Objectives: The purpose of this study was to compare haemodynamics at rest and during exercise after clinically indicated aortic valve replacement (AVR) for aortic stenosis among patients randomly assigned to one of three haemodynamically excellent bioprostheses.
Methods: In a single-centre, prospective trial, 60 patients undergoing clinically indicated AVR were randomly assigned to Freestyle, Magna Ease or Trifecta bioprostheses. Six months after surgery, patients underwent supine bicycle stress echocardiography for the assessment of aortic valve haemodynamics.
Results: There were 5 protocol deviations from random valve assignments, and 4 patients did not return for follow-up stress echo, yielding a study group of 56 patients {17 Freestyle, 21 Magna Ease, 18 Trifecta; median age 70 [interquartile range (IQR) 63-78 years], 37 (66%) men}. There were no statistically significant differences between groups in valve size, concomitant procedures or exercise variables. Resting haemodynamics revealed significant differences between groups in mean gradient [Freestyle 7 (IQR 5-9) mmHg, Magna Ease 9 (IQR 7-11) mmHg, Trifecta 5 (IQR 4-8) mmHg; P = 0.04], effective orifice area (EOA) [2.5 (IQR 2.2-2.7), 2.1 (IQR 1.7-2.3) and 2.6 (IQR 2.3-2.8), respectively; P = 0.02] and EOA index [1.22 (IQR 1.11-1.32), 1.02 (IQR 0.89-1.14) and 1.31 (IQR 1.00-1.42), respectively; P = 0.03]; in each case, Trifecta had better haemodynamics compared with Magna Ease. With exercise, significant differences between groups were evident in peak velocity at 50 watts and peak exercise; mean gradient at 25 watts, 50 watts and maximal exercise; and EOA at 25 watts and at peak exercise; all with haemodynamic superiority of Trifecta compared with Magna Ease. There were no statistically significant differences between Trifecta and Freestyle haemodynamics at rest or with exercise.
Conclusions: In a prospective, randomized study comparing haemodynamics after Freestyle, Magna Ease and Trifecta, all three valves exhibited good haemodynamics at rest and with exercise. There were small but significant differences between groups, with favourable haemodynamics associated with Trifecta compared to Magna Ease, and no significant differences between Trifecta and Freestyle. The Trifecta valve appears to offer haemodynamics similar to a stentless valve without the technical complexity of stentless valve implantation.
Clinicaltrialsgov Identifier: NCT01635244.
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http://dx.doi.org/10.1093/ejcts/ezv493 | DOI Listing |
Case Rep Surg
October 2024
Department of Cardiac Surgery, "Vito Fazzi" Hospital, Lecce, Italy.
Aortic valve replacement (AVR) in a patient with a bio-Bentall conduit can be very challenging, especially if there was a previous endocarditis process for significant morbidity and mortality. We report a case of sutureless AVR in an old patient with a bio-Bentall conduit (Carpentier-Edwards Perimount Magna Ease 25 aortic valve and Hemashield 30 aortic conduit), who developed an endocarditis on aortic prosthesis valve. We believe that sutureless AVR is the best option for redo-operation in older patients with a high surgical risk because it allows for easy rapid deployment implantation, avoids anchoring sutures on a fragile aortic anulus, and reduces cardiopulmonary and aortic cross-clamp times.
View Article and Find Full Text PDFJ Cardiovasc Transl Res
December 2024
Department of Mechanical and Materials Engineering, University of Denver, 2155 E. Wesley Ave, Room 439, Denver, CO, 80208, USA.
J Thorac Dis
August 2024
CAROL-Cardiothoracic Anatomy Research Operative Lab, Department of Cardiovascular Surgery and Transplantology, Institute of Cardiology, Jagiellonian University Medical College, Krakow, Poland.
Background: In the era of percutaneous aortic valve implantation, biological valves are the preferred prostheses implanted in patients undergoing surgical aortic valve replacement (sAVR). The aim was to present a real-life analysis of mid-term sAVR outcomes for the four aortic bioprostheses: the Hancock II, the Carpentier-Edwards Perimount Magna, the Carpentier-Edwards Perimount Magna Ease and the Trifecta valve.
Methods: This is a retrospective study based on data from the Polish National Cardiac Surgery Database.
Int J Cardiol Heart Vasc
October 2024
Division of Cardiac Surgery, University of Padova, Padova, Italy.
Surg Technol Int
July 2024
European Hospital, UniCamillus-Saint Camillus International University of Health Sciences, Rome, Italy.
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