For many decades, the only approach to treating severe tricuspid regurgitation, beyond simply treating the symptoms, was through invasive surgical procedures. The placement of a prosthetic annuloplasty ring is considered the gold standard for today’s surgical treatment of tricuspid regurgitation. More commonly referred to as annuloplasty, the surgery involves placing a rigid or flexible ring over the diseased tricuspid valve. This ring is then tightened by the surgeon to reduce the size/dilation of the valve to improve the symptoms caused by tricuspid regurgitation.
The goal of the Tri-Ring is to take this gold standard and translate it into a minimally invasive, fully percutaneous procedure that corrects and/or restores the physiological shape of the annulus, re-establish the 3D geometry of the tricuspid valve, and prevent further annular dilatation.
WHY TRI-RING™ MAKES SENSE
Predicated on the gold standard for surgical TR therapy
Complete and circumferential ring annuloplasty
REDUCE
STABILIZE
MAINTAIN
TWO SIMPLE STAGES – ONE POWERFUL APPROACH
STAGE 1:
TRI-RING™ IMPLANT PROCEDURE
The first stage involves implanting the Tri-Ring™ using our dedicated Ring Delivery System (RDS) through the steps outlined below.
GAIN ACCESS
The physician gains access through the right internal jugular vein using standard techniques (Figure 1). The RDS is then advanced down into the right atrium and then to the atrial side of the valve annulus (Figure 2).
OPTIMIZE POSITIONING PRIOR TO IMPLANT
The final positioning of the Tri-Ring is optimized under multi-modality imaging prior to releasing the ring with a single-firing mechanism (Figure 3). The delivery system is then removed leaving the annuloplasty ring and cord tether. (Figure 4). The cord tether is secured under the skin.
IMPLANTING THE RING
Once optimal placement is made at the valve annulus, the system’s ten anchors are simultaneously released from their respective launchers and into the surrounding tissue. Watch this video demonstrating this firing mechanism under fluoroscopy and TEE imaging.
Source: Reddy V, Abbo A, Ruiz C, et al. First-in-Human Percutaneous Circumferential Annuloplasty for Secondary Tricuspid Regurgitation. J Am Coll Cardiol Case Rep. 2020 Nov, 2 (14) 2176–2182. https://doi.org/10.1016/j.jaccas.2020.08.032
Individual stake
Annular tissue
Endocardium
Myocardium
Fabric lining
HEALING PERIOD
The Tri-Ring is left in the tissue for a 90-day healing period, allowing the native surrounding tissue to encapsulate the ring and secure the anchors in place, designed to form a durable bond. The illustration below depicts how the anchors are designed to become embedded into the surrounding tissue over time.
STAGE 2:
ADJUSTMENT PROCEDURE
After this healing period, the patient returns to the clinic. The Tri-Ring is re-accessed with our dedicated Adjustment Tool (AT). The physician adjusts the ring to reduce the overall ‘size’ of the valve and improve the hemodynamics of the valve.
OUR UNIQUE APPROACH IS DESIGNED TO BE NON-SURGICAL, SAFE & EASY TO USE
We’ve taken a proven concept for surgical therapy and made it minimally invasive and easy to use, because the impact of surgical tricuspid repair can be significant.
Long-term trends for patients undergoing surgical tricuspid repair in the US:
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8.1% of TR surgeries resulted in in-hospital death
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10.9% required permanent pacemaker implantation
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> 80% required more than 5 days post-operative stay at the hospital
In a separate, smaller prospective cohort study, 50% of patients undergoing surgical tricuspid repair were on cardiopulmonary bypass for 2 hours and over an hour of cross-clamp time (an important determinant of postoperative morbidity and mortality).
A non-surgical approach would help to overcome many of these challenges, inter-operative and post-operative complications, while delivering optimal therapy more cost effectively for payers.
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7. Alqahtani F, Berzingi CO, Aljohani, S, et al. Contemporary Trends in the Use and Outcomes of Surgical Treatment of Tricuspid Regurgitation. J Am Heart Assoc 2017;6:e007597
8. Ejiofor JI, Neely RC, Yammine M, et al. Surgical outcomes of isolated tricuspid valve procedures: repair versus replacement. Ann Cardiothorac Surg 2017;6(3):214-22. doi: 10.21037/acs.2017.05.02