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1.
Med Devices (Auckl) ; 14: 173-183, 2021.
Article in English | MEDLINE | ID: mdl-34163258

ABSTRACT

PURPOSE: Minimally invasive surgery (MIS) of the spine has been associated with favorable outcomes compared to open surgery. This study evaluated matched cohorts treated with MIS versus open posterior lumbar fusion for costs, payments, healthcare utilization and outcomes. PATIENTS AND METHODS: This study used the Premier Healthcare and IBM® MarketScan® Commercial and Medicare Databases. Patients with posterior lumbar fusion from 2015 to 2018 were identified and categorized as "Open" or "MIS". Cohorts were matched on patient and provider characteristics. Perioperative complications, hospital costs, healthcare utilization and post-operative outcomes and payments to providers were analyzed. Statistical significance was evaluated using T-tests and chi-square tests. RESULTS: After matching, 2,388 Open and 796 MIS from PHD, and 415 Open and 83 MIS from MarketScan were included. Statistically significant differences between MIS versus Open were found for index hospital costs, $29,181 (SD: $14,363) versus $27,616 (SD: $13,822), p=0.01; length of stay, 2.94 (SD: 2.10) versus 3.15 (SD: 2.03) days, p=0.01; perioperative urinary tract infection, 1.01% and 2.09% (p=0.05); and 30-day risk of hematoma/hemorrhage, 19.28% versus 8.43%, p=0.02. There were observed, but statistically non-significant differences in additional perioperative or post-operative complications, home discharge, 90-day all-cause and spine-related readmission, and 90-day post-operative payments. CONCLUSION: Compared to Open, patients that underwent MIS had statistically significant lower length of stay, lower perioperative UTI, greater hospital costs, and higher 30-day risk of hematoma/hemorrhage. The differences observed in post-operative complications and payments and readmissions warrant further investigation in larger matched cohorts.

2.
Spine J ; 21(1): 45-54, 2021 01.
Article in English | MEDLINE | ID: mdl-32890785

ABSTRACT

BACKGROUND CONTEXT: Spinal fusion surgeries are one of the most common types of operations performed during inpatient stays in the United States. Successful wound closure, including watertight closure at the skin layer, plays in important role in patient outcomes. PURPOSE: To compare the economic and clinical outcomes of spinal fusion surgeries using one of two sutureless skin closure techniques: skin staples plus waterproof wound dressings (SSWWD) or 2-octyl cyanoacrylate plus polymer mesh tape (2OPMT). STUDY DESIGN/SETTING: Retrospective study using a multi-hospital database. PATIENT SAMPLE: Patients undergoing inpatient spinal fusion surgery for a spine disorder between October 1, 2015 and March 31, 2019. OUTCOME MEASURES: Total costs from the hospital perspective, operating room time (ORT), hospital length of stay (LOS), non-home discharge, infection/wound complications during the 90-day global period (index surgery through 90 days post-discharge), and 30/60/90-day all-cause readmissions. METHODS: Outcomes were compared between study groups using nearest neighbor propensity score matching with exact matching on 45 primary procedure/diagnosis code groupings and generalized estimating equations to account for hospital-level clustering. This study was sponsored by Ethicon, Inc., a Johnson & Johnson company; the authors are employees or consultants of Johnson & Johnson. RESULTS: A total of 11,991 patients met the study criteria (2OPMT=5,961; SSWWD=6,030), of which 3,602 were included in each post-match study comparison group (total=7,204). As compared with the SSWWD group, the 2OPMT group had statistically significant lower median ORT (240 vs. 270 minutes; p=0.002), mean LOS (3.35 [SD=2.6] vs. 3.86 [SD=2.8] days, p=0.031), risks of non-home discharge status (17.63% vs. 23.10%, p=0.035), overall infections/wound complications (1.37% vs. 2.48%, p=0.015), and surgical site infection (1.11% vs. 2.07%, p=0.023). Differences between the study groups in total hospital costs, all-cause readmissions, and other sub-components of the infection/wound complication composite outcome were statistically insignificant (p>0.05). CONCLUSIONS: In this retrospective observational study of patients undergoing elective inpatient spinal fusion surgery, the use of 2OPMT for skin closure was associated with significantly lower ORT, LOS, non-home discharge, and 90-day rates of infections/wound complications as compared with SSWWD.


Subject(s)
Polymers , Spinal Fusion , Aftercare , Bandages , Cyanoacrylates , Humans , Patient Discharge , Retrospective Studies , Spinal Fusion/adverse effects , Surgical Mesh , Surgical Wound Infection , United States
3.
J Wound Care ; 29(Sup5a): S9-S20, 2020 May 01.
Article in English | MEDLINE | ID: mdl-32412893

ABSTRACT

OBJECTIVE: To compare economic and clinical outcomes of barbed sutures versus conventional sutures alone in wound closure for patients undergoing spinal surgery. METHOD: A retrospective study using the Premier Healthcare Database. The database was searched for patients who underwent elective inpatient spinal surgery (fusion or laminectomy) for a spinal disorder between 1 January 2014 and 30 June 2018 (first=index admission). Using billing records for medical supplies used during the index admission, patients were classified into mutually-exclusive groups: patients with any use of STRATAFIX (Ethicon, US) knotless tissue control devices (barbed sutures group); or patients with use of conventional sutures alone (conventional sutures group). Outcomes included the index admission's length of stay, total and subcategories of hospital costs, non-home discharge, operating room time (ORT, minutes), wound complications and readmissions within ≤90 days. Propensity score matching and generalised estimating equations were used to compare outcomes between the study groups. RESULTS: After matching, 3705 patients were allocated to each group (mean age=61.5 years [standard deviation, SD±12.9]; 54% were females). Compared with the conventional suture group, the barbed suture group had significantly lower mean ORT (239±117 minutes, versus 263±79 minutes conventional sutures, p=0.015). Operating room costs were also siginificantly lower in the barbed suture group ($6673±$3976 versus $7100±$2700 conventional sutures, p=0.020). Differences were statistically insignificant for other outcomes (all p>0.05). Subanalysis of patients undergoing fusions of ≥2 vertebral joints yielded consistent results. CONCLUSION: In this study, wound closure incorporating barbed sutures was associated with lower ORT and operating room costs, with no significant difference in wound complications or readmissions, when compared with conventional sutures alone.


Subject(s)
Hospital Costs/statistics & numerical data , Laminectomy/methods , Operative Time , Spinal Fusion/methods , Sutures , Adolescent , Adult , Aged , Female , Humans , Laminectomy/economics , Length of Stay/economics , Length of Stay/statistics & numerical data , Male , Middle Aged , Operating Rooms/economics , Patient Readmission/economics , Patient Readmission/statistics & numerical data , Postoperative Complications/economics , Postoperative Complications/epidemiology , Propensity Score , Retrospective Studies , Spinal Fusion/economics , Suture Techniques/economics , United States , Wound Closure Techniques , Young Adult
4.
Spine (Phila Pa 1976) ; 45(2): E90-E98, 2020 Jan 15.
Article in English | MEDLINE | ID: mdl-31513109

ABSTRACT

STUDY DESIGN: Retrospective administrative claims database analysis. OBJECTIVE: Identify distinct presurgery health care resource utilization (HCRU) patterns among posterior lumbar spinal fusion patients and quantify their association with postsurgery costs. SUMMARY OF BACKGROUND DATA: Presurgical HCRU may be predictive of postsurgical economic outcomes and help health care providers to identify patients who may benefit from innovation in care pathways and/or surgical approach. METHODS: Privately insured patients who received one- to two-level posterior lumbar spinal fusion between 2007 and 2016 were identified from a claims database. Agglomerative hierarchical clustering (HC), an unsupervised machine learning technique, was used to cluster patients by presurgery HCRU across 90 resource categories. A generalized linear model was used to compare 2-year postoperative costs across clusters controlling for age, levels fused, spinal diagnosis, posterolateral/interbody approach, and Elixhauser Comorbidity Index. RESULTS: Among 18,770 patients, 56.1% were female, mean age was 51.3, 79.4% had one-level fusion, and 89.6% had inpatient surgery. Three patient clusters were identified: Clust1 (n = 13,987 [74.5%]), Clust2 (n = 4270 [22.7%]), Clust3 (n = 513 [2.7%]). The largest between-cluster differences were found in mean days supplied for antidepressants (Clust1: 97.1 days, Clust2: 175.2 days, Clust3: 287.1 days), opioids (Clust1: 76.7 days, Clust2: 166.9 days, Clust3: 129.7 days), and anticonvulsants (Clust1: 35.1 days, Clust2: 67.8 days, Clust3: 98.7 days). For mean medical visits, the largest between-cluster differences were for behavioral health (Clust1: 0.14, Clust2: 0.88, Clust3: 16.3) and nonthoracolumbar office visits (Clust1: 7.8, Clust2: 13.4, Clust3: 13.8). Mean (95% confidence interval) adjusted 2-year all-cause postoperative costs were lower for Clust1 ($34,048 [$33,265-$34,84]) versus both Clust2 ($52,505 [$50,306-$54,800]) and Clust3 ($48,452 [$43,007-$54,790]), P < 0.0001. CONCLUSION: Distinct presurgery HCRU clusters were characterized by greater utilization of antidepressants, opioids, and behavioral health services and these clusters were associated with significantly higher 2-year postsurgical costs. LEVEL OF EVIDENCE: 3.


Subject(s)
Health Care Costs/statistics & numerical data , Health Resources/statistics & numerical data , Spinal Fusion/statistics & numerical data , Administrative Claims, Healthcare/statistics & numerical data , Adult , Analgesics, Opioid/therapeutic use , Anticonvulsants/therapeutic use , Antidepressive Agents/therapeutic use , Behavioral Medicine/statistics & numerical data , Cluster Analysis , Female , Health Resources/economics , Humans , Male , Middle Aged , Patient Acceptance of Health Care/statistics & numerical data , Postoperative Period , Preoperative Period , Retrospective Studies , Spinal Fusion/economics , Unsupervised Machine Learning
5.
Spine (Phila Pa 1976) ; 30(16 Suppl): S23-32, 2005 Aug 15.
Article in English | MEDLINE | ID: mdl-16103831

ABSTRACT

STUDY DESIGN: A retrospective review of the literature. OBJECTIVE: This work serves as a comprehensive update of cervical arthroplasty. SUMMARY OF BACKGROUND DATA: Cervical arthroplasty has developed as a means to preserve normal spinal motion after an anterior cervical discectomy. Preserving motion may lead to an acute improvement in patient outcome and may decrease the incidence of symptomatic adjacent segment disease in the long-term. METHODS: The literature concerning the outcomes following anterior cervical decompression and fusion, the indications for cervical arthroplasty, the indications and contraindications for arthroplasty, the surgical technique, and early outcome studies for those devices currently in U.S. FDA IDE trials are reviewed. RESULTS: The most data are available for the Prestige, Bryan, and ProDisc-C devices. While these devices all preserve normal segmental motion, the articulations vary (metal on metal, metal on polyurethane, and metal on ultra-high molecular weight polyethylene). Wear testing indicates that these devices will have a long life once implanted. Preliminary outcomes compare very favorably to anterior decompression and arthrodesis. CONCLUSIONS: Cervical arthroplasty is a promising new technology that may improve patient outcome following anterior cervical decompression.


Subject(s)
Arthroplasty , Cervical Vertebrae/surgery , Movement , Neck Pain/surgery , Spinal Fusion , Decompression, Surgical , Humans
6.
Clin Cancer Res ; 8(11): 3496-502, 2002 Nov.
Article in English | MEDLINE | ID: mdl-12429640

ABSTRACT

Iressa (ZD1839) is a p.o.-active, selective, epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) that blocks signal transduction pathways implicated in cancer cell proliferation, survival, and host-dependent processes promoting cancer growth. EGFR is up-regulated in primary malignant tumors of the central nervous system (CNS) and in many systemic tumors that metastasize to the CNS. The purpose of our study was to evaluate the efficacy and toxicity of p.o.-administered ZD1839 for the treatment of established intracerebral (i.c.) tumors expressing EGFR or the tumorigenic mutated variant EGFRvIII, which is constitutively phosphorylated. Oral administration of ZD1839 at 50 or 100 mg/kg/day for 3 weeks in athymic mice with established i.c. A431 human epidermoid carcinoma expressing EGFR increased median survival by 88% (P = 0.009) and 105% (P < 0.001), respectively. Additionally, there was no evidence of systemic or CNS toxicity. However, ZD1839 failed to inhibit either s.c. or i.c. in vivo tumor growth when tumorigenicity was conferred by EGFRvIII. Western blotting revealed that treatment with ZD1839 virtually ablated phosphorylation of EGFR Tyr-1173 in A431 tumors. However, treatment of NR6M tumors with ZD1839 only partially decreased phosphorylation of EGFRvIII Tyr-1173 while up-regulating overall expression, suggesting that EGFRvIII may not be susceptible to the same molecular mechanisms of tyrosine kinase inhibition as EGFR. In conclusion, ZD1839 is active in a brain tumor model expressing EGFR, but not EGFRvIII, as EGFR mutations may lead to relative therapeutic resistance. On the basis of these observations, we believe that clinical trials of ZD1839 against brain tumors expressing EGFR are warranted, but that special consideration should be given to tumors that coexpress EGFRvIII.


Subject(s)
Brain Neoplasms/drug therapy , Brain Neoplasms/metabolism , ErbB Receptors/antagonists & inhibitors , Quinazolines/pharmacology , 3T3 Cells , Administration, Oral , Animals , Antineoplastic Agents/pharmacology , Blotting, Western , DNA Mutational Analysis , Enzyme Inhibitors/pharmacology , Flow Cytometry , Gefitinib , Humans , Male , Mice , Mice, Inbred BALB C , Mice, Nude , Neoplasm Transplantation , Phosphorylation , Protein-Tyrosine Kinases/antagonists & inhibitors , Signal Transduction , Time Factors , Tumor Cells, Cultured , Tyrosine/metabolism
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