ABSTRACT
La endoprótesis Nellix es un nuevo dispositivo endoluminal diseñado para tratar los aneurismas aorto-ilíacos, sellando el saco del aneurisma, eliminando así la endofuga mientras se mantiene el flujo normal de las extremidades inferiores. Se compone de dos conductos dilatables por balón,cada uno rodeado por una endobolsa, que se llena in situ con un polímero. Cada conducto soporta la luz del flujo sanguíneo a través del saco del aneurisma hacia las arterias ilíacas. La endobolsa con polímero se mantiene alrededor de la luz y llena el saco del aneurisma, bloqueando el flujoretrógrado de las ramas laterales, anclando el dispositivo en el saco del aneurisma sin necesidad de fijación proximal y distal; además provee estabilidad posicional. Por lo tanto, este dispositivo puede ser utilizado para tratar no sólo los pacientes con cuello aórtico y anatomía ilíaca estándar,sino también en aquellos con anatomías adversas. Se presenta la primera experiencia clínica de Nellix en 34 pacientes durante el período 2008-2010. Los resultados auguran un buen futuro y la pronta aprobación por la Comunidad Europea.
A endoprótese Nellix é um novo dispositivo endoluminal desenhado para tratar os aneurismas aorto-ilíacos, fechando completamente a bolsa de aneurisma, eliminando assim a endofuga,enquanto é mantido o fluxo normal das extremidades inferiores. Compõe-se de dois condutos ampliáveis por um balão, cada um rodeado por uma endobolsa, que se enche in situ com umpolímero. Cada conduto suporta a luz do fluxo sanguíneo através da bolsa de aneurisma até as artérias ilíacas. A endobolsa com polímero é mantida ao redor da luz e enche a bolsa de aneurisma, bloqueando o fluxo retrógrado dos ramos laterais, funcionando como dispositivo âncora na bolsa de aneurisma, sem necessidade de fixação proximal e distal, e além disso proporciona estabilidade posicional. Portanto, este dispositivo pode ser utilizado para tratar não somente pacientes com colo aórtico e anatomia ilíaca standard, como também aqueles com anatomias adversas. Apresenta-se a primeira experiência clinica de Nellix em 34 pacientes durante o período 2008-2010. Os resultados auguram um bom futuro e a breve aprovação da Comunidade Européia.
The Nellix endoprosthesis is a new endoluminal device designed to treat aorto-iliac aneurysms by sealing the aneurysm sac, thus eliminating the endoleak space, while maintaining normal flow to the lower extremities. It consists of dual, balloon-expandable endoframes, each surroundedby an endobag, which is filled with an in-situ curing polymer. Each endoframe supports the blood flow lumen through the aneurysm sac to the iliac arteries. The polymer containing endobags surround the flow lumen and fill the aneurysm sac, blocking retrograde flow from side-branches, anchoringthe device within the aneurysm sax without the need for proximal and distal fixation, and further providing it with positional stability. Thus, this device can be used to treat not only patients with standard aortic neck and iliac anatomy but also those with adverse anatomies.We report the first clinical experience with Nellix in 34 patients during 2008-2010. The outcomes augur well and a speedy approval by the European Community.
Subject(s)
Female , Middle Aged , Aged, 80 and over , Iliac Aneurysm/surgery , Iliac Aneurysm/therapy , Blood Vessel Prosthesis Implantation , Endovascular Procedures , Iliac Artery , Treatment OutcomeABSTRACT
OBJECTIVE: All current aortic endografts depend on proximal and distal fixation to prevent migration. However, migration and rupture can occur, particularly in patients with aortic necks that are short or angulated, or both. We present our initial clinical experience with a new sac-anchoring endoprosthesis designed to anchor and seal the device within the aneurysm sac. METHODS: The initial worldwide experience using a new endoprosthesis for the treatment of aortic aneurysms (Nellix Endovascular, Palo Alto, Calif) was reviewed. The endoprosthesis consists of dual balloon-expandable endoframes surrounded by polymer-filled endobags designed to obliterate the aneurysm sac and maintain endograft position. Clinical results and follow-up contrast computed tomography (CT) scans at 30 days and 6 and 12 months were reviewed. RESULTS: The endograft was successfully deployed in 21 patients with infrarenal aortic aneurysms measuring 5.7 ± 0.7 cm (range, 4.3-7.4 cm). Two patients with common iliac aneurysms were treated with sac-anchoring extenders that maintained patency of the internal iliac artery. Infusion of 71 ± 37 mL of polymer (range, 19-158 mL) into the aortic endobags resulted in complete aneurysm exclusion in all patients. Mean implant time was 76 ± 35 minutes, with 33 ± 17 minutes of fluoroscopy time and 180 ± 81 mL of contrast; estimated blood loss was 174 ± 116 mL. One patient died during the postoperative period (30-day mortality, 4.8%), and one died at 10 months from non-device-related causes. During a mean follow-up of 8.7 ± 3.1 months and a median of 6.3 months, there were no late aneurysm- or device-related adverse events and no secondary procedures. CT imaging studies at 6 months and 1 year revealed no increase in aneurysm size, no device migration, and no new endoleaks. One patient had a limited proximal type I endoleak at 30 days that resolved at 60 days and remained sealed. One patient has an ongoing distal type I endoleak near the iliac bifurcation, with no change in aneurysm size at 12 months. CONCLUSION: Initial clinical experience with this novel intrasac anchoring prosthesis is promising, with successful aneurysm exclusion and good short-term results. This new device platform has the potential to address the anatomic restrictions and limitations of current endografts. Further studies with a longer follow-up time are needed.