Key Takeaways
- Medicare now covers transcatheter aortic valve replacement (TAVR) for both symptomatic and asymptomatic severe aortic valve stenosis.
- Studies have shown benefits to TAVR over clinical surveillance even before patients become symptomatic.
- Duke Heart & Vascular has the expertise and experience to provide the best outcomes for TAVR.
In September 2026, the U.S. Centers for Medicare & Medicaid Services (CMS) announced updated guidelines for transcatheter aortic valve replacement (TAVR) coverage for aortic stenosis (AS). TAVR is now covered for severe symptomatic AS and covered with evidence development (CED) for severe asymptomatic AS. Previously, asymptomatic AS was not covered and symptomatic AS was covered under CED provision.
“Aortic stenosis is one of the most prevalent valvular heart issues,” says Duke Health interventional cardiologist Andres M. Pineda Maldonado, MD. “Multiple studies show that early aortic valve replacement improves outcomes. This coverage change widens the net of patients who can receive TAVR.”
Early referral for AS can improve outcomes, he says: “Untreated severe AS has significant complications for patients: worsening symptoms, functional decline, hospital admissions for heart failure, or even life-threatening arrhythmias.”
Studies show benefit to early TAVR
Traditionally, asymptomatic AS was managed with only “watchful waiting” for symptoms to develop. Research has shown benefits of TAVR for an ever widening population. “CMS is now catching up with evidence-based practice,” Pineda says.
Published in the New England Journal of Medicine, the EARLY TAVR trial randomized patients with asymptomatic severe AS, low surgical risk, and an average age of 76 years to receive clinical surveillance or TAVR. Only 26.8% of patients receiving early TAVR suffered death, stroke, or an unplanned hospitalization for cardiovascular causes, versus 45.3% of surveillance-only patients. After the study, 87% of the surveillance-only patients received TAVR within four years.
TAVR was initially only offered to patients at high surgical risk. EARLY TAVR and other research also shows that TAVR has similar outcomes to surgical replacement (SAVR) for medium- and low-surgical risk patients. “The choice between SAVR versus TAVR is no longer centered on surgical risk, but individualized for each patient considering anatomic factors, age, life expectancy, valve durability and patient preferences,” says Pineda.
Duke Heart & Vascular has added a nurse coordinator specifically for TAVR to ensure patients are efficiently directed to optimal care. Tobi Ballentine, BSN, RN, serves as the Duke Structural Heart Program Manager.
Outcomes best at high-volume heart centers
Pineda highlights the TAVR experience and expertise of Duke Heart & Vascular. “Experience and volume are very important for cardiovascular treatments. At Duke, we’ve done TAVR for two decades and treated thousands of patients with severe AS.”
In addition to excellent TAVR outcomes, Pineda cites the multidisciplinary, collaborative heart team that provides comprehensive patient care. “We collaborate across surgery, interventional cardiology, imaging cardiology, and advanced practice providers to deliver the best treatment option for each patient, whether that’s SAVR, TAVR, or surveillance.”
Pineda also mentions the American Heart Association’s emphasis on early referral under volunteer president Manesh Patel, Duke’s chief of cardiology. “We’re striving to drive patient referrals under 90 days from diagnosis to treatment,” Pineda says. “Early referral improves outcomes.”