PMID- 37586823
OWN - NLM
STAT- MEDLINE
DCOM- 20231222
LR  - 20231222
IS  - 1468-201X (Electronic)
IS  - 1355-6037 (Linking)
VI  - 110
IP  - 2
DP  - 2023 Dec 20
TI  - Impact of leaflet thrombosis on valve haemodynamic status after transcatheter 
      aortic valve replacement.
PG  - 140-147
LID - 10.1136/heartjnl-2023-322946 [doi]
AB  - OBJECTIVES: The effect of subclinical leaflet thrombosis, characterised by 
      hypoattenuated leaflet thickening (HALT), on the valve haemodynamic function and 
      durability of the bioprosthetic valve, is not yet determined. We determined the 
      impact of HALT on valve haemodynamics after transcatheter aortic valve 
      replacement (TAVR) and the predictors of haemodynamic structural valve 
      deterioration (SVD). METHODS: The Anticoagulation vs Dual Antiplatelet Therapy 
      for Prevention of Leaflet Thrombosis and Cerebral Embolization after 
      Transcatheter Aortic Valve Replacement(ADAPT-TAVR) trial is a multicenter, 
      randomised trial that compared edoxaban and dual antiplatelet therapy in patients 
      who had undergone successful TAVR. The presence of HALT was evaluated by 
      four-dimensional CT at 6 months and serial echocardiography performed at 
      baseline, immediately post-TAVR and after 6 months. SVD was defined as at least 
      one of the following: (1) mean transprosthetic gradient >/=20 mm Hg, (2) change in 
      the mean gradient >/=10 mm Hg from baseline, or (3) new or increase in 
      intraprosthetic aortic regurgitation of at least >/=1 grade, resulting in moderate 
      or greater regurgitation. RESULTS: At 6 months, HALT was found in 30 of 211 
      (14.2%) patients. The presence of HALT did not significantly affect aortic valve 
      mean gradients (with vs without HALT; 14.0+/-4.8 mm Hg vs 13.7+/-5.5 mm Hg; p=0.74) 
      at 6 months. SVD was reported in 30 of 206 patients (14.6%) at 6-month follow-up 
      echocardiography. Older age (OR: 1.138; 95% CI: 1.019 to 1.293; p=0.033), use of 
      aortic valve size </=23 mm (OR: 6.254; 95% CI: 2.230 to 20.569; p=0.001) and mean 
      post-TAVR pressure gradient (OR: 1.233; 95% CI: 1.123 to 1.371; p<0.001) were 
      independent predictors of haemodynamic SVD; however, the presence of HALT was not 
      identified as a predictor of SVD. CONCLUSIONS: In patients who had undergone 
      successful TAVR, aortic valve haemodynamic status was not influenced by the 
      presence of HALT. Although HALT was not a predictor of haemodynamic SVD at 6 
      months, it warrants further longer-term follow-up to evaluate the effect on 
      long-term valve durability. TRIAL REGISTRATION NUMBER: NCT03284827 (https://www. 
      CLINICALTRIALS: gov).
CI  - (c) Author(s) (or their employer(s)) 2024. No commercial re-use. See rights and 
      permissions. Published by BMJ.
FAU - Jang, Mi Hee
AU  - Jang MH
AD  - Ulsan University Hospital, Ulsan, Korea.
FAU - Ahn, Jung-Min
AU  - Ahn JM
AUID- ORCID: 0000-0003-4031-391X
AD  - Cardiology, Asan Medical Center, Seoul, Korea.
FAU - Kang, Do-Yoon
AU  - Kang DY
AD  - Cardiology, Asan Medical Center, Seoul, Korea.
FAU - Kim, Kyung Won
AU  - Kim KW
AD  - Asan Image Metrics, Clinical Trial Center, Asan Institue for Life Sciences, Asan 
      Medical Center, Seoul, South Korea.
FAU - Koo, Hyun Jung
AU  - Koo HJ
AD  - Radiology, Asan Medical Center, Seoul, Korea.
FAU - Yang, Dong Hyun
AU  - Yang DH
AD  - Radiology, Asan Medical Center, Seoul, Korea.
FAU - Jung, Seung Chai
AU  - Jung SC
AD  - Radiology, Asan Medical Center, Seoul, Korea.
FAU - Kim, Byungjun
AU  - Kim B
AD  - Radiology, Korea University Anam Hospital, Seoul, Korea.
FAU - Wong, Yiu Tung Anthony
AU  - Wong YTA
AD  - Cardiology, Queen Mary Hospital, University of Hong Kong, Hong Kong, China.
FAU - Lam, Cheung Chi Simon
AU  - Lam CCS
AD  - Cardiology, Queen Mary Hospital, University of Hong Kong, Hong Kong, China.
FAU - Yin, Wei-Hsian
AU  - Yin WH
AD  - Cardiology, Heart Center, Cheng Hsin General Hospital, Taipei, Taiwan.
FAU - Wei, Jeng
AU  - Wei J
AD  - Cardiology, Heart Center, Cheng Hsin General Hospital, Taipei, Taiwan.
FAU - Lee, Yung-Tsai
AU  - Lee YT
AD  - Cardiology, Heart Center, Cheng Hsin General Hospital, Taipei, Taiwan.
FAU - Kao, Hsien-Li
AU  - Kao HL
AD  - Cardiology, National Taiwan University Hospital, Taipei, Taiwan.
FAU - Lin, Mao-Shin
AU  - Lin MS
AUID- ORCID: 0000-0003-3278-4156
AD  - Cardiology, National Taiwan University Hospital, Taipei, Taiwan.
FAU - Ko, Tsung-Yu
AU  - Ko TY
AD  - Cardiology, Hsin-Chu Branch, National Taiwan University Hospital, Hsin-Chu, 
      Taiwan.
FAU - Kim, Won-Jang
AU  - Kim WJ
AD  - Cardiology, CHA Ilsan Medical Center, Goyang-si, Gyeonggi-do, Korea.
FAU - Kang, Se Hun
AU  - Kang SH
AD  - Cardiology, CHA Bundang Medical Center, Seongnam, Gyeonggi-do, Korea.
FAU - Ko, Euihong
AU  - Ko E
AD  - Cardiology, Kokura Memorial Hospital, Kitakyushu, Fukuoka, Japan.
FAU - Lee, Seung-Ah
AU  - Lee SA
AD  - Cardiology, Asan Medical Center, Seoul, Korea.
FAU - Kim, Dae-Hee
AU  - Kim DH
AUID- ORCID: 0000-0002-8275-4871
AD  - Cardiology, Asan Medical Center, Seoul, Korea.
FAU - Kim, Hoyun
AU  - Kim H
AD  - Cardiology, Asan Medical Center, Seoul, Korea.
FAU - Choi, Yeonwoo
AU  - Choi Y
AD  - Cardiology, Asan Medical Center, Seoul, Korea.
FAU - Lee, Jinho
AU  - Lee J
AD  - Cardiology, Asan Medical Center, Seoul, Korea.
FAU - Park, Seung-Jung
AU  - Park SJ
AD  - Cardiology, Asan Medical Center, Seoul, Korea.
FAU - Park, Duk-Woo
AU  - Park DW
AUID- ORCID: 0000-0001-6643-0239
AD  - Cardiology, Asan Medical Center, Seoul, Korea dwpark@amc.seoul.kr.
LA  - eng
SI  - ClinicalTrials.gov/NCT03284827
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
DEP - 20231220
PL  - England
TA  - Heart
JT  - Heart (British Cardiac Society)
JID - 9602087
RN  - 0 (Platelet Aggregation Inhibitors)
SB  - IM
MH  - Humans
MH  - *Transcatheter Aortic Valve Replacement/adverse effects/methods
MH  - *Aortic Valve Stenosis
MH  - Platelet Aggregation Inhibitors/therapeutic use
MH  - *Heart Valve Prosthesis/adverse effects
MH  - Aortic Valve/diagnostic imaging/surgery
MH  - Hemodynamics
MH  - *Thrombosis/diagnostic imaging/etiology/prevention & control
MH  - Treatment Outcome
OTO - NOTNLM
OT  - aortic valve stenosis
OT  - transcatheter aortic valve replacement
COIS- Competing interests: D-WP reports grants from Daiichi Sankyo, ChongKunDang Pharm 
      and Daewoong Pharm; personal fees from Edwards and Medtronic; and grants and 
      personal fees from Abbott Vascular outside the submitted work. S-JP reports 
      grants and personal fees from Abbott Vascular; grants from Daiichi Sankyo, 
      ChongKunDang Pharm and Daewoong Pharm; and grants and personal fees from Edwards 
      outside the submitted work.
EDAT- 2023/08/17 00:42
MHDA- 2023/12/22 06:43
CRDT- 2023/08/16 21:22
PHST- 2023/05/09 00:00 [received]
PHST- 2023/08/03 00:00 [accepted]
PHST- 2023/12/22 06:43 [medline]
PHST- 2023/08/17 00:42 [pubmed]
PHST- 2023/08/16 21:22 [entrez]
AID - heartjnl-2023-322946 [pii]
AID - 10.1136/heartjnl-2023-322946 [doi]
PST - epublish
SO  - Heart. 2023 Dec 20;110(2):140-147. doi: 10.1136/heartjnl-2023-322946.