Randomized controlled trial between conventional versus sutureless bioprostheses for aortic valve replacement: Impact of mini and full sternotomy access at 1-year follow-up
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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 language | English |
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Pages (from-to) | 56-61 |
Number of pages | 6 |
Journal | International journal of cardiology |
Volume | 368 |
Publication status | Published - 1 Dec 2022 |
Peer-reviewed | Yes |
External IDs
Scopus | 85136122615 |
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Keywords
Keywords
- Aortic Valve Stenosis/surgery, Aortic Valve/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