Transcatheter Aortic Valve Replacement for Degenerated Transcatheter Aortic Valves: The TRANSIT International Project.


Journal

Circulation. Cardiovascular interventions
ISSN: 1941-7632
Titre abrégé: Circ Cardiovasc Interv
Pays: United States
ID NLM: 101499602

Informations de publication

Date de publication:
06 2021
Historique:
pubmed: 8 6 2021
medline: 26 10 2021
entrez: 7 6 2021
Statut: ppublish

Résumé

Transcatheter aortic valve replacement (TAVR) has determined a paradigm shift in the treatment of patients with severe aortic stenosis. However, the durability of bioprostheses is still a matter of concern, and little is known about the management of degenerated TAV. We sought to evaluate the outcomes of patients with a degenerated TAV treated by means of a second TAVR. The TRANSIT is an international registry that included cases of degenerated TAVR from 28 centers. Among around 40 000 patients treated with TAVR in the participating centers, 172 underwent a second TAVR: 57 (33%) for a mainly stenotic degenerated TAV, 97 (56%) for a mainly regurgitant TAV, and 18 (11%) for a combined degeneration. Overall, the rate of New York Heart Association class III/IV at presentation was 73.5%. Valve Academic Research Consortium 2 device success rate was 79%, as a consequence of residual gradient (14%) or regurgitation (7%). At 1 month, the overall mortality rate was 2.9%, while rates of new hospitalization and New York Heart Association class III/IV were 3.6% and 7%, respectively, without significant difference across the groups. At 1 year, the overall mortality rate was 10%, while rates of new hospitalization and New York Heart Association class III/IV were 7.6% and 5.8%, respectively, without significant difference across the groups. No cases of valve thrombosis were recorded. Selected patients with a degenerated TAV may be safely and successfully treated by means of a second TAVR. This finding is of crucial importance for the adoption of the TAVR technology in a lower risk and younger population. URL: https://www.clinicaltrials.gov; Unique identifier: NCT04500964.

Sections du résumé

BACKGROUND
Transcatheter aortic valve replacement (TAVR) has determined a paradigm shift in the treatment of patients with severe aortic stenosis. However, the durability of bioprostheses is still a matter of concern, and little is known about the management of degenerated TAV. We sought to evaluate the outcomes of patients with a degenerated TAV treated by means of a second TAVR.
METHODS
The TRANSIT is an international registry that included cases of degenerated TAVR from 28 centers. Among around 40 000 patients treated with TAVR in the participating centers, 172 underwent a second TAVR: 57 (33%) for a mainly stenotic degenerated TAV, 97 (56%) for a mainly regurgitant TAV, and 18 (11%) for a combined degeneration. Overall, the rate of New York Heart Association class III/IV at presentation was 73.5%.
RESULTS
Valve Academic Research Consortium 2 device success rate was 79%, as a consequence of residual gradient (14%) or regurgitation (7%). At 1 month, the overall mortality rate was 2.9%, while rates of new hospitalization and New York Heart Association class III/IV were 3.6% and 7%, respectively, without significant difference across the groups. At 1 year, the overall mortality rate was 10%, while rates of new hospitalization and New York Heart Association class III/IV were 7.6% and 5.8%, respectively, without significant difference across the groups. No cases of valve thrombosis were recorded.
CONCLUSIONS
Selected patients with a degenerated TAV may be safely and successfully treated by means of a second TAVR. This finding is of crucial importance for the adoption of the TAVR technology in a lower risk and younger population.
REGISTRATION
URL: https://www.clinicaltrials.gov; Unique identifier: NCT04500964.

Identifiants

pubmed: 34092097
doi: 10.1161/CIRCINTERVENTIONS.120.010440
doi:

Banques de données

ClinicalTrials.gov
['NCT04500964']

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

e010440

Commentaires et corrections

Type : CommentIn

Auteurs

Luca Testa (L)

IRCCS Policlinico S. Donato, Milan, Italy (L.T., M.A., N.B., A.P.R., M.C., F.D.M., G.B., F.B.).

Mauro Agnifili (M)

IRCCS Policlinico S. Donato, Milan, Italy (L.T., M.A., N.B., A.P.R., M.C., F.D.M., G.B., F.B.).

Nicolas M Van Mieghem (NM)

Erasmus University Medical Center, Rotterdam, the Netherlands (N.M.V.M.).

Didier Tchétché (D)

Groupe CardioVasculaire Interventionnel, Clinique Pasteur, Toulouse, France (D.T.).

Anita W Asgar (AW)

Montreal Heart Institute, Canada (A.W.A., L.S.).

Ole De Backer (O)

Rigshospitalet, Copenhagen University Hospital, Denmark (O.D.B.).

Azeem Latib (A)

Montefiore Medical Center, New York (A.L.).

Bernhard Reimers (B)

Humanitas Research Center, IRCCS, Rozzano-Milan, Italy (B.R., G.S.).

Giulio Stefanini (G)

Humanitas Research Center, IRCCS, Rozzano-Milan, Italy (B.R., G.S.).

Carlo Trani (C)

Policlinico Universitario A. Gemelli, Rome, Italy (C.T.).

Antonio Colombo (A)

Maria Cecilia Hospital, Cotignola, Ravenna, Italy (A.C., F.G.).

Francesco Giannini (F)

Maria Cecilia Hospital, Cotignola, Ravenna, Italy (A.C., F.G.).

Antonio Bartorelli (A)

Centro Cardiologico Monzino, IRCCS, Milan, Italy (A.B.).
Department of Biomedical and Clinical Sciences "Luigi Sacco", University of Milan, Italy (A.B.).

Wojtek Wojakowski (W)

Medical University of Silesia, Katowice, Poland (W.W.).

Maciej Dabrowski (M)

Department of Interventional Cardiology and Angiology, National Institute of Cardiology, Warsaw, Poland (M.D.).

Dariusz Jagielak (D)

Medical University, Gdańsk, Poland (D.J.).

Adrian P Banning (AP)

John Radcliffe Hospital, Oxford, United Kingdom (A.P.B., R.K.).

Rajesh Kharbanda (R)

John Radcliffe Hospital, Oxford, United Kingdom (A.P.B., R.K.).

Raul Moreno (R)

Hospital La Paz, IdiPAZ, CIBER-CV, Madrid, Spain (R.M.).

Joachim Schofer (J)

MVZ Department Structural Heart Disease at St. Georg, Hamburg, Germany (J.S.).

Niels van Royen (N)

Radboud University Medical Center, Nijmegen, the Netherlands (N.v.R.).

Duane Pinto (D)

Beth Israel Deaconess Medical Center, Boston, MA (D.P.).

Antoni Serra (A)

Hospital de la Santa Creu i Sant Pau, Barcelona, Spain (A. Serra).

Amit Segev (A)

The Heart and Vascular Center, Chaim Sheba Medical Center, Israel (A. Segev).

Arturo Giordano (A)

Pineta Grande Hospital, Caserta, Italy (A.G.).

Nedy Brambilla (N)

IRCCS Policlinico S. Donato, Milan, Italy (L.T., M.A., N.B., A.P.R., M.C., F.D.M., G.B., F.B.).

Antonio Popolo Rubbio (A)

IRCCS Policlinico S. Donato, Milan, Italy (L.T., M.A., N.B., A.P.R., M.C., F.D.M., G.B., F.B.).

Matteo Casenghi (M)

IRCCS Policlinico S. Donato, Milan, Italy (L.T., M.A., N.B., A.P.R., M.C., F.D.M., G.B., F.B.).

Jacopo Oreglia (J)

Niguarda Ca Granda Hospital, Milan, Italy (J.O.).

Federico De Marco (F)

IRCCS Policlinico S. Donato, Milan, Italy (L.T., M.A., N.B., A.P.R., M.C., F.D.M., G.B., F.B.).

Rudolph Tanja (R)

Heart and Diabetes Center NRW, Bad Oeynhausen, Germany (R. Tanja).

James M McCabe (JM)

University of Washington (J.M.M.).

Alexander Abizaid (A)

Instituto Dante Pazzanese de Cardiologia, San Paolo, Brazil (A.A.).

Michiel Voskuil (M)

University Medical Center, Utrecht, the Netherlands (M.V.).

Rui Teles (R)

Hospital de Santa Cruz, Centro Hospitalar de Lisboa Ocidental, Lisbon, Portugal (R. Teles).

Giuseppe Biondi Zoccai (G)

Department of Medico-Surgical Sciences and Biotechnologies, Sapienza University of Rome, Italy (G.B.Z.).

Giovanni Bianchi (G)

IRCCS Policlinico S. Donato, Milan, Italy (L.T., M.A., N.B., A.P.R., M.C., F.D.M., G.B., F.B.).

Lars Sondergaard (L)

Montreal Heart Institute, Canada (A.W.A., L.S.).

Francesco Bedogni (F)

IRCCS Policlinico S. Donato, Milan, Italy (L.T., M.A., N.B., A.P.R., M.C., F.D.M., G.B., F.B.).

Articles similaires

[Redispensing of expensive oral anticancer medicines: a practical application].

Lisanne N van Merendonk, Kübra Akgöl, Bastiaan Nuijen
1.00
Humans Antineoplastic Agents Administration, Oral Drug Costs Counterfeit Drugs

Smoking Cessation and Incident Cardiovascular Disease.

Jun Hwan Cho, Seung Yong Shin, Hoseob Kim et al.
1.00
Humans Male Smoking Cessation Cardiovascular Diseases Female
Humans United States Aged Cross-Sectional Studies Medicare Part C
1.00
Humans Yoga Low Back Pain Female Male

Classifications MeSH