Clip Found to Be Safe and Effective for Alleviating Tricuspid Regurgitation
By Jeffrey Zimmet, MD, PhD
Associate Professor of Medicine, University of California, San Francisco; Director, Cardiac Catheterization Laboratory, San Francisco VA Medical Center
SYNOPSIS: In this randomized trial of tricuspid transcatheter edge-to-edge repair, the intervention was found to be safe and effective at alleviating tricuspid regurgitation. Quality of life scores improved with intervention compared with medical therapy, although death and heart failure hospitalization rates were not significantly different.
SOURCE: Sorajja P, Whisenant B, Hamid N, et al. Transcatheter repair for patients with tricuspid regurgitation. N Engl J Med 2023; Mar 4. doi: 10.1056/NEJMoa2300525. [Online ahead of print].
Tricuspid valve regurgitation leads to the backflow of blood from the right ventricle to the right atrium, leading to venous congestion and right heart failure. This condition can cause debilitating symptoms and significant morbidity in a subset of patients. Traditionally, tricuspid regurgitation (TR) had been managed conservatively. With the recognition that severe TR detrimentally affects hard outcomes, including heart failure hospitalization and death, management of the valve itself has become a priority. Until recently, this has meant surgical repair or replacement. For many patients, the sequelae of right ventricular dysfunction and chronic hepatic congestion translates to high morbidity and mortality from surgery. Percutaneous therapies for tricuspid valve regurgitation have been proposed as a less invasive alternative, providing a potentially safer and more effective option for patients who are not good candidates for surgery.1 Transcatheter edge-to-edge repair (TEER), which initially was applied to the mitral valve, has emerged as the leading technique in this space. However, to date, evidence demonstrating the benefit of this procedure over medical therapy alone has been lacking.
The TriClip Transcatheter Tricuspid Valve Repair system is a purpose-built device that allows surgeons to place clip devices on the tricuspid leaflets by way of large-bore femoral venous access. Generally, surgeons perform the procedure on patients who are under general anesthesia, with guidance by echocardiography and fluoroscopy. In the TRILUMINATE trial, 350 patients were randomized 1:1 to either TEER or medical therapy. Enrollment occurred over two years at 65 centers in Canada, Europe, and the United States. All patients enrolled with severe, symptomatic TR confirmed by an independent echocardiography laboratory. The average age of enrolled patients was 78 years; just over half were women. A total of 90% had experienced atrial fibrillation, and one-quarter had been hospitalized in the prior year for heart failure.
For this relatively complex procedure, clips were successfully implanted in 170 of the 172 patients in whom it was attempted. A mean of 2.2 clips were implanted per patient, with an average device time of 90 ± 66 minutes and a median hospital stay of one day. There were no deaths during the procedural hospitalization, and only one death within 30 days of the procedure.
Echocardiographic core laboratory evaluation demonstrated TR improved significantly in the procedure group vs. controls. At one year, 126 of 143 TEER patients exhibited TR graded as moderate or less vs. only eight of 141 patients in the medical therapy group. The primary endpoint was a composite of all-cause mortality, tricuspid surgery, heart failure hospitalization, and quality of life improvement, as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ).
The primary endpoint favored the intervention group (win ratio, 1.48; 95% CI, 1.06-2.13; P = 0.02). However, when examining the individual components, the results showed no significant change in death or heart failure hospitalization rates. Still, the KCCQ score favored TEER, with a mean increase of 12.3 ± 1.8 points in the TEER group and 0.6 ± 1.8 points in the control group (P < 0.001). Moreover, the improvements in quality-of-life scores correlated with the degree of TR alleviation, with the greatest improvements seen in patients with less residual TR. The investigators concluded tricuspid TEER was safe and effective for alleviating the severity of TR and resulted in improvements in quality of life.
For years, effective percutaneous options to treat TR have been lacking. Initially, the TEER technique was applied to the tricuspid valve using devices designed for the mitral position. However, challenges with clip orientation, imaging, and a steep learning curve have resulted in variable outcomes for centers attempting the procedure. By applying best practices with the tricuspid-specific device in experienced centers, the TRILUMINATE investigators have convincingly demonstrated this procedure can be effectively accomplished in most patients, although admittedly with variable results. Notably, this study demonstrated remarkably favorable procedural technique safety in experienced hands, with no deaths or device embolization, and scant bleeding rates.
Some might be disappointed the intervention did not significantly lower hard outcomes. Here, the primary outcome was driven by the improvements seen in quality-of-life scoring, whose interpretation is somewhat complicated in an unblinded study without a sham control. However, patients enrolled in this study were not a particularly high-risk group, with relatively low rates of death and heart failure hospitalization overall. There remain questions about the generalizability of the procedure, and whether patient selection here may have excluded subjects at highest risk, in an environment where this procedure has been available in an off-label fashion for some years. Also, it remains to be seen how patients with more severe pathology will handle this procedure.
Nonetheless, this study represents a significant advancement for the procedure. I expect this device ultimately will be approved for general use in the United States. Ongoing research into the potential benefits and limitations of this technique will allow refinement of its applicability and may identify the patient populations that are most likely to benefit.
1. Giannini F, Colombo A. Percutaneous treatment of tricuspid valve in refractory right heart failure. Eur Heart J Suppl 2019;21:B43-B47.
In this randomized trial of tricuspid transcatheter edge-to-edge repair, the intervention was found to be safe and effective at alleviating tricuspid regurgitation. Quality of life scores improved with intervention compared with medical therapy, although death and heart failure hospitalization rates were not significantly different.
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