Gregory Rushing, MD, discusses the surgical options for LAAO.
So thank you all. I appreciate the opportunity to talk. I also appreciate that I am the last talk between you and your lunch. So I will try to make it try to make it quickly. So I was asked to talk about what are the surgical options And what is the actual data say with regards to surgical options for left atrial appendage closure. Have no disclosures. And so first I think before you talk about anything, you need to talk about. What is your problem? What's the scope of the problem? How big is it? And what are we dealing with? And and really atrial fibrillation is the problem. And when you have a moderator who's Canadian and you have a boss who is Canadian, you pick on the Canadians. So let's talk about the data that comes out of a health system where you have a nationalized health system. So we know that mortality rates are higher in patients who have atrial fibrillation, paroxysmal as well as permanent. And we know that people don't like to take medications. So if you look at two of these studies that both the nationalized health system, that patients don't fill their prescriptions after a hospital admission within 90 days for atrial fibrillation and patients don't like to take drugs. Well when you don't take anti coagulation fibrillation. This is what we worry about right. You see thrombosis in the left atrial appendage. And we know that in patients who have atrial fibrillation, 70% of all strokes are associated with cardio m bolic uh sources. And 90% of these strokes arise from the left atrial appendage. But there are other reasons to not take anti coagulation. And when you're married to a trauma surgeon, you hear about the other indications for not taking anti coagulation all the time. And so maybe these patients are smarter than the doctors are. But gastrointestinal bleeding as you see on the left or severe head bleeds as you see on the right are true patient concerns for taking anti coagulation therapies. And we know in our talks in the last session that when we talk about structural heart disease, patients don't want to be placed, don't want mechanical valves placed because they don't want to be on lifelong anti coagulation therapies. So after we've discussed the scope of the problem, what about our history. So 1948, Jama has the first actual published case of resection or occlusion of the left atrial appendage. And this is in a patient who had had multiple lower extremity embolization. And this patient was taken to the operating room. They had resection um and over so of the left atrial appendage during the operation, the heart stopped, they had to do cardiac massage. And in the immediate post operative period the patient had a large left hemispheric stroke. But they they did publish their follow up that within one year of follow up the patient was walking independently without the use of amputation. So in 1948 you can imagine that's pre cardiopulmonary bypass, that would be a very difficult operation to perform. And in the 19 eighties dr cox started his cut and sew method for the treatment of atrial fibrillation. And so we know that most of us in this room owe a lot to the innovation and the scientific rigor that dr cox utilized to figure out how to do ablation. And so surgeons led the way with abrasions. And we know that when he first started doing The cut and sew method which showed a freedom from stroke and a ten-year curate at 96% and freedom from stroke rate 99%. That part of this operation was to take off the left atrial appendage. Fast forward to one of the major international randomized trials layouts, one where we looked at surgical occlusion of the left atrial appendage. And this study was actually stopped by the data safety monitoring board because there was non occlusion of the appendage in patients on follow up. And the use of a stapling device that was utilized in this trial was resulting in greater than a one centimeter stubbed appendage that was left. And so if you ask our electrophysiology colleagues or noninvasive colleagues, they'll tell you that leaving a one centimeter stub is actually worse than leaving the whole appendage possibly. So, um this trial was stopped following. That was the the larry It device and the FDA announced a safety issue with this device, it wasn't actually taken off the market, but the number of larry it procedures precipitously dropped in the United States because of safety issues with regards to usually bleeding from pericardial access. The FDA then actually recalled the tiger paw device. So the tiger paw device showed that there was some left atrial bleeding because the device would cause laceration of the tissue. And as dr phillipe mentioned that tissue can be very very thin especially towards the base of the left atrium. Of course. Along comes the interventional cardiologist who are going to plug the left atrial appendage. Well things don't always go smoothly in the O. R. As we showed in 1948. And things don't always go smoothly in the cath lab as well. And so here you see surgeons taking amulet device out of the um atrium that had been dislodged and into the left ventricle. And in the right panel you see a watchman device that is now impeding flow into the visceral segment of the abdominal aorta. So sizing I'm sure all of these were sized with T. E. And none of them were sized with the C. T. Scan. But where surgeons really need to look at is in patients who were going to operate on anyway. So these are patients who are going to the operating room for revascularization. Their patients who are going to the operating room for valvular disease. What do we do with those patients who we have them on the heart lung machine. We have an opportunity to address their atrial fibrillation and or address stroke risk in patients without HR fibrillation. So this trial uh was uh in this was an interval presentation at the heart rhythm society last year. This trial has not completed. Its not been published yet but we showed that prophylactic closure of the left atrial appendage had less strokes than those who had no prophylactic closure of the left atrial appendage. And this population Leo's three was recently published in the last two years here, the New England Journal of Medicine. And this was really a landmark trial and the surgery world where we looked at what we the surgeons looked at um over 4000 patients randomized into two arms and these are patients who are going to the operating room for some other disease process but had a diagnosis of atrial fibrillation pre operatively and they were randomized to whether they got appendage closure. You could use a clip for this, you could use a cut and sew or you could use a stapler. They did not allow a purse string device. They did not allow larry it in this particular trial. And what they showed was there was a significant difference in the amount of ischemic stroke or systemic embolization in the patients who had operative management of their left atrial appendage. The leaps trial is a trial uh that is coming. It's not actually started yet. We are fortunate enough to be selected as one of the sites here will be a member of this trial here at university hospitals. And this is also looking at prophylactic closure of the left atrial appendage and patients going to surgery. These patients do not have atrial fibrillation. So this is a patient population who have coronary disease or valvular disease undergoing a cardiac surgery operation. They do not have a history of atrial fibrillation but have concerning um uh pathologies such as either diabetes A BNP, that's elevated a chad's fast score. That's greater than to age. So all of these things are things that look at for actual development of atrial fibrillation later in their life. So in the interest of time, I'll go to my next my last slide in in the interest of debate dr Phil B this is your patients. So if the presenter sends you the patient, I think you know that you've won the debate