Clinical Editor's Discussion: My First Lead-Free Coronary Angiogram

Morton Kern, MD, David Rizik, MD, and Arnold Seto, MD, MPA, discuss the use of systems permitting members of the catheterization laboratory team to work in the cath lab without having to wear lead aprons to protect from radiation exposure.

Read the original Clinical Editor's Corner, "My First Lead-Free Coronary Angiogram".

Further comments from the "Conversations in Cardiology" discussion group:

Re: Lead-less procedures…I LOVE IT.  I have been lead-free for all of my BPA procedures (which are long and challenging), and some of my cath procedures.  We have Rampart (although I also like the system that Jim Goldstein developed). The staff needs to get used to setting it up for every case where it is feasible, and that has been a challenge. It is a huge relief on the back and, over time, the occupational hazard from which many of us suffer will be lessened.

— Kenneth Rosenfield MD, MHCDS

I also in the past 3 weeks have been mostly lead-free and while I didn’t feel the ‘joy of nakedness’ Mort so beautifully wrote about…my back hurt less!

It seems that may be the next discussion for this group:  

Shouldn’t radiation protection in the CCL be the standard we move towards? Dave Rizik and others are leading this charge for discussion, but frankly I think that topic is much more critically relevant than how high my DES inflation is and for how long and would love to throw that topic out as a future discussion point.

— David Cox, MD

This transcript has been lightly edited for clarity.

Morton Kern, MD:

Hello everybody, this is Mort Kern and I'm bringing to you Cath Lab Digest Live, which is the editor's corner discussion of the Editor's Page with two of my very distinguished friends and colleagues, Dr. Arnold Seto and Dr. David Rizik from Phoenix. Today's Editors Page deals with my first experience doing a lead free coronary angiogram. I have to tell you, after 40 years in the cath lab to do a procedure without wearing lead, it made me feel like I was working in my underwear. It was really an experience. So the question is now how does somebody get to this point? So I just want to review for you what we know about lead protection, about radiation scatter, about methods that are now coming on the Editor's Page in April 2023. So let's just take a look.

I'm going to show you this first couple of slides just to set the stage. Then I'm going to talk to David and Arnold about radiation protection as we do it now and as we should do it next year. So this is the Editor's Page cover. The story really begins with all of us being exposed to scattered radiation. This is not a mystery. The beam comes from under the table, up through the patient, to the collecting image intensifier. The patient's bones and other tissues scatter radiation that's emitted from the radiation generator up. All that scattered radiation hits everything in the room, including all the people in the room. And so, that's why we wear lead protective gear to try and reduce the harmful effects of radiation.

Now, there was a nice paper a little while ago and they outlined all of the different methods we currently use at the moment to try and reduce radiation to the operators as much as possible. Everybody has lead shields, many people have disposable shielding they put on the patient, everybody wears lead aprons, often now vest and a skirt, radiation glasses. Arnold, I think you wear a lead cap, is that right?

Arnold Seto, MD:

Yes.

Morton Kern, MD:

A protective cap. I don't think David does. I don't think he even wears glasses.

David Rizik, MD:

Well now, Mort, the reason, I'd like to see really, really, really robust data that that lead cap makes a difference. The radiation comes this way, not this way. So understand, we're data-driven on this one.

Morton Kern, MD:

Correct. So I don't wear a cap or leaded glasses, but I did hear people have problems. So let me just take a couple more swings at this. There are systems in place that give better radiation shielding, or at least they're working on novel technologies to do that.

So here we have a little diagram. In JSCAI, there's going to be a review article on the subject of moving toward a lead-free environment from our team. This figure from that paper shows that at the top is the lab as we know it, plus a live monitoring x-ray badge to give real-time feedback. So if you're standing in a hot zone, it'll tell you to get out of the hot zone.

There's another system with a suspended ceiling lead called Zero-Gravity (Biotronik). Movable shields are all around our laboratory. There are remote performance robotic-controlled interventional procedures where the operator sits at a distance from the table and remotely controls the equipment out of the radiation field. Then lastly, there's these disposable radiation shields. But there's also one or two systems now that are very unique, novel, and really block a lot of radiation. I show them both here. The Rampart system, which is a large shield on a mask. It covers the table. There are movable and soft areas that drape over the patient, large under table shields, and it does a very good job of protecting lead, protecting radiation, permitting some operators to work without lead.

But this system on the right is the one that we trialed last month or a couple of months ago called the Protego system. It's a little bigger. It has a lot more shielding. It has ports to see the patient, and it has shielding all around the patient to keep the radiation confined to that area. So the unique aspect of this was that the personnel in the room, which are shown here, and this would be a full interventional room. So you got respiratory therapists, you got anesthesiologist, you got an echocardiographer, two operators, an assistant, another assistant nurse, somebody on the back table. And if you put that Protego lead shield in place, you get this zone of protection where none of the people in this zone need to wear lead. The exposure to my badge during that procedure was zero. I had a fellow, we had a couple of nurses in that area, and all of us got readings of zero.

Now on the other side of the shield though out here, these guys, they were wearing the conventional traditional lead. They got 11 milligrams during this diagnostic procedure. So it was pretty effective and I felt completely unique about doing a procedure within my underwear. They took a picture of us and you can see my fellows here operating. I'm standing next to him. I actually am wearing scrubs. I wasn't really in my underwear. The shield is here. We could look through the ports and see the patient. There's two television monitors. I think the system went in and out pretty well.

David, you have more experience with this than I have, so I wanted to hear from you what your experience was, if any different than mine, and where you think we're going, and what the limitations were.

David Rizik, MD:

Mort, this is probably the most important thing we're going to do over the next 5 to 10 years in interventional cardiology. The aspirational goal needs to be a zero radiation environment. You're talking about Protego. I think whatever the system, we need to start doing something. It's not just for the operators. You and I do do two or three cases in a day. The nurses and patient care technicians may be in there for 12 cases. And so, the entire room needs to be radiation-free. And you've touched on all the deleterious consequences.

Let me talk about Protego though for a minute because we have probably the best world experience with Protego. Right now. It comes down, as you can see, as a C-shaped or moon-shaped lead barrier over the patient. There are Radpads laying over the patient. What we learned very early on is there are two sources of the radiation. One is the image intensifier, but the other is the scatter, and the waste scatter is where most of the scatter comes from. In our database, and we've done now probably 150 cases ... We published one of the studies in JSCAI. We published a study in JSCAI doing complex coronary intervention. We will be publishing our TAVR experience, and I can tell you most of the scatter comes at the level of the waste. In 70% of our patients, 70% of our cases, there was zero radiation exposure to the primary and secondary operator and to the nurse. Let me say that again, 70% of the patients. In the Protego arm, there was zero radiation.

Morton Kern, MD:

I bet the other 30% had probably a low dose that came out of it?

David Rizik, MD:

Mostly about 0.1. There was one that had 0.2, I believe. But in the complex coronary intervention trial, it was 0.1, maybe one or two [cases] with 0.2. But let me put that into perspective. You could do, looking at the OSHA allowable thresholds, using Protego, if our data stands up, you could do 400 cases a year and be at less than 1% of the OSHA allowable with the current iteration of the Protego system. Let's say you got crazy this year and you said I want to do a thousand cases. You could do a thousand cases and be at 1.6% of the OSHA allowable threshold. Now compare that to interventionalists who take their badge off and put it in the drawer, this is a minuscule, minuscule exposure. The study that we published is using Protego is the lowest exposure in any radiation barrier protection trial ever. If you haven't seen it, you need to read the manuscript in JSCAI. This is a quantum leap forward in terms of radiation protection.

Morton Kern, MD:

I believe that entirely. That single experience is all I need to know that I wasn't getting any exposure. Now Arnold, I don't know if you got a chance behind me to work with it, but there are some areas that were not completely covered and some procedures will not get such a large benefit. So Arnold, why don't you comment on that for a moment.

Arnold Seto, MD:

Just as David mentioned, the people in the front of the room [are] the anesthesiologist for TAVR, the echocardiographer doing a TEE, sometimes the respiratory therapists, but the reality is that most procedures, the basic coronary procedures, don't require someone in front of the patient. One of the unique aspects of this device that the nurses really appreciated was that the windows and the video monitor. The nurses are required under modern sedation guidelines to be focused entirely on the patient's vital signs but also on their breathing. And so, they were used to frequently checking on the patient, moving up to the front and checking on the patient's airway. Now they don't even need to do that. They can stay from behind the shield, look at the video monitor. They were wildly enthusiastic.

I have to confess, I was a little skeptical at first and didn't know how well the staff would appreciate this device because of the setup time. But they were trained and they got used to it very quickly after one or two cases. They all loved it and they said that this is something that they would want to have. Many of them have worked at multiple other cath labs in the area and they would encourage everybody to have it for the benefit of the staff and the physicians.

I think that raises the question, the next question I would pose to you all, which is, how do you secure this device for your institution in this time of economic challenges? I think David, you probably can speak to this highly. I mean, how do you convince your institution to be-

David Rizik, MD:

I got to be honest with you, I proposed this five years ago and just got it this year. It's been swimming upstream. Let me draw a metaphor comparison or an analogy. In the NFL, you get a kid who comes out of the University of Michigan, my favorite university, and he graduates and he gets drafted into the NFL. Do you think he's thinking about concussion syndrome or chronic traumatic encephalopathy? The answer is he isn't. He is thinking about scoring touchdowns and his next contract. In a similar fashion, young interventional cardiologists coming out of training at great places, they're not thinking about radiation safety. They're thinking about what do I do to do really good angioplasty, really good TAVRs, do as many cases as I can to establish my career. Much like a rookie in the NFL. This is not a priority. And just as it hasn't been a priority in the past for NFL owners, I can tell you at the level of the C-suite, this has not been a priority in hospitals.

Morton Kern, MD:

David, let me suggest this. You're an administrator of a hospital. You have an opportunity to improve safety, known reduction in hazard to the lab personnel. You know this exists. It costs "X" dollars and yet you refuse to implement a safety advance in the lab and somebody gets back injury, gets a tumor, gets skin cancer. I think there's a potential problem for administrations who don't want to implement modern safety efforts.

David Rizik, MD:

Similar or not identical, if not identical, to what happened in the NFL a few years ago. All of a sudden owners realized a certain liability or culpability of not paying attention to this chronic traumatic encephalopathy or concussion syndrome. I think it's a perfect analogy.

Morton Kern, MD:

Administrators will, I mean if I had a floor that was slick and slippery and I had some way to prevent it from being slick and slippery, nobody broke their leg and I didn't do it, I would be liable. Now there are, and I just want to mention before we come back to that point, there are cases that at this moment in time might not be suitable for the Protego shielding system, and I know it's not designed yet that, but pacemakers on the right side or left side might be one, right?

David Rizik, MD:

Absolutely.

Morton Kern, MD:

So there will be a few cases, but I would say the majority of procedures as coronaries-

David Rizik, MD:

We tweeted out three weeks ago on a Friday, three successive cases, all zero radiation. First case of the day was a TAVR, second case of the day was an alcohol septal ablation, third case of the day was a MitraClip. We tweeted out and showed our badge exposure, zero radiation in three cases. Three different cases: an alcohol septal ablation, a MitraClip, and a TAVR. What I would ask Arnold, and I really want your opinion on this because I've been living this, turnover time initially with this it took an extra 10 minutes. Then as we got fast, with an extra seven minutes; and then an extra four minutes. Last week we did a TAVR where the setup time was literally one minute and 23 seconds. Don't you think getting fast time with this, Arnold, is the key rather than saying it prolongs turnover time in the lab?

Arnold Seto, MD:

I totally agree. That's why I thought was the concern would be from the staff because we're all familiar with putting on lead. It takes 30 seconds. But I was concerned that it would take them so long to set up the case that they would be getting frustrated. But no, they were very enthusiastic. Once it got going they realized, hey, no matter how long the case is, no matter how long the operator's taking or the fellow's taking, they can still be lead-free. They're comfortable and not sweating underneath their lead. So they're highly enthusiastic. And so, when we're approaching our administrations, you can count on both the physicians and the staff to be united in probably wanting devices such as this because they would both benefit and invest in their long-term health. So I think I was pleasantly surprised, I have to say. I'm generally a skeptic, but I was pleasantly surprised by this device and I think it is the future.

David Rizik, MD:

Mort, the question I have for you, you were an iconic figure for me when I was in medical school. We were at the same place, St. Louis University, and you really piqued my interest in becoming a cardiologist, and you taught us to use our senses. Radiation doesn't have an odor. You can't see it, you can't touch it, you can't feel it, you can't taste it. Yet, it's working against you. Is the fact that you don't see the effects of radiation or for that matter wearing the cumbersome lead for decades down the road, do you think that's one of the impediments to adoption to these advanced radiation barriers?

Morton Kern, MD:

So yes and no. I think that everybody knows there's radiation but they never see anybody who's really been affected by it. So there may be some skepticism. I think that if you said we have this system, everybody can get it now and you don't have to wear lead, I think they need to accept that as the proven action of the shielding, which I think is easy to do. You can do it. You can encourage them by installing a realtime radiation monitor badge system. That is very persuasive. Then it's just a matter of having the hospitals suck it up, buy the gear, and have the doctor say, "I'd rather work in a lead free environment. I don't want to wear lead. It hurts my back." I didn't even tell you that my back felt great at the end of the day. "It hurts my back. It does this, it does that. I get cataracts, headaches, and my left ear has got a big thing growing out of it."

So I think that once this is around and the docs say, "Oh, that guy uses it, that guy's using it, it's easy to accept." I mean much easier to accept than FFR, I'll tell you that. So that was the battle.

David Rizik, MD:

Arnold, my first boss, my first employer when I got out of training was Ted Dietrich. Ted was fearless in the cath lab. That guy did so many great things. Standing next to him was a great experience for those five or six years. This guy was one of the healthiest individuals I ever met. He developed a left-sided carotid atheroma and his coronaries were pristine, clean and his right carotid was pristine, clean, and he ended up with a carotid endarterectomy. Then he ended up dying of a left-sided brain tumor.

Morton Kern, MD:

Wow.

David Rizik, MD:

You only need to see this once where it has an effect on you. Don't you think this is a compelling enough of a story that we've seen over 30 interventional cardiologists and radiologists develop left-sided lesion?

Morton Kern, MD:

So though, have you encountered people who are skeptics? The guys who are skeptics are those who've never spoken or worked in the environment or witnessed it, I think. They're just not used to it. I think in the demonstration courses that they do at SCAI, I think the demonstration courses you do, I saw a couple in Detroit, I was there this weekend at downtown at St. Joe's and Henry Ford, which is by the way a couple of very nice hospitals, really great. But I think if the demonstration courses highlight and showcase these lead-free environments, it's going to happen.

Arnold Seto, MD:

Yes, I think David speaks to what we all feel. It's like, oh, I'm young, I'm an interventionalist. I'm a hotshot. That is never going to happen to me. Just like the back pain will never happen to me. The left-sided brain tumor won't happen to me. Your chances are small, but familiarity breeds contempt. We are familiar. We use the radiation. We never see it, like you say, and we just ignore it and accept it as part of our life.

I think what is going to convince people more is just the freedom from the lead. People can feel that on a daily basis. Being freed from the lead is going to be that immediate benefit that's going to hook them. If you tell me, "Oh, it's going to prevent you from having brain tumors 20 years from now," it's going to be less convincing than, "Oh, it's going to save your back from aching tomorrow."

Morton Kern, MD:

Nobody thinks they're going to get old, but they're going to get old. And in the career of intervention it, you get old. I mean, those cases get to you. I was so pleasantly surprised I just couldn't help myself and had to write up that article.

So I think we're on point with this and I'm looking forward to seeing how people respond to the JSCAI review article on the moving into a lead free environment. David, I think you're going to like it and I think you're going to be one of the proponents. In fact, we might even highlight this at some of our joint meetings, make this old sort of boring subject on radiation safety and protection hot again. I'll have to get a baseball hat that says that Make Radiation Hot Again. So I think I've said about everything we need to say in our little 20 minute, 30 minute Editor's Page. Any last minute thoughts, David or Arnold?

David Rizik, MD:

I think it's the most important thing. I started with this and I'll end with this. Workplace safety is the single most important thing that we will do as it relates to radiation protection over the next 5 to 10 years, and everyone needs to climb on board. For those who have been swimming against the current on this issue, it is time for decision makers and hospital systems to climb on board as well.

Morton Kern, MD:

I agree. Arnold?

Arnold Seto, MD:

I would just add that this was a lot less expensive than I thought it would be. When I compare this against the cost of a little bit of a software upgrade [that costs the same], I can afford this.

David Rizik, MD:

I love that. I love that.

Morton Kern, MD:

I mean, the value proposition is highly in the favor of radiation protection. Okay, I'm going to say thank you Cath Lab Digest for giving us this opportunity to share our thoughts and wisdom with the audience. I thank David Rizik for joining and Arnold Seto for joining and taking time out of your day. I hope to do this again in another month or so with our next Editor's Page. So with that I'll say thank you very much and keep reading Cath Lab Digest.