Actualization: Radiofrequency Sympathetic Denervation of the Renal Arteries for Refractory Arterial Hypertension

PICHON RIVIERE, A.; AUGUSTOVSKI, F.; GARCIA MARTI, S.; ALCARAZ, A.; GLUJOVSKY, D.; LOPEZ, A; REY-ARES, L.; BARDACH, A.; CIAPPONI, A; DEHESE, J

Documento de Evaluación de Tecnologías Sanitarias

IECS

Año: 2013 p. 1 - 30

1668-2793

Hypertension (AH) has a global estimated burden of a thousand million cases, resulting in 7.5 million deaths yearly (12.8% of total deaths). In Argentina, hypertension has a prevalence of 34.8% in in subjects over 18 years old. Refractory hypertension (RAH) is refers to the failure to control blood pressure values after administering at least three drugs of different mechanism of action, including a diuretic. It is estimated that it represents 10% of the hypertensive population. For this group of patients, it is stated that radiofrequency sympathetic denervation/ablation of the renal artery (RSDRA) may reduce the adrenergic hyperactivity and thus improve blood pressure control. Technology Sympathetic hyperactivity plays a major role in the onset, progression and persistence of AH. RSDRA is a minimally invasive intervention that consists in introducing an electrode through a percutaneous catheter into a vein to the renal arteries and subsequent use of high-frequency alternate current to obtain a coagulative necrosis of the neural tissue. Its implementation requires angiography, patient sedation, local anesthesia and a well-trained medical team. Purpose To assess the available evidence on the efficacy, safety and coverage related aspect regarding RSDRA use for refractory arterial hypertension. Methods A bibliographic search was carried out on the main databases: DARE, NHS EED, on Internet general search engines, in health technology evaluation agencies and health sponsors. Priority was given to the inclusion of systematic reviews; controlled, randomized clinical trials (RCTs); health technology and economic assessments (HTAs), clinical practice guidelines (CPGs) and coverage policies of other health systems. Results A systematic review (SR), an additional RCT, three observational studies, two CPGs, five HTAs and one coverage policy document were included. One SR published in 2013 included a total of 683 patients in two RCTs, two case-control studies and 13 case-series. Both RCTs included belong to the Symplicity-II study and reported a decrease in blood pressure (BP) in the RSDRA group when compared with the standard care group. One of the RCTs included 37 subjects and was designed to measure specifically the response in relation to exercise. The other one was conducted in 52 subjects with an analysis after 6 months. As regards BP control, the first one reported a decrease of 31/9 mmHg in systolic/diastolic BP after 3 months in the intervention arm; and the second -28.1/-9.7 mmHg after 12 months (p