Why the study?
Does the Tornus penetration catheter improve procedural success in PCI patients with calcified coronary lesions and balloon crossing failure?
Does the Tornus penetration catheter improve procedural success in PCI patients with calcified coronary lesions and balloon crossing failure?
The Tornus penetration catheter is an effective and safe bail-out device for facilitating balloon entry in complex, calcified coronary lesions and chronic total occlusions when standard balloon crossing fails.
May support Tornus bailout in calcified lesions after balloon failure; leaves open confirmation in prospective trials.
AIMS: Failure to cross a calcified tight stenosis or chronic total occlusion (CTO) with a balloon after having passed a guidewire is a rare but serious intricacy with a high likelihood of failure. We report our experience of a three years period (December 2004-November 2007) using a novel metal penetration catheter (Tornus) to bail-out 44 failures to cross a lesion with a balloon catheter. METHODS AND RESULTS: The Tornus (Asahi Intecc, Aichi, Japan), an over-the-wire metal exchange catheter that might be "screwed" counter-clockwise into a lesion, was used in 44/2881 PCI-patients with calcified and tortuous coronary anatomy in whom a 1.5 mm lubricious balloon catheter could not be pushed into the lesion despite optimal support of a 6 Fr guiding catheter and additional anchoring with a stiff-shafted guidewire (anchor wire) when applicable. In 39/421 patients the target was a chronic total occlusion and in 5/2460 patients it was a stenotic lesion or recent occlusion. In these 44 consecutive balloon-failures the Tornus completely passed 35 lesions (79.5%) - all but one were successfully followed with a balloon and stent. In one patient, the balloon did not follow despite successful passage of the Tornus. In 5/9 patients in whom the Tornus passed incompletely, the channel was opened sufficiently to allow for successful passage with a balloon. In three failures to dilate after Tornus, the procedure was successfully finished with the use of a Rotablator. Three of the 44 finally failed. Over all, the Tornus procedure relevantly contributed to success in 91% of the cases with failure of balloon crossing. We experienced no complications or fractures. CONCLUSION: The Tornus is an easy to use over-the-wire device to increase a coronary channel and enhance balloon entry of complex tight lesions and chronic total occlusions.
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Reifart et al. (2008) studied this question.
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