title: Early Feasibility Study of a Transcatheter Tricuspid Valve Annuloplasty: SCOUT Trial 30-Day Results.
abstract: BACKGROUND
  The SCOUT (Percutaneous Tricuspid Valve Annuloplasty System for Symptomatic Chronic Functional Tricuspid Regurgitation) trial is a prospective, single-arm, multicenter, early feasibility study of a novel transcatheter device to plicate the tricuspid annulus (TA) and reduce tricuspid regurgitation (TR).
  
  
  OBJECTIVE
  This study tested the feasibility and safety of a novel transcatheter device and assessed its early performance and functional outcomes.
  
  
  METHODS
  Between November 2015 and June 2016, 15 patients with New York Heart Association (NYHA) functional class ≥II and moderate or greater functional TR were enrolled. Primary performance and safety endpoint outcomes were technically successful at 30 days with no reintervention. Echocardiographic measurements (TA diameter, effective regurgitant orifice area [EROA], left ventricular stroke volume [LVSV]) and quality-of-life (QoL) measurements (NYHA functional class, Minnesota Living with Heart Failure Questionnaire [MLHFQ], and 6-min walk test [6MWT]) were performed at baseline and 30 days.
  
  
  RESULTS
  All patients (mean 73.2 ± 6.9 years of age, 87% female) underwent successful device implantation with no deaths, strokes, bleeding, tamponade, or valve reintervention. Technical success rate at 30 days was 80%, with 3 single-pledget annular detachments without reintervention. In the remaining 12 patients, there were significant reductions in TA (12.3 ± 3.1 cm2to 11.3 ± 2.7 cm2, respectively; p = 0.019) and EROA (0.51 ± 0.18 cm2vs. 0.32 ± 0.18 cm2, respectively; p = 0.020), with significant increase in LVSV (63.6 ± 17.9 ml vs. 71.5 ± 25.7 ml, respectively; p = 0.021). In the intention-to-treat cohort, there were significant improvements in NYHA functional class (≥1 class, p = 0.001), MLHFQ (47.4 ± 17.6 to 20.9 ± 14.8; p < 0.001), and 6MWT (245.2 ± 110.1 to 298.0 m ± 107.6 m; p = 0.008).
  
  
  CONCLUSIONS
  The 30-day results of the SCOUT trial confirmed the safety of the novel transcatheter device, which reduced TA and EROA, increased LVSV, and improved QoL. (Early Feasibility of the Mitralign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS) Also Known as TriAlign [SCOUT]; NCT02574650.).
authors.affiliation: Department of Medicine, Division of Cardiology/New York Presbyterian Hospital, New York-Presbyterian/Columbia University Medical Center, New York, New York; Cardiovascular Research Foundation, New York, New York. Electronic address: rth2@columbia.edu.
authors.forename: Rebecca T
authors.initials: RT
authors.lastname: Hahn
authors.affiliation: Marcus Heart Valve Center, Piedmont Heart Institute, Atlanta, Georgia.
authors.forename: Christopher U
authors.initials: CU
authors.lastname: Meduri
authors.affiliation: Bluhm Cardiovascular Institute, Feinberg School of Medicine, Northwestern University, Chicago, Illinois.
authors.forename: Charles J
authors.initials: CJ
authors.lastname: Davidson
authors.affiliation: University of Virginia, Charlottesville, Virginia.
authors.forename: Scott
authors.initials: S
authors.lastname: Lim
authors.affiliation: Department of Medicine, Division of Cardiology/New York Presbyterian Hospital, New York-Presbyterian/Columbia University Medical Center, New York, New York.
authors.forename: Tamim M
authors.initials: TM
authors.lastname: Nazif
authors.affiliation: Bluhm Cardiovascular Institute, Feinberg School of Medicine, Northwestern University, Chicago, Illinois.
authors.forename: Mark J
authors.initials: MJ
authors.lastname: Ricciardi
authors.affiliation: Bluhm Cardiovascular Institute, Feinberg School of Medicine, Northwestern University, Chicago, Illinois.
authors.forename: Vivek
authors.initials: V
authors.lastname: Rajagopal
authors.affiliation: University of Virginia, Charlottesville, Virginia.
authors.forename: Gorav
authors.initials: G
authors.lastname: Ailawadi
authors.affiliation: Marcus Heart Valve Center, Piedmont Heart Institute, Atlanta, Georgia.
authors.forename: Mani A
authors.initials: MA
authors.lastname: Vannan
authors.affiliation: Bluhm Cardiovascular Institute, Feinberg School of Medicine, Northwestern University, Chicago, Illinois.
authors.forename: James D
authors.initials: JD
authors.lastname: Thomas
authors.affiliation: University of Virginia, Charlottesville, Virginia.
authors.forename: Dale
authors.initials: D
authors.lastname: Fowler
authors.affiliation: Bluhm Cardiovascular Institute, Feinberg School of Medicine, Northwestern University, Chicago, Illinois.
authors.forename: Stuart
authors.initials: S
authors.lastname: Rich
authors.affiliation: Marcus Heart Valve Center, Piedmont Heart Institute, Atlanta, Georgia.
authors.forename: Randy
authors.initials: R
authors.lastname: Martin
authors.affiliation: Cardiovascular Research Foundation, New York, New York.
authors.forename: Geraldine
authors.initials: G
authors.lastname: Ong
authors.affiliation: Mitralign, Inc., Tewksbury, Massachusetts.
authors.forename: Adam
authors.initials: A
authors.lastname: Groothuis
authors.affiliation: Department of Medicine, Division of Cardiology/New York Presbyterian Hospital, New York-Presbyterian/Columbia University Medical Center, New York, New York.
authors.forename: Susheel
authors.initials: S
authors.lastname: Kodali
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D006328:Cardiac Catheterization; D058385:Cardiac Valve Annuloplasty / Q000379:methods*; D004452:Echocardiography; D005240:Feasibility Studies; D005260:Female; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation / Q000379:methods*; D006801:Humans; D008297:Male; D019060:Minimally Invasive Surgical Procedures / Q000379:methods; D011788:Quality of Life; D014261:Tricuspid Valve / Q000601:surgery*
keywords: echocardiography; transcatheter repair; tricuspid valve regurgitation