Fewer Complications with Vascular Closure Devices in Elective Interventions

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In patients undergoing transfemoral coronary angiography and percutaneous coronary intervention (PCI), use of a vascular closure device results in reduced rates of complications compared with manual compression, according to a large retrospective study published online April 6, 2012, ahead of print in the American Journal of Cardiology.

Giora Weisz, MD, of Columbia University Medical Center (New York, NY), and colleagues conducted a retrospective review and nested case-control study of 7,994 consecutive patients undergoing 9,108 elective procedures (34.8% PCI) at NewYork-Presbyterian Hospital/Columbia University Medical Center from January 1, 2008, to December 31, 2010. Four different types of closure device were deployed in 71.7% of patients, with the remainder receiving manual compression. Operators chose their own hemostasis strategy.

Fewer Complications with Closure Devices

Overall, complications occurred more frequently with manual compression than with closure devices. However, of the various types of complications that occurred, only significant groin bleeding was seen more frequently in the manual compression group vs. the device group (table 1).

Table 1. Vascular Complications by Femoral Closure Strategy

 

Vascular Closure Device
(n = 6,527)

Manual Compression
(n = 2,581)

P Value

Any Complication

42 (0.64%)

32 (1.24%)

0.004

Significant Groin Bleeding

19 (0.29%)

21 (0.81%)

< 0.001

Pseudoaneurysm

11 (0.17%)

9 (0.35%)

NS

Vascular Occlusion

7 (0.11%)

1 (0.04%)

NS

Arteriovenous Fistula

4 (0.06%)

1 (0.04%)

NS

Access-Site Infection

1 (0.02%)

0 (0%)

NS


Vascular closure deployment failed in 80 (1.23%) procedures, of which 8 (10%) had vascular complications.

The investigators conducted multivariable analyses to identify the predictors of complications. In a case-control analysis that compared the 74 cases of complications with 74 randomly selected procedures without complications, there was a trend toward vascular closure device as a predictor of lower complication rates. In a second analysis involving the entire study population, closure device use emerged as a significant predictor of reduced complication risk (table 2).

Table 2. Multivariable Predictors of Vascular Complications

 

Adjusted OR (95% CI)

P Value

Case Control (n = 148)
Sheath Size
Age
Closure Device

2.25 (0.97-5.19)
1.04 (1.01-1.07)
0.60 (0.26-1.37)

0.06
0.02
0.22

Full Study Population (n = 9,108)
Closure Device
Male Gender

0.52 (0.33-0.83)
0.66 (0.42-1.04)

< 0.01
0.07

Abbreviations: OR, odds ratio; CI, confidence interval.

 

Safety One of Several Benefits

“Over 95% of the elective coronary procedures in the [United States] are done using the femoral approach, with frequent use of vascular closure devices,” said Dr. Weisz in an e-mail communication with TCTMD. “The results of this study confirm that in a high-volume tertiary center like Columbia University Medical Center, this approach is not inferior to the alternative approach of radial access. Furthermore, the selective use of vascular closure devices was associated with an even lower rate of vascular complications.”

Robert J. Applegate, MD, of Wake Forest University School of Medicine (Winston-Salem, NC) agreed. “In low-risk patients, if your strategy is to use closure devices [this study shows that] it’s very effective,” he told TCTMD in a telephone interview.

Dr. Applegate added that there are other benefits as well. “The patients clearly ambulate faster; they reach hemostasis faster,” he said. “There are several studies that have identified that patient comfort is better with the closure device.”

On the other hand, “the use of vascular closure devices is not benign,” noted Dr. Weisz. The devices cost money, and there is a learning curve involved in using them optimally.

According to Dr. Weisz, “Each case should be considered on an individual basis. My rule of thumb is to use [vascular closure devices] only in cases in which the arterial puncture was anterior and single, [there is] no significant groin scar tissue, and after an angiogram of the femoral artery verifies that the access site is anatomically accurate (above the bifurcation but not too high) and [there is no] femoral artery disease.”

The final word on whether closure devices truly lower complication rates is a question that has not yet been definitively answered. “This is a source of ongoing discussion which is limited by the fact that there’s been no large randomized clinical trial [enrolling] patients to either be treated with a closure device or manual compression,” said Dr. Applegate. “I certainly would love to see industry and all the interested parties in this get together and perform a large randomized clinical trial so that we can once and for all answer the question.”

Study Details

Vascular complications were defined as:

  • Groin bleeding (hematoma, hemoglobin decrease > 3 g/dl, transfusion, retroperitoneal bleeding, or arterial perforation)
  • Pseudoaneurysm
  • Arteriovenous fistula formation
  • Obstruction
  • Infection

The closure devices used in the study were Angioseal (St. Jude Medical, St. Paul, MN), Perclose-Proglide and Starclose (Abbott Vascular, Redwood City, CA), and Mynx (AccessClosure, Mountain View, CA).

Note: Dr. Weisz and several coauthors of the study are faculty members of the Cardiovascular Research Foundation, which owns and operates TCTMD.

 


Source:
Smilowitz NR, Kirtane AJ, Guiry M, et al. Practices and complications of vascular closure devices and manual compression in patients undergoing elective transfemoral coronary procedures. Am J Cardiol. 2012;Epub ahead of print.

 

 

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Disclosures
  • Dr. Weisz reports no relevant conflicts of interest.
  • Dr. Applegate reports receiving research grants from and serving as a consultant for Abbott Vascular, St. Jude Medical, and Terumo Medical.

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