Document Type
Article
Publication Date
11-2-2021
Class Instructor(s)
Jacob Adkison, MSN, DNP & Charity Keplinger, DHSc, MPAS, PA-C
Abstract
Background: Our goal was to conduct a systematic review of available randomized controlled trials to compare the safety and efficacy of TAVR to SAVR by looking at absolute risk reduction in all-cause mortality for high risk surgical patients with severe aortic stenosis at 1, 2 and 5 years post-intervention.
Methods/Results: The PubMed database was searched according to the PRISMA guidelines from inception until September 2020. 6 high quality randomized controlled trials analyzing all-cause mortality for TAVR versus SAVR in the CoreValve US High-Risk Clinical Study and Placement of Aortic Transcatheter Valves (PARTNER) Trial populations at 1, 2 and 5 years post-intervention were included (n = 1,446 participants, randomly assigned to undergo TAVR (738) or SAVR (708)). The CoreValve Trial found a statistically significant absolute risk reduction of 4.9% with TAVR compared to SAVR at 1 year (superiority P-value of 0.04 and non-inferiority P-value of <0.001). The Partner Trial also found a statistically significant risk reduction of 2.6% with TAVR compared to SAVR at 1 year (non-inferiority P-value of <0.001). Additionally, the CoreValve Trial found a statistically significant absolute risk reduction of 6.4% with TAVR compared to SAVR at 2 years (superiority P-value of <0.05). The Partner Trial at 2 years and the CoreValve Trial at 5 years found small, but not statistically significant risk reduction for TAVR compared to SAVR.
Conclusion: This systematic review showed lower or comparable all-cause mortality rates for TAVR compared to SAVR over 2 study populations from large, multicenter randomized controlled trials analyzed at 1, 2, and 5 years intervals, thus demonstrating the viability of TAVR for high risk surgical patients with severe AS. Based on these results, as well as the additional advantages of TAVR being less invasive, resulting in less acute blood loss, and having a shorter hospital stay and recovery time compared to SAVR, healthcare providers should recommend TAVR as a safe and viable alternative to SAVR to their patients with severe AS at high surgical risk due to its reduced or comparable all-cause mortality rates up to 5 years post-intervention. If feasible, a trans-femoral approach for TAVR is recommended due to lower mortality rates.