Valve-in-Valve After Edwards INTUITY Valve Implantation in Small Aortic Annulus

Objectives: The aim of this study is to assess the impact of iterations of balloon expandable valves (Sapien, Sapien XT and Sapien 3) and degree of aortic valve calcification (AVC) on the severity of paravalvular regurgitation (PVR) after transcatheter aortic valve implantation (TAVI). Hypothesis: The iterations of the Sapien prosthesis might impact the frequency and grade of PVR. Methods: Multidetector computed tomography (MDCT) and echocardiographic examinations were performed in 262 patients (127 men, 81±7 years old, logistic EuroScore of 21±13%) who underwent TAVI with 23- and 26-mm balloon expandable valves. Patients receiving a 29-mm valves or undergoing valve-in-valve procedure were excluded. The degree of AVC was calculated with MDCT. PVR grade was assessed with echocardiography. The cover index was calculated as (prosthesis area- MDCT annulus area)/prosthesis area. Results: Sapien, Sapien XT and Sapien 3 prostheses were implanted in respective 103 (39%), 105 (40%) and 54 (21%) patients. Significant PVR (≥moderate) occurred in 14% of patients receiving the Sapien prosthesis and 10% receiving a Sapien XT prosthesis but none in patients of the Sapien 3 group (p=0.019) (Figure 1). Across the groups (Sapien vs. Sapien XT vs. Sapien 3) the aortic annulus size (4.4±0.8 cm2 vs. 4.4±0.7cm2 vs. 4.3±0.7cm2, respectively; p=0.2), degree of calcification (7.7±0.6 Au vs. 7.8±0.7 Au vs. 8.0±0.6 Au, respectively; p=0.1) and cover index (88±16% vs. 90±11% vs. 90±10%, respectively; p=0.4) were comparable. Significant PVR was independently associated with higher degree of AVC (OR 2.89 p=0.02)and cover index (OR 1.08, p=0.03) after adjusting for age, body surface area, gender, aortic annulus area and prosthesis iteration. Conclusions: The incidence of ≥moderate PVR significantly decreased over time with improvement in valve design. Significant PVR after TAVI remains independently associated with degree of AVC and cover index independently of the prosthesis iteration.

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Transcatheter aortic valve implantation in patients with a small aortic annulus: performance of supra-, intra- and infra-annular transcatheter heart valves

Clinical Research in Cardiology ◽

10.1007/s00392-021-01918-8 ◽

2021 ◽

Author(s):

Lisa Voigtländer ◽

Won-Keun Kim ◽

Victor Mauri ◽

Alina Goßling ◽

Matthias Renker ◽

...

Keyword(s):

Aortic Valve ◽

Transcatheter Aortic Valve Implantation ◽

Aortic Annulus ◽

Transcatheter Aortic Valve ◽

Small Aortic Annulus ◽

Number Of Patients ◽

Transcatheter Heart Valve ◽

Increased Risk ◽

Aortic Valve Implantation ◽

Valve Implantation

Abstract Background A small aortic annulus is associated with increased risk of prosthesis–patient mismatch (PPM) after transcatheter aortic valve implantation (TAVI). Whether specific transcatheter heart valve (THV) designs yield superior hemodynamic performance in these small anatomies remains unclear. Methods Data from 8411 consecutive patients treated with TAVI from May 2012 to April 2019 at four German centers were retrospectively evaluated. A small aortic annulus was defined as multidetector computed tomography-derived annulus area < 400 mm2. TAVI was performed with a balloon-expanding intra-annular (Sapien-3, n = 288), self-expanding intra-annular (Portico, n = 110), self-expanding supra-annular (Evolut, n = 179 and Acurate-Neo, n = 428) and mechanically expanding infra-annular (Lotus, n = 64) THV according to local practice. PPM was defined as indexed effective orifice area ≤ 0.85cm2/m2. Results A small annulus was found in 1069 (12.7%) patients. PPM was detected in 38.3% overall with a higher prevalence after implantation of a balloon-expanding intra-annular or mechanically expanding infra-annular THV compared to self-expanding intra- and supra-annular THV. Multivariable analysis linked self-expanding THV (Evolut: Odds ratio [OR] 0.341, Acurate-Neo: OR 0.436, Portico: OR 0.291), postdilatation (OR 0.648) and age (OR 0.968) to lower rates of PPM, while aortic valve calcification was associated with an increased risk (OR 1.001). Paravalvular regurgitation > mild was more frequent after TAVI with self-expanding THV (p = 0.04). Conclusion In this large contemporary multicenter patient population, a substantial number of patients with a small aortic anatomy were left with PPM after TAVI. Self-expanding supra- and intra-annular THV demonstrated superior hemodynamics in these patients at risk, however at the cost of higher rates of residual paravalvular regurgitation. Graphic abstract

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