Rationale: Medical therapy can ameliorate symptoms associated with aortic or mitral prosthetic paravalvular leaks (PVLs). However, repeat cardiac surgery is associated with increased morbidity and mortality, with added risk secondary to paravalvular tissue friability and heavy calcification. Thus, percutaneous closure of prosthetic PVLs is under investigation as an alternative to open surgical repair of these defects.
Technology Description: Transcatheter closure (TC) or percutaneous closure of prosthetic PVLs is a complex interventional cardiology procedure that involves the deployment of a wire mesh occluding device into the heart across or through each PVL site to close it.
Controversy: A major controversy related to this technique is the lack of a dedicated device for closure of prosthetic PVLs. None of the devices commercially available in the United States have been approved for marketing or gained clearance from the Food and Drug Administration for this use.
- Is TC closure effective for repair of aortic or mitral prosthetic PVLs?
- Is TC closure of aortic or mitral prosthetic PVLs safe?
- Have definitive patient selection criteria been established for TC closure of aortic or mitral prosthetic PVLs?
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