Left atrial appendage clip occlusion: early clinical results

J Thorac Cardiovasc Surg. 2010 May;139(5):1269-74. doi: 10.1016/j.jtcvs.2009.06.033. Epub 2009 Nov 1.

Abstract

Objective: Atrial fibrillation puts patients at significant risk for embolic stroke originating from the left atrial appendage. Few means are available for safe, effective, and durable left atrial appendage occlusion. A new clip device was evaluated with regard to safety and effectiveness for epicardial left atrial appendage occlusion.

Methods: Patients with atrial fibrillation undergoing elective cardiac surgery through a median sternotomy were enrolled for concomitant epicardial clip placement. Early postoperative and 3-month follow-up computed tomography studies were used to assess clip stability and left atrial appendage perfusion.

Results: From September 2007 to December 2008, 34 patients underwent successful clip placement. No device-related complications occurred. Operative mortality was 8.8% and not study or device related. Deployment was rapid, and left atrial appendage occlusion was confirmed by intraoperative transesophageal echocardiography in all patients. In addition to excellent clinical outcomes (no stroke/transient ischemic attack), serial computed tomography demonstrated stable clip location and appendage perfusion at 3 months in all patients.

Conclusion: Safe, effective, and durable left atrial appendage occlusion can easily be achieved with this new clip. Further trials are necessary to evaluate the role of the left atrial appendage occlusion in stroke prevention.

Trial registration: ClinicalTrials.gov NCT00567515.

Publication types

  • Clinical Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Aged, 80 and over
  • Atrial Appendage / diagnostic imaging
  • Atrial Appendage / surgery*
  • Atrial Fibrillation / complications
  • Atrial Fibrillation / diagnosis
  • Atrial Fibrillation / mortality
  • Atrial Fibrillation / surgery*
  • Cardiac Surgical Procedures / adverse effects
  • Cardiac Surgical Procedures / instrumentation*
  • Cardiac Surgical Procedures / mortality
  • Echocardiography, Transesophageal
  • Embolism / etiology
  • Embolism / prevention & control*
  • Equipment Design
  • Female
  • Humans
  • Male
  • Middle Aged
  • Pilot Projects
  • Risk Assessment
  • Risk Factors
  • Sternotomy
  • Stroke / etiology
  • Stroke / prevention & control*
  • Surgical Instruments*
  • Time Factors
  • Tomography, X-Ray Computed
  • Treatment Outcome

Associated data

  • ClinicalTrials.gov/NCT00567515