PMID- 28385308 OWN - NLM STAT- MEDLINE DCOM- 20170710 LR - 20180120 IS - 1558-3597 (Electronic) IS - 0735-1097 (Linking) VI - 69 IP - 14 DP - 2017 Apr 11 TI - Early Feasibility Study of a Transcatheter Tricuspid Valve Annuloplasty: SCOUT Trial 30-Day Results. PG - 1795-1806 LID - S0735-1097(17)30582-X [pii] LID - 10.1016/j.jacc.2017.01.054 [doi] AB - 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). OBJECTIVES: 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 cm(2) to 11.3 +/- 2.7 cm(2), respectively; p = 0.019) and EROA (0.51 +/- 0.18 cm(2) vs. 0.32 +/- 0.18 cm(2), 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.). CI - Copyright (c) 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved. FAU - Hahn, Rebecca T AU - Hahn RT AD - 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. FAU - Meduri, Christopher U AU - Meduri CU AD - Marcus Heart Valve Center, Piedmont Heart Institute, Atlanta, Georgia. FAU - Davidson, Charles J AU - Davidson CJ AD - Bluhm Cardiovascular Institute, Feinberg School of Medicine, Northwestern University, Chicago, Illinois. FAU - Lim, Scott AU - Lim S AD - University of Virginia, Charlottesville, Virginia. FAU - Nazif, Tamim M AU - Nazif TM AD - Department of Medicine, Division of Cardiology/New York Presbyterian Hospital, New York-Presbyterian/Columbia University Medical Center, New York, New York. FAU - Ricciardi, Mark J AU - Ricciardi MJ AD - Bluhm Cardiovascular Institute, Feinberg School of Medicine, Northwestern University, Chicago, Illinois. FAU - Rajagopal, Vivek AU - Rajagopal V AD - Bluhm Cardiovascular Institute, Feinberg School of Medicine, Northwestern University, Chicago, Illinois. FAU - Ailawadi, Gorav AU - Ailawadi G AD - University of Virginia, Charlottesville, Virginia. FAU - Vannan, Mani A AU - Vannan MA AD - Marcus Heart Valve Center, Piedmont Heart Institute, Atlanta, Georgia. FAU - Thomas, James D AU - Thomas JD AD - Bluhm Cardiovascular Institute, Feinberg School of Medicine, Northwestern University, Chicago, Illinois. FAU - Fowler, Dale AU - Fowler D AD - University of Virginia, Charlottesville, Virginia. FAU - Rich, Stuart AU - Rich S AD - Bluhm Cardiovascular Institute, Feinberg School of Medicine, Northwestern University, Chicago, Illinois. FAU - Martin, Randy AU - Martin R AD - Marcus Heart Valve Center, Piedmont Heart Institute, Atlanta, Georgia. FAU - Ong, Geraldine AU - Ong G AD - Cardiovascular Research Foundation, New York, New York. FAU - Groothuis, Adam AU - Groothuis A AD - Mitralign, Inc., Tewksbury, Massachusetts. FAU - Kodali, Susheel AU - Kodali S AD - Department of Medicine, Division of Cardiology/New York Presbyterian Hospital, New York-Presbyterian/Columbia University Medical Center, New York, New York. LA - eng SI - ClinicalTrials.gov/NCT02574650 PT - Journal Article 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. 2017 Apr 11;69(14):1807-1810. PMID: 28385309 MH - Aged MH - Aged, 80 and over MH - Cardiac Catheterization MH - Cardiac Valve Annuloplasty/*methods MH - Echocardiography MH - Feasibility Studies MH - Female MH - Heart Valve Prosthesis MH - Heart Valve Prosthesis Implantation/*methods MH - Humans MH - Male MH - Minimally Invasive Surgical Procedures/methods MH - Quality of Life MH - Tricuspid Valve/*surgery OTO - NOTNLM OT - echocardiography OT - transcatheter repair OT - tricuspid valve regurgitation EDAT- 2017/04/08 06:00 MHDA- 2017/07/14 06:00 CRDT- 2017/04/08 06:00 PHST- 2016/12/05 00:00 [received] PHST- 2017/01/23 00:00 [revised] PHST- 2017/01/24 00:00 [accepted] PHST- 2017/04/08 06:00 [entrez] PHST- 2017/04/08 06:00 [pubmed] PHST- 2017/07/14 06:00 [medline] AID - S0735-1097(17)30582-X [pii] AID - 10.1016/j.jacc.2017.01.054 [doi] PST - ppublish SO - J Am Coll Cardiol. 2017 Apr 11;69(14):1795-1806. doi: 10.1016/j.jacc.2017.01.054.