Initial clinical experience with the 4-F self-expanding XPERT stent system for infrapopliteal treatment of patients with severe claudication and critical limb ischemia.
OBJECTIVE
To evaluate the primary success and short-term patency associated with a new 4-F sheath-compatible self-expanding nitinol stent after failed conventional angioplasty of distal popliteal and infrapopliteal lesions in severe lifestyle-limiting claudication (LLC) and chronic critical limb ischemia (CLI).


METHODS
Between May 2003 and July 2005, 35 patients with Rutherford category 3-5 disease (16 patients with CLI, 19 patients with LLC) underwent percutaneous transluminal angioplasty (PTA) and stent implantation. Indications for stent placement were residual stenosis, flow-limiting dissections, or elastic recoil after PTA. Before and after the intervention and during the 6-month follow-up, clinical investigation, color-flow and duplex Doppler ultrasonography, and digital subtraction angiography were performed. Technical success, primary patency at 6 months, clinical improvement as defined by Rutherford with clinical and hemodynamic measures, and complications were evaluated.


RESULTS
A total of 22 patients underwent distal popliteal artery stent placement and 13 underwent tibioperoneal artery stent placement. Stent implantation was successfully performed in all patients. After stent placement, the primary cumulative patency rate for the study group at 6 months was 82%. The mean resting ankle-brachial index at baseline was 0.50 +/- 0.16 and significantly increased to 0.90 +/- 0.17 at 12-24 hours after intervention and 0.82 +/- 0.24 at latest follow-up (P < .001 for both). The sustained clinical improvement rate was 80% at the 6-month follow-up. The 6-month limb salvage rate regarding major amputation was 100%. The rate of major complications was 17%.


CONCLUSIONS
Infrapopliteal application of the new nitinol stent is a safe, feasible, and effective method with good short-term patency rate in the treatment of severe LLC and chronic CLI.
Kickuth
Ralph
R
Department of Diagnostic, Inselspital, University of Berne, Freiburgstrasse 20, CH-3010 Berne, Switzerland.
Keo
Hong Hak
HH
Triller
Jürgen
J
Ludwig
Karin
K
Do
Dai-Do
DD
D000368:Aged; D000369:Aged, 80 and over; D000497:Alloys; D015901:Angiography, Digital Subtraction; D017130:Angioplasty; D000800:Angioplasty, Balloon / Q000009:adverse effects; D016638:Critical Illness; D005240:Feasibility Studies; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007383:Intermittent Claudication / Q000209:etiology* / Q000473:pathology / Q000503:physiopathology / Q000628:therapy; D007511:Ischemia / Q000209:etiology* / Q000473:pathology / Q000503:physiopathology / Q000628:therapy; D053208:Kaplan-Meier Estimate; D017078:Laser-Doppler Flowmetry; D023821:Limb Salvage; D035002:Lower Extremity / Q000098:blood supply*; D008297:Male; D008875:Middle Aged; D016491:Peripheral Vascular Diseases / Q000473:pathology / Q000503:physiopathology / Q000601:surgery / Q000628:therapy*; D011150:Popliteal Artery / Q000503:physiopathology; D011474:Prosthesis Design; D012189:Retrospective Studies; D012720:Severity of Illness Index; D015607:Stents; D016909:Tibial Arteries / Q000503:physiopathology; D013997:Time Factors; D017211:Treatment Failure; D016896:Treatment Outcome; D018615:Ultrasonography, Doppler, Color; D014654:Vascular Patency
D000497:Alloys; C013616:nitinol