Transcarotid Approach for Transcatheter Aortic Valve Replacement With the Sapien 3 Prosthesis: A Multicenter French Registry

JACC Cardiovasc Interv. 2019 Mar 11;12(5):413-419. doi: 10.1016/j.jcin.2018.11.014. Epub 2019 Feb 13.

Abstract

Objectives: This study sought to describe the procedural and clinical outcomes of patients undergoing transcarotid (TC) transcatheter aortic valve replacement (TAVR) with the Edwards Sapien 3 device.

Background: The TC approach for TAVR holds the potential to become the optimal alternative to the transfemoral gold standard. Limited data exist regarding safety and efficacy of TC-TAVR using the Edwards Sapien 3 device.

Methods: The French Transcarotid TAVR prospective multicenter registry included patients between 2014 and 2018. Consecutive patients treated in 1 of the 13 participating centers ineligible for transfemoral TAVR were screened for TC-TAVR. Clinical and echocardiographic data were prospectively collected. Perioperative and 30-day outcomes were reported according to the updated Valve Academic Research Consortium (VARC-2).

Results: A total of 314 patients were included with a median (interquartile range) age of 83 (78 to 88) years, 63% were males, Society of Thoracic Surgeons mortality risk score 5.8% (4% to 8.3%). Most patients presented with peripheral artery disease (64%). TC-TAVR was performed under general anesthesia in 91% of cases, mostly using the left carotid artery (73.6%) with a procedural success of 97%. Three annulus ruptures were reported, all resulting in patient death. At 30 days, rates of major bleeding, new permanent pacemaker, and stroke or transient ischemic attack were 4.1%, 16%, and 1.6%, respectively. The 30-day mortality was 3.2%.

Conclusions: TC-TAVR using the Edwards Sapien 3 device was safe and effective in this prospective multicenter registry. The TC approach might be considered, in selected patients, as the first-line alternative approach for TAVR whenever the transfemoral access is prohibited. Sapien 3 device was safe and effective in our multicenter cohort.

Keywords: Sapien 3; TAVR; transcarotid.

Publication types

  • Multicenter Study
  • Observational Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Aged, 80 and over
  • Aortic Valve / diagnostic imaging
  • Aortic Valve / physiopathology
  • Aortic Valve / surgery*
  • Aortic Valve Stenosis / diagnostic imaging
  • Aortic Valve Stenosis / mortality
  • Aortic Valve Stenosis / physiopathology
  • Aortic Valve Stenosis / surgery*
  • Carotid Arteries*
  • Catheterization, Peripheral* / adverse effects
  • Catheterization, Peripheral* / mortality
  • Female
  • France
  • Heart Valve Prosthesis*
  • Humans
  • Male
  • Postoperative Complications / mortality
  • Postoperative Complications / therapy
  • Prospective Studies
  • Prosthesis Design
  • Punctures
  • Registries
  • Risk Assessment
  • Risk Factors
  • Time Factors
  • Transcatheter Aortic Valve Replacement / adverse effects
  • Transcatheter Aortic Valve Replacement / instrumentation*
  • Transcatheter Aortic Valve Replacement / mortality
  • Treatment Outcome