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

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

doi:10.1055/s-0038-1673665

The Thoracic and Cardiovascular Surgeon, Table of Contents

Thorac Cardiovasc Surg 2020; 68(06): 478-485
DOI: 10.1055/s-0038-1673665

Original Cardiovascular

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

Ralf Guenzinger

¹Department of Cardiovascular Surgery, German Heart Center Munich, Technische Universität München, Munich, Germany

²Insure (Institute for Translational Cardiac Surgery), Department of Cardiovascular Surgery, German Heart Center Munich, Technische Universität München, Munich, Germany

,

Ruediger S. Lange

¹Department of Cardiovascular Surgery, German Heart Center Munich, Technische Universität München, Munich, Germany

²Insure (Institute for Translational Cardiac Surgery), Department of Cardiovascular Surgery, German Heart Center Munich, Technische Universität München, Munich, Germany

,

Friedrich-Christian Rieß

³Clinic of Cardiac Surgery, Albertinen Cardiovascular Center, Hamburg, Germany

,

Thorsten Hanke

⁴Department of Cardiac Surgery, Asklepios Hospital Hamburg-Harburg, Hamburg, Germany

,

Nicolas Bischoff

⁵Department of Thoracic and Cardiovascular Surgery, Mulhouse Hospital Center-Emile Muller Hospital, Mulhouse, France

,

Jean-Francois Obadia

⁶Cardiovascular Surgery and Cardiac Transplantation, Hospitals of Lyon-Louis Pradel Hospital, Bron cedex, France

,

Gideon Sahar

⁷Department of Cardiothoracic Surgery, Soroka Medical Center, Be’er Sheva, Israel

,

Dani Bitran

⁸Department of Cardiothoracic Surgery, Shaare-Zedek Medical Center, Jerusalem, Israel

,

Harold Roberts Jr.

⁹West Virginia University Health Sciences Center, WVU Heart and Vascular Institute, Morgantown, WV Virginia, United States

,

Shuzhen Li

¹⁰Biostatistics Department, Medtronic, Mounds View, MN, USA

,

Steven F. Bolling

¹¹Department of Cardiac Surgery, University of Michigan, Ann Arbor, MI, United States

› Author Affiliations

Abstract

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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.

Keywords

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

Full Text

References

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