Advancing aortic valve replacement in low to intermediate risk patients: emerging evidence comparing transcatheter aortic-valve implantation and surgical aortic-valve replacement outcomes

Dear Editor, Aortic valve disease remains a leading contributor to cardiovascular morbidity and mortality in developing nations, often requiring aortic valve replacement1–3. The DEDICATE trial, a randomized, noninferiority trial, presents a significant investigation into the comparative outcomes of transcatheter aortic-valve implantation (TAVI) and surgical aortic-valve replacement (SAVR) among patients with severe aortic stenosis at low or intermediate surgical risk4. The study investigated 1414 patients categorized into either TAVI or SAVR group. The incidence of the composite of death from any cause or fatal or nonfatal stroke at 1 year was lower in the TAVI (5.4 vs. 10.0%) than in the SAVR group (HR=0.53; 95% CI=0.35–0.79; P<0.001 for noninferiority). This result significantly favors TAVI over SAVR under the study conditions; however, it also demonstrated the noninferiority of SAVR over TAVI. From a clinical perspective, these findings are particularly relevant for several reasons. First, the noninferiority of TAVI suggests that this less invasive procedure can be a viable and potentially preferable option for patients at low to intermediate risk of surgical complications. The significantly lower incidence of the primary composite outcome in the TAVI group underscores its safety profile, particularly in reducing the incidences of stroke and mortality within the first-year postoperation. Furthermore, secondary outcomes such as new-onset atrial fibrillation, which occurred in 12.4% of patients in the TAVI group compared to 30.8% in the SAVR group, and the need for permanent pacemaker implantation, present at 11.8% in the TAVI group versus 6.7% in the SAVR group, highlight some of the complexities associated with choosing an optimal intervention4. These findings suggest that while TAVI is associated with fewer instances of atrial fibrillation, it requires more frequent pacemaker implantation, a not insignificant consideration in treatment planning. Additionally, procedural complications were low in both groups, indicating that both TAVI and SAVR are becoming safer as techniques and technologies evolve. This trial also demonstrated the real-world applicability of TAVI, which was performed under the unrestricted choice of several contemporary transcatheter heart-valve devices, thus reflecting a broader spectrum of the clinical population compared to previous studies which were more controlled and limited in scope. These results could influence current guidelines, which generally reserve TAVI for higher-risk patients. The demonstration of TAVI’s noninferiority in a broader patient cohort, including those at lower surgical risks, suggests that its use could be expanded, offering a safer and equally effective treatment option to a wider range of patients. Moreover, the study’s findings are crucial for patient counseling and informed decision-making. Given the aging population and the prevalence of aortic stenosis, providing patients with the most current data on both procedures allows for informed discussions regarding their treatment options. Patients at low to intermediate risk who may prefer a less invasive procedure with a faster recovery time may find TAVI particularly appealing. However, it is also crucial to consider the long-term durability of TAVI compared to SAVR, as the study covers only the first postoperative year. Long-term outcomes, particularly concerning valve durability and the potential need for reintervention, remain to be seen and are essential for comprehensive treatment planning. In conclusion, the evidence from the DEDICATE trial highlights the advancing front of aortic valve replacement, offering substantial data that TAVI is a safe and effective alternative to SAVR in patients with low to intermediate surgical risk. As technologies improve and more data become available, the scope of TAVI is likely to expand, potentially making it the standard of care for even more patient groups. As clinicians, it is our responsibility to stay abreast of these developments, integrating new evidence into our clinical practice to improve patient outcomes continuously. Ethical approval Not applicable. Consent Not applicable. Sources of funding Not applicable. Author contribution A.A.: conceptualization, project administration, supervision, validation, writing – original draft, and writing – review and editing; N.A.W.: project administration, validation, writing –original draft, and writing – review and editing; P.S., R.K.S., D.S., M.A., M.N.K., S.G., Q.S.Z., and S.R.: supervision, validation, and writing – review and editing. Conflicts of interest disclosure The authors declare no conflicts of interest. Research registration unique identifying number (UIN) Not applicable. Guarantor Ayush Anand. Data availability statement Not applicable. Provenance and peer review Not commissioned, externally peer-reviewed. Assistance with the study Not applicable.

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