Not the Answer
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As it happens, Pam had gone to see Hugh Calkins about her pacemaker problem just as he was gearing up for a series of investigational studies to evaluate new ablation techniques and tools that had been developed in Europe. He himself was not seeking to learn and master these new, risky, and unproven medical procedures. He would learn the merits of the new methods and about the perils and effectiveness of the new catheter designs by supervising other doctors, EP fellows who were in training.
So Pam was given over to the care of a trainee, a trainee using an unfamiliar instrument to perform an investigational procedure, one which Calkins called “by far the most dangerous procedure ever performed in an electrophysiology lab,” and he did not know whether it was safe or effective.
The only thing that Hugh Calkins knew for sure when he began offering it to patients as a possible cure for Afib was that it was a “technically challenging and high risk” procedure. And he was letting trainees do the job—without informing the patients of that fact.
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In the 1990′s Calkins had been experimenting with linear ablations on dogs.
Starting around the year 2000, he set out to learn as much as he could about developing methods in Europe. He learned about the Lasso catheter developed in Bordeaux, France, that was used to map the pulmonary veins in the heart, to find segments of tissue that were misfiring and which could then be ablated. He flew to Italy to learn about circumferential ablations, wherein a continuous circular scar was made outside the entrance to the pulmonary veins.
The Europeans seemed to be having some success with the procedures, 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 outwieghed the risks to the patient.
These were the questions Hugh Calkins set out to answer with his ambitious series of investigations at Johns Hopkins. He would find out if catheter ablation for atrial fibrillation was safe, effective or even worthwhile. First, 75 consecutive patients would undergo the segmental approach developed in Bordeaux. Then another 75 consecutive patients would undergo the circumferential approach developed in Milan, and then another 70 or so people would get a combination of the two approaches.
He knew that the complication rates would be highest the among the first 100 or so patients for each procedure because no one had experience with these particular techniques and catheters. So there would be the usual learning curve. Patients would inevitably be injured as operators became familiar with the tools and comfortable with the technique, and the learning curve in this case would be especially hard on patients, given the training program under which it would be carried out.
The results of his investigations would be reported in dozens of journal articles over the next few years along with reports of complications, predicable or unforeseen, and how best to avoid them. He would speak at annual meetings and give talks at corporate sponsored events.
As an after dinner speaker, he’d toss off anecdotes to illustrate the risks he took.
“One of the problems was pulmonary vein stenosis. A typical case is someone who had pulmonary vein ablation shows up in the ER with three pulmonary veins completely blocked and the fourth one 90% blocked. The patient gets emergency heart surgery and dies. Another person gets an Afib ablation, you get a call, the patient has been diagnosed with lung cancer, well it wasn’t lung cancer, it was an occluded pulmonary vein that appeared to be lung cancer, but the patient got a lung removed. There was this iatrogenic epidemic of pulmonary vein stenosis… So, a 52% success rate, 6% complication rate, four deaths, so on and so forth …”
So on and so forth. That’s just how the EP cookie crumbles.
“When I talked to my colleagues, they said well this problem of collateral damage happens everywhere, and all of us have to think about collateral damage… I learned a lot of things the hard way… for persistent or permanent Afib this procedure is just awful—a 20% success rate. Complications in the study we did, they were memorable. Three strokes, three tamponades, the mitral valve lassoed, pulmonary vein stenosis, some vascular complications.”
Calkins later said that the numbers were so bad from the study that his partner Ron Berger told him not to publish it, saying “We’d never get anymore afib patients.” They decided to find a successful subset of patients for whom the procedure seem to have some effect and lead the article with that.
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Pam was one of the first 75 patients the investigation, and the results for the first group was pretty disappointing: a 52% success rate and complications galore: “When you think about complications, they were memorable, two strokes, three tamponades, the mitral valve Lassoed, an occluded pulmonary vein, some vascular complications… so I didn’t feel this was the answer—at least for the patients that I had to deal with, and deal with the aftermath,” Calkins said.
Lasso catheter entrapment in the mitral valve would become a signature complication, with dozens of cases being reported as the procedure became more popular. It was one of the things he learned, one of the reasons he decided that the procedure which he recommended to Pam was not the answer.
I don’t know how Hugh Calkins dealt with the “aftermath” of this endeavor, but I suspect that his life went on pretty much like before. Not so for those who became collateral damage.
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