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[First experiences with a 6F-sheath compatible self-expanding nitinol stent].

T Zeller1, U Frank, C Müller

  • 1Sektion klinische und interventionelle Angiologie, Herz-Zentrum Bad Krozingen, Germany. thomas.zeller@herzzentrum.de

Rofo : Fortschritte Auf Dem Gebiete Der Rontgenstrahlen Und Der Nuklearmedizin
|March 19, 2002
PubMed
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The new Dynalink nitinol stent demonstrated high flexibility and radial force in treating peripheral artery disease. This 6F-compatible device significantly improved patient outcomes, reducing stenosis and enhancing ankle-brachial index.

Area of Science:

  • Vascular Surgery
  • Interventional Cardiology
  • Biomaterials Engineering

Background:

  • Peripheral artery disease (PAD) necessitates effective endovascular treatments.
  • Nitinol stents offer unique mechanical properties for vascular repair.
  • A new 6F-compatible nitinol stent (Dynalink™) was developed to address limitations of existing devices.

Purpose of the Study:

  • To evaluate the efficacy, safety, and limitations of the Dynalink™ nitinol stent.
  • To assess the performance of the 6F-compatible stent in various peripheral arterial and venous lesions.
  • To determine the clinical impact of the Dynalink™ stent on patient outcomes and Rutherford classification.

Main Methods:

  • A prospective study involving 50 patients (33 men, 17 women; mean age 72 ± 8 years).

Related Experiment Videos

  • Implantation of 80 Dynalink™ stents into 75 vessels, including iliac, femoral, popliteal arteries, femoro-popliteal bypass, and subclavian vein.
  • Pre-interventional Rutherford classifications ranged from Class 1 to 5, with 40% ipsilateral and 60% cross-over stent placements.

    • Main Results:

    • Successful interventions were achieved in all cases, irrespective of challenging lesion access.
    • The Dynalink™ stent exhibited high flexibility and radial force without significant shortening.
    • Mean diameter stenosis decreased from 91% ± 10% to 4% ± 8%, and the ankle-brachial index improved from 0.46 ± 0.22 to 0.75 ± 0.23 (p < 0.001).
    • Post-intervention, 81% of patients improved to Rutherford Class 0.

    Conclusions:

    • The Dynalink™ 6F-compatible nitinol stent offers favorable flexibility and radial force with no shortening.
    • Its 6F diameter may reduce bleeding complications and allow use of 6F sealing devices.
    • Limitations include a 0.018-inch guidewire lumen and restricted stent size availability.