Risk acceptance for deep venous interventions of the lower limb.

Objectives

To discover the maximum risk acceptable to patients and clinicians for complications typical to endovascular interventions in the setting of proximal deep vein thrombosis (DVT) and post-thrombotic syndrome (PTS).

Design

This was an observational study comparing patient/clinician risk acceptances in interviews using validated Standard Gamble methodology.

Methods

30 patients with previous DVT and 30 vascular clinicians were given a scenario describing a hypothetical case of a patient being managed with acute iliofemoral DVT and another with PTS. Subjects were asked to provide the maximum risk they would accept for individual complications to cure the condition. To interpret variability, the Venous Clinical Severity Score, SF-36 domains and VEINES-QoL for each patient were plotted against their risk acceptance for major bleeding in the DVT scenario.

Results

For the DVT scenario, patients accepted high median risks compared to clinicians for major bleeding (40% vs 5%, p < .001), bleeding at other sites (50% vs 5%, p < .001), damage to blood vessels (60% vs 5%, p < .001), further procedures (80% vs 20%, p < .001), and treatment failure (75-80% vs 10-20%, p < .001). However, the gap was lower for intracranial bleeding (5% vs 1%, p = .004), pulmonary embolism (5 vs 5%, p = .39) or death (1% vs 0.75%, p = .77). For the PTS scenario, there were similar results again with a lower difference for pulmonary embolism (10% vs 5%, p = .02) and death (0.5% vs 1%, p = .72). Importantly, patient risk acceptance for major bleeding was negatively correlated to the emotional wellbeing (Rho = -0.43, p = .018) and social functioning (Rho = -0.38, p = .042) SF-36 domains.

Conclusion

Overall, patients accepted a greater chance of most adverse events compared with clinicians. Patients prepared to accept greater risk were those with poorer emotional wellbeing and social functioning. It is important to take these issues into account when making shared decisions with patients about the management of their DVT/PTS.