Safety and Efficacy of OPN Balloon in Patients With Calcified Coronary Artery Disease.

ABSTRACT

BACKGROUND: Patients with symptomatic calcified coronary lesions have poor outcomes. Such lesions require additional atherectomy devices for bed preparation. AIM: To assess the safety and efficacy of OPN balloon in patients with calcified coronary lesions. METHODS: This is an investigator-initiated, prospective, observational study. The primary outcome of the study was a procedural success. RESULTS: We studied 71 patients (133 lesions). Maximum lesions were located in LAD [46.6 %]. The OPN balloon was used for pre-dilatation alone in 28.6 % (Pre-stent OPN group), post-dilatation alone in 63.2 % of lesions (Post-stent OPN group), and in both situations in 8.3 % of lesions with procedural success in 98.5 % of patients. Further dilatation with different NC balloons was required in both groups (30 %). The median (IQR) OPN balloon diameter in the pre- and post-stent OPN group were 2.5 (2.5, 3.0) and 3.0 (3.0,3.0) mm (p = 0.001), respectively. The difference between the diameter of the stent and OPN balloon used in pre-stent OPN group was 0.5 (0.2, 0.5) mm while it was 0.0 (0.0,0.2) mm in the post-stent OPN group (p < 0.001). Eight complications and two deaths occured. Distal shaft rupture was also noticed. CONCLUSION: OPN balloon is safe, and effective in treating calcified coronary lesions. We propose to undersize the balloon by 0.5 mm for pre-dilatation followed by 0.25 mm larger NC balloon if needed. In the post-dilatation group, use a 11 size balloon in a non-tortuous straight segment. Use imaging especially when (1) the pressure taken more than the rated burst pressure, (2) an OPN balloon size is ≥3 mm (3) using 11 size OPN balloon in a tortuous segment.