TORCH-LATAM-004: Regional Advanced-Therapy Pathways for Adults With Acquired or Structural Heart Disease

Each TORCH regional network cluster is anchored in an authorized advanced-therapy or transplant center and may include activated evaluation, referral, advanced-heart-failure, structural-heart, intensive-care, mechanical-support, donor-origin, procurement, preservation, logistics, and data-coordination nodes. Adults with advanced heart failure secondary to acquired or structural 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 advanced-therapy candidacy, waiting-list activation, organ acceptance, allocation, and transplantation.

The recipient pathway records identification, referral, enrollment, completion of multidisciplinary adult evaluation, a documented advanced-pathway decision, barrier management, activation of an authorized pathway or official waiting list, longitudinal clinical and support status, transplantation, advanced structural intervention, 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 or combined transplantation; temporary or durable mechanical support; advanced structural intervention; recovery; surveillance; palliative care; and independently governed investigational protocols. TORCH does not assign an investigational drug, device, cell, organoid, xenograft, or other experimental therapy 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

• Adult aged 18 years or older at informed consent.
• Documented acquired or structural heart disease with advanced heart failure meeting a 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 according to applicable requirements.

Exclusion criteria

• Congenital heart disease as the primary condition, or absence of a documented pathophysiological relationship between acquired or structural heart disease and advanced heart failure.
• 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 advanced-pathway decision were already completed and remain clinically current before enrollment.