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SAN DIEGO – Endovascular renal sympathetic denervation by ultrasound in patients with resistant hypertension was superior to radiofrequency ablation of the main renal arteries, according to data from the RADIOSOUND-HTN study presented at TCT 2018.
In contrast, a combined approach of radiofrequency ablation of the main arteries, lateral branches and accessories was not superior to endovascular renal sympathetic denervation by ultrasound.
"This pilot study excludes specific recommendations regarding the preferable renal denervation approach" Philipp Lurz, MD, PhD, Chief Operating Officer of the Cardiology Department of the Leipzig Heart Center at the University of Leipzig in Germany, said at the press conference.
The researchers analyzed data from 120 patients with resistant hypertension, defined as systolic blood pressure greater than 160 mm Hg or diastolic blood pressure greater than 90 mm Hg, regardless of treatment with three or more classes of antihypertensive drugs. at least 4 weeks. Patients had to have a systolic BP during the day greater than 135 mm Hg on the measure of ambulatory BP and at least one main renal artery having a diameter of at least 5.5 mm to be included in the treatment. study.
MRI has also been performed to evaluate the anatomy of the renal artery. For patients unable to undergo MRI, a duplex ultrasound was performed.
Patients received one of three renal sympathetic denervation techniques:
- radiofrequency ablation of the main renal artery (n = 39);
- radiofrequency ablation of the main renal artery, accessories and limbs (n = 39); or
- Ultrasonic removal of the main renal artery (n = 42).
Radiofrequency ablation was performed with a multipolar catheter (Symplicity Spyral, Medtronic), and another catheter (Paradise, ReCor Medical) was used for renal sympathetic ultrasonic denervation.
Patients were followed by telephone at 1 month to assess early complications, BP and vital status. Outpatient blood pressure measurements and MRI or duplex ultrasound were repeated at 3 months. Structured patient interviews were conducted to assess adherence to treatment and changes at 1 month and 3 months.
The primary endpoint was a change in systolic BP at 3 months, as shown by outpatient BP measurements. The main secondary endpoints were changes in 24-hour systolic blood pressure, responder rate, and changes in diastolic blood pressure.
Both groups had balanced baseline clinical characteristics and drug treatment, in addition to initial baseline PA values for daytime and 24-hour ambulatory BP measurements.
The overall cohort had decreases in systolic and diastolic BP at 3 months of 9.5 / 6.3 mm Hg (P for both <0.001). This was also observed in each treatment group (P for all <0.001).
Larger reductions were observed in patients assigned to ultrasound ablation compared to radiofrequency ablations of the main renal artery (-13.2 mmHg vs -6.5 mmHg; mean difference = -6, 7, 98.3% CI, -13.2 to -0.2). No significant difference was observed in both radiofrequency ablation groups (-8.3 mm Hg for secondary branch ablation, mean difference = -1.8, 98.3% IC, -8.5 to 4.9) and between the ultrasound group and the ablation group = -4.9; 98.3% CI, -11.5 to 1.7).
A systolic response greater than 5 mmHg was observed in 66% of patients with radiofrequency ablation of the main renal artery, 73% of those assigned to primary radiofrequency ablation, accessories and limbs and 67% patients removal of the main renal artery (P = 0.77).
"Longer follow-up and larger multicenter studies are needed to make direct comparisons, particularly to determine the long-term safety of these technologies," Lurz said at the press conference. – by Darlene Dobkowski
References:
Lurz P, et al. Last-minute essays 5. Presented at: TTC Scientific Symposium; September 21-25, 2018; San Diego.
Fengler K, et al. circulation. 2018; doi: 10.1161 / CIRCULATIONAHA.118.037654.
Disclosures:
Lurz reports that he is receiving speaker and consultant fees from Medtronic and ReCor Medical. Please consult the study for all relevant financial information of other authors.
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