Optimal Oversizing Index Depending on Valve Type and Leakage-Proof Function for Preventing Paravalvular Leakage after Transcatheter Aortic Valve Implantation.

You-Jeong Ki,Hak Seung Lee,Jeehoon Kang,Han-Mo Yang,Hyun-Jae Kang,Kyung Woo Park,Jung-Kyu Han,Mineok Chang,Hyo-Soo Kim,Bon-Kwon Koo

doi:10.3390/jcm9123936

You-Jeong Ki, Hak Seung Lee + Show 8 more

Open Access

https://doi.org/10.3390/jcm9123936

Copy DOI

Abstract

Paravalvular leak (PVL) is an important complication of transcatheter aortic valve implantation (TAVI) and is associated with poor prognosis. We aimed to identify the risk factors for PVL after TAVI including patient (calcium amount or location), device (leakage-proof or not), and procedural (oversizing index (OI)) factors. The primary outcome was mild or greater PVL at 1-month follow-up echocardiography. Overall, 238 patients who underwent TAVI using eight types of valves (Edwards Sapien, Sapien XT, Sapien 3, CoreValve, Evolut R, Evolut PRO, Lotus, and Lotus Edge) were included. The incidence of significant PVL (≥mild PVL) was 24.4%. Although patient factors (calcification of valve) were not predictors of PVL, valve without leakage-proof function (Edwards Sapien, Sapien XT, and CoreValve) was a significant predictor of PVL (adjusted odds ratio, 3.194, 95% CI, 1.620–6.299). Furthermore, OI has a significant protective role against PVL (PVL increased by 45% when OI decreased by 5%). The best cutoff value of OI to predict the absence of PVL was ≥17.6% for the Evolut system and ≥10.2% for the Sapien system. The predictors of PVL after TAVI included factors from the device (valve without leakage-proof function) and procedure (under-sizing). In patients with a high risk of PVL, the procedure should be optimized using valves with leakage-proof function and adequate OI.

Highlights

Transcatheter aortic valve implantation (TAVI) has emerged as the new standard treatment of severe aortic stenosis (AS) in patients at intermediate and high surgical risk [1,2,3]
The valves included in the present study were Edwards Sapien (n = 11, 4.6%), Sapien XT (n = 4, 1.7%), Sapien 3 (n = 88, 37.0%), CoreValve (n = 37, 15.5%), Evolut R (n = 56, 23.5%), Evolut PRO (n = 19, 8.0%), Lotus (n = 20, 8.4%), and Lotus Edge (n = 3, 1.3%)
The best cutoff value (COV) of oversizing index (OI) to predict the absence of paravalvular leakage (PVL) were ≥17.6% for Evolut system and ≥10.2% for Sapien system; (3) The important risk factor for PVL in valves without leakage-proof function was the large amount of calcium on top of insufficient OI, while that in valve with the leakage-proof function was a self-expandable type of valve on top of insufficient OI; (4) The upper limit of OI to prevent PVL was 30% or higher in valves without leakage-proof function, while it was around 15% in valves with leakage-proof function

Summary

Introduction

Transcatheter aortic valve implantation (TAVI) has emerged as the new standard treatment of severe aortic stenosis (AS) in patients at intermediate and high surgical risk [1,2,3]. TAVI is non-inferior to surgery in terms of composite death or stroke in severe AS with low surgical risk patients [4]. Even in another study conducted in low-risk patients, TAVI performed with balloon-expandable valve was superior to surgery [5]. The risk for paravalvular leakage (PVL) is one of the main limitations of TAVI procedure, which is associated with increased mortality during follow-up [1,6]. It was generally believed that moderate or severe PVL impact long term clinical outcomes, the recently published studies showed that even mild PVL was associated with mortality. As the indications of TAVI were expanded, mild PVL may be important for long-term clinical outcomes [1,6,7]. The factors linked to PVL and mortality were increased left ventricular (LV) workload, infective endocarditis, and hemolysis [8,9,10]

Objectives

Methods

Results

Conclusion