Lower Extremity Revascularization Using Optical Coherence Tomography-Guided Directional Atherectomy

Final Results of the e v aluat i on of the Pantheri S Opt i cal C O herence Tomography Imagi N g Atherectomy System for Use in the Peripheral Vasculature (VISION) Study

Arne G. Schwindt, J. Gray Bennett, William H. Crowder, Suhail Dohad, Sean F. Janzer, Jon C. George, Barry Tedder, Thomas P. Davis, Ian M. Cawich, Roger S. Gammon, Patrick E. Muck, John P. Pigott, Dwight A. Dishmon, Lou A. Lopez, Jaafer A. Golzar, Jack R. Chamberlin, Michael J Moulton, Ramzan M. Zakir, Amir K. Kaki, Gary J. Fishbein & 4 others Huey B. McDaniel, Ayala Hezi-Yamit, John B. Simpson, Arjun Desai

Research output: Contribution to journalArticle

8 Citations (Scopus)

Abstract

Purpose: To evaluate the safety and efficacy of a novel optical coherence tomography (OCT)-guided atherectomy catheter in treating patients with symptomatic femoropopliteal disease. Methods: The VISION trial (ClinicalTrials.gov identifier NCT01937351) was a single-arm, multicenter, global investigational device exemption study enrolling 158 subjects (mean age 67.2±10.5 years; 87 men) across 20 participating sites. In this cohort, 198 lesions were treated with an average length of 53±40 mm using the Pantheris catheter alone or Pantheris + adjunctive therapy. The primary safety endpoint was the composite of major adverse events (MAEs) through 6 months (objective performance goal 43.2%). Technical success (primary efficacy outcome) was defined as the percent of target lesions with a residual diameter stenosis ≤50% after treatment with the Pantheris device alone (objective performance goal 87.0%). Procedural success was defined as reduction in stenosis to ≤30% after Pantheris ± adjunctive therapy. Tissue specimens retrieved from each treated lesion were histologically analyzed to evaluate the accuracy and precision of OCT image guidance. Results: The primary efficacy outcome was achieved in 192 (97.0%) of the 198 lesions treated with the Pantheris catheter. Across all lesions, mean diameter stenosis was reduced from 78.7%±15.1% at baseline to 30.3%±11.8% after Pantheris alone (p<0.001) and to 22.4%±9.9% after Pantheris ± adjunctive therapy (p<0.001). Of the 198 target lesions, 104 (52.5%) were treated with the Pantheris alone, 84 (42.4%) were treated with Pantheris + adjunctive angioplasty, and 10 (5.1%) with Pantheris + angioplasty + stenting. The composite MAE outcome through 6 months occurred in 25 (16.6%) of 151 subjects. There were no clinically significant perforations, 1 (0.5%) catheter-related dissection, 4 (2%) embolic events, and a 6.4% clinically driven target lesion revascularization rate at 6 months. The 40-lesion chronic total occlusion (CTO) subset (mean lesion length 82±38 mm) achieved a similar significant reduction in stenosis to 35.5%±13.6% after Pantheris alone (p<0.001). Histological analysis of atherectomy specimens confirmed <1% adventitia in 82.1% of the samples, highlighting the precision of OCT guidance. Characterization of the OCT-guided lesions revealed evidence of an underestimation of disease burden when using fluoroscopy. Conclusion: OCT-guided atherectomy for femoropopliteal disease is safe and effective. Additionally, the precision afforded by OCT guidance leads to greater removal of plaque during atherectomy while sparing the adventitia.

Original languageEnglish (US)
Pages (from-to)355-366
Number of pages12
JournalJournal of Endovascular Therapy
Volume24
Issue number3
DOIs
StatePublished - Jun 1 2017

Fingerprint

Atherectomy
Optical Coherence Tomography
Lower Extremity
Tomography
Pathologic Constriction
Catheters
Adventitia
Angioplasty
Safety
Equipment and Supplies
Fluoroscopy
Therapeutics
Dissection

Keywords

  • adventitia
  • angioplasty
  • atherectomy
  • femoropopliteal segment
  • guidance
  • histology
  • occlusion
  • optical coherence tomography
  • peripheral vascular disease
  • plaque
  • stenosis
  • stent
  • target lesion revascularization

ASJC Scopus subject areas

  • Surgery
  • Radiology Nuclear Medicine and imaging
  • Cardiology and Cardiovascular Medicine

Cite this

Lower Extremity Revascularization Using Optical Coherence Tomography-Guided Directional Atherectomy : Final Results of the e v aluat i on of the Pantheri S Opt i cal C O herence Tomography Imagi N g Atherectomy System for Use in the Peripheral Vasculature (VISION) Study. / Schwindt, Arne G.; Bennett, J. Gray; Crowder, William H.; Dohad, Suhail; Janzer, Sean F.; George, Jon C.; Tedder, Barry; Davis, Thomas P.; Cawich, Ian M.; Gammon, Roger S.; Muck, Patrick E.; Pigott, John P.; Dishmon, Dwight A.; Lopez, Lou A.; Golzar, Jaafer A.; Chamberlin, Jack R.; Moulton, Michael J; Zakir, Ramzan M.; Kaki, Amir K.; Fishbein, Gary J.; McDaniel, Huey B.; Hezi-Yamit, Ayala; Simpson, John B.; Desai, Arjun.

In: Journal of Endovascular Therapy, Vol. 24, No. 3, 01.06.2017, p. 355-366.

Research output: Contribution to journalArticle

Schwindt, AG, Bennett, JG, Crowder, WH, Dohad, S, Janzer, SF, George, JC, Tedder, B, Davis, TP, Cawich, IM, Gammon, RS, Muck, PE, Pigott, JP, Dishmon, DA, Lopez, LA, Golzar, JA, Chamberlin, JR, Moulton, MJ, Zakir, RM, Kaki, AK, Fishbein, GJ, McDaniel, HB, Hezi-Yamit, A, Simpson, JB & Desai, A 2017, 'Lower Extremity Revascularization Using Optical Coherence Tomography-Guided Directional Atherectomy: Final Results of the e v aluat i on of the Pantheri S Opt i cal C O herence Tomography Imagi N g Atherectomy System for Use in the Peripheral Vasculature (VISION) Study', Journal of Endovascular Therapy, vol. 24, no. 3, pp. 355-366. https://doi.org/10.1177/1526602817701720
Schwindt, Arne G. ; Bennett, J. Gray ; Crowder, William H. ; Dohad, Suhail ; Janzer, Sean F. ; George, Jon C. ; Tedder, Barry ; Davis, Thomas P. ; Cawich, Ian M. ; Gammon, Roger S. ; Muck, Patrick E. ; Pigott, John P. ; Dishmon, Dwight A. ; Lopez, Lou A. ; Golzar, Jaafer A. ; Chamberlin, Jack R. ; Moulton, Michael J ; Zakir, Ramzan M. ; Kaki, Amir K. ; Fishbein, Gary J. ; McDaniel, Huey B. ; Hezi-Yamit, Ayala ; Simpson, John B. ; Desai, Arjun. / Lower Extremity Revascularization Using Optical Coherence Tomography-Guided Directional Atherectomy : Final Results of the e v aluat i on of the Pantheri S Opt i cal C O herence Tomography Imagi N g Atherectomy System for Use in the Peripheral Vasculature (VISION) Study. In: Journal of Endovascular Therapy. 2017 ; Vol. 24, No. 3. pp. 355-366.
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title = "Lower Extremity Revascularization Using Optical Coherence Tomography-Guided Directional Atherectomy: Final Results of the e v aluat i on of the Pantheri S Opt i cal C O herence Tomography Imagi N g Atherectomy System for Use in the Peripheral Vasculature (VISION) Study",
abstract = "Purpose: To evaluate the safety and efficacy of a novel optical coherence tomography (OCT)-guided atherectomy catheter in treating patients with symptomatic femoropopliteal disease. Methods: The VISION trial (ClinicalTrials.gov identifier NCT01937351) was a single-arm, multicenter, global investigational device exemption study enrolling 158 subjects (mean age 67.2±10.5 years; 87 men) across 20 participating sites. In this cohort, 198 lesions were treated with an average length of 53±40 mm using the Pantheris catheter alone or Pantheris + adjunctive therapy. The primary safety endpoint was the composite of major adverse events (MAEs) through 6 months (objective performance goal 43.2{\%}). Technical success (primary efficacy outcome) was defined as the percent of target lesions with a residual diameter stenosis ≤50{\%} after treatment with the Pantheris device alone (objective performance goal 87.0{\%}). Procedural success was defined as reduction in stenosis to ≤30{\%} after Pantheris ± adjunctive therapy. Tissue specimens retrieved from each treated lesion were histologically analyzed to evaluate the accuracy and precision of OCT image guidance. Results: The primary efficacy outcome was achieved in 192 (97.0{\%}) of the 198 lesions treated with the Pantheris catheter. Across all lesions, mean diameter stenosis was reduced from 78.7{\%}±15.1{\%} at baseline to 30.3{\%}±11.8{\%} after Pantheris alone (p<0.001) and to 22.4{\%}±9.9{\%} after Pantheris ± adjunctive therapy (p<0.001). Of the 198 target lesions, 104 (52.5{\%}) were treated with the Pantheris alone, 84 (42.4{\%}) were treated with Pantheris + adjunctive angioplasty, and 10 (5.1{\%}) with Pantheris + angioplasty + stenting. The composite MAE outcome through 6 months occurred in 25 (16.6{\%}) of 151 subjects. There were no clinically significant perforations, 1 (0.5{\%}) catheter-related dissection, 4 (2{\%}) embolic events, and a 6.4{\%} clinically driven target lesion revascularization rate at 6 months. The 40-lesion chronic total occlusion (CTO) subset (mean lesion length 82±38 mm) achieved a similar significant reduction in stenosis to 35.5{\%}±13.6{\%} after Pantheris alone (p<0.001). Histological analysis of atherectomy specimens confirmed <1{\%} adventitia in 82.1{\%} of the samples, highlighting the precision of OCT guidance. Characterization of the OCT-guided lesions revealed evidence of an underestimation of disease burden when using fluoroscopy. Conclusion: OCT-guided atherectomy for femoropopliteal disease is safe and effective. Additionally, the precision afforded by OCT guidance leads to greater removal of plaque during atherectomy while sparing the adventitia.",
keywords = "adventitia, angioplasty, atherectomy, femoropopliteal segment, guidance, histology, occlusion, optical coherence tomography, peripheral vascular disease, plaque, stenosis, stent, target lesion revascularization",
author = "Schwindt, {Arne G.} and Bennett, {J. Gray} and Crowder, {William H.} and Suhail Dohad and Janzer, {Sean F.} and George, {Jon C.} and Barry Tedder and Davis, {Thomas P.} and Cawich, {Ian M.} and Gammon, {Roger S.} and Muck, {Patrick E.} and Pigott, {John P.} and Dishmon, {Dwight A.} and Lopez, {Lou A.} and Golzar, {Jaafer A.} and Chamberlin, {Jack R.} and Moulton, {Michael J} and Zakir, {Ramzan M.} and Kaki, {Amir K.} and Fishbein, {Gary J.} and McDaniel, {Huey B.} and Ayala Hezi-Yamit and Simpson, {John B.} and Arjun Desai",
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language = "English (US)",
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pages = "355--366",
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TY - JOUR

T1 - Lower Extremity Revascularization Using Optical Coherence Tomography-Guided Directional Atherectomy

T2 - Final Results of the e v aluat i on of the Pantheri S Opt i cal C O herence Tomography Imagi N g Atherectomy System for Use in the Peripheral Vasculature (VISION) Study

AU - Schwindt, Arne G.

AU - Bennett, J. Gray

AU - Crowder, William H.

AU - Dohad, Suhail

AU - Janzer, Sean F.

AU - George, Jon C.

AU - Tedder, Barry

AU - Davis, Thomas P.

AU - Cawich, Ian M.

AU - Gammon, Roger S.

AU - Muck, Patrick E.

AU - Pigott, John P.

AU - Dishmon, Dwight A.

AU - Lopez, Lou A.

AU - Golzar, Jaafer A.

AU - Chamberlin, Jack R.

AU - Moulton, Michael J

AU - Zakir, Ramzan M.

AU - Kaki, Amir K.

AU - Fishbein, Gary J.

AU - McDaniel, Huey B.

AU - Hezi-Yamit, Ayala

AU - Simpson, John B.

AU - Desai, Arjun

PY - 2017/6/1

Y1 - 2017/6/1

N2 - Purpose: To evaluate the safety and efficacy of a novel optical coherence tomography (OCT)-guided atherectomy catheter in treating patients with symptomatic femoropopliteal disease. Methods: The VISION trial (ClinicalTrials.gov identifier NCT01937351) was a single-arm, multicenter, global investigational device exemption study enrolling 158 subjects (mean age 67.2±10.5 years; 87 men) across 20 participating sites. In this cohort, 198 lesions were treated with an average length of 53±40 mm using the Pantheris catheter alone or Pantheris + adjunctive therapy. The primary safety endpoint was the composite of major adverse events (MAEs) through 6 months (objective performance goal 43.2%). Technical success (primary efficacy outcome) was defined as the percent of target lesions with a residual diameter stenosis ≤50% after treatment with the Pantheris device alone (objective performance goal 87.0%). Procedural success was defined as reduction in stenosis to ≤30% after Pantheris ± adjunctive therapy. Tissue specimens retrieved from each treated lesion were histologically analyzed to evaluate the accuracy and precision of OCT image guidance. Results: The primary efficacy outcome was achieved in 192 (97.0%) of the 198 lesions treated with the Pantheris catheter. Across all lesions, mean diameter stenosis was reduced from 78.7%±15.1% at baseline to 30.3%±11.8% after Pantheris alone (p<0.001) and to 22.4%±9.9% after Pantheris ± adjunctive therapy (p<0.001). Of the 198 target lesions, 104 (52.5%) were treated with the Pantheris alone, 84 (42.4%) were treated with Pantheris + adjunctive angioplasty, and 10 (5.1%) with Pantheris + angioplasty + stenting. The composite MAE outcome through 6 months occurred in 25 (16.6%) of 151 subjects. There were no clinically significant perforations, 1 (0.5%) catheter-related dissection, 4 (2%) embolic events, and a 6.4% clinically driven target lesion revascularization rate at 6 months. The 40-lesion chronic total occlusion (CTO) subset (mean lesion length 82±38 mm) achieved a similar significant reduction in stenosis to 35.5%±13.6% after Pantheris alone (p<0.001). Histological analysis of atherectomy specimens confirmed <1% adventitia in 82.1% of the samples, highlighting the precision of OCT guidance. Characterization of the OCT-guided lesions revealed evidence of an underestimation of disease burden when using fluoroscopy. Conclusion: OCT-guided atherectomy for femoropopliteal disease is safe and effective. Additionally, the precision afforded by OCT guidance leads to greater removal of plaque during atherectomy while sparing the adventitia.

AB - Purpose: To evaluate the safety and efficacy of a novel optical coherence tomography (OCT)-guided atherectomy catheter in treating patients with symptomatic femoropopliteal disease. Methods: The VISION trial (ClinicalTrials.gov identifier NCT01937351) was a single-arm, multicenter, global investigational device exemption study enrolling 158 subjects (mean age 67.2±10.5 years; 87 men) across 20 participating sites. In this cohort, 198 lesions were treated with an average length of 53±40 mm using the Pantheris catheter alone or Pantheris + adjunctive therapy. The primary safety endpoint was the composite of major adverse events (MAEs) through 6 months (objective performance goal 43.2%). Technical success (primary efficacy outcome) was defined as the percent of target lesions with a residual diameter stenosis ≤50% after treatment with the Pantheris device alone (objective performance goal 87.0%). Procedural success was defined as reduction in stenosis to ≤30% after Pantheris ± adjunctive therapy. Tissue specimens retrieved from each treated lesion were histologically analyzed to evaluate the accuracy and precision of OCT image guidance. Results: The primary efficacy outcome was achieved in 192 (97.0%) of the 198 lesions treated with the Pantheris catheter. Across all lesions, mean diameter stenosis was reduced from 78.7%±15.1% at baseline to 30.3%±11.8% after Pantheris alone (p<0.001) and to 22.4%±9.9% after Pantheris ± adjunctive therapy (p<0.001). Of the 198 target lesions, 104 (52.5%) were treated with the Pantheris alone, 84 (42.4%) were treated with Pantheris + adjunctive angioplasty, and 10 (5.1%) with Pantheris + angioplasty + stenting. The composite MAE outcome through 6 months occurred in 25 (16.6%) of 151 subjects. There were no clinically significant perforations, 1 (0.5%) catheter-related dissection, 4 (2%) embolic events, and a 6.4% clinically driven target lesion revascularization rate at 6 months. The 40-lesion chronic total occlusion (CTO) subset (mean lesion length 82±38 mm) achieved a similar significant reduction in stenosis to 35.5%±13.6% after Pantheris alone (p<0.001). Histological analysis of atherectomy specimens confirmed <1% adventitia in 82.1% of the samples, highlighting the precision of OCT guidance. Characterization of the OCT-guided lesions revealed evidence of an underestimation of disease burden when using fluoroscopy. Conclusion: OCT-guided atherectomy for femoropopliteal disease is safe and effective. Additionally, the precision afforded by OCT guidance leads to greater removal of plaque during atherectomy while sparing the adventitia.

KW - adventitia

KW - angioplasty

KW - atherectomy

KW - femoropopliteal segment

KW - guidance

KW - histology

KW - occlusion

KW - optical coherence tomography

KW - peripheral vascular disease

KW - plaque

KW - stenosis

KW - stent

KW - target lesion revascularization

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