Multicentre experience with optimus balloon-expandable cobalt-chromium vascular stents in congenital heart disease interventions: Early outcomes and extended possibilities

Abstract

Optimus™ and Optimus-CVS® (AndraTec, Germany) are balloon-expandable, cobalt-chrome, hybrid-cell designed stents with promising bare-metal and PTFE-covered specifications. We aim to evaluate Optimus stents in congenital heart disease (CHD) interventions. Retrospective multicentre review of CHD patients receiving Optimus stents. Stent mechanical behavior, clinical indications, and outcomes were assessed. A total of 132 stents (48.5% PTFE-covered, 53% XXL/15ZIG, 29.5% XL/12ZIG, 17.4% L/9-ZIG) were implanted (98.3% success rate) in 121 patients (59.5% males, 64.5% adults), median age 23.7 years (IQR, 15.5–40.7), and weight 63.5Kg (IQR, 49.5–77). Indications were right ventricular outflow tract standalone stenting or before revalvulation (66.1%), aortic coarctation treatment (14%), Fontan-circuit fenestration closure (9.9%), and miscellaneous (9.9%). 64 patients had covered stenting that was prophylactic in 45.3% of cases. In stenotic lesions (65/121, 53.7%), median percentage of achieved stent expansion was 91.3% (IQR, 82.3–96.8%), median vessel diameters increased from 13.8 mm (IQR, 9–17.3 mm) to 20.3 mm (IQR, 15.9–22.3 mm) ( P < 0.001), and percentage of vessel expansion was 39.4% (IQR, 18.6-84.3%). Median gradient across stenotic lesions decreased from 31 mmHg (IQR, 21–41) to 5 mmHg (IQR, 1–9) ( P < 0.001). In 20/28 (71.4%) patients, graft was dilated a median of 2 mm (IQR, 2–6 mm) above nominal diameter. Median stent shortening was 11% (IQR, 6.3%–15.1%) and was associated only with expansion diameter (OR: 0.58, 95% CI: 0.22–0.93). There was no stent embolization or dysfunction on follow-up, median 8 (IQR, 4–12) months. Optimus stents are effective tools for transcatheter treatment of simple and complex CHD. Optimus reliable mechanical behavior and particular covering design can promote widespread use.