Centre de Référence Malformations Cardiaques Congénitales Complexes - M3C, Hôpital Universitaire Necker-Enfants malades, Assistance Publique - Hôpitaux de Paris (AP-HP), Paris, France
Department of Adult Congenital Heart Disease, Hôpital Européen Georges-Pompidou, Assistance Publique - Hôpitaux de Paris (AP-HP), Paris, France.
Open Heart. 2023 Jan;10(1). doi: 10.1136/openhrt-2022-002157.
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.
Retrospective multicentre review of patients with CHD receiving Optimus stents. Stent mechanical behaviour, clinical indications and outcomes were assessed.
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.
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.
评估 Optimus 裸支架和聚四氟乙烯（PTFE）覆盖的 Optimus-CVS 球囊扩张、钴铬、混合细胞设计支架在先天性心脏病（CHD）介入治疗中的应用。
回顾性分析接受 Optimus 支架治疗的 CHD 患者。评估支架的机械性能、临床适应证和结果。
170 例患者（57.6%为男性，64.1%为成人）共植入 183 枚支架（49.2% XXL/15-ZIG，33.3% XL/12-ZIG，17.5% L/9-ZIG）（成功率 98.9%，严重程序并发症率 2.3%），中位年龄为 23.6 岁（IQR，15.2-39.2），体重为 63.5kg（IQR，47-75.7）。适应证为右心室流出道单纯支架置入或再瓣膜前（62.4%）、主动脉缩窄治疗（15.3%）、Fontan 回路开窗闭合（12.4%）和其他（10%）。170 例患者中有 86 例（50.6%）接受了 PTFE 覆盖支架（50%为预防性）。在 86 例有狭窄病变的患者中，中位支架扩张率为 93.4%（IQR，85.5%-97.7%），中位梯度从 28mmHg（IQR，19-41）降至 5mmHg（IQR，1-9）（p<0.001），中位血管直径从 13mm（IQR，7.9-17）增加至 18.9mm（IQR，15.2-22）（p<0.001），血管扩张率为 45.2%（IQR，19.8%-91.3%）。在 30 例（83.3%）移植患者中，中位扩张超过标称直径 2mm（IQR，2-5）。中位支架缩短率为 10.9%（IQR，6.1-15.1），仅与扩张直径相关（OR：0.66，95%CI：0.38 至 0.93）。中位随访 9（IQR，4-14）个月，无临床相关支架断裂、支架栓塞或功能障碍发生。
Optimus 支架是治疗简单和复杂先天性心脏病的有效工具。Optimus 支架可靠的机械性能和特殊的覆盖设计可以促进其广泛应用。
