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Comparative Safety of Vascular Closure Devices and Manual Closure Among Patients Having Percutaneous Coronary Intervention

Hitinder S. Gurm, MD; Carrie Hosman, PhD; David Share, MD; Mauro Moscucci, MD; Ben B. Hansen, PhD, for the Blue Cross Blue Shield of Michigan Cardiovascular Consortium
[+] Article, Author, and Disclosure Information

From the University of Michigan Medical Center and University of Michigan, Ann Arbor, Michigan; Blue Cross and Blue Shield of Michigan, Detroit, Michigan; and University of Miami, Miami, Florida.

Note: Dr. Gurm had full access to all of the data in the study and takes responsibility for integrity of the data and accuracy of data analysis.

Acknowledgment: The authors thank all of the study coordinators, investigators, and patients who participated in BMC2.

Financial Support: By Blue Cross Blue Shield of Michigan. Dr. Hansen is supported in part by the National Science Foundation (grant SES-0753164).

Potential Conflicts of Interest: Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M12-0899.

Reproducible Research Statement: Study protocol: Data dictionary available from Dr. Gurm (e-mail, hgurm@med.umich.edu). Statistical code: Available from Dr. Hosman (e-mail, chosman@umich.edu). Data set: Not available.

Requests for Single Reprints: Hitinder S. Gurm, MD, Division of Cardiovascular Medicine, University of Michigan Cardiovascular Center, 2A394, 1500 East Medical Center Drive, Ann Arbor, MI 48109-5853; e-mail, hgurm@med.umich.edu.

Current Author Addresses: Dr. Gurm: Division of Cardiovascular Medicine, University of Michigan Cardiovascular Center, 2A394, 1500 East Medical Center Drive, Ann Arbor, MI 48109-5853.

Drs. Hosman and Hansen: Statistics Department, University of Michigan, 439 West Hall, 1085 South University, Ann Arbor, MI 48109-1107.

Dr Share: 600 East Lafayette Boulevard, Mail Code 513P, Detroit, MI 48226-2998.

Dr Moscucci: University of Miami Miller School of Medicine, 1120 NW 14th Street, CRB Suite 1124, Miami, FL 33136.

Author Contributions: Conception and design: H.S. Gurm, M. Moscucci, B.B. Hansen.

Analysis and interpretation of the data: H.S. Gurm, C. Hosman, M. Moscucci, B.B. Hansen.

Drafting of the article: H.S. Gurm, C. Hosman.

Critical revision of the article for important intellectual content: H.S. Gurm, C. Hosman, D. Share, M. Moscucci, B.B. Hansen.

Final approval of the article: H.S. Gurm, C. Hosman, M. Moscucci, B.B. Hansen.

Statistical expertise: C. Hosman, B.B. Hansen.

Obtaining of funding: H.S. Gurm, D. Share, M. Moscucci.

Administrative, technical, or logistic support: H.S. Gurm.

Collection and assembly of data: H.S. Gurm.

Ann Intern Med. 2013;159(10):660-666. doi:10.7326/0003-4819-159-10-201311190-00004
Text Size: A A A

Background: The role of vascular closure devices (VCDs) in patients having percutaneous coronary intervention (PCI) is controversial, and recommendations for use vary.

Objective: To examine the use of and outcomes associated with VCDs in real-world practice.

Design: Observational cohort study.

Setting: 32 hospitals in Michigan that participate in a large multicenter quality improvement collaborative.

Patients: Consecutive patients having emergent and nonemergent PCI from 2007 to 2009.

Measurements: Vascular complications and the need for transfusion.

Results: Of the 85 048 PCIs performed during the study that met the inclusion criteria, 28 528 (37%) procedures used VCDs. In propensity score–matched analysis, VCDs were associated with reductions in vascular complications (odds ratio [OR], 0.78 [95% CI, 0.67 to 0.90]; P = 0.001) and postprocedure transfusions (OR, 0.85 [CI, 0.74 to 0.96]; P = 0.011). These findings were consistent across many prespecified subgroups except for patients with a body mass index (BMI) less than 25 kg/m2 and those treated with platelet glycoprotein (GP) IIb/IIIa inhibitors, in whom the benefit of VCDs over manual closure was attenuated. When the specific subtypes of vascular complications were evaluated, VCDs were associated with fewer hematomas (OR, 0.69 [CI, 0.58 to 0.83]; P < 0.001) or pseudoaneurysms (OR, 0.54 [CI, 0.38 to 0.76]; P < 0.001) but an increase in the odds of retroperitoneal bleeding (OR, 1.57 [CI, 1.12 to 2.20]; P = 0.009).

Limitation: Unmeasured confounding cannot be excluded despite the study having measured and balanced many confounders.

Conclusion: Vascular closure devices were associated with a significant reduction in vascular complications and need for transfusion in this large cohort of patients having transfemoral PCI. This benefit was lost in patients receiving GP IIb/IIIa inhibitors and those with normal or lean BMI and was counterbalanced by a small increase in the more serious risk for retroperitoneal bleeding.

Primary Funding Source: Blue Cross Blue Shield of Michigan and the National Science Foundation.


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Appendix Figure.

Standardized differences for selected variables in the unmatched and matched population showing the efficacy of the optimal balancing strategy.

A standardized difference <10% is generally assumed to represent adequate balancing of covariates. CHF = congestive heart failure; COPD = chronic obstructive pulmonary disease; GFR = glomerular filtration rate; Hg = hemoglobin; MI = myocardial infarction; PCI = percutaneous coronary intervention; PVD = peripheral vascular disease; TIA = transient ischemic attack.

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Propensity score–matched odds of vascular complications and transfusion in the overall cohort and subgroups of patients at varying risk for access site complications.

The P values reflect the test for interaction. BMI = body mass index; GP = glycoprotein; MI = myocardial infarction; PVD = peripheral vascular disease.* This P value reflects the test for significance for the overall comparison.

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Vascular Closure Device
Posted on November 26, 2013
Rahman Shah MD, M.Rehan Khan MD
UT memphis TN, VCU Richmond VA
Conflict of Interest: None Declared
In their article, Gum et al (1) repeatedly used the term “benefits of vascular closure devices (VCDs)” for several subgroups, which is misleading, as observational studies cannot provide evidence of cause and effect; they can only provide evidence of some relationship (between exposure and outcome) (2).
Moreover, they concluded that VCD use was associated with decreased vascular complication rates, which contradicts findings of multiple randomized trials (3, 4). Although most of these trials may have been underpowered, however several meta-analyses have shown that VCD use did not decrease vascular complication rate (3-4). Furthermore, VCD use reportedly increased the risk of groin infection and increased the risk of leg ischemia and need for surgery (4). The authors have not explained the reasons for the discrepancies between their findings and those of the meta-analyses.
The discrepancies may likely have been due to unmeasured confounding factors in their study, as each patient’s treatment is specifically chosen rather than randomly assigned in observational studies (2); in their study, VCDs were primarily used in healthy young patients. Moreover, VCD use may have been avoided in cases with apparent vessel wall injury or if femoral angiography indicated a high risk for bleeding (5). Although identifiable differences can be adjusted for in data analysis, it is impossible to be certain that such adjustments are adequate or whether one has documented all the relevant patient characteristics (2). As the authors did not adjust for several important variables, including peak activated clotting time, previous groin access, multiple puncture attempts, heavy calcification, operator experience, simultaneous use of venous access, and postoperative use of glycoprotein IIb/IIIa inhibitors (5) .
Furthermore, the authors indicated that many physicians preferentially use VCDs in cases of high (superior) arterial puncture, but have not provided any data from their study or a reference from the literature to support this assumption. As this finding is usually suggested as a contraindication for VCDs (5), conventional wisdom dictates that VCDs should be less frequently used in these patients.
In conclusion,VCDs should not be routinely used for the specific purpose of reducing vascular complications, as meta-analyses provide level A evidence but observational studies provide only level B evidence (3). However, the use of VCD is favorable to achieve improved patient comfort; free medical staff resources; and shorten the time needed for hemostasis, ambulation, and discharge (3-4). These recommendations are consistent with the current AHA Guidelines (3).

1. Gurm HS, Hosman C, Share D, Moscucci M, Hansen BB; Blue Cross Blue Shield of Michigan Cardiovascular Consortium. Comparative safety of vascular closure devices and manual closure among patients having percutaneous coronary intervention. Ann Intern Med. 2013;19;159(10):660-6.
2. Pocock SJ, Elbourne DR. Randomized trials or observational tribulations? N Engl J Med 2000;342:1907-1909
3. Patel MR, Jneid H, Derdeyn CP, Klein LW, Levine GN, Lookstein RA. Arteriotomy closure devices for cardiovascular procedures: a scientific statement from the American Heart Association. Circulation. Nov 2 2010;122(18):1882-93
4. Biancari F, D'Andrea V, Di Marco C, Savino G, Tiozzo V, Catania A. Meta-analysis of randomized trials on the efficacy of vascular closure devices after diagnostic angiography and angioplasty. Am Heart J. 2010;159(4):518-31.
5. Arterial Closure Device Insertion Technique. Accessed at http://emedicine.medscape.com/article/1839487-overview on 23 November 2013.
Author's Response
Posted on January 21, 2014
Hitinder S. Gurm, MD, Carrie Hosman, PhD, Ben Hansen, PhD
Blue Cross Blue Shield of Michigan
Conflict of Interest: None Declared
We agree with Shah and Khan that in themselves, observational data can establish association but not causation. Because of the possibility of unmeasured confounding, such associations are at best suggestive of a causal link. Although we take this to be widely understood, nonetheless we reaffirmed it in both the abstract and body of our paper. More important, we: adjusted for a broad array of potential confounders, including several of those mentioned by Drs. Shah and Khan; analyzed the sensitivity of the adjusted association to hypothetical further adjustments for additional confounders; and presented results from an empirical check on the completeness of the adjustment.
Our paper documents association, not causation, but absent evidence from well-powered RCTs we believe these associations to be relevant to clinicians evaluating whether to use VCDs in light of their past empirical performance. As we stated in our paper, matched observational studies cannot supplant large multicenter randomized controlled trials (1). Similarly, meta-analysis of small studies cannot supplant large adequately powered randomized controlled trials (2). The meta-analysis that have evaluated the utility of closure devices have been underpowered, and were heavily weighted by trials of devices that are no longer in use (3). Further, these studies involved the early experience with VCDs and the currently used devices have been significantly modified from the versions that were studies in these trials. There are little randomized data and no rigorously designed meta-analysis that have evaluated the use of contemporary VCDs. The incidence of vascular complications in patient undergoing contemporary percutaneous coronary interventions is less than 3%. This low event rate combined with the lack of economic incentives makes it unlikely that we will ever have an adequately powered well designed clinical trial to evaluate the clinical safety and efficacy of vascular closure devices. While it would be ideal to have such trials to guide every clinical decision, in the absence of such trials, well designed observational studies such as ours, can be especially helpful in informing clinical practice.

Hitinder S Gurm
Carrie Hosman
Ben Hansen
University of Michigan
1. Gurm HS, Hosman C, Share D, Moscucci M, Hansen BB, Blue Cross Blue Shield of Michigan Cardiovascular C. Comparative safety of vascular closure devices and manual closure among patients having percutaneous coronary intervention. Ann Intern Med. 2013;159(10):660-6.
2. LeLorier J, Gregoire G, Benhaddad A, Lapierre J, Derderian F. Discrepancies between meta-analyses and subsequent large randomized, controlled trials. N Engl J Med. 1997;337(8):536-42.
3. Biancari F, D'Andrea V, Di Marco C, Savino G, Tiozzo V, Catania A. Meta-analysis of randomized trials on the efficacy of vascular closure devices after diagnostic angiography and angioplasty. Am Heart J. 2010;159(4):518-31.

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