ACDs Modestly Reduce Access Site Complications, Major Bleeding

In real-world use, arterial closure devices (ACDs) are associated with only a small reduction in vascular access site complications and major bleeding after PCI, according to results presented at TCT 2014. 

Neil J. Wimmer, MD, MSc, of Brigham and Women’s Hospital, Boston, Mass., and colleagues used data from the NCDR CathPCI Registry to look at vascular access site complications and major bleeding for PCIs performed in the United States from July 2009 to September 2013. They evaluated patient groups treated by operators with both high and low ACD use, with a final study population of 1.1 million PCIs performed by 4,311 operators.

Differences in adverse outcomes

Researchers observed wide variation in closure device use among operators (see Figure). Patient characteristics were relatively similar between those treated by high and low ACD-use operators, he said.

mon.wimmer.figureOverall, 1.5% of cases resulted in access site complications (defined as hematoma of >5 cm, retroperitoneal bleeding, bleeding at the access site with post-PCI transfusion for patients with a pre-procedure hemoglobin of >8 g/dL and no CABG, and bleeding at the access site and absolute hemoglobin decrease from pre-PCI to post-PCI of ≥3 g/dL). Major bleeding occurred in

The absolute risk difference in vascular access site complications with ACDs, the study’s primary endpoint, was 0.36% (95% CI 0.31-0.42%; P<.001). The number needed to treat with ACDs to prevent one access site complication was 277. In cases of major bleeding, the absolute risk difference with ACDs was 0.73% (95% CI 0.64%-0.82%; P<.001). The number needed to treat with ACDs to prevent one major bleeding event was also high at 137, Wimmer reported.

He emphasized, however, that the study was observational and did not take into consideration the expertise of operators using ACDs.

The price of closure devices

Assuming each ACD costs $250, the total amount to prevent one vascular access site complication would be $69,250, and it would cost $34,250 to prevent one major bleeding complication, the researchers calculated.

“Bleeding and access site complications related to PCI are major common causes of morbidity and mortality, and while transradial PCI is becoming more popular in the United States, the majority of PCIs are still performed by a transfemoral approach,” Wimmer said during his presentation. “Closure devices, of which there are many, can be used for a number of reasons — either patient preference, physician preference or for their efficacy in preventing vascular access site complications. While the idea of closure devices as a bleeding avoidance strategy may still be somewhat controversial, it has been written about in several high-profile journals.”

  

Disclosures:

 

  • Wimmer reports no relevant conflicts of interest.

 

Comments