Renal Denervation: Unde Venis et Quo Vadis?

Abstract

Objective and Methods: Renal denervation is a minimally invasive, catheter-based option for the treatment of refractory hypertension. Indications and contraindications for renal denervation have been defined in an interdisciplinary manner. The efficacy and safety of the procedure were evaluated.

Results: Currently, indication for renal denervation is limited to patients with primary hypertension and a systolic blood pressure of ≥ 160 mm Hg (or ≥ 150 mm Hg in diabetes type 2) despite optimal medical therapy with ≥ 3 different antihypertensive drugs. In this specific patient population, an average blood pressure reduction of 32/14 mmHg was observed in non-randomized/-controlled trials after renal denervation. These results were not confirmed in the first randomized controlled trial with a non-significantly superior blood pressure reduction of 14.1 ± 23.9 mm Hg compared to controls (−11.74 ± 25.94 mm Hg, difference −2.39 mm Hg p = 0.26 for superiority with a margin of 5 mm Hg) who underwent a sham procedure.

Conclusion: The efficacy and long-term effects of renal denervation need to be re-evaluated in light of the HTN3 study results. To date, renal denervation should not be performed outside of clinical trials. Future trials should also assess if renal denervation can be performed with sufficient safety and efficacy in patients with hypertension-associated diseases. The use of renal denervation as an alternative therapy (e. g. in patients with drug intolerance) can currently not be advocated.

Key points:

• The indication for renal denervation should be assessed in an interdisciplinary fashion and according to current guidelines with a special focus on ruling out secondary causes for arterial hypertension.

• 5 – 10 % of patients with hypertension suffer from refractory hypertension, but only about 1 % of patients meet the criteria for a renal denervation.

• Renal denervation leads to a significant decrease in office blood pressure; however, the impact on 24-hour blood pressure measurements remains unclear.

• In the first randomized controlled trial on renal denervation with a control group undergoing a sham procedure, blood pressure reduction failed to reach the anticipated level of superiority over best medical treatment.

• Periprocedural complications are rare, but long-term safety can currently not be appraised due to the limited data available.

Citation Format:

• Naehle CP, Düsing R, Schild H. Renale Denervation: Unde venis et quo vadis?. Fortschr Röntgenstr 2015; 187: 237 – 247

Zusammenfassung

Zielsetzung und Methode: Die renale Denervation ist eine minimal-invasive, katheterbasierte Behandlungsoption zur Behandlung der therapierefraktären Hypertonie. Die Indikationen und Kontraindikationen wurden interdisziplinär erarbeitet und festgestellt. Effektivität und Sicherheit wurden evaluiert.

Ergebnisse: Derzeit ist die Indikation limitiert auf Patienten mit primärer Hypertonie, die trotz einer optimalen medikamentösen Therapie mit ≥ 3 unterschiedlichen Antihypertensiva einen systolischen Blutdruck von ≥ 160 mm Hg (bzw. ≥ 150 mm Hg bei Diabetes Typ 2) aufweisen. Nach renaler Denervation nahm in nicht kontrollierten Studien unter Berücksichtigung dieser Kriterien der Blutdruck um durchschnittlich 32/14 mm Hg ab. Diese Ergebnisse konnten in der ersten randomisierten kontrollierten Studie mit einer im Vergleich zur verblindeten Kontrollgruppe nicht signifikanten Reduktion des systolischen Blutdrucks von 14,1 mmHg nicht bestätigt werden.

Schlussfolgerung: Die Effektivität der renalen Denervation, aber auch die Langzeitsicherheit, müssen unter besonderer Berücksichtigung der HTN-3-Daten neu evaluiert werden. Aktuell sollte die renale Denervation außerhalb klinischer Studien nicht durchgeführt werden. Weitere Studien müssen klären, ob die renale Denervation bei hypertonieassoziierten Erkrankungen mit ausreichender Wirksamkeit und sicher durchgeführt werden kann. Die Anwendung als Alternative zur medikamentösen Therapie z. B. bei Medikamentenunverträglichkeit kann derzeit nicht befürwortet werden.

Key words

hypertension - radiofrequency (RF) ablation - renal arteries - safety

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