背景:左心室流出道(LVOT)梗阻是常见的,通常是经导管二尖瓣置换术(TMVR)的致命性并发症。在国家心脏30天时,二尖瓣前叶撕裂以防止流出道阻塞(LAMMPOON)是安全有效的,可以预防LVOT阻塞。肺,和血液研究所的LAMPOON试验。
目的:作者报告了5年的试验结果。
方法:国家心脏,肺,血液研究所的LAMPOON试验是一个前瞻性的,多中心,LAMMPOON和经中隔SAPIEN3TMVR在瓣环成形术环(瓣膜环内)或天然二尖瓣环钙化(MAC)(瓣膜环内)中的单臂安全性和可行性研究。所有受试者都具有较高的LVOT梗阻预测风险。不排除受试者的过度虚弱或合并症。主要终点是30天的技术成功和安全性。在1年时评估次要临床和超声心动图终点,在5年时进行临床随访。
结果:在2017年6月至2018年6月之间招募了30名受试者,在MAC瓣膜臂和环瓣臂之间相等。在30天,Lampooon在所有30个科目中都是成功的,没有笔划,1人(3%)死亡,和1(3%)中度LVOT梗阻。18人(65%)存活1年,7(25%)存活到5年。第一年有6人(20%)因心力衰竭住院。从基线到1年,堪萨斯城心肌病问卷评分提高24分,6分钟步行距离提高60米.N末端脑钠肽前体无明显变化。在1年,LVOT梯度仍然很低。
结论:尽管存在LVOT梗阻的风险,但LAMMPOON启用了TMVR。无与LAMMPOON相关的长期并发症。选择无法手术的患者限制了对TMVR后长期生存的评估。(NHLBIDIRLAMMPOON研究:经导管二尖瓣植入过程中防止左心室流出道阻塞的前二尖瓣叶的有意裂伤;NCT03015194)。
BACKGROUND: Left ventricular outflow tract (LVOT) obstruction is a common, often fatal complication of transcatheter mitral valve replacement (TMVR). Laceration of the anterior mitral leaflet to prevent outflow obstruction (LAMPOON) was safe and effective at preventing LVOT obstruction at 30 days in the National Heart, Lung, and Blood Institute LAMPOON trial.
OBJECTIVE: The authors report the 5-year trial outcomes.
METHODS: The National Heart, Lung, and Blood Institute LAMPOON trial was a prospective, multicenter, single-arm safety and feasibility study of LAMPOON and transseptal SAPIEN 3 TMVR in annuloplasty rings (valve-in-ring) or native mitral annular calcification (MAC) (valve-in-MAC). All subjects had high predicted risk for LVOT obstruction. Subjects were not excluded for excessive frailty or comorbidity. The primary endpoints were technical success and safety at 30 days. Secondary clinical and echocardiographic endpoints were assessed at 1 year and clinical follow-up at 5 years.
RESULTS: Thirty subjects were enrolled between June 2017 and June 2018, equally between the valve-in-MAC and valve-in-ring arms. At 30 days, LAMPOON was successful in all 30 subjects, with no strokes, 1 (3%) death, and 1 (3%) moderate LVOT obstruction. Eighteen (65%) survived to 1 year, and 7 (25%) survived to 5 years. Six (20%) were hospitalized for heart failure in the first year. From baseline to 1 year, there was a 24-point improvement in Kansas City Cardiomyopathy Questionnaire score and a 60-m improvement in 6-minute walk distance. There was no significant change in N-terminal pro-brain natriuretic peptide. At 1 year, LVOT gradients remained low.
CONCLUSIONS: LAMPOON enabled TMVR despite the risk for LVOT obstruction. There were no long-term complications associated with LAMPOON. The selection of inoperable patients limited assessment of long-term survival following TMVR. (NHLBI DIR LAMPOON Study: Intentional Laceration of the Anterior Mitral Leaflet to Prevent Left Ventricular Outflow Tract Obstruction During Transcatheter Mitral Valve Implantation; NCT03015194).