TY - JOUR
T1 - Early Multinational Experience of Transcatheter Tricuspid Valve Replacement for Treating Severe Tricuspid Regurgitation
AU - Hahn, Rebecca T.
AU - Kodali, Susheel
AU - Fam, Neil
AU - Bapat, Vinayak
AU - Bartus, Krzysztof
AU - Rodés-Cabau, Josep
AU - Dagenais, Francois
AU - Estevez-Loureiro, Rodrigo
AU - Forteza, Alberto
AU - Kapadia, Samir
AU - Latib, Azeem
AU - Maisano, Francesco
AU - McCarthy, Patrick
AU - Navia, Jose
AU - Ong, Geraldine
AU - Peterson, Mark
AU - Petrossian, George
AU - Pozzoli, Alberto
AU - Reinartz, Markus
AU - Ricciardi, Mark J.
AU - Robinson, Newell
AU - Sievert, Horst
AU - Taramasso, Maurizio
AU - Agarwal, Vratika
AU - Bédard, Elisabeth
AU - Tarantini, Giuseppe
AU - Colli, Andrea
N1 - Publisher Copyright:
© 2020 American College of Cardiology Foundation
PY - 2020/11/9
Y1 - 2020/11/9
N2 - Objectives: The aim of this registry was to evaluate the feasibility and safety of transcatheter tricuspid valve implantation (TTVI) in patients with extreme surgical risk. Background: Isolated tricuspid regurgitation (TR) surgery is associated with high in-hospital mortality. Methods: Thirty consecutive patients (mean age 75 ± 10 years; 56% women) from 10 institutions, with symptomatic functional TR, had institutional and notified body approval for compassionate use of the GATE TTVI system. Baseline, discharge, and 30-day follow-up echocardiographic data and procedural, in-hospital, and follow-up clinical outcomes were collected. Results: At baseline, all patients had multiple comorbidities, severe or greater TR, and reduced baseline right ventricular function. Technical success was achieved in 26 of 30 patients (87%). Device malpositioning occurred in 4 patients, with conversion to open heart surgery in 2 (5%). Of those who received the device, 100% had reductions in TR of ≥1, and 75% experienced reductions of ≥2 grades, resulting in 18 of 24 of patients (76%) with mild or less TR at discharge. All patients had mild or less central TR. There was continued improvement in TR grade between discharge and 30 days in 15 of 19 patients (79%). In-hospital mortality was 10%. At mean follow-up of 127 ± 82 days, 4 patients (13%) had died. Of patients alive at follow-up, 62% were in New York Heart Association functional class I or II, with no late device-related adverse events. Conclusions: Compassionate treatment of severe, symptomatic functional TR using a first-generation TTVI device is associated with significant reduction in TR and improvement in functional status with acceptable in-hospital mortality. Further studies are needed to determine the appropriate patient population and long-term outcomes with TTVI therapy.
AB - Objectives: The aim of this registry was to evaluate the feasibility and safety of transcatheter tricuspid valve implantation (TTVI) in patients with extreme surgical risk. Background: Isolated tricuspid regurgitation (TR) surgery is associated with high in-hospital mortality. Methods: Thirty consecutive patients (mean age 75 ± 10 years; 56% women) from 10 institutions, with symptomatic functional TR, had institutional and notified body approval for compassionate use of the GATE TTVI system. Baseline, discharge, and 30-day follow-up echocardiographic data and procedural, in-hospital, and follow-up clinical outcomes were collected. Results: At baseline, all patients had multiple comorbidities, severe or greater TR, and reduced baseline right ventricular function. Technical success was achieved in 26 of 30 patients (87%). Device malpositioning occurred in 4 patients, with conversion to open heart surgery in 2 (5%). Of those who received the device, 100% had reductions in TR of ≥1, and 75% experienced reductions of ≥2 grades, resulting in 18 of 24 of patients (76%) with mild or less TR at discharge. All patients had mild or less central TR. There was continued improvement in TR grade between discharge and 30 days in 15 of 19 patients (79%). In-hospital mortality was 10%. At mean follow-up of 127 ± 82 days, 4 patients (13%) had died. Of patients alive at follow-up, 62% were in New York Heart Association functional class I or II, with no late device-related adverse events. Conclusions: Compassionate treatment of severe, symptomatic functional TR using a first-generation TTVI device is associated with significant reduction in TR and improvement in functional status with acceptable in-hospital mortality. Further studies are needed to determine the appropriate patient population and long-term outcomes with TTVI therapy.
KW - tricuspid regurgitation
KW - tricuspid valve
KW - valve replacement
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U2 - 10.1016/j.jcin.2020.07.008
DO - 10.1016/j.jcin.2020.07.008
M3 - Article
C2 - 33153565
AN - SCOPUS:85094584645
SN - 1936-8798
VL - 13
SP - 2482
EP - 2493
JO - JACC: Cardiovascular Interventions
JF - JACC: Cardiovascular Interventions
IS - 21
ER -