）（P < 0.01）以及较低的穿刺高度（P = 0.03）。CFA直径<7.1 mm且SFAR阈值为1.01与VCD失败相关。
在更多样化的TF-TAVR人群中，MANTA VCD的技术成功率和主要穿刺部位血管并发症发生率令人放心。避免较小的血管直径和穿刺部位距CFA分叉较近可能会进一步改善结局。
