Going beyond the high-risk patient: the new boundaries for transcatheter device-focused therapy

Although congenital interventions continue to evolve to reach smaller and more complex patients, historically, adequate data collection and clinical trials have been lacking in comparison to adult coronary and structural interventions. This leads to difficulty in defining risk and providing meaningful data on risk-adjusted outcomes.

Risk-adjusted models have been recently developed for congenital interventions, and pre-procedural risk calculators are reaching everyday practice, providing an estimate of procedural risk to gauge the validity of a particular approach. These tools applied appropriately and consistently reviewed provide protection for physicians and patients alike and form the foundation of quality assessment and improvement. This review will outline many of the established and evolving interventions and surmise on how interventions in high-risk patients may be evaluated appropriately to encourage continued development of transcatheter therapies. Pre-assessment tools as well as risk-adjusted outcomes will be discussed, and the benefits and challenges of providing accurate data surrounding risk will be explored.

Risk assessment is part of the new frontier of congenital cardiac interventions. For the specialty to continue to meet expectations, appropriate engagement by institutions and physicians in evaluating risk must mirror the development of the technical aspects of procedures.