Endovascular Treatment of Infrainguinal Chronic Total Occlusions Using the TruePath Device: Features, Handling, and 6-Month Outcomes

Banerjee, Subhash; Sarode, Karan; Das, Thomas M.; Hadidi, Omar; Thomas, Rahul; Vinas, Ariel; Garg, Puja; Mohammad, Atif; Baig, Mirza S.; Shammas, Nicolas W.; Brilakis, Emmanouil S.

doi:10.1583/13-4527r.1

Cited by 17 publications

(11 citation statements)

References 14 publications

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“…This is utilized to drill through a CTO, ideally finding microchannels, as it traverses the CTO. 39 Finally, the Viance™ catheter (Covidien, Minneapolis, MN) is analogous to the CrossBoss™ catheter (Boston Scientific, Marlborough, MA), and is composed of a stainless steel catheter with a rounded-tip. This is utilized with a Fast-spin™ device to rotate the catheter as it advances through CTOs.…”

Section: Revascularization In Dmmentioning

confidence: 99%

Endovascular Devices and Revascularization Techniques for Limb-Threatening Ischemia in Individuals With Diabetes

Chung

2017

J Diabetes Sci Technol

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Diabetes mellitus (DM) is a rapidly worsening global epidemic over the last thirty-five years. The increased prevalence of DM has changed the phenotypic expression of atherosclerotic limb threatening ischemia (LTI), resulting in an increase in lesions in the tibial vessels. These patients are also afflicted with peripheral neuropathy, foot deformities, and medial calcification of the vasculature. In response to the evolving phenotype of atherosclerosis, newer minimally invasive tools and techniques have been developed to improve the blood supply in LTI. Arterial access, traditionally obtained from the contralateral common femoral artery (CFA) in a retrograde fashion, is now also frequently being obtained in the ipsilateral limb in an antegrade fashion. Retrograde access of the tibial, pedal, tarsal, or calf collateral vessels is also being utilized to provide a route through which wires, catheters, balloons and stents may be placed. Wires have evolved to have a variety of diameters, materials and coatings providing interventionalists with a wide variety of choices when attempting to traverse blockages in the arteries. When catheters and wires fail to traverse the lesion, newer chronic total occlusion (CTO) devices have been developed to aid in the placement of a wire across the offending lesions. Due to medial calcification associated with DM, atherectomy devices have been developed to debulk the atherosclerotic plaque within the vessel. High pressure balloon angioplasty with or without stents remain the mainstay of intervention, with drug-coated balloons (DCBs) and drug-eluting stents (DESs) now being frequently used to prevent reocclusions of atherosclerotic lesions.

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Section: Revascularization In Dmmentioning

confidence: 99%

Endovascular Devices and Revascularization Techniques for Limb-Threatening Ischemia in Individuals With Diabetes

Chung

2017

J Diabetes Sci Technol

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“…Vascular calcification visible on angiographic views prior to contrast injection was classified as mild (isolated foci of calcification), moderate (contiguous segments of calcification on one or alternating sides of the vessel), or severe (contiguous calcification on both sides of the vessel). [7][8][9][10] …”

Section: Definitionsmentioning

confidence: 99%

“…Technical descriptions of these approved devices have previously been published. 7,8,11 Endpoints and Definitions Outcome measures included crossing success, procedure success, complications, and major adverse events (MAEs). Crossing success was defined as placement of a guidewire in the distal true lumen, past the distal CTO cap, confirmed by either angiography or intravascular ultrasound (IVUS).…”

Section: Strategies and Devicesmentioning

confidence: 99%

“…Given these challenges, a crossing device must be firm to penetrate the proximal cap, highly maneuverable to allow directional guidance, and flexible, with a low profile to avoid large dissections or perforation. [6][7][8] Successful crossing of infrainguinal CTOs involves selection of an optimal initial crossing strategy, which can be broadly divided into 2 groups: use of a guidewire supported by a microcatheter (wire-catheter strategy) or use of a specialized CTO crossing device. However, there are to date no comparative clinical studies to guide decision making between these crossing strategies.…”

Section: Introductionmentioning

confidence: 99%

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Comparative Assessment of Guidewire and Microcatheter vs a Crossing Device–Based Strategy to Traverse Infrainguinal Peripheral Artery Chronic Total Occlusions

et al. 2015

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“…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%

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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Endovascular Treatment of Infrainguinal Chronic Total Occlusions Using the TruePath Device: Features, Handling, and 6-Month Outcomes

Abstract: TruePath facilitated successful crossing of infrainguinal CTOs following an unsuccessful guidewire recanalization, with significant improvement in symptoms and no complications.

Cited by 17 publications

References 14 publications

Endovascular Devices and Revascularization Techniques for Limb-Threatening Ischemia in Individuals With Diabetes

Endovascular Devices and Revascularization Techniques for Limb-Threatening Ischemia in Individuals With Diabetes

Comparative Assessment of Guidewire and Microcatheter vs a Crossing Device–Based Strategy to Traverse Infrainguinal Peripheral Artery Chronic Total Occlusions

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

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