Vascular closure device failure rates vary
Vascular closure device (VCD) failure occurred in 3.3 percent of PCI procedures but varied by device type, according to an analysis of data from a statewide registry in Massachusetts. Compared with patients who had successful VCD deployment, patients whose devices failed had a three-fold higher incidence of vascular complications.
The results showed room for improvement and underscore the need for a well-designed clinical trial, according to the writer of an accompanying editorial. The study and editorial appeared in the August issue of the Journal of the American College of Cardiology: Cardiovascular Interventions.
Venkatesan D. Vidi, MD, MPH, of the cardiovascular division at Brigham and Women’s Hospital in Boston, and colleagues designed their study to assess the frequency of VCD failures, factors that predict failures and the association of VCD failure with vascular complications. The researchers limited the study to three different VCDs: collagen plug–based (Angio-Seal, St. Jude Medical), nitinol clip–based (StarClose, Abbott Vascular) and suture-based (Perclose, Abbott Vascular). The decision to use a VCD and which type was up to the operator.
They used Massachusetts Department of Public Health angioplasty registry clinical and inpatient outcome data from 22 hospitals on PCI procedures involving femoral access between June 2005 and December 2007.
Unsuccessful deployment or failure to achieve immediate access site hemostasis was considered a deployment failure. The outcome measure was in-hospital vascular complication, with a major complication being any retroperitoneal hemorrhage, limb ischemia or any vascular access-related surgical intervention; minor complication as any groin bleeding, hematoma of less than 10 cm, pseudoaneurysm or arteriovenous fistula; and any as the occurrence of either a major or minor vascular complication.
Of the 23,813 procedures in which a VCD was used, most—78 percent—relied on a collagen plug-based VCD while 10 percent used a nitinol clip-based VCD and 12 percent a suture-based VCD. The deployment failure rate was 3.3 percent. Failure rates by types were 2.1 percent for the collagen plug–based VCDs, 6.1 percent for the suture-based VCDs and 9.5 percent for the nitinol clip-based VCDs.
Those patients whose device failed had an excess risk of any vascular complication of 7.7 percent compared with 2.8 percent for patients with a successful deployment. The risk of a major vascular complication was 3.3 percent vs. 0.8 percent, and of a minor vascular complication of 5.8 percent vs. 2.1 percent. Compared with collagen plug-based VCD, the nitinol clip-based VCD had two-fold increased risk and suture-based VCD had 1.25-fold increased risk, based on a propensity score-adjusted analysis. VCD failure was a significant predictor for vascular complications for collagen plug-based VCDs and nitinol clip–based VCDs but not for suture-based VCDs.
The authors suggested that operator learning curves may explain the higher failure rate for the nitinol clip-based VCDs, which were introduced in 2006. They pointed out that the collagen plug-based VCD had the lowest failure rate but its deployment failure was associated with the highest vascular complication rate compared with the other two types. They added that operators who chose the suture-based VCD had bailout mechanisms in the event of device failure, which perhaps is why the suture-based VCD’s deployment failure did not impact the vascular complication rate compared with its successful deployment.
“Although the nitinol clip-based VCD had a two-fold increased risk of VCD failure compared with the collagen plug-based VCD, there was no significant difference in the risk of vascular complications between nitinol clip-based and collagen plug-based VCDs, after adjustment for propensity to use the device,” Vidi and colleagues wrote. “In addition, although there was no significant difference in the risk of minor vascular complication rate among different VCDs after propensity score adjustment for baseline risk factors and VCD failure, there was a significantly decreased risk of major vascular complication rates of suture-based VCDs compared with collagen plug-based VCDs.”
As a retrospective, observational study, the results may be affected by unmeasured confounders, they wrote. The data did not include information about operator experience and the study evaluated only in-hospital complications and not later events.
In an accompanying editorial, Robert J. Applegate, MD, professor of internal medcine-cardiology at Wake Forest School of Medicine in Winston-Salem, N.C., noted that while the overall failure rate for VCDs is lower than was found in earlier studies, the 9.5 percent rate for nitinol clip-based devices showed that “opportunities for improvement in the safety and performance of these closure devices still remain.”
He cautioned against drawing conclusions about safety based on the findings and added that the study didn’t elucidate the reason for device failures. “[F]rom a clinical perspective, it would have been useful to provide information on the timing of the vascular complication (i.e., at deployment or after leaving the laboratory), because this might have provided insights into the mechanism of failure,” he wrote.
Vidi and colleagues concluded that their findings needed to be confirmed in prospective studies. Applegate argued that appropriately powered clinical trials were necessary to assess the safety and efficacy of the devices.
For more information on the pros and cons of vascular closure devices, please see our article in the July issue of Cardiovascular Business.
The results showed room for improvement and underscore the need for a well-designed clinical trial, according to the writer of an accompanying editorial. The study and editorial appeared in the August issue of the Journal of the American College of Cardiology: Cardiovascular Interventions.
Venkatesan D. Vidi, MD, MPH, of the cardiovascular division at Brigham and Women’s Hospital in Boston, and colleagues designed their study to assess the frequency of VCD failures, factors that predict failures and the association of VCD failure with vascular complications. The researchers limited the study to three different VCDs: collagen plug–based (Angio-Seal, St. Jude Medical), nitinol clip–based (StarClose, Abbott Vascular) and suture-based (Perclose, Abbott Vascular). The decision to use a VCD and which type was up to the operator.
They used Massachusetts Department of Public Health angioplasty registry clinical and inpatient outcome data from 22 hospitals on PCI procedures involving femoral access between June 2005 and December 2007.
Unsuccessful deployment or failure to achieve immediate access site hemostasis was considered a deployment failure. The outcome measure was in-hospital vascular complication, with a major complication being any retroperitoneal hemorrhage, limb ischemia or any vascular access-related surgical intervention; minor complication as any groin bleeding, hematoma of less than 10 cm, pseudoaneurysm or arteriovenous fistula; and any as the occurrence of either a major or minor vascular complication.
Of the 23,813 procedures in which a VCD was used, most—78 percent—relied on a collagen plug-based VCD while 10 percent used a nitinol clip-based VCD and 12 percent a suture-based VCD. The deployment failure rate was 3.3 percent. Failure rates by types were 2.1 percent for the collagen plug–based VCDs, 6.1 percent for the suture-based VCDs and 9.5 percent for the nitinol clip-based VCDs.
Those patients whose device failed had an excess risk of any vascular complication of 7.7 percent compared with 2.8 percent for patients with a successful deployment. The risk of a major vascular complication was 3.3 percent vs. 0.8 percent, and of a minor vascular complication of 5.8 percent vs. 2.1 percent. Compared with collagen plug-based VCD, the nitinol clip-based VCD had two-fold increased risk and suture-based VCD had 1.25-fold increased risk, based on a propensity score-adjusted analysis. VCD failure was a significant predictor for vascular complications for collagen plug-based VCDs and nitinol clip–based VCDs but not for suture-based VCDs.
The authors suggested that operator learning curves may explain the higher failure rate for the nitinol clip-based VCDs, which were introduced in 2006. They pointed out that the collagen plug-based VCD had the lowest failure rate but its deployment failure was associated with the highest vascular complication rate compared with the other two types. They added that operators who chose the suture-based VCD had bailout mechanisms in the event of device failure, which perhaps is why the suture-based VCD’s deployment failure did not impact the vascular complication rate compared with its successful deployment.
“Although the nitinol clip-based VCD had a two-fold increased risk of VCD failure compared with the collagen plug-based VCD, there was no significant difference in the risk of vascular complications between nitinol clip-based and collagen plug-based VCDs, after adjustment for propensity to use the device,” Vidi and colleagues wrote. “In addition, although there was no significant difference in the risk of minor vascular complication rate among different VCDs after propensity score adjustment for baseline risk factors and VCD failure, there was a significantly decreased risk of major vascular complication rates of suture-based VCDs compared with collagen plug-based VCDs.”
As a retrospective, observational study, the results may be affected by unmeasured confounders, they wrote. The data did not include information about operator experience and the study evaluated only in-hospital complications and not later events.
In an accompanying editorial, Robert J. Applegate, MD, professor of internal medcine-cardiology at Wake Forest School of Medicine in Winston-Salem, N.C., noted that while the overall failure rate for VCDs is lower than was found in earlier studies, the 9.5 percent rate for nitinol clip-based devices showed that “opportunities for improvement in the safety and performance of these closure devices still remain.”
He cautioned against drawing conclusions about safety based on the findings and added that the study didn’t elucidate the reason for device failures. “[F]rom a clinical perspective, it would have been useful to provide information on the timing of the vascular complication (i.e., at deployment or after leaving the laboratory), because this might have provided insights into the mechanism of failure,” he wrote.
Vidi and colleagues concluded that their findings needed to be confirmed in prospective studies. Applegate argued that appropriately powered clinical trials were necessary to assess the safety and efficacy of the devices.
For more information on the pros and cons of vascular closure devices, please see our article in the July issue of Cardiovascular Business.