Transcatheter Valve-In-Valve Implantation With the Edwards SAPIEN in Patients With Bioprosthetic Heart Valve Failure: The Milan Experience

EuroIntervention. 2012 Mar;7(11):1275-84. doi: 10.4244/EIJV7I11A202.


Aims: Reoperation for bioprosthetic heart valve failure is associated with significant morbidity and mortality, particularly in high-risk patients. Transcatheter valve-in-valve (VIV) implantation may offer a less invasive alternative. The aim of this study was to report our initial experience with transcatheter VIV implantation to treat degenerated tissue valves.

Methods and results: VIV implantation with the Edwards SAPIEN transcatheter heart valve (THV; Edwards Lifesciences Inc, Irvine, CA, USA) was performed in 18 high-risk patients (STS 8.2±5.2%; logistic EuroSCORE 37.4±20.8%) with symptomatic bioprosthetic failure (17 aortic, one mitral). Valve Academic Research Consortium (VARC) definitions were applied for endpoint adjudication. Transfemoral access was the preferred vascular approach (16 patients, with the mitral VIV delivered anterogradely through the femoral vein; one transaxillary and one transapical). The majority (83%) of procedures were performed under local anaesthesia and sedation. Device success was achieved in all but one patient who had a final transaortic gradient ≥20mmHg. Acute kidney injury occurred in three patients (Stage 3 in 1), life-threatening or major bleeding in four patients, while major vascular complications occurred in one patient. Permanent pacemaker implantation was required in two patients. There were no deaths or neurological events at 30-day follow-up. At a median follow-up of 11 months (interquartile range 6-16), the mortality rate was 5.6% and all patients were in NYHA class II or lower.

Conclusions: Transcatheter implantation of the Edwards THV within a degenerated aortic bioprosthesis, performed predominantly via the transfemoral route, is feasible and associated with good periprocedural and clinical outcomes in high-risk surgical patients.

Publication types

  • Clinical Trial

MeSH terms

  • Aged
  • Aortic Valve Insufficiency / mortality
  • Aortic Valve Insufficiency / surgery*
  • Aortic Valve Stenosis / mortality
  • Aortic Valve Stenosis / surgery*
  • Bioprosthesis
  • Cardiac Catheterization
  • Female
  • Femoral Vein
  • Follow-Up Studies
  • Heart Valve Prosthesis Implantation / instrumentation*
  • Heart Valve Prosthesis Implantation / methods*
  • Heart Valve Prosthesis*
  • Humans
  • Male
  • Middle Aged
  • Postoperative Complications / mortality
  • Prosthesis Failure*
  • Reoperation
  • Risk Factors