Collateral Damage: A Patient, a New Procedure and the Learning Curve

A HEART SURGEON named James Cox discovered a new use for the scalpel in 1987. If a person with Afib was having open heart surgery for some other reason, Cox could make a series of small incisions inside the heart while he had it right there in his hand.

The scar tissue emerged in the pattern of a maze, which blocked  the path of errant electrical impulses. It  has proved to be a reasonably safe and effective procedure.

It wasn’t long before cardiologists were trying to accomplish the same thing, using a hot-tipped catheter wire instead of a scalpel to make scars on the inside the heart, thus avoiding open-heart surgery. The idea soon caught on and competition in the medical device industry began driving research into development of a catheter-based version of the maze procedure as the cure for atrial fibrillation.  The market would be very lucrative for such a cure, with more than 2.2 million Americans afflicted and the number likely to double in the next 10 years.

Relatively simple forms of cardiac ablation were already being widely performed to treat less complicated heart rhythm problems. For a condition called atrial flutter, for example, burning a small, focused scar in a certain spot in the right atrium with a catheter could usually get the job done.

Atrial fibrillation was another matter entirely. Afib researchers believed early on that they needed to create continuous lines of scar tissue, or maybe even a series of scars, in the upper right chamber of the heart.

They adapted existing technology by pushing a hot-tipped catheter to the far side of the heart and then dragging it back like a lit cigarette. The “drag and burn” was about as graceful and precise as trying to fish your keys out of a locked car with a coat hanger. It was a crude and blunt method and a far cry from the tiny surgical incisions expertly placed by the steady hand of Dr. James Cox.

REGARDLESS OF HOW they went about doing it, dragging a hot wire around in the top right chamber of the heart had never really proven to lessen anyone’s atrial fibrillation troubles.  Although sketchy preliminary data was interpreted as promising, most researchers—including Hugh Calkins—believed that success and professional glory lay in obliterating certain sections of tissue in the left atrium, the far chamber, but that was a much trickier prospect and still a long way off.

In the meantime, they had to start somewhere, and more than anything else, the right atrium was accessible.

Ultimately, the consensus on the drag and burn method was that while it had shown some potential, it was too crude to be set loose on the populace—which is really saying something.

In the journals, Calkins emerged as an early true believer in catheter ablation for atrial fibrillation. One way or another, he was going to nail down the cure within the next few years. In an editorial headlined Progress Continues in the Quest to Cure Atrial Fibrillation with Catheter Ablation Techniques, he rallied for better tools. “Although the feasibility of curing atrial fibrillation with catheter ablation has been demonstrated using standard techniques, the procedure is extremely time consuming and associated with a high risk of complications,” he said. “For this reason there is general agreement that new types of ablation systems designed specifically to create continuous linear lesions are needed.”

Private enterprise once more into the breach, so began the process of catapulting a new generation of medical technology into to the market place–ready or not.

Funding flowed from Silicon Valley and  Wall Street into start-up businesses, and established medical device companies spun off new divisions.  Qualified R&D professionals were in high demand. Members of the EP research community rented themselves out to device manufactures. Goats and pigs and dogs were catheterized and cauterized, and the study data was analyzed. Techniques and theories were tried and abandoned as new ablation systems proliferated.

Collectively, the journal articles from the period convey a sense of anticipation, an anxious groping for the cure, and excitement at the prospect of being first in the field.