Multicentre experience with Optimus balloon-expandable cobalt–chromium stents in congenital heart disease interventions

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.