PMID- 33776017
OWN - NLM
STAT- MEDLINE
DCOM- 20220211
LR  - 20220211
IS  - 1347-4820 (Electronic)
IS  - 1346-9843 (Linking)
VI  - 85
IP  - 7
DP  - 2021 Jun 25
TI  - Two-Year Results of the 17-mm Avalus Aortic Valve in the PERIGON Japan Trial.
PG  - 1035-1041
LID - 10.1253/circj.CJ-20-1024 [doi]
AB  - BACKGROUND: The PERIcardial SurGical AOrtic Valve ReplacemeNt (PERIGON) Japan 
      Trial was developed to assess the safety and effectiveness of the 17-mm Avalus 
      bioprosthesis (Medtronic, Minneapolis, MN, USA) in patients undergoing surgical 
      aortic valve replacement.Methods and Results:The primary endpoint in the trial 
      was the percentage of patients achieving the composite of at least 1 class 
      improvement in New York Heart Association (NYHA) functional class at 1 year 
      compared with baseline and effective orifice area index (EOAI) of 0.6 
      cm(2)/m(2)or greater at 1-year after implantation, compared with a performance 
      goal of 60%. The present study reports outcomes through 2 years. Eleven patients 
      were implanted (10 [91%] female, median age 78.3 years). From baseline to 1 year, 
      10 subjects (91%) showed an improvement in NYHA classification. At 1 year, mean 
      (+/-SD) EOAI was 0.82+/-0.17 cm(2)/m(2), with 10 patients (91%) having an EOAI >/=0.6 
      cm(2)/m(2). As such, 9 of 11 patients (82%) successfully met the primary 
      endpoint. One death occurred between the 1- and 2-year follow-up visits, 
      unrelated to the valve. There were no valve reinterventions, explants, or device 
      deficiencies through 2 years. CONCLUSIONS: The PERIGON Japan Trial met its 
      primary endpoint. Surgical implantation of the 17-mm Avalus aortic bioprosthesis 
      can be performed with an acceptable incidence of device-related adverse events, 
      and the valve performs effectively based on echocardiographic findings.
FAU - Okita, Yutaka
AU  - Okita Y
AD  - Takatsuki General Hospital.
FAU - Fujita, Tomoyuki
AU  - Fujita T
AD  - National Cerebral and Cardiovascular Center.
FAU - Zaikokuji, Kenta
AU  - Zaikokuji K
AD  - Sakakibara Heart Institute.
FAU - Nakajima, Hiroyuki
AU  - Nakajima H
AD  - Saitama Medical University International Medical Center.
FAU - Yamanaka, Katsuhiro
AU  - Yamanaka K
AD  - Kobe University Hospital.
FAU - Fukumura, Yoshiaki
AU  - Fukumura Y
AD  - Tokushima Red Cross Hospital.
FAU - Yamaguchi, Atsushi
AU  - Yamaguchi A
AD  - Jichi Medical University Saitama Medical Center.
FAU - Murakami, Hirohisa
AU  - Murakami H
AD  - Hyogo Brain and Heart Center.
FAU - Yaku, Hitoshi
AU  - Yaku H
AD  - Kyoto Prefectural University of Medicine.
FAU - Gearhart, Elizabeth
AU  - Gearhart E
AD  - Medtronic.
FAU - Komiya, Tatsuhiko
AU  - Komiya T
AD  - Kurashiki Central Hospital.
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20210327
PL  - Japan
TA  - Circ J
JT  - Circulation journal : official journal of the Japanese Circulation Society
JID - 101137683
SB  - IM
MH  - Aged
MH  - *Aortic Valve/diagnostic imaging/surgery
MH  - *Aortic Valve Stenosis/surgery
MH  - Female
MH  - *Heart Valve Prosthesis Implantation
MH  - Humans
MH  - Japan
MH  - Male
MH  - Treatment Outcome
OTO - NOTNLM
OT  - Aortic regurgitation
OT  - Aortic stenosis
OT  - Bovine pericardial tissue valve
OT  - Surgical aortic valve
EDAT- 2021/03/30 06:00
MHDA- 2022/02/12 06:00
CRDT- 2021/03/29 06:10
PHST- 2021/03/30 06:00 [pubmed]
PHST- 2022/02/12 06:00 [medline]
PHST- 2021/03/29 06:10 [entrez]
AID - 10.1253/circj.CJ-20-1024 [doi]
PST - ppublish
SO  - Circ J. 2021 Jun 25;85(7):1035-1041. doi: 10.1253/circj.CJ-20-1024. Epub 2021 Mar 
      27.