Transcatheter or Surgical Aortic Valve Replacement in Patients With Severe Aortic Stenosis and Small Aortic Annulus: A Randomized Clinical Trial

Abstract

Background: The optimal treatment in patients with severe aortic stenosis (AS) and small aortic annulus (SAA) remains to be determined. The objectives of this study were to compare the hemodynamic and clinical outcomes between transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR) in patients with a SAA. Methods: Prospective multicenter international randomized trial performed in 15 university hospitals. Participants were 151 patients with severe AS and SAA (mean diameter <23 mm) were randomized (1:1) to TAVR (n=77) vs SAVR (n=74), The primary outcome was impaired valve hemodynamics (i.e. severe prosthesis patient mismatch [PPM ] or moderate-severe aortic regurgitation [AR]) at 60 days as evaluated by Doppler-echocardiography and analyzed in a central echocardiography core laboratory. Clinical events were secondary outcomes. Results: The mean age of the participants was 75±5 years, with 140 (93%) women, a median STS of 2.50 (1.67-3.28)%, and a median annulus diameter of 21.1 (IQR: 20.4-22.0) mm. There were no differences between groups in the rate of severe PPM or moderate-severe AR (severe PPM (TAVR: 4 [5.6 %], SAVR: 7 [10.3%], p=0.30), and moderate-severe AR (none in both groups). There were no differences between groups regarding mortality (TAVR: 1 [1.3%], SAVR: 1 [1.4%], p=1.00) and stroke (TAVR:0, SAVR: 2 [2.7%], p=0.24) at 30 days. After a median follow-up of 2 (1-4) years, there were no differences between groups regarding mortality (TAVR: 7 [9.1%], SAVR: 6 [8.1%], p=0.89), stroke (TAVR: 3 [3.9%], SAVR: 3 [4.1%], p=0.95), and cardiac hospitalization (TAVR: 15 [19.5%], SAVR: 15 [ 20.3%], p=0.80). Conclusions: In patients with severe AS and SAA (women in the vast majority), there was no evidence of superiority of contemporary TAVR vs. SAVR regarding valve hemodynamic results. After a median follow-up of 2 years, there were no differences in clinical outcomes between groups. These findings suggest that the 2 therapies represent a valid alternative for treating patients with SA and SAA, and treatment selection should likely be individualized according to baseline characteristics, additional anatomical risk factors, and patient preference. However, the results of this study should be interpreted with caution due to the limited sample size leading to an underpowered study, and need to be confirmed in future larger studies.

Incidence, Implications, and Treatment of Patients With Severe Aortic Stenosis and Small Aortic Annulus

“…On this background, Rodes-Cabau and colleagues report in this issue the results of the VIVA (Transcatheter Aortic Valve Replacement Versus Surgical Aortic Valve Replacement for Treating Elderly Patients With Severe Aortic Stenosis and Small Aortic Annuli: A Prospective Randomized Study; NCT03383445) trial, a randomized, multicenter, international trial that compared surgical and transcatheter AVR in 151 patients with severe aortic stenosis and SAA (diameter <23 mm). 12 The primary outcome of impaired valve hemodynamics (severe PPM and ≥moderate aortic regurgitation) at 60 days was similar in both arms, as was the composite of mortality, stroke, and cardiac hospitalization at 2 years.…”

“…4 In this regard, a trend towards worse outcome in the SAVR group is apparent in Figure 1. 12 Finally, this trial enrolled a very low-risk population with normal ejection fraction. The adverse effects of severe PPM are greater in patients with reduced ejection fraction or stroke volume.…”

Female Sex and Low Flow

“…The study population included 93% women with no differences between TAVR and SAVR in regard to prosthesis patient prosthesis mismatch and no differences in stroke or mortality at 30 days and 2 years. 12 Findings such as these also strengthen the need for such dedicated studies as WIN-TAVI, which is an international, multicenter, prospective, observational registry of women undergoing TAVR across multiple sites, mostly in Europe. Initial analysis from WIN-TAVI noted that in intermediate to high-risk women, TAVR was associated with low risk of 1-year mortality and stroke.…”

Advances in Clinical Cardiology 2023: A Summary of Key Clinical Trials

“…There was no difference in rates of pacemaker (PPM) implantation at 30 days (TAVI 5.6% vs SAVR 10.3%, p = 0.30) or a median of 2 years for mortality (TAVI 9.1%, SAVR 8.1%, p = 0.89) or stroke (TAVI 3.9% vs SAVR 4.1%, p = 0.95). However, the study was stopped prior to reaching sufficient numbers to achieve appropriate power; therefore, the data, which are much needed in this area, should be interpreted with caution [ 42 ].…”