Mitral Regurgitation

(Observational Study)

Study Summary

This was a study of ACE inhibition therapy in children with mitral regurgitation (MR) after repair of an atrioventricular septal defect (AVSD).

When this study first started, there were two parts. The first part, the observational study was being done to see if mitral valve leaking decreases after surgery for AVSD repair.

The second part of this study stopped on November 4, 2005 due to poor enrollment. It was being done to see if giving a medication called enalapril (an ACE inhibitor) will improve severe mitral valve regurgitation (leaking of the mitral valve) and decrease the heart size in patients who have had an AVSD (a hole in the heart) repaired.

181 Participants

Enrolled in the first part of this study.

Study Ended Due to Low Enrollment

The second part of this study was stopped due to poor enrollment.

Surgical Repair Associated with Catch-up Growth

Particularly in underweight children with a partial or transitional AVSD repaired between 3 and 18 months of age.

Who was in the observational study?

Participants were eligible if:
  • The AVSD repair was less than 28 days before enrollment.
  • They were 17.5 years or less.

The observational study enrolled 181 people.

What happened during the observational study?

Each eligible participant was asked to sign an informed consent form to allow the study staff to review and record information from the medical chart. The amount of mitral valve leaking was evaluated after an echocardiogram. A second echocardiogram was done at 6 months to compare the amount of MR with the amount seen on the first echocardiogram.

What were the results of the study?

Surgical repair of all AVSD types results in low morbidity and mortality and short hospital stays. Repair is associated with catch-up growth, particularly in underweight children with a partial or transitional AVSD repaired between 3 and 18 months of age.

Study Publications

  • Partial and Transitional Atrioventricular Septal Defect Outcomes

    L. Minich, Ann Thorac Surg 2010; 89:530-536.

    There have been many improvements in the surgery and care of children with atrioventricular septal defects (AVSD. This article describes the outcomes at 1 and 6 months after repair for children with two particular types of AVSD: partial and transitional AVSDs. Children had short hospital stays and few adverse events around the time of surgery. Also, children who were growing poorly before surgery showed good catch-up growth if the surgery was performed between 3 and 18 months of age. Some children have leaking of the left-sided atrioventricular valve after surgery, particularly if surgery is performed after age four.

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  • Lessons learned from a pediatric clinical trial: The Pediatric Heart Network Angiotensin Converting Enzyme Inhibition in Mitral Regurgitation Study

    J. Li, Am Heart J 2011; 161:233-40.

    The Pediatric Heart Network designed a placebo-controlled randomized trial to test the effect of enalapril on the amount of left heart valve regurgitation after atrioventricular septal defect (AVSD) repair. Prior to the launch of the trial, a feasibility study was performed to estimate the number of patients with at least moderate mitral regurgitation following AVSD repair. The study was subsequently terminated due to low patient accrual. Several factors led to the problems with enrolling patients: 1) the feasibility study used chart review to assess for valve regurgitation but the trial used echocardiography measurements; 2) clinicians and referring physicians were already believing that enalapril was a good drug to give and many patients eligible for the study were already taking the drug; 3) the echocardiography methods used were developed in adult populations and not children; 4) there are no good data to define the natural history of the disease process.

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  • Surgical management of complete atrioventricular septal defect: Associations with surgical technique, age and Trisomy 21

    A. Atz, J Thorac Cardiovasc Surg 2011; 141:1371-9.

    This study evaluated contemporary results after repair of a complete atrioventricular septal defect (AVSD) and to determine factors associated with poorer outcomes. Particular attention was paid to type of surgical repair, age at surgery, and presence of Trisomy 21. The type of surgical repair and having Trisomy 21 did not increase the risk of death or serious medical problems. Mortality and morbidity were low. Age at repair ≤2.5 months and need for concurrent surgical procedures were not associated with residual defects or degree of heart valve regurgitation, but were associated with higher resource utilization.

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  • Surgical interventions for Atrioventricular Septal defect subtypes: The Pediatric Heart Network experience

    A. Kaza, Ann Thorac Surg 2011;92:1468-75.

    Atrioventricular septal defects (AVSD) include abnormalities involving the walls between the heart chambers (atrial and ventricular septa) and the heart valves. The investigators compared patient characteristics, resource utilization, center differences, and outcomes among different types of AVSD. Survival in the current era is excellent, with few residual defects after surgical repair for all AVSD subtypes. Repair of the valves failed to decrease moderate or severe valve regurgitation at the 6-month follow-up. Being older when the heart is repaired increases the risk of moderate or severe valve regurgitation.

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  • Challenges in echocardiographic assessment of mitral regurgitation in children after repair of Atrioventricular Septal Defect

    A. Prakash, Pediatr Cardiol 2012; 33:205-214.

    It is difficult to quantify the amount of regurgitation from the mitral valve using echocardiography. Since children who have an atrioventricular septal defect repaired continue to have varying amounts of mitral regurgitation, the accuracy of proposed echocardiographic methods was proposed to evaluate the severity of the regurgitation. No method performed well. No method proved to be better than the echocardiographer’s subjective assessment of the size of the color Doppler jet and surrounding structures. Reliable assessment of mitral regurgitation remains challenging in this population.

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