Endovascular treatment of infrainguinal chronic total occlusions using the truePath device: Features, handling, and 6-month outcomes

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

Research output: Contribution to journalArticle

13 Citations (Scopus)

Abstract

Purpose: To report experience with a recently approved peripheral chronic total occlusion (CTO) crossing device in the superficial femoral (SFA), popliteal, and below-the-knee (BTK) arteries. Methods: Thirteen patients (all men; mean age 68.6±7.9 years) from the XLPAD registry (ClinicalTrials.gov identifier NCT01904851) were treated between April 2012 and August 2013 with the TruePath device after an unsuccessful guidewire crossing attempt. More than half of the patients had diabetes mellitus. Most lesions were TASC classification type C (n=5) or D (n=6), with mean lesion length 169.8±83.3 mm; 12 lesions were de novo and severely calcified. Procedure success was defined as successful revascularization of the CTO. Technical success was placement of a guidewire beyond the distal CTO cap into the true lumen without the need for a re-entry device. Results: All CTOs were successfully crossed using the TruePath, but 3 subintimal recanalizations required the use of a re-entry device (77% technical success). Eight lesions were stented, while the remaining were treated with balloon angioplasty and/or atherectomy. Average fluoroscopy time was 41.1±18.3 minutes, during which a mean 200.0±46.2 mL of iodinated contrast were used (radiation dose area product 211.2±202.6 Gy*cm2). There were no periprocedural complications. Significant improvement was seen in the 6-month ankle-brachial index (p=0.018) and Rutherford class (p=0.019). The 6-month clinically indicated target vessel revascularization rate was 8%. Conclusion: TruePath facilitated successful crossing of infrainguinal CTOs following an unsuccessful guidewire recanalization, with significant improvement in symptoms and no complications.

Original languageEnglish (US)
Pages (from-to)281-288
Number of pages8
JournalJournal of Endovascular Therapy
Volume21
Issue number2
DOIs
StatePublished - 2014

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Equipment and Supplies
Atherectomy
Ankle Brachial Index
Balloon Angioplasty
Fluoroscopy
Therapeutics
Thigh
Registries
Knee
Diabetes Mellitus
Arteries
Radiation

Keywords

  • Balloon angioplasty
  • Chronic total occlusion
  • Crossing device
  • Peripheral artery disease
  • Popliteal artery
  • Recanalization device
  • Stent
  • Superficial femoral artery

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Radiology Nuclear Medicine and imaging
  • Medicine(all)

Cite this

Endovascular treatment of infrainguinal chronic total occlusions using the truePath device : Features, handling, and 6-month outcomes. / Banerjee, Subhash; Sarode, Karan; Das, Thomas; Hadidi, Omar; Thomas, Rahul; Vinas, Ariel; Garg, Puja; Mohammad, Atif; Baig, Mirza S.; Shammas, Nicolas W.; Brilakis, Emmanouil S.

In: Journal of Endovascular Therapy, Vol. 21, No. 2, 2014, p. 281-288.

Research output: Contribution to journalArticle

Banerjee, Subhash ; Sarode, Karan ; Das, Thomas ; Hadidi, Omar ; Thomas, Rahul ; Vinas, Ariel ; Garg, Puja ; Mohammad, Atif ; Baig, Mirza S. ; Shammas, Nicolas W. ; Brilakis, Emmanouil S. / Endovascular treatment of infrainguinal chronic total occlusions using the truePath device : Features, handling, and 6-month outcomes. In: Journal of Endovascular Therapy. 2014 ; Vol. 21, No. 2. pp. 281-288.
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abstract = "Purpose: To report experience with a recently approved peripheral chronic total occlusion (CTO) crossing device in the superficial femoral (SFA), popliteal, and below-the-knee (BTK) arteries. Methods: Thirteen patients (all men; mean age 68.6±7.9 years) from the XLPAD registry (ClinicalTrials.gov identifier NCT01904851) were treated between April 2012 and August 2013 with the TruePath device after an unsuccessful guidewire crossing attempt. More than half of the patients had diabetes mellitus. Most lesions were TASC classification type C (n=5) or D (n=6), with mean lesion length 169.8±83.3 mm; 12 lesions were de novo and severely calcified. Procedure success was defined as successful revascularization of the CTO. Technical success was placement of a guidewire beyond the distal CTO cap into the true lumen without the need for a re-entry device. Results: All CTOs were successfully crossed using the TruePath, but 3 subintimal recanalizations required the use of a re-entry device (77{\%} technical success). Eight lesions were stented, while the remaining were treated with balloon angioplasty and/or atherectomy. Average fluoroscopy time was 41.1±18.3 minutes, during which a mean 200.0±46.2 mL of iodinated contrast were used (radiation dose area product 211.2±202.6 Gy*cm2). There were no periprocedural complications. Significant improvement was seen in the 6-month ankle-brachial index (p=0.018) and Rutherford class (p=0.019). The 6-month clinically indicated target vessel revascularization rate was 8{\%}. Conclusion: TruePath facilitated successful crossing of infrainguinal CTOs following an unsuccessful guidewire recanalization, with significant improvement in symptoms and no complications.",
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T2 - Features, handling, and 6-month outcomes

AU - Banerjee, Subhash

AU - Sarode, Karan

AU - Das, Thomas

AU - Hadidi, Omar

AU - Thomas, Rahul

AU - Vinas, Ariel

AU - Garg, Puja

AU - Mohammad, Atif

AU - Baig, Mirza S.

AU - Shammas, Nicolas W.

AU - Brilakis, Emmanouil S.

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N2 - Purpose: To report experience with a recently approved peripheral chronic total occlusion (CTO) crossing device in the superficial femoral (SFA), popliteal, and below-the-knee (BTK) arteries. Methods: Thirteen patients (all men; mean age 68.6±7.9 years) from the XLPAD registry (ClinicalTrials.gov identifier NCT01904851) were treated between April 2012 and August 2013 with the TruePath device after an unsuccessful guidewire crossing attempt. More than half of the patients had diabetes mellitus. Most lesions were TASC classification type C (n=5) or D (n=6), with mean lesion length 169.8±83.3 mm; 12 lesions were de novo and severely calcified. Procedure success was defined as successful revascularization of the CTO. Technical success was placement of a guidewire beyond the distal CTO cap into the true lumen without the need for a re-entry device. Results: All CTOs were successfully crossed using the TruePath, but 3 subintimal recanalizations required the use of a re-entry device (77% technical success). Eight lesions were stented, while the remaining were treated with balloon angioplasty and/or atherectomy. Average fluoroscopy time was 41.1±18.3 minutes, during which a mean 200.0±46.2 mL of iodinated contrast were used (radiation dose area product 211.2±202.6 Gy*cm2). There were no periprocedural complications. Significant improvement was seen in the 6-month ankle-brachial index (p=0.018) and Rutherford class (p=0.019). The 6-month clinically indicated target vessel revascularization rate was 8%. Conclusion: TruePath facilitated successful crossing of infrainguinal CTOs following an unsuccessful guidewire recanalization, with significant improvement in symptoms and no complications.

AB - Purpose: To report experience with a recently approved peripheral chronic total occlusion (CTO) crossing device in the superficial femoral (SFA), popliteal, and below-the-knee (BTK) arteries. Methods: Thirteen patients (all men; mean age 68.6±7.9 years) from the XLPAD registry (ClinicalTrials.gov identifier NCT01904851) were treated between April 2012 and August 2013 with the TruePath device after an unsuccessful guidewire crossing attempt. More than half of the patients had diabetes mellitus. Most lesions were TASC classification type C (n=5) or D (n=6), with mean lesion length 169.8±83.3 mm; 12 lesions were de novo and severely calcified. Procedure success was defined as successful revascularization of the CTO. Technical success was placement of a guidewire beyond the distal CTO cap into the true lumen without the need for a re-entry device. Results: All CTOs were successfully crossed using the TruePath, but 3 subintimal recanalizations required the use of a re-entry device (77% technical success). Eight lesions were stented, while the remaining were treated with balloon angioplasty and/or atherectomy. Average fluoroscopy time was 41.1±18.3 minutes, during which a mean 200.0±46.2 mL of iodinated contrast were used (radiation dose area product 211.2±202.6 Gy*cm2). There were no periprocedural complications. Significant improvement was seen in the 6-month ankle-brachial index (p=0.018) and Rutherford class (p=0.019). The 6-month clinically indicated target vessel revascularization rate was 8%. Conclusion: TruePath facilitated successful crossing of infrainguinal CTOs following an unsuccessful guidewire recanalization, with significant improvement in symptoms and no complications.

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KW - Chronic total occlusion

KW - Crossing device

KW - Peripheral artery disease

KW - Popliteal artery

KW - Recanalization device

KW - Stent

KW - Superficial femoral artery

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