Reduction of MANTA-associated vascular complications after implementation of key insights on failure mechanisms.

OBJECTIVES Report MANTA-associated vascular complications after implementation of key insights on failure mechanisms. BACKGROUND The MANTA vascular closure device is utilized to close large-bore arterial access sites. We have previously identified and published the mechanisms and predictors of MANTA-associated vascular complications. We identified three distinct mechanisms leading to MANTA-associated vascular complications, predictors were a common femoral artery (CFA) diameter <6 mm and clinically established peripheral artery disease (PAD). METHODS We compared 100 consecutive patients of the initial cohort (first n = 100) with consecutive patients in which the key insights acquired in the initial cohort were implemented (second n = 100). RESULTS The initial cohort (n = 100 patients) had a MANTA-related vascular complication rate of 11% (7% major and 4% minor), and 14% MANTA-related bleeding complications. In a subsequent cohort of n = 100 patients, we applied the abovementioned findings: we did not use the MANTA device if the CFA was <6 mm and in patients with PAD. In addition, femoral puncture was ultrasound guided. This strategy led to a decline in MANTA-related vascular complication rates: 2% (1% major and 1% minor) p = .03, as well as a reduction in MANTA-related bleeding complications to 5% p = .01. To the best of our knowledge, this is the lowest rate of MANTA-related vascular complication reported thus far. CONCLUSIONS Our strategy achieves low MANTA-related vascular and bleeding complication rates. Careful and critical examination of complications can lead to rapid identification of complication mechanism and its predictors. In turn, rapid implementation of these insights can lead to a decline in complication rates.