Years away from clinical use
At 2 months, 20% of the RDN group had a blood pressure below 135/85 mm Hg in the absence of antihypertensive medication, compared with 3% of controls.
No major adverse events such as renal failure, major vascular complications, embolism with end organ damage, or hypertensive crisis occurred during 2 months of follow-up. Follow-up will continue out to 3 years to evaluate the durability of therapeutic benefit.
The Paradise ultrasound system achieves circumferential ablation at a controllable depth of 1-6 mm in order to interrupt renal nerve traffic. Two or three ablations, each lasting 7 seconds, are delivered to each of the main renal arteries. The arterial wall is protected by water circulating through the balloon. The results were published simultaneously with Dr. Mauri’s presentation (Lancet 2018 May 23; doi: 10.1016/S0140-6736[18]31082-1).
SPYRAL HTN-ON MED
David E. Kandzari, MD, reported on the first 80 patients to complete 6 months of prospective follow-up in this ongoing international, single-blind, randomized trial of more than 400 patients with inadequately controlled hypertension on one to three commonly prescribed antihypertensive medications. Participants are being randomized to RDN via circumferential radiofrequency ablation using Medtronic’s Symplicity Spyral catheter or a sham control procedure. Although in this trial patients remain on their antihypertensive medications, an earlier randomized trial established proof of principle for efficacy in the absence of antihypertensive drugs.