Comparison of Two Pulmonary Valve Replacement Methods to Treat Tetralogy of Fallot

NCT ID: NCT00112320

Last Updated: 2012-12-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-04-30
• Study Completion Date: 2011-08-31

Brief Summary

Repair of tetralogy of Fallot (TOF), the most common form of cyanotic congenital heart disease, usually involves surgery on the outflow of the right ventricle (RV) and the pulmonary valve in order to relieve obstruction to blood flow from the RV to the lungs. This procedure often leads to regurgitation (leakage) of the pulmonary valve, which puts the burden of handling a larger than normal amount of blood flow on the RV. Over the years, that extra burden leads to enlargement of the RV and to a decrease in its function. Treatment often includes surgical insertion or replacement of a new pulmonary valve. Replacement of the damaged pulmonary valve aims to minimize the leakage and help the RV function better. This study is designed to compare two methods of how the operation (called pulmonary valve replacement [PVR]) is performed. In the first method, a new valve is inserted and only the area of the old valve is operated on; this is the standard PVR. The second method involves inserting the new valve in the same way as the standard method but, in addition, areas of the right ventricular wall that are scarred and not functioning well are removed (PVR plus right ventricular remodeling). This study will evaluate which method is more effective based on the size and function of the RV measured by cardiac magnetic resonance imaging (CMR) six months following surgery, as compared to its size and function before the operation.

Detailed Description

Background:

Surgical repair of TOF often results in chronic pulmonary regurgitation (PR) with associated RV dilatation and dysfunction. Mounting evidence indicates that PR leads to significant long-term morbidity and mortality, including arrhythmias, sudden death, and right heart failure. Using CMR, there is a high prevalence of regional dysfunction and aneurysms in the RV in patients with repaired TOF. Current standard clinical practice in patients with repaired TOF, severe PR, ventricular dysfunction, and/or clinical deterioration is to insert a bioprosthetic pulmonary valve to reduce the volume load on the RV. Although PVR can be achieved with low mortality, research has shown a persistent or worsening RV dysfunction postoperatively, despite a competent pulmonary valve. In patients with left ventricular (LV) aneurysms, surgical remodeling with aneurysm resection has been shown to improve LV mechanics. In view of the potentially deleterious effects of aneurysmal and akinetic wall segments on RV mechanics, researcher have recently modified their PVR surgical technique in selected patients to include surgical remodeling of the RV with resection of the akinetic wall segments. However, no studies have systematically compared the efficacy of PVR plus surgical RV remodeling to PVR alone.

Research Question:

Is there a difference between two surgical strategies-PVR alone (bioprosthetic pulmonary valve insertion and, when present, resection of right ventricular outflow tract [RVOT] aneurysm) versus PVR and surgical RV remodeling (bioprosthetic pulmonary valve insertion and resection of akinetic scarred areas on the anterior RV wall to reduce RV volume)-on RV mechanics and on the incidence of adverse events in patients with repaired TOF and chronic pulmonary regurgitation?

Conditions

Tetralogy of Fallot; Pulmonary Valve Insufficiency; Ventricular Dysfunction, Right

Keywords

Pulmonary Valve Regurgitation; Right Ventricular Dysfunction; Heart Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Standard PVR

Group Type: ACTIVE_COMPARATOR

Standard PVR

Intervention Type: PROCEDURE

PVR alone, which includes bioprosthetic pulmonary valve insertion and, when present, resection of right ventricular outflow tract (RVOT) aneurysm

2

PVR plus RV remodeling

Group Type: EXPERIMENTAL

PVR plus RV remodeling

Intervention Type: PROCEDURE

PVR and surgical RV remodeling, which includes bioprosthetic pulmonary valve insertion and resection of akinetic scarred areas on the anterior RV wall to reduce RV volume

Interventions

PVR plus RV remodeling

PVR and surgical RV remodeling, which includes bioprosthetic pulmonary valve insertion and resection of akinetic scarred areas on the anterior RV wall to reduce RV volume

Intervention Type: PROCEDURE

Standard PVR

PVR alone, which includes bioprosthetic pulmonary valve insertion and, when present, resection of right ventricular outflow tract (RVOT) aneurysm

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Undergoing PVR to repair TOF at Children's Hospital Boston
• Pulmonary regurgitation fraction greater than or equal to 25% (measured by CMR) and two or more of the following criteria:

1. RV end-diastolic volume index greater than or equal to 150 ml/m2 (Z score greater than 5)

2. RV end-systolic volume index greater than or equal to 70 ml/m2

3. LV end-diastolic volume index less than or equal to 65 ml/m2

4. RV ejection fraction less than 45%

5. RVOT aneurysm

6. Clinical criteria: exercise intolerance, symptoms and signs of heart failure, and use of cardiac medications

Exclusion Criteria

• Presence of either severe RV outflow tract obstruction (defined as peak-to-peak systolic gradient of greater than or equal to 60 mm Hg by cardiac catheterization) or severe RV hypertension at systemic or higher level
• Additional sources of RV volume overload other than PR and tricuspid valve regurgitation
• Contraindications to CMR

• Minimum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Boston Children's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Judith Geva

Study coordinator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tal Geva, MD

Role: PRINCIPAL_INVESTIGATOR

Boston Children's Hospital

Locations

Department of Cardiology, Children's Hospital Boston

Boston, Massachusetts, United States

Countries

United States

References

Geva T, Gauvreau K, Powell AJ, Cecchin F, Rhodes J, Geva J, del Nido P. Randomized trial of pulmonary valve replacement with and without right ventricular remodeling surgery. Circulation. 2010 Sep 14;122(11 Suppl):S201-8. doi: 10.1161/CIRCULATIONAHA.110.951178.

Reference Type: DERIVED

PMID: 20837914 (View on PubMed)

Other Identifiers

P50HL074734

Identifier Type: NIH

Identifier Source: secondary_id

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P50HL074734-01

Identifier Type: NIH

Identifier Source: secondary_id

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188

Identifier Type: -

Identifier Source: org_study_id