Mitral Annulus Calcification, Rheumatic Heart Disease
Conditions
Keywords
Mitral valve stenosis
Brief summary
Mitral stenosis (MS) is a heavily symptomatic valvular heart disease. Common causes of MS included chronic rheumatic heart disease (CRHD) and mitral annular calcification (MAC). Current guideline recommends percutaneous balloon mitral valvuloplasty (PBMV) being the first line intervention for rheumatic MS with favorable anatomy. However, severely calcified mitral valve (i.e. those with Wilkins scores\>8) makes the mitral valve non-pliable and carries high risk of severe mitral regurgitation (MR) (4-19%) with conventional balloon valvuloplasty. MAC is an increasingly recognized disease associated with atherosclerotic risk factors, and a well-recognized valve morphology that responses poorly with PBMV. Besides, conventional open-heart surgery for MAC-associated mitral valve dysfunction carries high mortality. Transcatheter mitral valve replacement with valve-in-MAC has become an alternative in treating these patients. However, valve-in-MAC is not always feasible and still carries operative and 30-day mortality. Intravascular lithotripsy is an approved adjunct interventional therapy in treating calcified lesions to facilitate stenotic lesion opening in peripheral vascular disease and coronary artery disease. The off-label use of current peripheral lithotripsy balloon in mitral valve as a compassionate treatment or as an adjunct treatment before mitral balloon valvuloplasty and transcatheter mitral valve replacement has been reported with success . A possible mechanism is that lithotripsy preferentially impacts hard tissue, disrupts calcium, and leaves soft tissue undisturbed, improving valve pliability, preventing leaflet damage, and making subsequent valvuloplasty safer. However, the off-label use of multiple peripheral lithotripsy balloons in mitral valve is technically complicated. SmartWave balloon was specifically designed lithotripsy balloon for calcified aortic stenosis. This first-in-human study aims to apply the SmartWave lithotripsy balloon in treating calcified mitral stenosis due to MAC or severely calcified rheumatic mitral valve.
Detailed description
Mitral stenosis (MS) is a heavily symptomatic valvular heart disease. Common causes of MS included chronic rheumatic heart disease (CRHD) and mitral annular calcification (MAC). Current guideline recommends percutaneous balloon mitral valvuloplasty (PBMV) being the first line intervention for rheumatic MS with favorable anatomy. However, severely calcified mitral valve (i.e. those with Wilkins scores\>8) makes the mitral valve non-pliable and carries high risk of severe mitral regurgitation (MR) (4-19%) with conventional balloon valvuloplasty. MAC is an increasingly recognized disease associated with atherosclerotic risk factors, and a well-recognized valve morphology that responses poorly with PBMV. Besides, conventional open-heart surgery for MAC-associated mitral valve dysfunction carries high mortality. Transcatheter mitral valve replacement with valve-in-MAC has become an alternative in treating these patients. However, valve-in-MAC is not always feasible and still carries operative and 30-day mortality. Intravascular lithotripsy is an approved adjunct interventional therapy in treating calcified lesions to facilitate stenotic lesion opening in peripheral vascular disease and coronary artery disease. The off-label use of current peripheral lithotripsy balloon in mitral valve as a compassionate treatment or as an adjunct treatment before mitral balloon valvuloplasty and transcatheter mitral valve replacement has been reported with success . A possible mechanism is that lithotripsy preferentially impacts hard tissue, disrupts calcium, and leaves soft tissue undisturbed, improving valve pliability, preventing leaflet damage, and making subsequent valvuloplasty safer. However, the off-label use of multiple peripheral lithotripsy balloons in mitral valve is technically complicated. SmartWave balloon was specifically designed lithotripsy balloon for calcified aortic stenosis. This first-in-human study aims to apply the SmartWave lithotripsy balloon in treating calcified mitral stenosis due to MAC or severely calcified rheumatic mitral valve.
Interventions
DEVICESmartWave Lithotripsy balloon
ntravascular lithotripsy is an approved adjunct interventional therapy in treating calcified lesions to facilitate stenotic lesion opening in peripheral vascular disease and coronary artery disease. The off-label use of current peripheral lithotripsy balloon in mitral valve as a compassionate treatment or as an adjunct treatment before mitral balloon valvuloplasty and transcatheter mitral valve replacement has been reported with success . A possible mechanism is that lithotripsy preferentially impacts hard tissue, disrupts calcium, and leaves soft tissue undisturbed, improving valve pliability, preventing leaflet damage, and making subsequent valvuloplasty safer.
Sponsors
Prince of Wales Hospital, Shatin, Hong Kong
Peijia Medical Technology (Suzhou) Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \>18 and * Able to give procedure and study consent and * Severe symptomatic mitral stenosis (MVA \<1.5cm\^2 derived by 3D planimetry or continuity equation or pressure half time) and * Presence of mitral annular calcification or * CRHD with severe leaflet calcification with Wilkins score \>8
Exclusion criteria
* Baseline \> moderate MR * Intracardiac thrombus as visualized by TEE * Pregnant patients. Female patients of childbearing potential must have a negative pregnancy test (per site standard test) within 7 days prior to index procedure. * Active infection with bacteremia * Current participation in another investigational drug or device study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in mitral valve area | Post-OP 6 and 12 month | Immediate and sustained improvement in mitral valve area (MVA \>1.5cm\^2) without significant worsening of MR (\> moderate) |
| Absence of peri-procedural complication | At and peri-procedure | Absence of peri-procedural complication (death, stroke, myocardial infarction, cardiac tamponade, conversion to open heart) defined according to the Mitral Valve Academic Research Consortium |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hemodynamic changes | Intra-operation | Invasive haemodyanmic changes after each lithotripsy cycle |
| Mitral valve calcification level | Baseline and post-procedure up to 1 year | Baseline and post-procedural mitral valve calcium distribution and volume determined by computed tomography |
| Symptom status change (New York Heart Aassociation functional class) | Baseline,Post-OP 1 month, 3 month, 6 month, 12 month | Symptom status change assessed by New York Heart Aassociation functional class |
| Symptom status change (By Kansas City Cardiomyopathy Questionnaire-12) | Baseline,Post-OP 1 month, 3 month, 6 month, 12 month | Symptom status change assessed by Kansas City Cardiomyopathy Questionnaire-12 |
| Debris histology | peri-operation | Sentinel captured debris will be collected and sent for histology analysis to look for signs of tissue damage or calcification break off. |
| NTproBNP | baseline, post-operation, Post-OP 1, 3, 6, 12 month | Change of NTproBNP |
| Lung Fluid | baseline, Post-OP 1, 3, 6, 12 month | Change in lung fluid percentage |
| Major Adverse Cardiac Event | 6 month and 12 month post-operation | 6 month and 12 month clinical event (death, heart failure hospitalization, stroke, myocardial infarction, mitral valve reintervention) |
Countries
Hong Kong
Contacts
CONTACTDaniel Xu, Nursing Officer
PRINCIPAL_INVESTIGATORKent So, MbChB
Chinese University of Hong Kong
Outcome results
None listed