Ignite Creation Date:
2024-05-05 @ 12:11 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00267995
Status:
TERMINATED
Last Update Posted:
2011-07-06
First Post:
2005-12-20
Brief Title:
Ross Aortic Valve Replacement Patients
Sponsor:
Childrens Healthcare of Atlanta
Organization:
Childrens Healthcare of Atlanta
Study Overview
Official Title:
Proposal for Retrospective Review of Ross Aortic Valve Replacement Patients
Status:
TERMINATED
Status Verified Date:
2007-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The Ross procedure has become the surgery of choice for aortic valve replacement in children This consists of taking a childs own pulmonary valve the autograft and replacing the childs diseased aortic valve with the autograft At times this can involve either enlarging or reducing the diameter of the aortic annulus to make the valve fit properly The patients own pulmonary valve is then replaced most typically with a human heart valve a homograft There has been some concern in the literature that as time goes on the autograft will dilate and the patient will develop progressive aortic insufficiency
Since 1994 we have performed almost 50 Ross procedures in children and young adults Contrary to many reports from the literature we have not recognized a problem with autograft enlargement and progressive aortic insufficiency One thing that we have done differently from other centers is that we have modified the insertion technique of the autograft into the native aortic root This involves a second buttressing suture layer Not only does this have the immediate effect of reducing bleeding complications we postulate that it has the long-term effect of stabilizing the autograft and preventing aortic root dilatation
We hypothesize that this proximal buttressing technique for the Ross procedure has a two-fold benefit Firstly it reduces the amount of bleeding in the postoperative period Secondly it prevents late autograft root dilatation
Since 1994 we have performed almost 50 Ross procedures in children and young adults Contrary to many reports from the literature we have not recognized a problem with autograft enlargement and progressive aortic insufficiency One thing that we have done differently from other centers is that we have modified the insertion technique of the autograft into the native aortic root This involves a second buttressing suture layer Not only does this have the immediate effect of reducing bleeding complications we postulate that it has the long-term effect of stabilizing the autograft and preventing aortic root dilatation
We hypothesize that this proximal buttressing technique for the Ross procedure has a two-fold benefit Firstly it reduces the amount of bleeding in the postoperative period Secondly it prevents late autograft root dilatation
Detailed Description:
This is a retrospective chart review examining our experience with the Ross procedure There will be a treatment and control group The treatment group will be children who have had the Ross procedure with the proximal buttressing technique The control or comparisons group would be Ross procedure patients who did not receive the proximal buttressing technique All childrens charts reviewed will be of patients who had their surgery at Childrens Healthcare of Atlanta between December 1994 and August 2003 only information available up until October 10 2003 will be used for this study We will review approximately 75 charts for this study
The first aim of the study would be to examine basic information regarding bleeding incidence The following information will be collected on both groups
Amount of chest tube bleeding within the first 24 hours and
Number of patients who required re-exploration for bleeding
Time from cardiopulmonary bypass removal to time leaving the operating room indicator of the need to dry up
The second aim of the study would be to review the echocardiograms on these patients The pulmonary valve size before the Ross procedure would be measured on the preoperative transthoracic or transesophageal echocardiogram This would then be compared with postoperative studies in the Operating Room by transesophageal echocardiography The pre-discharge echocardiogram and follow-up echocardiograms which are a routine for these patients and therefore would not be necessary to add to the study protocol would be reviewed Autograft root diameters would be measured The diameters would be at the level of the valve leaflets at the level of the commissures and at the sinotubular ridge These would be compared against published Z values for these patients by age weight and body surface area At the same time any degree of aortic insufficiency or left ventricular outflow tract obstruction would be noted and recorded One non-invasive cardiologist will review all old echocardiograms
The first aim of the study would be to examine basic information regarding bleeding incidence The following information will be collected on both groups
Amount of chest tube bleeding within the first 24 hours and
Number of patients who required re-exploration for bleeding
Time from cardiopulmonary bypass removal to time leaving the operating room indicator of the need to dry up
The second aim of the study would be to review the echocardiograms on these patients The pulmonary valve size before the Ross procedure would be measured on the preoperative transthoracic or transesophageal echocardiogram This would then be compared with postoperative studies in the Operating Room by transesophageal echocardiography The pre-discharge echocardiogram and follow-up echocardiograms which are a routine for these patients and therefore would not be necessary to add to the study protocol would be reviewed Autograft root diameters would be measured The diameters would be at the level of the valve leaflets at the level of the commissures and at the sinotubular ridge These would be compared against published Z values for these patients by age weight and body surface area At the same time any degree of aortic insufficiency or left ventricular outflow tract obstruction would be noted and recorded One non-invasive cardiologist will review all old echocardiograms
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None