Gioel Gabrio Secco1, Achim Buettner2, Rosario Parisi3, Gianfranco Pistis4, Matteo Vercellino4, Andrea Audo4, Mashayekhi Kambis2, Roberto Garbo5, Italo Porto6, Giuseppe Tarantini7, Carlo Di Mario8. 1. Department of Cardiology, "Santi Antonio e Biagio e Cesare Arrigo" Hospital, Alessandria, Italy. Electronic address: gioel.gabrio.secco@gmail.com. 2. University Heart Center Freiburg, Bad Krozingen, Germany. 3. NIHR Biomedical Research Unit, Royal Brompton & Harefield NHS Foundation Trust, London, UK. 4. Department of Cardiology, "Santi Antonio e Biagio e Cesare Arrigo" Hospital, Alessandria, Italy. 5. Interventional Cardiology, "San Giovanni Bosco" Hospital, Turin, Italy. 6. Department of Cardiovascular Medicine, University of Medicine, San Martino Hospital, Genova, Italy. 7. Department of Cardiology, University of Medicine, Padua, Italy. 8. NIHR Biomedical Research Unit, Royal Brompton & Harefield NHS Foundation Trust, London, UK; Department of Cardiology, Careggi University Hospital, Florence, Italy.
Abstract
BACKGROUND: Calcific coronary lesions can be so resistant to prevent symmetric stent dilatation with high risk of ISR/thrombosis. The aim of the current study is to evaluate the safety and efficacy of super high-pressure dilatation (>30-to-45Atm) using a dedicated NC-balloon (OPN, SIS-Medical-AG, Winterthur-Switzerland). METHODS: We retrospectively evaluated 326 consecutive undilatable lesions in which conventional NC-balloons failed to achieve adequate post-dilatation luminal gain. After the failed attempt an OPN-balloon was inflated up to achieve a uniform balloon expansion (maximal dilatation pressure of 45-50 Atm). Lesions were divided into two groups according to the final inflation pressure: Group-I: lesion responsive to 30-40Atm and Group-2:>40 Atm. Angiographic success was defined as residual angiographic stenosis<30% assessed by visual estimation with TIMI3-flow. Procedural success was defined as the achievement of angiographic success without any MACE. RESULTS: Angiographic success was achieved in 97.5%, procedural success in 96.6%; 53% of the lesions were responsive to a slower inflation pressure (Group I) while in the remaining 47%, the optimal expansion required a pressure > 40ATM (Group II). In 3 patients coronary rupture occurred after balloon inflation and was successfully treated with stent implantation with a final TIMI3-flow. The OPN alone was able to achieve adequate expansion in >90%. 0.9% days MACE were reported. CONCLUSION: The OPN-dedicated high-pressure balloon provides an effective and safe strategy for treatment of severe resistant coronary lesions.
BACKGROUND:Calcific coronary lesions can be so resistant to prevent symmetric stent dilatation with high risk of ISR/thrombosis. The aim of the current study is to evaluate the safety and efficacy of super high-pressure dilatation (>30-to-45Atm) using a dedicated NC-balloon (OPN, SIS-Medical-AG, Winterthur-Switzerland). METHODS: We retrospectively evaluated 326 consecutive undilatable lesions in which conventional NC-balloons failed to achieve adequate post-dilatation luminal gain. After the failed attempt an OPN-balloon was inflated up to achieve a uniform balloon expansion (maximal dilatation pressure of 45-50 Atm). Lesions were divided into two groups according to the final inflation pressure: Group-I: lesion responsive to 30-40Atm and Group-2:>40 Atm. Angiographic success was defined as residual angiographic stenosis<30% assessed by visual estimation with TIMI3-flow. Procedural success was defined as the achievement of angiographic success without any MACE. RESULTS: Angiographic success was achieved in 97.5%, procedural success in 96.6%; 53% of the lesions were responsive to a slower inflation pressure (Group I) while in the remaining 47%, the optimal expansion required a pressure > 40ATM (Group II). In 3 patientscoronary rupture occurred after balloon inflation and was successfully treated with stent implantation with a final TIMI3-flow. The OPN alone was able to achieve adequate expansion in >90%. 0.9% days MACE were reported. CONCLUSION: The OPN-dedicated high-pressure balloon provides an effective and safe strategy for treatment of severe resistant coronary lesions.
Authors: Keyvan Karimi Galougahi; Evan Shlofmitz; Allen Jeremias; Shawnbir Gogia; Ajay J Kirtane; Jonathan M Hill; Dimitri Karmpaliotis; Gary S Mintz; Akiko Maehara; Gregg W Stone; Richard A Shlofmitz; Ziad A Ali Journal: Curr Cardiol Rep Date: 2021-03-05 Impact factor: 2.931