PMID- 26653620
OWN - NLM
STAT- MEDLINE
DCOM- 20160412
LR  - 20151215
IS  - 1558-3597 (Electronic)
IS  - 0735-1097 (Linking)
VI  - 66
IP  - 22
DP  - 2015 Dec 8
TI  - First-in-Man Experience of a Novel Transcatheter Repair System for Treating 
      Severe Tricuspid Regurgitation.
PG  - 2475-83
LID - S0735-1097(15)06686-3 [pii]
LID - 10.1016/j.jacc.2015.09.068 [doi]
AB  - BACKGROUND: Isolated tricuspid valve surgery is associated with high morbidity 
      and mortality, especially in patients with prior cardiac surgery. The 
      transcatheter Forma Repair System (Edwards Lifesciences, Irvine, California) is 
      designed to provide a surface for native leaflet coaptation to reduce tricuspid 
      regurgitation (TR) by occupying the regurgitant orifice area. OBJECTIVES: This 
      study sought to evaluate the feasibility and exploratory efficacy with this 
      transcatheter repair system for the treatment of severe TR. METHODS: Seven 
      high-risk patients with severe TR and clinical signs of heart failure were 
      declined for surgery and offered transcatheter treatment with this device. All 
      procedures were performed within a cardiac catheterization laboratory or hybrid 
      operating room under general anesthesia with transesophageal echocardiographic 
      guidance. Vascular access was via the left axillary vein. Baseline 
      characteristics, procedural and in-hospital outcomes, as well as 30-day follow-up 
      were prospectively collected. RESULTS: All patients had severe TR and New York 
      Heart Association (NYHA) functional class II to IV (mean age 76 +/- 13 years; mean 
      logistic EuroSCORE 25.7 +/- 17.4%), and underwent device implantation to improve 
      tricuspid leaflet coaptation, thereby reducing TR. Device implantation was 
      successful without procedural complications in all patients, with significant 
      reductions in TR severity (moderate in 3 patients and mild in 4 patients). Median 
      hospital length of stay was 4 days. At 30-day follow-up, all patients but 1 
      demonstrated improvements in NYHA functional status (to class II) with pronounced 
      reductions in the presence and severity of peripheral edema. TR severity was 
      assessed as being moderate at 30-day transthoracic echocardiography follow-up in 
      all patients. No complications related to the device or vascular access were 
      observed during follow-up. CONCLUSIONS: A transcatheter-based treatment option 
      for severe TR appears safe and feasible with this repair system. Improvements in 
      TR severity were documented in all patients, which were accompanied by 
      improvements in peripheral edema and functional status.
CI  - Copyright (c) 2015 American College of Cardiology Foundation. Published by Elsevier 
      Inc. All rights reserved.
FAU - Campelo-Parada, Francisco
AU  - Campelo-Parada F
AD  - Quebec Heart & Lung Institute, Quebec City, Quebec, Canada.
FAU - Perlman, Gidon
AU  - Perlman G
AD  - St. Paul's Hospital, Vancouver, British Columbia, Canada.
FAU - Philippon, Francois
AU  - Philippon F
AD  - Quebec Heart & Lung Institute, Quebec City, Quebec, Canada.
FAU - Ye, Jian
AU  - Ye J
AD  - St. Paul's Hospital, Vancouver, British Columbia, Canada.
FAU - Thompson, Christopher
AU  - Thompson C
AD  - St. Paul's Hospital, Vancouver, British Columbia, Canada.
FAU - Bedard, Elisabeth
AU  - Bedard E
AD  - Quebec Heart & Lung Institute, Quebec City, Quebec, Canada.
FAU - Abdul-Jawad Altisent, Omar
AU  - Abdul-Jawad Altisent O
AD  - Quebec Heart & Lung Institute, Quebec City, Quebec, Canada.
FAU - Del Trigo, Maria
AU  - Del Trigo M
AD  - Quebec Heart & Lung Institute, Quebec City, Quebec, Canada.
FAU - Leipsic, Jonathon
AU  - Leipsic J
AD  - St. Paul's Hospital, Vancouver, British Columbia, Canada.
FAU - Blanke, Philipp
AU  - Blanke P
AD  - St. Paul's Hospital, Vancouver, British Columbia, Canada.
FAU - Dvir, Danny
AU  - Dvir D
AD  - St. Paul's Hospital, Vancouver, British Columbia, Canada.
FAU - Puri, Rishi
AU  - Puri R
AD  - Quebec Heart & Lung Institute, Quebec City, Quebec, Canada.
FAU - Webb, John G
AU  - Webb JG
AD  - St. Paul's Hospital, Vancouver, British Columbia, Canada. Electronic address: 
      john.webb@vch.ca.
FAU - Rodes-Cabau, Josep
AU  - Rodes-Cabau J
AD  - Quebec Heart & Lung Institute, Quebec City, Quebec, Canada. Electronic address: 
      josep.rodes@criucpq.ulaval.ca.
LA  - eng
PT  - Journal Article
DEP - 20151011
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. 2015 Dec 8;66(22):2484-6. PMID: 26468094
MH  - Aged
MH  - Aged, 80 and over
MH  - Cardiac Catheterization/*instrumentation
MH  - Cohort Studies
MH  - Equipment Design
MH  - Exercise Tolerance
MH  - Feasibility Studies
MH  - Female
MH  - Heart Valve Prosthesis Implantation/*instrumentation
MH  - Humans
MH  - Male
MH  - Quality of Life
MH  - Treatment Outcome
MH  - Tricuspid Valve Insufficiency/*surgery
OTO - NOTNLM
OT  - transcatheter valve tricuspid repair
OT  - valve repair
OT  - valve surgery
EDAT- 2015/12/15 06:00
MHDA- 2016/04/14 06:00
CRDT- 2015/12/15 06:00
PHST- 2015/08/25 00:00 [received]
PHST- 2015/09/18 00:00 [revised]
PHST- 2015/09/24 00:00 [accepted]
PHST- 2015/12/15 06:00 [entrez]
PHST- 2015/12/15 06:00 [pubmed]
PHST- 2016/04/14 06:00 [medline]
AID - S0735-1097(15)06686-3 [pii]
AID - 10.1016/j.jacc.2015.09.068 [doi]
PST - ppublish
SO  - J Am Coll Cardiol. 2015 Dec 8;66(22):2475-83. doi: 10.1016/j.jacc.2015.09.068. 
      Epub 2015 Oct 11.