Abstract
Objectives
The OPN super high-pressure noncompliant (NC) balloon (SIS Medical AG) can safely reach inflation pressures of 45 to 50 atm, offering a valuable option for complex coronary interventions. This study aimed to evaluate its safety and efficacy in a real-world setting.Methods
The authors conducted an observational, single-center registry including consecutive patients treated with the OPN balloon over 13 years. Procedural indication, safety, and efficacy were assessed using quantitative coronary angiography (QCA). Major adverse cardiovascular events (MACE)-defined as cardiovascular death, myocardial infarction, or target lesion revascularization-were analyzed at 1-year follow-up.Results
A total of 275 patients (289 lesions) were included. The cohort was highly complex (mean age 70 ± 10 years, 66% multivessel disease, 66% diabetes, 35% in-stent restenosis [ISR]). The main indication was plaque preparation (68%), followed by stent optimization (32%). Procedural success was 95%, with one-third of lesions requiring inflation pressures of greater than or equal to 40 atm. QCA demonstrated a significant increase in minimal lumen diameter (1.31 ± 0.66 mm to 2.13 ± 0.62 mm, P Conclusions
In routine clinical practice, the OPN NC balloon demonstrated high efficacy and an excellent safety profile, achieving significant luminal gain at ultra-high pressures. These findings support its role for lesion preparation and stent optimization.