St. Jude Medical Trifecta aortic valve: results from a prospective regional multicentre registry
St. Jude Medical Trifecta aortic valve: results from a prospective regional multicentre registry
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DOI：
10.1186/s13019-015-0379-6
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发表时间：
2015-11-20
影响因子：
1.6
通讯作者：
Beghi, Cesare
中科院分区：
文献类型：
--
作者：
Mariscalco, Giovanni;Mariani, Silvia;Beghi, Cesare
背景：Trifeta主动脉生物假体(St.Jude Medical，Inc.，St.Jude Medical，Inc.，St.Paul，MN，USA)是一种带支架的心包瓣膜，初步效果良好。这项研究的目的是在多中心区域注册中评估其早期临床和血流动力学表现。方法：2011年1月至2012年6月，意大利9个中心前瞻性地登记了178例接受Trifeta生物瓣膜置换术的患者。结果：平均年龄75.4±7.7岁，其中男性95例(53%)。瓣膜置换术适应证包括狭窄123例(69%)，混合性病变25例(14%)，反流30例(17%)。NYHA功能III/IV级93例(52%)，住院死亡5例(2.8%)。无瓣膜相关并发症发生。中位随访期20.5个月(范围1~34个月)。早期(6个月)血栓栓子事件和2例心内膜炎(1例外植体)登记在案。出院后未见瓣膜血栓形成或结构恶化。在30个月时，无全因死亡率为87%，无瓣膜相关死亡率为99.4%，无心内膜炎为97.5%，无瓣膜植入物为98%。术后1年，瓣膜直径为19~27 mm，平均瓣口压差为8~16 mm，有效瓣口面积指数为1.0~1.2 cm(2)/m(2)。没有患者发生严重的假体-患者错配。结论：随着时间的推移，三联生物假体提供了良好的临床和血流动力学结果。
Background: The Trifecta aortic bioprosthesis (St. Jude Medical, Inc., St. Paul, MN, USA) is a stented pericardial heart valve with excellent preliminary results. Aim of the study was to evaluate its early clinical and hemodynamic performances in a multicenter regional registry.Methods: Between January 2011 and June 2012, 178 consecutive patients undergoing aortic valve replacement with the Trifecta bioprosthesis were prospectively enrolled at 9 Italian centers. Clinical and echocardiographic data were collectedat discharge, 6-months and at 1-year postoperatively.Results: The average age was 75.4 +/- 7.7 years, and 95 (53 %) were men. Indication for valve replacement included stenosis in 123 patients (69 %), mixed lesions in 25 (14 %), and regurgitation in 30 (17 %). Ninety-three (52 %) patients were in NYHA functional class III/IV. Hospital mortality accounted for 5 (2.8 %) patients. No valve-related perioperative complications were encountered. Median follow-up was 20.5 months (range: 1-34). Early (6 months) thromboembolic events and two endocarditis (1 explant) were registered. No valve thrombosis or structural deterioration were observed after discharge. At 30-months, freedom from all-cause mortality was 87 %, freedom from valve-related mortality 99.4 %, freedom from endocarditis 97.5 %, and freedom from valve explants 98 %. At 1-year, mean gradients ranged from 8 to 16 mmHg, and effective orifice area indexes from 1.0 to 1.2 cm(2)/m(2) for valve sizes from 19 to 27 mm, respectively. No patients had severe prosthesis-patient mismatch.Conclusions: Trifecta bioprosthesis provided favourable clinical and hemodynamic results over time.