Lessons Learned from a Large Volume Experience with the Zenith Fenestrated Aortic Stent Graft
S. Keisin Wang, MD, Ashley R. Gutwein, MD, Alan P. Sawchuk, MD, Raghu L. Motaganahalli, MD, Michael P. Murphy, MD, Alok K. Gupta, MD, Gary W. Lemmon, MD, Andres Fajardo, MD.
Indiana University School of Medicine, Indianapolis, IN, USA.
Objectives: The Zenith Fenestrated (Cook Medical) aortic stent graft system was approved for commercial use by the FDA in April of 2012. We report our single-center experience of 102 consecutively treated patients with the ZFEN platform. Methods: A retrospective review of our prospectively maintained FEVAR databases at a tertiary care academic institution in the Midwestern U.S. was performed. All ZFEN procedures from 10/2012 until 03/2017 were included into the descriptive statistical analysis. Continuous and categorical variables were compared using two tailed Student’s T-test and Fisher’s Exact Test, respectively. Results: A total of 102 patients received FEVAR at our facility since FDA approval in 2012. All but one of the procedures were elective in nature. Overall intraoperative characteristics included a mean blood loss of 381 ± 383 mLs (mean ± SD), fluoroscopy time of 63 ± 30 mins, radiation dosage of 437 ± 270 RADs, contrast volume of 98 ± 36 mLs, and a total OR time of 234 ± 86 mins. Average number of visceral arteries stented was 2.07 ± 0.54. Technical success was achieved in 98% of the patients. A significant learning curve was observed as statistically significant (p<0.05) improvements in EBL (2.3-fold) and radiation dosage (19% decrease) were observed in the second half compared to the first half of patients treated. Interestingly, no improvements were made to fluoroscopy time, contrast usage, or operating time. Overall, mean length of stay was 3.6 ± 4.3 days with a 30-day mortality of 2.0%. 30-day morbidity included 4.9% incidence of any bowel ischemia (including mucosal injury), 0.9% of spinal cord ischemia, 2.9% of renal failure requiring HD, 0.9% of stroke, and 3.9% of MI. Average follow-up was 492 ± 454 days. 19 patients were deemed lost to follow-up (no clinic visit in last 15 months). Reintervention during the follow-up phase was 18.6%. Of the 212 visceral arteries stented, we noted 6 instances of stent thrombosis, 6 of kinking or stenosis, and 1 of stent fracture. Endoleak was present or could not be excluded in 15.6% of all FEVARs at last available CTA. Conclusion: In our experience, FEVAR seems to be safe and effective at short- and mid-term follow-up. There is a significant rate of reintervention observed and close monitoring is fundamental in maintaining good long-term results.
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