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Controlling high blood pressure mechanically

Scott & White vascular surgeon Dr. Todd Bohannon, left, meets with Gary Lindley of Fort Worth. Scott Gaulin/Telegram
Gary Lindley of Fort Worth is feeling pretty good these days.

For the past 33 years, from age 27 to 60, Lindley has suffered from high blood pressure that couldn’t be controlled with medication or lifestyle changes.

In November, Lindley had a medical device about the size of an iPod implanted below his collarbone that regulates his blood pressure. In that time his blood pressure has dropped significantly.

Scott & White Memorial Hospital is one of 26 medical centers in the United States participating in clinical trials of the Rheos Baroreflex Hypertension Therapy System.

The system uses the body’s own blood pressure sensors in the sinus of the carotid artery to control blood pressure. Thin wires with electrical contacts are attached at one end to the Rheos generator, and are wrapped around the left and right carotid arteries at the other end.

When activated, the receptors send signals to the brain, which is interpreted as a rise in blood pressure. The brain counteracts the perceived blood pressure increase by sending signals to the rest of the body, including the heart, blood vessels and kidneys, to lower blood pressure.

“We’re trying to use the patient’s own regulatory system to our benefit by a continuous electrical stimulus to the carotid artery,” said Dr. Todd Bohannon, Scott & White vascular surgeon.

Vascular surgeon Dr. Robert Feldtman is the primary investigator at Scott & White in the Rheos Baroreflex Hypertension Therapy System study

Scott & White has implanted the device in nine patients, the largest number of any of the other study participants.

Scott & White’s first two patients, including Lindley, had their devices turned on, Bohannon said. The remainder are part of the study whose devices are turned on or off depending on a random selection.

Neither the patient nor the health care provider knows whose Rheos device is on or off for six months. During that six months, the participants continue to take their prescribed medications.

After six months all patients have their Rheos device turned on.

Scott & White was approached by CVRx Inc., developer of Rheos, to participate in the trial, Bohannon said. The study is scheduled to take place over three years, with participants followed for five years.

“The patients will be followed well beyond that,” he said.

The study group is varied, Bohannon said, with both men and women of various ages represented. The youngest Rheos implant patient in the Scott & White study is 35 years old.

The costs of the procedure are covered by CVRx Inc. The patients come in once a month to be checked.

In the United States there are about 72 million people who have high blood pressure, according to the American Heart Association. Around 25 percent of people with hypertension cannot control their high blood pressure despite use of multiple medications.

“More than 50,000 people die each year as a result of hypertension and there aren’t many options for those people who are maxed out on their medications,” Bohannon said. “This targets people who have no real good options.”

Participants in the trial are screened carefully in order to provide the Rheos device to those who have the highest chance of success, he said.

Individuals who have plaque buildup in their carotid arteries would not be good candidates for the study because there’s a possibility the device would be placed in an area where future surgery might be needed.

The patients in the study have all been eager to participate, Bohannon said.

“They’re at the end of their rope . . . they know their options are really not there and the potential problems are right around the corner,” he said. “They are very motivated.”

Prior to getting involved in the study, Lindley had changed doctors to one who was confident he could get the blood pressure under control. However, that was not to be. Lindley takes 12 pills a day for high blood pressure.

“I got real depressed and told my wife ‘we can’t retire, we can’t afford the medications,’” he said.

Lindley learned of the CPRx device from an article sent to him from a friend.

Once he contacted the company in early November it all moved rather quickly. Lindley was in Temple in about a week and asked that the surgery take place the week of Thanksgiving.

“It has given me hope,” Lindley said of the procedure.

Lindley’s son is on blood pressure medication and will probably be a good candidate for the Rheos in time, he predicted.

Lindley said just prior to the surgery he was having headaches, was depressed and feeling hopeless.

Since it’s been known all along that Lindley’s Rheos device was activated from the beginning, his progress can be attributed to the device.

“He came to us with blood pressures of 200 over 100 sustained on all of his medications,” said Karla Coco, clinical research coordinator in the vascular surgery division.

A couple of weeks ago Lindley called Ms. Coco prior to having a heart catheterization and his blood pressure was 127 over 72 with a heart rate of 74.

Everyone, including Lindley’s Fort Worth doctor, was shocked it was so low.

“It’s unbelievable because the only thing he’s done different is get a device,” she said. “He’s still on all of the same meds.”

“Emotionally, it’s given me so much.” Lindley said. “I can look forward to retirement and I can see my grandkids grow up. Also there’s something out there that can help my son.”

jgibbs@temple-telegram.com

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