Scientific evidence in the cardiologic arena has progressed enormously in the last couple of years. It is a huge challenge for respected societies, such as the American Heart Association (AHA) and American College of Cardiology (ACC), to undertake the burden of providing to the world their recommendations for clinical practice based on this evidence. The Latin American Association of Cardiac and Endovascular Surgery (LACES) would like to thank the authors involved in such a task. As a growing association that represents an economic and health care reality that is different from others, we have decided to carefully select guidelines that consider our socioeconomic situation. As such, in this statement, we will highlight the aspects of the recently released AHA/ACC Guidelines for the Management of Patients with Valvular Heart Disease 2020 with which we disagree, intending to support Latin American surgeons in their practice.1Otto C.M. Nishimura R.A. Bonow R.O. et al.2020 ACC/AHA guideline for the management of patients with valvular heart disease: executive summary: a report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines.Circulation. 2021; 143: e35-e71PubMed Google Scholar Trials on transcatheter aortic valve implantation (TAVI) and surgical aortic valve replacement (SAVR) have been constructed based on surgical risk; for this reason, the previous AHA/ACC Guidelines for the Management of Patients with Valvular Heart Disease based its recommendation for the type of intervention on surgical risk. Although we support the concept that age, expected survival, and valve durability are the cornerstone for patient-heart team discussion, trials have not evaluated outcomes based on age. Furthermore, the age range used to support TAVI is well below the mean age of the low-risk trials (73 years old for PARTNER 3 [The Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients With Aortic Stenosis] and 74 years old for Evolut Low Risk), and there is absolutely no reference to support this range defined by the authors. Therefore, LACES considers it an important methodological flaw, subject to high risk of reversal, to recommend as Class of Recommendation (COR) I Level of Evidence A (the highest imprimatur of guideline recommendations) any indication for TAVI or SAVR based on age. We consider this discrepancy of utmost importance because AHA/ACC recommendations will guide treatment and provide legal framework in several countries of thousands of patients, which in this case is devoid of scientific evidence. LACES does not support any COR I Level of Evidence A recommendation that is not supported by large randomized control trials. Large randomized control trials have been constructed based on surgical risk. Therefore, we do not support any recommendation on TAVI or SAVR based on age. The authors have clearly stated the importance of life expectancy and valve durability to help decide the best strategy. Nonetheless, there is no mention about the long-term risk of paravalvular leak or permanent pacemaker implantation on long-term survival in low-risk and young patients. The PARTNER 2 (Placement of AoRTic TraNscathetER Valves) trial has shown patients with a mild paravalvular leak to have worse survival at 5 years (P = .06) than patients with none or trace.2Leon M.B. Smith C.R. Mack M.J. et al.PARTNER 2 Investigators. Transcatheter or surgical aortic-valve replacement in intermediate-risk patients.N Engl J Med. 2016; 374: 1609-1620Crossref PubMed Scopus (2819) Google Scholar We believe this issue to be as important as valve durability and therefore be seriously incorporated in the decision for patients with a life expectancy of longer than 5 years. Until there are no data on its detrimental effect, we do not believe it is safe to recommend TAVI in patients with more than 5 years of life expectancy. Because there is no evidence longer than a median of 5 years of follow-up to support the safety of TAVI in intermediate-risk and low-risk patients and also regarding the detrimental effect of paravalvular leak, LACES does not support any COR I for TAVI in patients with a life expectancy longer than 5 years. Surgical risk defined by the current guidelines is another novel topic in which this association has a different view. High risk has been defined by the current guidelines as any of the following:•Society of Thoracic Surgeons risk exceeding 8%,•2 or more indices in frailty,•1 to 2 organ system compromise not to be improved postoperatively, and•possible procedure-specific impediment. Organ system compromise has been defined as:•cardiac dysfunction: severe left ventricular systolic or diastolic dysfunction or right ventricular dysfunction, fixed pulmonary hypertension;•kidney dysfunction: chronic kidney disease stage 3 or worse;•pulmonary dysfunction: forced expiratory volume in 1 second of less than 50% or diffusion capacity for carbon dioxide of less than 50% of predicted;•central nervous system dysfunction:dementia, Alzheimer disease, Parkinson disease, cerebrovascular accident with persistent physical limitation;•gastrointestinal dysfunction: Crohn disease, ulcerative colitis, nutritional impairment, or serum albumin below 3.0 g/dL;•cancer: active malignancy; and•liver dysfunction: any history of cirrhosis, variceal bleeding, or elevated international normalized ratio in the absence of vitamin K antagonists therapy. There is no reference to support defining high surgical risk under these conditions, and we consider the organ system compromise definition to be very broad, resulting probably in a high percentage of patients in this category who will receive a treatment for which there is no evidence to support superiority. LACES considers that surgical risk stratification should continue to be based on validated scores that result from complex statistical methods and therefore does not support defining high surgical risk based on criteria that do not derive from big data adjusted survival analyses. Current guidelines have excluded completely the option of SAVR in patients at high surgical risk. Even more, the authors have provided similar recommendations for high surgical risk and prohibitive surgical risk. We consider this recommendation is unacceptable, and our association will not support or endorse it for the following reasons. Trials have specifically evaluated separately each of these surgical risks (PARTNER 1A and 1B), providing strong and solid evidence based on the population of patients included. PARTNER 1A compared SAVR with TAVR in patients at high risk and PARTNER 1B compared medical treatment and TAVR in patients with prohibitive surgical risk. Therefore, the conclusion and subsequent guidelines recommendations should be based on the population and comparative groups involved. We support palliative care in patients with prohibitive surgical risk in whom TAVI is not feasible. In patients at high surgical risk, no evidence shows that TAVI is superior to SAVR. The actual evidence is that TAVI is not inferior to SAVR in high risk, and therefore, guidelines recommendation giving Level of Evidence A should reflect this. Current evidence shows TAVR to be noninferior to SAVR in patients at high risk, therefore LACES considers both options to have the same level of recommendation. LACES does not support giving the same recommendation in patients at high and prohibitive risk. After careful consideration of the new 2020 AHA/ACC clinical guidelines for valvular heart disease, we have found several points concerning the recommendations for using transcatheter edge-to-edge mitral valve (MV) repair as a treatment in the setting of functional mitral regurgitation (FMR), with which we are totally at odds. If coronary artery bypass grafting (CABG) is needed, then surgery is indicated as the COR IIA. However, the main disagreement is concerning patients not undergoing CABG. In these new guidelines, transcatheter edge-to-edge MV repair is considered as a COR IIA, if the patient has severe MR stage D (regurgitant volume, ≥60 mL; regurgitant fraction, ≥50%; effective regurgitant orifice area, ≥0.4 cm2), left ventricular (LV) ejection fraction of less than 0.50, if symptoms persist on optimal guideline-directed medical therapy, with MV anatomy as favorable, LV ejection fraction of 0.20 to 0.50, LV end-diastolic diameter of 70 mm or more, and systolic pulmonary artery pressure of 70 mm Hg or less. Recommendation has been based mainly on data from the COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation) trial. The first thing we need to say is that FMR is not a valvular disease, but a final LV condition leading to heart failure. Every single one of the attempts on the MV (surgical as well as percutaneous) will be just a palliative measure to alleviate the MR. Prognosis remains unaltered, while the quality of life or freedom from symptoms can be improved using any treatment directed to mitigate or even eliminate MR, regardless of the approach. MR repair using restrictive annuloplasty is the more reproducible technique for this purpose. Nevertheless, there has been a great concern because of the MR recurrence in the short-term. Although it is true that surgical annuloplasty might not be optimal for patients with FMR, it is also true that there are some other surgical options on the MV that can be highly recommended as a definite treatment directed to stop the further dilation and remodeling of the LV. MV replacement is another surgical choice. However, one consideration of paramount importance is that all of these foregoing facts apply the same, regardless of whether the approach is surgical or percutaneous. Moreover, when comparing the results of the COAPT trial (Abbott funded) with the Percutaneous Repair with the MitraClip Device for Severe Functional/Secondary Mitral Regurgitation (MITRA-FR) trial (French Ministry of Health and Research National Program Funded), both trials differed considerably in the primary outcome.3Stone G.W. Lindenfeld J. Abraham W.T. et al.COAPT Investigators. Transcatheter mitral-valve repair in patients with heart failure.N Engl J Med. 2018; 379: 2307-2318Crossref PubMed Scopus (1219) Google Scholar,4Obadia J.F. Messika-Zeitoun D. Leurent G. et al.MITRA-FR Investigators. Percutaneous repair or medical treatment for secondary mitral regurgitation.N Engl J Med. 2018; 379: 2297-2306Crossref PubMed Scopus (806) Google Scholar Besides, a recently published post hoc analysis of a subgroup of patients from the MITRA-FR trial who met COAPT inclusion criteria found transcatheter edge-to-edge MV repair failed to show superiority over optimal medical therapy. Therefore, longer-term outcomes are required as well as additional trials. In light of the aforementioned details, LACES does not support COR IIA for transcatheter edge-to-edge MV repair in the presence of FMR. The contradicting outcomes between the only 2 trials that have evaluated this technique and the limited 2 to 3 years of data from the COAPT trial do not justify the wide expectations of a COR IIA for the percutaneous approach. Concerning FMR, all of the available long-term information is coming from surgical experience, with a significant long-term follow-up of up to 14 years or even longer. From this experience, it has been so very clear that the most powerful predictor for failure after edge-to-edge MV repair is the lack of an annuloplasty ring. As it stands now in the current version, the transcatheter edge-to-edge MV repair therapy is a ringless technique, and therefore, longer-term outcomes are needed before we are able to evaluate the safety of a ringless technique. In regard with comparison to mitral surgery, the Endovascular Valve Edge-to-Edge Repair Study (EVEREST II) trial included 27% of patients with FMR.5Feldman T. Kar S. Elmariah S. et al.EVEREST II Investigators. Randomized comparison of percutaneous repair and surgery for mitral regurgitation: 5-year results of EVEREST II.J Am Coll Cardiol. 2015; 66: 2844-2854Crossref PubMed Scopus (439) Google Scholar The primary outcome (freedom from death, surgery in the percutaneous group, MR 3+ or 4+, surgery in the repair group) at 1, 2, and 5 years was significantly worse for the percutaneous edge-to-edge group. There is no other randomized controlled trial that evaluates long-term outcomes of surgery vs transcatheter edge-to-edge. Considering the worse long-term outcomes of the transcatheter edge-to-edge (EVEREST II trial) and absence of long-term safety using a ringless technique, LACES does not support a higher level of COR for the percutaneous approach compared with surgery. We believe careful evaluation of surgical risk by a heart team should define the best approach. Finally, we believe one of the main drivers of big societies, such as the AHA, ACC, European Society of Cardiology, and European Association for Cardio-Thoracic Surgery, is to strive to achieve excellence in the treatment of cardiovascular disease worldwide. Scientific societies should acknowledge this to be worldwide leaders in the field. When guidelines start to diverge from a critical assessment of the scientific evidence with unsupported extrapolations, they lose reliability, practice turns arbitrary, and leaders are lost. This statement has been submitted to several journals in order to achieve worldwide diffusion of the position of our association.