5-Year Outcomes of Anterior Mitral Leaflet Laceration to Prevent Outflow Obstruction.
5-Year Outcomes of Anterior Mitral Leaflet Laceration to Prevent Outflow Obstruction.
- 2024
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. 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). Copyright Published by Elsevier Inc. 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. 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. 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.
English
1936-8798
NIHMS2003597 [mid] PMC11424260 [pmc] S1936-8798(24)00861-6 [pii]
*Cardiac Catheterization
*Feasibility Studies
*Heart Valve Prosthesis
*Heart Valve Prosthesis Implantation
*Mitral Valve
*Mitral Valve Insufficiency
*Recovery of Function
*Ventricular Outflow Obstruction
Aged
Aged, 80 and over
Cardiac Catheterization/ae [Adverse Effects]
Cardiac Catheterization/is [Instrumentation]
Female
Heart Valve Prosthesis Implantation/ae [Adverse Effects]
Heart Valve Prosthesis Implantation/is [Instrumentation]
Heart Valve Prosthesis Implantation/mo [Mortality]
Hemodynamics
Humans
Male
Middle Aged
Mitral Valve Annuloplasty/ae [Adverse Effects]
Mitral Valve Annuloplasty/is [Instrumentation]
Mitral Valve Annuloplasty/mo [Mortality]
Mitral Valve Insufficiency/dg [Diagnostic Imaging]
Mitral Valve Insufficiency/mo [Mortality]
Mitral Valve Insufficiency/pp [Physiopathology]
Mitral Valve Insufficiency/su [Surgery]
Mitral Valve/dg [Diagnostic Imaging]
Mitral Valve/pp [Physiopathology]
Mitral Valve/su [Surgery]
Prospective Studies
Risk Factors
Time Factors
Treatment Outcome
United States
Ventricular Function, Left
Ventricular Outflow Obstruction/dg [Diagnostic Imaging]
Ventricular Outflow Obstruction/et [Etiology]
Ventricular Outflow Obstruction/mo [Mortality]
Ventricular Outflow Obstruction/pc [Prevention & Control]
Ventricular Outflow Obstruction/pp [Physiopathology]
Ventricular Outflow Obstruction/su [Surgery]--Automated
MedStar Heart & Vascular Institute
Clinical Trial
Journal Article
Multicenter Study
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. 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). Copyright Published by Elsevier Inc. 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. 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. 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.
English
1936-8798
NIHMS2003597 [mid] PMC11424260 [pmc] S1936-8798(24)00861-6 [pii]
*Cardiac Catheterization
*Feasibility Studies
*Heart Valve Prosthesis
*Heart Valve Prosthesis Implantation
*Mitral Valve
*Mitral Valve Insufficiency
*Recovery of Function
*Ventricular Outflow Obstruction
Aged
Aged, 80 and over
Cardiac Catheterization/ae [Adverse Effects]
Cardiac Catheterization/is [Instrumentation]
Female
Heart Valve Prosthesis Implantation/ae [Adverse Effects]
Heart Valve Prosthesis Implantation/is [Instrumentation]
Heart Valve Prosthesis Implantation/mo [Mortality]
Hemodynamics
Humans
Male
Middle Aged
Mitral Valve Annuloplasty/ae [Adverse Effects]
Mitral Valve Annuloplasty/is [Instrumentation]
Mitral Valve Annuloplasty/mo [Mortality]
Mitral Valve Insufficiency/dg [Diagnostic Imaging]
Mitral Valve Insufficiency/mo [Mortality]
Mitral Valve Insufficiency/pp [Physiopathology]
Mitral Valve Insufficiency/su [Surgery]
Mitral Valve/dg [Diagnostic Imaging]
Mitral Valve/pp [Physiopathology]
Mitral Valve/su [Surgery]
Prospective Studies
Risk Factors
Time Factors
Treatment Outcome
United States
Ventricular Function, Left
Ventricular Outflow Obstruction/dg [Diagnostic Imaging]
Ventricular Outflow Obstruction/et [Etiology]
Ventricular Outflow Obstruction/mo [Mortality]
Ventricular Outflow Obstruction/pc [Prevention & Control]
Ventricular Outflow Obstruction/pp [Physiopathology]
Ventricular Outflow Obstruction/su [Surgery]--Automated
MedStar Heart & Vascular Institute
Clinical Trial
Journal Article
Multicenter Study