Efficacy of Super Slow Inflation as Lesion Preparation for Drug-Coated Balloons in Femoropopliteal Lesions

Abstract

Background: Drug-coated balloon strategies in endovascular therapy often result in severe dissection, so lesion preparation must be improved. We evaluated the efficacy of a gradual inflation method, termed "super slow inflation" (SSI), in preparing lesions to avoid severe dissections. Methods and Results: The association between balloon pressure and the dilatation of a model constricted vessel, as well as the load applied to the balloon surface, were determined using a burst leak detector for a quick inflation (QI; 1 atm/s) protocol and SSI (1 atm/20 s). A retrospective, single-center, non-randomized study evaluated differences in vessel dissection patterns after balloon angioplasty depending on inflation method in 81 consecutive patients (mean [±SD] age 74.6±9.2 years; 54 males) who underwent balloon angioplasty for de novo femoropopliteal lesions between January 2017 and March 2019. In the constricted vessel model, vessel dilatation increased gradually using SSI, with the maximum dilatation load being approximately 100 g lower for the SSI than QI protocol. In patients, the rate of severe vessel dissection was significantly lower in the SSI than non-SSI group (17.6% vs. 55.2%, respectively; P<0.001). Multivariate regression analysis revealed that SSI was an independent factor preventing severe dissection (odds ratio 0.18; 95% confidence interval 0.06-0.53; P=0.002). Conclusions: SSI is a gentle and effective method for the preparation of femoropopliteal lesions to reduce the incidence of severe angiographic dissection when using drug-coated balloons.