Myocardial Injury After Balloon Predilatation Versus Direct Transcatheter Aortic Valve Replacement: Insights From the DIRECTAVI Trial

Mariama Akodad, François Roubille, Gregory Marin, Benoit Lattuca, Jean-Christophe Macia, Delphine Delseny, Thomas Gandet, Pierre Robert, Laurent Schmutz, Christophe Piot, Eric Maupas, Gabriel Robert, Frederic Targosz, Bernard Albat, Guillaume Cayla, Florence Leclercq, Mariama Akodad, François Roubille, Gregory Marin, Benoit Lattuca, Jean-Christophe Macia, Delphine Delseny, Thomas Gandet, Pierre Robert, Laurent Schmutz, Christophe Piot, Eric Maupas, Gabriel Robert, Frederic Targosz, Bernard Albat, Guillaume Cayla, Florence Leclercq

Abstract

Background Myocardial injury is associated with higher mortality after transcatheter aortic valve replacement (TAVR) and might be increased by prior balloon aortic valvuloplasty (BAV). We aimed to evaluate the impact of prior BAV versus direct prosthesis implantation on myocardial injury occurring after (TAVR) with balloon-expandable prostheses. Methods and Results The DIRECTAVI (Direct Transcatheter Aortic Valve Implantation) trial, an open-label randomized study, demonstrated noninferiority of TAVR without BAV (direct TAVR group) compared with systematic BAV (BAV group) with the Edwards SAPIEN 3 valve. High-sensitivity troponin was assessed before and the day after the procedure. Incidence of myocardial injury after the procedure (high-sensitivity troponin elevation >15× the upper reference limit [14 ng/L]) was the main end point. Impact of myocardial injury on 1-month adverse events (all-cause mortality, stroke, major bleeding, major vascular complications, transfusion, acute kidney injury, heart failure, pacemaker implantation, and aortic regurgitation) was evaluated. Preprocedure and postprocedure high-sensitivity troponin levels were available in 211 patients. The mean age of patients was 83 years (78-87 years), with 129 men (61.1%). Mean postprocedure high-sensitivity troponin was 124.9±81.4 ng/L in the direct TAVR group versus 170.4±127.7 ng/L in the BAV group (P=0.007). Myocardial injury occurred in 42 patients (19.9%), including 13 patients (12.2%) in the direct TAVR group and 29 (27.9%) in the BAV group (P=0.004). BAV increased by 2.8-fold (95% CI, 1.4-5.8) myocardial injury probability. Myocardial injury was associated with 1-month adverse events (P=0.03). Conclusions BAV increased the incidence and magnitude of myocardial injury after TAVR with new-generation balloon-expandable valves. Myocardial injury was associated with 1-month adverse events. These results argue in favor of direct SAPIEN 3 valve implantation. Registration URL: https://www.Clinicaltrials.gov; Unique identifier: NCT02729519.

Keywords: balloon aortic valvuloplasty; direct implantation; myocardial injury; transcatheter aortic valve replacement; troponin.

Conflict of interest statement

Leclercq received research grants from Edwards, Medtronic, Boehringer; consultant fees from Boehringer; and lecture fees from AstraZeneca and Bayer. Lattuca received research grants from ACTION Study group, Biotronik, Boston Scientific, Daiichi‐Sankyo, Fédération Française de Cardiologie, and the Institute of CardioMetabolism and Nutrition; consultant fees from Daiichi‐Sankyo and Eli Lilly; and lecture fees from AstraZeneca and Novartis. Cayla has received research grants/consultant fees/lectures fees from Amgen, AstraZeneca, Abbott, Bayer, Biotronik, Bristol‐Myers Squibb, Pfizer, and Sanofi‐Aventis. Akodad received research grants from Edwards Lifescience, Medtronic, and Biotronik. Robert received research grants from Edwards Lifescience. The remaining authors have no disclosures to report.

Figures

Figure 1. Flow chart of the DIRECTAVI…
Figure 1. Flow chart of the DIRECTAVI (Direct Transcatheter Aortic Valve Implantation) trial and of the myocardial injury ancillary study.
Among the 236 patients allocated to randomization in the DIRECTAVI trial, preprocedure and postprocedure troponin were available in 211 patients (89.4%) (104 [90.4%] in the balloon aortic valvuloplasty [BAV] group and 107 [88.4%] in the direct transcatheter aortic valve replacement [TAVR] group). TAVI indicates transcatheter aortic valve implantation.
Figure 2. Preprocedure and postprocedure troponin according…
Figure 2. Preprocedure and postprocedure troponin according to the group of patients (predilatation [balloon aortic valvuloplasty (BAV)] and direct transcatheter aortic valve replacement [TAVR]).
Mean preprocedure troponin level was similar between both groups (P=0.3). Mean postprocedure troponin level was significantly higher in the predilatation (BAV) group in comparison to the direct TAVR group (P=0.007). *TAVR: Transcatheter aortic valve replacemen. **Data are outside the axis limits: Hs‐TnT=858 ng/mL, Hs‐TnT=630 ng/mL and Hs‐TnT=546 ng/mLBAV indicates balloon aortic valvuloplasty
Figure 3. Primary end point: myocardial injury…
Figure 3. Primary end point: myocardial injury according to Valve Academic Research Consortium‐2 criteria in the balloon aortic valvuloplasty (BAV) and direct transcatheter aortic valve replacement (TAVR) groups.
Myocardial injury was significantly more frequent in the BAV group compared with the direct TAVR group (P=0.004). DIRECTAVI indicates Direct Transcatheter Aortic Valve Implantation.

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