Patients Younger Than 60 Years With Bioprosthetic Surgical Aortic Valve Replacement
Ruggero de Paulis1, Thomas Senage2, Michael A. Borger3, Matthias Siepe4, Pierluigi Stefano5, Guenther Laufer6, Thierry Langanay7, Bart Meuris8.
1European Hospital, Rome, Italy, 2CHU Nantes, Nantes, France, 3Leipzig Heart Center, Leipzig, Germany, 4Heart Center University of Freiburg, Freiburg, Germany, 5Careggi University Hospital, Florence, Italy, 6Medical University Wien, Vienna, Austria, 7Rennes University Hospital Center, Rennes, France, 8UZ Leuven, Leuven, Belgium.
Objectives: To avoid lifelong anticoagulation bioprosthetic surgical aortic valve replacement (sAVR) is increasingly adopted in younger patients. For informed decisions, knowledge of the real-world outcome of such a choice is critical.
Methods: INDURE is a prospective, multicenter, echocardiography corelab supported registry in patients younger than 60 years undergoing bioprosthetic sAVR with a follow-up of 5 years. We aim to determine VARC-2 defined time-related valve safety and freedom from stage-3 hemodynamic structural valve deterioration (SVD).
Results: Until July 2021, 441 patients were documented across 21 sites in Europe and Canada. Patients had a mean age of 53.5±6.9 years, a EuroScore II of 1.6±1.9%, and 23% were female. Predominant AV pathology was stenosis (71.4%). Among patients younger than 50 years (n=104) stenosis (62.1 vs. 74.3%; p=0.017) and tricuspid valves (16.5 vs. 29.3%; p=0.010) were less common compared to patients aged 50 to 60 (n=337). Most patients (72%) underwent full sternotomy, with 53% undergoing isolated sAVR and medium valve sizes (23 and 25mm) were most commonly used (59.1%). Post-procedural, mean PG was 11.6±4.4mmHg (peak 20.7±7.8), and EOA 2.1±0.6cm2 (indexed 1.1±0.3). Values changed only slightly at year-1 follow-up. All-cause mortality was 0.5% at discharge (5.2% at year-1; 75% not valve-related), stroke 0.7% (2.0% at year-1), life-threatening bleeding 3.2% (7.5% at year-1) and pacemaker requirement 3.9% (12.3% at year-1). At year-1, 0 patients developed stage-3 SVD, one patient had endocarditis (0.7%) with severe transprosthetic regurgitation and need for repeat procedure, in 3 patients valve thrombosis (2.1%) was diagnosed. Event rates did not differ between the two age subgroups.
Conclusions: Procedural outcomes seem to be excellent and comparable across subgroups defined by age with respect to gradients and orifice areas. Preliminary safety outcomes at year-1 of the ongoing follow-up of INDURE were 5.2% all-cause mortality, 0.7% endocarditis and 2.1% valve thrombosis. Stage-3 SVD did not occur.
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