Comparison of sinonasal quality of life and health status in patients undergoing microscopic and endoscopic transsphenoidal surgery for pituitary lesions: a prospective cohort study.

OBJECT: Despite the widespread adoption of endoscopic transsphenoidal surgery for pituitary adenomas, the sinonasal quality of life (QOL) and health status in patients who have undergone this technique have not been compared with these findings in patients who have undergone the traditional direct uninostril microsurgical technique. In this study, the authors compared the sinonasal QOL and patient-reported health status after use of these 2 surgical techniques. METHODS: The study design was a nonblinded prospective cohort study. Adult patients with sellar pathology and planned transsphenoidal surgery were screened at 4 pituitary centers in the US between October 2011 and August 2013. The primary end point of the study was postoperative patient-reported sinonasal QOL as measured by the Anterior Skull Base Nasal Inventory-12 (ASK Nasal-12). Supplementary end points included patient-reported health status estimated by the 8-Item Short Form Health Survey (SF-8) and EuroQol (EQ)-5D-5L instruments, and sinonasal complications. Patients were followed for 6 months after surgery. RESULTS: A total of 301 patients were screened and 235 were enrolled in the study. Of these, 218 were analyzed (111 microsurgery patients, 107 endoscopic surgery patients). Demographic and tumor characteristics were similar between groups (p ≥ 0.12 for all comparisons). The most common complication in both groups was sinusitis (7% in the microsurgery group, 13% in the endoscopic surgery group; p = 0.15). Patients treated with the endoscopic technique were more likely to have postoperative nasal debridements (p < 0.001). The ASK Nasal-12 and SF-8 scores worsened substantially for both groups at 2 weeks after surgery, but then returned to baseline at 3 months. At 3 months after surgery, patients treated with endoscopy reported statistically better sinonasal QOL compared with patients treated using the microscopic technique (p = 0.02), but there were no significant differences at any of the other postoperative time points. CONCLUSIONS: This is the first multicenter study to examine the effect of the transsphenoidal surgical technique on sinonasal QOL and health status. The study showed that surgical technique did not significantly impact these patient-reported measures when performed at high-volume centers. Clinical trial registration no.: NCT01504399 ( clinicaltrials.gov ).

Predictors of sinonasal quality of life and nasal morbidity after fully endoscopic transsphenoidal surgery.

OBJECT: Despite the increasing application of endoscopic transsphenoidal surgery for pituitary lesions, the prognostic factors that are associated with sinonasal quality of life (QOL) and nasal morbidity are not well understood. The authors examine the predictors of sinonasal QOL and nasal morbidity in patients undergoing fully endoscopic transsphenoidal surgery. METHODS: An exploratory post hoc analysis was conducted of patients who underwent endoscopic pituitary surgery and were enrolled in a prospective multicenter QOL study. End points of the study included patient-reported sinonasal QOL and objective nasal endoscopy findings. Multivariate models were developed to determine the patient and surgical factors that correlated with QOL at 2 weeks through 6 months after surgery. RESULTS: This study is a retrospective review of a subgroup of patients studied in the clinical trial "Rhinological Outcomes in Endonasal Pituitary Surgery" (clinical trial no. NCT01504399, clinicaltrials.gov ). Data from 100 patients who underwent fully endoscopic transsphenoidal surgery were included. Predictors of a lower postoperative sinonasal QOL at 2 weeks were use of nasal splints (p = 0.039) and female sex at the trend level (p = 0.061); at 3 months, predictors of lower QOL were the presence of sinusitis (p = 0.025), advancing age (p = 0.044), and use of absorbable nasal packing (p = 0.014). Health status (multidimensional QOL) was also predictive at 2 weeks (p = 0.001) and 3 months (p < 0.001) and was the only significant predictor of sinonasal QOL at 6 months (p < 0.001). A Kaplan-Meier analysis was performed to study time to resolution of nasal crusting, mucopurulence, and synechia as observed during nasal endoscopy after surgery. The mean time (± SEM) to absence of nasal crusting was 16.3 ± 2.1 weeks, mucopurulence was 6.2 ± 1.1 weeks, and synechia was 4.4 ± 0.5 weeks. Use of absorbable nasal packing was associated with more severe mucopurulence. CONCLUSIONS: Sinonasal QOL following endoscopic pituitary surgery reaches a nadir at 2 weeks and recovers by 3 months postoperatively. Use of absorbable packing and nasal splints, while used in a minority of patients, negatively correlates with early sinonasal QOL. Sinonasal QOL and overall health status are well correlated in the postoperative period, suggesting the important influence of sinonasal QOL on the patient experience.

Sellar Masses that Present with Severe Hyponatremia.

OBJECTIVE: Hyponatremia is a known but underrecognized presentation of sellar lesions. Herein, we present a series of patients who presented with single or multiple episodes of hyponatremia. METHODS: Over 5 years, patients undergoing endonasal surgery for a de novo sellar mass with hyponatremia as an initial presentation were included. Pathology, sodium levels, pituitary hormonal status, and treatment course were documented. RESULTS: Of 282 patients, 16 (5.7%) (9 males, 7 females, age 32 to 84 years) presented with severe hyponatremia, with a mean serum sodium level of 115 ± 6 mmol/L (range, 101 to 125 mmol/L), and 3 patients had 2 or more episodes. Severe hyponatremia was a presenting sign in 0, 4.1, 14.3, and 37.5% of patients with craniopharyngiomas (n = 10), pituitary adenomas (n = 243), Rathke's cleft cysts (RCCs) (n = 21), and sellar arachnoid cysts (n = 8), respectively (P<.01). Half of the patients presenting with hyponatremia, including 6 of 10 patients with adenomas and 2 of 3 patients with RCCs, had pituitary apoplexy or cyst rupture. All patients had anterior pituitary gland dysfunction, including 81% with hypoadrenalism and 69% with hypothyroidism. Following surgery, hormonal status was unchanged or improved in 15 patients (median follow-up, 14 months). No patient had tumor/cyst recurrence or recurrent hyponatremia. CONCLUSION: Severe hyponatremia was a presenting sign in 5.7% of patients with sellar pathology, most frequently in patients with arachnoid cysts, RCCs, and pituitary apoplexy. Patients with new-onset severe hyponatremia and no obvious pharmacologic or systemic cause should undergo pituitary hormonal evaluation and brain imaging. Surgical resection and correction of hormonal deficiencies are associated with resolution of recurrent hyponatremic episodes.

Prevalence of pituitary hormone dysfunction, metabolic syndrome, and impaired quality of life in retired professional football players: a prospective study.

Hypopituitarism is common after moderate and severe traumatic brain injury (TBI). Herein, we address the association between mild TBI (mTBI) and pituitary and metabolic function in retired football players. Retirees 30-65 years of age, with one or more years of National Football League (NFL) play and poor quality of life (QoL) based on Short Form 36 (SF-36) Mental Component Score (MCS) were prospectively enrolled. Pituitary hormonal and metabolic syndrome (MetS) testing was performed. Using a glucagon stimulation test, growth hormone deficiency (GHD) was defined with a standard cut point of 3 ng/mL and with a more stringent body mass index (BMI)-adjusted cut point. Subjects with and without hormonal deficiency (HD) were compared in terms of QoL, International Index of Erectile Function (IIEF) scores, metabolic parameters, and football career data. Of 74 subjects, 6 were excluded because of significant non-football-related TBIs. Of the remaining 68 subjects (mean age, 47.3±10.2 years; median NFL years, 5; median NFL concussions, 3; mean BMI, 33.8±6.0), 28 (41.2%) were GHD using a peak GH cutoff of <3 ng/mL. However, with a BMI-adjusted definition of GHD, 13 of 68 (19.1%) were GHD. Using this BMI-adjusted definition, overall HD was found in 16 (23.5%) subjects: 10 (14.7%) with isolated GHD; 3 (4.4%) with isolated hypogonadism; and 3 (4.4%) with both GHD and hypogonadism. Subjects with HD had lower mean scores on the IIEF survey (p=0.016) and trended toward lower scores on the SF-36 MCS (p=0.113). MetS was present in 50% of subjects, including 5 of 6 (83%) with hypogonadism, and 29 of 62 (46.8%) without hypogonadism (p=0.087). Age, BMI, median years in NFL, games played, number of concussions, and acknowledged use of performance-enhancing steroids were similar between HD and non-HD groups. In summary, in this cohort of retired NFL players with poor QoL, 23.5% had HD, including 19% with GHD (using a BMI-adjusted definition), 9% with hypogonadism, and 50% had MetS. Although the cause of HD is unclear, these results suggest that GHD and hypogonadism may contribute to poor QoL, erectile dysfunction, and MetS in this population. Further study of pituitary function is warranted in athletes sustaining repetitive mTBI.

Prospective validation of a patient-reported nasal quality-of-life tool for endonasal skull base surgery: The Anterior Skull Base Nasal Inventory-12.

OBJECT: Patient-reported quality-of-life (QOL) end points are becoming increasingly important health care metrics. To date, no nasal morbidity instrument specifically designed for patients undergoing endonasal skull base surgery has been developed. In this study, the authors describe the development and validation of a site-specific nasal morbidity instrument to assess patient-reported rhinological outcomes following endonasal skull base surgery. METHODS: Eligible patients included those with planned endonasal transsphenoidal surgery for sellar pathology identified in outpatient neurosurgical clinics of 3 skull base centers from October 2011 to July 2012. An initial 23-question pool was developed by subject matter experts, review of the literature, and from the results of a previous validation study to assess for common rhinological complaints. Symptoms were ranked by patients from "No Problem" to "Severe Problem" on a 6-point Likert scale. Exploratory factor analysis, change scores, and importance rank were calculated to define the final instrument consisting of 12 items (The Anterior Skull Base Nasal Inventory-12, or ASK Nasal-12). Psychometric validation of the final instrument was performed using standard statistical techniques. RESULTS: One hundred four patients enrolled in the study. All patients completed the preoperative survey and 100 patients (96%) completed the survey 2-4 weeks after surgery. Internal consistency of the final instrument was 0.88. Concurrent validity measures demonstrated a strong correlation between overall nasal functioning and total scores (p < 0.001). Test-retest reliability measures demonstrated a significant intraclass correlation between responses (p < 0.001). Effect size as calculated by standardized response mean suggested a large effect (0.84). Discriminant validity calculations demonstrated that the instrument was able to discriminate between preoperative and postoperative patients (p < 0.001). CONCLUSIONS: This prospective study demonstrates that the ASK Nasal-12 is a validated, site-specific, unidimensional rhinological outcomes tool sensitive to clinical change. It can be used in conjunction with multidimensional QOL instruments to assess patient-reported nasal perceptions in endonasal skull base surgery. This instrument is being used as a primary outcome measure in an ongoing multicenter nasal morbidity study. Clinical trial registration no.: NCT01504399 (ClinicalTrials.gov).

Value of endoscopy for maximizing tumor removal in endonasal transsphenoidal pituitary adenoma surgery.

OBJECT: Endoscopy as a visual aid (endoscope assisted) or as the sole visual method (fully endoscopic) is increasingly used in pituitary adenoma surgery. Authors of this study assessed the value of endoscopic visualization for finding and removing residual adenoma after initial microscopic removal. METHODS: Consecutive patients who underwent endoscope-assisted microsurgical removal of pituitary adenoma were included in this study. The utility of the endoscope in finding and removing residual adenoma not visualized by the microscope was noted intraoperatively. After maximal tumor removal under microscopic visualization, surgeries were categorized as to whether additional tumor was removed via endoscopy. Tumor removal and remission rates were also noted. Patients undergoing fully endoscopic tumor removal during this same period were excluded from the study. RESULTS: Over 3 years, 140 patients (41% women, mean age 50 years) underwent endoscope-assisted adenoma removal of 30 endocrine-active microadenomas and 110 macroadenomas (39 endocrine-active, 71 endocrine-inactive); 16% (23/140) of patients had prior surgery. After initial microscopic removal, endoscopy revealed residual tumor in 40% (56/140) of cases and the additional tumor was removed in 36% (50 cases) of these cases. Endoscopy facilitated additional tumor removal in 54% (36/67) of the adenomas measuring ≥ 2 cm in diameter and in 19% (14/73) of the adenomas smaller than 2 cm in diameter (p < 0.0001); additional tumor removal was achieved in 20% (6/30) of the microadenomas. Residual tumor was typically removed from the suprasellar extension and folds of the collapsed diaphragma sellae or along or within the medial cavernous sinus. Overall, 91% of endocrine-inactive tumors were gross-totally or near-totally removed, and 70% of endocrine-active adenomas had early remission. CONCLUSIONS: After microscope-based tumor removal, endoscopic visualization led to additional adenoma removal in over one-third of patients. The panoramic visualization of the endoscope appears to facilitate more complete tumor removal than is possible with the microscope alone. These findings further emphasize the utility of endoscopic visualization in pituitary adenoma surgery. Longer follow-ups and additional case series are needed to determine if endoscopic adenomectomy translates into higher long-term remission rates.

Early morning cortisol levels as predictors of short-term and long-term adrenal function after endonasal transsphenoidal surgery for pituitary adenomas and Rathke's cleft cysts.

OBJECTIVE: Patients undergoing pituitary adenoma or Rathke cleft cyst (RCC) removal are often administered perioperative glucocorticoids regardless of lesion size and preoperative adrenocorticotropic hormone/cortisol levels. To minimize unnecessary glucocorticoid therapy, we describe a protocol in which patients with normal preoperative serum cortisol and adrenocorticotropic hormone levels are given glucocorticoids only if postoperative day 1 or 2 (POD1 or POD2) cortisol levels decrease below normal. METHODS: A total of 207 consecutive patients undergoing endonasal surgery for an adenoma or RCC were considered for study. Of these, 68 patients with preoperative adrenal insufficiency or Cushing disease were excluded. Glucocorticoids were withheld unless POD1 or POD2 morning cortisol values were below normal (≤4 µg/dL). Subsequent adrenal status was assessed through follow-up biochemical and clinical evaluations. RESULTS: The 139 patients included 119 with macroadenomas, 14 microadenomas, and 6 RCCs (follow-up, 3-41 months; median, 10 months). Nine patients (6.5%), all with macroadenomas (mean diameter, 26 ± 10 mm) had low POD1 or POD2 cortisol values and received glucocorticoids; of these, five patients were weaned off within 3-28 weeks of surgery. Overall, 12 of 139 patients (8.6%) were treated for early (n = 9) or delayed (n = 3) adrenal insufficiency but only 5 patients (3.6%) remain on glucocorticoid replacement. No patient experienced an adrenal crisis. Using morning POD1 or POD2 cortisol values >4 µg/dL as a measure of adequate hypothalamic-pituitary-adrenal axis function, yields a sensitivity of 96%, a specificity of 57%, and a positive predictive value of 98%. CONCLUSIONS: In patients with normal preoperative cortisol levels undergoing endonasal removal of a pituitary adenoma or RCC, normal morning cortisol values on POD1 and POD2 reliably predicts adequate and safe adrenal function in 98% of patients. This simple protocol of withholding postoperative glucocorticoids avoids unnecessary steroid exposure and poses minimal risk to the well-informed closely monitored patient.

Endonasal transsphenoidal surgery: the patient's perspective-survey results from 259 patients.

BACKGROUND: Patient impressions remain an important yet often overlooked aspect of surgical success. Herein we present postoperative questionnaire results in patients after a standard direct endonasal approach, an extended suprasellar endonasal approach, and a reoperative transsphenoidal surgery for tumor removal with the operating microscope. METHODS: From July 1998 through April 2005, of 452 patients undergoing endonasal surgery, 346 were sent questionnaires, and of these, 259 (75%) completed them. Nasal packing was placed for 24 hours in the first 95 patients but not in the last 357. RESULT: Overall, 73% of patients reported a better experience than expected and 8% worse than expected. A worse than expected overall experience was noted in 15% of patients with nasal packing compared with 5% of patients without packing (P = .001). Of patients with preoperative headache, 49% resolved, 34% somewhat resolved, and 5% worsened. The frequency of rhinological complaints declined from 2 weeks to 3 months postsurgery (P < .001); by 3 months or more postsurgery, 67% to 87% of patients had no rhinological complaints and 1% to 2% had severe complaints. Of 30 patients with prior sublabial surgery, the endonasal procedure afforded easier recovery (87%), less pain (80%), better nasal airflow (79%), and a shorter hospital stay (median 3 vs 5 days) (P < .001). Of 28 patients with complications, the severity of rhinological complaints was similar to those without complications except this subgroup reported greater loss of sense of smell 3 months after surgery (P < .001). CONCLUSIONS: Rhinological recovery is typically rapid and relatively complete after direct endonasal transsphenoidal surgery using both standard and extended suprasellar approaches. Compared with the sublabial route, the endonasal approach is associated with less pain, better nasal airflow, and a shorter hospital stay.