“There are many areas in which there can be a conflict between the patient’s best interest and the physician’s own personal interest. The economic impact of invasive and interventional cardiology has led to pressures from several directions. Seeking increased revenues, hospitals and departments of medicine exert pressure on cardiologists for more procedures and higher fees. National and state credentialing standards for minimal procedural volumes influence cardiologists in case selection, especially low-risk cases”
– Catheterization and Cardiovascular Interventions
Research doctors recruit people for clinical trials and prospective studies by putting the word out to local specialists that they are in the market for patients seeking treatment for a particular condition.
If you are a research doctor in the employ of a global corporation that pays you to train other doctors how to use certain medical devices—which they manufacture—the last thing you want is to be treating really sick people. The old and feeble are generally not resilient enough. In order to maintain high volume and foster attractive success rates, you need a hardier breed of customer; the younger and healthier, the better.
The ideal candidate for pulmonary vein ablation for atrial fibrillation is a relatively young, otherwise healthy person with occasional Afib who has failed at least two anti-arrhythmic drugs. At their first meeting, Pam was 47, otherwise very healthy, and the spin that Hugh Calkins would put on her case was that she had failed three anti-arrhythmic drugs.
So she fit the low-risk profile when her local cardiologist, who would later join the staff at Hopkins, suggested that Pam go to Johns Hopkins because they just might be able to cure her Afib.
When Pam and I drove up to Hopkins for her appointment with Hugh Calkins that September of 2001, the pall of 9/11 still blanketed the country. People went about their business, but the shock was still there, undercurrent in all conversation. There was a computer screen on his desk. The screen saver was a beautiful photograph of the original hospital. But the image was refreshed by disintegrating, which was very disturbing. Every minute or so the dome of the building, and then the brick facade, would fragment. The building would break into little pieces and collapse and disappear.
Pam saw it too and then Calkins saw it. “Guess I ought to change that,” he said.
There was not much to the physical exam, since Pam’s heart was strong and healthy, and for the moment, ticking away as steadily as a contented Rolex. As we perused patronizing brochures, Calkins talked about the possibility of fixing Pam’s bouts of atrial fibrillation with a catheter ablation procedure.
While it was a relatively new procedure, Calkins said, he had performed it many times at Hopkins with no complications. He told us the procedure was successful in curing Afib between 80 and 85% of the time, and that if, for some reason, the procedure didn’t take, she could always come back for a “touch up.” There were risks as there were in any medical procedure.
The distinct take home message here was that this was an established, safe and effective procedure. You can trust me with your life, said Hugh Calkins, the Doctor of Medicine. Hugh Calkins the Research Scientist held a somewhat different view.
Somewhere in the stacks of medical journals in his office that day, there was a recent issue of Cardiology in Review with a paper that he wrote sizing up the state of affairs at the time.
He had concluded that “catheter ablation of AF should be considered to be an experimental procedure.” The little evidence that had been collected indicated that while right-sided linear ablations may have been safe, they were not especially effective. The treatment he was proposing to Pam, pulmonary vein ablation in the left atrium, was fraught with unknown dangers to the patient but showed promise of being effective.
But the whole concept was so new that there were still a lot of unknowns. No one knew how long the effects would last. No one knew all of the side effects or complications. No one knew as yet whether the benefits of the procedure outweighed the risks to the patient.
The specific reason Hugh Calkins considered catheter ablation for Afib to be an experimental procedure in 2001 was because there were no “prospective multi-center reports to describe the results and complications.”
So that’s what he was doing. Although we didn’t know it, the reason that Pam was in Hugh Calkins’s office that day was because he had a study in progress, a study that would describe the results and complications of pulmonary vein ablation for atrial fibrillation, an experimental procedure—and she was just the kind of patient he was looking for…