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People with treatment-resistant hypertension could benefit from a new procedure that the FDA recently approved.
The minimally invasive procedure targets nerves near the kidneys to help control high blood pressure when medications fail to do so.
Dr. Samin Sharma, an interventional cardiologist and director of the Mount Sinai Cardiovascular Clinical Institute at Mount Sinai Fuster Heart Hospital in New York City, performed the new procedure on a patient with uncontrolled hypertension earlier this month.
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"When the device came, we said, ‘We are going to try it on you,’" Sharma told Fox News Digital.
"He said yes and was very happy."
A team of interventional cardiologists from Mount Sinai Fuster Heart Hospital in New York City performed the first Symplicity™ blood pressure procedure in December 2023. (Mount Sinai Fuster Heart Hospital)
Here's how it works
The treatment uses a device that ablates the overstimulated sympathetic nerves near the kidneys, Sharma said.
It can help control the patient’s blood pressure for at least five years, possibly preventing life-threatening events such as heart attack, stroke, brain bleeds and kidney failure.
"Renal denervation continues to be an experimental therapy that has shown some promise as a proof of concept."
Two devices — Medtronic’s Symplicity Spyral Renal Denervation system and Recor Medical’s Paradise Ultrasound Renal Denervation system — have received FDA approval for this treatment as of the end of December 2023.
The device is indicated "to reduce blood pressure as an adjunctive treatment in patients with hypertension in whom lifestyle modifications and antihypertensive medications do not adequately control blood pressure," according to the FDA’s approval statement.
The procedure is intended for individuals who do not show blockage of the kidney arteries, Sharma noted.
During the one-hour procedure, interventional cardiologists insert a thin tube into the renal artery, which sends sound waves or radiofrequency energy that targets and ablates the overactive sympathetic nerves that are connected to the kidney, Sharma told Fox News Digital.
The patient's blood pressure after the procedure is now averaging 135/85 — the lowest it has been in many years. Mount Sinai is one of the few hospitals in the country to perform this "game-changing" procedure. (Mount Sinai Fuster Heart Hospital)
"You kind of destroy the nerve endings," the doctor said.
This calms the nerves’ excessive activity — which mitigates blood pressure to the brain.
Studies have shown that this ablation technique helps to lower systolic (the top number) and diastolic (the bottom number) blood pressure readings in individuals for months or even years.
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There is most likely no negative impact on the kidneys, Sharma told Fox News Digital.
As with any procedure, however, there are some risks involved.
One potential risk is that an artery is damaged during the procedure.
"Hypertension is the most frequent modifiable risk factor for heart disease, and blood pressure control in our country is not where it needs to be," a doctor told Fox News Digital. (iStock)
"Damage can occur in about one in 500 cases," Sharma said.
"We don’t expect this to happen, but that is a [potential] complication."
Why results have been life-changing
On Dec. 4, Sharma and his team of doctors at Mount Sinai performed the procedure on Adit Dhawan, 44.
Dhawan, a married father who lives on Long Island, New York, spoke to Fox News Digital about the experience.
Ever since he was diagnosed with high blood pressure at age 19, he'd taken several different medications over the decades, none of which helped.
Dhawan also followed a relatively healthy diet and exercised regularly.
Despite these efforts, his blood pressure has averaged 150/90-100 mm Hg since he was in his twenties, he told Fox News Digital.
A normal blood pressure reading is between 110-120/70-80 mm Hg, according to medical experts.
A normal blood pressure reading is between 110-120/70-80 mm Hg, according to medical experts. (Tobias Hase/picture alliance via Getty Images)
A few months ago, when Dhawan took the measurement at home, the result was even higher than what he typically saw.
"It was super high — 170/100. That’s when I freaked out," he said.
When he sought Sharman’s help, the doctor told Dhawan about the new procedure — and he was eager to give it a try.
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After the procedure, which Dhawan described as "not bad," he took Tylenol for some mild soreness that lasted for about three days.
Now, just three weeks later, he is already seeing the benefits of the procedure. Dhawan is already taking far fewer blood pressure medications and is back to running and exercising, he told Fox News Digital.
"I’m really glad, because high blood pressure is a silent killer," he said. "I’m very happy. Everything is fine. All my vitals are great."
Based on trials and short-term follow-up, a doctor noted that the procedure seems to provide modest benefit in lowering blood pressure. (iStock)
Dhawan’s blood pressure is now averaging 135/85 — the lowest it has been in many years.
As of Dec. 2023, Mount Sinai is one of the few places in the country where this "game-changing" procedure has been performed. Other hospitals that have performed the procedure include NewYork-Presbyterian/Columbia University; Gates Vascular Institute in Buffalo, New York; Smidt Heart Institute at Cedars-Sinai in Los Angeles; and Cleveland Clinic in Cleveland, Ohio.
What doctors are saying
Several physicians not involved with Dhawan’s case spoke to Fox News Digital about the new treatment for uncontrolled hypertension.
"In high-quality randomized studies, the renal denervation procedure has been shown to improve blood pressure control … in patients with difficult-to-control blood pressure and those with high blood pressure who are on one or two medications," said Dr. Manesh R. Patel, M.D., chief of cardiology and co-director of the Duke Heart Center at Duke University in Durham, North Carolina.
As Patel told Fox News Digital, he is excited that there's now another therapy available for patients with high blood pressure.
"Hypertension is the most frequent modifiable risk factor for heart disease, and blood pressure control in our country is not where it needs to be," the doctor told Fox News Digital.
"Therefore, having a procedure to support control, on top of medications, is an important step forward."
Two devices — Medtronic’s Symplicity Spyral Renal Denervation system and Recor Medical’s Paradise Ultrasound Renal Denervation system — both received FDA approval for this treatment as of the end of December 2023. (AP Images)
When asked about concerns regarding the procedure’s potential effect on the kidneys, Patel said, "The studies done to date have shown the renal denervation procedure has been well-tolerated and there has been a low risk of causing any damage."
Dr. Steven Potter, M.D., an experienced kidney and pancreas transplant surgeon at Medstar Georgetown Transplant Institute in Washington, D.C., also commented on the newly approved procedure.
"The global costs of hypertension are enormous, and innovative treatment options could prove to hold great value," Potter told Fox News Digital.
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"At this point, renal denervation continues to be an experimental therapy that has shown some promise as a proof of concept."
Based on trials and short-term follow-up, Potter noted that the procedure seems to provide modest benefit in lowering blood pressure, although "the results of studies have been conflicting, with some showing significant benefit and others failing to do so."
Hypertension is defined as a systolic blood pressure greater than 130 mm Hg or a diastolic blood pressure greater than 80 mm Hg. (iStock)
More experience with, and research into, the procedure are needed "before its appropriate role in clinical practice is determined," he added.
High blood pressure affects nearly half of U.S. adults, according to the Centers for Disease Control and Prevention (CDC). Only about one out of four patients with hypertension are able to control it.
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Hypertension is defined as a systolic blood pressure greater than 130 mm Hg or a diastolic blood pressure greater than 80 mm Hg.
In 2021, hypertension was a primary or contributing cause of 691,095 deaths in the U.S.
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