PMID- 35789382
OWN - NLM
STAT- MEDLINE
DCOM- 20220804
LR  - 20220920
IS  - 1873-734X (Electronic)
IS  - 1010-7940 (Print)
IS  - 1010-7940 (Linking)
VI  - 62
IP  - 3
DP  - 2022 Aug 3
TI  - Surgical aortic valve replacement with a stented pericardial bioprosthesis: 
      5-year outcomes.
LID - 10.1093/ejcts/ezac374 [doi]
LID - ezac374
AB  - OBJECTIVES: This analysis evaluated the safety, durability and haemodynamic 
      performance of a stented bovine pericardial valve through 5 years of follow-up in 
      patients with an indication for surgical aortic valve replacement. METHODS: 
      Kaplan-Meier analysis was used to estimate the incidence of survival and 
      valve-related thromboembolism, major paravalvular leak, endocarditis, structural 
      valve deterioration (SVD) and reintervention. The mean aortic gradient and New 
      York Heart Association (NYHA) functional class were also evaluated. RESULTS: A 
      total of 1118 patients have received the Avalus valve; 564 have completed the 
      5-year follow-up. The median follow-up was 4.85 years (4810 patient-years total 
      follow-up). At baseline, the mean age was 70.2 +/- 9.0 years; 75.1% of patients 
      were male. The Society of Thoracic Surgeons predicted risk of mortality was 
      2.0 +/- 1.4%. Most patients were in NYHA functional class II (46.8%) or III 
      (40.3%). At the 5-year follow-up, the overall Kaplan-Meier survival rate was 
      88.1% (85.9-90.0%). The Kaplan-Meier event rates were 5.6% (4.3-7.2%) for 
      thromboembolism, 4.4% (3.2-6.0%) for endocarditis, 0.2% (0.0-0.7%) for a major 
      paravalvular leak and 3.2% (2.3-4.6%) for reintervention. There were no cases of 
      SVD. The mean gradient decreased from 42.1 +/- 17.1 mmHg at baseline, to 
      13.1 +/- 4.7 mmHg at discharge and remained stable at 12.5 +/- 4.6 mmHg at 5 years. 
      More than 95% of patients were in NYHA functional class I/II 5 years after 
      surgery. CONCLUSIONS: The findings of a high survival rate, excellent safety, no 
      SVD and stable haemodynamic performance and functional status through 5 years of 
      follow-up are encouraging. Additional follow-up is needed to assess the long-term 
      durability of this contemporary surgical bioprosthesis.
CI  - (c) The Author(s) 2022. Published by Oxford University Press on behalf of the 
      European Association for Cardio-Thoracic Surgery.
FAU - Klautz, Robert J M
AU  - Klautz RJM
AUID- ORCID: 0000-0002-6507-3855
AD  - Department of Cardiothoracic Surgery, Leiden University Medical Center, Leiden, 
      Netherlands.
FAU - Dagenais, Francois
AU  - Dagenais F
AD  - Division of Cardiac Surgery, Quebec Heart and Lung Institute, Quebec, QC, Canada.
FAU - Reardon, Michael J
AU  - Reardon MJ
AD  - Department of Cardiovascular Surgery, Houston Methodist DeBakey Heart and 
      Vascular Center, Houston, TX, USA.
FAU - Lange, Rudiger
AU  - Lange R
AD  - Department of Cardiovascular Surgery, German Heart Centre Munich, Munich, 
      Germany.
FAU - Moront, Michael G
AU  - Moront MG
AD  - Department of Cardiothoracic Surgery, ProMedica Toledo Hospital, Toledo, OH, USA.
FAU - Labrousse, Louis
AU  - Labrousse L
AUID- ORCID: 0000-0001-8542-9049
AD  - Medico-Surgical Department of Valvulopathies, Bordeaux Heart University Hospital, 
      Bordeaux-Pessac, France.
FAU - Weissman, Neil J
AU  - Weissman NJ
AD  - MedStar Health Research Institute, MedStar Health, Washington, DC, USA.
FAU - Rao, Vivek
AU  - Rao V
AUID- ORCID: 0000-0003-1920-0937
AD  - Department of Surgery, Toronto General Hospital, Toronto, ON, Canada.
FAU - Patel, Himanshu J
AU  - Patel HJ
AUID- ORCID: 0000-0001-7639-2416
AD  - Department of Cardiac Surgery, Frankel Cardiovascular Center, University of 
      Michigan, Ann Arbor, MI, USA.
FAU - Liu, Fang
AU  - Liu F
AD  - Cardiac Surgery Clinical Research and Medical Science, Medtronic, Mounds View, 
      MN, USA.
FAU - Sabik, Joseph F
AU  - Sabik JF
AD  - Department of Surgery, University Hospitals Cleveland Medical Center and Case 
      Western Reserve University School of Medicine, Cleveland, OH, USA.
LA  - eng
PT  - Journal Article
PL  - Germany
TA  - Eur J Cardiothorac Surg
JT  - European journal of cardio-thoracic surgery : official journal of the European 
      Association for Cardio-thoracic Surgery
JID - 8804069
SB  - IM
CIN - Eur J Cardiothorac Surg. 2022 Aug 3;62(3):. PMID: 35984311
MH  - Aged
MH  - Animals
MH  - Aortic Valve/surgery
MH  - *Aortic Valve Insufficiency/surgery
MH  - *Aortic Valve Stenosis/surgery
MH  - *Bioprosthesis/adverse effects
MH  - Cattle
MH  - *Endocarditis/surgery
MH  - Female
MH  - Follow-Up Studies
MH  - *Heart Valve Prosthesis/adverse effects
MH  - *Heart Valve Prosthesis Implantation/adverse effects
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Prosthesis Design
MH  - *Thromboembolism/etiology
MH  - Treatment Outcome
PMC - PMC9346377
OTO - NOTNLM
OT  - Aortic valve disease
OT  - Bovine pericardial aortic bioprosthesis
OT  - Cardiac surgery
OT  - Surgical aortic valve replacement
EDAT- 2022/07/06 06:00
MHDA- 2022/08/05 06:00
PMCR- 2022/07/05
CRDT- 2022/07/05 19:34
PHST- 2022/01/06 00:00 [received]
PHST- 2022/04/21 00:00 [revised]
PHST- 2022/07/04 00:00 [accepted]
PHST- 2022/07/06 06:00 [pubmed]
PHST- 2022/08/05 06:00 [medline]
PHST- 2022/07/05 19:34 [entrez]
PHST- 2022/07/05 00:00 [pmc-release]
AID - 6631229 [pii]
AID - ezac374 [pii]
AID - 10.1093/ejcts/ezac374 [doi]
PST - ppublish
SO  - Eur J Cardiothorac Surg. 2022 Aug 3;62(3):ezac374. doi: 10.1093/ejcts/ezac374.