Columbia Leads the Way with New Ultrasound Procedure for Uncontrolled Blood Pressure

Columbia conducts a first-of-its-kind procedure to treat hypertension using an ultrasound device, heralding a potential breakthrough in treatment for millions.

Dr. Ajay Kirtane bedside next to the first patient to receive the renal denervation ultrasound device

Pictured with a patient is Ajay Kirtane, MD, Director of the Columbia Interventional Cardiovascular Care program 

For the millions of people worldwide struggling with stubborn high blood pressure (hypertension), a new treatment option is emerging from the realms of modern medical science. A cutting-edge procedure using a minimally invasive FDA-approved ultrasound device to treat hypertension was recently performed at Columbia University Irving Medical Center/NewYork-Presbyterian Hospital. 

Hypertension remains a persistent health challenge, affecting a substantial portion of the global population. Despite the numerous treatment options available, a significant subset of the population continues to grapple with uncontrolled blood pressure, rendering them vulnerable to severe health risks such as heart failure, stroke, heart attacks, and irreversible kidney damage.

"There are many patients out there like the one we treated today - with hypertension refractory to multiple medications, and with multiple hospitalizations and even a prior stroke due to uncontrollable blood pressure," states Ajay Kirtane, MD, SM, an interventional cardiologist and Director of Interventional Cardiovascular Care at Columbia. “To at least have some hope that we may be able to control their blood pressure better is so gratifying.”

Over several years, Dr. Kirtane has played a pivotal role serving as a Principal or Co-Principal Investigator evaluating the device, the ReCor Medical Paradise System, in three trials: RADIANCE-HTN SOLO, RADIANCE-HTN TRIO, and RADIANCE II. The most recent study, RADIANCE II, built on existing data that ultrasound renal denervation can lower blood pressure in patients with mild-moderate hypertension. 

The Underlying Mechanism

The interplay between kidney nerves and hypertension forms the crux of this innovative therapeutic approach. Individuals often experience hypertension stemming from hyperactive nerves in the kidneys, triggering processes that elevate blood pressure. While existing antihypertensive medications provide crucial support, they do not directly target the renal nerves. 

Enter the Solution

The ultrasound renal denervation system bridges this treatment gap by leveraging advanced ultrasound therapy to prevent hyperactive renal nerves from signaling. Administered through a minimally invasive catheter-based procedure, the therapy disrupts the signals that contribute to hypertension, effectively restoring balance to the intricate mechanisms governing blood pressure regulation.

In the clinical trial, the patients demonstrated good tolerance to the procedure, with the majority being discharged home on the same day. In a previous article, Dr. Kirtane mentioned notable enhancements in blood pressure readings as early as one month following the intervention.

Encouraging Outcomes

On August 22nd, the Circulatory Systems Devices Panel of the FDA’s Medical Devices Advisory Committee voted 12–0 in favor with regard to safety and 8–3 in favor (with one vote abstaining) for the efficacy of the system to treat high blood pressure with ultrasound renal denervation.

In a recent presentation at TCT 2023 this October, Dr. Kirtane highlighted the persistence of the beneficial effects of renal denervation even after the re-initiation of antihypertensive medications during the RADIANCE trials. 

The burden of taking blood pressure medications remained lower in the renal denervation arm than in the sham arm through 6 months, with a significant blood pressure-lowering effect still observed after accounting for differential drug use between months 2 and 6. 

Despite acknowledging the modest drop in blood pressure, Dr. Kirtane emphasized the potential of renal denervation as a viable option for patients struggling to achieve adequate blood pressure control. “It is truly remarkable to witness the approval of this technology that has the potential to help patients with difficult-to-control hypertension who are in need of other options beyond lifestyle modification and medications. I just want to thank all of the collaborators and the many patients who committed along the years to the careful study of this technology, allowing this to come to fruition,” says Dr. Kirtane.

For those grappling with uncontrolled blood pressure, the promising results of the ultrasound renal denervation system offers a glimmer of hope. As it inches closer to mainstream, it has the potential to redefine the landscape of hypertension management, ushering in an era of improved well-being for many worldwide.

If you experience uncontrolled blood pressure, please seek medical attention. 

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