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ISSN 2448-5640 (Print)
Diario Oficial de la Sociedad Mexicana de Cirugía Cardiaca, A.C., y del Colegio Mexicano de Cirugía Cardiovascular y Torácica, A.C.

2026, Number 4

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Cir Card Mex 2026; 11 (4)

Questioning the interpretive hierarchy in the seven-year outcomes of the Evolut Low Risk trial

García-Villarreal OA, Flores-García JA

Language: English
References: 17
Page: 150-159
PDF size: 896.79 Kb.


ABSTRACT

The 7-year follow-up of the Evolut Low Risk Trial extends the comparison between transcatheter (TAVR) and surgical (SAVR) aortic valve replacement in low-risk patients, shifting the clinical question from early safety to long-term durability. While all-cause mortality and disabling stroke remain comparable, a significant divergence emerges in reintervention rates (9.8% vs 6.0%; subdistribution Hazard Ratio [sHR] 1.68; 95%CI: 1.10-2.58; p = 0.02), driven predominantly by structural regurgitation (5.6% vs 1.6%; sHR 3.39; 95%CI: 1.62-7.07; p < 0.001). Notably, approximately 65% of TAVR reinterventions required surgical explantation, underscoring an asymmetry in rescue strategies. Methodological concerns include substantial sponsor involvement, emphasis on as-treated analyses, incomplete late clinical followup during the critical durability phase, absence of adjudicated echocardiography at year six, and retrospective classification of procedural performance according to subsequent versions of the device’s instructions for use. The trial does not specify which surgical bioprostheses were used in the SAVR arm, which limits the rigorous interpretation of the long-term structural comparison. Moreover, narrative framing prioritizes mortality equivalence over structural divergence. In low-risk patients with long life expectancy, durability –not early survival– constitutes the decisive outcome. These findings confirm the short-term benefits of TAVR but also highlight persistent concerns about long-term valve durability and lifetime management, limiting their direct extrapolation to younger, low-risk patients.


REFERENCES

  1. Forrest JK, Yakubov SJ, Deeb GM, Reardon MJ; Evolut Low RiskTrial Investigators. Six-year outcomes after transcatheter vs surgicalaortic valve replacement in low-risk patients with aortic stenosis. JAm Coll Cardiol. 2026;S0735-1097(26)05423-9. doi: 10.1016/j.jacc.2026.02.5063.

  2. Clinicaltrials.gov [Internet]. Clinicaltrials.gov. [cited 2026 Feb 19].Available in: https://clinicaltrials.gov/study/NCT02701283

  3. Johnston DR, Soltesz EG, Vakil N, et al. Long-term durability ofbioprosthetic aortic valves: implications from 12,569 implants.Ann Thorac Surg. 2015;99(4):1239-1247. doi: 10.1016/j.athoracsur.2014.10.070.

  4. Life expectancy [Internet]. Cdc.gov. 2026 [cited 2026 Feb 12].Available in: https://www.cdc.gov/nchs/fastats/life-expectancy.htm

  5. Schneider L. US Life expectancy is rebounding. JAMA.2025;334(10):849. doi: 10.1001/jama.2025.10994.

  6. Life Expectancy Table [Internet]. Health.ny.gov. [cited 2026 Feb12]. Available in: https://www.health.ny.gov/health_care/medicaid/publications/docs/adm/06adm-5att8.pdf

  7. Witte RS, Witte JS. Statistics. 11th ed. Nashville, TN: John Wiley &Sons; 2021.

  8. Hernán MA, Hernández-Díaz S. Beyond the intention-to-treat incomparative effectiveness research. Clin Trials. 2012;9(1):48-55. doi:10.1177/1740774511420743.

  9. Smith VA, Coffman CJ, Hudgens MG. Interpreting the results ofintention-to-treat, per-protocol, and as-treated analyses of clinicaltrials. JAMA. 2021;326(5):433-434. doi: 10.1001/jama.2021.2825.

  10. Sondergaard L, Ihlemann N, Capodanno D, et al. Durability oftranscatheter and surgical bioprosthetic aortic valves in patients atlower surgical risk. J Am Coll Cardiol. 2019;73(5):546-553. doi:10.1016/j.jacc.2018.10.083.

  11. García-Villarreal OA. Reoperation rate versus failure rate as qualityindicators in transcatheter edge-to-edge repair for mitral regurgitation.Am J Cardiol. 2024;231:70-71. doi: 10.1016/j.amjcard.2024.08.036.

  12. Medtronic. Urgent medical device correction. [cited 2026 Feb 12].Available in: https://www.medtronic.com/content/dam/medtroniccom/global/HCP/Documents/evolut-urgent-medical-devicecorrection-letter-oct-2020.pdf

  13. Yun JJ, Saleh OA, Chung JW, et al. Cardiac operations aftertranscatheter aortic valve replacement. Ann Thorac Surg.2022;114(1):52-59. doi: 10.1016/j.athoracsur.2021.10.022.

  14. Bowdish ME, Habib RH, Kaneko T, Thourani VH, Badhwar V.Cardiac surgery after transcatheter aortic valve replacement: trends and outcomes. Ann Thorac Surg. 2024;S0003-4975(24)00254-6. doi:10.1016/j.athoracsur.2024.03.024.

  15. Abbott trifecta valves: Potential risk of early structural valvedeterioration - letter to health care providers [Internet]. U.S. Foodand Drug Administration. FDA; 2024 [cited 2026 Feb 19]. Availablein: https://www.fda.gov/medical-devices/letters-health-careproviders/abbott-trifecta-valves-potential-risk-early-structural-valvedeterioration-letter-health-care

  16. Nielsen PH, Hjortdal V, Modrau IS, et al. Durability after aortic valvereplacement with the Mitroflow versus the Perimount pericardialbioprosthesis: a single-centre experience in 2393 patients. Eur JCardiothorac Surg. 2016;49(6):1705-1710. doi: 10.1093/ejcts/ezv432.

  17. Krasniqi L, Dahl JS, Jensen CG, et al. Long-term survival ofMitroflow and Perimount aortic valve replacements: A valve sizestratifiedretrospective observational study. J Card Surg [Internet].2024;2024(1). Available in: http://dx.doi.org/10.1155/2024/6712990




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