Safety and efficacy of self‑expandable Evolut R vs. balloon‑expandable Sapien 3 valves for transcatheter aortic valve implantation: A systematic review and meta‑analysis

Abstract

The aim of this study was to systematically search literature and conduct a meta-analysis comparing the clinical efficacy and safety of Evolut R and Sapien 3 valves for transcatheter aortic valve implantation (TAVI). The PubMed, Biomed Central, Scopus, Cochrane library and Google scholar databases were searched for articles published up to June, 2019. A total of 5 studies were included. In total, 795 patients underwent TAVI with Evolut R, while 665 patients received the Sapien 3 valve in the included studies. Overall device success with Evolut R was 95.7% and with Sapien 3 was 94.2%. Pooled data indicated no significant differences between the 2 valves (OR, 1.12; 95% CI, 0.66–1.89; P=0.68; I2=0%). No significant differences were observed in the incidence of none to mild paravalvular leakage between the 2 groups (OR, 1.71; 95% CI, 0.83–3.54; P=0.14; I2=0%). Both mean [random; mean difference (MD) = −3.96; 95% CI, −4.61 to −3.31; P<0.00001, I2=0%] and peak (random; MD = −6.85; 95% CI, −8.22 to −5.48; P<0.00001, I2=0%) aortic valve gradients were significantly lower with Evolut R. No significant differences were observed in the 30-day mortality (OR, 1.32; 95% CI, 0.45–3.87; P=0.62; I2=0%) or 30-day stroke outcomes (OR, 0.76; 95% CI, 0.32–1.81; P=0.54; I2=0%) between the 2 devices. On the whole, the findings of this study indicate that Evolut R and Sapien 3 valves may be comparable in terms of device success and short-term complications. The differences between the 2 devices for post-operative moderate to severe paravalvular leak and permanent pacemaker implantation remain unclear. There is thus a need for a large multi-center randomized controlled trial to provide stronger evidence on this subject.

Transcatheter aortic valve replacement with Evolut R versus Sapien 3 in Japanese patients with a small aortic annulus: The OCEAN‐TAVI registry

“…Recently, several studies have compared Sapien 3 and Evolut R with respect to clinical outcomes, procedural efficiency, and hemodynamics. [6][7][8][9] A few studies have directly compared the efficacy and hemodynamics after TAVR of third-generation THVs, focusing on patients with small aortic annuli. 2,10,11 However, there have been no long-term hemodynamic follow-up data with third-generation THVs.…”

“…Self‐expanding THVs show superiority to balloon‐expandable THVs in patients with a small annulus, resulting in lower rates of PPM, because of the supra‐annular leaflet function in self‐expanding THVs (as opposed to an intra‐annular level in balloon‐expandable THVs) and could lead to a larger effective orifice and lower residual gradients, regardless of annular size. Recently, several studies have compared Sapien 3 and Evolut R with respect to clinical outcomes, procedural efficiency, and hemodynamics 6‐9 . A few studies have directly compared the efficacy and hemodynamics after TAVR of third‐generation THVs, focusing on patients with small aortic annuli 2,10,11 .…”

Long-Term Outcome with New Generation Prostheses in Patients Undergoing Transcatheter Aortic Valve Replacement

“…Nevertheless, acute kidney injury stage 2 or higher was tendentially more often recorded in the S3 group. Finkelstein et al describe similar observations, while other studies do not see differences between both prostheses [10,13,14]. Additionally, patients in the ER group had lower prosthetic mean gradients in the follow up echocardiography, which is a common finding in the literature [10,13].…”

Valve‐in‐valve transcatheter aortic valve replacement to treat multijet paravalvular regurgitation: A case series and review

“…First generation TAVR valves reported moderate or severe PVR rates of 10.5% for the SAPIEN valve and 7.8% in the CoreValve. Second generation Sapien XT and Evolut R valves reported moderate or severe PVR at rates of 3.7% and 3.3% respectively 27,28 . However, current third generation valves continue to improve PVR rates with the SAPIEN 3 reporting a moderate or severe PVR rate of 0.5% and Evolut Pro reporting moderate or severe PVR in 2.9% 1,29,30 .…”