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making hypertension history

Temple Pioneers a Revolutionary Hypertension Treatment

Hazelene Jackson and John Blebea, MD

Courage. Determination. And plenty of grit. Those are just a few of Hazelene Jackson's traits that helped set the stage for her to become the first patient in Pennsylvania to be implanted with a still-experimental medical device designed to treat drug-resistant hypertension, or high blood pressure.

Of course, Jackson's pretty smart, too -- so, before agreeing to enroll in the FDA-approved clinical trial, she sized-up the surgeon who would be performing the delicate procedure. She quickly concluded that John Blebea, MD, Professor and Chief of Vascular Surgery at Temple University School of Medicine and Temple University Hospital, was the man for the job. Indeed, since joining Temple a little more than four years ago, Blebea -- a nationally renowned expert in vascular surgery -- had already introduced several other clinical innovations to Temple. Moreover, he is consistently named one of the country's "Top Doctors" in multiple national and local consumer-oriented guides.

Drug-Resistant Hypertension

Called the "silent killer," hypertension is the leading cause of stroke, heart attack, heart failure, and kidney disease. For most of the estimated 72 million Americans diagnosed with the chronic condition, treatment involves the use of medications -- which, in most instances, may require the use of multiple drugs each day. However, for nearly one-quarter of all such patients, no amount (or combination) of pills can effectively manage their disease.

And that's the precise patient population -- those with drug-resistant hypertension -- that the novel device, called the Rheos (TM) system, hopes to treat. Rather than rely totally on drugs, the system is designed to jump-start the body's natural regulation system to reduce high blood pressure -- which kicks in when electrical impulses race from baroreceptors (nerves nestled in the carotid arteries of the neck) to the brain -- to signal that an inappropriate increase in blood pressure has occurred.

Once alerted, the brain rushes signals to all parts of the body -- with instructions to take whatever measures are necessary to reduce the blood-pressure level.

The proprietary Rheos (TM) system, manufactured by CVRX, includes an iPod-sized "pulse generator" that is implanted below the collar bone; two thin electrode wires (connected to the pulse generator) that are implanted and delicately wrapped around the baroreceptors on top of the left and right carotids, respectively; and an external device used by physicians to non-invasively regulate the electrical energy from the pulse generator to the wires. "Think of it as a pacemaker for blood pressure," says Blebea, who serves as principal investigator at Temple for the clinical trial.

An Eager Participant

A resident of Northeast Philadelphia, Jackson was an ideal candidate for the innovative device. "She's had severely high blood pressure since her 20s, with her most recent average monitored at 215 [systolic] over 110 [diastolic]," explained Arnold Meshkov, MD, her Temple cardiologist, adding that a normal reading is about 160 over 90. "She's also been evaluated by multiple physicians, been hospitalized multiple times, suffered a serious stroke in September of 2004, and has been taking up to seven different medications a day," added Meshkov, who serves as co-investigator for the study.

"I've been on an abundance of medications," echoed Jackson, "and the problem is that after I've taken a particular medicine for three months or more, my body starts to build a tolerance for it. It's a great hassle to have to take so many pills."

In addition, as part of the side effects of taking so many pills, Jackson's energy had been severely suppressed -- so much so that she had forgone many of her favorite activities -- including sewing, cooking, gardening, dancing, deep-sea fishing, and playing with her four beloved grandchildren. "Oh, and I love to gamble ... just love the slots!" she laughs.

Consequently, Jackson was eager to participate in the study. "Does it sound scary? No, it sounds great!" she says enthusiastically. "I feel like I'll be giving birth to a solution to my problem. And even if it doesn't work for me, others will benefit from what the doctors learn. I want everybody to be able to live ... and live to the fullest."

The Pioneering Surgery

In the early morning hours of December 17, 2007, Blebea methodically prepared for Hazelene Jackson's surgery. His gentlemanly demeanor contrasts somewhat to the laser-like focus, exacting precision, and nerves of steel he brings to the Operating Room. This history-making morning, Blebea's sole objective would be to successfully implant the medical device and its ancillary wires into his 53-year-old patient.

Five hours later, Blebea reported, "Everything went according to plan. There were no surprises -- which is good. And, although this was a new procedure, it involved the same methods and techniques I've used on hundreds of patients previously during surgery on the carotid arteries to prevent stroke."

His patient concurred. Just two days after surgery, she appeared -- along with her husband Elijah, and daughter Marie -- before a roomful of local reporters to announce that she felt "fantastic!"

"It's not even on yet, and I feel like the million-dollar person," she added.

Getting Turned On

As part of the research study's protocol, the system is not activated until 30 days after surgery, to allow the patient to heal. So, one month after her implant, Jackson returned to Temple University Hospital to have her pulse-generator turned on.

"Upon turning on the stimulator, we successfully decreased her blood pressure from 200/101 to 120/75 -- normal!" said Blebea. "The effect was better than either we or the patient could have hoped for.

"Not only was her blood pressure within the normal range for the first time in decades," he continued, "but it was taking place without any side effects or symptoms of any kind. Furthermore, it was achieved with only a moderate level of stimulation."

At press time, Jackson's blood pressure has remained consistently normal, based on daily readings. Her Temple doctors will continue to carefully monitor her pressure for the next year so the results can become part of the study's conclusions.

For Jackson, though, the immediate results have been optimal. "I already feel like I've been given a new lease on life," she said, adding that she also dropped 7 pounds and quit smoking -- cold turkey. "And I'm cha-cha-cha'ing again!" she added, with a wink.

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By Rebecca Harmon

From January/February 2008 issue of Capsule

A Publication of Temple University Health System

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