Direct implantation of transcatheter heart valves (THVs) using third-generation balloon-expandable devices without prior balloon aortic valvuloplasty (BAV) was found to be safe and noninferior to the more conventional approach of transcatheter aortic valve replacement (TAVR) preceded by BAV in patients with severe aortic stenosis, according to study results published in JACC: Cardiovascular Interventions.
Although TAVR preceded by BAV is the conventional nonsurgical treatment strategy for severe aortic stenosis, certain BAV-associated complications make a direct approach without prior BAV an attractive alternative.
In this single-center, randomized, prospective, open-label, noninferiority study, the Direct Transcatheter Aortic Valve Implantation (DIRECTAVI; Clinicaltrials.gov identifier: NCT02729519) trial, 236 patients with severe aortic stenosis who were scheduled to undergo TAVR were enrolled between May 2016 and May 2018. Participants were randomly assigned to undergo TAVR with BAV (BAV control group; n=115; median age, 83 years; 39.1% women), or direct implantation without BAV (direct implantation test group; n=121; median age, 83 years; 37.2% women). The Edwards SAPIEN 3 THV was used to perform TAVR in all patients.
The study’s primary outcome was the rate of device success, as defined by the Valve Academic Research Consortium-2 criteria, assessed using a 7% noninferiority margin and an assumption of 95% success rate in the BAV group. Secondary outcomes included adverse events 30 days postintervention and those related to the procedure, as well as postdilatation rate.
Successful implantation of the THV was achieved in 78.0% of participants. Device success rate was higher in the direct implantation group (n=97) vs in the BAV group (n=97; 80.2% vs 75.7%, respectively; mean difference, 4.5%; 95% CI, −4.4% to 13.4%; Pnon-inferiority =.02). A total of 7 patients (5.8%) who received direct implantation required the addition of BAV during TAVR to cross the valve. There was no severe aortic regurgitation or severe prosthesis-patient mismatch reported in either treatment group. A single valve was positioned correctly in all individuals who underwent TAVR.
The majority of adverse events were related to pacemaker implantation, with rates of 20.9% and 19.0% in the BAV and direct implantation groups, respectively (P =.70). There were no significant between-group differences regarding postdilatation rates, radiation exposure, contrast volume, or procedural duration. There were 2 fatalities related to the procedure, both in the direct implantation group, but no major bleeding was reported.
Study limitations include a small sample size and postdilatations performed at physician discretion, without formal study indications.
“The efficacy and safety of direct implantation are demonstrated in this study using new-generation balloon expandable THVs, but upstream selection of patients on the basis of valve and aortic anatomy is probably necessary for extension of this strategy,” noted the authors.
Leclercq F, Robert P, Akodad M, et al. Prior balloon valvuloplasty versus direct transcatheter aortic valve replacement. JACC Cardiovasc Interv. 2020;13(5):594-602