Reparación endovascular de aneurisma aórtico abdominal: estudio piloto de endoprótesis Ovation™: resultados comparativos / Endovascular repair of abdominal aortic aneurysm: comparative results of a pilot study using the Ovation™ prosthesis

RESUMEN

Introducción: Las endoprótesis actuales para tratar aneurismas aórticos (AAA) requieren introductores de alto diámetro (18-25F) y se sustentan excluyendo el aneurisma, mediante la fuerza radial de stents metálicos. Objetivo: prótesis Ovation™ (TriVascular, EEUU) con aquellas disponibles en el mercado. Material y Método: Entre Noviembre 2009 y Agosto 2010 tratamos 47 AAA. En 10 pacientes usamos Ovation™ (Grupo 1). Grupo Control (2) diez pacientes tratados contemporáneamente con endoprótesis comerciales. Ovation™ es tri-modular, de PTFE y nitinol con un stent barbado para fijación supra-renal. Sella bajo las arterias renales mediante 2 anillos llenados con un polímero durante el implante. Usa introductor 13-15F. Usa-Philips-Allura (Best, Holanda). Comparamos duración del procedimiento, hospitalización y complicaciones. Utilizamos test de Fisher exacto y t de student no pareado. Resultados: Éxito técnico 100 por ciento. Sin diferencia entre grupos (edad, sexo, tamaño AAA, riesgo ASA, laboratorio preoperatorio). Tiempo operatorio (hrs) 2,12 +/- 0,7 vs. 2,0 +/- 0,6 (NS). Estadía postoperatoria (hrs) 44,5 +/- 10,7 vs 49,5 +/- 32,0 (NS). El cuello del AAA y la permanencia en UTI fueron más cortos en grupo 1 (p= 0,035 y 0,0451). Seguimiento (4,5-12 meses) sin eventos adversos, endofugas tipo I ni III, ni re-intervenciones. Conclusiones: Los resultados con Ovation™ a corto plazo son comparables con los de otras endoprótesis, cumpliendo con estándares de eficacia y seguridad. Ovation ™ navega por vasos pequeños, permite un despliegue preciso y sellado efectivo en cuellos > 7 mm, ampliando el tratamiento endovascular del AAA.

ABSTRACT

Background. Current endografts used in treatment of abdominal aortic aneurysm (AAA), use large (18-25F) delivery systems. Graft fixation and aneurysm sealing is obtained by a proximal stent, requiring an aortic neck >15 mm. Objective. To compare the efficacy and safety of Ovation™ endograft (TriVascular, USA) with standard endografts. Methods. Between November 2009 and August 2010 we treated 47 AAA. In 10 patients we used Ovation™ (Group 1). Ten patients treated during the same period with commercially available endografts were used as controls (Group (2). The Ovation™ endo-prosthesis is tri-modular, made of PTFE andnitinol with low profile (13-15F) and has a barbed suprarenal stent for fixation. Sealing is obtained independently through 2 inflatable rings filled with a biocompatible polymer during the procedure. Implantation followed the standard procedure through femoral exposure, using the Philips Allura imaging equipment (Best, Netherlands). Procedure duration, length of stay (LOS) and complications were compared between groups. Fisher exact test and unpaired Student’s t test were used for comparisons. Results. Results. Technical success was 100 percent. We observed no difference between groups (age, sex, AAA size, ASA risk, preoperative lab work). Procedure time (hrs) was 2,12 +/- 0,7 vs. 2,0 +/- 0,6 (NS), LOS (hrs) was 44,5 +/- 10,7 vs. 49,5 +/- 32,0 (NS) in Groups 1 and 2, respectively. Aneurysm neck length and ICU stay were shorter in Group 1 (p= 0,035 and 0,0451 respectively). During a 12 month follow up no adverse events, type I or III endoleak, or secondary interventions have occurred. Conclusion. Results with Ovation™ are comparable to other endografts currently available, achieving the same standards of efficacy and safety. Its highly flexible delivery system allows navigation through small vessels, easy deployment and effective sealing of AAA with necks > 7 mm, broadening the span of patients suitable for endovascular treatment.