Results of the Aortic Valve Reconstruction in Children

Summary

Aortic valve disease counts up to 5% of cases of congenital heart disease being one of the most common congenital malformations of the cardiovascular system. This disease requires replacement of the damaged valve which in itself is not a trivial task to complete in children as there is still no available best practice for valve replacement. Today, the following alternative variants are performed in children: mechanical aortic prosthesis, xenografts, allografts, and pulmonary autograft (Ross procedure) and each has its potential advantages and disadvantages.

Mechanical aortic prostheses require lifelong anticoagulation therapy and repeated surgeries to replace mechanical valves during child growth. Available xenografts in children also has suboptimal results not only because of absence of growth potential, but also due to development of degenerative changes in biological tissue of the graft leaflets. Allograft tissues are exposed to rapid biodegradation in the recipient body and thus requiring repeated surgeries associated with higher difficulty, high risk of hemorrhages, and injury of the coronary injuries. Ross procedure was proposed as theoretically the most evidence-based reconstruction of the aortic valve in children. Even successfully performed Ross operation transforms one-valve disorder into two-valve disease.

The accumulation of knowledge on the anatomy of the aortic root and improvement of surgical techniques led to the development of new methods for reconstruction of the valve function. The technique is widely applied in adult cardiac surgery, uses glutaraldehyde-treated autopericardium for augmentation of the leaflets. Absence of foreign material provides no need for anticoagulation therapy. Potentially, reconstruction of the aortic valve with autopericardium can be widely used in children.

Aim is to study safety, clinical and hemodynamic efficacy of the method of the aortic valve reconstruction with autopericardium in children with aortic valve disease. Patients aged 29 days to 12 years will be included into the study. The data according to the protocol of the study will be assessed at the stage of inclusion, during the surgery, in 30 days after the surgery, and in 1, 2, and 3 years after the surgery. Data about all the patients included into the research will be analyzed in order to study the endpoints and achieve the research aim.

Conditions

• Aortic Valve Insufficiency

Interventions

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Physical examination

A physical examination is a routine screening procedure used to investigate a patient's symptoms or complaints. It consists of a series of questions regarding patient medical history followed by an examination of the symptoms to determine the correct diagnosis and treatment plan.

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The Ross Classification for Heart Failure in Children

The assessment is performed by pediatric cardiologist according to the classic Ross scale. One of the 4 classes of chronic heart failure is registered.

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The Aristotle score

Surgical risks will be assessed by the ARISTOTLE score developed specially for the task. The calculation will be performed online, available from http://www.aristotleinstitute.org.

OTHER

Assessment of administered specific therapy

The data will be registered as groups of administered medicines: * Antiplatelet agents * Loop diuretics * Potassium-sparing diuretics * Angiotensin-converting enzyme inhibitors

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Multispiral computed tomography/3D echocardiography

All patients enrolled in the study should be routinely examined with multispiral computed tomography (MS-CT) or 3D-echo before surgery and 3 years later. As a result, a 3D aortic root reconstruction will be made to assess its size and anatomy and subsequently build a 3D soft model for surgery imitation. At the study onset, we plan to perform MS-CT, then 3D-echo. If the correlation resulting from 3D-echo and the actual sizes will be high, the isolated 3D-echo will be preferred in the future. If none of the methods is available, the patients will not be enrolled in the study. The following data will be registered for further analysis: * Perimeter of the aortic valve * Diameter of the aortic valve at sinuses level * Height of the aortic sinuses * Morphology of the aortic valve

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Transthoracic and transesophageal echocardiography

Transthoracic echocardiography is carried out at baseline, at discharge and then annually. It is performed in order to assess the contractile function of the heart and hemodynamic characteristics of the aortic valve and its autopericardium graft. Transesophageal echocardiography is carried out directly after the withdrawal of the artificial circulation when performing augmentation of the aortic valve with autopericardium in order to asses hemodynamic characteristics of the aortic neo-valve.

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12-lead electrocardiogram

Registering 12-lead electrocardiogram (ECG) is used as a tool for assessment of the regularity of the heart rhythm as well as screening and predictive tool for assessment of fibrosis and hypertrophy processes in the myocardium. The following data will be registered: * Heart rate * Sinus rhythm (yes/no) * Positive R wave in leads V5-6 * Angle α less than 0 * Presence/absence of abnormal Q wave * Presence/absence of ST-segment depression in precordial leads

Sponsors & Collaborators

• National Medical Research Center for Children's Health, Russian Federation

  lead OTHER_GOV

Principal Investigators

• Dmitry V. Ryabtsev, PhD · National Research Center of Children's Health

Eligibility

Min Age

29 Days

Max Age

12 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-02-18

Primary Completion

2026-10-31

Completion

2027-10-31

Countries

• Russia

Study Locations