Leading Treatment For Structural Heart Disease
The leading treatment option for AS and other structural diseases is transcatheter aortic valve replacement (TAVR). The overall complication rate of TAVR is relatively low -- around 4%. However, patients who experience complications have increased hospital lengths-of-stay and higher one-year mortality rates.
In this video, Suyog A. Mokashi, MD , director of the Aortic Surgery Program at Temple Health, covers major and minor vascular complications of TAVR, how to recognize them, and appropriate interventions.
Early Referral Guidelines for Better Outcomes
It is imperative for cardiologists to promptly refer patients for evaluation by structural heart specialists for Transcatheter Aortic Valve Replacement (TAVR). In Philadelphia alone, 29% of patients with aortic stenosis cases are undertreated , made more concerning by the fact that prognosis for patients with AS is more deadly than some cancers.
Early referral is key. Indications for referral include high-risk secondary diagnoses like heart failure, and patients who have moderate AS but may not be immediate candidates for surgery.
Summary
Suyog A. Mokashi, MD, director of the Aortic Surgery Program at Temple University Hospital, discusses how TAVR is an effective and safe treatment option for patients experiencing aortic stenosis and other structural diseases of the heart
Data shows that patients in Philadelphia and surrounding counties are significantly undertreated for aortic stenosis, despite the treatment options available and poor prognosis if left untreated.
Early referral to a structural heart program is imperative putting patients into a treatment pathway, allowing specialists to treat the condition before it becomes advanced.
This content was featured at CVI Philadelphia’s Echocardiography Update on January 7, 2024. This recording is intended for educational purposes and is not eligible for CME credits.
Temple Health would like to Thank CVI Philadelphia for the content of this presentation and their partnership. For more information on CVI Philadelphia and their course offerings, please visit www.CVIphiladelphia.org.
Good morning. Uh Thank you, Doctor Sri doctor Kane for, for having me up here and uh talk about complications in TVER. I have no disclosures. Um I wanna start by talking about the vascular complications in TVER. And you know, we we categorize them in terms of a major vascular and minor vascular complications, major vascular being dissections, ruptures and annual rupture, which I'm gonna sort of drill in on a little bit later. Um minor vascular occasion being really access site injuries. And as you can see up here on the slide, I they're, they're listed is in terms of both and the reason for that is there's not necessarily universal standard definition of what we call major and minor vascular complications. So there, there's a little bit of overlay between the two. the top and major complications. We rarely see the minor complications with the percutaneous closure device failure are a little bit more common but are are are somewhat easily treatable. Um The overall complication rate is down to about 4%. However, there is a strong correlation with an increased length of stay 30 day in both one year mortality. Now take this with a grain of salt also because this comes from the partner one trial, as everyone knows came out in 2012. So the data from that is a bit historic and now the 15 year mark and the initial devices used in that partner one trial were also larger scale devices with the 24 to 26 sheet. Now, we're down to about a 14 to 16. Um The risk factors for vascular complications are female peripheral vascular disease. Generally, when we look at the femoral, the common femoral artery, we aim for a diameter of five, maybe 5.5. Um uh Another sort of proxy is the sheath of femoral artery ratio less than 1.05. But certainly with circumduction calcification patterns, we do see a higher risk of vasco injury, but we've also now sort of in our arbiter is alternate access. So the overall vasco complications are, like I said, down to about 4% of less and you know, the prevent and the really the antidote to this is real diligent preprocedural planning, which which you all do for us. Um conduction abnormalities requiring pacemakers. The most common conduction abnormality after TVER is a high degree a V block. Uh and a new onset left bundle branch block, the new onset left bundle branch block, mainly this occurs uh during the procedure itself. I mean, you it really occurs when we're in the engine. So usually soon after deploying the valve, um or within the 1st 24 hours. Uh with, you know, sort of the Metronic core valve, it's about 14 to 27% with the Edwards 14 to 24%. Now again, these are all comers in a bit of a wider range and the risk appetite for putting in a pacemaker is a bit institutional individual dependent too. Um which is why, you know, the next statement says the overall pacemaker rate for TVER is anywhere from 3% to 36%. Realistically, it's closer to the 4 to 5% range. Um We do know that the most common reasons we're doing is a high degree a V block worse, worsening, left bundle branch block and the meeting time to place him after the tas anywhere is really around the three day mark is when we put the pacemakers with the surgical valve, it tends to be in the 7 to 10 day range. Uh I wanna sort of look under the hood a little bit more about this to look at the impact of pre-existing conditions, um conduction abnormalities for which we put a pacemaker in after the TVER. So for all comers, we look at the pre-existing right and left bundle branch block and, and they sort of both range in the 10 to 14%. Um The exact correlation between the left bundle branch block and the pacemaker is unclear. Uh but, and it is not associated with an increased overall higher mortality or cardiovascular morbidity. However, the pre-existing right bundle branch block is established as one of the more consistent predictors of pacemaker after tver and double clicking on this a little bit further. So in the France two registry, with 100 8, 883 patients, they found the permanent pacemaker rate of about 30% which is, which is significantly high. But again, just to put a little background on this, this was the majority of first generation core valves. There was also an asymmetry toward female and also a smaller annulus with a greater proportion of aortic insufficiency. Um with the STS AC C or TV T registry look with about 10,000 patients, the overall pacemaker rate is as expected probably about 7%. However, there is a 30% increase in all cause mortality. Um and, and heart failure at one year. Another study by Albury looked at at 1300 patients of which 15% required a pacemaker again, resulting in a higher risk cause mortality at one year. And Jorgenson looked at about 800 patients also found that sort of at the one year mark. So really up to the one year mark, we don't really see the effect of the pacemaker, but it is clear after that one year mark, they do have a higher risk of uh morbidity mortality. Um The next complication is a para valve leak. Um So this is a, this just came out one month ago, from American Journal of Cardiology. And this looked at patients, 80% of the patients had a Edward SAPIEN valve which is a um balloon expandable valve. And 20% had the evolut Pro which is a self expanding valve. Um and they categorized it in terms of having a low risk leak versus high risk leak. A low risk being a trace to mild air power valve leak and the high risk being moderate to severe. And they found that when you look at the moderate, which is again a moderate to severe power valve leak, in terms of the Edward SAPIEN and the evolut pro, there is really no difference between the two valves. However, there is some asymmetry when we look at sort of the trace, the mild with the uh with the Metronic having a disproportionately higher risk of traced the mild para valve leak, coronary ruction. I gotta say, you know, when, when a cardiac emergency goes down a lot of times I look at the surgeon, but this is one of those cases. I'm glad they don't look at me. Um I mean, this, this is a real tough one. Fortunately it, it's relatively uncommon in the German Aortic Valve Registry. This only seen 0.3% of the time. Uh and again, in the Sts AC T BT registry, it's seen 0.4% of the time. Um and a particular higher risk of coronary obstruction is valve and valve particularly when we put in a bioprosthetic valve of a 19 or 21 coronary osteo less than 10 millimeters and smaller sinus of valsalva, either lower height, less than 15 millimeters or with less than 28 millimeters and a narrow S TJ. The mortality is high and the success rate for rein intervening is noted to be about 78%. Um And it's actually even lower with the uh with the self expandable valves. Um In this uh in this one illustration from Jack and it's a, it's a little bit harder to visualize. They found that the incident was only 0.8%. But again, both the in hospitals and the one year mortality was disproportionately higher as expected with, with coronary obstruction valve embolization. Um This is coming from the, the travel registry published in the European Heart Journal in 2019, out of 29,000 towers. The incident, this was only 1%. Um the risk factors for having a valve ization or malposition of the valve manipulation of the valve. And more commonly pacing failure, it is there is a higher risk percentage when we post dilate the valves. But again that there is a fair number of valves that post dilate and we don't associate valve embolization. Um in terms of the sort of the antidote for this, the bailout measures are repositioning maneuvers, implanting a second prosthesis and surgery 20% of the time. But I do wanna sort of put your attention to the graft on the very right, the, again, the 30 day, and the one year mortality is significantly higher if you do have a valve, um, valve embolization. And it's actually higher if the valve embolize in the ventricle than the aorta, which we'd sort of expect because there's really, there's not at least that I know of good transcatheter options. When it embolize in the ventricle, it almost uniformly ends up, uh ends up being surgery. And then finally, it's the sort of the most dreaded. Uh, the most dreaded of all is the annular rupture. Um Luckily, I don't think almost anyone's really had experience with this and, you know, especially now with their newer, now with the third generation of these transcatheter valves. Um and the annual rupture, I it's sort of that catchment phrase referring to everything from an intra annular sub annular and super annular, basically just tear of the etic annulus. Um It's that it's that umbrella term, it's exclusively seen with the Edwards valve, but again, this is really exceedingly low. Um And we do see this when we oversize these valves more than 20% which, which obviously we barely use a smaller aortic annulus, less than 20 calcification of the annulus and the LVOT. Um again, uh really the only treatment for this is surgery and this really ends up being sort of a kind of a Hail Mary operation. So fortunately, it's, it's a pretty unexpected complication. So II I sort of summarize all this by saying, you know, the overall complication of TVER is is is relatively low. I mean, we're talking really less than 5%. The pacemaker still is in that 5 to 7% range. But in terms of the earlier complications I showed with the vascular complications, the para leaks, those are all, especially the ones that we treat were all exceedingly low. So great. Thank you very much.
