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Published on: December 9, 2022
A prospective randomized trial comparing the safety and efficacy of three commercially available closure devices
Lampros K Michalis1, Michael R Rees, Demetrios Patsouras
1Cardiac Department, University Hospital of Ioannina, Ioannina, Greece. lmihalis@cc.uoi.gr
Insights
This study compared three arterial closure devices for coronary procedures. Angioseal offered earlier ambulation after angiography but slower hemostasis, with similar safety profiles across devices.
Area of Science:
- Cardiology
- Interventional Cardiology
- Vascular Access
Background:
- Arterial puncture site closure is crucial after percutaneous coronary procedures.
- Evaluating the safety and efficacy of different closure devices is essential for optimizing patient care.
Purpose of the Study:
- To compare the safety and efficacy of Angioseal, Vasoseal, and Duett closure devices.
- To assess device performance in patients undergoing coronary angiography and angioplasty.
Main Methods:
- Prospective randomized, single-center trial.
- Inclusion of 851 patients undergoing coronary angiography or angioplasty.
- Comparison of Angioseal, Vasoseal, and Duett devices for arterial puncture site closure.
Main Results:
- Similar device deployment rates across all three devices.
- Angioseal demonstrated slower hemostasis but earlier ambulation in angiography patients.
- Vasoseal showed a higher complication rate after angioplasty compared to angiography.
- Lower peripheral embolization rates observed with Angioseal.
- Severe complications were more frequent in patients receiving abciximab.
Conclusions:
- All three closure devices exhibited high deployment success and acceptable safety.
- Angioseal facilitated earlier ambulation post-angiography.
- The use of closure devices following abciximab may increase complication risks.
Purpose:
We compared the safety and efficacy of three closure devices (Angioseal, Vasoseal and Duett) used to close arterial puncture sites in patients who underwent coronary percutaneous procedures.
Methods:
A prospective randomized, single-center trial was carried out of consecutive patients who underwent coronary angiography [705 patients: Angioseal (243),Vasoseal (228) and Duett (234)] or angioplasty [146 patients:Angioseal (47), Vasoseal (52) and Duett (47)].
Results:
In the angiography patients the device deployment rates were similar, with the Angioseal been significantly slower in achieving hemostasis (p = 0.0001) but resulting in earlier ambulation (p = 0.0001). In the coronary angioplasty patients the deployment rates were similar to those for angiography: time to hemostasis was longer for the Angioseal (p = 0.003), while ambulation times were not different, although prolonged compared with angiography (p = 0.0001). The three devices had similar major complication rates. The Vasoseal had a higher major complication rate after angioplasty than after angiography (p = 0.004). The incidence rate of peripheral embolization was lower when the Angioseal was utilized. Severe complications were mainly seen in patients who received abciximab.
Conclusions:
The three closure devices had high rates of successful deployment and were relatively safe. The Angioseal resulted in earlier ambulation after angiography. Utilization of closure devices after abciximab administration possibly increased the complications.
