Excimer laser with adjunctive balloon angioplasty and heparin-coated self-expanding stent grafts for the treatment of femoropopliteal artery in-stent restenosis: Twelve-Month Results from the SALVAGE Study

John R. Laird, Khung Keong Yeo, Krishna Rocha-Singh, Tony Das, James Joye, Eric Dippel, Bhagat Reddy, Charles Botti, Michael R. Jaff

Research output: Contribution to journalArticle

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Abstract

Objectives The aim of the study is to evaluate the safety and effectiveness of treating femoropopliteal in-stent restenosis (ISR) with debulking with excimer laser followed by implantation of a VIABAHN endoprosthesis. Background The optimal treatment strategy for femoropopliteal ISR is unclear. Methods The SALVAGE study is a multicenter prospective registry involving nine US centers. Patients with femoropopliteal ISR with moderate to severe intermittent claudication or critical limb ischemia (Rutherford categories 2-5) and an ankle-brachial index (ABI) =0.8 were treated with excimer laser and the VIABAHN endoprosthesis. The primary efficacy endpoint is primary patency at 12 months as measured by duplex ultrasonography. The primary safety endpoint is the major adverse event (MAE) rate at 30 days. Results Twenty-seven patients were enrolled. The mean lesion length was 20.7 ± 10.3 cm. The majority of lesions were TASC (TASC I) C and D (81.4%). All lesions were pretreated with excimer laser and percutaneous transluminal angioplasty (PTA) prior to VIABAHN implantation. Technical success was achieved in 100% of cases. There were no MAE at 30 days. Primary patency at 12 months was 48%. The ankle brachial index increased from 0.58 ± 0.24 at baseline to 0.90 ± 0.17 at 12 months. There was improvement in all quality-of-life parameters. The 12-month TLR rate was 17.4%. Conclusions The strategy of excimer laser atherectomy and PTA followed by implantation of a self-expanding stent graft for the treatment of femoropopliteal ISR is safe and associated with high procedural success. Primary patency rate at 12-months was suboptimal; however, the TLR rate was low. © 2012 Wiley Periodicals, Inc.

Original languageEnglish (US)
Pages (from-to)852-859
Number of pages8
JournalCatheterization and Cardiovascular Interventions
Volume80
Issue number5
DOIs
StatePublished - Nov 1 2012

Fingerprint

Excimer Lasers
Balloon Angioplasty
Stents
Heparin
Arteries
Transplants
Ankle Brachial Index
Angioplasty
Atherectomy
Therapeutics
Safety
Intermittent Claudication
Registries
Ultrasonography
Ischemia
Extremities
Quality of Life

Keywords

  • angioplasty
  • arteriolosclerosis
  • atherosclerosis
  • balloon
  • laser-assisted
  • peripheral arterial disease

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Radiology Nuclear Medicine and imaging

Cite this

Excimer laser with adjunctive balloon angioplasty and heparin-coated self-expanding stent grafts for the treatment of femoropopliteal artery in-stent restenosis : Twelve-Month Results from the SALVAGE Study. / Laird, John R.; Yeo, Khung Keong; Rocha-Singh, Krishna; Das, Tony; Joye, James; Dippel, Eric; Reddy, Bhagat; Botti, Charles; Jaff, Michael R.

In: Catheterization and Cardiovascular Interventions, Vol. 80, No. 5, 01.11.2012, p. 852-859.

Research output: Contribution to journalArticle

Laird, John R. ; Yeo, Khung Keong ; Rocha-Singh, Krishna ; Das, Tony ; Joye, James ; Dippel, Eric ; Reddy, Bhagat ; Botti, Charles ; Jaff, Michael R. / Excimer laser with adjunctive balloon angioplasty and heparin-coated self-expanding stent grafts for the treatment of femoropopliteal artery in-stent restenosis : Twelve-Month Results from the SALVAGE Study. In: Catheterization and Cardiovascular Interventions. 2012 ; Vol. 80, No. 5. pp. 852-859.
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abstract = "Objectives The aim of the study is to evaluate the safety and effectiveness of treating femoropopliteal in-stent restenosis (ISR) with debulking with excimer laser followed by implantation of a VIABAHN endoprosthesis. Background The optimal treatment strategy for femoropopliteal ISR is unclear. Methods The SALVAGE study is a multicenter prospective registry involving nine US centers. Patients with femoropopliteal ISR with moderate to severe intermittent claudication or critical limb ischemia (Rutherford categories 2-5) and an ankle-brachial index (ABI) =0.8 were treated with excimer laser and the VIABAHN endoprosthesis. The primary efficacy endpoint is primary patency at 12 months as measured by duplex ultrasonography. The primary safety endpoint is the major adverse event (MAE) rate at 30 days. Results Twenty-seven patients were enrolled. The mean lesion length was 20.7 ± 10.3 cm. The majority of lesions were TASC (TASC I) C and D (81.4{\%}). All lesions were pretreated with excimer laser and percutaneous transluminal angioplasty (PTA) prior to VIABAHN implantation. Technical success was achieved in 100{\%} of cases. There were no MAE at 30 days. Primary patency at 12 months was 48{\%}. The ankle brachial index increased from 0.58 ± 0.24 at baseline to 0.90 ± 0.17 at 12 months. There was improvement in all quality-of-life parameters. The 12-month TLR rate was 17.4{\%}. Conclusions The strategy of excimer laser atherectomy and PTA followed by implantation of a self-expanding stent graft for the treatment of femoropopliteal ISR is safe and associated with high procedural success. Primary patency rate at 12-months was suboptimal; however, the TLR rate was low. {\circledC} 2012 Wiley Periodicals, Inc.",
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T1 - Excimer laser with adjunctive balloon angioplasty and heparin-coated self-expanding stent grafts for the treatment of femoropopliteal artery in-stent restenosis

T2 - Twelve-Month Results from the SALVAGE Study

AU - Laird, John R.

AU - Yeo, Khung Keong

AU - Rocha-Singh, Krishna

AU - Das, Tony

AU - Joye, James

AU - Dippel, Eric

AU - Reddy, Bhagat

AU - Botti, Charles

AU - Jaff, Michael R.

PY - 2012/11/1

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N2 - Objectives The aim of the study is to evaluate the safety and effectiveness of treating femoropopliteal in-stent restenosis (ISR) with debulking with excimer laser followed by implantation of a VIABAHN endoprosthesis. Background The optimal treatment strategy for femoropopliteal ISR is unclear. Methods The SALVAGE study is a multicenter prospective registry involving nine US centers. Patients with femoropopliteal ISR with moderate to severe intermittent claudication or critical limb ischemia (Rutherford categories 2-5) and an ankle-brachial index (ABI) =0.8 were treated with excimer laser and the VIABAHN endoprosthesis. The primary efficacy endpoint is primary patency at 12 months as measured by duplex ultrasonography. The primary safety endpoint is the major adverse event (MAE) rate at 30 days. Results Twenty-seven patients were enrolled. The mean lesion length was 20.7 ± 10.3 cm. The majority of lesions were TASC (TASC I) C and D (81.4%). All lesions were pretreated with excimer laser and percutaneous transluminal angioplasty (PTA) prior to VIABAHN implantation. Technical success was achieved in 100% of cases. There were no MAE at 30 days. Primary patency at 12 months was 48%. The ankle brachial index increased from 0.58 ± 0.24 at baseline to 0.90 ± 0.17 at 12 months. There was improvement in all quality-of-life parameters. The 12-month TLR rate was 17.4%. Conclusions The strategy of excimer laser atherectomy and PTA followed by implantation of a self-expanding stent graft for the treatment of femoropopliteal ISR is safe and associated with high procedural success. Primary patency rate at 12-months was suboptimal; however, the TLR rate was low. © 2012 Wiley Periodicals, Inc.

AB - Objectives The aim of the study is to evaluate the safety and effectiveness of treating femoropopliteal in-stent restenosis (ISR) with debulking with excimer laser followed by implantation of a VIABAHN endoprosthesis. Background The optimal treatment strategy for femoropopliteal ISR is unclear. Methods The SALVAGE study is a multicenter prospective registry involving nine US centers. Patients with femoropopliteal ISR with moderate to severe intermittent claudication or critical limb ischemia (Rutherford categories 2-5) and an ankle-brachial index (ABI) =0.8 were treated with excimer laser and the VIABAHN endoprosthesis. The primary efficacy endpoint is primary patency at 12 months as measured by duplex ultrasonography. The primary safety endpoint is the major adverse event (MAE) rate at 30 days. Results Twenty-seven patients were enrolled. The mean lesion length was 20.7 ± 10.3 cm. The majority of lesions were TASC (TASC I) C and D (81.4%). All lesions were pretreated with excimer laser and percutaneous transluminal angioplasty (PTA) prior to VIABAHN implantation. Technical success was achieved in 100% of cases. There were no MAE at 30 days. Primary patency at 12 months was 48%. The ankle brachial index increased from 0.58 ± 0.24 at baseline to 0.90 ± 0.17 at 12 months. There was improvement in all quality-of-life parameters. The 12-month TLR rate was 17.4%. Conclusions The strategy of excimer laser atherectomy and PTA followed by implantation of a self-expanding stent graft for the treatment of femoropopliteal ISR is safe and associated with high procedural success. Primary patency rate at 12-months was suboptimal; however, the TLR rate was low. © 2012 Wiley Periodicals, Inc.

KW - angioplasty

KW - arteriolosclerosis

KW - atherosclerosis

KW - balloon

KW - laser-assisted

KW - peripheral arterial disease

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