title: First-in-Man Experience of a Novel Transcatheter Repair System for Treating Severe Tricuspid Regurgitation.
abstract: 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.
  
  
  OBJECTIVE
  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.
authors.affiliation: Quebec Heart & Lung Institute, Quebec City, Quebec, Canada.
authors.forename: Francisco
authors.initials: F
authors.lastname: Campelo-Parada
authors.affiliation: St. Paul's Hospital, Vancouver, British Columbia, Canada.
authors.forename: Gidon
authors.initials: G
authors.lastname: Perlman
authors.affiliation: Quebec Heart & Lung Institute, Quebec City, Quebec, Canada.
authors.forename: François
authors.initials: F
authors.lastname: Philippon
authors.affiliation: St. Paul's Hospital, Vancouver, British Columbia, Canada.
authors.forename: Jian
authors.initials: J
authors.lastname: Ye
authors.affiliation: St. Paul's Hospital, Vancouver, British Columbia, Canada.
authors.forename: Christopher
authors.initials: C
authors.lastname: Thompson
authors.affiliation: Quebec Heart & Lung Institute, Quebec City, Quebec, Canada.
authors.forename: Elisabeth
authors.initials: E
authors.lastname: Bédard
authors.affiliation: Quebec Heart & Lung Institute, Quebec City, Quebec, Canada.
authors.forename: Omar
authors.initials: O
authors.lastname: Abdul-Jawad Altisent
authors.affiliation: Quebec Heart & Lung Institute, Quebec City, Quebec, Canada.
authors.forename: Maria
authors.initials: M
authors.lastname: Del Trigo
authors.affiliation: St. Paul's Hospital, Vancouver, British Columbia, Canada.
authors.forename: Jonathon
authors.initials: J
authors.lastname: Leipsic
authors.affiliation: St. Paul's Hospital, Vancouver, British Columbia, Canada.
authors.forename: Philipp
authors.initials: P
authors.lastname: Blanke
authors.affiliation: St. Paul's Hospital, Vancouver, British Columbia, Canada.
authors.forename: Danny
authors.initials: D
authors.lastname: Dvir
authors.affiliation: Quebec Heart & Lung Institute, Quebec City, Quebec, Canada.
authors.forename: Rishi
authors.initials: R
authors.lastname: Puri
authors.affiliation: St. Paul's Hospital, Vancouver, British Columbia, Canada. Electronic address: john.webb@vch.ca.
authors.forename: John G
authors.initials: JG
authors.lastname: Webb
authors.affiliation: Quebec Heart & Lung Institute, Quebec City, Quebec, Canada. Electronic address: josep.rodes@criucpq.ulaval.ca.
authors.forename: Josep
authors.initials: J
authors.lastname: Rodés-Cabau
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D006328:Cardiac Catheterization / Q000295:instrumentation*; D015331:Cohort Studies; D004867:Equipment Design; D017079:Exercise Tolerance; D005240:Feasibility Studies; D005260:Female; D019918:Heart Valve Prosthesis Implantation / Q000295:instrumentation*; D006801:Humans; D008297:Male; D011788:Quality of Life; D016896:Treatment Outcome; D014262:Tricuspid Valve Insufficiency / Q000601:surgery*
keywords: transcatheter valve tricuspid repair; valve repair; valve surgery