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  • Leaflet Morphology Not a Factor in Cardioband Success or Efficacy, Study Concludes

    Leaflet morphology does not affect the efficacy and safety of transcatheter direct annuloplasty using Cardioband that reduces tricuspid regurgitation (TR) grade and heart failure symptoms, a new study finds.

    The research team concluded that Cardioband’s efficacy was separate from valvular anatomy and encouraged its use in patients with complex leaflet morphology requiring transcatheter treatment of secondary TR.

    In a manuscript published Monday online and in the March 27 issue of JACC: Cardiovascular Interventions, the team also suggested the assessment of leaflet morphology be part of procedural planning in TR patients, adding that this assessment might assist in tailoring repair techniques to patient anatomy.

    “To date, tricuspid transcatheter edge-to-edge repair (T-TEER), is the most widely used technique for interventional tricuspid repair largely because of shorter procedure times and steeper learning curve when compared with Cardioband,” the team said.

    “There is evidence that complex leaflet morphology negatively impacts efficacy and safety in some patients undergoing T-TEER, whereas our data show no effect of complex leaflet morphology on outcomes in Cardioband procedures.”

    T-TEER and Cardioband

    Until recently, isolated treatment of secondary TR was restricted to a few select patients, due to the nearly 15% surgical mortality rate for isolated TR.

    Leaflet approximation and direct annuloplasty are currently the two main mechanisms of transcatheter tricuspid valve repair, with T-TEER the most widely used CE-certified technique for leaflet approximation

    Also, CE-approved is Edwards Lifesciences’ Cardioband, which is used in direct annuloplasty and has been proven safe and effective in reducing TR grade and symptoms of heart failure.

    The study authors began the retrospective study of 120 patients, who had previously undergone direct transcatheter tricuspid valve annuloplasty with the Cardioband at three tertiary centers.

    Conducted between 2018 and 2021, the study looked at 10 patients at each center per year. These patients had a median age of 80 years and almost 70% of patients were female.

    The majority of these patients presented with dyspnea, New York Heart Association functional class III or IV (91.7%), and over 90% were taking loop diuretic agents.

    The primary endpoint was defined as a residual TR ≥3 at discharge. However, in four patients, a discharge echocardiography was not obtained, so for the endpoint analyses, the team obtained the postinterventional TR grade from the peri-interventional echocardiography.

    As secondary endpoints, the team investigated TR grade reduction ≥1 and ≥2 grades from baseline to discharge echocardiography.

    Safety endpoints included the recording of cardiac tamponade, device-related right coronary artery (RCA) perforation (with leak of contrast media) and/or stenting of the RCA.

    Main results

    The team from the University of Cologne and Ruhr University Bochum, both in Germany, found a total of 48.3% of patients had a three-leaflet morphology, 5% a two-leaflet morphology, and 46.7% had >3 tricuspid leaflets.

    Baseline characteristics did not differ relevantly between groups except for a higher incidence of torrential TR grade (50% vs 26.6%) in complex morphologies.

    Postprocedural improvement of one (90.6% vs 92.9%) and two (71.9% vs 67.9%) TR grades was not significantly different between groups, but patients with complex morphology more often had residual TR ≥3 at discharge (48.2% vs 26.6%; P=0.014).

    This difference did not remain significant (P=0.112) after adjusting for baseline TR severity, coaptation gap and nonanterior jet localization.

    Safety endpoints such as complications of the RCA and technical success did not show significant differences.

    “Our study now is the first to show that the procedure (annuloplasty with the Cardioband) was effective in reducing TR grades regardless of leaflet morphology,” said the research team, led by Maria Isabel Körber, MD, from the University of Cologne.

    “From the mechanistic point of view, our findings are intuitive: by performing annuloplasty, the Cardioband technique causes a general reduction of the annular dimension.

    “Thus, a generalized effect on all coaptation lines within the valve can be assumed irrespective of number and location of separate leaflets, provided that relevant tenting of leaflets is absent.”

    Cardioband concerns

    In an accompanying editorial, Julinda Mehilli, MD, and Florian Zauner, MD, from the Medizinische Klinik I, Landshut-Achdorf Hospital in Landshut, Germany, highlighted the duration of the intervention as a concern.

    Direct Cardioband annuloplasty remains long, with the procedure’s reported mean duration time of 238 ±98 minutes compared to T-TEER’s reported mean of 86 ±39 minutes.

    The physicians also drew attention to the occurrence of pericardial tamponade (2.8%), RCA perforation (5.6%), rescue coronary stenting (7.5%) and conversion to surgery (5%) as considerably high when compared to T-TEER.

    Other concerns include the one half of patients with complex leaflet morphology, who have residual TR >3 after direct annuloplasty.

    “The present study provides important insights about the feasibility of direct Cardioband annuloplasty for treatment of TR despite challenging valve anatomy,” they said.

    “At the same time, it highlights the limits of the current technology—the necessity of stringent anatomical selection criteria and complex handling of the current device version—which limit its widespread use.”


    Körber MI, Roder F, Gerçek M, et al. Leaflet Morphology and its Implications for Direct Transcatheter Annuloplasty of Tricuspid Regurgitation, JACC Cardiovasc Interv 2023;16:693–702.

    Mehilli J, Zauner F. Efficacy of Tricuspid Valve Direct Annuloplasty and Valve Anatomical Configuration, JACC Cardiovasc. Interv 2023;16:703–705.

    Image Credit: faustasyan –

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