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Background: Fenestrated devices currently require a 3-4 week manufacturing period prior to implantation, as such there have been efforts to develop “Off-the-Shelf” (OTS) devices to reduce the time before definitive treatment can be accomplished. Initial estimates predicted that 60-70% of patients might be amenable to this approach. We examined all patients treated for complex aortic problems at our institution during the past twelve months to evaluate the suitability and early outcomes of the OTS devices versus commercially available endovascular options.
Methods: Between July 2012 and July 2013 patients undergoing aortic aneurysm repair were extracted from a prospectively managed aortic database. Two OTS devices, the Cook p-branch and the Endologix Ventana device, were available thru clinical trials during this time frame. The custom Cook Zenith Fenestrated device (ZFEN) was also available and FDA approved during the study period. Patient demographics and suitability for repair with an OTS device were determined based on anatomic criteria.
Results: Out of 178 aortic aneurysms treated at our institution during this time period, there were a total of 94 patients with TAAA (II-IV) including pararenal (suprarenal and juxtarenal) aneurysms. Only 22 (23%) patients met anatomic criteria for OTS devices with 16 patients having these investigational devices implanted. The major exclusion criterion for the p-Branch device was renal artery location (axial and circumferential) while the limiting factor for the Ventana device was infra-SMA neck length restrictions. Four of the patients who would have fit criteria for an OTS device choose to have an FDA approved (ZFEN) device implanted instead and two patients opted for open repair as a result of follow-up requirements. An additional 17 patients received custom designed (ZFEN) devices (N=21, 22%), while 57 (61%) others did not meet criteria for any available endovascular device and were repaired using alternative management strategies. The mean age and maximal aortic diameter of the two cohorts (OTS: ZFEN) was 71.8: 72.0 years (p=NS) and 61.3: 58.0 mm (p=NS) respectively. Technical success was 100%, with an overall 30-day mortality of 2.7% (N=1, ZFEN). Major complications occurred in four patients (11%: OTS-1, ZFEN-3) and included renal dissection-1, SMA dissection-1, perinephric hematoma-1, and contrast-induced nephropathy-1.
Conclusions: Pararenal aneurysms comprise the minority of patients presenting for repair to a complex aortic referral center. While OTS device strategies will reduce the waiting times for patients with complex aortic aneurysmal disease, a significant number will still require custom made devices or other repairs until additional device designs become available. Early experience with OTS devices does not demonstrate any significant renal risks, however the treatment numbers are low and should be interpreted with caution until larger confirmatory studies are published. Further studies comparing the outcomes of these techniques are required to establish the best approach to handle endovascular repair of complex aortic aneurysms.