TORCH-LATAM-002: Regional Pathway for Adult Heart Transplant Evaluation and Candidacy

Each TORCH regional network cluster is anchored in an authorized transplant center and may include activated evaluation, referral, identification, donor-origin, procurement, preservation, logistics, and data-coordination nodes. Adults may be identified at transplanting or non-transplanting centers when an authorized route to specialized evaluation exists. The transplant center 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 evaluation, documented candidacy decision, barrier management, activation of an authorized pathway or official waiting list, clinical change while waiting, donor-recipient opportunity, transplantation, or an alternative outcome. Study enrollment is analytically distinct from transplant candidacy and official wait-list status.

The donor-organ pathway records identification of a possible donor, confirmation of the applicable donation pathway, authorization, organ characterization, activation of an evaluable donor-organ opportunity, compatibility assessment, organ acceptance or rejection, procurement, preservation, transport, implantation, and final disposition. Donation after brain death and donation after circulatory determination of death are represented as distinct branches; normothermic regional perfusion is recorded only when applicable.

The two pathways converge at a traceable donor-organ-recipient matching episode. A characterized organ may be assessed for more than one compatible recipient, and each offer, decision, reason for non-acceptance, reassignment, urgency change, distance, logistics constraint, and final disposition is time-stamped. TORCH does not create a supranational allocation authority and does not 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. Lack of an automated interface does not by itself exclude a site or participant when an authorized, secure, timely, and auditable fallback is available. Cross-border activity is activated only after applicable ethical, regulatory, institutional, data-protection, financial, and operational approvals.

Inclusion criteria

• Age 18 years or older.
• Advanced heart failure or acquired or structural heart disease meeting a protocol-defined trigger for specialized heart transplant evaluation.
• Identification within an activated TORCH network cluster with an operational route to at least one authorized transplant center.
• Ability to complete the protocol-defined follow-up directly or through an authorized network pathway.
• Provision of informed consent according to applicable requirements.

Exclusion criteria

• Primary congenital heart disease managed under the pediatric or congenital TORCH protocol.
• No authorized route for protocol evaluation or follow-up at the time of enrollment.
• Unable or unwilling to provide informed consent when required.
• The prespecified multidisciplinary evaluation and transplant-candidacy decision were already completed before the enrollment reference time.