Deformation and stenosis of the sinus‐SuperFlex‐DS stent after ductal stenting for the hybrid stage 1 procedure

Abstract

We present five cases of sinus-SuperFlex-DS stent stenosis during early follow up that resulted in inadequate ductal patency and required urgent re-stenting with a balloon-expandable stent. This causes concern that these stents lack sufficient radial force against ductal constriction and if used need to be kept under close scrutiny.

Stents in Congenital Heart Disease: State of the Art and Future Scenarios

“…Table 1 provides a clear picture of the wide variety of devices that have been used over the years and are still currently adopted, following the stent classification proposed in paragraph 2. Cook Formula 414 (O) [73] Precise (O) [74] Protégé (O) [70,74,75] Sinus-Repo-DS (C) [68] Ductal stenting may be performed as a palliative procedure to ensure ductal patency in newborns with single ventricle physiology, with either duct-dependant systemic circulation (HLHS) or duct-dependant pulmonary circulation (pulmonary atresia). Table 1 provides a clear picture of the wide variety of devices that have been used over the years and are still currently adopted, following the stent classification proposed in paragraph 2.…”

“…Ad Hoc for CHD Balloon-Expandable Self-Expandable Cook Formula 414 (O) [73] Pulmonary atresia Palmaz-Schatz (C) [7,46,49,79] Multi-Link Vision (O) [80][81][82][83] Promus Premier * (O) [80] Driver (O) [83][84][85][86] Tsunami (O) [84] Libertè (O) [84,85] Ephesos (O) [85] Jostent (C) [87] Express (O) [87] Cordis Bx Velocity * (O) [87] AVE S670 (O) [87] VeriFLEX (O) [82,83] Integrity (O) [82,83] Omega (O) [82] Skylor (C) [82] Amazonia * (O) [82] NA NA * Drug-eluting stent (DES); others, where no specification is provided, are bare metal stents (BMS).…”

“…Balloon-expandable stents, selected among coronary, renal, and biliary devices, are only indicated in case of ductal stenosis to reduce stent migration risk [68]. The great advantage of self-expandable stents relies on their higher flexibility and conformability to duct shape with respect to balloon-expandable stents and the possibility of implantation through smaller sheaths [70,73,77,93]. Among the most common complications, stent migration, need for re-stenting, aortic isthmus jialing, and stent obstruction are reported [70,77,92].…”

“…The former is characterized by an open-cell design to provide an effective combination between conformability and radial force, with diameters ranging from 4 mm to 9 mm; the latter has a closed-cell design and is indicated for combined treatment of aortic coarctation, with size of 5 mm and 6 mm. However, controversial outcomes have been reported: while some studies reveal positive follow-up with sufficient radial strength, good hemodynamics, and reduced wall trauma [77,78], others report early collapse due to insufficient radial force and severe restenosis [73,76].…”

“…stent (C)[68,71,72] Omnilink (O)[68,72] Saxx stent (C)[68,71,72] Precise (O)[74] Protégé (O)[70,74,75] Sinus-Repo-DS (C)[68] Sinus-SuperFlex-DS (O)[73,[76][77][78] Sinus-SuperFlex-DS (O)[73,[76][77][78] Appl. Sci.…”