Initial clinical experience with a sac-anchoring endoprosthesis for XXXX repair.

@entity1 @entity449 @entity1070 @entity190 @entity2948 @entity439 @entity1029
OBJECTIVE: All current aortic endografts depend on proximal and distal fixation to prevent migration. However, migration and rupture can occur, particularly in @entity1 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 @entity439 sac. METHODS: The initial worldwide experience using a new endoprosthesis for the treatment of @entity449 (Nellix Endovascular, Palo Alto, @entity2948 ) was reviewed. The endoprosthesis consists of dual balloon-expandable endoframes surrounded by polymer-filled endobags designed to obliterate the @entity439 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 @entity1 with @entity449 measuring 5.7    0.7 cm (range, 4.3-7.4 cm). Two @entity1 with common @entity1029 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 @entity439 in all @entity1 . Mean implant time was 76    35 minutes, with 33    17 minutes of fluoroscopy time and 180    81 mL of contrast; estimated @entity190 was 174    116 mL. One @entity1 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 @entity439 - or device-related adverse events and no secondary procedures. CT imaging studies at 6 months and 1 year revealed no increase in @entity439 size, no device migration, and no new @entity1070 . One @entity1 had a limited proximal type I endoleak at 30 days that resolved at 60 days and remained sealed. One @entity1 has an ongoing distal type I endoleak near the iliac bifurcation, with no change in @entity439 size at 12 months. CONCLUSION: Initial clinical experience with this novel intrasac anchoring prosthesis is promising, with successful @entity439 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.
