News | Heart Valve Technology | November 18, 2016

Mitralign Reports First Transcatheter Tricuspid Repair in Patient with Cardiac Implantable Device Lead

Atlanta procedure marks first use of investigational Trialign System for this specific form of tricuspid regurgitation

Mitralign, Trialign System, tricuspid regurgitation, first transcatheter repair, cardiac implantable device lead, Piedmont

November 18, 2016 — Mitralign Inc. announced the successful compassionate use treatment of a patient suffering from tricuspid regurgitation (TR) with their investigational Trialign System. The patient was suffering from TR due to a cardiac implantable electronic device lead.

“We are pleased to be the first center in the world to report treatment of a patient with mechanically induced TR due to their pacemaker lead,” commented Christopher Meduri, M.D., MPH, interventional cardiologist at Piedmont’s Marcus Heart Valve Center, Atlanta. “We continually receive referrals for patients looking for treatment of their tricuspid regurgitation, and a substantial proportion of these patients have leads. This large population of patients has a significant unmet need that could potentially be addressed with a less invasive intervention like this.”

The Trialign System is an investigational device and is limited by federal (or United States) law to investigational use only. It is not available for sale or commercial distribution. With the small footprint of the implant, the Trialign System is designed to offer versatility as a frontline solution to address patients with TR. The SCOUT I Early Feasibility Study utilizing the Trialign System is currently enrolling patients in the United States. This patient was treated under the U.S. Food and Drug Administration (FDA) Compassionate Use Exemption.

Watch the VIDEO "Transcatheter Tricuspid Valve Repair and Replacement Technologies," and discussion with Rebecca Hahn, M.D.

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 and Europe alone, there are an estimated 7.2 million patients suffering from TR1.

It is estimated that 50 percent of patients with mitral regurgitation have moderate to severe tricuspid regurgitation2. The annual incidence of patients with TR is increasing with an estimated 220,000 patients in the U.S., 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 surgeries3, 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 reports5-11.

For more information: www.mitralign.com

 

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 tricuspidvalve 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

Among high-risk, chronic, coronary patients who undergo angioplasty, there were no additional benefits from ticagrelor compared to the current standard of care clopidogrel. #AHA #AHA20 #AHA2020
News | Cath Lab | November 16, 2020
November 16, 2020 — The use of the more potent antiplatelet medication ticagrelor (Brilinta) was not superior to clop
A large subgroup analysis of the VOYAGER PAD randomized clinical trial showed neither a mortality risk nor benefit associated with the use of paclitaxel drug-coated devices (DCD) in the treatment of peripheral artery disease (PAD). The study also found that the benefit of rivaroxaban use on reducing ischemic limb and cardiovascular outcomes was consistent regardless of whether a DCD was used. #TCT2020 #TCTconnect
Feature | Cath Lab | October 18, 2020
October 18, 2020 – A large subgroup analysis of a randomized clinical trial showed neither a mortality risk nor benef
A longitudinal vessel assessment may demonstrate co-existence of multiple plaque morphologies on OCT, including superficial calcification with thrombus, healed plaque, plaque rupture, lipidic plaque with a thin capped fibrous atheroma (TCFA). #TCTconnect #TCT2020

A longitudinal vessel assessment may demonstrate co-existence of multiple plaque morphologies on OCT, including superficial calcification with thrombus, healed plaque, plaque rupture, lipidic plaque with a thin cap fibro-atheroma (TCFA).

News | Cath Lab | October 18, 2020
October 18, 2020 – Data from the...
The DISRUPT CAD III study showed intravascular lithoplasty from Shockwave Medical was effective in breaking up calcified coronary lesions. #TCT2-0

The DISRUPT CAD III study showed intravascular lithoplasty from Shockwave Medical was effective in breaking up calcified coronary lesions.

Feature | Cath Lab | October 16, 2020
October 15, 2020 — Shockwave Medical's Intravascular Lithotripsy (IVL) system to treat severely calcified coronary ar
Videos | Cath Lab | October 16, 2020
This is an example pf the Shockwave Medical Intravascular Lithotripsy (IVL) catheter system designed to break up heav
Videos | Cath Lab | July 15, 2020
Richard Botto, CVT, RCSA, chief cardiovascular technologist, division of cardiology, cardiac cath lab, offers an over
Videos | Cath Lab | July 13, 2020
The Vieussens’ arterial ring (VAR) is a connection between the conus artery and the left anterior descending (LAD) co
News | Cath Lab | July 06, 2020
July 6, 2020 — Black patients who undergo percutaneous coronary intervention (PCI) are at an increased risk for major