Good Evolution of Bicuspid Valves with EVOLUTE or EVOLUTE PRO

Courtesy of Dr. Carlos Fava.

TAVR has matured over time and has advanced onto low risk patients, but one of its greatest challenges continues to be bicuspid valve patients. These represent between 1% and 2% of the population and over 20% of young adults requiring surgical valve replacement (SAVR). 

The study looked at 27,086 patients from the STS/ACC TVT REGISTRY undergoing TAVR with EVOLUTE or EVOLUTE PRO between July 2015 and September 2018. 932 had bicuspids (3.44%) and the rest had tricuspid valves.

Patients with bicuspid valves were younger (72 vs. 81 years old), mostly men, with fewer comorbidities and lower STS score (5.3±4.2% vs. 6.9±4.8% p<0.001).

In addition, they presented a bigger annulus and higher mean gradient with no differences in aortic valve area. 

To make homogeneous groups, patients were matched with Propensity Score, which left 929 pairs in each group.

Read also: SAPIEN 3: Good Outcomes in Bicuspids.

There were no differences in procedure. 92% received a femoral approach, 58% received general anesthesia, procedural success was similar and mean hospital stay was two days, with no differences in in-hospital mortality, stroke, pacemaker need, coronary obstruction, or vascular complications. 

At 30 days and one year, there were no differences between bicuspid and tricuspid patients as regards all-cause mortality (2.6% vs. 1.7%; p=0.18 and 3.9% vs. 4.4%; p=0.93), stroke (3.4% vs. 2.7%; p=0.41 and 3.9% vs. 4.4%; p=0.93), coronary obstruction, major bleeding or pacemaker implantation.

Reintervention rate was higher at 30 days and one year in the bicuspid group (0.8% vs. 0.1%; p =0.03 and1.7% vs. 0.3%; p= 0.01).

Read also: TAVR Reaches Low-Risk Patients with Bicuspid Valves.

Hemodynamic profile was similar, area was 1.9 cm2 and gradient was slightly higher at 30 days in bicuspids, with no differences at one year. Moderate to severe aortic regurgitation was higher at 30 days among bicuspid patients (5.6% vs. 2.1%; p < 0.001). The EVOLUTE PRO presented less moderate to severe regurgitation. There were no differences between bicuspid and tricuspid patients in mild regurgitation at 30 days (2.2% vs.1.5% p=0.71).

Both groups improved functional class and quality of life with no differences. 

Conclusion

There were no differences in all-cause mortality, stroke or hemodynamic profile at 30 days and 12 months. Patients presenting an intermediate risk for surgery, TAVR in severe aortic stenosis in bicuspid valves showed acceptable safety and low risk of complications. 

Courtesy of Dr. Carlos Fava.

Original Title: Transcatheter Aortic Valve Replacement in Bicuspid Versus Tricuspid Aortic Valves From the STS/ACC TVT Registry.

Reference: John K. Forrest, et al. J Am Coll Cardiol Intv 2020;13:1749-59.

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