SERMO Cardiologists will be covering the 2016 American College of Cardiology Scientific Sessions. We’ll be sharing some of their posts here on the SERMO blog – for more coverage, sign into SERMO.
At the 2016 American College of Cardiology Scientific Sessions this morning live from snowy and blustery Chicago, the first late-breaking clinical trial session was quite a victory for proponents of nonsurgical aortic valve replacement. Previous trials had established that TAVR had equivalent outcomes compared to surgical AV replacement in patients who were deemed very high risk for surgery but with improved technique, better valves and lower complications from TAVR, many felt it was time to offer the procedure to a lower risk group of patients with symptomatic severe aortic stenosis.
These intermediate risk AS patients typically have an estimated risk of dying withint 30 days of >4% with surgery.
The PARTNER IIA trial enrolled 2032 patients over 5 years at multiple sites with the following criteria:
• Severe AS: Echo-derived AVA ≤ 0.8 cm2 (or AVA index < 0.5 cm2/m2) and mean AVG > 40 mm Hg or peak jet velocity > 4.0 m/s • Cardiac Symptoms: NYHA Functional Class ≥ II • Intermediate Risk: 1. Determined by the multi-disciplinary Heart Team 2. Using a guideline STS ≥ 4%, and 3. Adjudicated by case review committee
and randomized half to TAVR and half to SAVR.
Three-quarters of the TAVR patients where done via transfemoral approach, the remainder by transapical approach.
At two years, the primary end point of mortality or disabling stroke was similar in the two groups with a nonstatisitically significant trend favoring TAVR over SAVR.
Other clinical endpoints supported the concept that TAVR has significantly less bleeding risk, acute kidney injury and atrial fibrillation than SAVR whereas TAVR had significantly more vascular complications.
Echocardiographically derived aortic valve area was significantly larger at two years after TAVR compared to SAVR (1.54cm2 versus 1.4 cm2)
In the transfemoral subgroup (76% of patients), TAVR using SAPIEN XT significantly reduced all-cause mortality or disabling stroke vs. surgery (ITT: p = 0.05, AT: p = 0.04)
I have to admit I was a TAVR skeptic as late as two years ago but the data from well -performed randomized trials continues to accumulate, indicating that TAVR is a viable alternative to SAVR for many patients.
For my patients with aortic stenosis who are on the cusp (excuse pun) of needing a new valve, I advise them that watchful waiting is best, because over time, the TAVR approach will be an even better option than SAVR and at some point may totally replace SAVR.
Simultaneous with presentation of the abstract today, the paper was published in NEJM along with an accompanying editorial with the title “Will TAVR Become the Predominant Method for Treating Severe Aortic Stenosis?”