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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
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 Funding Funded by Medtronic. The funding supported echocardiography facilities and research staff.
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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


Publication History

Received: 16 May 2018

Accepted: 06 September 2018

Article published online:
16 November 2018

© 2020. Thieme. All rights reserved.

Georg Thieme Verlag KG
Stuttgart · New York

 

  • References

  • 1 Cohen SR, Sell JE, McIntosh CL, Clark RE. Tricuspid regurgitation in patients with acquired, chronic, pure mitral regurgitation. I. Prevalence, diagnosis, and comparison of preoperative clinical and hemodynamic features in patients with and without tricuspid regurgitation. J Thorac Cardiovasc Surg 1987; 94 (04) 481-487
    CrossrefPubMedGoogle Scholar
  • 2 Dreyfus GD, Martin RP, Chan KM, Dulguerov F, Alexandrescu C. Functional tricuspid regurgitation: a need to revise our understanding. J Am Coll Cardiol 2015; 65 (21) 2331-2336
    CrossrefPubMedGoogle Scholar
  • 3 Fukuda S, Gillinov AM, Song JM. , et al. Echocardiographic insights into atrial and ventricular mechanisms of functional tricuspid regurgitation. Am Heart J 2006; 152 (06) 1208-1214
    CrossrefPubMedGoogle Scholar
  • 4 Taramasso M, Vanermen H, Maisano F, Guidotti A, La Canna G, Alfieri O. The growing clinical importance of secondary tricuspid regurgitation. J Am Coll Cardiol 2012; 59 (08) 703-710
    CrossrefPubMedGoogle Scholar
  • 5 Bernal JM, Morales D, Revuelta C, Llorca J, Gutiérrez-Morlote J, Revuelta JM. Reoperations after tricuspid valve repair. J Thorac Cardiovasc Surg 2005; 130 (02) 498-503
    CrossrefPubMedGoogle Scholar
  • 6 Nishimura RA, Otto CM, Bonow RO. , et al; American College of Cardiology/American Heart Association Task Force on Practice Guidelines. 2014 AHA/ACC guideline for the management of patients with valvular heart disease: executive summary: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol 2014; 63 (22) 2438-2488
    Google Scholar
  • 7 Vahanian A, Alfieri O, Andreotti F. , et al; ESC Committee for Practice Guidelines (CPG); Joint Task Force on the Management of Valvular Heart Disease of the European Society of Cardiology (ESC); European Association for Cardio-Thoracic Surgery (EACTS). Guidelines on the management of valvular heart disease (version 2012): the Joint Task Force on the Management of Valvular Heart Disease of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS). Eur J Cardiothorac Surg 2012; 42 (04) S1-S44
    CrossrefPubMedGoogle Scholar
  • 8 Guenther T, Mazzitelli D, Noebauer C. , et al. Tricuspid valve repair: is ring annuloplasty superior?. Eur J Cardiothorac Surg 2013; 43 (01) 58-65 , discussion 65
    CrossrefPubMedGoogle Scholar
  • 9 Tang GH, David TE, Singh SK, Maganti MD, Armstrong S, Borger MA. Tricuspid valve repair with an annuloplasty ring results in improved long-term outcomes. Circulation 2006; 114 (1, Suppl) I577-I581
    PubMedGoogle Scholar
  • 10 Wang H, Liu X, Wang X, Lv Z, Liu X, Xu P. Comparison of outcomes of tricuspid annuloplasty with 3D-rigid versus flexible prosthetic ring for functional tricuspid regurgitation secondary to rheumatic mitral valve disease. J Thorac Dis 2016; 8 (11) 3087-3095
    CrossrefPubMedGoogle Scholar
  • 11 Fukuda S, Saracino G, Matsumura Y. , et al. Three-dimensional geometry of the tricuspid annulus in healthy subjects and in patients with functional tricuspid regurgitation: a real-time, 3-dimensional echocardiographic study. Circulation 2006; 114 (1, Suppl) I492-I498
    CrossrefPubMedGoogle Scholar
  • 12 Lancellotti P, Tribouilloy C, Hagendorff A. , et al; Scientific Document Committee of the European Association of Cardiovascular Imaging. Recommendations for the echocardiographic assessment of native valvular regurgitation: an executive summary from the European Association of Cardiovascular Imaging. Eur Heart J Cardiovasc Imaging 2013; 14 (07) 611-644
    CrossrefPubMedGoogle Scholar
  • 13 Färber G, Tkebuchava S, Dawson RS. , et al. Minimally invasive, isolated tricuspid valve redo surgery: a safety and outcome analysis. Thorac Cardiovasc Surg 2018
    Google Scholar
  • 14 Chan V, Burwash IG, Lam BK. , et al. Clinical and echocardiographic impact of functional tricuspid regurgitation repair at the time of mitral valve replacement. Ann Thorac Surg 2009; 88 (04) 1209-1215
    CrossrefPubMedGoogle Scholar
  • 15 Dreyfus GD, Corbi PJ, Chan KM, Bahrami T. Secondary tricuspid regurgitation or dilatation: which should be the criteria for surgical repair?. Ann Thorac Surg 2005; 79 (01) 127-132
    CrossrefPubMedGoogle Scholar
  • 16 Huttin O, Voilliot D, Mandry D, Venner C, Juillière Y, Selton-Suty C. All you need to know about the tricuspid valve: tricuspid valve imaging and tricuspid regurgitation analysis. Arch Cardiovasc Dis 2016; 109 (01) 67-80
    CrossrefPubMedGoogle Scholar
  • 17 McCarthy PM, Bhudia SK, Rajeswaran J. , et al. Tricuspid valve repair: durability and risk factors for failure. J Thorac Cardiovasc Surg 2004; 127 (03) 674-685
    CrossrefPubMedGoogle Scholar
  • 18 Navia JL, Nowicki ER, Blackstone EH. , et al. Surgical management of secondary tricuspid valve regurgitation: annulus, commissure, or leaflet procedure?. J Thorac Cardiovasc Surg 2010; 139 (06) 1473-1482.e5
    CrossrefPubMedGoogle Scholar
  • 19 Izutani H, Nakamura T, Kawachi K. Flexible band versus rigid ring annuloplasty for functional tricuspid regurgitation. Heart Int 2010; 5 (02) e13
    CrossrefPubMedGoogle Scholar
  • 20 Pfannmüller B, Doenst T, Eberhardt K, Seeburger J, Borger MA, Mohr FW. Increased risk of dehiscence after tricuspid valve repair with rigid annuloplasty rings. J Thorac Cardiovasc Surg 2012; 143 (05) 1050-1055
    CrossrefPubMedGoogle Scholar
  • 21 De Bonis M, Lapenna E, Taramasso M. , et al. Mid-term results of tricuspid annuloplasty with a three-dimensional remodelling ring. J Card Surg 2012; 27 (03) 288-294
    CrossrefPubMedGoogle Scholar
  • 22 Ratschiller T, Guenther T, Guenzinger R. , et al. Early experiences with a new three-dimensional annuloplasty ring for the treatment of functional tricuspid regurgitation. Ann Thorac Surg 2014; 98 (06) 2039-2044
    CrossrefPubMedGoogle Scholar
  • 23 Fukuda S, Song JM, Gillinov AM. , et al. Tricuspid valve tethering predicts residual tricuspid regurgitation after tricuspid annuloplasty. Circulation 2005; 111 (08) 975-979
    CrossrefPubMedGoogle Scholar
  • 24 Kabasawa M, Kohno H, Ishizaka T. , et al. Assessment of functional tricuspid regurgitation using 320-detector-row multislice computed tomography: risk factor analysis for recurrent regurgitation after tricuspid annuloplasty. J Thorac Cardiovasc Surg 2014; 147 (01) 312-320
    CrossrefPubMedGoogle Scholar
  • 25 Yoda M, Tanabe H, Kadoma Y, Suma H. Mid-term results of tricuspid annuloplasty using the MC3 ring for secondary tricuspid valve regurgitation. Interact Cardiovasc Thorac Surg 2011; 13 (01) 7-10
    CrossrefPubMedGoogle Scholar
  • 26 Vergnat M, Jackson BM, Cheung AT. , et al. Saddle-shape annuloplasty increases mitral leaflet coaptation after repair for flail posterior leaflet. Ann Thorac Surg 2011; 92 (03) 797-803
    CrossrefPubMedGoogle Scholar
  • 27 Filsoufi F, Salzberg SP, Coutu M, Adams DH. A three-dimensional ring annuloplasty for the treatment of tricuspid regurgitation. Ann Thorac Surg 2006; 81 (06) 2273-2277
    CrossrefPubMedGoogle Scholar
  • 28 Ghoreishi M, Brown JM, Stauffer CE. , et al. Undersized tricuspid annuloplasty rings optimally treat functional tricuspid regurgitation. Ann Thorac Surg 2011; 92 (01) 89-95 , discussion 96
    CrossrefPubMedGoogle Scholar
  • 29 Lang RM, Bierig M, Devereux RB. , et al; American Society of Echocardiography's Nomenclature and Standards Committee; Task Force on Chamber Quantification; American College of Cardiology Echocardiography Committee; American Heart Association; European Association of Echocardiography, European Society of Cardiology. Recommendations for chamber quantification. Eur J Echocardiogr 2006; 7 (02) 79-108
    CrossrefPubMedGoogle Scholar