Failure to post-dilate BeSmooth peripheral stents to adult vessel size diameters during bench-side tests - 07/09/23
Résumé |
Introduction |
Low-profile stent implantation remains a rescue treatment for aortic coarctation and branch pulmonary arteries stenosis in small children. Stent re-expansion to cope with vascular growth remains problematic.
Objective |
To evaluate ex-vivo feasibility and mechanical behavior of over-dilating BeSmooth peripheral stents (Bentley InnoMed, Germany).
Methods |
Three BeSmooth stents in diameters of 7, 8, and 10mm were dilated to nominal pressure and then 13atm. Test-1 (sequential up-sizing post-dilation without re-stenting): BeSmooth Ø7×23mm was post-dilated using 12, 14, and 16mm high-pressure balloons. Test-2 (post-dilation until plateau/breakpoint then re-stenting): BeSmooth Ø10×57mm was post-dilated with 14mm balloon until plateau/breakpoint and then with 48mm bare-metal Optimus-XXL stent hand-mounted on 14mm balloon. Test-3 (straightforward re-stenting): BeSmooth Ø8×57mm was directly post-dilated with 48mm bare-metal Optimus-XXL stent hand-mounted on 16mm balloon. The stents’ diameter and length were measured. Balloon rupture and stent fracture patterns were closely evaluated.
Results/Expected results |
Test-1: BeSmooth Ø7×23mm was post-dilated to 10mm diameter with a little shortening. Up-sizing the stent to 11mm with the Ø14mm balloon led to the stent shrinking to 3.2mm. At 20atm pressure, BeSmooth Ø7×23mm shortened to 2mm forming a 12mm diameter solid ring circle, and the 16mm woven balloon ruptured radially. Test-2: The BeSmooth Ø10×23mm reached a plateau diameter of 13mm without shortening and the balloon did not rupture. Stent-in-stent re-expansion showed that at 10atm pressure, BeSmooth Ø10×57mm fractured longitudinally in various dispatched breaking points at a diameter of 13mm without shortening and ruptured the balloon with multiple pinholes. Test-3: At 10atm pressure, BeSmooth Ø8×57mm fractured centrally at three different points at a diameter of 11.5mm without shortening and the balloon broke radially in half.
Conclusion/Perspectives |
In our benchmark tests, extreme shortening, severe balloon rupture, or unpredictable stent fracture patterns at small balloon diameters limits the safe post-dilation of BeSmooth stents beyond 13mm. BeSmooth stents are not ideal candidates for off-label stent interventions in smaller patients.
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Vol 15 - N° 4
P. 280 - septembre 2023 Retour au numéroBienvenue sur EM-consulte, la référence des professionnels de santé.
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