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Safety, effectiveness and mid-term follow-up in 136 consecutive patients with moderate to severely calcified lesions

Sorin Giusca1, Michael Lichtenberg2, Melanie Schueler3

  • 1Cardiology and Vascular Medicine, GRN Hospital Weinheim, Weinheim, Germany.

Heart and Vessels
|September 11, 2020
PubMed

Insights

The Phoenix atherectomy device safely treats complex, calcified peripheral artery disease lesions. This study shows promising mid-term clinical success when combined with drug-coated balloons.

Area of Science:

  • Cardiovascular Medicine
  • Interventional Cardiology
  • Vascular Surgery

Background:

  • Peripheral artery disease (PAD) affects millions globally, often involving complex and calcified lesions.
  • Current treatment options for severe PAD can be limited, necessitating advanced therapeutic approaches.

Purpose of the Study:

  • To evaluate the safety and effectiveness of the Phoenix atherectomy device in treating complex and calcified lesions in patients with PAD.
  • To analyze clinical outcomes, including Rutherford class improvement, and procedural success rates.

Main Methods:

  • A prospective study of 136 consecutive patients with chronic PAD undergoing Phoenix atherectomy.
  • Lesions were classified by complexity (TASC) and calcification (PACSS).
  • Atherectomy was frequently combined with drug-coated balloon (DCB) angioplasty; bail-out stenting was noted.

Main Results:

  • 151 lesions were treated, with a majority classified as complex (TASC C/D) and significantly calcified (mean PACSS 3.3).
  • Technical and procedural success rates were high (75% and 99%, respectively).
  • Low rates of perforation (2%) and asymptomatic embolism (4%) were observed, with 83-100% clinical success in claudication and critical limb ischemia patients.

Conclusions:

  • Phoenix atherectomy, especially when combined with DCB angioplasty, is a safe and effective option for complex, calcified PAD lesions.
  • The procedure demonstrated promising mid-term clinical outcomes with a low need for bail-out stenting.
  • This approach offers a viable solution for patients with challenging PAD presentations.

Keywords:
ClaudicationCritical limb ischemiaDuplex sonographyLower limbRotational atherectomy

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