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Reduction of MANTA-associated vascular complications after implementation of key insights on failure mechanisms
Federico Moccetti1, Mathias Wolfrum1, Matthias Bossard1
1Heart Center Lucerne, Cardiology, Lucerne, Switzerland.
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.
Insights
Implementing insights on MANTA device failure mechanisms significantly reduced vascular complications. Avoiding the device in patients with small common femoral arteries or peripheral artery disease lowered complication rates.
Area of Science:
- Vascular surgery
- Interventional cardiology
- Medical device safety
Background:
- The MANTA vascular closure device is used for large-bore arterial access.
- Previous research identified mechanisms and predictors of MANTA-associated vascular complications, including common femoral artery diameter <6mm and peripheral artery disease (PAD).
Purpose of the Study:
- To report MANTA-associated vascular complication rates after implementing key insights on failure mechanisms.
- To evaluate the impact of a refined strategy on complication rates.
Main Methods:
- A comparative study of 200 patients, divided into an initial cohort (n=100) and a second cohort (n=100) where insights were applied.
- The refined strategy involved avoiding MANTA device use in patients with common femoral artery diameter <6mm or PAD, and utilizing ultrasound-guided femoral puncture.
Main Results:
- The initial cohort experienced an 11% MANTA-related vascular complication rate and 14% bleeding complication rate.
- The second cohort, using the refined strategy, showed a significant reduction in vascular complications to 2% (p=0.03) and bleeding complications to 5% (p=0.01).
- This represents a notable decrease in complication rates, potentially the lowest reported for the MANTA device.
Conclusions:
- A strategy based on understanding MANTA device failure mechanisms effectively reduces vascular and bleeding complication rates.
- Critical analysis of complications enables rapid identification of mechanisms and predictors.
- Implementing these insights swiftly leads to improved patient safety and outcomes.
