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)

Raj R. Makkar, Hasan Jilaihawi, Tarun Chakravarty, Gregory P. Fontana, Samir Kapadia, Vasilis Babaliaros, Wen Cheng, Vinod H. Thourani, Joseph Bavaria, Lars Svensson, Susheel Kodali, Takahiro Shiota, Robert Siegel, E. Murat Tuzcu, Ke Xu, Rebecca T. Hahn, Howard C. Herrmann, Mark Reisman, Brian Whisenant, Scott LimNirat Beohar, Michael Mack, Paul Teirstein, Charanjit Rihal, Pamela S. Douglas, Eugene Blackstone, Augusto Pichard, John G. Webb, Martin B. Leon

Research output: Contribution to journalArticle

85 Scopus citations

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).

Original languageEnglish (US)
Pages (from-to)418-430
Number of pages13
JournalJournal of the American College of Cardiology
Volume62
Issue number5
DOIs
StatePublished - Jul 30 2013

Keywords

  • TAVI
  • TAVR
  • TVE
  • embolization
  • outcomes
  • transcatheter valve
  • valve-in-valve

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Fingerprint Dive into the research topics of '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)'. Together they form a unique fingerprint.

  • Cite this

    Makkar, R. R., Jilaihawi, H., Chakravarty, T., Fontana, G. P., Kapadia, S., Babaliaros, V., Cheng, W., Thourani, V. H., Bavaria, J., Svensson, L., Kodali, S., Shiota, T., Siegel, R., Tuzcu, E. M., Xu, K., Hahn, R. T., Herrmann, H. C., Reisman, M., Whisenant, B., ... Leon, M. B. (2013). 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). Journal of the American College of Cardiology, 62(5), 418-430. https://doi.org/10.1016/j.jacc.2013.04.037