I’ve got two stories in progress about organ donors who paid a heavy price for believing in the better angels of American medicine. Below is an essay about the selling of a particular procedure.
I got a call the other day from Lorraine, a feisty 60-year-old school bus aide from Tampa whose decidedly healthy husband was killed a couple of years ago while undergoing liver donation surgery at the Lahey Clinic.
Lorraine had originally contacted me last year, after reading the book I wrote about my wife’s near death from a botched cardiac catheter ablation procedure at Johns Hopkins. She was calling me now because her son had been diagnosed with atrial fibrillation, and the docs were talking about doing an ablation if medications don’t do the trick. Catheter ablation for afib involves snaking tiny wires into your heart to cauterize areas thought to produce disturbing heart rhythms.
I don’t know how symptomatic Lorraine’s son is, or what drugs they’ve tried, and I really try to not be a dispenser of medical advice, but I urged further opinions and lots of research for her son before he agreed to an ablation. That’s because since publishing my book, I’ve been contacted by two people whose loved ones were killed by inexperienced ablation catheter operators, and I know of others. I’ve heard from, or about, many more afib patients who have been injured during the procedure. The last thing Lorraine needs is to have another family member fall victim to an iatrogenic medical tragedy. Her son’s doctor told him that catheter ablation for afib is “a common procedure.”
From what I can tell, it looks like that’s the best that can be said for the undertaking.
Of course, your view of safety and effectiveness of the procedure depends on several factors, such as where you get your information (or your funding) — and what you’d like to believe. The average person — heretofore blissfully unfamiliar with the term electrophysiology — whose heart suddenly starts thudding wildly in his or her chest, will, upon hearing the words atrial fibrillation, turn to Google. There they will find an avalanche of corporate-driven PR masquerading as news which proclaims the availability of a minimally invasive cure at the local hospital.
A story on the website of the Rapid City Journal, “After Atrial Fibrillation, Woman gets Rhythm Back” quotes the local cardiologist as saying that “This can be literally cured… The success rate for the procedure is 90 percent.”
“Ablation gets Heartbeat back in Rhythm” reads a headline in a Chicago Sun-Times online newspaper. The story, bylined “From Submitted Reports,” (read: press releases) tells of local people who were debilitated by afib and had given up hope of returning to a healthy lifestyle until they discovered that “One of the most effective treatments is minimally invasive atrial fibrillation ablation… Most patients stay overnight or go home the same day.” For one of the patients featured in the story, “atrial fibrillation ablation was the solution he’d been looking for. The procedure ‘cured’ his problem, which meant no more powerful medications with risky side effects.”
There is no cure for atrial fibrillation, and the story doesn’t mention that the head of the local EP Lab who administers these “cures” is a paid consultant to the medical device industry.
The Googling afibber will also come across plenty of websites like AtrialFibrilation.com, home of the “Afib Alliance” which touts “high success rates with catheter ablation,” and states that “catheter ablation has been considered by many as a potentially curative therapy.” You’d have to click on the About button to find that “This website is provided as a service by Biosense Webster,” and then do a bit more research to find out that Biosense Webster is a division of Johnson & Johnson, which has just about cornered the market on afib ablation equipment — and ablation practitioners.
And this from the American Heart Association:
How effective and safe is this procedure?
Radiofrequency ablation has a success rate of over 90 percent, a low risk of complications and the patient can resume normal activities in a few days. It causes little or no discomfort and is done under mild sedation with local anesthesia. For these reasons, it’s now widely used and is the preferred treatment for many types of rapid heartbeats.
So if your doctor suggests that you have an ablation, and you are looking for some reassurance, you’ll find plenty — at first glance. And that is enough for most people. It is a scary condition and people want to believe that modern medicine has licked the problem. They want to be able to undergo a “minimally invasive” procedure and be done with it and go on with their lives.
One crucial point that all the press releases gloss over when touting the procedure is that the aura of success was nurtured at high-volume centers working with ideal patients; relatively young and healthy people. Also, more than one procedure is often needed — and even then the results are likely temporary. All of which is OK with some people who are highly symptomatic and are willing to try just about anything to make the terrible problem go away.
Doctors too, of course, want to believe in a safe and effective cure, and they trust too willingly in the contrived studies and corporate propaganda that come out of the nation’s premier medical research facilities. Doctors, like anyone else, have limits on how much information they can absorb, and it is perfectly understandable that a primary care physician, or even a cardiologist, would go along with the conventional medical wisdom on the issue.
Since the notion first occurred to ambitious electrophysiologists in the late 1990′s that they might be able to replicate their success in offering stents as a catheter-based alternative to coronary bypass surgery, questions about the safety, effectiveness, and even validity of catheter ablation for afib were limited to diffident offerings on the back pages of cardiology journals. America’s premier medical research hospitals — backed by multi-national device companies — pumped out a steady stream of highly favorable and optimistic research articles.
In the parlance of the business, the procedure was pronounced “ready for prime time,” by the medical establishment, and EP’s trained at Ivy League research hospitals fanned out across the country to help regional medical centers set up shop, and from there the procedure has become common practice at local hospitals.
But second thoughts are starting to seep into the medical mainstream.
In a recent Trials and Fibrillations column, Dr. John Mandrola writes:
“Here’s a challenge: Pick up a cardiology or electrophysiology journal and show me a negative piece about catheter ablation of atrial fibrillation. It’s true; our world is mostly free of doubters.
“Then there is the real world, one populated with other medical specialties, and those daring enough to ask, “What, exactly, are you ablating?” As it turns out, not all doctors think so highly of the notion of ablating a disease that we do not fully understand.”
Dr. Mandrola quotes Dr. Rita Redberg’s recent JAMA article from the “Less is More” series:
“Because ablation has never been studied in a randomized blinded fashion, we cannot know whether patients experience fewer symptoms after ablation because subjective symptoms frequently decrease following a procedure or whether the ablation itself was beneficial. Furthermore, the clinical benefit on survival and morbidity of this invasive procedure, which has substantial procedural risks, remains to be established.”
Last year, MedPage ran a story headlined Ablation for Afib Dogged by Complications about a study that highlighted the high complication and recurrence rates associated with the procedure:
In a comment accompanying the study, David E. Haines, MD, of Oakland University William Beaumont School of Medicine in Royal Oak, Mich., observed that atrial fibrillation ablation “has offered the promise to free patients of symptoms of palpitations, dyspnea, and fatigue,” and to reduce long-term risks of stroke and death. “These advantages are compelling, and they explain the wide adoption of a procedure that is technically challenging and has results that can be characterized as mediocre at best,” Haines argued. Haines particularly cautioned against the performance of complex procedures such as this in low-volume centers by clinicians with insufficient experience. “As long as a hospital is able to profit from supporting interventional procedures by its physicians, there will be a tendency to set a low bar for granting privileges to any doctor who claims proficiency,” he stated.
Notably, Haines also “called for all centers providing atrial fibrillation ablation to adopt quality assurance programs that closely follow long-term outcomes, and to provide patients with adequate data and context about the center’s experience and results.”
The assumption being that centers performing the procedure don’t know or care about long-term outcomes, and that patients are not being told the truth about how safe and effective the procedure is, or what the track record and experience is at a given hospital.
Dr. Mandrola’s insular “real world” comprises those doctors who are not electrophysiologists — and who are daring enough to question an established procedure — and not all of them “think so highly of the notion of ablating a disease that we do not fully understand.”
But the real “real world,” is the one Dr. Haines touches on. It is the world populated by patients, regular people who did not go to medical school, people who assume that their doctors do indeed fully understand their disease, as well as the risks and rewards of the procedure they propose as a cure. These patients assume that when they agree to put their very lives into a doctor’s hands, that the doctor is comfortable and confident in performing the prescribed treatment.
When I suggested as much to a medical device professional on an online forum, he replied that, as with anything else in this world, one must do a lot of research, and that in medicine, like anything else — it’s caveat emptor.
That’s a hell of way for a sick person to have to approach American medicine.