Hypertention: New Guidelines for Treatment and Renal Denervation Methods approved by FDA underway to be covered by Medicare
Reporter: Aviva Lev-Ari, PhD, RN
Guidelines acknowledge the impact of renal denervation
The ACC/AHA guidelines also acknowledge the growing importance of renal denervation (RDN), a relatively new treatment for uncontrolled hypertension that involves ablating overactive renal nerves to help lower a person’s blood pressure. In fact, RDN received a class IIb recommendation for patients who have already been evaluated by a multidisciplinary team.
Two RDN treatments are currently approved by the U.S. Food and Drug Administration:
In addition, the U.S. Centers for Medicare and Medicaid Services is in the final stages of considering full Medicare coverage for RDN procedures, and a final decision is expected in the months ahead.
Both Recor Medical and Medtronic celebrated the inclusion of RDN in these updated recommendations.
“As leading voices in cardiovascular health practices, the AHA and ACC strengthen support for RDN as a treatment option for high blood pressure,” Lara Barghout, president and CEO of Recor Medical, 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.”
“These updated hypertension guidelines are pivotal for physicians, as they validate RDN as an additional option for managing hypertension in patients who do not sufficiently respond to lifestyle modifications and pharmaceutical treatments,” Jason Weidman, senior vice president and president of Medtronic’s coronary and renal denervation business, said in a separate statement. “To date, we are seeing great interest from healthcare systems across the United States that are looking to offer the Symplicity blood pressure procedure. 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.”
SOURCES
Original Report
New patient evaluation strategies
Another key takeaway from these guidelines is the recommendation that healthcare professionals use the PREVENT risk calculator to estimate a patient’s risk of a heart attack, stroke or heart failure. The AHA developed PREVENT in 2023. It is the first risk calculator of its kind to focus on how cardiovascular, kidney and metabolic health all work together to influence a person’s long-term risk of experiencing adverse cardiovascular outcomes.
The new document also recommends using
- a patient’s ratio of urine albumin and creatinine for all patients presenting with high blood pressure.
- In the past, this test was only classified as “optional” for these patients.
Lifestyle and medication recommendations
The guidelines define <130/80 mm Hg as the overarching blood pressure treatment goal for all adult patients, though “additional considerations” may be considered when patients require institutional care, have a limited predicted lifespan or are pregnant. While normal blood pressure is seen as anything <120 mm Hg systolic and <80 mm Hg diastolic, elevated blood pressure includes 120-129 mm Hg systolic and <80 mm Hg diastolic.
Also, the groups behind this document recommended that all adults follow a heart-healthy eating pattern, reduce sodium intake, increase dietary potassium intake, adopt a moderate physical activity program, manage stress and reduce or eliminate alcohol intake if they wish to help manage their blood pressure. Patients with an average blood pressure of ≥130/80 mm Hg should start taking medications to lower their blood pressure if an initial three to six months of lifestyle modification do not make a significant difference. When patients with stage 2 hypertension are prescribed medications, the guidelines recommend the initiation of antihypertensive drug therapy with two first-line agents or difference classes in a single pill to help “improve adherence and reduce time to achieve blood pressure control.”
“High blood pressure is the most common and most modifiable risk factor for heart disease,” Daniel W. Jones, MD, chair of the guideline writing group and dean and professor emeritus of the University of Mississippi School of Medicine in Jackson, Mississippi, said in a statement. “By addressing individual risks earlier and offering more tailored strategies across the lifespan, the 2025 guideline aims to aid clinicians in helping more people manage their blood pressure and reduce the toll of heart disease, kidney disease, Type 2 diabetes and dementia.”
486 articles in this Open Access Online had address Hypertension
https://pharmaceuticalintelligence.com/?s=Hypertension
48 articles in this Open Access Online had address Renal Denervation
https://pharmaceuticalintelligence.com/?s=Renal+Denervation
2012pharmaceutical
sjwilliamspa