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

Abstract

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.