Randomized control study of the outback LTD reentry catheter versus manual reentry for the treatment of chronic total occlusions in the superficial femoral artery

Authors

  • Roberto Gandini MD,

    Corresponding author
    • Department of Diagnostic Imaging, University Hospital Tor Vergata, Molecular Imaging, Interventional Radiology and Radiation Therapy, Rome, Italy
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  • Sebastiano Fabiano MD,

    1. Department of Diagnostic Imaging, University Hospital Tor Vergata, Molecular Imaging, Interventional Radiology and Radiation Therapy, Rome, Italy
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  • Sergio Spano MD,

    1. Department of Diagnostic Imaging, University Hospital Tor Vergata, Molecular Imaging, Interventional Radiology and Radiation Therapy, Rome, Italy
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  • Tommaso Volpi MD,

    1. Department of Diagnostic Imaging, University Hospital Tor Vergata, Molecular Imaging, Interventional Radiology and Radiation Therapy, Rome, Italy
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  • Daniele Morosetti MD,

    1. Department of Diagnostic Imaging, University Hospital Tor Vergata, Molecular Imaging, Interventional Radiology and Radiation Therapy, Rome, Italy
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  • Antonio Chiaravalloti MD,

    1. Department of Diagnostic Imaging, University Hospital Tor Vergata, Molecular Imaging, Interventional Radiology and Radiation Therapy, Rome, Italy
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  • Giovanni Nano MD,

    1. Department of Diagnostic Imaging, University Hospital Tor Vergata, Molecular Imaging, Interventional Radiology and Radiation Therapy, Rome, Italy
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  • Giovanni Simonetti MD

    1. Department of Diagnostic Imaging, University Hospital Tor Vergata, Molecular Imaging, Interventional Radiology and Radiation Therapy, Rome, Italy
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  • Conflict of interest: Nothing to report.

Correspondence to: Roberto Gandini, MD Department of Diagnostic Imaging, University Hospital Tor Vergata, Molecular Imaging, Interventional Radiology and Radiation Therapy, Viale Oxford, 81 – 00133, Rome, Italy. E-mail: radiologiainterventistica@hotmail.it

Abstract

Purpose

To assess the efficacy and safety of the Outback device in patients with a chronic total occlusion (CTO) of the superficial femoral artery and evaluate its impact on fluoroscopy and procedural times.

Materials and methods

From October 2006 to March 2007, 52 patients affected by TASC II-D superficial femoral artery CTO were treated with subintimal recanalization. Clinical indications for endovascular recanalization were: claudication, tissue loss, and at rest leg pain with critical limb ischemia. In 26 patients the manual reentry technique was used and in 26 the OUTBACK®LTD Re-Entry Catheter was used. Total procedure time, fluoroscopy time and precision in targeting the expected reentry site have been compared.

Results

Technical success was achieved in all cases (100%). In group 2, the planned in-target re-entry was achieved in 11/26 cases (42.3%). The procedure was performed with a traditional antegrade approach in 23/26 (88.4%) cases and in three cases (11.6%) a combined antegrade/retrograde approach was necessary. In group 1, the in-target re-entry was achieved in 26/26 cases (100%). In group 2, the mean procedural time was 55.4 ± 14.2 min with a mean fluoroscopy time 39.6 ± 13.9 min compared to 36.0 ± 9.4 min and 29.8 ± 8.9 min, respectively, of group 1 (P < 0.0001).

Conclusions

In our experience, the use of this device is very useful for the revascularization of chronic femoral occlusions, even calcific, in which an accurate re-entry cannot be achieved with the conventional subintimal technique. In these cases, the Outback device grants high technical success rates and a significant reduction of procedural and fluoroscopy times. © 2013 Wiley Periodicals, Inc.

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