“Just another risk to put on the consent form.”– Hugh Calkins
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“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,” Calkins relates. “The patient gets emergency heart surgery and dies. Another person gets an A-Fib 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…”
… And the complications kept on coming, each one unexpected, and each one unprecedented. There were four reported cases of “gastric hypomotility and pyloric spasm.” The victims suffered terrible bloating of their stomach and vicious bouts vomiting because their stomachs had become permanently paralyzed. He wrote in 2006 about what was “perhaps the most feared and most lethal of the many complications,” the atrio-esophageal fistula. They probably call it The Widow Maker back in the doctor’s lounge. “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 drown in your own blood right then and there, you’ll die very soon in some equally grisly manner.
“Just another risk to put on the consent form,” said Hugh Calkins.
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Results: Thirty-two deaths (0.98 per 1,000 patients) were reported during 45,115 procedures in 32,569 patients. Causes of deaths included tamponade in 8 patients (1 later than 30 days), stroke in 5 patients (2 later than 30 days), atrioesophageal fistula in 5 patients, and massive pneumonia in 2 patients. Myocardialinfarction, intractable torsades de pointes, septicemia, sudden respiratory arrest, extrapericardial pulmonary vein (PV) perforation, occlusion of both lateral PVs, hemothorax, and anaphylaxis werereported to be responsible for 1 death each, while asphyxia from tracheal compression secondary to subclavian hematoma, intracranial bleeding, acute respiratory distress syndrome, and esophageal perforation from an intraoperative transesophageal echocardiographic probe were causes of 1 late death each….
devastating complications may occasionally occur, some of them ultimately leading to death of the patient (5,7). Systematic assessment of death rates and precipitating causes is difficult, because of the rare occurrence of death, making its description anecdotal in single-center reports (8–10), and because of reluctance to publicize this information (7). As a consequence, physicians performing CA of AF sometimes discuss this complication, but a clear picture about its incidence in the real-world practice is lacking. http://content.onlinejacc.org/cgi/content/full/53/19/1798
During the presentation, Calkins said the two current treatment options for AF, including conventional radiofrequency ablation catheters, are not designed well enough to treat persistent AF, given that persistent patients often have multiple triggers, rotors, and drivers of the arrhythmia within the atrium. These catheters are time-consuming to use, as physicians create lesions in different areas, but the Medtronic catheter system is a multielectrode device, so they are able to ablate multiple areas of the left atrium much more easily.
Wrapping up the panel meeting, Yancy said that despite the negative vote on risks and benefits, it simply can’t be approved “yet.” Better safety results, as well as possible technical tweaks to the catheter, are needed, he said.
Collateral Damage: A Patient, a New Procedure and the Learning Curve 
FYI, at age 72 I developed occasional Afib and/or atrial flutters; one lasted for two weeks until cardioversion. Afterwards, I got an Afib attack every four or five months. I was put on metropolol and jantoven and Pravastatin. As I had engaged in regular exercise all my life I decided to increase the frequency and duration of my regular running and light weight-lifting. My idea was to force my heart to beat stronger and steadier for ever longer periods. It worked and my BP dropped from 140/90 to 115/66 in the course of this change, as my weight dropped from 180 to 160, and cholesterol fell from 200 to 140. I had worked out about one hour a day; I increased this gradually to two hours a day: running-walking for nearly an hour followed by an easy hour on the stationary bike reading the paper, followed by 15 minutes of hard pulling on the rowing machine followed by 15 minutes of sit ups and light weight-lifting. Guess what? My last Afib lasted only a couple of hours and the ER didn’t bother to give me any meds, just sent me home, as it was very mild and clearing up, which it did. That was a year ago and I have been free from Afib ever since. What’s more, I now hold my state record for the 1500 and 3000 meter races in my age group and I feel great, only slightly tired after my 44 minute runs three times a week at 11 minutes per mile. I work out every day but one and on days when I don’t do the long jogs on the indoor track I work out an equal time on the treadmill or Precor foot-and-arm slider machine. The result is that I feel like superman. My cardiologist stresses prevention, and medication. Add exercise to this mix, which he strongly endorses, and you have a powerful combination that can demolish the flutters and Afibs. And I don’t mean manage; I mean demolish, terminate, wipe out, destroy. I have good ears and I haven’t heard my heart even skip a beat in a year. People who want to beat this affliction need to understand the cure is largely in their own hands—and feet.