Transcatheter aortic valve replacement in low risk patients: a review of PARTNER 3 and Evolut low risk trials

Abstract

Transcatheter aortic valve replacement (TAVR) has become a mainstay in treatment for patients with severe aortic stenosis who are considered high-risk surgical candidates. The use of TAVR in low-risk patients with severe aortic stenosis is being explored as an alternative to surgical aortic valve replacement (SAVR). Recent results from the Medtronic Evolut Low Risk trial and the Placement of Aortic Transcatheter Valves (PARTNER) 3 trial shed light on the use of TAVR in low-risk surgical candidates. The Evolut Low Risk trial compared TAVR with a self-expanding supra-annular bioprosthesis to SAVR in 1468 patients with severe aortic stenosis who were low surgical risk. Patients with a mean age of 74 and a mean Society of Thoracic Surgeons (STS) risk score of 1.9% were randomized to either TAVR or SAVR groups. Using the composite end point of death or disabling stroke at 24 months, the study found an incidence of 5.3% in the TAVR arm and 6.7% in the surgical arm. The Evolut Low Risk trial thus concluded that TAVR was statistically noninferior but not superior to SAVR (difference, −1.4 percentage points; 95% Bayesian credible interval for the difference, −4.9 to 2.1; posterior probability of noninferiority, >0.999). The PARTNER 3 trial assigned 1,000 patients with severe aortic stenosis and low surgical risk to either TAVR with transfemoral placement of balloon expandable valve or SAVR. Patients with a mean age of 73 and a mean STS score of 1.9% were randomized to either TAVR or SAVR groups. With respect to the primary endpoint of composite death from any cause, stroke, or rehospitalization, the study found an occurrence of 8.5% in TAVR and 15.1% in SAVR, confirming both noninferiority and superiority in the TAVR group [absolute difference, −6.6 percentage points; 95% confidence interval (CI), −10.8 to −2.5; P<0.001 for noninferiority; hazard ratio, 0.54; 95% CI, 0.37 to 0.79; P=0.001 for superiority]. Both the Evolut low risk trial and the PARTNER 3 trial provide evidence that the use of TAVR extends beyond the scope of high and intermediate risk surgical patients and is at the very least equivalent to SAVR in the treatment low-risk surgical candidates when using a transfemoral approach in patients without bicuspid aortic valves. In this article we provide an extensive review on the Evolute low risk and PARTNER 3 trials, including a discussion on clinically relevant outcomes.

Transcatheter Heart Valve Implantation in Bicuspid Patients with Self-Expanding Device

“…It is proposed that the good performance of SAPIEN 3 in BAVs is likely due to the high radial strength offered by the metallic steel frame. Recently, clinical findings with the Evolut R and Pro devices on bicuspid patients have been documented [18]. It is worth noting that both the self-expanding and balloon-expandable devices are characterized by a longer sealing skirt to avoid the leakage as compared to the previous generation.…”

Temporal Trend, Prevalence, Predictors, and Outcomes of Pericardial Diseases in Patients Undergoing Transcatheter Aortic Valve Repair

“…Transcatheter aortic valve repair (TAVR) is a minimally invasive procedure for the treatment of severe AS. It is becoming an increasingly more utilized treatment option over traditional surgical aortic valve replacement (SAVR) in many patient populations [2]. The major driving factor to this trend is due to emerging data showing an overall decrease in mortality and procedure-related complications coupled with patients and physicians' desire for the less invasive procedures [3].…”

“…As further research continues, subsequent clinical trials showed TAVR noninferiority to SAVR for both high and intermediate surgical risk patients [5]. During the most recent clinical trials, Placement of Aortic Transcatheter Valves (PARTNER) 3 and Evolut R, TAVR was shown to be a noninferior and, in some cases, superior alternative to SAVR for low surgical risk patients due to decreased mortality and non-inferiority, respectively [2,6,7]. As the indications for TAVR continue to expand, several periprocedural and postprocedural complications have gained interest in recent years.…”

TAVR or SAVR: Unfinished Business

“…We agree that in general very young patients should have an SAVR with a mechanical prosthesis. There are some promising factors of TAVR that are also worth considering such as the lower risk of atrial fibrillation and shorter hospitalizations, 19 and the 5-year NOTION trial data showing larger prosthetic valve area and lower mean gradients with TAVR compared with SAVR in low-risk patients. 20 In addition, mortality and stroke have improved over the past decade with TAVRs probably due to a combination of experience with the procedure and patient selection, higher volume of procedures, and improvement in the valve systems.…”