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Data on plug-based large-bore arteriotomy vascular closure device related access complications
Rutger-Jan Nuis1, David Wood2, Herbert Kroon1
1Department of Cardiology, Erasmus Medical Center, Room Nt-645, Dr. Molewaterplein 40, 3015 GD Rotterdam, the Netherlands.
Data in Brief
|April 15, 2021
Summary
This study analyzes access complications from the MANTA vascular closure device in large-bore arteriotomy, offering insights into management and TAVR procedures. It includes data from multiple studies, representing a large patient population for improved understanding.
Area of Science:
- Cardiovascular Interventions
- Medical Device Technology
- Clinical Data Analysis
Background:
- Large-bore arteriotomy closure is crucial for percutaneous cardiovascular interventions.
- The MANTA vascular closure device (VCD) is widely used, particularly in transcatheter aortic valve replacement (TAVR).
- Understanding access complications and device performance is essential for patient safety and procedural success.
Purpose of the Study:
- To provide supplementary data on frequency, impact, and predictors of access complications associated with the plug-based MANTA VCD.
- To analyze complication types, management strategies, and hemostasis times for the MANTA VCD.
- To conduct a subgroup analysis on TAVR procedures and evaluate potential learning curve effects.
Main Methods:
- Patient-level data meta-analysis from European (CE mark) and North American (SAFE-MANTA) device approval studies and the MARVEL registry.
- Inclusion of 891 patients enrolled between 2015-2019 across 28 investigational sites.
- Inclusion of 78 'roll-in' cases to assess operator learning curve effects.
Main Results:
- The dataset represents the largest study population for MANTA VCD arteriotomy closure, encompassing diverse operator experience levels.
- Insights into complication types, management, hemostasis times, and mortality causes are provided.
- Subgroup analysis specific to TAVR procedures using contemporary valve platforms is included.
Conclusions:
- This comprehensive dataset enhances understanding of the MANTA VCD's performance and associated access complications.
- The findings support further research into percutaneous large-bore arteriotomy management.
- Data provides valuable insights for optimizing device use and patient outcomes in complex cardiovascular interventions.
