Optimizer Smart System question from an Anesthesiologist

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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.

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Hey,

Not an expert or anything but the device seems like it's a modulation therapy (not a resync). Probably would see it systolic failures. I briefly read the description, but does not sound like a device that would be appropriate in diastolic failure. OH. Typed all that stuff up and found indications section - "The OPTIMIZER Smart system is indicated for use in patients who are older than 18 years of age with symptomatic heart failure due to systolic left ventricular dysfunction despite appropriate medical therapy".

Based on the MRI section, pretty much everything you said regarding DOWN/OOO. Programming the OPTIMIZER into OOO and making sure (may require a call to the center for rep to come out and take care of it) that device returns to its programmed mode.

"OPTIMIZER Smart IPG should not be exposed to magnetic resonance devices. If magnetic resonance methods have to be used, one can lower the risk of adverse events by programming the OPTIMIZER Smart IPG into Standby (OOO) mode. The patient’s peripheral pulse should be monitored while the magnetic resonance method is in progress. Immediately thereafter, the OPTIMIZER Smart IPG should be checked for proper function. If the device is found to have reverted to its “DOWN” mode, it needs to be reset."

Not sure if that answers anything.
 
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