Modelled impact of virtual fractional flow reserve in patients undergoing coronary angiography (VIRTU-4).

BACKGROUND: The practical application of 'virtual' (computed) fractional flow reserve (vFFR) based on invasive coronary angiogram (ICA) images is unknown. The objective of this cohort study was to investigate the potential of vFFR to guide the management of unselected patients undergoing ICA. The hypothesis was that it changes management in >10% of cases. METHODS: vFFR was computed using the Sheffield VIRTUheart system, at five hospitals in the North of England, on 'all-comers' undergoing ICA for non-ST-elevation myocardial infarction acute coronary syndrome (ACS) and chronic coronary syndrome (CCS). The cardiologists' management plan (optimal medical therapy, percutaneous coronary intervention (PCI), coronary artery bypass surgery or 'more information required') and confidence level were recorded after ICA, and again after vFFR disclosure. RESULTS: 517 patients were screened; 320 were recruited: 208 with ACS and 112 with CCS. The median vFFR was 0.82 (0.70-0.91). vFFR disclosure did not change the mean number of significantly stenosed vessels per patient (1.16 (±0.96) visually and 1.18 (±0.92) with vFFR (p=0.79)). A change in intended management following vFFR disclosure occurred in 22% of all patients; in the ACS cohort, there was a 62% increase in the number planned for medical management, and in the CCS cohort, there was a 31% increase in the number planned for PCI. In all patients, vFFR disclosure increased physician confidence from 8 of 10 (7.33-9) to 9 of 10 (8-10) (p<0.001). CONCLUSION: The addition of vFFR to ICA changed intended management strategy in 22% of patients, provided a detailed and specific 'all-in-one' anatomical and physiological assessment of coronary artery disease, and was accompanied by augmentation of the operator's confidence in the treatment strategy.

Organisational failure: rethinking whistleblowing for tomorrow's doctors.

The duty to protect patient welfare underpins undergraduate medical ethics and patient safety teaching. The current syllabus for patient safety emphasises the significance of organisational contribution to healthcare failures. However, the ongoing over-reliance on whistleblowing disproportionately emphasises individual contributions, alongside promoting a culture of blame and defensiveness among practitioners. Diane Vaughan's 'Normalisation of Deviance' (NoD) provides a counterpoise to such individualism, describing how signals of potential danger are collectively misinterpreted and incorporated into the accepted margins of safe operation. NoD is an insidious process that often goes unnoticed, thus minimising the efficacy of whistleblowing as a defence against inevitable disaster. In this paper, we illustrate what can be learnt by greater attention to the collective, organisational contributions to healthcare failings by applying NoD to The Morecambe Bay Investigation. By focusing on a cluster of five 'serious untoward incidents' occurring in 2008, we describe a cycle of NoD affecting trust handling of events that allowed poor standards of care to persist for several years, before concluding with a poignant example of the limitations of whistleblowing, whereby the raising of concerns by a senior consultant failed to generate a response at trust board level. We suggest that greater space in medical education is needed to develop a thorough understanding of the cultural and organisational processes that underpin healthcare failures, and that medical education would benefit from integrating the teaching of medical ethics and patient safety to resolve the tension between systems approaches to safety and the individualism of whistleblowing.