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)

J Am Coll Cardiol. 2013 Jul 30;62(5):418-30. doi: 10.1016/j.jacc.2013.04.037. Epub 2013 May 15.


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.

Trial registration: NCT00530894.

Keywords: AR; AT; BSA; CABG; CT; LV; TAVI; TAVR; TEE; THV; TIA; TV; TV-in-TV; TVE; V-in-V; aortic regurgitation; as-treated; body surface area; computed tomography; coronary artery bypass; embolization; left ventricular; outcomes; transcatheter aortic valve implantation; transcatheter aortic valve replacement; transcatheter heart valve; transcatheter prosthetic valve; transcatheter prosthetic valve within a transcatheter prosthetic valve; transcatheter valve; transcatheter valve embolization; transcatheter valve-in-surgical valve; transesophageal echocardiograms; transient ischemic attack; valve-in-valve.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Aged, 80 and over
  • Aortic Valve / diagnostic imaging
  • Aortic Valve / surgery*
  • Aortic Valve Insufficiency / surgery
  • Balloon Occlusion*
  • Cardiac Catheterization*
  • Cardiovascular Diseases / mortality
  • Female
  • Heart Valve Prosthesis Implantation / methods*
  • Heart Valve Prosthesis Implantation / mortality
  • Heart Valve Prosthesis*
  • Hemorrhage / epidemiology
  • Humans
  • Ischemic Attack, Transient / epidemiology
  • Male
  • Multivariate Analysis
  • Operative Time
  • Outcome Assessment, Health Care
  • Patient Readmission / statistics & numerical data
  • Radiography
  • Sex Distribution
  • Stroke / mortality
  • Ultrasonography

Associated data