Reline using the GORE® VIABAHN® Endoprosthesis as first line therapy when treating complex in-stent restenosis (ISR)

Before: Angiogram shows femoral atherectomy

Challenge

  • In 2007 (age 72) the patient presented with claudication requiring superficial femoral artery (SFA) cryoplasty
  • Over an 11-year period the patient received multiple reinterventions:
    • Less than three months after initial treatment — Symptoms returned. Patient was treated with laser atherectomy at adductor hiatus and a 7 x 100 mm self-expanding bare metal nitinol stent was placed.
    • 2011 — Recurrent symptoms due to ISR treated with laser atherectomy and plain old balloon angioplasty (POBA)
    • 2012 — Repeat laser atherectomy and POBA
    • 2015 — Debilitating dyspnea and return of distal disease based on drop of ankle-brachial index and elevated duplex velocity with Ratio > 2; No peripheral intervention undertaken as limb ischemia was less symptomatic than coronary disease
    • 2018 (age 83) — Successful transcatheter aortic valve replacement and alleviation of dyspnea. Patient re-presented with significant short distance claudication with inability to complete cardiac rehab; ISR with peak systolic velocity > 400 cm / s

Image courtesy of Benjamin J. Pearce, MD. Used with permission.

Angiogram

Procedure

  • Due to multiple attempts at prior atherectomy and POBA, procedure entered with intent to reline the bare metal stents (BMS) with the GORE® VIABAHN® Endoprosthesis
  • Contralateral access gained to perform aortogram and rule out inflow / outflow disease
  • A 6 Fr TERUMO® DESTINATION® Guiding Sheath placed after anticoagulation
  • Angio confirmed ISR with two vessel runoff via large anterior tibial and peroneal arteries and some proximal progression of SFA disease
  • Crossed with 0.035” SPECTRANETICS QUICK-CROSS® Support Catheter and TERUMO® GLIDEWIRE® Guidewire
  • A 7 mm MEDTRONIC SPIDERFX Embolic Protection Device placed through SPECTRANETICS QUICK-CROSS® Support Catheter
  • Pre-treated with a 5 x 100 mm POBA including new disease proximal to old stent
  • First deployed a 6 mm x 15 cm GORE® VIABAHN® Endoprosthesis and then overlapped with a 6 mm x 10 cm GORE® VIABAHN® Endoprosthesis

Image courtesy of Benjamin J. Pearce, MD. Used with permission.

Angiogram showing result

Result

  • Completion with no significant residual stenosis and no embolization of runoff
  • Due to age and travel, the patient was kept overnight and discharged the next morning with palpable dorsalis pedis pulse

Image courtesy of Benjamin J. Pearce, MD. Used with permission.

Case takeaways

For any complex SFA ISR, relining with covered stent grafts has become a “go to” procedure as first line therapy. The Gore RELINE Clinical Study with the GORE® VIABAHN® Endoprosthesis showed high primary patency even in the most challenging disease: 75% 12-month primary patency with an average lesion length of over 17 cm.1 In this ISR disease case, relining the BMS with a GORE® VIABAHN® Endoprosthesis produced a favorable outcome and successfully excluded the neointimal hyperplasia associated with ISR of the BMS.

TERUMO, DESTINATION and GLIDEWIRE are trademarks of Terumo Medical Corporation.
SPECTRANETICS and QUICK-CROSS are trademarks of Spectranetics Corp.
MEDTRONIC and SPIDERFX are trademarks of Medtronic, Inc.

The outcomes and observations reported are based on individual case experience and the patients treated. The steps described here may not be complete, and are not intended to be a replacement for the Instructions for Use or the education, training and professional judgment of Healthcare Providers. Healthcare Providers remain solely responsible for making decisions about patient care and the use of medical technologies.

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1. Bosiers M, Deloose K, Callaert J, et al. Superiority of stent-grafts for in-stent restenosis in the superficial femoral artery: twelve-month results from a multicenter randomized trial. Journal of Endovascular Therapy 2015;22(1):1-10.

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