Endo-Bentall Repair for Inoperable Aortic Disease: Balancing Innovation and Ethical Responsibility.

OBJECTIVE

To evaluate the ethics of introducing the Endo-Bentall (a novel high risk procedure) in the context of compassionate care and to make practical recommendations to support its incorporation into practice.

METHODS

A seven step ethical framework was systematically applied to three clinical vignettes involving the Endo-Bentall procedure. Ethical issues identified across cases were synthesised and used to develop practical recommendations for clinical practice.

RESULTS

Decision making regarding the Endo-Bentall procedure is challenging in the absence of robust outcome data. Patients amenable to treatment represent a highly heterogeneous population, with a high degree of variability in procedural risk, likelihood of technical success, consequences of failure, and uncertainty of long term durability. Despite this, ethical justification may be achievable in carefully selected cases where anticipated benefits proportionately outweigh risks, particularly in the context of otherwise limited therapeutic alternatives.

CONCLUSION

Ethical implementation of the Endo-Bentall procedure is possible in select patients. However, structured safeguards are necessary. These include enhanced informed consent processes with explicit disclosure of the learning curve, limited validation, and unknown long term outcomes; mitigation of potential conflicts of interest through independent or external case review; formal oversight mechanisms despite its classification as compassionate or innovative care; and integration within a learning health system framework with ongoing data reporting and outcome monitoring.