Minimally Invasive Transforaminal Lumbar Interbody Fusion in the Ambulatory Surgery Center Versus Inpatient Setting: A 1-Year Comparative Effectiveness Analysis

Neurosurgery 93:867–874, 2023

Ambulatory surgery centers (ASCs) have emerged as an alternative setting for surgical care as part of the national effort to lower health care costs. The literature regarding the safety of minimally invasive transforaminal lumbar interbody fusion (MIS TLIF) in the ASC setting is limited to few small case series.

OBJECTIVE: To assess the safety and efficacy of MIS TLIF performed in the ASC vs inpatient hospital setting.

METHODS: A total of 775 patients prospectively enrolled in the Quality Outcomes Database undergoing single-level MIS TLIF at a single ASC (100) or the inpatient hospital setting (675) were compared. Propensity matching generated 200 patients for analysis (100 per cohort). Demographic data, resource utilization, patient-reported outcome measures (PROMs), and patient satisfaction were assessed.

RESULTS: There were no significant differences regarding baseline demographic data, clinical history, or comorbidities after propensity matching. Only 1 patient required inpatient transfer from the ASC because of intractable pain. All other patients were discharged home within 23 hours of surgery. The rates of 90-day readmission (2.0%) and reoperation (0%) were equivalent between groups. Both groups experienced significant improvements in all PROMs (Oswestry Disability Index, EuroQol-5D, back pain, and leg pain) at 3 months that were maintained at 1 year. PROMs did not differ between groups at any time point. Patient satisfaction was similar between groups at 3 and 12 months after surgery.

CONCLUSION: In carefully selected patients, MIS TLIF may be performed safely in the ASC setting with no statistically significant difference in safety or efficacy in comparison with the inpatient setting.

Severity, timeline, and management of complications after stereotactic brain biopsy

J Neurosurg 136:867–876, 2022

The literature shows discrepancies in stereotactic brain biopsy complication rates, severities, and outcomes. Little is known about the timeline of postbiopsy complications. This study aimed to analyze 1) complications following brain biopsies, using a graded severity scale, and 2) a timeline of complication occurrence. The secondary objectives were to determine factors associated with an increased risk of complications and to assess complication related management and extra costs.

METHODS The authors retrospectively examined 1500 consecutive stereotactic brain biopsies performed in adult patients at their tertiary medical center between April 2009 and April 2019.

RESULTS Three hundred eighty-one biopsies (25.4%) were followed by a complication, including 88.2% of asymptomatic hemorrhages. Symptomatic complications involved 3.0% of the biopsies, and 0.8% of the biopsies were fatal. The severity grading scale had a 97.6% interobserver reproducibility. Twenty-three (51.1%) of the 45 symptomatic complications occurred within the 1st hour following the biopsy, while 75.6% occurred within the first 6 hours. Age ≥ 65 years, second biopsy procedures, gadolinium-enhanced lesions, glioblastomas, and lymphomas were predictors of biopsy-related complications. Brainstem biopsy-targeted lesions and cerebral toxoplasmosis were predictive of mortality. Asymptomatic hemorrhage was associated with delayed (> 6 hours) symptomatic complications. Symptomatic complications led to extended hospitalization in 86.7% of patients. The average extra cost for management of a patient with postbiopsy symptomatic complication was $35,702.

CONCLUSIONS Symptomatic complications from brain biopsies are infrequent but associated with substantial adverse effects and cost implications for the healthcare system. The use of a severity grading scale, as the authors propose in this article, helps to classify complications according to the therapeutic consequences and the patient’s outcome. Because this study indicates that most complications occur within the first few hours following the biopsy, postbiopsy monitoring can be tailored accordingly. The authors therefore recommend systematic monitoring for 2 hours in the recovery unit and a CT scan 2 hours after the end of the biopsy procedure. In addition, they propose a modern algorithm for optimal postoperative management of patients undergoing stereotactic biopsy.

Laser Ablation of Abnormal Neurological Tissue Using Robotic Neuroblate System (LAANTERN)

Neurosurgery 86:538–547, 2020

Stereotactic laser ablation (SLA) has demonstrated potential utility for a spectrum of difficult to treat neurosurgical pathologies in multiple small and/or retrospective single-institutional series. Here, we present the safety profile of SLA of intracranial lesions from the Laser Ablation of Abnormal Neurological Tissue using Robotic NeuroBlate System (LAANTERN; Monteris Medical) multi-institutional, international prospective observational registry.

OBJECTIVE: To determine the procedural safety of SLA for intracranial lesions.

METHODS: Prospective procedural safety and hospitalization data from the first 100 treated LAANTERN patients was collected and analyzed.

RESULTS: Mean age and baseline Karnofsky Performance Status (KPS) were 51(±17) yr and 83(± 15), respectively. In total, 81.2% of patients had undergone prior surgical or radiation treatment. Most patients had a single lesion (79%) ablated through 1 burr hole (1.2±0.7 per patient), immediately following a lesion biopsy. In total, >90% of the lesion was ablated in 72% of treated lesions. Average total procedural time was 188.2 ± 69.6 min, and average blood loss was 17.7 ± 55.6 ccs. The average length of intensive care unit (ICU) and hospital stays before discharge were 38.1 ± 62.7 h and 61.1 ± 87.2 h, respectively. There were 5 adverse events (AEs) attributable to SLA (5/100; 5%). After the procedure, 84.8% of patients were discharged home. There was 1 mortality within 30 d of the procedure (1/100; 1%), which was not attributable to SLA.

CONCLUSION: SLA is a safe, minimally invasive procedure with favorable postprocedural ICU and hospital utilization profiles.

Anterior Cervical Discectomy and Fusion in the Outpatient Ambulatory Surgery Setting: Analysis of 2000 Consecutive Cases

Neurosurgery 2019 DOI:10.1093/neuros/nyz514

In an effort to improve efficiency of care, ambulatory surgery centers (ASCs) have emerged as lower-cost options. Anterior cervical discectomy and fusion (ACDF) is one of the most prevalent spine surgeries performed and rarely requires overnight stays in the hospital, supporting its migration to the ASC. Recent analyses have called into question the safety of outpatient ACDF, potentially slowing its adoption. ASC-ACDF studies have largely been limited to small series, precluding an accurate assessment of safety.

OBJECTIVE: To analyze 2000 ASC-ACDF cases, describe patient selection and perioperative protocol, and report associated safety profile.

METHODS: A total of 2000 patients who underwent 1 to 3 level ACDF in a single ASC from 2006 to 2018 were included in this retrospective analysis. Patients were observed in a 4-h postanesthesia care unit (PACU) with a multimodal pain management regiment. Data were collected on patient demographics, comorbidities, operative details, and 30- and 90-d morbidity.

RESULTS: Of the 2000 patients, 10 (0.5%) required transfer to an inpatient setting within the 4-h observation. Reasons for transfer included hematoma (2), pain control (2), cerebrospinal fluid leak (1), and medical complications (5). Six patients (0.3%) underwent reoperation within 30 d. All-cause 30-d readmission was 1.9%.

CONCLUSION: An analysis of 2000 ACDF patients in an ASC setting with a standardized perioperative protocol demonstrates that surgical complications occur at a low rate (<1%) and can be appropriately diagnosed and managed in a 4-h PACU. In an effort to decrease healthcare costs, surgeons can safely perform ACDFs in an ASC utilizing patient selection criteria and perioperative management protocols similar to those reported here.

Outcomes after coverage of lenticulostriate vessels by flow diverters: a multicenter experience

J Neurosurg 132:473–480, 2020

With the increasing use of flow diversion as treatment for intracranial aneurysms, there is a concomitant increased vigilance in monitoring complications. The low porosity of flow diverters is concerning when the origins of vessels are covered, whether large circle of Willis branches or critical perforators. In this study, the authors report their experience with flow diverter coverage of the lenticulostriate vessels and evaluate their safety and outcomes.

METHODS The authors retrospectively reviewed 5 institutional databases of all flow diversion cases from August 2012 to June 2018. Information regarding patient presentation, aneurysm location, treatment, and outcomes were recorded. Patients who were treated with flow diverters placed in the proximal middle cerebral artery (MCA), proximal anterior cerebral artery, or distal internal carotid artery leading to coverage of the medial and lateral lenticulostriate vessels were included. Clinical outcomes according to the modified Rankin Scale were reviewed. Univariate and multivariate analyses were performed to establish risk factors for lenticulostriate infarct.

RESULTS Fifty-two patients were included in the analysis. Postprocedure cross-sectional images were available in 30 patients. Two patients experienced transient occlusion of the MCA during the procedure; one was asymptomatic, and the other had a clinical and radiographic ipsilateral internal capsule stroke. Five patients had transient symptoms without radiographic infarct in the lenticulostriate territory. Two patients experienced in-stent thrombosis, leading to clinical MCA infarcts (one in the ipsilateral caudate) after discontinuing antiplatelet therapy. Discontinuation of dual antiplatelet therapy prior to 6 months was the only variable that was significantly correlated with stroke outcome (p < 0.01, OR 0.3, 95% CI 0–0.43), and this significance persisted when controlled for other risk factors, including age, smoking status, and aneurysm location.

CONCLUSIONS The use and versatility of flow diversion is increasing, and safety data are continuing to accumulate. Here, the authors provide early data on the safety of covering lenticulostriate vessels with flow diverters. The authors concluded that the coverage of these perforators does not routinely lead to clinically significant ischemia when dual antiplatelet therapy is continued for 6 months. Further evaluation is needed in larger cohorts and with imaging follow-up as experience develops in using these devices in more distal circulation.

3-Tesla MRI of deep brain stimulation patients: safety assessment of coils and pulse sequences

J Neurosurg 132:586–594, 2020

Physicians are more frequently encountering patients who are treated with deep brain stimulation (DBS), yet many MRI centers do not routinely perform MRI in this population. This warrants a safety assessment to improve DBS patients’ accessibility to MRI, thereby improving their care while simultaneously providing a new tool for neuromodulation research.

METHODS A phantom simulating a patient with a DBS neuromodulation device (DBS lead model 3387 and IPG Activa PC model 37601) was constructed and used. Temperature changes at the most ventral DBS electrode contacts, implantable pulse generator (IPG) voltages, specific absorption rate (SAR), and B1+rms were recorded during 3-T MRI scanning. Safety data were acquired with a transmit body multi-array receive and quadrature transmit-receive head coil during various pulse sequences, using numerous DBS configurations from “the worst” to “the most common.” In addition, 3-T MRI scanning (T1 and fMRI) was performed on 41 patients with fully internalized and active DBS using a quadrature transmit-receive head coil. MR images, neurological examination findings, and stability of the IPG impedances were assessed.

RESULTS In the phantom study, temperature rises at the DBS electrodes were less than 2°C for both coils during 3D SPGR, EPI, DTI, and SWI. Sequences with intense radiofrequency pulses such as T2-weighted sequences may cause higher heating (due to their higher SAR). The IPG did not power off and kept a constant firing rate, and its average voltage output was unchanged. The 41 DBS patients underwent 3-T MRI with no adverse event.

CONCLUSIONS Under the experimental conditions used in this study, 3-T MRI scanning of DBS patients with selected pulse sequences appears to be safe. Generally, T2-weighted sequences (using routine protocols) should be avoided in DBS patients. Complementary 3-T MRI phantom safety data suggest that imaging conditions that are less restrictive than those used in the patients in this study, such as using transmit body multi-array receive coils, may also be safe. Given the interplay between the implanted DBS neuromodulation device and the MRI system, these findings are specific to the experimental conditions in this study.

 

Safety of Outpatient Anterior Cervical Discectomy and Fusion: A Systematic Review and Meta-Analysis

Neurosurgery 86:30–45, 2020

Anterior cervical discectomy and fusion (ACDF) is being increasingly offered on an outpatient basis. However, the safety profile of outpatient ACDF remains poorly defined.

OBJECTIVE: To review the medical literature on the safety of outpatient ACDF.

METHODS: We systematically reviewed the literature for articles published before April 1, 2018, describing outpatient ACDF and associated complications, including incidence of reoperation, stroke, thrombolytic events, dysphagia, hematoma, and mortality. A random-effects analysis was performed comparing complications between the inpatient and outpatient groups.

RESULTS: We identified 21 articles that satisfied the selection criteria, of which 15 were comparative studies. Most of the existing studies were retrospective, with a lack of level I or II studies on this topic. We found no statistically significant difference between inpatient and outpatient ACDF in overall complications, incidence of stroke, thrombolytic events, dysphagia, and hematoma development. However, patients undergoing outpatient ACDF had lower reported reoperation rates (P < .001), mortality (P < .001), and hospitalization duration (P < .001).

CONCLUSION: Our meta-analysis indicates that there is a lack of high level of evidence studies regarding the safety of outpatient ACDF. However, the existing literature suggests that outpatient ACDF can be safe, with low complication rates comparable to inpatient ACDF in well-selected patients. Patients with advanced age and comorbidities such as obesity and significant myelopathy are likely not suitable for outpatient ACDF. Spine surgeons must carefully evaluate each patient to decide whether outpatient ACDF is a safe option. Higher quality, large prospective randomized control trials are needed to accurately demonstrate the safety profile of outpatient ACDF.

Minimally Invasive Spinal Surgery in the Elderly: Does It Make Sense?

Minimally Invasive Spinal Surgery in the Elderly- Does It Make Sense

Neurosurgery 77:S108–S115, 2015

Lumbar degenerative disease can have varied pathoanatomy, with stenosis, spondylolisthesis, and scoliosis contributing to significant pain and disability. Among appropriately selected patients, surgical intervention can treat both back pain and leg pain and improve quality of life in a cost-effective manner with an acceptable safety profile. The evolution of minimally invasive surgical (MIS) techniques offers the potential to decrease the physiological impact of surgery and to improve the complication profile while achieving the same spine surgical objectives. The utility of such techniques among elderly patients >65 years of age has not been rigorously evaluated, and this systematic review sought to define the utility and safety of MIS spinal surgery for decompression, interbody fusion, and deformity correction in this population.

Review of 2 studies for MIS lumbar decompression reveals that the majority of elderly patients exhibit significant improvements in pain (change in visual analog score for leg pain, 3.4 points) and disability (change in Oswestry Disability Index, 19 points), with inadvertent durotomy in 3% of patients. Review of 4 studies for MIS lumbar interbody fusion reveals robust improvement in pain (change in visual analog score for leg pain, 3.4 points; change in visual analog score for back pain, 7.2 points), with inadvertent durotomy in 5% of patients.

Narrative review was performed for adult degenerative deformity correction, revealing that MIS techniques are feasible for managing such patients with acceptable rates of osseous union and complication. On the basis of largely low-quality, retrospective evidence, we recommend that elderly patients should not be excluded from MIS interventions for symptomatic lumbar degenerative spinal disease.

Adverse Events Associated With Deep Brain Stimulation for Movement Disorders: Analysis of 510 Consecutive Cases

DBS 2 leads metal head holder

Operative Neurosurgery 11:190–199, 2015

Although numerous studies have focused on the efficacy of deep brain stimulation (DBS) for movement disorders, less is known about surgical adverse events, especially over longer time intervals.

OBJECTIVE: Here, we analyze adverse events in 510 consecutive cases from a tertiary movement disorders center at up to 10 years postoperatively.

METHODS: We conducted a retrospective review of adverse events from craniotomies between January 2003 and March 2013. The adverse events were categorized into 2 broad categories—immediate perioperative and time-dependent postoperative events.

RESULTS: Across all targets, perioperative mental status change occurred in 18 (3.5%) cases, and symptomatic intracranial hemorrhage occurred in 4 (0.78%) cases. The most common hardware-related event was skin erosion in 13 (2.5%) cases. The most frequent stimulation-related event was speech disturbance in 16 (3.1%) cases. There were no significant differences among surgical targets with respect to the incidence of these events. Time-dependent postoperative events leading to the revision of a given DBS electrode for any reason occurred in 4.7% 6 1.0%, 9.3% 6 1.4%, and 12.4% 6 1.5% of electrodes at 1, 4, and 7 years postoperatively, respectively. Staged bilateral DBS was associated with approximately twice the risk of repeat surgery for electrode replacement vs unilateral surgery (P = .020).

CONCLUSION: These data provide low incidences for adverse events in a large series of DBS surgeries for movement disorders at up to 10 years follow-up. Accurate estimates of adverse events will better inform patients and caregivers about the potential risks and benefits of surgery and provide normative data for process improvement.

Minimally invasive microsurgery for anterior circulation aneurysms

MIS for Anterior Circulation Aneurysms

Acta Neurochir (2014) 156:493–503

The aim of our study was to evaluate minimally invasive techniques for the treatment of anterior circulation aneurysms versus standard surgery, and to calculate the impact of these techniques on health resources, length of stay, and treatment costs.

Methods A consecutive series of 24 patients with ruptured and 30 with unruptured anterior circulation aneurysms treated with minimally invasive microsurgery (MIM) by the same surgeon was compared with a matched series of standard microsurgeries (SM) conducted for 23 ruptured and 22 unruptured aneurysms. Complication rates, aneurysm obliteration, modified Rankin Scale (mRS) outcomes, length of stay, and treatment costs were assessed.

Results Surgical complications, aneurysm obliteration rates and mRS outcomes were comparable between MIM and SM groups in ruptured and unruptured aneurysm cohorts. MIM resulted in shorter operative times both in unruptured (102.7±4.35 vs 194.7±10.26 min, p<0.0001) and ruptured aneurysms (124.3±827 vs 209±13.84 min, p<0.0001). Length of stay was reduced in patients with MIM for unruptured aneurysms (1.55±24 vs 4.28±0.71 days, p<0.000,1) but not in those with ruptured aneurysms. MIM reduced treatment costs of unruptured aneurysm patients, mainly through reduced utilization of inpatient resources (non-acute bed costs in CAD: 371.2±80.99 vs 1440±224.1, p<0.0001), whereas costs were comparable in patients with ruptured aneurysms.

Conclusion Minimally invasive surgery is a safe and effective approach for the treatment of ruptured and unruptured aneurysms of the anterior circulation. In patients with unruptured aneurysms, reduced invasiveness and shorter operative times decreased length of stay, which reflects improved patient postoperative recovery. Overall, this translated into bed resource economy and cost reduction.

Safety and efficacy of Gliadel wafers for newly diagnosed and recurrent glioblastoma

Acta Neurochir (2012) 154:1371–1378

Combining Gliadel wafers and radiochemotherapy with TMZ may carry the risk of increased adverse events (AE). We analyzed the efficacy and safety in patients with glioblastoma who underwent multimodal treatment with implantation of Gliadel wafers.

Methods One hundred sixty-five consecutive patients with newly diagnosed (77 patients) or recurrent (88 patients) glioblastoma were studied. Forty-seven patients underwent surgery + Gliadel. The impact of age (≥65 vs. <65), resection extent (gross total vs. partial), use of Gliadel and adjuvant treatment (TMZ vs. other schemes/no adjuvant therapy) on overall survival (OS, for patients with newly diagnosed glioblastoma) and on recurrence-survival (for patients with recurrent glioblastoma) was analyzed with Cox regression. The impact of age, history (newly diagnosed vs. recurrent glioblastoma), number of Gliadel wafers implanted (0 vs. <8 vs. 8), resection extent (gross-total vs. partial) and adjuvant treatment (TMZ vs. other schemes/no adjuvant therapy) on the occurrence of AE and on the occurrence of implantation site-related AE (ISAE) was analyzed with the logistic regression model. Significance was set at p<0.05.

Results Multivariate analysis showed the only factor associated with longer survival, both for newly diagnosed and for recurrent GBM, was resection extent. Both patients with a higher number of wafers implanted and patients with recurrent tumors were significantly at risk for AE and ISAE. Patients with eight Gliadel wafers implanted had a 3-fold increased risk of AE and a 5.6-fold increased risk of ISAE, and patients with recurrent tumor had a 2.8-fold increased risk of AE and a 9.3-fold increased risk of ISAE.

Conclusions Adding Gliadel to standard treatment did not significantly improve the outcome. The toxicity after Gliadel use was significantly higher, both for patients with newly diagnosed and patients with recurrent glioblastoma.

Endoscopic endonasal skull base surgery: analysis of complications in the authors’ initial 800 patients

J Neurosurg 114:1544–1568, 2011. DOI: 10.3171/2010.10.JNS09406

The development of endoscopic endonasal approaches, albeit in the early stages, represents part of the continuous evolution of skull base surgery. During this early period, it is important to determine the safety of these approaches by analyzing surgical complications to identify and eliminate their causes.

Methods. The authors reviewed all perioperative complications associated with endoscopic endonasal skull base surgeries performed between July 1998 and June 2007 at the University of Pittsburgh Medical Center.

Results. This study includes the data for the authors’ first 800 patients, comprising 399 male (49.9%) and 401 female (50.1%) patients with a mean age of 49.21 years (range 3–96 years). Pituitary adenomas (39.1%) and meningiomas (11.8%) were the 2 most common pathologies. A postoperative CSF leak represented the most common complication, occurring in 15.9% of the patients. All patients with a postoperative CSF leak were successfully treated with a lumbar drain and/or another endoscopic approach, except for 1 patient who required a transcranial repair. The incidence of postoperative CSF leaks decreased significantly with the adoption of vascularized tissue for reconstruction of the skull base (< 6%). Transient neurological deficits occurred in 20 patients (2.5%) and permanent neurological deficits in 14 patients (1.8%). Intracranial infection and systemic complications were encountered and successfully treated in 13 (1.6%) and 17 (2.1%) patients, respectively. Seven patients died during the 30-day perioperative period, 6 of systemic illness and 1 of infection (overall mortality 0.9%).

Conclusions. Endoscopic endonasal skull base surgery provides a viable median corridor based on anatomical landmarks and is customized according to the specific pathological process. This corridor should be considered as the sole access or may be combined with traditional approaches. With the incremental acquisition of skills and experience, endoscopic endonasal approaches have an acceptable safety profile in select patients presenting with various skull base pathologies.