In an update to their guidelines for treating high blood pressure, a group of cardiovascular medical societies has included a new recommendation for adding renal denervation procedures as an option paired with traditional therapies and lifestyle changes.
The publication from the American Heart Association (AHA) and the American College of Cardiology (ACC) replaces hypertension guidelines issued in 2017 and follows a review of clinical studies and medical literature. The report was also endorsed by a host of other academies and groups and was simultaneously published in the affiliated journals JACC, Circulation and Hypertension.
Renal denervation—which isolates the overactive nerves surrounding the arteries that feed the kidneys through a catheter-based, single-shot ablation procedure that interrupts the signals to the brain linked to persistently high blood pressure—received a class 2b recommendation.
According to the AHA and the ACC, that category shows that benefits may outweigh or equal the risks—as demonstrated by randomized, sham-controlled trials of the approach—but it is still considered weaker than class 2a’s moderate and class 1’s strong recommendations, which include patient medication reviews and the addition of pharmaceutical regimens such as certain diuretic drugs.
The paper said that renal denervation may be a reasonable adjunctive treatment for stubbornly high blood pressure, but, given the absence of long-term follow-up in clinical studies—including measurements of ultimate cardiovascular disease outcomes—it should not yet be considered a curative therapy or a replacement for antihypertensive meds.
The guidelines also limit the recommendation to patients with resistant or uncontrolled hypertension, including people with a systolic blood pressure of 140 mmHg or more, who have not already seen success with multiple drug therapies.
Renal denervation approaches from Medtronic and Otsuka’s Recor Medical both claimed long-sought FDA approvals in late 2023, following years of development and setbacks in clinical trials. Medtronic’s radiofrequency-powered Symplicity Spyral catheter previously underwent a redesign, while Recor’s Paradise ultrasound system had been in the works since 2009.
At the top of this year, the Centers for Medicare & Medicaid Services launched temporary, transitional pass-through payments to each company for their respective outpatient procedures—and, earlier this summer, Medicare proposed initiating full nationwide coverage for the devices.
According to Medtronic and Recor, the new guideline recommendations underscore the importance of the technology as an emerging therapy for hypertension.
“As leading voices in cardiovascular health practices, the AHA and ACC strengthen support for renal denervation as a treatment option for high blood pressure,” Recor’s president and CEO, Lara Barghout, said in a statement.
“We are pleased to see that the strength of our RADIANCE Global Program formed the basis for the positive inclusion in the guidelines, which not only reinforce the credibility of this therapy—they directly align with the compelling clinical evidence behind the Paradise Ultrasound Renal Denervation System, which has consistently demonstrated safe, effective blood pressure reduction,” Barghout added.
“To date, we are seeing great interest from healthcare systems across the United States that are looking to offer the Symplicity blood pressure procedure,” said Medtronic’s Jason Weidman, president of the company's coronary and renal denervation business. “The updated renal denervation guidelines will enable greater patient access to this potentially life-changing intervention—not only in the United States, but globally as well.”
Medtronic has also been testing its denervation approach in vessels outside of the kidneys. In July, the company reported treating its first patient in a pilot program aimed at the main arteries in the liver, as part of a series of clinical studies that will examine participants both on and off blood pressure medications.
The procedure would be incorporated alongside renal denervation, with the goal of urging the vascular walls to relax and let blood flow more easily into the liver itself. The common hepatic artery carries about twice as many nerves compared to the renal arteries, with those nerves being about three times larger while the vessel is about the same size and diameter.
The AHA and ACC guidelines more broadly emphasize prevention and earlier treatments to reduce the risks of heart attack and stroke—as well as in maintaining brain health, including staving off cognitive decline and dementia.
They also urge checking for high blood pressure during pregnancy, to detect preeclampsia, and recommend the use of the AHA’s PREVENT cardiovascular risk calculator—which includes updated measures of kidney and metabolic health, as well as ZIP codes as a proxy for social determinants of health.