Eric In my experience in Omaha, I have been impressed that most non-EP cardiologists are very good at referring their eligible patients for ICD implant. However, the same can not be said for general internists and family practitioners. Although some of these docs are up to date on ICD indications and are good about referring their eligible patients, there are others who are not as aware. The reasons for this are unclear. We are taking steps to educate our referring internists and FP's, but perhaps we should be doing more. Mark Niebauer, MD Director of EP Univ Nebraska Medical Center

Thanks, Mark. Your perspective is very helpful. I wonder how much the problem transcends the internists and FP's....and how much the public is spooked. Perhaps your efforts of getting the primary care physicians up to speed will make a difference.

Many patients decline ICD's because they believe that they will have a warning symptom that will let them know if they "really" need one. It's often hard to educate them that death may be the first symptom. Also, I would love to see an analysis of ICD implantation rates in a traditional HMO cohort of patients vs. those with other types of insurance. I'd be very surprised if HMO patients are getting this beneficial (but pricey) therapy.

The internet has become one of the most prolific tools for dissemination of information. Weather right or wrong, patients and referring MDs know about recalls, most have read and believe that 1/3 are possibly/probably are unnecessary. Factor this into massive Medicare $$$ concerns and Defibs running as high as 30K, the general opinion is obviously, does this patient truly need one. Referring cardiologist and internest are the gate keepers to this delima. Education to the current guidelines, including class 11a is going to be necessary. Embracement by the HRS of a nationwide non-invasive screening method will help in this. Having more non-implanting MDs looking for more patients who are at risk for SCD with a non-invasive screening test will put more pre-qualified patients into the EPs office. More finite evidence will be required to convience more to be implanted.

These devices are very expensive and we are aggressively 'sold' devices by device companies. Consumer Reports (12.07) says they are used too often. The NYTimes implies in multiple articles that leads have problems and companies are not straightforward. Our many ICD patients rarely have shocks as 'events' are rare. Everyone is worried about lead problems and fractures. Patients are very worried about false shocks. Respectfully: are you kidding?

Great to get some comments on this topic. If we pride ourselves on practicing evidence-based medicine, the evidence from RCTs is pretty overwhelming for ICD benefit....and the NNT of 10 (worst case, extrapolating real world vs RCT) is remarkable c.f. pharmacologic treatments. I wouldn't use the NY Times or ConsumerReports to assess the trial results....but they are sure to impact public perspective So the patient concerns are understandable and echoed here.......is this an example of public perception overriding rigorous evidence? Are the technical failures in recent years responsible for trumping the trial results? Agree that it would be great to have a test to reduce the NNT, but that appears to be a ways off. It appears, overall, to be a very unique situation in contemporary medicine.

Practicing evidenced based Medicine??? That varies from MD to MD. Residency to residency A large percentage of the readers here agree/believe that a MTWA test should be used prior to ICD implantation. (Go back and look at the poll conducted here). Some also believe that the same test would help jump start the sluggish ICD market. Is that evidenced based? Some say yes, some say no. Either way, conducting a non-invasive test on a patient that is reluctant to recieve an ICD doesn't seem to be that unreasonable. It would be another body of evidence that could be used to help that patient move forward in their personal, internet influenced decision. The old days of "Trust me" you need this, are not like the coming days of "I read/found this on the internet" Do you know anything about..........

Dr. Topol: Just discovered your blog and it's great to see you embracing the blog format -- and again thanks for coming to speak to us in San Francisco several months ago at California Pacific on cell therapy! I feel the ICD issue points out how the data and physician behavior often diverge, which is fascinating to me. Although the number to needed to save a life is small with ICDs, as you point out, the number needed to harm is not anywhere near that of pacemakers or stents -- and this number needed to harm is exaggerated by every "harm" story put out by the media. In addition, the fact that heart failure specialists like Lynn Stevenson have emphasized the risks has truly dealt the field a blow. An interesting parallel is the example of TPA in acute stroke, which apparently is incredibly underused, even though negative events are still outweighed by the benefit, the drug involves simple IV push, and has been out for twenty years. I feel that eventually ICD device therapy will mature to the point where risk stratification and safety will improve to the point of pacemakers. Do you feel that TWA has merit as a risk stratification tool? I have a specific example, in which a patient who had a large anterior wall MI 20 years ago came to me as a new patient. He had essentially no follow up or heart failure care since his original MI, had no symptoms, and had a fixed defect on stress testing without evidence of inducible ischemia. He was asymptomatic and was referred to me for preoperative evaluation. Unfortunately he had a very dilated LV with an EF in the 30s. But even as I discussed the possibility of an ICD with him, it was clearly an uphill battle: he had been asymptomatic for twenty years. It seems a risk stratification tool like TWA is an unmet need.

Thanks, Ed. Certainly MASTER as presented at the AHA didn't help support the value of TWA for selecting ICD use....here is the link of theheart.org coverage which also goes do the data presented. http://www.theheart.org/article/831215.do

Eric, couldn't resist posting on this one. I think AICD's now are like unto my favorite vehicle, the JAGUAR. (Now say it correctly JAG-UUU-ar). It's the only car I ever thought was "beautiful". The soft supple leather and wood grain are fabulous, the ride smooth as glass, the seating technology that of rocket science. The steering wheel has a satiny feel and I can go from 0 - infinity in just a few seconds. My husband gently cautioned me, being the conosseur of automobiles that he is, that it might be more trouble than it's worth. I bought a gently used one to ease the guilt. It was about three years old. Sure enough, at the young age of 4 years, it has already had three automatic window motors replaced (at just over 1,000$ apiece), the change box stuck (several hundred to replace), a head light smashed by an elderly driver (turned that in on insurance, but it was STEEP ). Now, a couple more years down the rode (love it so much I can't bear the thought of parting with it-talk about sick-0!), the "boot open" light has been stuck "ON" for three months, then last night the "LH Headlight indicator failure" sign flashed "ON" (not certain what that means). With regard to automobiles and AICD's, I agree......there is no where near the same impact on human life but the American public has a very keen "lemon" radar and we are socialized to "never go there", no matter what the price.(Should have listened to my husband). When Jaguar, Medtronic and St. Jude finally realize they have something in common.....they should all get together and let the healing begin. Right or wrong, Even with a fabulous drive, curb side appeal, OR the promise of years of longer life......whether it's cars or defibrillators,......... America will still rarely ever knowingly purchase a LEMON. It's' more difficult to sell an AICD to my patient population every day and the "R" word ALWAYS comes up. (Recall). So, we still have work to do and I haven't let that deter me from making the pitch, but a few have flat turned me down and a couple are mad at me because I talked them into it. Gotta go. My JAG-UUU-ar is waiting. Melissa

Thanks, Melissa. Love the JAGUUUar analogy. The "R" word seems to be the main story here......quite interesting for a medical device to be stigmatized. Today's WSJ editorial weighs in on the topic http://online.wsj.com/article/SB119923693299961231.html?mod=opinion_main_review_and_outlooks So far, in aggregate, ICD failures may have been associated with 10-12 deaths cf how many tens of thousands lives saved? at the least, the topic is provocative.

How hard would it be to "sell" the non-invasive MTWA? One more piece of evidence might be the answer. "Mr. Or Ms. Patient, there is one more non-invasive test that exist that we can do to help you with this difflcult decision." My understanding is, ICD implants are being put in 35% more of the time where this question is being asked. This doesn't seem to unreasonable. And as far as the Masters Study, utilizing firing ICDs as an end point in a this study might raise the question of how many fired to questionable lead problems? Anybody checking into that one?

Hi Dr. Topol, great to see your new blog. My two cents as a med student -- and therefore as someone who's still on the lay public side of things -- is that I believe there's a considerable popular stigma against ICDs. When I think of ICDs two things primarily come to mind, 1) the Guidant controversy, and 2) Vice President Dick Cheney. I see Mr. Cheney's case as an unusual example of the glass half-empty/half-full scenario: some might understand that his ICD is keeping him alive, but many others likely view his having an ICD as simply contributing to the image of his generally debilitated heart. For prospective patients who don't regularly read the NYT or WSJ -- someone like my father, for instance -- the common perception of Mr. Cheney as a "cardiac cripple" would easily be enough to spook them, let alone fears of specific device malfunctions reported in the news. Albert

Hi Eric, I've been thinking about the same issue a lot. There is no lack of EPs, at least not in urban areas. There are plenty of colleagues around who will be happy (and have availability) to double or triple their number of implants. This is a "behavioral" problem. With drugs (beta-blockers, statins, etc) you know that the NNT is high, but we do not try to identify who benefits and who doesn't. We use an "epidemiological" approach and assume that everybody benefits a little. With ICDs, our bias is to be more "elegant", more discriminative. With the ICD, unless you receive a shock for a true spontaneous event, you did not "benefit", but you run the expense, risk of complications, recalls, etc. So everybody is waiting for a better risk-stratification tool, forgetting the favorable NNT, even with current "shotgun" indications. I think this a manifestion of how our mind works. We already identified this issue in a book chapter we wrote with Jim Maloney in 1991, we dubbed it the "No pain, no gain" concept of ICD therapy. Most academic EPs find ICDs intellectually boring. And atrial fibrillation ablation is so challenging and attractive... So there has beeb no strong voices from the hardcore EP community regarding these issues, a void that has been filled by people from other fields, like heart failure, at times with a different agenda. First time ever I participate in a "blog". I hope it's not too long Regards Sergio

Great to get your insights on this, Sergio. From your post along with others, it is very interesting to get a handle on perceptions....from the EP community, and as Albert Luo points out from the patient/family side. The "big ticket" ICD item apparently induces a very lofty set of expectations. Seems like we may need to adjust the term NNT to factor in cost and as far as practicing "evidence-based medicine", as long as it's not too much expense up front--in which case the evidence will be disregarded! And add to that the patient outright refusals that Melissa highlighted, it doesn't look like the situation will be imminently changing.

Hi Dr. Topol, Video blogging is a fantastic idea and kudos for your initiative. While I love the Jaguar analogy, recalls with cars are relatively simpler unless they entail an incident like the Firestone tire recall with FORD SUVs, which had resulted in several deaths because of the propensity of these vehicles to overturn with Firestone tires. We all know that recalling an ICD is far more complicated and considerably more risky than the initial deployment...perhaps explaining the decline in referrals. Let us also not forget that Ximelagatran led to only "one" clearly documented death from liver failure but could not be approved in the US despite being far easier and equally efficient as warfarin. Unless the safety with these devices is demonstrably improved, the use is only like to continue stagnating or even decline. Thanks

Dr Topol, Regarding increasing referral from family practice and internists for ICDs, there might be a fairly easy way to gently "remind" them. As we are the ones that read the echos they order a simple sentence at the end of the impression/conclusion in patients with an EF of 35% or less, such as "Consider referral to EP for placement of ICD in patients with EF less than 35% as this has been shown to improve mortality". A simimlar approach was found efficacious in increasing beta blocker usage in this same population. Circulation. 2007;115:2829-2834

Dr. Topol: Real simple here... 1) If plumbers were compensated for putting in ICDs, there would be more ICDs. So, if you want more ICDs put in... have the plumbers put them in. Not unusual for me to walk by the cath lab and hear the following as the cath ends... "OK, sir, everthing's is O.K., your grafts and vessels are wide open... I'll go tell your wife." You look over at the monitor and see the last shot which is the ventriculogram and it shows an EF not more than 20%...OK sir, everything's OK, right? 2) Big pharma has managed to insert all their products on to the care pathways of hospitals as part of the effort to "ensure quality" and "practice evidence based medicine". So, what you see is simple "box checking" for ASA, Beta blockers, ACE inhibitors, etc. I get a letter from the department chairman if I "forget" to write for an ACE inhibitor if the EF is less than 35. And, let's not forget the importance of documenting that you know the EF... who is the beneficiary there... GE, Phillips, Siemans... another check box on the "care pathway". These companies don't spend a dime for all this product pushing... it's all done in the name of "quality" and the expense is borne by the hospital. So, the question is... where is the device industry here? If there were a box to check off there would be more ICDs put in... but, we don't look at ICDs like we do meds, or they haven't pushed the right buttons on K-Street in Washington to get themselves on the hospital care pathways. My advice to the device industry is... get on the gravy train by getting yourself a check box. Stop wasting time with "product development specialists" in the field that help you give "referal dinners". Make it mandatory. Stop giving physicians the "choice" if the data is so compelling. BTW, it's telling that the number of elements that relate to EP practice that go into making a "Top 100 Hospital" is exactly zero.