PMID- 30999993
OWN - NLM
STAT- MEDLINE
DCOM- 20200304
LR  - 20221207
IS  - 1558-3597 (Electronic)
IS  - 0735-1097 (Linking)
VI  - 73
IP  - 15
DP  - 2019 Apr 23
TI  - 6-Month Outcomes of Tricuspid Valve Reconstruction for Patients With 
      Severe Tricuspid Regurgitation.
PG  - 1905-1915
LID - S0735-1097(19)33704-0 [pii]
LID - 10.1016/j.jacc.2019.01.062 [doi]
AB  - BACKGROUND: Severe tricuspid regurgitation (TR) is associated with high morbidity 
      and mortality rates with limited treatment options. OBJECTIVES: The authors 
      report the 6-month safety and performance of a transcatheter tricuspid valve 
      reconstruction system in the treatment of moderate to severe functional TR in 30 
      patients enrolled in the TRI-REPAIR (TrIcuspid Regurgitation RePAIr With 
      CaRdioband Transcatheter System) study. METHODS: Between October 2016 and July 
      2017, 30 patients were enrolled in this single-arm, multicenter, prospective 
      trial. Patients were diagnosed with moderate to severe, symptomatic TR in the 
      absence of untreated left-heart disease and deemed inoperable because of 
      unacceptable risk for open-heart surgery by the local heart team. Clinical, 
      functional, and echocardiographic data were prospectively collected before and up 
      to 6 months post-procedure. An independent core lab assessed all 
      echocardiographic data, and an independent clinical event committee adjudicated 
      the safety events. RESULTS: Mean patient age was 75 years, 73% were female, and 
      23% had ischemic heart disease. At baseline, 83% were in New York Heart 
      Association (NYHA) functional class III to IV, and mean left ventricular ejection 
      fraction was 58%. Technical success was 100%. Through 6 months, 3 patients died. 
      Between 6 months and baseline, echocardiography showed average reductions of 
      annular septolateral diameter of 9% (42 mm vs. 38 mm; p < 0.01), proximal 
      isovelocity surface area effective regurgitant orifice area of 50% (0.8 cm(2) vs. 
      0.4 cm(2); p < 0.01), and mean vena contracta width of 28% (1.2 cm vs. 0.9 cm; 
      p < 0.01). Clinical assessment showed that 76% of patients improved by at least 1 
      NYHA functional class with 88% in NYHA functional class I or II. Six-minute walk 
      distance improved by 60 m (p < 0.01), and Kansas City Cardiomyopathy 
      Questionnaire score improved by 24 points (p < 0.01). CONCLUSIONS: Six-month 
      outcomes show that the system performs as intended and appears to be safe in 
      patients with symptomatic and moderate to severe functional TR. Significant 
      reduction of TR through decrease of annular dimensions, improvements in heart 
      failure symptoms, quality of life, and exercise capacity were observed. Further 
      studies are warranted to validate these initial promising results. (TrIcuspid 
      Regurgitation RePAIr With CaRdioband Transcatheter System [TRI-REPAIR]; 
      NCT02981953).
CI  - Copyright (c) 2019 American College of Cardiology Foundation. Published by Elsevier 
      Inc. All rights reserved.
FAU - Nickenig, Georg
AU  - Nickenig G
AD  - Department of Cardiology, University Hospital Bonn, Bonn, Germany. Electronic 
      address: georg.nickenig@ukbonn.de.
FAU - Weber, Marcel
AU  - Weber M
AD  - Department of Cardiology, University Hospital Bonn, Bonn, Germany.
FAU - Schueler, Robert
AU  - Schueler R
AD  - Department of Cardiology, University Hospital Bonn, Bonn, Germany.
FAU - Hausleiter, Jorg
AU  - Hausleiter J
AD  - Ludwig-Maximilians University Hospital Munich, Munich, Germany.
FAU - Nabauer, Michael
AU  - Nabauer M
AD  - Ludwig-Maximilians University Hospital Munich, Munich, Germany.
FAU - von Bardeleben, Ralph S
AU  - von Bardeleben RS
AD  - Department of Cardiology, University Medical Center Mainz, Mainz, Germany.
FAU - Sotiriou, Efthymios
AU  - Sotiriou E
AD  - Department of Cardiology, University Medical Center Mainz, Mainz, Germany.
FAU - Schafer, Ulrich
AU  - Schafer U
AD  - Structural Heart Division, University Heart Center Hamburg, Hamburg, Germany.
FAU - Deuschl, Florian
AU  - Deuschl F
AD  - Structural Heart Division, University Heart Center Hamburg, Hamburg, Germany.
FAU - Kuck, Karl-Heinz
AU  - Kuck KH
AD  - Department of Cardiology, St. George Hospital, Hamburg, Germany.
FAU - Kreidel, Felix
AU  - Kreidel F
AD  - Department of Cardiology, St. George Hospital, Hamburg, Germany.
FAU - Juliard, Jean-Michel
AU  - Juliard JM
AD  - Department of Cardiology, Hopital Bichat, AP-HP, Paris, France; Departement de 
      Cardiologie, Universite Paris-Diderot, Paris, France; INSERM U-1148, Paris, 
      France.
FAU - Brochet, Eric
AU  - Brochet E
AD  - Department of Cardiology, Hopital Bichat, AP-HP, Paris, France; Departement de 
      Cardiologie, Universite Paris-Diderot, Paris, France; INSERM U-1148, Paris, 
      France.
FAU - Latib, Azeem
AU  - Latib A
AD  - Dipartimento Cardio-Toraco-Vascolare, San Raffaele Institute, Milan, Italy.
FAU - Agricola, Eustachio
AU  - Agricola E
AD  - Dipartimento Cardio-Toraco-Vascolare, San Raffaele Institute, Milan, Italy.
FAU - Baldus, Stephan
AU  - Baldus S
AD  - Heart Center, University Hospital Cologne, Cologne, Germany.
FAU - Friedrichs, Kai
AU  - Friedrichs K
AD  - Heart Center, University Hospital Cologne, Cologne, Germany.
FAU - Vandrangi, Prashanthi
AU  - Vandrangi P
AD  - Edwards Lifesciences, Irvine, California.
FAU - Verta, Patrick
AU  - Verta P
AD  - Edwards Lifesciences, Irvine, California.
FAU - Hahn, Rebecca T
AU  - Hahn RT
AD  - Cardiovascular Research Foundation, New York, New York.
FAU - Maisano, Francesco
AU  - Maisano F
AD  - Department of Cardiovascular Surgery, University Hospital Zurich, Zurich, 
      Switzerland.
LA  - eng
SI  - ClinicalTrials.gov/NCT02981953
PT  - Clinical Trial
PT  - Journal Article
PT  - Multicenter Study
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. 2019 Apr 23;73(15):1916-1918. PMID: 30999994
MH  - Age Factors
MH  - Aged
MH  - Aged, 80 and over
MH  - Cardiac Catheterization/*methods
MH  - Echocardiography, Doppler/methods
MH  - Female
MH  - Follow-Up Studies
MH  - Heart Valve Prosthesis Implantation/*methods/mortality
MH  - Hospital Mortality/*trends
MH  - Humans
MH  - Internationality
MH  - Male
MH  - Middle Aged
MH  - Minimally Invasive Surgical Procedures/methods
MH  - Prospective Studies
MH  - Plastic Surgery Procedures/methods/mortality
MH  - Risk Assessment
MH  - Severity of Illness Index
MH  - Survival Rate
MH  - Time Factors
MH  - Treatment Outcome
MH  - Tricuspid Valve Insufficiency/diagnostic imaging/mortality/*surgery
OTO - NOTNLM
OT  - TRI-REPAIR
OT  - annular reduction
OT  - tricuspid regurgitation
OT  - tricuspid repair
EDAT- 2019/04/20 06:00
MHDA- 2020/03/05 06:00
CRDT- 2019/04/20 06:00
PHST- 2018/12/17 00:00 [received]
PHST- 2019/01/14 00:00 [revised]
PHST- 2019/01/21 00:00 [accepted]
PHST- 2019/04/20 06:00 [entrez]
PHST- 2019/04/20 06:00 [pubmed]
PHST- 2020/03/05 06:00 [medline]
AID - S0735-1097(19)33704-0 [pii]
AID - 10.1016/j.jacc.2019.01.062 [doi]
PST - ppublish
SO  - J Am Coll Cardiol. 2019 Apr 23;73(15):1905-1915. doi: 10.1016/j.jacc.2019.01.062.