Angioplasty, once performed only at hospitals with onsite cardiac surgery capabilities, is now available at 10 smaller community institutions in Georgia, thanks to a ground-breaking study.
Mel Ottinger has lived the sporting life, always content with a racquet in his hand or a whistle around his neck.
“I’ve always played tennis, was the Tennessee state champion in badminton,” says Ottinger, captain of Chattanooga’s 2004 USA League Senior National Championship tennis team. “I coached basketball at Dalton State College [for 10 years], taught P.E. there for 37 years.”
He and his wife Marilyn are tireless walkers, familiar fixtures throughout Dalton. He doesn’t smoke or drink. At age 67, Ottinger is the picture of excellent health.
Ottinger has been treated the past several years for atrial fibrillation, an attention-grabbing but manageable heart rhythm disorder. But on March 14, around 3:20 in the afternoon, while he was patronizing a Dalton trophy shop shortly before a scheduled visit with his cardiologist, newer, meaner trouble surfaced.
“It wasn’t really pain, more like pressure, so much pressure, like someone had parked a car on my chest,” says Ottinger, who kept his appointment and told the receptionist he wasn’t feeling very good – and looked the part.
“The nurse did an EKG [electrocardiogram], calmly told me she’d be back in a minute, and then made me eat some aspirin. I’m wondering what’s going on when two EMTs come in. I still didn’t really understand. Nobody ever said, ‘You’re having a heart attack.’
“I think that was on purpose.”
Ottinger was rushed to the emergency cardiac unit at Hamilton Medical Center, where he was promptly presented with two options – he could be transported 28 miles to Memorial Hospital in Chattanooga for an emergency angioplasty, or he could stay in Dalton at Hamilton and the specialist, Dr. Steven Stubblefield, would come to him.
He chose the latter, receiving an angioplasty and double stent placement that cleared his completely blocked right coronary artery. It’s a choice that would have been impossible until a few years ago. In 2005, the Georgia Department of Community Health selected 10 community hospitals – including Hamilton – to participate in the Atlantic Cardiovascular Patient Outcomes Research Team (C-PORT) study, a clinical trial that allows hospitals without an open-heart surgery program to perform coronary angioplasties.
“It’s been demonstrated consistently that angioplasty saves both lives and heart muscle in a way that’s unparalleled by any other treatment,” says John Bowling, Ham-ilton’s president and CEO. “I think the state has shown great foresight in accommodating the C-PORT study as a means to demonstrate the efficacy of this treatment, and make it available to residents of non-urban areas in Georgia.”
In Georgia, angioplasty is typically performed only at medical institutions with onsite cardiac surgical facilities because of the small risk of complications requiring emergency open-heart surgery. There are 20 of these facilities in Georgia, half of them in the Atlanta area.
The C-PORT study, headed by Johns Hopkins Medical Institutions cardiologist Dr. Tom Aversano, focuses on the use of angioplasty and stent placement, or percutaneous coronary intervention (PCI), at community hospitals.
The 10 C-PORT sites in Georgia (see list, page 54) are part of the trial’s second phase. The first phase, which began in 1996, was based on the premise that there are two ways to treat a patient with coronary blockage having a heart attack: clot-busting drugs (thrombolysis) or angioplasty.
“The question was, could we provide primary angioplasty without co-located surgery and still have better outcomes than thrombolytic therapy. Yes we can,” Aversano says. “Primary angioplasty is the better therapy for heart attack patients. The dilemma is it has to be applied quickly, hopefully within 90 minutes of the patient’s presentation in the ER.
“But regulations in Georgia, and most other states when we first started this study back in 1996, prohibited [angioplasty] without co-located cardiac surgery, so most hospitals could not supply this therapy.”
Researchers like Aversano argue that geography and fate should not be the determining factors in whether a patient receives a life-saving angioplasty or the more widely available thrombolysis.
Most states now permit primary (emergency) angioplasty for heart attack patients without co-located cardiac surgery. But those patients are the minority – most angioplasty procedures are elective, planned procedures to treat blockages.
The second phase study Georgia entered in 2005 concerns that larger population, while also benefiting emergency patients like Ottinger.
“We want to find out if angioplasty performed at hospitals without onsite cardiac surgery is safe and effective, and we want to know if the outcomes for patients are equivalent for hospitals with and without cardiac surgery,” Aversano says. “In most countries around the world, angioplasty without co-located cardiac surgery is already being done. In 27 states in the U.S., it’s being done.
“But the regulatory bodies, and societies like the American Heart Association and the American College of Cardiology, don’t have enough information about the safety, efficacy and equivalence of outcomes for elected angioplasty. Our aim is to gather and provide data to the people that make public policy, so they can make decisions based on real information.”
Patients undergoing elected angioplasty will be randomly placed at either a C-PORT center, or a major healthcare center that has heart surgery available. Study administrators will then compare short and long term results of those procedures. But patients who are suffering from a heart attack may choose to quickly undergo an emergency angioplasty at a C-PORT site.
“The C-PORT idea is based largely on the appreciation that early treatment with coronary angioplasty can be lifesaving and should be made available,” says Dr. John Douglas, Professor of Medicine and Director of Interventional Cardiology and the Cardiac Catheterization Laboratory at Emory University Hospital.
“You can’t have an angioplasty site everywhere,” Douglas says. “But you’d like to see the procedure available in as many sites as is practical.”
Each year, approximately 1.2 million angioplasties are performed in the United States (about 30,000 of them in Georgia) at an average cost of $40,000. Douglas reckons he has performed between 15,000 and 20,000 PCI procedures, dating back to 1980, the year he partnered with the man who invented coronary angioplasty 30 years ago this month.
On Sept. 16, 1977, at University Hospital in Zurich, Switzerland, a 38-year-old German physician, the late Andreas Gruentzig, snaked a tiny balloon-tipped catheter into one of Adolph Bachman’s arteries, inflated the balloon and smashed open a dangerous blood clot. As of July 2007, blood was still flowing freely through Bachman’s body.
Gruentzig became instantly world famous after that first procedure and went on to perform almost 200 angioplasties over the next few years as physicians from around the world, including John Douglas, flew to Zurich to learn the revolutionary new procedure.
Douglas was a member of the team that performed the first coronary angioplasty at Emory in July 1980. By the time Gruentzig arrived at Emory several months later, the hospital had performed about 50 angioplasties.
“He wanted to come to the U.S. and had his choice of opportunities,” Douglas says. “All of the major heart centers to choose from, and he decided to come to Emory. There was a lot of interest in learning the procedure at the time, and we did two courses a year in which there would be 300 or so physicians from all over. Emory became a leading teaching center.”
Gruentzig eventually became Emory’s Director of Interventional Cardiology, the same title Douglas now holds. Before long, under Gruentzig’s expert guidance, Emory was doing 1,000 angioplasties a year.
“He was a charismatic, brilliant person, driven and charming, a superb physician,” Douglas says about his old friend. “The reason, I think, coronary angioplasty became so successful was in large part due to his ability early on to get the necessary support from his colleagues, surgical colleagues who had to basically stand by and be ready to step in if the angioplasty procedure didn’t work.”
But Gruentzig realized early on that treating a narrow or blocked artery with a balloon angioplasty alone had its limitations. In some cases, the arterial wall weakened after balloon dilation. Sometimes, the artery collapsed after the balloon was deflated, necessitating emergency bypass graft surgery to repair the problem.
A major breakthrough in the process emerged in the 1980s with the development of stenting, now a standard component of PCI. A self-expanding tube made of metal or plastic wire mesh – a stent – is placed around a balloon at the tip of a catheter and guided through the artery to the impasse. The balloon is inflated and the stent locks into place to prevent the artery from reclosing.
Today, most angioplasty patients receive “drug-eluting” stents, which are coated with medication that can be slowly released to help prevent re-clotting. Like all other coronary stents, these medicine-coated tubes are designed to remain in the artery permanently.
“Andreas knew that angioplasty by itself was not a perfect solution,” says Douglas, who performed the first stent procedure in the United States, in 1987. “He knew something else was needed and had some insight into stenting, though I’m not sure how much he knew about it.”
Gruentzig was a visionary who foresaw the main problems that interventional cardiologists would face in the future, but would not live long enough to find the solutions.
Gruentzig had an ap-pointment to meet with Richard Schatz, co-inventor of the Palmaz-Schatz stent, about a year before the first successful stenting procedure in France.
But the night before the scheduled meeting, Oct. 27, 1985, Gruentzig was en route to Atlanta following a weekend getaway with his wife and two dogs when his twin-engine plane crashed in Forsyth.
It was a tragic coincidence. Gruentzig suffered the same fate as his father, a Luftwaffe pilot who died in a burning plane during World War II.
Heart disease is still the leading cause of death in the United States, claiming more than 600,000 lives a year. Early intervention practices, such as quitting smoking and practicing healthy eating habits, are proven methods to reducing the risk for developing heart disease.
PCI – angioplasty and stenting – has long been established as standard treatment for people with chronic stable angina (chest pain), blocked arteries or coronary artery disease – or people like Mel Ottinger who are having a heart attack.
“I have no doubt that [PCI] saved my life,” Ottinger says.
The first C-PORT study proved that, Aversano says. But does PCI work better than medicine at preventing heart attacks or death in patients with mild chest pain or partially obstructed arteries? The answer is a resounding “no,” according to the results of a five-year study released in March.
PCI has proven itself as a means to improve symptoms associated with blocked arteries, such as chest pain and shortness of breath.
“I feel better,” says Kenneth Holmes, 68, of Augusta, who has two medicated stents courtesy of Emory’s Dr. Douglas. “Before the procedure, I had a lot of stress in my chest whenever I walked or did any exercise. Now my blood is flowing better, I can walk without feeling that awful pain in my chest.”
Still, when it comes to prevention, The COURAGE study (for Clinical Outcomes Utilizing Revascularization and Aggressive Drug Eval-uation) showed that angioplasty and heart stents are on equal footing with medical therapy.
“There never has been a study that suggests coronary angioplasty prevents heart attacks or prolongs life,” says Emory interventional cardiologist John Douglas. “Not even the most aggressive angioplasty advocate would make that claim.”
Even so, the study seems to be causing an irregular heartbeat in the $6 billion stent industry. Stent manufacturer Boston Scientific, which had already reported a 17 percent drop in stent sales this year, saw its stock price drop 7 percent after the study’s release. Some analysts have predicted industry sales will fall 10-15 percent this year.
Also, according to The Wall Street Journal, U.S. doctors performed 10 percent fewer stenting procedures in April than in March (when the study was released), and 15 percent fewer than in April 2006.
That drop in PCI procedures could be a response on the part of doctors and patients to the debate over whether angioplasty is being widely prescribed unnecessarily. It could be a quicker-than-expected reaction to COURAGE; or maybe it’s related to growing concern over stent thrombosis.
Unlike restenosis (re-blocking of an artery that was previously opened through PCI), stent thrombosis is a more dangerous (and rare) complication related to drug eluting stents.
And doctors at major heart centers are reporting an increase in heart surgeries, which comes on the heels of recent studies that suggest invasive bypass surgery could extend many patients’ lives longer than stents.
“Angioplasty is clearly less invasive, that’s a primary advantage,” Douglas says. “The disadvantage is that you could be looking at more procedures in the future, while surgery is seen as a more permanent fix.”
Doctors at Emory are working on a combination of less invasive arterial bypass surgery with stenting to treat patients with multiple blockages – instead of splitting the sternum (as in conventional bypass procedure), the surgeon approaches from between the ribs.
“Healing of the breastbone takes weeks. This less invasive procedure offers the best of both worlds,” Douglas says.
It’s all about choices. For Mel Ottinger of Dalton, the choice was simple. Stay home at Hamilton and leave Chattanooga to the rush hour commuters. He felt his heart rebelling at 3:20 in the afternoon. By 6:15 that evening he was enjoying the NCAA Men’s Basketball Tournament on a TV set in the ICU. He went home in a day and a half with zero heart damage, spent the next 12 weeks in cardiac rehab.
“I worked on the treadmill, stationary bike, StairMaster, a machine to strengthen the upper body, did stretching exercises,” says Ottinger, heart attack survivor, lifelong athlete and former college P.E. coach. “Come to think of it, I should have been teaching the class.”