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I read with great interest the study by Nikolsky et al. (1) describing a meta-analysis of the vascular closure device complication rate as compared to manual compression. As the investigators describe, the complication rate with arteriotomy closure devices in diagnostic catheterization appears to be similar between closure device and compression. Moreover, the complication rate appears similar for interventional procedures for the market-leading products, Angio-Seal and Perclose, with a higher complication rate seen with the VasoSeal device (1).
As with other interventional technologies, an evolution has occurred in closure device technology that outpaces the published data. In our own portfolio of Perclose suture closure products, key improvements have been seen with each generation of product. The Closer product was introduced in 1999 and saw a fundamental change with needles that captured suture from above the arteriotomy rather than having a platform where needles were actually positioned in the artery and delivered suture to the surface. We believe that the Closer provided a patient safety feature and greater reliability, which may not have been reflected in the meta-analysis, which included 15 Perclose-related studies on the older TechStar and ProStar product lines reported by Nikolsky. A more recent patient set was examined by Tavris et al. (2), where analysis of the large ACC-NCDR database of 166,680 patients saw a reduction in vascular complications and death in patients who had the Angio-Seal and Perclose vascular closure devices used when compared to manual compression or compression devices. This finding was assessed from patient data collected between 2001 and 2002.
Similarly, a meta-analysis may not reflect a change in practice style or technique, which might be better detected in a randomized clinical trial or database survey. Of the 15 Perclose studies examined, only 4 were with 6- to 7-F sheaths; the others were actually larger sheath sizes, which is uncommon in practice over the past five to six years. Suture-based devices in particular have been commonly used in larger-diameter puncture sites. Closure devices have reduced their size as practice patterns have moved toward a smaller dimension, and this shift may be reflected in outcomes seen with the newer devices as well as with manual compression with or without a compression-assist device.
Despite the criticisms mentioned above, the Nikolsky et al. (1) study is an important signal for our field. Although no study is perfect, reports such as those by Nikolsky et al. (1) and Tavris et al. (2) have shown that the predominant technologies on the market are equivalent and potentially superior to manual compression in providing patient comfort and safety. Higher-risk clinical scenarios have to be considered, especially in the female patient (3); however, the time may be ripe for more study and a head-to-head randomized clinical trial.
Please note: Dr. Chou is a current employee of Abbott Laboratories and currently serves as General Manager of the Vessel Closure Technologies business unit, overseeing among other products the Perclose suture-mediated closure system.
- American College of Cardiology Foundation