The official position of the Latin American Association of Cardiac and Endovascular Surgery (LACES) regarding the recently released SOLACI/ SIAC Clinical Guidelines on TAVI versus SAVR

Response to LACES in relation to Clinical Practice Guideline for Transcatheter Versus Surgical Valve Replacement in Patients with Severe Aortic Stenosis in Latin America

“…7 LACES also stated that we "have mentioned, but not analyzed, the role that costs have on TAVI implementation in Latin America", and that "in times of extreme pressure on health resources, regardless of the countries' economic situation, adopting a new technology that is five to 10 times more expensive than the existing standard, with inferior results, seems illogical and requires serious reflection." 1 Dayan et al seem to agree with our clinical practice guideline, i.e., implementing TAVI may result in large costs, which was the main concern that led the guideline panel to make a conditional recommendation. Also, as we repor ted in the supplement, "access to highcost health tech nology is markedly heterogeneous in Latin America.…”

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Letter to: Latin American Association of Cardiac and Endovascular Surgery. Dayan et al 1 , on behalf of the Latin American Association of Cardiac and Endo vascular Surgery (LACES), expressed their concerns about the development and relevance of our clinical practice guideline for the use of transcatheter aortic valve implant (TAVI) or surgical aortic valve replacement (SAVR), in patients with severe aortic stenosis living in Latin America. 2 In this response, we address several points raised in their letter.

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“…Not including regional evidence is a significant flaw, and suggests serious selection bias in the evi dence process." 1 It also stated that "a guideline to help physicians and stakeholders de cide the best course of action in Latin America must come from LatinAmerican effec tiveness data. It is impossible to recommend something for our region when we do not know what is going on."…”

“…It is impossible to recommend something for our region when we do not know what is going on." 1 This assessment is not aligned with fundamental principles of Grading of Recommendations Assessment, Development and Evaluation (GRADE) guidance, which states that the body of evidence should encompass all studies provi ding the best available evidence for a given question. 3 Although LACES positions state that "different centers from Latin America have generated essential data to produce highquality effectiveness results", 1 in our systematic review update, we did not iden tify randomized control trials that included patients treated in Latin America.…”

“…In this way, the results of randomi zed controlled trials, metaanalyses, and national databases show the opposite". 1 With "the opposite", they assumed TAVI showed inferior results compared to SAVR, disregarding any degree of uncertainty. To support their statement, they se lected one observational registry, in which patients treated with TAVI and SAVR had substantial baseline differences in age and surgical risk.…”