~5mClinical performance of a novel bioprosthetic surgical aortic valve in a German high-volume center
El-Sayed Ahmad A, Giammarino S, Salamate S, Fehske W, Sirat S, Amer M, Bramlage P, Bakhtiary F and Doss M.
Journal of Cardiac Surgery. 2022; 37: 4833–40
Key points:
- The mid-term follow-up results of this single- centre study, in a patient population with a mean age of 56.8 years, indicate favourable procedural outcomes, with adequate durability and no cases of structural valve deterioration (SVD).
- At Year 3, haemodynamic performance was stable and adequate.
- INSPIRIS RESILIA aortic valve may represent a bioprosthesis suitable for younger patients, giving excellent results.
Background information
- Surgical aortic valve replacement (SAVR) using bioprosthetic valves is becoming increasingly popular in younger patients.
- The INSPIRIS RESILIA aortic valve features a tri-leaflet bovine pericardial tissue mounted under a flexible frame and has been developed to reduce calcification, therefore, increasing durability.
Aim
- To analyse mid-term follow-up data in patients who underwent SAVR with an INSPIRIS RESILIA bioprosthetic heart valve at the Heart Centre in Siegberg-Wuppertal.
Type of study
- A single-centre, non- randomised retrospective study.
Endpoints
- The primary endpoint was the haemodynamic properties of the RESILIA tissue valve at mid-term follow-up.
- Secondary objectives included mortality and valve-related complications (according to Valve Academic Research Consortium-3 criteria).1
Limitations
- This is a retrospective, non- randomised, single-centre study with a small sample size and no control group.
Methods
- All patients with aortic valve disease who received an INSPIRIS RESILIA aortic valve between April 2017 and December 2019 at the Division of Cardiac Surgery, Heart Centre Siegberg-Wuppertal, University Witten- Herdecke, Germany (n=154) were included.
- Follow-up data were collected in the clinic or by telephone during the 3-month closing interval ending in April 2021.
- Echocardiographic data were collected twice a year.
Results
Study population
- Mean (± standard deviation) patient follow-up was 2.05 ± 0.77 years.
- Baseline characteristics are listed in Table 1.
Mortality and valve-related complications
- 30-day, 1-year and 3-year freedom from mortality were 98.7%, 97.3% and 87.7%, respectively; the rate of valve-related mortality was 0%.
- There were no cases of SVD or valve-related thrombosis and one (0.6%) case of reoperation due to endocarditis.
Table 1: Patient baseline characteristics
Haemodynamic properties
- At last follow-up:– Effective orifice area was 1.9 cm2. – Peak gradient was 23.6 mmHg. – Mean gradient was 13.9 mmHg.
- Figure 1 shows peak and mean gradients at 3-year follow-up by valve size.
Figure 1: Peak and mean gradients at 3-year follow-up for each valve size
Conclusions
- The INSPIRIS RESILIA valve shows adequate mid-term durability and haemodynamic performance.
- Further studies are required to assess long-term durability and efficacy, especially in younger patients.
Reference
- Genereux P, Piazza N, Alu MC et al. Valve Academic Research Consortium 3: Updated endpoint definitions for aortic valve clinical research.
Eur Heart J. 2021; 42: 1825–57
This document is a summary of the El-Sayed Ahmed A et al. paper and covers key information including aim, type of study, methods, results and conclusions.
The full abstract is available at:
Abbreviations
No clinical data are available that evaluate the long-term impact of RESILIA tissue in patients.
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