Percutaneous Device Closure for Significant Paravalvular Leakage After Transcatheter or Surgical Valve Replacement

Percutaneous Device Closure for Significant Paravalvular Leakage After Transcatheter or Surgical Valve replacement_Pilot Study

This study evaluates the effectiveness and safety of Percutaneous Device Closure for Significant Paravalvular Leakage after transcatheter or surgical valve replacement.

Inclusion Criteria:

• Significant Paravalvular Leakage After Transcatheter or Surgical Valve Replacement

• Required treatment of paravalvular leakage due to heart failure or hemolysis

• There is a formal agreement of heart team as following

  • predicted high-risk (STS score ≥8 OR Logistic EuroSCORE ≥20% OR operative mortality is ≥15%)

• Inoperable status due to old age or frailty

• Written consent

Exclusion Criteria:

• Risk of valve embolization because of valve dehiscence or instability
• Acute myocardial ischemia (enzyme elevation, ST elevation on EKG(electrocardiogram), or chest pain/discomfort)
• Evidence of intracardiac mass, thrombus or vegetation on Transthoracic/Transesophageal echocardiographic study
• Life expectancy less than 6 months due to non-cardiac disease
• Pregnant or breastfeeding