Interventions for valvular disease and heart failure

Impact of moderate or severe left ventricular outflow tract calcification on clinical outcomes of patients with severe aortic stenosis undergoing transcatheter aortic valve implantation with self- and balloon-expandable valves: a post hoc analysis from the SOLVE-TAVI trial

EuroIntervention 2022;18:759-768. DOI: 10.4244/EIJ-D-22-00156

Serdar Farhan
Serdar Farhan1, MD; Georg Stachel2,3, MD; Steffen Desch2,3,4,5, MD; Thomas Kurz4,5, MD; Hans-Josef Feistritzer2,3, MD, PhD; Philipp Hartung2,3, MD; Ingo Eitel4,5, MD; Holger Nef6, MD; Oliver Doerr6, MD; Alexander Lauten7, MD; Ulf Landmesser5,8, MD; Marcus Sandri2,3, MD; David Holzhey3,9, MD; Michael Borger3,9, MD, PhD; Hüseyin Ince10, MD; Alper Öner10, MD; Roza Meyer-Saraei4,5, PhD; Harm Wienbergen11, MD; Andreas Fach11, MD; Norbert Frey5,12, MD; Suzanne de Waha-Thiele3,9, MD; Holger Thiele2,3, MD
1. The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, NY, USA; 2. Department of Internal Medicine and Cardiology, Heart Center Leipzig, University of Leipzig, Leipzig, Germany; 3. Department of Cardiology, Heart Center Leipzig at University of Leipzig, Leipzig, Germany; Leipzig Heart Institute, Leipzig, Germany; 4. University Clinic Schleswig-Holstein, Kiel, Germany and University Heart Center Lübeck, Lübeck, Germany; 5. German Center for Cardiovascular Research (DZHK), Campus Lübeck, Lübeck, Germany; 6. Medizinische Klinik I, Abteilung für Kardiologie, Universitätsklinikum Marburg/Gießen, Gießen, Germany; 7. Department of Cardiology and Intensive Care Medicine, Helios Klinikum Erfurt, Erfurt, Germany; 8. Universitätsklinikum Charité, Campus Benjamin Franklin, Berlin, Germany; 9. Department of Cardiac Surgery, Heart Center Leipzig at University of Leipzig, Leipzig, Germany; 10. Medizinische Klinik I im Zentrum fuer Innere Medizin (ZIM), Universitaetsklinikum Rostock, Rostock, Germany; 11. Klinikum Links der Weser, Herzzentrum Bremen, Bremen, Germany; 12. Department of Cardiology, Angiology and Pneumology, University Hospital Heidelberg, Heidelberg, Germany

Background: Left ventricular outflow tract (LVOT) calcification has been associated with worse outcomes in patients undergoing transcatheter aortic valve implantation (TAVI) and may influence the selection of prosthetic valve type.

Aims: We aimed to evaluate the impact of LVOT calcification on outcomes after TAVI with a self-expanding valve (SEV) versus a balloon-expandable valve (BEV).

Methods: Patients of the SOLVE-TAVI trial, randomised to Edwards SAPIEN 3 or Medtronic Evolut R, were divided according to LVOT calcification into no/mild (≤1 calcium nodule extending <5 mm and covering <10% of the LVOT perimeter) and moderate/severe LVOT calcification groups. The primary endpoint was a composite of death, stroke, moderate/severe paravalvular regurgitation, permanent pacemaker implantation and annulus rupture at 30 days. Additional endpoints included all-cause and cardiovascular mortality at 1 year.

Results: Out of 416 eligible patients, moderate/severe LVOT calcification was present in 143 (34.4%). Moderate/severe LVOT calcification was associated with significantly longer fluoroscopy time and higher rates of pre- and post-dilation. Regardless of the LVOT calcification group, there was no significant difference in the primary endpoint associated with the valve type (no/mild LVOT calcification group: SEV 25.0% vs BEV 27.0%; hazard ratio [HR] 1.10, 95% confidence interval [95% CI]: 0.68-1.73; p=0.73 and moderate/severe LVOT calcification group: SEV 25.0% vs BEV 19.4%; HR 0.76, 95% CI: 0.38-1.61; p=0.49), no significant interaction between LVOT calcification and valve type (pint=0.29) and no differences between SEV vs BEV within LVOT calcification groups regarding 1-year all-cause and cardiovascular mortality.

Conclusions: Moderate/severe LVOT calcification was associated with longer fluoroscopy time and an increased need for pre- and post-dilation, but not with a higher incidence of early and mid-term adverse clinical outcomes, regardless of valve type. ( NCT02737150)

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