Imaging to assess renal vascular anatomy (duplex ultrasound). This may or may not be an additional resource (previous appropriate images may be available) MBS - 1 service - Resources provided in association with the proposed medical service to deliver the proposed intervention (from Step 1, e.g., pre-treatments, co-administered interventions). Patient monitoring Private or Public Hospital Catheterization laboratory Equipment for monitoring blood pressure, heart rate & oxygenation - Nursing and technician support Private or Public Hospital Catheterization laboratory Nursing and technician support for duration of renal denervation procedure - Medication Private or Public Hospital Catheterization laboratory Medication and dosage during the procedure is tailored to individual patient circumstances, but likely to include anxiolytic and amnestic medication; anticoagulants; pain medication and vasodilators - Consumables Private or Public Hospital Catheterization laboratory 1 set of consumables, including renal denervation catheter and other disposables required for endovascular procedures. - Radiology (angiography) MBS Catheterization laboratory 1 service which should be included as part of the fee for the proposed service - Anaesthetist MBS Catheterization laboratory Attendance varies according to jurisdictional guidelines and requirement of general anaesthetic Renal artery stent Private or Public Hospital Catheterization laboratory Possible 1 service; MBS 35309 Hospitalisation for procedure, including pre-procedure admission and overnight stay Private or Public Hospital Private or Public Hospital 1 inpatient episode (overnight stay) or day case - Diagnostic and pathology services (including tests for urea (66500), electrolytes, full blood exam) MBS Private or Public Hospital 1 service for each required test -
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