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Published on: February 26, 2013
5-Year Outcomes of Anterior Mitral Leaflet Laceration to Prevent Outflow Obstruction
Jaffar M Khan1, Vasilis C Babaliaros2, Adam B Greenbaum3
1Cardiovascular 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.
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).
Insights
Laceration of the anterior mitral leaflet to prevent outflow obstruction (LAMPOON) safely enabled transcatheter mitral valve replacement in high-risk patients. Five-year follow-up showed no LAMPOON complications, though survival was limited by patient selection.
Area of Science:
- Cardiovascular Medicine
- Interventional Cardiology
- Cardiac Surgery
Background:
- Left ventricular outflow tract (LVOT) obstruction is a critical complication of transcatheter mitral valve replacement (TMVR).
- The Laceration of the Anterior Mitral Leaflet to Prevent Outflow Obstruction (LAMPOON) procedure was previously shown to be safe and effective at preventing LVOT obstruction at 30 days.
Purpose of the Study:
- To report the 5-year clinical and echocardiographic outcomes of intentional anterior mitral leaflet laceration prior to SAPIEN 3 TMVR.
- To evaluate the safety and efficacy of the LAMPOON procedure in patients at high risk for LVOT obstruction.
Main Methods:
- A prospective, multicenter, single-arm study (National Heart, Lung, and Blood Institute LAMPOON trial) assessed LAMPOON combined with transseptal SAPIEN 3 TMVR.
- The study included patients with native mitral annular calcification (MAC) or in annuloplasty rings, all with high predicted risk for LVOT obstruction.
- Primary endpoints were technical success and safety at 30 days; secondary endpoints included clinical and echocardiographic assessments at 1 year and clinical follow-up at 5 years.
Main Results:
- LAMPOON was technically successful in all 30 enrolled subjects, with no strokes and low rates of death (3%) and moderate LVOT obstruction (3%) at 30 days.
- Survival to 5 years was 25% (7/30), with 20% hospitalized for heart failure in the first year.
- Significant improvements were observed from baseline to 1 year in quality of life (Kansas City Cardiomyopathy Questionnaire score +24 points) and functional capacity (6-minute walk distance +60 m), with sustained low LVOT gradients.
Conclusions:
- The LAMPOON procedure effectively enabled TMVR in patients at risk of LVOT obstruction.
- No long-term complications directly attributed to the LAMPOON procedure were observed.
- The study population consisted of inoperable patients, which limited the assessment of long-term survival outcomes following TMVR.
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