A real-world analysis of hybrid CDA and ACDF compared to multilevel ACDF.

BACKGROUND: Multilevel anterior cervical discectomy and fusion (mACDF) is the gold standard for multilevel spinal disease; although safe and effective, mACDF can limit regular spinal motion and contribute to adjacent segment disease (ASD). Hybrid surgery, composed of ACDF and cervical disc arthroplasty, has the potential to reduce ASD by retaining spinal mobility. This study examined the safety of hybrid surgery by utilizing administrative claims data to compare real-world rates of subsequent surgery and post-procedural hospitalization within populations of patients undergoing hybrid surgery versus mACDF for multilevel spinal disease. METHODS: This observational, retrospective analysis used the MarketScan Commercial and Medicare Database from July 2013 through June 2020. Propensity score matched cohorts of patients who received hybrid surgery or mACDF were established based on the presence of spinal surgery procedure codes in the claims data and followed over a variable post-period. Rates of subsequent surgery and post-procedural hospitalization (30- and 90-day) were compared between hybrid surgery and mACDF cohorts. RESULTS: A total of 430 hybrid surgery patients and 2,136 mACDF patients qualified for the study; average follow-up was approximately 2 years. Similar rates of subsequent surgery (Hybrid: 1.9 surgeries/100 patient-years; mACDF: 1.8 surgeries/100 patient-years) were observed for the two cohorts. Hospitalization rates were also similar across cohorts at 30 days post-procedure (Hybrid: 0.67% hospitalized/patient-year; mACDF: 0.87% hospitalized/patient-year). At 90 days post-procedure, hybrid surgery patients had slightly lower rates of hospitalization compared to mACDF patients (0.23% versus 0.42% hospitalized/patient-year; p < 0.05). CONCLUSIONS: Findings of this real-world, retrospective cohort study confirm prior reports indicating that hybrid surgery is a safe and effective intervention for multilevel spinal disease which demonstrates non-inferiority in relation to the current gold standard mACDF. The use of administrative claims data in this analysis provides a unique perspective allowing the inclusion of a larger, more generalizable population has historically been reported on in small cohort studies.

Cost-Utility Analysis of Anterior Vertebral Body Tethering versus Spinal Fusion in Idiopathic Scoliosis from a US Integrated Healthcare Delivery System Perspective.

PURPOSE: Anterior vertebral body tethering (VBT) is a non-fusion, minimally invasive, growth-modulating procedure with some early positive clinical outcomes reported in pediatric patients with idiopathic scoliosis (IS). VBT offers potential health-related quality of life (HRQoL) benefits over spinal fusion in allowing patients to retain a greater range of motion after surgery. We conducted an early cost-utility analysis (CUA) to compare VBT with fusion as a first-choice surgical treatment for skeletally immature patients (age >10 years) with moderate to severe IS, who have failed nonoperative management, from a US integrated healthcare delivery system perspective. PATIENTS AND METHODS: The CUA uses a Markov state transition model, capturing a 15-year period following index surgery. Transition probabilities, including revision risk and subsequent fusion, were based on published surgical outcomes and an ongoing VBT observational study (NCT02897453). Patients were assigned utilities derived from published patient-reported outcomes (PROs; SRS-22r mapped to EQ-5D) following fusion and the above VBT study. Index and revision procedure costs were included. Probabilistic (PSA) and deterministic sensitivity analyses (DSA) were performed. RESULTS: VBT was associated with higher costs but also higher quality-adjusted life years (QALYs) than fusion (incremental costs: $45,546; QALYs gained: 0.54). The subsequent incremental cost-effectiveness ratio for VBT vs fusion was $84,391/QALY gained. Mean PSA results were similar to the base case, indicating that results were generally robust to uncertainty. The DSA indicated that results were most sensitive to variations in utility values. CONCLUSION: This is the first CUA comparing VBT with fusion in pediatric patients with IS and suggests that VBT may be a cost-effective alternative to fusion in the US, given recommended willingness-to-pay thresholds ($100,000-$150,000). The results rely on HRQoL benefits for VBT compared with fusion. For improved model accuracy, further analyses with longer-term PROs for VBT, and comparative effectiveness studies, would be needed.

Systematic review of operative outcomes of robotic surgical procedures performed with endoscopic linear staplers or robotic staplers.

A comprehensive review of operative outcomes of robotic surgical procedures performed with the da Vinci robotic system using either endoscopic linear staplers (ELS) or robotic staplers is not available in the published literature. We conducted a literature search to identify publications of robotic surgical procedures in all specialties performed with either ELS or robotic staplers. Twenty-nine manuscripts and six abstracts with relevant information on operative outcomes published from January 2011 to September 2017 were identified. Given the relatively recent market release of robotic staplers in 2014, comparative perioperative clinical outcomes data on the performance of ELS vs. robotic staplers in robotic surgery is very sparse in the published literature. Only three comparative studies of surgeries with the da Vinci robotic system plus ELS vs. da Vinci plus robotic staplers were identified; two in robotic colorectal surgery and the other in robotic gastric bypass surgery. These comparative studies illustrate some nuances in device design and usability, which may impact outcomes and cost, and therefore may be important to consider when selecting the appropriate stapling technologies/technique for different robotic surgeries. Comparative perioperative data on the use of ELS vs. robotic staplers in robotic surgery is scarce (three studies), and current literature identifies both types of devices as safe and effective. Given the longer clinical history of ELS and its relatively more robust evidence base, there may be trade-offs to consider before switching to robotic staplers in certain robotic procedures. However, this literature review may serve as an initial reference for future research.