Long-term outcome upon treatment of calcified lesions of the lower limb using scoring angioplasty balloon (AngioSculpt™)

Abstract

Aims: In peripheral artery disease (PAD), endovascular treatment success of heavily calcified lesions is often compromised by a number of vascular complications, such as recoils, dissections and need for target vessel re-interventions. The increasing use of scoring balloon techniques has raised the hope for better periprocedural outcomes; however, the knowledge regarding the actual benefits of the scoring balloon technique in comparison to standard therapy is still limited. Thus, the aim of the current study was to determine the safety and effectiveness of scoring balloon angioplasty in a real-life patients’ collective with PAD. Methods and Results: A total of 425 patients with moderate to severely calcified femoropopliteal lesions received interventional treatment between 2011 and 2018 at the single center; 230 received a treatment with a scoring balloon (AngioSculpt™), and 195 received a plain procedure without AngioSculpt™. Key questions of this analysis were: (1) whether AngioSculpt™ can be used as a safe and effective stand-alone treatment in heavily calcified lesions in a 24-month follow-up, as well as (2) whether target lesion preparation with scoring balloon bears additional benefits to standard treatment (PTA ± stent implantation). In terms of freedom from target lesion revascularization there were no significant differences between AngioSculpt™ and standard procedure (82.3% vs. 78.1%, P > 0.05). Vessel preparation with balloon angioplasty had no additional effects on survival and amputation rates in comparison to standard treatment without AngioSculpt™ (P > 0.05). The deployment of a scoring balloon did not reduce the subsequent need for additional stent implantations (32.6%, and 32.3%, P > 0.05). Conclusion: Lesion preparation with AngioSculpt™ scoring balloon represents a safe and effective tool in the treatment of complex femoropopliteal lesions. In this retrospective analysis, AngioSculpt™ scoring balloon angioplasty did not significantly improve vessel patency- both when used as an adjunctive in preparation for stenting and as stand-alone treatment. A prospective study is needed to further investigate the scoring balloon treatment options. Graphic abstract: [Figure not available: see fulltext.].