A“Do We Know What We’re Doing?”
AA
AAPulmonary Vein Ablation for Atrial Fibrillation was all the rage there for a while, according to Hugh Calkins. “For centers that wanted to be doing the ultimate novel unknown thing,” he told the FDA panel, “the latest thing is ablation of pulmonary veins. So the patients would be steered to that so they could build up their experience with that procedure.”
Not everyone was thrilled that patients were being steered toward the ultimate novel unknown thing so that electrophysiologists could build up their experience and tell colleagues at cocktail parties that they were au courant.
Dr. Cox, for one, was bemused that the EP world had adopted and adapted his maze procedure. The normal disdain that surgeons generally harbor toward lesser medical professionals notwithstanding, Cox thought that the electrophysiologists’ reach had certainly exceeded their grasp this time. “It is important to remember that there is such a thing as surgical precision,” he writes. “When we surgeons report our results for pulmonary vein ablation, we are reporting the effects of placing a precise line of ablation around the pulmonary vein orifices. No such precision exists when cardiologists encircle the pulmonary veins with a catheter.”
In adapting the Maze procedure for their catheter techniques, the cardiologists had been kind of feeling their way along, seeing what worked and what didn’t work. For instance, doctors could sometimes detect the stenosis immediately or fairly soon after an ablation, but initially didn’t think much of it: “Focal PV stenosis is observed frequently after RF catheter ablation applied within the vein, but usually is without clinical significance,” noted a 2001 study.
Not to worry.
But as the months and years went by, people started showing up at the doctor’s office with flu-like symptoms. So the general practitioners, not privy to the inner workings of the ablationist movement, would send the patient home with some cough syrup. Meanwhile the stenosis progressively worsened.
“What we’ve learned obviously as we look back, four years ago we were ablating deep into the pulmonary veins creating all this pulmonary vein stenosis thinking we were doing good. At the end of the day, a lot of people were stepping back and saying ‘We have to be out of the pulmonary veins…’ ” — Hugh Calkins.
Another lesson learned. And the complications kept on coming, each one unexpected, each one unprecedented. Calkins wrote in 2006 about what was “perhaps the most feared and most lethal of the many complications,” the atrio-esophageal fistula. “Among patients who do not exsanguinate from upper gastrointestinal tract bleeding,” a surgeon writes, “presentation includes sepsis and embolic cerebrovascular disease.” That is to say that they’ve burned a hole through your heart into your esophagus and if you don’t bleed out on the spot, you’ll die very soon in a very grisly manner.
It was of little comfort to those who suffered the effects of these latest “previously unreported complications” that their misery added to the EP learning curve and advanced the cause of science. These patients put their very lives into the hands of physicians who led them to believe that they knew what they were doing. The truth is that the doctors were learning as they went along and they obviously did not know what they were doing; they did not know the consequences of their actions. Even some members of the EP community have doubts. Writing in the journal Europace in 2008, two doctors ask: “Catheter ablation of atrial fibrillation: do we know what we are doing?”
The question is the answer.
With ablation in the pulmonary veins turning out to be not such a good idea, the next new thing was to ablate neat and precise lines near the entrance to the pulmonary veins.
But neatness and precision would be quite a feat, given that a catheter operator has to maneuver tiny wires around in a beating heart—and you’ve got to be able to see what you’re doing. Again, I haven’t been to medical school, but I heartily agree with Calkins on this insightful comment concerning interventional cardiology: “Visualization of the catheter tip in relation to the cardiac anatomy is crucial,” says the professor. I think pretty much everyone would agree with that statement.
Unlike Dr. Cox, who has no trouble visualizing his scalpel in relation to the heart because he can see them both with his own eyes, cardiologists like Hugh Calkins were using fluoroscopy (X-Rays) to get an idea of where the catheter wires might be. However, Hugh Calkins acknowledges the deficiencies of X-Ray vision, and says that “Fluoroscopy provides only limited information about the relationship between catheter positions… and detailed anatomic information can not be obtained with fluoroscopy.”
So: “Visualization of the catheter tip in relation to the cardiac anatomy is crucial,” but “detailed anatomic information can not be obtained with fluoroscopy.” Hugh Calkins, daredevil, flying blind.
Dr. Cox says that he performed the Maze procedure on about three dozen people who had undergone failed catheter ablation procedures. He got to look inside these people’s hearts and see first-hand the results of the electrophysiologists’ handiwork—and note that Dr. Cox does not recognize the self-designated subspecies electrophysiologist. They are all cardiologists to him:
“Their patients are not receiving a simple pulmonary vein isolation procedure as one would commonly envision that operation, but rather virtually the entire inside of the patient’s left atrium is being obliterated. This is an entirely different interventional procedure….
“Unfortunately, the patients who are undergoing this procedure by cardiologists are almost certainly unaware of the level of destruction that is being created inside their left atria and that the lesions there bear no resemblance whatsoever to a simple line of scar around the pulmonary veins. Ideally, the interventional cardiologists performing these procedures are unaware of this fact as well.”
Patients undergoing catheter ablation for Afib are unaware that contrary to receiving strategically targeted and precisely placed lines of scar tissue, the insides of their hearts are actually being subjected to massive, wanton destruction—obliteration.
And Dr. Cox wants to believe that the cardiologists don’t know the damage they are doing.
