Manta versus Perclose ProGlide vascular closure device after transcatheter aortic valve implantation: Initial experience from a large European center

• Published in: Cardiovascular revascularization medicine 2022-04, Vol.37, p.34-40
• Main Authors: Dumpies, Oliver, Kitamura, Mitsunobu, Majunke, Nicolas, Hartung, Phillip, Haag, Anna, Wilde, Johannes, Desch, Steffen, Sandri, Marcus, Crusius, Lisa, Noack, Thilo, Kiefer, Philipp, Leontyev, Sergey, Borger, Michael, Thiele, Holger, Holzhey, David, Abdel-Wahab, Mohamed
• Format: Article
• Language: English
• Subjects: Aortic Valve - diagnostic imaging; Aortic Valve - surgery; Aortic Valve Stenosis - complications; Aortic Valve Stenosis - diagnostic imaging; Aortic Valve Stenosis - surgery; Femoral Artery - diagnostic imaging; Femoral Artery - surgery; Hemorrhage - etiology; Hemostatic Techniques - adverse effects; Humans; Manta; TAVI; Transcatheter Aortic Valve Replacement - adverse effects; Treatment Outcome; Vascular closure device; Vascular Closure Devices; Vascular complications
• ISSN: 1553-8389; 1878-0938
• DOI: 10.1016/j.carrev.2021.06.134

Vascular and bleeding complications are common after transcatheter aortic valve implantation (TAVI) and are associated with worse outcomes. The plug-based Manta (M) vascular closure device (VCD) is a novel option to achieve haemostasis for large-bore arterial access sites. We aimed to compare vascular and bleeding complications between the M-VCD and the established suture-based Perclose ProGlide (P)-VCD. From February to September 2019 a total of 578 patients underwent transfemoral TAVI at a single high-volume centre. Access site closure was performed using M-VCD in 195 patients (33.7%) and P-VCD in 383 patients (66.3%). We assessed vascular and access site-related complications as well as bleeding events according to the Valve Academic Research Consortium-2 definition. Overall vascular complications occurred less frequently in the M-VCD group (10.7% vs. 19.0%, p = 0.011) driven by a significantly lower rate of major vascular events (2.0% vs. 6.5%, p = 0.025). Access site-related complications were significantly less frequent in the M-VCD cohort (10.7% vs. 16.6%, p = 0.048). The M-VCD was associated with significantly lower rates of major (0.5% vs. 4.4%, p = 0.009) and life-threatening bleeding (0% vs. 2.3%, p = 0.032). In multivariable analysis, the use of M-VCD was the only independent predictor of vascular complications (odds ratio 0.54, 95% confidence interval 0.32–0.91, p = 0.022). The M-VCD was associated with a reduction of vascular and access-site complications as well as severe bleeding after transfemoral TAVI compared to the P-VCD in this observational study. •The plug-based Manta closure device is a new option for large-bore arterial access.•Access site-related vascular complications were less frequently with the Manta device.•The ProGlide device is associated with more severe bleeding complications.