title: Multicenter evaluation of Edwards SAPIEN positioning during transcatheter aortic valve implantation with correlates for device movement during final deployment.
abstract: OBJECTIVE
  This study sought to evaluate the exact location of Edwards SAPIEN (Edwards Lifesciences, Irvine, California) devices in different stages of implantation and to quantify possible operator-independent device movement during final deployment.
  
  
  BACKGROUND
  Accurate device positioning during transcatheter aortic valve implantation is crucial in order to achieve optimal results.
  
  
  METHODS
  This multicenter study consisted of 68 procedures with reliable pacemaker capture. Device positions were assessed using fluoroscopic images and the C-THV system (Paieon Medical, Rosh Ha'Ayin, Israel).
  
  
  RESULTS
  The location after implantation was significantly higher than in the final stage of rapid pacing: 16.7 ± 16.3% of device height below the plane of the lower sinus border versus 32.6 ± 13.8%, p < 0.0001. Operator-independent device-center upper movement during final deployment was 2 ± 1.43 mm, range: -1.3 to 4.6 mm. Device movement was asymmetrical, occurring more in the lower part of the device than in its upper part (3.2 ± 1.4 mm vs. 0.75 ± 1.5 mm, p < 0.001), resulting in device shortening. Multivariate analysis revealed that moderate and severe aortic valve calcification had 49% higher upward movement than mild calcification (p = 0.03), and aortic sinus volume was negatively correlated with movement size (r = -0.35, p = 0.005). This movement was independent of device version (SAPIEN vs. SAPIEN XT), procedural access (transfemoral vs. transapical), and interventricular septum width.
  
  
  CONCLUSIONS
  The final Edwards SAPIEN position is mostly aortic in relation to the lower sinus border. There is an operator-independent upward movement of the device center during the final stage of implantation. Anticipated upward movement of the device should influence its positioning before final deployment.
authors.affiliation: Department of Cardiology, Institute of Interventional Cardiology, Rabin Medical Center, Beilinson Campus, Petach Tikva, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.
authors.forename: Danny
authors.initials: D
authors.lastname: Dvir
authors.affiliation: Department of Cardiology, Institute of Interventional Cardiology, Rabin Medical Center, Beilinson Campus, Petach Tikva, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.
authors.forename: Ifat
authors.initials: I
authors.lastname: Lavi
authors.affiliation: Department of Cardiology, Charles Nicolle Hospital, University of Rouen, Rouen, France.
authors.forename: Hélène
authors.initials: H
authors.lastname: Eltchaninoff
authors.affiliation: Department of Cardiology, Hôpital Bichat, Paris, France.
authors.forename: Dominique
authors.initials: D
authors.lastname: Himbert
authors.affiliation: Department of Cardiology, Sha'are Zedek Medical Center, Jerusalem, Israel.
authors.forename: Yaron
authors.initials: Y
authors.lastname: Almagor
authors.affiliation: Department of Cardiology, Hôpital Bichat, Paris, France.
authors.forename: Fleur
authors.initials: F
authors.lastname: Descoutures
authors.affiliation: Department of Cardiology, Hôpital Bichat, Paris, France.
authors.forename: Alec
authors.initials: A
authors.lastname: Vahanian
authors.affiliation: Department of Cardiology, Charles Nicolle Hospital, University of Rouen, Rouen, France.
authors.forename: Christophe
authors.initials: C
authors.lastname: Tron
authors.affiliation: Department of Cardiology, Charles Nicolle Hospital, University of Rouen, Rouen, France.
authors.forename: Alain
authors.initials: A
authors.lastname: Cribier
authors.affiliation: Department of Cardiology, Institute of Interventional Cardiology, Rabin Medical Center, Beilinson Campus, Petach Tikva, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel. Electronic address: rkornowski@clalit.org.il.
authors.forename: Ran
authors.initials: R
authors.lastname: Kornowski
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001024:Aortic Valve Stenosis / Q000628:therapy*; D006328:Cardiac Catheterization / Q000009:adverse effects / Q000295:instrumentation*; D002304:Cardiac Pacing, Artificial; D005260:Female; D005471:Fluoroscopy; D005602:France; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation / Q000009:adverse effects / Q000295:instrumentation* / Q000379:methods*; D006801:Humans; D007557:Israel; D008297:Male; D015999:Multivariate Analysis; D011446:Prospective Studies; D011474:Prosthesis Design; D015641:Radiography, Interventional / Q000379:methods; D018570:Risk Assessment; D012307:Risk Factors; D016896:Treatment Outcome