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Fully Endoscopic Mitral Valve Repair with Percutaneous Cannulation of Groin Vessels
Published on: May 26, 2023
Percutaneous closure devices do not reduce the risk of major access site complications in patients undergoing
Jennifer S McDonald1, David F Kallmes, Giuseppe Lanzino
1Department of Radiology, Mayo Clinic, Rochester, MN 55905, USA. mcdonald.jennifer@mayo.edu
Insights
Closure devices offer minimal benefit for minor complications after carotid stent placement. Major adverse events and other risks remain similar whether or not a closure device is used.
Area of Science:
- Cardiovascular Interventions
- Medical Device Safety
- Vascular Surgery
Background:
- Carotid stent placement is a common procedure to prevent stroke.
- Femoral access site complications can occur after endovascular procedures.
- Closure devices aim to reduce access site complications.
Purpose of the Study:
- To compare the risk of femoral access site complications in patients undergoing carotid stent placement treated with versus without a closure device.
- To evaluate the impact of closure devices on minor and major access site complications.
- To assess secondary outcomes including mortality, stroke, and transfusion rates.
Main Methods:
- Analysis of a national patient database (Premier Perspective) from 2006-2011.
- Identification of patients undergoing carotid stent placement.
- Propensity score matching to adjust for patient characteristics and reduce selection bias.
Main Results:
- Among 12,287 patients, 52% received a closure device.
- Closure devices were associated with a small, likely not clinically relevant, reduction in minor access site complications (4.2% vs 5.4%).
- No significant difference was observed in major access site complications, in-hospital mortality, or stroke rates between groups.
Conclusions:
- Closure device use did not substantially reduce the risk of major adverse events after carotid stent placement.
- A small improvement in minor access site complications was noted, but its clinical significance is questionable.
- The routine use of closure devices for carotid stent placement may not be warranted based on these findings.
Purpose:
To examine the risk of femoral access site complications in patients undergoing carotid stent placement who were treated with a closure device compared with patients who were not treated with a closure device.
Materials And Methods:
A national, multihospital patient database, the Premier Perspective database, was used to identify patients hospitalized for carotid stent placement from 2006-2011. To reduce potential selection bias, a propensity score was generated for each patient using relevant clinical variables. Propensity score adjustment via 1:1 matching was performed on patients who did and did not receive a closure device. Primary outcomes were minor femoral access site complications and major complications requiring procedural intervention. Secondary outcomes included in-hospital mortality, stroke, and blood transfusion.
Results:
Among 12,287 patients who underwent carotid stent placement at 217 hospitals, 6,398 (52%) received a closure device on the day of the procedure. After propensity score matching, patients who received a closure device had a lower likelihood of minor access site complications (4.2% vs 5.4%; odds ratio = 0.77; 95% confidence interval, 0.55-0.93; P = .0071) compared with patients who did not receive a closure device; however, this difference was small and likely not clinically relevant. Both groups had a similar risk of major access site complications (P = .32), in-hospital mortality (P = .0520), and stroke (P = .31).
Conclusions:
Use of a closure device was not associated with a substantially reduced risk of major adverse events after carotid stent placement and was associated with only a small improvement in minor access site complications.
