Multicentre experience with Optimus balloon-expandable cobalt–chromium stents in congenital heart disease interventions
Damien Bonnet,
Clément Karsenty,
Caroline Ovaert,
Sébastien Hascoet,
Zakaria Jalal,
Sophie Malekzadeh-Milani,
Raymond N Haddad,
Ali Houeijeh,
Alban-Elouen Baruteau,
Estibaliz Valdeolmillos
Affiliations
Damien Bonnet
Centre de Référence Malformations Cardiaques Congénitales Complexes - M3C, Hôpital Universitaire Necker-Enfants malades, Assistance Publique – Hôpitaux de Paris (AP-HP), Paris, France
Clément Karsenty
Pediatric and Congenital Cardiology, Children`s Hospital and INSERM U1048, I2MC, Institut des Maladies Métaboliques et Cardiovasculaires, Université de Toulouse, Toulouse, France
Caroline Ovaert
Cardiologie pédiatrique et congénitale, Timone enfants, AP-HM et INSERM 1251, Aix-Marseille Université, Marseille, France
Sébastien Hascoet
Congenital Heart Diseases, Centre Chirugical Marie Lannelongue, Le Plessis-Robinson, France
Zakaria Jalal
1Department of Pediatric and Congenital Cardiology, University Hospital of Bordeaux, Pessac, France
Sophie Malekzadeh-Milani
Department of Congenital and Pediatric Cardiology, Necker-Sick Children University Hospital, M3C-Necker, Université de Paris, Paris, France
Raymond N Haddad
Centre de Référence Malformations Cardiaques Congénitales Complexes - M3C, Hôpital Universitaire Necker-Enfants malades, Assistance Publique – Hôpitaux de Paris (AP-HP), Paris, France
Ali Houeijeh
Department of Pediatric Cardiology, Lille University Hospital, Lille, France
Alban-Elouen Baruteau
Department of Pediatric Cardiology and Pediatric Cardiac Surgery, Nantes University Hospital, Nantes, France
Estibaliz Valdeolmillos
Department of Pediatric Cardiology and Congenital Heart Disease, Marie Lannelongue Hospital, Groupe Hospitalier Paris Saint Joseph, Le Plessis-Robinson, France
Objectives To evaluate bare-metal Optimus and polytetrafluoroethylene (PTFE)-covered Optimus-CVS balloon-expandable, cobalt–chromium, hybrid cell–designed stents in congenital heart disease (CHD) interventions.Methods Retrospective multicentre review of patients with CHD receiving Optimus stents. Stent mechanical behaviour, clinical indications and outcomes were assessed.Results 183 stents (49.2% XXL/15-ZIG, 33.3% XL/12-ZIG, 17.5% L/9-ZIG) were implanted (98.9% success rate, 2.3% serious procedural complication rate) in 170 patients (57.6% men, 64.1% adults), median age 23.6 years (IQR, 15.2–39.2) and weight 63.5 kg (IQR, 47–75.7). Indications were right ventricular outflow tract stand-alone stenting or before revalvulation (62.4%), aortic coarctation treatment (15.3%), Fontan-circuit fenestration closure (12.4%) and miscellaneous (10%). 86/170 (50.6%) patients had PTFE-covered stenting (50% prophylactic). In 86/170 (50.6%) patients with stenotic lesions, median percentage of achieved stent expansion was 93.4% (IQR, 85.5%–97.7%), median gradient decreased from 28 mm Hg (IQR, 19–41) to 5 mm Hg (IQR, 1–9) (p<0.001), median vessel diameters increased from 13 mm (IQR, 7.9–17) to 18.9 mm (IQR, 15.2–22) (p<0.001) and percentage of vessel expansion was 45.2% (IQR, 19.8%–91.3%). In 30/36 (83.3%) patients with graft, median dilation of 2 mm (IQR, 2–5) above nominal diameter was achieved. Median stent shortening was 10.9% (IQR, 6.1–15.1) and was associated only with expansion diameter (OR: 0.66, 95% CI: 0.38 to 0.93). No clinically relevant fracture, stent embolisation or dysfunction occurred on a median follow-up of 9 (IQR, 4–14) months.Conclusions Optimus stents are effective tools for transcatheter treatment of simple and complex CHD. Optimus stents’ reliable mechanical behaviour and particular covering design can promote widespread use.
