Use of a Synthetic Dura Substitute in the Skull Base Reconstruction following Transsphenoidal Hypophysectomy

Background: Skull base reconstruction following endoscopic endonasal transsphenoidal surgery remains an important step in the prevention of postoperative cerebrospinal fluid (CSF) leaks. These leaks increase the risk of serious complications, most notably ascending meningitis and tension pneumocephalus. Dural grafts are commonly utilized in this repair, both in patients without intraoperative CSF leaks and in patients with low-flow leaks. Cerafix (Acera Surgical) is an FDA-cleared 100% synthetic resorbable electrospun dura substitute that can be utilized as an onlay graft or sutured in place. This dura substitute is able to be easily delivered endoscopically to the operative site. Being completely synthetic, Cerafix removes the risk of allergic reaction and disease transmission. Preclinical studies on this dural substitute have shown decreased local inflammation, irritation and fibrosis while increasing neoduralization when compared with the standard bovine dural substitute.

Objective: To assess the safety and efficacy of an electrospun dura substitute in the dural repair and skull base reconstruction following transsphenoidal hypophysectomy.

Methods: Twelve patients underwent endoscopic endonasal transsphenoidal hypophysectomies at Memorial Hermann Hospital between October 2016 and July 2017 with dural reconstruction using the Cerafix dura substitute. All procedures were performed by the same surgical team.

Results: The twelve patients ranged in age from 20 to 71 years (mean: 49.83, SD: 16.4) with eight showing symptoms prior to imaging. Four patients had preoperative endocrine dysfunction, including two with elevated prolactin, one with elevated growth hormone and one with decreased cortisol. Intraoperatively it was noted that 6/12 (50%) of patients had cavernous sinus invasion, and 4/12 (33.3%) had compression of the optic chiasm. One intraoperative CSF leak occurred, which was repaired and did not recur postoperatively. There were no intraoperative complications related to the dura substitute. The average length of stay was 3.5 days (range: 1–5 days; median = 3.5, SD: 1.24) and 7/12 patients developed diabetes insipidus. On follow-up imaging, 6 patients achieved gross-total resection, 3 achieved near-total resection, 2 had residual tumor and 1 suffered an unrelated cardiac arrest and was lost to follow-up. One patient formed a delayed CSF leak (1/12, 8.33%) requiring an additional intervention, consistent with the currently reported rate of 8.6%5. The closure was performed utilizing both mucosal grafts and the Cerafix dura substitute. The dura substitute showed adequate closure intraoperatively and showed granulation and healing postoperatively at both 2 weeks ([Fig. 1]) and 10 weeks ([Fig. 2]). At 6 months post-op, healthy mucosa was shown covering the dural and mucosal grafts ([Fig. 3]).

Conclusion: The Cerafix dura substitute provided a safe, effective reconstruction following transsphenoidal hypophysectomy with minimal CSF leaks while removing the risk of iatrogenic disease transmission.

Fig. 1 Two weeks: patient showing mucosal inflammation (black arrow) and granulation tissue (blue arrow) covering both Cerafix and mucosal grafts.

Fig. 2 Ten weeks: mucosal swelling resolved and continued granulation (blue arrow) covering the grafts.

Fig. 3 Six months: graft not visible and is covered by healthy mucosa (blue arrow).

No conflict of interest has been declared by the author(s).