LAKE FOREST, Calif.—NaviGate Cardiac Structures Inc. (NCSI) has announced today that the first tricuspid regurgitation (TR) patient to receive their replacement tricuspid valved stent via transjugular access has reached their one year post-procedure with excellent valvular function. This patient, along with 15 others treated to date under compassionate use protocols for severe tricuspid regurgitation, have received NCSI’s GATE tricuspid valved stent, which is designed to lead to restored valvular function and improved quality of life.
The first transjugular implantation of the GATE tricuspid valved stent occurred at the Cleveland Clinic in April 2017. At one year, the valvular bioprosthesis is demonstrating excellent leaflet mobility and valve function. In the patient’s own words, “I could not walk from one end of my house to the other before the valve was implanted. Now, it feels great to go everywhere.” Dr. Samir Kapadia and Dr. José Navia, the implanting Cardiac Team at Cleveland Clinic, explained that the patient has no more ascites and edema, which accounts in large part for the patient’s loss of nearly 20 Kg (about 40 lbs).
A total of 4 patients have been successfully treated with the device at the Cleveland Clinic under compassionate use basis, with no 30-day mortality. Of these, a patient undergoing intervention in the last two months demonstrated the possibility that the GATE tricuspid bioprosthesis can be implanted in patients with pacemaker leads traversing their tricuspid valve. This patient, a 79-year-old woman, was released with a well-functioning 52mm valve and seemingly improved quality of life. She has since returned from her distant home state for valvular function and clinical condition assessment more than a month post-intervention. A 77-year-old woman, having undergone an intervention at Cleveland Clinic on the day prior with a 48mm GATE, was released on day 5 after her massive TR+5 was corrected to a trace incompetence. Reassessment of this patient at one month provided evidence of excellent valvular function.
Columbia Presbyterian Hospital in New York has treated the largest number of patients with the GATE tricuspid bioprosthesis, with all patients in good condition at 7, 4 and 2 months post-procedure. The first two Columbia Presbyterian Hospital implants, now at 7 months, are a 92-year-old woman and a 94-year-old man who are now enjoying good mobility and are quite active.
In Canada, NCSI has recently reported on a 78-year-old man with torrential TR who received a 40mm GATE tricuspid bioprosthesis at Quebec Heart and Lung Institute in early February 2018. This patient, the first to receive NCSI’s tricuspid valved stent in Canada, remembers a love for dance from decades ago, and reportedly has a rekindled desire to live until age 100. In Frankfurt, Germany, two patients were treated with the GATE tricuspid bioprosthesis in January 2018. Both patients, one of whom had pacemaker leads through his tricuspid valve, are doing well.
In Padua, Italy, a 66-year-old male who received a 52mm diameter (the largest developed for this purpose) GATE tricuspid bioprosthesis in July 2017 to treat a failing tricuspid valve from his heart transplant that had been performed 20 years earlier is also doing well. This patient drives himself from a neighboring city for periodic follow-up assessments that extend now to almost 11 months. The results were published this month by Colli et. al. (“Transcatheter tricuspid valve replacement with a self-expanding bioprosthesis”) in the Journal of Thoracic and Cardiovascular Surgery.
In 2018, eight additional patients have received the GATE tricuspid valved stent in response to compassionate pleas to find a therapy to alleviate symptoms resulting from tricuspid valvular incompetence. The GATE atrioventricular valved stent is not yet approved for use in the US. The aforementioned patient implants were performed under compassionate pleas sanctioned by Health Canada, European Health agencies and the US FDA.
NCSI is currently in the process of gathering requisite information supporting initiation of clinical feasibility trials to assess the safety and effectiveness of the GATE System for dysfunctional tricuspid valve therapy. Presently, NCSI’s catheter-guided GATE bioprosthesis is the only orthotopic transcatheter valve replacement under development to treat severe tricuspid regurgitation.
“NCSI is working diligently to move into a feasibility clinical trial to initiate Safety and Effectiveness research of the tricuspid bioprosthesis,” said Dr. R. Quijano, CEO of NCSI. “These compassionate plea patient implants are instructive and obviously are good for the patients who have no other recourse, although we find several who cannot be helped by the valve since their ventricular function is beyond repair and their postoperative course would be troubled. Careful patient selection is imperative to obtain proof of what the GATE tricuspid valved stent bioprosthesis can or cannot do, and that requires a well-controlled clinical trial to obtain such evidence, which we hope to start later in the year. Until then, we have requests from many centers in Europe, the U.S. and Canada to do both: more compassionate cases and a full trial.”