Frequency, impact and predictors of access complications with plug-based large-bore arteriotomy closure - A patient level meta-analysis.

Abstract

BACKGROUND/PURPOSE\nThe 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.\n\n\nMETHODS/MATERIALS\nThis 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.\n\n\nRESULTS\nEight hundred ninety-one patients (mean age 80) underwent transcatheter aortic valve replacement (n\xa0=\xa0814), endovascular aortic repair (n\xa0=\xa071), balloon aortic valvuloplasty (n\xa0=\xa04) or mechanical circulatory support (n\xa0=\xa02). 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\xa0=\xa00.001), left femoral access (OR: 2.18, CI: 1.17-4.06, p\xa0=\xa00.015) and unfavorable arteriotomy phenotype (combination of a small femoral artery diameter with a deep arteriotomy; OR 2.27: 1.26-4.10, p\xa0=\xa00.006) 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.\n\n\nCONCLUSIONS\nLarge-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.\n\n\nSTUDY SUMMARY\nThis study of 891 patients undergoing percutaneous interventions with large-bore arteriotomies showed that the MANTA closure device provides safe and rapid hemostasis in >95%. Independent predictors of MANTA failure were female gender, left femoral access and unfavorable arteriotomy phenotype (i.e. combination of a small femoral artery diameter with a deep arteriotomy). Patients exhibiting the latter were especially at risk for vessel dissection, stenosis or closure.