Abstract
Background A certain degree of prosthesis oversizing is recommended for the SAPIEN 3 (S3; Edwards
Lifesciences Corp., Irvine, California, United States) to ensure device success. We
aimed to investigate midterm outcomes in patients who received oversized (OS) S3 valve
after transapical–transcatheter aortic valve replacement (TA-TAVR).
Methods Out of 122 patients with aortic stenosis who underwent TA-TAVR using S3 at our institution,
42 received OS prosthesis. We used computed tomography (CT) derived effective diameter
to assess oversizing. We defined oversizing if the labeled diameter of the selected
valve for implantation was ≥2 mm bigger than the effective annulus diameter calculated
by the annulus area. We conducted a midterm follow-up and compared the OS cohort with
the non-OS (nOS) cohort.
Results The study groups showed similar risk score and age (STS [Society of Thoracic Surgery]
score: 5.4 ± 3; mean age: 80.7 ± 5.7). The 30-day mortality was 7.1% in OS versus
2.4% in nOS. The 30-day all-stroke was 2.4% in OS versus 0% in nOS. The 1- and 3-year
all-cause mortality were 28.5 and 42.8% in OS versus 21.9 and 26.8% in nOS, respectively.
Midterm freedom from death and from cardiocerebral events was similar in both groups.
Moderate/severe paravalvular leakage occurred in 0% in OS versus 5.4% in nOS. The
postdilation rate was 7.1% in OS versus 15.3% in nOS. The rate of new permanent pacemaker
implantation (PPI) was 15.7% in OS versus 9.3% in nOS. The STS score was detected
as an independent predictor of mortality.
Conclusion Oversizing reduces the risk of device failure and intraprocedural postdilation but
increases the risk of PPI. Early and midterm morbidity and mortality after OS and
nOS with S3 are comparable.
Keyword
heart valve - transapical - aortic valve - outcomes
