Sutureless versus transcatheter aortic valve replacement in patients with aortic stenosis: An updated meta-analysis of short- and mid-term outcomes with trial sequential analysis.

BACKGROUND

The efficacy and safety of a novel aortic valve replacement treatment (SAVR) technique, sutureless aortic valve replacement (SU-AVR), compared to transcatheter aortic valve replacement (TAVR) in the treatment of aortic stenosis, is unclear in short and mid-term outcomes due to limited data.

METHODS

PubMed, Scopus, Embase, Web of Science, and the Cochrane Library were systematically searched for studies comparing SU-AVR with TAVR. Risk ratios (RR) with 95 % confidence intervals (CIs) were computed for binary outcomes. Trial sequential analysis (TSA) was performed to assess whether the results in our meta-analysis were conclusive.

RESULTS

This systematic review and meta-analysis included 22 observational studies of symptomatic patients. When comparing SU-AVR to TAVR, similar risk of in-hospital mortality (RR 0.67, 95 % CI 0.37-1.24, p = 0.20, I2 = 15.1 %) and two-year mortality (RR 0.73, 95 % CI 0.39-1.37, p = 0.32, I2 = 61.5 %) were noted. However, SU-AVR was associated with significantly lower 30-day mortality (RR 0.46, 95 % CI 0.28-0.75, p = 0.002, I2 = 0.9 %), total number of valvular leakages (RR 0.13, 95 % CI 0.05-0.32, p < 0.00, I2 = 59.5 %), and one-year mortality (RR 0.51, 95 % CI 0.32-0.80, p = 0.003, I2 = 0.0 %). In the TSA analysis, 30-day mortality, one-year mortality, and total leakage rate showed true-positive results in the method. The two-year mortality rate yielded false-negative results due to the too low required information size.

CONCLUSION

In patients with aortic stenosis, SU-AVR was associated with similar in-hospital mortality and two-year mortality rates compared with TAVR; however, it was associated with significantly lower 30-day mortality, total number of valvular leakages, and one-year mortality rates.