A newly designed 0.018-in.-compatible inner dilator as a novel option for endovascular therapy with the crossover approach

Cardiovasc Interv Ther. 2020 Jul;35(3):276-282. doi: 10.1007/s12928-019-00620-x. Epub 2019 Sep 11.

Abstract

This study aimed to investigate the efficacy of guiding sheath delivery with the crossover approach using a newly customized inner dilator for a 0.018-in. guidewire of the Destination® guiding sheath (Terumo Corporation, Tokyo, Japan) (18-system), compared with that of the conventional-type 0.035-in. guidewires with inner dilators (35-system), and to predict failure of guiding sheath delivery. We conducted a prospective multicenter case series study of the contralateral crossover approach using Destination®, to determine whether the 18-system could be a rescue system in cases in which the conventional 35-system failed. To evaluate the efficacy of the 18-system, we created an in vitro aortoiliac bifurcation model by using a silicone vessel. We enrolled 172 cases consecutively. The initial crossover approach with the 35-system failed in 37 cases (21.5%), and a second attempt with the 18-system was successful in all failed cases. The bifurcation angles in the 35-system failure cases were significantly steeper than those in the 35-system success cases. A receiver operating characteristic curve analysis demonstrated that an aortoiliac bifurcation angle of 68° was the optimal cut-off value for predicting failure of the crossover procedure. Data from the analysis using the silicone vessel model suggested that the 18-system provided superior results, especially in aortoiliac bifurcation angles steeper than 60°, consistent with the in vivo findings. The results of the initial use of the 18-system with the crossover approach suggest that it may be superior to the conventional 35-system, especially in cases of steeper aortoiliac bifurcation angles.

Keywords: Contralateral crossover approach; Endovascular therapy; Guiding sheath; Peripheral artery disease.

Publication types

  • Multicenter Study

MeSH terms

  • Aged
  • Aged, 80 and over
  • Aorta
  • Catheterization, Peripheral / instrumentation*
  • Catheterization, Peripheral / methods*
  • Endovascular Procedures / instrumentation*
  • Endovascular Procedures / methods*
  • Female
  • Femoral Artery / pathology
  • Femoral Artery / surgery
  • Humans
  • Iliac Artery
  • Japan
  • Male
  • Middle Aged
  • Peripheral Arterial Disease / surgery*
  • Popliteal Artery / pathology
  • Popliteal Artery / surgery
  • Prospective Studies
  • Stents*
  • Treatment Outcome