Medtronic
 
 

Heart Failure

CRT Procedure- and Device-Related Risks

The accompanying graphs show CRT procedure- and device-related risks using combined data from Medtronic's MIRACLE, MIRACLE ICD and InSync III/Attain OTW 4193 trials, and Guidant's Contak CD trial. Each clinical trial utilized a clinical events review committee to evaluate complications, including defined procedure-related mortality.

chart #1

*Not available in the U.S.

chart #2

The above graphs demonstrate that:

  • Mostly due to challenging coronary venous anatomy, implants have been unsuccessful in about 10% of cases.
  • Complication rates by category appeared to be reduced with the Medtronic Attain 4193 over-the-wire (OTW) lead that was primarily used in the InSync III trial.
  • Coronary sinus dissection or perforation generally resolved without further complication.
  • Left ventricular lead complications (primarily dislodgement), occurred in 9% of all cases (4% in the InSync III study).
  • There is a learning curve. Implant times decrease with increased center-based experience.2

For CRT mortality comparison, the 30-day mortality in the CABG-PATCH and AVID trials was 5.4% and 2.4%, respectively.

References
  1. Greenberg, et al. PACE 2003;26 (4p2): 952 (Abstract 93).
  2. Leon A, Abraham W, Curtis A, et. al. Safety of Transvenous Cardiac Resynchronization System Implantation in Patients with Chronic Heart Failure: Combined Results of Over Two Thousand Patients From a Multicenter Study Program. (Manuscript accepted for publication; in press).

Additional Information