PMID- 32553252
OWN - NLM
STAT- MEDLINE
DCOM- 20210114
LR  - 20210203
IS  - 1558-3597 (Electronic)
IS  - 0735-1097 (Linking)
VI  - 75
IP  - 24
DP  - 2020 Jun 23
TI  - Subclinical Leaflet Thrombosis in Transcatheter and Surgical 
      Bioprosthetic Valves: PARTNER 3 Cardiac Computed Tomography Substudy.
PG  - 3003-3015
LID - S0735-1097(20)35090-7 [pii]
LID - 10.1016/j.jacc.2020.04.043 [doi]
AB  - BACKGROUND: Subclinical leaflet thrombosis, characterized by hypoattenuated 
      leaflet thickening (HALT) and reduced leaflet motion observed on 4-dimensional 
      computed tomography (CT), may represent a form of bioprosthetic valve 
      dysfunction. OBJECTIVES: The U.S. Food and Drug Administration mandated CT 
      studies to understand the natural history of this finding, differences between 
      transcatheter and surgical valves, and its association with valve hemodynamics 
      and clinical outcomes. METHODS: The PARTNER 3 (The Safety and Effectiveness of 
      the SAPIEN 3 Transcatheter Heart Valve in Low-Risk Patients With Aortic Stenosis) 
      CT substudy randomized 435 patients with low-surgical-risk aortic stenosis to 
      undergo transcatheter aortic valve replacement (n = 221) or surgery (n = 214). 
      Serial 4-dimensional CTs were performed at 30 days and 1 year and were analyzed 
      independently by a core laboratory. RESULTS: The incidence of HALT increased from 
      10% at 30 days to 24% at 1 year. Spontaneous resolution of 30-day HALT occurred 
      in 54% of patients at 1 year, whereas new HALT appeared in 21% of patients at 1 
      year. HALT was more frequent in transcatheter versus surgical valves at 30 days 
      (13% vs. 5%; p = 0.03), but not at 1 year (28% vs. 20%; p = 0.19). The presence 
      of HALT did not significantly affect aortic valve mean gradients at 30 days or 1 
      year. Patients with HALT at both 30 days and 1 year, compared with those with no 
      HALT at 30 days and 1 year, had significantly increased aortic valve gradients at 
      1 year (17.8 +/- 2.2 mm Hg vs. 12.7. +/- 0.3 mm Hg; p = 0.04). CONCLUSIONS: 
      Subclinical leaflet thrombosis was more frequent in transcatheter compared with 
      surgical valves at 30 days, but not at 1 year. The impact of HALT on 
      thromboembolic complications and structural valve degeneration needs further 
      assessment.
CI  - Copyright (c) 2020 The Authors. Published by Elsevier Inc. All rights reserved.
FAU - Makkar, Raj R
AU  - Makkar RR
AD  - Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles, California. 
      Electronic address: Raj.Makkar@cshs.org.
FAU - Blanke, Philipp
AU  - Blanke P
AD  - St. Paul's Hospital, University of British Columbia, Vancouver, British Columbia, 
      Canada.
FAU - Leipsic, Jonathon
AU  - Leipsic J
AD  - St. Paul's Hospital, University of British Columbia, Vancouver, British Columbia, 
      Canada.
FAU - Thourani, Vinod
AU  - Thourani V
AD  - Piedmont Heart Institute, Atlanta, Georgia.
FAU - Chakravarty, Tarun
AU  - Chakravarty T
AD  - Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles, California.
FAU - Brown, David
AU  - Brown D
AD  - Baylor Scott and White Healthcare, Plano, Texas.
FAU - Trento, Alfredo
AU  - Trento A
AD  - Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles, California.
FAU - Guyton, Robert
AU  - Guyton R
AD  - Emory University, Atlanta, Georgia.
FAU - Babaliaros, Vasilis
AU  - Babaliaros V
AD  - Emory University, Atlanta, Georgia.
FAU - Williams, Mathew
AU  - Williams M
AD  - New York University Langone Medical Center, New York, New York.
FAU - Jilaihawi, Hasan
AU  - Jilaihawi H
AD  - New York University Langone Medical Center, New York, New York.
FAU - Kodali, Susheel
AU  - Kodali S
AD  - Columbia University Medical Center/NewYork-Presbyterian Hospital, New York, New 
      York.
FAU - George, Isaac
AU  - George I
AD  - Columbia University Medical Center/NewYork-Presbyterian Hospital, New York, New 
      York.
FAU - Lu, Michael
AU  - Lu M
AD  - Department of Biostatistics, Edwards Lifesciences, Irvine, California.
FAU - McCabe, James M
AU  - McCabe JM
AD  - University of Washington, Seattle, Washington.
FAU - Friedman, John
AU  - Friedman J
AD  - Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles, California.
FAU - Smalling, Richard
AU  - Smalling R
AD  - The University of Texas Health Science Center at Houston, Houston, Texas.
FAU - Wong, Shing Chiu
AU  - Wong SC
AD  - Cornell University New York, New York, New York.
FAU - Yazdani, Shahram
AU  - Yazdani S
AD  - Inova Heart and Vascular Institute (Fairfax Inova), Falls Church, Virginia.
FAU - Bhatt, Deepak L
AU  - Bhatt DL
AD  - Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical 
      School, Boston, Massachusetts.
FAU - Bax, Jeroen
AU  - Bax J
AD  - Leiden University Medical Centre, Leiden, the Netherlands.
FAU - Kapadia, Samir
AU  - Kapadia S
AD  - Cleveland Clinic, Cleveland, Ohio.
FAU - Herrmann, Howard C
AU  - Herrmann HC
AD  - University of Pennsylvania, Philadelphia, Pennsylvania.
FAU - Mack, Michael
AU  - Mack M
AD  - Baylor Scott and White Healthcare, Plano, Texas.
FAU - Leon, Martin B
AU  - Leon MB
AD  - Columbia University Medical Center/NewYork-Presbyterian Hospital, New York, New 
      York.
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - J Am Coll Cardiol
JT  - Journal of the American College of Cardiology
JID - 8301365
SB  - IM
CIN - J Am Coll Cardiol. 2020 Jun 23;75(24):3016-3019. PMID: 32553253
CIN - J Am Coll Cardiol. 2020 Oct 20;76(16):1913-1914. PMID: 32805350
MH  - Aged
MH  - Aortic Valve Stenosis/*surgery
MH  - Bioprosthesis/*adverse effects
MH  - Canada/epidemiology
MH  - Female
MH  - Four-Dimensional Computed Tomography
MH  - Heart Valve Prosthesis/*adverse effects
MH  - Humans
MH  - Male
MH  - Postoperative Complications/diagnostic imaging/*epidemiology/etiology
MH  - Thrombosis/diagnostic imaging/*epidemiology/etiology
MH  - Transcatheter Aortic Valve Replacement/*adverse effects/mortality
MH  - United States/epidemiology
OTO - NOTNLM
OT  - hypoattenuated leaflet thickening
OT  - leaflet thrombosis
OT  - reduced leaflet motion
OT  - subclinical leaflet thrombosis
EDAT- 2020/06/20 06:00
MHDA- 2021/01/15 06:00
CRDT- 2020/06/20 06:00
PHST- 2020/03/31 00:00 [received]
PHST- 2020/04/15 00:00 [accepted]
PHST- 2020/06/20 06:00 [entrez]
PHST- 2020/06/20 06:00 [pubmed]
PHST- 2021/01/15 06:00 [medline]
AID - S0735-1097(20)35090-7 [pii]
AID - 10.1016/j.jacc.2020.04.043 [doi]
PST - ppublish
SO  - J Am Coll Cardiol. 2020 Jun 23;75(24):3003-3015. doi: 10.1016/j.jacc.2020.04.043.