预防流出道梗阻的前二尖瓣叶裂伤 5 年结果。
5-Year Outcomes of Anterior Mitral Leaflet Laceration to Prevent Outflow Obstruction.
机构信息
Cardiovascular Branch, Division of Intramural Research, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland, USA; St. Francis Hospital and Heart Center, Roslyn, New York, USA.
Structural Heart and Valve Center, Emory University Hospital, Atlanta, Georgia, USA. Electronic address: https://twitter.com/BabaliarosArgos.
出版信息
JACC Cardiovasc Interv. 2024 Sep 23;17(18):2157-2167. doi: 10.1016/j.jcin.2024.05.041. Epub 2024 Sep 4.
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.
OBJECTIVES
The authors report the 5-year outcomes of intentional anterior mitral leaflet laceration before SAPIEN 3 TMVR, in patients at risk of LVOT obstruction.
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).
背景
左心室流出道（LVOT）阻塞是经导管二尖瓣置换术（TMVR）的常见且常致命的并发症。在国立心肺血液研究所的 LAMPOON 试验中，为预防 LVOT 阻塞，在 30 天时，预防性切开前二尖瓣叶以预防流出道阻塞（LAMPOON）术既安全又有效。
目的
作者报告了在有 LVOT 阻塞风险的患者中，在 SAPIEN 3TMVR 之前进行有意的前二尖瓣叶切开术的 5 年结果。
方法
国立心肺血液研究所的 LAMPOON 试验是一项前瞻性、多中心、单臂的 LAMPOON 和经房间隔 SAPIEN 3TMVR 的安全性和可行性研究，适用于瓣环成形术（瓣中瓣）或二尖瓣环钙化（MAC）（瓣中瓣）。所有患者均具有 LVOT 阻塞的高预测风险。对于过度虚弱或合并症，未排除患者。主要终点为 30 天的技术成功率和安全性。次要临床和超声心动图终点在 1 年时评估，临床随访在 5 年时进行。
结果
在 2017 年 6 月至 2018 年 6 月期间，共有 30 名患者入组，平均分配到 MAC 瓣中瓣和瓣环瓣中瓣两组。在 30 天时，30 名患者的 LAMPOON 均成功，无中风，1 例（3%）死亡，1 例（3%）中度 LVOT 阻塞。18 名（65%）在 1 年内存活，7 名（25%）在 5 年内存活。第 1 年有 6 名（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 端脑利钠肽前体无显著变化。1 年时，LVOT 梯度仍较低。
结论
尽管存在 LVOT 阻塞风险，但 LAMPOON 可使 TMVR 得以进行。与 LAMPOON 相关的无长期并发症。无法手术患者的选择限制了对 TMVR 后长期生存的评估。（NHLBI DIR LAMPOON 研究：经导管二尖瓣置换术中切开前二尖瓣叶以预防左心室流出道梗阻；NCT03015194）。
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