Multicenter evaluation of Edwards SAPIEN positioning during transcatheter aortic valve implantation with correlates for device movement during final deployment.

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Citation: Jacc: Cardiovascular Interventions. 5(5):563-70, 2012 May.PMID: 22625196Institution: MedStar Heart & Vascular InstituteForm of publication: Journal ArticleMedline article type(s): Evaluation Studies | Journal Article | Multicenter Study | Research Support, Non-U.S. Gov'tSubject headings: *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 OutcomeLocal holdings: Available online through MWHC library: 2008 - presentISSN:
  • 1876-7605
Name of journal: JACC. Cardiovascular interventionsAbstract: 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.All authors: Almagor Y, Cribier A, Descoutures F, Dvir D, Eltchaninoff H, Himbert D, Kornowski R, Lavi I, Tron C, Vahanian ADigital Object Identifier: Date added to catalog: 2013-09-17
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Journal Article MedStar Authors Catalog Article Available 22625196

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.

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