Table 6: Summary of extended PICO to define research question that assessment will investigate Population Intervention Comparator Outcomes Patients with Catheter-based renal Optimal medical Clinical outcomes of confirmed denervation in addition management cardiovascular or renal treatment-resistant to optimal medical disease hypertension management Systolic and diastolic (uncontrolled, Included: blood pressure elevated blood Quality of life Any ablative pressure, despite device designed for use treatment with 3 or Mortality in the renal arteries. more Also secondary and Evidence regarding safety outcomes as medications different types of listed in ‘Outcomes’ (including a devices (e.g. section above diuretic) in whom other causes of should be hypertension have provided in a generic been excluded). manner where possible. Sub-population: However, PASC recognises that each Any device is quite distinct evidence from other similar regarding the technologies and may use of renal have a different clinical denervation in safety and effectiveness patients with profile. eGFR < 45ml/min/1.73m2 Due to the differences should be between devices and provided brands, the assessment separately. must provide evidence regarding the safety and Excluded: effectiveness of each Patients catheter separately to whose blood enable MSAC to pressure is determine whether controlled but devices are equivalent requires at least in their clinical utility. four Any evidence regarding antihypertensive the equivalence of medications. safety and effectiveness of one catheter to another should be presented.
Table 6: Summary of extended PICO to define research question that assessment will investigate Population Intervention Comparator Outcomes Patients with confirmed treatment-resistant hypertension (uncontrolled, elevated blood pressure, despite treatment with 3 or more medications (including a diuretic) in whom other causes of hypertension have been excluded). Sub-population: Any evidence regarding the use of renal denervation in patients with eGFR < 45ml/min/1.73m2 should be provided separately. Excluded: Patients whose blood pressure is controlled but requires at least four antihypertensive medications. Catheter-based renal denervation in addition to optimal medical management Included: Any ablative device designed for use in the renal arteries. Evidence regarding different types of devices (e.g. should be provided in a generic manner where possible. However, PASC recognises that each device is quite distinct from other similar technologies and may have a different clinical safety and effectiveness profile. Due to the differences between devices and brands, the assessment must provide evidence regarding the safety and effectiveness of each catheter separately to enable MSAC to determine whether devices are equivalent in their clinical utility. Any evidence regarding the equivalence of safety and effectiveness of one catheter to another should be presented. Optimal medical management Clinical outcomes of cardiovascular or renal disease Systolic and diastolic blood pressure Quality of life Mortality Also secondary and safety outcomes as listed in ‘Outcomes’ section above
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