Heart & Vascular

Renal Denervation Procedure Marks New Era in Hypertension Management

May 24, 2024 - Eden McCleskey

In the battle against hypertension, a new weapon has emerged.

Renal denervation is a minimally invasive procedure that disrupts blood pressure-elevating signals sent from the renal arteries to the central nervous system. It offers patients with chronic or treatment-resistant hypertension the potential for long-term relief.

Houston Methodist recently became the first hospital in Houston to perform the groundbreaking procedure, the only non-pharmacologic treatment for hypertension approved by the FDA.

"This is an important milestone and hopefully the beginning of a new era marked by more innovative, durable and diverse treatment options for a condition that affects so many and contributes to so much of the global burden of disease," said Dr. Alpesh Shah, director of Coronary Interventions at Houston Methodist. "Prescription drugs are effective, widely available and affordable, but they don't work for everyone, and adherence is an enormous problem."

Hypertension affects nearly one out of every two American adults, and, alarmingly, only one out of five individuals with the condition has it under control.

Since FDA approval in March, Dr. Shah has performed the procedure on three Houston Methodist patients, with no complications and promising blood pressure results reported so far. He will track their cases — and those of additional procedures he performs in the next one to two years — in his role as local principal investigator for a national clinical outcomes trial.

Similar to cardiac catheterization, renal denervation is performed by inserting a catheter in the femoral artery, navigating to the renal arteries and ablating the nerve endings there that cause elevations in blood pressure.

The renal afferent nerve fibers carry information from the kidneys to various regions of the central nervous system that play an important role in the regulation of the autonomic nervous system and cardiovascular function. Hyperactivation of renal afferent nerves dysregulates these activities and contributes to the development of hypertension and cardiovascular disease.

"The idea is to interrupt the crosstalk between the kidneys and the central nervous system using radiofrequency ablation," Dr. Shah explained. "We ablate anywhere from four to 12 spots on both the left and the right sides, allowing us to reduce overall nerve activity in the renal arteries and lower blood pressure by up to 10-15 mm."

Roughly equivalent to what one prescription blood-pressure lowering medication typically achieves, the sustained 10 mm drop in systolic blood pressure the procedure triggers can reduce risk of cardiovascular mortality by up to 40 percent while conferring additional protective benefits against dementia, memory loss, stroke and more, according to studies.

The FDA's approval of the procedure represents a significant shift toward embracing long-term, procedure-based treatments in response to increasing patient demand.

While originally intended for resistant cases, the procedure can now be offered to anyone who suffers from primary hypertension, a win for the shared decision-making model of patient care.

"We have patients who say, 'I'm 45 years old, and I'd really rather not go on one or more medications for the rest of my life,'" Dr. Shah said. "It's like atrial fibrillation. People can live with it, but eventually they said to us, 'I don't want to be in a-fib all the time, can't you just ablate it and make it go away?' We developed a process for that, and now we're doing something similar for hypertension."

Dr. Shah says it's important to review eligibility criteria and stresses the importance of distinguishing primary hypertension from secondary causes. Rigorous assessment, including ambulatory blood pressure monitoring, ensures suitability for the procedure.

"Fortunately, there are hardly any safety concerns for this therapy, regardless of patient age, because it's an ambulatory procedure requiring local anesthesia only and patients can typically go home on the same day," Dr. Shah said.

"However, on the bad news side, we have found that it doesn't work for everyone," Dr. Shah added. "Up to one third of patients don't achieve the minimal clinical benefit defined as a 5 mm blood pressure drop."

As a key participant in the SPYRAL AFFIRM hypertension trial, Dr. Shah and team hope to identify factors influencing the success or failure of treatment response. Previous trials faced similar mixed results and identified challenges with patient selection and medication titration.

"Although results don't always manifest, sustained benefits often emerge over time, with significant reductions in blood pressure observed in the majority of cases," Dr. Shah said. "It's also important to look at durability. Everything we've seen and studied points to this being permanent 'one and done' kind of therapy. And in the realm of hypertension management that's a huge differentiator."

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