Transcatheter aortic valve replacement (TAVR) has become an established treatment approach for many patients with aortic stenosis. Its use in aortic regurgitation (AR), however, presents different anatomical and procedural considerations.
Aortic stenosis is commonly associated with calcification and narrowing of the native aortic valve. In pure aortic regurgitation, the valve may have little or no calcification, while the aortic annulus or root may also be enlarged. These differences can make stable positioning and anchoring of a transcatheter valve more challenging.
These anatomical considerations have contributed to the development of transcatheter valve systems designed specifically for native aortic regurgitation.
One of these is the J-Valve Transfemoral (J-Valve TF) System, which uses a patented anchoring design developed for the anatomical characteristics encountered in aortic regurgitation.
What Is Transcatheter Aortic Valve Replacement?
Transcatheter aortic valve replacement, also known as TAVR or transcatheter aortic valve implantation (TAVI), is a catheter-based procedure in which a prosthetic valve is implanted within the native aortic valve.
Unlike surgical aortic valve replacement, the native valve is not removed. Instead, the transcatheter valve is delivered to the heart, positioned within the existing valve and deployed to take over its function.
TAVR was initially developed and clinically established primarily for aortic stenosis, where the native valve becomes narrowed and commonly calcified.
Applying transcatheter valve technology to native aortic regurgitation presents a different set of challenges because the underlying valve anatomy is often different.
What Is the Transfemoral Approach to TAVR?
The transfemoral approach allows a transcatheter heart valve to be delivered through the femoral artery, a major blood vessel in the groin.
During transfemoral TAVR, the valve and delivery system are introduced into the femoral artery and advanced through the vascular system towards the heart. Imaging is used to support procedural planning, positioning and valve deployment.
Because the valve is delivered through the vascular system, the transfemoral approach does not require the chest incision used for conventional open-heart valve replacement.
Whether transfemoral TAVR is appropriate depends on several factors, including vascular anatomy, aortic valve and root anatomy, the patient’s overall clinical condition and the characteristics of the transcatheter system being used.
Why Is TAVR More Challenging in Aortic Regurgitation?
The anatomical differences between aortic stenosis and aortic regurgitation are important when considering transcatheter valve treatment.
Limited or Absent Valve Calcification
Calcific aortic stenosis is characterised by progressive narrowing and calcification of the native valve. This calcified anatomy can contribute to the anchoring of many conventional transcatheter valves.
Pure native aortic regurgitation often has little or no valve calcification. Without the same calcified anatomy, achieving stable positioning and anchoring can be more difficult for transcatheter valves developed primarily for aortic stenosis.
Larger Aortic Annulus or Root
Some patients with aortic regurgitation also have enlargement of the aortic annulus, aortic root or ascending aorta.
A larger annulus can present additional challenges for transcatheter valve sizing and fixation, particularly when the anatomy falls outside the dimensions for which a valve system was originally developed.
Valve Positioning and Anchoring
The combination of limited calcification and enlarged anatomy can make valve positioning and anchoring more challenging.
Clinical experience with transcatheter valves developed primarily for aortic stenosis and used off-label in native AR has identified complications including valve malposition, migration or embolisation, residual aortic regurgitation and the need for additional intervention.
These challenges have contributed to the development of transcatheter systems with anchoring mechanisms designed specifically for native aortic regurgitation.
Why Have Dedicated TAVR Systems Been Developed for Aortic Regurgitation?
For much of the development of TAVR, transcatheter valve technologies and regulatory approvals focused primarily on aortic stenosis.
For patients with severe aortic regurgitation who require valve intervention, surgery remains an established treatment when the patient is suitable for surgery. Current European guidelines state that transcatheter treatment may be considered at experienced centres for selected patients with severe AR who are ineligible for surgery and have suitable anatomy.
However, the anatomical characteristics of native AR mean that simply applying a valve developed for calcific aortic stenosis may present limitations.
Dedicated AR systems have therefore been developed with design features intended to address considerations such as limited valve calcification and the need for stable positioning within the native valve anatomy.
J-Valve TF and Its Approach to Aortic Regurgitation
The J-Valve TF System is a transcatheter heart valve system developed for the treatment of aortic regurgitation through a transfemoral approach.
The valve consists of a self-expanding nitinol frame, bovine pericardial valve leaflets and three nitinol anchor rings. It is delivered using a steerable transfemoral delivery system.
A Patented Anchoring Design
A distinguishing feature of J-Valve TF is its patented anchoring design.
The system incorporates three anchor rings designed to locate and position the prosthetic valve within the native aortic valve sinuses.
This design is particularly relevant to native aortic regurgitation because these patients may have little or no valve calcification. Rather than relying only on calcified native valve tissue for fixation, the anchor rings interact with the native valve anatomy to support positioning of the prosthesis.
Self-Expanding Valve
J-Valve TF uses a self-expanding nitinol valve frame. Once the system is positioned, the frame expands within the native valve anatomy.
The valve frame and anchor-ring system are designed to work together during valve positioning and deployment.
Transfemoral Delivery
J-Valve was initially evaluated using a transapical approach, in which the valve was delivered through access at the apex of the heart.
The J-Valve TF system was subsequently developed for transfemoral delivery, allowing the valve to be introduced through the femoral artery. Published descriptions of the transfemoral system identify a steerable and flexible delivery catheter designed for this approach.
Progress in Transcatheter Treatment for Aortic Regurgitation
The development of dedicated transcatheter systems reflects continued work to address the anatomical challenges of native aortic regurgitation.
J-Valve has progressed from earlier transapical experience to the development and clinical evaluation of the transfemoral system.
Clinical evaluation has accompanied this development. At EuroPCR 2024, 12-month follow-up results for J-Valve TF were presented, contributing further clinical information on the transfemoral system.
In September 2025, J-Valve TF received approval from China’s National Medical Products Administration for the transfemoral treatment of aortic regurgitation. It became the first transfemoral TAVR system approved in China specifically for AR. Read more
The development of dedicated systems such as J-Valve TF reflects the broader progression of transcatheter treatment approaches designed around the anatomy of native aortic regurgitation.
How Are Treatment Decisions Made in Aortic Regurgitation?
Transcatheter treatment is not appropriate for every patient with aortic regurgitation.
Treatment decisions depend on factors including the severity of the regurgitation, symptoms, changes in heart size or function, aortic anatomy, other medical conditions and whether the patient is suitable for surgery.
For patients with severe AR who are being considered for transcatheter intervention, detailed anatomical assessment is also important because valve size, aortic root dimensions and vascular access can influence whether a particular transcatheter system is suitable.
More broadly, treatment for aortic regurgitation depends on the severity of the condition, whether symptoms are present and whether the disease is progressing.
Conclusion
Transcatheter treatment of aortic regurgitation presents different anatomical challenges from TAVR for aortic stenosis.
Pure native AR often has little or no valve calcification and may be associated with enlargement of the aortic annulus or root. These characteristics can make positioning and anchoring more challenging for transcatheter valves developed primarily for calcific aortic stenosis.
Dedicated transcatheter systems have therefore been developed around the anatomical characteristics of native AR.
The J-Valve TF System combines a self-expanding transcatheter valve with a patented three-anchor-ring design intended to locate and position the prosthesis within the native aortic valve anatomy. The development of the transfemoral system, its clinical evaluation and its approval in China represent steps in the continuing development of transcatheter treatment for aortic regurgitation.
Treatment decisions remain individualised and depend on the patient’s valve disease, anatomy, overall clinical condition and suitability for the available treatment approaches.
Key References
- 2025 ESC/EACTS Guidelines for the Management of Valvular Heart Disease
- Samimi S, et al. Meta-Analysis of Dedicated vs Off-Label Transcatheter Devices for Native Aortic Regurgitation. JACC: Cardiovascular Interventions. 2025.
- Garcia S, et al. Treatment of Aortic Regurgitation With a Novel Device: Results of the J-Valve Early Feasibility Study. JACC: Cardiovascular Interventions. 2024.
- Mayo Clinic. Aortic Valve Regurgitation: Diagnosis and Treatment.
- Genesis MedTech. J-VALVE TF Approved by NMPA, China’s First Transfemoral TAVR for Aortic Regurgitation. 2025.
This article is intended for general educational purposes and does not replace individual medical advice, diagnosis or treatment from a qualified healthcare professional.