Double Survival Rate Using Merlin Monitor

Check this research article that states that Patients using a Merlin Monitor and submittting regular reports have a survival rate that is double that of patients that are not remotely monitored:

http://investors.sjm.com/m/#/Press_Releases/74718c6d-a239-4804-84d9-2f00fa6fa3f9

My Merlin reassures me. Please read the comments below from PM members.

25 Comments

Moderation

by Artist - 2016-04-04 01:04:35

I think it is reasonable to take a more moderate approach in considering this article. To disregard the entire article is not reasonable or justified. I temper my reading of the article by my personal experience with the Merlin monitor that sits in my bedroom and automatically reads and submits a report EVERY NIGHT. My cardilogists gets a full report every 90 days and uses that information when I go to his office every 90 days for a follow up appointment. I recently was hospitalized for 5 days with absolutely frightening arrythmias. At the time I was put on a 30 day monitor due in part, from information my cardiologist obtained from my Merlin monitor which helped to reinforce other data he had. Wearing the 30 day monitor resulted in an emergency call to the ER and a phone call telling me to go to the ER immediately. That hospitalization very possibley saved my life. You will note that the article was published in 2014. It is possible that if you had more current information and personal experience your opinion would not be so jaded and skeptical. I think your negativity may be a disservice to PM members that could be helped by having a monitor checking them every night as mine does. As far as I am concerned, having the monitor helped my cardiologist make the right decisions and was instrumental in saving my life!

I agree with GoodDog

by IAN MC - 2016-04-04 04:04:58

This is an interesting piece of information, Artist ,which has been around for a couple of years now and thanks for posting it.

I don't believe that GoodDog's comments are in any way being a disservice to PM members, they are merely putting it into context.

I believe that it possible that there is a subset of implant patients who may benefit from continual monitoring , maybe those who have advanced heart failure or need frequent defibrillation.

I belong to the vast majority of PM patients who would have occasional bradycardia without the PM. I have an annual PM checkup and am very happy with that. I would definitely refuse to have Merlin or anything similar.

The problem is that some patients may benefit from it but, because there are megabucks to be made if every one of the 5 million implant patients around the world were remotely monitored , commercial interests distort the facts.

I am genuinely pleased that you believe that your monitor was instrumental in saving your life.

Ian

Comments by Artist

by IAN MC - 2016-04-04 05:04:00

Hello again : I can honestly say that if I had tachycardia for over 3 hrs with a HR of over 234 bpm I wouldn't need Merlin to diagnose it . A finger on my pulse would have quickly diagnosed that. I used to get tachycardia before I had an ablation and know how awful it feels. Your tachycardia kept reappearing so ,even without Merlin, you would surely have known what was happening to your heart rate and would have ended up seeing the cardiologist?

With or without Merlin you would have still ended up having a 30 day monitor or am I missing something ?

Glad there was a happy ending though

Ian

Comments by IAN

by Artist - 2016-04-04 05:04:23

Ian, I do not have advanced heart disease or need frequent defibrillation. I had a PM implanted to deal with my bradicardia so that I could take medication to control a whole list of arrythmias that I have. To infer that only people with advanced heart disease or in need of frequent defibrillation really benefit from monitoring, is not logical in my opinion. We all know that there are arrythmias that can be life threatening. The day that I got the prompt appointment with my cardiologist, the EKG they gave me in his office was normal. They then contacted the physician that had ordered my Merlin monitor and sure enough, the Merlin had just transmitted a report to them that documented a HR of over 234 BPM that had lasted more than three hours and then intermittently repeated for shorter durations over and over. Because my statements were backed up by the Merlin report the cardiologist had me wear a 30 day monitor and two days later that resulted in the phone call from the hospital ER instructing me to go there immediately. The ER staff had poorly concealed expressions of OMG when they did an EKG and started administering an IV. I know that there are alot of people just like me that might be making a decision regarding the use of a Merlin. Lets say that the research comments are exaggerations and only 10% of patients being monitored are helped by information that is transmitted to their physicians and of that only 2% experienced a situation where monitoring actually resulted in helping to save their life. Thats a huge number of people. Granted all businesses are motivated by profit. But that does not in and of itself nullify the technological advances in the treatment of cardiac disease. I may contact St. Jude to see if there is any more current research information. I would like to see them survey doctors and ask them if the Merlin monitor has been beneficial in assessing the care needs of their patients. I would also like to see a current survey mailed to the thousands of patients being monitored to get their input. Apparently Medicare sees the Monitor as a legitimate tool in the care and treatment of cardiac patients or they would not be paying for the device and monitoring reports.

Missing Something

by Artist - 2016-04-04 06:04:36

IAN, I'm one of those people that hates to make a fuss and hopes that if I just breathe deeply and take my medication the arrythmias will stop. I also feel that doctors tend to minimize complaints by women and that they also are more likely to take action when verbal comments are backed up by factual reports. The fact that my EKG was normal when I went to the doctor didn't help the situation. It was not until they checked the Merlin report that they seemed to take me that seriously. The fact that they then ordered the holter monitor and that later on resulted in the ER directing me to go there, helps a person like me that does not like to complain and does not like to be hospitalized. Dumb me for sure. When the first incident occurred, I went to bed hoping that I would wake up in the morning so I could call the doctor's nurse to get an appointment right away. Live and learn. Oh, by the way, I am awaiting notification regarding an appointment at UAB to have an ablation. They tell me my procedure involves puncturing the heart wall between the right and left atrium and will take 5 to 6 hours. I will then be hospitalized overnight since it takes time for the Heparin they administer to leave my system and the danger of bleeding will no longer be a concern.

You can't forget

by Good Dog - 2016-04-04 07:04:04

There was a time when I was very naive and thought that companies selling pacemakers and the associated technology were only in the business to help people. I thought that profits were secondary. Well, certainly they are in the business to help people. The company couldn't survive without doing that. However, it is important to remember that there is only one thing that can take precedence over helping people. That is; making money! They both go hand-in-hand, but it goes without saying that if they aren't making money and keeping the shareholders happy, the current management will cease to exist. They are always looking for ways to improve the bottom line. It seems that sometimes they sell products and services that are cost effective for the consumer and sometimes not. I believe that as IAN indicated, there is a subset of PM patients that can benefit from the Merlin technology to a much greater extent than others. For those folks, it may be of great benefit. I still think that for the others, it is just plain overkill. It sounds great, but not something I would have benefited from over the previous 30 years. Not even one little bit. Sometimes we don't think about who is paying for unnecessary medical treatment and equipment, but we should.
The entire reason for the study and the associated article is the need to justify the cost. If they can't justify it, then they can't continue to sell it to everyone. Well, they haven't justified it as yet. So we'll see........................
Again, just my 2 cents.................

Finger On Pulse

by Artist - 2016-04-04 08:04:15

IAN commented that he does not need a Merlin to tell him that his HR is 234, he can just put a finger on his wrist to check. The Merlin monitors a patient when they are asleep in bed at night and could be totally unaware of the arrythmias that may be occuring frequently and need medical attention. I also have sleep apnea and that combined with tachycardia could result in oxygen deprivation. My Omron heart monitor will not even register such a high heart rate and merely displays an error code. So the Merlin watches over me at night and gives me some reassurance. The Merlin sent a report to my doctor documenting a 3 hour HR of 234 BPM that I was unaware of because I was sound asleep. Perhaps the issue is not the impact of profit making, but the standards set for authorizing a prescription for a Merlin. Standards could specify that a patient has to have a history of certain arrythmias before insurance will pay the costs. I have no idea what those criteria might be or whether any patient with an installed PM or defibrillator is automatically given the option of having Merlin monitoring.

Interesting comments

by WillieG - 2016-04-04 10:04:17

I have enjoyed reading the pros and cons of home monitoring. When I left the hospital in June of 2014, I was given a box with Boston Scientific's Latitude Monitoring System. Nobody mentioned what it was for or any instructions, but we read the directions, hooked it up to the phone line, and I have done the remote interrogations every 3 months. I assumed It just came with the PM and didn't realize many of you don't have them nor want one. It would be interesting to know what they cost, as I have never thought about that either. It is convenient to not have to drive to the hospital so it saves about an hour and a half 4 times a year. Also, it would be nice to be notified if you would have a rare, life threatening arrhythmia. I don't have strong feeling either way...just enjoying learning from others thoughts.

I did participate in a marketing research study from last week's posting here on the PM Club. They were gathering info as to if we would prefer an app on our smart phones to the regular monitoring box at home. I asked if there would be a cost and was told no. So seems like a "winner idea" to me as you can take your phone on a trip and not have to reschedule a transmission if you were out of town for awhile. So this may be how we will do transmissions in the future! Phones rule!

Also, for those of you that don't like a monitor by your bedside table, I learned from calling Boston Scientific, that they work thru a wall as long as within 11 feet. So I have mine in another room and am not reminded by the green light that I have a PM. Just FYI!

Willie

by Tracey_E - 2016-04-04 11:04:57

Mine is wrapped in a towel, under the bed.

This "article" is a press release from SJM so I'd take any results from it with a grain of salt. If someone neutral were duplicating the same results, that would be different. Home monitors can be a good thing but for most of us, I think it's overkill and personally, I feel like it's an invasion.

Wanna hear the fun part? I called and told them about what happened to me over the weekend. I have an appointment for an in office interrogation tomorrow. So, where's the Merlin report?! No different than any other episode I've had in the last 20 years.

Hooey

by Good Dog - 2016-04-04 12:04:08

That is a bunch of Hooey............

There is one important fact that can't be overstated: "These associations require further investigation". I would think that geographical locations are a really important factor which weren't taken into account.
Also, it referenced "weekly" monitoring, not daily! What about monthly?
2.4 times the survival rate; could that be a coincidence? There is little or no information in that article (facts) that explain why the survival rate was 2.4 times than those without remote monitoring. All they found was an association! How many died? Maybe 6 people. Is it possible that some would have died even with remote monitoring?
It only takes a little common sense to determine this article means little or nothing relative to the real world.
I'll bet that St. Jude wined and dined the doctor that published it. Do you think it might be a little biased?
Do ya think????

Tracey, I went & read about...

by donr - 2016-04-05 01:04:29

...Merlins & monitoring last night. I started by asking Google "How does a Merlin work?" & I got absolutely NOTHING of substance that would have caused you to unwrap yours from the towel & plug it in!

After at least 45 min I finally found something that described the interaction between the device, the Merlin, the SJM data collection agency & your physician. Which generates a question - "If this monitoring system is so great, why did your Cardio NOT know that your device was NOT transmitting any data?????"

I think it's the human-machine interface that failed again.

As I understand what I found last night, the Merlin can make no changes to what the device does - it can only wake it up & download data, even to the point where it acts like an "Under the bed Holter," & monitors you all night long.

Interestingly, on Inga's Blog her opening paragraph discussed a German host who wondered exactly what the monitoring was supposed to do (or words to that effect), leading me to believe that the human-machine interface is badly flawed at this point. It is obvious to me that you received zero discussion that convinced you to plug the infernal device in & use it. That appears to be a relatively common occurrence.

Recall that I mentioned follow up by the organization that monitors my INR self -testing? They faithfully call me when I don't test myself when they want me to. Well, Emory Clinic took over the INR monitoring from my Cardio's office & centralized it in an INR clinic. Well, they called me three weeks ago after I had run a test & we discussed when I'd test again. I keep forgetting to run the test & i am now well over a week late & no nagging from them! Another human breakdown.

The cardiac community is definitely struggling w/ this real time monitoring capability it has available.

Don

Donr My Interest In This

by Artist - 2016-04-05 01:04:35

Donr, you imply that I am preoccupied with the nuances of pacing. That is not the case at all. My comments and involvement here are generated by a sincere wish to share my experience with the Merlin because in my experience it is a helpful device. The only reason I am in volved in the "nuances" of pacing is my interest in joining a discussion that evaluates the usefulness of a Merlin. My interest was kicked off when I read Tracey's prior post about disliking her Merlin. Many of the replies to that post also expressed alot of negative remarks about the Merlin that I thought might steer people away from using what I think is a very useful device. I get on with my life and do not dwell on my arrythmias until I have a health crisis. There still seems to be alot of confusion regarding the specifics of how the Merlin works. My belief is that in addition to performing a brief check every night, it can sense severe problems and generate an immediate report based on that.
Acting like an under the bed Holter monitor every night is undeniably a very useful tool. I will read Inga's blog. Thanks for the info.

Hmmm

by Cabg Patch - 2016-04-05 04:04:03

I think everybody should go back and read all of Artists posts regarding Merlin. When I did, I certainly came away with a totally different interpretation of how beneficial that bedside monitor has really been than she does. Judge for yourselves then decide for yourselves how beneficial a home monitor might be for you.

Folks, don't just accept something by one opinion, study the facts and decide for yourselves. Here's the bottom line in my mind. Nobody has ever, ever survived life and you ain't gonna be the first. Stop focusing on every little nuance of your health and enjoy your time, I guarantee no matter what, it'll be too short, so don't waste it. LIVE

This is NOT...

by donr - 2016-04-05 04:04:12

...hooey! Well, anyway the STUDY the PRESS RELEASE refers to is not. The PRESS RELEASE is US Prime Hooey!

Our resident expert on this subject is absent so far. Golden_Snitch (AKA Inga, of Berlin, Germany), has not yet chimed in. She has reported on the actual AHR session where the report was given in one of her Blogs. MOF, she has written TWO Blogs on it & promised a third, but not yet delivered on her promise.

If you want to read what she wrote giving the details of the actual study, go to: https://arrhythmianewsforpatients.wordpress.com/2015/07/

That should bring up her July 2015 BLOG. The various articles are in reverse sequence down the page. Scroll down & you will stumble on "Part 2" first. Since you stumbled & did a cyber face plant, get up, brush yourself off & scroll down to "Part 1."

As I read her promise in "Part 2," the promised "Part 3" would have data on what we are enjoying a cyber slug-fest on right NOW.

As a sidebar. Today after lunch I had a discussion about our discussion & the basic topic - "Remote Monitoring," w/ my MD Daughter. As usual, the discussion got louder & louder as we tried to talk over one another. She falls on the side of "Artist," while I fell w/ Ian, GoodDog & myself. When we finally started letting one another express an idea to completion, we concluded as follows:

1) Not every patient is emotionally, technically & interested in all the nuances of pacing & what is happening to them & their interaction w/ the PM/ICD. (Artist, I think this partially describes you)

2) Much of the data collected in daily/weekly/monthly remote monitoring is asymptomatic precursors of a problem that may rear its ugly head in the future. (Ian, I think this would apply to you w/ your relatively benign Brady)

3) IF the event is a serious problem, the cardio knows about it & can intervene more timely. potentially saving a host's life. (Artist, You again)

4) My position on the host being notified immediately would probably generate a blizzard of calls to the cardio community that were a result of a contemporaneous event that was a "Not to worry" event. AAAARG! right in the nether regions below my belt.)

5) My position on the loop not being closed was valid & reflects the problems w/ human-machine interfaces. (Mine, again)

6) Remote monitoring poses several ethical problems as it evolves. It is not NECESSARY for everyone. The medical community has to show some decent judgment on who gets monitored remotely & how frequently. It cannot get itself bogged down in its own bells & whistles. Taking this discussion to the extreme, they would have every baby implanted w. a device so they could all be monitored daily for life! (I think we all agree on this point)

7) As somethjng that is supposed to promote better, cheaper, more efficient care, if applied inappropriately could fail because it grows into an unweildly, empire-building, bureaucratic Tyrannosaurus Rex that gobbles down resources w/o control. (This thought is mine)

8) I think I was a victim of that issue when the TM room failed to find evidence of an arrhythmia in my records - we choked on an unanalyzed gargantuan pile of data. (my thought again)

Well, it's late - time to go stack some Z's.

Donr.


Specific Information

by Artist - 2016-04-05 04:04:48

I hope I am not doing the wrong thing in copying and pasting some of the information from Inga's blog. I had alittle trouble navigating to part one of her blog so thought this might help.
"What kind of data is being transmitted? Data transmitted includes, for instance, battery status, lead impedance (indicates if the leads are functioning well or if there is a fracture etc.), and pacing thresholds (if very high, the device has to stimulate with a higher voltage which in turn drains the battery more quickly). Another important set of data is related to the patient's rhythm: Did the device detect any arrhythmias and how did it treat them in case the patient has an ICD? How many extra beats did the patient have? What does the heart rate curve show? Important to note: Remote monitoring allows for transmission of data only, the clinician cannot make changes to device settings. If the data transmitted indicate that a change of settings or any other treatment is required, the patient is called and scheduled for an in-office visit.

Now that I've covered the basics of remote monitoring, let's take a look at the benefits clinical research has revealed so far. I will do this in two parts as there are several importants aspects to attend to. The first part deal with the greatest benefit of home monitoring, namely the reduction of mortality in heart patients:

In 2013 researchers from Germany presented first results from the IN-TIME trial.This trial looked analyized the benefits of remote monitoring in more than 600 heart failure patients who had either received an ICD or a CRT-D (bi-ventricular pacemaker combined with ICD) implant. Home monitoring reduced all-cause mortality in these patients by over 50 percent. It also turned out that the patients™ condition was less likely to worsen when being home monitored. Only 18.9 % of patients using Home Monitoring experienced the worsening of heart failure, compared to 27.2 % in the control group. Patients with a known history of atrial fibrillation especially benefited from home monitoring because worsening of this arrhythmia could be detected and addressed earlier than in standard care. Prof. Hindricks, coordinating investigator of IN-TIME, said: œImprovements in patients health are likely due to the early detection of the onset or progression of ventricular and atrial tachyarrhythmias and the early recognition of therapy settings that may need adjusting. (Source) He also explained:

This is the link for more information:
https://arrhythmianewsforpatients.wordpress.com/category/home-monitoring/

The article says that home monitoring is especially beneficial for patients with AFIB. That's me, and I certainly have benefitted from home monitoring. I don't understand some of the negativity. The Merlin is not a spying device invading someone's privacy. It cannot change settings or cause arrythmias etc. It does not interfere with the PM's function when it reads the device. I know I am being repetitive but my Merlin is like a guardian angel bringing me some comfort as it watches over me when I sleep.

Once again

by Good Dog - 2016-04-05 07:04:02

I am so glad you like it...............the Merlin, I mean. It gives you peace of mind. That is a good thing! It is certainly helpful for you and lots of other folks.

Understand, my problem is not with the Merlin itself.

I would want no part of it. Medtronic sold me a device that allows me to download and transmit my PM data on a scheduled (usually a 3 month) basis. However, I can do it anytime whenever the need arises. It records Afib events and pretty much all of the same data as the Merlin. The biggest difference is that I put it in the drawer when I want and I decide when to plug it in and interrogate my PM.

The point here is.......are they asking patients if they want the Merlin? Are they determining and providing it only to those in need of it? Or just selling it to everyone?
If they aren't giving folks a choice, that is where I have an issue.
O.K. I'll give it a rest now!

Choice

by WillieG - 2016-04-05 07:04:28

Thanks you, Artist, for taking your time to let us know all that the Merlin does. Probably helpful to those who do have AFib and other problems. But Good Dog does have a point that patients aren't given a choice. That was me almost 2 years ago. I was hoping someone might post what these devices cost. With only exercise induced AV block, I am probably at a low risk of any life threatening ahrrymias developing. I assumed it was more for convenience and saving time for the interrogations. Thanks for starting a very interesting and informative discussion.

Don

by IAN MC - 2016-04-05 08:04:34

I enjoyed your suggestion that every baby should have an implanted monitor. This could easily happen one day because health-care industries are increasingly realising that the biggest market of all is healthy people.

Instead of trying to squeeze more and more profit out of sick people why not go for the biggest customer-base of all i.e. people who don't need any treatments at all.

This is already happening with statin prescribing, food supplements, and antihypertensive medicines. Remote monitoring of EVERYONE with an implant is yet a further example of this trend.

Cheers, Don, and keep taking the tablets . Just one other thing, how do I buy shares in remote monitoring companies ?

Ian

Depends on condition

by SaraTB - 2016-04-05 11:04:27

This has been interesting. I have complete heart block, no other issues, on no medication. I was originally doing quarterly phone checks, until I wanted to cancel my landline. Talked to my EP about it, and he agreed that my condition didn't warrant the phone checks if I didn't want them. Just a 6 monthly office visit.

Now we've relocated to another part of the country, and my new EP (who is involved in the research with the Micra, incidentally) is also entirely happy for me not to do the phone checks. I used to have annual ultrasounds to check my valves, after years of right ventricular pacing, but EP even says he doesn't need those: we'll know if it's deteriorating because I'll feel it. Even has me on only annual office visits, until the battery is closer to EOL.

He pointed out that the next PM will have monitoring, but if he suggests I have one, I'll be in a perfect place to challenge it.

So, it's always worth pushing back with your doctor if you don't want it: they may just be working on the assumption that you want the reassurance. Many of us don't. Some do. And if your condition warrants it, the EP can discuss that.

Ian, good...

by donr - 2016-04-05 12:04:08

...afternoon. Thanks for the comment.

Have you been to Inga's Blog yet? It took me a while to find it last night, even after reading it last summer & making a comment on her Part 1 rumination. MOF, I actually stumbled on it by accident, doing a cyber face plant in it, not even realizing that it was her work!

I really wish she would chime in here - her ideas would add a bit of insight none of us have - by virtue of her "new" job in the cardiac community. I firmly believe that she would support your concept of who should be monitored & why.

I had an interesting cardiac epiphany two nights ago. It sticks me firmly on the fence between you & Artist with respect to sensing tachy events. I was sitting here wide awake at my square-eyed Cyclops, when I suddenly sensed a different HR! It was about 16 beats at a rate somewhere between 180 & 240 BPM. I felt them & started counting them "1,2,3,4,1,2,3,4..." for 4 iterations.

I felt perfectly normal other than the 16 beats that caught my attention because they were different. Now that supports your contention that if you had a tachy event, you could feel it w/ a finger at your throat & get yourself to the ER if necessary. Upon further rumination I wondered if it would have awakened my were I deeply asleep? Supporting Artist & her support for monitoring.

Like Gooddog says, "The jury is still out."

Don




Out of Range

by Artist - 2016-04-05 12:04:28

Tracey I read your previous post about feeling like you were going to pass out and breaking out in a cold sweat. You also say in the same message that you were out of the range of your Merlin. Unless I misunderstood your message, that is why the Merlin did not report the incident in real time. It might be shown when the full 90 day report is generated and backtracks to show a full 90 day history. Who really knows. Inspite of reading all available instructions and going to the St. Jude web site, I still feel as though more specific information is needed that more fully explains exactly how the monitor functions.

Artist

by Tracey_E - 2016-04-05 12:04:35

I didn't say I thought the Merlin caused it. I wondered if the daily self check- which Merlin sends in- caused it. My question was if the daily self checks were initiated by the device or the Merlin box (answer is the device so it doesn't matter that I wasn't near the box, the device still would have run the daily check). I don't know if Merlin didn't show anything or my doctor's office hasn't checked the Merlin reports, but they asked me to come in today to interrogate. Isn't that why I have the Merlin? Seems kinda redundant.

Bottom line

by Good Dog - 2016-04-05 12:04:51

I think that the bottom line remains..............................

The jury is still out...

In Conclusion

by Artist - 2016-04-06 05:04:28

1. Home monitoring helps improve the care and possibly lowers the mortality rate for some, but not all, people that have implanted devices.

2. Because the manufacturers of these devices are motivated by profit margins, there is speculation that the devices are being over prescribed and are forced on people that may not actually benefit from home monitoring.

3. There is widespread confusion regarding the actual functions of a home monitor and specifically how it impacts patient care and interfaces with the implantable device.

As a result of this discussion I will be asking my EP, cardiologist and the MD in charge of the Specialty Clinic what guidelines they use in deciding to prescribe a home monitor. I really doubt that, in the case of a person that suffered from bradycardia, and had a pacemaker implanted which controlls that, would then be required to have a home monitoring device. If the system is being abused and the profit margin has corrupted the medical system, the degree of corruption could vary from location to location and doctor to doctor. So, this brings up the question regarding what guidelines /requirements must be satisfied before Medicare or other health care insurance providers will pick up the costs. Perhaps those guidelines need to be modified. I hope that Inga will be made aware of this discussion and provide more information in part 3 of her blog.

I was told Merlin was free

by DodgerFan - 2016-04-09 07:04:37

At my 2 week post op pacemaker clinic an engineer from St. Jude offered it and said it was free. He gave me a cellular adapter (also free). The device scans each night and sends to the clinic weekly. If I go on vacation it catches up when I get home. It doesn't make noise. I don't even think about it.

I have not been billed. Neither has the insurance.

He did say that the more "tenured" patients would often turn it down for fear they were being spied on.

I don't see what the big deal is.

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