Study Using Trialign System for Transcatheter Tricuspid Repair Shows Positive Outcomes

Mitralign Inc., a developer of transcatheter tricuspid and mitral valve repair solutions, has released one-year follow up data from the SCOUT I Early Feasibility Study designed to evaluate the performance of its Trialign System. The data presented by Rebecca Hahn, M.D., New York-Presbyterian/Columbia University Medical Center, continue to demonstrate clinically meaningful results from the study’s first cohort, including sustained improvements at one year in NYHA status (90 percent in Class I/II) and Minnesota Living with Heart Failure Score, MLWHF, (from 49.6 ± 15.7 to 19.2 ± 12.4, p=0.003). Additional outcomes at one year include a 21 percent improvement in a six-minute walk test (from 236.5 ± 107.4 to 285.4 ± 115.5), a 21.6 percent reduction in PISA EROA from baseline, and a 17.1 percent improvement in LVOT Stroke Volume from baseline.
 
“The SCOUT I study is the first, Early Feasibility Study in the U.S. with core lab adjudicated one year data showing long-term improvement in a population of subjects with severe, progressive TR,” stated Hahn. “Patients in the study continue to report feeling better, which is supported by sustained improvement in multiple clinical and quality of life measures.”
 
“One year is the benchmark for sustainability in a therapy and we are very pleased with the results,” said Rick Geoffrion, CEO of Mitralign. “As a leader in the transcatheter tricuspid space, we continue to show robust clinical data as we drive towards the commercialization of the product.”
 
The Trialign System is currently enrolling in the SCOUT I Early Feasibility Study and the SCOUT II CE Mark Study.
 
Tricuspid regurgitation occurs when the tricuspid valve fails to open and close properly, causing blood to flow backwards into the right atrium. If left untreated, TR can lead to heart enlargement and heart failure. In the United States alone, there are an estimated 2.5 million patients suffering from TR.¹
 
It is estimated that 50 percent of patients with mitral regurgitation have moderate to severe tricuspid regurgitation.² The annual incidence of patients with TR is increasing with an estimated 220,000 patients in the United States, and 330,000 patients in the European Union developing moderate-severe TR each year.¹ Despite the large prevalence of patients, TR is generally untreated by surgery with approximately 10,000 tricuspid valve surgeries performed annually in the United States.³ Annuloplasty repair is the most used technique for tricuspid valve surgery and represents 90 percent of the current volume. Isolated tricuspid valve surgery is particularly rare representing only 10 percent of current procedures while the remaining 90 percent are performed in conjunction with other left-heart surgeries.^{3, 4} Permanent pacemaker (PPM) or implantable cardioverter defibrillator (ICD) lead placement has been shown to increase the frequency and/or severity of TR in multiple reports.^5-11
 
Mitralign Inc. is the valve repair company with the only direct transcatheter annuloplasty system designed to treat both functional mitral regurgitation and tricuspid regurgitation. The company is a venture-backed, medical innovation firm located near Boston, Mass. The Trialign System is an investigational device and is limited by federal (or United States) law to investigational use. The Mitralign Percutaneous Annuloplasty System (MPAS) received CE mark approval in February 2016 for the treatment of functional mitral regurgitation (FMR) and is not commercially available in the United States.

References
1. Tricuspid Regurgitation Global Strategic Market Assessment. Dymedex Consulting. 2016
2. Argarwal, S, et al. Interventional Cardiology Perspective of Functional Tricuspid Regurgitation. Circ Cardiovasc Interv 2009;2:565-573
3. STS Adult Cardiac Surgery Database Executive Summary. 2014
4. Armen K. et al. Ann Thorac Surg. 2013;96:1546–52
5. Fanari Z. et al. The effects of right ventricular apical pacing with transvenous pacemaker and implantable cardioverter defibrillator on mitral and tricuspid regurgitation. J Electrocardiol 2015; 48: 791-797.
6. Sadreddini M, et al. Tricuspid valve regurgitation following temporary or permanent endocardial lead insertion, and the impact of cardiac resynchronization therapy. Open Cardiovasc Med J 2014; 8: 113-120.
7. Paniagua D. et al. Increased prevalence of significant tricuspid regurgitation in patients with transvenous pacemaker leads. Am J Cardiol 1998; 82: 1130-2.
8. Klutstein M, et al. Tricuspid incompetence following permanent pacemaker implantation. Pacing Clin Electrophysiol 2009: 32(Suppl 1): S135-7.
9. Kim JB, Spevack DM, Tunick PA, et al. The effect of transvenous pacemaker and implantable cardioverter defibrillator lead placement on tricuspid valve function: an observational study. J Am Soc Echo cardiogr 2008; 21: 284-7.
10. Mazine A, et al. Transvalvularpacemaker leads increase the recurrence of regurgitation after tricuspid valve repair. Ann Thorac Surg 2013; 96: 816-22.
11. Alizadeh A, et al. Induction and aggravation of atrioventricular valve regurgitation in the course of chronic right ventricular apical pacing. Europace 2011; 13: 1587-90.