Self-expanding TAVR matches or outperforms balloon-expandable TAVR for small aortic annulus

medwireNews: Clinical outcomes among patients with severe aortic stenosis and a small aortic annulus who undergo transcatheter aortic valve replacement (TAVR) with a self-expanding supra-annular valve are noninferior to patients given a balloon-expandable valve, research shows. In addition, use of a self-expanding supra-annular valve offers superior outcomes to that of a balloon-expandable valve when considering bioprosthetic valve dysfunction at 12 months, report Howard Herrmann (Hospital of the University of Pennsylvania, Philadelphia, USA) and co-authors in The New England Journal of Medicine. They say: “Patients with a small aortic annulus are an important subgroup of symptomatic patients with aortic stenosis, predominantly women, who undergo TAVR.” These individuals “are at particular risk for high residual gradients and prosthesis–patient mismatch, which are associated with major adverse cardiovascular events, including death, heart failure, and reduced quality of life.” The researchers compared outcomes among 716 patients (mean age 80 years, 87% women) with symptomatic severe aortic stenosis and an aortic valve annulus area of 430 mm2 or less who were randomly assigned to undergo TAVR with either a self-expanding supra-annular valve (Evolut PRO/PRO+/FX, Medtronic, Minneapolis, USA) or a balloon-expandable valve (SAPIEN 3/3 Ultra, Edwards Lifesciences, Irvine, USA). At 12 months, 9.4% of the 355 patients who received a self-expanding valve had died, or had experienced a disabling stroke or rehospitalization for heart failure. This rate was statistically noninferior to the rate of 10.6% observed among the 361 participants given a balloon-expandable valve. Of the individual components, the respective rates were 5.1% and 5.9% for death, 3.1% and 2.6% for disabling stroke, and 3.8% and 3.5% for rehospitalization for heart failure. The trial also assessed bioprosthetic valve dysfunction at 12 months, which comprised clinical valve thrombosis, endocarditis, aortic valve reintervention, hemodynamic structural valve dysfunction (aortic valve mean gradient ≥20 mmHg), or nonstructural valve dysfunction, defined as severe prosthesis–patient mismatch or at least moderate total aortic regurgitation. This second co-primary endpoint occurred in 9.4% of participants with a self-expanding valve and 41.6% of those with a balloon-expandable valve. The lower rate with the self-expanding valve showed statistical superiority over the balloon-expandable valve rate, the researchers note. Clinical valve thrombosis occurred in 0.3% of participants in each arm, while endocarditis was observed in 0.6% and 2.3% of the self-expanding valve and balloon-expandable valve arms, respectively. Corresponding rates were 0.9% and 0.6% for aortic valve reintervention, 3.2% and 32.2% for hemodynamic structural valve dysfunction, and 5.9% and 18.2% for nonstructural valve dysfunction. Herrmann and team also found that the self-expanding valve was superior to the balloon-expandable valve for a number of secondary end points at 12 months including aortic valve mean gradient (7.7 vs 15.7 mmHg), effective orifice area (1.99 vs 1.50 cm2), bioprosthetic valve dysfunction in women (10.2 vs 43.3%), and moderate or severe prosthesis–patient mismatch at 30 days (11.2 vs 35.3%). Conversely, there were no significant differences between the two groups regarding major safety end points including 30-day rates of coronary obstruction, conversion to surgery, major bleeding, acute kidney injury, and hospital readmission, and 12-month incidences of cardiovascular death, reintervention, valve thrombosis, and hospital readmission. The study findings were also presented at the American College of Cardiology Scientific Sessions 2024 in Atlanta, Georgia, USA. medwireNews is an independent medical news service provided by Springer Healthcare Ltd. © 2024 Springer Healthcare Ltd, part of the Springer Nature Group N Engl J Med 2024; doi:10.1056/NEJMoa2312573 ACC 2024; Atlanta, Georgia, USA: 6–8 April

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Self-expanding TAVR matches or outperforms balloon-expandable TAVR for small aortic annulus

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