Randomized controlled trial between conventional versus sutureless bioprostheses for aortic valve replacement: Impact of mini and full sternotomy access at 1-year follow-up

Research output: Contribution to journalResearch articleContributedpeer-review

Contributors

  • Theodor Fischlein - , Paracelsus Private Medical University (Author)
  • Elena Caporali - , Turkish Cardiology Society (Author)
  • Thierry Folliguet - , Department of Cardiac Surgery (Author)
  • Utz Kappert - , Heart Center Dresden University Hospital (Author)
  • Bart Meuris - , University Hospitals Leuven (Author)
  • Malakh L Shrestha - , Hannover Medical School (MHH) (Author)
  • Eric E Roselli - , Cleveland Clinic Ohio (Author)
  • Nikolaos Bonaros - , Innsbruck Medical University (Author)
  • Olivier Fabre - , Bois Bernard Private Hospital, Lens Hospital (Author)
  • Pierre Corbi - , CHU de Poitiers (Author)
  • Giovanni Troise - , Poliambulanza Foundation Hospital (Author)
  • Martin Andreas - , Medical University of Vienna (Author)
  • Frederic Pinaud - , University Hospital Angers (Author)
  • Steffen Pfeiffer - , Paracelsus Private Medical University (Author)
  • Sami Kueri - , University Medical Center Freiburg (Author)
  • Erwin Tan - , Catharina Ziekenhuis (Author)
  • Pierre Voisine - , Quebec Heart and Lung Institute (Author)
  • Evaldas Girdauskas - , University Hospital Hamburg Eppendorf (Author)
  • Filip Rega - , University Hospitals Leuven (Author)
  • Julio García-Puente - , Hospital Virgen de la Arrixaca (Author)
  • Roberto Lorusso - , Maastricht University Medical Centre (UMC+) (Author)

Abstract

BACKGROUND: The present study is a sub-analysis of the multicenter, randomized PERSIST-AVR trial (PERceval Sutureless Implant versus Standard Aortic Valve Replacement) comparing the in-hospital and 1-year results of sutureless versus conventional stented bioprostheses in isolated surgical aortic valve replacement (SAVR) within two different surgical approaches: mini-sternotomy (MS) and full-sternotomy (FS).

METHODS: A total of 819 patients (per-protocol population) underwent preoperative randomization to sutureless or stented biological valve at 47 centers worldwide. Sub-analysis on isolated SAVR was performed. Results were compared between sutureless and stented within the two different surgical approaches.

RESULTS: 285 patients were implanted with Perceval (67% in MS) and 293 with stented valves (65% in MS). Sutureless group showed significantly reduced surgical times both in FS and MS. In-hospital results show no differences between Perceval and stented valves in FS, while a lower incidence of new-onset of atrial fibrillation (3.7% vs 10.8%) with Perceval in MS. After 1-year, use of sutureless valve showed a significant reduction of MACCE (5.2% vs 10.8%), stroke rate (1.0% vs 5.4%), new-onset of atrial fibrillation (4.2% vs 11.4%) and re-hospitalizations (21.8 days vs 47.6 days), compared to stented valves but presented higher rate of pacemaker implantation (11% vs 1.6%).

CONCLUSIONS: Sutureless bioprosthesis showed significantly reduced procedural times during isolated SAVR in both surgical approaches. Patients with sutureless valves and MS access showed also better 1-year outcome regarding MACCEs, stroke, re-hospitalization and new-onset atrial fibrillation, but presented a higher rate of permanent pacemaker implantation compared to patients with stented bioprosthesis.

Details

Original languageEnglish
Pages (from-to)56-61
Number of pages6
JournalInternational journal of cardiology
Volume368
Publication statusPublished - 1 Dec 2022
Peer-reviewedYes
Externally publishedYes

External IDs

Scopus 85136122615

Keywords

Keywords

  • Aortic Valve/surgery, Aortic Valve Stenosis/surgery, Atrial Fibrillation/diagnosis, Bioprosthesis, Follow-Up Studies, Heart Valve Prosthesis, Heart Valve Prosthesis Implantation/methods, Humans, Prosthesis Design, Retrospective Studies, Sternotomy/methods, Treatment Outcome