{"title":"[使用Direct Flow医疗系统的经皮主动脉瓣置换术:卢森堡注册的结果]。","authors":"Y Maazoun, D R Wagner, P Frambach","doi":"","DOIUrl":null,"url":null,"abstract":"<p><p>Percutaneous aortic valve replacement (TAVI) is one of the most innovative procedure in interventional cardiology. The Direct Flow Medical transcatheter aortic valve (DFM) is a new nonmetallic valve which allows perfect repositioning and valve retrieval prior to the final deployment. This study is a prospective non-randomized evaluation of the DFM system in the Luxembourg registry. The study focused on 15 patients who received between March 2013 and October 2013 a percutaneous aortic valve replacement by DFM prosthesis. All clinical and echocardiographic data have been collected prospectively. Fifteen inoperable patients with severe aortic stenosis were evaluated. The average age of our population was 83 +/- 4.16 years, mean STS score was 16%. 46% of patients were in NYHA class III and 33.3% in NYHA class IV. Mean ejection fraction was 59% +/- 12.7, the average mean gradient was 52.86 +/- 18.5 mm Hg and mean aortic orifie was 0.63 +/- 0.15 cm2. Procedural success rate was 100%. The mean trans- valvular gradient decreased from 52.86 +/- 18.5 mm Hg to 12 +/- 4.2 mm Hg (p < 0.001). The average hospital stay was 14 +/- 7.6 days. The non-fatal major event rate at one month was 33.3%. The mortality rate at one month was limited to 6.6%. These results allow us to confirm the efficacy and safety of the DFM valve.</p>","PeriodicalId":72476,"journal":{"name":"Bulletin de la Societe des sciences medicales du Grand-Duche de Luxembourg","volume":null,"pages":null},"PeriodicalIF":0.0000,"publicationDate":"2014-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"[Percutaneous aortic valve replacement using the Direct Flow Medical system: results of the Luxembourg registry].\",\"authors\":\"Y Maazoun, D R Wagner, P Frambach\",\"doi\":\"\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p>Percutaneous aortic valve replacement (TAVI) is one of the most innovative procedure in interventional cardiology. The Direct Flow Medical transcatheter aortic valve (DFM) is a new nonmetallic valve which allows perfect repositioning and valve retrieval prior to the final deployment. This study is a prospective non-randomized evaluation of the DFM system in the Luxembourg registry. The study focused on 15 patients who received between March 2013 and October 2013 a percutaneous aortic valve replacement by DFM prosthesis. All clinical and echocardiographic data have been collected prospectively. Fifteen inoperable patients with severe aortic stenosis were evaluated. The average age of our population was 83 +/- 4.16 years, mean STS score was 16%. 46% of patients were in NYHA class III and 33.3% in NYHA class IV. Mean ejection fraction was 59% +/- 12.7, the average mean gradient was 52.86 +/- 18.5 mm Hg and mean aortic orifie was 0.63 +/- 0.15 cm2. Procedural success rate was 100%. The mean trans- valvular gradient decreased from 52.86 +/- 18.5 mm Hg to 12 +/- 4.2 mm Hg (p < 0.001). The average hospital stay was 14 +/- 7.6 days. The non-fatal major event rate at one month was 33.3%. The mortality rate at one month was limited to 6.6%. These results allow us to confirm the efficacy and safety of the DFM valve.</p>\",\"PeriodicalId\":72476,\"journal\":{\"name\":\"Bulletin de la Societe des sciences medicales du Grand-Duche de Luxembourg\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2014-01-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Bulletin de la Societe des sciences medicales du Grand-Duche de Luxembourg\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Bulletin de la Societe des sciences medicales du Grand-Duche de Luxembourg","FirstCategoryId":"1085","ListUrlMain":"","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
引用次数: 0
摘要
经皮主动脉瓣置换术(TAVI)是介入心脏病学中最具创新性的手术之一。直流式医学经导管主动脉瓣(DFM)是一种新型的非金属瓣膜,它可以在最终部署之前实现完美的重新定位和瓣膜回收。本研究是对卢森堡注册的DFM系统进行前瞻性非随机评估。该研究集中于2013年3月至2013年10月期间接受经皮主动脉瓣置换DFM假体的15例患者。所有临床和超声心动图资料均已前瞻性收集。我们对15例严重主动脉瓣狭窄不能手术的患者进行了评估。本组患者平均年龄83±4.16岁,平均STS评分为16%。46%的患者为NYHA III级,33.3%的患者为NYHA IV级。平均射血分数为59% +/- 12.7,平均梯度为52.86 +/- 18.5 mm Hg,平均主动脉瓣面积为0.63 +/- 0.15 cm2。手术成功率100%。平均跨瓣梯度从52.86 +/- 18.5 mm Hg降至12 +/- 4.2 mm Hg (p < 0.001)。平均住院时间为14±7.6天。1个月非致死性重大事件发生率为33.3%。一个月死亡率控制在6.6%。这些结果使我们能够确认DFM瓣膜的有效性和安全性。
[Percutaneous aortic valve replacement using the Direct Flow Medical system: results of the Luxembourg registry].
Percutaneous aortic valve replacement (TAVI) is one of the most innovative procedure in interventional cardiology. The Direct Flow Medical transcatheter aortic valve (DFM) is a new nonmetallic valve which allows perfect repositioning and valve retrieval prior to the final deployment. This study is a prospective non-randomized evaluation of the DFM system in the Luxembourg registry. The study focused on 15 patients who received between March 2013 and October 2013 a percutaneous aortic valve replacement by DFM prosthesis. All clinical and echocardiographic data have been collected prospectively. Fifteen inoperable patients with severe aortic stenosis were evaluated. The average age of our population was 83 +/- 4.16 years, mean STS score was 16%. 46% of patients were in NYHA class III and 33.3% in NYHA class IV. Mean ejection fraction was 59% +/- 12.7, the average mean gradient was 52.86 +/- 18.5 mm Hg and mean aortic orifie was 0.63 +/- 0.15 cm2. Procedural success rate was 100%. The mean trans- valvular gradient decreased from 52.86 +/- 18.5 mm Hg to 12 +/- 4.2 mm Hg (p < 0.001). The average hospital stay was 14 +/- 7.6 days. The non-fatal major event rate at one month was 33.3%. The mortality rate at one month was limited to 6.6%. These results allow us to confirm the efficacy and safety of the DFM valve.