Six-Month Performance of a 3-Dimensional Annuloplasty Ring for Repair of Functional Tricuspid Regurgitation

Ralf Guenzinger, Ruediger S. Lange, Friedrich Christian Rieβ, Thorsten Hanke, Nicolas Bischoff, Jean Francois Obadia, Gideon Sahar, Dani Bitran, Harold Roberts, Shuzhen Li, Steven F. Bolling

Research output: Contribution to journalArticlepeer-review

4 Scopus citations

Abstract

Background Functional tricuspid regurgitation (FTR) secondary to left-sided heart disease may lead to poor quality of life and reduced long-term survival. This study evaluated clinical and functional outcomes of patients undergoing tricuspid valve (TV) repair using a rigid three-dimensional ring (Contour 3D, Medtronic) concomitant with another procedure. Methods From September 2011 to July 2015, 112 patients (mean age 70.9 ± 9.0 years) were enrolled at 10 centers in Europe, Israel, and the United States. Inclusion criteria were FTR ≥ moderate and/or tricuspid annular diameter (TAD) ≥ 40 mm. Echocardiography was planned before surgery and at discharge with echocardiographic and clinical follow-ups performed 6 months postoperatively. Results Three fourths (74.4%) of patients had higher than moderate TR. Mean TAD was 41.0 ± 7.3 mm; 61.7% of patients were in the New York Heart Association (NYHA) class III/IV. The most common concomitant procedure was mitral valve repair (57 patients, 53.3%). The 30-day mortality rate was 0.9% (n = 1). The mean EuroSCORE II was 8.9 ± 8.4% (median: 5.9%; interquartile range: 3.5-11.5%). The observed to expected ratio (O/E) based on the median was 0.1. Six deaths occurred during follow-up (three cardiac related). Mean implanted ring size was 30.3 ± 2.7. At 6 months, 94.4% of patients showed ≤ mild TR, and 92.0% were in NYHA class I/II (p < 0.001 vs baseline for both). Mean pressure gradient across the TV was 2.0 ± 1.1 mm Hg; leaflet coaptation length was 7.5 ± 3.3 mm. Conclusion The Contour 3D annuloplasty ring used for treatment of FTR substantially reduced TR for up to 6 postoperative months with low mean pressure gradients across the TV and significant improvement in NYHA class. Registration www.ClinicalTrials.gov, NCT01532921.

Original languageEnglish
Pages (from-to)478-485
Number of pages8
JournalThoracic and Cardiovascular Surgeon
Volume68
Issue number6
DOIs
StatePublished - Sep 1 2020

Keywords

  • 3-dimensional tricuspid annuloplasty ring
  • functional tricuspid regurgitation
  • tricuspid annular dilatation
  • tricuspid valve annuloplasty

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