Material and methods
Study subjects : all patients diagnosed with isolated aortic valve
disease, had indications for surgery according to AHA guidelines,
underwent aortic valve reconstruction surgery using autologous
pericardium by Ozaki’s procedure at Cardiovascular Center, E Hospital
from June 2017 to December 2019.
Study design : an observational study of all patients with
isolated aortic valve disease undergoing aortic valve reconstruction
surgery by Ozaki’s technique.
Surgical procedures : All surgical procedures were performed by
surgeons who received direct hands-on training and training certificate
from Prof. Ozaki. This surgery was performed via a sternotomy, therein
the pericardium was elaborately dissected and harvested in a minimum
size of 8x8 cm by ultrasonic scalpel. Then, the pericardium was treated
with glutaraldehyde 0,6% solution in 10 minutes before being rinsed
with normal saline for 6 minutes (repeatedly three times). The
establishment of the cardiopulmonary bypass system utilized 03 cannulas
inserted respectively in ascending aorta, superior vena cava, and
inferior vena cava. After opening the ascending aorta, diseased cusps
were resected entirely. The measured distance of 2 commissures indicated
the size of the reconstructed cusp using autologous pericardium. The
constructed cusps were then sutured to the respective annulus. The
aortic valve should be tested before closing the incision of the aorta.
After aortic cross-clamp was release and the return of beating heart,
transesophageal echocardiography was performed to evaluate valvular
morphology and hemodynamics following termination of cardiopulmonary
bypass.
Data collection and statistical analysis : preoperative variables
(clinical features, subclinical parameters, echocardiography),
intraoperative variables (aortic annulus size, the number of constructed
cusps, aortic cross-clamp time, cardiopulmonary bypass time, …), short
and mid-term outcomes (clinical features, echocardiography,
complications, survival rate) were collected during a minimum of 12
months follow-up. Data were analyzed by R 4.0.0 software using t-test
and ANOVA test to compare the means of different groups.
Research ethics : Our study was approved by Hanoi Medical
University Institutional Ethical Review Board with approval number
NCS06/HMUIRB (the most prestigious medical university of Vietnam) and
the Ethics Committee of E hospital (approval number 1018/BB-BE).
Patients were provided full information about different surgical methods
for aortic valve disease and the advantages or disadvantages of each
method before making decision.