Determining Variable Costs in the Acute Urolithiasis Cycle of Care Through Time-Driven Activity-Based Costing.

OBJECTIVE: To characterize full cycle of care costs for managing an acute ureteral stone using time-driven activity-based costing. METHODS: We defined all phases of care for patients presenting with an acute ureteral stone and built an overarching process map. Maps for sub-processes were constructed through interviews with providers and direct observation of clinical spaces. This facilitated calculation of cost per minute for all aspects of care delivery, which were multiplied by associated process times. These were added to consumable costs to determine cost for each specific step and later aggregated to determine total cost for each sub-process. We compared costs of eight common clinical pathways for acute stone management, defining total cycle of care cost as the sum of all sub-processes that comprised each pathway. RESULTS: Cost per sub-process included $920 for emergency department (ED) care, $1665 for operative stent placement, $2368 for percutaneous nephrostomy tube placement, $106 for urology clinic consultation, $238 for preoperative center visit, $4057 for ureteroscopy with laser lithotripsy (URS), $2923 for extracorporeal shock wave lithotripsy, $169 for clinic stent removal, $197 for abdominal x-ray, and $166 for ultrasound. The lowest cost pathway ($1388) was for medical expulsive therapy, whereas the most expensive pathway ($8002) entailed a repeat ED visit prompting temporizing stent placement and interval URS. CONCLUSION: We found a high degree of cost variation between care pathways common to management of acute ureteral stone episodes. Reliable cost accounting data and an understanding of variability in clinical pathway costs can inform value-based care redesign as payors move away from pure fee-for-service reimbursement.

Costs and complications of hospital admissions for inferior vena cava filter malfunction.

OBJECTIVE: Inferior vena cava filter (IVCF) malfunction can result from penetration, fracture, or migration of the device necessitating retrieval. Endovascular and open retrieval of IVCF have been described in institutional series without comparison. This study examines national hospital admissions for IVCF malfunction and compares the outcomes of open and endovascular retrieval. METHODS: The National Inpatient Sample database (2016-2017) was reviewed for admissions with International Classification of Diseases, Tenth Revision (ICD-10) codes specific for IVCF malfunction. All ICD-10 procedural codes were reviewed, and patients were divided based on open or endovascular IVCF retrieval. Patient characteristics, outcomes, and costs of hospitalization were compared between the two groups. RESULTS: There were 665 patients admitted with a diagnosis of IVCF malfunction. Open IVCF retrieval was performed in 100 patients and endovascular removal in 90 patients. Of those undergoing open surgery, 45 patients (45%) required median sternotomy and 55 (55%) required abdominal surgeries. Most patients were white females with a mean age of 54.4 years (range, 49.3-59.6 years) with a history of deep venous thrombosis (55.3%) or pulmonary embolism (31.6%). Most patients with IVCF malfunction were treated in large (81.6%) or urban teaching (94.7%) hospitals situated most commonly in the South (42.1%) and Northeast (29.0%) with no difference in characteristics of the patients or the centers between the two groups. Patients undergoing open IVCF retrieval were more likely to undergo surgery on an elective basis compared with endovascular IVCF retrieval (75.0% vs 11.1%; P < .001). Open IVCF retrieval was associated with a higher likelihood of thromboembolic complication compared with endovascular retrieval (20% vs 0%; P = .04). There was a trend toward higher infectious complications and overall complications with endovascular removal, but this difference did not reach statistical significance. Open retrieval was associated with a mortality of 5.0% compared with no inpatient mortality with endovascular retrieval (P = .33). The mean hospital length of stay was no difference between the two groups. Open retrieval was associated with significantly higher hospital costs than endovascular retrieval ($34,276 vs $19,758; P = .05). CONCLUSIONS: Filter removal for patients with IVCF malfunction is associated with significant morbidity and cost, regardless of modality of retrieval. The introduction of specific ICD-10 codes for IVCF malfunction allows researchers to study these events. The development of effective tools for outpatient retrieval of malfunctioning IVCF could decrease related hospitalization and have potential savings for the healthcare system.

Trends in utilization, mortality, and resource use after implantation of left ventricular assist devices in the United States.

OBJECTIVES: Adoption of implantable left ventricular assist devices has dramatically improved survival and quality of life in suitable patients with end-stage heart failure. In the era of value-based healthcare delivery, assessment of clinical outcomes and resource use associated with left ventricular assist devices is warranted. METHODS: Adult patients undergoing left ventricular assist device implantation from 2008 to 2016 were identified using the National Inpatient Sample. Hospitals were designated as low-volume, medium-volume, or high-volume institutions based on annual institutional left ventricular assist device case volume. Multivariable logistic regression was used to evaluate adjusted odds of mortality across left ventricular assist device volume tertiles. RESULTS: Over the study period, an estimated 23,972 patients underwent left ventricular assist device implantation with an approximately 3-fold increase in the number of annual left ventricular assist device implantations performed (P for trend <.001). In-hospital mortality in patients with left ventricular assist devices decreased from 19.6% in 2008 to 8.1% in 2016 (P for trend <.001) and was higher at low-volume institutions compared with high-volume institutions (12.0% vs 9.2%, P < .001). Although the overall adjusted mortality was higher at low-volume compared with high-volume institutions (adjusted odds ratio, 1.66; 95% confidence interval, 1.28-2.15), this discrepancy was only significant for 2008 and 2009 (low-volume 2008 adjusted odds ratio, 5.5; 95% confidence interval, 1.9-15.8; low-volume 2009 adjusted odds ratio, 2.3; 95% confidence interval, 1.4-3.8). CONCLUSIONS: Left ventricular assist device use has rapidly increased in the United States with a concomitant reduction in mortality and morbidity. With maturation of left ventricular assist device technology and increasing experience, volume-related variation in mortality and resource use has diminished. Whether the apparent uniformity in outcomes is related to patient selection or hospital quality deserves further investigation.

Impacto financeiro no tratamento cirúrgico do glaucoma / Financial impact on glaucoma surgical treatment

Resumo Objetivo: Segunda maior causa de cegueira mundial, o glaucoma, ocasionalmente necessita de procedimento cirúrgico para controle. Tendo o Brasil um Sistema Único de Saúde (SUS), e crise político-econômica em 2016, objetiva-se avaliar o impacto financeiro na decisão terapêutica do glaucoma nos últimos 6 anos no Brasil, e considerar atual discussão sobre indicação de procedimentos intervencionistas precocemente no seu algoritmo terapêutico. Métodos: Estudo ecológico da população brasileira, com base no Sistema de Informações Hospitalares do SUS, avaliando comportamento temporal dos procedimentos cirúrgicos do SUS para tratamento do glaucoma, e variação do dólar como influenciador da tendência temporal sobre os procedimentos. Realizada a análise de Regressão Linear Simples, com significância estatística de P<0.05. Resultados: Entre 2013 e 2018 foram internados 24888 indivíduos por glaucoma, prevalência do sexo masculino (51.68%), brancos (32,57%) e idosos (57.84%). Regiões Sudeste (45.61%) e Nordeste (26.36%) com maior número de internações, sendo a Trabeculectomia (84,18%) principal procedimento realizado. Houve associação da Trabeculectomia e Implante de Válvula, individualmente e atrelados, com os valores do dólar nas regiões Centro-Oeste (β= 1,103 com P= 0,007 para Trabeculectomias e β= 1,105 com P=0,012 para ambos os procedimentos) e Sul (β= 16,727 e P= 0,006 para os Implantes), e associação entre aumento de Implantes na região Sul e maior cobertura na atenção básica (β= 0.64 e P= 0.009). Conclusão: Observou-se não interferência do dólar, e aumento dos procedimentos na região Sul e Centro-Oeste. Os resultados corroboram tendência intervencionista, podendo ser representada pelo possível uso dos procedimentos disponibilizados pelo SUS de forma precoce.

Abstract Objective: The second leading cause of blindness worldwide, glaucoma, occasionally requires surgical procedure for control. Given that Brazil has an Unified Health System (SUS) and a political-economic crisis in 2016, we aim to evaluate the financial impact on the therapeutic decision of glaucoma in the last 6 years in Brazil, and to consider the current discussion about early interventionist indication in its therapeutic algorithm. Methods: Ecological study of the Brazilian population, based on the SUS Hospital Information System, evaluating the temporal behavior of SUS surgical procedures on glaucoma treatment, and dollar variation as influencing the temporal trend on the procedures. Simple Linear Regression analysis was performed, with statistical significance of P <0.05. Results: Between 2013 and 2018, 24888 individuals were hospitalized for glaucoma, male prevalence (51.68%), whites (32.57%) and elderly (57.84%). Southeast (45.61%) and Northeast (26.36%) Regions with the largest number of hospitalizations, and Trabeculectomy (84.18%) being the main procedure performed. There was an association of trabeculectomy and valve implantation, individually and linked, with dollar values in the Midwest (β = 1.103 with P = 0.007 for Trabeculectomies and β = 1.105 with P = 0.012 for both procedures) and South (β). = 16,727 and P = 0,006 for Implants), and association between increased Implants in the South region and greater coverage in primary care (β = 0.64 and P = 0.009). Conclusion: Non-dollar interference was observed, and increased procedures in the South and Midwest. The results corroborate an interventionist tendency and may be represented, possible, by the use of procedures provided by the SUS in an early manner.

Racial disparities in in-hospital outcomes after left ventricular assist device implantation.

BACKGROUND: Previous studies of patients undergoing various cardiac surgeries demonstrated worse outcomes among African-American (AA) patients. It remains unclear if the race is a predictor of outcomes among left ventricular assist device (LVAD) recipients. METHODS: Patients who underwent LVAD implantation between 2010 and 2017 were identified using the National Inpatient Sample. The race was classified as Caucasians vs AA vs Hispanics, and endpoints were in-hospital outcomes, length of stay, and cost. Procedure-related complications were identified via the International Classification of Diseases-9 (ICD-9) and ICD-10 coding and analysis performed via mixed-effect models. RESULTS: A total of 27 132 adults (5114 unweighted) underwent LVAD implantation in the U.S. between 2010 and 2017, including Caucasians (63.8%), AA (23.8%), and Hispanics (6%). The number of LVAD implantations increased in both Caucasians and AA during the study period. AA LVAD recipients were younger, with higher rates of females and mostly comorbidities, but lower rates of coronary artery disease and bypass grafting compared to Caucasians and Hispanics. Medicaid and median income at the lowest quartile were more frequent among AA LVAD recipients. We did not identify differences in stroke, bleeding complications, tamponade, infectious complications, acute kidney injury requiring hemodialysis, and in-hospital mortality among racial groups. AA LVAD recipients had lower rates of routine discharge than Caucasians and Hispanics, longer length of stay than Caucasians, but similar cost of hospitalization. After adjustment for clinical comorbidities, race was not a predictor of in-hospital mortality. CONCLUSION: We identified differences in clinical characteristics but not in in-hospital complications among LVAD recipients of a different races.

Cost of Thoracotomy Approach: An Analysis of the LATERAL Trial.

BACKGROUND: Less invasive techniques for left ventricular assist device implantation have been increasingly prevalent over past years and have been associated with improved clinical outcomes. The procedural economic impact of these techniques remains unknown. We sought to study and report economic outcomes associated with the thoracotomy implantation approach. METHODS: The LATERAL clinical trial evaluated the safety and efficacy of the thoracotomy approach for implantation of the HeartWare centrifugal-flow ventricular assist device system (HVAD). We collected UB-04 forms in parallel to the trial, allowing analysis of index hospitalization costs. All charges were converted to costs using hospital-specific cost-to-charge ratios and were subsequently compared with Medicare cost data for the same period (2015-2016). Because thoracotomy implants were off-label for all left ventricular assist devices during that period, the Medicare cohort was assumed to consist predominately of traditional sternotomy patients. RESULTS: Thoracotomy patients demonstrated decreased costs compared with sternotomy patients during the index hospitalization. Mean total index hospitalization costs for thoracotomy were $204,107 per patient, corresponding to 21.6% reduction (P < .001) and $56,385 savings per procedure compared with sternotomy. Across almost all cost categories, thoracotomy implants were less costly. CONCLUSIONS: In LATERAL, a clinical trial evaluating the safety and efficacy of the thoracotomy approach for HVAD, costs were lower than those reported in Medicare patient claims occurring over the same period. Because Medicare data can be presumed to consist of predominately sternotomy procedures, thoracotomy appears less expensive than traditional sternotomy.

Better With Time: An Economic Assessment of Long-Term Mechanical Circulatory Support in a Population Surviving at Least 1 Year with a Left Ventricular Assist Device.

This study aims to identify the major components of left ventricular assist device (LVAD)-related costs in a population on long-term mechanical circulatory support to gain insight into opportunities for improvements in quality, safety, and efficiency of care for end-stage heart failure patients. This was a single institution, retrospective cost analysis of patients who received a Heartmate II or HeartWare LVAD between November 2005 and October 2015. Payments for hospitalization for device implantation and subsequent readmissions were represented as the institution's 2015 Medicare reimbursement rate. The incidence, average Medicare reimbursement, and length of stay of readmissions were analyzed for the first year postimplant. A full year of LVAD-related hospitalizations in patients surviving ≥12 months, has a median Medicare reimbursement of $247,208. The most common complications related to ventricular assist devices were gastrointestinal bleeding, driveline infection, stroke, and pump thrombosis. Over 90% of total costs were incurred during the initial hospitalization. Seventy-five percent of first-time readmissions occurred within the first 4 months post discharge. Intensive care unit costs accounted for the single largest cost category during readmissions for all of the 4 most common complications. The trends demonstrated suggest that longer lengths of LVAD support in appropriately selected patients results in progressively decreasing cost-per-month up to 12 months, given the large upfront cost of device implantation and relatively modest additional costs of readmissions. This analysis emphasizes the importance of devices with improved complication profiles and clinical protocols to reduce unnecessary intensive care unit stays to increase the cost effectiveness of long-term ventricular assist device therapy.

Consumer Prices for Surgical Management of End-Stage Hallux Rigidus.

Background. Hallux rigidus is the most prevalent arthritic condition of the foot. Treatment of end-stage disease traditionally consists of a first metatarsophalangeal joint (MTPJ) arthrodesis; however, the use of a synthetic cartilage implant is becoming more common. With the high prevalence of disease and implementation of new treatment modalities, health care consumers should be aware of the costs associated with management. The purpose of this study was to determine access to the cost and variability in price of first MTPJ arthrodesis and synthetic cartilage implantation. Methods. Forty academic centers were contacted using a standardized patient script. The patient was a 59-year-old female who had failed conservative treatment of hallux rigidus. Each institution was contacted up to 3 times in an attempt to obtain a full bundled operative quote for a first MTPJ arthrodesis and synthetic cartilage implantation. Results. Twenty centers (50%) provided a quote for first MTPJ arthrodesis and 15 centers (38%) provided a quote for synthetic cartilage implantation. Only 14 centers (35%) were able to provide a quote for both procedures. The mean bundled price for MTPJ arthrodesis was $21 767 (range $8417 to $39 265). The mean bundled price for synthetic cartilage implantation was $21 546 (range $4903 to $74 145). There was no statistically significant difference between the bundled price for first MTPJ arthrodesis and synthetic cartilage implantation. Conclusions. There was limited availability of consumer prices for first MTPJ arthrodesis and synthetic implantation, thus impeding health care consumers' decision making. There was a wide range of quotes for both procedures, indicating potential cost savings.Levels of Evidence: IV, basic science.

Vascular complications associated with percutaneous left ventricular assist device placement: A 10-year US perspective.

BACKGROUND: Over the last decade, there has been a significant increase in the use of percutaneous left ventricular assist devices(p-LVADs). p-LVADs are being increasingly used during complex coronary interventions and for acute cardiogenic shock. These large bore percutaneous devices have a higher risk of vascular complications. We examined the vascular complication rates from the use of p-LVAD in a national database. METHODS: We conducted a secondary analysis of the National In-patient Sample (NIS) dataset from 2005 till 2015. We used the ICD-9-CM procedure codes 37.68 and 37.62 for p-LVAD placement regardless of indications. We investigated common vascular complications, defining them by the validated ICD 9 CM codes. χ2 test and t test were used for categorical and continuous variables, respectively for comparison. RESULTS: A total of 31,263 p-LVAD placements were identified during the period studied. A majority of patients were male (72.68%) and 64.44% were white. The overall incidence of vascular complications was 13.53%, out of which 56% required surgical treatment. Acute limb thromboembolism and bleeding requiring transfusion accounted for 27.6% and 21.8% of all vascular complications. Occurrence of a vascular complication was associated with significantly higher in-hospital mortality (37.77% vs. 29.95%, p < .001), length of stay (22.7 vs. 12.2 days, p < .001) and cost of hospitalization ($ 161,923 vs. $ 95,547, p < .001). CONCLUSIONS: There is a high incidence of vascular complications with p-LVAD placement including need for vascular surgery. These complications are associated with a higher in-hospital, LOS and hospitalization costs. These findings should be factored into the decision-making for p-LVAD placement.

Costs and complications of endovascular inferior vena cava filter retrieval.

OBJECTIVE: Advanced endovascular techniques are frequently used for challenging inferior vena cava (IVC) filter retrieval. However, the costs of IVC filter retrieval have not been studied. This study compares IVC filter retrieval techniques and estimates procedural costs. METHODS: Consecutive IVC filter retrievals performed at a tertiary center between 2009 and 2014 were retrospectively reviewed. Procedures were classified as standard retrieval (SR) if they required only a vascular sheath and a snare device and as advanced endovascular retrieval (AER) if additional endovascular techniques were used for retrieval. Cost data were based on hospital bills for the procedures. Patients' characteristics, filter dwell time, retrieval procedure details, complications, and costs were compared between the groups. All statistical comparisons were performed using SAS 9.3 software. RESULTS: There were 191 IVC filter retrievals (SR, 157; AER, 34) in 183 patients (mean age, 55 years; 51% male). Fifteen filters (7.9%) were placed at an outside hospital. The indications for placement were mostly therapeutic (76% vs 24% for prophylaxis). All IVC filters were retrievable, with Bard Eclipse (Bard Peripheral Vascular, Tempe, Ariz; 34%) and Cook Günther Tulip (Cook Medical, Bloomington, Ind; 24%) the most common. Venous ultrasound examination of the lower extremities of 133 patients (70%) was performed before retrieval, whereas only 5 patients (2.6%) received a computed tomography scan of the abdomen. There was no difference in the mean filter dwell time in the two groups (SR, 147.9 ± 146.1 days; AER, 161.4 ± 91.3 days; P = .49). AERs were more likely to have had prior attempts at retrieval (23.5%) compared with SRs (1.9%; P < .001). The most common AER techniques used were the wire loop and snare sling (47.1%) and the stiff wire displacement (44.1%). Bronchoscopy forceps was used in four cases (11.8%); this was the only off-label device used. AERs were more likely to require more than one venous access site for the retrieval procedure (23.5% vs 0%; P < .001). AERs were significantly more likely to have longer fluoroscopy time (34.4 ± 18.3 vs 8.1 ± 7.9 minutes; P < .001) and longer total procedural time (102.8 ± 59.9 vs 41.1 ± 25.0 minutes; P < .001) compared with SRs. The complication rate was higher with AER (20.6%) than with SR (5.2%; P = .006). Most complications were abnormal radiologic findings that did not require additional intervention. The procedural cost of AER was significantly higher (AER, $14,565 ± $6354; SR, $7644 ± $2810; P < .001) than that of SR. This translated to an average increase in cost of $6921 ± $3544 per retrieval procedure for AER. CONCLUSIONS: Advanced endovascular techniques provide a feasible alternative when standard IVC filter retrieval techniques do not succeed. However, these procedures come with a higher cost and higher rate of complications.

Prophylactic Inferior Vena Cava Filters Prior to Bariatric Surgery: Insights From the National Inpatient Sample.

OBJECTIVES: The aim of this study was to determine in-hospital mortality, post-surgical thromboembolic events, and health care costs associated with the placement of prophylactic inferior vena cava filters (IVCFs) prior to bariatric surgery. BACKGROUND: The role of prophylactic IVCFs prior to bariatric surgery is controversial, and the nationwide clinical outcomes associated with this practice are unknown. METHODS: This observational study used the National Inpatient Sample database to identify obese patients who underwent bariatric surgery from January 2005 to September 2015. Using propensity score matching, outcomes associated with patients receiving prophylactic IVCFs prior to their bariatric surgery were compared with those among patients who did not receive IVCFs. RESULTS: A total of 258,480 patients underwent bariatric surgery, of whom 1,047 (0.41%) had prophylactic IVCFs implanted. Patients with prophylactic IVCFs compared with those without IVCFs had a significantly higher rate of the combined endpoint of in-hospital mortality or pulmonary embolism (1.4% vs. 0.4%; odds ratio: 3.75; 95% confidence interval [CI]: 1.25 to 11.30; p = 0.019). Additionally, prophylactic IVCFs were associated with higher rates of lower extremity or caval deep vein thrombosis (1.8% vs. 0.3%; odds ratio: 6.33; 95% CI: 1.87 to 21.4; p < 0.01), length of stay (median 3 days vs. 2 days; p < 0.01), and hospital charges (median $63,000 vs. $37,000; p < 0.01). CONCLUSIONS: In this nationwide observational study, prophylactic IVCF implantation prior to bariatric surgery was associated with worse clinical outcomes and increased health care resource utilization.

Intra-Scleral Ciliary Sulcus Suprachoroidal Microtube: Making Supraciliary Glaucoma Surgery Affordable.

PURPOSE: The suprachoroidal space (SCS) has been a successful target to lower intraocular pressure (IOP) in glaucoma patients. We present the results of 4 patients who underwent a novel glaucoma surgical procedure to lower IOP: Intrascleral Ciliary Sulcus-Suprachoroidal Microtube. METHODS: A sterile medical grade silicone microtube (Tube extender, New World Medical) was surgically placed to drain aqueous from the posterior chamber ciliary sulcus of the eye to the SCS. The internal diameter of the tube was 300 um and the length varied from 8-10mm. After informed consent was obtained and witnessed, this procedure was performed in glaucoma patients with pseudophakia. The tube was placed intrasclerally beneath an inferotemporal sclera flap (50% thickness approximately 4mm x 4mm). The anterior end of the tube was inserted into the ciliary sulcus approximately 2mm from the limbus and the posterior end was placed into the SCS approximately 4mm from the limbus. The microtube was sutured to the sclera with a 10-0 nylon suture. 8-0 vicryl sutures were used to close the sclera flap and the conjunctiva inferotemporally. RESULTS: All 4 patients had lower IOP. The average reduction of IOP was 36% at 3 months. The amount of glaucoma medications per patient at 3 months dropped from an average of 3 to 0.25. The risks are similar to traditional glaucoma incisional surgery. CONCLUSION: This new technique of Intrascleral Ciliary Sulcus-Suprachoroidal Microtube in all four patients with mild, moderate, and advanced glaucoma demonstrated a significant lowering of IOP and a decrease in the number of medications. Further research is required to assess long term efficacy and safety.

Early cost-utility estimation of the surgical correction of pectus excavatum with the Nuss bar.

OBJECTIVES: The surgical correction of pectus excavatum (PE) with a Nuss bar provides satisfactory outcomes, but its cost-effectiveness is yet unproven. We prospectively analysed early outcomes and costs for Nuss bar placement. METHODS: Fifty-four patients aged 16 years or older (6 females and 48 males; mean age, 17.9 years; range 16.0-29.4 years) with a PE filled out a Short Form-36 Health Survey (SF-6D) preoperatively and 1 year after a Nuss procedure. Costs included professional fees and fees for the operating room, materials and hospital care. Changes in the responses to the SF-36 or its domains were compared using the Wilcoxon signed rank test and the utility test results were calculated preoperatively and postoperatively from the SF-6D. The quality-adjusted life years (QALYs) were calculated from the results of these tests. RESULTS: Significant improvements in physical functioning, social functioning, mental health and health transition (all P < 0.05) were noted. The other SF-36 subgroups showed improvement; however, the improvement was not significant. The SF-6D utility showed improvement from 0.76 preoperatively to 0.79 at the 1-year follow-up (P = 0.096). The mean direct costs were €8805. The 1-year discounted QALY gain was 0.03. The estimated cost-utility ratio was €293 500 per QALY gained. CONCLUSIONS: Despite a significant improvement in many domains of the SF-36, the results of the SF-6D cost-utility analysis showed only a small improvement in cost-effectiveness (> €80 000/QALY) for patients with PE 1 year after Nuss bar placement. Based on this discrepancy, general health outcome measurements as the basis for cost-utility analysis in patients with PE may not be the best way forward.

Osseointegrated Prosthetic Implants for People With Lower-Limb Amputation: A Health Technology Assessment.

BACKGROUND: Osseointegrated prosthetic implants are biocompatible metal devices that are inserted into the residual bone to integrate with the bone and attach to the external prosthesis, eliminating the need for socket prostheses and the problems that may accompany their use. We conducted a health technology assessment of osseointegrated prosthetic implants, compared with conventional socket prostheses, for people with lower-limb amputation who experience chronic problems with their prosthetic socket, leading to prosthesis intolerance and reduced mobility. Our analysis included an evaluation of effectiveness, safety, cost-effectiveness, the budget impact of publicly funding osseointegrated prosthetic implants, and patient preferences and values. METHODS: We performed a systematic literature search of the clinical evidence on the safety and effectiveness of the latest iterations of three implant systems: the Osseointegrated Prostheses for the Rehabilitation of Amputees (OPRA) Implant System, the Endo-Exo-Femur-Prosthesis, and the Osseointegration Group of Australia-Osseointegration Prosthetic Limb (OGAP-OPL). We assessed the risk of bias of individual studies and determined the quality of the body of evidence according to the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) Working Group criteria. We performed a systematic economic literature search and conducted a cost-utility analysis with a lifetime horizon from a public payer perspective. We also analyzed the net budget impact of publicly funding osseointegrated prosthetic implants in Ontario. To contextualize the potential value of osseointegrated prosthetic implants, we spoke with people with lower-limb amputations. RESULTS: We included nine studies in the clinical evidence review. All studies included patients with above-the-knee amputation who underwent two-stage surgery and mostly had short-term follow-up. With osseointegrated prosthetic implants, scores for functional outcomes improved significantly as measured by 6-Minute Walk Test (6MWT), Timed Up and Go (TUG) test, and Questionnaire for Persons with a Transfemoral Amputation (Q-TFA). The scores for quality of life measured by SF-36 showed significant improvement in the physical component summary but a nonsignificant decline for the mental component summary. The most frequently seen adverse event was superficial infection, occurring in about half of patients in some studies. Deep or bone infection was a serious adverse event, with variable rates among the studies depending on the length of follow-up. The treatment of deep or bone infection required long-term antibiotic use, surgical debridement, revision surgery, and implant extraction in some cases. Other adverse events included femoral bone fracture, implant breakage, issues with extramedullary parts that required replacement, and implant removal. Our assessment of the quality of the clinical evidence according to the GRADE criteria found low certainty in terms of improvement in functional outcomes, low certainty for quality of life, and high certainty of an increase in adverse events; all findings compared receiving an osseointegrated prosthetic implant with not receiving an osseointegrated prosthetic implant.In our economic model, osseointegrated prosthetic implants were found to be more effective and more expensive than having people remain users of an uncomfortable socket prosthesis. Our best estimate of the incremental cost-effectiveness ratio (ICER) for osseointegration, compared with an uncomfortable socket, was $94,987 per quality-adjusted life-year (QALY) gained. The probability of osseointegration being cost-effective was 54.2% at a willingness-to-pay value of $100,000 per QALY gained. The annual net budget impact of publicly funding osseointegrated prosthetic implants in Ontario over the next 5 years, for a small population of eligible candidates, would range from $1.5 million in year 1 to $0.6 million in year 5, for a 5-year total of $5.3 million.We interviewed 13 people with a lower-limb amputation; nine had experience with both a conventional socket prosthesis and an osseointegrated prosthetic implant, three had experience with a conventional socket prosthesis only, and one had only recently undergone amputation and had not yet chosen a prosthesis. People who had received an osseointegrated prosthetic implant said they had better mobility and quality of life than before receiving this implant but had concerns about the ongoing risk of infection and potential for problems with implant maintenance. People using a conventional socket prosthesis said cost was the only factor preventing them from undergoing an osseointegration procedure. CONCLUSIONS: In the studies included in the clinical evidence review, most people who received osseointegrated prosthetic implants were followed for only a few years. Studies showed that functional outcomes and physical ability improved with osseointegrated prosthetic implants (GRADE: Low), but there was uncertainty about the impact of these implants on people's emotional health (GRADE: Low). Osseointegrated prosthetic implants can lead to serious adverse events such as bone infection and bone fracture in some patients, which may require additional surgeries (GRADE: High). The reference case of the primary economic evaluation represented a conservative estimate of cost-effectiveness and found osseointegration may be cost-effective, but there is a large degree of uncertainty given parameter uncertainty and the need to use proxy costs. Scenario analyses explored potential variations in approaches to modelling and parameter selection. Qualitative interviews with people with a lower-limb amputation and caregivers underscored the challenges of conventional socket prostheses, but cost remains an important barrier to pursuing osseointegrated prosthetic implantation.

Evaluation of locally manufactured patient-specific custom made implants for cranial defects using a silicone mould.

BACKGROUND: Cranial vault defects can pose a significant problem for neurosurgeons where autologous bone is no longer available for cranioplasty. Numerous materials exist to create implants which include polymethyl methacrylate (PMMA) and titanium. A technique using 3-dimensional CT scan reconstruction of a cranial defect and creating a silicon mould which can be autoclaved in theatre to create a PMMA implant was developed. OBJECTIVE: The aim of this study is to evaluate the efficacy, cosmetic result, safety and cost-effectiveness of this procedure and compare this to existing techniques. METHOD: An ambispective study was performed in patients requiring cranioplasty with a custom made implant. Patients were assessed for risk factors and cosmetic outcome, surgical technique was described and complications and cost compared to existing literature between 2010 and 2016. RESULTS: Thirty retrospective and 30 consecutive prospective patients were recruited into the study. Overall sepsis rate was 8.3%. All septic cases had superficial sepsis of which 2 grafts were removed due to cerebrospinal fluid leakage resulting in wound breakdown. A 100% accurate implant to defect ratio was achieved leading to a high satisfaction rate. Average cost was 5 times cheaper than the closest market related product. CONCLUSION: Patient specific moulds using PMMA to create custom implants are safe, have excellent cosmetic results and are a very cost-effective option to manage cranial defects. Accurate planning strategies for large craniotomies, where bone will potentially be discarded, add to surgical effectiveness and cost-saving to the patient.

Implantable cardioverter-defibrillator therapy in Australia, 2002-2015.

OBJECTIVES: To quantify the number of implantable cardioverter-defibrillator (ICD) procedures in Australia by year, patient age and sex, and to estimate age group-specific population rates and the associated costs. Design, setting: Retrospective observational study; analysis of Australian National Hospital Morbidity Database hospital procedures data. PARTICIPANTS: Patients with an ICD insertion, replacement, adjustment, or removal procedure code, July 2002 - June 2015. MAIN OUTCOME MEASURES: Number of ICD procedures by procedure year, patient age (0-34, 35-69, 70 years or more) and sex; age group-specific population procedure rates; number of procedures associated with complications. RESULTS: The number of ICD procedures increased from 1844 in 2002-03 to 6504 in 2014-15; more than 75% of procedures were in men. In 2014-15, the ICD insertion rate for people aged 70 years or more was 78.1 per 100 000 population, 22 per 100 000 for those aged 35-69 years, and 1.40 per 100 000 people under 35. The reported complication rate decreased from 45% in 2002-03 to 19% in 2014-15, partly because of a change in the coding of complications. The number of removals corresponded to at least 4% of the number of insertions each year. The aggregate cost of hospitalisations with an ICD procedure during 2011-14 was $445 644 566. CONCLUSION: ICD procedures are becoming more frequent in Australia, particularly in people aged 70 or more. Patterns of care associated with ICD therapy, particularly patient- and hospital-related factors associated with adverse events, should be investigated to better understand and improve patient outcomes.

Perception Versus Reality in the Cost of Orthopedic Trauma Implants.

OBJECTIVE: Health care costs are increasing in medicine and in orthopedics. Device choice in orthopedic cases can impact the cost of the procedure and thus result in cost savings. This study aims to determine whether orthopedic attendings and residents accurately estimate device costs they are implanting in trauma cases and whether costs would influence their surgical device selection. DESIGN: Using nationally published average cost data for 13 implants, a survey was distributed at 6 US academic centers. Respondents were asked to select the correct cost from cost ranges. They also answered yes/no questions about their choices regarding published research outcomes for specific fractures. Residents' answers were compared with faculty answers using t tests for each cost estimate question, and chi-square tests for yes/no questions and frequencies. RESULTS: A total of 51 faculty members and 76 residents responded. Attending estimates were closer to the actual cost for most devices. The average total error in cost estimate for all 13 implants was $11,288.36 for residents (35.6% difference) and $10,208.33 for faculty members (32.2% difference). Significantly more faculty members estimated costs within 10% versus residents. When asked if the literature showed differences in outcome when using different implants to treat 4 common fractures, most answered these questions correctly. Further, 71.1% of residents said their choice of implant would change if costs affected physician reimbursements versus 58% for faculty members. CONCLUSIONS: Our data indicate orthopedic physicians are not aware of true implant costs and nearly half of attendings would not consider cost as a factor in deciding between equivalent implants, even if this affected their reimbursement. Most notably, participants showed a poor ability to closely estimate the cost of more expensive implants (actual device cost greater than $2000). Our results suggest that medical cost containment should be stressed to the next generation of surgeons.

Inferior Vena Cava Filter Malpractice Litigation: Damned if You Do, Damned if You Don't.

BACKGROUND: The aim of this study was to analyze malpractice litigation trends and to better understand the causes and outcomes of suits involving inferior vena cava filters (IVCF) to prevent future litigation and improve physician education. METHODS: Jury verdict reviews from the Westlaw database from January 1, 2000, to December 31, 2015, were reviewed. The search term "inferior vena cava filter" was used to compile data on the demographics of the defendant, plaintiff, allegation, complication, and verdict. RESULTS: A total of 156 cases were identified. Duplicates and cases in which the IVCF was incidentally included were excluded from the analysis. Forty-nine cases involving either failure to place or a complication of IVCF placement were identified. Throughout the last 15 years, there has been increased number of jury verdicts toward IVCF. The most frequent defendants were internal medicine physicians (38%), vascular surgeons (19%), and cardiothoracic surgeons (12%). The most frequent claims were denied treatment or delay in treatment (in 35% of cases), negligent surgery (in 24% of cases), and failure to diagnose and treat complications (in 24% of cases). Of these, the most frequent specific claims were failure to place IVC filter (41%), implantation failure such as misplacement and/or misaligned implant (24%), erosion of IVC/retroperitoneal bleed (6%), and discontinuation of anticoagulation prematurely (6%). Seventeen cases (35%) were found for the plaintiff, with median awards worth of $1,092,500. In the 21 cases where pulmonary embolism (PE) was involved (43% of cases), 19 were fatal (90%). Of the fatal PE cases, 8 cases ended with verdicts in favor of the plaintiff (42%). Both nonfatal PE cases were won by the defense. CONCLUSIONS: IVCF placement with subsequent PE and death results in verdicts that favor the plaintiffs. This study emphasizes that adequate and transparent communication regarding preoperative planning, decision for IVCF placement, and informed consent may reduce the frequency of litigation. Public awareness of complications related to the placement of IVCF is increasing largely and spurned by aggressive advertising and marketing by plaintiff attorneys. Conditions for which IVCF placement is contemplated carry significant risk of malpractice litigation.

Cost-effectiveness analysis of stent type in endoscopic treatment of gastric leak after laparoscopic sleeve gastrectomy.

BACKGROUND: Gastric leak is the most feared surgical postoperative complication after sleeve gastrectomy. An endoscopic procedure is usually required to treat the leak. No data are available on the cost-effectiveness of different stent types in this procedure. METHODS: Between April 2005 and July 2016, patients with a confirmed gastric leak undergoing endoscopic treatment using a covered stent (CS) or double-pigtail stent (DPS) were included. The primary objective of the study was to assess overall costs of the stent types after primary sleeve gastrectomy. Secondary objectives were the cost-effectiveness of each stent type expressed as an incremental cost-effectiveness ratio (ICER); the incremental net benefit; the probability of efficiency, defined as the probability of being cost-effective at a threshold of €30 000, and identification of the key drivers of ICER derived from a multivariable analysis. RESULTS: One hundred and twelve patients were enrolled. The overall mean costs of gastric leak were €22 470; the mean(s.d.) cost was €24 916(12 212) in the CS arm and €20 024(3352) in the DPS arm (P = 0·018). DPS was more cost-effective than CS (ICER €4743 per endoscopic procedure avoided), with an incremental net benefit of €25 257 and a 27 per cent probability of efficiency. Key drivers of the ICER were the inpatient ward after diagnosis of gastric leak (surgery versus internal medicine), type of institution (private versus public) and duration of hospital stay per endoscopic procedure. CONCLUSION: DPS for the treatment of gastric leak is more cost-effective than CS and should be proposed as the standard regimen whenever possible.

Introduction into the NHS of magnetic sphincter augmentation: an innovative surgical therapy for reflux - results and challenges.

Introduction Gastro-oesophageal reflux disease (GORD) is a common, chronic debilitating condition. Surgical management traditionally involves fundoplication. Magnetic sphincter augmentation (MSA) is a new definitive treatment. We describe our experience of introducing this innovative therapy into NHS practice and report the early clinical outcomes. Methods MSA was introduced into NHS practice following successful acceptance of a cost-effective business plan and close observation of National Institute for Health and Care Excellence (NICE) recommendations for new procedures, including a carefully planned prospective data collection over a two-year follow-up period. Results Forty-seven patients underwent MSA over the 40-month period. Reflux health-related quality of life (GERD-HRQL) was significantly improved after the procedure and maintained at one- and two-year (P < 0.0001) follow-up. Drug dependency went from 100% at baseline to 2.6% and 8.7% after one and two years. High levels of patient satisfaction were reported. There were no adverse events. Conclusions MSA is highly effective in the treatment of uncomplicated GORD, with durable results and an excellent safety profile. This laparoscopic, minimally invasive procedure provides a good alternative for patients where surgical anatomy is unaltered. Our experience demonstrates that innovative technology can be incorporated into NHS practice with an acceptable business plan and compliance with NICE recommendations.