Thorac cardiovasc Surg
DOI: 10.1055/s-0038-1673665
Original Cardiovascular
Georg Thieme Verlag KG Stuttgart · New York

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

Ralf Guenzinger
1  Department of Cardiovascular Surgery, German Heart Center Munich, Technische Universität München, Munich, Germany
2  Insure (Institute for Translational Cardiac Surgery), Department of Cardiovascular Surgery, German Heart Center Munich, Technische Universität München, Munich, Germany
,
Ruediger S. Lange
1  Department of Cardiovascular Surgery, German Heart Center Munich, Technische Universität München, Munich, Germany
2  Insure (Institute for Translational Cardiac Surgery), Department of Cardiovascular Surgery, German Heart Center Munich, Technische Universität München, Munich, Germany
,
Friedrich-Christian Rieß
3  Clinic of Cardiac Surgery, Albertinen Cardiovascular Center, Hamburg, Germany
,
Thorsten Hanke
4  Department of Cardiac Surgery, Asklepios Hospital Hamburg-Harburg, Hamburg, Germany
,
Nicolas Bischoff
5  Department of Thoracic and Cardiovascular Surgery, Mulhouse Hospital Center-Emile Muller Hospital, Mulhouse, France
,
Jean-Francois Obadia
6  Cardiovascular Surgery and Cardiac Transplantation, Hospitals of Lyon-Louis Pradel Hospital, Bron cedex, France
,
Gideon Sahar
7  Department of Cardiothoracic Surgery, Soroka Medical Center, Be’er Sheva, Israel
,
Dani Bitran
8  Department of Cardiothoracic Surgery, Shaare-Zedek Medical Center, Jerusalem, Israel
,
Harold Roberts Jr.
9  West Virginia University Health Sciences Center, WVU Heart and Vascular Institute, Morgantown, WV Virginia, United States
,
Shuzhen Li
10  Biostatistics Department, Medtronic, Mounds View, MN, USA
,
Steven F. Bolling
11  Department of Cardiac Surgery, University of Michigan, Ann Arbor, MI, United States
› Author Affiliations
Further Information

Publication History

16 May 2018

06 September 2018

Publication Date:
16 November 2018 (online)

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.

Registrationwww.ClinicalTrials.gov, NCT01532921.