Transcatheter Tricuspid Valve Repair Appears Feasible in First-in-Human Case

Successful transcatheter repair of a regurgitant tricuspid valve has provided proof of principle that the strategy is feasible and safe. The first-in-human case, reported in the March 31, 2015, issue of the Journal of the American College of Cardiology, also suggests that the percutaneous therapy can provide hemodynamic improvements, at least in some patients.Take Home: Transcatheter Tricuspid Valve Repair Appears Feasible in First-in-Human Case

“Transcatheter tricuspid valve repair could become an effective treatment for high-surgical risk patients who are nonresponsive to optimal medical therapy,” write Rebecca T. Hahn, MD, of Columbia University Medical Center/New York Presbyterian Hospital (New York, NY), and colleagues.

The patient was an 89-year-old woman who presented with recurrent right heart decompensation. Echocardiography showed preserved LV size and function (LVEF 55%) with reduced forward stroke volume (42 mL); mild to moderate mitral and aortic regurgitation; severe dilation of the right atrium and ventricle with slightly impaired right ventricular function; and severe tricuspid regurgitation with tethered, nonthickened leaflets. Right atrial pressure was 22 mm Hg, and pulmonary artery systolic pressure was 40 mm Hg. According to the authors, the findings were consistent with “isolated tricuspid regurgitation.”

With a logistic EuroSCORE of 28%, the patient was deemed to be at prohibitive risk for surgery.

TEE was performed at baseline as well as during and after the procedure. With the patient under general anesthesia, operators advanced an 8-Fr deflectable catheter through the internal jugular vein across the tricuspid valve and into the right ventricle under echocardiographic guidance. Using the Mitralign system (Mitralign; Tewksbury, MA), they positioned 2 sutured pledgets, or anchoring pads, in the annulus around the posterior leaflet. Then a lock device was used to cinch together the pledgets, thereby tightening the annulus. The result is similar to “bicuspidization” achieved by a surgical technique.

The Mitralign technology was designed to treat functional mitral regurgitation and is currently being investigated for that indication in Europe.

Hemodynamic Improvement

After the procedure, the annular area was reduced by 57%, from 14.1 cm2 to 6.05 cm2, while the effective regurgitant orifice area shrank by 53%, from 1.35 cm2 to 0.63 cm2. Hemodynamic parameters also improved over baseline, with a reduction in right atrial pressure from 22 mm Hg to 9 mm Hg and an increase in LV stroke volume from 42 mL to 72 mL.

The procedure was well tolerated; the patient was extubated the same day and discharged after 5 days. Although she continued to need aggressive medical management, the authors report that she felt better, her edema lessened, and her renal function improved.

Dr. Hahn and colleagues say that “[a]ssessment of the effect of the procedure on symptoms, right heart remodeling, and clinical outcomes requires clinical trials involving additional patients.”

In an accompanying editorial, William W. O’Neill, MD, of Henry Ford Hospital (Detroit, MI), and Brian P. O’Neill, MD, of the Temple University Heart and Vascular Institute (Philadelphia, PA), point out that despite the poor prognosis associated with tricuspid valve disease, thus far “transcatheter interventions… have been restricted primarily to patients with a degenerating bioprosthesis, with mixed results.”

Nonetheless, the editorialists say, “our aging population, the increasing prevalence of atrial fibrillation, the increase in iatrogenic [tricuspid regurgitation] from transvenous pacemaker leads, and the likely increase in life expectancy of patients with effectively treated [aortic stenosis] and [mitral stenosis] will mandate development of transcatheter therapy.”

The current report marks a first step in a long journey, they comment.

More Cases, More Success

“The interesting thing about this effort is that for the first time with these new [valve] devices, Mitralign understood that imaging plays a major role in the success of the procedure,” Dr. Hahn told TCTMD in an interview, noting that echocardiography enables more precise placement of the sutures and avoidance of complications.

Since the original case, she reported, the researchers have performed 4 additional procedures, all successful. They are working through issues such as “the ideal number of pledgets to use, the ideal location, and how much of the annulus to grab in a single suturing plication [tuck],” she said. Operators need to gauge how much tension the tissue being pulled together can tolerate without tearing, she explained, and that depends in part on how much of the annulus can be grabbed.

“Because the procedure is performed on the venous side with a stick in the jugular vein, there have been no bleeding complications or strokes,” Dr. Hahn added.

The first patient had isolated tricuspid regurgitation, she observed, and “those are the types of patients we would like to target in the beginning.” But overall the cases have been of mixed presentation, she reported, with some patients having valve prolapse and 1 having had mitral intervention. “In the end, we would hope that this device cold treat any etiology of tricuspid regurgitation, assuming that annular dilatation is contributing to it,” Dr. Hahn said.

Is the Procedure Right for All Tricuspid Regurgitation?

But in a telephone interview with TCTMD, Ted Feldman, MD, of Evanston Hospital (Evanston, IL), underlined the uncertainty about which patients should be treated. “They picked a very good patient for a first-in-human procedure, but nobody understands what will happen in cases of secondary tricuspid regurgitation, which is the bulk of the patients,” he said. “You just don’t know whether their other disease is going to overwhelm the benefits of tricuspid therapy.” He pointed to analogous considerations with regard to use of MitraClip in patients with functional mitral regurgitation and LV disease.

In addition, it remains to be seen whether the results of the transcatheter procedure will be as long-lasting as those of the surgical technique that it resembles, Dr. Hahn said.

She acknowledged that there are other percutaneous approaches to tricuspid regurgitation. “Some treat the secondary effect and others the primary problem. We have great hopes for the ones that are attempting to treat the actual anatomic problem,” Dr. Hahn commented.

“The triscuspid is a new frontier for everybody, but anytime you have a first-in-human [effort] and implantation is successful in 5 out of 5 cases, it’s quite something,” she said

Dr. Feldman also found the extension of valve therapy exciting. “A proof of concept in the tricuspid valve is the beginning of a whole new activity for us,” he said.

Note: Dr. Hahn is a staff member of the Cardiovascular Research Foundation, which owns and operates TCTMD.

 


Sources:
1. Schofer J, Bijuklic K, Tiburtius C, et al. First-in-human transcatheter tricuspid valve repair in a patient with severely regurgitant tricuspid valve. J Am Coll Cardiol. 2015;65:1190-1195.
2. O’Neill WW, O’Neill BP. Transcatheter tricuspid valve intervention: the next frontier [editorial]. J Am Coll Cardiol. 2015;65:1196-1198.

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Disclosures
  • Mitralign provided devices and training support for device use in the study.
  • Drs. Hahn and Brian O’Neill report no relevant conflicts of interest.
  • Dr. William O’Neill reports receiving stock options from Mitralign and serving as a consultant for Edwards Lifesciences.
  • Dr. Feldman reports receiving consulting fees and research grants from Abbott Vascular, Boston Scientific, and Edwards Lifesciences.

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