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.