The Inspiris Resilia aortic valve demonstrated safe early outcomes and significantly lower mean trans-prosthetic pressure gradients (9 vs 12 mm Hg, p=0.001) compared to the Magna Ease valve.
Cohort (n=125)
No
Does the Inspiris Resilia aortic valve provide non-inferior clinical and hemodynamic outcomes compared to the Carpentier-Edwards Magna Ease valve in patients undergoing surgical aortic valve replacement?
The Inspiris Resilia aortic valve demonstrates safe early clinical outcomes and potentially improved early hemodynamics compared to the Magna Ease valve.
Tasa de eventos absoluta: 9% vs 12%
valor p: p=0.001
Introduction: The Inspiris Resilia aortic valve® (INSPIRIS) is a pericardial bio-prosthesis with a new sterilization procedure that shows promising results in terms of reduced calcification. Methods: The 30-day mortality and morbidity were analyzed, comparing the INSPIRIS implanted between May 2017 and the end of January 2019, with its "predecessor", the Carpentier-Edwards Perimound Magna Ease (ME). Echocardiography was performed one-week after surgery. 125consecutively operated patients were included (59 INSPIRIS, 66 ME). Results: One patient in the ME group died and one patient in the INSPIRIS group had a complicated postoperative course due to right heart failure. Two patients (one INSPIRIS, one ME patient) suffered a perioperative stroke. The hemodynamic evaluation shows an effective reduction of mean transvalvular pressure gradients after surgery in both groups. INSPIRIS tended to have lower trans-prosthetic pressure gradients (9 mm Hg, Interquartile range IQR 11-7 mm Hg versus 12 mm Hg, IQR 15-9 mmHg; P = 0.001), reduced trans-prosthetic blood flow acceleration (209 cm/s, IQR 220-190 cm/s versus227 cm/s, IQR 263-191 cm/s; P = 0.003) and increased permeability indices (57%, IQR 67%- 47% versus42%, IQR 48%-38%; P8%; P < 0.001). Conclusion: There are only few clinical data available from INSPIRIS, and the present analysis confirms good results initial postoperatively with a tendency towards possibly improved hemodynamics compared to ME.
Shala et al. (Wed,) conducted a cohort in Aortic valve disease (n=125). Inspiris Resilia aortic valve vs. Carpentier-Edwards Perimound Magna Ease was evaluated on Postoperative mean trans-prosthetic pressure gradient in patients with severe native valve stenosis (p=0.001). The Inspiris Resilia aortic valve demonstrated safe early outcomes and significantly lower mean trans-prosthetic pressure gradients (9 vs 12 mm Hg, p=0.001) compared to the Magna Ease valve.