“The Procedure: Ready for Prime Time”

“Few decisions bespeak greater trust and confidence than the decision of the patient to proceed with surgery. Implicit in that decision is a willingness of the patient to put his life or her life in the hands of a known and trusted medical doctor… the doctor who, without the consent of the patient, permits another surgeon to operate violates not only a fundamental tenet of the medical profession, but also a legal obligation.”   – Supreme Court of New Jersey

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 In the brochures about Catheter Ablation for Atrial Fibrillation at Johns Hopkins, there are pictures of smiling, grateful patients sitting up shortly after the procedure, watching television or entertaining visitors. Looks like you don’t even have to spend the night at the hospital: “When patients are done with their procedure, they need to lie quietly for several hours, but can eat and drink, and, as shown here, enjoy a good television show. All recovery rooms come with television sets. Nurses check on patients routinely to make sure they have everything they need.”

A regular day at the spa.

A 1999 Hopkins press release touting catheter ablation for arrhythmias other than Afib announces “the first comprehensive, multi-center study of the techniques [sic] effectiveness is now complete. It was led by Johns Hopkins director of electrophysiology Dr. Hugh Calkins.” The procedure is represented as being proven and painless, safe and effective:

Study Affirms Value Of Non-Surgical Treatment For Arrhythmia

BALTIMORE, MD Jan. 18, 1999 A widely used nonsurgical treatment for rapid heart rhythms is safe and beneficial for both children and adults, according to results of a national study led by Johns Hopkins physicians…

A doctor guides a catheter with an electrode on its tip to the source of the problem. It then fires a painless burst of energy, ending the electrical misfires. Problem solved.

“This is the first large multicentre study to suggest that radiofrequency catheter ablation is safe and effective therapy and that it can now be considered as an alternative to drug therapy in the treatment of certain cardiac arrhythmias,” said Hugh Calkins, M.D., lead author of the study and director of electrophysiology at Hopkins.

“The technology has now advanced to the point at which we can do the procedure on an outpatient basis, curing patients within a matter of hours and sending them home the same day,” Calkins said.

Problem solved. Same day.

The basic findings of the study were that catheter ablation is in fact a safe and effective procedure. Patients are cured in a matter of hours.

Overall, on more than a thousand patients, it was successful 95 percent of the time, had a six percent recurrence rate, and a three percent incidence of complications. Equally rosy scenarios are painted on a Hopkins website about the Afib procedure, entitled Finally a Way to get Rid of Afib, published in 2003.

It tells the literally heart warming story of one David Erdman, a rugged outdoorsman who was “sure he had climbed his last mountain” because his Afib was getting worse.

After an episode of heart palpitations during a recent hiking expedition caused him to fall by the trail side, Erdman was sure he was going to die…

   But Erdman’s cardiologist felt differently. He’d heard that electrophysiologist Hugh Calkins was offering a new technique to treat Afib at Hopkins and encouraged his patient to give it a try. Calkins would thread a catheter from Erdman’s leg up to his heart and, using a high-energy probe, burn the tissue that was causing the problem…

   Results have been encouraging. The ablation has been able to cure 80 percent of the patients Calkins has treated for intermittent Afib and 50 percent of those with chronic Afib. The secret to success, Calkins says, is knowing how to use MRI and a special catheter-shaped like a branding iron and armed with some 20 electrodes-to zero-in on the disruptive tissues in the four pulmonary veins.

   “Target the active pulmonary vein and the success rate jumps to 90 percent,” he says, “The procedure is ready for prime-time. Physicians and their patients should know about it.”

Essentially, Hugh Calkins was claiming to the public that he had a cure for atrial fibrillation in 2003. The last word from Hopkins is that “Erdman hasn’t experienced Afib in a year and currently is planning a six-day backpacking trip to Mt. Whitney in California’s High Sierras.”

 What is proclaimed to the public while trolling for customers is different from what is written in medical journals. Pam and I had been living in Brochure Land, where the outlook is always sunny, bright and confident.

But in the professional journals, which patients don’t read because they trust their physicians, the landscape is much more grim, and strewn with complications and bad outcomes.

This professional dispatch from Hugh Calkins was written in 2005, three years after he nearly killed my wife:

“…there has never been a procedure in the field of electrophysiology with such a high complication rate. There have been more than a handful of deaths from this procedure, and as more and more people start doing it and are on that learning curve, it could be a bit of a mess. ”

    Indeed.


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