27/12/2023
27/12/2023
NEW YORK, Dec 27: In a major medical advancement, the FDA has recently given the green light to a groundbreaking procedure that could provide relief for individuals struggling with treatment-resistant hypertension. This minimally invasive approach specifically targets nerves near the kidneys to manage high blood pressure when traditional medications prove ineffective.
Dr. Samin Sharma, an interventional cardiologist and the director of the Mount Sinai Cardiovascular Clinical Institute at Mount Sinai Fuster Heart Hospital in New York City, successfully conducted this innovative procedure earlier this month on a patient grappling with uncontrolled hypertension.
"When the device arrived, we immediately decided to try it on the patient," said Dr. Sharma in an interview with Fox News Digital. The patient, upon agreement, expressed considerable satisfaction with the outcome.
The procedure involves the use of a specialized device designed to ablate overstimulated sympathetic nerves near the kidneys. Dr. Sharma notes that this method has the potential to control a patient's blood pressure for a minimum of five years, reducing the risk of life-threatening events such as heart attacks, strokes, brain bleeds, and kidney failure.
Two devices, namely Medtronic’s Symplicity Spyral Renal Denervation system and Recor Medical’s Paradise Ultrasound Renal Denervation system, have received FDA approval for this groundbreaking treatment as of December 2023.
The FDA's approval statement specifies that the device is intended "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." Dr. Sharma clarified that the procedure is suitable for individuals without blockages in the kidney arteries.
During the one-hour procedure, interventional cardiologists insert a thin tube into the renal artery, utilizing sound waves or radiofrequency energy to target and ablate overactive sympathetic nerves connected to the kidney. According to Dr. Sharma, this process involves destroying nerve endings, effectively calming excessive nerve activity, and mitigating blood pressure in the brain.
Studies have indicated that this ablation technique significantly lowers both systolic (the top number) and diastolic (the bottom number) blood pressure readings in individuals, with effects lasting for months or even years.
Dr. Sharma assured Fox News Digital that there is likely no negative impact on the kidneys. However, as with any medical procedure, some risks are involved. One potential risk includes artery damage during the procedure, occurring in about one in 500 cases.
On December 4, Dr. Sharma and his medical team at Mount Sinai performed the procedure on Adit Dhawan, a 44-year-old resident of Long Island, New York, who had struggled with high blood pressure since the age of 19. Despite a healthy lifestyle and regular exercise, Dhawan's blood pressure remained consistently high.
Following the procedure, Dhawan described the experience as "not bad," with only mild soreness that lasted for about three days, alleviated by Tylenol. Three weeks post-procedure, Dhawan reported significant benefits, requiring fewer blood pressure medications and resuming regular physical activity.
Several physicians not directly involved with Dhawan's case expressed optimism about the new treatment for uncontrolled hypertension. Dr. Manesh R. Patel, M.D., chief of cardiology and co-director of the Duke Heart Center at Duke University, emphasized the positive outcomes observed in high-quality randomized studies.
Dr. Steven Potter, M.D., a transplant surgeon at MedStar Georgetown Transplant Institute, acknowledged the global impact of hypertension and highlighted the potential value of innovative treatment options. He cautioned, however, that further research and experience are needed to determine the appropriate role of renal denervation in clinical practice.
As hypertension affects nearly half of US adults, with significant mortality rates, this newly approved procedure offers a promising avenue for those struggling to control their blood pressure. Ongoing research and medical experiences will play a crucial role in defining the broader impact and role of this procedure in the future.