Clinical Trial: Retrospective Pulmonary Valve Replacement Imaging

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Proposal for Retrospective Review of Imaging Pre- and Post - Pulmonary Valve Replacement

Brief Summary: This is a retrospective chart review examining children and adults with history of Tetralogy of Fallot or pulmonary stenosis who have undergone subsequent pulmonary valve replacement. The primary interest of the study is to analyze the routine pre- and post-operative imaging studies.

Detailed Summary:

Congenital heart defects having a component of pulmonary stenosis (narrowing) are often palliated in childhood by disrupting the pulmonary valve. This arrangement can provide an excellent quality of life as these children grow and enter young adulthood. Unfortunately, the pulmonary insufficiency that is created by disrupting the pulmonary valve results in volume overload of the right heart. This may eventually lead to right ventricular dilation and irreversible right heart failure. In addition, volume load of the right heart may affect the inter-ventricular septum and left heart function as well. Placement of a competent pulmonary valve at a subsequent operation, hopefully at a time without the replacement valve size constraints present at the initial operation, is a means to eliminate the volume overload and prevent these further sequelae.

Unfortunately, the optimal timing for subsequent pulmonary valve replacement is controversial. One of the currently used indications for valve replacement includes a right ventricular to left ventricular volume ratio greater than two. However, determining the boundaries of the right ventricle by echocardiography and magnetic resonance imaging is difficult in the absence of a pulmonary valve. The boundaries are determined by an arbitrary estimation of where the pulmonary valve should be. Other potential indicators for pulmonary valve replacement may be right ventricular area and right ventricular strain, determined by echocardiography. These measurements are not affected by the absence of the pulmonary valve. They may provide better markers for impending right ventricular failure and a simpler means to follow serial improvement following valve replacement.

While the emphasis after pulmonary valve disruption typically lies on the right ventricle, there is evidence that the left ventricle
Sponsor: Emory University

Current Primary Outcome: The first primary aim of the study would be to identify the risk factors for early development of right heart dilation and failure following Tetralogy of fallot repair. [ Time Frame: January 1, 1994 and December 31, 2009 ]

Original Primary Outcome:

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Emory University

Dates:
Date Received: March 9, 2007
Date Started: February 2007
Date Completion:
Last Updated: November 25, 2013
Last Verified: November 2013