Clinical Outcomes in Fenestrated Extra-Cardiac Fontan in Low Preoperative Risk Profiles
Clinical Outcomes in Fenestrated Extra-Cardiac Fontan in Low Preoperative Risk Profiles
Evaluation of fenestration benefit in Extra-cardiac total cavo-pulmonary connection (Fontan
 procedure) in single ventricle anomaly, comparing clinical outcomes of patients with low
 preoperative risk profiles in prospective study
Study Population:

 This study will include all patients referred for an elective Fontan procedure at the period
 of the study, who demonstrated a standard risk profile. An Informed consent will be obtained
 from the guardians before enrollment in the investigation. All procedures followed will be in
 accordance with institutional guidelines.

 Randomization Technique:

 Patients will be assigned to undergo either a fenestrated or non-fenestrated Extra-cardiac
 Fontan, based on a table of randomly generated numbers. Preoperative clinical data will be
 collected and compared to ensure appropriate randomization.

 Preoperative Evaluation:

 Enrolment Criteria:

 Preoperative evaluation consists of ECG, transthoracic echocardiogram, and complete cardiac
 catheterization.

 Patients with the following parameters will be eligible for enrollment in the study:

 Sinus Rhythm Atriovnetricular valve regurgitation not more than mild Aortic (neoaortic) valve
 regurgitation not more than mild Normal systolic dominant ventricle function Mean pulmonary
 artery pressure not more than 15 mmHg (measured directly or estimated by pulmonary vein wedge
 pressure) Pulmonary vascular resistance not more than 2 woods unit End diastolic ventricular
 filling pressure not more than 8 mm Hg

 Patient with the following will not be eligible for inclusion:

 Patients with pulmonary artery distortion, stenosis or thrombus requiring surgical or
 interventional additional procedures before or during the Fontan operation. Pacemaker
 insertion before or during Fontan operation. Significant pulmonary arteriovenous
 malformations (AVMs) rendering fenestration potentially a cause of excessive cyanosis.
 Patients for whom the cardiology/cardiac surgery case conference decision is strongly in
 favor of fenestration for any other cause.

 Ventricular filling pressure will be directly measured as the end-diastolic pressure in the
 dominant systemic ventricle. The degree of systemic atrioventricular valve regurgitation will
 be assessed semi-quantitatively by echocardiographic color Doppler, primarily based on width
 of jet origin. The regurgitation jet will be graded as none, mild, moderate, or severe.
 Rhythm is assessed with preoperative ECG or Holter monitor (if required). Coil occlusion of
 aortopulmonary collaterals is not an exclusion criterion and is recommended before the Fontan
 operation.

 Operative Technique and postoperative management:

 Treatment Patients underwent an extracardiac Fontan operation. The extracardiac Fontan
 channel will be constructed with a Polytetrafluoroethylene (PTFE) tube graft from the
 inferior vena cava to the pulmonary artery. The size if the graft is determined by the
 surgeon and ranged from 16 to 22 mm in diameter. The fenestration consists of a single 3- to
 6-mm communication between the Fontan channel and the common atrium.

 Postoperative treatment will include administration of captopril, and aggressive use of
 diuretics. All patients will receive aspirin (81 mg per day) and warfarin with a target
 International Normalized Ration INR of 2-2.5 beginning on the first postoperative day. To
 maximize caloric intake, patients ill not be fluid restricted after the initial postoperative
 period. All patients will be placed on fat free diet for 6 weeks. Chest tubes will be left in
 place until drainage is less than 5 mL/kg in a 24-hour period. A chest tube will be
 reinserted only if a symptomatic pleural effusion is diagnosed. Steroids and Octreotide will
 be started after 2 weeks of persistent drainage or immediately if Chylothorax is diagnosed
 biochemically.

 The attending cardiologist and surgeon determined the need for and timing of postoperative
 cardiac catheterization. Patients will be discharged from the intensive care unit when
 hemodynamic and respiratory stability is ensured and a stable heart rhythm is maintained. The
 patients will be discharged from hospital after all chest tubes are removed and when the
 clinical status permits.

 Assessment of Outcomes:

 The primary end is the total length of chest tube drainage in days. If chest tube reinsertion
 is required during the same admission, this time will be added to the primary outcome. Other
 outcome variables include length of stay in the intensive care unit, total hospital stay in
 days, total amount of chest tube drainage, occurrence of stroke,readmissions, reoperation, or
 death within 90 days of discharge. All end points are defined a priori. The day of surgery
 counted as day 1 for all variables. All reoperations will be assessed including returning to
 the operating room for bleeding or poor hemodynamics, replacement of chest tubes, cardiac
 catheterization, and late fenestration.

 Statistical Analysis:

 Sample size estimates is based on a retrospective analysis of the last 100 patients who
 underwent the Fontan procedure at out institutionwith 80% power to avoid a type II
 statistical error. A reduction in total chest tube drainage days of 15% is considered
 clinically significant. The median length of chest tube drainage (estimated as one day less
 than the median postoperative length of hospitalization) was 19 days. Given a clinically
 significant difference of 15%, the calculated days of difference were 19 X 0.15 = 2.85. We
 set the relevant difference to be 3 days. Using a modified Lehr's equation for sample size in
 count data, we estimate the number in each group to be, n=4/〖(√(γ_1 )-√(γ_2 ))〗^2
 =4/〖(√19-√16)〗^2 =31patients.

 Descriptive statistics will be calculated for all variables. Medians and ranges describe
 continuous variables. Categorical variables will be summarized as frequencies. The Mann
 Whitney U test will be used for all continuous variables; analysis and Fisher's exact test
 will be applied for all dichotomous variables.

 Count data for hospital length of stay, intensive care unit length of stay, and length of
 chest tube drainage will be compared by means of Poisson regression or Cox proportional
 hazards models. A probability value of 0.05 will indicate statistical significance. All
 calculations were performed with R-project statistical software (www.r-project.org).
Inclusion Criteria:

 -  This study will includeall patients referred for an elective TCPC procedure at the
 period of the study, who demonstrated a standard risk profile

 -  Preoperative evaluation consisted of ECG, transthoracic echocardiogram, and complete
 cardiac catheterization.

 Patients with the following parameters will be eligible for enrollment in the study:

 -  Sinus Rhythm

 -  Atriovnetricular valve regurgitation not more than mild

 -  Aortic (neoaortic) valve regurgitation not more than mild

 -  Normal systolic dominant ventricle function

 -  Mean pulmonary artery pressure not more than 15 mmHg (measured directly or estimated
 by pulmonary vein wedge pressure)

 -  Pulmonary vascular resistance not more than 2 woods unit

 -  End diastolic ventricular filling pressure not more than 8 mm Hg

 Patient with the following will not be eligible for inclusion:

 -  Patients with pulmonary artery distortion, stenosis or thrombus requiring surgical or
 interventional additional procedures before or during the Fontan operation.

 -  Pacemaker insertion before or during Fontan operation.

 -  Significant pulmonary arteriovenous malformations (AVMs) rendering fenestration
 potentially a cause of excessive cyanosis.

 -  Patients for whom the cardiology/cardiac surgery case conference decision is strongly
 in favor of fenestration for any other cause.