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Arterial puncture closing devices compared with standard manual compression after cardiac catheterization: systematic
Maria Koreny1, Eva Riedmüller, Mariam Nikfardjam
1Department of Emergency Medicine, University of Vienna, Vienna General Hospital, Vienna, Austria.
Insights
Arterial puncture closing devices (APCDs) may offer marginal benefits but raise concerns. This meta-analysis suggests APCDs might increase risks of hematoma and pseudoaneurysm, questioning their overall efficacy and safety.
Area of Science:
- Cardiovascular Interventions
- Medical Device Technology
- Evidence-Based Medicine
Background:
- Arterial puncture closing devices (APCDs) were developed to improve patient outcomes after percutaneous coronary interventions.
- APCDs aim to replace manual compression and reduce patient recovery time.
Purpose of the Study:
- To evaluate the safety and efficacy of various APCDs compared to standard manual compression.
- The study focused on patients undergoing coronary angiography or percutaneous vascular interventions.
Main Methods:
- A systematic literature search was conducted across multiple databases (MEDLINE, EMBASE, etc.) and the Cochrane Register.
- Included were randomized controlled trials assessing vascular complications and efficacy metrics like time to hemostasis.
- Data were independently abstracted, and random-effects models were used for pooled analysis, with attention to methodological quality.
Main Results:
- Thirty trials involving up to 4000 patients were analyzed.
- Overall, APCDs showed no significant increase in hematoma, bleeding, arteriovenous fistula, or pseudoaneurysm compared to manual compression.
- However, APCDs significantly reduced time to hemostasis but were associated with increased risks of hematoma and pseudoaneurysm when analyzed using intention-to-treat principles.
Conclusions:
- This meta-analysis of 30 randomized trials, many of poor quality, provides limited evidence for APCD effectiveness.
- Concerns exist regarding the potential for APCDs to elevate the risk of hematoma and pseudoaneurysm formation.
- Further high-quality research is needed to definitively establish the safety and efficacy profile of APCDs.
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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