Supra-, intra- and infra-annular transcatheter heart valves for the treatment of aortic stenosis in patients with a small aortic annulus – a large multicenter analysis
L. Voigtländer1, W.-K. Kim2, J.-M. Sinning3, V. Mauri4, A. Goßling1, M. Linder1, M. Renker2, A. Sugiura5, T. Schmidt6, N. Schofer1, D. Westermann1, C. W. Hamm7, G. Nickenig3, M. Adam4, H. Reichenspurner8, S. Blankenberg1, L. Conradi8, M. Seiffert1
1Allgemeine und Interventionelle Kardiologie, Universitäres Herz- und Gefäßzentrum Hamburg GmbH, Hamburg; 2Abteilung für Kardiologie, Kerckhoff Klinik GmbH, Bad Nauheim; 3Medizinische Klinik und Poliklinik II, Universitätsklinikum Bonn, Bonn; 4Klinik III für Innere Medizin, Herzzentrum der Universität zu Köln, Köln; 5Med. Klinik II - Kardiologie, Universitätsklinik Bonn, Bonn; 6Klinik für Kardiologie, Angiologie, Pneumologie und Internistische Intensivmedizin, Herzzentrum der Universität zu Köln, Köln; 7Medizinische Klinik I - Kardiologie und Angiologie, Universitätsklinikum Gießen und Marburg GmbH, Gießen; 8Klinik und Poliklinik für Herz- und Gefäßchirurgie, Universitäres Herz- und Gefäßzentrum Hamburg GmbH, Hamburg;

Background:

A small aortic annulus is associated with increased risk for patient-prosthesis 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. This large multicenter analysis aimed (i) to determine the incidence of PPM in patients with a small aortic annulus undergoing TAVI and (ii) to compare outcome and hemodynamic performance of different THV in this patient population.

 

Methods:

Data from 8,500 consecutive patients who underwent TAVI for the treatment of severe aortic stenosis from May 2012 to April 2019 at four German centers were retrospectively evaluated. A small aortic annulus was defined as MDCT-derived annulus area <400 mm2. TAVI was performed with balloon-expandable, self-expanding, and mechanically-expandable devices according to local practice. PPM was defined as indexed effective orifice area ≤0.85cm2/m2. Hemodynamic and echocardiographic performance and early clinical outcomes were assessed.

 

Results:

A small annulus was found in 994 (11.7%) patients who were included in this analysis. 93.8% of these patients were female, median age was 82.9 [79.5-86.2] years. Median annulus area was 368.1 mm2 [343.4-382.9] and larger in patients treated with balloon-expandable intra-annular THV (376.0 mm2 [351.9-386.0]; p<0.001). TAVI was performed with self-expanding supra- (Evolut: 16.3%; Acurate neo: 40.5%), balloon-expandable and self-expanding intra- (Sapien-3: 27.1%; Portico: 10.7%), and mechanically-expandable infra-annular THV (Lotus: 5.4%). PPM after TAVI was detected in 34.6% of patients with a small aortic annulus. The incidence was higher after balloon-expandable intra-annular (53.5%) or mechanically-expandable infra-annular (36.7%) compared to self-expanding intra- and supra-annular THV implantation (Portico: 19.8%, Evolut: 23.9% and Acurate neo: 29.4%, p<0.001). Accordingly, residual mean transvalvular gradients were higher in patients with ballon-expandable intra-annular (12.8 mmHg [IQR 9.0-16.0]) and mechanically-expandable infra-annular (12.0 mmHg [IQR 9.8-15.9]) compared to self-expanding intra-  and supra-annular devices (Portico: 9.0 mmHg [IQR 7.0-11.0]; Evolut: 7.0 mmHg [IQR 5.0-10.0] and Acurate neo: 9.0 mmHg [IQR 6.0-12.0], respectively (p<0.001). Paravalvular regurgitation ³ moderate was more common after implantation of self-expanding (Evolut: 4.9%, Acurate neo: 7.2%; Portico: 5.7%) vs. ballon-expandable devices (1.5%; p=0.005). All-cause mortality was 9.7% at 12 months and similar among all groups.

 

Conclusion:

In this large contemporary multicenter patient population, a substantial number of patients with a small aortic anatomy was left with PPM after TAVI. Self-expanding supra- or intra-annular THV demonstrated superior hemodynamics in these patients at risk, however at the cost of higher rates of residual paravalvular regurgitation. 
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