Multicenter evaluation of Edwards SAPIEN positioning during transcatheter aortic valve implantation with correlates for device movement during final deployment.
JACC Cardiovasc Interv
; 5(5): 563-570, 2012 May.
Article
em En
| MEDLINE
| ID: mdl-22625196
ABSTRACT
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.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.
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Estenose da Valva Aórtica
/
Próteses Valvulares Cardíacas
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Cateterismo Cardíaco
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Implante de Prótese de Valva Cardíaca
Tipo de estudo:
Clinical_trials
/
Etiology_studies
/
Evaluation_studies
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Observational_studies
/
Risk_factors_studies
Limite:
Aged
/
Aged80
/
Female
/
Humans
/
Male
País/Região como assunto:
Asia
/
Europa
Idioma:
En
Revista:
JACC Cardiovasc Interv
Assunto da revista:
ANGIOLOGIA
/
CARDIOLOGIA
Ano de publicação:
2012
Tipo de documento:
Article
País de afiliação:
Israel