Endovascular treatment of popliteal artery segments P1 and P2 in patients with critical limb ischemia: initial experience using a helical nitinol stent with increased radial force.
OBJECTIVE
To evaluate efficacy, safety, and midterm patency of a helical, self-expanding nitinol stent after failed percutaneous transluminal angioplasty (PTA) of popliteal artery segments P1 and P2 in patients with chronic critical limb ischemia (CLI) or lifestyle-limiting claudication.


METHODS
Between February 2009 and March 2011, 40 patients (23 men; mean age 77±10 years) classified as Rutherford category 3 (n = 10) or 4/5 (n = 30) underwent PTA of the proximal and mid popliteal artery followed by implantation of a SUPERA stent for elastic recoil, residual stenosis, or flow-limiting dissection. All patients had an elevated operative risk. Before and after the procedure and during the 12-month follow-up, a clinical investigation, ankle-brachial-index (ABI) measurement, and color-coded duplex sonography and/or digital subtraction angiography were performed. Primary endpoints were limb salvage and anatomical patency at 12 months.


RESULTS
Stent implantation was successful in all patients. The major complication rate was 7.5% (an access-site pseudoaneurysm, 2 retroperitoneal hematomas, and 1 death from retroperitoneal bleeding). Mean follow-up was 15.9 months (range 0.5-27.9). The mean baseline ABI of 0.37 significantly increased to 0.91 at 12 months (p<0.01). Three (7.5%) patients underwent bypass surgery owing to lack of clinical improvement (<0.10 improvement in ABI). Primary and secondary patency rates at 12 months in the 34 patients eligible for follow-up were 68.4% and 79.8%, respectively. The major amputation rate was 5% at 1 year. Five (12.5%) in-stent stenoses and 1 of 2 (5.0%) in-stent occlusions were successfully recanalized (the second occlusion was asymptomatic).


CONCLUSIONS
Implantation of this helical stent into segments of the popliteal artery at the knee joint in CLI patients is a safe and clinically effective bailout method with acceptable intermediate patency.
Institute of Radiology, University of Würzburg, Germany. Goltz@roentgen.uni-wuerzburg.de
Jan P
JP
Goltz
Christian O
CO
Ritter
Richard
R
Kellersmann
Detlef
D
Klein
Dietbert
D
Hahn
Ralph
R
Kickuth
D000368:Aged; D000369:Aged, 80 and over; D000497:Alloys; D015901:Angiography, Digital Subtraction; D000800:Angioplasty, Balloon / Q000009:adverse effects / Q000295:instrumentation*; D055109:Ankle Brachial Index; D001157:Arterial Occlusive Diseases / Q000150:complications / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy*; D003251:Constriction, Pathologic; D016638:Critical Illness; D005260:Female; D005858:Germany; D006801:Humans; D007383:Intermittent Claudication / Q000175:diagnosis / Q000209:etiology / Q000503:physiopathology / Q000628:therapy*; D007511:Ischemia / Q000175:diagnosis / Q000209:etiology / Q000503:physiopathology / Q000628:therapy*; D053208:Kaplan-Meier Estimate; D023821:Limb Salvage; D035002:Lower Extremity / Q000098:blood supply*; D018810:Magnetic Resonance Angiography; D008297:Male; D008875:Middle Aged; D011150:Popliteal Artery / Q000000981:diagnostic imaging / Q000503:physiopathology; D011474:Prosthesis Design; D012189:Retrospective Studies; D018570:Risk Assessment; D012307:Risk Factors; D015607:Stents; D013997:Time Factors; D016896:Treatment Outcome; D018615:Ultrasonography, Doppler, Color; D014654:Vascular Patency
D000497:Alloys; C013616:nitinol