Prosthesis-patient mismatch with intra-annular self-expanding valves: an analysis of the PORTICO IDE trial.

BACKGROUND

Aortic valve replacement in small aortic annuli is associated with an increased risk of impaired haemodynamics.

AIMS: We sought to evaluate haemodynamic outcomes and prosthesis-patient mismatch (PPM) in aortic stenosis (AS) patients treated with Portico, Evolut, and SAPIEN 3 transcatheter aortic valves (TAVs) in small (diameter ≤23 mm) and large (diameter >23 mm) aortic annuli.

METHODS

PORTICO IDE was a prospective, multicentre, international, premarket randomised controlled trial comparing Portico to Evolut and SAPIEN 3 TAVs. An independent core laboratory evaluated the mean transvalvular pressure gradient (MG) and the effective orifice area (EOA), and PPM was calculated based on the core lab results.

RESULTS

A total of 675 patients with severe AS at high or extreme surgical risk were included (Portico: 362 patients; Evolut: 109; SAPIEN 3: 204). At 30 days, the EOA and rates of severe PPM in small aortic annuli were similar between Portico and Evolut (EOA 1.65 cm2 vs 1.78 cm2; p=0.09; PPM 3.3% vs 3.0%; p=1.0) with a higher MG (8.5 mmHg vs 6.9 mmHg; p=0.034) for Portico. No significant differences were observed between Portico and Evolut for large aortic annuli (MG 8.3 mmHg vs 7.4 mmHg; p=0.069; EOA 1.93 cm2 vs 2.02 cm2; p=0.18; PPM 5.4% vs 3.2%; p=0.83). Portico was superior to SAPIEN 3 in both small (MG 8.5 mmHg vs 13.7 mmHg; p<0.0001; EOA 1.65 cm2 vs 1.40 cm2; p<0.0001; PPM 3.3% vs 26.3%; p<0.0001) and large annuli (MG 8.3 mmHg vs 10.9 mmHg; p<0.0001; EOA 1.93 cm2 vs 1.67 cm2; p<0.0001; PPM 5.4% vs 10.9%; p=0.0014). At 5 years, the rate of structural valve deterioration in patients with small aortic annuli was significantly lower in patients treated with Portico (2.2%) versus SAPIEN 3 (13.9%; p=0.03).

CONCLUSIONS

Haemodynamic performance was similar for the intra-annular Portico and supra-annular Evolut. Portico haemodynamics outperformed the balloon-expandable SAPIEN 3 for PPM and mean gradient in both small and large aortic annuli.