Okay, we'll talk about the subacromial balloon spacer with Joe Boot. Thank you, Scott and Mike, for the opportunity to present. Talk about the subacromial balloon spacer disclosure in the Academy Handbook. Over 35,000 balloons have been done worldwide. Close to 8,000 have been done since FDA approval in 2021. I've done 58 since FDA approval and 10 during the FDA IDE. I'll present an overview of my experience so far. So indications are really important. This is for massive irreparable superior cuff tears, minimal to no OA, able to elevate to at least 90 degrees, intact subscap, failed conservative management and functional deltoid. Don't get that confused. Otherwise, it will fail. Absolutely. So short glimpse of the FDA IDE trial. This is the most rigorous study I've ever been involved with. It was a non-inferiority study, randomization to balloon versus repair of the tissue. There was no partial repair and balloon. It was only balloon or repair. This is the Lancet study, which is getting a lot of traction. But I will say that, you know, if you compare these two studies, first of all, this was a randomized prospective study done in the U.S. And we had lead surgeons, which were primarily sports and shoulder surgeons. Thirty-seven authors for 184 randomized patients, two years of rigorous follow-up, controlled by the FDA, which is like having the IRS in your house for two years. This was the Lancet trial, lead surgeons and knee surgeon. A hundred and ninety-five authors for 117 patients, randomized trial. So I'm not really sure of the data, but this is what they're stating. Did not recommend for the balloon for massive irreparable tears. Several concerns with indications for that study. Their group had forward elevation of 67 degrees, which in general means their subscap was deficient, which was. Twenty-five percent of the patients with the balloon had a partial cuff tear that was repaired. The rehab protocol was undisclosed. Very small percentage of patients at two-year follow-up, no rehab follow-up. Forty-nine percent of patients were still on analgesics at one year. So Ricky Bobby, you're right. My experience, this is my experience so far. Sixty-eight patients total. Fifty-eight since the FDA IDE. About 22% with a repair. Seventy-eight percent just a balloon. Go in, get out, finish. Mean pre-op ASES 39, VAS 6. Adhering to range of motion. You can see the forward elevation on average is 130 degrees, abduction to 85. Forward elevation in these patients mean follow-up of 16 months at this point, up to six years. Forward elevation increased by 27 degrees. Patients at one year or more increased by 37 degrees. The green is positive. The red is negative. So about a 10%, I would say, failure rate in general. ASES scores, similar pattern at one year. Thirty-four point improvement. Again, green is positive. Red is bad. VAS, same pattern again. Decrease in VAS score of three-and-a-half points. And again, this is in the 40 patients so far that we have adequate follow-up on. The post-op rehab protocol, this is not my average patient age. This is one of my research fellows. But in general, I tell them to focus on deltoid rehab very early. So a modified Redding protocol. So I'm not searching indications. I don't do this in 20-year-olds. But this is kind of my rehab protocol. I think it's very important to engage in because this is a rehab accelerator. This is about getting in, getting the surgery done, and getting them rehabbing and moving quickly with their arm. Steady rise improvement. There is a dip around three months. So they will have sometimes I think an inflammation around three months. You got to basically counsel them through that. They'll recover nicely with that. Just keep going with the therapy. Ease and safety. I have not had any complications with doing this operation. The biggest complication I've had is one GI bleed with a prophylactic aspirin after the procedure. Shortened operative time obviously is an important pleaser for the patient, the staff, and yourself. Learning curve is really pretty short with this. And the economics have been a limitation, but they've improved. So the reimbursement from the HCPCS code at this point is $13,000 for your hospital, $8,200 for your ASC that's hospital affiliated. This is the first case I ever did in the United States. This is a 69-year-old gentleman. At the time he was I think 63. He presented, he had a previous balloon in 2016. This is the first balloon. You can see his ASCS was 26. He went up to 100 at one year. And this is him at two years follow-up. Boom, at five years he started diminishing. And the FDA was approving this balloon. He was ready for a second balloon actually. So this is his range of motion before the second balloon. So still again on label as far as range of motion. I looked at his x-rays. Really no significant change as far as glenohumeral arthritis or HMATA score in my opinion. This is his MRI before the second time around. Again, when I went into his shoulder, which I'll show you in a second, first of all he opted for a second balloon. Very few patients will opt for a second rotator cuff repair in my hands, in my experience. Most of them will look at you sideways and run away. So does he meet any indications? Irreparable massive rotator cuff, non-severe OA, intact subscap, forward elevation of 90 degrees. Yes, go balloon. So this is his procedure. So you can see cartilage was intact. I am not a biceps killer. So much of you are probably in the audience looking at this and saying, why didn't you do the biceps tendonesis? I just get in, put the balloon in. This looks like a primary, right? Nothing, no scar tissue, nothing. So put the second balloon in. This is real time, operative time, just kidding. This is the balloon going in and pretty self-explanatory. Start rehabilitation at two weeks. Took a little longer the second time around as far as his rehab. At one year, this is his outcome. So again, he's 69. I think this is a reasonably good win. Quick snippets of cases I've done. These are not all gimme patients, paraplegics, patients with complex issues and had really interesting outcomes so far. I've been fairly pleased overall in general. So again, these are a bunch of snippets of patients that we've been following carefully. Pearls, this is a rehab accelerator and facilitator. There is a dip around three months. Safety, I don't think it burns any bridges. Pain relief and functional improvement's important to patients and they're fairly satisfied with this. Longevity, I've been seeing patients at this point at five years follow-up, no bridges burned. I've done one reverse and did not see any significant adhesions. Stick to the indications. Thank you.

subacromial balloon spacer

indications

Joe Boot

patient outcomes

reimbursement