Balancing the Yin and the Yang of Vascular Closure

Vascular access complications from diagnostic coronary angiography and percutaneous intervention are a major cause of morbidity and mortality. The use of vascular closure devices is common practice and their use to decrease complications is controversial. The 2011 ACCF/AHA/SCAI Guidelines for Percutaneous Coronary Intervention give the use of vascular closure devices a IIa recommendation for the purposes of achieving faster hemostasis and earlier ambulation compared with manual compression, but do not recommend their use (Class III recommendation) for the purpose of decreasing vascular complications including bleeding.¹ Of concern, previous studies suggest that the use of vascular closure devices increases the rate of vascular complications.^2-4

The study by Lupi et al⁵ in the current issue of the Journal of Invasive Cardiology examined the differences in various complication rates between manual compression and vascular closure with the Angio-Seal. The authors retrospectively reviewed their center’s vascular complication rates from transfemoral cardiac catheterization with or without percutaneous intervention by identifying 1241 patients who underwent Angio-Seal closure from 2008-2010 and a control group of 672 patients who underwent manual closure in the preceding 7 months prior to Angio-Seal adoption. Following exclusion of a group of patients accounting for the learning curve associated with the vascular closure device, 88 vascular complications were observed in the combined cohort of 1913 patients. The complications that were identified included groin bleeding, groin hematoma ≥5 cm, groin pseudoaneurysm, groin arteriovenous fistula, groin infection, retroperitoneal bleeding, limb-threatening ischemia, femoral surgical/interventional repair, and the need for transfusion. Of the 88 complications identified, 55 (4.4%) occurred in those undergoing vascular device closure and 33 (4.9%) occurred in the manual closure group. Although the incidence of vascular complications was similar between the two groups, the vascular complication types varied between manual closure and vascular closure. The patients who underwent vascular device closure experienced a higher rate of retroperitoneal bleeding and need for transfusion whereas those who underwent manual closure experienced more groin hematomas, pseudoaneurysms, and a delay to hospital discharge. Additionally, the differences seen in the rates of groin hematoma and retroperitoneal bleeding were unchanged following propensity score matching.

The complication rates with various hemostatic mechanisms have been evaluated in the past with many small, underpowered randomized controlled trials and a large meta-analysis suggesting that vascular closure devices may be associated with an increase in vascular complications.³ The study by Lupi et al is an important contribution to the literature, as it suggests that various hemostatic mechanisms are plagued by different vascular complications, namely, retroperitoneal bleeding and need for transfusion with vascular closure devices and groin hematomas and pseudoaneurysms with manual closure. Similar differences in complication rates with various hemostatic strategies have been previously observed, as well.^6,7 The knowledge of the various types of complications associated with each strategy/mechanism should play a key role in deciding what type of strategy to utilize.

Among patients undergoing transfemoral cardiac catheterization with or without percutaneous coronary intervention, the decision on the method of obtaining hemostasis is often operator or institution-specific. Furthermore, proper patient selection for various hemostatic mechanisms is paramount and requires that the operator be familiar with the advantages and disadvantages of the various techniques available. As technology in vascular closure devices continues to expand and physicians gain greater experience with the various devices, complication rates may decline further. Although the use of vascular closure devices is widespread, there is a lack of economic incentive to prompt future large studies. Nevertheless, their widespread use with potential for serious or even life-threatening complications invokes the need for well-designed, adequately powered randomized-controlled trials.

References

1. Levine GN, Bates ER, Blankenship JC, et al. 2011 ACCF/AHA/SCAI guideline for percutaneous coronary intervention: a report of the Americal College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines and the Society for Cardiovascular Angiography and Interventions. J Am Coll Cardiol. 2011;58(24):E44-E122.
2. Biancara F, D’Andrea V, Di Marco C, et al. Meta-analysis of randomized trials on the efficacy of vascular closure devices after diagnostic angiography and angioplasty. Am Heart J. 2010;159(4):518-531.
3. Koreny M, Riedmuller E, Nikfardjam M, et al. Arterial puncture closing devices compared with standard manual compression after cardiac catheterization: systematic review and meta-analysis. JAMA. 2004;291(3):350-357.
4. Nikolsky E, Mehran R, Halkin A, et al. Vascular complications associated with arteriotomy closure devices in patients undergoing percutaneous coronary procedures: a meta-analysis. J Am Coll Cardiol. 2004;44(6):1200-1209.
5. Lupi A, Rognoni  A, Secco GG, et al. Different spectrum of vascular complications after vascular closure device Angio-Seal deployment or manual compression. J Invasive Cardiol. 2012;24(3):90-96.
6. Resnic FS, Arora N, Matheny M, Reynolds MR. A cost-minimization analysis of the Angio-Seal vascular closure device following percutaneous coronary intervention. Am J Cardiol. 2007;99(6):766-770.
7. Trimarchi S, Smith DE, Share D, et al. Retroperitoneal hematoma after percutaneous coronary intervention: prevalence, risk factors, management, outcomes, and predictors of mortality: a report from the BMC2 (Blue Cross Blue Shield of Michigan Cardiovascular Consortium) registry. JACC Cardiovasc Interv. 2010;3(8):845-850.

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From the Division of Cardiovascular Medicine, University of Michigan Cardiovascular Center, Ann Arbor, Michigan.
Disclosure: The authors have completed and returned the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr. Gurm is a grant recipient from the NIH, Blue Cross Blue Shield of Michigan, and AHRO.
Address for correspondence: Hitinder S. Gurm, MD, Division of Cardiovascular Medicine, University of Michigan Cardiovascular Center, 2A394, 1500 E. Medical Center Drive, Ann Arbor, MI 48109-5853. Email: hgurm@med.umich.edu