Q&A: How supra-annular, self-expanding TAVR valves open up options for future interventions
Transcatheter aortic valve replacement (TAVR) procedures have surged more than 30% since 2020, with more than 107,000 patients receiving a new prosthetic valve in 2023 alone.1 As this trend continues, it’s increasingly important that cardiologists consider the long-term impact on future coronary interventions patients may need.
Consider, for example, a 65-year-old patient who undergoes TAVR and then has a heart attack a decade later. Cardiologists will need to access the coronaries in a hurry, and limited access could delay treatment.
That’s what makes commissural alignment so important—it provides more options for potential future interventions. If cardiologists are unable to access the patient’s coronaries, it can negatively impact hemodynamics, impair future coronary access, and make valve-in-valve TAVR attempts much more difficult.
“Fortunately, advanced TAVR technology has reduced those concerns in my clinic,” says Guilherme Attizzani, MD, director of the valve and structural heart center at University Hospitals Cleveland Medical Center (UHCMC) and a professor at Case Western Reserve University.†
Attizzani and his colleagues at UHCMC perform TAVR on more than 400 patients per year. They implanted the world’s first EvolutTM PRO+ TAVR valve and were early adopters of both the EvolutTM FX and EvolutTM FX+.
Cardiovascular Business spoke with Attizzani about how newer valves are providing more options for patient management and why general cardiologists need to make sure the best valve option is used during every TAVR procedure.
"Now that we are treating younger, low-risk patients, the broader cardiology community should be focusing on long-term needs such as durability, valve performance and lifetime patient management. The supra-annular, self-expandable design has a strong track record and sets our patients up for a successful procedure and smooth recovery. "
Guilherme Attizzani, MD, director of the valve and structural heart center at University Hospitals Cleveland Medical Center
Read the full conversation below:
Cardiovascular Business: What is commissural alignment? Why is it so important?
Guilherme Attizzani, MD: Commissural alignment means, simply, lining up the commissures of the prosthetic heart valve with the patient’s native commissures so that coronary access is more achievable.
It matters because we are now treating patients who are progressively younger and lower risk with TAVR. And for us to deliver results that are as good as SAVR2—and maybe even better—commissural alignment has become a crucial aspect of the procedure.
When surgeons perform SAVR, they align the commissures because they have a direct visualization. The goal is to prevent the commissural posts of the surgical valve from being in front of the coronary ostia. If that happens, commissure misalignment impairs the ability to cannulate the coronaries when you have to perform a heart catheterization, for example, or when the placement of a coronary stent may be necessary. You really do not want to have anything in the way.
We should be able to do the same thing when we perform TAVR. We want the ability to cannulate the coronaries after the valve has been implanted. There have even been some benchtop evidence suggesting reduced leaflet stress may impact valve durability,3 but we still need more information on that. For now, the primary goal remains to allow for easier access to the coronary arteries.
How has TAVR technology evolved to help cardiologists with commissural alignment?
Medtronic’s EvolutTM transcatheter heart valves have been updated multiple times over the years to help clinicians secure commissural alignment. In fact, the platform’s most recent addition, the EvolutTM FX+, was designed with windows on the frame that were four times larger than previous versions. This new frame is designed to help enable lifetime management solutions such as coronary access.4,5,6
Before that, the EvolutTM FX was a big upgrade, because Medtronic added gold markers that show up in imaging. The cardiologist can confirm there is commissural alignment by literally lining up the markers.
The gold markers, I should add, have been a reliable way to know if commissural alignment has been achieved. I participated in one study that found lining up the markers ensures commissural alignment in 97% of patients.6
Do these upgrades mean supra-annular, self-expanding valves are ultimately a better treatment option?
There are many things to consider here. Commissural alignment is a big piece of the puzzle, because it facilitates access to the coronaries and will make it easier to do valve-in-valve TAVR 10 or 15 years down the road if necessary.7, 8 There also is the fact that the supra-annular, self-expanding valves deliver superior hemodynamic data—reduced gradients in small annulus patients, for example—when comparing Evolut vs SAPIEN at one year.9 Evolut also has shown to be a more durable option compared to SAVR out to five years.10
Another big advantage with supra-annular, self-expanding valves is they allow for liberal over-sizing, as seen in the SMART trial, so you can safely put a much bigger valve in place when needed.9
Now that we are treating younger, low-risk patients, the broader cardiology community should be focusing on long-term needs such as durability, valve performance and lifetime patient management. The supra-annular, self-expandable design has a strong track record and sets our patients up for a successful procedure and smooth recovery.
Combine all of these different things together and I do think supra-annular, self-expanding valves are a very attractive option.
What does this all mean for the general cardiologist?
Cardiologists can appreciate the importance of the improved access that comes with commissural alignment. If a patient has already had TAVR and then he or she has a heart attack, it is going to be much easier to care for that patient if there is nothing blocking access to the coronaries.
Cardiologists will also enjoy the peace of mind that comes when patients receive a supra-annular, self-expanding TAVR valve. They know their patients will not be stranded in the rare instance they need percutaneous coronary intervention after TAVR, for example. Also, their patients are going to feel more comfortable with the idea of TAVR, because they’ll know the valve they are receiving was designed with future therapies in mind.
Again, there has even been research suggesting leaflet stress may impact durability,3 but more information is needed. If true, this would be a big deal for any cardiologist.
What else should cardiologists be thinking about when it comes to TAVR in today’s evolving healthcare environment?
It’s important for general cardiologists to know which valves their interventional and surgical colleagues are implanting so that they can make more informed referral decisions for their patients. Some interventional groups may only implant intra-annular balloon-expandable valves, just like some surgical teams may only implant small surgical valves. It happens, and this is something a cardiologist should be aware of so that they can refer their patients to the best therapy option for their unique situation.
It is always a good idea to educate yourself as much as possible. When I refer a patient of mine to another physician, I know I’m going to ask questions so that I understand what is happening. I want to know the rationale behind different choices. I want to know my patient is in safe hands.
† Dr. Attizzani did not receive compensation for this piece. However, he has received compensation from Medtronic Medical Education and Proctor Programs.
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References:
1. STS/ACC TVT Registry data on file.
2. John Forest, et al. 4-Year Outcomes of Patients With Aortic Stenosis in the Evolut Low Risk Trial. JACC. Volume 82, Issue 22. 28 November 2023, Pages 2163-2165.
3. Viktória Stanová, Régis Rieu, Lionel Thollon, et al. Leaflet Mechanical Stress in Different Designs and Generations of Transcatheter Aortic Valves: An in Vitro Study, Structural Heart, Volume 8, Issue 2, 2024.
4. Medtronic computational data model on file compared to the Evolut platform. Bench top computational model may not be indicative of clinical performance. Evolut FX+ Test Report: DO1106198 Rev. A
5. Attizzani GF et al. Commissure, and Coronary Alignment Post-TAVR With Evolut FX System: CANNULATE TAVR Study. JACC Cardiovasc Interv. 2024 Mar 25;17(6):825-827. doi: 10.1016/j.jcin.2023.10.033. Epub 2023 Oct 23. PMID: 37902149.
6. Yoon SH et al. Commissural and Coronary Alignment After Transcatheter Aortic Valve Replacement Using the New Supra-Annular, Self-Expanding Evolut FX System. Circ Cardiovasc Interv. 2023 Apr;16(4):e012657. doi: 10.1161/CIRCINTERVENTIONS.122.012657. Epub 2023 Apr 3. PMID: 37009735
7. Bapat VN et al. A Guide to Transcatheter Aortic Valve Design and Systematic Planning for a Redo-TAV (TAV-in-TAV) Procedure. JACC Cardiovasc Interv. 2024 Jul 22;17(14):1631-1651. doi: 10.1016/j.jcin.2024.04.047. PMID: 39048251.
8. Tang G.H.L., Zaid S., Fuchs A., et al. "Alignment of transcatheter aortic-valve neo-commissures (ALIGN TAVR): impact on final valve orientation and coronary artery overlap". J Am Coll Cardiol Intv 2020;13:1030-1042.
9. Tchétché D, Mehran R, Blackman DJ, et al. Transcatheter Aortic Valve Implantation by Valve Type in Women With Small Annuli: Results From the SMART Randomized Clinical Trial. JAMA Cardiol. Published online October 09, 2024. doi:10.1001/jamacardio.2024.3241
10. Yakubov S, et al. Impact of Bioprosthetic Valve Performance on 5-Year Clinical Outcomes after Self-Expanding TAVI or Surgery in Patients at Intermediate or Greater Surgical Risk. Presented at NY Valves; June 2024
Michael has more than 18 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.