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

Abstract

ObjectivesTo evaluate bare-metal Optimus and polytetrafluoroethylene (PTFE)-covered Optimus-CVS balloon-expandable, cobalt–chromium, hybrid cell–designed stents in congenital heart disease (CHD) interventions.MethodsRetrospective multicentre review of patients with CHD receiving Optimus stents. Stent mechanical behaviour, clinical indications and outcomes were assessed.Results183 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.ConclusionsOptimus 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.

Case Report: Transcatheter treatment of aortic coarctation in a 58-year-old patient with LACHT syndrome and left lung agenesis

“…Following expansion, the stent adhered well to the vessel wall at the level of the narrowing segment. Despite some procedural and technical advantages of other new-generation endovascular stents ( 11 ), we have selected the CP stent because of the availability in the armamentarium and operators' experience with CP stents. Even though the residual pressure gradient was not optimal, significant control over blood pressure was achieved with medications.…”

“…Even though the residual pressure gradient was not optimal, significant control over blood pressure was achieved with medications. We refrained from further expansion or additional stent placement to avoid the risk of vessel tearing due to excessive expansion ( 11 ). Subsequent follow-up showed that the patient's blood pressure was normalized with medication, supporting the correctness of our comprehensive decision.…”

Prevalence of Cobalt in the Environment and Its Role in Biological Processes

“…Moreover, Co is present in superalloys, other alloys, heavy metals (cement carbides), magnets, wear-resistant materials, recording materials, batteries, tires, paint dryers, soaps, and catalysts [13]. Recently, Co-chromium balloon-expandable vascular stents have been used in congenital heart disease interventions [14].…”