Early Clinical Experience With the TRICENTO Bicaval Valved Stent for Treatment of Symptomatic Severe Tricuspid Regurgitation: A Multicenter Registry
Standard
Early Clinical Experience With the TRICENTO Bicaval Valved Stent for Treatment of Symptomatic Severe Tricuspid Regurgitation: A Multicenter Registry. / Wild, Mirjam G; Lubos, Edith; Cruz-Gonzalez, Ignacio; Amat-Santos, Ignacio; Ancona, Marco; Andreas, Martin; Boeder, Niklas F; Butter, Christian; Carrasco-Chinchilla, Fernando; Estevez-Loureiro, Rodrigo; Kempfert, Jörg; Köll, Benedikt; Montorfano, Matteo; Nef, Holger M; Toggweiler, Stefan; Unbehaun, Axel; Werner, Paul; Windecker, Stephan; Praz, Fabien.
In: CIRC-CARDIOVASC INTE, Vol. 15, No. 3, e011302, 03.2022.Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review
Harvard
APA
Vancouver
Bibtex
}
RIS
TY - JOUR
T1 - Early Clinical Experience With the TRICENTO Bicaval Valved Stent for Treatment of Symptomatic Severe Tricuspid Regurgitation: A Multicenter Registry
AU - Wild, Mirjam G
AU - Lubos, Edith
AU - Cruz-Gonzalez, Ignacio
AU - Amat-Santos, Ignacio
AU - Ancona, Marco
AU - Andreas, Martin
AU - Boeder, Niklas F
AU - Butter, Christian
AU - Carrasco-Chinchilla, Fernando
AU - Estevez-Loureiro, Rodrigo
AU - Kempfert, Jörg
AU - Köll, Benedikt
AU - Montorfano, Matteo
AU - Nef, Holger M
AU - Toggweiler, Stefan
AU - Unbehaun, Axel
AU - Werner, Paul
AU - Windecker, Stephan
AU - Praz, Fabien
PY - 2022/3
Y1 - 2022/3
N2 - BACKGROUND: Patients with severe tricuspid regurgitation present late and are often ineligible for surgery or transcatheter repair systems. Transfemoral venous implantation of a bicaval valved stent has been proposed as therapeutic option in selected patients. The aim of this study was to summarize the early procedural and clinical outcomes of the novel TRICENTO system for the treatment of patients with symptomatic severe tricuspid regurgitation.METHODS: All consecutive patients treated with the custom-made TRICENTO implant at the participating centers were included in this retrospective multicentre registry.RESULTS: A total of 21 high-risk patients (mean age 76±7 years; 67% female) with severe or higher grade tricuspid regurgitation were analyzed. The majority of the patients were in New York Heart Association class III/IV (95%), had peripheral edema (95%), and previous hospitalization for right heart failure (67%). Technical success was 100%, and there was no case of in-hospital mortality. During follow-up (median 61 days), symptomatic improvement was observed (65% in New York Heart Association class I/II; P<0.001). Computed tomography revealed asymptomatic fractures of the TRICENTO prosthesis in 3 patients. Cardiac magnetic resonance imaging obtained in 7 patients showed a significant decrease (252±65 mm3 at baseline versus 216±58 mm3 at follow-up, P=0.006) of right ventricular end-diastolic volume. The overall-survival rate was 76% at 1 year.CONCLUSIONS: The present data indicate the feasibility of transfemoral bicaval valved stent implantation for the treatment of severe tricuspid regurgitation. Functional improvement and signs of right ventricular reverse remodeling were observed. Stent fractures did not impair valve function, but require refinement of prosthesis design and careful assessment of eligibility criteria.
AB - BACKGROUND: Patients with severe tricuspid regurgitation present late and are often ineligible for surgery or transcatheter repair systems. Transfemoral venous implantation of a bicaval valved stent has been proposed as therapeutic option in selected patients. The aim of this study was to summarize the early procedural and clinical outcomes of the novel TRICENTO system for the treatment of patients with symptomatic severe tricuspid regurgitation.METHODS: All consecutive patients treated with the custom-made TRICENTO implant at the participating centers were included in this retrospective multicentre registry.RESULTS: A total of 21 high-risk patients (mean age 76±7 years; 67% female) with severe or higher grade tricuspid regurgitation were analyzed. The majority of the patients were in New York Heart Association class III/IV (95%), had peripheral edema (95%), and previous hospitalization for right heart failure (67%). Technical success was 100%, and there was no case of in-hospital mortality. During follow-up (median 61 days), symptomatic improvement was observed (65% in New York Heart Association class I/II; P<0.001). Computed tomography revealed asymptomatic fractures of the TRICENTO prosthesis in 3 patients. Cardiac magnetic resonance imaging obtained in 7 patients showed a significant decrease (252±65 mm3 at baseline versus 216±58 mm3 at follow-up, P=0.006) of right ventricular end-diastolic volume. The overall-survival rate was 76% at 1 year.CONCLUSIONS: The present data indicate the feasibility of transfemoral bicaval valved stent implantation for the treatment of severe tricuspid regurgitation. Functional improvement and signs of right ventricular reverse remodeling were observed. Stent fractures did not impair valve function, but require refinement of prosthesis design and careful assessment of eligibility criteria.
KW - Aged
KW - Aged, 80 and over
KW - Cardiac Catheterization
KW - Female
KW - Heart Valve Prosthesis Implantation
KW - Humans
KW - Male
KW - Registries
KW - Retrospective Studies
KW - Severity of Illness Index
KW - Stents
KW - Time Factors
KW - Treatment Outcome
KW - Tricuspid Valve/diagnostic imaging
KW - Tricuspid Valve Insufficiency/diagnostic imaging
U2 - 10.1161/CIRCINTERVENTIONS.121.011302
DO - 10.1161/CIRCINTERVENTIONS.121.011302
M3 - SCORING: Journal article
C2 - 35236096
VL - 15
JO - CIRC-CARDIOVASC INTE
JF - CIRC-CARDIOVASC INTE
SN - 1941-7640
IS - 3
M1 - e011302
ER -
