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Cleveland Clinic Team 'Navigates' Tricuspid Regurgitation Case

Doctors implanted a new valved stent from Navigate Cardiac Structures Inc. Into a patient with severe tricuspid regurgitation under a compassionate plea.

Amanda Pedersen

Long and short axis TEE views of the Gate atrioventricular valved stent implanted in the tricuspid valve of a beating heart of swine

A 64-year-old woman with an extensive history of severe tricuspid regurgitation received a new valved stent for the condition through a compassionate plea.

Cleveland Clinic doctors performed the transcatheter procedure, putting in a Gate tricuspid atrioventricular valved stent from Navigate Cardiac Structures Inc.

The Lake Forest, CA-based company licenses the technology from Cleveland Clinic, and the platform also includes percutaneous valve devices for mitral valve replacement. Navigate estimated that the market opportunity for these two conditions is close to $20 billion a year.

As the market for transcatheter aortic valve replacement (TAVR) continues to grow and mature, many cardiovascular companies have taken an interest in transcatheter mitral replacement and repair, as well as the so-called forgotten tricuspid valve.

Navigate said it made modifications to the device that differentiates it from all others that are currently made for atrioventricular valves. The device is designed in the form of a diffuser, or truncated cone, which gives it a low-height profile that can be more easily threaded through the vasculature to reach the atrioventricular valves, allowing it to reside without protrusion into either of the adjacent chambers (atrium or ventricle) for mitral or tricuspid valves.

The company said the valve demonstrated "excellent valvular function, indicating correction of the massive regurgitation problem," after implantation. The patient became stable and her doctors reported at 30 days post-procedure that she is doing well.

"This is a step forward in the treatment of tricuspid regurgitation," said Jose Navia, a Cleveland Clinic cardiovascular surgeon who is also a Navigate scientific advisory board member and a company shareholder.

"The patient's annulus measured 49.7 mm in diameter and there are currently no valved stents that can secure such a dimension without extending into any of the chambers and still provide valvular function," said Samir Kapadia, a Cleveland Clinic interventional cardiologist and Navigate scientific advisory board member. Kapadia noted that there are millions of patients presenting with the same problem.

Navigate is running clinical trials in Chile and Poland of its Navi mitral valved stent for the correction of functional mitral regurgitation, a similar condition. One patient in Chile has just passed the one-year mark and returned to work with a functional valve, the company noted.

Navigate's president and CEO, Rodolfo Quijano, said the company wants to develop devices to replace the lost function of both atrioventricular valves, the tricuspid and the mitral. These devices could be used by cardiologists delivered either by threading through the vasculature, so long as the patient does not have any blood clots in those vessels, or through minimally invasive surgical and beating-heart techniques by a surgeon when the vasculature method is not an option, Quijano said.

The attractive market opportunity for transcatheter mitral and tricuspid repair and replacement devices has drawn a mixture of large and small companies to the space.

Edwards Lifesciences Corp. Recently agreed to acquire Or Yehuda, Israel-based Valtech Cardio Ltd. For $340 million, plus up to $350 million in additional milestone payments. Edwards is also developing the Pascal transcatheter mitral valve replacement (TMVR) system and is expected to initiate a CE mark study for that device this year.

Abbott Laboratories also has a horse in the TMVR race with technology inherited through its 2015 acquisition of Tendyne Holdings Inc. And through an investment in Cephea Valve Technologies Inc., of Santa Cruz, CA.

Medtronic also entered the TMVR space in 2015 through its $458 million acquisition of Redwood City, CA-based Twelve Inc.

Amanda Pedersen is Qmed's news editor. Reach her at [email protected].

[Image credit: Navigate Cardiac Structures Inc.]

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Aortic Regurgitation Device Passes In Pivotal Trial

SAN FRANCISCO -- Aortic valve regurgitation treated with the investigational JenaValve Trilogy appeared safe and effective in the ALIGN AR trial.

The device met the safety benchmark, with a 26.7% rate of combined 30-day all-cause mortality, all stroke, life-threatening or major bleeding, major vascular complications, acute kidney injury or dialysis, valve intervention, new permanent pacemaker, and moderate or worse paravalvular leak (P<0.0001 for noninferiority to the prespecified margin of 40.5%).

JenaValve also met the primary efficacy endpoint for 1-year all-cause mortality, with a rate of 7.8% that was significantly noninferior compared with the prespecified margin of 25%, reported Vinod Thourani, MD, of Piedmont Heart Institute in Atlanta, at the Transcatheter Cardiovascular Therapeutics (TCT) meeting hosted by the Cardiovascular Research Foundation.

New pacemaker implantation rates were high in the trial, at 24.0%, but steadily declined to a "respectable" 14% by the last tertile of treated patients. Thourani chalked this up to a change in insertion technique placing locators above the nadir of native valve cusps, reduction in oversizing, and evolution in management of periprocedural conduction abnormalities.

TCT press conference panelist Kendra Grubb, MD, surgical director of the Emory Structural Heart and Valve Center in Atlanta, called the 14% rate on par with or better than what's been seen with use of self-expanding valves.

"I think this is very encouraging," she said. "You're talking about a high-risk patient population that didn't have surgical options, and what you're seeing here are very excellent results."

Moderate to severe paravalvular regurgitation occurred in only 0.6% of patients at 30 days and 6 months and was not seen at 1 year. Mild regurgitation declined from 18.0% at 30 days to 5.2% at 6 months and 7.8% at 1 year, which Thourani emphasized as "very low" rates that are "really some of the best in class for paravalvular regurgitation ever shown" from a transcatheter heart valve (THV) prosthesis.

Press conference panelist Bernard Prendergast, MD, of Cleveland Clinic London, noted that these patients are different and have different anatomy than aortic stenosis patients, so using a transcatheter aortic valve replacement (TAVR) device approved for aortic stenosis off label for aortic regurgitation "can be successful, but it is fraught with risk of embolism and other adverse consequences."

He noted the long journey for this valve after a pivot from transapical-only access and from going from an aortic stenosis TAVR population to aortic regurgitation. "Although it's a less common disease, it's one with major needs," Prendergast said. "I'm very excited by these results."

Device developer JenaValve Technologies said in a statement that the results are intended to support an application to the FDA for an indication. "If approved, the Trilogy THV System would become the first and only TAVR system in the U.S. Indicated for the treatment of symptomatic, severe AR [aortic regurgitation]."

Another TCT press conference panelist Pinak Shah, MD, director of the Cardiac Catheterization Lab at Brigham and Women's Hospital in Boston, predicted no hesitation in interventionalists switching from current TAVR devices, should it be approved.

"There will be no inertia, because we don't have an alternative. And I'm not so worried about the pacemaker rate. I don't think we were worried about pacemaker rates in the first PARTNER trial [with TAVR in prohibitive surgical risk patients] because we had no alternative," he said. "I am very excited to put this to use because we have an unmet need."

The trial included 180 patients with high surgical risk and symptomatic, severe aortic regurgitation at 20 sites. Exclusion criteria included valve calcification and unsuitable anatomy, notably bicuspid valves or more than moderate mitral regurgitation. Slightly more than half of the patients screened were excluded.

As another factor that would rule out the procedure, "a lot of these patients have abnormal aortas that need to be replaced," noted TCT press conference co-moderator David Cohen, MD, MSc, of Saint Francis Hospital in Roslyn, New York.

Even so, Thourani argued that it's a "huge patient population, quite honestly. People talk about tricuspid regurgitation being forgotten; I actually have rethought about that over the last 5 years. AR is a forgotten disease," he said. "It is staggering that the number of these patients are starting to come out of the woodwork because people know that it's there. ... Once we open this up, I think we'll see this proliferation of a disease management that we normally have ignored."

Commenting on the study, Clyde Yancy, MD, of Northwestern University in Chicago, cautioned that the noninferiority thresholds were "quite generous."

Another concern is long-term durability of the valves, he told MedPage Today.

Nevertheless, he concluded, "There are so many patients that have aortic insufficiency in whom surgery is high risk because they're older, and we haven't had this transcatheter approach to address AR. ... But this really could be a significant step forward. The alternative is evidence-based medical therapy for reduced ejection fraction heart failure with no real evidence other than empiricism that it ought to work in a dilated ventricle based on regurgitation."

"This is the first step, I hope, of more refinement in the technology and more precision in candidate selection," he said, "but this is a missing area in clinical cardiovascular medicine. We don't have this."

Correction: An earlier version of this story stated that the study investigated treatment of tricuspid valve regurgitation; this has been corrected.

Disclosures

Thourani disclosed relationships with Abbott, Edwards Lifesciences, Boston Scientific, and DASI Simulations.

Grubb disclosed relationships with Boston Scientific, Edwards Lifesciences, Medtronic, and Ancora Heart.

Shah disclosed relationships with Edwards Lifesciences.

Primary Source

Transcatheter Cardiovascular Therapeutics

Source Reference: Thourani VH "ALIGN-AR trial: Initial outcomes of the JenaValve Trilogy transcatheter aortic valve replacement in high risk patients with symptomatic severe native aortic regurgitation" TCT 2023.

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