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Valve-in-valve (ViV) transcatheter aortic valve replacement (TAVR) has been associated with favorable outcomes in patients with degenerated stentless bioprosthesis. However, whether the outcomes after ViV TAVR for failed stentless bioprosthesis differ between balloon-expandable valves (BEVs) and self-expanding valves (SEVs) remains unknown. Therefore, we retrospectively analyzed 59 consecutive patients who underwent ViV TAVR for failed stentless bioprsothesis with BEVs (n = 42) versus SEVs (n = 17) in a single-health care system between 2013 and 2022. Overall, the mean age was 70.8 years and 74.6% were men. The mean transcatheter valve size was 26.3 ± 2.2 mm for BEVs and 26.4 ± 4 mm for SEVs (p = 0.93). The mean Society of Thoracic Surgeons score was 6.0 ± 3.6 for BEVs and 7.5 ± 5.5 for SEVs (p = 0.22). Compared with patients who received BEVs, those who received SEVs had higher rates of device malposition (2.4% vs 23.5%, p <0.01), postdeployment balloon dilation (11.9% vs 35.5%, p = 0.04) and need for a second transcatheter device (2.4% vs 35.5%, p <0.01). However, both groups showed similar improvement in aortic valve function at 30-day and 1-year follow-up (incidence of 1-year severe patient-prosthesis mismatch in BEVs: 17.6% vs 14.3% in SEVs, p = 0.78). The 1- and 3-year mortality did not differ between BEVs and SEVs (11.9% vs 11.8% and 25% vs 30%, respectively, Log rank p = 0.9). In conclusion, performing ViV TAVR for failed stentless bioprsothesis is technically challenging, especially when using SEVs; however, satisfactory positioning is possible in most cases, with excellent hemodynamic and clinical outcomes with BEVs and SEVs., Competing Interests: Declaration of competing interest Karim Al-Azizi is a proctor/consultant for Edwards Lifesciences, consultant/part of the advisory board for Medtronic, consultant for Boston Scientific, and part of the speaker bureau for Philips. Michael Mack is a trial coprincipal investigator for Abbott and Edwards Life sciences and a trial study chair for Medtronic—all uncompensated. Molly Szerlip is a proctor, speaker, and consultant for Edwards Lifesciences; part of the advisory board, consultant, and proctor for Abbott Vascular; part of the steering committee for Medtronic; and speaker and consultant for Boston Scientific. The remaining authors have no competing interest to declare., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Background: Few randomized trials have compared bioprostheses for transcatheter aortic valve replacement, and no trials have compared bioprostheses with supra-annular design. The SCOPE 2 trial (Safety and Efficacy Comparison of Two TAVI Systems in a Prospective Randomized Evaluation 2) was designed to compare the clinical outcomes of the ACURATE neo and CoreValve Evolut bioprostheses for transcatheter aortic valve replacement.Methods: SCOPE 2 was a randomized trial performed at 23 centers in 6 countries between April 2017 and April 2019. Patients ≥75 years old with an indication for transfemoral transcatheter aortic valve replacement as agreed by the heart team were randomly assigned to receive treatment with either the ACURATE neo (n=398) or the CoreValve Evolut bioprostheses (n=398). The primary end point, powered for noninferiority of the ACURATE neo bioprosthesis, was all-cause death or stroke at 1 year. The key secondary end point, powered for superiority of the ACURATE neo bioprosthesis, was new permanent pacemaker implantation at 30 days.Results: Among 796 randomized patients (mean age, 83.2±4.3 years; mean Society of Thoracic Surgeons Predicted Risk of Mortality score, 4.6±2.9%), clinical follow-up information was available for 778 (98%) patients. Within 1 year, the primary end point occurred in 15.8% of patients in the ACURATE neo group and in 13.9% of patients in the CoreValve Evolut group (absolute risk difference, 1.8%, upper 1-sided 95% confidence limit, 6.1%; P=0.0549 for noninferiority). The 30-day rates of new permanent pacemaker implantation were 10.5% in the ACURATE neo group and 18.0% in the CoreValve Evolut group (absolute risk difference, -7.5% [95% CI, -12.4 to -2.60]; P=0.0027). No significant differences were observed in the components of the primary end point. Cardiac death at 30 days (2.8% versus 0.8%; P=0.03) and 1 year (8.4% versus 3.9%; P=0.01), and moderate or severe aortic regurgitation at 30 days (10% versus 3%; P=0.002) were significantly increased in the ACURATE neo group.Conclusions: Transfemoral transcatheter aortic valve replacement with the self-expanding ACURATE neo did not meet noninferiority compared with the self-expanding CoreValve Evolut in terms of all-cause death or stroke at 1 year, and it was associated with a lower incidence of new permanent pacemaker implantation. In secondary analyses, the ACURATE neo was associated with more moderate or severe aortic regurgitation at 30 days and cardiac death at 30 days and 1 year. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03192813. [ABSTRACT FROM AUTHOR]