Abstract Background In patients with isolated HER2+ BrCBM and no extracranial disease (ECD), there are no consensus guidelines on optimal treatment approaches following CNS-directed therapy. Our goal was to determine the implications of ECD at time of first HER2+ BrCBM on intracranial progression-free survival (PFS1) and overall survival (OS). Methods Retrospective analysis was performed on 77 patients with HER2+ BrCBM who received 1st CNS radiation from 2006–2020. Demographics, dates of metastatic and intracranial diagnosis, ECD status at 1st BrCBM, and outcomes were collected. The primary endpoint was PFS1 defined as time from first CNS radiation to the subsequent documentation of intracranial progression (RANO-BM). OS was defined as time from 1st CNS radiation and 1st metastatic disease to date of death/last known alive. ECD status was defined by RECIST1.1 from staging scans within 30 days of 1st BrCBM. Results In this patient cohort, 25% (19/77) had isolated brain relapse/no ECD. Median age was 50 years. Most patients (58%) developed first BrCBM during adjuvant or early-line metastatic therapy. All patients with no ECD presented with isolated brain relapse as first metastatic presentation. Patients with concurrent ECD presented with first BrCBM at a median of 16.6m (95% CI: 10.5 to 25.3) after initial metastatic presentation. Median OS from initial metastatic presentation to death was worse for patients with isolated brain relapse (25.3m, 95% CI: 16.8 to 35.3) compared to those with concurrent ECD (49.7m, 95% CI: 43.2 to 62; p=0.01). Median OS from first CNS involvement to death was not statistically different amongst groups. Conclusions Patients with isolated HER2+ BrCBM as their initial metastatic event have substantially worse OS compared to patients with concurrent ECD developing CNS metastases later in their disease course. This population with isolated brain relapse deserves investigation of novel treatment algorithms, including earlier introduction of brain-penetrable HER2-targeted agents.
OBJECTIVE Stereotactic body radiation therapy (SBRT) offers efficient, noninvasive treatment of spinal neoplasms. Single-fraction (SF) high-dose SBRT has a relatively narrow therapeutic window, while hypofractionated delivery of SBRT may have an improved safety profile with similar efficacy. Because the optimal approach of delivery is unknown, the authors examined whether hypofractionated SBRT improves pain and/or functional outcomes and results in better tumor control compared with SF-SBRT. METHODS This is a single-institution retrospective study of adult patients with spinal metastases treated with SF- or three-fraction (3F) SBRT from 2008 to 2019. Demographics and baseline characteristics, radiographic data, and post-treatment outcomes at a minimum follow-up of 3 months are reported. RESULTS Of the 156 patients included in the study, 70 (44.9%) underwent SF- SBRT (median total dose 1700 cGy) and 86 (55.1%) underwent 3F-SBRT (median total dose 2100 cGy). At baseline, a higher proportion of patients in the 3F-SBRT group had a worse baseline profile, including severity of pain (p < 0.05), average use of pain medication (p < 0.001), and functional scores (p < 0.05) compared with the SF-SBRT cohort. At the 3-month follow-up, the 3F-SBRT cohort experienced a greater frequency of improvement in pain compared with the SF- SBRT group (p < 0.05). Furthermore, patients treated with 3F-SBRT demonstrated a higher frequency of improved Karnofsky Performance Scale (KPS) scores (p < 0.05) compared with those treated with SF-SBRT, with no significant difference in the frequency of improvement in modified Rankin Scale scores. Local tumor control did not differ significantly between the two cohorts. CONCLUSIONS Patients who received spinal 3F-SBRT more frequently achieved significant pain relief and an increased frequency of improvement in KPS compared with those treated with SF-SBRT. Local tumor control was similar in the two groups. Future work is needed to establish the relationship between fractionation schedule and clinical outcomes.
BACKGROUND CONTEXT In complex spine surgery, indications and approaches are challenging and stakes are high. There is little data on how these surgical decisions are made. There is growing concern that decision-making variability and poor planning lead to suboptimal short- and long-term outcomes. Complex spine surgery has an approximated risk of major complication of 19%, an overall complication rate of up to 55%, and a readmission rate of 7.5% (Friedman et al 2020). Multidisciplinary spine conferences have been shown in prior case series to alter surgical plans in 19%-28% of cases (Benton et al 2021, Chan et al 2016). Multidisciplinary planning conferences have also been shown to improve perioperative optimization. PURPOSE The goal of our study was to determine the effect of spine indications conferences on surgical decision-making and planning in complex spine patients at our institution. Additionally, we wanted to better understand how this process might aid in addressing difficult decisions in high-risk patients. STUDY DESIGN/SETTING To answer our questions, we collected data on patients presented at our weekly indications conference. The study had Duke University IRB approval. PATIENT SAMPLE Patient sample included patients presented at the Duke Spine Center weekly indications conference in a 6-month period in 2020. Primary surgeons chose patients to present and there was no presentation requirement. OUTCOME MEASURES We assessed primary surgeon plan vs consensus plan vs implemented plan to determine the role of indications conference on surgical planning and decision-making. We then assessed correlations between demographic, clinical, and complication data on this population. Complication data assessed was specifically, our preoperative Pythion risk calculator (Corey et al 2018) as well as our morbidity and mortality report. Methods The primary surgeon's preconference plan and the conference consensus plan were recorded following each indications conference. The actual surgical plan implemented was obtained from chart review. We performed a chart review for demographic and clinical factors. Complication data were obtained from the Pythion Risk Calculator (Corey et al 2018) and the morbidity and mortality conference list. Preliminary summary statistics were performed. Results Our analysis included 143 patients over a 6-month period. Orthopedic and neurosurgery spine surgeons attended conferences and a range of 10 to 26 surgeons attended weekly during the study period. Eighty-two (57%) patients identified as male and 62 (43%) female with an average age of 59 years. For 64 of the patients presented, the consensus plan agreed with the surgeon's initial plan without change. Seventy-six of the surgical or nonsurgical treatment plans were new and/or different from the primary surgeon's initial plan after group consensus. One patient was excluded as the primary surgeon did not attend the conference and for 2 patients, the group did not reach consensus. Additional therapies such as injections, neurology consultation, management of osteoporosis, medical optimization, and weight loss were recommended for 36 patients. In 70% of cases, the primary surgeon implemented the plan suggested in conference. The average estimated risk of a surgical complication for this patient sample by the Pythion calculator was 40%. Seven patients (4.9%) had complications presented at the morbidity and mortality conference. Of the patients with complications, the group agreed with the primary surgeon's plan for 4 patients, no consensus plan was reached for 2 of the patients, and a new surgical plan was suggested for 1 of the patients. The implemented plan was consistent with the conference plan in all of these cases. Conclusions This abstract presents summary statistics from an in-depth evaluation of our institution's spine indication conference and its association with surgical plan as well as the role it plays in complication avoidance in high-risk patients. FDA DEVICE/DRUG STATUS This abstract does not discuss or include any applicable devices or drugs. In complex spine surgery, indications and approaches are challenging and stakes are high. There is little data on how these surgical decisions are made. There is growing concern that decision-making variability and poor planning lead to suboptimal short- and long-term outcomes. Complex spine surgery has an approximated risk of major complication of 19%, an overall complication rate of up to 55%, and a readmission rate of 7.5% (Friedman et al 2020). Multidisciplinary spine conferences have been shown in prior case series to alter surgical plans in 19%-28% of cases (Benton et al 2021, Chan et al 2016). Multidisciplinary planning conferences have also been shown to improve perioperative optimization. The goal of our study was to determine the effect of spine indications conferences on surgical decision-making and planning in complex spine patients at our institution. Additionally, we wanted to better understand how this process might aid in addressing difficult decisions in high-risk patients. To answer our questions, we collected data on patients presented at our weekly indications conference. The study had Duke University IRB approval. Patient sample included patients presented at the Duke Spine Center weekly indications conference in a 6-month period in 2020. Primary surgeons chose patients to present and there was no presentation requirement. We assessed primary surgeon plan vs consensus plan vs implemented plan to determine the role of indications conference on surgical planning and decision-making. We then assessed correlations between demographic, clinical, and complication data on this population. Complication data assessed was specifically, our preoperative Pythion risk calculator (Corey et al 2018) as well as our morbidity and mortality report. The primary surgeon's preconference plan and the conference consensus plan were recorded following each indications conference. The actual surgical plan implemented was obtained from chart review. We performed a chart review for demographic and clinical factors. Complication data were obtained from the Pythion Risk Calculator (Corey et al 2018) and the morbidity and mortality conference list. Preliminary summary statistics were performed. Our analysis included 143 patients over a 6-month period. Orthopedic and neurosurgery spine surgeons attended conferences and a range of 10 to 26 surgeons attended weekly during the study period. Eighty-two (57%) patients identified as male and 62 (43%) female with an average age of 59 years. For 64 of the patients presented, the consensus plan agreed with the surgeon's initial plan without change. Seventy-six of the surgical or nonsurgical treatment plans were new and/or different from the primary surgeon's initial plan after group consensus. One patient was excluded as the primary surgeon did not attend the conference and for 2 patients, the group did not reach consensus. Additional therapies such as injections, neurology consultation, management of osteoporosis, medical optimization, and weight loss were recommended for 36 patients. In 70% of cases, the primary surgeon implemented the plan suggested in conference. The average estimated risk of a surgical complication for this patient sample by the Pythion calculator was 40%. Seven patients (4.9%) had complications presented at the morbidity and mortality conference. Of the patients with complications, the group agreed with the primary surgeon's plan for 4 patients, no consensus plan was reached for 2 of the patients, and a new surgical plan was suggested for 1 of the patients. The implemented plan was consistent with the conference plan in all of these cases. This abstract presents summary statistics from an in-depth evaluation of our institution's spine indication conference and its association with surgical plan as well as the role it plays in complication avoidance in high-risk patients.
1041 Background: BCBMs are very common in metastatic HER2+ breast cancer. CNS-directed local therapy is the gold standard for treatment, followed by systemic HER2-targeted therapies. In patients with HER2+ BCBM and stable extracranial disease (ECD), consensus guidelines recommend continuing current systemic therapy after local therapy. Our goal was to determine the implications of ECD status at time of HER2+ BCBM first CNS involvement on outcomes including intracranial progression-free survival (PFS1) and overall survival (OS). Methods: Retrospective analysis was performed on data extracted from 77 patients with HER2+ BCBM who received CNS radiation at Duke between 2006 and 2020 following initial documentation of CNS involvement. Demographics, dates of metastatic and intracranial diagnosis, ECD status at first CNS involvement, systemic therapy, and outcomes were collected. The primary endpoint was PFS1 defined as the time from first CNS radiation to the subsequent documentation of intracranial progression (RANO-BM). OS was defined as time from first CNS radiation and first metastatic disease to date of death or last known alive. ECD status was defined by RECIST1.1 from systemic staging scans within 30 days of first CNS involvement. Results: In this patient cohort of HER2+ BCBMs undergoing CNS radiation at first CNS involvement, >50% of patients had extracranial disease control: no ECD (25%) or stable/responding disease (31%). 52% of patients’ tumors were ER+. Median age was 50 years (range 27 – 75). Most patients (58%) developed first CNS involvement during adjuvant or first/second line metastatic therapy. For first CNS radiation, 49% received SRS and 48% WBRT. All patients with no ECD presented with isolated CNS disease as first metastatic presentation. Median OS in this cohort from initial metastatic disease to death was markedly worse for patients with no ECD (25.3m, 95% CI: 16.8 to 35.3) compared to those with progressive or stable/responding ECD (48.8m, 95% CI: 28.1 to 65; and 52.9 months, 95% CI: 43.7 to 73.3, respectively; p=0.03). Median OS from first CNS involvement to death was not statistically different amongst groups. This analysis did not detect median PFS1 differences based on ECD after first CNS radiation: progressive ECD (6.3m), no ECD (8.7m), or stable/responding ECD (10.6m) (p=0.13), though clinically meaningful differences were observed. Conclusions: Patients with isolated HER2+ BCBM with no ECD at the time of their initial CNS involvement (25% of population) have substantially worse OS compared to patients who present with ECD and develop CNS metastases later in their disease course. This population with isolated CNS disease at metastatic presentation deserves investigation of novel treatment algorithms, including earlier introduction of brain penetrable HER2-targeted agents.
CONTEXT:Critically ill patients with brain metastases (BM) face significant uncertainty regarding prognosis and survival and can benefit from Palliative care (PC). However, research regarding the role of PC in this population is lacking. OBJECTIVES:We sought to compare BM patients admitted to an intensive care unit who received an inpatient PC consult (PC cohort) to those who did not (Usual Care, UC cohort). METHODS:We performed a single-institution retrospective cohort analysis. Our outcome variables were mortality, time from intensive care unit admission to death, disposition, and change in code status. We also evaluated PC's role in complex medical decision making, symptom management and hospice education. RESULTS:PC consult was placed in 31 of 118 (28%) of patients. The overall mortality rates were not statistically different (78.8% vs. 90.3%, P= 0.15, UC vs. PC cohort). Patients in the PC cohort had a shorter time to death, higher rate of death within 30 days of admission, increased rate of discharge to hospice, and increase percentage of code status change to "do not attempt resuscitation" during the admission. The primary services provided by PC were symptom management (n = 21, 67.7%) and assistance in complex medical decision making (n = 20, 64.5%). CONCLUSION:In our patient cohort, PC is an underutilized service that can assist in complex medical decision making and symptom management of critically ill BM patients. Further prospective studies surveying patient, family and provider experiences could better inform the qualitative impact of PC in this unique patient population.
Abstract INTRODUCTION There is increasing recognition that palliative care (PC) can benefit patients with advanced cancers. However, early referral to PC is not yet a reality for patients diagnosed with a primary brain tumor. We hypothesize that lack of knowledge and/or misperceptions regarding PC by patients, caregivers, or their providers remain barriers. METHODS This is an IRB-exempt, one-time QR-accessible REDcap questionnaire administered to patients, caregivers, and providers at the Preston Robert Tisch Brain Tumor Center between September 2020 and May 2021. We administered 9 questions regarding knowledge and beliefs about PC from the Health Information National Trends Survey 5, Cycle 2: results of this nationally representative U.S. sample are publicly available and used for comparison. RESULTS We had 141 survey respondents: 25 providers, 59 patients, and 57 caregivers. The median patient and caregiver ages were 49 (21-74) and 50 years (24-73), respectively. Caregivers were more likely female (55.2 %) and identified as a spouse or domestic partner (58.2%). Providers, were equally distributed by years of experience. Compared to patients and caregivers, providers reported more baseline knowledge of PC (p< 0.0001, p< 0.0001) and better understood the role of PC in pain/symptom management (p=0.0038, p=0.0087) and social/emotional support (p=0.0044, p=0.0279). Interestingly, most providers (76.0%) disagreed with the statement “the goal of palliative care is to give patients more time at the end of life.” Compared to a general U.S. sample (n=1,162) our patients (n=39) were better informed in only 2 of 9 questions. Whereas, caregivers (n=48) were better informed in 6 of 9 questions. CONCLUSION Neuro-oncology providers were knowledgeable, but a minor gap in understanding the goal of PC was identified. Caregivers were overall more knowledgeable than patients. However, Neuro-oncology patients, had similar knowledge and beliefs compared to a nationally representative sample. PC interventions should prioritize filling knowledge gaps for Neuro-oncology patients.
Introduction Given the high symptom burden and complex clinical decision making associated with a diagnosis of brain metastases (BM), specialty palliative care (PC) can meaningfully improve patient quality of life. However, no prior study has formally evaluated patient-specific factors associated with PC consultation among BM patients. Methods We examined the rates of PC consults in a cohort of 1303 patients with BM admitted to three tertiary medical centers from October 2015 to December 2018. Patient demographics, surgical status, 30-day readmission, and death data were collected via retrospective chart review. PC utilization was assessed by identifying encounters for which an inpatient consult to PC was placed. Statistical analyses were performed to compare characteristics and outcomes between patients who did and did not receive PC consults. Results We analyzed 1303 patients admitted to the hospital with BM. The average overall rate of inpatient PC consultation was 19.6%. Rates of PC utilization differed significantly by patient race (17.5% in White/Caucasian vs 26.0% in Black/African American patients, P = .0014). Patients who received surgery during their admission had significantly lower rates of PC consultation (3.9% vs 22.4%, P < .0001). Patients who either died during their admission or were discharged to hospice had significantly higher rates of PC than those who were discharged home or to rehabilitation (P < .0001). Conclusions In our dataset, PC consultation rates varied by patient demographic, surgical status, discharging service, and practice setting. Further work is needed to identify the specific barriers to optimally utilizing specialty PC in this population.
Primary spine tumors are rare neoplasms that affect about 0.62 per 100,000 individuals in the US. Intramedullary spinal cord tumors (IMSCTs) are the rarest of all primary tumors involving the spine and can cause pain, imbalance, urinary dysfunction and neurological deficits. These types of tumors oftentimes necessitate surgical treatment, yet there is a lack of data on hospital length of stay and complication rates following treatment. Given that treatment candidacy, quality of life, and outcomes are tied so closely to potential for prolonged length of stay and postoperative complications, it is important to better understand the factors that increase the risk of these outcomes in patients with IMSCTs. Methods: The National Surgical Quality Improvement Program (NSQIP) database was queried for all patients undergoing surgery for treatment of intramedullary spinal cord tumors between 2005 and 2017. Univariate and multivariate analysis were performed to assess patient risk factors influencing prolonged length of stay and post-op complications. Results: A total of 638 patients were included in the analysis. Pre-operative American Society of Anesthesiology (ASA) physical status classification of 3 and above (OR 1.89; p = 0.0005), dependent functional status (OR 2.76; p = 0.0035) and transfer from facilities other than home (OR 8.12; p <0.0001) were independent predictors of prolonged length of stay (>5 days). The most commonly reported complications were pneumonia (5.7%), urinary tract infection (9.4%), septic shock (3.8%), superficial incisional infection (5.7%), organ or space infection (5.7%), pulmonary embolism (11.3%), DVT requiring therapy (15.1%) and wound dehiscence (5.7%). Conclusion: Our study demonstrated the significant influence of clinical variables on prolonged hospitalization of IMSCT patients. This should be factored into clinical and surgical decision making and when counseling patients of their expected outcomes. (c) 2021 Published by Elsevier Ltd.
Study Design: Retrospective cohort study using the National Surgical Quality Improvement Program. Objective: The objective of this study was to identify preoperative factors that impact the decision to perform prophylactic muscle flap closure and assess risk factors for wound healing complications in patients undergoing spinal procedures with and without muscle flap closure. Summary of Background Data: Prior studies suggest that muscle flap closure following complex spine surgery results in a lower risk of wound healing complications. However, these studies have been limited to single institutions and/or surgeons. Methods: The National Surgical Quality Improvement Program database was queried for all patients undergoing spine surgery between 2005 and 2017 with and without concomitant muscle flaps. Preoperative and perioperative variables were extracted. Univariate and multivariate analyses were performed to assess risk factors influencing surgical site infection (SSI) and wound disruption, as well as to delineate which preoperative factors increased the likelihood of patients receiving flap closures a priori. Results: Concomitant muscle flaps were performed on 758 patients; 301,670 patients did not receive a flap. Overall 29 (3.83%) patients in the flap group experienced SSI compared to 5154 (1.71%) in the nonflap group (P<0.0001). Preoperative steroid use [odds ratio (OR) 0.5; P<0.0001], wound infection (OR 0.24; P<0.0001), elevated white blood cell count (OR 1.034; P<0.0001), low hematocrit (OR 0.94; P<0.0001), preoperative transfusion (OR 0.22; P=0.0068) were significantly associated with utilization of muscle flaps. Perioperative factors including a contaminated wound (OR 4.72; P<0.0001), the American Society of Anesthesiologists classification of severe disease (OR 1.92; P=0.024), and longer operative time (OR 1.001; P=0.0024) were significantly associated with postoperative wound disruption. In addition, after propensity score matching for these factors that increase risk of wound complications, there was no difference in the rates of SSI between the flap and nonflap group. Conclusion: Our results suggest that patients with a higher burden of illness preoperatively are more likely to receive prophylactic paraspinal flaps which can reduce the rates of wound-related complications.
Introduction: Estimating the risk of extended length of stay (LOS) or non-routine discharge disposition is helpful in surgical decision-making for patients with brain metastases (BM). In 2020, an online calculator was introduced by Khalafallah et al. that stratified the risk of patients with brain tumors based on poor surgical outcomes. We applied the calculator to our population of BM patients to determine its generalizability and validity. Methods: We included BM patients who underwent a cranial procedure between 2015 and 2018 at a single academic institution. Patient age, race, marital status, admission status, KPS score, and medical co-morbidities (5-point modified frailty index (mFI-5)) were included in the analysis. We calculated the areas under the Receiver Operating Characteristics (ROC) curves to determine the validity of the model proposed in predicting extended LOS (>7 days) and need for specialty care at discharge (non-routine discharge disposition). Results: We analyzed 244 patients (mean age 61.2 years (SD 11.1), 57.0% female, and 78.1% Caucasian). The areas under the ROC curves were 0.8427 and 0.8422 for extended LOS and non-routine discharge disposition, suggesting high accuracy of the models for these outcomes. However, the (mFI-5) was not a significant predictor of either outcome in our multivariate analyses. Conclusions: We validated Khalafallah et al.’s predictive models of extended LOS and non-routine discharge disposition in our patient population, which included a broader range of surgical procedures. Further investigation of this model could clarify how the type of neurosurgical procedure influences outcomes, the role of the mFI-5, and its overall generalizability.
Background context: Preoperative optimization of medical comorbidities prior to spinal surgery is becoming an increasingly important intervention in decreasing postoperative complications and ensuring a satisfactory postoperative course. The treatment of preoperative anemia is based on guidelines made by the American College of Cardiology (ACC), which recommends packed red blood cell transfusion when hematocrit is less than 21% in patients without cardiovascular disease and 24% in patients with cardiovascular disease. The literature has yet to quantify the risk profile associated with preoperative pRBC transfusion. Purpose: To determine the incidence of complications following preoperative pRBC transfusion in a cohort of patients undergoing spine surgery. Study design: Retrospective review of a national surgical database. Patient sample: The national surgical quality improvement program database Outcome neasures: Postoperative physiologic complications after a preoperative transfusion. Complications were defined as the occurrence of any DVT, PE, stroke, cardiac arrest, myocardial infarction, longer length of stay, need for mechanical ventilation greater than 48 h, surgical site infections, sepsis, urinary tract infections, pneumonia, or higher 30-day mortality. Methods: The national surgical quality improvement program database was queried, and patients were included if they had any type of spine surgery and had a preoperative transfusion. Results: Preoperative pRBC transfusion was found to be protective against complications when the hematocrit was less than 20% and associated with more complications when the hematocrit was higher than 20%. In patients with a hematocrit higher than 20%, pRBC transfusion was associated with longer lengths of stay, and higher rates of ventilator dependency greater than 48 h, pneumonia, and 30-day mortality. Conclusion: This is the first study to identify an inflection point in determining when a preoperative pRBC transfusion may be protective or may contribute to complications. Further studies are needed to be conducted to stratify by the prevalence of cardiovascular disease.
Price, Meghan; Howell, Elizabeth P BS; Dalton, Tara; Ramirez, Luis; Williamson, Theresa; Painter, Brice; Check, Devon; Kamal, Arif; Goodwin, C. Rory MD, PhD Author Information
There is no validated model for delivering palliative care (PC) in the glioblastoma (GBM) population. The primary objectives were to assess the feasibility and determine the acceptability of a time-based model of integrated specialty PC to patients and providers. Secondary objectives were to estimate the impact on healthcare utilization and quality of life (QoL) compared to historical controls. We consented and referred patients to PC at their initial Neuro-Oncology consultation between 4/2018 and 5/2019. We conducted QoL assessments (NCCN Distress Tool; Functional Assessment of Cancer Therapy-Brain (FACT-BR); Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F); Epworth Sleepiness Scale (ESS)) at (1) baseline (2) immediately after chemoradiation, and (3) 6 months following chemoradiation. Ongoing PC follow-up was at the discretion of the PC provider. We administered the Edmonton Symptom Assessment System (ESAS) before and after PC visits. We measured patient and referring provider satisfaction using FAMCARE-16 and a PC departmental survey, respectively. We did not meet our goal enrollment of 50 patients. 32 were offered participation, 12 consented and 8 attended at least one PC visit. The mean number of PC visits was 1.6. Mean age was 62 (42–79). 75% had a KPS ≥80. Of those that did not complete the study, 2 died and 5 either withdrew consent or declined further visits. At baseline, 91.7 % had a NCCN distress score ≥4. Patients were overall satisfied with the intervention. Introduction of specialty PC at the time of GBM diagnosis is challenging. Participants reported their experience as overall positive. Results from referring providers are pending. Due to low-enrollment we did not pursue further statistical comparisons regarding healthcare utilization compared to historical controls.
Study Design: Systematic review and meta-analysis. Objective: To perform a systematic review of clinical outcomes between stand-alone anchored spacers and traditional cages with plate fixation for dysphagia and pseudoarthrosis using data from clinical trials. Methods: Our search protocol was added to PROSPERO register and systematic review using PRISMA method was performed. Then, we systematically searched for studies addressing stand-alone anchored spacers in patients who underwent ACDF. Mean Neck Disability Index (NDI), dysphagia incidence % (Dinc%), and Swallowing–Quality of Life (SQOL) scores during preoperative, immediate postoperative and last follow-up visits were extracted. Chi-square and analysis of variance (ANOVA) tests were used for statistical comparisons ( P ≤ .05). Results: The initial search generated 506 articles in CENTRAL and 40 articles in MEDLINE. Finally, 14 articles were included. Total number of patients was 1173 (583 anchored stand-alone and 590 plate). Dinc% scores were statistically significantly lower in the stand-alone anchored spacer compared to the plate-screw construct ( P ≤ .05). ANOVA showed no statistically significant difference in the comparisons of SQOL. On the other hand, NDI scores were statistically significantly lower in baseline of stand-alone anchored spacer and the plate-screw construct compared with both immediate postoperative and last follow-up visits ( P ≤ .05). Conclusions: Our study results revealed that the stand-alone anchored spacers were associated with less dysphagia in the immediate and last follow-up.