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Reply: Only randomized trials can define the gold standard

2022; Elsevier BV; Volume: 13; Linguagem: Inglês

10.1016/j.xjtc.2022.02.044

2666-2507

Giovanni Soletti, Mario Gaudino,

Cardiac, Anesthesia and Surgical Outcomes

The authors reported no conflicts of interest.The Journal policy requires editors and reviewers to disclose conflicts of interest and to decline handling or reviewing manuscripts for which they may have a conflict of interest. The editors and reviewers of this article have no conflicts of interest. The authors reported no conflicts of interest. The Journal policy requires editors and reviewers to disclose conflicts of interest and to decline handling or reviewing manuscripts for which they may have a conflict of interest. The editors and reviewers of this article have no conflicts of interest. We read with great interest the letter to the editor authored by Jahanyar and colleagues in response to the article published by the Cleveland Clinic group.1Mokashi S.A. Rosinski B.F. Desai M.Y. Griffin B.P. Hammer D.F. Kalahasti V. et al.Aortic root replacement with bicuspid valve reimplantation: are outcomes and valve durability comparable to those of tricuspid valve reimplantation?.J Thorac Cardiovasc Surg. 2022; 163: 51-63.e5Abstract Full Text Full Text PDF PubMed Scopus (9) Google Scholar In the Cleveland series of 607 patients (92 with bicuspid aortic valve [BAV]), Mokashi and colleagues1Mokashi S.A. Rosinski B.F. Desai M.Y. Griffin B.P. Hammer D.F. Kalahasti V. et al.Aortic root replacement with bicuspid valve reimplantation: are outcomes and valve durability comparable to those of tricuspid valve reimplantation?.J Thorac Cardiovasc Surg. 2022; 163: 51-63.e5Abstract Full Text Full Text PDF PubMed Scopus (9) Google Scholar concluded that aortic root replacement with valve-sparing reimplantation was a reliable option for selected patients with either BAV or tricuspid aortic valve, as a propensity score–based comparison showed no statistically significant difference in death and in-hospital complications. After a follow-up of 8 years, mortality was similar in the 2 groups (P = .07), whereas a greater number of aortic valve reoperations were noted in patients with BAV, raising concerns for long-term outcomes. In contrast, Jahanyar and colleagues cite their experience with BAV repair at a single institution in Brussels, performed with a 180° reimplantation-El Khoury technique.2de Meester C. Vanovershelde J.-L. Jahanyar J. Tamer S. Mastrobuoni S. Van Dyck M. et al.Long-term durability of bicuspid aortic valve repair: a comparison of 2 annuloplasty techniques.Eur J Cardiothorac Surg. 2021; 60: 286-294Crossref PubMed Scopus (12) Google Scholar,3Jahanyar J. El Khoury G. de Kerchove L. Commissural geometry and cusp fusion insights to guide bicuspid aortic valve repair.J Thorac Cardiovasc Surg Tech. 2021; 7: 83-92Scopus (15) Google Scholar In this series, authors reported a freedom from reoperation of 91% at 12 years in the BAV group, greater than that reported in the BAV cohort (77%) analyzed by the Cleveland Clinic group. Jahanyar and colleagues argue that the difference could have been driven primarily by a greater recurrence of aortic regurgitation, even though this remains unclear. Considering the long-term outcomes obtained at their institution, the authors conclude by recommending that their reimplantation technique should be favored over prosthetic valve replacement when feasible. According to Jahanyar and colleagues,3Jahanyar J. El Khoury G. de Kerchove L. Commissural geometry and cusp fusion insights to guide bicuspid aortic valve repair.J Thorac Cardiovasc Surg Tech. 2021; 7: 83-92Scopus (15) Google Scholar the 180° reimplantation technique is well-thought-out, successfully adapts to the complex anatomy of BAV, and facilitates the surgical repair. While we agree in principle, we also believe that both approaches may be used as long as the surgeon possesses technical experience and expertise. At present, we are lacking sufficient, solid comparative data from large observational studies or, better, randomized clinical trials to make an evidence-based decision on which surgical approach should be preferred. Yet, we certainly agree that there is an unspoken need to provide cardiac surgeons and patients with solid data to inform practice and optimize clinical outcomes. To accomplish such a goal, our community should in primis avoid estimating treatment effects based on comparisons between observational studies, which are undoubtedly more representative of clinical practice but are intrinsically prone to a greater risk of bias and confounders.4Howes N. Chagla L. Thorpe M. McCulloch P. Surgical practice is evidence based.Br J Surg. 1997; 84: 1220-1223Crossref PubMed Scopus (183) Google Scholar,5Gaudino M. Charlson M. Sellke F. The challenge of estimating treatment effects in cardiac surgery.JAMA Cardiol. 2021; 6: 1355-1356Crossref PubMed Scopus (2) Google Scholar Second, surgeons should now be aware that answers to long-awaited and unresolved questions can only be derived from appropriately designed and adequately powered high-quality trials, for which specific recommendations to overcome challenges have been developed by experts and trialists in the field.6Gaudino M. Kappetein A.P. Di Franco A. Bagiella E. Bhatt D.L. Boening A. et al.Randomized trials in cardiac surgery: JACC review topic of the week.J Am Coll Cardiol. 2020; 75: 1593-1604Crossref PubMed Scopus (22) Google Scholar,7Gaudino M. Chikwe J. Bagiella E. Fremes S. Jones D.R. Meyers B. et al.Challenges to randomized trials in adult and congenital cardiac and thoracic surgery.Ann Thorac Surg. 2022; 113: 1409-1418Abstract Full Text Full Text PDF PubMed Scopus (4) Google Scholar In the history of our clinical practice, there have already been plenty of examples of widely adopted treatments based on observational studies that were subsequently found to be ineffective when tested in appropriately powered randomized trials.5Gaudino M. Charlson M. Sellke F. The challenge of estimating treatment effects in cardiac surgery.JAMA Cardiol. 2021; 6: 1355-1356Crossref PubMed Scopus (2) Google Scholar This is a unique opportunity to not repeat our past mistakes, to come together, and to give our patients an evidence-guided answer. So, let trials have the last word. Reimplantation should be the gold standard to treat the regurgitant bicuspid aortic valveJTCVS TechniquesVol. 13PreviewMokashi and associates1 have recently shared the Cleveland Clinic's intermediate-term experience with reimplantation of tricuspid aortic valves (TAV) and bicuspid aortic valves (BAV). In a propensity score–matched analysis, the authors demonstrated excellent 5-year outcomes with 100% survival in the BAV and 98% survival in the TAV group. Freedom from reoperation in the BAV and TAV cohort was 94% and 98%, respectively. Although both procedures were done with equal safety and short-term outcomes, the authors were concerned due to greater transvalvular gradients and less ventricular reverse remodeling in the BAV cohort, as well as less freedom from reoperations in the BAV cohort at 8 years (77%). Full-Text PDF Open Access