Prepared by: Dr. Muhammet Ali Ekiz

Title of the Study: Outcomes of Transcatheter Aortic Valve Implantation in Patients with Native Bicuspid Aortic Valve and Concomitant Aortopathy: the PROSPERO-TAVI Study

Published in Congress: EuroPCR 2025

Link:https://media.pcronline.com/diapos/EuroPCR2025.pdf
Introduction: Bicuspid aortic valve (BAV) is the most common congenital valve anomaly and is frequently associated with aortic stenosis. Aortic dilatation (aortopathy) accompanying BAV complicates treatment strategies in these patients. Current surgical guidelines recommend surgical intervention for aortic diameters of 45 mm and above. However, transcatheter aortic valve implantation (TAVI) has been increasingly used in recent years in elderly patients and those at high surgical risk. Nevertheless, data on aortic progression and long-term clinical outcomes after TAVI in patients with BAV and concomitant aortopathy are limited. The PROSPERO-TAVI study aims to fill this knowledge gap.

Objective: The PROSPERO-TAVI study aims to evaluate 5-year aortic progression and clinical outcomes after TAVI in patients with native BAV and concomitant aortopathy.

Methods: PROSPERO-TAVI is an international, multicenter, ambispective registry including consecutive BAV patients who underwent TAVI between January 2018 and December 2019. A total of 261 patients from 17 centers were included in the study. The primary endpoints were defined as aortopathy progression (aortic event, surgical intervention, or >2 mm aortic dilation). Secondary endpoints included all-cause mortality, cardiac death, stroke, valve-related stroke, and bioprosthetic valve failure (BVF).

Results: The mean age of the patients was 78 years (IQR: 72–82.9), and 46.6% were female. The proportion of patients with an aortic diameter ?45 mm was 14.2%. Over the five-year follow-up, aortopathy progression was generally rare; aortic event: 0.4%, surgical aortic intervention: 0.4%, aortic dilation: 1.5%. No significant differences in clinical outcomes were observed between patients with (?45 mm) and without aortopathy. The technical success rate of TAVI was 96.2%, with low PVR rates (moderate-severe: 8.4%). The 5-year IPTW-adjusted all-cause mortality rate was 30.6%, and the cardiac death rate was 9.3%. Valve-related stroke and valve failure rates were similarly low.

Discussion: The PROSPERO-TAVI study provides an important contribution in assessing the long-term safety and efficacy of isolated TAVI in bicuspid aortic valve patients with concomitant aortopathy. Although current clinical guidelines recommend a surgical approach in patients with an aortic diameter ?45 mm, the study results show that TAVI is a safe option compared to surgery in elderly patients with suitable anatomy. In particular, the rarity of aortopathy progression and minimal changes in aortic diameter suggest that a non-surgical follow-up strategy may be considered in this patient group. Moreover, the fact that clinical outcomes (death, stroke, BVF) were similar regardless of aortic diameter supports the feasibility of isolated TAVI even in patients with an aortic diameter ?45 mm. However, the evaluation of horizontal aorta and anatomical variations should be considered in patient selection. Nevertheless, PROSPERO-TAVI provides valuable information in the clinical decision-making process by demonstrating that isolated TAVI is safe and effective in elderly BAV patients, even in the presence of aortopathy.

Conclusion:
The PROSPERO-TAVI study demonstrates that isolated TAVI is safe and effective in patients with native BAV and concomitant aortopathy. Aortic complications were rare over the 5-year follow-up, and additional surgical intervention was generally not required in those with an aortic diameter ?45 mm. These findings support that isolated TAVI is a reasonable option in elderly patients with suitable anatomical features.