Registry: Closure Devices Reduce Vascular Complications After Transfemoral PCI

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In general, use of a vascular closure device after transfemoral percutaneous coronary intervention (PCI) decreases the risk of vascular complications, according to a large registry study of real-world patients published online November 18, 2013, ahead of print in the Annals of Internal Medicine. However, the benefit is lost in patients who are lean or normal weight or receiving a glycoprotein IIb/IIIa inhibitor (GPI), and the devices increase the risk of dangerous retroperitoneal bleeding.

A team led by Hitinder S. Gurm, MD, of the University of Michigan (Ann Arbor, MI), analyzed data from 85,048 transfemoral PCI procedures performed at 32 centers participating in the Blue Cross Blue Shield of Michigan Cardiovascular Consortium (BMC2) between 2007 and 2009.

Overall, 28,528 (37%) received vascular closure devices. These patients were younger and less likely to have comorbidities or be undergoing primary PCI than those who received manual closure. However, the analysis focused on 68,874 propensity-matched patients, 1.9% of whom experienced vascular complications, with 2.7% requiring a prostprocedure transfusion.

Device Closure Safer

Vascular closure device use was associated with reduced risk of vascular complications and need for postprocedural transfusion. It had no effect on in-hospital mortality, although the limited number of events reduced the reliability of this finding (table 1).

Table 1. Association of Vascular Closure Device Use with Key Clinical Outcomes

 

OR

95% CI

P Value

Vascular Complications

 0.78

 0.67-0.90

 0.001

Transfusion Needed

0.85

0.74-0.96

0.011

In-hospital Death

0.82

0.45-1.48

0.51


Specifically, closure devices were tied to reduction in hematomas, the most common type of vascular complication (OR 0.69; 95% CI 0.58-0.82; P < 0.001), and pseudoaneurysms (OR 0.57; 95% CI 0.41-0.78; P = 0.007) but an increase in retroperitoneal bleeding (OR 1.57; 95% CI 1.13-2.16; P = 0.001).

The benefit of vascular closure devices was evident in most prespecified subgroups, particularly those that received bivalirudin. Exceptions were patients with a BMI below 25 kg/m2 and those who received a GPI. The latter were less likely to experience pseudoaneurysm (OR 0.53; 95% CI 0.31-0.90; P = 0.019), although this advantage was counterbalanced by a higher risk of retroperitoneal bleeding (OR 1.88; 95% CI 1.25-2.83; P = 0.003).

According to the authors, the fact that vascular closure devices are better tolerated and permit more rapid ambulation than manual closure, together with their modest cost, “probably accounts for the widely prevalent use of [the devices] despite a relative paucity of high-quality data supporting their efficacy.”

However, they acknowledge, the benefit of closure devices is limited to overweight patients, for whom manual control of the access site is often difficult and prone to failure. Moreover, previous meta-analyses suggested that the devices may increase the incidence of groin infection, and the current study confirms an increased risk of retroperitoneal bleeding.

Device Decision Should Be Individualized

Because of the seriousness of the latter complication and the fact that it negates the benefit of closure devices in patients receiving GPIs, the investigators recommend that clinicians “carefully weigh this increased risk for retroperitoneal bleeding against the expected reduction in pseudoaneurysms and hematomas. The decision to use these devices needs to be individualized for each patient.”

In a telephone interview with TCTMD, Dr. Gurm said that when a closure device is being considered, “the first thing [clinicians] should do is a femoral angiogram” to determine if the access site is suitable.”

Moreover, he said, the potential benefit of a closure device is influenced by the skill of those who remove sheaths and perform manual compression, typically fellows, nurses, or technicians. Hospitals in which these personnel perform such tasks less often, for instance only once or twice a month, tend to have more vascular complications. On the other hand, he noted, “at my institution we have a dedicated sheath-pulling team, and our vascular complication rate is less than 1%. That’s hard to beat with any device.

“One way to look at [the study] is that it shows you can get very good results with manual closure,” Dr. Gurm suggested. The benefit of closure devices appears to be limited mainly to obese individuals--although they comprise the majority of cath lab patients, he said. In addition, patients on bivalirudin--who already reap the benefit of reduced bleeding from the drug--make especially good candidates for mechanical closure. On the other hand, the devices should generally be avoided in patients who are lean or receiving GPIs, he advised.

Are Devices Being Used in Those Who Don’t Need Them?

The current positive results largely parallel those of several previous registries, Robert J. Applegate, MD, of Wake Forest Baptist Medical Center (Winston-Salem, NC), told TCTMD in a telephone interview, but the real issue is whether the devices are being used in patients who are at already at very low risk, or perhaps have some mechanistic effect that was not captured in the small randomized trials. 

Dr. Applegate noted that the anatomic criteria for deploying a closure device--an access site in the common femoral artery, minimal arterial disease, a vessel large enough to accommodate the device, a stick that is neither too low nor too high--tends to steer use toward patients in whom manual compression would be unlikely to cause complications anyway.  

The idea that leaner patients do not need a closure device is already widely appreciated by clinicians, Dr. Applegate noted. On the other hand, the finding that patients receiving GPIs do not benefit is more puzzling, he commented. “I think in clinical practice these patients are more likely to get a device, with interventionalists thinking that if there is a chance to reduce their increased bleeding risk, then that’s what they should attempt to do.

“It certainly gives one pause to think that there can be an interaction between closure devices and potent platelet inhibition that balances in favor of manual compression,” he added, suggesting that unmeasured confounders may be at play in the current finding.

Looking forward, Dr. Gurm said that even in obese patients, “I suspect that if we were to move to more radial [PCI] we would see less bleeding and we wouldn’t need closure devices.” Dr. Applegate agreed but worried that meanwhile, young physicians focusing on becoming radialists may lose the skills required to perform good femoral access, including deployment of closure devices when appropriate.

Study Details

Vascular complications were defined as access site-related acute thrombosis, loss of limb, retroperitoneal bleeding, need for surgical repair, pseudoaneurysm, hematoma requiring transfusion or arteriovenous fistula.

The most commonly used closure devices were:

  • Angio-Seal (St. Jude Medical, Minneapolis, MN): 56.5%
  • Perclose (Abbott, Santa Clara, CA): 9.7%
  • Starclose (Abbott): 9.5%

 


Source:
Gurm HS, Hosman C, Share D, et al. Comparative safety of vascular closure devices and manual closure among patients having percutaneous coronary intervention. Ann Intern Med. 2013;Epub ahead of print.

 

  • Dr. Applegate reports receiving research grants from Abbott Vascular and St. Jude Medical and serving as a consultant for Abbott Vascular.

 

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Disclosures
  • The study received financial support from Blue Cross Blue Shield of Michigan and the National Science Foundation.
  • Dr. Gurm reports receiving grants from the Agency for Healthcare  Research and Quality, Blue Cross Blue Shield of Michigan, the National Institutes of Health, and Osprey Medical.

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