Study finds 35 million patients may be eligible for renal denervation
A nationwide data analysis found that nearly one-third of U.S. adults with hypertension may be eligible for therapy by two catheter renal denervation (RDN) devices cleared by U.S. Food and Drug Administration (FDA). However, the study's authors noted that eligibility alone does not indicate which of the 35 million patients are most likely to benefit from the treatment. The study was published June 4 online in JACC: Interventions.[1]
Co-author of the study Eric Secemsky, MD—a cardiologist and researcher from Beth Israel Deaconess Medical Center and Harvard Medical—and his team used data from the National Health and Nutrition Examination Survey (NHANES) to estimate the proportion of hypertension patients who meet the FDA's criteria for consideration of RDN.
The researchers then broke down how many patients would qualify for RDN using the same criteria of each study for the two approved devices. They also looked at how many patients would qualify under the Society for Cardiovascular Angiography and Interventions (SCAI) 2023 RDN position statement on patient selection and best practices.
The authors found that on-medication, sham-controlled randomized trials had the most selective enrollment criteria, matching only about 2% of U.S. adults with hypertension. In contrast, U.S. single-arm registries and the SCAI 2023 position statement estimated a much larger potential eligibility, approaching 25 million Americans. This discrepancy underscores the challenge of generalizing highly selective trial results to a broader patient population in real-world settings.
Hypertension affects nearly half of the U.S. population, yet despite the availability of effective treatment options, around 75% of patients still struggle with uncontrolled hypertension. Multiple randomized trials have shown that RDN significantly reduces blood pressure as an adjunctive treatment for patients with poorly controlled hypertension. However, up to 30% of patients do not respond to RDN. The authors emphasized the importance of improving patient selection to optimize the treatment's effectiveness.
"These findings are particularly notable because of limitations in the current knowledge around RDN. In randomized trials, up to one-third of patients did not experience meaningful BP changes. On the basis of our estimates, if all patients were treated with RDN according to the FDA criteria, more than 10 million patients may be treated without meaningful benefit," Secemsky, et al. wrote.
The group added that that the economic burden of an ineffective invasive procedure, like RDN, can be significant. Although previous studies have explored markers for long-term blood pressure reduction, there are currently no clinically available tools to predict which patients will respond to RDN.
This study could help better define the scope of the problem and identify ways to narrow down the patient selection process, potentially streamlining future research on responder identification, the authors concluded.
The full study is available at the link below.
Dave Fornell has covered healthcare for more than 17 years, with a focus in cardiology and radiology. Fornell is a 5-time winner of a Jesse H. Neal Award, the most prestigious editorial honors in the field of specialized journalism. The wins included best technical content, best use of social media and best COVID-19 coverage. Fornell was also a three-time Neal finalist for best range of work by a single author. He produces more than 100 editorial videos each year, most of them interviews with key opinion leaders in medicine. He also writes technical articles, covers key trends, conducts video hospital site visits, and is very involved with social media. E-mail: [email protected]