I always believe that medical decisions are to be made individually and with a frank conversation regarding risks and benefits on both sides. Ultimately, it is the patient’s choice and I am here to provide them with my knowledge to assist. This is why I don’t order Lifevests on frail patients who can’t physically endure the device or on patients who don’t possess adequate cognitive functioning. This is also why several patients have opted against ICD implant because sudden death seemed preferable than painful shocks.
But there are also patients who want an ICD no matter what. Particularly, my non-ischemic CMP patients — who are often younger and more active — want to be protected. I have made it a practice to consider Lifevests for these patients and extend them if their EF seems to improve after 3 months. Many times, their EFs are near normal after 9 months on GDMT.
The data is old comparative to our new world of HF medicines. But it is the only data we have. So, it comes down to discussions and shared critical thinking with your patients. I believe that most of my colleagues think similarly but some are afraid of legal repercussions. This is why “American doctors” sometimes are pushed into procedures (often by family) anyways. Support the patient-physician relationship first.
I am a Hospitalist and our Cardiologists routinely recommend Lifevests in patients admitted with new diagnosis non-ischemic cardiomyopathy. I have not found compelling evidence to support this practice but rationalized it as a temporizing maneuver while seeing if remodeling occurs on new CHF meds. I would be interested in others’ thoughts on this matter.
Yes, this is always the paradox with overdiagnosis/overtreatment. Patients assume that just by virtue of being treated, they have benefited. Human biology is not so simple though. They may benefit also by not being treated at all. People just can not wrap their heads around this concept. Educating the lay person about this is especially tough when medical and patient advocacy groups are not interested in recognizing this basic truth.
Sad commentary noted after this article. Most implanting EP docs like me explain in great detail about the ICD. We explain what a shock is like, how multiple shocks for inappropriate detection can still occur. We talk about scd and how that’s not a bad way to go. I can’t speak for everybody.
We also deal with patients that have a conspiracy mindset like those voicing their concerns below. It’s pretty hard to save these folks from themselves, especially given the COVId experience. These patients are draining to deal with and are clinic bombs often. It’s like a debate for them, like they want to try and prove us wrong and that we are just in it for the money.
I agree that the NICM as a group suffers less from SCD. At this point we have the evidence we have and the literature base can be supplemented as new information is published. It’s exhausting to have one of us always pointing the finger behind the curtain and saying “gotcha” and stirring up the conspiracy crowd, especially as it comes to technology we currently use to great benefit to patients. Having a voice does not always make that voice correct, even if loudly projected.
I have been following the data on potential benefits of ICD in non ischemic cardiomyopathy for some time, Agree with a lot of your discussion. It gets even more frustrating when I see patients given a Lifevest at great discomfort and cost. However not all cardiomyopathy’s are the same..Consequently some assessment of additional risk eg evaluation of scar and scar burden may be advisable to further get between the weeds as to specific subsets who may benefit. Maybe a prospective trial??
Interesting review. In my center, I think DANISH led to offering more CRT-P to older patients with NICM and LBBB, but otherwise not a great deal of change. Any concerns about selection bias in a trial like DANISH or PROFID? Once a therapy becomes standard practice, it seems possible that less favorable ICD candidates will be enrolled in the trial and better candidates will get an ICD and not be enrolled. The very high rate of CRT use would suggest that DANISH was not a typical NICM population. In the US there is also the problem of physician liability which may lead to slower change in practice.
I'm afraid this is a case of provider laziness, coupled with a philosophy of "throw any and all possible treatments for potential harm at the problem". It seems that younger physicians are increasingly prone to overtreat and I suspect that fear of harming the patient is at play, even when the treatment carries as much potential for harm as the ICD does.
Also, the kind of longstanding relationship between physician and patient that Adam Cifu has is rapidly going by the wayside. I believe that an old fashioned discussion of the true risks and benefits would prevent overtreatment in most cases.
Another angle on this is from the perspective of the patient. Most people I know who are not in the health care field are woefully uneducated about how to actually discuss their health with a physician. There are great questions to ask when offered an ICD that many people just wouldn't think of. For instance: What are the risks for me from this device? What does a shock feel like? What complaints do you hear from patients that have this device? If I have a life-threatening arrhythmia and the device can't stop it what might happen to me? What is your understanding of how it is to die of ventricular arrhythmias? What is your understanding of how it is to die with the ICD in place (in other words, could it prolong my life but leave me living like a vegetable for some time?) Can we talk about how I want my last years to play out? Maybe I would rather die from sudden death.
Never understood why someone wanted an ICD in the first place... Sudden death is my holy grail!!! The likely alternative is dementia (the leading cause of death of women in my country)
Thank you for education on this subject. I 'think' I'm in the non-ischemic HF category but this has never been made clear to me. I've had an ICD for 3 years supplemented with 100mg Amiodarone. No shocks so far, but still experiencing AF., but with an EF of approx. 40& Please continue to publish and comment on relevant studies! Subscriber, Cliff (age 82)
I would expect patients with ischemic heart disease to have a higher incidence of arrhythmic death when compared to those with no ischemic component. I am a little surprised that the differences are so small. It is hard to make too much out of these studies where the differences between the groups bounce back and forth on both sides of the line of "statistical significance". Everyone should pay close attention to the metanalysis where four studies with null outcomes were combined into one that was magically significant. Shows why "meta" studies should all be disregarded. I suspect Dr. Mandrola may not be really perplexed that this particular study is ignored.
My own personal experience with an ICD was a living nightmare. My mother survived cardiac arrest at age 58 but had only had 75% of her heart muscle left and was living with an EF of less than 35% for several years. So they implanted an ICD in her at age 75, telling her that this would save her if she had another cardiac arrest. She did have another one at age 86. The ICD shocked her over 25 times as her heart kept stopping and that little device was determined to keep her heart going. An ambulance quickly took her to the hospital where they had to intubate her to keep her breathing. Her blood pressure plummeted so they gave her 3 different medications to prop it up. I had medical power of attorney but not knowing what her true condition was I wanted them to keep her going. After she had been days in the ICU and still unable to breathe on her own, the cardiologist told me that he knew she only had 10% of her heart muscle left and would never breathe on her own again. It would have been nice if he had shared that with everyone else. After that, I had the job of telling my mother and asking her permission to turn off all the interventions that were keeping her alive, including that ICD. So the ICD had restarted her heart, but to what purpose? The damage to her heart was done. I find it hard to believe that this result is not happening time and again with these devices. The cost? Over $80k, all paid by insurance. But this was several years ago, I shudder to think what it would be now. Again and again I am reminded of that saying from Jurassic Park, “your scientists were so preoccupied with whether or not they could, they didn't stop to think if they should.”
I'm sorry for the loss of your mother. Forgive my ignorant question. Are you saying that she would have been better off never having the ICD and that when she had her arrest at age 86, had she not had the ICD she might have died right away rather than being propped alive by it, but with a substandard quality of life at the end with the ICD?
I’ve incorporated Danish into my practice since the results came out. But I work in Canada, and we don’t practice in indentured servitude to the “coloured boxes” as Dr. JMM likes to refer to them. I seldomly refer NICM for primary prevention ICD, though I will think longer for younger pts due to that heterogeneous subgroup.
This simply joins a long line of examples of the dereliction of duty among guideline writers, who either issue unfathomable recommendations in the absence of evidence of benefit, or who refuse to downgrade recommendations in the evidence of absence of benefit (as seen here) (some may quibble about whether Danish proves an evidence of absence).
And I do invoke nefarious behaviour, which Dr. JMM often takes great pains to avoid doing. The results in this scenario are clear. When class 1 recommendations ignore results such as these, there can be no other explanation than a confluence of conflicts of interest which wag the dog among guideline authors.
Oh goody, more faked trials. When was the last time we had any trial for any drug or device that wasn't fudged, finagled or otherwise twisted 180 degrees to make the results seem like magic? I no longer believe any trials I have read about for any drug or device. In the overall scheme of life and health care, is there any ABSOLUTE proof that all this crap makes a difference to the average patient?
It's all probabilities and a flip of the coin. Some win and some lose even though they may be 99.99% the same in physical make-up and health. 99% of health care is entrenched in the marketing of FEAR. They say you're gonna die and we can save you (for a Heavenly price) and we trust them. For any medically related trial, how can you control or monitor all factors that might change the output of the trial? There are thousands of inputs and all might be variable.
My first ICD cost $28,000 (not including the surgeon’s fees, hospital charges, and associated medical expenses). That was in 2004. I get a new model every five years, plus I am monitored remotely at home and away. This is a big business — and only the most naive readers will ignore the monetary incentive of implanting unnecessary ICDs in patients with good insurance.
I always believe that medical decisions are to be made individually and with a frank conversation regarding risks and benefits on both sides. Ultimately, it is the patient’s choice and I am here to provide them with my knowledge to assist. This is why I don’t order Lifevests on frail patients who can’t physically endure the device or on patients who don’t possess adequate cognitive functioning. This is also why several patients have opted against ICD implant because sudden death seemed preferable than painful shocks.
But there are also patients who want an ICD no matter what. Particularly, my non-ischemic CMP patients — who are often younger and more active — want to be protected. I have made it a practice to consider Lifevests for these patients and extend them if their EF seems to improve after 3 months. Many times, their EFs are near normal after 9 months on GDMT.
The data is old comparative to our new world of HF medicines. But it is the only data we have. So, it comes down to discussions and shared critical thinking with your patients. I believe that most of my colleagues think similarly but some are afraid of legal repercussions. This is why “American doctors” sometimes are pushed into procedures (often by family) anyways. Support the patient-physician relationship first.
I am a Hospitalist and our Cardiologists routinely recommend Lifevests in patients admitted with new diagnosis non-ischemic cardiomyopathy. I have not found compelling evidence to support this practice but rationalized it as a temporizing maneuver while seeing if remodeling occurs on new CHF meds. I would be interested in others’ thoughts on this matter.
Yes
It's called dying in the heat of a battle. a patient dies on medical therapy three years from now and the family says if only they had that bypass.
The odds of winning the lotto is about one in 300 million
The risk of a heart catheterization causing a stroke one in 1000 let's make it 10,000
Everyone thinks they're gonna win the lotto but that stroke that's the other guy .
Everyone knows someone who did well after a procedure, but the doctors have memories are the ones who didn't well burned into our mind.
We know about doing no harm - the patient and more often the families think more is always better.
Yes, this is always the paradox with overdiagnosis/overtreatment. Patients assume that just by virtue of being treated, they have benefited. Human biology is not so simple though. They may benefit also by not being treated at all. People just can not wrap their heads around this concept. Educating the lay person about this is especially tough when medical and patient advocacy groups are not interested in recognizing this basic truth.
Sad commentary noted after this article. Most implanting EP docs like me explain in great detail about the ICD. We explain what a shock is like, how multiple shocks for inappropriate detection can still occur. We talk about scd and how that’s not a bad way to go. I can’t speak for everybody.
We also deal with patients that have a conspiracy mindset like those voicing their concerns below. It’s pretty hard to save these folks from themselves, especially given the COVId experience. These patients are draining to deal with and are clinic bombs often. It’s like a debate for them, like they want to try and prove us wrong and that we are just in it for the money.
I agree that the NICM as a group suffers less from SCD. At this point we have the evidence we have and the literature base can be supplemented as new information is published. It’s exhausting to have one of us always pointing the finger behind the curtain and saying “gotcha” and stirring up the conspiracy crowd, especially as it comes to technology we currently use to great benefit to patients. Having a voice does not always make that voice correct, even if loudly projected.
I have been following the data on potential benefits of ICD in non ischemic cardiomyopathy for some time, Agree with a lot of your discussion. It gets even more frustrating when I see patients given a Lifevest at great discomfort and cost. However not all cardiomyopathy’s are the same..Consequently some assessment of additional risk eg evaluation of scar and scar burden may be advisable to further get between the weeds as to specific subsets who may benefit. Maybe a prospective trial??
Interesting review. In my center, I think DANISH led to offering more CRT-P to older patients with NICM and LBBB, but otherwise not a great deal of change. Any concerns about selection bias in a trial like DANISH or PROFID? Once a therapy becomes standard practice, it seems possible that less favorable ICD candidates will be enrolled in the trial and better candidates will get an ICD and not be enrolled. The very high rate of CRT use would suggest that DANISH was not a typical NICM population. In the US there is also the problem of physician liability which may lead to slower change in practice.
I'm afraid this is a case of provider laziness, coupled with a philosophy of "throw any and all possible treatments for potential harm at the problem". It seems that younger physicians are increasingly prone to overtreat and I suspect that fear of harming the patient is at play, even when the treatment carries as much potential for harm as the ICD does.
Also, the kind of longstanding relationship between physician and patient that Adam Cifu has is rapidly going by the wayside. I believe that an old fashioned discussion of the true risks and benefits would prevent overtreatment in most cases.
Another angle on this is from the perspective of the patient. Most people I know who are not in the health care field are woefully uneducated about how to actually discuss their health with a physician. There are great questions to ask when offered an ICD that many people just wouldn't think of. For instance: What are the risks for me from this device? What does a shock feel like? What complaints do you hear from patients that have this device? If I have a life-threatening arrhythmia and the device can't stop it what might happen to me? What is your understanding of how it is to die of ventricular arrhythmias? What is your understanding of how it is to die with the ICD in place (in other words, could it prolong my life but leave me living like a vegetable for some time?) Can we talk about how I want my last years to play out? Maybe I would rather die from sudden death.
Never understood why someone wanted an ICD in the first place... Sudden death is my holy grail!!! The likely alternative is dementia (the leading cause of death of women in my country)
Thank you for education on this subject. I 'think' I'm in the non-ischemic HF category but this has never been made clear to me. I've had an ICD for 3 years supplemented with 100mg Amiodarone. No shocks so far, but still experiencing AF., but with an EF of approx. 40& Please continue to publish and comment on relevant studies! Subscriber, Cliff (age 82)
“Yet our experts still give an ICD the highest possible recommendation.”
Of course they do. Same old thing: follow the money. Not the science.
I would expect patients with ischemic heart disease to have a higher incidence of arrhythmic death when compared to those with no ischemic component. I am a little surprised that the differences are so small. It is hard to make too much out of these studies where the differences between the groups bounce back and forth on both sides of the line of "statistical significance". Everyone should pay close attention to the metanalysis where four studies with null outcomes were combined into one that was magically significant. Shows why "meta" studies should all be disregarded. I suspect Dr. Mandrola may not be really perplexed that this particular study is ignored.
My own personal experience with an ICD was a living nightmare. My mother survived cardiac arrest at age 58 but had only had 75% of her heart muscle left and was living with an EF of less than 35% for several years. So they implanted an ICD in her at age 75, telling her that this would save her if she had another cardiac arrest. She did have another one at age 86. The ICD shocked her over 25 times as her heart kept stopping and that little device was determined to keep her heart going. An ambulance quickly took her to the hospital where they had to intubate her to keep her breathing. Her blood pressure plummeted so they gave her 3 different medications to prop it up. I had medical power of attorney but not knowing what her true condition was I wanted them to keep her going. After she had been days in the ICU and still unable to breathe on her own, the cardiologist told me that he knew she only had 10% of her heart muscle left and would never breathe on her own again. It would have been nice if he had shared that with everyone else. After that, I had the job of telling my mother and asking her permission to turn off all the interventions that were keeping her alive, including that ICD. So the ICD had restarted her heart, but to what purpose? The damage to her heart was done. I find it hard to believe that this result is not happening time and again with these devices. The cost? Over $80k, all paid by insurance. But this was several years ago, I shudder to think what it would be now. Again and again I am reminded of that saying from Jurassic Park, “your scientists were so preoccupied with whether or not they could, they didn't stop to think if they should.”
I love this line from Jurassic Park, so appropriate for today.
I'm sorry for the loss of your mother. Forgive my ignorant question. Are you saying that she would have been better off never having the ICD and that when she had her arrest at age 86, had she not had the ICD she might have died right away rather than being propped alive by it, but with a substandard quality of life at the end with the ICD?
Unfortunately this kind of scenario is all too common these days.
I’ve incorporated Danish into my practice since the results came out. But I work in Canada, and we don’t practice in indentured servitude to the “coloured boxes” as Dr. JMM likes to refer to them. I seldomly refer NICM for primary prevention ICD, though I will think longer for younger pts due to that heterogeneous subgroup.
This simply joins a long line of examples of the dereliction of duty among guideline writers, who either issue unfathomable recommendations in the absence of evidence of benefit, or who refuse to downgrade recommendations in the evidence of absence of benefit (as seen here) (some may quibble about whether Danish proves an evidence of absence).
And I do invoke nefarious behaviour, which Dr. JMM often takes great pains to avoid doing. The results in this scenario are clear. When class 1 recommendations ignore results such as these, there can be no other explanation than a confluence of conflicts of interest which wag the dog among guideline authors.
Oh goody, more faked trials. When was the last time we had any trial for any drug or device that wasn't fudged, finagled or otherwise twisted 180 degrees to make the results seem like magic? I no longer believe any trials I have read about for any drug or device. In the overall scheme of life and health care, is there any ABSOLUTE proof that all this crap makes a difference to the average patient?
It's all probabilities and a flip of the coin. Some win and some lose even though they may be 99.99% the same in physical make-up and health. 99% of health care is entrenched in the marketing of FEAR. They say you're gonna die and we can save you (for a Heavenly price) and we trust them. For any medically related trial, how can you control or monitor all factors that might change the output of the trial? There are thousands of inputs and all might be variable.
You won’t say the obvious, doctor, so I will.
My first ICD cost $28,000 (not including the surgeon’s fees, hospital charges, and associated medical expenses). That was in 2004. I get a new model every five years, plus I am monitored remotely at home and away. This is a big business — and only the most naive readers will ignore the monetary incentive of implanting unnecessary ICDs in patients with good insurance.