Major Advances in Structural Heart Disease in 2024

 FDA Approvals for Tricuspid Regurgitation Devices

• In February, the Evoque tricuspid valve replacement system (Edwards Lifesciences) became the first transcatheter tricuspid device approved in the US, based on data from the TRISCEND II trial, which showed significant quality-of-life improvements.
• Two months later, the FDA approved the TriClip (Abbott) for transcatheter edge-to-edge repair, supported by the TRILUMINATE trial, where TriClip outperformed medical therapy in reducing death, hospitalization, and improving quality of life in patients not suitable for surgery.

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Controversy in TAVI Outcomes and Usage

• The SMART trial found that TAVI with a self-expanding supra-annular valve had similar 1-year outcomes to a balloon-expandable valve but with lower rates of bioprosthetic dysfunction in patients with a small aortic annulus, sparking debate over valve selection.
• A registry analysis presented at the American Association for Thoracic Surgery 2024 meeting revealed that over half of patients under 65 with severe aortic stenosis received TAVI in 2021, despite guidelines favoring surgical aortic valve replacement (SAVR), raising concerns about overuse in younger patients.

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EARLY TAVR Trial: Benefits of Early Intervention

• The EARLY TAVR trial showed a lower rate of death, stroke, or unplanned cardiovascular hospitalization in asymptomatic patients with severe aortic stenosis who underwent early TAVI compared to clinical surveillance.
• Over a median follow-up of 3.8 years, early TAVI reduced unplanned hospitalizations (20.9% vs. 41.7%), driving the primary endpoint difference.

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Challenges for the Acurate neo2 Valve

• The ACURATE trial found that the Acurate neo2 TAVI valve (Boston Scientific) failed to achieve noninferiority versus Evolut (Medtronic) and Sapien (Edwards Lifesciences) in symptomatic severe aortic stenosis patients, questioning its potential for FDA approval despite its availability in Europe.

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Post-TAVI Challenges and Redo Procedures

• Data from the Society of Thoracic Surgeons Adult Cardiac Surgery Database revealed a fourfold increase in post-TAVI cardiac surgeries for failed procedures between 2017 and 2023.
• The TVT Registry reported a rise in TAVR explants and redo TAVR procedures, emphasizing the need to monitor outcomes, especially as TAVI is considered for earlier use in patients.

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Cerebral Embolic Protection and PROTECT-TAVI Trial

• Enrollment for the PROTECT-TAVI trial, testing TAVI with cerebral embolic protection using the Sentinel system (Boston Scientific), was stopped due to little prospect of demonstrating a benefit and potential harm.
• The PROTECTED TAVR trial previously missed its primary endpoint and showed unexplained geographic differences, further questioning the viability of cerebral embolic protection as a routine adjunct in TAVI.

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Industry Developments and Future Outlook

• Edwards Lifesciences acquired JenaValve and plans to seek FDA approval for the JenaValve Trilogy system in 2025, which would make it the first transcatheter therapy for severe aortic regurgitation.
• New devices and therapies, including the Evoque and TriClip, are expected to shape discussions on device selection, health system preferences, and reimbursement strategies in the coming years.