Structural heart disease refers to a group of cardiac defects other than coronary artery disease. Structural heart intervention is a rapidly growing field in cardiology. In the past decade, there has been paradigm shift in the management of structural heart disease from conventional open-heart surgery to transcatheter interventions. With increasing evidence supporting structural heart interventions including transcatheter aortic valve implantation or transcatheter edge to edge repair, there has important updates in recent guidelines in treating structural heart disease. Besides, new device innovations bloomed over the past few years and had expanded the possible treatment options for high surgical risk patients. Some breakthrough devices had been approved recently by the US Food and Drug Administration and some other devices are occasionally used on compassionate ground. However, there has been lack of data in structural heart interventions in Asia Pacific regions outside Japan \[8\]. In this study, we would like to analyze the epidemiological trends, patient characteristics, procedural outcomes and clinical outcomes of structural heart interventions, and compare them with historical cohorts, matched cohort receiving medical therapy and matched cohort receiving open heart surgeries.
Study Type
OBSERVATIONAL
Enrollment
1,000
The study allows us to understand the trend of transcatheter interventions in structural heart disease, clinical outcomes and allows the comparison of the outcomes of structural heart interventions to medical therapy and surgery at PWH, and to HA hospitals.
Prince of Wales Hospital
Hong Kong, Shatin, Hong Kong
Procedural success rate
Procedural success rate
Time frame: Post-procedure until 1 year post OP
Procedural safety endpoints
Rate of vascular complication in enrolled subjects , ,
Time frame: Post-procedure until 1 year post OP
Procedural safety endpoints
Rate of myocardial infarction in enrolled subjects
Time frame: Post-procedure until 1 year post OP
Procedural safety endpoints
Rate of stroke in enrolled subjects
Time frame: Post-procedure until 1 year post OP
Procedural safety endpoints
Rate of cardiac perforation in enrolled subjects
Time frame: Post-procedure until 1 year post OP
Procedural safety endpoints
Rate of device embolization in enrolled subjects
Time frame: Post-procedure until 1 year post OP
Procedural safety endpoints
Rate of death in enrolled subjects
Time frame: Post-procedure until 1 year post OP
Procedural safety endpoints
Rate of conversion to open heart surgery in enrolled subjects
Time frame: Post-procedure until 1 year post OP
Clinical outcome
NTproBNP at 3 months
Time frame: 3 months
Clinical outcome
NYHA class at 3 months
Time frame: 3 months
Clinical outcome
NTproBNP at 12 months
Time frame: 12 months
Clinical outcome
NYHA class at 12 months
Time frame: 12 months
Echocardiogram outcome
peri-device leak at post-OP 3 months compared with baseline
Time frame: 3 months
Echocardiogram outcome
LVEF at post-OP 3 months compared with baseline
Time frame: 3 months
Echocardiogram outcome
Valve residual regurgitation at post-OP 3 months compared with post-OP
Time frame: 3 months
Echocardiogram outcome
Degree of Valve stenosis at post-OP 3 months compared with baseline
Time frame: 3 months
Echocardiogram outcome
Degree of Valve stenosis at post-OP 12 months compared with baseline
Time frame: 12 months
Echocardiogram outcome
Peri-device leak at post-OP 12 months
Time frame: 12 months
Echocardiogram outcome
LVEF at post-OP 12 months compared with baseline
Time frame: 12 months
Echocardiogram outcome
valve residual regurgitation at post-OP 12 months compared with baseline
Time frame: 12 months
Clinical outcome
NYHA class comparison with matched historical cohort at PWH * Clinical outcome comparison with medical therapy cohort at PWH * Clinical outcome comparison with surgical cohort at PWH * Clinical outcome comparison with matched cohort at HA
Time frame: 12 months
Clinical outcome
NTproBNP comparison with matched historical cohort at PWH * Clinical outcome comparison with medical therapy cohort at PWH * Clinical outcome comparison with surgical cohort at PWH * Clinical outcome comparison with matched cohort at HA
Time frame: 12 months
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