Key result
The Carpentier-Edwards Perimount Magna aortic bioprosthesis demonstrated a significantly lower incidence of patient-prosthesis mismatch (42.6%) compared to the Standard model (65.3%, p<0.0001) early after surgery.
Why the study?
Does the Carpentier-Edwards Perimount Magna (CEPM) valve improve early postoperative hemodynamic performance compared to the Carpentier-Edwards Perimount Standard (CEPS) valve in patients undergoing aortic valve replacement?
Observational (n=377)
Single-blind
No
Does the Carpentier-Edwards Perimount Magna (CEPM) valve improve early postoperative hemodynamic performance compared to the Carpentier-Edwards Perimount Standard (CEPS) valve in patients undergoing aortic valve replacement?
Absolute Event Rate: 42.6% vs 65.26%
p-value: p=<0.0001
The CEPM aortic bioprosthesis demonstrates a more favorable early hemodynamic profile and lower incidence of patient-prosthesis mismatch compared to the CEPS valve.
May favor Magna valve to reduce early PPM risk; leaves open long-term outcome benefits pending randomized data.
OBJECTIVES: This study was designed to describe Doppler-echocardiography values of Carpentier-Edwards Perimount Standard (CEPS) and Carpentier-Edwards Perimount Magna (CEPM) aortic prosthetic valves, evaluated by a single, experienced echo-laboratory, early in the postoperative phase. METHODS: Three-hundred-seventy-seven consecutive patients, who had had a CEPS or a CEPM implanted in our Hospital due to aortic stenosis and/or insufficiency, underwent baseline Doppler echocardiography evaluation within 7 days after surgery. Hemodynamic performances of CEPS and CEPM were accurately described, evaluating flow-dependent (transprosthetic velocities and gradients) and flow-independent (effective orifice area, indexed effective orifice area and Doppler velocity index) Doppler-echocardiography parameters. RESULTS: Out of the 377 patients 48.8% were men (n = 184), mean age was 74.63 ± 6.77 years, mean BSA was 1.78 ± 0.18 m2, mean ejection fraction was 57.78 ± 8%. Two-hundred and sixty two CEPS and 115 CEPM were implanted. Comparing size-by-size CEPS with CEPM, both prostheses showed a good hemodynamic profile, with fairly similar values of pressure gradients (PGmax and mean, in mmHg, = 37,18 ± 11.57 and 20.81 ± 7.44 in CEPS n°19 compared to 32,47 ± 7,76 and 17,67 ± 4.63 in CEPM n°19 and progressively lower in higher sized prostheses, having PGmax and mean 15 ± 3,16 and 9.15 ± 1,29 in CEPS n°29 compared to 15,67 ± 1,53 and 9 ± 1 in CEPM n°29) and EOAi (being 0,65 ± 0,33 cm²/m² in CEPS n°19 compared to 0,77 ± 0,29 cm²/m² in CEPM n°19 and progressively higher in higher sized prostheses, being 1,28 ± 0,59 cm²/m² in CEPS n°29 compared to 1,07 ± 0,18 cm²/m² in CEPM n°29), the latter resulting, however, basically less flow obstructive. CONCLUSIONS: Our data confirm the good hemodynamic performance of both aortic bioprostheses and the more favourable hemodynamic profile of CEPM compared to CEPS, pointing out the need to perform routinely an accurate baseline Doppler-echocardiography evaluation early after surgery to allow an adequate interpretation of data at follow-up.
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Minardi et al. (2011) conducted an observational in Aortic stenosis and/or aortic insufficiency (n=377). Carpentier-Edwards Perimount Magna (CEPM) vs. Carpentier-Edwards Perimount Standard (CEPS) was evaluated on Incidence of patient-prosthesis mismatch (PPM) (p=<0.0001). The Carpentier-Edwards Perimount Magna aortic bioprosthesis demonstrated a significantly lower incidence of patient-prosthesis mismatch (42.6%) compared to the Standard model (65.3%, p<0.0001) early after surgery.
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