Incidence and clinical implications of stent fractures of the Xpert self-expanding nitinol stent in infrainguinal arteries

Vasa. 2009 Feb;38(1):47-52. doi: 10.1024/0301-1526.38.1.47.

Abstract

Background: Different stents in infrainguinal arteries have recently been associated with stent fractures and unfavorable clinical outcome, although data is limited regarding fractures of the Xpert selfexpanding nitinol stent. Thus, purpose of the present investigation was to evaluate its incidence and clinical implications in lower limb arteries.

Patients and methods: Fifty-three consecutive patients (53 limbs) with peripheral arterial disease underwent secondary Xpert stent implantation due to suboptimal primary balloon angioplasty (PTA). Median age was 76 years. Stent fractures were evaluated by plain X-ray at median follow-up of 16 months. Stent patency was assessed by duplex ultrasound and sustained clinical improvement was defined as improvement of the ABI of > or = 0.10 together with improvement of at least one Rutherford class above the baseline finding throughout follow-up.

Results: Median length of femoropopliteal and infrapopliteal lesion was 3.0 and 2.3 cm, respectively. Sixtyfive stents were implanted in 43 limbs with femoropopliteal and 10 stents in 10 limbs with infrapopliteal lesion, respectively. Stent fractures occurred in 3 of 43 limbs (7.0%) of patients with femoropopliteal lesion with stent-based fracture rate of 4.6%. All fractured stents showed multiple struts fractures and occurred in the distal and middle superficial femoral artery. No stent fracture was observed in infrapopliteal lesions. The fractured stents were not associated with any clinical deterioration. Sustained clinical improvement was 71.0% and 54.6% for femoropopliteal and infrapopliteal lesions, respectively. Stent patency assessed by duplex was 65.2 and 63.9% for femoropopliteal and infrapopliteal lesions, respectively.

Conclusions: Fractures of the Xpert stent were seldom and not associated with unfavorable clinical outcome at midterm follow-up.

MeSH terms

  • Aged
  • Aged, 80 and over
  • Alloys*
  • Angioplasty, Balloon / instrumentation*
  • Equipment Failure Analysis
  • Female
  • Femoral Artery* / diagnostic imaging
  • Femoral Artery* / physiopathology
  • Humans
  • Lower Extremity / blood supply*
  • Male
  • Middle Aged
  • Peripheral Vascular Diseases / diagnostic imaging
  • Peripheral Vascular Diseases / physiopathology
  • Peripheral Vascular Diseases / therapy*
  • Popliteal Artery* / diagnostic imaging
  • Popliteal Artery* / physiopathology
  • Prosthesis Design
  • Prosthesis Failure*
  • Radiography
  • Retrospective Studies
  • Stents*
  • Time Factors
  • Treatment Outcome
  • Ultrasonography, Doppler, Duplex
  • Vascular Patency

Substances

  • Alloys
  • nitinol