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Titel:

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

Dokumenttyp:
Journal Article
Autor(en):
Guenzinger, Ralf; Lange, Ruediger S; Rieß, Friedrich-Christian; Hanke, Thorsten; Bischoff, Nicolas; Obadia, Jean-Francois; Sahar, Gideon; Bitran, Dani; Roberts, Harold; Li, Shuzhen; Bolling, Steven F
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.
Zeitschriftentitel:
Thorac Cardiovasc Surg
Jahr:
2020
Band / Volume:
68
Heft / Issue:
6
Seitenangaben Beitrag:
478-485
Volltext / DOI:
doi:10.1055/s-0038-1673665
PubMed:
http://view.ncbi.nlm.nih.gov/pubmed/30452076
Print-ISSN:
0171-6425
TUM Einrichtung:
Klinik für Herz- und Gefäßchirurgie (Prof. Lange)
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