ABC | Volume 114, Nº2, February 2020

Viewpoint Treatment of Aortic Stenosis in Elderly Individuals in Brazil: How Long Can We Wait? Marcelo Antônio Cartaxo Queiroga Lopes, 1, 2 Bruno Ramos Nascimento, 3 Gláucia Maria Moraes de Oliveira 4 Sociedade Brasileira de Cardiologia, 1 Rio de Janeiro, RJ – Brazil Hospital Alberto Urquiza Wanderley, 2 João Pessoa, PB – Brazil Universidade Federal de Minas Gerais, 3 Belo Horizonte, MG – Brazil Universidade Federal do Rio de Janeiro, 4 Rio de Janeiro, RJ – Brazil Mailing Address: Marcelo Antônio Cartaxo Queiroga Lopes • Cardiocenter – Av. Ministro José Américo de Almeida, 1450, Torre, Hospital Alberto Urquiza Wanderley. Postal Code 58.040-300, João Pessoa, PB – Brazil E-mail: mqueiroga@cardiol.br , marcelocartaxoqueiroga@gmail.com Manuscript received January 02, 2020, revised manuscript January 03, 2020, accepted January 03, 2020 Keywords Life Expectancy; Aging; Aged; Stenosis Valve Aortic/surgery; Heart Valve Prosthesis; Heart Valve Prosthesis Implantation; Transcatheter Aortic Valve Replacement/trends. DOI: https://doi.org/10.36660/abc.2020003 The growing life expectancy of the population is increasing the occurrence of diseases affecting the elderly age group, notably the non-rheumatic degenerative valvular diseases and, in particular, aortic stenosis, whose prevalence in elderly individuals older than 75 years has been estimated at 3 to 5%. This is the most common valvular heart disease among elderly individuals, and its severe form is associated with highmorbidity and mortality. The life expectancy of patients with aortic stenosis presenting with heart failure and rhythm disturbances is estimated to be less than 2 years. The standard treatment for this disease is cardiac surgery with replacement of the aortic valve by a prosthesis. However, due to high surgical risk, especially in very elderly patients with associated comorbidities, cardiac surgery is contraindicated in about 30% of the cases or is performed with high morbidity and mortality rates according to preoperative scores. For these critically ill patients, a new, less invasive technique consisting of transcatheter aortic valve implantation (TAVI) of a bioprosthesis has been considered the therapeutic option of choice, initially tested in patients at very high surgical risk, but currently with evidence of noninferiority compared to open surgery in lower-risk individuals. 1,2 The first TAVI procedure in the world was performed in France in 2002 by Professor Alain Cribier, and the method was pioneered in Brazil in 2008. Since then, a considerable number of patients has been treated. However, despite robust evidence of safety and efficacy, this therapy has still not been incorporated into the supplemental or public health care systems ( Sistema Único de Saúde [SUS]) in the country. Despite the fact that TAVI has already been evaluated and accepted in the health care systems of several countries with evidence of cost-effectiveness even in individuals at intermediate operative risk, 3 the Ministry of Health, based on a position stand from the National Commission for Incorporation of Technologies in the SUS (Conitec), established in 2013, in response to a request by the Brazilian Society for Hemodynamics and of Interventional Cardiology (SBHCI) acting as the petitioner, considered that there was no convenience in incorporating this therapy in Brazil. Conitec, at the time, based on the opinion of a reviewer and disregarding the opinion of prestigious national universities presented in a public consultation on the subject, recommended against the incorporation of the procedure, justifying this decision on three points: a) TAVI would not be a safe and effective procedure due to an allegedly high incidence of stroke within the first 30 days after the procedure, b) the budgetary impact of incorporating TAVI into the SUS would approach 1 billion reais per year, and c) methodological inaccuracies could have affected the economic model presented by the petitioner and the PARTNER B study, which served as the main background for the incorporation of this procedure by all health technology assessment agencies in the world that have requested the incorporation of this technology. Currently, robust data published since the issuance of this report, from at least six major randomized clinical trials and international registries, 1,2,4 suggest no doubt about the appropriateness of the technique in selected patients, resulting in a recent expansion of risk groups in which TAVI would have similar results compared to open surgery, including a reduction in important outcomes like length of hospital stay and neurological events. However, there is no way to obscure the fact that the budgetary impact of the procedure can be high, especially given the demographic changes that the country has been going through in recent decades. Estimates of costs with the technique by the Ministry of Health, as discussed below, seem at first glance inaccurate and based on data that may not reflect the national reality. Estimates of the frequency of use of the procedure calculated by technicians of the Ministry of Health overestimate the access to TAVI in Brazil, projecting a budgetary impact that exceeds a billion dollars. Data from the 2017 Global Burden of Disease (GBD) study analyzing non-rheumatic heart valve diseases show that even though the age-standardized prevalence of these grouped diseases has remained relatively stable in Brazil from 1990 to 2017, there was a significant increase in Non-rheumatic calcific aortic valve disease, from 53.5 (95% uncertainty interval [95%II]: 48.1 – 59.9) per 100,000 inhabitants in 1990 to 64.4 (95%II: 57.2 – 72.5) per 100,000 inhabitants in 2017 for both men (18.5%) and women (24.2%). 5 The increase in the absolute prevalence rate of this valvular disease was even more significant, surpassing 114% (95%II: 105.5 – 124.3%) over 27 years, and suggesting a progressive and still growing impact from aortic valve diseases on the country's health care systems (Figure 1). 5,6 313