The study demonstrates the effectiveness of a procedure performed under the skin for the treatment of uncontrolled high blood pressure

High blood pressure remains poorly controlled worldwide and is becoming more common. Lifestyle changes and blood pressure-lowering medications are the mainstays of treating high blood pressure, but despite the wide availability of these approaches, many hypertensive patients do not receive adequate treatment. Those with uncontrolled high blood pressure are at increased risk of heart attack, heart failure, kidney disease, and stroke.

A recent study published in gamma Demonstrates the effectiveness of a procedure performed under the skin, similar to stent placement, for treating uncontrolled high blood pressure, or blood pressure that cannot be controlled despite the use of blood pressure control medications and agents. This minimally invasive procedure uses ultrasound energy delivered through a small balloon to remove or cut off the nerve supply to the renal artery (RDN), or major blood vessels that supply blood to the kidney. Used alone or as a supplement to blood pressure medications, renal nerve denervation targets overactive kidney nerves. This was a randomized clinical trial with 224 patients with uncontrolled hypertension. The trial was co-authored by Stephen Jenkins, MD, FACC, FSCAI, FSVM, chief of interventional cardiology and director of interventional cardiology research at Ochsner Health.

Ochsner Hospital participated in the RADIANCE-HTN trial series that examined the effect of ultrasound renal denervation in refractory hypertensive patients. In this pivotal, randomized, multinational trial, Ochsner Hospital was the number 2 registrant in the United States. This simple catheter-based procedure provides an alternative to drug treatment for high blood pressure by decreasing sympathetic nerve activity in the arteries that leads to high blood pressure.”

Dr Stephen Jenkins

In addition to lifestyle changes and drug therapy, catheter-based renal denervation (RDN), a minimally invasive procedure involving a small incision, has emerged as a treatment for resistant hypertension. The traditional RDN procedure uses radiofrequency ablation to burn off the nerves in the renal arteries leading to the kidneys. This process leads to a decrease in nerve activity, which leads to a drop in blood pressure.

The uRDN ​​system, a minimally invasive procedure for treating overactive nerves, is performed by inserting a small, flexible catheter through a small hole in the wrist or groin. The catheter is then placed into the artery that supplies the kidneys. Ultrasound energy or ultrasound is delivered to the tissue surrounding the artery for several seconds which reduces nerve activity and lowers blood pressure. The device is removed after both kidneys have been treated during the procedure.

Two placebo-controlled trials previously demonstrated that ultrasonic renal neural denervation (uRDN) reduces blood pressure (BP) in patients with mild, moderate, and resistant hypertension. This larger pivotal trial in patients with uncontrolled high blood pressure was expanded effectiveness and safety monitoring.

IThe Radiance II trial, which was co-authored by Jenkins, showed positive results even for those with uncontrolled high blood pressure, with persistently low blood pressure after two months of treatment. This means that URDN is an alternative to medical treatment and an effective blood pressure lowering treatment for hypertensive patients.

In addition, the combined analysis results from RADIANCE SOLO, RADIANCE TRIO, and RADIANCE II have been published concurrently in heart gamma. The analysis included data from more than 500 patients with mild-to-moderate, resistant hypertension randomly assigned to the three studies. The results of the pooled analysis showed a consistent blood pressure lowering effect across a wide range of hypertension.


Journal reference:

Dear, m. et al. (2023) Ultrasound endovascular renal denervation for the treatment of hypertension. The RADIANCE II randomized clinical trial. gamma.

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