Treatment of In-Stent Restenosis Using a Dedicated Super High-Pressure Balloon
Thomas Seiler, Adrian Attinger-Toller, Giacomo Maria Cioffi, Mehdi Madanchi, Mario Teufer, Mathias Wolfrum, Federico Moccetti, Stefan Toggweiler, Richard Kobza, Matthias Bossard, Florim Cuculi, Thomas Seiler, Adrian Attinger-Toller, Giacomo Maria Cioffi, Mehdi Madanchi, Mario Teufer, Mathias Wolfrum, Federico Moccetti, Stefan Toggweiler, Richard Kobza, Matthias Bossard, Florim Cuculi
Abstract
Background: Treatment of in-stent restenosis (ISR) is challenging and treatment failure rate remains high. Correction of stent under-expansion and neointimal compression using the twin-layer OPN™ highly non-compliant balloon (NCB) at high pressure (>30 atm) may lead to increased luminal gain and thus better clinical outcomes. We evaluated periprocedural safety and clinical long-term outcomes after ISR treatment using the OPN™ NCB in a real-world population.
Methods: From an ongoing registry, consecutive ISR patients treated with the OPN™ NCB at a tertiary cardiology center in Switzerland were analyzed. We evaluated procedural efficacy, periprocedural complications, target lesion/vessel failure (TLF/TVF), and major adverse cardiovascular events (MACE).
Results: Totally, 208 ISR lesions were treated in 188 patients (mean age 68 ± 13 years, 78 % males). Most lesions were moderately to heavily calcified (89 %), the majority (70.2 %) had complex lesion characteristics (AHA Type B2/C lesions) and 50.5 % were non-focal ISR lesions. After ISR treatment using high pressure pre- and post-dilatation (mean pressure 33 ± 6 atm) with the OPN™ NCB device, the rate of major complications was low (0.96 % coronary perforation, 4 % major dissections, 1.9 % no-reflow and 0.5 % acute vessel closure). At 1-year follow-up, MACE occurred in 19.7 %; 15.4 % patients had TVF; MI and stent thrombosis was found in 5.9 % and 2.1 % of all patients, respectively; and 5 patients died.
Conclusions: For ISR treatment, using the super non-compliant OPN™ balloon at very high pressures is safe. Moreover, its use might lead to a low rate of TLF/TVF during long-term follow-up, but this requires further evaluation in dedicated comparative trials.
Keywords: Angioplasty; High-pressure balloon; In-stent restenosis; OPN; PCI; Safety.
Conflict of interest statement
Declaration of competing interest AAT has received consulting and speaker fees from SIS Medical. RK has received institutional grants from Abbott, Biosense-Webster, Biotronik, Boston-Scientific, Medtronic, SIS Medical and act as a consultant for Biosense-Webster, Biotronik and Medtronic. MB has received consulting and speaker fees from Abbott Vascular, Abiomed and SIS Medical. FC has received consulting and speaker fees from SIS Medical, Abiomed and Abbott Vascular. All other authors have no conflicts of interest to declare.
Copyright © 2022 The Authors. Published by Elsevier Inc. All rights reserved.
Source: PubMed