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. The authors report the 5-year outcomes of intentional anterior mitral leaflet laceration before SAPIEN 3 TMVR, in patients at risk of LVOT obstruction. 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. 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. 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; )

中文翻译：

---

二尖瓣前叶撕裂预防流出道梗阻的 5 年结果


左心室流出道 (LVOT) 梗阻是经导管二尖瓣置换术 (TMVR) 的常见且常常致命的并发症。在国家心肺血液研究所 LAMPOON 试验中，撕裂二尖瓣前叶以防止流出道梗阻 (LAMPOON) 可以安全有效地预防 30 天时的 LVOT 梗阻。作者报告了在 SAPIEN 3 TMVR 之前对有 LVOT 梗阻风险的患者进行故意二尖瓣前叶撕裂的 5 年结果。国家心肺血液研究所 LAMPOON 试验是一项前瞻性、多中心、单臂安全性和可行性研究，研究 LAMPOON 和经间隔 SAPIEN 3 TMVR 在瓣环成形术环（瓣环）或天然二尖瓣环钙化 (MAC) 中的应用。 MAC 中的阀门）。所有受试者的 LVOT 梗阻预测风险均较高。受试者并未因过度虚弱或合并症而被排除。主要终点是 30 天时的技术成功和安全性。第 1 年评估次要临床和超声心动图终点，第 5 年进行临床随访。 2017 年 6 月至 2018 年 6 月期间，共有 30 名受试者入组，其中 Valve-in-MAC 组和 Valve-in-ring 组的受试者人数相等。 30 天时，LAMPOON 在所有 30 名受试者中均获得成功，无中风、1 例 (3%) 死亡和 1 例 (3%) 中度 LVOT 梗阻。 18 名 (65%) 存活至 1 年，7 名 (25%) 存活至 5 年。第一年有六人 (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了 24 分，6 分钟步行距离提高了 60 米。 N-末端脑钠肽前体没有显着变化。 1 年时，LVOT 梯度仍然较低。尽管存在 LVOT 梗阻的风险，LAMPOON 仍启用了 TMVR。 LAMPOON 没有出现与 LAMPOON 相关的长期并发症。无法手术患者的选择限制了 TMVR 后长期生存率的评估。（NHLBI DIR LAMPOON 研究：经导管二尖瓣植入期间故意撕裂二尖瓣前叶以防止左心室流出道阻塞；）