HEALTH ARTICLE REVIEW
- Selected from among the confusing welter of research -
Arteries propped open with drug-coated stents are less likely to clog up again so that the patient does not have to return again due to choked arteries.
Dr. Samin Sharma, an immigrant from India who had to plead for his first cardiology job in US has revived the fortunes of Mount Sinai, a prestigious old institution that just a few years ago was stumbling financially. Dr. Samin Sharma exclusively works with stents for treatment of blocks in coronary vessels (the blood vessels of heart) that lead to heart attack.
IN DEPTH
Article on Samin Sharma
Cardiovascular surgeon who installs Stents in Mount Sinai Hospital, appearing in Business Week, titled,
Heart Trouble, dated OCTOBER 29, 2007
The tiny stent sparked a lucrative industry--and made Dr. Samin Sharma a star. Vice versa, he has helped fuel a booming stent market. The star doctor's salary has risen steadily over the years and now stands at $3 million.
One must, however, question about the device's safety and efficacy.
On a sweltering summer morning, Dr. Samin K. Sharma, King of Stents, marches into the cardiology wing of Mount Sinai Hospital in New York, prepared for a 16-hour day in which he will clear and repair the arteries of 18 patients. Sharma specializes in installing stents, tiny metal devices that hold open blocked blood vessels. As he'll be the first to note, he does more stent procedures than anyone else in doctor-rich New York and possibly in the entire country. he has played a critical role in popularizing the stent as an alternative to drugs.
On the table, patient David Viggiano is asking questions. (Although sedated, stent patients remain awake.) Viggiano, a 42-year-old security guard with colorful tattoos on his arms, suffered a heart attack three years ago near his home in suburban New York. He was riding his bicycle through a cemetery, a setting that still haunts him. As he awaits his procedure, Viggiano is aware that qualms have arisen over certain kinds of stents. "I heard they had problems," he says, as an X-ray machine whirs back and forth over his chest.
Sharma considers the patient's hazy anxiety. Since Viggiano is relatively young, and potent drugs may interfere with his active lifestyle, the doctor sticks with his preferred treatment and installs a stent. "Everything looks good," Sharma tells Viggiano in a booming voice, as he implants the device.
NATIONWIDE DEBATE
Before the next patient is wheeled in, another signal of uncertainty arrives. A nurse calls out to Sharma about a cardiologist who's on the phone. The other doctor wonders whether a patient whom Sharma is scheduled to see needs to be treated with stents at all. Later, Sharma says that he now fields calls like this all the time. "Every day," he says, "every day."
Sharma, a spiritual man who fasts once a week in a Hindu purifying ritual, explains his devotion to stents in terms of relieving patient suffering. But recently the 50-year-old physician finds himself enmeshed in a nationwide debate over whether his specialty, interventional cardiology, has been driven by economic motives to overuse the device. Galvanizing the controversy is a series of scientific studies released since last year that raise a pair of vexing questions: Do stents coated with drugs intended to prevent arteries from closing up again sometimes cause potentially fatal blood clots? And apart from the question of dangerous side effects, are stents really more effective than medicine, improved diet, and exercise in treating coronary artery disease?
The stir over stents has jolted a whole industry that took shape in the 1990s to cash in on the device's popularity. Boston Scientific (BSX ) and Johnson & Johnson (JNJ ), both of which make drug-coated stents and for which Sharma has performed many clinical trials, have slipped badly. With stent procedures down 13% nationally this year, Boston Scientific's stock is off 17%, and the company is expected to announce layoffs; J&J has said it will lay off more than 3,400 people, including many in its stent business. JPMorgan Chase (JPM ) estimates that sales of drug-coated stents will drop 23% in 2007, to $4.1 billion.
At Mount Sinai, a highly regarded teaching hospital on Manhattan's Upper East Side, the spreading angst shows up in hallways and classrooms. Traditional cardiologists are openly challenging Sharma, sending him fewer referrals. "It's a lot easier for doctors in general to send someone to angioplasty"--during which stents are implanted--"than it is to take the time to explain to them why they don't need it," says Dr. Ira S. Nash, an associate professor of cardiology at Sinai who favors the use of drugs. "He is incredibly enthusiastic about angioplasty," says Nash, referring to Sharma, "but in my heart of hearts, I believe he's overselling it."
[He is overselling himself too, by getting a laudatory article published in Business Weekly - Dr. Ashok Koparday's remark]
After double-digit growth in angioplasties by Sharma's team since 2002, volume in his cath (short for catheterization) lab has fallen 3% this year.
If top management at the hospital is worried about these developments, there's little outward evidence of it. Sinai executives repeatedly have fended off rivals attempting to hire away Sharma and grab his lucrative practice.
medicated stent. In about five hours, patient goes home with an open artery."
He reassures patients that they can prevent clots by taking blood-thinning drugs for several years. And he insists that people with severe chest pain, fatigue, and other symptoms of angina feel better when they get stents than when they're treated with medicine alone. "In my opinion, we are doing the right thing for society and for the patients," Sharma says.
He first arrived at Mount Sinai unannounced and unwelcome in 1988, after completing his U.S. training at another New York hospital. He showed up in the office of Valentin Fuster, Sinai's chief of cardiology, and begged for an angioplasty fellowship. When Fuster politely informed him that all fellowships were taken by Sinai graduates, Sharma offered to work for free. "We just don't do that," Fuster recalls saying. "But I saw passion and depth. I thought he might be an exception." Sharma refused to go away. He volunteered for scut work and toiled in the emergency room to earn cash. A year later, Fuster hired him.
Sharma, by all accounts, developed a virtuoso touch for threading catheters into blood vessels and clearing arteries others wouldn't touch. Back then, angioplasty was performed with a small balloon inflated inside the artery. Sharma relishes memories of patients half-asleep on the table, thanking him for letting them breathe freely without the stunning chest pain caused by angina. "Instant gratification," he calls it. "You open the artery, put in the balloon, and the pain goes away."
ANGIOPLASTY
The advent of the bare-metal stent in 1994, and the drug-coated variety nine years later, greatly lessened the risk that newly opened arteries would close up.
The drug-eluting stent is a $2,000 woven stainless-steel tube no more than an inch long. Each incremental stent improvement has intensified Sharma's enthusiasm for angioplasty as a primary weapon against heart disease. He's not alone: As angioplasty rose over the past decade, it partly displaced bypass surgery, which fell by 25%. By last year, more than 80% of patients getting stents received the drug-coated variety.
A diminutive figure who wears dapper business suits when not in his blue operating scrubs, Sharma recites his stats like a baseball player boasting about home runs. "In 1999, I did 1,000 cases," he says. "Last year I did about 1,400. I'm the only one in New York State who has been doing more than 1,000 since 1999." [Donkey praising his own tail!] (No one keeps national figures.) Counting procedures by the 11 other members of his staff, the Sharma cath lab did 5,174 angioplasties in 2006, nearly double the number performed three years earlier. The lab also boasts one of the best safety records in the state.
Every other month, Sharma travels to India for the weekend to perform angioplasties, free of charge, at a heart hospital he built in his hometown of Jaipur. In September he made an extra trip home to install two stents in his 72-year-old mother after she complained of shortness of breath during her daily two-mile walk. She is recovering well, he says.
HIGH-MARGIN SPECIALTY
Sharma played a central role in another sort of recovery at Mount Sinai. The 2,000-doctor hospital was struggling in March, 2003, when Dr. Kenneth L. Davis took over as chief executive. During the previous six months, Sinai had lost $50 million, partly as the result of tougher caps on Medicare reimbursement rates. A merger with neighboring New York University Medical School turned out to be such an administrative disaster that Davis dissolved the union. While trimming costs, Davis also decided to build up practices in high-margin specialties. "Interventional cardiology was one of myriad areas where we were eager to facilitate growth," he says. Sharma's cath lab was central to this campaign, performing procedures that typically brought in as much as $20,000 apiece for the hospital.
Sharma convinced his bosses that to capitalize fully on the stent boom, Mount Sinai should turn his cath lab into a 24/7 operation. At a cost of $400,000 a year, he figured, the hospital could put enough doctors and nurses on call to do emergency angioplasties late at night and on weekends. Soon the lab was averaging 15 off-hours patients a month. Interventional cardiology became a key revenue source for Sinai. By the end of 2006 the hospital's total patient revenues had grown 41%, to $1.2 billion. Cardiology services, excluding surgeries such as heart bypass, contribute 15% of that, most of which comes from Sharma's cath lab.
After years of giddy growth, the stent business hit its first bump in March, 2006. A Swiss study concluded that a potentially deadly clot called late stent thrombosis is twice as likely to occur in patients who receive drug-coated stents as in those who get bare-metal stents. Several studies presented at a conference in Barcelona six months later reiterated the risk. Although late stent thrombosis is rare, occurring in fewer than 1% of patients by some estimates, it happens without warning a year or more after the device is implanted, and "most cases are catastrophic," Sharma says. He has seen patients die of late stent thrombosis. "They felt so good for one year, and then they disappeared."
In March of this year, a trial conducted by scientists with the Veterans Affairs Dept. delivered a bigger blow. The VA study, known by its acronym, Courage, found that using stents to treat patients with minor blockages and mild symptoms was no more effective in preventing heart attacks or death than a cocktail of medicines, including cholesterol-fighting statins and blood pressure drugs. Sharma and other critics have complained that Courage didn't give stents due credit for relieving pain. They blasted the trial investigators for using bare-metal stents instead of drug-coated ones. Nevertheless, Sharma concedes the research has prompted introspection unlike any in his 20-year career. "What Courage really told us," he says, "is that maybe we were doing more angioplasties than we needed to be doing."
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