Valcare Reports First US Transseptal Implant Of Amend Annuloplasty

We report the first transseptal implantation of the transpalmonary AMEND annuloplasty system in the United States. Surgeons and cardiologists from various disciplines are actively seeking less invasive surgical solutions for patients with severe mitral regurgitation (MR), a common heart valve condition that can rapidly progress to heart failure if left untreated. The technique presented here allows for the transcatheter delivery of a semi-rigid annuloplasty ring, thus reproducing a time-tested surgical fix for MR in a less invasive form that can be offered to patients deemed too poor a surgical risk for open-heart surgery.

This first procedure performed in the U.S. marks another important step in the development of the structural heart program at Banner – University Medical Center Phoenix. Paul Sorajja, MD, cardiologist in the University of Arizona Sarah Barron Gabay Center for Structural Heart Disease performed the first implant of the structural heart device using the AMEND™ Transcatheter Mitral Valve Repair (TMVr) system to deliver a surgical-grade, mitral valve repair without a sternotomy. This procedure was performed as part of the AMEND TS Early Feasibility Study (EFS) ( NCT06951672 ).

Why It Matters

Mitral regurgitation (MR) occurs when the mitral valve fails to close properly, and thus allows flow of blood from the left ventricle to the left atrium during diastole. For many decades, the established treatment for MR has been surgical annuloplasty, in which the mitral valve is repaired by reshaping and reinforcing the diseased annulus. However, many patients in need of durable repair are older and have other severe medical disease that places them at very high risk for a poor surgical outcome. Fortunately, a technique for transseptal, transcatheter annuloplasty has been developed that allows a much less invasive approach to durable repair of MR.

Unique System

The AMEND device is an entirely new category of transcatheter mitral replacement devices: a closed, semi-rigid ring that anatomically remolds the native anatomy similar to what conventional surgery achieves in a permanent repair. Unlike other devices on the market that simply clip the edges of diseased mitral leaflets together (edge-to-edge repair), AMEND will be the first technology to enable percutaneous annular sizing, the cornerstone of over 95% of successful mitral surgical repairs.

Hospitals and Healthsystems

While the individual patient benefits may still be evolving, the technology may have far reaching implications for the systems of care. Transseptal annuloplasty will require modifications to current hospital staffing models and/or the creation of hybrid operating rooms or catheterization laboratories. Furthermore, training programs will need to be developed to integrate surgeons and interventional cardiologists.

Payers, Policymakers, and Patient Outcomes

The integration of transcatheter technologies in the management of mitral regurgitation will pose new challenges to payers and policy makers including the development of coverage criteria and reimbursement rates, as well as ensuring appropriate post discharge follow-up of these patients. The potential impact of these technologies extends to potentially altering treatment algorithms for patients for whom a surgical approach would be contraindicated. However, simply transcatheterizing the mitral valve does not guarantee patient-centered outcomes. Focusing on anatomic repair of the mitral valve using transcatheter annuloplasty is believed to obviate the need for valve replacement and less durable therapies. In addition, this approach could result in patients with severe mitral regurgitation having less pain, a shorter hospitalization, and a more rapid return to activity, while still maintaining the option for future intervention if necessary.

Who It Affects

Patients

The initial patients for whom benefit of percutaneous mitral mitral spatial shortening would occur would be patients with symptomatic moderate-to-severe (3+) or severe (4+) functional mitral regurgitation who are considered to be too poor surgical candidates for open heart surgical repair of mitral regurgitation. These patients are typically older and may have other severe medical illnesses. The alternative to no therapy for these patients would be a percutaneous mitral annuloplasty. Such a procedure would provide meaningful relief of symptoms and potentially improve long-term survival for these high risk patients without subjecting them to the risks associated with sternotomy and cardiopulmonary bypass.

The purpose of the AMEND TS Early Feasibility Study is to evaluate the safety of the TS device in treating patients with severe mitral regurgitation. The small study will enroll up to 15 patients at seven centers across the country. The main purpose of the study is to demonstrate that the TS device can safely be delivered through the femoral vein, transseptally, and accurately and securely attached to the native mitral annulus.

Clinicians

The interventions specialist is not alone in how this will affect his or her practice. Cardiologists will still be involved in the workflow, learning new aspects of the procedure and interacting with the surgeon at key points in the procedure for managing complications and planning for hybrid strategies. Cardiac surgeons will also re-consider who are the ideal patients for this option, and how they will incorporate a transcatheter based therapy into their practice. However, the Heart Team, comprised of surgeons and interventionalists will be even more central to this new therapy, which is essentially a surgical tool delivered in the medical environment.

Payers and Healthsystems

Healthsystems and payers will start planning for the allocation of future resources as Mesenchymal Stem Cells (MSCs) progress from research to clinical applications. As MSCs become clinically available, more emphasis will be put on the costs per procedure (including the cost of the devices used) and on the procedure volume in which the technology can be safely offered. Regulators and guideline- making panels will be increasingly interested in defining criteria for the selection of appropriate patients and centers, as well as in defining training modalities for operators and standards of follow up of patients treated in centers offering this emerging technology.

What Changes

• New treatment pathway: Clinicians gain a minimally invasive alternative that aims to reproduce surgical annuloplasty anatomy without open-heart surgery, broadening options for high-risk patients. This is not just an extra tool, but a fundamental shift in how we approach the mitral valve’s architecture.
• Intensive care coordination: Successful adoption requires multidisciplinary heart teams, new training programs, and infrastructure upgrades to manage both elective and complex cases. The complexity of the AMEND procedure requires precise quadrant fixation, echocardiographic guidance, and demands a high level of technical synergy between the implanter and the imaging specialist.
• Focus on follow-up and outcomes: Expect increased emphasis on structured long-term monitoring and registries to track durability, safety, and the need for subsequent interventions. The AMEND study includes a primary safety endpoint at 30 days, monitoring for a composite of death, stroke, MI, or non-elective surgery, but will track patients for up to five years to assess the long-term integrity of the ring.
• Procedurally, transseptal access means the device is delivered through a catheter inserted in a vein and advanced into the left atrium by crossing the interatrial septum (the tissue between the atria). This avoids the chest incision and heart-stopping required in many surgical repairs. Clinicians and patients should understand that minimally invasive does not mean risk-free. There are trade-offs involving device positioning, interaction with the surrounding valve structures, and the potential need for complementary therapies.

Implication for Clinical Practice

The technology offers potential combination use with other transcatheter therapies. For example, a percutaneous annuloplasty could be performed to “normalize” the annulus first, followed by a TEER procedure. Alternatively, a percutaneous annuloplasty could be used as a component of a staged combination procedure or a single combination procedure with other transcatheter therapies such as future leaflet or chordal therapies, to provide an anatomically-sophisticated and personally-tailored MR therapy alternative to current surgical methods, but with a less-invasive “through the groin” approach. The therapy could also be designed in a step-wise fashion where additional therapies could be added in sequence. Alternatively, a single treatment session could be used that incorporates multiple therapies similar to the current surgical armworm.

Technical and Safety Considerations

For any new device to go clinical it is important to consider safety and medium term risk. A study of the intermediate and late complications and re-interventions is crucial to the clinician when deciding which device to use and when to refer to transcatheter or surgical intervention for patients with acute variceal bleeding. In the AMEND TS study technical success was defined as: • No procedural mortality; • No need for emergency surgery; • Complete retrieval of the delivery system with the device’s ring correctly positioned and fixed into place.

Valcare Medical’s Mitral Valve Edge-to-Edge Repair device utilizes a semi-rigid, D-shaped annular frame to repair Mitral Regurgitation. The D-shape configuration preserves native orifice geometry, mitigating the effects of septal to lateral dimension mismatch that cause functional MR. Unlike flexible annuloplasty rings, which can distort within the high-pressure left ventricle, the semi-rigid configuration of the Valcare Medical device provides a fixed dimension at the repaired MR orifice, improving long-term durability.

Patients and surgeons need to be aware of the chances of residual regurgitation, the long term durability of the repair and the need for further intervention. The AMEND ring is ‘future-proof’ and allows for a valve-in-ring procedure should the patient require further intervention years later. Other surgical techniques may not allow this option.

Broader Economic and Policy Implications

Access and equity to appropriate care will become a growing concern as devices become more complex and concentrated in a handful of tertiary centers and programs staffed by highly specialized teams. The AMEND TS study is currently recruiting at top medical transplant centers including Banner University Medical Center, Scripps Health and Piedmont Healthcare. As transthoracic indication for implant of transplant devices becomes more prevalent, third party payers and health systems will be required to balance strict credentialing and volume requirements with the desire to train a broader referral network so that all patients have access to timely evaluation and surgical care for transplant without excessive travel.

Real-World Uptake

From a cost and reimbursement perspective, how a technology is implemented in the real world (outside of clinical trials) beyond the hospital based operating room will be driven by the cost of the device itself as well as how procedures utilizing the technology are reimbursed. There will be particular emphasis placed on the economics of shorter hospital stays and fewer readmissions. From a payer’s perspective (including third party payers such as insurance companies), there will be a push for durable benefit prior to reimbursement of the technology. From a healthcare system perspective, the cost of creating the necessary infrastructure as well as additional personnel will be weighed against long-term savings to the healthcare system and improved quality of life for patients with heart failure. The value of a $30,000 device compared to the cost of a single heart failure hospital stay (averaging $150,000) will be particularly compelling. It takes several years of data to offset the initial investment of adopting a new technology.

Professional Development

The transcatheter approach to annuloplasty technology will require the training of healthcare providers in hybrid skills to deliver devices and technology through the catheterization laboratory and to image-guided implantation and monitoring of patients pre- and post-procedure by the interventional cardiologist and the cardiac surgeon. Workforce organizations, credentialing bodies and physician societies such as the American College of Cardiology (ACC) and the Society of Thoracic Surgeons (STS) will play a strong role in establishing a set of skill competencies and training pathway for this emerging technology.

The Role of Data and Clinical Evidence

However, in the near term evidence based on real-world evidence and post-market surveillance will likely be the top priority. Clinical and health systems will get to see early feasibility and registry data in the operating room and administratively to guide strategy and policy in the near term. However, definitive data regarding efficacy and durability will require longer follow-up. The AMEND TS study is expected to hit primary completion late 2026 with the study itself wrapping up in 2037 – only 5 years from now.

Clearly a rapid pace to address the medical and surgical community’s need for effective MR based treatment options.

Patient-Centered Innovation

Finally, patient-centered communication should be a major priority. For the patient for whom a transseptal annuloplasty is indicated, a decision to pursue this option should be an informed one, and the patient and physician should understand the potential risks and benefits as well as comparisons to other possible treatment strategies, including potential advantages and disadvantages, and how these decisions might affect future treatment options. The use of shared decision-making tools and multidisciplinary conference among all providers involved in a patient’s management will aid in weighing the quality-of-life improvements against the known and unknown risks of the procedure.

The psychological implications for our elderly patients of less-invasive alternatives for treating heart failure cannot be overstated. Many are so fearful of being placed on “surgical sedation” and never waking up from open-heart surgery, that they decline treatment opting instead for medical management of their heart failure. The psychological benefits and improved overall recovery for our patients of transcatheter valve replacement is profound, as most patients are home in 24 to 48 hours with no more than a bandage on their leg.

Conclusion

The first U.S. transseptal implantation of the AMEND™ system is an important development for the care of the mitral valve. It does not replace surgical repair of the mitral valve, but does offer another method of treatment that can be particularly advantageous in certain patients. This technology will not replace surgical repair of the mitral valve but will provide the surgeon and patient with another option that will allow for the best anatomical, risk and preference based approach to patient care. The fact that this gold standard surgical procedure has now been successfully translated to the cath lab is an important advancement in the field of cardiovascular medicine provided by Valcare Medical.