ABC | Volume 114, Nº2, February 2020

Viewpoint Arq Bras Cardiol. 2020; 114(2):313-318 Lopes et al. Treatment of aortic stenosis in elderly individuals in Brazil Table 1 – Number of hospitalizations related to the treatment of valve disease in Brazil from 2008 to 2018. Source: DATASUS. 9 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 TOTAL VALVE DISEASE* 1,606 1,753 1,647 1,878 1,938 1,938 1,849 1,940 2,068 2,023 2,090 20,730 VULVAR SURGERY 8,045 8,344 7,745 8,297 8,518 8,176 8,130 7,937 7,756 7,758 7,574 88,280 MITRAL VALVULOPLASTY 477 551 478 473 403 431 408 341 206 236 200 4,204 OTHER VALVULOPLASTY 451 477 445 486 456 527 515 513 399 427 391 5,087 * Hospitalizations due to other surgical procedures related to valve diseases among patients with aortic stenosis – even in developed countries – around 20% have a severe form of the disease. Of these, only about 60% would be eligible for TAVI, with 20% of inoperable or intermediate or high-risk patients. Of these, only about 60% would be eligible for TAVI, with 20% of inoperable or intermediate or high-risk patients - the better established indications for the procedure. 14 Despite the absence of primary estimate data for TAVI indication in Brazil, we can apply demographic and epidemiological data for further detailing. Considering the latest GBD2017modeling in relation to the prevalence of calcific aortic valvular disease, we would have 64.4/100,000 inhabitants. 5 Data from an IBGE census estimated an approximately 12.9 million elderly individuals aged ≥ 70 years in Brazil in 2019, which would result in roughly 8,400 patients with clinically significant disease in a very conservative estimate. If, alternatively, the estimated prevalence in the literature of about 3 to 5% in individuals ≥ 75 years is applied to IBGE data 15 (a population of 7.7 million), and extrapolating the results from the largest available meta-analysis of aortic stenosis, 14 we would have about 9,300 to 12,000 patients presumably eligible for TAVI in Brazil in 2019. Considering the estimates of the National Supplementary Health Agency that 24.3% of the Brazilian population had access to private health care plans in 2019, and also the aforementioned issues related to difficulties in access and infrastructure limitations in the annual history of valvular surgeries in the SUS, 9 the projections of financial impact presented by Conitec are undoubtedly overestimated against objective data. Of note, the Ministry of Health's technical position remains unchanged, at least in relation to the frequency of use and the budgetary impact of TAVI in Brazil. In the discussion of Project Act 5.460/2016 determining the mandatory coverage of TAVI in the SUS, which has already been approved by the Chamber of Deputies, the Ministry of Health – in response to the Finance and Taxation Commission on June 26, 2018, after 11 years from the request to Conitec – maintained its position regarding the projections discussed here. 16 Finally, in addition to budgetary issues, it is of fundamental importance the development of technological infrastructure and professional training in the Brazilian public health system for the implementation of complex treatments in most diverse areas, in a process of industrial development of health care, contemporary to the inexorable process of medical innovation. Regarding the example of structural cardiovascular interventions, other modalities – such as percutaneous repair of mitral regurgitation and percutaneous treatment of congenital valvular heart disease – have already been described in the literature, and should soon be brought also to the discussion table of public policy managers and lawmakers. In this sense, emphasis should be placed on recent efforts by the national cardiological societies, with the seal of the Brazilian Medical Association, for the development of courses for training and professional certification. In conclusion, the process of incorporating new technologies into the SUS – notably TAVI – must be currently discussed in depth and in a multidisciplinary and professional fashion, based on objective data and technical discretion, with due emphasis on epidemiological, technical, infrastructural, and budgetary issues. The persistence of the overly restrictive position in the incorporation of technologies into the health care system in Brazil (in TAVI’s case, the delay in the incorporation exceeds a decade), in addition to resulting in the inconvenient phenomenon of requiring a judicial process, impels to other routes to obtain treatment access, which are much slower and more complex, such as the legislative path, thwarting the just expectations placed by the civil society in the Public Power, especially considering that universal, full, equal, and free access to the health care system has been established in Brazil in article 196 of the Federal Constitution. Acknowledgment We would like to thank Renato Azeredo Teixeira for formatting the figures. Author contributions Conception and design of the research, Acquisition of data, Analysis and interpretation of the data, Statistical analysis, Writing of the manuscript and Critical revision of the manuscript for intellectual content: Lopes MACQ, Nascimento BR, Oliveira GMM Potential Conflict of Interest No potential conflict of interest relevant to this article was reported. Sources of Funding There were no external funding sources for this study. Study Association This study is not associatedwith any thesis or dissertationwork. Ethics approval and consent to participate This article does not contain any studies with human participants or animals performed by any of the authors. 317