Assessment of post-operative healing following endoscopic, transnasal, transsphenoidal pituitary surgery without formal sellar grafting

Assessment of post-operative healing following endoscopic, transnasal, transsphenoidal pituitary surgery without formal sellar grafting

Am J Otolaryngol xxx (xxxx) xxxx Contents lists available at ScienceDirect Am J Otolaryngol journal homepage: www.elsevier.com/locate/amjoto Assess...

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Am J Otolaryngol xxx (xxxx) xxxx

Contents lists available at ScienceDirect

Am J Otolaryngol journal homepage: www.elsevier.com/locate/amjoto

Assessment of post-operative healing following endoscopic, transnasal, transsphenoidal pituitary surgery without formal sellar grafting☆ ⁎

Danny Jandalia, , Sarah Shearerb, Richard Byrnec,d, Peter Papagiannopoulosa, Bobby A. Tajudeena,d, Pete S. Batraa,d Department of Otorhinolaryngology – Head and Neck Surgery, Rush Medical College, Chicago, IL, United States of America Rush Medical College, Chicago, IL, United States of America c Department of Neurosurgery, Rush University Medical Center, Chicago, IL, United States of America d Rush Center of Skull Base and Pituitary Surgery, Rush University Medical Center, Chicago, IL, United States of America a

b

A R T I C LE I N FO

A B S T R A C T

Keywords: Pituitary adenoma Endoscopic surgery Minimally invasive surgery Cerebrospinal fluid leak Sella Reconstruction

Introduction: Multiple options exist for sellar reconstruction after endoscopic transnasal, transsphenoidal surgery (TSS) including free mucosa, fat, bone and synthetic materials. The objective of this study was to assess healing and mucosalization of the sellar face following TSS without formal sellar grafting or reconstruction. Methods: Single institution retrospective chart review was conducted for patients undergoing TSS without intraoperative CSF leaks between January 2014 and March 2017 at Rush University Medical Center. No formal sellar reconstruction was performed for the entire patient group. Follow-up endoscopic data and clinical notes were coded for time to mucosalization of the sella as well as degree of abnormal mucosal healing, epistaxis, crusting and scarring. Results: 83 patients were included in this study. Mean time to mucosalization was 119 days (range, 17 to 402 days). Incidence of abnormal mucosal healing, epistaxis, crusting and scarring increased from the first to the second postoperative visit but trended down by the third visit. Nasal crusting was the most common finding, followed by abnormal mucosal healing. Chi square analysis showed smoking to be associated with prolonged time to full mucosalization of the sella. Two patients (2.4%) had post-operative CSF leaks requiring lumbar drain placement. Conclusion: Adequate sellar healing is achievable in all cases without formal grafting or reconstruction after TSS. Great care must be exercised given the small inherent risk of unmasking a subclinical intraoperative CSF leak. Patients should be followed closely endoscopically during the first four months after TSS to minimize the impact of crusting.

1. Introduction Endoscopic transnasal, transsphenoidal surgical (TSS) approach for pituitary tumor resection has become the technique of choice over the past two decades, as an alternative to conventional transcranial or sublabial open approaches [1,2]. Endoscopic TSS affords several advantages, including enhanced visualization, wider access, angled view, more complete tumor removal, improved cosmesis and decreased hospital stay [3,4]. Although the endoscopic TSS has become commonplace at most tertiary care institutions, considerable variability exists in the surgical technique and many intraoperative decisions are guided by surgeon

preference. A key area of divergence in decision making is the need for formal reconstruction at the conclusion of TSS when no intraoperative CSF leak is identified. Options for reconstruction include simply sealing with hemostatic material, or using autologous mucosa, fat, bone grafts or pedicled nasoseptal flaps. Each form of reconstruction has varied possible associated sinonasal morbidities for the patient. At our institution, endoscopic TSS is the standard of care for pituitary tumors. In cases where no intraoperative CSF leak is present, no formal reconstruction is performed with autogenous grafting. The sella is simply closed with absorbable hemostatic material and a layer of dural sealant. The aim of our study was to review this subset of patients with no formal grafting to assess the time to full mucosalization of the



Part of this work was presented at the Annual ARS meeting on September 8, 2017 in Chicago, Illinois. Corresponding author at: Department of Otorhinolaryngology – Head and Neck Surgery, Rush University Medical Center, 1611 W. Harrison St., Suite 550, Chicago, IL 60612, United States of America. E-mail address: [email protected] (D. Jandali). ⁎

https://doi.org/10.1016/j.amjoto.2019.102306 Received 15 August 2019 0196-0709/ © 2019 Elsevier Inc. All rights reserved.

Please cite this article as: Danny Jandali, et al., Am J Otolaryngol, https://doi.org/10.1016/j.amjoto.2019.102306

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3. Surgical technique

Table 1 Baseline characteristics and tumor pathology. Variables Age group

Gender Chronic rhinosinusitis Allergic rhinitis Diabetes Smoking Pathology

16–35 36–65 66–86 Female Male No Yes No Yes No Yes Never or past Current Macroadenoma - ACTH secreting - FSH secreting - GH secreting - Prolactin secreting - Other Microadenoma - ACTH secreting - GH secreting Other

n = 83

%

14 48 21 45 38 77 6 73 10 63 20 73 10 73 5 3 9 2 2 6 4 2 4

17% 58% 25% 54% 46% 93% 7% 88% 12% 76% 24% 88% 12% 88% 6% 4% 11% 2% 2% 7% 5% 2% 5%

The endoscopic TSS performed at Rush University Medical Center mirrors that performed at other institutions. The patient is prepped and draped in the usual fashion with the cranium secured with a Mayfield head fixation system. Image guidance visual tracking system is calibrated prior to the start of surgery. The otolaryngology team then proceeds with the creation of the sellar window. Initially, bilateral transnasal sphenoidotomies are performed. A posterior septectomy is then created for bi-nostril access. The posterior septum and keel are then taken down with a high speed drill. With the sella in view, the mucosa is cauterized and the bone of the sellar face is then carefully removed exposing the sellar dura. A four-handed, two-surgeon bi-nostril approach is performed for tumor resection in conjunction with neurosurgery. At the end of tumor resection, if no intraoperative CSF leak is encountered, the sella is simply draped with absorbable hemostatic material (Surgicel®, Ethicon®, Cincinnati, Ohio) and subsequently reinforced with dural sealant (DuraSeal®, Integra LifeSciences, Plainsboro, New Jersey). At our institution, no abdominal fat, free mucosal graft, bone graft or nasoseptal flap is routinely used for patients without an intra-operative CSF leak.

4. Results sella by endoscopy, prevalence of rhinologic morbidity, and rate of postoperative CSF leak. The goal was to add to the body of knowledge regarding postoperative nasal morbidity after TSS and better characterize sellar healing without formal reconstruction. The results of this study may question the need for formal sellar reconstruction when no intraoperative CSF leak is identified.

Of the 83 patients reviewed, 78 patients (94.0%) returned for the first follow-up clinic visit, 74 (89.2%) returned for the second and 72 (86.7%) returned for the third. The average length of follow-up was 9.5 days for the first visit, 28 days for the second visit, and 58.4 days for the third visit. The average endoscopic outcome score for the first three visits were 1.08, 1.28 and 1.05, respectively. Fig. 1 illustrates the percentage of each nasal outcome by visit number. Crusting was the most common outcome seen with an incidence of 58% at the first follow-up visit, 61% at the second and 56% incidence at the third. Abnormal mucosal healing was the second most common outcome, with a 6% incidence at the first visit, 43% at the second and 35% at the third. Nasal scarring was seen in 37%, 22% and 14% of patients at each subsequent visit, respectively. Epistaxis was the least common outcome, with a 6%, 4%, 3% incidence at each visit, respectively. 71 patients (85.5%) were observed to achieve full sellar mucosalization in a mean time of 119 days and median time of 101 days (range, 17 to 402 days). Two patients (2.4%) had postoperative CSF leaks requiring lumbar drain placement. Both of these patients had macroadenomas. A chi square analysis was performed to determine if current smoking, allergic rhinitis, and/or diabetes had an impact on time to mucosalization (Tables 2–4). Current smoking was the only factor that

2. Materials and methods A retrospective chart review was performed of patients who underwent endoscopic TSS at Rush University Medical Center for endoscopic pituitary adenoma resection between January 2014 and March 2017. Patients were excluded if formal sellar reconstruction was performed, an intraoperative CSF leak was present, there was conversion to an open craniotomy and/or the patient was lost to follow up. A total of 83 patients were included. Patient demographics (gender and age), comorbidities (chronic rhinosinusitis, allergic rhinitis, diabetes and smoking status) and surgical pathology are reported in Table 1. Endoscopic data and clinic notes for the first three follow-up visits were reviewed. Instances of abnormal mucosal healing (defined as mucosal edema), epistaxis, crusting and nasal scarring were recorded for patients at each visit, according to the charted endoscopic data. Patients received a score of zero, not present, or one, present, for each nasal outcome and a total score out of four was calculated for the first three follow-up visits, similar to the analysis performed by Chaudhry et al. assessing endoscopic healing following pituitary surgery [5]. The time to complete mucosalization of the sellar region was recorded for all patients who returned for a fourth follow-up visit. In order to identify factors affecting time to mucosalization, patients who achieved full mucosalization were divided into two categories; one category included patients whose time to mucosalization was less than the median time for the cohort, and the second category included the patients whose time to mucosalization was greater than or equal to the median time. The median (101 days) was used instead of the mean (119 days) due to the presence of outliers skewing the mean higher (64.8% patients had healing times less than the mean versus 49.3% less than the median). Chi square analysis was performed to determine if comorbid factors (allergic rhinitis, diabetes or smoking status) were significantly associated with the time to mucosalization. There were too few patients with chronic rhinosinusitis who achieved full mucosalization (less than five) to permit statistical analysis.

Fig. 1. Nasal outcomes by visit. 2

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Table 2 Allergic rhinitis v. time to mucosalization category.

No allergic rhinitis (n = 63) Allergic rhinitis (n = 8)

Healing time < median

Healing time ≥ median

P-value

30 (47.6%) 5 (62.5%)

33 (52.4%) 3 (37.5%)

0.428

mucosa after endoscopic sinus surgery [10]. This prospective study looked at 18 patients with chronic rhinosinusitis and 18 with nasal polyposis after endoscopic sinus surgery. They looked at allergic rhinitis and smoking and found no association with poor mucosal healing. The only measures that were associated with poor mucosal healing were history of sinus surgery and initial disease severity based on preoperative CT. Our study, on the other hand, found an association between poor mucosal healing and smoking. Smoking has deleterious effects on the vasculature and this can impair the normal healing process. Similarly, we did not find an association between other preoperative factors (allergic rhinitis and diabetes) and length of time to full sellar mucosalization, indicating that healing is independent of these risk factors. CSF leak remains the major risk to endoscopic transnasal TSS. Previous studies have compared rates of postoperative CSF leaks and other complications among different methods of reconstruction. Couldwell et al. reported a series of 4200 transsphenoidal surgeries; the incidence of postoperative CSF leaks was no higher in the group of patients without formal reconstruction, and no additional complications such as pneumatocele or infection were seen [11]. Seda et al. studied 567 patients who underwent TSS for pituitary and sellar tumors. 503 patients had no intraoperative CSF leak, and the sellar floor was closed with hemostatic material only [12]. After a mean follow-up time of 4.1 years, none of the patients without intraoperative CSF leaks developed a CSF leak, meningitis or visual loss. The authors concluded closure of the sellar floor with hemostatic material and fibrin glue without grafting or the use of implants is a safe and efficient method to prevent postoperative complications after TSS. A 2003 study by Shiley et al. looked at factors predicting postoperative CSF leaks. They found that in patients without intraoperative CSF leaks, 4% of patients developed a postoperative leak who underwent sellar closure, versus 2.1% of the patients who did not undergo closure [13]. This difference was not significant. They determined that CSF leakage after sellar closure is likely to be related to the presence of an intraoperative leak rather than to the closure. Cappabianca et al. conducted a retrospective analysis of 146 patients who underwent endoscopic TSS for resection of pituitary adenomas [14]. Reconstruction was not performed and three patients (2.05%) developed postoperative CSF leaks. Our study did have a 2.4% rate of postoperative CSF leak, comparable to aforementioned studies. Nonetheless, given the potential for serious adverse patient consequences for postoperative CSF leakage, the surgical team must exercise vigilance in the postoperative period. Previous studies have found that the method of reconstruction is not associated with development of CSF leaks, but rather ensuring careful inspection for intraoperative CSF leak is the important factor in avoiding postoperative CSF leaks [13,15]. If CSF leak is suspected, then more formal reconstruction with pedicled flaps and/or fat grafts is warranted at the time of surgery.

showed a statistically significant increase in the time to mucosalization (P = 0.012). Diabetes and allergic rhinitis both did not affect the time to mucosalization (P = 0.284 and P = 0.428, respectively). 5. Discussion There has been a recent focus on studies assessing sinonasal morbidity in patients after TSS. A systematic review by Awad et al. identified the most common sinonasal morbidities following endoscopic transsphenoidal surgery [6]. The authors identified 7 series (two prospective and five retrospective) and found the four most common signs and symptoms were nasal crusting (50.8%), nasal discharge (40.4%), nasal airflow blockage (40.1%), and decreased or absent sense of smell (26.7%). In our study, crusting was the most common endoscopic outcome. Its incidence was greatest at the second follow-up visit, with a rate of 61%. Abnormal mucosal healing (defined as mucosal edema) was the second most observed outcome and its incidence also peaked at the second visit. Our findings indicate a rising trend in crusting and abnormal mucosal healing, suggesting there may be a temporary rise in nasal morbidity over the first four weeks. Both of these outcomes decreased by the third visit. Little et al. looked at sinonasal quality of life (QOL) and nasal morbidity following endoscopic pituitary surgery [7]. Predictors of lower QOL at three months were presence of sinusitis, advancing age and use of absorbable nasal packing. They also measured the time to resolution of nasal crusting, the most commonly observed morbidity in our study. Crusting resolved in 16 weeks. While we do not report the time to resolution of crusting, there was a downward trend in crusting by the third postoperative visit. Both nasal scarring and epistaxis decreased from the first to the third visit, suggesting that these outcomes peak directly after surgery and decrease with time. Little et al. found that it took 4.4 weeks for synechiae to resolve postoperatively [7]. By the third postoperative visit only 14% of the patients in our study had evidence of sinonasal scarring. Epistaxis is a rare morbidity following TSS. Koren et al. report a 0% incidence of epistaxis following TSS [8]. Thompson et al. looked at the incidence of epistaxis following endoscopic skull base surgery (with the vast majority reported as pituitary adenomas), reporting a 3% incidence in 330 patients [9]. Our postoperative care strategy is regimented. Saline sprays are started on postoperative day one, while saline irrigations start after the first postoperative visit. This continues until complete healing is achieved. Furthermore, serial endoscopy with debridement is performed in the clinic setting to facilitate the healing process. Any infectious exacerbations are managed with culture directed antibiotics. Seventy-one patients (85.5%) were seen to achieve full sellar mucosalization in a median time of 101 days. The remainder of the patients did not return for at least four follow-up visits, so it is unknown when they achieved mucosalization. Watelet et al. looked at factors that predict healing of the sinonasal Table 3 Diabetes v. time to mucosalization category.

No diabetes (n = 55) Diabetes (n = 16)

Healing time < median

Healing time ≥ median

P-value

29 (52.7%) 6 (37.5%)

26 (47.3%) 10 (62.5%)

0.284

3

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Table 4 Smoking v. time to mucosalization category.

No current smoking (n = 65) Smoking (n = 6)

Healing time < median

Healing time ≥ median

P-value

35 (53.8%) 0 (0%)

30 (46.2%) 6 (100%)

0.012

6. Conclusion [2]

The current series carefully characterizes the healing that occurs after TSS without formal reconstruction of the sellar face. The primary endoscopic outcomes observed in our study were crusting and abnormal mucosal healing, which stresses the importance of follow-up endoscopic exams to monitor and address these issues. Full sellar mucosalization was achieved in the vast majority of our patients, suggesting that patients without reconstruction heal without adverse sequela. Current smoking was significantly associated with a longer time to full sellar mucosalization, re-enforcing the importance of smoking cessation prior to surgery. CSF leak is a potential complication, and requires more formal reconstruction if encountered intraoperatively.

[3]

[4] [5]

[6] [7]

Declaration of competing interest

[8]

DJ: No conflict of interest. No financial disclosures. SS: No conflict of interest. No financial disclosures. RB: No conflict of interest. No financial disclosures. PP: No conflict of interest. No financial disclosures. BAT: Sinopsys Surgical (consultant). PSB: Medtronic (research grant), Regeneron, Optinose (consultant), Springer (royalties).

[9] [10]

[11] [12]

[13]

Acknowledgements No acknowledgements.

[14]

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