“Just another risk to put on the consent form.”- Hugh Calkins
“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.
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.
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.