Safety and feasibility of outpatient ACDF in an ambulatory setting: A retrospective chart review

Cervical total disc replacement (TDR) is an increasingly accepted procedure for the treatment of symptomatic cervical degenerative disc disease. Multiple Level I evidence clinical trials have established cervical TDR to be a safe and effective procedure in the short-term. The objective of this study is to provide a long-term assessment of TDR versus anterior discectomy and fusion for the treatment of one- and two-level disc disease. This study was a continuation of a prospective, multicenter, randomized, US FDA IDE clinical trial comparing cervical TDR with the Mobi-C© Cervical Disc versus ACDF through 7 years follow-up. Inclusion criteria included a diagnosis of symptomatic cervical degenerative disc disease at one or two cervical levels. TDR patients were treated using a Mobi-C© artificial disc (Zimmer Biomet, Austin TX, USA). ACDF with allograft and anterior plate was used as a control treatment. Outcome measures were collected preoperatively and postoperatively at 6 weeks, at 3, 6, 12, 18 months, annually through 60 months, and at 84 months. Measured outcomes included Overall success, Neck Disability Index (NDI), VAS neck and arm pain, segmental range of motion (ROM), patient satisfaction, SF-12 MCS/PCS, major complications, and subsequent surgery rate. The primary endpoint was an FDA composite definition of success comprising clinical improvement and an absence of major complications and secondary surgery events. A total of 599 patients were enrolled and treated, with 164 treated with one-level TDR, 225 treated with two-level TDR, 81 treated with one-level ACDF, and 105 treated with two-level ACDF. At seven years, follow-up rates ranged from 73.5% to 84.4% (overall 80.2%).The overall success rates of two level TDR and ACDF patients were 60.8% and 34.2%, respectively (p<0.0001). The overall success rates of one level TDR and ACDF patients were 55.2% and 50%, respectively (p>0.05). Both the single and two level TDR and ACDF groups showed significant improvement from baseline NDI scores, VAS neck and arm pain scores, and SF-12 MCS/PCS scores (p<0.0001). In the single level cohort, there was an increased percentage of TDR patients who reported themselves as "very satisfied" (TDR 90.9% vs ACDF 77.8%; p= 0.028). There was a lower rate of adjacent level secondary surgery in the single level TDR patients (3.7%) versus the ACDF patients (13.6%; p = 0.007).In the two level TDR group, the NDI success rate was significantly greater in the TDR group (TDR: 79.0% vs. ACDF: 58.0%; p=0.001). There was significantly more improvement in NDI change score at 7 years in the TDR patients versus ACDF. The TDR group had a significantly higher rate of patients who were "very satisfied" with their treatment compared to the ACDF group (TDR: 85.9% vs. ACDF: 73.9%). The rate of subsequent surgery at the index level was significantly lower in the TDR group compared to the ACDF group (TDR: 4.4% vs. ACDF: 16.2%; p=0.001). The rate of adjacent level secondary surgery was significantly lower in the two level TDR (4.4%) patients compared to the ACDF (11.3%; p=0.03) patients. In both single and two level cohorts, the percentage of patients with worse NDI (2.5%-3.8% of two level surgeries and 1.2%-2.5% of single level surgeries) or worse neck pain (5%-6.8% of the two level surgeries and 1.3% - 3.8% of the single level surgeries) was strikingly low in both groups but trended lower in the TDR patients. At seven years, the composite success analysis demonstrated clinical superiority of two level TDR over ACDF and non-inferiority of single level TDR versus ACDF. There were lower rates of secondary surgery and higher adjacent level disc survivorship in both groups. Both surgeries were remarkably effective in alleviating pain relative to baseline and the rate of patients with worse disability or neck pain was surprisingly low. Overall, greater than 95% of patients (from both groups) who underwent TDR and 88% of patients who underwent ACDF were "very satisfied" at seven years. The differences in clinical effectiveness of TDR versus ACDF becomes more apparent as treatment increases from one to two levels, indicating a significant benefit for TDR over ACDF for two-level procedures. The Mobi-C Clinical Trial (ClinicalTrials.gov registration number: NCT00389597) was conducted at 24 sites in the US and was approved by the Institutional Review Board, Research Ethics Committee, or local equivalent of each participating site. 1.

Aim: A retrospective analysis of the outcome of anterior cervical discectomy and fusion comparing cage-only and cage-and-plate fixation on the basis of radiographic changes. Setting: In the department of Neurosurgery of a tertiary care hospital for two-year duration from January 2019 to December 2020. Methods: 56 patients who endured one-level ACDF (n = 34) and two-level ACDF (n = 22) for cervical disc disease were enrolled in the study and underwent a 12-months follow-up. Patients were separated according to cervical level and divided into cage-only group (ACDF-C) and cage-and-plate fixation group (ACDF-CP). The subsidence and status of fusion were evaluated on the radiography. Results: Comparing the ACDF-C with ACDF-CP at one level, the subsidence was detected in 50% of patients in the former group and in 33.3% of cases in the later at 12 months follow up. The two groups do not have statistically significant variance in terms of occurrence percentage (p = 0.32). In the two levels comparison of ACDF, ACDF-C had significantly more subsidence (75%) than the ACDF-CP group (28.5%; p= 0.046). The rate of fusion in single level ACDF of ACDF-C was not much different on statistics from that in the ACDF-CP group (87.5% and 88.8%, p= 0.43). The fusion was also similar in the two levels ACDF (ACDF-C= 87.5% and ACDF-CP= 92.8%; p= 0.30). Conclusions: This study’s radiological outcome did not exhibit any extra advantage of plate fixation compared to the cage-only in the 1-level ACDF subjects; however in ACDF at 2-level, a subsidence is much more probable without fixation of plate and therefore adding a plate to cage must be taken important. Keywords: cervical plate, cervical discectomy, spinal fusion, subsidence.

Friday, September 28, 2018 10:30 AM–12:00 PM abstracts: complications of cervical spine surgery: 155. Same day discharge after anterior cervical discectomy and fusion in suitable patients has similarly low readmission rates as admitted patients

Lateral mass (LM) fixation has become a standard in cervical spine instability treatment; however, maximal biomechanical stability combined with low morbidity remains a challenge. We evaluated our own patient cohort for bicortical screw placement and complication rates and investigated optimal screw trajectories with preoperative multiplanar computed tomography (CT) scans. Fifty-five patients were retrospectively evaluated after LM fixation at various subaxial cervical spine levels with a modified Magerl technique. Postoperative CTs and clinical records were used to determine LM anatomy, screw lengths, bicortical screw percentages, and complication rates. Additionally, 3D CT subaxial cervical spine data sets from 45 additional subjects with clinical indications for cervical spine imaging were evaluated. Subject LM geometries (thickness) were evaluated at different sagittal angulations (strict sagittal, 20°, 30° and the optimal angulation) for the optimal screw trajectories at the C3-C7 segments. In total, 284 LM screws were placed, with a mean screw length of 16 mm and an 88% bicortical bone purchase. Additionally, a 3.8% malplacement rate was observed. LM thickness varied substantially between each subaxial cervical level and at each of the investigated angulations. The optimal angulation, at which LM thickness was maximal, increased continuously from C3 (14°) to C7 (38°). This increase permitted 8% (C3) to 39% (C7) gains in screw length compared with the strict sagittal plane assessments. The optimal LM trajectory varied for each subaxial segment. The knowledge of LM geometry allows for safe, long and even bicortical screw placements using preoperative sagittal CT imaging evaluations.

92. Opioid use after anterior cervical spine surgery: what is the appropriate prescription quantity?

Introduction Hospital clinical pharmacy practice in the UK has developed beyond traditional boundaries of ward-based inpatient services. Royal Pharmaceutical Society Hospital Pharmacy Standards recommend pharmacy team members are integrated into multidisciplinary teams across the organisation to ensure safe and appropriate medicines use whatever the setting1. Pharmacy professionals provide pharmaceutical care and specialist services in outpatient and ambulatory settings and through participation in multidisciplinary team (MDT) meetings. Within the outpatient setting, research typically focusses on single outpatient clinics within specific disciplines, little evidence describes the overall contribution to patient care across whole pharmacy services2. Aim To describe the scope of clinical pharmacy services occurring beyond traditional ward-based services in a tertiary hospital; including quantification of outpatient clinics and MDT meetings provided by pharmacy professionals. Methods The Deputy Chief Pharmacist invited clinical Principal Pharmacists to participate in semi-structured interviews exploring the scope of “non-traditional” services across the Trust during March 2023. Non-traditional services were defined as direct clinical care outside of ward-based inpatient clinical pharmacy services. Indirect clinical care activities such as guideline writing, drug expenditure and governance activities were excluded. Inpatient board rounds/ward rounds and any service not currently provided due to vacancy were excluded. Participants were asked to quantify services provided, advise who provided the services and to describe contributions provided by the pharmacy team. The study was deemed service evaluation and ethical approval waived. Results 100% invited pharmacists participated. Pharmacists attended and contributed to over 150 MDT meetings monthly across 24 sub-specialities; 80% were for outpatients. In tertiary/quaternary services, these frequently covered patients beyond local geography. MDT meetings were typically attended by specialist, principal or consultant pharmacists. Common contributions included: provision of pro-active advice/responding to queries; medicines optimisation; monitoring; income or compliance assurance; prescribing/deprescribing. Specialist pharmacists provided 80-100 outpatient clinic sessions across 17 sub-specialities through a mix of face-to-face and virtual appointments, advanced pharmacy technicians provided on-treatment and counselling clinics. Activities included: initiation, monitoring, adjustment and cessation of medicines; patient counselling and MDT referral. Medicines prescribed were typically high cost, complex and higher risk. Pharmacists prescribed and clinically verified homecare medicines and provided ongoing annual review of outpatient medicines, including prescribing/deprescribing. Teams described medicines reconciliation and counselling in ambulatory haematology settings, off-site units and infusion suites. The team organised, optimised and provided advice and counselling for patients requiring antimicrobial therapies at home. Clinical pharmacists and pharmacy technicians provided medicines information to patients, internal and external healthcare professionals. Discussion/Conclusion This study provides evidence of the broad scope of clinical pharmacy practice beyond the boundaries of traditional ward-based services in a tertiary teaching hospital. This study was limited to a single organisation, specific clinical pharmacy activities and outcomes of these services were not fully quantified. Formal collation of clinical pharmacy activities within “non-traditional” outpatient and ambulatory settings is limited because activity data collection forms in hospital pharmacy are typically validated in traditional ward-based pharmacy services. We recommend further studies to validate activity collection tools to benchmark the activities of clinical pharmacy professionals providing services in outpatient and ambulatory settings both within and between hospital Trusts.

P33. Risk factors for allograft subsidence following ACDF

Stand-alone zero-profile devices have already proven safety, and a reduced dysphagia rate was assumed. So far, no level-one evidence is available to prove the proposed advantages of zero-profile implants in multilevel procedures. The aim of this RCT was to compare the clinical and radiological outcome of a zero-profile spacer versus cage + plate in two-level ACDF. Consecutive patients with contiguous two-level cDD were randomly assigned either to the interventional group (zero-profile device) or to the control group (cage + plate). Primary endpoint of the study was the prevalence of dysphagia at 24 months. Disability, progress of adjacent segment degeneration, fusion status and loss of correction were analyzed as secondary outcome measure. Primary outcome parameter was statistically analyzed by Chi-square test. Forty-one patients met inclusion criteria and were randomly assigned to the interventional and the control group. Dysphagia was frequent in either group at 3 months FU favoring interventional group (p = 0.078). At final FU, less patients of the interventional group complained about dysphagia, but the difference was not significant. No relevant differences at final FU were recorded for NPDI, loss of correction and adjacent-level degeneration. Fusion rate was slightly lower in the interventional group. Two-level ACDF either by a stand-alone zero-profile spacer or cage + plate is safe. Using a zero-profile cage dysphagia was infrequent at 24 months, but the value did not reach statistical significance in comparison with the cage + plate. Hence, this randomized trial was not able to prove the proposed clinical superiority for dysphagia rates for zero-profile anchored spacer in two-level cDD.

266. Higher paraspinal muscle density effect on outcomes after ACDF

Abdominal myomectomy—a safe procedure in an ambulatory setting

Feasibility of Outpatient Autologous Stem Cell Transplantation in Multiple Myeloma and Risk Factors Predicting Hospital Admission

IntroductionThe movements of the cervical spine during head rotation are too complicated to measure using conventional radiography or computed tomography (CT) techniques. In this study, we measure three-dimensional segmental motion of cervical spine rotation in vivo using a non-invasive measurement technique.Material and methodsSixteen healthy volunteers underwent three-dimensional CT of the cervical spine during head rotation. Occiput (Oc) – T1 reconstructions were created of volunteers in each of 3 positions: supine and maximum left and right rotations of the head with respect to the bosom. Segmental motions were calculated using Euler angles and volume merge methods in three major planes.ResultsMean maximum axial rotation of the cervical spine to one side was 1.6° to 38.5° at each level. Coupled lateral bending opposite to lateral bending was observed in the upper cervical levels, while in the subaxial cervical levels, it was observed in the same direction as axial rotation. Coupled extension was observed in the cervical levels of C5-T1, while coupled flexion was observed in the cervical levels of Oc-C5.ConclusionsThe three-dimensional cervical segmental motions in rotation were accurately measured with the non-invasive measure. These findings will be helpful as the basis for understanding cervical spine movement in rotation and abnormal conditions. The presented data also provide baseline segmental motions for the design of prostheses for the cervical spine.

The changing role of monitored anesthesia care in the ambulatory setting.

The present study aimed to evaluate the feasibility of percutaneous bone biopsy in an ambulatory setting as part of the management of diabetic foot osteomyelitis (DFO) on an outpatient basis. DFO may complicate some cases of apparently nonsevere foot infections in patients with diabetes and greatly increase the risk of a lower extremity amputation. It has been suggested that bone culture-based antibiotic therapy is a predictive factor of success in patients with diabetes treated nonsurgically for osteomyelitis of the foot. It is recommended to identify the causative microorganism(s) by the means of either a surgical or percutaneous bone biopsy taken appropriately to select the proper antibiotic therapy. Percutaneous bone biopsy in patients not requiring surgery is, however, not performed in everyday practice as it should be according to the current recommendations. In the present retrospective study, we report a series of 23 consecutive patients with a suspicion of DFO in whom 28 bone samples were collected by percutaneous biopsy at the bedside in an outpatient setting. The percentage of positive cultures was in accordance with that reported in the literature. The mean number of isolates per specimen was 1.04. After a mean 12-month follow-up, the remission was almost of 78%. No adverse event related to the bone biopsy was noted. After a 1-year follow-up, no recurrence was recorded among the patients in remission. The results of the present study suggest that bedside percutaneous bone biopsy performed in the ambulatory setting is a valuable and safe tool in the management of DFO on an outpatient basis.

Study Design:Broad narrative review.Objective:To review and summarize the current literature on the cost efficacy of performing ACDF, lumbar discectomy and short segment fusions of the lumbar spine performed in the outpatient setting.Methods:A thorough review of peer- reviewed literature was performed on the relative cost-savings, as well as guidelines, outcomes, and indications for successfully implementing outpatient protocols for routine spine procedures.Results:Primary elective 1-2 level ACDF can be safely performed in most patient populations with a higher patient satisfaction rate and no significant difference in 90-day reoperations and readmission rates, and a savings of 4000 to 41 305 USD per case. Lumbar discectomy performed through minimally invasive techniques has decreased recovery times with similar patient outcomes to open procedures. Performing lumbar microdiscectomy in the outpatient setting is safe, cheaper by as much as 12 934 USD per case and has better or equivalent outcomes to their inpatient counterparts. Unlike ACDF and lumbar microdiscectomy, short segment fusions are rarely performed in ASCs. However, with the advent of minimally invasive techniques paired with improved pain control, same-day discharge after lumbar fusion has limited clinical data but appears to have potential cost-savings up to 65-70% by reducing admissions.Conclusion:Performing ACDF, lumbar discectomy and short segment fusions in the outpatient setting is a safe and effective way of reducing cost in select patient populations.