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DIRECT: TAVR without vs. with pre-dilatation confers similar outcomes
Transcatheter aortic valve replacement without balloon pre-dilatation was noninferior to the procedure with pre-dilatation, according to a study published in JACC: Cardiovascular Interventions.
“To our knowledge, this is the first prospective randomized study to investigate the safety and feasibility of direct transcatheter aortic valve implantation with a self-expanding valve,” Konstantinos Toutouzas, MD, of the first department of cardiology at Athens School of Medicine in Greece, and colleagues wrote. “The DIRECT trial is also the first randomized trial using the VARC-2 definitions for the evaluation of a self-expanding valve.”
TAVR for severe aortic stenosis
Researchers analyzed data from 171 patients from four centers in Greece and Israel with severe aortic stenosis who were undergoing TAVR with a self-expandable valve (CoreValve, Evolut R or Evolut Pro; Medtronic). Patients were assigned to undergo TAVR with (n = 86; mean age, 82 years; 48% men) or without pre-dilatation (n = 85; mean age, 81 years; 58% men) with balloon aortic valvuloplasty. Before the procedure, patients underwent echocardiography, a physical examination, minimal multi-slice CT and cardiac angiography.
The primary endpoint was device success defined by Valve Academic Research Consortium (VARC)-2 criteria: correct positioning, absence of procedural mortality and intended performance of the prosthetic heart valve. Secondary endpoints were short-term stroke, vascular complications and permanent pacemaker implantation.
Device success in patients assigned TAVR without pre-dilatation was noninferior to patients who underwent pre-dilatation (76.5% vs. 74.4%; mean difference, 2.1 points; 90% CI, –8.9 to 13).
Post-balloon dilatation was performed in 29.4% of patients assigned TAVR without pre-dilatation vs. 15.1% of those assigned TAVR with pre-dilatation (P = .03).
There were no major differences between the two groups regarding major vascular complications (log-rank P = .49) and permanent pacemaker implantation (log-rank P = .54).
Events after 30 days
One stroke occurred in a patient assigned TAVR without pre-dilatation (log-rank P = .31) with no deaths in the first 30 days after the procedure.
“Confirmation of the findings in larger randomized studies or well-designed registries could designate direct TAVI as standard approach,” Toutouzas and colleagues wrote.
“The present study is an important contribution that reassures the feasibility and safety of direct-TAVR approach with the self-expanding CoreValve/Evolut devices,” Fernando Luiz de Melo Bernardi, MD, and Henrique Barbosa Ribeiro, MD, PhD, both of the Heart Institute at the University of São Paulo, wrote in a related editorial. “Most likely, avoiding [balloon aortic valvuloplasty] can be advised to a great proportion of TAVR cases performed with the current [transcatheter heart valve] and in the context of ‘minimalist’ approach. Nonetheless, in patients with more severe aortic stenosis (higher gradients, lower aortic valve and/or higher burden of calcium) and in those where difficulties in crossing the [transcatheter heart valve] are anticipated, pre-[balloon aortic valvuloplasty] should still be advised.” – by Darlene Dobkowski
Disclosures: The DIRECT trial was funded by a research grant from Medtronic. Toutouzas reports he is a proctor for Medtronic CoreValve. Bernardi and Ribeiro report no relevant financial disclosures. Please see the study for all other authors’ relevant financial disclosures.