SOLACI | Latin American Society of Interventional Cardiology

Degenerative aortic stenosis (AS) is the most common valve condition. A significant number of AS patients presents a small aortic annulus (SAA), especially women. Treating this group of patients remains challenging, seeing as they have a high incidence of suboptimal hemodynamic results.

TCT 2023 | Ensayo VIVA: TAVI vs. Cirugía en Pacientes con Estenosis Aórtica Severa y Anillo Aórtico Pequeño

Despite the development of TAVR (transcatheter aortic valve replacement), the current guidelines do not take into account annulus size, hemodynamic outcomes of prosthetic valves or gender. There are data from observational and sub studies suggesting the superiority of TAVR vs surgical aortic valve replacement (SAVR) in the treatment of patients with SAA.

The aim of this multicenter randomized study was to compare hemodynamic and clinical outcomes of TAVR vs SAVR in the treatment of AS with SAA.

Primary end point was defined as improved hemodynamic results, including severe patient-prosthesis mismatch (PPM) and/or moderate-severe aortic regurgitation (AR) at 60 days. Secondary end point included mean transvalvular gradient at 60 days, as well as clinical variables such as mortality, stroke, major bleeding, de novo atrial fibrillation, definite pacemaker implantation and rehospitalization for cardiac causes at 30 days.

A total 156 patients were randomized, 79 were treated with TAVR and 75 with SAVR. Mean age was 75, and patients were mostly women. Mean STS score was 2.5. Mean annulus diameter was 21.1 mm. Most TAVR patients received self-expanding valves (59.2%) followed by balloon expandable valves (40.8%), and mean prosthetis size was 23 mm.

There were no differences between the groups as regards severe PPM or moderate-severe AR (severe PPM: TAVR: 5.6%, SAVR: 10.3%, p=0.30) and AR moderate-severe (none in both groups). Neither were there differences in mortality or stroke at 30 days. After mean 2-year followup, there were no differences in mortality (p=0.89), stroke (p=0.95) or cardiac hospitalization (p=0.80).

Conclusion

In patients with AS and SAA, no significant differences were found between TAVR and SAVR as regards hemodynamic valve outcomes at 2 year followup. These findings suggest that both therapeutic strategies are valid options to treat patients with AS and SAA, and that treatment should be decided on a case by case basis according to baseline characteristics, additional anatomical risk factors and patient preference. However, we should interpret outcomes with precaution seeing the limited size of this study population.

Dr. Andrés Rodríguez.
Member of the Editorial Board of SOLACI.org.

Original Title: Transcatheter or Surgical Aortic Valve Replacement in Patients with Severe Aortic Stenosis and Small Aortic Annulus: A Randomized Clinical Trial.

Reference: Josep Rodés-Cabau, MD, PhD et al TCT 2023.