الفهرس 
IntroductionOnly 14 pages are availabe for public view
 |  | from | 16 |  |  |
| | | from | 16 | | |
Abstract
Valve replacement still remains the mainstay surgical therapeutic option for patients with valvular heart disease. Unfortunately, to date, no prosthetic valve meets the criteria of the ideal valve that mimics a normal native valve, and each of the currently available prosthetic valves has inherent limitations.
Both On-X valve and St.Jude valve are bileaflet mechanical valve prosthesis of different designs. The SJM standard bileaflet prosthesis is the “gold standard” against which most other mechanical valves are compared. It is the most frequently implanted mechanical heart valve prosthesis worldwide. It has extremely durable design with excellent hemodynamic function. The On-X valve has multiple design features that is claimed to promote effective hemodynamics.
This study aims to compare the early postoperative hemodynamic function and major clinical events in patients receiving SJM valve & On-X valve in mitral position.
In this study, sixty patients of mitral valve disease patients who were scheduled for elective MVR at Ain Shams University Hospitals. These patients were randomly assigned into 2 groupes: Group A: 30 patients received On-X bileaflet mechanical valve; Group B: 30 patients received SJM bileaflet mechanical valve. Exclusion criteria were: Patients in congestive heart failure, Preoperative infective endocarditis, coexistent condition with significant mortality, Emergency operation & Redo-operation and patients with associated coronary disease & ischemic mitral insufficiency.
Preoperative variables include age, gender, body surface area, NYHA class, Euroscore, risk factors and full echocardiographic data.
Intraoperative variables include valve size used, other procedures, inotropic support, cardiopulmonary bypass and aortic cross clamp times.
Postoperative variables include mechanical ventilation time, ICU time, hospital stay, postoperative complications and complete laboratory profile and full echocardiography with valve function assessments.
Results: There were no hospital mortalities in either group. There were 19 female patients in group A and 17 female in group B. The age distribution was 38.7±10.4 years for group A and 40.5±11.7 years for group B. The BSA was 1.74±0.17 and 1.75±0.21 respectively. There was no statistical significance between the two groups regarding demographic data, clinical presentation and preoperative risk factors. Preoperative echocardiographic assessment showed no significant statistical difference (P>0.05) between the two groups regarding EDD, ESD, EF, LAD, PASP, or mitral valve pathology.
There was no significant difference in the aortic cross clamp time, total bypass time or the need of inotropes in both groups. The total ICU stay hours and ventilation hours were 39.5 + 13.0 and 11.9 + 5.0 hours respectively in group A while in the group B they were 46.0 + 21.9 and 12.7 + 8.9 hours respectively with no statistical significance between the two groups.
There was no valve thrombosis, neurological events, valve endocarditis or mortality during the follow-up time in both groups. Postoperative complications was 6 patients (20%) in group A (2 Re-exploration for bleeding 6.7%, 2 Rhythm disturbance 6.7%, 2 Wound infection 6.7%), 5 patients (16.7%) in group B (2 Re-exploration for bleeding 6.7%, 1 Rhythm disturbance 3.3%, 1 Wound infection 3.3%, 1 bleeding event 3.3%), with no statistical significance between the two groups.
As regard Valve function by echocardiography, after 6 months, all valves was working properly with no obstruction, leaflet limitation or paravalvular leak. The mean PPG and MPG was slightly lower in group A (10.1±1.3 and 5.0±0.7 respectively) than in group B (10.2±2.3 and 5.2±1.3 respectively. The mean Effective orifice area (EOA) was higher in group A (2.0±0.3) than in group B (1.9±0.2) but the difference was of no statistical significance (P value > 0.005). The mean Indexed EOA (IEOA=EOA/BSA) was higher in group A (1.1±0.1) than in group B (1.0±0.1) the difference was of statistical significance (P value 0.034).
In group A, the mean EOA and IEOA was (1.79±0.28) (1.12±0.18) with valve size 25, (2.05±0.30) (1.18±0.18) with 27-29 valve and (2.37±0.26) (1.27±0.18) with 31-33 valve respectively. In group B, The mean EOA and IEOA was (1.53±0.13) (0.98±0.07) with valve size 25, (1.92±0.24) (1.08±0.11) with 27 valve, (2.05±0.16) (1.15±0.14) with 29 valve and (2.13±0.25) (1.19±0.15) with 31 valve respectively.
The incidence of PPM was lower in group A than in group B. in group A 13 (43.3%) patients had no PPM, 16 patients (53.3%) had moderate PPM and only one patient (3.3%) had severe PPM. In group B 9 (30.0%) patients had no PPM, 20 patients (66.7%) had moderate PPM and only one patient (3.3%) had severe PPM.