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Frequency, Impact, and Predictors of Access Complications With Plug-Based Large-Bore Arteriotomy Closure - A
Rutger-Jan Nuis1, David Wood2, Herbert Kroon1
1Department of Cardiology, Erasmus Medical Center, Rotterdam, the Netherlands.
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.
Insights
The MANTA vascular closure device (VCD) offers safe and fast hemostasis for large-bore arteriotomies. Female gender, left femoral access, and unfavorable arteriotomy phenotypes are linked to higher complication risks.
Area of Science:
- Vascular Surgery
- Interventional Cardiology
- Medical Device Technology
Background:
- The MANTA vascular closure device (VCD) is used for large-bore arteriotomy hemostasis.
- Limited data exists on MANTA-related complications and their predictors.
- This study addresses the need for understanding MANTA complication frequency, impact, and predictors.
Purpose of the Study:
- To determine the frequency of MANTA-related access complications.
- To assess the clinical impact of these complications.
- To identify predictors of MANTA-related access complications.
Main Methods:
- Patient-level meta-analysis of 2 device approval studies and 1 post-approval registry.
- Primary endpoint: composite of major and minor access complications.
- Technical success defined as hemostasis without surgery or stenting.
Main Results:
- Technical success rate was 96.4% in 891 patients (mean age 80).
- Access complications occurred in 9.1% of patients; 3.6% required bailout surgery/stenting.
- Predictors of complications included female gender, left femoral access, and unfavorable arteriotomy phenotype.
Conclusions:
- MANTA VCD provides fast, safe hemostasis with an acceptable complication rate.
- Complications like dissection, stenosis, or occlusion were linked to unfavorable arteriotomy phenotypes.
- Improved procedure planning and risk stratification can enhance MANTA VCD performance.
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