Outcomes of Trans-catheter Aortic Valve Replacement Among Patients with Low Gradient Severe Aortic Stenosis: Pairwise and Network Meta-analysis With Trial Sequential Analysis.
Background
Trans-catheter aortic valve replacement (TAVR) has emerged as an effective therapy for severe aortic stenosis. Data is conflicting regarding comparison of TAVR outcomes among patients with low gradient (LG) vs high gradient (HG) severe aortic stenosis.
Methods
We conducted a literature search of PubMed, Embase, and Cochrane library . Studies reporting outcomes of TAVR in patients with severe aortic stenosis and low gradient were included. The primary endpoint was all-cause mortality. Secondary endpoints included cardiovascular and periprocedural mortality.
Results
A total of 19 studies; with 27,204 patients were included in the current analysis. The HG group had less periprocedural, all-cause and cardiovascular mortality compared to the LG group, 6% vs 7.5%; OR 0.76 (95% CI 0.66,0.87); I2=18%, 21% vs 29%; OR 0.59 (95% CI 0.52,0.67); I2= 62%, 12.6% vs 18.7%; OR 0.61 (95% CI0.49,0.76); I2=62%, respectively, p < 0.0001 for all. The network meta-analysis revealed that the best all-cause mortality outcomes were seen in the HG group followed by the paradoxical low gradient group (PLG) with worse outcomes in the classical low gradient (CLG) group.(Figure) The cumulative Z-curve of the trial sequential analysis successfully crossed the conventional test boundary as well as the trial sequential monitoring boundary for all the outcomes, indicating firm evidence for better outcomes in the HG group compared to the LG group.
Conclusions
Patients with HG severe aortic stenosis have better periprocedural mortality, all-cause mortality and cardiovascular mortality compared to low gradient patients post TAVR.