Sheath Size Associated with Radial Occlusion After Transradial PCI

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While the rate of radial artery occlusion as a result of transradial cardiac catheterization may be higher than previously thought, using a lower sheath size can cut the incidence by more than half, according to a registry study appearing in the January 2012 issue of JACC: Cardiovascular Interventions.

Researchers led by Stephan Gielen, MD, of the University of Leipzig Heart Center (Leipzig, Germany), prospectively enrolled 455 patients who received a transradial procedure between November 2009 and August 2010 at their institution, using either 5-Fr (n = 153) or 6-Fr (n = 302) arterial sheaths. Duplex ultrasound was performed in each patient before discharge.

Most patients underwent diagnostic coronary angiography (85.5%), with a smaller proportion receiving PCI (14.5%). More patients in the 6-Fr group had PCI (21.2% vs. 1.2%; P < 0.001) and left ventriculography (37.7% vs. 24.8%; P = 0.006) compared with the 5-Fr group. The overall rate of radial artery occlusion was 24.8%, with a higher frequency in patients in whom the larger-size sheaths were used. The same was true for overall access site complications, while other events such as pseudoaneurysm and bleeding were similar (table 1).

Table 1. Vascular Access Site Complications

 

5-Fr Sheath
(n = 152)

6-Fr Sheath
(n = 303)

P Value

Total Access Site Complications

14.5%

34.3%

< 0.001

Radial Artery Occlusion

13.7%

30.5%

< 0.001

Pseudoaneurysm

0

1.0%

0.56

Arteriovenous Fistula

0.7%

1.0%

1.00

Moderate/Severe Bleeding

0

0

Mild Bleeding

0

2.0%

0.19


On multivariable analysis, predictors of postprocedural radial artery occlusion included:

  • Use of 6-Fr sheaths (OR 2.68; 95% CI 1.56-4.59; P < 0.001)
  • Female sex (OR 2.36; 95% CI 1.50-3.73; P < 0.001)
  • Age (OR 0.96 per year; 95% CI 0.94-0.98; P = 0.001)
  • Presence of occlusive PAD (OR 2.04; 95% CI 1.02-4.22; P = 0.04)

Subgroup analysis looking only at patients who received diagnostic catheterization via the transradial route found that all of the independent predictors remained significant with the exception of PAD.

Among patients who developed radial artery occlusion, 42.5% were symptomatic within 24 hours after the transradial procedure and an additional 7.1% became symptomatic 2 to 8 days later upon resuming physical activities at home. Critical limb ischemia did not occur in any patient; symptoms were mainly a painful forearm and hand (thenar eminence). Of 91 patients with radial artery occlusion (22 were lost to follow-up), 59% were treated with low-molecular weight heparin. Recanalization rates were higher in patients receiving heparin compared with those who did not receive anticoagulation (55.6% vs. 13.5%; P < 0.001) after a mean of 14 days.

“The present large prospective registry demonstrates that clinical assessment alone might miss clinically relevant [radial artery occlusion] and might therefore underestimate the true risk of [radial artery occlusion],” the authors write, adding that the study results “confir[m] that 5-F[r] sheaths reduce the rate of [radial artery occlusion] by as much as 55%—a finding with significant implications for the routine use of transradial coronary catheterization.”

They point out that interestingly, 22 patients showed radial artery occlusion on ultrasound while the radial pulse was still palpable, “underlin[ing] the necessity of performing vascular ultrasound examinations in each patient before discharge even if clinical assessment does not show abnormalities.”

Size Does Matter

In a telephone interview with TCTMD, Ian C. Gilchrist, MD, of Hershey Medical Center (Hershey, PA), praised the study for confirming that “occlusion is a function of the size of the sheath.” He added that in general, it is an acknowledged principal that “each French size you go down cuts the radial occlusion rate in half.”

Both he and Asim N. Cheema, MD, PhD, of Hamilton General Hospital (Hamilton, Canada), agreed that the implication for clinical practice is to use smaller sheaths, but not always.

“For clinical practice, this study does show that for diagnostic angiography, when people have a choice between 6- and 5-Fr, they should use 5-Fr,” Dr. Cheema told TCTMD in a telephone interview. “But for PCI, we might not be there yet,” since the larger-size sheath provides more support for delivering stents and dealing with lesions.

Routine Ultrasound Not So Clear-Cut

The idea of routine ultrasound, however, sparked disagreement. “In many cases, nurses and doctors don’t check if the artery is open, they’re just happy there’s no bleeding,” Dr. Gilchrist said. “But most cath labs have fairly sophisticated ultrasound equipment already, and it’s not very difficult to quickly check everyone’s wrist to make sure it’s still open.”

Dr. Cheema advocated a different approach. “I would suggest just doing it in people who become symptomatic, otherwise it would be too much resource utilization,” he said. “We know that many radial artery occlusions recanalize over time, so why are you doing ultrasound on all of them? My personal suggestion would be if they’re not symptomatic, try a conservative approach and don’t do anything. If they’re symptomatic, then obviously you have to do something.”

In an editorial accompanying the study, Sunil V. Rao, MD, of the Duke Clinical Research Institute (Durham, NC), pointed out that the rates of radial occlusion in the study are “concerning” since they are “substantially higher than previously reported.” Dr. Cheema commented that most estimates in clinical practice put the rate at around 10%.

Drs. Rao, Gilchrist, and Cheema all sited the low unfractionated heparin dose given in the study (2,500 U), compared with the more standard dose of 5,000 U. “Given that the body mass index of the registry patients was > 25 kg/m2, thereby defining them as ‘overweight’ or ‘obese,’ this is a significant underdosing of anticoagulation and clearly not enough to reduce the risk of [radial artery occlusion],” Dr. Rao writes.

Complication Should Not Be ‘Overblown’

Dr. Gilchrist noted that, overall, the paper serves to quantify an issue that has not been well studied. “People that do a lot of radial artery catheterization know that the radial artery occludes at times,” he said. “In fact, it can be relatively frequent.”

What would be unfortunate, he continued, is if the current data caused people to shy away from the procedure. “When stories like this come out there’s always concern among those of us who are radial enthusiasts that the hazard will be overblown. This is a very safe procedure and this technique appears to improve mortality, such as in MI studies, and has a lot of very positive features.”

And the actual risk of morbidity is relatively minor, Dr. Gilchrist stressed. “Radial artery occlusion doesn’t result in mortality, or a hand falling off. There’s maybe two or three cases of an awful hand complication in the literature,” he said. “Most of them that are closed at day 1 will be open at day 30 even if you don’t do anything special. It’s not the type of complication that should make or break whether you want to get into radial artery catheterization.”

 


Sources:
1. Uhlemann M, Möbius-Winkler S, Mende M, et al. The Leipzig prospective vascular ultrasound registry in radial artery catheterization: Impact of sheath size on vascular complications. J Am Coll Cardiol Intv. 2012;5:36-43.

2. Rao SV. Observations from a transradial registry: Our remedies oft in ourselves do lie. J Am Coll Cardiol Intv. 2012;5:44-46.

 

Disclosures:

  • Drs. Gielen, Gilchrist, and Cheema report no relevant conflicts of interest.
  • Dr. Rao reports serving as a consultant for Terumo Medical.

 

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