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Hey all,
Recently came across one of these devices (https://www.fda.gov/media/123082/download) and have a few questions for you guys/gals;
So the gist (summary by me based on my relatively brief reading) is I guess this is a new device aimed at some form of myocardial stimulation with the aim of improved contractility and reduction of symptoms. It does this via electrical impulses that are stronger than typical pacing delivered to the myocardium during the absolute refractory period. So knowing that it’s clearly a sensing device though not a pacing one.
Questions;
Should I expect to start seeing these in many HF patients or only those with HFrEF?
Should all patients have a concomitant ICD for ATP/shock capabilities either because of their HF or because of the possible impulse derived ventricular arrhythmia?
If in reduced EF patients should I expect only in the population that gets a CRT device? This seems a bit odd as per my reading it’s only delivering impulses to the RV and not to both ventricles but I’m not sure why it couldn’t send impulses to both ventricles. Some sources indicate it’s only approved for those who CAN’T get a CRT device….
Lastly, how should we treat these in regards to EMI? My assumption is that as it’s not a pacing device and it’s therapy is for longterm symptom improvement I really shouldn’t need to worry about it. It’s unclear if it’s magnet responsive but the fda document does indicate it will sense EMI and revert to a “Down” mode of OOO. But in that setting it also sounds like it’ll need to be reset/reprogrammed.
For example, let’s say I have a pt with an AICD and dual chamber pacemaker in the setting of reduced EF and this new optimizer device. My typical process is magnet or programmed d/c of ATP/Defib therapy +/- asynchronous programming if significant degree of pacer dependancy. But is that all I need? Or should I do anything to the optimizer?
Thanks for the discussion.
Recently came across one of these devices (https://www.fda.gov/media/123082/download) and have a few questions for you guys/gals;
So the gist (summary by me based on my relatively brief reading) is I guess this is a new device aimed at some form of myocardial stimulation with the aim of improved contractility and reduction of symptoms. It does this via electrical impulses that are stronger than typical pacing delivered to the myocardium during the absolute refractory period. So knowing that it’s clearly a sensing device though not a pacing one.
Questions;
Should I expect to start seeing these in many HF patients or only those with HFrEF?
Should all patients have a concomitant ICD for ATP/shock capabilities either because of their HF or because of the possible impulse derived ventricular arrhythmia?
If in reduced EF patients should I expect only in the population that gets a CRT device? This seems a bit odd as per my reading it’s only delivering impulses to the RV and not to both ventricles but I’m not sure why it couldn’t send impulses to both ventricles. Some sources indicate it’s only approved for those who CAN’T get a CRT device….
Lastly, how should we treat these in regards to EMI? My assumption is that as it’s not a pacing device and it’s therapy is for longterm symptom improvement I really shouldn’t need to worry about it. It’s unclear if it’s magnet responsive but the fda document does indicate it will sense EMI and revert to a “Down” mode of OOO. But in that setting it also sounds like it’ll need to be reset/reprogrammed.
For example, let’s say I have a pt with an AICD and dual chamber pacemaker in the setting of reduced EF and this new optimizer device. My typical process is magnet or programmed d/c of ATP/Defib therapy +/- asynchronous programming if significant degree of pacer dependancy. But is that all I need? Or should I do anything to the optimizer?
Thanks for the discussion.