043 - Standard balloon angioplasty versus Serranator serration balloon angioplasty for the treatment of BTK disease
Fraz Hafner, N/A – Resident, Division of Angiology, Medical University Graz
Purpose: The aim of this subgroup analysis was to compare acute angiographic results after endovascular treatment using the Serranator serration balloon catheter in patients participating in the PRELUDE BTK trial to POBA of the infrapopliteal arteries in patients with chronic limb threatening ischemia (CLTI). A secondary objective was to assess post-treatment hemodynamic improvements. Both patient cohorts were treated at the Vascular Medicine Center in Graz, Austria.
Material and Methods: Our center enrolled 15 subjects and treated 17 lesions within the multi-center prospective core laboratory adjudicated PRELUDE-BTK study for treatment of critical infrapopliteal lesions. A separate analysis of 25 lesions were treated with POBA and then compared to the Serranator subset. In both cohorts, lesions were treated with either plain angioplasty or Serranator as a stand-alone therapy; subsequent methods such as drug elution technologies were not utilized. Acute angiographic results were analyzed by the SynvaCor angiographic core laboratory. To assess volumetric flow rates data was analyzed with a fluid flow simulation software and compared against Poiseuille’s Law.
Results: Final residual stenosis was 17.2±8.2% in the Serranator group versus 33.7±15.7% in the POBA group. The mean lumen diameter (MLD) gain for the Serranator group and the POBA group were 1.64±.41 mm and 1.37±.63 mm respectively. The average atmospheric balloon inflation pressure was 5 ATM in the Serranator group versus 9 ATM in the POBA group. Neither group required a bailout stent, however it was notable that there were significantly more chronic total occlusions (CTOs) treated in the Serranator group at 41.2% versus 12% in the POBA group. Regarding the effectiveness in improving hemodynamic blood flow for non-CTO lesions, the calculated average ratio of post-treatment to pre-treatment flow rates in the Serranator group was 238% than that for the POBA group. For CTO cases where pretreatment flow rate was zero, final residual stenosis was used as the parameter for comparison. The Serranator group showed a 62% improvement in final residual stenosis over POBA.
Conclusions: ndovascular treatment of the infrapopliteal arteries by use of the Serranator Serration Balloon provides a novel and promising method of action as compared to standard balloon angioplasty and, thus, may have a leading role in complex below the knee arterial lesions.