Multicenter evaluation of Edwards SAPIEN positioning during transcatheter aortic valve implantation with correlates for device movement during final deployment.
Multicenter evaluation of Edwards SAPIEN positioning during transcatheter aortic valve implantation with correlates for device movement during final deployment.
Available online through MWHC library: 2008 - present
BACKGROUND: Accurate device positioning during transcatheter aortic valve implantation is crucial in order to achieve optimal results. 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. Copyright 2012 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved. 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). OBJECTIVES: 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. 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.
English
1876-7605
*Aortic Valve Stenosis/th [Therapy]
*Cardiac Catheterization/is [Instrumentation]
*Heart Valve Prosthesis Implantation/is [Instrumentation]
*Heart Valve Prosthesis Implantation/mt [Methods]
*Heart Valve Prosthesis
Aged, 80 and over
Aged
Cardiac Catheterization/ae [Adverse Effects]
Cardiac Pacing, Artificial
Female
Fluoroscopy
France
Heart Valve Prosthesis Implantation/ae [Adverse Effects]
Humans
Israel
Male
Multivariate Analysis
Prospective Studies
Prosthesis Design
Radiography, Interventional/mt [Methods]
Risk Assessment
Risk Factors
Treatment Outcome
MedStar Heart & Vascular Institute
Evaluation Studies
Journal Article
Multicenter Study
Research Support, Non-U.S. Gov't
Available online through MWHC library: 2008 - present
BACKGROUND: Accurate device positioning during transcatheter aortic valve implantation is crucial in order to achieve optimal results. 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. Copyright 2012 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved. 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). OBJECTIVES: 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. 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.
English
1876-7605
*Aortic Valve Stenosis/th [Therapy]
*Cardiac Catheterization/is [Instrumentation]
*Heart Valve Prosthesis Implantation/is [Instrumentation]
*Heart Valve Prosthesis Implantation/mt [Methods]
*Heart Valve Prosthesis
Aged, 80 and over
Aged
Cardiac Catheterization/ae [Adverse Effects]
Cardiac Pacing, Artificial
Female
Fluoroscopy
France
Heart Valve Prosthesis Implantation/ae [Adverse Effects]
Humans
Israel
Male
Multivariate Analysis
Prospective Studies
Prosthesis Design
Radiography, Interventional/mt [Methods]
Risk Assessment
Risk Factors
Treatment Outcome
MedStar Heart & Vascular Institute
Evaluation Studies
Journal Article
Multicenter Study
Research Support, Non-U.S. Gov't