Rutger-Jan Nuis1, David Wood2, Herbert Kroon1, Maarten van Wiechen1, Darra Bigelow3, Chris Buller3, Joost Daemen1, Peter de Jaegere1, Zvonimir Krajcer4, John Webb2, Nicolas Van Mieghem5. 1. Department of Cardiology, Erasmus Medical Center, Rotterdam, the Netherlands. 2. Centre for Cardiovascular and Heart Valve Innovation, St. Paul's and Vancouver General Hospital, Vancouver, Canada. 3. Clinical and Medical Affairs, Teleflex Inc., Exton, PA, USA. 4. Baylor St Luke Hospital, Houston, TX, USA. 5. Department of Cardiology, Erasmus Medical Center, Rotterdam, the Netherlands. Electronic address: n.vanmieghem@erasmusmc.nl.
Abstract
BACKGROUND/ PURPOSE: The MANTA is a dedicated plug-based large-bore vascular closure device (VCD) providing safe hemostasis in most patients, but data on the clinical impact and mechanisms of MANTA related complications are limited. This study sought to determine the frequency, impact and predictors of MANTA-related access complications. METHODS/MATERIALS: This patient-level meta-analysis included data from 2 medical device approval studies and 1 post-approval registry. The primary endpoint was the composite of major and minor access complications. Technical success was defined as hemostasis with MANTA closure device without need for vascular surgery or stenting. RESULTS: Eight hundred ninety-one patients (mean age 80) underwent transcatheter aortic valve replacement (n = 814), endovascular aortic repair (n = 71), balloon aortic valvuloplasty (n = 4) or mechanical circulatory support (n = 2). Technical success was 96.4% and median time to hemostasis was 31 (interquartile range: 17-76) seconds. The primary endpoint occurred 9.1% and bailout vascular surgery or stenting was necessary in 32 patients (3.6%). Female gender (OR: 2.63, CI: 1.46-4.73, p = 0.001), left femoral access (OR: 2.18, CI: 1.17-4.06, p = 0.015) and unfavorable arteriotomy phenotype (combination of a small femoral artery diameter with a deep arteriotomy; OR 2.27: 1.26-4.10, p = 0.006) independently predicted access complications. Access complications most often consisted of vessel dissection, stenosis or occlusion and predominantly occurred in patients with an unfavorable arteriotomy phenotype. CONCLUSIONS: Large-bore arteriotomy closure with MANTA VCD provided fast and safe hemostasis with an acceptable complication rate. Refined procedure planning and risk-stratification may further improve MANTA VCD performance.
BACKGROUND/ PURPOSE: The MANTA is a dedicated plug-based large-bore vascular closure device (VCD) providing safe hemostasis in most patients, but data on the clinical impact and mechanisms of MANTA related complications are limited. This study sought to determine the frequency, impact and predictors of MANTA-related access complications. METHODS/MATERIALS: This patient-level meta-analysis included data from 2 medical device approval studies and 1 post-approval registry. The primary endpoint was the composite of major and minor access complications. Technical success was defined as hemostasis with MANTA closure device without need for vascular surgery or stenting. RESULTS: Eight hundred ninety-one patients (mean age 80) underwent transcatheter aortic valve replacement (n = 814), endovascular aortic repair (n = 71), balloon aortic valvuloplasty (n = 4) or mechanical circulatory support (n = 2). Technical success was 96.4% and median time to hemostasis was 31 (interquartile range: 17-76) seconds. The primary endpoint occurred 9.1% and bailout vascular surgery or stenting was necessary in 32 patients (3.6%). Female gender (OR: 2.63, CI: 1.46-4.73, p = 0.001), left femoral access (OR: 2.18, CI: 1.17-4.06, p = 0.015) and unfavorable arteriotomy phenotype (combination of a small femoral artery diameter with a deep arteriotomy; OR 2.27: 1.26-4.10, p = 0.006) independently predicted access complications. Access complications most often consisted of vessel dissection, stenosis or occlusion and predominantly occurred in patients with an unfavorable arteriotomy phenotype. CONCLUSIONS: Large-bore arteriotomy closure with MANTA VCD provided fast and safe hemostasis with an acceptable complication rate. Refined procedure planning and risk-stratification may further improve MANTA VCD performance.
Authors: Rutger-Jan Nuis; David Wood; Herbert Kroon; Maarten van Wiechen; Darra Bigelow; Chris Buller; Joost Daemen; Peter de Jaegere; Zvonimir Krajcer; John Webb; Nicolas Van Mieghem Journal: Data Brief Date: 2021-03-18