MILD procedure

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NJPAIN

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Who is doing MILD and seeing impressive results?
If you are getting impressive results what do you think that the “keys” to success are?

I have done 6 or 7. Half with a steroid injection at the end and half without. The 3 receiving steroids have a typical steroid type response with return of pain in 4-6 weeks The 3 without steroids had no improvement at all. The one patient who had MILD with steroid and 4 weeks of relief that was then followed with Vertiflex is the only one who has long lasting relief.

I know people who are doing dozens of these every month. Are they getting good results or just ESI results with increased reimbursement? Is treating ALL levels with stenosis during a single session necessary for success?

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Great post on Linked-In with 50+ comments. It can be useful for patients who cannot have "real" treatment.
MIS decompression is always better. And not much more invasive.
I would recommend against this for any of my family or my patients.
 
Been doing the procedure for ~2 years. Performed 40 thus far. 33 have done great, 4 had improvement but didn't think it was worth it, and 3 had no improvement.

Very selective with my patients:
- 1-2 level stenosis
- No huge disc bulge/herniation (or stenosis primary due to bulge)
- Patient with primary neuroclaudication complaints. I tell people it does great to increase walking/standing endurance but may not do much for constant pain or radic pain.

I'm sure my results would be worse if I offered the procedure more.
 
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Rep got after me because I haven’t done many. Said other docs schedule MILD once first or second ESI has failed.

I politely told rep they are the worst
 
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Rep got after me because I haven’t done many. Said other docs schedule MILD once first or second ESI has failed.

I politely told rep they are the worst
again, another reason why majority of procedural reps need to go
 
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n = 2

Both had zero actual benefit, and both received surgery within 6-8 weeks after the procedure.

As with every other procedure not including traditional pain procedures, I'm dubious of any of you that boast great results.
 
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n = 2

Both had zero actual benefit, and both received surgery within 6-8 weeks after the procedure.

As with every other procedure not including traditional pain procedures, I'm dubious of any of you that boast great results.
For some strange reason, it seems to work better for the docs I know who own their asc. Stimulators seem to work better for them than others as well. Not sure I understand why that happens.
 
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I don't like that no matter how much LF you remove, you can't expect to see any debulking on MRI. But reasonable if can't have a lami, which again is rare.

To those who have done it, do you know how much fluoro time? Seems like a lot with you standing right next to c-arm on lateral.
 
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I don't like that no matter how much LF you remove, you can't expect to see any debulking on MRI. But reasonable if can't have a lami, which again is rare.

To those who have done it, do you know how much fluoro time? Seems like a lot with you standing right next to c-arm on lateral.

I’ve gotten before and after MRIs on a patient and can see the ligamentum flavum is reduced. Radiologist also saw no central stenosis at the area treated, which was previously read as mod-severe due to LFH. She has neural foraminal stenosis at a lower region that needs a separate epidural. But she can stand and walk straight now.

I’m very selective in who I will do this on. I think I’ve done maybe one this year. If you’re 0 for 2 you may need to reevaluate your technique or diagnostics

I’ll have to ask the tech what my fluoro time is. I do it pulsed so it’s not too bad if I recall. I also take more pictures towards the end than I do in the beginning because you know where your depth is and when you’re nearing the safety margin.
 
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Great post on Linked-In with 50+ comments. It can be useful for patients who cannot have "real" treatment.
MIS decompression is always better. And not much more invasive.
I would recommend against this for any of my family or my patients.

I tell my patients that if they can't have anesthesia or a real surgery, it makes sense to try. I counsel them on the fact that I normally am not removing anything from the lateral elements.

I've had mostly wins in the 20 or so I've done, but there are always other pain generators.
I do offer it before SCS for patients with more functional issues as it dos seem to help with walking/function more than ESI/SCS.

C-arm time is technique dependent. The arm is in CLO so not a true lateral. I would love to have better underbed shielding, as times for these cases can hit 5 - 10 minutes. It takes longer with trainees, so my cases are still hitting that, but if I do a level solo I can hit it in 2-3 minutes imaging time. I skip the epidurogram.

"Results: Mean patient fluoroscopy exposure time was 2.1 min ±0.9 (range: 1.1-5.6) fluoroscopy time per unilateral level decompressed. The mean patient radiation skin exposure from mild® was 1.1 ± 0.9 mGym2 , and the mean total dose was 142.3 ± 108.6 mGy per procedure. On average, the physician was exposed to an average deep tissue exposure of 4.1 ± 3.2 mRem, 2.9 ± 2.2 mRem estimated eye exposure, and 14.7 ± 11.0 mRem shallow tissue exposure per unilateral level decompressed. An individual physician would exceed the annual exposure limit of 5 Rem after approximately 610 mild® procedures per year."
 
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No money in this procedure. They are just filing up their block time at best. No financial motivator in facility fees or pro fees.
 
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I’ve done 4 in the last 6 months, and 3 of them have fantastic relief. I do not do a LESI at the end either. We will see how long the relief lasts, but it is very promising for a minimally invasive procedure that doesn’t even require a single stitch. Most of these patients did not want surgery or are poor surgical candidates.
 
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Same as intracept and vertiflex. They either enjoy doing it, ego, or think it is indicated. Nothing financial with pro fees or facility fees to entice anyone to make a bad decision for financial gain
 
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Ok. So with all of your help I have narrowed it down to either it is a BS procedure or my technique stinks. Out of the 7 or so I have done, two have had post-procedure MRI and both looked unchanged. That makes me conclude that I am not using the so called tissue sculptor properly. My rep doesn’t seem to care as he is busy running all over the Midwest and has no interest in an account, like me, who won’t “stack” 4 or 5 cases to make it worthwhile.

For those of you who have seen success:

1. Do you routinely do an ESI with the procedure? I’m inclined to be more impressed with the results without ESI.
2. Can you describe your technique with the sculptor? Is 3 bites x 3 enough? Other tips?
3. Does proper patient selection require choosing patients with predominantly single level disease? Unfortunately, most if not all of mine have had multiple level severe disease and much like with Vertiflex I have targeted the worst level. I have a hard time convincing myself to do 3 or 4 levels bilaterally but perhaps that is why I am not seeing good results.

Thanks
 
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Same as intracept and vertiflex. They either enjoy doing it, ego, or think it is indicated. Nothing financial with pro fees or facility fees to entice anyone to make a bad decision for financial gain

I’m 100% happy to punt MILD, vertiflex, intracept, and stim implants to HOPD employed docs as I make much more doing other things.
 
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Ok. So with all of your help I have narrowed it down to either it is a BS procedure or my technique stinks. Out of the 7 or so I have done, two have had post-procedure MRI and both looked unchanged. That makes me conclude that I am not using the so called tissue sculptor properly. My rep doesn’t seem to care as he is busy running all over the Midwest and has no interest in an account, like me, who won’t “stack” 4 or 5 cases to make it worthwhile.

For those of you who have seen success:

1. Do you routinely do an ESI with the procedure? I’m inclined to be more impressed with the results without ESI.
2. Can you describe your technique with the sculptor? Is 3 bites x 3 enough? Other tips?
3. Does proper patient selection require choosing patients with predominantly single level disease? Unfortunately, most if not all of mine have had multiple level severe disease and much like with Vertiflex I have targeted the worst level. I have a hard time convincing myself to do 3 or 4 levels bilaterally but perhaps that is why I am not seeing good results.

Thanks

I think you’re probably not debulking enough. I keep scraping until my arm is sore. They started pushing fewer bites to mitigate concerns over radiation exposure.

After I’m finished debulking both sides I see a change in the contrast pattern in the epidural space, you should see the stream widen. I’ve gotten a repeat MRI years later and I can see a difference at the same level.
 
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I think you’re probably not debulking enough. I keep scraping until my arm is sore. They started pushing fewer bites to mitigate concerns over radiation exposure.

After I’m finished debulking both sides I see a change in the contrast pattern in the epidural space, you should see the stream widen. I’ve gotten a repeat MRI years later and I can see a difference at the same level.

Thanks for the input. How about the issue of doing multiple levels?
 
I think you’re probably not debulking enough. I keep scraping until my arm is sore. They started pushing fewer bites to mitigate concerns over radiation exposure.

After I’m finished debulking both sides I see a change in the contrast pattern in the epidural space, you should see the stream widen. I’ve gotten a repeat MRI years later and I can see a difference at the same level.
I still struggle to see how this is a better option than a surgeon doing mis/endoscopic lami?
 
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I still struggle to see how this is a better option than a surgeon doing mis/endoscopic lami?

I don’t think that it is. My main motivation for not giving up on this yet is that our surgeons are so incredibly selective about who they operate on. Any excuse, especially age and weight, is used to turn them away or discourage them. I insist that every patient see a surgeon FIRST. Most are discouraged from having surgery and encouraged to continue non operative management even when it has failed. Some are encouraged to seek SCS rather than decompression as it is “ low risk, high reward”. I think that makes even less sense than MILD or similar. So, lots of patients with no options available locally and don’t see a 2 1/2 hour trip to the metro area as an option.
 
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I still struggle to see how this is a better option than a surgeon doing mis/endoscopic lami?

Oh, it’s not. Most of the people I did it on were old and fat and my neurosurgeon partner was very :| on having to do surgery. It’s not for the healthy skinny 67 yo

Thanks for the input. How about the issue of doing multiple levels?

I’ve done two levels a few times. Not my fav and very tiring.

Re: an epidural steroid injection at the same time: most of the time I don’t since they’ve already had one recently. But if it’s been a long time I may throw one in. It’s definitely cheating but won’t make a difference long term.
 
I don’t think that it is. My main motivation for not giving up on this yet is that our surgeons are so incredibly selective about who they operate on. Any excuse, especially age and weight, is used to turn them away or discourage them. I insist that every patient see a surgeon FIRST. Most are discouraged from having surgery and encouraged to continue non operative management even when it has failed. Some are encouraged to seek SCS rather than decompression as it is “ low risk, high reward”. I think that makes even less sense than MILD or similar. So, lots of patients with no options available locally and don’t see a 2 1/2 hour trip to the metro area as an option.

I have found working in two private orthopedic practices, that many spine surgeons just don’t want to deal with Medicare patients and find reasons not to operate on them.

Most private practice ortho groups live and die by the ASC facility fees generated in their ASC. Medicare not only pays terrible professional fees, but the only Medicare spine surgery allowed in an ASC is a discetomy. Lamis, lumbar or cervical fusions all have to be done in HOPD, which is a pain, a time suck, and a money loser for a private spine surgeon.
So even a healthish Medicare patient makes far less for a private practice spine surgeon than commercial or WC patient. So again they find reasons not to operate on Medicare patients.

My approach to these patients is that if they are truly sick, on oxygen, 86+ years old, then I send them to a Denver physician who does MILD. It helps more than half of them.

However most of these Medicare patients are just oldish, such as 70 to 80 with some mild cardiopulmonary, +/- smoker , obese, DM. They only have relative, not absolute anesthesia contraindications.

I tell all of them that I have nothing else to offer. They need surgery and that due to their age/health, their only surgical choice is the University hospital. It’s a multi hour round trip, but if they can’t make time for that trip after I share a long term solution with them, then I have zero sympathy for their spine complaints and show them the door.

I do warn the obese patients that they need to lose weight or even the university spine surgeons won’t touch them.

The vast majority of this second group of Medicare spine patients are eventually offered surgery by the university spine team, even if they were previously denied by PP spine surgeons.
 
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I think you’re probably not debulking enough. I keep scraping until my arm is sore. They started pushing fewer bites to mitigate concerns over radiation exposure.

After I’m finished debulking both sides I see a change in the contrast pattern in the epidural space, you should see the stream widen. I’ve gotten a repeat MRI years later and I can see a difference at the same level.
Nice, sounds like you're doing a more thorough job than most. But this is a lot of radiation:
times for these cases can hit 5 - 10 minutes. It takes longer with trainees, so my cases are still hitting that, but if I do a level solo I can hit it in 2-3 minutes
Doesn't seem like it has a firm endpoint, similar to Tenex, which is unsatisfying
 
Nice, sounds like you're doing a more thorough job than most. But this is a lot of radiation:
Yeah, it is difficult to let a trainee work and figure things out, but I try hard not to take over too soon.

In terms of outcomes, the biggest problem I see when people first start is failing to get good bone bites. The lip of that bone ronguer should be up and under the inferior lamina, with the handle pushed aggressively towards the head to get a good solid bite of that lamina. That releases the ligament to allow you to scoop. Otherwise you're just debulking interspinous ligament/fat/etc, and not getting solid scoops of that deeper ligamentum flavum.
 
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I haven’t been trained on this but I am curious for those who do it - how does one ensure a consistent amount of flavum removed?

It seems like it is variable and not consistent.
 
It is variable based on technique and operator comfort
 
I still struggle to see how this is a better option than a surgeon doing mis/endoscopic lami?
less invasive, reduced risk of csf leak, reduced to nonexistent recovery period compared to lami, and possible when surgery is not an option.


to answer a few of the questions
1. the most ive ever had radiation wise was 3 min 50 seconds.
2. i average around 1 min 15 seconds for 1 level, up to 2 min for 2.
3. patient selection is key. for me, the only patients being offered this are those who have seen a surgeon for decompression and have been denied.
4. try to only do 1 level. always do bilateral.
5. i usually "do" an epidural at the end. my technique is still to place the touhy to start the procedure, see the contrast line, then give contrast at the end followed by depo and saline. sometimes the epidural is the hardest part.
6. the vast majority of my cases are not deemed surgical candidates due to underlying medical comorbidities, the most common being advanced age.
7. i spend almost all the time with the ronguer, not the tissue sculptor. i do about 9 or so passes with the tissue sculptor, but if im worried about safety or a lot of rad already used, i tend to skip it.
8. i tell the patient that this procedure will not prevent surgery if they feel they need to have surgery. of the 60 or so cases ive done, only 2 have gone on to surgery. again, most of my patients were already deemed poor surgical candidates.
9. of those 60, 60% have professed benefit - in either back pain, walking tolerance, or both.


most common failures are with multilevel disease, if there is significant disc or bone component to the stenosis.


for someone with axial only back pain without claudication symptoms, i think MBB before MILD is the play. MBB is also helpful after MILD if the MILD does not help with the axial back pain, and of the people who failed MILD with regards to continued axial back pain, my gut feeling is that roughly half of them get benefit from RFA
 
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less invasive, reduced risk of csf leak, reduced to nonexistent recovery period compared to lami, and possible when surgery is not an option.


to answer a few of the questions
1. the most ive ever had radiation wise was 3 min 50 seconds.
2. i average around 1 min 15 seconds for 1 level, up to 2 min for 2.
3. patient selection is key. for me, the only patients being offered this are those who have seen a surgeon for decompression and have been denied.
4. try to only do 1 level. always do bilateral.
5. i usually "do" an epidural at the end. my technique is still to place the touhy to start the procedure, see the contrast line, then give contrast at the end followed by depo and saline. sometimes the epidural is the hardest part.
6. the vast majority of my cases are not deemed surgical candidates due to underlying medical comorbidities, the most common being advanced age.
7. i spend almost all the time with the ronguer, not the tissue sculptor. i do about 9 or so passes with the tissue sculptor, but if im worried about safety or a lot of rad already used, i tend to skip it.
8. i tell the patient that this procedure will not prevent surgery if they feel they need to have surgery. of the 60 or so cases ive done, only 2 have gone on to surgery. again, most of my patients were already deemed poor surgical candidates.
9. of those 60, 60% have professed benefit - in either back pain, walking tolerance, or both.


most common failures are with multilevel disease, if there is significant disc or bone component to the stenosis.


for someone with axial only back pain without claudication symptoms, i think MBB before MILD is the play. MBB is also helpful after MILD if the MILD does not help with the axial back pain, and of the people who failed MILD with regards to continued axial back pain, my gut feeling is that roughly half of them get benefit from RFA

MILD is placebo. If you're doing a ESI at the end of the procedure, that's fraud. It's like doing a steroid shot after a PRP injection.
 
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Ok. So with all of your help I have narrowed it down to either it is a BS procedure or my technique stinks. Out of the 7 or so I have done, two have had post-procedure MRI and both looked unchanged. That makes me conclude that I am not using the so called tissue sculptor properly. My rep doesn’t seem to care as he is busy running all over the Midwest and has no interest in an account, like me, who won’t “stack” 4 or 5 cases to make it worthwhile.

For those of you who have seen success:

1. Do you routinely do an ESI with the procedure? I’m inclined to be more impressed with the results without ESI.
2. Can you describe your technique with the sculptor? Is 3 bites x 3 enough? Other tips?
3. Does proper patient selection require choosing patients with predominantly single level disease? Unfortunately, most if not all of mine have had multiple level severe disease and much like with Vertiflex I have targeted the worst level. I have a hard time convincing myself to do 3 or 4 levels bilaterally but perhaps that is why I am not seeing good results.

Thanks
1. Never done ESI or epidurogram with these. Am very particular about getting perfect CLO.
2. I am very aggressive with the bone rongeur - at minimum you need a good path for the ligament sculpter. If running into resistance need to debulk more. I do not generally take more than the 3 x 3 bites of ligament - maybe once or twice in my cases. Sometimes I'll come back with the rongeur post sculpter to debulk more.
3. Most I do is two levels. Always do bilateral. Never could do the midline approach so I enter twice each level. People with >2 level moderate+ stenosis will not do well in my experience.

Echo above that I sometimes need to come back and do MBB/RF for persistent axial pain.
 
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MILD is placebo. If you're doing a ESI at the end of the procedure, that's fraud. It's like doing a steroid shot after a PRP injection.
If someone told me my ligamentum flavum wasn’t causing my claudication, I’d be pissed.

If you don’t add steroid after your procedure, how are you supposed to build a laser empire?
 
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I did training on this procedure almost 2 years ago, and in the time since then I've probably seen 4 patients who I think could benefit from it. Unfortunately, the hospital where I do Intracept won't credential me to do it without a proctor, and the company will only send me a proctor if I get 4 cases lined up on the same day. So I guess I'm just not going to do it.
 
MILD is placebo. If you're doing a ESI at the end of the procedure, that's fraud. It's like doing a steroid shot after a PRP injection.
no, that can be considered part of the procedure.

when you (not i) inject steroids at the end of an RFA, are you committing fraud? or worse, as part of an MBB?

when you add steroids as part of a diagnostic SI injection, are you committing fraud?
 
I did training on this procedure almost 2 years ago, and in the time since then I've probably seen 4 patients who I think could benefit from it. Unfortunately, the hospital where I do Intracept won't credential me to do it without a proctor, and the company will only send me a proctor if I get 4 cases lined up on the same day. So I guess I'm just not going to do it.
im in the same boat with intracept.

have to do training.

rep says i have to have at least 5 cases "lined up" (ie schedule) before they will "accept" me for training.

system will not allow me to "line up" intracept until training has been done.
 
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im in the same boat with intracept.

have to do training.

rep says i have to have at least 5 cases "lined up" (ie schedule) before they will "accept" me for training.

system will not allow me to "line up" intracept until training has been done.
One of my problems.

I don't get how anyone can get trained on this thing.
 
no, that can be considered part of the procedure.

when you (not i) inject steroids at the end of an RFA, are you committing fraud? or worse, as part of an MBB?

when you add steroids as part of a diagnostic SI injection, are you committing fraud?

I don't inject steroids at the end of a RFA. Studies show it does reduce neuritis.


I don't inject steroids for a DIAGNOSTIC SIJ inejction.

#believethescience
 
One of my problems.

I don't get how anyone can get trained on this thing.
Just do it with Merit Medical, Stryker, or Medtronic. They all have vertebral body ablation hardware
 
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It’s not that hard. Just put 5 patients with modic changes in to their approval portal. Even if they are Medicare. Then they will send you to the course. Financially it’s hardly worth doing at least in my wrvu world.
 
It’s interesting those with the strongest opinions have done the fewest cases
 
I don't inject steroids at the end of a RFA. Studies show it does reduce neuritis.


I don't inject steroids for a DIAGNOSTIC SIJ inejction.

#believethescience
yet you can...

Diagnostic SIJI are considered reasonable and necessary for patients who meet ALL the following criteria:

5. The diagnostic SIJI provided a minimum of 75% relief of primary (index) pain with the diagnostic SIJI (a positive diagnostic response is defined as ≥75% sustained and constant pain relief for the duration of the local anesthetic and ≥75% sustained and constant pain relief for the duration of the anti-inflammatory steroid) was measured by the SAME pain scale* at baseline. The measurements of pain must be taken pre-injection on the day of the SIJ injection, post-intervention on the day of the injection, and the days following the injection to substantiate and corroborate the pain scores consistent with the pain relief for the duration of the local anesthetic and/or steroid used.



point is, the main treatment for MILD is the actual debulking of the ligamentum flavum. that is what is being billed. adding steroids at the end is not fraud. the examples i am giving are to point out the hypocrisy of labelling steroids at the end of procedure as fraud.
 
yet you can...

Diagnostic SIJI are considered reasonable and necessary for patients who meet ALL the following criteria:

5. The diagnostic SIJI provided a minimum of 75% relief of primary (index) pain with the diagnostic SIJI (a positive diagnostic response is defined as ≥75% sustained and constant pain relief for the duration of the local anesthetic and ≥75% sustained and constant pain relief for the duration of the anti-inflammatory steroid) was measured by the SAME pain scale* at baseline. The measurements of pain must be taken pre-injection on the day of the SIJ injection, post-intervention on the day of the injection, and the days following the injection to substantiate and corroborate the pain scores consistent with the pain relief for the duration of the local anesthetic and/or steroid used.



point is, the main treatment for MILD is the actual debulking of the ligamentum flavum. that is what is being billed. adding steroids at the end is not fraud. the examples i am giving are to point out the hypocrisy of labelling steroids at the end of procedure as fraud.

It's intellectually dishonest. Just because it's legal doesn't mean it's right.
 
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If you told me you're debulking my ligamentum flavum, but instead are giving an ILESI...I'd be pissed.
 
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usually 2 mg versed 50-100 mcg fentanyl.

10-15 ml 1% lidocaine:0.25% bupivacaine 1:1

i did one recently with that local only
 
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