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.
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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).
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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).
Conclusion
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.
JAHA-120-018405freeOriginal 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.
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