@article{6d0f85102f494abaa372c4caedc52399,
title = "Determinants and outcomes of acute transcatheter valve-in-valve therapy or embolization: A study of multiple valve implants in the U.S. PARTNER trial (Placement of aortic transcatheter valve trial Edwards SAPIEN transcatheter heart valve)",
abstract = "Objectives This study investigated the determinants and outcomes of acute insertion of a second transcatheter prosthetic valve (TV) within the first (TV-in-TV) or transcatheter valve embolization (TVE) after transcatheter aortic valve replacement (TAVR). Background TAVR failure can occur with both TV-in-TV and TVE as a consequence of TAVR malpositioning. Only case reports and limited series pertaining to these complications have been reported to date. Methods Patients undergoing TAVR in the PARTNER (Placement of AoRTic TraNscathetER Valve Trial Edwards SAPIEN Transcatheter Heart Valve) randomized trial (cohorts A and B) and accompanying registries were studied. Data were dichotomized for those with and without TV-in-TV or TVE, respectively. Results From a total of 2,554 consecutive patients, 63 (2.47%) underwent TV-in-TV and 26 (1.01%) TVE. The indication for TV-in-TV was significant aortic regurgitation in most patients, often due not only to malpositioning but also to leaflet dysfunction. Despite similar aortic valve function on follow-up echoes, TV-in-TV was an independent predictor of 1-year cardiovascular mortality (hazard ratio [HR]: 1.86, 95% confidence interval [CI]: 1.03 to 3.38, p = 0.041), with a nonsignificant trend toward greater all-cause mortality (HR: 1.43, 95% CI: 0.88 to 2.33, p = 0.15). Technical and anatomical reasons accounted for most cases of TVE. A multivariable analysis found TVE to be an independent predictor of 1-year mortality (HR: 2.68, 95% CI: 1.34 to 5.36, p = 0.0055) but not cardiovascular mortality (HR: 1.30, 95% CI: 0.48 to 3.52, p = 0.60). Conclusions Acute TV-in-TV and TVE are serious sequelae of TAVR, often resulting in multiple valve implants. They carry an excess of mortality and are caused by anatomic and technical factors, which may be avoidable with judicious procedural planning. (THE PARTNER TRIAL: Placement of AoRTic TraNscathetER Valve Trial; NCT00530894).",
keywords = "TAVI, TAVR, TVE, embolization, outcomes, transcatheter valve, valve-in-valve",
author = "Makkar, {Raj R.} and Hasan Jilaihawi and Tarun Chakravarty and Fontana, {Gregory P.} and Samir Kapadia and Vasilis Babaliaros and Wen Cheng and Thourani, {Vinod H.} and Joseph Bavaria and Lars Svensson and Susheel Kodali and Takahiro Shiota and Robert Siegel and Tuzcu, {E. Murat} and Ke Xu and Hahn, {Rebecca T.} and Herrmann, {Howard C.} and Mark Reisman and Brian Whisenant and Scott Lim and Nirat Beohar and Michael Mack and Paul Teirstein and Charanjit Rihal and Douglas, {Pamela S.} and Eugene Blackstone and Augusto Pichard and Webb, {John G.} and Leon, {Martin B.}",
note = "Funding Information: Dr. Makkar is a consultant to Medtronic; a recipient of a research grant from Edwards Lifesciences ; and is a stockholder of Entourage Medical. Dr. Jilaihawi consults with Edwards Lifesciences, St. Jude Medical, and Venus Medtech. Dr. Fontana is a national principal investigator, member of the scientific advisory board, and consultant to St. Jude Medical; a site principal investigator for Medtronic; a site principal investigator and member of Speakers' Bureau for Sorin; and holds equity in and is a consultant to Entourage Medical. Dr. Babaliaros has received consulting fees/honoraria from DirectFlow and St. Jude Medical. Dr. Thourani has received consulting fees/honoraria from Edwards Lifesciences, Sorin Medical, St. Jude Medical, and DirectFlow. Dr. Bavaria is a site principal investigator in the PARTNER trial. Dr. Svensson has received travel reimbursements from Edwards Lifesciences related to work as an unpaid member of the PARTNER Executive Committee. Dr. Kodali has received consulting/honoraria fees from Edwards Lifesciences and Medtronic; and is a member of the Scientific Advisory Board of Thubrikar Aortic Valve, Inc., the Medical Advisory Board of Paieon Medical, and the TAVI Advisory Board of St. Jude Medical. Dr. Tuzcu has received travel reimbursements from Edwards Lifesciences related to work as an unpaid member of the PARTNER Executive Committee. Dr. Herrmann has received consulting fees/honoraria from St. Jude Medical and Paieon; and holds equity in Microinterventional Devices. Dr. Reisman is a consultant for Boston Scientific. Dr. Whisenant has received consulting fees/honoraria from Edwards, Boston Scientific, and Medtronic; holds principal ownership/partnership positions with Coherex Medical; and has received a research grant from Gore Medical . Dr. Lim has received consulting fees/honoraria from Boston Scientific, Guerbet, and St. Jude Medical. Dr. Teirstein has received consulting fees/honoraria from Abbott Vascular, Boston Scientific, and Medtronic; and holds equity in Shepherd Sciences. Dr. Rihal is a site principal investigator for the PARTNER trial. Dr. Blackstone has received travel reimbursements from Edwards Lifesciences related to work as an unpaid member of the PARTNER Executive Committee. Dr. Pichard has received consulting fees/honoraria from Edwards Lifesciences. Dr. Webb has received consulting fees/honoraria from Edwards Lifesciences. Dr. Leon has received travel reimbursements from Edwards Lifesciences related to work as an unpaid member of the PARTNER Executive Committee. ",
year = "2013",
month = jul,
day = "30",
doi = "10.1016/j.jacc.2013.04.037",
language = "English (US)",
volume = "62",
pages = "418--430",
journal = "Journal of the American College of Cardiology",
issn = "0735-1097",
publisher = "Elsevier USA",
number = "5",
}