PMID- 33509390
OWN - NLM
STAT- MEDLINE
DCOM- 20210806
LR  - 20211101
IS  - 1558-3597 (Electronic)
IS  - 0735-1097 (Linking)
VI  - 77
IP  - 4
DP  - 2021 Feb 2
TI  - Feasibility Study of the Transcatheter Valve Repair System for Severe Tricuspid 
      Regurgitation.
PG  - 345-356
LID - S0735-1097(20)37916-X [pii]
LID - 10.1016/j.jacc.2020.11.047 [doi]
AB  - BACKGROUND: Tricuspid regurgitation (TR) is a prevalent disease with limited 
      treatment options. OBJECTIVES: This is the first 30-day report of the U.S. 
      single-arm, multicenter, prospective CLASP TR early feasibility study of the 
      PASCAL transcatheter valve repair system in the treatment of TR. METHODS: 
      Patients with symptomatic TR despite optimal medical therapy, reviewed by the 
      local heart team and central screening committee, were eligible for the study. 
      Data were collected at baseline, discharge, and the 30-day follow-up and were 
      reviewed by an independent clinical events committee and echocardiographic core 
      laboratory. Feasibility endpoints included safety (composite major adverse event 
      [MAE] rate), echocardiographic, clinical, and functional endpoints. RESULTS: Of 
      the 34 patients enrolled in the study, the mean age was 76 years, 53% were women, 
      the mean Society of Thoracic Surgeons score was 7.3%, 88% had atrial 
      fibrillation/flutter, 97% had severe or greater TR, and 79% had New York Heart 
      Association (NYHA) functional class III/IV symptoms. Twenty-nine patients (85%) 
      received implants; at 30 days, 85% of them achieved a TR severity reduction of at 
      least 1 grade, with 52% with moderate or less TR (p < 0.001). The MAE rate was 
      5.9%, and none of the patients experienced cardiovascular mortality, stroke, 
      myocardial infarction, renal complication, or reintervention. Eighty-nine percent 
      of the patients improved to NYHA functional class I/II (p < 0.001), the mean 
      6-min walk distance improved by 71 m (p < 0.001), and the mean Kansas City 
      Cardiomyopathy Questionnaire score improved by 15 points (p < 0.001). 
      CONCLUSIONS: In this early experience, the repair system performed as intended, 
      with substantial TR reduction, favorable safety results with a low MAE rate, no 
      mortality or reintervention, and significant improvements in functional status, 
      exercise capacity, and quality of life. (Edwards CLASP TR EFS [CLASP TR EFS]; 
      NCT03745313).
CI  - Copyright (c) 2021 American College of Cardiology Foundation. Published by Elsevier 
      Inc. All rights reserved.
FAU - Kodali, Susheel
AU  - Kodali S
AD  - Columbia University Medical Center, New York, New York, USA. Electronic address: 
      skodali@columbia.edu.
FAU - Hahn, Rebecca T
AU  - Hahn RT
AD  - Columbia University Medical Center, New York, New York, USA; Cardiovascular 
      Research Foundation, New York, New York, USA.
FAU - Eleid, Mackram F
AU  - Eleid MF
AD  - Mayo Clinic, Rochester, Minnesota, USA.
FAU - Kipperman, Robert
AU  - Kipperman R
AD  - Atlantic Health System Morristown Medical Center, Morristown, New Jersey, USA.
FAU - Smith, Robert
AU  - Smith R
AD  - Baylor Scott & White The Heart Hospital, Plano, Texas, USA.
FAU - Lim, D Scott
AU  - Lim DS
AD  - University of Virginia Health System, Charlottesville, Virginia, USA.
FAU - Gray, William A
AU  - Gray WA
AD  - Lankenau Medical Center, Wynnewood, Pennsylvania, USA.
FAU - Narang, Akhil
AU  - Narang A
AD  - Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA.
FAU - Pislaru, Sorin V
AU  - Pislaru SV
AD  - Mayo Clinic, Rochester, Minnesota, USA.
FAU - Koulogiannis, Konstantinos
AU  - Koulogiannis K
AD  - Atlantic Health System Morristown Medical Center, Morristown, New Jersey, USA.
FAU - Grayburn, Paul
AU  - Grayburn P
AD  - Baylor Scott & White The Heart Hospital, Plano, Texas, USA.
FAU - Fowler, Dale
AU  - Fowler D
AD  - University of Virginia Health System, Charlottesville, Virginia, USA.
FAU - Hawthorne, Katie
AU  - Hawthorne K
AD  - Lankenau Medical Center, Wynnewood, Pennsylvania, USA.
FAU - Dahou, Abdellaziz
AU  - Dahou A
AD  - Cardiovascular Research Foundation, New York, New York, USA.
FAU - Deo, Shekhar H
AU  - Deo SH
AD  - Edwards Lifesciences, Irvine, California, USA.
FAU - Vandrangi, Prashanthi
AU  - Vandrangi P
AD  - Edwards Lifesciences, Irvine, California, USA.
FAU - Deuschl, Florian
AU  - Deuschl F
AD  - Edwards Lifesciences, Irvine, California, USA.
FAU - Mack, Michael J
AU  - Mack MJ
AD  - Baylor Scott & White The Heart Hospital, Plano, Texas, USA.
FAU - Leon, Martin B
AU  - Leon MB
AD  - Columbia University Medical Center, New York, New York, USA.
FAU - Feldman, Ted
AU  - Feldman T
AD  - Edwards Lifesciences, Irvine, California, USA.
FAU - Davidson, Charles J
AU  - Davidson CJ
AD  - Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA.
CN  - CLASP TR EFS Investigators
LA  - eng
SI  - ClinicalTrials.gov/NCT03745313
PT  - Clinical Trial
PT  - Journal Article
PT  - Multicenter Study
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. 2021 Feb 2;77(4):357-359. PMID: 33509391
CIN - J Am Coll Cardiol. 2021 May 11;77(18):2350-2351. PMID: 33958134
MH  - Aged
MH  - Aged, 80 and over
MH  - Cardiac Valve Annuloplasty/*instrumentation/statistics & numerical data
MH  - Echocardiography
MH  - Endovascular Procedures/*instrumentation/statistics & numerical data
MH  - Feasibility Studies
MH  - Female
MH  - Humans
MH  - Male
MH  - Prospective Studies
MH  - Treatment Outcome
MH  - Tricuspid Valve/*surgery
MH  - Tricuspid Valve Insufficiency/diagnostic imaging/*surgery
OTO - NOTNLM
OT  - PASCAL
OT  - echocardiography
OT  - leaflet repair
OT  - tricuspid valve insufficiency
COIS- Author Disclosures This study was funded by Edwards Lifesciences. Dr. Kodali has 
      received grant support from Edwards Lifesciences. Drs. Davidson, Gray, Lim, 
      Smith, Grayburn, Mack, and Leon have received grant support/consulting fees from 
      Edwards Lifesciences. Dr. Hahn has served as a speaker and consultant for Edwards 
      Lifesciences; and has been the Chief Scientific Officer for the Echocardiography 
      Core Laboratory at the Cardiovascular Research Foundation for multiple 
      industry-sponsored trials for which she has received no direct industry 
      compensation. Drs. Deo, Vandrangi, Deuschl, and Feldman are employees of Edwards 
      Lifesciences. All other authors have reported that they have no relationships 
      relevant to the contents of this paper to disclose.
EDAT- 2021/01/30 06:00
MHDA- 2021/08/07 06:00
CRDT- 2021/01/29 05:40
PHST- 2020/07/07 00:00 [received]
PHST- 2020/11/03 00:00 [revised]
PHST- 2020/11/06 00:00 [accepted]
PHST- 2021/01/29 05:40 [entrez]
PHST- 2021/01/30 06:00 [pubmed]
PHST- 2021/08/07 06:00 [medline]
AID - S0735-1097(20)37916-X [pii]
AID - 10.1016/j.jacc.2020.11.047 [doi]
PST - ppublish
SO  - J Am Coll Cardiol. 2021 Feb 2;77(4):345-356. doi: 10.1016/j.jacc.2020.11.047.