Author + information
- Noriyuki Wakana1,
- Kan Zen1,
- Kazuaki Yakabe2,
- Daisuke Kambayashi3,
- Taku Kato4,
- Yoshinori Tsubakimoto5,
- Takuo Nakagami6,
- Shinichiro Yamaguchi6,
- Kenji Yanishi1,
- Naohiko Nakanishi1,
- Takeshi Nakamura1 and
- Satoaki Matoba1
- 1Department of Cardiovascular Medicine, Kyoto Prefectural University School of Medicine, Japan
- 2Department of Cardiovascular Medicine, Nijigaoka Hosptal, Nagasaki, Japan
- 3Department of Cardiovascular Medicine, Fukuchiyama City Hospital, Kyoto, Japan
- 4Department of Cardiovascular Medicine, Otowa Hospital, Kyoto, Japan
- 5Japanese Red Cross Kyoto Daini Hospital, Japan
- 6Department of Cardiovascular Medicine, Omihachiman Community Medical Center, Shiga, Japan
The contralateral crossover method of using a guiding sheath (GS) with an inner dilator for a 0.035-inch guidewire (35-system) is standard in endovascular therapy (EVT) for femoropopliteal artery disease but has some limitations. This study aimed to investigate the efficacy of GS delivery with a newly customized inner dilator for a 0.018-inch guidewire (18-system) of the Destination® Guiding Sheath (Terumo Corporation, Tokyo, Japan) compared with that of the 35-system.
We conducted a prospective multicenter study using Destination® to determine whether the cases in which the 35-system had failed could be rescued using a new 18-system consisting of an inner dilator customized for the 0.018-inch guidewire. We registered 172 such cases, a multi-institution trial involving eight institutions in Japan. The subjects who underwent EVT for femoropopliteal artery disease using a crossover approach with 6 Fr. guiding sheath from April 2013 to October 2014 were included in the analysis. A contralateral crossover procedure with the default 35-system, in which the Radifocus® Guidewire M standard type was initially used, was attempted first in all cases that were supposed to be treated using the contralateral antegrade approach. Selection of the contralateral crossover or ipsilateral antegrade approach was not based on the properties of the iliac artery or aortoiliac bifurcation, but on the properties of the target lesion. When this was unsuccessful, the operator switched to the 18-system and tried again with the same crossover approach.
Analysis in Silicone Vessel Model
To evaluated the efficacy of 18-sytem in crossover approach, we developed a vitro aortoiliac bifurcation model, which was created by silicone vessel, and of which the angles we can change freely. We put this silicon vessel in water pool which was kept 37 degree Celsius. We consisted of 7 types of bifurcation angles from 40° to 100° and then we tried to deliver the 35-system and 18-system respectively by changing the wire; a 0.035-inch Radifocus® Guidewire M standard type and stiff (Terumo Corporation, Tokyo, Japan), and a 0.018-inch Thruway TM Guidewire® (Boston Scientific Corporation, Natick, MA, USA).
We conducted a prospective multicenter study using Destination® to determine whether the 18-system could rescue the cases in which conventional 35-system failed. We registered 172 such cases. 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 cases. Factors of 35-system failure were evaluated by comparing with 35-system success cases (Figure 1). Angles of bifurcation in 35-system failure cases were significantly steeper compared to those in 35-system success cases (54.4 ± 7.9° vs 90.7 ± 14.3°, P<0.01). Also, multivariate analysis showed the only angle of bifurcation as an independent factor in 35-system failure cases. To evaluated the efficacy of 18-system, we developed a vitro aortoiliac bifurcation model created by silicone vessel, which consisted of 7 types of bifurcation angles from 40° to 100°. We could not deliver the 35-system through a bifurcation in which the angle was steeper than 50°; however, we could deliver the 18-system at any angle (Figure 2 and Table 1). These data suggested that 18-system provides superior results, especially in an acute aortoiliac bifurcation, consistently with vivo findings.
Initial use of the Destination® for the 18-system with a contralateral crossover approach seems to be superior to using the conventional 35-system, creating a novel option in endovascular therapy for femoropopliteal artery disease.