Primary Use of the TruePath Crossing Device for Infrainguinal Chronic Total Occlusions With Intravascular Ultrasound
Yoshimitsu Soga1, Miho Nakamura1, Kaoru Hirose1
11 Department of Cardiology, Kokura Memorial Hospital, Kitakyushu, Japan.
Insights
The TruePath device effectively recanalized infrainguinal chronic total occlusions (CTOs) in 60% of cases. Intraluminal crossing was achieved in 97% of successful cases, with few complications.
Area of Science:
- Vascular Surgery
- Interventional Cardiology
- Medical Device Technology
Background:
- Infrainguinal chronic total occlusions (CTOs) present a significant challenge in peripheral artery disease management.
- Revascularization is crucial for limb salvage and improving quality of life.
- Novel crossing devices are needed to improve procedural success rates.
Purpose of the Study:
- To evaluate the efficacy and safety of the TruePath crossing device as a primary tool for recanalizing infrainguinal CTOs.
- To assess the rate of successful CTO crossing using the TruePath device alone.
- To determine the rate of intraluminal crossing and device-related complications.
Main Methods:
- Retrospective analysis of 50 patients with 55 infrainguinal CTOs treated with the TruePath device.
- Mean occlusion length was 138±55 mm, with 65% being femoropopliteal lesions.
- Primary outcome: CTO crossing with TruePath alone. Secondary outcomes: assisted success, complications, and intravascular ultrasound (IVUS) documented intraluminal crossing.
Main Results:
- Complete success in crossing CTOs was achieved in 60% (33/55) of lesions.
- Intraluminal crossing rate was 97% by IVUS in successful cases.
- Complete/assisted success was achieved in 87% (48/55) of lesions, with a low device-related complication rate of 1.8%.
Conclusions:
- The TruePath device demonstrates satisfactory complete success and a high rate of intraluminal crossing for infrainguinal CTOs.
- Few device-related complications were observed.
- Severe calcification (PACCS grade 4) was identified as an independent predictor of TruePath failure.
Purpose:
To evaluate the use of the TruePath crossing device as the primary recanalization tool for infrainguinal chronic total occlusions (CTO).
Methods:
A retrospective analysis was conducted of 50 patients (mean age 75 years; 26 men) with 55 infrainguinal CTOs treated with the TruePath between March 2017 and September 2017 at a single center. The mean occlusion length was 138±55 mm, and femoropopliteal lesions accounted for 65% of the 55 lesions. The primary outcome measure was CTO crossing using the TruePath alone; secondary outcomes were assisted success (>50% lumen gain using the TruePath), device-related complications, and intraluminal crossing evaluated by intravascular ultrasound (IVUS).
Results:
Complete success was achieved in 33 (60%) of 55 lesions having a mean occlusion length of 145±72 mm. Among these, the true lumen crossing rate was 97% according to IVUS evaluation. Assisted success was achieved in 15 (68%) of the 22 failures. Complete/assisted success, in which the TruePath was thought to have contributed to CTO crossing, was attained in 48 (87%) of the 55 lesions. Three (5.5%) complications were observed: a perforation, an access-site hematoma, and acute occlusion; only the perforation was device related (1.8%). Multivariate analysis showed PACCS grade 4 (odds ratio 4.5, 95% confidence interval 1.33 to 15.5, p=0.02) was an independent predictor of TruePath failure.
Conclusion:
Primary use of the TruePath crossing device for infrainguinal CTOs demonstrated a satisfactory complete success rate and a high rate of IVUS-documented intraluminal crossing with few device-related complications. Severe calcification is an independent predictor of TruePath failure.
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