Adventures in angioplasty
The cardiology team at MetroWest Medical Center in Framingham, Mass., is a Q-tip's width away from fixing a blocked coronary artery for retired bridal shoe salesman Bob Speen, but time is running out after an hour's worth of failed attempts.
With Frank Sinatra softly crooning "Between the Devil and the Deep Blue Sea" from a nearby CD player, the team stares at four monitors displaying images of Speen's internal plumbing, courtesy of a robotic arm that hovers over the 76-year-old's chest and zaps him with X-rays.
Cardiologist Dr. James Alderman has been injecting contrast dye so the arteries stand out onscreen, but he will soon have to call it a day because of the extra strain the chemicals are placing on Speen's kidneys, weakened from years of high blood pressure.
Well into a procedure called angioplasty, Alderman has snaked a series of thin tubes and wires into an incision near Speen's groin, through the Framingham resident's femoral artery and aorta, and into his right coronary artery. Now he's close to reopening a section of the vessel that is 90 percent blocked, thereby providing enough oxygen-rich blood to Speen's ticker to stave off chest pain or a future heart attack.
Speen is resting comfortably thanks to mild sedatives and is listening to Ol' Blue Eyes, his musical selection for the afternoon. Having signed a waiver, he is having his procedure at the leading institution in a state-run medical study.
Its purpose: To determine whether suburban hospitals can safely offer non-emergency angioplasties without having cardiac surgeons on hand. While Speen could have been assigned to a Boston hospital with such backup as part of the trial, his wish to stay close to home has been granted through the randomized selection process.
"I lucked out," the 76-year-old said before being wheeled in for his angioplasty.
Standing 3 feet away from his patient, Alderman is relying on years of experience and his sense of feel to thread a tube called a catheter through the medical piping the team has already placed in Speen's vessels. At the end of the catheter is a collapsed mesh wire cylinder called a stent that will be expanded by a tiny balloon, allowing it to enlarge the artery and restore full blood flow.
That's the hope, anyway. But Alderman is having trouble sliding the mesh and balloon combination into just the right spot, since Speen's particular artery curves sharply just past the choked-off section. Meanwhile, the buildup of artery-blocking plaque -- usually made up of bits of fat and cholesterol -- has turned the vessel into an unbending "stone cave," Alderman says.
When the veteran cardiologist pulls one of the catheters out, it's bent from the resistance. In all likelihood, he could safely place the stent a little short, but that creates the possibility of causing a clot and possible heart attack down the road.
"I don't want to take that chance," he says.
When the stent still won't budge, Alderman announces he's going to try a different combination of wires and tubes.
"I'm just going to take everything out," he says, as time continues to slip away.
The heart of the matter
Speen's case is unusual: Alderman estimates that 80 percent of angioplasties at MetroWest Medical Center are not as challenging, though the procedure can still take anywhere from four minutes to four hours.
The hospital began offering angioplasties in 2003 after getting state permission to do so during time-sensitive emergencies.
For less urgent cases like Speen's, the Department of Public Health established a study three years ago to determine whether suburban hospitals without cardiac surgeons can perform "elective" angioplasties as safely as institutions with the backup service, most of which are in Boston.
Joining the Mass Comm Trial two summers ago, MetroWest Medical Center has enrolled the most patients among the 14 participating hospitals, but is precluded by the Public Health Department from releasing data until the study is over.
"What we're trying to do is study the question," says Paul Dreyer, the director of the department's Division of Health Care Quality.
Roughly 1,000 residents have joined the study, which requires hospitals without on-site surgery to prove that their mortality rates are no worse than institutions with cardiac backup.
In rare cases, the balloons used in the procedure can tear an artery, with some of the affected patients needing their chests cracked open and a vein harvested from their body as a grafted vessel to bypass the injured area. When that happens, MetroWest sends its patients by ambulance or helicopter to Boston's Beth Israel-Deaconess Medical Center, or less frequently, to the city's Brigham and Women's Hospital.
All told, hospitals without cardiac backup perform elective angioplasties in 32 states. While a few states, like Massachusetts, are participating in rigorous trials, the majority freely allow the procedure.
In the spring, researchers studying data collected nationally on elective and time-sensitive angioplasties concluded that on-site cardiac backup did not make a difference, with patients in both categories of hospitals needing emergency bypasses only three to four times in every 1,000 cases.
Of those bypass patients, 12.6 percent died at facilities with cardiac surgery, 13.6 at those without, according to the data, collected by the Society for Cardiovascular Angiography and Interventions and the American College of Cardiology.
Still, while emergency transfers from hospitals like MetroWest Medical Center are infrequent, critics question why patients ever need to be put in that situation when facilities offering both angioplasty and cardiac surgery are readily available nearby.
"Why take the risk?" Dreyer said, citing the skepticism, not the state's stance. "That's the main argument. The issue is very hotly contested."
Elective angioplasties are profitable in contrast to emergency procedures, a money-loser in Massachusetts because staff are on-call 24 hours a day, seven days a week. Suburban hospitals like MetroWest Medical Center also point to the sharpening of staff skills that additional cases provide and to patients' desire to stay in familiar surroundings close to home.
"There's a tremendous advantage to having a sophisticated procedure like this in your community," Alderman says. While suburban cardiologists used to travel with their patients to Boston to perform elective angioplasties, the study allows convenient access to other doctors seen at the hospital and puts less strain on family members, participants say.
"There's nothing like having the procedure done here," says 83-year-old Anthony Manzella of Framingham, a patient of Alderman's whose first stent the cardiologist placed at Brigham and Women's in 2001. He received a second stent at MetroWest Medical Center several months ago.
While American College of Cardiology guidelines still state that hospitals should have backup for both elective and emergency angioplasties, spokeswoman Amy Murphy says it's "not one of our stronger recommendations." She adds that the organization will likely look at the results of the recently announced study when the issue is next revisited.
"Some would say our guidelines take a very conservative approach and we would agree with that," Murphy says.
For his part, Alderman cites statistics from his hospital's emergency angioplasty program, including a 2007 mortality rate well under the national 1 percent average. By the end of the year, 94 percent of patients had an inflated balloon in their artery within 90 minutes of walking in the emergency room door, an industry benchmark well above both the state and national averages.
Finally, despite handling 222 cases in the last four years, not a single patient was transferred due to a complication.
"There were naysayers for that at first," Alderman says, referring to emergency angioplasties without cardiac backup. "The proof is in the outcomes."
Patience pays off
The Chairman of the Board sings "Nothing but blue skies," as the MetroWest Medical Center cardiology team stares at a cabinet full of tubes and wires and assesses its options, trying to find the elusive winning combination from a number of different sizes, shapes and materials.
Speen lies quietly as he waits to see if the odds will continue in his favor. To ensure no "cherry-picking" of cases in the state trial -- a possible catch in the national study released this spring, Alderman says -- some patients are randomly assigned to go to hospitals with cardiac backup.
To determine each patient's destination, the team opens a sealed envelope from the state and announces the verdict. While Speen had a successful triple-bypass in Boston 10 years ago, he and his wife, Sonya, had not wanted to leave their community again.
"We were holding our breath," she says later of the envelope results. "Best prize I've won in a long time."
As his patient rests, Alderman selects the piece of equipment that will begin the procedure anew: A metal sheath to protect the initial sections of artery from the tubes and wires soon to come. But when he goes to put it in, Speen's extra-curvy vessels put up a fight, a randomly occurring condition aptly named "tortuosity."
"I don't know how we got that thing in the first time," Alderman says.
The vessels eventually relent, only to become ornery again when the cardiologist tries to thread the first catheter. This time, he employs one with a special curve at the end that makes it look like a fishhook.
Finally, an hour after pulling all the tubes and wires, the team is ready for another stent attempt. But when Alderman tries to position the balloon and mesh wire, his path is again blocked.
With the stent still a no-go, the team decides to set aside the mesh wire and try a catheter with a thin balloon, hoping to make some space for their ultimate goal.
"Going up," cardiovascular technician Angela Powers says, inflating the balloon to 270 pounds per square inch, nine times the pressure put into a car tire.
"That may have done it," Alderman replies.
The team tries a stent one more time. At 5:12 p.m., nearly 2-1/2 hours after starting the procedure, the bit of mesh wire is finally in place. The balloon is inflated to expand the device, then deflated and removed.
"Oh baby, we did it," Alderman says. "All that paid off."
Speen, snoring earlier but now awake, jokingly asks the team if they should place another stent just in case.
"Is two better since you're in there?" he quips.
Needing extra kidney monitoring, Speen spends the next two nights in the hospital before being discharged.
Reached at home two weeks after the angioplasty, Sonya Speen says, "Bob is doing great. He is doing really, really well."
Michael Morton can be reached at email@example.com or 508-626-4338.