Patient and Institutional Costs of Failure of Angioplasty of the Superficial Femoral Artery.

BACKGROUND: Debate surrounds the optimal management of superficial femoral artery (SFA) disease. Randomized trial data rarely reflect real world findings, specifically the consequences to the patient of angioplasty failure. We observed the effect of a failed SFA angioplasty on the need for repeated clinic visits, hospital readmissions, imaging requirements, and reinterventions. METHODS: We reviewed a consecutive series of 148 patients (94 men, median age 72 years) undergoing solely SFA angioplasty over a 2-year period. Patient preangioplasty demographics and 2-year post-PTA follow-up data were collated, including hospital attendances (inpatient/outpatient), further imaging (including radiation exposure) and revascularization attempts. We defined "failed angioplasty" as presence of clinical symptoms with radiological evidence of significant restenosis after an initial successful primary SFA angioplasty. RESULTS: Fifty-four patients represented with a failed angioplasty (median time of 4 months after index PTA). In this group, failure of index angioplasty resulted in a further 185 restenosis-related clinic visits and a total of 537 bed days of inpatient stay. This group underwent a further 149 imaging events and required a further 34 endovascular revascularization procedures and 12 infrainguinal bypass procedures. These interventions and investigations corresponded to overall effective radiation dose across all patients of 190.69 mSv. Of the cohort of 99 patients who did not have a "failed angioplasty," they required 100 clinic visits, 21 further scans (total radiation dose 6.42 mSv), and 36 bed days of inpatient admission. CONCLUSIONS: Failed angioplasty results in significant additional consequences for patients and health-care systems. Further work should focus on refining decision-making, providing the right procedure to the right patient at the right time.

Medicare costs for endovascular abdominal aortic aneurysm treatment in the Vascular Quality Initiative.

BACKGROUND: Reintervention after endovascular repair (EVR) of abdominal aortic aneurysms is common. However, the cumulative financial impact of reintervention after EVR on a national scale is poorly defined. Our objective was to describe the cost to Medicare for aneurysm treatment (EVR plus reinterventions) among a cohort of patients with known follow-up for 5 years after repair. METHODS: We identified patients who underwent EVR within the Vascular Quality Initiative who were linked to their respective Medicare claims file (n = 13,995). We excluded patients who underwent EVR after September 30, 2010, and those who had incomplete Medicare coverage (n = 12,788). The remaining cohort (n = 1207) had complete follow-up until death or 5 years (Medicare data available through September 30, 2015). We then obtained and compiled the corresponding Medicare reimbursement data for the index EVR hospitalization and all subsequent reinterventions. RESULTS: We studied 1207 Medicare patients who underwent EVR and had known follow-up for reinterventions for 5 years. The mean age was 76.2 years (±7.1 years), 21.6% of patients were female, and 91.1% of procedures were elective. The Kaplan-Meier reintervention rate at 5 years was 18%. Among patients who underwent reintervention, 154 (73.7%) had a single reintervention, 40 (19.1%) had two reinterventions, and 15 (7.2%) had three or more reinterventions. The median cost to Medicare for the index EVR hospitalization was $25,745 (interquartile range, $21,131-$28,774). The median cost for subsequent reinterventions was $22,165 (interquartile range, $17,152-$29,605). The cumulative cost to Medicare of aneurysm treatment (EVR plus reinterventions) increased in a stepwise fashion among patients who underwent multiple reinterventions, with each reintervention being similar in cost to the index EVR. CONCLUSIONS: The overall cost incurred by Medicare to reimburse for each reintervention after EVR is roughly the same as for the initial procedure itself, meaning that Medicare cost projections would be greater than $100,000 for any individual who undergoes an EVR with three reinterventions. The long-term financial impact of EVR must be considered by surgeons, patients, and healthcare systems alike as these cumulative costs may hinder the fiscal viability of an EVR-first therapeutic approach and highlight the need for judicious patient selection paradigms.

Cost Effectiveness of External Beam Radiation Therapy versus Percutaneous Image-Guided Cryoablation for Palliation of Uncomplicated Bone Metastases.

PURPOSE: To evaluate the cost effectiveness of incorporating cryoablation in the treatment regimens for uncomplicated bone metastases using radiation therapy (RT) in single-fraction RT (SFRT) or multiple-fraction RT (MFRT) regimens. MATERIALS AND METHODS: A Markov model was constructed using 1-month cycles over a lifetime horizon to compare the cost effectiveness of multiple strategies, including RT followed by RT (RT-RT) for recurrent pain, RT followed by cryoablation (RT-ablation), and cryoablation followed by RT (ablation-RT). RT-RT consisted of 8 Gy in 1 fraction/8 Gy in 1 fraction (SFRT-SFRT) and 30 Gy in 10 fractions/20 Gy in 5 fractions (MFRT-MFRT). Probabilities and utilities were extracted from a search of the medical literature. Costs were calculated from a payer perspective using 2017 Medicare reimbursement in an outpatient setting. Incremental cost effectiveness ratios (ICERs) were calculated using strategies evaluated for willingness-to-pay threshold of $100,000 per quality-adjusted life-year (QALY). To account for model uncertainty, one-way and probabilistic sensitivity analyses were performed. RESULTS: In the base case analysis, SFRT-ablation was cost effective relative to SFRT-SFRT at $96,387/QALY. MFRT-ablation was cost effective relative to MFRT-MFRT at $85,576/QALY. Ablation-SFRT and ablation-MFRT were not cost effective with ICERs >$100,000/QALY. In one-way sensitivity analyses, results were highly sensitive to variation in multiple model parameters, including median survival (base: 9 months), with SFRT-SFRT favored at median survival ≤8.7 months. Probabilistic sensitivity analysis examining SFRT-based regimens showed that SFRT-ablation was preferred in 36.9% of simulations at WTP of $100,000/QALY. CONCLUSIONS: Cryoablation is a potentially cost-effective alternative to reirradiation with RT for recurrent of pain following RT; however, no strategy incorporating initial cryoablation was cost effective.

Initial financial impact of office-based laboratories on Medicare payments for percutaneous interventions for peripheral artery disease.

OBJECTIVE: Percutaneous interventions for peripheral artery disease (PAD) are transitioning away from hospital-based settings to office-based laboratories (OBLs). Those in favor of OBL use reference lower hospitalization rates and high efficiency; however, critics claim financial incentives may lead to multiple procedures and higher atherectomy use. We sought to determine how Medicare payments are affected by OBL use. METHODS: We identified physicians performing percutaneous interventions for PAD from 2006 to 2013 in a 20% Medicare sample. Physicians performing a majority of interventions at OBLs were classified as high OBL users; control physicians performed interventions at hospital-based settings. The primary outcomes were total Medicare payments at 30 days and 1 year. Generalized log-gamma regression models were used to evaluate factors influencing payments reported as a percentage change and 95% confidence interval (95% CI). A secondary analysis was performed of physicians who transitioned from hospital-based settings to OBLs, "switch physicians." A multivariate model with difference-in-differences regression was used to evaluate the effects of transitioning to OBLs. RESULTS: A total of 89 high OBL users performed percutaneous interventions on 887 patients, and 3715 control physicians treated 54,213 patients during the time period. Payments for patients treated by high OBL users were significantly higher compared with control physicians at 30 days ($4465), 90 days ($8925), and 1 year ($27,436). Major factors increasing payments at 1 year were treatment by a high OBL user (49%; 95% CI, 42%-56%), hospital admissions (127%; 95% CI, 123%-131%), repeated lower extremity procedures (41%; 95% CI, 39%-43%), and lower extremity wound (20%; 95% CI,18%-22%). Factors decreasing payments at 1 year were living in a rural setting (8%; 95% CI, 7%-9%) and dementia (5%; 95% CI, 3%-7%). Analysis of 292 switch physicians identified 3888 patients treated before OBLs (pre-switch) and 3246 after OBLs (post-switch). Transitioning to OBLs was associated with higher payments at 30 days and 90 days, and this increase was higher compared with control physicians. CONCLUSIONS: These findings highlight that OBL use for PAD interventions significantly influences Medicare payments, and its widespread adaptation should be made with caution. The main factors driving payments were hospitalization admissions, repeated lower extremity procedures, and wound status. Further work is needed to evaluate the appropriate use of OBLs to optimize patient outcomes and resource allocations.

Comparing Retreatments and Expenditures in Flow Diversion Versus Coiling for Unruptured Intracranial Aneurysm Treatment: A Retrospective Cohort Study Using a Real-World National Database.

BACKGROUND: Flow diverters (FDs) have marked the beginning of innovations in the endovascular treatment of large unruptured intracranial aneurysms, but no multi-institutional studies have been conducted on these devices from both the clinical and economic perspectives. OBJECTIVE: To compare retreatment rates and healthcare expenditures between FDs and conventional coiling-based treatments in all eligible cases in Japan. METHODS: We identified patients who had undergone endovascular treatments during the study period (October 2015-March 2018) from a national-level claims database. The outcome measures were retreatment rates and 1-yr total healthcare expenditures, which were compared among patients who had undergone FD, coiling, and stent-assisted coiling (SAC) treatments. The coiling and SAC groups were further categorized according to the number of coils used. Retreatment rates were analyzed using Cox proportional hazards models, and total expenditures were analyzed using multilevel mixed-effects generalized linear models. RESULTS: The study sample comprised 512 FD patients, 1499 coiling patients, and 711 SAC patients. The coiling groups with ≥10 coils and ≥9 coils had significantly higher retreatment rates than the FD group with hazard ratios of 2.75 (1.30-5.82) and 2.52 (1.24-5.09), respectively. In addition, the coiling group with ≥10 coils and SAC group with ≥10 coils had significantly higher 1-year expenditures than the FD group with cost ratios (95% CI) of 1.30 (1.13-1.49) and 1.31 (1.15-1.50), respectively. CONCLUSION: In this national-level study, FDs demonstrated significantly lower retreatment rates and total expenditures than conventional coiling with ≥ 9 coils.

Metronidazole versus lactic acid for treating bacterial vaginosis (VITA): protocol for a randomised controlled trial to assess the clinical and cost effectiveness of topical lactic acid gel for treating second and subsequent episodes of bacterial vaginosis.

BACKGROUND: Bacterial vaginosis (BV) affects 30-50% of women at some time in their lives and is an embarrassing and distressing condition which can be associated with potentially serious comorbidities. Current antibiotic treatments such as metronidazole are effective but can result in side effects, and recurrence is common. This trial aims to investigate whether lactic acid gel is clinically effective and cost effective in the treatment of recurrent BV compared with metronidazole. METHODS: VITA is an open-label, multicentre, parallel group randomised controlled trial for women with a clinical diagnosis of BV and at least one previous BV episode in the past 2 years. Participants will be randomised 1:1 to intravaginal lactic acid gel 5 ml once daily for 7 days or oral metronidazole tablets 400 mg twice daily for 7 days. All participants will be followed up for 6 months to assess health status and healthcare costs. A subgroup will be interviewed to further explore adherence, tolerability and acceptability of treatment. The estimated sample size is 1900 participants to detect a 6% absolute increase in response rate to 86% in those receiving lactic acid gel. The primary outcome is participant-reported resolution of BV at Week 2. DISCUSSION: Results from this trial will help inform UK treatment guidelines for BV and may provide an alternative effective treatment for recurrent episodes of this condition which avoids repeated exposure to antibiotics. TRIAL REGISTRATION: ISRCTN, ISRCTN14161293. Registered on 8 September 2017.

Comparison of perioperative costs with fast-track vs standard endovascular aneurysm repair.

BACKGROUND: Perioperative health care utilization and costs in patients undergoing elective fast-track vs standard endovascular aneurysm repair (EVAR) remain unclear. METHODS: The fast-track EVAR group included patients treated with a 14 Fr stent graft, bilateral percutaneous access, no general anesthesia or intensive care monitoring, and next-day hospital discharge. The standard EVAR group was identified from Medicare administrative claims using a matching algorithm to adjust for imbalances in patient characteristics. Hospital outcomes included operating room time, intensive care monitoring, hospital stay, secondary interventions, and major adverse events (MAEs). Perioperative outcomes occurring from hospital discharge to 30 days postdischarge included MAE, secondary interventions, and unrelated readmissions. RESULTS: Among 1000 matched patients (250 fast-track; 750 standard), hospital outcomes favored the fast-track EVAR group, including shorter operating room time (2.30 vs 2.83 hrs, P<0.001), shorter hospital stay (1.16 vs 1.69 d, P<0.001), less need for intensive care monitoring (4.4% vs 48.0%, P<0.001), and lower secondary intervention rate (0% vs 2.4%, P=0.01). Postdischarge outcomes also favored fast-track EVAR with a lower rate of MAE (0% vs 7.2%, P<0.001) and all-cause readmission (1.6% vs 6.8%, P=0.001). The total cost to the health care system during the perioperative period was $26,730 with fast-track EVAR vs $30,730 with standard EVAR. Total perioperative health care costs were $4000 (95% CI: $3130-$4830) lower with fast-track EVAR vs standard EVAR, with $2980 in savings to hospitals and $1030 savings to health care payers. CONCLUSION: A fast-track EVAR protocol using a 14 Fr stent graft resulted in shorter procedure time, lower intensive care utilization, faster discharge, lower incidence of MAE, lower readmission rates, and lower perioperative costs compared to standard EVAR.

Cost-effectiveness analysis of endovascular versus open repair of abdominal aortic aneurysm in a high-volume center.

OBJECTIVE: Endovascular aneurysm repair (EVAR) for abdominal aortic aneurysms (AAAs) is the standard treatment for anatomically suitable patients. EVAR has been associated with a lower perioperative morbidity and mortality compared with open surgical repair (OSR) at the expense of increased reinterventions and costs. We aimed to compare the outcomes of EVAR and OSR for elective AAA repair. The primary end point was cost per QALY at 3 years. Secondary end points were perioperative morbidity and mortality; freedom from reintervention; length of hospital, high-dependency unit, and intensive care unit stay; and freedom from all-cause mortality. METHODS: The project was approved by the Galway Clinical Research Ethics Committee. This project followed the Declaration of Helsinki. This was an audit of interventions that had already taken place. No active clinical intervention was undertaken, and patients' anonymity was preserved; thus, individual patient consent was not obtained. Data on all elective AAA repairs at a tertiary referral vascular center were collected from 2002 to 2015. Demographics and outcomes were reported according to the Society for Vascular Surgery guidelines. QALY was measured on the basis of a quality-adjusted time without symptoms or toxicity assessment. Data were analyzed using parametric and nonparametric tests. RESULTS: Between 2002 and 2015, a total of 494 patients required elective AAA surgery; 401 underwent EVAR and 93 underwent OSR. Demographics and vascular-related risk factors were similar in both groups. Median (interquartile range) cost per QALY at 3 years was €5776 (€5541-€6481) for EVAR vs €7101 (€5812-€8952) for OSR (P < .001). EVAR was associated with reduced perioperative morbidity (12.2% vs 50%; P < .001). There was no significant association between procedure and perioperative mortality (EVAR, 1.7%; OSR, 4.3%; P = .130). There was no significant association found between the procedure and reintervention (P = .502). Our subgroup analysis found no association between procedure and improvement in all-cause mortality, QALYs, costs, or cost per QALY. CONCLUSIONS: EVAR is cost-effective with improved cost per QALY compared with OSR.

Cardiac implantable electronic device (CIED) infections are expensive and associated with prolonged hospitalisation: UK Retrospective Observational Study.

BACKGROUND: There are limited reports outlining the financial cost of treating cardiac implantable electronic device (CIED) infection outside the United States. This study aimed to determine the average treatment cost of CIED infection in a large UK tertiary referral centre and compared costs of different treatment pathways that are recognised in the management of CIED infection (early versus delayed re-implantation). METHODS: We retrospectively analysed cost and length of stay (LOS) data for consecutive patients undergoing infected CIED extraction with cardiac resynchronization therapy (CRT-D [with defibrillator], CRT-P [with pacemaker]), implantable cardioverter-defibrillators (ICDs) and permanent pacemakers (PPMs). RESULTS: Between January 2013 and March 2015, complete data was available for 84 patients (18 [21.4%] CRT-D, 24 [28.6%] ICDs and 42 [50.0%] PPMs). When all cases were considered the cost of infection ranged from £5,139 (PPM) to £24,318 (CRT-D). Considering different treatment strategies; 41 (48.8%) underwent CIED extraction and re-implantation during the same admission (early re-implant strategy (ER). 43 (51.2%) underwent extraction, but were then discharged home to be re-admitted for day-case re-implantation (delayed re-implant strategy (DR)). Median LOS was significantly shorter in DR compared to ER (5.0 vs. 18.0 days, p<0.001). The total cost of CIED infection episode was similar for both treatment strategies (median £14,241.48 vs. £14,741.70 including wearable defibrillator (Lifevest) and outpatient antibiotics costs, ER vs. DR; p = 0.491). CONCLUSION: CIED infections are expensive and associated with significant health-economic burden. When all device types were considered, a DR strategy is associated with reduced LOS without an increased cost penalty.

Sodium Nitrite-Mediated Cardioprotection in Primary Percutaneous Coronary Intervention for ST-Segment Elevation Myocardial Infarction: A Cost-Effectiveness Analysis.

OBJECTIVES: In the follow-up of patients in a trial of intracoronary sodium nitrite given during primary percutaneous coronary intervention (PCI) after acute myocardial infarction (AMI), we found a reduction in the incidence of major adverse cardiac events (MACEs). Specifically, MACE rates were 5.2% versus 25.0% with placebo at 3 years ( P = .013). Such MACE reductions should also be associated with economic benefit. Thus, we assessed the cost utility of sodium nitrite therapy versus standard primary PCI only. METHODS AND RESULTS: We developed a model to simulate costs and quality-adjusted life years (QALYs) over the first 36 months after ST-Segment Elevation Myocardial Infarction (STEMI). Decision tree analysis was used to assess different potential cardiovascular outcomes after STEMI for patients in both treatment groups. Model inputs were derived from the NITRITE-AMI study. Cost of comparative treatments and follow-up in relation to cardiovascular events was calculated from the United Kingdom National Health Service perspective. Higher procedural costs for nitrite treatment were offset by lower costs for repeat revascularization, myocardial infarction, and hospitalization for heart failure compared to primary PCI plus placebo. Nitrite treatment was associated with higher utility values (0.91 ± 0.19 vs 0.82 ± 0.30, P = .041). The calculated incremental cost-effectiveness ratio of £2177 per QALY indicates a cost-effective strategy. Furthermore, positive results were maintained when input parameters varied, indicating the robustness of our model. In fact, based on the difference in utility values, the cost of nitrite could increase by 4-fold (£2006 per vial) and remain cost-effective. CONCLUSION: This first analysis of sodium nitrite as a cardioprotective treatment demonstrates cost-effectiveness. Although more comparative analysis and assessment of longer follow-up times are required, our data indicate the considerable potential of nitrite-mediated cardioprotection.

Costs and outcomes in evaluating management of unhealed surgical wounds in the community in clinical practice in the UK: a cohort study.

OBJECTIVE: To evaluate the patient pathways and associated health outcomes, resource use and corresponding costs attributable to managing unhealed surgical wounds in clinical practice, from initial presentation in the community in the UK. METHODS: This was a retrospective cohort analysis of the records of 707 patients in The Health Improvement Network (THIN) database whose wound failed to heal within 4 weeks of their surgery. Patients' characteristics, wound-related health outcomes and healthcare resource use were quantified, and the total National Health Service (NHS) cost of patient management was estimated at 2015/2016 prices. RESULTS: Inconsistent terminology was used in describing the wounds. 83% of all wounds healed within 12 months from onset of community management, ranging from 86% to 74% of wounds arising from planned and emergency procedures, respectively. Mean time to healing was 4 months per patient. Patients were predominantly managed in the community by nurses and only around a half of all patients who still had a wound at 3 months were recorded as having had a follow-up visit with their surgeon. Up to 68% of all wounds may have been clinically infected at the time of presentation, and 23% of patients subsequently developed a putative wound infection a mean 4 months after initial presentation. Mean NHS cost of wound care over 12 months was £7300 per wound, ranging from £6000 to £13 700 per healed and unhealed wound, respectively. Additionally, the mean NHS cost of managing a wound without any evidence of infection was ~£2000 and the conflated cost of managing a wound with a putative infection ranged from £5000 to £11 200. CONCLUSION: Surgeons are unlikely to be fully aware of the problems surrounding unhealed surgical wounds once patients are discharged into the community, due to inconsistent recording in patients' records coupled with the low rate of follow-up appointments. These findings offer the best evidence available with which to inform policy and budgetary decisions pertaining to managing unhealed surgical wounds in the community.

An Economic Analysis of Stent Grafts for Treatment of Vascular Access Stenosis: Point-of-Care and Medicare Perspectives in the United States.

PURPOSE: To conduct an economic analysis on the impact of increased stent graft (SG) use for treatment of arteriovenous graft (AVG) anastomotic stenosis or arteriovenous fistula (AVF)/AVG in-stent restenosis (ISR) from United States point-of-care (POC) and Medicare perspectives. MATERIALS AND METHODS: The analyses compared initial device and reintervention costs over 2 years between current and projected treatment mixes, including percutaneous transluminal angioplasty (PTA), bare metal stents (BMSs), and SGs. In projected scenarios, the absolute increase in SG use was approximately 3%. Costs included procedure reimbursement rates (Medicare) and device list prices (POC) for index procedures and reinterventions. Reintervention rates and types were informed by the RENOVA and RESCUE randomized trials. Reinterventions were primarily PTA only; however, stent use occurred a proportion of the time. BMS reintervention rates were assumed to be identical to PTA based on observational data. A population size of 1,000 patients was assumed. RESULTS: To the POC (n = 1,000), increased SG use was predicted to result in cost savings ranging from $4,106 to $34,420 for AVG anastomotic stenosis. For AVF/AVG ISR, increased SG use was predicted to result in either a cost increase of $17,187 or a cost savings of $13,159. To Medicare (n = 1,000), increased SG use was predicted to save costs for both populations, with savings ranging from $57,401 to $169,544. CONCLUSIONS: The use of SG for treatment of AVG anastomotic stenosis and AVF/AVG ISR appears to be economically favorable for POC providers and Medicare. Further data on reintervention rates are required from other SG trials to validate findings.

Healthcare reconsultation in working-age adults following hospitalisation for community-acquired pneumonia.

Community-acquired pneumonia (CAP) is associated with prolonged symptom persistence during recovery. However, the effect of the residual symptom load on healthcare utilisation is unknown. The aim of this study was to quantify healthcare reconsultation within 28 days of hospital discharge for an index episode of CAP, and explore reasons for these reconsultations. Adults of working age admitted to any of four hospitals in the UK, with a primary diagnosis of CAP, were prospectively studied. Of 108 patients, 71 (65.7%) reconsulted healthcare services within 28 days of discharge; of these, 90.1% consulted their GP. Men were less likely to reconsult than women (adjusted odds ratio [aOR] 0.34, 95% confidence interval 0.13-0.91, p=0.032). Persistence of respiratory symptoms accounted for the majority of these reconsultations. Healthcare utilisation is high in working-age adults after an episode of hospitalised CAP and, in most cases, is due to failure to resolve index symptoms.

A cost-minimization analysis of large overjet reduction with two removable functional appliances based on a randomized controlled trial.

Objective: The purpose of this study was to assess and relate the societal costs of reducing large overjet with a prefabricated functional appliance (PFA), or a slightly modified Andresen activator (AA), using a cost-minimization analysis (CMA). Design, settings, and participants: A multicentre, prospective, randomized clinical trial was conducted with patients from 12 general dental practices. Ninety-seven patients with an Angle Class II, division 1 malocclusion, and an overjet of ≥6 mm were randomly allocated by lottery to treatment with either a PFA or an AA. The PFA and AA groups consisted of 57 and 40 subjects, respectively. Blinding was not performed. Duration of treatment, number of scheduled/unscheduled appointments, and retreatment were registered. Direct and indirect costs were analysed with reference to intention-to-treat (ITT), successful (S), and unsuccessful (US) outcomes. Societal costs were described as the total of direct and indirect costs, not including retreatments. Interventions: Treatment with a PFA or an AA. Results: The direct and societal costs were significantly lower for the PFA than for the AA group. The number of visits was lower in the PFA group, when ITT was considered, and for the US cases as well. No difference in retreatment rate could be seen between the groups. Limitations: Costs depend on local factors and thus should not be generalized to other settings. Harms: No harms were detected during the study. Conclusion: The success rate of the both appliances was low. However, the PFA was the preferred approach for reduction of a large overjet in mixed dentition, since it minimized costs and there were no difference in clinical outcomes between PFA and AA. Registration: This trial was registered at 'FoU i Sverige' (http://www.fou.nu/is/sverige), registration number: 97131. Protocol: The protocol was not published before trial commencement.

Anti-TNF Re-induction Is as Effective, Simpler, and Cheaper Compared With Dose Interval Shortening for Secondary Loss of Response in Crohn's Disease.

BACKGROUND AND AIMS: The optimal duration of dose-intensified therapy following secondary loss of response [LOR] to anti-tumour necrosis factor [TNF] therapy remains unclear. Anti-TNF re-induction involves a finite period of intensified therapy and may be a cost-effective means of re-capturing response. This study aimed to compare the efficacy, durability, and cost of anti-TNF re-induction and dose interval shortening [DIS] for secondary LOR in Crohn's disease [CD]. METHODS: This was a retrospective observational study in CD patients who developed secondary LOR to maintenance anti-TNF therapy, requiring subsequent re-induction and/or DIS. The primary outcome was treatment failure within 12 months. Secondary outcomes included factors associated with time to failure, disease activity, and incremental anti-TNF costs. RESULTS: Of 423 patients with CD on anti-TNF therapy, 80 [19%] developed secondary LOR, with 33 and 55 patients undergoing subsequent anti-TNF re-induction and DIS, respectively. There was no significant difference in the incidence of treatment failure at 12 months following re-induction and DIS, respectively [p = 0.27]. Factors predictive of a longer time to failure included a higher baseline serum albumin, male sex, and thiopurine co-therapy [each p < 0.05], whereas higher baseline faecal calprotectin was associated with shorter time to failure. There was no significant difference in clinical remission or objective disease activity across both groups. The median incremental cost of re-induction and DIS was AUD 4 838 and AUD 13 190, respectively. CONCLUSIONS: In patients with CD who develop secondary LOR, re-induction may represent an effective and less expensive first-line strategy, reserving dose intensification strategies such as DIS for non-responders.

The Impact of Cryoballoon Versus Radiofrequency Ablation for Paroxysmal Atrial Fibrillation on Healthcare Utilization and Costs: An Economic Analysis From the FIRE AND ICE Trial.

BACKGROUND: This study sought to assess payer costs following cryoballoon or radiofrequency current (RFC) catheter ablation of paroxysmal atrial fibrillation in the randomized FIRE AND ICE trial. METHODS AND RESULTS: A trial period analysis of healthcare costs evaluated the impact of ablation modality (cryoballoon versus RFC) on differences in resource use and associated payer costs. Analyses were based on repeat interventions, rehospitalizations, and cardioversions during the trial, with unit costs based on 3 national healthcare systems (Germany [€], the United Kingdom [£], and the United States [$]). Total payer costs were calculated by applying standard unit costs to hospital stays, using International Classification of Diseases, 10th Revision diagnoses and procedure codes that were mapped to country-specific diagnosis-related groups. Patients (N=750) randomized 1:1 to cryoballoon (n=374) or RFC (n=376) ablation were followed for a mean of 1.5 years. Resource use was lower in the cryoballoon than the RFC group (205 hospitalizations and/or interventions in 122 patients versus 268 events in 154 patients). The cost differences per patient in mean total payer costs during follow-up were €640, £364, and $925 in favor of cryoballoon ablation (P=0.012, 0.013, and 0.016, respectively). This resulted in trial period total cost savings of €245 000, £140 000, and $355 000. CONCLUSIONS: When compared with RFC ablation, cryoballoon ablation was associated with a reduction in resource use and payer costs. In all 3 national healthcare systems analyzed, this reduction resulted in substantial trial period cost savings, primarily attributable to fewer repeat ablations and a reduction in cardiovascular rehospitalizations with cryoballoon ablation. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Identifier: NCT01490814.

Impact of subsequent metastases on costs and medical resource use for prostate cancer patients initially diagnosed with localized disease.

BACKGROUND: The impact of subsequent metastases on costs and medical resource use (MRU) for prostate cancer (PC) patients initially diagnosed with localized disease was estimated. METHODS: Surveillance, Epidemiology, and End Results data, linked to Medicare (1999-2012), were used to identify 7482 patients diagnosed with subsequent metastases 12 months or more after the initial diagnosis of localized PC (cases), and they were matched to 25,709 localized PC patients without subsequent metastases (controls). Patients were followed for costs and MRU from 12 months before their index date (subsequent metastases or a matched date for controls) up to 12 months after it. Costs and MRU were stratified by the setting/type of care/service. Multivariate mixed effects regression analyses were used to construct and compare longitudinal trajectories of marginal predicted costs and predicted probabilities of MRU between cases and controls. RESULTS: Among the controls, predicted monthly costs remained relatively stable throughout the entire observation period (weighted mean per patient per month, $2746; range during 24 months, $2603-2858). In contrast, among the cases, costs increased from $2622 (95% confidence interval [CI], $2525-2719) 12 months before the diagnosis of subsequent metastases to $4767 (95% CI, $4623-4910) 1 month before the diagnosis of subsequent metastases, peaked during the month of metastases at $13,291 (95% CI, $13,148-13,435), and remained significantly higher than costs for the controls thereafter (eg, $4677 at + 12 months; 95% CI, $4549-4805). Costs and MRU increased across a wide range of settings/types, including inpatient, outpatient, home health, and hospice settings. CONCLUSIONS: In PC patients initially diagnosed with localized disease, a diagnosis of subsequent metastases is associated with substantially increased costs and MRU. Cancer 2017;123:3591-601. © 2017 American Cancer Society.

Early discharge compared with ordinary discharge after percutaneous coronary intervention - a systematic review and meta-analysis of safety and cost.

AIM: We aimed to summarize the pooled effect of early discharge compared with ordinary discharge after percutaneous coronary intervention (PCI) on the composite endpoint of re-infarction, revascularization, stroke, death, and incidence of rehospitalization. We also aimed to compare costs for the two strategies. METHODS: The study was a systematic review and a meta-analysis of 12 randomized controlled trials including 2962 patients, followed by trial sequential analysis. An estimation of cost was considered. Follow-up time was 30 days. RESULTS: For early discharge, pooled effect for the composite endpoint was relative risk of efficacy (RRe)=0.65, 95% confidence interval (CI) (0.52-0.81). Rehospitalization had a pooled effect of RRe=1.10, 95% CI (0.88-1.38). Early discharge had an increasing risk of rehospitalization with increasing frequency of hypertension for all populations, except those with stable angina, where a decreasing risk was noted. Advancing age gave increased risk of revascularization. Early discharge had a cost reduction of 655 Euros per patient compared with ordinary discharge. CONCLUSION: The pooled effect supports the safe use of early discharge after PCI in the treatment of a heterogeneous population of patients with coronary artery disease. There was an increased risk of rehospitalization for all subpopulations, except patients with stable angina. Clinical trials with homogeneous populations of acute coronary syndrome are needed to be conclusive on this issue.

Different challenges, different approaches and related expenditures of community-based tuberculosis activities by international non-governmental organizations in Myanmar.

BACKGROUND: International non-governmental organizations (INGOs) have been implementing community-based tuberculosis (TB) care (CBTBC) in Myanmar since 2011. Although the National TB Programme (NTP) ultimately plans to take over CBTBC, there have been no evaluations of the models of care or of the costs of providing CBTBC in Myanmar by INGOs. METHODS: This was a descriptive study using routinely-collected programmatic and financial data from four INGOs during 2013 and 2014, adjusted for inflation. Data analysis was performed from the provider perspective. Costs for sputum examination were not included as it was provided free of charge by NTP. We calculated the average cost per year of each programme and cost per patient completing treatment. RESULTS: Four INGOs assisted the NTP by providing CBTBC in areas where access to TB services was challenging. Each INGO faced different issues in their contexts and responded with a diversity of strategies. The total costs ranged from US$ 140 754 to US$ 550 221 during the study period. The cost per patient completing treatment ranged from US$ 215 to US$ 1 076 for new cases and US$ 354 to US$ 1 215 for retreatment cases, depending on the targeted area and the package of services offered. One INGO appeared less costly, more sustainable and patient oriented than others. CONCLUSIONS: This study revealed a wide variety of models of care and associated costs for implementing CBTBC in diverse and challenging populations and contexts in Myanmar. Consequently, we recommend a more comprehensive evaluation, including development of a cost model, to estimate the costs of scaling up CBTBC country-wide, and cost-effectiveness studies, to best inform the NTP as it prepares to takeover CBTBC activities from INGOs. While awaiting evidence from these studies, model of CBTBC that have higher sustainability potential and allocate more resources to patient-centered care should be given priority support.

Contemporary economic and clinical evaluations of endovascular repair for intact descending thoracic aortic aneurysms.

BACKGROUND: The aim of this study was to assess clinical and contemporary costs associated with elective endovascular repair of intact descending thoracic aortic aneurysms (DTAA) into the mid-term follow-up. METHODS: A retrospective review of a prospectively maintained clinical database including 29 consecutive patients from July 2005 to December 2009 treated with elective endovascular repair (TEVAR) or TEVAR and surgical infrarenal repair (hybrid) of intact DTAA was performed. Mean age was 74.5 years old (±7.1). Primary clinical endpoints include mortality and major morbidity. Additionally a comprehensive economic appraisal of individual in-hospital and follow-up costs was executed. Economic endpoints include in-hospital and follow-up costs and patient discharge status. Elective endovascular and open repairs' clinical and economical outcomes in contemporary literature were assessed for comparison according to PRISMA standards. RESULTS: Immediate mortality was 6.9% (1/24 TEVAR and 1/5 hybrid). Three respiratory complications were recorded (11%; 2 TEVAR, 1 hybrid). Renal and cardiac complication rates were 7.4% (1 TEVAR, 1 hybrid) and 3.7% (1 TEVAR) respectively. Routine discharge home was achieved for 85% of patients (95.7% TEVAR, 25% hybrid). Three endoleaks were treated throughout the follow-up (2 TEVAR, 1 hybrid; mean 30.4 mo, ±19.9) rendering an 11% (3/27) reintervention rate. Average immediate cost was €21,976.87 for elective endovascular repair and €33,783.21 for elective endovascular hybrid repair. Additional reintervention and routine follow-up costs augmented immediate costs by 12.4%. CONCLUSIONS: This study supports satisfying immediate clinical outcomes for TEVAR and TEVAR+surgical infrarenal procedures. Although limited by a small population size and difficulties in economic comparisons, this study presents the real world social and economic cost scenario for both elective TEVAR and TEVAR hybrid treatment of DTAA of both the in-hospital and at mid term follow-up periods.