Value of single-level circumferential fusion: a 10-year prospective outcomes and cost-effectiveness analysis comparing posterior facet versus pedicle screw fixation.

Purpose: To compare the clinical and economic outcomes of facet versus pedicle screw instrumentation for single-level circumferential lumbar spinal fusion.

Methods: Outcomes included self-assessment of back and leg pain, pain drawing, ODI, pain medication usage, and procedure success. The CEA was based on the 10-year data collected, and the base-case was from a US payer perspective.

Letter--The Authors Respond.

No additional funding was received for the writing of this letter. The published study referred to in this letter was funded by Janssen Scientific Affairs, which employs Maiese and funded Cornerstone Research Group, a health economic consulting group, to conduct the study. Grima is a founding partner of Cornerstone Research Group, which employs Hollmann, Goyert, and Moldaver.

A U.S. Cost Analysis of Triplet Regimens for Patients with Previously Treated Multiple Myeloma.

Background: In recent years, the FDA has approved several 3-agent (i.e., triplet) combinations for previously treated multiple myeloma (MM), and the National Comprehensive Cancer Network (NCCN) now recommends triplet regimens over doublets.

A US hospital budget impact analysis of a skin closure system compared with standard of care in hip and knee arthroplasty.

Background: Medicare's mandatory bundle for hip and knee arthroplasty necessitates provider accountability for quality and cost of care to 90 days, and wound closure may be a key area of consideration. The DERMABOND PRINEO Skin Closure System (22 cm) combines a topical skin adhesive with a self-adhering mesh without the need for dressing changes or suture or staple removal. This study estimated the budget impact of the Skin Closure System compared to other wound closure methods for hip and knee arthroplasty.

Barriers to and Budget Impact of Lumbar Total Disc Replacement Utilization.

: Evidence on the favorable efficacy, safety, and cost effectiveness of lumbar total disc replacement (TDR) compared with fusion for lumbar degenerative disc disease is mounting; however, a key barrier identified for TDR utilization is lack of coverage by US health insurers. Although economic considerations in a fee-for-service model should not be a determining factor in patient access, concerns regarding the budget impact of lumbar TDR surgery may unfortunately underlie coverage decisions. On the basis of the data available and economic modeling, the panel agreed that there is no indication that there would be a dramatic increase in patients seeking lumbar TDR.

Challenges and Solutions for Lumbar Total Disc Replacement Implantation.

: Long-term data are now available to support the safety and efficacy of lumbar total disc replacement (TDR). Five-year randomized and controlled trials, meta-analyses, and observational studies support a similar or lower risk of complications with lumbar TDR compared with fusion. The panel concluded that published data on commercially available lumbar TDR devices demonstrate minimal concerns with late-onset complications, and that the risk of adjacent segment degeneration and reoperations can be reduced with lumbar TDR versus fusion.

Defining the Ideal Lumbar Total Disc Replacement Patient and Standard of Care.

: Lumbar total disc replacement, now in use since 2004, was determined by the panel to be a standard of care for the treatment of symptomatic single-level lumbar degenerative disc disease in the active patient subpopulation as outlined by the investigational device exemption study criteria. The large body of evidence supporting this statement, including surgeons' experiences, was presented and discussed. Consensus statements focusing on decision-making criteria reflected that efficacy, long-term safety, clinical outcomes with validated measures, and cost-effectiveness should form the basis of decision-making by payers.

Process for Consensus Statements on Lumbar Total Disc Replacement.

: Consensus statements regarding the evidence-base for lumbar total disc replacement, as it pertains to payer decision-making, were developed through a modified-Delphi technique involving 17 spine surgeons and a former payer medical director. The Delphi process involved one round of anonymous survey and one round with a face-to-face meeting. The survey was a 51-item, electronically administered questionnaire to determine level of agreement with proposed statements on the evidence for lumbar total disc replacement and to provide additional diagnosis and management practice information for further deliberations.

Foreword: Proceedings From the First Annual Lumbar Total Disc Replacement Summit.

: This publication focuses on proceedings from the First Annual Lumbar Total Disc Replacement Summit, held October 25, 2016 in Boston, MA. The Summit brought together 17 thought leading surgeons who employed a modified-Delphi method to determine where consensus existed pertaining to the utilization of lumbar total disc replacement as a standard of care for a subpopulation of patients suffering from degenerative disc disease.

Endovascular Interventions for Femoropopliteal Peripheral Artery Disease: A Network Meta-Analysis of Current Technologies.

Purpose: To use network meta-analysis (NMA) to determine the optimal endovascular strategy for management of femoropopliteal peripheral artery disease (PAD) given the lack of multiple prospective randomized trials to guide treatment decisions.

Materials And Methods: NMA is a new meta-analytic method that permits comparisons among any 2 therapies by combining results of a collection of clinical trials conducted in the same or similar patient population. NMA was used to analyze data from 15 randomized controlled trials (RCTs) and 10 prospective, multicenter, single-arm trials (combined evidence [CE] NMA) that evaluated target lesion revascularization (TLR) for 5 endovascular strategies: bare metal stent (BMS), polymer-covered metal stent (CMS), drug-eluting stent (DES), drug-coated balloon (DCB) and percutaneous transluminal angioplasty (PTA).

Time and resources of peripherally inserted central catheter insertion procedures: a comparison between blind insertion/chest X-ray and a real time tip navigation and confirmation system.

Background: The Sherlock 3CG™ Tip Confirmation System (TCS) provides real-time peripherally inserted central catheter (PICC) tip insertion information using passive magnetic navigation and patient cardiac electrical activity. It is an alternative tip confirmation method to fluoroscopy or chest X-ray for PICC tip insertion confirmation in adults. The purpose of this study was to evaluate time and cost of the Sherlock 3CG TCS and blind insertion with chest X-ray tip confirmation (BI/CXR) for PICC insertions.

A hospital cost analysis of a fibrin sealant patch in soft tissue and hepatic surgical bleeding.

Background: Despite hemostat use, uncontrolled surgical bleeding is prevalent. Drawbacks of current hemostats include limitations with efficacy on first attempt and suboptimal ease-of-use. Evarrest is a novel fibrin sealant patch that has demonstrated high hemostatic efficacy compared with standard of care across bleeding severities.

Health and economic outcomes associated with uncontrolled surgical bleeding: a retrospective analysis of the Premier Perspectives Database.

Background: Bleeding remains a common occurrence in surgery. Data describing the burden of difficult-to-control bleeding and topical absorbable hemostat use are sparse. This study was conducted to estimate the clinical and economic impact that remains associated with uncontrolled surgical bleeding, even when hemostats are used during surgery.

Biomarker use is associated with reduced clinical trial failure risk in metastatic melanoma.

Given the high morbidity and mortality associated with metastatic melanoma, considerable attention has been paid to identifying potential therapies. Until recently, few therapies have been specifically approved for treating metastatic melanoma. In an attempt to increase clinical trial successes, many therapies are implementing biomarkers for patient stratification.