title: Management of implant failure during transcatheter aortic valve implantation.
abstract: BACKGROUND
  Transcatheter aortic valve implantation (TAVI) is an emerging alternative to palliative medical therapy for nonsurgical patients with severe aortic stenosis. There is a paucity of detailed data on the management and outcome of complications related to the sub-optimal deployment of the prosthesis. We appraised the incidence and management of early implant failure occurring during TAVI.
  
  
  METHODS
  Of 110 patients who underwent TAVI using the third generation 18-French CoreValve ReValving System (Medtronic, MN) in our Institution between June 2007 and January 2010, we identified those experiencing early implant failure and reported on their management and clinical outcome. The primary endpoint was the incidence of major adverse cardiovascular and cerebrovascular event (MACCE) at 30 days and mid-term follow up.
  
  
  RESULTS
  Early implant failure occurred in 18 of 110 patients (16.3%). The most common cause was prosthesis under-expansion conditioning moderate to severe peri-valvular leak (44.4%). Prosthesis deployment too low or too high with respect to the aortic annulus leading to severe peri-valvular leak occurred in 22.2% and 5.5% of patients, respectively. Need of valve retrieve after the first attempt of deployment occurred in four cases (22.2%). Prosthesis embolization in the ascending aorta occurred in 5.5% of patients who experienced early implant failure. All implant failure cases were managed percutaneously with gain in aortic valve area from 0.44 ± 0.17 to 1.28 ± 0.27 cm(2) (P < 0.001), decrease of mean transaortic gradient from 55.00 ± 19.51 to 11.58 ± 5.91 mmHg (P < 0.001) and no MACCE at 30 days. After 11 ± 6 months, MACCE occurred cumulatively in two patients (11.1%).
  
  
  CONCLUSIONS
  Early implant failure can complicate the TAVI procedure with the CoreValve system, but it can be managed safely and effectively with bailout transcatheter techniques, avoiding surgery, with good early and mid-term clinical and echocardiographic results.
authors.affiliation: Division of Cardiology, Ferrarotto Hospital, University of Catania, Catania, Italy. gpussia@hotmail.com
authors.forename: Gian Paolo
authors.initials: GP
authors.lastname: Ussia
authors.forename: Marco
authors.initials: M
authors.lastname: Barbanti
authors.forename: Sebastiano
authors.initials: S
authors.lastname: Immè
authors.forename: Marilena
authors.initials: M
authors.lastname: Scarabelli
authors.forename: Massimiliano
authors.initials: M
authors.lastname: Mulè
authors.forename: Valeria
authors.initials: V
authors.lastname: Cammalleri
authors.forename: Patrizia
authors.initials: P
authors.lastname: Aruta
authors.forename: Anna Maria
authors.initials: AM
authors.lastname: Pistritto
authors.forename: Davide
authors.initials: D
authors.lastname: Capodanno
authors.forename: Wanda
authors.initials: W
authors.lastname: Deste
authors.forename: Maria Concetta
authors.initials: MC
authors.lastname: Di Pasqua
authors.forename: Corrado
authors.initials: C
authors.lastname: Tamburino
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001024:Aortic Valve Stenosis / Q000401:mortality / Q000628:therapy*; D001027:Aortography; D006328:Cardiac Catheterization / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D002318:Cardiovascular Diseases / Q000209:etiology / Q000628:therapy; D016009:Chi-Square Distribution; D020878:Device Removal; D004452:Echocardiography; D005260:Female; D005548:Foreign-Body Migration / Q000209:etiology / Q000628:therapy; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation / Q000009:adverse effects / Q000295:instrumentation* / Q000379:methods / Q000401:mortality; D006801:Humans; D007558:Italy; D053208:Kaplan-Meier Estimate; D016015:Logistic Models; D008297:Male; D011474:Prosthesis Design; D011475:Prosthesis Failure; D012189:Retrospective Studies; D018570:Risk Assessment; D012307:Risk Factors; D012720:Severity of Illness Index; D013997:Time Factors