Tuesday, October 23, 2007

To angio, or not to angio? Or, "Grandpa died, but it was a good learning experience ..."

I have commented in the past about the overuse of "metrics" from often ill-conceived efforts or biased efforts to find justification for cavalier activities that ignore common sense, but this story may represent a new milestone:

Battle over a key heart procedure (link)

By Josh Goldstein
Philadelphia Inquirer
Tue, Oct. 23, 2007

Is cardiac angioplasty without surgical backup safe? A S. Jersey dispute is part of a major study.

Last year, more than 16,000 patients in the eight-county Philadelphia area had cardiac angioplasty to treat heart disease - many for elective, non-emergency procedures.

Five years ago, virtually no angioplasties were performed at hospitals that did not have on-site open-heart surgery available, in case something went wrong. Last year, more than 700 were done at hospitals without such surgical backup.

The question of whether that was safe is roiling the cardiology establishment in South Jersey, where Virtua-West Jersey Hospital Marlton is participating in a major study that seeks to find the answer.

South Jersey's three hospitals with open-heart programs - Cooper University Hospital, Deborah Heart and Lung Center, and Our Lady of Lourdes Medical Center - are campaigning to block Virtua from expanding into the profitable angioplasty market.

The procedure, in which a tiny balloon is used to open blocked heart vessels, can generate hospital fees ranging from nearly $17,000 to more than $25,000, according to the federal Centers for Medicare and Medicaid Services.

"This is an issue because it is cardiac care and it is lucrative," said James P. Dwyer, Virtua's chief medical officer. [indeed - just a bit of conflict of interest and bias is created by that fact - ed.]

Currently, 23 states allow at least some hospitals to perform angioplasty without surgical backup. The new study at the center of South Jersey's cardiac wars is a nine-state look led by Johns Hopkins University.

Dwyer said the protocols for the research were "appropriate scientifically" and had proper safeguards to protect patients.

At the Christiana Care Health System a decade ago, I led data modeling of invasive cardiology and its procedures down to an extremely fine-grained level of several hundred data elements. I also led development of an information system utilizing this data that could easily show that there were occasions where "the unexpected happened." It took several days just to develop the terminology and dataset on failed angioplasties, what happened to the stent, and what happened to the patient. Ruptured coronary artery, dissection, stent lost in body, and acute myocardial infarction were just a few examples of what can (and does) happen, even under the best of conditions where the patient appears stable and the coronary lesion uncomplicated and easy to approach via catheter.

Without cardiac surgical backup, a patient with an "unexpected event" would have to be rushed by ambulance to the nearest cardiac surgical facility. Until the friendly Asgard provide us with beaming technology, that means time - and the amount of time from the potentially catastrophic invasive cardiology adverse event to the thoracic incision is itself subject to unpredictable variables.

It doesn't matter how good the invasive cardiology team is, either. These events do happen, and there is nothing that can be done about some of them without "open access."

In effect, performing invasive cardiology procedures without onsite cardiac surgical backup is simply asking the patient the question "do you feel lucky?"

The study's opponents contend it is an end run around a New Jersey law that requires hospitals to demonstrate a community's need and to get approval from state regulators before expanding into high-end medical services.

Jan Weber, chief of the division of cardiology at Our Lady of Lourdes, said there was no demand for the expanded services. Few residents of the Garden State live more than 30 minutes from a hospital with an open-heart program, and if the procedures are spread out among many hospitals, the quality of care will suffer, Weber said.

"Our primary concern has been safety," he said.

There has been little controversy in Pennsylvania, where 11 hospitals, including five in Philadelphia and its western suburbs, have permission to perform angioplasty without surgical backup.

I was actually unaware of this. I consider it cavalier at best. Profitable, but quite cavalier.

In heart care, time is critical, and having surgical care available on-site can save lives, said Joseph E. Parrillo, chief of medicine at Cooper.

"You lose heart muscle for every minute of delay," he said. "If that rare emergency case is your wife or your mother, then do you say, 'Too bad?'"

Arup K. Roy, a doctor of internal medicine, says no. Roy contends that his father died as a result of complications from an angioplasty at Virtua.

In an Oct. 14 letter to the New Jersey Department of Health and Senior Services and others, Roy said a series of missteps at Virtua led to his 84-year-old father's death.

Community hospitals are "not capable to handle these sorts of complex procedures, and down the road they will kill more people like my father," Roy said during an interview last week.

I agree with that assessment and sympathize with Dr. Roy. My own father died as a result of malpractice at a large hospital that was fully equipped to do every intervention - but could not diagnose bilateral golfball-sized renal adenocarcinomas in over two years and fourteen trips to the urological O.R. Doing risky procedures in secondary facilities is asking for trouble.

Virtua officials expressed sympathy for the doctor's grief, but insisted that the medical record did not support his conclusion that angioplasty triggered a dissected aortic aneurysm (sic) and caused his father's death.

A dissecting aortic aneuryism is a tear in the layers of the aorta, the body's main artery, creating a "false space" where blood can travel, distort the anatomy, and result in blockage of blood supply to major organs. It is a dire condition and true medical emergency, but can be treated surgically. (The hospital denied there was a dissecting aneurysm, claiming death was due to cancer, but this is to be further investigated.)

Thomas Aversano, the Hopkins interventional cardiologist who is leading the study, said the continued rise in heart disease made it necessary to turn more community hospitals into centers that excel at cardiac care.

The debate reflects not just economics, but a longstanding tension between cardiovascular surgeons, who do open-heart surgery, and interventional cardiologists, who do angioplasty.

"It is difficult in the absence of angioplasty to recruit and or retain the best cardiologists," Aversano said in an interview.

It may be necessary to turn more community hospitals into centers that "excel at cardiac care," but is doing so at the expense of the uncommon patient who dies due to delays in surgical intervention an ethical way to go about it?

Aversano said he would "absolutely" have an angioplasty at one of the hospitals participating in his study.

That's perhaps easy for a Johns Hopkins interventional cardiologist to say, and I'll bet he'd do it - as a last resort. I'd rather suspect he'd primarily desire to be transported to the nearest full-service facility first, unless really in dire straights. On a personal note, when I was faculty at Yale and needed radioablation of my Bundle of Kent, damned if I was going to have it at a secondary facility. My choice was Yale-New Haven Hospital...

Others were not so sure [about angioplasty at a smaller hospital]. "I live in New Jersey, but no, I would not allow myself to have an angioplasty at a smaller hospital until we have proven it is safe," said David L. Fischman, co-director of the cardiac catheterization lab at Thomas Jefferson University Hospital.

That is indeed a more cautious approach. The problem is that it can never be "proven" to be "safe" for those patients who get into serious trouble and die due to time delays to surgery.

The automobile industry once had an analogous ethical dilemma re: the costs of fixing exploding fuel tanks vs. costs of litigation over people injured and killed by same. Does "Pinto" ring any bells?

The financial analysis that Ford conducted on the Pinto concluded that it was not cost-efficient to add an $11 per car cost in order to correct a flaw. Benefits derived from spending this amount of money were estimated to be $49.5 million. This estimate assumed that each death, which could be avoided, would be worth $200,000, that each major burn injury that could be avoided would be worth $67,000 and that an average repair cost of $700 per car involved in a rear end accident would be avoided. It further assumed that there would be 2,100 burned vehicles, 180 serious burn injuries, and 180 burn deaths in making this calculation. When the unit cost was spread out over the number of cars and light trucks which would be affected by the design change, at a cost of $11 per vehicle, the cost [of fixing the design flaw] was calculated to be $137 million, much greater then the $49.5 million benefit [through decreased payouts for driver death and horrendous burn injury - ed].

One can only wonder if such "scientific" (i.e., amoral) financial analyses inform decisionmaking about permitting angioplasty at facilities that do not offer cardiac surgery.

-- SS

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