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

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Abstract

To investigate the safety and effectiveness of the Phoenix atherectomy device for the treatment of complex and calcified lesions in patients with peripheral artery disease (PAD). 136 consecutive all-comer patients with chronic PAD underwent Phoenix atherectomy. Safety in terms of vessel injury and embolism, efficacy and clinical success in terms of ≥ 1Rutherford class (RF) improvement during follow-up were systematically analyzed. Lesion calcification was categorized by the Peripheral Arterial Calcium Scoring System (PACSS), whereas lesion complexity was classified by the Transatlantic Inter-Society Consensus (TASC). 151 lesions were treated in 136 consecutive patients. Clinical follow-up was available at 10.3 ± 4.2 months in 132 (97%) patients. 55 patients (40%) had intermittent claudication, 16 (12%) rest pain and 65 (48%) had ischemic ulcerations (mean RF class = 4.2 ± 1.1). 15 (11%) patients had TASC B lesions, whereas the majority 72 (53%) and 49 (36%) exhibited TASC C and D lesions, respectively. Mean PACSS score was 3.3 ± 0.9. Mean lesion length was 106 ± 92 mm. Atherectomy was combined with drug-coated balloon (DCB) in 129 (95%) patients. Nine (6.6%) patients with infra-inguinal lesions received stents. Technical and procedural success were recorded in 102 (75%) and 135 (99%), respectively. Perforation was noticed in 2 (1%), whereas asymptomatic embolism occurred in 6 (4%) patients. Clinical success was present in 54 (100%) patients with claudication and in 65 of 78 (83%) patients with critical limb ischemia (CLI). Atherectomy in combination with DCB angioplasty can be safely performed in patients with complex, calcified peripheral lesions with a relatively low rate of bail-out stenting and promising clinical mid-term results.

German Clinical Trials Register: DRKS00016708.

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Funding

The GRN Hospital Weinheim (G.K. & S.G.) received an institutional research grant from Volcano, Philips.

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Authors and Affiliations

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

    Sorin Giusca & Grigorios Korosoglou

  2. Vascular Center Klinikum Arnsberg, Arnsberg, Germany

    Michael Lichtenberg

  3. Practice for Cardiology and Vascular Medicine, Hirschberg, Germany

    Melanie Schueler

  4. Practice for Vascular Medicine and Gastroenterology, Weinheim, Germany

    Ulrike Heinrich

  5. Diabetology and Gastroenterology, GRN Hospital Weinheim, Weinheim, Germany

    Christoph Eisenbach

  6. Fuerst-Stirum Hospital, Cardiology and Vascular Medicine, Bruchsal, Germany

    Martin Andrassy

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  1. Sorin Giusca
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Correspondence to Grigorios Korosoglou.

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The GRN Hospital Weinheim (G.K. & S.G.) received an institutional research grant from Volcano, Philips. No conflicts of interests to declare on behalf of all other authors of this study.

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Giusca, S., Lichtenberg, M., Schueler, M. et al. Safety, effectiveness and mid-term follow-up in 136 consecutive patients with moderate to severely calcified lesions undergoing phoenix atherectomy. Heart Vessels 36, 366–375 (2021). https://doi.org/10.1007/s00380-020-01695-w

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