Adult congenital heart disease

A congenital heart defect is a problem with the heart's structure that is present at birth. Treatment has improved, so most children with these defects now live to adulthood, and more and more adults live with congenital heart disease. A US government patient page advises regular follow-up visits, including with a doctor who specializes in adult congenital heart disease when that is needed. Some defects are in the valves, and some can be closed or treated through a catheter.

Also called Adult congenital heart defects · Congenital heart disease in adults

Condition
In this atlas

Overview

Technical summary

Covers the adult survivors of congenital heart defects. A US government patient page describes the defects as present at birth and lists the heart walls, the valves and the large vessels as the most common sites; MedlinePlus says symptoms of milder defects may not appear until childhood or adulthood. A US government patient page ranks heart failure first among causes of death in adults with these defects. This atlas links two catheter devices here: the Amplatzer Septal Occluder (atrial septal defect) and the Melody pulmonary valve (pediatric and adult patients), both by their US approval scope only. The broader concept of congenital heart disease has no record in this atlas yet.

Recognition

A US government patient page says congenital heart defects are usually found from symptoms or newborn and prenatal screening, and that many adults now live with them.

Burden

No burden claims are published.

Claims and evidence

No claims are published for this condition yet.

Clinical links

Each link reports what one cited claim says about one population. "Evaluated for" means studied, not shown to work. These links do not show that anything is effective or right for you.

Claim, not a settled fact Evaluated for this: Amplatzer Septal Occluder (Evaluated for, seen from the other side)
Applies to Recipient not specified
- Patients with echocardiographic evidence of an ostium secundum atrial septal defect and clinical evidence of right ventricular volume overload, and patients who have had a fenestrated Fontan procedure and now need the fenestration closed. The order gives no age range.
- Not stated in the FDA record
- United States (decision by the US Food and Drug Administration)
- Not stated in the FDA record
- Gestational age Not reported
- Postnatal age Not reported
Follow-up Not applicable (regulatory decision)
The Amplatzer Septal Occluder is FDA-approved for closing atrial septal defects in the secundum position through a catheter, in patients with echocardiographic evidence of an ostium secundum defect and clinical evidence of right ventricular volume overload (a left-to-right shunt of 1.5 to 1 or right ventricular enlargement). The approval order also covers closing the fenestration after a fenestrated Fontan procedure. This states what the device is approved for. It is not a finding about how well the device works or how safe it is.
Limitations. Describes the approval scope only. The order cited gives no age range, no trial results and no comparison with surgery; the summary of safety and effectiveness was not read. The link to adult congenital heart disease is the atlas's filing of the record: the approval does not say the patients are adults, and the NHLBI pages describe atrial septal defects as defects present at birth.
Claim, not a settled fact Evaluated for this: Melody transcatheter pulmonary valve (Evaluated for, seen from the other side)
Applies to Mixed recipients
- Children and adults whose right ventricular outflow tract (RVOT) conduit is a complete (circumferential) tube that measured 16 mm or more across when implanted and that is now malfunctioning, with a clinical reason for intervention and at least moderate regurgitation, stenosis with a mean RVOT gradient of 35 mmHg or more, or both.
- Used as an addition to surgical care for these patients (order wording, paraphrased)
- United States (decision by the US Food and Drug Administration)
- Pediatric and adult patients, as the order words it; no age bounds are given
- Gestational age Not reported
- Postnatal age Not reported
Follow-up Not applicable (regulatory decision)
The Melody Transcatheter Pulmonary Valve is FDA-approved, as an adjunct to surgery, for pediatric and adult patients with a full (circumferential) right ventricular outflow tract conduit that was 16 mm or more when implanted and is now dysfunctional, with a clinical indication for intervention and at least moderate regurgitation and/or stenosis with a mean gradient of 35 mmHg or more. These statements say what the device is approved for in its original approval. They are not findings about how well it works or how safe it is. The 2017 supplement that added a dysfunctional surgical bioprosthetic pulmonary valve has its own decision record.
Limitations. Describes the approval scope only. The orders cited report no trial results and no comparison with surgery; the summaries of safety and effectiveness were not read. The patients are described as pediatric and adult, so this atlas files the record under adult congenital heart disease for navigation only. The 2017 supplement has its own context, claim and decision record.

Record details

Record id: cardio:adult-congenital-heart-disease
Content hash: 17f33c6ecdea7a56b66935f249e8afd0d330df67db029a36d72f4dd0bd481e36