Feasibility and efficacy of an ultra-short side branch-dedicated balloon in coronary bifurcation stenting.

Abstract

Side branch (SB) dilation with an ultra-short balloon after main vessel (MV) stenting may minimise stent failure in coronary bifurcation lesions. We sought to investigate the feasibility and efficacy of the Glider balloon (GB), a side branch (SB)-dedicated balloon 4 mm in length, in coronary bifurcation stenting. In bench testing, stent configuration was examined with micro-focus computed tomography after crossover stenting followed by GB dilation or kissing balloon inflation (KBI). In the clinical study we performed GB dilatation after MV stenting for 207 lesions in 194 patients. Failure of the GB dilation and additional procedures due to inducible stent failure were investigated as well as adverse cardiac events at 1-year follow-up. In bench testing GB dilation maintained cross-sectional stent area without significant deformation and presented effective jailed strut removal in a high-angled bifurcation model. In the clinical study the cohort included left main, true bifurcation lesion, and two-stent treatment in 42.0%, 45.9%, and 14.0%, respectively. The proximal optimisation technique (POT) or POT-like inflation was performed in 82.1%. GB crossing failure, SB stenting due to dissection, and stent deformation requiring correction by KBI or MV dilation occurred in 8.7%, 1.4%, and 5.8%, respectively. Finally, simple GB dilation without KBI was completed in 91.8% for SB dilation. At one-year follow-up, target lesion revascularisation, cardiac death, myocardial infarction, and stent thrombosis were found in 7.2%, 2.1%, 2.1%, and 1.0%, respectively. Simple GB dilation after adequate expansion of the proximal MV stent provided acceptable acute and long-term results as an alternative to KBI.