Treatment of Calcified Lesions Using a Dedicated Super-High Pressure Balloon: Multicenter Optical Coherence Tomography Registry

Abstract

Background: Calcified lesions often lead to difficulty achieving optimal stent expansion. OPN non-compliant (NC) is a twin layer balloon with high rated burst pressure that may modify calcium effectively.

Methods: Retrospective, multicenter registry in patients undergoing optical coherence tomography (OCT) guided intervention with OPN NC. Superficial calcification with > 180o arc and > 0.5 mm thickness, and/or nodular calcification with > 90o arc were included. OCT was performed in all cases before and after OPN NC, and after intervention. Primary efficacy endpoints were frequency of expansion (EXP) ≥80 % of the mean reference lumen area and mean final EXP by OCT, and secondary endpoints were calcium fractures (CF), and EXP ≥90 %.

Results: 50 cases were included; 25 (50 %) superficial, and 25 (50 %) nodular. Calcium score of 4 in 42 (84 %) cases and 3 in 8 (16 %). OPN NC was used alone, or after other devices if further modification was needed, NC in 27 (54 %), cutting in 29 (58 %), scoring in 1 (2 %), IVL in 2 (4 %); or if non-crossable lesion, rotablation in 5 (10 %) cases. EXP ≥80 % was achieved in 40 (80 %) cases with mean final EXP post intervention of 85.7 % ± 8.9. CF were documented in 49 (98 %) cases; multiple in 37 (74 %). There were 1 flow limiting dissection requiring stent deployment and 3 non-cardiovascular related deaths in 6 months follow-up. No records of perforation, no-reflow or other major adverse events.

Conclusion: Among patients with heavy calcified lesions undergoing OCT guided intervention with OPN NC, acceptable expansion was achieved in most cases without procedure related complications.

Keywords: Calcified lesions; OCT; OPN; PCI; Super high-pressure balloon.

Conflict of interest statement

Declaration of competing interest Authors have the following disclosures relevant to this manuscript: The OPN NC Registry was supported by an AFP grant through Hamilton Health Sciences. Dr. Pinilla-Echeverri has served as a consultant and speaker, received research grant support, and served on the Advisory Board for Abbott Vascular; has served on the Advisory Board for Philips; has served as a consultant for Conavi, Amgen, Bayer, and Novartis. Dr. Bossard has served as consultant and speaker fees for Abbott Vascular, Abiomed, Amgen, Astra Zeneca, Bayer, Boehringer Ingelheim, Dachii Sankyo, Novartis, SIS Medical and Vifor. Dr. Chavarria has served as a consultant and speaker for Abbott Vascular. Dr. Dutra has served as a consultant for Abbott Vascular. Dr. Attinger has served as a speaker for SIS Medical. Dr. Sibbald has served as a consultant for Abbott Vascular. Dr. Cuculi has received consulting and speaker fees from Abiomed, Boston Scientific, SIS Medical and Abbott Vascular. Dr. Sheth has served as a consultant, served on the Speakers Bureau, received research grant support, and served on the Advisory Board for Abbott Vascular. Dr. Hillani, Dr. Cioffi, Dr. Guerrero, Dr. Madanchi and Ellen Kossmann have nothing to disclose.

Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.