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Published on: May 26, 2023
Collagen plug-based vascular closure devices do not decrease vascular and bleeding complications occurring after
Florence Leclercq1, Delphine Delseny1, Richard Gervasoni1
1Department of Cardiology, University of Montpellier, Montpellier, France.
Insights
Collagen plug-based vascular closure devices (VCDs) did not reduce, but rather increased, femoral access complications after balloon aortic valvuloplasty. Their routine use in elderly patients undergoing this procedure is questionable.
Area of Science:
- Cardiology
- Interventional Cardiology
- Vascular Surgery
Background:
- The efficacy of vascular closure devices (VCDs) in preventing vascular complications post-femoral intervention is debated.
- Balloon aortic valvuloplasty (BAV) frequently involves femoral access, carrying risks of complications.
Purpose of the Study:
- To assess the effectiveness of collagen plug-based VCDs in mitigating femoral access complications after BAV.
- To compare complication rates between VCDs and manual/mechanical compression in BAV patients.
Main Methods:
- A prospective study analyzed 180 patients undergoing BAV via femoral retrograde technique.
- Group 1 (75 patients) used 8F collagen plug-based VCDs; Group 2 (105 patients) used manual/mechanical compression.
- Data collected included major adverse events, bleeding (BARC ≥3), and vascular access complications; no heparin was used.
Main Results:
- No significant reduction in vascular and bleeding complications was observed with VCD use (RR 2.60, CI 1.10-3.09; P=0.05).
- Complication rates were similar across subgroups, and hospital stay duration was not improved by VCDs.
- Collagen plug-based VCDs were associated with an increased risk of femoral access complications in this cohort.
Conclusions:
- Collagen plug-based VCDs may increase femoral access complications after BAV, particularly when small sheaths and no heparin are used.
- The routine application of VCDs in elderly patients with potential limb atherosclerosis undergoing BAV warrants careful consideration.
- Further research is needed to clarify the role of VCDs in specific patient populations and procedural contexts.
Background:
The benefits of vascular closure devices (VCDs) in the prevention of vascular complications after femoral intervention remain controversial.
Aim:
To evaluate the efficiency of collagen plug-based VCDs in the prevention of femoral access complications after balloon aortic valvuloplasty.
Methods:
We conducted a prospective analysis of consecutive patients who underwent balloon aortic valvuloplasty by femoral retrograde technique in our centre between 2009 and 2012. Group 1 included 75 patients in whom femoral puncture haemostasis was obtained with the use of an 8F collagen plug-based VCD (Angio-Seal™; Saint-Jude Medical, Inc.); group 2 included 105 patients who had manual or mechanical groin compression (FemoStop™; RADI Medical Systems, Inc.). We did not use heparin during the procedure. We collected data on major in-hospital adverse events, major bleeding (Bleeding Academic Research Consortium classification≥3) and vascular access complications.
Results:
We included 180 patients with severe and symptomatic aortic stenosis. Indications for valvuloplasty were mainly bridge to transcatheter aortic valve implantation or palliative therapy (72%). The groups were similar in terms of median age, lower limb artery disease and body mass index. Vascular and bleeding complications occurred in 11.1% of patients and were not decreased with the use of VCDs (relative risk 2.60, 95% confidence interval 1.10-3.09; P=0.05). These findings were consistent across all prespecified subgroups. Duration of hospital stay was not reduced by VCDs.
Conclusions:
Based on the results of this study, performed with small-size sheaths and without heparin, collagen plug-based VCDs increase femoral access complications following aortic valvuloplasty. Systematic use of VCDs in elderly patients, with probable advanced limb atherosclerosis, is questionable.
