Background: To evaluate the efficacy, safety and limitation of a new 6F-compatible nitinol stent (Dynalink(TM).
Material and methods: We treated 50 patients (17 women, 33 men, mean age 72 +/- 8 years) by implanting 80 Dynalink(TM)-stents into 75 vessels during a 6-month period. Target lesions were: iliac artery: 25, femoral artery: 31, popliteal artery: 16, femoro-popliteal bypass: 5, subclavian vein: 3. Preinterventional Rutherford classifications: Class 1 : 3 legs (5 %), class 2 : 27 legs (51 %), class 3 : 16 legs (31 %), class 4 : 2 legs (4 %), class 5 : 5 legs (9 %). 40 % stents each were implanted ipsilateral, 60 % cross-over.
Results: All interventions were successful regardless of a sometimes anatomically difficult access to the lesion. The device was characterised by a high flexibility and radial force and the stent did not shorten.
Complications: One distal stent dislocation during placement occurred, no puncture site complication. The mean diameter stenosis was reduced from 91 +/- 10 % (75 - 100 %) to 4 +/- 8 % (0 - 30 %). The ankle-brachial index was improved from 0.46 +/- 0.22 to 0.75 +/- 0.23 (p < 0.001). Post-interventional Rutherford classifications: Class 0 : 43 legs (81 %), class 1 : 5 legs (4,5 %), class 5 : 5 legs (4,5 %).
Conclusions: The new 6F-sheath compatible nitinol stent is characterised by a good flexibility, radial force, and a lack of shortening. By the reduction of the diameter of the device to 6F, the potential risk of a local bleeding complication may be reduced and 6F sealing devices will be usable. Disadvantages are the 0.018 inch guide-wire lumen and the limited stent sizes.