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Arterial Puncture Closing Devices Compared With Standard Manual Compression After Cardiac Catheterization: Systematic Review and Meta-analysis

Maria Koreny, MD; Eva Riedmüller, MD; Mariam Nikfardjam, MD; Peter Siostrzonek, MD; Marcus Müllner, MD, MSc
JAMA. 2004;291(3):350-357. doi:10.1001/jama.291.3.350.
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Context Arterial puncture closing devices (APCDs) were developed to replace standard compression at the puncture site and to shorten bed rest following percutaneous coronary intervention.

Objective To assess the safety and efficacy of APCDs (Angioseal, Vasoseal, Duett, Perclose, Techstar, Prostar) compared with standard manual compression in patients undergoing coronary angiography or percutaneous vascular interventions.

Data Sources A systematic literature search of MEDLINE (1966-January 2003), EMBASE (1989-January 2003), PASCAL (1996-January 2003), BIOSIS (1990-January 2003), and CINHAL (1982-January 2003) databases and the Cochrane Central Register of Controlled Trials for relevant articles in any language.

Study Selection Included randomized controlled trials reporting vascular complications at the puncture site (hematoma, bleeding, arteriovenous fistula, pseudoaneurysm) and efficacy (time to hemostasis, time to ambulation, time to discharge from hospital).

Data Extraction Two reviewers abstracted the data independently and in duplicate. Disagreements were resolved by discussion among at least 3 reviewers. The most important criteria were adequacy of allocation concealment, whether the analysis was according to the intention-to-treat principle, and if person assessing the outcome was blinded to intervention group. Random-effects models were used to pool the data.

Data Synthesis Thirty trials met the selection criteria and included up to 4000 patients. When comparing any APCD with standard compression, the relative risk (RR) of groin hematoma was 1.14 (95% confidence interval [CI], 0.86-1.51; P = .35); bleeding, 1.48 (95% CI, 0.88-2.48; P = .14); developing an arteriovenous fistula, 0.83 (95% CI, 0.23-2.94; P = .77); and developing a pseudoaneurysm at the puncture site, 1.19 (95% CI, 0.75-1.88; P = .46). Time to hemostasis was shorter in the group with APCD compared with standard compression (mean difference, 17 minutes; range, 14-19 minutes), but there was a high degree of heterogeneity among studies. Only 2 studies explicitly reported allocation concealment, blinded outcome assessment, and intention-to-treat analysis. When limiting analyses to only trials that used explicit intention-to-treat approaches, APCDs were associated with a higher risk of hematoma (RR, 1.89; 95% CI, 1.13-3.15) and a higher risk of pseudoaneurysm (RR, 5.40; 95% CI, 1.21-24.5).

Conclusions Based on this meta-analysis of 30 randomized trials, many of poor methodological quality, there is only marginal evidence that APCDs are effective and there is reason for concern that these devices may increase the risk of hematoma and pseudoaneurysm.

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Figure 2. Groin Hematoma and Bleeding
Graphic Jump Location
CI indicates confidence interval; RR, relative risk. Murray et al13 provided 2 comparisons using 2 different forms of collagen. Sanborn et al29 provided 2 comparisons because data were presented for 2 strata: one when diagnostic angiography was performed and another when coronary angioplasty was performed. The size of the point estimates is defined by study weight. The weight is a function of the number of events, the total number of participants, and the random-effects method used to combine the trials.
Figure 3. Arteriovenous Fistula and Psuedoaneurysm
Graphic Jump Location
CI indicates confidence interval; RR, relative risk. Sanborn et al29 provided 2 comparisons because data were presented for 2 strata: one when diagnostic angiography was performed and another when coronary angioplasty was performed. The size of the point estimates is defined by study weight. The weight is a function of the number of events, the total number of participants, and the random-effects method used to combine the trials.
Figure 4. Funnel Plot for Time to Hemostasis
Graphic Jump Location
The mean difference of each trial is plotted against its precision. The dotted vertical line is the pooled mean difference. Ideally, the funnel should have a symmetrical shape around the overall effect with a wide base and a narrow peak. The skewness in the figure indicates that small studies showing a less pronounced time difference between devices and standard compression are missing from the published literature.

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