A clinical trial at Robert Wood Johnson University (RWJUH) and Rutgers Robert Wood Johnson Medical School (RWJMS) is evaluating a minimally invasive treatment of a severe heart valve disorder. This alternative treatment may offer hope to patients when traditional surgery is not an option. The new, advanced procedure treats tricuspid regurgitation (TR), a condition in which the tricuspid valve between the two right heart chambers does not close tightly, allowing blood to flow backward in the heart as it pumps. TR increases the heart’s workload and can lead to heart failure, liver disease and lung damage.
“The tricuspid valve has been called the ‘forgotten valve’ because there has been no good way to treat it,” says Mark J. Russo, MD, MS, Professor of Surgery and Chief of Cardiac Surgery at RWJMS, who is principal investigator for the clinical trial. TR can be treated with open heart surgery, but patients are often too sick to endure it, and medications that treat symptoms don’t resolve the underlying problem. The clinical trial is studying a procedure that doesn’t involve open heart surgery. Instead, a minimally invasive investigational device called the EVOQUE system uses a thin tube called a catheter to implant a replacement tricuspid valve through a blood vessel.
The trial is comparing the safety and effectiveness of the EVOQUE system plus optimal medical therapy (OMT) with OMT alone in treatment of people with severe or greater TR.
“There’s little trauma or pain associated with the procedure, and recovery is much faster than with open heart surgery,” Dr. Russo says. “This could completely transform TR treatment.”
HEART VALVE EXPERTISE
RWJUH and RWJMS have long been at the forefront of catheter-based heart valve therapies. “That’s evident from our large surgical valve program, our transcatheter valve program and our large number of clinical trials,” Dr. Russo says. “Predecessors to EVOQUE in the transcatheter space have included minimally invasive therapies such as MitraClip and TAVR.”
MitraClip is a system for repairing the heart’s mitral valve, which lies between the heart’s two left chambers. The system uses a catheter to attach a small clip to the valve to help it close more completely and restore normal blood flow.
TAVR (transcatheter aortic valve replacement) is used to treat aortic stenosis, a condition in which the aortic valve—the largest heart valve—becomes thick and stiff, hindering blood flow and potentially leading to heart failure.
“We have at least a dozen clinical trials of valvular therapies, giving patients access to treatments they can’t get elsewhere,” Dr. Russo says. “A number of therapies promise to completely transform treatment, and these impactful trials represent some of the most meaningful work being done right now in the cardiovascular field.”
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Minimally invasive valve surgery is a specialized approach to treating heart valve disease that avoids the need to “crack the chest.” This method uses sophisticated instruments to perform the surgery through a smaller incision at the side of the chest and offers the patients less pain and faster recovery. We perform nearly all of our isolated valve surgeries minimally invasively.
An aortic aneurysm is a bulging, weakened area in the wall of main blood vessel in the body. The risk of aortic catastrophe, including dissection and rupture, increases dramatically with an aneurysm. Surgery may be recommended when the aorta is larger than 4.5-6 cms. Factors including family history, lifestyle, and need for other heart surgery guide decisions about surgery.
Transcatheter aortic valve replacement (TAVR), also known as transcatheter aortic valve implantation (TAVI), is a minimally invasive approach to the treatment of aortic stenosis. In most patients, it requires no incision and typically patients are discharged within 1 day. Dr Russo is among the most experienced TAVR surgeons in the US.
A “bypass” or “cabg” surgery is the most commonly performed heart surgery. It is necessary when the coronary arteries, which provide blood to the heart become narrow preventing sufficient blood from passing through, and thus depriving the heart of oxygen and nutrients. RWJUH has CABG outcomes that exceed national benchmarks.
When other treatments are insufficient, a heart transplant is a surgical procedure offered to patients with the most severe damage to the heart. RWJUH is one of a limited number of centers in the US that offer advance heart failure surgery, including heart transplant. Dr. Russo has participated in 500+ successful transplant surgeries.
The MitraClip device is a small clip that helps your mitral valve to close more completely. The procedure does not require opening the chest or stopping the heart. Instead, through a vein in the leg, a thin tube (called a catheter) is guided to the mitral valve. Dr. Russo is among the highest volume Mitraclip operators in the Northeast.
Transcatheter aortic valve replacement vs OMM (randomized) for asymptomatic severe AS The EARLY TAVR trial (Edwards) looks at transcatheter aortic valve replacement (TAVR) as an effective treatment for patients with asymptomatic aortic stenosis. Patients are randomized to either treatment with TAVR or clinical surveillance until the develop symptoms, at which point they are eligible to be treated with TAVR. Read More
This study objective is to establish the safety and effectiveness of the Edwards SAPIEN 3/ SAPIEN 3 Ultra Transcatheter Heart Valve in subjects with moderate, calcific aortic stenosis. Patients are randomized to S3 TAVR device or medical management. Read More
ALIGN-AR evaluates the safety and probable benefit of the transfemoral JenaValve Pericardial TAVR System in patients with symptomatic severe aortic regurgitation. Patients who are high risk for open surgical aortic valve replacement/repair are eligible. RWJUH is one of only 15 centers in the U.S. that can offer this therapy that has been granted a “Breakthrough Device Designation” by the US Food and Drug Administration. This designation is reserved for investigative therapies designed to treat a serious or life-threatening disease or condition and where preliminary clinical evidence indicates that the therapy may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development.
Transcatheter aortic valve replacement for severe AS with a novel deviceEvaluates the safety and efficacy of Acurate (Boston Scientific) valve for transcatheter aortic valve replacement. For patients with severe aortic stenosis who are at intermediate or greater risk for SAVR. Patients are randomized to Acurate or commerical TAVR device. Read More
The study is a prospective, multi-center, randomized controlled pivotal clinical trial to evaluate the safety and effectiveness of the EVOQUE System with optimal medical therapy (OMT) compared to OMT alone in the treatment of patients with at least severe tricuspid regurgitation. Subjects will be followed at discharge, 30 days, 3 months, 6 months and annually through 5 years.
This study will establish the safety and effectiveness of the SAPIEN M3 System in subjects with symptomatic, at least 3+ mitral regurgitation (MR) for whom commercially available surgical or transcatheter treatment options are deemed unsuitable.
The SUMMIT-Tendyne trial (Abbott) evaluates the safety and effectiveness of using the Tendyne Mitral Valve System for the treatment of symptomatic mitral regurgitation or mitral annular calcification in patients who are not appropriate for conventional mitral valve surgery. In the randomized arm, patients are treated with either the Tendyne device or MitraClip, while patients in the non-randomized and MAC arms receive the Tendyne device. https://clinicaltrials.gov/ct2/show/NCT03433274
CLASP IID/F is a prospective, multicenter, randomized, controlled pivotal trial to evaluate the safety and effectiveness of transcatheter mitral valve repair in patients with degenerative/functional mitral regurgitation with the Edwards PASCAL Transcatheter Valve Repair System compared with the commercially available device (Abbott MitraClip).
RESTORE is a prospective, multicenter, non-randomized trial designed to evaluate the safety and effectiveness of the HARPOON™ Beating Heart Mitral Valve Repair System in patients with severe degenerative mitral regurgitation (DMR).