SpaceOAR - Augmenix, Boston Scientific, and Conflicts of Interest

medgator · May 14, 2024

communitydoc13 said:
Rectum-spacer related acute toxicity – endoscopy results of 403 prostate cancer patients after implantation of gel or balloon spacers

Rectal spacers are used to limit dose to the anterior rectal wall in high dose external beam radiation therapy of the prostate and have been shown to reduce radiation induced toxicity. Here we report the complication rate and toxicity of the implantation ...

www.ncbi.nlm.nih.gov

Not particular to BioProtect, but interesting that acute Grade 3 toxicity (~2-3%) more common in this series for balloon vs gel spacing.

Had to look up what it actually is... I thought balloons weren't new to the specialty but that's what this looks like it is?

First physicians to implant BioProtect Balloon in US describe benefits of the spacer

Dr. Shawn Zimberg and Dr. Dean Laganosky discuss the BioProtect Balloon Transplant System, a rectal spacer for use in prostate cancer radiation.

www.urologytimes.com

evilbooyaa · May 14, 2024

medgator said:
Had to look up what it actually is... I thought balloons weren't new to the specialty but that's what this looks like it is?

First physicians to implant BioProtect Balloon in US describe benefits of the spacer

Dr. Shawn Zimberg and Dr. Dean Laganosky discuss the BioProtect Balloon Transplant System, a rectal spacer for use in prostate cancer radiation.

www.urologytimes.com

It seems like it's a balloon shoved into the area where a spaceOAR normally sits. So not an intrarectal balloon (which is old school and laughably unnecessary), but a balloon shoved through the perineum into the space where a gel normally would go. I presume once the balloon is placed, it is inflated? I'm shocked that the people interviewed about how wonderful this is do not feel any need to explain exactly what the hell is going on during a procedure like this.

Well, not really shocked. Because 'We're going to shove a balloon into your taint' doesn't have the greatest ring to it...

communitydoc13 · May 14, 2024

medgator said:
Had to look up what it actually is... I thought balloons weren't new to the specialty but that's what this looks like it is?

First physicians to implant BioProtect Balloon in US describe benefits of the spacer

Dr. Shawn Zimberg and Dr. Dean Laganosky discuss the BioProtect Balloon Transplant System, a rectal spacer for use in prostate cancer radiation.

www.urologytimes.com

The acute spacer toxicity study actually was in reference to a BioProtect product. So this product has been available other places for a long time.

radiation123 · May 15, 2024

Gfunk6 said:
Have any of you guys switched to BioProtect? We are going to trial it in our clinic coming up soon. A lot of benefits relative to SpaceOAR:

1. Practically zero chance of rectal wall infiltration
2. Practically 100% reproducible spacing between rectum and prostate (vs. "spray and pray")
3. Lasts for a shorter period of time that SpaceOAR
4. Reversible

I just recently switched from SpaceOAR vue to Bioprotect balloon. I have only done a couple balloons but I think I like it better overall. The space created is a little larger and more symmetrical.

The downside is I think the procedure is a little more uncomfortable and the visibilty on the cone beam CT is not as good as SpaceOAR Vue. There is also a little bit more blood loss because of the incision/puncture.

What do you do for pain management for your patients for SpaceOAR? I was using Ativan and Percocet but was thinking to switching something like Pro-Nox to increase patient comfort.

radiation123 · May 15, 2024

communitydoc13 said:
Rectum-spacer related acute toxicity – endoscopy results of 403 prostate cancer patients after implantation of gel or balloon spacers

Rectal spacers are used to limit dose to the anterior rectal wall in high dose external beam radiation therapy of the prostate and have been shown to reduce radiation induced toxicity. Here we report the complication rate and toxicity of the implantation ...

www.ncbi.nlm.nih.gov

Not particular to BioProtect, but interesting that acute Grade 3 toxicity (~2-3%) more common in this series for balloon vs gel spacing.

It looks like in the above paper they did a hydrodissection before placement of the baloon. I believe that the company no longer recommends doing a hydrodissction before placement as it increases risk of rectal perforation/damage. I bet if they didnt do a hydrodissction the risk of rectal perforation would be close to zero.

metallica81788 · May 15, 2024

Or we could just not do any of these gel balloon things?

Gfunk6 · May 15, 2024

radiation123 said:
I just recently switched from SpaceOAR vue to Bioprotect balloon. I have only done a couple balloons but I think I like it better overall. The space created is a little larger and more symmetrical.

The downside is I think the procedure is a little more uncomfortable and the visibilty on the cone beam CT is not as good as SpaceOAR Vue. There is also a little bit more blood loss because of the incision/puncture.

What do you do for pain management for your patients for SpaceOAR? I was using Ativan and Percocet but was thinking to switching something like Pro-Nox to increase patient comfort.

I don’t prescribe pain meds after SpaceOAR VUE placement. But I am pretty aggressive with my local so that probably helps a lot.

Gfunk6 · May 15, 2024

@evilbooyaa or @Neuronix

Could one of you please move the posts on this thread regarding hydrogel management to another thread so that this conversation can be continued productively?

communitydoc13 · May 16, 2024

radiation123 said:
It looks like in the above paper they did a hydrodissection before placement of the baloon. I believe that the company no longer recommends doing a hydrodissction before placement as it increases risk of rectal perforation/damage. I bet if they didnt do a hydrodissction the risk of rectal perforation would be close to zero.

This seems weird. Recent, fairly comprehensive pubs on practicalities of space placement emphasize hydrodissection (which in principal I would think of as a safety measure).

Implantation of a biodegradable rectum balloon implant: Tips, Tricks and Pitfalls

A rectum balloon implant (RBI) is a new device to spare rectal structures during prostate cancer radiotherapy. The theoretical advantages of a RBI are to reduce the high radiation dose to the anterior rectum wall, the possibility of a post-implant correction, ...

www.ncbi.nlm.nih.gov

Edit: I can think of a hypothesis here (bad hydro causes perforation and focal weakness in rectal wall), but do not see anything validating that hydrodissection is the cause of balloon perforation. This product (available in Europe for 14 years or so?) is now being sold to US docs as the solution to spacer associated toxicity. It is not clear to me that we have any data validating this position.

RickyScott · May 16, 2024

the issue for me is that one or major 2 events out of 1000 balloons placed probably offsets any benefit.

BobbyHeenan · May 16, 2024

RickyScott said:
the issue for me is that one or major 2 events out of 1000 balloons placed probably offsets any benefit.

yup.

I think after all the massaging of the data I've decided that in practical terms with the gel we are looking at a slight drop in % chance they'd need APC coagulation of proctitis (say from ?high single digits to low single digits?) and go from 0% to 1-2% chance of a major major problem.

OTN · May 16, 2024

...and I would rather have APC coagulation performed than barrier gel placement, as you don't have to violate the wall of any organ.

evilbooyaa · May 16, 2024

Gfunk6 said:
@evilbooyaa or @Neuronix

Could one of you please move the posts on this thread regarding hydrogel management to another thread so that this conversation can be continued productively?

I think pre/post-meds around SpaceOAR is of relevance in the thread discussiong spaceOAR and other rectal balloons.

The other stuff about the evils of Benzos I'm going to move into its own thread

SpaceOAR - Augmenix, Boston Scientific, and Conflicts of Interest

medgator

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