A “Jail Escape Technique”(JET) Protects Side Branch During Provisional Stenting:Feasibility And First-in-Man Study

1.Background and Objective:Coronary artery bifurcation lesions account for 20% of all lesions managed by percutaneous coronary intervention(PCI).The European Bifurcation Club recommends provisional stenting as the preferred strategy and technique for managing the majority of bifurcation lesions.However,side branch(SB)ostial compromise caused by carina or plaque shift is still one of the mian concerns in provisional stenting.Additionally,a high degree(?50%)of post-procedural SB stenosis was shown to be associated with inducible myocardial ischemia.Therefore,final kissing balloon inflation is recommended after main vessel(MV)stenting results.While distal rewiring and stent expansion toward the SB are associated with better results during provisional stenting,there are still limitations including technical challenges,and residual unopposed strut in front of the carina.We evaluated the feasibility of a novel technique for achieving distal side branch(SB)access and improved strut apposition during provisional stenting of coronary artery bifurcation lesions.2.Methods:2.1 Preclinical testing2.1.1 The “Jail Escape Technique”(JET)was performed in phantom model of coronary bifurcation by passing the proximal tip of the SB wire between the main vessel(MV)stent struts and balloon before implantation,allowing the MV stent to push the SB wire against the distal part of the carina.The MV stent can then be deployed without jailing the SB wire.Final kissing balloon inflation was performed.2.2 Distal SB access and strut distribution at the carina were tested in swine model of coronary bifurcation.2.3 Stent securement testing.Stent distortion,dislodgement forces,and material damage were evaluated with tensile testing and SEM(Scanning electron microscopy).2.4 First in man trial.Human feasibility was tested on 32 patients with JET.MACE were evaluated at 6-month follow-up.3.Results:3.1 Preclinical testing demonstrated that the SB wire was located at the most distal part of the carina and no strut malapposition at the carina was present after balloon inflation.3.2 Animal experiments revealed correct strut apposition,and the SB wire was located at the most distal part of the carina as well.3.3 JET did not affect stent securement.Stent distortion,dislodgement forces,or material damage were not affected.3.3.1 No obvious stent distortions were observed in the JET stents other than with respect to the slightly protruding strut crown at the wire insertion point.3.3.2 JET showed larger stent dislodgement force than the minimally dislodgement force(6.105 ± 0.73 N vs.5.74 N),as specified by the manufacturer.3.3.3 SEM at 32-fold and 42-fold magnification did not show any obvious damage to the polymeric material.3.4 JET was successfully performed in 30 of 32 patients.No major adverse cardiovascular events occurred in any patient at 6-month follow-up.4.Conclusion4.1 The novel wiring technique “JET” is feasible.4.2 JET enables sufficient distal SB access by angiographic guidance.4.3 JET eliminates strut malapposition at the carina if kissing balloon inflation is needed.