Author + information
- Received March 4, 2013
- Revision received April 13, 2013
- Accepted April 30, 2013
- Published online July 30, 2013.
- Raj R. Makkar, MD∗∗ (, )
- Hasan Jilaihawi, MD∗,
- Tarun Chakravarty, MD∗,
- Gregory P. Fontana, MD†,
- Samir Kapadia, MD‡,
- Vasilis Babaliaros, MD§,
- Wen Cheng, MD∗,
- Vinod H. Thourani, MD§,
- Joseph Bavaria, MD⋮,
- Lars Svensson, MD‡,
- Susheel Kodali, MD¶,
- Takahiro Shiota, MD∗,
- Robert Siegel, MD∗,
- E. Murat Tuzcu, MD‡,
- Ke Xu, PhD¶,
- Rebecca T. Hahn, MD¶,
- Howard C. Herrmann, MD⋮,
- Mark Reisman, MD#,
- Brian Whisenant, MD∗∗,
- Scott Lim, MD††,
- Nirat Beohar, MD‡‡,
- Michael Mack, MD§§,
- Paul Teirstein, MD⋮⋮,
- Charanjit Rihal, MD, MBA¶¶,
- Pamela S. Douglas, MD##,
- Eugene Blackstone, MD‡,
- Augusto Pichard, MD∗∗∗,
- John G. Webb, MD††† and
- Martin B. Leon, MD¶
- ∗Cedars-Sinai Heart Institute, Los Angeles, California
- †Lenox Hill Heart and Vascular Institute, New York, New York
- ‡Cleveland Clinic, Cleveland, Ohio
- §Emory University, Atlanta, Georgia
- ⋮Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania
- ¶Columbia University Medical Center/NY Presbyterian Hospital, New York, New York
- #Swedish Medical Center, Seattle, Washington
- ∗∗Intermountain Medical Center, Salt Lake City, Utah
- ††University of Virginia Health System, Charlottesville, Virginia
- ‡‡Northwestern University Feinberg School of Medicine, Chicago, Illinois
- §§Baylor Healthcare System, Plano, Texas
- ⋮⋮Scripps Clinic and Scripps Translational Science Institute, La Jolla, California
- ¶¶Mayo Clinic, Rochester, Minnesota
- ##Duke Clinical Research Institute, Durham, North Carolina
- ∗∗∗Washington Hospital Center, Washington, DC
- †††St. Paul's Hospital, Vancouver, British Columbia, Canada
- ↵∗Reprint requests and correspondence:
Dr. Raj R. Makkar, Heart Institute, Cedars-Sinai Medical Center, Cardiovascular Intervention Center, 8631 West Third Street, #121-E, Los Angeles, California 90048.
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)
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.
- Received March 4, 2013.
- Revision received April 13, 2013.
- Accepted April 30, 2013.
- American College of Cardiology Foundation