Long-term data support durability and sustained outcomes with balloon-expandable TAVR valves
Tsuyoshi Kaneko, MD, is a hybrid cardiac surgeon who specializes in both complex heart surgeries and catheter-based interventional procedures. He diagnoses and treats severe aortic stenosis on a daily basis, working with cardiologists to determine if the best path forward is transcatheter aortic valve replacement (TAVR), surgical aortic valve replacement (SAVR) or something else entirely.
Kaneko, director of cardiothoracic surgery and chair of cardiovascular disease at Washington University in St. Louis, says there is no one-size-fits-all approach to patient care. Instead, it’s about evaluating each patient’s circumstances and considering the advantages of each treatment option.
“I firmly believe there are pros and cons to both surgery and transcatheter therapies,” he explains. “TAVR is minimally invasive, and the recovery is much faster. Surgery, on the other hand, may be a better choice if the patient has a ton of calcium or a high-risk anatomy.”
Kaneko has had a front-row seat to this discussion and the increasing use of TAVR. He still remembers the early days, when it was reserved for high-risk patients who were not good candidates for cardiac surgery. “Today,” he says, “it is an established treatment option for many patients who are high-, intermediate- and low-risk patients with severe aortic stenosis.”
“The progress and breakthroughs in TAVR care over the past few decades is unbelievable,” he continues. “Not only have catheters evolved, but the procedure has developed to be more standardized, with a higher degree of consistency. As we see more real world and clinical data, we continue to learn more about this important technology.”
Long-term clinical data provide support for TAVR durability
Multiple recent studies have provided long-term outcomes data for TAVR. These trials have been critical for clinicians because transcatheter heart valves do degrade over time and eventually need to be replaced. Clinicians don’t want to be implanting heart valves that need to be replaced after just a handful of years—and patients don’t want that either.
“Valve durability is particularly important as low-risk patients are undergoing TAVR treatment earlier," Kaneko says. "We are seeing more and more patients who are outliving their valves, and we want them to achieve the best possible long-term outcomes.”
Many studies, including the PARTNER trials, have explored and addressed such topics. In the landmark PARTNER 3 trial, 1,000 low-risk patients were randomized to undergo either TAVR or SAVR. TAVR patients received a balloon-expandable, intra-annular SAPIEN 3 transcatheter heart valve from Edwards Lifesciences. SAVR patients received a surgical bioprosthetic valve. In 2025, researchers shared updated data from PARTNER 3 that confirmed TAVR and SAVR were associated with comparable outcomes a full seven years after treatment.1 Even the valve hemodynamics were low for both groups. Mean aortic valve gradients were 13.1 mm Hg after TAVR and 12.1 mm Hg after surgery, and mean effective orifice areas (EOAs) were 1.9 cm2 after TAVR and 1.8 cm2 after surgery.
The PARTNER II study, meanwhile, has been tracking intermediate-risk patients randomized to undergo TAVR with a balloon-expandable, intra-annular transcatheter heart valve or SAVR.3 A 10-year update found that SAPIEN 3 TAVR and SAVR are associated with comparable outcomes and valve durability, confirming that these valves are still performing well a full decade later.3
“Valve durability is particularly important as low-risk patients are undergoing TAVR treatment earlier. We are seeing more and more patients who are outliving their valves, and we want them to achieve the best possible long-term outcomes.”
- Tsuyoshi Kaneko, MD, Director of Cardiothoracic Surgery and John M Shoenberg Chair of Cardiovascular Disease, Washington University in St. Louis
In both PARTNER 3 and PARTNER II, reintervention rates, a key component also related to valve durability, were low among TAVR patients.1, 2, 3
“Reintervention rate is something both cardiologists and surgeons watch very closely,” Kaneko notes. “There is always risk when you have patients return to the hospital for another procedure. If we have to reintervene because of valve durability, that is not ideal.”
The SAPIEN 3 Ultra RESILIA transcatheter heart valve. Image courtesy of Edwards Lifesciences.
Valve choice a key component of TAVR
The choice of which valve to use during TAVR procedures comes down to what is best for each patient. One option includes the Edwards Lifesciences SAPIEN 3 platform, which was developed with intentional design features that are important for the long-term treatment of the patient. These include a low-profile frame, intended to support future coronary access, and availability in a wide range of sizes, providing treatment options for patients with a range of aortic annulus sizes.
The SAPIEN 3 Ultra RESILIA valve, which the FDA approved in 2022, was further designed to include an innovative change: tissue that utilizes advanced anti-calcification technology designed to block calcium-binding residual aldehyde groups, a key contributor to valve deterioration over time.
Compared to the SAPIEN 3 transcatheter valve, the SAPIEN 3 Ultra valve is also distinct with its taller, textured skirt that limits paravalvular leak (PVL) after treatment.
“PVLs have been associated with adverse clinical outcomes and remain an important consideration following valve replacement,” Kaneko says. “Reducing PVLs may contribute to long-term valve performance and help patients keep their valves longer.”
The power of collaboration
As Kaneko reflects on TAVR’s rise over the years, a trend that shows no signs of slowing down, he says none of it would be possible without teamwork. Since TAVR was first introduced, the Heart Team—a multidisciplinary group that includes representatives from the fields of interventional cardiology, cardiac surgery, medical imaging and more—has been a required part of every treatment decision made for a patient with severe aortic stenosis.
“Heart Teams are an integral part of the patient and physician experience, serving as a key collaborator,” Kaneko says. “I am eager for the continued partnership with these teams and how we can further work together to collectively serve our patients to choose the best therapies, including surgery and TAVR.”
Optimism about the future
In addition to his optimism about collaborative care, Kaneko is eager to discuss the future of TAVR. Kaneko believes valve durability should continue to be at the heart of each and every conversation about severe aortic stenosis.
“I think we can be cautiously optimistic about the long-term value of TAVR,” he says. “I am looking forward to ongoing data readouts, including the 10-year results for low-risk patients, to support the promise of this life-changing procedure and what future intervention possibilities could look like for patients.”
References:
1. Leon et al. Transcatheter or Surgical Aortic-Valve Replacement in Low-Risk Patients at 7 Years. N Engl J Med 2026;394:773-783.
2. Mack, M. J. Long-Term Follow-up of the PARTNER 3 Low-Risk Randomized Trial: Seven-Year Clinical and Echocardiographic Outcomes. Presented at: TCT 2025; San Francisco, CA; October 27, 2025.
3. Nazif, T, Simonato, M, Makkar, R. et al. 10-Year Outcomes of SAPIEN 3 Transcatheter Aortic Valve Replacement or Surgery in Intermediate-Risk Patients. JACC. 2026 Jun, 87 (23) 3296–3308.
Important Safety Information
Edwards SAPIEN 3, Edwards SAPIEN 3 Ultra, and Edwards SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve System
Indications: The Edwards SAPIEN 3, SAPIEN 3 Ultra, and SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve system is indicated to reduce the risks associated with progression from asymptomatic to symptomatic severe native calcific aortic stenosis in patients who are judged by a heart team to be appropriate for transcatheter heart valve replacement therapy.
The Edwards SAPIEN 3, SAPIEN 3 Ultra, and SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve system is indicated for relief of aortic stenosis in patients with symptomatic heart disease due to severe native calcific aortic stenosis who are judged by a Heart Team, including a cardiac surgeon, to be appropriate for the transcatheter heart valve replacement therapy.
The Edwards SAPIEN 3, SAPIEN 3 Ultra, and SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve system is indicated for patients with symptomatic heart disease due to a failing (stenosed, insufficient, or combined) surgical or transcatheter bioprosthetic aortic valve, or a native mitral valve with an annuloplasty ring who are judged by a heart team, including a cardiac surgeon, to be at high or greater risk for open surgical therapy (i.e., predicted risk of surgical mortality ≥ 8% at 30 days, based on the Society of Thoracic Surgeons (STS) risk score and other clinical co-morbidities unmeasured by the STS risk calculator).
The Edwards SAPIEN 3, SAPIEN 3 Ultra, and SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve system is indicated for patients with symptomatic heart disease due to a failing (stenosed, insufficient, or combined) surgical bioprosthetic mitral valve who are judged by a heart team, including a cardiac surgeon, to be at intermediate or greater risk for open surgical therapy (i.e., predicted risk of surgical mortality ≥ 4% at 30 days, based on the Society of Thoracic Surgeons (STS) risk score and other clinical co-morbidities unmeasured by the STS risk calculator).
Contraindications: The valves and delivery systems are contraindicated in patients who cannot tolerate an anticoagulation/antiplatelet regimen or who have active bacterial endocarditis or other active infections, or who have significant annuloplasty ring dehiscence.
Warnings: Observation of the pacing lead throughout the procedure is essential to avoid the potential risk of pacing lead perforation. There may be an increased risk of stroke in transcatheter aortic valve replacement procedures, as compared to balloon aortic valvuloplasty or other standard treatments in high or greater risk patients. The devices are designed, intended, and distributed for single use only. Do not resterilize or reuse the devices. There are no data to support the sterility, nonpyrogenicity, and functionality of the devices after reprocessing. Incorrect sizing of the valve may lead to paravalvular leak, migration, embolization, residual gradient (patient-prosthesis mismatch), and/or annular rupture. Accelerated deterioration of the valve due to calcific degeneration may occur in children, adolescents, or young adults and in patients with an altered calcium metabolism. Prior to delivery, the valve must remain hydrated at all times and cannot be exposed to solutions other than its shipping storage solution and sterile physiologic rinsing solution. Valve leaflets mishandled or damaged during any part of the procedure will require replacement of the valve. Caution should be exercised in implanting a valve in patients with clinically significant coronary artery disease. Patients with pre-existing prostheses should be carefully assessed prior to implantation of the valve to ensure proper valve positioning and deployment. Do not use the valve if the tamper-evident seal is broken or the storage solution does not completely cover the valve (SAPIEN 3 and SAPIEN 3 Ultra only), the temperature indicator has been activated, the valve is damaged, or the expiration date has elapsed. Do not mishandle the delivery system or use it if the packaging or any components are not sterile, have been opened or are damaged (e.g., kinked or stretched), or if the expiration date has elapsed. Use of excessive contrast media may lead to renal failure. Measure the patient’s creatinine level prior to the procedure. Contrast media usage should be monitored. Patient injury could occur if the delivery system is not un-flexed prior to removal. Care should be exercised in patients with hypersensitivities to cobalt, nickel, chromium, molybdenum, titanium, manganese, silicon, and/or polymeric materials. The procedure should be conducted under fluoroscopic guidance. Some fluoroscopically guided procedures are associated with a risk of radiation injury to the skin. These injuries may be painful, disfiguring, and long-lasting. Valve recipients should be maintained on anticoagulant/antiplatelet therapy, except when contraindicated, as determined by their physician. This device has not been tested for use without anticoagulation. Do not add or apply antibiotics to the storage solution (SAPIEN 3 and SAPIEN 3 Ultra only), rinse solution, or to the valve. Balloon valvuloplasty should be avoided in the treatment of failing bioprostheses as this may result in embolization of bioprosthesis material and mechanical disruption of the valve leaflets. Do not perform stand-alone balloon aortic valvuloplasty procedures in the INSPIRIS RESILIA aortic valve for the sizes 19-25 mm. This may expand the valve causing aortic incompetence, coronary embolism or annular rupture. Transcatheter valve replacement in mitral annuloplasty rings is not recommended in cases of partial annuloplasty ring dehiscence due to high risk of PVL. Transcatheter valve replacement in mitral annuloplasty rings is not recommended in cases of partial (incomplete) annuloplasty rings in the absence of annular calcium due to increased risk of valve embolization. Transcatheter valve replacement in mitral annuloplasty rings is not recommended in cases of rigid annuloplasty rings due to increased risk of PVL or THV deformation.
Precautions: Long-term durability has not been established for the valve. Regular medical follow-up is advised to evaluate valve performance. Limited clinical data are available for transcatheter aortic valve replacement in patients with a congenital bicuspid aortic valve who are deemed to be at low surgical risk. Anatomical characteristics should be considered when using the valve in this population. In addition, patient age should be considered as long-term durability of the valve has not been established. Data on TAVR in patients with asymptomatic severe aortic stenosis are based on study of predominantly low surgical risk patients. Limited clinical data to inform benefit-risk considerations are available for TAVR in patients with asymptomatic severe aortic stenosis who are deemed to be at intermediate or greater surgical risk. Glutaraldehyde may cause irritation of the skin, eyes, nose, and throat. Avoid prolonged or repeated exposure to, or breathing of, the solution. Use only with adequate ventilation. If skin contact occurs, immediately flush the affected area with water; in the event of contact with eyes, seek immediate medical attention. For more information about glutaraldehyde exposure, refer to the Safety Data Sheet available from Edwards Lifesciences. If a significant increase in resistance occurs when advancing the catheter through the vasculature, stop advancement and investigate the cause of resistance before proceeding. Do not force passage, as this could increase the risk of vascular complications. As compared to SAPIEN 3, system advancement force may be higher with the use of SAPIEN 3 Ultra/SAPIEN 3 Ultra RESILIA THV in tortuous/challenging vessel anatomies. To maintain proper valve leaflet coaptation, do not overinflate the deployment balloon. Appropriate antibiotic prophylaxis is recommended post-procedure in patients at risk for prosthetic valve infection and endocarditis. Additional precautions for transseptal replacement of a failed mitral valve bioprosthesis include, the presence of devices or thrombus or other abnormalities in the caval vein precluding safe transvenous femoral access for transseptal approach; and the presence of an Atrial Septal Occluder Device or calcium preventing safe transseptal access. Special care must be exercised in mitral valve replacement to avoid entrapment of the subvalvular apparatus. Safety and effectiveness have not been established for patients with the following characteristics/comorbidities: non-calcified aortic annulus; severe ventricular dysfunction with ejection fraction < 20%; congenital unicuspid aortic valve; pre-existing prosthetic ring in the tricuspid position; severe mitral annular calcification (MAC); severe (> 3+) mitral insufficiency, or Gorlin syndrome; blood dyscrasias defined as leukopenia (WBC < 3000 cells/mL), acute anemia (Hb < 9 g/dL), thrombocytopenia (platelet count < 50,000 cells/mL), or history of bleeding diathesis or coagulopathy; hypertrophic cardiomyopathy with or without obstruction (HOCM); echocardiographic evidence of intracardiac mass, thrombus, or vegetation; a known hypersensitivity or contraindication to aspirin, heparin, ticlopidine (Ticlid), or clopidogrel (Plavix), or sensitivity to contrast media, which cannot be adequately premedicated; significant aortic disease, including abdominal aortic or thoracic aneurysm defined as maximal luminal diameter 5 cm or greater, marked tortuosity (hyperacute bend), aortic arch atheroma (especially if thick [> 5 mm], protruding, or ulcerated) or narrowing (especially with calcification and surface irregularities) of the abdominal or thoracic aorta, severe “unfolding” and tortuosity of the thoracic aorta; access characteristics that would preclude safe placement of the Edwards sheath, such as severe obstructive calcification or severe tortuosity; bulky calcified aortic valve leaflets in close proximity to coronary ostia; a concomitant paravalvular leak where the failing prosthesis is not securely fixed in the native annulus or is not structurally intact (e.g., wireform frame fracture, annuloplasty ring dehiscence); or a partially detached leaflet of the failing bioprosthesis that in the aortic position may obstruct a coronary ostium. For Left axillary approach, a left subclavian takeoff angle ~ ≥ 90° from the aortic arch causes sharp angles, which may be responsible for potential sheath kinking, subclavian/axillary dissection and aortic arch damage. For left/right axillary approach, ensure there is flow in Left Internal Mammary Artery (LIMA)/Right Internal Mammary Artery (RIMA) during procedure and monitor pressure in homolateral radial artery. Residual mean gradient may be higher in a “THV-in-failing prosthesis” configuration than that observed following implantation of the valve inside a native aortic annulus using the same size device. Patients with elevated mean gradient post procedure should be carefully followed. It is important that the manufacturer, model and size of the preexisting prosthesis be determined, so that the appropriate valve can be implanted and a prosthesis-patient mismatch be avoided. Additionally, pre-procedure imaging modalities must be employed to make as accurate a determination of the inner diameter as possible.
Potential Adverse Events: Potential risks associated with the overall procedure, including potential access complications associated with standard cardiac catheterization, balloon valvuloplasty, the potential risks of conscious sedation and/or general anesthesia, and the use of angiography: death; stroke/transient ischemic attack, clusters, or neurological deficit; paralysis; permanent disability; respiratory insufficiency or respiratory failure; hemorrhage requiring transfusion or intervention; cardiovascular injury including perforation or dissection of vessels, ventricle, atrium, septum, myocardium, or valvular structures that may require intervention; pericardial effusion or cardiac tamponade; thoracic bleeding; embolization including air, calcific valve material, or thrombus; infection including septicemia and endocarditis; heart failure; myocardial infarction; renal insufficiency or renal failure; conduction system defect which may require a permanent pacemaker; arrhythmia; retroperitoneal bleed; arteriovenous (AV) fistula or pseudoaneurysm; reoperation; ischemia or nerve injury or brachial plexus injury; restenosis; pulmonary edema; pleural effusion; bleeding; anemia; abnormal lab values (including electrolyte imbalance); hypertension or hypotension; allergic reaction to anesthesia, contrast media, or device materials; hematoma; syncope; pain or changes (e.g., wound infection, hematoma, and other wound care complications) at the access site; exercise intolerance or weakness; inflammation; angina; heart murmur; and fever. Additional potential risks associated with the use of the valve, delivery system, and/or accessories include: cardiac arrest; cardiogenic shock; emergency cardiac surgery; cardiac failure or low cardiac output; coronary flow obstruction/transvalvular flow disturbance; device thrombosis requiring intervention; valve thrombosis; device embolization; device migration or malposition requiring intervention; left ventricular outflow tract obstruction; valve deployment in unintended location; valve stenosis; structural valve deterioration (wear, fracture, calcification, leaflet tear/tearing from the stent posts, leaflet retraction, suture line disruption of components of a prosthetic valve, thickening, stenosis); device degeneration; paravalvular or transvalvular leak; valve regurgitation; hemolysis; device explants; nonstructural dysfunction; mechanical failure of delivery system and/or accessories; and non-emergent reoperation.
Edwards Crimper
Indications: The Edwards crimper is indicated for use in preparing the Edwards SAPIEN 3 transcatheter heart valve, Edwards SAPIEN 3 Ultra transcatheter heart valve, and the Edwards SAPIEN 3 Ultra RESILIA transcatheter heart valve for implantation.
Contraindications: There are no known contraindications.
Warnings: The device is designed, intended, and distributed for single use only. Do not resterilize or reuse the device. There are no data to support the sterility, nonpyrogenicity, and functionality of the device after reprocessing. Do not mishandle the device. Do not use the device if the packaging or any components are not sterile, have been opened or are damaged, or the expiration date has elapsed.
Precautions: For special considerations associated with the use of the Edwards crimper prior to THV implantation, refer to the THV Instructions for Use.
Potential Adverse Events: There are no known potential adverse events associated with the Edwards crimper.
CAUTION: Federal (United States) law restricts these devices to sale by or on the order of a physician.
Edwards, Edwards Lifesciences, the stylized E logo, Edwards SAPIEN, Edwards SAPIEN 3, Edwards SAPIEN 3 Ultra, INSPIRIS, INSPIRIS RESILIA, PARTNER, PARTNER II, PARTNER 3, RESILIA, SAPIEN, SAPIEN 3, and SAPIEN 3 Ultra are trademarks or service marks of Edwards Lifesciences Corporation. All other trademarks are the property of their respective owners.
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Michael has more than 19 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.