Intravascular Ultrasound Guidance During Peripheral Vascular Interventions: Long-term Clinical Outcomes and Costs From the Japanese Perspective.

PURPOSE: The value of intravascular ultrasound (IVUS) guidance during peripheral vascular revascularization procedures is incompletely understood. Moreover, data on long-term clinical outcomes and costs are limited. The objective of this study was to compare outcomes and costs between IVUS and contrast angiography alone in patients undergoing peripheral revascularization procedures in Japan. MATERIALS AND METHODS: This retrospective comparative analysis was performed using the Japanese Medical Data Vision insurance claims database. All patients undergoing revascularization for peripheral artery disease (PAD) between April 2009 and July 2019 were included. Patients were followed until July 2020, death, or a subsequent revascularization procedure for PAD. Two patient groups were compared: one undergoing IVUS imaging or the other contrast angiography alone. The primary end point was major adverse cardiac and limb events, including all-cause-mortality, endovascular thrombolysis, subsequent revascularization procedures for PAD, stroke, acute myocardial infarction, and major amputations. Total health care costs were documented over the follow-up and compared between groups, using a bootstrap method. RESULTS: The study included 3956 patients in the IVUS group and 5889 in the angiography alone group. Intravascular ultrasound was significantly associated with reduced risk of a subsequent revascularization procedure (adjusted hazard ratio: 0.25 [0.22-0.28]) and major adverse cardiac and limb events (0.69 [0.65-0.73]). The total costs were significantly lower in the IVUS group, with a mean cost saving over follow-up of $18 173 [$7 695-$28 595] per patient. CONCLUSION: The use of IVUS during peripheral revascularization provides superior long-term clinical outcomes at lower costs compared with contrast angiography alone, warranting wider adoption and fewer barriers to IVUS reimbursement for patients with PAD undergoing routine revascularization. CLINICAL IMPACT: Intravascular ultrasound (IVUS) guidance during peripheral vascular revascularization has been introduced to improve the precision of the procedure. However, questions over the benefit of IVUS in terms of long-term clinical outcome and over cost have limited its use in everyday clinical practice. This study, performed in a Japanese health insurance claims database, demonstrates that use of IVUS provides a superior clinical outcome over the long term at a lower cost compared to angiography alone. These findings should encourage clinicians to use IVUS in routine peripheral vascular revascularization procedures and encourage providers to reduce barriers to use.

The cost-effectiveness of guideline-driven use of drug-eluting stents: propensity-score matched analysis of a seven-year multicentre experience.

Background: In routine clinical practice, the implantation of a drug-eluting stent (DES) versus a bare metal stent (BMS) for percutaneous coronary intervention (PCI) has been guided by criteria for appropriate use. The cost-effectiveness (CE) of adopting these guidelines, however, is not clear, and was investigated from the perspective of the Australian healthcare payer.Methods and results: Baseline and 12-month follow-up data of 12,710 PCI patients enrolled in the Melbourne Interventional Group (MIG) registry between 2004 and 2011 were analysed. Costs inputs were derived from a clinical costing database and published sources. Propensity-score-matching was performed for DES and BMS groups within sub-groups. Incremental cost-effectiveness ratios (ICERs) were evaluated for all patients, and sub-groups of patients with '0', 1, 2, or ≥3 indications for a DES. The incremental cost per target vessel revascularization avoided for the overall population was $24,683, and for patients with 0, 1, and 2 indications for a DES was $44,635, $33,335, and $23,788, respectively. However, for those with >3 indications, DES compared with BMS was associated with cost savings. At willingness to pay thresholds of $45,000-$75,000, the probability of cost-effectiveness of DES for the overall cohort was 71-91%, '0' indications, 49-67%, 1 indication, 56-82%, 2 indications, 70-90%, and ≥3 indications, 97-99%.Conclusions: The cost-effectiveness of DES compared with BMS increased with increasing risk profile of patients from those who had 1, 2, to ≥3 indications for a DES. When compared with BMS, DES was least cost effective among patients with '0' indications for a DES. Based on these results, selective use of DES implantation is supported. These findings may be useful for evidence-based clinical decision-making.

The Real-World Cost-Effectiveness of Coronary Artery Bypass Surgery Versus Stenting in High-Risk Patients: Propensity Score-Matched Analysis of a Single-Centre Experience.

BACKGROUND: There are limited economic evaluations comparing coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI) for multi-vessel coronary artery disease (MVCAD) in contemporary, routine clinical practice. OBJECTIVE: The aim was to perform a cost-effectiveness analysis comparing CABG and PCI in patients with MVCAD, from the perspective of the Australian public hospital payer, using observational data sources. METHODS: Clinical data from the Melbourne Interventional Group (MIG) and the Australian and New Zealand Society of Cardiac and Thoracic Surgeons (ANZSCTS) registries were analysed for 1022 CABG (treatment) and 978 PCI (comparator) procedures performed between June 2009 and December 2013. Clinical records were linked to same-hospital admissions and national death index (NDI) data. The incremental cost-effectiveness ratios (ICERs) per major adverse cardiac and cerebrovascular event (MACCE) avoided were evaluated. The propensity score bin bootstrap (PSBB) approach was used to validate base-case results. RESULTS: At mean follow-up of 2.7 years, CABG compared with PCI was associated with increased costs and greater all-cause mortality, but a significantly lower rate of MACCE. An ICER of $55,255 (Australian dollars)/MACCE avoided was observed for the overall cohort. The ICER varied across comparisons against bare metal stents (ICER $25,815/MACCE avoided), all drug-eluting stents (DES) ($56,861), second-generation DES ($42,925), and third-generation of DES ($88,535). Moderate-to-low ICERs were apparent for high-risk subgroups, including those with chronic kidney disease ($62,299), diabetes ($42,819), history of myocardial infarction ($30,431), left main coronary artery disease ($38,864), and heart failure ($36,966). CONCLUSIONS: At early follow-up, high-risk subgroups had lower ICERs than the overall cohort when CABG was compared with PCI. A personalised, multidisciplinary approach to treatment of patients may enhance cost containment, as well as improving clinical outcomes following revascularisation strategies.

Cost-Effectiveness of Pediatric Cochlear Implantation in Rural China.

OBJECTIVES: To evaluate the cost utility of cochlear implantation (CI) for severe to profound sensorineural hearing loss (SNHL) among children from rural settings in P.R. China (China). RESEARCH DESIGN: A cost-utility analysis (CUA) was undertaken using data generated from a single-center substudy of the Cochlear Pediatric Implanted Recipient Observational Study (Cochlear P-IROS). The data were projected over a 20-year time horizon using a decision tree model. SETTING: The Chinese healthcare payer and patient perspectives were adopted. INTERVENTION: Unilateral CI of children with a severe-to-profound SNHL compared with their preimplantation state of no treatment or amplification with hearing aids ("no CI" status). MAIN OUTCOME MEASURE/S: Incremental costs per quality adjusted life year (QALY) gained. RESULTS: The mean total discounted cost of unilateral CI was CNY 252,506 (37,876 USD), compared with CNY 29,005 (4,351 USD) for the no CI status from the healthcare payer plus patient perspective. A total discounted benefit of 8.9 QALYs was estimated for CI recipients compared with 6.7 QALYs for the no CI status. From the healthcare payer plus patient perspective, incremental cost-effectiveness ratio (ICER) for unilateral CI compared with no CI was CNY 100,561 (15,084 USD) per QALY. The healthcare payer perspective yielded an ICER of CNY 40,929 (6,139 USD) per QALY. Both ICERs fell within one to three times China's gross domestic product per capita (GDP, 2011-2015), considered "cost-effective" by World Health Organization (WHO) standards. CONCLUSIONS: Treatment with unilateral CI is a cost-effective hearing solution for children with severe to profound SNHL in rural China. Increased access to mainstream education and greater opportunities for employment, are potential downstream benefits of CI that may yield further societal and economic benefits. CI may be considered favorably for broader inclusion in medical insurance schemes across China.

A systematic review of cost-effectiveness of percutaneous coronary intervention vs. surgery for the treatment of multivessel coronary artery disease in the drug-eluting stent era.

Aims: The suitability of percutaneous coronary intervention (PCI), compared with coronary artery bypass grafting (CABG), for patients with complex multivessel coronary artery disease (MVCAD) remains a contentious topic. While the body of evidence regarding the clinical effectiveness of these revascularization strategies is growing, there is limited evidence concerning their long-term cost-effectiveness. We aim to critically appraise the body of literature investigating the cost-effectiveness of CABG compared with PCI using stents, and to assess the quality of the economic evidence available. Methods and results: A systematic review was performed across six electronic databases; Medline, Embase, the NHS Economic Evaluation Database, the Database of Abstracts of Reviews of Effects, the health technology assessment database, and the Cochrane Library. All studies comparing economic attractiveness of CABG vs. PCI using bare-metal stents (BMS) or drug-eluting stents (DES) in balanced groups of patients were considered. Sixteen studies were included. These comprised studies of conventional CABG vs. BMS (n = 8), or DES (n = 4); off-pump CABG vs. BMS (n = 2), or DES (n = 1); and minimally invasive direct CABG vs. BMS (n = 2). The majority adopted a healthcare payer perspective (n = 14). The incremental cost-effectiveness ratios (ICERs) reported across studies varied widely according to perspective and time horizon. Favourable lifetime ICERs were reported for CABG in three trials. For patients with left main coronary artery disease, however, DES was reported as the dominant (more effective and cost-saving) strategy in one study. Conclusion: Overall, CABG rather than PCI was the favoured cost-effective treatment for complex MVCAD in the long term. While the evidence base for the cost-effectiveness of DES compared with CABG is growing, there is a need for more evaluations adopting a societal perspective, and time horizons of a lifetime or 10 or more years.

One-year experience with the Cochlear™ Paediatric Implanted Recipient Observational Study (Cochlear P-IROS) in New Delhi, India.

BACKGROUND: Currently, there is a significant lack of data concerning long-term outcomes following paediatric cochlear implantation in terms of quality of life. There is a need for a long-term, prospective study in this regard. This study aims at highlighting the preliminary results, one year post surgery of a five year prospective study. METHODS: The Cochlear™ Paediatric Implanted Recipient Observational Study (P-IROS) is a prospective, patient outcomes registry for routinely implanted children. The study collects data using questionnaires post-surgery and at regular intervals up to five years. RESULTS: At our Centre, 159 cochlear implant surgery procedures were carried out between January 2014 and December 2014. Category of Auditory Performance II score increased from '0' to '3' at six months and to '5' at 12 months for children aged 0-3 years, although this was not statistically significant. However, the same trend was statistically significant for the age 3-6 year and age 6-10 year brackets. The quality of life of the child improved significantly. Analysis of communication mode revealed a statistically significant overall shift to the auditory-oral mode from total communication. CONCLUSION: Cochlear implantation is a life-changing intervention. The evidence in support of what it can achieve safely is clear. However, the costs associated with it raise the question if it will remain an effective option for life in all children. The Cochlear P-IROS is an attempt to answer the same over a five year period. Our study in New Delhi, so far concludes that cochlear implantation in a population with limited access to funds is very effective, one year after surgery.

A global patient outcomes registry: Cochlear paediatric implanted recipient observational study (Cochlear(™) P-IROS).

BACKGROUND: Currently, there is a paucity of data concerning the long-term outcomes, educational placement and quality of life of children implanted with hearing devices from large and representative samples of the population. To address this concern, a large, prospective, multicentre, multinational patient-outcomes registry for paediatric recipients of implantable hearing devices was developed. The benefits of this registry, its approach and methodology are described. METHODS/DESIGN: The Cochlear(™) Paediatric Implanted Recipient Observational Study (Cochlear P-IROS) is a prospective international patient-outcomes registry for children who are implanted in routine clinical practice with one or more hearing devices. The study aims to collect data on patient comorbidities, device use, auditory performance, quality of life and health-related utilities, across different types of implantable hearing devices from a range of manufacturers. Patients will be evaluated with a set of standardised and non-standardised questionnaires prior to initial device activation (baseline) and at six-monthly follow-up intervals up to 24 months and annually thereafter. The Cochlear P-IROS utilises a secure web interface to administer electronic case report forms to clinicians and families of implanted children. The web interface is currently available in five languages: English, Japanese, Korean, Mandarin and Russian. The interface also provides printable versions of the case report forms translated into 22 local languages for collection of data prior to entry online; additional languages may be added, as required. Participation in the Cochlear P-IROS registry is investigator-driven and voluntary. To date, the Cochlear P-IROS has recruited implant clinics across Australia, China, India, Indonesia, Turkey and Vietnam. The registry also aims to recruit multiple clinics in Cuba, Israel, Japan, Malaysia, Singapore, South Africa, South Korea and Russia. DISCUSSION: The use of a registry such as the Cochlear P-IROS will generate valuable data to support research interests of academics and clinicians around the globe. The data generated will be relevant for a wide range of stakeholders including regulators, payers, providers, policy makers, patients and their families, each with a different perspective for the acceptance and adoption of implantable hearing devices for the treatment of hearing loss.

Prolonged effectiveness of coronary artery bypass surgery versus drug-eluting stents in diabetics with multi-vessel disease: an updated systematic review and meta-analysis.

BACKGROUND: Currently, the appropriateness of percutaneous coronary intervention (PCI) using drug-eluting stents (DES) versus coronary artery bypass grafting (CABG) for patients with diabetes (DM) and multi-vessel disease (MVD) is uncertain due to limited evidence from few randomised controlled trials (RCTs). We aimed to compare the clinical effectiveness of CABG versus PCI-DES in DM-MVD patients using an evidence-based approach. METHODS: A systematic review and meta-analyses were conducted to compare the risk of all-cause mortality, myocardial infarction (MI), repeat revascularisation, cerebrovascular events (CVE), and major adverse cardiac or cerebrovascular events (MACCE). RESULTS: A total of 1,837 and 3,052 DM-MVD patients were pooled from four RCTs (FREEDOM, SYNTAX, VA CARDS, and CARDia) and five non-randomised studies. At mean follow-up of 3 years, CABG compared with PCI-DES was associated with a lower risk of all-cause mortality and MI in RCTs. By contrast, no significant differences were observed in the mean 3.5-year risk of all-cause mortality and MI in non-randomised trials. However, the risk of repeat revascularisations following PCI-DES compared with CABG was 2.3 (95% CI=1.8-2.8) and 3.0 (2.3-4.2)-folds higher in RCTs and non-randomised trials, respectively. Accordingly, the risk of MACCE at 3 years following CABG compared with PCI-DES was lower in both RCTs and non-randomised trials [0.65 (: 0.55-0.77); and 0.77 (0.60-0.98), respectively]. CONCLUSIONS: Based on our pooled results, we recommend CABG compared with PCI-DES for patients with DM-MVD. Although non-randomised trials suggest no additional survival-, MI-, and CVE- benefit from CABG over PCI-DES, these results should be interpreted with care.

Cardiovascular readmissions and excess costs following percutaneous coronary intervention in patients with chronic kidney disease: data from a large multi-centre Australian registry.

BACKGROUND: Chronic kidney disease (CKD) is a well-established risk factor for adverse events in patients undergoing percutaneous coronary intervention (PCI). However, few data exists on the subsequent healthcare resource use and related incremental costs in this patient subgroup. The present study compares the rates of cardiac-related hospitalisations and the associated direct costs, post-PCI in patients with and without CKD. METHODS: Healthcare costs were estimated for 12,998 PCI patient-procedures from the Melbourne Interventional Group (MIG) registry, collected between February 2004 and October 2010. Information collected included the use of cardiovascular drugs and cardiac-related hospitalisations from those that completed 12-month follow-up. Individual patients were assigned unit costs based on published data from the National Hospital Cost Data Collection for Admissions in Victoria (2008-2009) and the Pharmaceutical Benefit Scheme (PBS) schedule (2011-2012). Bootstrap multiple linear regression was used to estimate the direct excess healthcare costs, adjusting for age and gender and relevant comorbidities. RESULTS: Excess cardiac-related readmissions occurred among patients with "severe CKD or dialysis" (estimated glomerular filtration rate (eGFR): <30 ml/min/1.73 m(2); n = 330; 35%), compared to "moderate CKD" (eGFR: 30-60 ml/min/1.73 m(2); n = 2648; 28%), or the "referent CKD status" (eGFR: ≥ 60 ml/min/1.73 m(2); n = 10,020; 24%). On average, excess (95%CI) overall direct costs were significantly higher in patients with severe CKD or dialysis compared to those with referent CKD status [$AUD 2206 ($AUD 1148 to 3688)]. CONCLUSIONS: From the healthcare payer's perspective, PCI patients with severe CKD compared to no-CKD imposed significantly higher burden on subsequent healthcare resources. Hospitalisations accounted for the majority of these expenditures.

An Australian risk prediction model for determining early mortality following aortic valve replacement.

OBJECTIVE: To develop a multivariable logistic risk model for predicting early mortality following aortic valve replacement (AVR) in adults, and to compare its performance against existing AVR-dedicated models. METHODS: Prospectively collected data from the Australasian Society of Cardiac and Thoracic Surgeons (ASCTS) database project were used. Thirty-five preoperative variables from AVR literature were considered for analysis by chi-square method and multiple logistic regression. Using the bootstrap re-sampling technique for variable selection, five plausible models were identified. Based on models' calibration, discrimination and predictive capacity during n-fold validation, a final model, the AVR-Score, was chosen. An additive score, derived from the final model, was also validated externally in a consecutive cohort. The performance of AVR-dedicated risk models from the North West Quality Improvement Program (NWQIP) and the Northern New England Cardiovascular Study (NNE) groups were also assessed using the receiver operating characteristic (ROC) curve and the Hosmer-Lemeshow (H-L) chi-square test. RESULTS: Between July 2001 and June 2008, a total of 3544 AVR procedures were performed. Early mortality was 4.15%. The AVR-Score contained the following predictors: age, New York Heart Association class, left main disease, infective endocarditis, cerebrovascular disease, renal dysfunction, previous cardiac surgery and estimated ejection fraction. Our final model (AVR-Score) obtained an average area under ROC curve of 0.78 (95% confidence interval (CI): 0.76, 0.80) and an H-L p-value of 0.41 (p>0.05) during internal validation, indicating good discrimination and calibration capacity. External validation of the additive score on a consecutive cohort of 1268 procedures produced an ROC of 0.73 (0.62, 0.84) and an H-L p-value of 0.48 (p>0.05). The NWQIP and NNE risk models achieved acceptable discrimination of ROC of 0.77 (0.73, 0.81). However, both models obtained H-L p-values of 0.002 (p<0.05), indicating a poor fit in our cohort. CONCLUSION: Existing AVR-dedicated risk models were deemed inappropriate for risk prediction in the Australian population. A preoperative risk model was developed using prospective data from a contemporary AVR cohort.