Three renal denervation systems show encouraging outcomes

PARIS — Significant reductions in BP were reported in association with three renal denervation systems, concluded findings presented here.

Joost Daemen, MD, PhD, of the Erasmus MC Thoraxcenter, the Netherlands, presented findings on the Paradise ultrasound renal denervation system on behalf of the ACHIEVE investigators; Stephen G. Worthley, PhD, of the University of Adelaide, Australia, presented findings from the EnligHTN III first in human study testing the EnligHTN next-generation renal denervation system (St. Jude Medical); and Joachim Schofer, MD, of the Heart Center Hamburg, Germany, presented preliminary 12- and 18-month results of the Vessix renal denervation system (Boston Scientific) from the REDUCE-HTN trial.

Ultrasound renal denervation system

According to Daemen, the Paradise device features intraluminal delivery of ultrasound energy, including a cylindrical transducer centered in a cooling balloon that preserves the arterial wall. Energy is delivered twice in 10 seconds and is adjusted for vessel size. A generator controls whether the balloon is inflated or deflated and cools the fluid flow.

The catheter is 6F for femoral access and 5F for radial access. Balloon sizes are 5 mm, 6 mm, 7 mm and 8 mm.

In the study, 67 patients were treated with the catheter.

At 3 months, both office (–14/–4 mm Hg; P<.001) and ambulatory (–8/–4 mm Hg; P<.05) BP were reduced. Similar results were reported at 6 months for office (–17/–6 mm Hg; P<.001) and ambulatory (–9/–3 mm Hg; P<.05) BP.

The number of patients with an ambulatory BP <140 mm Hg increased from 7% to 46%, according to Daemen.

At baseline, there were 7 patients with BP >130 mm Hg to 140 mm Hg. By the 6-month mark, there were 13 patients with BP ≤130 mm Hg and 33 patients with BP >130 mm Hg to 140 mm Hg.

EnligHTN III

The aim of the prospective, multicenter, single arm EnligHTN III study was to determine whether the EnligHTN next-generation renal denervation system (St. Jude Medical) is safe and effective utilizing simultaneous ablations.

“The time for this procedure is approximately 22 minutes, down from 42 minutes for the first generation,” Worthley said at a press conference.

The analysis included 39 patients who underwent the procedure in Australia and New Zealand.

Reduction of office BP at 6 months served as the primary endpoint and adverse events at 6 months served as the primary safety endpoint. Secondary endpoints included reduction in ambulatory BP, renal function and renal safety.

Patients were evaluated at 30 days, and again at 3 and 6 months after the procedure.

Reductions in office BP from baseline occurred at 1 month (systolic, –19 mm Hg; P<.0001; diastolic, –7 mm Hg; P=.0005), 3 months (systolic, –26 mm Hg; P<.0001; diastolic, –9 mm Hg; P<.0001) and 6 months (systolic, –25 mm Hg; P<.0001; diastolic, –7 mm Hg; P<.0001).

The multi-electrode EnligHTN system should tested in a randomized controlled trial, Worthley said.

Additional follow-up in EnligHTN III is planned for 12, 18 and 24 months.

Vessix renal denervation system

The Vessix renal denervation system has balloons of 4 mm to 7 mm, a helical pattern of bipolar radiofrequency electrodes and bipolar energy delivery of 68°C. The device is approved in Europe and Australia.

Joachim Schofer

Main efficacy measures included office BP at 18 months and 24-hour ambulatory BP at 6 and 12 months.

There were 51 patients with resistant hypertension included in this interim analysis.

Preliminary data showed a reduction in office BP at 1 month from baseline (–22.7/–10 mm Hg; P<.0001), which continued through 18 months (–30.2/–12.7 mm Hg; P<.0001). “We have not seen this sustained reduction before,” Schofer said.

The researchers also observed a clinically meaningful response — >5 mm Hg — in 84% of the cohort. – by Rob Volansky

For more information:

Daemen J, Schofer J and Worthley SG. Hot line on resistant hypertension: Trial updates and registries. Presented at: EuroPCR; May 20-23, 2014; Paris.

Disclosure: Daemen reports no relevant financial disclosures. Schofer reports financial disclosures with Boston Scientific. Worthley reports financial disclosures with Medtronic and St. Jude Medical.