Performing balloon predilation or valvuloplasty before a transcatheter aortic valve replacement (TAVR) may increase the incidence and magnitude of myocardial injury with new-generation balloon-expandable valves.
Some papers argue in favor or against direct implantation, others remain neutral, but this research is the first one to express a different point of view.
Historically, the biggest fear about valvuloplasty performed prior to TAVR was stroke. Now, a new factor comes into the picture: myocardial injury.
The DIRECTAVI (Direct Transcatheter Aortic Valve Implantation), an open-label randomized study, aimed to demonstrate the noninferiority of direct implantation compared with systematic previous valvuloplasty with the SAPIEN 3 valve. Levels of troponin were assessed at baseline and a day after the procedure.
The primary endpoint was troponin elevation >15× the upper reference limit (14 ng/l).
Researchers also assessed the impact of myocardial injury on certain clinical events a month after the procedure. Such events include mortality, stroke, major bleeding, vascular complications, transfusion, kidney injury, heart failure, pacemaker implantation, and aortic regurgitation.
Troponin test results from 211 individuals were available at baseline and a month after the procedure. The mean age for this patient population was 83 (78-87 years old).
The results for high-sensitivity troponin after the procedure were 124.9 ± 81.4 ng/l in the direct implantation group, and 170.4 ± 127.7 ng/L in the systematic predilation group (p = 0.007). Myocardial injury occurred in 12.2% of individuals with direct implantation, and in 27.9% of individuals in the prior valvuloplasty group (p=0.004).
Systematic valvuloplasty before TAVR almost tripled the rates of myocardial injury (hazard ratio [HR]: 2.8; 95% confidence interval [CI]: 1.4 to 5.8).
The presence of myocardial injury was assessed in troponin laboratory tests and also in adverse events unfolding a month after the procedure (p = 0.03).
Conducting a systemic balloon valvuloplasty before transcatheter aortic valve replacement increases the incidence and magnitude of myocardial injury with new-generation balloon-expandable valves. Myocardial injury resulted in adverse events a month after the procedure.
The findings of this trial suggest performing direct implantation of the S3 valve.
Original Title: Myocardial Injury After Balloon Predilatation Versus Direct Transcatheter Aortic Valve Replacement: Insights From the DIRECTAVI Trial.
Reference: Mariama Akodad et al. J Am Heart Assoc. 2020;9:e018405. DOI: 10.1161/JAHA.120.018405.