1. Manta versus Perclose ProGlide vascular closure device after transcatheter aortic valve implantation: Initial experience from a large European center
- Author
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Nicolas Majunke, Holger Thiele, Thilo Noack, David Holzhey, Philipp Kiefer, Johannes Wilde, Sergey Leontyev, Mitsunobu Kitamura, Marcus Sandri, Phillip Hartung, Lisa Crusius, Steffen Desch, Anna Haag, Oliver Dumpies, Michael A. Borger, and Mohamed Abdel-Wahab
- Subjects
Severe bleeding ,endocrine system ,medicine.medical_specialty ,Transcatheter aortic ,Hemostatic Techniques ,business.industry ,Hemorrhage ,Aortic Valve Stenosis ,General Medicine ,Odds ratio ,Independent predictor ,Confidence interval ,Surgery ,Femoral Artery ,Transcatheter Aortic Valve Replacement ,Treatment Outcome ,Aortic Valve ,Cohort ,Access site ,Humans ,Medicine ,Vascular closure device ,Cardiology and Cardiovascular Medicine ,business ,Vascular Closure Devices - Abstract
Background 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. Objective We aimed to compare vascular and bleeding complications between the M-VCD and the established suture-based Perclose ProGlide (P)-VCD. Methods 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. Results 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). Conclusions 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.
- Published
- 2022