Clin Res Cardiol (2022).

Feasibility and outcome of transcatheter aortic valve implantation in patients with extra large annuli - a multicenter study
A. Hof1, H. S. Wienemann2, S. Geißen2, E. Kuhn3, K. Eghbalzadeh3, T. K. Rudolph4, V. Veulemans5, T. Zeus5, A. Sedaghat6, S. Ludwig7, N. Schofer8, S. Baldus9, M. Adam2, V. Mauri2
1Herzzentrum - Kardiologie, Universitätsklinikum Köln, Köln; 2Klinik III für Innere Medizin, Herzzentrum der Universität zu Köln, Köln; 3Klinik und Poliklinik für Herz- und Thoraxchirurgie, Herzzentrum, Universitätsklinikum Köln, Köln; 4Allgemeine und Interventionelle Kardiologie/Angiologie, Herz- und Diabeteszentrum NRW, Bad Oeynhausen; 5Klinik für Kardiologie, Pneumologie und Angiologie, Universitätsklinikum Düsseldorf, Düsseldorf; 6Medizinische Klinik und Poliklinik II, Universitätsklinikum Bonn, Bonn; 7Klinik für Kardiologie, Universitäres Herz- und Gefäßzentrum Hamburg GmbH, Hamburg; 8Allgemeine und Interventionelle Kardiologie, Universitäres Herz- und Gefäßzentrum Hamburg GmbH, Hamburg; 9Klinik für Kardiologie, Angiologie, Pneumologie und Internistische Intensivmedizin, Herzzentrum der Universität zu Köln, Köln;
Background: Severe aortic valve stenosis is a common disease in the elderly population and is associated with a high mortality rate. Over the past decade, transcatheter aortic valve implantation (TAVI) has evolved to a leading invasive therapeutic option. However, many patients in need for aortic valve replacement present with an aortic annulus size beyond the manufacturer’s recommendation. Profound evidence on the performance of available TAVI prostheses in these patients is lacking.

 136 patients with large annuli exceeding the manufacturer’s instructions for use (IFU; annulus area ≥683 mm2 for S3 29mm or annulus perimeter ≥94.2 mm for ER 34 mm) were treated at five German heart centers with the balloon-expandable Sapien 3 (S3) or the self-expanding Evolut R (ER) valve. Postinterventional clinical outcome and valve performance in these patients was compared to a patient cohort treated with S3 29 mm or ER 34 mm within the recommended sizing range. 

 Mean aortic valve area was 733±54 mmin the extra-large annulus group ranging from 683,0 mm2 to 939,9 mm2, and 567±53 mmin the normal range group (p<0.0001). Mean aortic valve perimeter was 96,85±6,71 mm in patients with extra-large annuli (89,3 mm - 115,9 mm) versus 86,09±4,02 mm.  Device success was comparable in both groups with 87.8% vs. 89.6% (p=0.769) and also in-hospital mortality presented to be the same in both groups (2.2% vs. 2.2%), although procedure time (86±43 min vs. 74±31 min; p<0.001) and ICU stay (4.7±11.3 days vs. 3.1±4.4; p=0.027) was significantly longer in patients with extra-large annuli. Furthermore, we did not observe significant differences in major procedure-related complications such as annulus rupture, cardiac tamponade, valve embolization, stroke, vascular complications or major bleeding events. There was no significant alteration in pacemaker implantation rate or increase in moderate and severe paravalvular leakage (PVL) in patients with large annuli as compared to the standard population (7.1% vs. 8.4%; p=0.653). Likewise, we did not see any differences in PVL or pacemaker implantation rate when comparing both valve types in patients with extra-large annuli. Device success was similar for both types of valve prostheses in this cohort. 

 In this multicenter study, reporting the largest cohort of patients with extra-large annuli so far, aortic valve replacement with third generation TAVI prostheses was feasible and safe in patients with annulus sizes exceeding the manufacturers recommendation with an aortic valve area of up to 939,9 mm². Device success was comparable to the control group and there was no higher incidence for PVL or major adverse effects in the extra-large annuli cohort after TAVI procedure.