Efficacy and Cost of Maxillary Patient-Specific Implants in Orthognathic Surgery: A Review of Three Patient Cases.

INTRODUCTION: Patient-specific implants (PSIs) are accurate, efficient alternatives to traditional plate fixation. They are well-suited for use in procedures that require the utmost accuracy, stability, and efficiency. Although PSIs have demonstrated such qualities in craniomaxillofacial reconstruction, they have so far found limited utilization elsewhere. CASE PRESENTATION: We explored the departmental protocol for Lefort 1 PSI orthognathic surgery at a high-volume, tertiary referral center. Three cases were selected that matched predetermined criteria, which included treatment by the same surgical team, concurrent Lefort 1 osteotomy and bilateral sagittal split osteotomy, Angle's type 3 malocclusion, lack of interdental osteotomies, and American Society of Anesthesiologists classification 2 or less without metabolic or osseous diseases. The operative outcomes from these patients were then compared to similar cases also meeting the same criteria and conducted within the same time period. CONCLUSION: The use of PSI in Lefort 1 osteotomy is associated with anatomically sound designs that could contribute to postoperative stability of the jaws. They also have not shown increased rates of complications such as infection, dehiscence, or relapse at 6 weeks postoperatively but may in fact decrease the operative duration. These findings are consistent with the results gleaned from literature on the use of PSI in craniomaxillofacial reconstruction.

Left atrial appendage closure with the watchman device reduces atrial fibrillation management costs.

AIMS: To report hospitalization costs of patients with non-valvular atrial fibrillation (AF) submitted to percutaneous left atrial appendage closure (LAAC) with the Watchman device. METHODS: Pre- and post-procedural hospitalization AF-related costs were calculated using the DRG system (diagnosis-related groups) and compared. RESULTS: Between 2012 and 2016, 677 non-valvular AF patients underwent LAAC. Median time from first cardiac hospitalization to LAAC was 5.9 years (IQR 1.6-9.1) and median follow-up after LAAC was 4.8 years (IQR 3.6-5.6). LAAC mortality was 1.3% and follow-up mortality 16.9%. Median pre-LAAC hospitalization cost was € 17,867 (IQR € 7512-35,08) and post-LAAC € 8772 (IQR € 1183-25,159) (p < 0.0001). Annualized cost pre-LAAC was 3773 € (IQR € 1644-8,493) and post-LAAC 2,001 € (IQR € 260-6913) (p < 0.0001). Follow-up survivors had significantly lower post-LAAC costs (p < 0.0001) and after a survival cut-off time of 4.6 years LAAC procedural and post-procedural hospitalization costs achieved parity with pre-LACC costs (AUC 0.64; p = 0.02). CHA2DS2-VASc score (B = 0.04; p = 0.02; 95% CI 0.006-0.08), and HAS-BLED score (B = 0.08; p = 0.004; 95% CI 0.02-0.14) were independent determinants for annualized hospitalization costs post-LAAC. At Cox-regression analysis the DRG mean clinical complexity level (CCL) was the only independent determinant for follow-up mortality (OR = 2.2; p < 0.0001; 95% CI 1.6-2.8) with a cut-off value of 2.25 to predict follow-up mortality (AUC 0.72; p < 0.0001; Spec. 70%; Sens. 70%). CONCLUSION: Hospitalization costs pre-LAAC are consistent, and after LAAC, they are significantly reduced. Costs seem related to the patient's risk profile at the time of the procedure. With the increase in post-LAAC survival time, the procedure becomes economically more profitable.

Arthroplasty implants and materials: Cost awareness and value perception.

Arthroplasty procedures are commonly performed and contribute to healthcare expenditures seen in the United States. Surgical team members may make selections among implants and materials without always knowing their relative cost. The current study reports on a survey aimed to investigate the perceptions of an academic group about the relative cost and value of commonly used operating room implants and materials related to joint arthroplasty cases using 10 matched pairs of items. Of the 124 persons eligible to take the survey, 102 responded (response rate of 82.3%) including attendings, fellows, residents, physician assistants (PAs), advanced practice registered nurses (APRNs) and registered nurses (RNs). On average for the ten pairs of items, the more expensive items were correctly selected by 90.2+/-13.9% (mean+/- standard deviation) of respondents with a range from 54.9% to 100%. Of note, the cost differences were significantly overestimated for 8/10 item pairs. The majority of respondents perceived the more expensive item as the item with the higher clinical value for 9/10 item pairs. Most arthroplasty attendings (91.3%) indicated willingness to use the less expensive item of two similar items. Nonetheless, 17.9% of fellows, residents, PAs, APRNs and RNs indicated that they would not feel comfortable suggesting using the less expensive item. Although attending arthroplasty surgeons stated a desire to consider costs, a knowledge deficit with regards to identifying the extent of cost differences was identified, and a significant portion of the surgical support team reported being hesitant to suggest less expensive options.

Prioritizing solutions to incorporate Prosthetics and Orthotics services into Iranian health benefits package: Using an analytic hierarchy process.

INTRODUCTION: Health benefits package (HBP) is regarded as one of the main dimensions of health financing strategy. Even with increasing demands for prosthetics and orthotics (P&O) services to approximately 0.5% of the world's population, only 15% of vulnerable groups have the chance to make use of such benefits. Inadequate coverage of P&O services in the HBP is accordingly one of the leading reasons for this situation in many countries, including Iran. AIMS: The main objective of this study was to find and prioritize solutions in order to facilitate and promote P&O services in the Iranian HBP. STUDY DESIGN: A mixed-methods (qualitative-quantitative) research design was employed in this study. METHODS: This study was conducted in two phases. First, semi-structured interviews were undertaken to retrieve potential solutions. Then an analytic hierarchy process (AHP) reflecting on seven criteria of acceptability, effectiveness, time, cost, feasibility, burden of disease, and fairness was performed to prioritize them. RESULTS: In total, 26 individuals participated in semi-structured interviews and several policy solutions were proposed. Following the AHP, preventive interventions, infant-specific interventions, inpatient interventions, interventions until 6 years of age, and emergency interventions gained the highest priority to incorporate in the Iranian HBP. CONCLUSION: A number of policy solutions were explored and prioritized for P&O services in the Iranian HBP. Our findings provide a framework for decision- and policy-makers in Iran and other countries aiming to curb the financial burdens of P&O users, especially in vulnerable groups.

3D-Printer-Assisted Patient-Specific Polymethyl Methacrylate Cranioplasty: A Case Series of 16 Consecutive Patients.

BACKGROUND: To develop a novel 3D-printer-assisted method to fabricate patient-specific implants for cranioplasty and to demonstrate its feasibility and its use in 16 consecutive cases. METHODS: We report on 16 consecutive patients who have undergone cranioplasty surgery for an extensive skull defect after decompressive surgery and in which the bone flap was not available. We present the workflow for the implant production using a 3D-printer-assisted molding technique. Preoperative, intraoperative, and postoperative data were analyzed/evaluated. RESULTS: Eleven out of our 16 patients (68.7%) presented with extensive hemispheric bone defects. Indication for initial craniotomy were traumatic brain injury (4; 25%), acute subdural hematoma (4; 25%), ischemic stroke (3; 18.8%), tumor (3; 18.8%), and ruptured aneurysm (2; 12.5%). Median (range) operation time was 121 (89-206) minutes. Median (range) intraoperative blood loss was 300 (100-3300) mL. The mean (range) follow-up period is 6 (0-21) months. Complications occurred in 7 out of our 16 patients (43.8%), in 6 (37.5%) of which a reoperation was required to evacuate an extra-axial hematoma (3; 50%), for shunting of an epidural fluid collection (1; 16.7%), or for skin flap necrosis (1; 16.7%). One patient (16.7%) developed a chronic asymptomatic subdural fluid collection that was stable over the follow-up period. CONCLUSIONS: Our workflow to intraoperatively produce patient-specific implants in a timely manner to cover cranial defects proved to be feasible. The results are cosmetically appealing, and postoperative CT scans show well-fitting implants. As implantable printable substrates are already available, we aim to advance and certify 3D-printed patient-specific implants in the near future.

Preventing glaucoma progression using the trabecular micro-bypass implant iStent inject®. A cost-effectiveness analysis / Prevenindo a progressão do glaucoma por meio do implante de by-pass trabecular iStent inject®. Uma análise de custo-efetividade

ABSTRACT Objective To assess the economic impact of reducing glaucoma progression by using the trabecular micro-bypass implant, iStent inject®, in the Reference Centers for glaucoma treatment within the Brazilian Public Unified Health System (SUS). Methods In a cost-effectiveness analysis, a Markov model was developed, and the costs were obtained from the SUS perspective (medical direct costs). Effectiveness was measured in progression-free life-years. The time horizon was the mean life expectancy of the Brazilian population. The model parameters were obtained through a review and a critical analysis of the literature. The base case comprised a hypothetical cohort of patients with open-angle glaucoma, using anti-glaucoma eye drops and followed up at Reference Centers of SUS. We tested whether the incorporation of iStent inject® as an alternative second-line therapy would be cost-effective. The outcome measure was the incremental cost-effectiveness ratio (R$/progression-free life-years). We tested the robustness of the model by univariate and probabilistic sensitivity analyses. Results The use of iStent inject® led to decreased progression rate of glaucoma, evidenced by the amount of progression-free life-years obtained with each treatment strategy (7.82 progression-free life-years with iStent inject® versus 6.33 progression-free life-years with medical treatment), thereby improving glaucoma control. There was also a reduction in future costs associated with eye drops, filtering surgeries, and treatment complications. Incremental cost-effectiveness ratio ranged from R$ 6,429.30 to R$ 7,550.97/progression-free life-years. The model proved to be robust in the sensitivity analyses. Conclusion This analysis showed that iStent inject®, when used after the failure of the first-line therapy, is able to reduce the rate of glaucoma progression at an acceptable cost.

RESUMO Objetivo Avaliar o impacto econômico da redução da progressão do glaucoma pelo uso do implante de by-pass trabecular iStent inject® no ambiente dos Centros de Referência para tratamento do Sistema Único de Saúde (SUS). Métodos Em uma análise de custo-efetividade, elaborou-se um modelo de Markov, cujos custos foram obtidos a partir da perspectiva do SUS financiador (custos médicos diretos). A efetividade foi medida em anos de vida livres de progressão. O horizonte temporal foi a expectativa de vida média da população brasileira. Os parâmetros do modelo foram obtidos pela revisão e pela análise crítica da literatura. O caso base foi composto de uma coorte hipotética de portadores de glaucoma de ângulo aberto em uso de colírios antiglaucomatosos e em acompanhamento nos Centros de Referência do SUS. Testou-se se a incorporação do iStent inject® como alternativa à segunda linha de tratamento seria custo-efetiva. A medida de desfecho foi a razão de custo-efetividade incremental (R$/anos de vida livres de progressão). A robustez do modelo foi testada por meio de análises de sensibilidade univariada e probabilística. Resultados A utilização do iStent inject® proporcionou uma diminuição da velocidade de progressão do glaucoma, evidenciada pela quantidade de anos de vida livres de progressão obtida com cada estratégia de tratamento (7,82 anos de vida livres de progressão com iStent inject® versus 6,33 anos de vida livres de progressão com tratamento com colírios), melhorando, dessa forma, o controle do glaucoma. Houve ainda redução nos custos futuros associados aos colírios, às cirurgias filtrantes e às complicações do tratamento. A razão de custo-efetividade incremental variou de R$6.429,30 a R$7.550,97/anos de vida livres de progressão. O modelo mostrou-se robusto nas análises de sensibilidade. Conclusão O iStent inject®, quando usado após a falha do primeiro medicamento, é capaz de reduzir a taxa de progressão do glaucoma a um custo aceitável.

From Concept to Counter: A Review of Bringing an Orthopaedic Implant to Market.

Physicians offer unique contributions to the orthopaedic implant design process by providing creative ideas and insightful clinical expertise. This article provides a brief overview of the pertinent considerations of transforming a concept into an orthopaedic implant and bringing it to the market. Implant concept choice should consider medical or surgical necessity, regional variability, market characteristics, cost of goods sold, and average selling price. Implant development requires adherence to regulatory requirements and device classification. Implant production incorporates design specifications, mechanical testing, sterilization, packaging, and marketing and sales. Orthopaedic implant company agreements determine physician compensation through royalties and/or the purchase of intellectual property. After rollout, physicians participate in monitoring for device safety. Bringing an orthopaedic implant from a concept to the market can be lengthy and complicated, but innovation is essential for advancing patient care and well-being.

An advanced prosthetic manufacturing framework for economic personalised ear prostheses.

Craniofacial prostheses are commonly used to restore aesthetics for those suffering from malformed, damaged, or missing tissue. Traditional fabrication is costly, uncomfortable for the patient, and laborious; involving several hours of hand-crafting by a prosthetist, with the results highly dependent on their skill level. In this paper, we present an advanced manufacturing framework employing three-dimensional scanning, computer-aided design, and computer-aided manufacturing to efficiently fabricate patient-specific ear prostheses. Three-dimensional scans were taken of ears of six participants using a structured light scanner. These were processed using software to model the prostheses and 3-part negative moulds, which were fabricated on a low-cost desktop 3D printer, and cast with silicone to produce ear prostheses. The average cost was approximately $3 for consumables and $116 for 2 h of labour. An injection method with smoothed 3D printed ABS moulds was also developed at a cost of approximately $155 for consumables and labour. This contrasts with traditional hand-crafted prostheses which range from $2,000 to $7,000 and take around 14 to 15 h of labour. This advanced manufacturing framework provides potential for non-invasive, low cost, and high-accuracy alternative to current techniques, is easily translatable to other prostheses, and has potential for further cost reduction.

Future considerations in prosthetic urology.

Since their popularization, genitourinary prosthetics have remained a gold-standard therapy for the treatment of erectile dysfunction and stress urinary incontinence and in cases of testicular loss or dysfunction. They have also represented an area of significant innovation, which has contributed to excellent long-term outcomes. Given this history, the objective of the current review was to provide a 5-10-year outlook on anticipated trends and developments in the field of genitourinary prosthetics. To accomplish this objective, a PubMed and patent search was performed of topics relating to penile and testicular prostheses and urinary sphincters. In regard to penile prostheses, findings demonstrated several new concepts including temperature-sensitive alloys, automated pumps, devices designed specifically for neophalluses, and improved malleable designs. With artificial urinary sphincters, new concepts include the ability to add or remove fluid from an existing system, two-piece systems, and new mechanisms to occlude the urethra. For testicular prosthetics, future implementations may not only better replicate the feel of a biological testicle but also add endocrinological functions. Beyond device innovation, the future of prosthetics is also one of expanding geographic boundaries, which necessitates variable cost modeling and regulatory considerations. Surgical trends are also changing, with a greater emphasis on nonnarcotic, postoperative pain control, outpatient surgeries, and adjunctive techniques to lengthen the penis and address concomitant stress incontinence, among others. Concomitant with device and surgical changes, future considerations also include a greater need for education and training, particularly given the rapid expansion of sexual medicine into developing nations.

Implant wastage in orthopaedic trauma: a UK experience.

INTRODUCTION: Implant wastage is an under-reported issue in orthopaedics, yet it has been shown to have a significant cost burden on healthcare budgets. In a background of a perilous financial climate in the UK health service, our aim was to define the frequency and costs of implant wastage in orthopaedic trauma. MATERIALS AND METHODS: The trauma theatre's implant logbook was retrospectively analysed between April 2017 and April 2018. Wasted implants were identified by the study authors independently. Patient demographics, implant details and costs were among the data collected. Product codes of wasted implants were used to identify implant costs through the manufacturer. RESULTS: Implant wastage occurred in 25.1% of trauma procedures during the study period. Most wasted implants (91%) were screws. The total cost of implant wastage was £8,377.25 during the 12-month period, accounting for 2% of the total implant budget. Wasted intramedullary nails accounted for almost 50% of the total cost. More than 51% of affected procedures involved a trainee as the primary operator. DISCUSSION: We report the first study of implant wastage in orthopaedics from the UK. Total implant wastage was higher than reported in most of the published literature, although it represented a small portion of the budget. Implant wastage is attributable to surgeons or operating theatre staff in most cases and is compounded by surgeons' limited understanding of implant costs. Initiatives to reduce implant wastage should include raising awareness of costs and departmental wastage to surgeons and operating theatre staff as well as employing preoperative planning techniques.

A scoping literature review of studies assessing effectiveness and cost-effectiveness of prosthetic and orthotic interventions.

Purpose: Approximately 1.5% of the world's population (∼100 million people) need a prosthesis/orthosis. The objective of the study was to establish an overview of the literature that has examined prosthetic and orthotic interventions with a view to inform policy development.Methods: Fourteen databases were searched from 1995-2015. Studies reporting primary research on the effectiveness or cost-effectiveness of prosthetic and orthotic interventions were examined. Metadata and information on study characteristics were extracted from the included studies.Results: The searches resulted in a total of 28,958 articles, a focus on studies with the words "randomized" OR "randomized" OR "cost" OR "economic" in their citation reduced this total to 2644. Research has predominantly been conducted in Australia, Canada, Germany, Netherlands, UK and USA. A total of 346 randomized controlled trials were identified, with only four randomized controlled trials examining prosthetic interventions. The majority of research examined lower limb orthoses in the adult population and used a wide range of outcome measures.Conclusions: While various international organizations have highlighted the value of providing prosthetic and orthotic services, both to the user and society as a whole, the availability of scientific research to inform policy is limited. Future structured evaluation of prosthetic and orthotic interventions/services is warranted to inform future policy developments.Implications for rehabilitationResearch into prosthetic and orthotic interventions has grown substantially in the last 20 years, with most of this research conducted in a small number of countries and focusing on the use of lower limb orthotics in adult populations.Research to date has utilized an extensive range of outcome measures, the development of agreed standardized sets of outcomes would allow comparison and combination of results in future research.This study highlights the need for further research in this area, especially studies which examine the cost-effectiveness of prosthetic and orthotic provision.

Cost Analysis of Implants in the Surgical Repair of Orbital Floor Fractures.

OBJECTIVE: Options for the management of orbital floor fractures continue to evolve offering both potential advantages as well as higher costs. To date, the effect of implant choice on the cost associated with the repair of orbital floor fractures has not been studied. METHODS: A retrospective review at a tertiary care, level I trauma center examining all adult, uncomplicated orbital floor fractures that underwent open reduction and internal fixation from 2013 to 2016. Patients with concurrent operative facial fractures were excluded. The main outcomes were overall cost of care from injury to last follow-up and operating room-related costs. Costs were determined using computerized records of charges as well as the hospital Charge Description Master. Kruksal-Wallis rank sum tests were used to analyze for differences between groups. RESULTS: Twenty-eight patients fulfilled the inclusion criteria. Eight different stock, non-patient specific, implants were used for repair. The cost of individual types of implants ranged from $70.25 to $7 718.00. Total cost of care per patient across all implant types averaged $35 585.57 (range $25 586.26 to $49 985.74, P = .34). Operation-related charges accounted for the vast majority (94.4%) of the total cost of care. One complication occurred requiring operative re-positioning of the implant with an additional $13 042.41 in charges. CONCLUSIONS: In the setting of uncomplicated orbital floor fractures, surgeons should select an implant that allows them to carry out the repair in a safe, timely fashion. Additional large-scale studies would help to further delineate cost differences.

[Treatment of congenital ptosis in a low-income country: polypropylene frontalis sling at the African Institute of Tropical Ophthalmology]. / Traitement du ptosis congénital dans un pays à faible revenu : suspension du releveur au muscle frontal par le polypropylène à l'Institut d'Ophtalmologie tropicale de l'Afrique (IOTA).

INTRODUCTION: Treatment of congenital ptosis is exclusively surgical; the frontalis sling method is most appropriate when the ptosis is severe, with no upper eyelid levator function. This surgery typically utilizes various materials (autologous fascia lata, silicone, nylon, or polypropylene bands, etc.). MATERIALS AND METHODS: This was a retrospective descriptive study of 22 children under 16 years of age, treated for congenital ptosis by frontalis suspension of the levator muscle of the upper eyelid using the polypropylene technique, between January 1, 2014 and June 30, 2017 at the African Institute of Tropical Ophthalmology teaching hospital. RESULTS: In our study, the surgical result (prior to correction of recurrences) was satisfactory in 81.82 % of cases, with a recurrence rate of 13.64 %. The mean follow-up was 14 months, ranging from 4 to 25 months. DISCUSSION: The use of polypropylene provides encouraging results in ptosis surgery, while also offering the advantage of being low cost and more available. Its use in developing countries deserves special attention.

iFuse Implant System for Treating Chronic Sacroiliac Joint Pain: A NICE Medical Technology Guidance.

Treatment and management of sacroiliac joint pain is often non-surgical, involving packages of care that can include analgesics, physiotherapy, corticosteroid injections and radiofrequency ablation. Surgical intervention is considered when patients no longer respond to conservative management. The iFuse Implant System is placed across the sacroiliac joint using minimally invasive surgery, stabilising the joint and correcting any misalignment or weakness that can cause chronic pain. The iFuse system was evaluated in 2018 by the UK National Institute for Health and Care Excellence (NICE) as part of the Medical Technologies Evaluation Programme (MTEP). Clinical evidence for iFuse suggests improved pain, Oswestry disability index (ODI) and quality of life compared to non-surgical management. The company (SI-Bone®) submitted two cost models indicating that iFuse was cost saving compared with open surgery and non-surgical management. Clinicians advised that non-surgical management was the most appropriate comparator and Cedar (a health technology research centre) made changes to the model to test the impact of higher acquisition and procedure costs. Cedar found iFuse to be cost incurring by approximately £560 per patient at 7 years. During the consultation period, the company reduced the cost of some iFuse consumables, and Cedar extended the time horizon to test the assumption that iFuse would become cost saving over time. These changes indicated that iFuse becomes cost saving at 8 years (approximately £129 per patient), after which the cost saving continues to increase. NICE published guidance in October 2018 recommending that the case for adoption of the iFuse system in the UK National Health Service (NHS) was supported by the evidence.

Association of Cost Savings and Surgical Quality With Single-Vendor Procurement for Spinal Implants.

Importance: Significant cost savings can be achieved from consolidating purchases of spinal implants with a single vendor. However, it is currently unknown whether sole-source contracting or vendor rationalization more broadly affects patient care. Objectives: To describe the single-vendor procurement of spinal implants, characterize the economic benefits of sole-source contracting, and gauge whether vendor rationalization is associated with a diminished quality of care. Design, Setting, and Participants: This retrospective cohort study assessed adult patients receiving single-level lumbar interbody fusions at a single institution from January 1, 2009, to July 31, 2017. Exclusion criteria included multilevel fusions and prior spinal fusions. Exposures: Patients were analyzed based on the number of vendors available to surgeons at the time of the patient's surgery. January 1, 2009, to December 31, 2010, was defined as the multivendor period (10 vendors); January 1, 2011, to December 31, 2014, was defined as the dual-vendor period; and January 1, 2015, to July 31, 2017, was defined as the single-vendor period. Main Outcomes and Measures: Rates of 12-month revision surgery, complications, 30-day readmissions, and postoperative patient-reported outcomes, as measured by 5-dimension European Quality of Life (EQ-5D) and Patient-Reported Outcomes Measurement Information System-Global Health (PROMIS-GH) utilities. Propensity score weighting was performed to control for confounding. The Holm method was used to correct for multiple testing. Annual cost savings associated with the dual-vendor and single-vendor periods were also reported. Results: A total of 1373 patients (mean [SD] age, 59.2 [12.6] years; 763 [55.6%] female; 1161 [84.6%] white) were analyzed. Rates of revisions after adjusting for confounding were 3.2% (95% CI, 1.5%-6.7%) for the multivendor period, 4.5% (95% CI, 3.1%-6.5%) for the dual-vendor period, and 3.0% (95% CI, 1.7%-5.0%) for the single-vendor period. Complication rates were 5.3% (95% CI, 2.7%-10.1%) for the multivendor period, 7.2% (95% CI, 5.4%-9.6%) for the dual-vendor period, and 6.4% (95% CI, 4.6%-8.8%) for the single-vendor period. Readmission rates were 14.2% (95% CI, 9.7%-20.2%) for the multivendor period, 12.6% (95% CI, 10.1%-15.5%) for the dual-vendor period, and 9.7% (95% CI, 7.4%-12.7%) for the single-vendor period. Revisions, complications, and patient-reported outcomes were statistically equivalent across all periods. Readmissions were not statistically equivalent but not statistically different. The savings attributable to vendor rationalization were 24% for the dual-vendor and 21% for the single-vendor periods. Conclusions and Relevance: The single-vendor procurement of spinal implants was associated with significant cost savings without evidence of an associated decline in the quality of care. Large hospital systems may consider sole-source purchasing as a viable cost reduction strategy.

Cost-Effectiveness of Transcatheter Mitral Valve Repair Versus Medical Therapy in Patients With Heart Failure and Secondary Mitral Regurgitation: Results From the COAPT Trial.

BACKGROUND: The COAPT trial (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation) demonstrated that edge-to-edge transcatheter mitral valve repair (TMVr) with the MitraClip resulted in reduced mortality and heart failure hospitalizations and improved quality of life compared with maximally tolerated guideline-directed medical therapy (GDMT) in patients with heart failure and 3 to 4+ secondary mitral regurgitation. Whether TMVr is cost-effective compared with GDMT in this population is unknown. METHODS: We used data from the COAPT trial to perform a formal patient-level economic analysis of TMVr+GDMT versus GDMT alone for patients with heart failure and 3 to 4+ secondary mitral regurgitation from the perspective of the US healthcare system. Costs for the index TMVr hospitalization were assessed using a combination of resource-based accounting and hospital billing data (when available). Follow-up medical care costs were estimated on the basis of medical resource use collected during the COAPT trial. Health utilities were estimated for all patients at baseline and 1, 6, 12, and 24 months with the Short Form Six-Dimension Health Survey. RESULTS: Initial costs for the TMVr procedure and index hospitalization were $35 755 and $48 198, respectively. Although follow-up costs were significantly lower with TMVr compared with GDMT ($26 654 versus $38 345; P=0.018), cumulative 2-year costs remained higher with TMVr because of the upfront cost of the index procedure ($73 416 versus $38 345; P<0.001). When in-trial survival, health utilities, and costs were modeled over a lifetime horizon, TMVr was projected to increase life expectancy by 1.13 years and quality-adjusted life-years by 0.82 years at a cost of $45 648, yielding a lifetime incremental cost-effectiveness ratio of $40 361 per life-year gained and $55 600 per quality-adjusted life-year gained. CONCLUSIONS: For symptomatic patients with heart failure and 3 to 4+ secondary mitral regurgitation, TMVr increases life expectancy and quality-adjusted life expectancy compared with GDMT at an incremental cost per quality-adjusted life-year gained that represents acceptable economic value according to current US thresholds. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01626079.

What is the cost burden of surgical implant waste? An analysis of surgical implant waste in an orthopedics and trauma surgery department of a French university hospital in 2016.

BACKGROUND: During an orthopedic or trauma surgery procedure, when an implantable medical device is unpackaged, not implanted and cannot be resterilized, it is considered "waste". The cost burden falls on the hospital. The French Social Security Code provides for add-on reimbursement for certain expensive or very specialized devices (supplementary list of costly implants). To allow its restocking without linking it to a patient or reimbursement request, the wasted implant is tracked in a computerized database. The economic impact of these wasted implants is not known in France. This led us to conduct a retrospective study: 1) to determine the percentage and number of wasted implants, 2) to identify elements related to the surgery that impact implant waste. HYPOTHESIS: Various elements of the surgical environment (type of procedure, specialty, surgeon experience, time of year) can independently contribute to the non-implantation of a medical device. METHODS: We carried out a retrospective observational study of data collected prospectively in the database of our teaching hospital in 2016. The primary outcome was the percentage of wasted implants. The secondary outcome was the mean cost of these wasted implants. These parameters were determined for all the implants used in orthopedics and trauma surgery and tracked in this department, then for each variable hypothesized to led to non-implantation. Our analysis was descriptive, then comparative. RESULTS: In our database, 29,073 devices were tracked (€3,761,180), of which 1995 devices were wasted (6.9%). The total cost of the wasted implants was €179,193 (4.8% of the overall cost). The breakdown of the wasted implants was 430 (4.4%) from the add-on list (average cost of €293.10) versus 1565 implants associated with the hospital's diagnosis-related group payment system (average cost of €33.90). Trauma surgery procedures had significantly more wasted implants than orthopedic surgery (1135 vs. 860 (p<0.01)), although the individual cost was less (€59.20 vs. €130.10 (p<0.01)). Fracture fixation implants were more likely to be wasted than ligament reconstruction or arthroplasty implants, with a lower mean cost. More implants were wasted during hip arthroplasty than during other arthroplasty procedures. Less experienced surgeons wasted more implants than more experienced surgeons (1087 vs. 905 (p<0.01)) but these implants cost less (€69.20 vs. €114.80 (p<0.05)). The percentage of implants wasted was higher during the resident changeover period relative to the other months of the year (772 vs. 1223 (p<0.01)). DISCUSSION: This study is the first attempt at quantifying the number and cost of wasted implants in the context of orthopedics and trauma surgery at a teaching hospital in France. While trauma surgery is associated with more wasted implants, the cost burden is higher in orthopedics. Surgeons, by virtue of their experience and teaching mandate, have a decisive role managing this cost burden. TYPE OF STUDY: IV, Retrospective study.

Magnetic Resonance Examinations of Patients With Implanted Active Devices. A Low-Cost Approach in Slew Rate Evaluation.

Time-varying magnetic field gradients involved in magnetic resonance examinations can damage implanted electronic systems. The quantity related to this side effect is the gradient slew rate, which is usually not directly available on magnetic resonance console. The present study proposes a low-cost approach in slew rate assessment, which is useful in risks versus benefits evaluation as well as in sequences optimization. The experimental method is based on an analog circuit, which senses the output voltage of the scanner waveform generator. This allows taking easy and reliable slew rate measurements, even during clinical examinations on patients. Whereas previous studies required managing a considerable amount of data, the present work addresses only the maximal slew rate of any clinical sequence. Experimental results show that the smooth gradient mode, selectable on the two scanners examined, is very effective in patient safety improvement. In particular, it reduces slew rate values in the range from 52.4 up to 132.4 T m-1 s-1 , i.e. far below the interval 216-346 T m-1 s-1 , indicated as slew rate tolerance limit of modern implanted electronic devices. Bioelectromagnetics. 2019;40:512-521. © 2019 Bioelectromagnetics Society.

Translating Biofabrication to the Market.

Biofabrication holds great potential to revolutionize important industries in the health, food, and textile sectors, but its translation to market is still challenging. I analyze the current state of innovation and commercialization in biofabrication and try to assess its limitations, strengths, and future progress.