title: A prospective "oversizing" strategy of the Edwards SAPIEN bioprosthesis: results and impact on aortic regurgitation.
abstract: OBJECTIVE
  Moderate to severe aortic regurgitation is occurring in 20% to 30% of cases after transcatheter aortic valve implantation.
  
  
  METHODS
  The purpose of the study was to investigate the impact of a prospective policy of "oversizing" the Edwards SAPIEN bioprosthesis (Edwards Lifesciences LLC, Irvine, Calif) relative to the diameter of the aortic annulus on the rate and severity of aortic regurgitation in 28 consecutive patients initially considered eligible for transcatheter aortic valve implantation on the basis of angiography, multislice computed tomography, and transthoracic echocardiography. This policy included the systematic use of transesophageal echocardiography to exclude borderline patients and the modification of the procedure to use the larger device possible. The results were studied on an individual patient basis.
  
  
  RESULTS
  Because 6 of 28 patients (21%) had an annulus diameter greater than 24 mm by transesophageal echocardiography, 22 patients underwent implantation of the Edwards SAPIEN prosthesis. In 6 of 22 patients, the procedure was adapted to follow our "oversizing" policy. As a result, the "prosthesis/annulus cover index" was 12.4% ± 4.3%. The procedure was successful in 21 of 22 patients (95%), and 18 patients were available for echocardiography at 1 month. Although a moderate to severe aortic regurgitation was observed pretreatment in 4 of 18 patients (22%), it was no longer the case at 1 month (0/18, 0%; P = .03). The improvement was secondary to a disappearance of the aortic regurgitation in all 7 patients with a significant aortic regurgitation at pretreatment, whereas the new aortic regurgitations appearing in 5 of the 11 patients with no aortic regurgitation at pretreatment were only mild aortic regurgitations.
  
  
  CONCLUSIONS
  In patients with a successful implantation of an Edwards SAPIEN valve, a simple "oversizing" policy based on a systematic use of transesophageal echocardiography and modification of the procedure may prevent the occurrence of moderate and severe aortic regurgitations.
authors.affiliation: Department of Cardiology, University Medical Center, Utrecht, The Netherlands.
authors.forename: Mariam
authors.initials: M
authors.lastname: Samim
authors.forename: Pieter R
authors.initials: PR
authors.lastname: Stella
authors.forename: Pierfrancesco
authors.initials: P
authors.lastname: Agostoni
authors.forename: Jolanda
authors.initials: J
authors.lastname: Kluin
authors.forename: Faiz
authors.initials: F
authors.lastname: Ramjankhan
authors.forename: Gertjan
authors.initials: G
authors.lastname: Sieswerda
authors.forename: Ricardo
authors.initials: R
authors.lastname: Budde
authors.forename: Marijke
authors.initials: M
authors.lastname: van der Linden
authors.forename: Francis
authors.initials: F
authors.lastname: Juthier
authors.forename: Carlo
authors.initials: C
authors.lastname: Banfi
authors.forename: Christopher
authors.initials: C
authors.lastname: Hurt
authors.forename: Morsal
authors.initials: M
authors.lastname: Samim
authors.forename: Marieke
authors.initials: M
authors.lastname: Hillaert
authors.forename: Lex
authors.initials: L
authors.lastname: van Herwerden
authors.forename: Michel E
authors.initials: ME
authors.lastname: Bertrand
authors.forename: Pieter A M
authors.initials: PA
authors.lastname: Doevendans
authors.forename: Eric
authors.initials: E
authors.lastname: Van Belle
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000704:Analysis of Variance; D001021:Aortic Valve / Q000000981:diagnostic imaging / Q000503:physiopathology; D001022:Aortic Valve Insufficiency / Q000175:diagnosis / Q000209:etiology / Q000503:physiopathology / Q000628:therapy*; D001024:Aortic Valve Stenosis / Q000150:complications / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy*; D001705:Bioprosthesis; D006328:Cardiac Catheterization / Q000009:adverse effects / Q000295:instrumentation*; D016009:Chi-Square Distribution; D015150:Echocardiography, Doppler; D017548:Echocardiography, Transesophageal; D005260:Female; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation / Q000009:adverse effects / Q000295:instrumentation*; D006801:Humans; D008297:Male; D061330:Multidetector Computed Tomography; D011237:Predictive Value of Tests; D011446:Prospective Studies; D011474:Prosthesis Design; D012720:Severity of Illness Index; D013997:Time Factors; D016896:Treatment Outcome