Meta-Analysis of Randomized Trials on the Efficacy of Vascular Closure Devices
Background The aim of this meta-analysis was to evaluate the safety and efficacy of vascular closure devices (VCDs).
Methods This meta-analysis was performed in accordance with the Cochrane Handbook for Systematic Reviews.
Results The literature search yielded 31 prospective, randomized studies including 7,528 patients who were randomized to VCDs or manual/mechanical compression after diagnostic angiography and/or endovascular procedures. Most of these studies have excluded patients at high risk of puncture site complications. Meta-analysis showed similar results in the study groups in terms of groin hematoma, bleeding, pseudoaneurysm, and blood transfusion. Lower limb ischemia and other arterial ischemic complications (0.3% vs 0%, P = .07) as well as need of surgery for vascular complications (0.7% vs 0.4%, P = .10) were somewhat more frequent with arterial puncture closure devices. The incidence of groin infection was significantly more frequent with VCDs (0.6% vs 0.2%, P = .02). The use of VCD was uniformly associated with a significantly shorter time to hemostasis. Such differences where more evident in patients undergoing percutaneous coronary intervention, whereas these methods were associated with similar rates of adverse events among patients undergoing diagnostic coronary angiography.
Conclusions The use of VCDs is associated with a significantly shorter time to hemostasis and thus may shorten recovery. However, the use of VCDs is associated with a somewhat increased risk of infection, lower limb ischemia/arterial stenosis/device entrapment in the artery, and need of vascular surgery for arterial complications. Further studies are needed to get more conclusive results, particularly in patients at high risk of femoral puncture-related complications.
Peripheral and coronary diagnostic angiography, as well as percutaneous endovascular procedures, is associated with a certain risk of access site complications that may necessitate surgical repair, blood transfusion, and prolonged in-hospital treatment. Vascular closure devices (VCDs) have been developed to reduce the time to access site hemostasis and allow earlier sheath removal and ambulation. Similarly, a reduced risk of puncture site complication is expected with the use of these devices. A large number of studies have been performed to evaluate the safety and efficacy of several types of VCDs whose results have encouraged their widespread use. However, a few years ago, meta-analyses on this topic failed to show a real advantage with the use of these devices. Of particular concern is the perceived increased risk to develop severe complications at the puncture site. Despite this, a significant number of studies have been done; and some are still going on this issue.
It is of concern that several recent prospective, randomized studies have been performed to evaluate the superiority of one device over the others without any control group.
The aim of the present study is to review the available results of currently available prospective randomized studies on the use of VCDs to get more conclusive results on their safety and efficacy.
Abstract and Introduction
Abstract
Background The aim of this meta-analysis was to evaluate the safety and efficacy of vascular closure devices (VCDs).
Methods This meta-analysis was performed in accordance with the Cochrane Handbook for Systematic Reviews.
Results The literature search yielded 31 prospective, randomized studies including 7,528 patients who were randomized to VCDs or manual/mechanical compression after diagnostic angiography and/or endovascular procedures. Most of these studies have excluded patients at high risk of puncture site complications. Meta-analysis showed similar results in the study groups in terms of groin hematoma, bleeding, pseudoaneurysm, and blood transfusion. Lower limb ischemia and other arterial ischemic complications (0.3% vs 0%, P = .07) as well as need of surgery for vascular complications (0.7% vs 0.4%, P = .10) were somewhat more frequent with arterial puncture closure devices. The incidence of groin infection was significantly more frequent with VCDs (0.6% vs 0.2%, P = .02). The use of VCD was uniformly associated with a significantly shorter time to hemostasis. Such differences where more evident in patients undergoing percutaneous coronary intervention, whereas these methods were associated with similar rates of adverse events among patients undergoing diagnostic coronary angiography.
Conclusions The use of VCDs is associated with a significantly shorter time to hemostasis and thus may shorten recovery. However, the use of VCDs is associated with a somewhat increased risk of infection, lower limb ischemia/arterial stenosis/device entrapment in the artery, and need of vascular surgery for arterial complications. Further studies are needed to get more conclusive results, particularly in patients at high risk of femoral puncture-related complications.
Introduction
Peripheral and coronary diagnostic angiography, as well as percutaneous endovascular procedures, is associated with a certain risk of access site complications that may necessitate surgical repair, blood transfusion, and prolonged in-hospital treatment. Vascular closure devices (VCDs) have been developed to reduce the time to access site hemostasis and allow earlier sheath removal and ambulation. Similarly, a reduced risk of puncture site complication is expected with the use of these devices. A large number of studies have been performed to evaluate the safety and efficacy of several types of VCDs whose results have encouraged their widespread use. However, a few years ago, meta-analyses on this topic failed to show a real advantage with the use of these devices. Of particular concern is the perceived increased risk to develop severe complications at the puncture site. Despite this, a significant number of studies have been done; and some are still going on this issue.
It is of concern that several recent prospective, randomized studies have been performed to evaluate the superiority of one device over the others without any control group.
The aim of the present study is to review the available results of currently available prospective randomized studies on the use of VCDs to get more conclusive results on their safety and efficacy.
SHARE
