Implantable cardiac defibrillators (ICDs)can save lives if a person goes into a shockable rhythm (VT or VF), which would otherwise progress to impaired perfusion and death (termed sudden cardiac death - SCD), but instead, the ICD shocks them back to sinus rhythm.
I was heavily pressured to get an ICD three months after heart failure diagnosis. I refused. Doctors do not thoroughly explain the very real risks of ICD's and scare patients about the possibility of sudden death. Two years later, my ejection fraction was in the 40's. 10 years later my condition is stable. Implantation of an ICD is a serious medical intervention that may help some people. Doctors need to be sure that an ICD will be of benefit to the patient and thoroughly explain the risks so that the patient can make an informed decision.
It is hard to not agree with the authors that the definitive way to determine who best benefits from ICD placement (especially to find a new group that might benefit) is to run an RCT.
Having said that, is not clear to me why such an RCT would necessarily need to have all cause mortality as the primary endpoint. It seems to me that using that endpoint would require more participants than say using MACE as the primary endpoint, making the trial more difficult, more costly, possibly taking longer, etc. There is little reason to think that use of an ICD will to any degree significantly affect other systems, therefore would MACE not be the preferred primary endpoint? What am I not understanding here?
My point in this comment is touched on in the authors' Item #4, where they write "The people you identify as needing an ICD cannot have a high competing cause of death." (I am not a cardiologist so I might be incorrect with my question.)
Thanks for the interesting question. The standard endpoint for ICD trials has always been total mortality. There is little doubt that ICDs would reduce arrhythmia mortality in most situations. Total mortality better captures cumulative positive and negative effects, as well as competing risk from non-arrhythmic causes.
The idea is to live longer. It’s not about whether you avoided one of a hundred ways of dying but died anyway. MACE is a bad end point. Does a defibrillator stop strokes? Is stopping a non fatal MI going to prolong life?
Thanks for this. The proof will be in the pudding, and the pudding can only be an adequately powered RCT. We shall see.
I was heavily pressured to get an ICD three months after heart failure diagnosis. I refused. Doctors do not thoroughly explain the very real risks of ICD's and scare patients about the possibility of sudden death. Two years later, my ejection fraction was in the 40's. 10 years later my condition is stable. Implantation of an ICD is a serious medical intervention that may help some people. Doctors need to be sure that an ICD will be of benefit to the patient and thoroughly explain the risks so that the patient can make an informed decision.
It is hard to not agree with the authors that the definitive way to determine who best benefits from ICD placement (especially to find a new group that might benefit) is to run an RCT.
Having said that, is not clear to me why such an RCT would necessarily need to have all cause mortality as the primary endpoint. It seems to me that using that endpoint would require more participants than say using MACE as the primary endpoint, making the trial more difficult, more costly, possibly taking longer, etc. There is little reason to think that use of an ICD will to any degree significantly affect other systems, therefore would MACE not be the preferred primary endpoint? What am I not understanding here?
My point in this comment is touched on in the authors' Item #4, where they write "The people you identify as needing an ICD cannot have a high competing cause of death." (I am not a cardiologist so I might be incorrect with my question.)
Thanks for the interesting question. The standard endpoint for ICD trials has always been total mortality. There is little doubt that ICDs would reduce arrhythmia mortality in most situations. Total mortality better captures cumulative positive and negative effects, as well as competing risk from non-arrhythmic causes.
The idea is to live longer. It’s not about whether you avoided one of a hundred ways of dying but died anyway. MACE is a bad end point. Does a defibrillator stop strokes? Is stopping a non fatal MI going to prolong life?
"Amazing". One of the top 5 most overused words in the English language.
Actually, that is literally true.