Authors' recommendations: 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. Key Questions: 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?

Project Status: Completed

Year Published: 2017

URL for published report: The report may be purchased from: http://www.hayesinc.com/hayes/crd/?crd=72166

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: United States

Organisation Name: HAYES, Inc.

Contact Address: 157 S. Broad Street, Suite 200, Lansdale, PA 19446, USA. Tel: 215 855 0615; Fax: 215 855 5218

Contact Name: saleinfo@hayesinc.com

Contact Email: saleinfo@hayesinc.com

Copyright: Winifred S. Hayes, Inc