Silver Cross Clinical Trial Takes the Pressure Off Hypertensive Patient

High blood pressure is an all-too-common issue that can cause major health issues, such as stroke, heart attack, heart failure and other heart conditions, and damage your kidneys, memory and vision.

Sometimes, even diet and medication can’t alleviate high blood pressure. But a procedure under clinical trial at Silver Cross Hospital in New Lenox is showing promise.

Last fall, Silver Cross and Heart Care Centers of Illinois announced they were the first hospital and only cardiology practice in Illinois to offer refined renal denervation therapy for the treatment of uncontrolled hypertension or high blood pressure.

Renal denervation addresses the fact that high blood pressure can be caused by overactive signals between the kidneys and the brain.  Renal Denervation (RDN) uses radiofrequency ablation to burn the nerves in the renal arteries. This process causes a reduction in the nerve activity and signaling, which may decrease blood pressure.

“Renal denervation has been studied for over a decade,” said Dr. Ravi Ramana, an interventional cardiologist and primary study investigator on staff at Silver Cross. “Several companies were working on the technology, which showed promise in some clinical trials, but not sufficiently successful for Food and Drug Administration (FDA) approval.”

One company, Medtronic, kept working on the technology, Dr. Ramana said, and ultimately developed the Symplicity Spyral Renal Denervation System.

Satisfied after seeing the results of other clinical trials using this device, Dr. Ramana brought the trial to Silver Cross last year. He found his first trial participant courtesy of fellow interventional cardiologist,  Dr. Joseph Stella.

Kathy Sarich of Lockport said she had only recently become Dr. Stella’s patient, but had high blood pressure for a couple decades, despite various and combined medications.

“To be honest, I also hadn’t been very good with my diet,” said Sarich, 62. “I’m overweight, and I work long hours, so I pick up fast food.”

On Dr. Stella’s recommendation, Sarich met with Dr. Ramana, who explained the procedure.

The device is placed using a catheter inserted into the groin area, through the abdominal aorta and into the arteries leading to the kidney (renal arteries). The device is placed in various locations in the renal arteries but only the areas that need ablating are stimulated.

“The procedure takes about an hour and a half,” Dr. Ramana said. “And we kept her overnight at the hospital just to monitor.”

Sarich said she doesn’t remember much about the day of surgery last November, except for feeling very special.

“There were different people in the room checking out the insertion, making sure it wasn’t bleeding. But then I saw people watching on the other side of the glass in the operating room. I felt like a celebrity,” she said.

 The surgery went well, and Sarich was back on her feet in no time.

“I really didn’t notice any difference. But I never had any symptoms with the high blood pressure, either. When I went in for my first follow-up in February, I learned my systolic pressure had dropped 20 points, just after three months,” Sarich explained.

Dr. Ramana said this is very encouraging, but added it’s too early to consider taking Sarich off or even reducing her high blood pressure medication. However, if continued follow-up clinical appointments show continued improvement of blood pressure, he said, they would consider it.

Meanwhile, Dr. Stella recommended another of his patients for the trial in the next few weeks, Dr. Ramana said.

“The idea is to help get their blood pressure to a safe level to help reduce the risk of stroke, heart attack or death without maxing out on medications,” he said. “And the Symplicity Spyral Renal Denervation System appears encouraging.”

For more information, visit silvercross.org