Balloon Filling Algorithm for Optimal Size of Balloon Expandable Prosthesis During Transcatheter Aortic Valve...

Aim is to report on the results of an optimized balloon filling algorithm and suggest a refinement of the implantation approach to maximize safety. Appropriate sizing of balloon expandable valves during transcatheter aortic valve implantation is crucial. Study comprised 370 consecutive patients receiving SAPIEN 3 valve between 2015 and 2018. Valve expansion/recoil measurement in the inflow area, annular area, and outflow area was performed previously and postimplantation. Nominal balloon filling resulted in underexpansion-23 mm (20.96 mm), 26 mm (23.88 mm), and 29 mm (27.56 mm) SAPIEN 3 valves at the annular level. Increased balloon filling by 2 cc resulted in a gradual increase in valve diameter reaching 97.35% (23 mm), 96.50% (26 mm), and 96.11% (29 mm) of the nominal valve diameter. Final diameters were usually higher in the valvular inflow and outflow tracts. The 29 mm valve did not reach its nominal diameter with 2 cc overfilling and in none of inflow area (95.48%), annular area (96.11%), or outflow area (96.86%). Device success (by VARC II) was 96.2%. No root or septal rupture, device migration, mitral valve injury, coronary obstruction, or dissection occurred. Rate of new permanent pacemaker implantation was 8.3%. Paravalvular leakage was none or trace in most patients. Mean valve gradient was 10.77 mm Hg postprocedure. 1.9% of the patients had a maximum gradient of >40 mm Hg, 2.2% >20 mm Hg. In conclusion, an optimized balloon filling algorithm resulted in appropriate valve gradients, low levels of paravalvular leakage, low rates of permanent pacemaker implantation and no annular rupture.