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November 2, 2023

Clinical performance of a novel bioprosthetic surgical aortic valve in a German high-volume center
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Clinical performance of a novel bioprosthetic surgical aortic valve in a German high-volume center

El-Sayed Ahmad A, Giammarino S, Salamate S, […]

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Clinical 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

  1. 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:

doi: 10.1111/jocs.17198

Abbreviations

No clinical data are available that evaluate the long-term impact of RESILIA tissue in patients. 

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