Biotronik CLS info pls!

Hi. I am about to have a PM implanted, this CLS does not seem to be frequently used, would appreciate info on this device, advantages, problems, reasons for choice of same, any one with this care to comment? :) Thanks!


7 Comments

CLS

by golden_snitch - 2014-03-10 01:03:40

Hi BPM!

Sorry, but I'm just going to copy and paste (and update) what I already wrote in some other comments when the question what's the best rate response sensor came up. Since you are specifically asking about the CLS, I guess that you have already made sure that you need a rate response sensor. But just to make sure: If you have heart block only, you will most likely not need the rate response sensor.

I have had accelerometer only, accelerometer + minute ventilation, and now have closed-loop stimulation. I'd always prefer either the accelerometer + minute ventilation or the CLS. Unfortunately, haven't been able to put my CLS sensor to the test, yet, because of some setbacks in my recovery process. The accelerometer + minute ventilation, however, worked really well as compared to accelerometer alone. It's just that I can no longer have the minute ventilation sensor, because my epicardial pacer leads don't work with it. This is why I now chose the CLS sensor. An accelerometer alone, like in all the Medtronic pacers, sucks. It has lots of limitations. Would never suggest to anyone, who really needs the rate response, to go for an accelerometer only. Now, let's talk about rate response sensors:

1) Among all the accelerometers on the market, I have only heard the best about the Medtronic accelerometer. Medtronic has about 9 rate response parameters that can be optimized either automatically or manually. So, there is a lot of room for optimization. That should be done using a treadmill, probably also a holter monitor, and Medtronic pacers also have an exercise test that the cardio can activate. When activated this test runs for 15 minutes so that you can make a quick walk, run up and down some stairs etc., and then afterwards the pacer shows what the RR has done, what your own rhythm has done, and then the cardio can optimize settings accordingly. However, as all accelerometers, the Medtronic one has its limitations because it needs upper body movement to sense activity. Consequently, riding your bike will be difficult, but walking, running, swimming should be fine.

2) A dual-sensor rate response (also called: blended sensor) with accelerometer and minute ventilation sensor might also work for you. From my personal experience I can say that I have had accelerometer plus minute ventilation for many years - first in my old Medtronic Kappa 401, then in my Sorin Reply -, and was doing well with this combination. It did need quite a lot of fine tuning, too, but then worked well. All the heart rhythm specialists I know say it's the best rate response sensor with the most physiologic response.

3) I now have a Biotronik Evia with CLS. My first days with CLS were rough. I was going into tachycardia and actually up to my max programmed rate of 140bpm basically whenever I moved. Fortunately, the automatic optimization has done a pretty good job in the first two weeks, so now I'm getting much more appropriate heart rates. I no longer go for walks with 140bpm, but am down to somewhere between 90-120. Also, I can move around my apartment without going into tachy all the time. However, to get this optimization, I had to move. About three weeks ago - surgery was Jan. 14th -, I had a couple of days when the pacemaker site was so sore again that I could hardly move at all. What happened? The rate response became more sensitive again, and as soon as I got up and walked to the kitchen or tried to take a little walk in the park, my heart rate was back at or close to the upper max. sensor rate. If you check the manual, you'll find out that the mechanism is the following: If the CLS sensor detects that during a 24h period beginning at midnight you spend 1 hour or more at 90% of the upper max sensor rate (called "activity rate"), the sensor gain will be reduced 10% --> the rate response will respond slower, less aggressive (lower rates). On the other hand, the sensor gain will be increased by 10%, if you do not reach or exceed the activity rate for 30 minutes every day over 7 consecutive days. This is exactly what happened in my case.

I have read, I believe, all studies that have been published about CLS. And from those studies I understand that CLS does indeed respond to mental stress, but when it comes to physical exercise I have not found any data that would support superiority of CLS to dual-sensor RR or a good accelerometer. The studies have often concentrated on CLS response to mental stress, because this is what's unique in rate response sensor. CLS should however be better for physical exercise, too, since it does not need upper body movement to sense activity, and therefore allows for a greater variety of sports. But I really have no data on this and no personal experience just now. I'm planning to start going to work by bike this week, and will let you know if CLS likes cycling :-)

Best wishes

Inga

Do yourself a favor...

by donr - 2014-03-10 10:03:14

...send a Pvt Msg to Golden_Snitch about this. She is THE expert. I checked out your comment in Paul's thread. You've already been exposed to her (Inga is her real name).

There is no one more helpful than she in this instance.

She will probably be by later today, but guarantee it by sending the Pvt Msg.

One piece of advice - there are some things you cannot change - having an electrical problem w/ the heart will not go away. The problems can be corrected by various technologies w/i PM's, but you have to relax & work w/ them. Work yourself into a lather over it & you only compound the problems. The PM's have so many parameters that can be varied that it sometimes takes a while to find the optimum batch of settings for YOU. You must be patient, but at the same time a strong advocate for your situation.

Don

CLS

by BPM - 2014-03-10 10:03:42

Hello, Thanks so much for your advice, Ill try n get my mind about this and put some more sensible questions together, I really appreciate this,

Kind Regards

BPM

Good research Golden_snitch but might be a tad incorrect

by simmsl - 2014-03-11 01:03:36

Golden_snitch I loved your response! Your seem to know a lot so it made me question what I know which is a good thing.

However CLS doesn't use activity rate or sensor gain. This is accelerometer language. Biotronik devices have CLS and accelerometer features. Your information about 24 hr, 90%, increasing by 10%, etc is all correct but relates to the accelerometer part and not the CLS feature. I will however do some more research into CLS and how it works because your have spurred me on to understand more.

So is CLS worth it? Short answer is yes. Accelerometers are good and Golden_Snitch states the down side very well. All companies have auto adjustment features which again Golden_Snitch, apart from calling it CLS, nicely commented on and very nicely stated the one limitation.

The Blended sensors option is better than just the accelerometer. I do like this option. CLS though is my favourite by far.

I will not bore you with how it works (but will definitely give you the information if you like?) but it is the best.

Also Biotronik, which is what you have, has other features which are better than the other companies.
1. Best device for helping to prevent atrial fibrillation onset (due to CLS)
2. Best device to help people with neuorcardiogenic syncope (due to CLS)
3. Diagnostic data available just takes me to heaven! It is not over the top data either like some other companies. Biotonik have thought this out well and it really helps when trying to nut out some things.

So all companies provide good devices but I rank Biotronik with its CLS and IRSPLus algorithms as being the best of the best.

CLS

by golden_snitch - 2014-03-11 04:03:44

Hi!

Thanks for the correction. I looked into the manual again, and you are absolutely right.

However, CLS does seem to work about the same way. I mean, I tested it personally (not only in theory), and the response definitely changed every 24 hours when I was very active, and after a couple of days when I wasn't active at all. I used a Polar heart rate monitor during walks. And also, the Biotronik tech said that with CLS my cardio can adjust several settings, and if that doesn't suffice, he'll go into the next level (which only reps/techs can log in to), and there are some more programmable settings. The marketing guy said the same about CLS. So, now I'm wondering what is in fact programmable with CLS, if not those options that the manual lists?

Thanks for your input!

Inga

CLS options

by golden_snitch - 2014-03-11 04:03:58

I found this:

"In addition to the conventional ‘basic rate’ and ‘upper pacing rate’ of the pacemaker, several programmable CLS-related parameters can influence the stimulation rate. The major among these parameters, ‘CLS response’ can be set to a very low, low, medium, high, or very high level, to enhance or diminish stimulation rate responsiveness to the impedance signal. The default level is medium. Next, the ‘resting rate control’ parameter can prevent overshooting of the stimulation rate in resting patients whose postural changes exert an influence on heart contractility by rapid preload reduction.3,16 The programmable values are +10, +20 (default), +30, +40, etc. beats/min (bpm). The selected ‘resting rate control’ value (e.g. +20 bpm) will be superimposed to the programmed basic rate (e.g. 60 bpm) to determine the rate (in this case, 80 bpm) up to which the stimulation rate is calculated normally. Above this rate boundary, the CLS-driven rate increase will be either largely suppressed if the background accelerometer sensor detects no body movement, or not suppressed at all if the accelerometer detects movement." http://europace.oxfordjournals.org/content/early/2012/03/28/europace.eus062.full

I know that my resting rate control has been adjusted, CLS response is medium. Vp is on. Anything else?
Why are these things not explained in the manual???

Inga

CLS System

by gaman - 2015-04-27 02:04:22

I had a Biotronik Entovis DR-T dual chamber pm installed 3 weeks ago this coming Friday. It has the CLS algorithm. I've yet to see my heart rate increase with exercise. Can tell from monitoring pulse and also in leg fatigue (I'm sure there's not enough blood being pumped during exercise). Resting heart rate has been fine. Does it take this type of pacemaker a certain period to start increasing heart rate during exercise? Right now they have it set 60/130 (low/high).

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