Hugh Calkins on Afib Ablation

November, 2014

“Just another risk to put on the consent form… ”
                                               – Hugh Calkins, MD

“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.


Complications of Atrial Fibrillation Ablation When Prevention Is Better Than Cure

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May 22, 2013

“Five Stars. This book is an on-target indictment of  dangerous, unethical, and money-driven factions within our health care industry. Many ill patients receive quality care in America, but far too many are also victims of the dark heart that poisons American healthcare. Read it. It could save your life.”  – Patient Safety America
“Blew me away…” “I am on my SECOND reading of this book. And I will probably have to read it several times to have its sheer magnitude sink in.  It is truly astonishing.”
“It is indeed essential reading… “
Collateral Damage is more than simply a book about statistics and afib and we need to be very clear on this. It is a book about big business, the drug and medical products business, teaching hospitals,  and much, much more… “
“A searing, poignant and cautionary tale. This book has really shaken me. I urge everyone to read it… “
“Thought provoking and very well written… “
“Outstanding and a must read for anyone over 40 or anyone who is contemplating surgery. A real eye opener to say the very least. I am on my third reading…”
“It lays bare an example of the issue that lies at the base of our skyrocketing medical costs and our skyrocketing rates of medical harm.  I think it is a bombshell.” “A gripping narrative… a good read…” – Brad Wright, Wright on Health
“I can tell you one thing for certain, it will give you background to be able to ask some very difficult questions with tact and diplomacy and it will most certainly motivate you to ask the questions that need to be asked… “
“A brilliant expose´ of the current role of industry in rapid technological advance and its need for profit from its efforts. Dan Walter highlights the uncomfortable relationship that industry now has with the medical profession… an eloquent indictment of the health care mess.” – Brian Todd, Author, The Third Lion
“Riveting…  A fascinating story, and a very important one… “ –
“It is, simply put, a must read for anyone who truly cares about patients. Pam’s experiences can fill a textbook in what NOT to do from both a medical and nursing standpoint. Thanks for being courageous enough to write about your experience …  As for me, I think that I have learned much by seeing this unique viewpoint.” – Hypocafeinemia
“A great story,  a must read by all interventional cardiologists and electrophysiologists. This is a real life experience of  a patient who underwent a electrophysiology study and   ablation   procedure for atrial fibrillation. It describes how the procedure became a nightmare. Written in a  most  readable fashionInterventional cardiologists need  not get hurt by this  narration  instead  they should  do a  reality check on the dangers  of  the some  of the  complex  procedures.” – Dr. S. Venkatesan
“I highly recommend this book. It is a well-written study of one person’s experience at the hands of the most exalted research hospital in our country. I am a medical malpractice defense attorney. I read Mr. Walter’s book because I wanted to hear a patient’s viewpoint… Mr. Walter brilliantly tells the story of how one of the foremost teaching/research hospitals in the country practiced on his wife without disclosing that they were doing so. I was riveted, and ultimately ashamed of what is an all too common practice.  I wish that all of the physicians at Johns Hopkins would read it, and realize that their patients are not research rats.” — Customer Reviews
“This is a high-speed read. The torture this patient endured is vividly told not to mention the heartache – so beautifully described – of both. It is well researched and diligently narrated. As I read it, I can feel a number of emotions ranging from sadness, frustration, fear and then anger. I didn’t know whether to blow a big whistle or just cry. The voice is both clear and compassionate. I love this book.” –Claire Stibbe, Author, Chasing Pharaohs
“It is very difficult to adequately explain to patients the complexity of this procedure, the uncertainties regarding success and the myriad of complications that can occur. I will recommend this book to every patient considering this procedure from now on.”
“I am a practicing cardiologist who did electrophysiology training. Your story is honest, true and a very apt and telling description of a horror story.” “I work at Hopkins and unfortunately have experienced a similar situation. Your voice is important. Thank you for publishing this. We need to look at ourselves and understand if we’re really performing as the BEST hospital. We have a long way to go. Your story needs to be heard by all. Continue publishing.”
“My knees and hands were trembling as I read the already published nine chapters.” ” … scared the *&#% out of me! I’ve had more bad experiences than good (involving Emergency care) not inpatient as your wife had. I realize how vulnerable we all are and pray that the person holding my heart (literally and figuratively) will treat me as that they would their own wife, mother, daughter or sister.”
“An eye opener and very sobering for those of us who perform such procedures.”
“Thank you for taking the time to write this. You’ve performed a significant public service.”
“These words of tragedy help us, and I am grateful you wrote them.  They help us learn, and this makes us better, both as clinicians and as people.” “Thanks for sharing this true account. I applaud the bravery of anyone who writes an expose’. The public should be aware of the corruption involved in the medical establishment despite how troubling the reality.Rated with six stars.” –Walden Carrington,  Author Titanic: Rose Dawson’s Story
“As for Dan’s book, from my perspective it is not really about this particular procedure. What Dan has done is to expose the mechanisms of medical corruption, and particularly the corruption of medical research.  There has been a lot of excellent investigative work in the press about corruption, conflict of interest, and subversion of the medical literature.  Some of these stories are very specific, such at the Milwaukee Sentinel Journal on back surgery and other specific procedures and devices.  But I have not seen anyone do what Dan has done, with detailed research documents that use the doctors’ own words against them.  The value of Dan’s book is in the fact that it lays bare an example of the issues that fuel the skyrocketing rates of medical harm and the medical costs that go with it. I think it is a bombshell.  But people need to understand the significance of what he is saying.”
************** editing:
Louise E. (— Date:   04-23-11 18:05 I read Dan’s book, a searing , poignant and cautionary tale. Although I remember Pam’s postings on the Forum from several years ago, this book has really shaken me. Not only was Pam’s health status permanently changed through multiple medical errors, but both she and Dan were again victimized in their efforts to seek justice. I urge everyone to read this account. ____________ Author: Murray L. (— Date:   04-29-11 08:21 1. I concur that reading this outstanding but poignant account of the Walters experiences should be made MANDATORY for anyone considering ablation procedure(s). It is indeed essential reading. 2. I am on my SECOND reading of this book. And I will probably have to read it several times to have its sheer magnitude sink in. I am a scientist (physics) and business management/IT ‘expert’ (well, it’s been a long time since Physics 101 but the scientist never leaves) and as such demand total understanding of the situation. It is truly astonishing. 3. Answering my own question; Kindle readers will actually read the book to you in voice quite well. I am just installing the Kindle reader for my IBM PC platform and it is also avaialable for most smartphone platforms at no charge (I can ‘read’ the book while otherwise occupied or in transit in the car). This book is ‘smack on’…. and to whomever said they were sitting there and hearing their doc sound just like one of the characters in the book I can only concur with that as well. I am up for a change in cardiologist who considers me a piece of meat (I understand now) and is pushing me at a teaching hospital for reasons unknown (now I know) and a doctor that I have never heard of for reasons unknown (now I know). Read the book. __________________ “Collateral Damage” is more than simply a book about statistics and aFib and we need to be very clear on this. It is also a book about big business, the drug and medical products business, teaching hospitals, ensuring one knows who is diddling inside their beating heart, spotaneous stupidity or, as with my barbeque “not reading the directions twice” before assembly, and much much more. Pam Walter, truth be known, is simply a player in the book. A ‘for instance’ and a figurehead perhaps. It is a dreadful story and one that garners my absolute empathy to be sure, but understand that the book is so far and above “MORE” than a story about Pam. It is a ‘must read” for all aFibbers. NOW! Not the night before you are going in for ablation, etc. It is thought provoking and very well written in my humble opinion and will, at the very least, make one think to the extent that when sitting down with your EP you will know some questions that you really DO want to ask. The top question on my list is going to be “Just exactly who is going to be diddling around inside my beating heart and where will you be during the course of this procedure, from start to finish?” It will bring you directly to face your own mortality and the possibility that things can and do go wrong, albeit rarely. I can tell you one thing for certain, it will give you background to be able to ask some very difficult questions with tact and diplomacy and it will most certainly motivate you to ask the questions that need to be asked. Thanks to Dan and Pam for bringing this book to us. Sympathy and empathy for the grief gone through in making it possible. And thoughts and best wishes for the future to both of you. With my personal thanks for just one more piece of enlightenment that no aFibber should really be without. “These words of tragedy help us, and I am grateful you wrote them.  They help us learn, and this makes us better, both as clinicians and as people.” ________________ I may be the last person on this listserv to read Dan Walter’s book, Collateral Damage.  Blew me away.  Especially because of the FDA medical device user fees re-authorization timing. My review is on’ll be placing other patient safety posts on this blog from time-to-time — along with photographs and poetry posts. Best,

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