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Use of a New Hybrid Heparin-Bonded Nitinol Ring Stent in the Popliteal Artery: Procedural and Mid-term Clinical and Anatomical Outcomes

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Abstract

Purpose

To report the immediate and mid-term clinical and anatomical outcomes of a novel, hybrid, heparin-bonded, nitinol ring stent (TIGRIS; Gore Medical) when used for the treatment of lesions located in the popliteal artery.

Materials and Methods

This was a prospective single-centre registry. Patients eligible for inclusion were individuals suffering from symptomatic popliteal arterial occlusive disease (Rutherford–Becker stage 3–6; P1–P3 segments) and treated with placement of the TIGRIS stent(s). Patients were prospectively scheduled for clinical review and duplex ultrasound follow-up after 6 and 12 months. Outcome measures included immediate technical success, primary vessel patency, in-stent binary restenosis (evaluable by Duplex at 50 % threshold; PSVR > 2.0), freedom from target lesion revascularization (TLR) and amputation-free survival (AFS) estimated by Kaplan–Meier (K–M) survival analysis. Cox proportional-hazards regression analysis was also performed to adjust for confounders and search for independent predictors of outcomes.

Results

From August 2012 to March 2014, a total of 54 popliteal TIGRIS stents were implanted in 50 limbs of 48 patients (27 men and 21 women; mean age 76.0 ± 1.7 years). Median Rutherford–Becker stage was five at baseline and 37/50 (74.0 %) were chronic total occlusions. Technical success was achieved in all cases (100 %). Stented lesion length was 114.2 ± 36.9 mm (range 6–20 cm). Median follow-up was 11.8 ± 0.8 months. After 12 months, primary patency of the TIGRIS stent was 69.5 ± 10.2 % with an 86.1 ± 5.9 % freedom from TLR and 87 ± 5.0 % AFS (K–M estimates).

Conclusion

The TIGRIS hybrid heparin-bonded nitinol ring stent is a safe and effective endovascular option for complex occlusive disease of the popliteal artery.

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Acknowledgments

None.

Conflicts of interest

Dr. A. Parthipun, Dr. A. Diamantopoulos, Dr. P. Kitrou, Dr. S. Padayachee, Dr. Karunanithy, Dr. I. Ahmed and Mr. H. Zayed have no conflicts of interest to report. Corresponding author Dr. K. Katsanos has received lectures’ honoraria and travel sponsorship in relationship to this work as well as research support by Gore Medical for a project unrelated to this work.

Informed Consent

Informed consent was obtained from all individual participants included in the study.

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    Authors and Affiliations

    1. Department of Interventional Radiology, Guy’s and St. Thomas’ Hospitals, NHS Foundation Trust, King’s Health Partners, London, SE1 7EH, UK

      Aneeta Parthipun, Athanasios Diamantopoulos, Panagiotis Kitrou, Narayan Karunanithy, Irfan Ahmed & Konstantinos Katsanos

    2. Department of Ultrasonic Angiology, Guy’s and St. Thomas’ Hospitals, NHS Foundation Trust, King’s Health Partners, London, SE1 7EH, UK

      Soundrie Padayachee

    3. Department of Vascular Surgery, Guy’s and St. Thomas’ Hospitals, NHS Foundation Trust, King’s Health Partners, London, SE1 7EH, UK

      Hany Zayed

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    1. Aneeta Parthipun
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    Correspondence to Konstantinos Katsanos.

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    Aneeta Parthipun and Athanasios Diamantopoulos have equal contribution in this work and both qualify for first authorship position.

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    Parthipun, A., Diamantopoulos, A., Kitrou, P. et al. Use of a New Hybrid Heparin-Bonded Nitinol Ring Stent in the Popliteal Artery: Procedural and Mid-term Clinical and Anatomical Outcomes. Cardiovasc Intervent Radiol 38, 846–854 (2015). https://doi.org/10.1007/s00270-015-1113-4

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