PMID- 36378942
OWN - NLM
STAT- MEDLINE
DCOM- 20230105
LR  - 20230415
IS  - 1540-8191 (Electronic)
IS  - 0886-0440 (Print)
IS  - 0886-0440 (Linking)
VI  - 37
IP  - 12
DP  - 2022 Dec
TI  - Eight-year outcomes of aortic valve replacement with the Carpentier-Edwards 
      PERIMOUNT Magna Ease valve.
PG  - 4999-5010
LID - 10.1111/jocs.17140 [doi]
AB  - INTRODUCTION: The Carpentier-Edwards PERIMOUNT Magna Ease valve is a 
      third-generation bioprosthesis for aortic valve replacement (AVR). This is a 
      postapproval study reporting on its 8-year outcomes. METHODS: Adults undergoing 
      AVR with the Magna Ease valve between October 2007 and December 2012 were 
      enrolled for this prospective, nonrandomized, single-arm, and multicenter study. 
      Assessments occurred preoperatively, at hospital discharge, 6 months, 1 year, and 
      annually thereafter for up to 8 years. Outcomes included safety endpoints, 
      hemodynamic performance, and New York Heart Association (NYHA) functional class. 
      RESULTS: Of the 258 study patients, 67.5% were in NYHA Class I or II, and 32.5% 
      were in NYHA Class III or IV at baseline. Concomitant procedures were performed 
      in 44.2%. Total follow-up was 1597.6 patient-years, and median follow-up was 7 
      years (interquartile range: 5.5-8.0 years). Eight years following AVR, the 
      functional class remained improved from baseline with 93.9% in NYHA Class I/II 
      and 6.1% in NYHA Class III; 38 deaths had occurred, 8 of which were valve 
      related; freedom from all-cause mortality was 80.7% (95% confidence intervals: 
      74.9, 86.4); freedom from valve-related mortality was 95.8% (92.8, 98.8); freedom 
      from reintervention, explant, major bleeding events, and structural valve 
      deterioration was 89.8% (85.1, 94.6), 94.8% (91.7, 97.9), 85.1% (80.0, 90.1), and 
      90.1% (84.7, 95.4), respectively; effective orifice area was 1.5 +/- 0.5 cm(2) , 
      the mean gradient was 14.8 +/- 8.3 mmHg, and 88.6% of patients had no or trivial 
      aortic regurgitation. CONCLUSIONS: This study demonstrated satisfactory safety 
      and sustained hemodynamic and functional improvements at 8 years following AVR 
      with the Magna Ease valve.
CI  - (c) 2022 The Authors. Journal of Cardiac Surgery published by Wiley Periodicals 
      LLC.
FAU - Tsui, Steven
AU  - Tsui S
AD  - Department of Cardiothoracic Surgery and Transplantation, Royal Papworth 
      Hospital, Cambridge, UK.
FAU - Rosenbloom, Michael
AU  - Rosenbloom M
AD  - Division of Cardiothoracic Surgery, Cooper University Hospital, Camden, New 
      Jersey, USA.
FAU - Abel, James
AU  - Abel J
AD  - Division of Cardiac and Thoracic Surgery, St Paul's Hospital, University of 
      British Columbia, Vancouver, British Columbia, Canada.
FAU - Swanson, Jeffrey
AU  - Swanson J
AD  - Providence Heart Valve Clinic, Providence St Vincent's Hospital, Portland, 
      Oregon, USA.
FAU - Haverich, Axel
AU  - Haverich A
AD  - Department of Cardiothoracic, Transplantation and Vascular Surgery, Medizinische 
      Hochschule Hannover, Hannover, Germany.
FAU - Zacharias, Joseph
AU  - Zacharias J
AUID- ORCID: 0000-0003-1832-0638
AD  - Department of Cardiothoracic Surgery, Blackpool Victoria Hospital, Blackpool, UK.
FAU - Schorlemmer, Gilbert
AU  - Schorlemmer G
AD  - Department of Cardiac, Vascular and Thoracic Surgery, St Mark's Hospital, Salt 
      Lake, Utah, USA.
FAU - Cohen, Gideon
AU  - Cohen G
AD  - Department of Surgery, Division of Cardiac Surgery, Sunnybrook Health Sciences 
      Center, North York, Ontario, Canada.
FAU - Moulton, Michael
AU  - Moulton M
AD  - Division of Cardiothoracic Surgery, University of Nebraska Medical Center, Omaha, 
      Nebraska, USA.
FAU - Lange, Rudiger
AU  - Lange R
AD  - Department of Cardiovascular Surgery, German Heart Center Munich, Munich, 
       Bavaria, Germany.
LA  - eng
GR  - Edwards Lifesciences/
PT  - Journal Article
PT  - Multicenter Study
DEP - 20221115
PL  - United States
TA  - J Card Surg
JT  - Journal of cardiac surgery
JID - 8908809
SB  - IM
MH  - Adult
MH  - Humans
MH  - Aortic Valve/surgery
MH  - Prospective Studies
MH  - Prosthesis Design
MH  - *Heart Valve Prosthesis
MH  - *Heart Valve Prosthesis Implantation
MH  - *Bioprosthesis
MH  - Follow-Up Studies
MH  - Retrospective Studies
PMC - PMC10100054
OTO - NOTNLM
OT  - aortic stenosis
OT  - aortic valve replacement
OT  - bioprosthesis
OT  - bioprosthetic valve
COIS- Financial support from British Standards Institute and 3R Life Sciences: Steven 
      Tsui. Shareholder in Edwards Lifesciences: Michael Rosenbloom. Honoraria for 
      meetings from Edwards Lifesciences; owns stock in Kardium Inc.: James Abel. 
      Consulting fees from Edwards Lifesciences: Axel Haverich. Financial support from 
      Edwards Lifesciences, Medtronic, CryoLife Inc., Ethicon, Cambridge Medical 
      Robotics, and LSI Solutions(R): Joseph Zacharias. Consulting fees from Edwards 
      Lifesciences: Gideon Cohen. Financial support from Medtronic and owns stock in 
      Highlife: Rudiger Lange. Gilbert Schorlemmer, Jeffrey Swanson, and Michael 
      Moulton declare no conflict of interest.
EDAT- 2022/11/16 06:00
MHDA- 2023/01/06 06:00
PMCR- 2023/04/13
CRDT- 2022/11/15 15:23
PHST- 2022/10/06 00:00 [received]
PHST- 2022/10/29 00:00 [accepted]
PHST- 2022/11/16 06:00 [pubmed]
PHST- 2023/01/06 06:00 [medline]
PHST- 2022/11/15 15:23 [entrez]
PHST- 2023/04/13 00:00 [pmc-release]
AID - JOCS17140 [pii]
AID - 10.1111/jocs.17140 [doi]
PST - ppublish
SO  - J Card Surg. 2022 Dec;37(12):4999-5010. doi: 10.1111/jocs.17140. Epub 2022 Nov 
      15.