ICD complications

New developments in St Jude Medical’s Riata lead failure

April 13, 2012 By Dr John

There is a big story out today in the small world of electrophysiology. I’ll try to give it a non-technical wide-angle view.

My friend and fellow real world doctor, Dr. Jay Schloss from Cincinnati is at it again. Jay conitunes on his quest to give doctors and patients the most useable information possible on the matter of St Jude Medical’s (SJM)Â lead woes.

As a person whose everyday job entails implanting cardiac devices, I feel compelled to join the conversation.

Here goes:

Dr. Schloss’ most recent piece, published today, not in a medical journal, but on the blog of Larry Husten, Cardiobrief, addresses the contentiously debated views onÂ SJM’sÂ troubled defibrillator leads.

My summary of the background:

SJM has a real problem with their defibrillator leads. No lead is perfect, but the Riata family is especially troubled: 1) In too high a percentage, Riata leads are externalizing (coming apart) inside the body, and 2) Itâ€™s now clear from Dr Robert Hauserâ€™s recent reportÂ that internal lead shorts have resulted in patient deathsâ€”when the life-shaving shock fails. That patients have died because Riata leads failed has upped the volume of this previously mundane medical device failure. Further complicating the matter for SJM is the fact that their current lead Durata, shares many of the same design features as its troubled parents. SJM says its current lead has a â€˜superâ€™ insulation and will hold up; many of us have our doubts. How much confidence to have in SJMâ€™s leads wasnâ€™t bolstered by this report on their LV pacing leads, which also look dubious.

To no oneâ€™s surprise, St Jude MedicalÂ had a response to all this bad news. They had choices in how to respond; clearly, different options were discussed in the boardroom. One approach would have been to admit that Riata/Riata ST leads have a problem; apologize for the human error of engineering; state clearly they are doing their best to follow and identify patients before a bad outcome occurs and then go on to support their (supportable) belief that Durata will hold up. Thatâ€™s not the path they chose. Rather, they took the view that the best defense is a good offense. SJM publicly and loudly asked for retraction of the paper in Heart Rhythm.Â Their chief complaint with the Dr. Hauser paper was notÂ that their own lead had tragic failures but that the number of deaths with the MedtronicÂ Quattro lead (their competitor) were undercounted. In other words, they didnâ€™t defend their failures; they set out to impugn their competitorâ€™s product. WeÂ were bad, but they were worse.

This debate went public. The WSJ and NYTimes and many more mainstream media outlets carried the story. My social media and EP colleague, Dr Wes Fisher is all over this story.

Amidst the storm, enters the calm, well-mannered and thoughtful Dr. Jay Schloss…again. For free, on his own time, with no residents and fellows, or research nurses, Jay looked at every case that St Jude submitted in their responseâ€”hundreds of them. Then, he took the time to write about them in a research-type manner. His detailed report speaks for itself.

Iâ€™ll offer a summary: Jay found–as most expected– that the SJM-reported deaths related to Medtronicâ€™s Quattro lead were either indeterminate or not lead-related. Dr Hauser’s report rightly included only deaths that were felt certain to be directly lead-related. Remember, all (or many)Â patents that die with an ICD get reported, but clearly not all are lead-related. Ever diplomatic, Dr. Schloss calls these differing ways to look at the data: “significant methodological differences.”

I have three concluding remarks:

Dr Schloss should be commended on this important work. He has provided excellent and unbiased information. Even more inspiring is that he has done this out of a passion for his work–helping patients with heart disease. To me, this isÂ really cool. So good!

Second, a note on St Jude Medical’s strategy for dealing with Dr Hauser’s peer-reviewed and well-vetted report on Riata-related deaths: I’m disappointed. I can’t help feeling they tried to hoodwink us. Of course, it’s not fair to count non-lead-related deaths. And what of the public tantrums? Look, I’m a SJM customer. They make good products, that help me, help patients. But come on guys? In medicine, the rule of thumb in cases of complications is to be truthful, contrite and more helpful–not defensive and accusatory.

Finally, How about the role of social media? Naysayers point to the wily-nilyness of Facebook and blawgs. But times have changed–for the better. Now, social media not only allows, but amplifies, the important voices of realÂ docs who are embroiled in real messes.Â Â No longer is the only word on clinical matters coming from protected ivy-walled academic centers. I’m not knocking the voices of academia. We need their work, but us regular doctors often want to know what are fellow regular doctors are thinking and doing. I tell patients who have challenging problems thatÂ recruiting more minds to work on the problem almost always helps. So yes, I believe social media stands to help both patients and doctors alike.

JMM

ICD recalls, Social Media and Preventing Heart Disease

February 22, 2012 By Dr John

I can’t possible write two posts tonight.

Therefore, please consider this Cycling Wed post a mosaic. (I like that word, don’t you? Give me a break smarties.)

Seriously…

Today, my friend and fellow heart rhythm doctor Jay Schloss (Cincinnati) published this meticulous and well-balanced essay concerning the recent recall of St Jude Medical’s Riata defibrillator lead. The work exudes detail and clarity. As an editorial helper, I can testify that Jay logged Ironman-level hours into getting every paragraph right. As Jay doesn’t (yet) have a blog, good-hearted journalist Larry Husten offered his blog Cardiobrief as a canvas. Nice.

Influential cardiologist-blogger Doctor Wes Fisher rightly said Jay’s “tour de force” piece was a must read for heart doctors and industry people. That’s true. Jay offers real and actionable information on a complex and moving target. Remember, accurate information lies at the crux of good decision-making–in everything.

Having learned so much from working with Jay and Wes on the Riata story, I felt compelled to offer this broad overview on my Trials and Fibrillations blog over at theHeart.org.

Though this stuff is technical, and seemingly specific to a narrow audience, I see two big picture items that are relevant to a general audience.

One is the role of social media’s influence in medical and patient education. Before blogs, Twitter and Facebook existed, an interested doc or patient had to read sterile journal-speak. Sure, such works come from prominent universities and major thought leaders, but one is often left wanting for more. “What does the author really think?…What do real doctors say?”

Shazam…Enter guys like Jay and Wes, and so many other medical bloggers. Here are regular doctors researching the crap out of something, meshing it with real experience and then action-verbing it all together in a readable piece. The end-result: strikingly helpful information, albeit without words like ‘stakeholders.‘

The second big picture item at play with the Riata story: It’s less than ideal to intervene after disease has already occurred. Though an ICD shock can save a life, and it often does, these devices and their imperfect, man-made hardware confer significant risk to the patient. Defibrillators are not alone in this regard. All the things we do to treat heart disease–prescribing pills, squishing blockages and burning heart tissue–have limitations and significant risks.

This is why I believe so strongly in preventing heart disease in the first place.

It’s why I recommend riding bikes, eating less pizza, going to bed on time, giving hugs, embracing optimism and…FTW…

Grinning.

JMM

Two messages taught by recent cardiac device recalls

January 20, 2012 By Dr John

Cardiac devices were in the news today. And you guessed it; the reports centered on problems.

In this case the story includes dramatic visuals. The St Jude defibrillator wire, Riata, a commonly-used wire has been ‘recalled’ by the FDA because of electrical failures in at least 10% of cases. The dramatic part here includes the fact that internal wires can become ‘externalized‘ in the body. That’s medical speak for bare metal getting exposed inside the heart!

A very detailed summary on TheHeart.org goes over the minutes of an expert panel. It’s very early in the natural history of this problem, so neither I nor the experts know what to do. We are at a scary moment for some: there aren’t guidelines.

It would be beyond the scope of this blog to cover the medical details of an extremely complex ICD issue.

Rather, two thoughts come to mind. Thoughts that apply in a general sense to heart disease and doctoring.

Prevention:

The act of implanting cardiac devices constitutes serious business. Man-made devices will always harbor flaws.This recall, along with the recent Sprint Fidelis lead (Medtronic) recall shine an important light on the whole idea of treating heart disease after the fact. These ‘limitations of technology’ only strengthen my argument for prevention. Decreasing the number of heart attacks and treating high blood pressure over the long-term would dramatically lower the number of people exposed to the risks of implanting complicated hardware into the body.

Role of judgement:

The second thing that these connundrums highlight is the important role of judgement. There are no protocols, no evidence-base, no guidelines, and in this case, not even a consensus. Doctors have to read about the problem, assess how the problem could affect their patient and then discuss options with the patient. There’s not a right answer. Dealing with this problem takes horse-sense, mastery-of-the-obvious, gumption and humility. This challenge, I find refreshing.

JMM

A new ‘message’ on expensive medical devices: The ICD as an example

October 24, 2011 By Dr John

Nearly six months have passed since â€œemergencyâ€ meetings were called.

Gosh, if I had a dollar for every emergency meeting. Itâ€™s amazing how looking back at these crises makes our angst seem silly. Like many things medical, time and deep breaths have a way of sorting things out.

The latest heart-rhythm crisis centered on the DOJ investigation into possible overuse of ICDs (Implantable Cardiac Defibrillators). After many months, it seems calm enough now to write a post reflecting on some of the lessons learned. And where we are now in our thinking about ICDs.

The first part of 2011 was a stormy time to be an ICD-implanter or an ICD hospital. It wasnâ€™t just the DOJ investigation; the debate was also fueled by this well known JAMA study from Duke suggesting one in five ICDs are implanted outside of the evidence base.

What got me thinking about ICDs was getting this congratulations from an industry watcher whom I gave the prediction (earlier this year) that cardiac device implants would be plummeting. She sent these words in an email to me:

I have to give you credit for predicting the ICD market would decline. The third quarter looks very soft (down about 10 percent).

The reasons for the decline in ICD implants are instructive. It taught me a lot. (And when bloggers learn, they like to share.)

I know what you may be thinking? Whatâ€™s so earth-shattering about the idea that a DOJ investigation and a negative study from Duke resulted in fewer ICD implants?

Let me tell you my thinkingâ€¦

On the surface, one might argue that enhanced scrutiny of ICDs caused the decline through direct effects. Facts like most ICD-implanting hospitals have instituted pre-implant audits and checklists. Gone are the days when an implanting doctor simply scheduled an ICD or pacemaker. Now, the doctor has to impeccably document that a patient considered for an ICD meets absolute indications. (That these absolutes were penned in 2006 and that clinical judgment has no box on the checklist remains a source of inflammation.)

But if you think ICDs are on the decline just because of these added hurdles, I believe you would be wrong.

I think the main reason for the recent (and future) decline in ICD implants comes from the indirect effects of enhanced scrutiny. By indirect effect, I mean to say there is now a new message about ICDs.

Whatâ€™s the new ICD message? Whoâ€™s hearing it? What was the old message?

Letâ€™s start with the old message on ICDs:

The old message on ICDs held that patients with a weak heart (measured by a low ejection fraction) NEEDED an ICD.

Who was hearing this message?

The main people who heard this message were the general medical community. The doctors on the front lines of medical care, those who control referrals, heard guide-line writers (â€œexpertsâ€) say that patients needed ICDs, or else they could die. ICDs were likened to b-blockers, ACE-inhibitors or statins. Only pills do not deliver 750 volt shocks or get infected with MRSA.

What was the result of the old ICD message?

Patients got referred to implanters of ICDs for the implant, not for a consult that asked,

â€œGiven the competing co-morbidities of my patient and her wishes for a painless and peaceful death, do you think she would benefit from an ICD?â€Â

At the same time (from 2001 to 2009) the medical community repeatedly heard experts tout the life-saving benefits of ICDs, many â€˜installersâ€™ understood that implanting an ICD is easy, well-compensated and doing so avoided conflict with the referring doc. Implanting doctors also knew that all but the most sophisticated patients think ~~doing~~ installing something is better than not.

Going against the â€˜message,â€™ and referring doctorsâ€™ wishes, by not implanting the device, proved many fold harder than the thirty minute surgery. So ICD implants rose dramatically from 2001 to 2009.

Whatâ€™s the new message on ICDs?

The new message on ICDs emphasizes three issues that have always been true, but not part of the original message (or perhaps lost in translation):

ICDs are indeed useful, life-saving in fact, but only when skillfully applied in a narrowly-defined group of patients. (There is considerable debate on where these lines of benefit should be drawn and who should be the drawersâ€”doctors or government.)
ICDs are not like insurance policies: they confer substantial risk. Recent recalls of ICD leads have highlighted these risks.
Patients considered for ICDs should get the benefit of a thorough explanation of what one can expect from an ICD. And how it may affect the end of life.

Whether you like the new â€˜messageâ€™ or not, three facts remain obvious:

The new ‘message’ is a reality. No patient NEEDs an ICD. The current decline in ICD use will likely continue.

I am conflicted about ICDs. On the one hand, I have always believed that patients considered for an ICD hear the entire story–pros, cons, expectations. I have been a vocal advocate for better patient selection, more skillful ICD management and frank discussions with patients on how an ICD can change the mode of deathâ€“from sudden and painless to something less desirable.

But on the other hand, I loathe the idea of government bureaucrats inserting themselves into the doctor-patient relationship. As a thinker and ‘regular’ doctor, I am inflamed when non-clinical statisticians (even ones from Harvard or Duke) make decisions like recommending an ICD seem black or white, right or wrong. Itâ€™s hard for me to accept that clinical judgment is not an adequate reason to implant an ICD. Patients are people, not stats, and people often fall into gray areas.

And finally, itâ€™s sad, shameful almost, that weâ€“as a societyâ€“value the surgery to implant an ICD so much more than having a difficult discussion with the patient and family. Try explaining the concept of competing causes of death to the patient whose son stands in the corner of the room with his arms folded and face twisted in disgust that I even suggest that an ICD may not help Dad.

Change is constant. Thank goodness.

But are we going in the right direction?

I hope so.

JMM

â€œItâ€™s just a generator changeâ€

October 5, 2010 By Dr John

Cardiac devices are battery powered. Like your TV remote, they require change–every 5-10 years or so.

No worries…”it’s just a generator change” is a phrase one hears frequently in the cath lab. They are supposed to be easy cases.

But they are not always. And here is more recent evidence that the simple pacemaker/defibrillator replacement surgeryâ€”especially if a new lead is requiredâ€”is more complicated than meets the eye.

In this report published in Circulation from 72 academic and private centers, major complications occurred in 4% (of a thousand) of patients who underwent generator change, and in a breathtaking 15% of those undergoing generator change with a new lead. Although there were no peri-procedure deaths, eight patients who died in the follow-up period were deemed “peri-procedural.”

When high complication rates are reported, doctors in the field, especially those in the sweet-spot of their practice years, would like to think their complication rates are lower. They may be, or they may not be. The data is the data.

The authors should be commended for reporting such humbling data. This is an important report, for both doctors and patients alike.

It reinforces my long-held view that ICDs are not like insurance policies. They carry substantial, and much under-estimated risk.

JMM

Double countingâ€¦

July 14, 2010 By Dr John

The implantable cardiac defibrillator (ICD) is a life saving therapy. But, like any medical treatment there are potential adverse effects.

With ICDs, we are trying to prevent thisâ€¦(a slide from the 1980s)

But in doing so we sometimes get this…

Which is supposed to look like thisâ€¦(same patient–hours later, with no intervention)

ICDs have been likened to having a paramedic in one’s chest; ready to defibrillate at a moments notice, automatically.

Some have even gone so far as calling ICDs “insurance policies.”

But it bears emphasis that unlike holders of insurance policies, ICDs confer risk. Not just the risk of surgical implantation, but an ongoing risk each and every day.

Like the risk of receiving an inappropriate shock. A shock, because the ICD mistakenly thinks the heart is beating too rapidly.

The above referenced ICD recordings are from a patient who has had an ICD for years. It was placed for a chronic and unusual (but not rare) cardiac condition known for its intermittent flares of life-threatnening arrhythmia.

Her rhythm had been stable for many months. The home monitor recorded no evidence of “mini” episodes nor any hardware issues. The device was not on recall. She was seen a month ago and all cardiac measures were stable.

But yet, without warning, nor any other symptoms she received 4 extremely painful ICD shocks. The t-wave, the electrical representation of cardiac relaxation, enlarged to the point where the ICD counters considered it a heart beat. This made a heart rate of 120 look like a rate of 240. Since 240 beats per minute is way over the threshold for danger, the ICD delivers a shock. ICDs can not discern a real arrhythmia from artifact in most cases.

Most patients can tolerate one shock, as the pain is over almost before the brain has time to process the magnitude of the insult. But almost no one can tolerate multiple shocks. The first shock starts the fear cycle. First is extreme anxiety, but after a second or third shock, anxiety from the possibility of more shocks progresses quickly to near terror.

In this case an evaluation did not reveal any obvious cause for this out-of-the-blue over-sensing issue. It just happened. Fortunately, programming changes were made to the ICD sensing algorithm and things have been quiet thus far.

In the case of any ICD shock(s), reassurance to the patient is paramount. However, reassuring words from a doctor who does not know the sensation of a painful wide awake shock often falls short. She lies motionless in bed, wearing a painful-to-see fearful expression, as if to say “I am too scared to move.” This sticks with you.

Wise people know nothing in life is free. In ICD treatment this is surely the case.

For us “seasoned” electrophysiologists, cases such as this serve to further complicate the landscape of future treatment decisions. Maybe it’s why making treatment recommendations seems to get more difficult with age.

JMM

Clinical decision making 301: The Sprint Fidelis ICD leadâ€¦

June 18, 2010 By Dr John

The implantable defibrillator (ICD) is an amazing life-saving device. Â When used in the appropriate patient, the scientific data supporting its benefit is rock solid. The sudden death-averting appropriate ICD shock in the middle of the night, allows the patient to enjoy breakfast with his spouse, rather than admission to the morgue.

ICD function seems simple: sense the event, charge the capacitor and deliver the shock. However, transmission of all these electrons requires durable leads. Â Leads that can withstand 100,000 heart beats per day as well as repetitive torsion from the chest musculature.

History:

Years ago, like many other “installers” of ICDs, I was a believer. Â The new lead was lower profile (thinner), handled beautifully, and was easier to install. Â It was even a pretty blue color. And, it emanated from a conservative and trusted Fortune 500 medical device company–the company that invented pacemakers.

Who knew the Sprint Fidelis lead would be such a disaster. Â I wasn’t the only electrophysiologist duped, as more than 250,000 of these troublesome leads were implanted world-wide.

Compared with a non-recalled ICD lead, the Medtronic’s Sprint Fidelis ICD lead is highly prone to abrupt failure. Â Lead failure, or an electrical short, is manifested as electrical noise. Â Noise is transmitted to the sensing circuits of the device which results in two adverse outcomes. Â First, electrical noise may inhibit pacing output. Pacing failure in a pacemaker dependent patient is nearly always a really bad thing. Secondly, and much more commonly seen in any ICD lead failure is electrical noise masquerading as ventricular fibrillation (VF). Â Once VF is detected, the device charges and delivers therapy.

In the case of the Sprint Fidelis lead fracture,Â “delivers therapy” is medical speak for a wide awake patient receiving repeated 750 volt shocks. Â This is a terrible outcome. For many patients inappropriate shocks are a life changer–for the worse.

On the surface, dealing with this issue seems easy: what’s your point, Doctorâ€¦Just take that terrible lead out, or put a new one in. Â Fix it.

Here is the issue: Â Statistics get in the way.

The Fidelis lead fracture rate is 2-3% per year, and fortunately, the death rate is even lower, at less than 0.5%. Â Said in other words, for the patient with the recalled lead, each year brings an approximate 1 in 40 chance of sudden painful shocks. Â A negative.

However, a recently reported multi-center survey showed that the complication rate from revising the recalled lead is significantly higher, approaching a 15% surgical risk, with half of these complications described as major. This seemingly high complication rate makes perfect sense, as the complication rate for simply replacing an ICD generator–in experienced centers–approaches 11 percent.

As is nearly always the case, I agree with the distinguished and level-headed professor, Dr Fred Morady who advises against prophylactic lead revision. (Dr Morady doesn’t know me, but many years ago, a colleague and I visited his lab as our first exposure to AF ablation, and I am grateful for his generosity.) His comments on this most recent Sprint Fidelis study are as follows…

The incidence of fracture of the Sprint Fidelis lead initially was estimated to be 1-1.5%/year, but the incidence has increased over time and now appears to be 2-3%/year. The most common clinical consequence of lead fracture is inappropriate shocks, and fortunately the risk of syncope or death resulting from lead failure has been very low (<0.1%). In light of the 15% complication rate associated with lead revision, the risk:benefit ratio of lead revision currently favors close observation of Sprint Fidelis leads that show no signs of malfunction.

Fortunately, the decision to operate on these leads is made easier by the fact that many Sprint Fidelis patients are approaching the 4-7 year lifespan of their ICD generators. Elective replacement of an ICD generator for battery depletion allows for an opportunity to revise the lead with less incremental risk. Â I have not seen any “expert” statements yet, but it seems justified to revise the lead at the time of elective ICD generator change. It passes the,Â “it’s what I would have done for myself,” test.

Presentation to the patientâ€¦

This is far from easy. Â ICD patients with recalled hardware are often a worried cohort. Wouldn’t you be? Â I’d be a nut-job, for sure. Â Just launching into the notion that your recalled device is fine now, but could go haywire at any moment isn’t even remotely straightforward.

As is often the case in medical practice, mathematically comprehensible population statistics prove difficult to apply to the individual patient who sits before you in the office. Obviously, the presentation of this challenging scenario varies depending on the patient.

It’s easy when it goes like this…

Me: Â “You have a recalled wireâ€¦presently, your wire is OKâ€¦it might failâ€¦if you get a shock, call 911â€¦but for now it is more risky to operate on you, so we are just going to watch it closely. Â Soon, your ICD will need changing because of a low batteryâ€¦We will fix the wire then.”

Patient:Â “Ok, Doc, whatever you say, I trust you.”

In this case of unpredictable painful electrical shocks versus high surgical risk, trusting the doctor, and moving on with life, without the burden of the details seems better to me.

If it was my body with that fateful blue lead, I wonder whether I would make the right medical decision, or would I say, “I know it is riskier to operate, but I want it fixed?”

JMM

ICDs are not insurance policiesâ€¦

May 17, 2010 By Dr John

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 Womenâ€™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 Â± 11.7 years). The patients were followed for 7.9 Â± 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.