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Rarity of Longitudinal Stent Deformation Confirmed in Clinical Practice
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Study results published in the Journal of Interventional Cardiology have found that longitudinal stent deformation occurs rarely in clinical practice, and bench testing revealed it in only one brand of stent.
Longitudinal stent deformation was seen twice with thin-strut coronary stents, leading researchers to solicit further possible cases, as well as conduct bench testing to identify the stents vulnerability to longitudinal compression.
Six patients with longitudinal stent deformation were identified (0.31% of 1,907 stents) — all with the Promus Element stent (Boston Scientific) — from 2,705 coronary interventions performed with 4,588 stents (41.6% Promus Element; 24.4% Xience Prime [Abbott]) from cases occurring between July 2010 and November 2011. Wire bias was a predisposing factor in four cases, which interventionalists treated with post-dilatation and/or additional stenting. No adverse events occurred during a mean follow-up of 5.8 months.
In bench testing, all contemporary stents could be compressed when subjected to longitudinal compression. Longitudinal stent deformation occurred in all stents, but at different levels of force. Most shortening at 50 g was observed with the Promus Element (38.9%). According to the product’s package insert, the company has received 136 longitudinal stent deformation-related complaints from 829,372 sold Element and Omega stents (0.016%).
All stents in this study showed some re-elongation after post-dilatation.
“Compression of Promus Element occurs at a lower force, but it is the only stent where deformations are detected with X-ray,” because its platinum-chrome alloy offers excellent radio-opacity despite the thin-strut design, the researchers wrote.
Disclosure: The researchers report no relevant financial disclosures.
Perspective
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Paul D. Williams, MD
All of the data published subsequent to the findings in our original study [published in EuroIntervention in November 2011] back up the initial observation that the increased reporting of longitudinal stent deformation is as a result of the introduction of the Element platform. The Element has now been shown in numerous bench studies to have significantly less longitudinal strength than other contemporary platforms. This finding is clinically relevant with four case series now published reporting an increased rate of deformation with the Element platform in real-world patients; these include our series, this one in the Journal of Interventional Cardiology and two in Catheterization and Cardiovascular Interventions (Shannon et al and Liebundgut et al). However, even with the Element stent, longitudinal stent deformation appears to be rare (0.5%-1% of stents) and the impact on hard clinical outcomes remains uncertain as there are no direct comparator studies between the Element and other platforms in "real-world" patients currently completed.
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