MARC details
| 000 -LEADER |
|---|
| fixed length control field |
05568nam a22005777a 4500 |
| 008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION |
|---|
| fixed length control field |
221213s20222022 xxu||||| |||| 00| 0 eng d |
| 022 ## - INTERNATIONAL STANDARD SERIAL NUMBER |
|---|
| International Standard Serial Number |
2574-3805 |
| 024 ## - OTHER STANDARD IDENTIFIER |
|---|
| Standard number or code |
10.1001/jamanetworkopen.2022.38792 [doi] |
| 024 ## - OTHER STANDARD IDENTIFIER |
|---|
| Standard number or code |
2797783 [pii] |
| 024 ## - OTHER STANDARD IDENTIFIER |
|---|
| Standard number or code |
PMC9614584 [pmc] |
| 040 ## - CATALOGING SOURCE |
|---|
| Original cataloging agency |
Ovid MEDLINE(R) |
| 099 ## - LOCAL FREE-TEXT CALL NUMBER (OCLC) |
|---|
| PMID |
36301543 |
| 245 ## - TITLE STATEMENT |
|---|
| Title |
Long-term Outcomes of Transcatheter Aortic Valve Replacement With the Lotus Valve vs CoreValve/EvolutR: A Secondary Analysis of the REPRISE III Randomized Clinical Trial. |
| 251 ## - Source |
|---|
| Source |
JAMA Network Open. 5(10):e2238792, 2022 Oct 03. |
| 252 ## - Abbreviated Source |
|---|
| Abbreviated source |
JAMA netw. open. 5(10):e2238792, 2022 Oct 03. |
| 253 ## - Journal Name |
|---|
| Journal name |
JAMA network open |
| 260 ## - PUBLICATION, DISTRIBUTION, ETC. |
|---|
| Year |
2022 |
| 260 ## - PUBLICATION, DISTRIBUTION, ETC. |
|---|
| Manufacturer |
FY2023 |
| 260 ## - PUBLICATION, DISTRIBUTION, ETC. |
|---|
| Publication date |
2022 Oct 03 |
| 265 ## - SOURCE FOR ACQUISITION/SUBSCRIPTION ADDRESS [OBSOLETE] |
|---|
| Publication status |
epublish |
| 266 ## - Date added to catalog |
|---|
| Date added to catalog |
2022-12-13 |
| 520 ## - SUMMARY, ETC. |
|---|
| Abstract |
Conclusions and Relevance: The REPRISE III trial found that, at 5 years, the clinical outcomes of the Lotus valve were comparable to those of the CoreValve/EvolutR and that the Lotus valve was safe and effective. |
| 520 ## - SUMMARY, ETC. |
|---|
| Abstract |
Design, Setting, and Participants: This prespecified secondary analysis assessed the final 5-year clinical, functional, and echocardiographic outcomes of 912 patients from the REPRISE III trial, which was conducted at 55 centers in North America, Europe, and Australia between September 22, 2014, and December 24, 2015. Patients had high risk for aortic stenosis or severe or symptomatic aortic stenosis. Data were analyzed from September 22, 2014, to May 21, 2021. |
| 520 ## - SUMMARY, ETC. |
|---|
| Abstract |
Importance: Long-term follow-up after transcatheter aortic valve replacement (TAVR) is of interest given that longitudinal data on mortality and durability of transcatheter heart valves are limited. The REPRISE III (Repositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus Valve System-Randomized Clinical Evaluation) randomized clinical trial compared the mechanically expanded Lotus valve with the self-expanding CoreValve/EvolutR TAVR platforms. |
| 520 ## - SUMMARY, ETC. |
|---|
| Abstract |
Intervention: Lotus valve or CoreValve/EvolutR TAVR platforms. |
| 520 ## - SUMMARY, ETC. |
|---|
| Abstract |
Main Outcomes and Measures: Valve Academic Research Consortium-2 end points, hemodynamic measures, functional status, and health status were examined through the 5-year follow-up. |
| 520 ## - SUMMARY, ETC. |
|---|
| Abstract |
Objective: To describe the final 5-year outcomes of the REPRISE III trial. |
| 520 ## - SUMMARY, ETC. |
|---|
| Abstract |
Results: A total of 912 patients (mean [SD] age, 82.8 [7.3] years; 463 women [50.8%]) were randomized to either the Lotus valve group (n = 607) or CoreValve/EvolutR group (n = 305), with a baseline Society of Thoracic Surgeons risk score of 6.8%. Clinical follow-up data from the REPRISE III trial were available for 581 patients (95.7%) in the Lotus valve group and 285 patients (93.4%) in the CoreValve/EvolutR group. At 5 years, the cumulative event rate for all-cause mortality was 50.9% in the Lotus valve group vs 52.8% in the CoreValve/EvolutR group (P = .59). Disabling stroke was less frequent with the Lotus valve vs CoreValve/EvolutR (cumulative event rates, 8.3% vs 12.2%; P = .04), whereas the cumulative event rates for overall stroke were similar in both groups (14.1% vs 15.3%; P = .38). Insertion of a new permanent pacemaker (38.9% vs 27.3%; P < .001) and detection of prosthetic aortic valve thrombosis (5.8% vs 1.8%; P = .007) were more common in the Lotus valve group than in the CoreValve/EvolutR group. A smaller proportion of patients who received the Lotus valve experienced valve malpositioning (0% vs 2.6%; P < .001) and required the use of a second valve (1.0% vs 3.8%; P < .001) during the procedure compared with those who received the CoreValve/EvolutR. Compared with the Lotus valve group, the CoreValve/EvolutR group had a significantly lower mean (SD) aortic gradient (7.8 [4.2] mm Hg vs 12.6 [6.7] mm Hg; P < .001) and larger valve areas (1.57 [0.56] cm2 vs 1.42 [0.42] cm2; P = .10). After 5 years, the proportion of patients with moderate or greater paravalvular leak was not significantly higher with the CoreValve/EvolutR than with the Lotus valve (1.9% vs 0%; P = .31); however, the proportion of patients with mild paravalvular leak was higher in the CoreValve/EvolutR group compared with the Lotus valve group (23.1% vs 7.8%; P = .006). Long-term, similar improvements in New York Heart Association class and Kansas City Cardiomyopathy Questionnaire score were observed in both groups. |
| 520 ## - SUMMARY, ETC. |
|---|
| Abstract |
Trial Registration: ClinicalTrials.gov Identifier: NCT02202434. |
| 546 ## - LANGUAGE NOTE |
|---|
| Language note |
English |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name entry element |
*Aortic Valve Stenosis |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name entry element |
*Stroke |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name entry element |
*Thrombosis |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name entry element |
*Transcatheter Aortic Valve Replacement |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name entry element |
Aged, 80 and over |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name entry element |
Aortic Valve Stenosis/su [Surgery] |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name entry element |
Aortic Valve/su [Surgery] |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name entry element |
Female |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name entry element |
Humans |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name entry element |
Stroke/et [Etiology] |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name entry element |
Transcatheter Aortic Valve Replacement/ae [Adverse Effects] |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name entry element |
Transcatheter Aortic Valve Replacement/mt [Methods] |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name entry element |
Treatment Outcome |
| 651 ## - SUBJECT ADDED ENTRY--GEOGRAPHIC NAME |
|---|
| Institution |
MedStar Heart & Vascular Institute |
| 657 ## - INDEX TERM--FUNCTION |
|---|
| Medline publication type |
Journal Article |
| 657 ## - INDEX TERM--FUNCTION |
|---|
| Medline publication type |
Randomized Controlled Trial |
| 700 ## - ADDED ENTRY--PERSONAL NAME |
|---|
| Local Authors |
Waksman, Ron |
| Institution Code |
MHVI |
| 790 ## - Authors |
|---|
| All authors |
Allocco DJ, Bajwa T, Bjursten H, Buchbinder M, Gotberg M, Iyer VS, Kereiakes DJ, Kleiman NS, Linke A, Makkar RR, Mishkel GJ, Rajagopal V, Reardon MJ, Rizik DG, Stoler RC, Thourani VH, Waksman R |
| 856 ## - ELECTRONIC LOCATION AND ACCESS |
|---|
| DOI |
<a href="https://dx.doi.org/10.1001/jamanetworkopen.2022.38792">https://dx.doi.org/10.1001/jamanetworkopen.2022.38792</a> |
| Public note |
https://dx.doi.org/10.1001/jamanetworkopen.2022.38792 |
| 942 ## - ADDED ENTRY ELEMENTS (KOHA) |
|---|
| Koha item type |
Journal Article |
| Item type description |
Article |
