News | Heart Valve Technology | November 06, 2017

Positive, Sustained Improvement at One Year in SCOUT I Transcatheter Tricuspid Repair Trial

Study used the Trialign system for transcatheter repair of tricuspid regurgitation in first cohort of patients presented at TCT 2017

Mitralign's Trialign system is used for transcatheter repair of tricuspid valve regurgitation. TCT 2017

November 6, 2017 — One year follow-up data from the SCOUT I Early Feasibility Study for the Mitralign Trialign System showed positive results. The data was presented by Rebecca Hahn, M.D., FASE, director of interventional echocardiography and professor of medicine at Columbia University Medical Center / New York-Presbyterian Hospital, New York, and the national principal investigator for the SCOUT I Trial, at the 2017 Transcatheter Cardiovascular Therapeutics (TCT) conference. 

Data continues to demonstrate clinically meaningful results from the study’s first cohort, including sustained improvements at one year in NYHA status (90% 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 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 US with core lab adjudicated 1 year data showing long-term improvement in a population of subjects with severe, progressive TR,” stated Dr. Rebecca Hahn. “Patients in the study continue to report feeling better, which is supported by sustained improvement in multiple clinical and quality of life measures.”

Watch the VIDEO “Transcatheter Tricuspid Valve Repair and Replacement Technologies,” a discussion with Hahn about the Trialign device.

“One year is the benchmark for sustainability in a therapy and we are very pleased with the results,” stated 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.

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 US, and 330,000 patients in the EU developing moderate-severe TR each year1. Despite the large prevalence of patients, TR is generally untreated by surgery with approximately 10,000 tricuspid valve surgeries performed annually in the U.S.[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]

For more information: www.mitralign.com

 

Related Content

TCT 2017 Late-breaking Clinical Trial Presentations

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. Transvalvular pacemaker 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.

Related Content

Gallery | Cath Lab | October 31, 2019
This is a photo essay of the interventional cardiology and structural heart technologies on the expo floor and discus
The Alphenix Aero Package from Canon Medical Systems USA, Inc. enables OBLs and ASCs to attain premium technology at a flexible price point by tailoring Canon Medical’s Alphenix systems to fit their facilities’ needs.

The Alphenix Aero Package from Canon Medical Systems USA, Inc. enables OBLs and ASCs to attain premium technology at a flexible price point by tailoring Canon Medical’s Alphenix systems to fit their facilities’ needs.

Technology | Cath Lab | October 28, 2019
Office based labs (OBLs) and ambulatory surgery centers (ASCs) require a fresh perspective from imaging vendors.
Marco Costa, M.D., Ph.D., MBA, president, UH Harrington Heart and Vascular Institute, performing a cath lab procedure.

Marco Costa, M.D., Ph.D., MBA, president, UH Harrington Heart and Vascular Institute, performing a cath lab procedure.

News | Cath Lab | October 28, 2019
October 28, 2019 — Leaders within University Hospitals and the Harrington Heart and Vascular Institute had a vision t
OmniVision Announces Guinness World Record for Smallest Image Sensor

OmniVision's OVM6948 CameraCubeChip, a fully packaged, wafer-level camera module measuring 0.65mm x 0.65mm x 1.158mm, built on OmniVision's OV6948, winner of the Guinness World Record for “The Smallest Image Sensor Commercially Available.”

News | Cath Lab | October 22, 2019
October 22, 2019 — OmniVision Technologies Inc.
People watch the presentation of the five-year EXCEL Trial data by Gregg Stone, M.D., live in the Abbott booth at TCT 2019. Abbott makes the Xience stent used in the trial, which compared equally with long term surgical outcomes. #TCT2019

People watch the live presentation of the five-year EXCEL Trial data by Gregg Stone, M.D., in the Abbott booth at TCT 2019. Abbott makes the Xience stent used in the trial, which compared equally with long-term CABG surgical outcomes. 

Feature | Cath Lab | October 03, 2019
October 3, 2019 – Five-year data from the EXCEL Trial showed patients with left main coronary disease treated with pe
Two Stents Implanted in Democratic Presidential Candidate Bernie Sanders, suffers chest pain
News | Cath Lab | October 02, 2019 | Dave Fornell, Editor
October 2, 2019 — Democratic presidential candidate Sen.
Bypass Surgery and Coronary Stenting Yield Comparable 10-Year Survival
News | Cath Lab | September 25, 2019
Ten-year survival rates are similar for bypass surgery and coronary stenting with drug-eluting stents in randomized...
Complete Revascularization Superior to Culprit Lesion-only Intervention
News | Cath Lab | September 10, 2019
An international randomized trial has shown that complete revascularization reduces major cardiovascular events...
The cath lab staff UH Portage Medical Center.

The cath lab staff UH Portage Medical Center.

Feature | Cath Lab | September 09, 2019 | Anjan Gupta, M.D., FACC, FSCAI
Primary percutaneous coronary intervention (PCI) is the preferred treatment for acute...
Overlay Init