Primary Use of the TruePath Crossing Device for Infrainguinal Chronic Total Occlusions With Intravascular Ultrasound Evaluation

Soga, Yoshimitsu; Nakamura, Miho; Hirose, Kaoru; Ito, Nobuhiro; Tomoi, Yusuke; Hiramori, Seiichi; Ando, Kenji

doi:10.1177/1526602818793901

Cited by 5 publications

(5 citation statements)

References 18 publications

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“… 8 Moreover, an increased risk for recanalization failure in calcified vessels has been reported with the use of both crossing and re-entry devices. 12 , 17 In this context, severe calcification increases the likelihood of unsuccessful crossing regardless the primary recanalization strategy. Thus, a combination of different techniques might be needed in heavily calcified disease.…”

Section: Discussionmentioning

confidence: 99%

Risk Factor Analysis for Crossing Failure in Primary Antegrade Wire-Catheter Approach for Femoropopliteal Chronic Total Occlusions

et al. 2022

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Introduction: Antegrade wire-catheter crossing remains the primary approach for femoropopliteal interventions. Nonetheless, data reporting on crossing failure are limited. Aim of this study is to identify risk factors for antegrade crossing failure in patients with femoropopliteal chronic total occlusions (CTOs). Methods: This is a single-center, retrospective analysis. Patients with femoropopliteal CTOs treated between May 2018 and February 2020 were included into this study. Primary endpoint of this analysis was primary crossing success defined as successful antegrade crossing without the use of retrograde access, crossing or re-entry devices. The assisted crossing success was additionally analyzed. A logistic regression analysis identified risk factors for failed primary antegrade crossing. Results: Data from 300 patients were analyzed. The majority (n=183, 61%) presented with lifestyle limiting claudication. The mean lesion length was 180 mm [interquartile range (IQR) 100–260 mm], whereas the median CTO length was 100 mm (IQR=50–210 mm). A chronic total occlusion crossing approach based on plaque morphology (CTOP) type I configuration was observed in 9% (n=26) of the lesions, type II in 61% (n=183), type III in 8% (n=25), and type IV in 66 CTOs (n= 66, 22%). Severe calcification based on the Peripheral Arterial Calcium Scoring Scale (PACSS), Peripheral Academic Research Consortium (PARC), and 360° grading systems was identified in 17%, 24%, and 28% of the lesions, respectively. A contralateral femoral access was used in 278 cases (93%). The primary crossing success amounted to 70% (n=210). The use of a re-entry device in 28 patients (9%) or of a combined antegrade–retrograde approach in 11% (n=34) of the cases increased the assisted crossing success to 89% (n=267). The presence of calcification (odds ratio [OR]=4.2, 95% CI=1.7–10.2) or of circumferential calcium (OR=2.5, 95% CI=1.3–4.9), a CTOP class ΙΙΙ or ΙV (OR=1.9, 95% CI=1.4–2.6), a proximal superficial femoral artery (SFA) occlusion (OR=3.5, 95% CI=1.7–7.4) and a CTO at P3 (OR=4.1, 95% CI=1.5–10.8) were associated with an increased risk for antegrade crossing failure. Conclusions: In this study, chronic total occlusions (CTO) morphology, calcification burden, and lesion’s location were identified as independent risk factors for failed antegrade crossing. Nonetheless, the use of alternative crossing strategies significantly increased the overall crossing success.

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Section: Discussionmentioning

confidence: 99%

Risk Factor Analysis for Crossing Failure in Primary Antegrade Wire-Catheter Approach for Femoropopliteal Chronic Total Occlusions

et al. 2022

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“…In addition, high success rates have been reported only in some institutions, with more variable results in others. 4,6,7 Therefore, it is difficult to apply these earlier findings to daily clinical practice. In the current prospective multicenter study, over 90% of the total route was intraplaque in successful crossing cases using the reentry device and IVUS.…”

Section: Discussionmentioning

confidence: 99%

“…Furthermore, several previous comparative studies were limited by operator experience and small samples sizes, so results may not necessarily reflect those in daily clinical practice. 4,6,7 The application of intravascular ultrasound (IVUS) for EVT evaluation is also growing. 8 A previous report evaluating intraluminal wire crossing of CTOs with IVUS assessment found that the proportion of plaque crossings (relative to total route distance) may affect primary patency.…”

Section: Introductionmentioning

confidence: 99%

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IVUS Assessment of the Crossing Pathway of an Intraluminal Reentry Device Used in the Primary Treatment of Infrainguinal Chronic Total Occlusions

et al. 2019

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Purpose: To examine with intravascular ultrasound (IVUS) the crossing pathways of the TruePath reentry device during primary antegrade recanalization of infrainguinal chronic total occlusions (CTOs). Methods: Between July 2017 and September 2018, a prospective multicenter study enrolled 143 consecutive patients (mean age 75±9 years; 101 men) with 146 CTOs treated in an antegrade approach using the TruePath reentry device with IVUS assessment of the crossing pathway in successful cases. Outcome measures were complete success (reentry device reached the distal true lumen), assisted success (reentry device use followed by a conventional guidewire to reach the distal true lumen), reentry device crossing route by IVUS assessment, and procedure- and device-related complications. Regression analyses were employed to identify any relevant associations between baseline patient variables and the outcome measures; results are presented as the odds ratio (ORs) and 95% confidence interval (CI). Results: Complete success was achieved in 82 (56.2%) lesions; any success (complete plus assisted) was documented in 117 (80.1%) lesions. Four (3%) perioperative device-related complications were observed. The crossing route was intraplaque for most of the total crossing distance in both complete success cases (95.3%±13.2%) and any success cases (94.8%±14.4%), with relatively short subintimal (3.6%±10.2% and 4.2%±11.2%, respectively) or intramedial (1.2%±5.8% and 1.0%±5.4%, respectively) crossing. CTO length was a significant risk factor for not achieving complete success (OR 1.74, 95% CI 1.13 to 2.68, p=0.012), and a history of failed revascularization was associated with not achieving any success (OR 6.40, 95% CI 1.28 to 28.9, p=0.038). Conclusion: The intraplaque route was the primary pathway taken by the TruePath reentry device as it crossed infrainguinal CTOs. Crossing rates were acceptable, with few device-related complications. However, a longer CTO length and a failed revascularization history negatively affected the success rate.

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“…The success rate of endovascular treatment (EVT) for chronic total occlusion (CTO) of the superficial femoral artery (SFA) has improved due to the development of re-entry devices and CTO crossing devices and the retrograde approach (Schneider 2017 ; Soga et al 2018 ; Schmidt et al 2012 ). However, certain lesions remain challenging to treat.…”

Section: Introductionmentioning

confidence: 99%

Successful re-entry using the outback® elite catheter via retrograde popliteal access with IVUS guidance for femoropopliteal occlusion: a case report

et al. 2020

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Background: There are still cases that are difficult to treat for femoropopliteal chronic total occlusion (CTO). The Outback® Elite catheter is effective re-entry device to treat such kind of difficult cases, however, it might be difficult to use the Outback® Elite catheter antegradely in cases with severely calcified lesions. In this case, we performed EVT using the Outback Elite® catheter via the retrograde popliteal approach. Case presentation: We report a case of a 77-year-old male with end-stage renal disease who presented with pain and cyanosis of his left foot. Control angiography showed total occlusion from the middle of the left superficial femoral artery to the proximal portion of the popliteal artery. The CTO lesion was severely calcified, which prevented the antegrade advancement of any guidewire. Retrograde popliteal puncture was performed with the patient in the supine position. After intentional retrograde subintimal wiring, the Outback® Elite catheter was advanced via the retrograde approach after the identification of a suitable re-entry site using intravascular ultrasound. After wire crossing, one nitinol stent was deployed and sufficient antegrade flow was achieved without any complications. Conclusions: Using Outback® Elite from retrograde should be considered in cases where antegrade advancement fails and bidirectional wiring cannot pass through the CTO lesion.

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Primary Use of the TruePath Crossing Device for Infrainguinal Chronic Total Occlusions With Intravascular Ultrasound Evaluation

Abstract: 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.

Cited by 5 publications

References 18 publications

Risk Factor Analysis for Crossing Failure in Primary Antegrade Wire-Catheter Approach for Femoropopliteal Chronic Total Occlusions

Risk Factor Analysis for Crossing Failure in Primary Antegrade Wire-Catheter Approach for Femoropopliteal Chronic Total Occlusions

IVUS Assessment of the Crossing Pathway of an Intraluminal Reentry Device Used in the Primary Treatment of Infrainguinal Chronic Total Occlusions

Successful re-entry using the outback® elite catheter via retrograde popliteal access with IVUS guidance for femoropopliteal occlusion: a case report

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