Periprocedural management of direct oral anticoagulants in patients with atrial fibrillation and active cancer.

BACKGROUND: Cancer and atrial fibrillation (AF) are common concurrent disorders. Direct oral anticoagulants (DOACs) are prescribed to prevent stroke in patients with AF. Patients with cancer often undergo invasive procedures for diagnostic or therapeutic purposes, necessitating interruption of anticoagulation. There are limited data to guide best periprocedural anticoagulation management practices in the setting of active cancer. OBJECTIVES: To describe patient characteristics, periprocedural management, and clinical outcomes in DOAC-treated patients with AF according to active cancer status. METHODS: We conducted descriptive and comparative analyses using data from the PAUSE study. Multivariable logistic regression was used to determine whether active cancer status was an independent risk factor for bleeding outcomes. Covariates were selected a priori based on biological rationale and preexisting knowledge. RESULTS: Patients with active cancer were older (P < .001), more likely to be thrombocytopenic (P = .026), have moderate renal dysfunction (P = .005), and more likely to receive low-dose DOAC therapy (P < .001). A greater proportion of patients with active cancer underwent a high-bleed-risk procedure (P < .001), with longer periprocedural DOAC-interruption intervals (P <.001) and lower preprocedural residual DOAC levels (P = .002). Active cancer was an independent predictor for surgical major bleeding (OR = 2.45; 95% CI, 1.08-5.14) after adjusting for study center, procedure category and bleed risk, thrombocytopenia, hypertension, and the use of a P2Y12 inhibitor. CONCLUSIONS: Active cancer status is associated with an increased risk of surgical major bleeding among DOAC-treated patients with AF undergoing interruption of anticoagulation for elective invasive procedures.

Embolization of parastomal and small bowel ectopic varices utilizing a transhepatic antegrade approach: A case series.

Background: The ideal approach to managing parastomal and small bowel ectopic varices (EVs) is yet to be established. Purpose: To evaluate outcomes following percutaneous antegrade transhepatic venous obliteration (PATVO) in patients presenting with bleeding from parastomal or small bowel EVs. Material and Methods: A case series of 12 patients presenting with active or recurrent bleeding from parastomal or small bowel EVs who underwent 17 PATVO interventions at our tertiary care institution was performed. Data extraction from electronic medical records included baseline characteristics and procedural details. Endpoints included technical success, early clinical success, and re-bleeding. Results: Technical success was 100% (n = 17), and early clinical success was 82.3% (n = 14). No patient experienced any intra- or post-operative complications. Rebleed rates after initial PATVO in patients who achieved early clinical success was as follows: 3-month, 0% (n = 0); 6-month, 20% (n = 2); 12-month, 20% (n = 2). Rebleed rates after all PATVO procedures (including patients undergoing repeat procedures) that achieved early clinical success were as follows: 3-month, 0% (n = 0); 6-month, 14% (n = 2; 12-month, 14% (n = 2). All patients with re-bleeding required reintervention with either PATVO, transjugular intrahepatic portosystemic shunt (TIPS) or both. Conclusion: PATVO can be safely performed to treat bleeding from parastomal and small bowel EVs. In patients who present with recurrent bleeding despite PATVO, TIPS with/without embolization of bleeding varices remains a valid option as described by the literature.

Safety of High-Dose 3% Sodium Tetradecyl Sulfate for Sclerotherapy of Renal Cysts in Patients with Autosomal Dominant Polycystic Kidney Disease.

This study assessed the safety profile of high-volume (>10 mL) 3% sodium tetradecyl sulfate (STS) sclerotherapy for the treatment of renal cysts in patients with autosomal dominant polycystic kidney disease. A total of 211 sclerotherapy treatments were performed in 169 patients over a 5-year period, with a comparison of 2 patient cohorts based on the STS volumes used. The first cohort (n = 112) received a high volume (greater than 10 mL) of STS, and the second cohort (n = 57) received a low volume (less than 10 mL). The minor adverse event rate for the cohorts was 14.5% and 9.6%, respectively (P = .310), with postprocedure pain being the most common event. One major adverse event occurred, for which the patient required hospitalization for infection after low-volume STS treatment. Doses of STS higher than those currently recommended by the Food and Drug Administration for intravascular use allow large renal cysts to be treated safely in the setting of autosomal dominant polycystic kidney disease.

Image-Guided Percutaneous Biopsy for Pancreatic Lesions: 10-Year Experience in a Tertiary Cancer Center.

INTRODUCTION: Image-guided biopsy is an important tool in the diagnosis of solid pancreatic masses. This study aims to evaluate the accuracy and complications associated with this procedure. METHODS: We conducted a retrospective cohort study of all patients referred to interventional radiology for pancreatic biopsy at our institution from July 2004-July 2015. Two radiologists independently reviewed the images, technical aspects, and clinical characteristics. RESULTS: A total of 82 patients underwent pancreatic biopsy using a combination of computed tomography (CT) and/or ultrasound guidance. Mean age was 67.8 years with 56% males. Most lesions were located in the head (63.4%), followed by the tail (19.5%), and the body (17.1%). The procedures were performed using the anterior (79.3%), lateral (7.3%), or posterior (13.4%) approach, with direct access in 85.4% of the patients and indirect access (transgastric or transhepatic) in 14.6% of cases. Core biopsies were obtained in 81.7% of cases, and fine needle aspiration was performed in 18.3% of cases. Needle size varied from 18-22 gauge (median 20 gauge). The median number of samples collected was 3 (range 1-8). A conclusive result was obtained in 82.9% of cases. There were 9 (11%) patients with minor complications: minor bleeding, pain, and inadvertent bowel puncture with no clinical repercussion. There were no deaths or major complications. CONCLUSION: Percutaneous image-guided pancreatic mass biopsy can be performed safely with excellent accuracy. Our results are comparable with endoscopic biopsy/aspiration, and percutaneous biopsy may be used as an alternative, particularly at institutions where endoscopy facilities are limited.

Cost utility of fractional flow reserve-guided percutaneous coronary intervention in multivessel coronary artery disease in Brazil.

OBJECTIVE: The fractional flow reserve (FFR) versus angiography for multivessel evaluation (FAME) study has demonstrated that FFR substantially reduces major adverse cardiac events and resource utilization in coronary artery disease (CAD) patients. We aimed to assess the cost utility of FFR in percutaneous coronary interventions (PCI) from the perspective of the Brazilian Public Health System (SUS). DESIGN: Patient-level cost-utility analysis along the FAME study. PARTICIPANTS: Multivessel coronary artery disease patients. INTERVENTION: PCI, either guided by FFR or by angiography alone. SETTING: The procedure costs were based on the mean amount of unitary resource utilization multiplied by the costs from SUS reimbursement list. The utilities were derived using Brazilian weights for time trade-off European Quality of Life-5 Dimensions. The World Health Organization recommendation based on gross domestic product per capita (international dollars [I$] 35 876/quality-adjusted life year [QALY]) was used as willingness-to-pay threshold. MAIN OUTCOME MEASURE: We determined the incremental cost-utility ratio (ICUR) in I$ per QALY gained during the 1-year time horizon. RESULTS: One-year costs were I$ 8931 for the angiography-guided PCI and I$ 8968 for the FFR-guided PCI, resulting in an incremental cost of I$ 37. Effectiveness during 1 year was 0.798 QALYs for angiography-guided PCI and 0.811 for FFR-guided PCI, resulting in an incremental effectiveness of 0.013 QALYs. The base-case ICUR of FFR versus angiography-guided PCI was 2780 I$/QALY. Cost-saving results are achieved with a FFR price reduction of at least 2.2%. CONCLUSIONS: Developing countries should give attention to strategies proven to be cost-effective in other health systems. In our analysis, FFR-guided PCI is very cost-effective in the Brazilian SUS and with a minimal price reduction of the device, FFR could be cost saving.

Toronto PowerWire fenestration technique to access false lumen branches in fenestrated endovascular aneurysm repair for chronic type B dissection.

Chronic type B aortic dissection with aneurysmal degeneration requiring intervention presents significant therapeutic challenges. Thoracic endovascular aortic repair with a fenestrated endograft is a feasible option, but false lumen branches without an adjacent re-entry or perforation in the septum can pose a significant challenge. We present two cases of fenestrated endovascular aneurysm repair for chronic type B aortic dissection in which a renal artery from the false lumen was cannulated by creating a "neofenestration" through the dissection flap using a radiofrequency PowerWire (Baylis Medical Inc, Montreal, Quebec, Canada) technique (Toronto PowerWire fenestration technique).

Contemporary Context of Drug-Eluting Stents in Brazil: A Cost Utility Study.

BACKGROUND: Although drug-eluting stents (DES) have been widely incorporated into clinical practice in developed countries, several countries restrict their use mainly because of their high cost and unfavorable incremental cost-effectiveness ratios (ICER). OBJECTIVE: To evaluate the cost-effectiveness of DES in comparison with bare-metal stents (BMS) for treatment of coronary artery disease (CAD). DESIGN: Markov model. DATA SOURCES: Published literature, government database, and CAD patient cohort. TARGET POPULATION: Single-vessel CAD patients. TIME HORIZON: One year and lifetime. PERSPECTIVE: Brazilian Public Health System (SUS). INTERVENTION: Six strategies composed of percutaneous intervention with a BMS or 1 of 5 DES (paclitaxel, sirolimus, everolimus, zotarolimus, and zotarolimus resolute). OUTCOME MEASURES: Cost for target vessel revascularization avoided and cost for quality-adjusted life year gained. BASE CASE ANALYSIS: In the short-term analysis, sirolimus was the most effective and least costly among DES (ICER of I$20,642 per target vessel revascularization avoided), with all others DES dominated by sirolimus. Lifetime cumulative costs ranged from I$18,765 to I$21,400. In the base case analysis, zotarolimus resolute had the most favorable ICER among the DES (ICER I$62,761), with sirolimus, paclitaxel, and zotarolimus being absolute dominated and everolimus extended dominated by zotarolimus resolute, although all the results were above the willingness-to-pay threshold of 3 times the gross domestic product per capita (I$35,307). SENSITIVITY ANALYSIS: In deterministic sensitivity analysis, results were sensitive to cost of DES, number of stents used per patient, baseline probability, and duration of stent thrombosis risk. The probabilistic sensitivity analysis demonstrated a probability of 81% for BMS being the strategy of choice, with 9% for everolimus and 9% zotarolimus resolute, at the willingness-to-pay threshold. CONCLUSION: DES is not a good value for money in SUS perspective, despite its benefit in reducing target vessel revascularization. Since the cost-effectiveness of DES is mainly driven by the stents' cost difference, they should cost less than twice the BMS price to become a cost-effective alternative.

Transarterial Embolization for Hepatocellular Carcinoma: A Comparison between Nonspherical PVA and Microspheres.

Transarterial chemoembolization (TACE) and transarterial embolization (TAE) have improved the survival rates of patients with unresectable hepatocellular carcinoma (HCC); however, the optimal TACE/TAE embolic agent has not yet been identified. The aim of this study was to compare the effect of two different embolic agents such as microspheres (ME) and polyvinyl alcohol (PVA) on survival, tumor response, and complications in patients with HCC submitted to transarterial embolization (TAE). Eighty HCC patients who underwent TAE between June 2008 and December 2012 at a single center were retrospectively studied. A total of 48 and 32 patients were treated with PVA and ME, respectively. There were no significant differences in survival (P = 0.679) or tumoral response (P = 0.369) between groups (PVA or ME). Overall survival rates at 12, 18, 24, 36, and 48 months were 97.9, 88.8, 78.9, 53.4, and 21.4% in the PVA-TAE group and 100, 92.9, 76.6, 58.8, and 58% in the ME-TAE group (P = 0.734). Patients submitted to TAE with ME presented postembolization syndrome more frequently when compared with the PVA group (P = 0.02). According to our cohort, the choice of ME or PVA as embolizing agent had no significant impact on overall survival.

Survival rates according to barcelona clinic liver cancer sub-staging system after transarterial embolization for intermediate hepatocellular carcinoma.

AIM: To investigate the survival rates after transarterial embolization (TAE). METHODS: One hundred third six hepatocellular carcinoma (HCC) patients [90 barcelona clinic liver cancer (BCLC) B] were submitted to TAE between August 2008 and December 2013 in a single center were retrospectively studied. TAE was performed via superselective catheterization followed by embolization with polyvinyl alcohol or microspheres. The date of the first embolization until death or the last follow-up date was used for the assessment of survival. The survival rates were calculated using the Kaplan-Meier method, and the groups were compared using the log-rank test. RESULTS: The overall mean survival was 35.8 mo (95%CI: 25.1-52.0). The survival rates of the BCLC A patients (33.7%) were 98.9%, 79.0% and 58.0% at 12, 24 and 36 mo, respectively, and the mean survival was 38.1 mo (95%CI: 27.5-52.0). The survival rates of the BCLC B patients (66.2%) were 89.0%, 69.0% and 49.5% at 12, 24 and 36 mo, respectively, and the mean survival was 29.0 mo (95%CI: 17.2-34). The survival rates according to the BCLC B sub-staging showed significant differences between the groups, with mean survival rates in the B1, B2, B3 and B4 groups of 33.5 mo (95%CI: 32.8-34.3), 28.6 mo (95%CI: 27.5-29.8), 19.0 mo (95%CI: 17.2-20.9) and 13 mo, respectively (P = 0.013). CONCLUSION: The BCLC sub-staging system could add additional prognosis information for post-embolization survival rates in HCC patients.

Cost-Effectiveness of High, Moderate and Low-Dose Statins in the Prevention of Vascular Events in the Brazilian Public Health System / Efetividade de Estatinas em Dose Alta, Moderada e Baixa na Prevenção de Eventos Vasculares no SUS

Background: Statins have proven efficacy in the reduction of cardiovascular events, but the financial impact of its widespread use can be substantial. Objective: To conduct a cost-effectiveness analysis of three statin dosing schemes in the Brazilian Unified National Health System (SUS) perspective. Methods: We developed a Markov model to evaluate the incremental cost-effectiveness ratios (ICERs) of low, intermediate and high intensity dose regimens in secondary and four primary scenarios (5%, 10%, 15% and 20% ten-year risk) of prevention of cardiovascular events. Regimens with expected low-density lipoprotein cholesterol reduction below 30% (e.g. simvastatin 10mg) were considered as low dose; between 30-40%, (atorvastatin 10mg, simvastatin 40mg), intermediate dose; and above 40% (atorvastatin 20-80mg, rosuvastatin 20mg), high-dose statins. Effectiveness data were obtained from a systematic review with 136,000 patients. National data were used to estimate utilities and costs (expressed as International Dollars - Int$). A willingness-to-pay (WTP) threshold equal to the Brazilian gross domestic product per capita (circa Int$11,770) was applied. Results: Low dose was dominated by extension in the primary prevention scenarios. In the five scenarios, the ICER of intermediate dose was below Int$10,000 per QALY. The ICER of the high versus intermediate dose comparison was above Int$27,000 per QALY in all scenarios. In the cost-effectiveness acceptability curves, intermediate dose had a probability above 50% of being cost-effective with ICERs between Int$ 9,000-20,000 per QALY in all scenarios. Conclusions: Considering a reasonable WTP threshold, intermediate dose statin therapy is economically attractive, and should be a priority intervention in prevention of cardiovascular events in Brazil. .

Fundamento: Estatinas tem eficácia comprovada na redução de eventos cardiovasculares, mas o impacto financeiro de seu uso disseminado pode ser substancial. Objetivo: Conduzir análise de custo-efetividade de três esquemas de doses de estatinas na perspectiva do SUS. Métodos: Foi desenvolvido modelo de Markov para avaliar a razão de custo-efetividade incremental (RCEI) de regimes de dose baixa, intermediária e alta, em prevenção secundária e quatro cenários de prevenção primária (risco em 10 anos de 5%, 10%, 15% e 20%). Regimes com redução de LDL abaixo de 30% (ex: sinvastatina 10mg) foram considerados dose baixa; entre 30-40% (atorvastatina 10mg, sinvastatina 40mg), dose intermediária; e acima de 40% (atorvastatina 20-80 mg, rosuvastatina 20 mg), dose alta. Dados de efetividade foram obtidos de revisão sistemática com aproximadamente 136.000 pacientes. Dados nacionais foram usados para estimar utilidades e custos (expressos em dólares internacionais - Int$). Um limiar de disposição a pagar (LDP) igual ao produto interno bruto per capita nacional (aproximadamente Int$11.770) foi utilizado. Resultados: A dose baixa foi dominada por extensão nos cenários de prevenção primária. Nos cinco cenários, a RCEI da dose intermediária ficou abaixo de Int$10.000 por QALY. A RCEI de dose alta ficou acima de Int$27.000 por QALY em todos os cenários. Nas curvas de aceitabilidade de custo-efetividade, dose intermediária teve probabilidade de ser custo-efetiva acima de 50% com RCEIs entre Int$9.000-20.000 por QALY em todos os cenários. Conclusões: Considerando um LDP razoável, uso de estatinas em doses intermediárias é economicamente atrativo, e deveria ser intervenção prioritária na redução de eventos cardiovasculares no Brasil. .

Cost-effectiveness of high, moderate and low-dose statins in the prevention of vascular events in the Brazilian public health system.

BACKGROUND: Statins have proven efficacy in the reduction of cardiovascular events, but the financial impact of its widespread use can be substantial. OBJECTIVE: To conduct a cost-effectiveness analysis of three statin dosing schemes in the Brazilian Unified National Health System (SUS) perspective. METHODS: We developed a Markov model to evaluate the incremental cost-effectiveness ratios (ICERs) of low, intermediate and high intensity dose regimens in secondary and four primary scenarios (5%, 10%, 15% and 20% ten-year risk) of prevention of cardiovascular events. Regimens with expected low-density lipoprotein cholesterol reduction below 30% (e.g. simvastatin 10mg) were considered as low dose; between 30-40%, (atorvastatin 10mg, simvastatin 40 mg), intermediate dose; and above 40% (atorvastatin 20-80 mg, rosuvastatin 20mg), high-dose statins. Effectiveness data were obtained from a systematic review with 136,000 patients. National data were used to estimate utilities and costs (expressed as International Dollars - Int$). A willingness-to-pay (WTP) threshold equal to the Brazilian gross domestic product per capita (circa Int$11,770) was applied. RESULTS: Low dose was dominated by extension in the primary prevention scenarios. In the five scenarios, the ICER of intermediate dose was below Int$10,000 per QALY. The ICER of the high versus intermediate dose comparison was above Int$27,000 per QALY in all scenarios. In the cost-effectiveness acceptability curves, intermediate dose had a probability above 50% of being cost-effective with ICERs between Int$ 9,000-20,000 per QALY in all scenarios. CONCLUSIONS: Considering a reasonable WTP threshold, intermediate dose statin therapy is economically attractive, and should be a priority intervention in prevention of cardiovascular events in Brazil.

The Economic Burden of HIV/AIDS and myocardial infarction treatment in Brazil.

OBJECTIVE: To analyze the expenses of HIV/AIDS and acute myocardial infarction (AMI) treatment in Brazil. METHODS: A search in the Brazilian epidemiological database (DATASUS) on AMI and AIDS hospitalizations and their costs was done from January 1998 to December 2011. The number of HIV/AIDS cases and antiretroviral treatment (ART) costs was obtained from public Brazilian databases. RESULTS: In 5 years, HIV/AIDS cases increased 38.5%, mainly in patients aged 25-49. There were 180,640 patients in ART in 2007 at a cost of R$ 3,920 per patient/year. The hospitalizations due to AIDS were stable over the last 13 years; however, the hospitalizations due to AMI have increased 78%. In 2007, the expenses with hospitalizations for HIV/AIDS and AMI (25-49 years) were approximately 0.12 and 1.52% of the Ministry of Health budget allocated to reimburse inpatient costs. The expenses on ART totaled 1.5% of the total budget (all age groups). CONCLUSION: The prevalence of HIV/AIDS is still increasing in Brazil. There are scientific evidences suggesting an increased incidence of AIM in this population. Considering the high costs for the treatment of both diseases, an economic analysis is important to alert health managers to strengthen the preventive measures to guarantee the financial sustainability of such treatment.

Impact of statin dose on major cardiovascular events: a mixed treatment comparison meta-analysis involving more than 175,000 patients.

BACKGROUND: The benefit of statins in the reduction of cardiovascular events was demonstrated in several placebo-controlled trials. More intensive therapy seems to be associated with greater benefit. Our objective was to compare different statin doses in the reduction of cardiovascular events and deaths, combining direct and indirect evidence, through mixed treatment comparisons (MTC). METHODS: We conducted a systematic review in MEDLINE and Cochrane CENTRAL. A random-effects Bayesian MTC model was used to combine placebo-controlled and direct statin comparison trials. Intensity of statin doses was classified according to expected LDL-cholesterol reduction effect: ≤30% as low; 30-40%, intermediate, and ≥40%, high. Outcomes evaluated were non-fatal myocardial infarction (MI), stroke, coronary revascularization and coronary, cardiovascular and all-cause death. Inconsistency was assessed with split-node methodology. RESULTS: 47 trials (11 with direct statin comparisons) were included. High doses reduced non-fatal MI by 28% (95% CI: 18%-36%) and by 14% (7%-21%) when compared to low and intermediate doses, respectively. High doses also diminished revascularization [RR versus low and intermediate doses of 0.81 (0.69-0.95) and 0.88 (0.77-0.99), respectively] and stroke [RR of 0.83 (0.68-0.99) against low doses]. Regimen intensity did not change death rates (e.g., for all-cause mortality, RRs of 0.93 (0.80-1.06) and 0.98 (0.87-1.08) for high vs. low and intermediate doses, respectively). No statistical inconsistencies were found in the analyses. CONCLUSIONS: In this study, in which all available evidence from statin trials was simultaneously analyzed, the benefit of more intensive therapy was restricted to non-fatal events.

Cost-effectiveness of implantable cardioverter defibrillators in Brazil in the public and private sectors.

BACKGROUND: Many randomized clinical trials have demonstrated the effectiveness of the implantable cardioverter-defibrillator (ICDs) in death reduction of chronic heart failure (CHF) patients. Some developed countries studies have evaluated its cost-effectiveness, but these data are not applicable to Brazil. OBJECTIVE: To evaluate the cost-effectiveness of ICD in CHF patients under two perspectives in Brazil: public and supplementary health systems. METHODS: A Markov model was developed to analyze the incremental cost-effectiveness ratio (ICER) of ICD compared to conventional therapy in patients with CHF. Effectiveness was measured in quality-adjusted life years (QALYs). We searched the literature for data regarding effectiveness and complications. Costs were retrieved from public and health insurances reimbursement codebooks and from mean cost of admissions from a public and a private hospital. One-way sensitivity analysis was performed in all variables of the model. RESULTS: ICER was R$ 68,318/QALY in the public and R$ 90,942/QALY in the private perspective. These values are much higher than the one suggested by the World Health Organization of 3 times the gross domestic product per head (R$ 40,545 in Brazil). The results were sensitive to the cost of the device, battery replacement interval and ICD effectiveness. In a simulation resembling MADIT-I population survival and ICD benefit, ICER was R$ R$ 23,739/QALY in the public and R$ 33,592/QALY in the private perspective. CONCLUSION: The ICER of ICD is elevated in the general ICC population, in either the public or private perspective. A more favorable result occurs in patients with a high sudden death risk.

Custo-efetividade de cardiodesfibriladores implantáveis no Brasil nos setores público e privado / Cost-effectiveness of implantable cardioverter defibrillators in Brazil in the public and private sectors

FUNDAMENTO: Vários ensaios clínicos randomizados demonstraram a efetividade do cardiodesfibrilador implantável (CDI) na redução de morte de pacientes com insuficiência cardíaca congestiva (ICC). Estudos de países desenvolvidos já avaliaram a custo-efetividade do CDI, porém as informações não são transferíveis para o Brasil. OBJETIVO: Avaliar a custo-efetividade do CDI em pacientes com ICC sob duas perspectivas: pública e saúde suplementar. MÉTODOS: Um modelo de Markov foi criado para analisar a relação de custo-efetividade incremental (RCEI) do CDI, comparado à terapia convencional, em pacientes com ICC. Efetividade foi medida em anos de vida ajustados para qualidade (QALY). Na literatura, buscaram-se dados de efetividade e complicações. Custos foram extraídos das tabelas do SUS e de valores praticados pelos convênios, assim como médias de internações hospitalares. Análises de sensibilidade univariadas foram feitas em todas as variáveis do modelo. RESULTADOS: A RCEI foi de R$ 68.318/QALY no cenário público e R$ 90.942/QALY no privado. Esses valores são superiores aos sugeridos como pontos de corte pela Organização Mundial da Saúde, de três vezes o PIB per capita (R$ 40.545 no Brasil). Variáveis mais influentes na análise de sensibilidade foram: custo do CDI, intervalo de troca do gerador e efetividade do CDI. Em simulação de cenário semelhante ao MADIT-I, as relações foram de R$ 23.739/QALY no cenário público e R$ 33.592/QALY no privado. CONCLUSÃO: Para a população em geral com ICC, a relação de RCEI do CDI, tanto na perspectiva pública como na privada, é elevada. Resultados mais favoráveis ocorrem em pacientes com alto risco de morte súbita.

BACKGROUND: Many randomized clinical trials have demonstrated the effectiveness of the implantable cardioverter-defibrillator (ICDs) in death reduction of chronic heart failure (CHF) patients. Some developed countries studies have evaluated its cost-effectiveness, but these data are not applicable to Brazil. OBJECTIVE: To evaluate the cost-effectiveness of ICD in CHF patients under two perspectives in Brazil: public and supplementary health systems. METHODS: A Markov model was developed to analyze the incremental cost-effectiveness ratio (ICER) of ICD compared to conventional therapy in patients with CHF. Effectiveness was measured in quality-adjusted life years (QALYs). We searched the literature for data regarding effectiveness and complications. Costs were retrieved from public and health insurances reimbursement codebooks and from mean cost of admissions from a public and a private hospital. One-way sensitivity analysis was performed in all variables of the model. RESULTS: ICER was R$ 68,318/QALY in the public and R$ 90,942/QALY in the private perspective. These values are much higher than the one suggested by the World Health Organization of 3 times the gross domestic product per head (R$ 40,545 in Brazil). The results were sensitive to the cost of the device, battery replacement interval and ICD effectiveness. In a simulation resembling MADIT-I population survival and ICD benefit, ICER was R$ R$ 23,739/QALY in the public and R$ 33,592/QALY in the private perspective. CONCLUSION: The ICER aof ICD is elevated in the general ICC population, in either the public or private perspective. A more favorable result occurs in patients with a high sudden death risk.

Cost-effectiveness of implantable cardioverter-defibrillators in Brazil: primary prevention analysis in the public sector.

BACKGROUND: Several studies have demonstrated the effectiveness and cost-effectiveness of implantable cardioverter-defibrillators (ICDs) in chronic heart failure (CHF) patients. Despite its widespread use in developing countries, limited data exist on its cost-effectiveness in these settings. OBJECTIVE: To evaluate the cost-effectiveness of ICD in CHF patients under the perspective of the Brazilian Public Healthcare System (PHS). METHODS: We developed a Markov model to evaluate the incremental cost-effectiveness ratio (ICER) of ICD compared with conventional therapy in patients with CHF and New York Heart Association class II and III. Effectiveness was evaluated in quality-adjusted life years (QALYs) and time horizon was 20 years. We searched MEDLINE for clinical trials and cohort studies to estimate data from effectiveness, complications, mortality, and utilities. Costs from the PHS were retrieved from national administrative databases. The model's robustness was assessed through Monte Carlo simulation and one-way sensitivity analysis. Costs were expressed as international dollars, applying the purchasing power parity conversion rate (PPP US$). RESULTS: ICD therapy was more costly and more effective, with incremental cost-effectiveness estimates of PPP US$ 50,345/QALY. Results were more sensitive to costs related to the device, generator replacement frequency and ICD effectiveness. In a simulation resembling the MADIT-I population survival and ICD benefit, the ICER was PPP US$ 17,494/QALY and PPP US$ 15,394/life years. CONCLUSIONS: In a Brazilian scenario, where ICD cost is proportionally more elevated than in developed countries, ICD therapy was associated with a high cost-effectiveness ratio. The results were more favorable for a patient subgroup at increased risk of sudden death.