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

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).
• 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.