title: Transcatheter umbrella closure of valvular and paravalvular leaks.
abstract: OBJECTIVE
  Our aim was to adapt the technique of transcatheter umbrella closure of intracardiac defects for closure of valvular and paravalvular defects.
  
  
  BACKGROUND
  The double-umbrella device developed by Rashkind and Cuaso has been safely and effectively delivered across a host of intracardiac defects, but transcatheter closure of valvular and paravalvular leaks has not been reported.
  
  
  METHODS
  Between February 1987 and September 1990, eight patients who were believed to be poor operative candidates were taken to the catheterization laboratory for transcatheter double-umbrella closure of a valvular or a paravalvular leak. Four patients had a paravalvular leak around a prosthetic aortic valve. The other four patients had a valvular leak: one patient with a regurgitant native aortic valve after a Stansel procedure and three patients with a regurgitant porcine valve in a left ventricular apex to descending aorta conduit.
  
  
  RESULTS
  Placement of a double-umbrella device was attempted in seven of the eight patients and was successful in all seven. Device placement was not attempted in one patient because of the crescentic shape of his defect. Two patients required two devices for each closure; the other five required only one device each. Angiography, performed on six patients after device closure, demonstrated that three patients had a completely occluded defect, two had trivial residual flow and one patient had mild residual flow through the device. All significant complications occurred in one patient who had hemolysis and oliguria that resolved when the initial umbrella was replaced by a larger device. In addition, two devices migrated to the patient's pulmonary arteries but were retrieved in the catheterization laboratory without difficulty. No other early or late complications occurred in 21 to 50 months of follow-up. Of the four patients with a paravalvular leak, the one who did not receive a device died at operation, one patient died at operation for an associated defect (in the operating room the umbrella was found securely in place across the paraaortic defect) and two patients are clinically well at home after 21 and 32 months, respectively. Of the four patients with closure of a valvular leak, one patient remains well at home 50 months later, one patient died at operation for associated defects and two patients had additional successful surgical treatment and remain well 29 months after device placement.
  
  
  CONCLUSIONS
  Transcatheter umbrella closure appears to be a reasonable alternative for closure of a valvular or paravalvular leak in patients who are poor operative candidates.
authors.affiliation: Department of Cardiology, Children's Hospital, Boston, Massachusetts 02115.
authors.forename: M
authors.initials: M
authors.lastname: Hourihan
authors.forename: S B
authors.initials: SB
authors.lastname: Perry
authors.forename: V S
authors.initials: VS
authors.lastname: Mandell
authors.forename: J F
authors.initials: JF
authors.lastname: Keane
authors.forename: J J
authors.initials: JJ
authors.lastname: Rome
authors.forename: J A
authors.initials: JA
authors.lastname: Bittl
authors.forename: J E
authors.initials: JE
authors.lastname: Lock
mesh_terms: D001021:Aortic Valve / Q000000981:diagnostic imaging / Q000503:physiopathology; D001705:Bioprosthesis / Q000706:statistics & numerical data; D006328:Cardiac Catheterization / Q000295:instrumentation / Q000379:methods* / Q000706:statistics & numerical data; D004621:Embolization, Therapeutic / Q000295:instrumentation / Q000379:methods* / Q000706:statistics & numerical data; D005500:Follow-Up Studies; D006349:Heart Valve Diseases / Q000000981:diagnostic imaging / Q000453:epidemiology / Q000503:physiopathology / Q000628:therapy; D006350:Heart Valve Prosthesis / Q000706:statistics & numerical data; D006439:Hemodynamics; D006801:Humans; D010166:Palliative Care; D011183:Postoperative Complications / Q000000981:diagnostic imaging / Q000453:epidemiology / Q000503:physiopathology / Q000628:therapy*; D011475:Prosthesis Failure; D011859:Radiography