1. Six-Month Performance of a 3-Dimensional Annuloplasty Ring for Repair of Functional Tricuspid Regurgitation.
- Author
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Guenzinger R, Lange RS, Rieß FC, Hanke T, Bischoff N, Obadia JF, Sahar G, Bitran D, Roberts H Jr, Li S, and Bolling SF
- Subjects
- Aged, Europe, Female, Heart Valve Prosthesis Implantation adverse effects, Heart Valve Prosthesis Implantation mortality, Hemodynamics, Humans, Israel, Male, Middle Aged, Mitral Valve Annuloplasty adverse effects, Mitral Valve Annuloplasty mortality, Postoperative Complications mortality, Product Surveillance, Postmarketing, Prospective Studies, Prosthesis Design, Recovery of Function, Risk Factors, Time Factors, Treatment Outcome, Tricuspid Valve diagnostic imaging, Tricuspid Valve physiopathology, Tricuspid Valve Insufficiency diagnostic imaging, Tricuspid Valve Insufficiency mortality, Tricuspid Valve Insufficiency physiopathology, United States, Heart Valve Prosthesis, Heart Valve Prosthesis Implantation instrumentation, Mitral Valve Annuloplasty instrumentation, Tricuspid Valve surgery, Tricuspid Valve Insufficiency surgery
- 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., Competing Interests: Ralf Guenzinger has no conflicts of interest to declare. Ruediger Lange is a consultant for Medtronic. Jean-Francois Obadia is a consultant for St. Jude Medical, Edwards Lifesciences, Medtronic, Landanger, and Delacroix-Chevalier and receives research support from Abbott. Shuzhen Li is an employee and shareholder of Medtronic. All other authors have no conflicts of interest to declare., (Thieme. All rights reserved.)
- Published
- 2020
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