News

The FDA approved the Autus Size-Adjustable Valve from Edwards Lifesciences, the first pulmonary valve replacement designed to expand with patient growth, reducing repeat surgeries in pediatric congenital heart disease. The pivotal study of 62 patients aged 18 months to 16 years demonstrated 100% freedom from device-related complications at 30 days, no reinterventions at 6 months, and favorable hemodynamics through 1 year with mean RVOT gradients ≤40 mmHg and less than moderate regurgitation.

Digest: This first-in-class balloon-expandable valve (13-22 mm) with polymeric leaflets addresses a critical unmet need in pediatric congenital valve disease by potentially eliminating multiple open-heart surgeries during childhood growth.

The TRIC-I-HF trial demonstrated that transcatheter tricuspid valve repair plus optimal medical therapy was superior to medical therapy alone in patients with symptomatic severe tricuspid regurgitation and heart failure. The intervention reduced all-cause death and HF hospitalization with benefits emerging early and sustained to 3 years, along with meaningful quality of life improvements.

Digest: This represents the first time transcatheter tricuspid repair has shown significant reductions in hard clinical endpoints (mortality and HF hospitalization), not just quality of life, potentially establishing a new standard of care for severe tricuspid regurgitation patients.

The phase 3 LIBREXIA trial evaluating milvexian, an oral factor XIa inhibitor, was halted early for futility in patients with recent acute coronary syndrome at high risk for recurrent ischemic events. Milvexian added to antiplatelet therapy did not reduce cardiovascular death, MI, or ischemic stroke compared with placebo, though no excess bleeding risk was observed.

Digest: This trial demonstrates that factor XIa inhibition does not provide additional ischemic protection in ACS patients on antiplatelet therapy, though the lack of bleeding signal may inform ongoing anticoagulation strategies in structural heart interventions where thrombotic and hemorrhagic balance is critical.

The U.S. Department of Justice charged 455 defendants, including 90 physicians and licensed healthcare professionals, with over $6.5 billion in alleged Medicare and Medicaid fraud in a 2026 national enforcement sweep. Healthcare law experts emphasize the need to distinguish between intentional fraud and honest billing mistakes resulting from complex regulatory requirements, as federal investigations continue with CMS deferring over $1 billion in Medicaid payments pending documentation review.

Digest: Heightened federal fraud enforcement and compliance scrutiny may impact structural heart practices through increased billing audits, reimbursement delays, and pressure to document medical necessity for high-cost procedures like TAVR and mitral interventions.

At the Heart in Diabetes CME Conference, Dr. Katherine Tuttle presented an updated pillar-based treatment paradigm for chronic kidney disease, incorporating SGLT2 inhibitors, non-steroidal mineralocorticoid antagonists, GLP-1 receptor agonists, and RAS inhibitors, with endothelin type A receptor antagonists for nondiabetic CKD. Combination therapy in patients with type 2 diabetes and moderate albuminuria demonstrated significant risk reductions including 58% reduction in CKD progression (HR=0.42), 55% reduction in heart failure hospitalization (HR=0.45), and 35% reduction in major adverse cardiovascular events (HR=0.65) compared to conventional care.

Digest: Cardiometabolic optimization with these agents directly impacts structural heart patient selection, procedural risk stratification, and outcomes, as CKD and diabetes are critical comorbidities affecting valve intervention candidacy and post-procedural prognosis.

The SMART trial's 3-year results showed that self-expanding supra-annular TAVR valves (Evolut platform, Medtronic) demonstrated superior hemodynamics and less thrombosis compared to balloon-expandable valves (Sapien platform, Edwards Lifesciences) in patients with small aortic annuli (≤430 mm²). There was no difference in the composite clinical endpoint of mortality, disabling stroke, or heart failure rehospitalization between groups (self-expanding 25.4% vs balloon-expandable 22.6%; HR 1.13, 95% CI 0.83-1.53, P=0.44).

Digest: These extended follow-up data support the use of self-expanding supra-annular valves for improved hemodynamic performance in small annuli patients, particularly relevant for lower-risk and younger TAVR candidates where long-term valve function is critical.