PMID- 28475690
OWN - NLM
STAT- MEDLINE
DCOM- 20180518
LR  - 20220317
IS  - 1873-734X (Electronic)
IS  - 1010-7940 (Print)
IS  - 1010-7940 (Linking)
VI  - 52
IP  - 3
DP  - 2017 Sep 1
TI  - Safety, effectiveness and haemodynamic performance of a new stented aortic valve 
      bioprosthesis.
PG  - 425-431
LID - 10.1093/ejcts/ezx066 [doi]
AB  - OBJECTIVES: We assessed the safety, effectiveness and haemodynamic performance of 
      a new bovine stented aortic valve bioprosthesis (Avalus). METHODS: The PERIGON 
      Pivotal Trial is a prospective, non-randomized, multicentre study. Subjects had 
      symptomatic moderate or severe aortic stenosis or chronic, severe aortic 
      regurgitation. Death, valve-related adverse events (AEs), functional recovery and 
      haemodynamic performance were assessed at discharge, 3-6 months and 1 year. The 
      primary analysis compared 'late' (>30 days post-implant) linearized rates of 
      valve-related thromboembolism, thrombosis, all and major haemorrhage, all and 
      major paravalvular leak (PVL) and endocarditis after implantation with objective 
      performance criteria (OPC) for AEs, in accordance with EN ISO 5840:2009. We 
      hypothesized that the upper 95% confidence bounds of the true linearized AE rates 
      would be >/= 2 x OPC; rejection of the null hypothesis would demonstrate that these 
      rates were below acceptable rates. The analysis was required to include at least 
      150 patients followed to 1 year and 400 valve-years. Kaplan-Meier survival 
      analysis was also performed. RESULTS: Total number of valve-years was 459.5 
      (n = 686). Linearized rates were <2 x OPC for death and valve-related 
      thromboembolism, valve thrombosis, all and major PVL, and endocarditis, but 
      >/=2 x OPC for all and major haemorrhage. Survival at 1 year (n = 270) was 96.4%. 
      Patients showed good functional recovery, and haemodynamic performance was within 
      expected range. CONCLUSIONS: This analysis demonstrated a good safety profile and 
      clinical effectiveness of the Avalus valve except for bleeding rates. The 
      linearized rates of all and major haemorrhage may be related to long-term 
      anticoagulation for non-valvular indications and the length of follow-up of this 
      cohort. TRIAL REGISTRATION: NCT02088554 (www.clinicaltrials.gov).
CI  - (c) The Author 2017. Published by Oxford University Press on behalf of the European 
      Association for Cardio-Thoracic Surgery.
FAU - Klautz, Robert J M
AU  - Klautz RJM
AD  - Department of Cardiothoracic Surgery, Leiden University Medical Centre, Leiden, 
      Netherlands.
FAU - Kappetein, A Pieter
AU  - Kappetein AP
AD  - Department of Cardio-Thoracic Surgery, Erasmus Medical Centre, Rotterdam, 
      Netherlands.
FAU - Lange, Rudiger
AU  - Lange R
AD  - German Heart Centre, Technical University of Munich, Munich, Germany.
FAU - Dagenais, Francois
AU  - Dagenais F
AD  - Deparment of Cardiac Surgery, Quebec Heart and Lung Institute, Quebec City, 
      Canada.
FAU - Labrousse, Louis
AU  - Labrousse L
AD  - Department of Cardiac and Vascular Surgery, University Hospital of Bordeaux, 
      Bordeaux, France.
FAU - Bapat, Vinayak
AU  - Bapat V
AD  - Department of Cardiothoracic Surgery, St Thomas' Hospital, London, UK.
FAU - Moront, Michael
AU  - Moront M
AD  - Department of Cardiothoracic Surgery, ProMedica Toledo Hospital, Toledo, OH, USA.
FAU - Misfeld, Martin
AU  - Misfeld M
AD  - Department of Cardiac Surgery, Leipzig Heart Centre, University Hospital, 
      Leipzig, Germany.
FAU - Zeng, Cathy
AU  - Zeng C
AD  - Statistical Services Department, Medtronic, Minneapolis, MN, USA.
FAU - Sabik Iii, Joseph F
AU  - Sabik Iii JF
AD  - Department of Surgery, University Hospitals, Cleveland Medical Center, Case 
      Western Reserve University School of Medicine, Cleveland, OH, USA.
CN  - PERIGON Investigators
LA  - eng
SI  - ClinicalTrials.gov/NCT02088554
PT  - Clinical Trial
PT  - Journal Article
PT  - Multicenter Study
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
MH  - Acute Disease
MH  - Aged
MH  - Animals
MH  - Aortic Valve/diagnostic imaging/*surgery
MH  - Aortic Valve Insufficiency/diagnosis/physiopathology/*surgery
MH  - Aortic Valve Stenosis/diagnosis/physiopathology/*surgery
MH  - *Bioprosthesis
MH  - Cattle
MH  - Chronic Disease
MH  - Female
MH  - Follow-Up Studies
MH  - *Heart Valve Prosthesis
MH  - Hemodynamics/*physiology
MH  - Humans
MH  - Male
MH  - Prospective Studies
MH  - Prosthesis Design
MH  - *Stents
MH  - Time Factors
MH  - Treatment Outcome
PMC - PMC5848807
OTO - NOTNLM
OT  - Aortic stenosis
OT  - Aortic valve haemodynamics
OT  - Aortic valve replacement
OT  - Avalus valve
OT  - Bioprosthetic valves
OT  - Bovine pericardial valves
EDAT- 2017/05/06 06:00
MHDA- 2018/05/19 06:00
PMCR- 2017/05/04
CRDT- 2017/05/06 06:00
PHST- 2016/10/07 00:00 [received]
PHST- 2017/02/07 00:00 [accepted]
PHST- 2017/05/06 06:00 [pubmed]
PHST- 2018/05/19 06:00 [medline]
PHST- 2017/05/06 06:00 [entrez]
PHST- 2017/05/04 00:00 [pmc-release]
AID - 3798543 [pii]
AID - ezx066 [pii]
AID - 10.1093/ejcts/ezx066 [doi]
PST - ppublish
SO  - Eur J Cardiothorac Surg. 2017 Sep 1;52(3):425-431. doi: 10.1093/ejcts/ezx066.