Author + information
- Received December 5, 2016
- Revision received January 23, 2017
- Accepted January 24, 2017
- Published online April 3, 2017.
- Rebecca T. Hahn, MDa,b,∗ (, )
- Christopher U. Meduri, MDc,
- Charles J. Davidson, MDd,
- Scott Lim, MDe,
- Tamim M. Nazif, MDa,
- Mark J. Ricciardi, MDd,
- Vivek Rajagopal, MDd,
- Gorav Ailawadi, MDe,
- Mani A. Vannan, MBBSc,
- James D. Thomas, MDd,
- Dale Fowler, MDe,
- Stuart Rich, MDd,
- Randy Martin, MDc,
- Geraldine Ong, MDb,
- Adam Groothuis, PhDf and
- Susheel Kodali, MDa
- aDepartment of Medicine, Division of Cardiology/New York Presbyterian Hospital, New York-Presbyterian/Columbia University Medical Center, New York, New York
- bCardiovascular Research Foundation, New York, New York
- cMarcus Heart Valve Center, Piedmont Heart Institute, Atlanta, Georgia
- dBluhm Cardiovascular Institute, Feinberg School of Medicine, Northwestern University, Chicago, Illinois
- eUniversity of Virginia, Charlottesville, Virginia
- fMitralign, Inc., Tewksbury, Massachusetts
- ↵∗Address for correspondence:
Dr. Rebecca T. Hahn, Columbia University Medical Center, New York-Presbyterian Hospital, 177 Fort Washington Avenue, New York, New York 10032.
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 cm2 to 11.3 ± 2.7 cm2, respectively; p = 0.019) and EROA (0.51 ± 0.18 cm2 vs. 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.)
Dr. Hahn is a speaker for Edwards Lifesciences, Abbott Vascular, Boston Scientific, and GE Medical; is an unpaid national principal investigator for the SCOUT Trial; and is an uncompensated director of Echo Core for multiple industry-sponsored trials. Dr. Meduri is a consultant and proctor for and has received a research grant from Medtronic; is an advisory board member, consultant, and proctor for Boston Scientific; and has received research grants from Edwards Lifesciences. Dr. Nazif is a consultant for Edwards Lifesciences. Dr. Rajagopal is a consultant for Boston Scientific, Abbott Vascular, Medtronic, and Edwards Lifesciences.
Dr. Alawadi is a consultant for Abbott Vascular, Edwards Lifesciences, Medtronic, St. Jude Medical, and Atricure. Dr. Vannan is a speaker for and has research support from Abbott Vascular and Siemens Healthcare. Dr. Thomas has received honoraria from and is a consultant for Siemens, GE Medical, and Edwards Lifesciences. Dr. Martin is a speaker for Medtronic, Edwards Lifesciences, and Abbott Vascular; and holds stock/ownership in BayLabs. Dr. Groothuis is an employee of and holds ownership stock in Mitralign. Dr. Kodali is a consultant for Dura Biotech; consults for and has received research support from Edwards Lifesciences, Medtronic, and Abbott Vascular; and holds equity in Thubrikar Aortic Valve and BioTrace. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received December 5, 2016.
- Revision received January 23, 2017.
- Accepted January 24, 2017.
- 2017 American College of Cardiology Foundation