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 ¼ 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.
© 2017 The Egyptian Society of Cardio-thoracic Surgery. Publishing services by Elsevier B.V.
This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/
licenses/by-nc-nd/4.0/). |
