TAVR technology keeps evolving, improving outcomes without compromising valve performance
Transcatheter aortic valve replacement (TAVR) has become a go-to treatment for symptomatic severe aortic stenosis (ssAS) in much of the world, particularly for patients at high risk for surgical valve replacement, allowing cardiologists to implant bioprosthetic heart valves without open heart surgery [1].
The inspiration for TAVR goes back to 1989, when Danish interventional cardiologist Henning Rud Andersen, MD, implanted an early version of a TAVR valve into a 175-pound pig.[2] The procedure went on to gain CE mark approval in 2006 and U.S. Food and Drug Administration (FDA) approval in 2011, and the research and innovation have been constant ever since.
Deepak R. Talreja, MD, chief of cardiology at Sentara Heart Hospital in Virginia, has seen much of this innovation firsthand. He started implanting transcatheter heart valves in 2011, participated in multiple TAVR trials and helped found the team at Sentara Heart Hospital which is now one of the busiest structural heart programs in the United States.
“We started by performing TAVR on inoperable patients who were not candidates for heart surgery, and those patients did well,” he explains. “Today, it’s exciting that we can provide a minimally invasive AVR procedure for patients of all risk classes that provides excellent outcomes and better hemodynamics than surgical aortic valve replacement (SAVR) for many patients. [3,4,5]
TAVR technology has gone through many changes since those early days, leading to improved clinical outcomes and support for lifetime management strategies when it comes to treating younger, healthier, and low-risk patients. [5] These advancements have helped enable positive short- and long-term patient outcomes, helping heart teams feel much more at ease when recommending TAVR over surgery. [6]
Excellent design, excellent outcomes
The key to TAVR’s continued success over three and a half decades has been innovation. At any given moment, countless research teams all over the world are seeking new and creative ways to make this advanced technology safer and more effective than ever.
For example, the Medtronic EvolutTM TAVR platform has a self-expanding, supra-annular design that was built to conform to the patient’s native anatomy and provide optimal flow through the valve. The EvolutTM Low Risk Trial confirmed that Medtronic’s supra-annular, self-expanding design was associated with consistently positive patient outcomes, sustained valve performance and excellent hemodynamics data through four years. [5]
“The single most important thing to focus on when it comes to TAVR valves is performance and longevity. There are some details a cardiologist may not need to worry about—high-level clinical nuances that would just confuse the patient. But performance and longevity, including the durability of the valve and its long-term effectiveness, are everything."
Deepak R. Talreja, MD, chief of cardiology at Sentara Heart Hospital in Norfolk, Virginia
One of the primary reasons companies keep updating their TAVR valves is that they want to optimize care so that the patient’s lifetime care management is not limited. In the past, for example, cardiologists would sometimes encounter problems when trying to line up the bioprosthetic valve with the patient’s native aortic valve anatomy to allow access to the coronaries. This creates a potential issue down the road if that same patient later requires percutaneous coronary intervention (PCI) or another life-saving heart procedure that requires clinicians to access the coronaries. [7]
Medtronic acknowledged that concern with the 2022 release of its EvolutTM FX transcatheter heart valve, which included three gold markers that show up on imaging and helps operators achieve commissural alignment. [8]
Medtronic then went one step further with its newest technology, the EvolutTM FX+ valve, by engineering a window cell that is four times larger than previous Evolut iterations and designed to align in front of each coronary ostia. The larger window helps enable coronary access when needed. [9]
“In my experience, the improved coronary access helps cardiologists feel much more comfortable with TAVR,” Talreja says. “That was one of the biggest remaining concerns—that TAVR patients would be in trouble if they had a heart attack, and their doctors had to act right away. These upgrades with the markers and bigger coronary access windows help make that fear a thing of the past.”
TAVR in 2024 and beyond: What general cardiologists need to know
In his role at Sentara Heart Hospital, Talreja straddles the line between general cardiology and interventional cardiology. He sees heart patients in the office, working to diagnose what ails them and develop treatment plans, and he also leads complex interventional and structural heart procedures in the cath lab.
This has given Talreja a unique perspective on TAVR; he understands what general cardiologists need to know about this life-changing technology when they speak to their patients.
“The single most important thing to focus on when it comes to TAVR valves is performance and longevity,” he says. “There are some details a cardiologist may not need to worry about—high-level clinical nuances that would just confuse the patient. But performance and longevity, including the durability of the valve and its long-term effectiveness, are everything. When you’re implanting a valve, you want it to perform well without issues and last as long as possible so the patient can focus on enjoying better quality of life.”
Talreja points to the recent SMART trial, recently published in New England Journal of Medicine, as a key study every cardiologist should be familiar with. SMART included one-year data from 737 TAVR patients with small annuli randomized to receive either a self-expanding EvolutTM valve from Medtronic or a balloon-expandable SAPIEN 3 valve from Edwards Lifesciences. Eighty-seven percent of patients in the trial were women. Overall, Medtronic’s supra-annular valves were associated with comparable safety and clinical outcomes and superior valve performance in bioprosthetic valve dysfunction compared to SAPIEN valves after one year. [10]
“SMART showed us the obvious benefits of the Medtronic platform,” Talreja says. “What matters most when selecting a TAVR valve is: which one is the most durable? Which one will provide superior valve performance to give you that good quality of life with positive outcomes? The EvolutTM platform really delivers when it comes to all of those things. Add in what I believe is an improved design with the EvolutTM FX+ and it’s an even better treatment option now.”
Talreja says the EvolutTM Low Risk Trial was another crucial study in terms of evaluating valve performance. It demonstrated that Evolut ™ TAVR’s valve hemodynamics benefits compared to SAVR extend to a full four years after treatment.[5]
“That is a beautiful trial,” Talreja says. “It showed us that the EvolutTM TAVR valves are performing better than surgery one year, three years and even four years after treatment. [5] This is the kind of impressive data you want to show to your patients to help them feel at ease.”
† Dr. Talreja did not receive compensation for this piece. However, he has received compensation from Medtronic Medical Education and Proctor Programs.
Click here for indications, safety and warnings. Like any other procedure, TAVR risks can include death, stroke, bleeding.
™* Third-party brands are trademarks of their respective owners. All other brands are trademarks of a Medtronic company.
Click here for additional information.
References:
- Shrivastava S, Shrivastava S, Mumtaz K, Mostafa JA. Evolving Indications of Transcatheter Aortic Valve Replacement Compared to Surgical Valve Replacement: A Review of the Current Literature. Cureus. 2022 Mar 21;14(3):e23364.
- Henning Rud Andersen. How Transcatheter Aortic Valve Implantation (TAVI) Was Born: The Struggle for a New Invention. Front. Cardiovasc. Med., 28 September 2021.
- Gleason, T.G., et al., 5-Year Outcomes of Self-Expanding Transcatheter Versus Surgical Aortic Valve Replacement in High-Risk Patients. J Am Coll Cardiol, 2018. 72(22): p. 2687-2696.
- Van Mieghem, N.M., et al., Self-expanding Transcatheter vs Surgical Aortic Valve Replacement in Intermediate-Risk Patients: 5-Year Outcomes of the SURTAVI Randomized Clinical Trial. JAMA Cardiol, 2022. 7(10): p. 1000-1008.
- 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.
- Yakubov, S.J., Impact of Bioprosthetic Valve Performance on 5-Year Clinical Outcomes after Self-Expanding TAVI or Surgery in Patients at Intermediate or Greater Surgical Risk. Presentation at New York Valves, 2024.
- ALIGN consortium : Tang GHL et al. Rationale, Definitions, Techniques, and Outcomes of Commissural Alignment in TAVR: From the ALIGN-TAVR Consortium. JACC Cardiovasc Interv. 2022 Aug 8;15(15):1497-1518.
- 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.
- 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
- Howard C. Herrmann, et al. Self-Expanding or Balloon-Expandable TAVR in Patients with a Small Aortic Annulus. N Engl J Med 2024;390:1959-1971.
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.