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. 2023 Oct 4;37(4):ivad115.
doi: 10.1093/icvts/ivad115.

Durability of bioprosthetic aortic valve replacement in patients under the age of 60 years - 1-year follow-up from the prospective INDURE registry

Bart Meuris  1 , Jean-Christian Roussel  2 , Michael A Borger  3 , Matthias Siepe  4   5   6 , Pierluigi Stefano  7 , Günther Laufer  8 , Thierry Langanay  9 , Alexis Theron  10 , Martin Grabenwöger  11 , Konrad Binder  12 , Philippe Demers  13 , Renzo Pessotto  14 , Wouter van Leeuwen  15 , Thierry Bourguignon  16 , Sergio Canovas  17 , Giovanni Mariscalco  18 , Enrico Coscioni  19 , Francois Dagenais  20 , Olaf Wendler  21 , Gianluca Polvani  22 , Matthias Eden  23 , Beate Botta  24 , Peter Bramlage  24 , Ruggero De Paulis  25
Affiliations

Durability of bioprosthetic aortic valve replacement in patients under the age of 60 years - 1-year follow-up from the prospective INDURE registry

Bart Meuris et al. Interdiscip Cardiovasc Thorac Surg. .

Abstract

Objectives: We report 1-year safety and clinical outcomes in patients <60 years undergoing bioprosthetic surgical aortic valve intervention.

Methods: The INSPIRIS RESILIA Durability Registry is a prospective, multicentre registry to assess clinical outcomes of patients <60 years. Patients with planned SAVR with or without concomitant replacement of the ascending aorta and/or coronary bypass surgery were included. Time-related valve safety, haemodynamic performance and quality of life (QoL) at 1 year were assessed.

Results: A total of 421 patients were documented with a mean age of 53.5 years, 76.5% being male and 27.2% in NYHA class III/IV. Outcomes within 30 days included cardiovascular-related mortality (0.7%), time-related valve safety (VARC-2; 5.8%), thromboembolic events (1.7%), valve-related life-threatening bleeding (VARC-2; 4.3%) and permanent pacemaker implantation (3.8%). QoL was significantly increased at 6 months and sustained at 1 year. Freedom from all-cause mortality at 1 year was 98.3% (95% confidence interval 97.1; 99.6) and 81.8% were NYHA I versus 21.9% at baseline. No patient developed structural valve deterioration stage 3 (VARC-3). The mean aortic pressure gradient was 12.6 mmHg at 1 year and the effective orifice area was 1.9 cm2.

Conclusions: The 1-year data from the INSPIRIS RESILIA valve demonstrate good safety and excellent haemodynamic performance as well as an early QoL improvement.

Clinical trial registration: clinicaltrials.gov: NCT03666741.

Keywords: Structural valve degeneration; Surgical aortic valve replacement; Valve durability.

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Figures

Figure 1:
Figure 1:
Study flowchart. FU: follow-up.
Figure 2:
Figure 2:
(A) Valve size distribution and (B) haemodynamics over time by valve size. AV: atrioventricular; EOA: effective orifice area; PG: pressure gradient.
Figure 3:
Figure 3:
NYHA functional class versus baseline. NYHA: New York Heart Association.
Figure 4:
Figure 4:
Quality of life changes versus baseline. (A) SF-12v2 and (B) KCCQ. KCCQ: Kansas City Cardiomyopathy Questionnaire; MCS: mental component summary; PCS: physical component summary; SF-12v2: Short Form-12 Health Survey Version 2.
None
See this image and copyright information in PMC

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