Midterm Results of Proximal Aneurysm Sealing With the Ovation Stent-Graft According to On- vs Off-Label Use

Abstract

Use of the Ovation stent-graft in patients with neck length <7 mm achieved midterm outcomes similar to patients with ≥7-mm-long necks. These midterm data show that the use of the Ovation system for the treatment of infrarenal abdominal aortic aneurysm is not restricted by the conventional measurement of aortic neck length, affirming the recent Food and Drug Administration-approved changes to the IFU.

Ten-year outcome analysis of the Italian Excluder Registry with the Gore Excluder endograft for infrarenal abdominal aortic aneurysms

“…Despite the identification of EG design as one of the factors influencing EG-related complications, few outcome data sets from devicespecific analyses are available beyond 5 years. 2,4,6,[20][21][22][23][24][25][26][27][28][29] We previously reported the midterm analysis of the 872 patients enrolled in ITER. 13 In an effort to better elucidate the long-term performance of EVAR with this device, data collection was extended to 10 years from the indexed intervention.…”

Percutaneous endovascular abdominal aneurysm repair: State‐of‐the art

“…102,121 The risk of sac rapture has greatly diminished with new-generation endografts but remains a nonnegligible risk for young patients with long life expectancy ( Figure 8). 14,59,60,118,[122][123][124] This underscores the importance of surveillance post EVAR and prompt intervention for sac growth >5 mm or a persistent endoleak. 117,121 5.6 | Evidence supporting access site closure after EVAR Percutaneous femoral access for EVAR has increased compared to surgical cutdown.…”

“…96 Data from the new generation endografts will shift the balance favoring EVAR over surgical EVAR for most patients, and future trials will hopefully confirm that EVAR is the first-line treatment for all anatomically suitable AAA. 14,59,60,118,[122][123][124] Finally, a multidisciplinary team approach, including the vascular surgeon, interventional cardiologist and/or radiologist, may be necessary to ensure the safety and success of a comprehensive EVAR program. 130…”

Rationale for a new registry on EVAR: The EXTREME study

“…This new device separates fixation from sealing: fixation is guaranteed by suprarenal stent and anchors, while sealing is ensured by inflatable rings filled with a low-viscosity, non-embolic, radiopaque fill polymer. The presence of the polymer-filled network also allows the graft to conform to the patient's aortic neck, providing a precise and reliable sealing in a great variety of anatomies [10]. Different from common stent-graft platforms, separation between fixation and sealing ensures that in the Ovation endograft stent and fabric do not compete for the same space within the shaft and an ultra-low-profile delivery systems can be achieved (14–15F outer diameter for the main body, and 12–15F for the iliac limbs), allowing to treat patients presenting a wide range of iliac access [11].…”

“…The Ovation stent-graft safety, increasing the range of AAAs suitable for standard EVAR procedures as reported in several (although limited) series, promises to be the best available options [10], [11], [12].…”