s
s
Sections
You've read 3 of 10 free articles this month.
Get unlimited access to PressDemocrat.com, the eEdition and our mobile app starting at 99 cents per month.
Already a subscriber?
You've read 6 of 10 free articles this month.
Get unlimited access to PressDemocrat.com, the eEdition and our mobile app starting at 99 cents per month.
Already a subscriber?
You've read all of your free articles this month.
Get unlimited access to PressDemocrat.com, the eEdition and our mobile app starting at 99 cents per month.
Already a subscriber?
We've got a special deal for readers like you.
Get unlimited access to PressDemocrat.com, the eEdition and our mobile app starting 99 cents per month and support local journalism.
Already a subscriber?
Thanks for reading! Why not subscribe?
Get unlimited access to PressDemocrat.com, the eEdition and our mobile app starting 99 cents per month and support local journalism.
Already a subscriber?
Want to keep reading? Subscribe today!
Ooops! You're out of free articles. Starting at just 99 cents per month, you can keep reading all of our products and support local journalism.
Already a subscriber?

Half an hour before the operation, Richard Boyd, 67, laid back on a medical table in Santa Rosa Memorial Hospital's heart institute, easing his nerves with a crime novel.

Boyd, a retired phone company administrator who lives in Santa Rosa, loves a good pulp read, full of suspense and mystery. But the mystery he doesn't like is the one that sometimes shrouds a heart attack.

Last June, Boyd suffered a severe heart failure that he initially mistook for arthritis in his shoulder hours before he ended up at Memorial's emergency department.

On Wednesday, as part of a nationwide clinical trial, Boyd became one of about 160 patients who have received a new, implantable cardiac device designed to alert them of an imminent heart attack.

The device, known as the AngelMed Guardian, is being tested at 40 sites across the country. Memorial Hospital's Heart & Vascular Institute is one of only five locations in California and the only one in the North Coast currently participating in the trial, which will ultimately include 3,000 patients at 50 sites.

Wednesday's surgery was a classic case of how medical-device testing is done in the United States. The trial relies on patients like Boyd to be the human guinea pig; on local cardiac specialists like surgeon Dr. Sanjay Dhar and his partner, Dr. Stephen Halpern, to carry out the operation; and for engineers from the Shrewsbury, N.J.-based company to make sure the device works.

The ultimate goal is to certify the experimental device for standard use in patients across the country, a technological step with huge potential for both care and profit in creating an early warning system against heart attacks.

The device is implanted much the same way as a modern pacemaker, and is similar in size. But unlike a pacemaker, which regulates the beating of the heart, the AngelMed Guardian detects shifts in the heart's electrical signal caused by reduced blood flow through one of the three major coronary arteries.

Just before the procedure, Linda Sederholm, a registered nurse who assisted in the operation inside one of three catheterization labs, told Boyd, "You're a pioneer."

He was placed under "conscious sedation" and Dhar made an incision a few inches long below his left clavicle. With the visual aid of a fluoroscope, a real-time X-ray imaging device, Dhar inserted a wire lead through a vein and threaded it to the heart using a sheath.

Once in place, the lead's tip was anchored into the tissue of the ventricle wall. In time, more tissue will grow over the lead and secure it to the heart, like wire solder in electronic devices.

The device was pushed through the incision and sutured in place so that it can't move. The engineers for the company, which pays for much of the procedure's cost, then tested the device to make sure the hand-held monitor was receiving the desired signal.

The hand-held device has two warning alerts, one advising the patient to call his cardiologist, and another, more serious, alert advising an immediate trip to the emergency room, Halpern said. He is medical director of the Santa Rosa office of Radiant Research, a company that focuses on clinical trials, and has been in private practice with Dhar for 12 years.

A heart attack, medically known as a myocardial infarction, happens when a section of the heart muscle dies or is damaged because of reduced blood supply.

Halpern said that great strides have been made in reducing the "door-to-balloon" time, the interval between a patient's arrival to the emergency department and the moment the patient's artery is opened with a balloon-tipped catheter.

But he said few advances have been made in reducing the amount of time between the onset of heart attack symptoms and the arrival at the emergency room.

Last June, Boyd said he had no idea he was having a heart attack.

"I still don't really know what happened," he said, interviewed by phone the day before his Wednesday implant procedure.

"I started feeling a pain in my shoulder, but it was the same kind of pain I had in my wrist, which was diagnosed as arthritis two years earlier," he said.

He went to bed that night and woke up with the same level of pain, and by 11 a.m. it had become excruciating. That's when he went to the emergency room at Memorial Hospital. He said his cardiologist, Dhar, told him he was having a "massive heart attack."

"Sometimes a pain in the shoulder is nothing more than a pain in the shoulder," Boyd said. "Other times, it's a warning that you're having a heart attack."

In the AngelMed clinical trial, a randomized study, half the patients will have the device turned on at their first follow-up visit, about seven to 14 days after it has been implanted, said Kim Young, site director for Radiant Research in Santa Rosa.

The other half will wait six months before it is turned on, she said. Unlike in a double-blind clinical trial, Boyd will know if his device is one of the ones that will be turned on immediately.

Peace of mind is what Boyd said he's hoping for, adding that if he feels pain somewhere and the device does not go off, he'll be reassured. If it does go off, he said he won't worry about it because the device is designed to give him plenty of warning.

You can reach Staff Writer Martin Espinoza at 521-5213 or martin.espinoza@pressdemocrat.com.