[First experiences with a 6F-sheath compatible self-expanding nitinol stent].
BACKGROUND
To evaluate the efficacy, safety and limitation of a new 6F-compatible nitinol stent (Dynalink(TM).


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.


RESULTS
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.
Zeller
T
T
Sektion klinische und interventionelle Angiologie, Herz-Zentrum Bad Krozingen, Germany. thomas.zeller@herzzentrum.de
Frank
U
U
Müller
C
C
Bürgelin
K H
KH
Sinn
L
L
Horn
B
B
Roskamm
H
H
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000497:Alloys; D000792:Angiography; D000800:Angioplasty, Balloon; D001157:Arterial Occlusive Diseases / Q000000981:diagnostic imaging / Q000628:therapy*; D005260:Female; D006801:Humans; D007866:Leg / Q000098:blood supply*; D008297:Male; D008875:Middle Aged; D015607:Stents / Q000009:adverse effects
D000497:Alloys; C013616:nitinol