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Closure of a Patent Foramen Ovale PFO: An Intervention Sequence
Published on: December 23, 2022
Network meta-analysis of studies comparing closure devices for femoral access after percutaneous coronary
Mario Iannaccone1, Gaëlle Saint-Hilary2, Davide Menardi2
1SS. Annunziata Hospital, Savigliano, ASL CN1.
Insights
Vascular closure devices do not reduce complications compared to manual compression after femoral procedures. However, devices like Angioseal significantly shorten hemostasis time, with StarClose showing the best complication profile.
Area of Science:
- Cardiovascular Medicine
- Interventional Cardiology
- Medical Devices
Background:
- Femoral vascular access is common after coronary angiography and percutaneous coronary intervention.
- Evidence comparing the efficacy and safety of various vascular closure devices (VCDs) against manual compression is limited.
- Comparative data across different sheath diameters, patient age, and sex is particularly lacking.
Purpose of the Study:
- To conduct a network meta-analysis comparing the efficacy and safety of different VCDs versus manual compression for femoral artery access closure.
- To evaluate complication rates and time to hemostasis across various VCDs.
- To assess the influence of sheath diameter, patient age, and sex on VCD performance.
Main Methods:
- A systematic review and network meta-analysis of 30 studies involving 5620 patients undergoing femoral procedures.
- Manual compression served as the control group in all included studies.
- Comparison of multiple VCDs including Angioseal, Exoseal, Perclose, Vasoseal, DUETT, StarClose, and Techstar.
Main Results:
- No VCD demonstrated superiority over manual compression in reducing overall vascular complications.
- Metaregression analysis confirmed these findings were consistent across varying sheath diameters, patient age, and sex.
- Several VCDs, including Angioseal, Vasoseal, Perclose, Femoseal, and Techstar, significantly reduced time to hemostasis compared to manual compression.
Conclusions:
- Vascular closure devices do not offer a significant advantage over manual compression in preventing complications.
- VCDs, particularly Angioseal, provide a notable benefit by reducing the time required for hemostasis.
- StarClose emerged as the device with the highest probability of being the best in terms of complication rates.
Introduction:
Different devices have been released for closure of femoral vascular access after coronary angiography or percutaneous coronary intervention, whereas evidence about their efficacy and safety when compared with manual compression or head to head is lacking, especially across different diameters of sheaths, age and sex.
Results:
A total of 30 studies were included in the analysis. Manual compression was evaluated as the control group in all of the included studies (5620 patients), Angioseal in 15 studies (17-29) (1812 patients), Exoseal in two studies (30-31) (1773 patients), Perclose in six (29, 32-37) (849 patients), Vasoseal in eight (36, 38-43) (699 patients), DUETT in one study (44) (392 patients), StarClose in two studies (23, 45) (334 patients), Techstar in two studies (37, 46) (252 patients) and extravascular staple in one study (47) (242 patients). At network meta-analysis, all the devices resulted as not superior to manual compression to reduce all vascular complications, and these results did not vary at metaregression for age, sex and diameter of sheaths. Manual compression significantly increased time to hemostasis when compared with Femoseal (5.72; 1.91-19.10), Vasoseal (5.11; 2.32-11.33), Perclose (3.46; 1.70-7.06), Angioseal (14.95; 7.84-28.57) and Techstar (9.78; 1.81-53.65), while was similar to StarClose, DUETT and Exoseal.
Conclusion:
Different vascular devices for closure of femoral access did not results superior to manual compression to reduce complications, whereas offered a shorted time to hemostasis. StarClose was the device with the highest probability to perform best in terms of complication, whereas Angioseal was superior in terms of reduction of time to hemostasis.
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