Self-expanding TAVR valves deteriorate less than surgical valves at 5 years
Click Here to Manage Email Alerts
WASHINGTON — The 5-year rate of structural valve deterioration was lower in self-expanding valves for transcatheter aortic valve replacement than in surgical valves, researchers reported.
Michael J. Reardon, MD, and colleagues conducted a pooled analysis of patients with severe aortic stenosis who underwent TAVR with a self-expanding valve (CoreValve/Evolut family of products, Medtronic) or surgical AVR and were included in the CoreValve U.S. Pivotal Trial or the SURTAVI trial. Reardon presented the findings at the American College of Cardiology Scientific Session.
“Our guidelines no longer use risk as a standalone reason to choose TAVR over surgery,” Reardon, professor of cardiothoracic surgery and Allison Family Distinguished chair of cardiovascular research at Houston Methodist DeBakey Heart and Vascular Center, said during the late-breaking clinical trial presentation. “Because of that, all of us are seeing young, low-risk patients increasingly being sent to our valve clinics and offered TAVR. Because of this, the lifetime management of these patients requires an understanding of bioprosthetic valve durability and failure, both of transcatheter valves and surgical prostheses.”
A balloon-expandable valve (Sapien family of products, Edwards Lifesciences) was associated with worse rates of structural valve deterioration than surgical valves in its second generation (Sapien XT) and similar rates in its third generation (Sapien 3), Reardon said, noting that the self-expanding valve was previously found to have a lower rate of hemodynamic valve deterioration than surgical valves.
The aim of the present study was “to evaluate the 5-year incidence, outcomes and predictors of hemodynamic structural valve deterioration” in patients from trials of the self-expanding valve, Reardon said. Structural valve deterioration was defined as an increase in the mean gradient of at least 10 mm Hg between discharge or 30-day echocardiogram to last available echocardiogram and a gradient on last available echocardiogram of at least 20 mm Hg, or new onset or increase of intra-prosthetic aortic regurgitation to at least moderate.
The comparisons between transcatheter and surgical valves were derived from two randomized controlled trial populations including 971 patients who received a surgical valve (mean age, 81 years; 54% men) and 1,128 patients who received a transcatheter valve (mean age, 81 years; 56% men), and the analyses addressing outcomes associated with and predictors of structural valve deterioration included those populations and an additional 2,663 patients from nonrandomized trials who underwent TAVR (mean age, 83 years; 54% men).
At 5 years, after adjustment for the competing risk of mortality, the rates of structural valve deterioration were 4.38% in the surgery group and 2.57% in the TAVR group (P = .0095), Reardon said during the presentation.
The difference was wider in patients with annular diameters of 23 mm or less (surgery, 5.86%; TAVR, 1.39%; P = .049), and was narrower in patients with annular diameters of more than 23 mm (surgery, 3.96%; TAVR, 2.48%; P = .067), he said, noting there were fewer patients in the TAVR group who had structural valve deterioration among those who had moderate deterioration and those who had severe deterioration.
Among all patients who had TAVR or surgery, structural valve deterioration was associated with the following outcomes at 5 years: all-cause mortality (HR = 1.98; 95% CI, 1.42-2.76; P < .001), CV mortality (HR = 1.82; 95% CI, 1.17-2.84; P = .008), hospitalization for aortic valve disease or worsening HF (HR = 2.11; 95% CI, 1.19.3.74; P = .01) and a composite of all-cause mortality or hospitalization for aortic valve disease or worsening HF (HR = 1.96; 95% CI, 1.38-2.8; P < .001), Reardon said.
Higher body surface area predicted structural valve deterioration (HR = 1.28; 95% CI, 1.06-1.55; P = .011), while male sex, older age, prior PCI, hypertension and prior atrial fibrillation or flutter were protective against it, he said, noting that the data did not allow the researchers to determine why people who had PCI and AF were less likely to have structural valve deterioration, but that possible explanations are earlier mortality or use of anticoagulation or antiplatelet therapy.
“The CoreValve Evolut supra-annular self-expanding prosthesis is now the first and only transcatheter valve bioprosthesis to demonstrate lower rates of structural valve deterioration compared to surgery,” Reardon said. “Why is this important? Because every week, I have patients coming to my clinic who are suitable for both TAVR and surgery, and one question they always ask me is, how long will the valve last that you are going to put in me? How likely is this valve to dysfunction? This helps us answer that question.”
Perspective
Back to TopJames B. McClurken, MD, FACC
The results are somewhat surprising; a favorable surprise. I expected the valves to be equivalent at 5 years, and then perhaps down the line we would see adequate power to make the superiority of the TAVR valve a valid finding.
There is some hint as to the reason why there was a difference at 5 years. The larger patients seemed to have less durability of their valves, which may have to do with the velocity of flow, the stress on the leaflets and patient-prosthetic mismatch inherently in patients who are very large. We see that surgical valves don’t last as long in patients who have effectively too small of a valve for their body size, which may not have been the case if they had a different body size. What we are seeing that the self-expanding transcatheter valve in that setting seemed to have less of that phenomenon occurring. That is possibly because some of the patient-prosthetic mismatch may be related to the fact that the natural valve is in the annulus, and the leaflet of the self-expanding valve is above that, so you don’t take up valuable real estate with the leaflet’s architecture being fixed at the annulus, which is the narrowest part of the whole area. If you are not crimping at that, that may be significant in the long term for durability.
We hope that we will start to see more evolution with our tissues in longevity management. There is a lot of research going on in how to make the leaflets better in the long term. Unfortunately, animal studies do not always equate to humans. We may have to wait 10 years to see if a valve is holding up in human biology as it did in animal biology.
We still look at each patient individually, and in most centers that have TAVR as an option, the choice of procedure is a team decision except in the most extreme circumstances. In a relatively healthy young person, we will likely try to talk them into a mechanical surgical valve, but many people don’t want to take warfarin, which is required for mechanical valves, so younger and younger patients are asking for TAVR. And that requires us to think about reinterventions down the road. Different valve platforms are better suited for different circumstances, and we have to consider factors such as size of the annulus and presence of a bulging sinus. Mechanical valves have bench-tested over 100 years, but once one hits age 70, the risk of being on warfarin goes up, and a fall becomes a much bigger deal.
Collapse
Reardon MJ, et al. Late-Breaking Clinical Trials IV. Presented at: American College of Cardiology Scientific Session; April 2-4, 2022; Washington, D.C. (hybrid meeting).
Click Here to Manage Email Alerts