Dr John M

cardiac electrophysiologist, cyclist, learner

ICDs are not insurance policies…

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Although this study did not make headlines, its findings jumped off the page of the 566 page supplement listing all of HeartRhythm 2010’s abstracts. 
The presentation, from a Harvard group, revealed more sobering news on the risks of ICD implantation.  Enlightenment on ICD complications was hidden away in this study that primarily looked at something else. (It was hard to get a link to the exact page of the journal, so I added a ‘cut-paste’ version at the end of this post.)
Before going forward, as a prologue, it should be clear that I am strongly for ICD therapy. I also believe, however, for ICDs to improve outcomes they require wisdom in their application, skill in their implantation and vigilance in their follow-up.
The abstract was a small study of 30 ICD patients implanted for suspected Brugada Syndrome, a rare congenital heart rhythm disorder which many clinicians look for, but few find. The researchers present two clinically relevant observations. 
First, although all thirty patients had suspected Brugada Syndrome, only two (of 30) patients received appropriate shocks from their ICD; these two had previously known arrhythmias. The other 28 patients who were implanted for primary prevention (prophylactically) did not have an arrhythmia requiring ICD therapy. This is important news for practicing heart rhythm doctors, as all of us have faced the decision of whether to implant an ICD in a seemingly healthy patient with suspected Brugada syndrome. My count is five patients seen for this problem.
Even more clinically relevant, was the striking, but likely generalizable to the real world, rate of ICD complications. They report that five patients (15%) received thirteen inappropriate shocks. Additionally, of a young (average age 46), seemingly healthy cohort, the researchers report there were eight patients (24%) who developed 11 device related complications during follow-up.
At Harvard, nearly one in three ICD patients developed implant-related ICD complications, and one in five had painful inappropriate shocks.  
The point is not in criticizing a high complication rate; on the contrary, their intellectual honesty is laudable, and these complication rates probably mirror reality.
The larger point–which deserves more emphasis–in the reporting of real-life complications of ICD therapy is that ICDs are not akin to insurance policies against death. An insurance policy confers no inherent risk to the policy holder, whereas the ICD patient is exposed to well delineated finite risks. 
In providing extremely useful information on an uncommon disorder which electrophysiologists occasionally see, and realistic data on the important, but often down-played ICD risks, Dr William Stevenson’s group deserves significant praise for an outstanding abstract.
This is the kind of study that directly benefits practicing heart rhythm doctors.
JMM
Addendum:
LONG-TERM FOLLOW-UP IN PATIENTS WITH PRESUMPTIVE BRUGADA SYNDROME TREATED WITH IMPLANTED DEFIBRILLATORS
Daniel Steven, MD, Kurt C. Roberts-Thomson, MBBS, PhD, Jens Seiler, MD, Keiichi Inada, MD, Usha Tedrow, MD, MS, Bruce Koplan, MD, MPH, Michael O. Sweeney, MD, Laurence M. Epstein, MD and William G. Stevenson, MD. Brigham and Women’s Hospital, Boston, MA
Introduction: Important progress has been made in understanding the pathophysiology and clinical characteristics of patients with Brugada syndrome (BS), but risk stratification remains difficult and controversial. Methods: Data of 58 patients referred for possible BS between 1995 and 2008 were retrospectively reviewed. A total of 33 (57%) patients underwent ICD implantation for BS, 30 (91%) with no documented sustained arrhythmia but had a positive drug challenge (n= 8 (27%)) or concerning findings at electrophysiology study (n= 22 (73%)). Results: The cohort consisted of 30 (91%) men and 3 (9%) women (age at ICD placement: 46.4 ± 11.7 years). The patients were followed for 7.9 ± 3.6 years. The ECG consisted of type I Brugada in 18 (54.5%) and type II in 12 (36.4%) patients. In three patients (9.1%) no ECG abnormality was observed in the absence of antiarrhythmic drugs. During the follow-up (FU), 2 patients (both received their ICD for secondary prevention) required 2 ICD shock for termination of one VT and one VF episode. In the primary prevention cohort no ventricular arrhythmias were noted. Five patients (15%) experienced 13 inappropriate shocks. In three patients, ICD discharge was related to rapid conducted atrial fibrillation and short coupled premature ventricular capture beats in one patients. In one patient, retrospective evaluation did not reveal the reason for ICD discharge. Eight patients (24%) developed 11 device related complications during the FU consisting of severe subclavian vein thrombosis (1), lead revision for high shock threshold (1), early battery depletion (4), pericardial effusion (1), revision for lead fracture (2) and infected devices (2). Conclusions: Risk stratification for patients with BS for primary prevention remains challenging. The present data indicate that patients without prior cardiac arrest seem to be at low risk for long-term occurrence of ventricular arrhythmias. ICD placement inherits the risk of device related complications and inappropriate shock delivery in this young cohort with a considerably longer life expectancy as compared to patients with structural heart disease requiring ICD implantation.

Think critically about treatment recommendations: The H1N1 example…

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Patients are asking me about the H1N1 vaccine. Usually, as a “one more thing” question at the tail end of a visit.

This question churns the angst machine. The face twists in unknowing.
It doesn’t have to be so bad. Could just give the party line and say, “get the shot.” Have a nice day and we’ll see you later. Easy, right? Move on, John, you are behind already. It gets dark really early these days.
Problem is, us arrhythmia specialists are spoiled by our science. Treatments for cardiac rhythm issues have been thoroughly studied in carefully controlled, large, randomized trials against placebo. There are major New England Journal studies published that support the benefits of therapies like catheter ablation and defibrillators. Real studies with real outcomes against placebo. Science. Purity.
The difficulty with answering a simple request on the swine flu vaccine are numerous….
H1N1 gets much press, but, as a statistical danger is quite meek. In the first 300 days of 2009 it has proven 0.77% as dangerous as traffic accidents and .005% as hazardous as cardiovascular disease.
Secondly, due to the media hype, the H1N1 vaccine has been rushed to market. It is untested. How could it be tested?
Thirdly, there is little data to demonstrate efficacy. How does one know? There are no comparisons between large cohorts of vaccinated individuals against unvaccinated. For example, let’s just say the vaccine prevented 10,000 cases of swine flu and one death, but caused 10 major complications and one death. It would be a statistical wash. These comparisons have not been done.
We cardiologists are skeptical. History helps us. In the 1980’s there were medicines that effectively suppressed premature beats (PVC’s) after a heart attack. As post-heart attack PVC’s conferred a worse prognosis, it reasoned that suppression would be good? A no brainer, right? However, when compared to placebo, the drugs did suppress the extra beats, but, the group who took the drug had a much higher death rate. The drugs worked as expected, but unexpectedly, resulted in a higher death rate.
I am not saying the vaccine is dangerous, deadly or ineffective, only that there is insufficient prospective data. It is unknown. The recommendation to vaccinate comes not from scientific comparisons, but rather, from a consensus of “experts.” How do they know? Is it grey hair, PhD’s, nice white coats or “they just know?”
Compare the 8000 global deaths this year from swine flu versus 14 million from cardiac disease or 6.4 million from cancer. Where is the balance?
A larger point: when a therapy is recommended for you, ask yourself or your doctor if there if there is good science to support the treatment. “Expert” recommendations pale in comparison to real trials with real patients and hard endpoints. Think.
The H1N1 vaccine question illustrates perspective.
My answer is, “I do not know.” We will probably know in the future. Based on the above link the answer for most of my patients is: they are 5000 times more likely to die from heart disease and 100 times more likely to die in a traffic accident.
Not knowing is OK, as long as, you know that you don’t know.
JMM

Misinformation in medicine is really bad…

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The editor in chief of the Journal of the American College of Cardiology, (aka: JACC, the leading cardiology journal) has written an opinion statement concerning end of life care. He discusses a clear cut case of an elderly patient who is dying from advanced heart disease. He appropriately describes the transitioning of life prolonging treatment to supportive symptom relief known as palliative care. So far, not so controversial.

However, in the following paragraphs he goes on to discuss physician assisted suicide. How does choosing appropriate end of life supportive care focused on the relief of symptoms even remotely engender the idea of assisted suicide? This is outrageous. Physician assisted suicide is not palliative care.
The political firestorm of late concerning discussions of a patient’s goals of care at the end of life have morphed into the notion of “death squads.” This is preposterous. It is a fueled by misinformation. Every time I discuss implanting a defibrillator with a patient, it involves consideration of end of life goals, as a defibrillator interrupts a peaceful sudden cardiac death with a 750 volt shock. No death squads, just a discussion on goals of care.
It is sad that a leader in Cardiology has spread such misinformation on the choice of supportive palliative care. Why is this so relevant?
Patients are living so much longer, often with chronic diseases that in years past would have been fatal. Also, medicine, particularly cardiac care, has become so technologically advanced, that often times my most difficult decision is when NOT to apply these advanced therapies. How do I know when not to operate or prescribe a risky procedure?
I try to be a master of the obvious. I think, would I have recommended this procedure for Non or Gramps. A good test indeed.
The moving of catheters, leads and ablation of cardiac tissue to terminate arrhythmias is the easy part. Deciding on applying the technology in the best interest of the patient and explaining the decision tree is much harder.
JMM