Early Outcomes After Percutaneous Closure of Access Site in Transfemoral Transcatheter Valve Implantation Using the Novel Vascular Closure Device Collagen Plug-Based MANTA

• Published in: The American journal of cardiology Vol. 124; no. 8; pp. 1265 - 1271
• Main Authors: Gheorghe, Livia, Brouwer, Jorn, Mathijssen, Harold, Nijenhuis, Vincent J, Rensing, Benno JWM, Swaans, Martin J, Chan Pin Yin, Dean RPP, Heijmen, Robin H., De Kroon, Tom, Sonker, Uday, Van der Heyden, Jan AS, Ten Berg, Jurrien M
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 15.10.2019; Elsevier Limited
• Subjects: Aged, 80 and over; Aortic valve; Aortic Valve - surgery; Aortic Valve Stenosis - surgery; Bleeding; Boring tools; Calcification; Catheterization, Peripheral - methods; Catheters; Collagen; Collagen - pharmacology; Complications; Equipment Design; Feasibility; Feasibility Studies; Female; Femoral Artery; Follow-Up Studies; Hemostatic Techniques - instrumentation; Humans; Implantation; Male; Medical imaging; Mortality; Retrospective Studies; Software; Time Factors; Transcatheter Aortic Valve Replacement - methods; Transplants & implants; Treatment Outcome; Variables; Vascular Closure Devices; Veins & arteries; United States > US; California
• ISSN: 0002-9149; 1879-1913
• DOI: 10.1016/j.amjcard.2019.07.030

A new collagen-based MANTA vascular closure device (VCD) was developed for closing large-bore arteriotomies after transfemoral transcatheter aortic valve implantation (TAVI). We evaluated safety and feasibility at 30-day follow-up in terms of vascular and bleeding complications and mortality of the collagen-based MANTA VCD compared with the suture-based Prostar XL VCD in a cohort of 366 patients who underwent transfemoral TAVI between January 2015 and April 2018. The MANTA VCD was used in 168 patients and the Prostar XL VCD in 198 patients, with successful closure of 98.8% and 98.5%, respectively. VARC-2 defined as major vascular and bleeding complications was similar in both groups (MANTA vs Prostar XL): 0.6% versus 1.0% (p = 0.661) and 0.6% versus 1.5% (p = 0.102). Minor vascular and bleeding complications, were significantly more frequent (10.7 vs 18.8 %, p = 0.003 and 13.7 vs 19.7%, p = 0.080, respectively) in the Prostar XL cohort. Thirty-day all-cause mortality was 2.7%, without significant difference between the groups (p = 0.278). The MANTA device is a safe and feasible option for vascular access closure in patients undergoing transfemoral TAVI.