Transfemoral valve-in-valve implantation for degenerated bioprosthetic aortic valves using the new balloon-expandable Edwards Sapien 3 valve

Catheter Cardiovasc Interv. 2016 Oct;88(4):636-643. doi: 10.1002/ccd.26565. Epub 2016 May 3.

Abstract

Background: Surgical aortic bioprosthetic valves deteriorate 10 to 20 years after operation. Valve-in-valve implantation with first generation transcatheter aortic valve implantation (TAVI) devices has shown to be feasible. We report a first case series with the new Edwards Sapien 3 valve for transfemoral aortic valve-in-valve implantation.

Methods and results: Nine patients underwent valve-in-valve-TAVI with the Edward Sapien 3 valve. Seven patients presented with severe aortic stenosis and two patients with severe aortic insufficiency of surgical aortic bioprosthesis. Procedures were performed in local anaesthesia under fluoroscopic guidance with pre-procedural 256 multislice computed tomography for procedural planning. In all patients the Edwards Sapien 3 was successfully implanted decreasing the mean echocardiographic gradient from 42 ± 22mmHg to 18 ± 7mmHg (p < 0.01). Device success according to VARC 2 criteria was achieved in 8 out of 9 patients. There was no death, coronary obstruction, use of second valve or need for post-dilation. Furthermore there were no access-site complications, no minor or major bleedings or vascular injury. Two patients required pacemaker implantation within the first 7 days after valve-in-valve TAVI. Post-procedural echocardiography demonstrated no or trace aortic regurgitation. Early safety events within 30 days according to VARC-2 definition occurred in 1 patient.

Conclusions: The Edwards Sapien 3 valve for treatment of failed surgical bioprostheses is feasible and is associated with no relevant post-procedural aortic regurgitation and a low risk of access site complications. © 2016 Wiley Periodicals, Inc.

Keywords: aortic stenosis; paravalvular insufficiency; transcatheter aortic valve implantation.

MeSH terms

  • Aged
  • Aged, 80 and over
  • Aortic Valve / diagnostic imaging
  • Aortic Valve / physiopathology
  • Aortic Valve / surgery*
  • Aortic Valve Insufficiency / diagnostic imaging
  • Aortic Valve Insufficiency / etiology
  • Aortic Valve Insufficiency / physiopathology
  • Aortic Valve Insufficiency / therapy*
  • Aortic Valve Stenosis / diagnostic imaging
  • Aortic Valve Stenosis / etiology
  • Aortic Valve Stenosis / physiopathology
  • Aortic Valve Stenosis / therapy*
  • Aortography
  • Balloon Valvuloplasty
  • Bioprosthesis*
  • Cardiac Catheterization / instrumentation*
  • Cardiac Catheterization / methods
  • Catheterization, Peripheral*
  • Female
  • Femoral Artery* / diagnostic imaging
  • Heart Valve Prosthesis Implantation / adverse effects
  • Heart Valve Prosthesis Implantation / instrumentation*
  • Heart Valve Prosthesis Implantation / methods
  • Heart Valve Prosthesis*
  • Hemodynamics
  • Humans
  • Male
  • Middle Aged
  • Prosthesis Design
  • Prosthesis Failure
  • Punctures
  • Time Factors
  • Treatment Outcome