TORCH-LATAM-003: Regional Advanced-Therapy Pathways for Congenital Heart Disease

Each TORCH regional network cluster is anchored in an authorized advanced-therapy or transplant center and may include activated evaluation, referral, congenital cardiology, pulmonary hypertension, intensive-care, mechanical-support, donor-origin, procurement, preservation, logistics, and data-coordination nodes. Children and adults with congenital heart disease may be identified at transplanting or non-transplanting centers when an authorized route to specialized evaluation exists. Authorized centers and competent authorities retain all legal and clinical authority for candidacy, waiting-list activation, organ acceptance, allocation, and transplantation.

The recipient pathway records identification, referral, enrollment, completion of multidisciplinary congenital evaluation, a documented advanced-pathway decision, barrier management, activation of an authorized pathway or official waiting list, longitudinal clinical and support status, transplantation, regulated external-protocol enrollment, or an alternative outcome. Study enrollment is analytically distinct from advanced-therapy candidacy and official wait-list status.

The pathway permits clinically documented redirection among heart, lung, heart-lung, or other authorized transplant evaluation; temporary or durable mechanical support; recovery; surveillance; palliative care; and independently governed investigational protocols. TORCH does not assign an investigational therapy, device, cell, organoid, or xenograft and does not infer efficacy or safety for such products.

Where legally authorized, donor-organ and recipient pathways converge at traceable compatibility and offer episodes. Each decision, non-acceptance reason, reassignment, urgency change, distance, logistics constraint, and final disposition is time-stamped. TORCH does not create a supranational allocation authority or override governmental or institutional systems.

Interoperability may range from audited manual transfer to structured documents, batch exchange, application programming interfaces, standards-based exchange, or validated remote-monitoring devices. Cross-border activity is activated only after applicable ethical, regulatory, institutional, data-protection, financial, and operational approvals.

Inclusion criteria

• Child or adult of any age with congenital heart disease; enrollment of minors requires parent or legal-representative permission and assent when applicable.
• Congenital heart disease with advanced cardiac and/or respiratory failure, associated pulmonary hypertension, or another protocol-defined trigger for specialized advanced-therapy evaluation.
• Identification within an activated TORCH network cluster with an operational route to at least one authorized advanced-therapy or transplant center.
• Ability to complete protocol-defined follow-up directly or through an authorized network pathway.
• Provision of informed consent by the participant or legally authorized representative, and assent when applicable, according to local requirements.

Exclusion criteria

• Absence of congenital heart disease as the underlying condition defining the advanced cardiac and/or respiratory-failure pathway.
• No authorized route for protocol evaluation or follow-up at the time of enrollment.
• Unable or unwilling to provide informed consent or legally authorized permission when required.
• The prespecified multidisciplinary evaluation and advanced-pathway decision were already completed and remain clinically current before enrollment.