Drag and Burn
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 catheter wire instead of a knife, 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. Wall Street investment houses funded start-up businesses, and established companies spun off new divisions. Qualified R&D professionals were in high demand. Techniques and theories were tried and abandoned, and new ablation systems were developed. Goats and pigs and people were catheterized and cauterized, and the study data analyzed.
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. A debate arose over exactly where the scars should be placed inside the heart and how many there should be. There was discussion about taking the next step and ablating in the left side of the heart, which raised the procedure to a higher level of risk. But then again the stakes were high as well.
Cardima, a young company based in Fremont, California, had been working on the REVELATION project for about five years, with funding from Goldman Sachs and other Wall St. investment houses. Millions had been spent to prepare for the FDA presentation. As soon as the investigational studies were approved and underway, the product was promoted at trade shows, in magazine articles, symposiums and ads. Business press releases heralded advances along the way, breathing life into the company stock and soothing anxious investors. There was politics. The company successfully lobbied the FDA to expedite the review process—on pretty shaky ground.
The popular technique at the time involved burning scar tissue by snaking a catheter with a hot tip into the upper right heart chamber and then dragging it back like a lit cigarette. They called it “drag and burn” in the trade. For the beginner, it was like trying to fish the keys out of a locked car with a coat hanger. It was a crude, blunt method, and a far cry from the tiny surgical incisions precisely placed by the steady hand of Dr. James Cox. The REVELATION would be a step up from the drag and burn approach. It was a linear ablation catheter with electrodes lined up one behind another at the far end and you could just lay it against the heart wall and burn the entire single line at once, like branding a cow. The REVELATION supposedly made straight, neat, continuous lines of scar tissue.
∞
Johns Hopkins fosters a cozy relationship with the corporate world, and device manufacturers cozied right up when catheter ablation for atrial fibrillation looked to be the next hot investment. Professor Calkins had been collaborating with companies like Johnson & Johnson, Medtronic and St. Jude Medical on various techniques 
and technologies since the mid 1990’s. He’d also done business with Biosense Webster, Ablation Frontiers, Boston Scientific, ProRhythm, IRhythm, CryoCor, Reliant, Bard, Guidant, Sanofi Aventis, CyberHeart and a company called AtriCure.
Of these companies, Medtronic, Boston Scientific, Guidant, Atricure and St. Jude recently caught the attention of the Justice Department for paying kickbacks to doctors to use their ablation devices and bilk millions from Medicare.
And, in a strange twist, Calkins sits on “The Medical Advisory Board” for TASER International. TASER’s only product, a stun gun, has been known to actually cause fatal arrhythmias. Hugh Calkins is paid to say it ain’t necessarily so. It’s like the teacher who was being considered for a job, and the school board wanted to know whether he would teach that the world was round or flat.
He said he could teach it either way.
Here is how Cardiac Pathways, an emerging device manufacturer for whom Calkins was also consulting, described its business situation in 1996: “Since inception, the Company has been primarily engaged in researching, developing, testing and obtaining regulatory clearances for the mapping and ablation catheters and mapping and ablation equipment. The Company believes that these systems and their component catheters and equipment are currently the Company’s only significant potential products.”
Here was the strategy they laid out to produce and sell actual products: “Build upon relationships with electrophysiologists. The Company has developed strong relationships with prominent electrophysiologists worldwide who have been involved and will continue to be involved in the Company’s clinical and product development. The Company intends to continue to build these substantial relationships through clinical investigator meetings, participation in physician-run symposia and meetings to discuss clinical issues and treatments. The Company’s strategy is to leverage these relationships with leading electrophysiologists to gain market acceptance of its products in the United States and internationally.”
Hugh Calkins was one of the prominent electrophysiologists being cultivated—and presumably leveraged—by Cardiac Pathways Corporation. It was their Chilli Ablation catheter that was used on my wife to make the scar tissue in her heart. (Hugh Calkins was in the audience, representing Cardiac Pathways on the day that Jeff Brinker, his underling, voted with the FDA panel that approved the Chilli catheter in 1998 — despite a 30% mortality rate during the clinical trials.)
As for Cardima, the company’s stock price nearly doubled in 1998 on the announcement that the REVELATION system with the potential to cure atrial fibrillation had been approved in Europe. Cardima immediately began laying the groundwork for approval in the US, and in 1999, Calkins started giving Baltimore’s Chinatown competition for the city’s mongrel population. Many a stray has been sacrificed on the altar of science at Hopkins, the canines in this case delivered up in order to test the professor’s theory that burning three straight parallel lines into the top right chamber of the heart would cure atrial fibrillation.
The theory outlived the dogs (not by much as it turns out) and the results of the study were duly published in one of the EP trade journals. Calkins reported that Cardima’s REVELATION catheter system performed magnificently. (On the Internet, Cardima files their copy of the article under Assets/Calkins.) The company parlayed the successful results of the dog study into FDA approval for an investigational study on humans. And now, four years and millions of dollars later, the tools had been developed, the patients had been treated. The investors’ money had been spent and the study was complete.
