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.
OBJECTIVE Recent studies have shown similar clinical outcomes between Parkinson disease (PD) patients treated with deep brain stimulation (DBS) under general anesthesia without microelectrode recording (MER), so-called "asleep" DBS, and historical cohorts undergoing "awake" DBS with MER guidance. However, few studies include internal controls. This study aims to compare clinical outcomes after globus pallidus internus (GPi) and subthalamic nucleus (STN) DBS using awake and asleep techniques at a single institution. METHODS PD patients undergoing awake or asleep bilateral GPi or STN DBS were prospectively monitored. The primary outcome measure was stimulation-induced change in motor function off medication 6 months postoperatively, measured using the Unified Parkinson's Disease Rating Scale part III (UPDRS-III). Secondary outcomes included change in quality of life, measured by the 39-item Parkinson's Disease Questionnaire (PDQ-39), change in levodopa equivalent daily dosage (LEDD), stereotactic accuracy, stimulation parameters, and adverse events. RESULTS Six-month outcome data were available for 133 patients treated over 45 months (78 GPi [16 awake, 62 asleep] and 55 STN [14 awake, 41 asleep]). UPDRS-III score improvement with stimulation did not differ between awake and asleep groups for GPi (awake, 20.8 points [38.5%]; asleep, 18.8 points [37.5%]; p = 0.45) or STN (awake, 21.6 points [40.3%]; asleep, 26.1 points [48.8%]; p = 0.20) targets. The percentage improvement in PDQ-39 and LEDD was similar for awake and asleep groups for both GPi (p = 0.80 and p = 0.54, respectively) and STN cohorts (p = 0.85 and p = 0.49, respectively). CONCLUSIONS In PD patients, bilateral GPi and STN DBS using the asleep method resulted in motor, quality-of-life, and medication reduction outcomes that were comparable to those of the awake method.
Deep brain stimulation is typically performed with intraoperative microelectrode recording and test stimulation for target confirmation. Recent studies have shown accurate, clinically efficacious results after lead placement without microelectrode recording or test stimulation, using interventional magnetic resonance imaging (MRI) or intraoperative computed tomography (CT; iCT) for verification of accuracy. The latter relies on CT-MRI fusion. To validate CT-MRI fusion in this setting, we compared stereotactic coordinates determined intraoperatively using CT-MRI fusion with those obtained on postoperative MRI. Deep brain stimulation electrodes were implanted with patients under general anesthesia. Direct targeting was performed on preoperative MRI, which was merged with preimplantation iCT images for stereotactic registration and postimplantation iCT images for accuracy confirmation. Magnetic resonance imaging was obtained 6 weeks postoperatively for comparison. Postoperative MRI was obtained for 48 patients, with 94 leads placed over a 1-year period. Vector error of the targeted contact relative to the initial plan was 1.1 ± 0.7 mm on iCT and 1.6 ± 0.7 mm on postoperative MRI. Variance comparisons (F-tests) showed that the discrepancy between iCT- and postoperative MRI-determined errors was attributable to measurement error on postoperative MRI, as detected in inter-rater reliability testing. In multivariate analysis, improved lead placement accuracy was associated with frame-based stereotaxy with the head of the bed at 0° compared with frameless stereotaxy with the head of the bed at 30° (P = 0.037). Intraoperative CT can be used to determine lead placement accuracy in deep brain stimulation surgery. The discrepancy between coordinates determined intraoperatively by CT-MRI fusion and postoperatively by MRI can be accounted for by inherent measurement error.
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 patientreported measures when performed at high-volume centers.Clinical trial registration no.: NCT01504399 (clinicaltrials.gov).http://thejns.org/doi/abs
abbreviatioNs CSF = cerebrospinal fluid; EOR = extent of tumor resection; GTR = gross-total resection; QOL = quality of life; STR = subtotal resection; TNTS = transnasal transsphenoidal. obJective The comparative efficacy of microscopic and fully endoscopic transsphenoidal surgery for pituitary adenomas has not been well studied despite the adoption of fully endoscopic surgery by many pituitary centers. The influence of surgeon experience has also not been examined in this setting. The authors therefore compared the extent of tumor resection (EOR) and the endocrine outcomes of 1 very experienced surgeon performing a microscopic transsphenoidal surgery technique with those of a less experienced surgeon using a fully endoscopic transsphenoidal surgery technique for resection of nonfunctioning pituitary adenomas in a concurrent series of patients. methods Post hoc analysis was conducted of a cohort of adult patients prospectively enrolled in a pituitary adenoma quality-of-life study between October 2011 and June 2014. Patients were followed up for 6 months after surgery. Patients were treated either by a less experienced surgeon (100 independent cases) who practices fully endoscopic surgery exclusively or by a very experienced surgeon (1800 independent cases) who practices microscopic surgery exclusively. Patient demographic characteristics, tumor characteristics, hypopituitarism, complications, and length of hospital stay were analyzed. Tumor volumes and EOR were determined by formal volumetric analysis involving manual segmentation of MR images performed before surgery and within 6 months after surgery. Logistic regression analysis was used to determine predictors of EOR. results Fifty-five patients underwent fully endoscopic transsphenoidal surgery, and 80 patients underwent fully microscopic transsphenoidal surgery. The baseline characteristics of the 2 treatment groups were well matched. EOR was similar between the endoscopic and microscopic groups, respectively, as estimated by gross-total resection rate (78.2% vs 81.3%, p = 0.67), percentage of tumor resected (99.2% vs 98.7%, p = 0.42), and volume of residual tumor (0.12 cm 3 vs 0.20 cm 3 , p = 0.41). Multivariate modeling suggested that preoperative tumor volume was the most important predictor of EOR (p = 0.001). No difference was found in the development of anterior gland dysfunction (p > 0.14), but there was a higher incidence of permanent posterior gland dysfunction in the microscopic group (p = 0.04). Combined rates of major complications and unplanned readmissions were lower in the endoscopic group (p = 0.02), but individual complications were not significantly different. coNclusioNs A less experienced surgeon using a fully endoscopic technique was able to achieve outcomes similar to those of a very experienced surgeon using a microscopic technique in a cohort of patients with nonfunctioning tumors smaller than 60 cm 3 . The study raises the provocative notion that certain advantages afforded by the fully endoscopic technique may impact the learning c...
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).
OBJECTIVE As the number of deep brain stimulation (DBS) procedures performed under general anesthesia ("asleep" DBS) increases, it is more important to assess the rates of adverse events, inpatient lengths of stay (LOS), and 30-day readmission rates in patients undergoing these procedures compared with those in patients undergoing traditional "awake" DBS without general anesthesia. METHODS All patients in an institutional database who had undergone awake or asleep DBS procedures performed by a single surgeon between August 2011 and August 2014 were reviewed. Adverse events, inpatient LOS, and 30-day readmissions were analyzed. RESULTS A total of 490 electrodes were placed in 284 patients, of whom 126 (44.4%) underwent awake surgery and 158 (55.6%) underwent asleep surgery. The most frequent overall complication for the cohort was postoperative mental status change (13 patients [4.6%]), followed by hemorrhage (4 patients [1.4%]), seizure (4 patients [1.4%]), and hardware-related infection (3 patients [1.1%]). Mean LOS for all 284 patients was 1.19 ± 1.29 days (awake: 1.06 ± 0.46 days; asleep: 1.30 ± 1.67 days; p = 0.08). Overall, the 30-day readmission rate was 1.4% (1 awake patient, 3 asleep patients). There were no significant differences in complications, LOS, and 30-day readmissions between awake and asleep groups. CONCLUSIONS Both awake and asleep DBS can be performed safely with low complication rates. The authors found no significant differences between the 2 procedure groups in adverse events, inpatient LOS, and 30-day readmission rates.
O ver the past 30 years, deep brain stimulation (DBS) has evolved into a mainstream therapy for patients with Parkinson's disease (PD) that is supported by Level 1 evidence. 5,6,25,31,32 The clinical efficacy of DBS depends on appropriate lead placement within the targeted structure. 3,7,20,22 obJective Recent studies show that deep brain stimulation can be performed safely and accurately without microelectrode recording or test stimulation but with the patient under general anesthesia. The procedure couples techniques for direct anatomical targeting on MRI with intraoperative imaging to verify stereotactic accuracy. However, few authors have examined the clinical outcomes of Parkinson's disease (PD) patients after this procedure. The purpose of this study was to evaluate PD outcomes following "asleep" deep brain stimulation in the globus pallidus internus (GPi). methods The authors prospectively examined all consecutive patients with advanced PD who underwent bilateral GPi electrode placement while under general anesthesia. Intraoperative CT was used to assess lead placement accuracy. The primary outcome measure was the change in the off-medication Unified Parkinson's Disease Rating Scale motor score 6 months after surgery. Secondary outcomes included effects on the 39-Item Parkinson's Disease Questionnaire (PDQ-39) scores, on-medication motor scores, and levodopa equivalent daily dose. Lead locations, active contact sites, stimulation parameters, and adverse events were documented. results Thirty-five patients (24 males, 11 females) had a mean age of 61 years at lead implantation. The mean radial error off plan was 0.8 mm. Mean coordinates for the active contact were 21.4 mm lateral, 4.7 mm anterior, and 0.4 mm superior to the midcommissural point. The mean off-medication motor score improved from 48.4 at baseline to 28.9 (40.3% improvement) at 6 months (p < 0.001). The PDQ-39 scores improved (50.3 vs 42.0; p = 0.03), and the levodopa equivalent daily dose was reduced (1207 vs 1035 mg; p = 0.004). There were no significant adverse events. coNclusioNs Globus pallidus internus leads placed with the patient under general anesthesia by using direct anatomical targeting resulted in significantly improved outcomes as measured by the improvement in the off-medication motor score at 6 months after surgery.Clinical trial registration no.: NCT01997398 (clinicaltrials.gov)
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