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FDA-Approved Renal Denervation Benefits Patients with Resistant Hypertension

June 05, 2024

Skilled interventional cardiologists and hypertension experts at Orlando Health Heart and Vascular Institute are the first in Central Florida to offer a recently approved technology to patients experiencing uncontrolled high blood pressure.

Renal Denervation

Renal artery denervation (RDN) is a minimally invasive, catheter-based intervention that addresses hypertension resistant to other therapies. Under the direction of board-certified interventional cardiologist Farhan J. Khawaja, MD, Orlando Health has successfully treated several cases with the novel procedure as of May 2024 —more than any other regional institution.

“Renal denervation offers an adjunctive therapy for improved blood-pressure control beyond antihypertensive agents,” says Dr. Khawaja, who has been involved in renal denervation research and testing for more than a decade.

Estimated to affect 47% of American adults, hypertension is one of the country’s leading causes of death. Renal denervation benefits patients who: 

  • Have uncontrolled hypertension despite compliance on multiple antihypertensives at maximally tolerated dosages OR
  • Are intolerant to anti-hypertensive medications and/or lifestyle changes OR
  • Are at high risk for subsequent cardiovascular events (patients with coronary artery disease, previous stroke, congestive heart failure)

Performed under fluoroscopic guidance by an experienced interventionalist, a thin catheter entered from the groin and placed in renal arteries disrupts the nerve signals between the kidney and brain, either using radiofrequency energy or thermal ablation with ultrasound energy. The procedure is proven effective with no damage to the arteries or kidneys and only rare access site complications. Both technologies were evaluated in separate multicenter federal trials and approved by the U.S. Food and Drug Administration in November 2023.

Farhan J. Khawaja, MD
Farhan J. Khawaja, MD

“Our program is quite robust and systematic in its approach,” says Dr. Khawaja, whose team participated in both trials and is currently using radiofrequency ablation with patients enrolled in the open AFIRM trial. “We've performed several cases successfully with several more eligible patients in line for the procedure.”

While reimbursement in the commercial space is evolving, Orlando Health is offering the procedure through continued clinical trial enrollment. “We strongly believe in this technology as an adjunct therapy within a defined and responsible hypertension program.  We want appropriate patients to have access to it while the system works through insurance coverage and authorization issues which are commonly encountered with new technology,” says Dr. Khawaja.

Orlando Health Heart and Vascular Institute is a nationally recognized leader in cardiovascular innovation, exemplary heart care, advanced research and education. Board-certified cardiovascular providers are highly skilled in leading technologies, including innovative diagnostic services and nonsurgical or minimally invasive treatment options.

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