Key result
CardiaMed prosthetic valves were safe and no worse than St. Jude Medical valves for mitral valve replacement, with early post-operative complications occurring in 13.3% vs 16.7% of patients.
Why the study?
Does the CardiaMed prosthetic valve provide comparable early post-operative hemodynamic function and clinical outcomes to the St. Jude Medical valve in patients undergoing elective mitral valve replacement?
RCT (n=60)
randomized
No
Does the CardiaMed prosthetic valve provide comparable early post-operative hemodynamic function and clinical outcomes to the St. Jude Medical valve in patients undergoing elective mitral valve replacement?
Absolute Event Rate: 13.3% vs 16.7%
The CardiaMed freely floating leaflet prosthesis demonstrates comparable safety and hemodynamic performance to the standard St. Jude Medical valve for mitral valve replacement at 6-month follow-up.
CardiaMed valves may be considered for mitral replacement; confirms noninferiority to St. Jude in early complications.
Background With the availability of a wide variety of valve prostheses, surgeons are still searching for the ideal valve, striving for improved hemodynamics, durability and thrombogenicity. The purpose of this prospective, randomized, comparative study was to evaluate the early post-operative hemodynamic function and major clinical events in patients receiving CardiaMed™ prosthetic valves in comparison to St. Jude Medical™ (SJM) valves in the mitral valve position. Methods Between Sept 2013 and Sept 2015, 60 elective mitral valve replacement (MVR) patients in Ain Shams Hospital, Cairo, Egypt were divided into two groups of 30. Group I received the CardiaMed valve and Group II received the SJM valve. All patients were followed up at discharge from hospital, and at three and six months post-operatively. Results There were no statistical differences between groups regarding the demographic data, preoperative clinical and functional NYHA class, cardiac assessment or mitral valve pathology. By the end of the follow up, there was no valve-related co-morbidity. Early post-operative complications were seen in 4 patients (13.3%) in Group I and in 5 patients in Group II (16.7%), namely; re-exploration for bleeding, rhythm disturbance, or wound infection. The PPG and MPG were slightly higher in Group I (10.9 ± 1.2 and 5.3 ± 0.9) than in Group II (10.2 ± 2.3 and 5.2 ± 1.3); p = 0.798 and 0.107 respectively. There was no significant statistical difference between the groups regarding the post-operative echo follow-up data. Conclusions CardiaMed freely floating leaflet prostheses showed good hemodynamic characteristics. The prosthesis adequately corrects hemodynamics and is safe and no worse than the St. Jude Medical valve in the mitral valve position.
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Ahmed et al. (2017) conducted an RCT in elective mitral valve replacement (MVR) (n=60). CardiaMed prosthetic valve vs. St. Jude Medical (SJM) valve was evaluated on early post-operative complications. CardiaMed prosthetic valves were safe and no worse than St. Jude Medical valves for mitral valve replacement, with early post-operative complications occurring in 13.3% vs 16.7% of patients.
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