CONFIENT Introduction

Transcription

1 CONFIENT Introduction January 10, 2008 Not available for sale in the U.S. CAUTION: Investigational Device. Limited by Federal Law to investigational use.

2 Disclaimer This material describes products in development that will receive approvals or clearances by the FDA prior to market release. Some of the content in this presentation with regards to labeling and claims are subject to change pending FDA approval.

3 CONFIENT tells the RV Pacing story Incremental capabilities available with the CONFIENT device system RF capability RV Pacing % Alert Atrial Burden Alert AVSH and Dynamic AV Delay to 400 ms QHR Battery BSC Branding

4 What is the programmability of CONFIENT s AV Delay? 400 ms AV Delays can be achieved through use of: Dynamic AV Delay Longest Maximum AV Delay 400ms AV Search Hysteresis Increasing AVS % can extend search window out to 400ms Programmable values: Fixed AV Delay: ms Dynamic AV Delay Minimum: ms Maximum: ms* AV Search Hysteresis Search Interval: cycles AV Increase: % (to a maximum of 400ms)* * New capability

5 What a 400 ms AV Delay means for the patient The Benefit More time after an atrial event for intrinsic ventricular conduction to occur Designed to reduce unnecessary RV pacing while maintaining AV synchrony The Challenge Increased chance of programming parameter interactions Increased risk of VT underdetection

6 Timing Cycles As Vp As Vp As Vp AV PVARP AV PVARP AV PVARP TARP TARP TARP In this example, the P-waves are sensed and tracked resulting in 1-to-1 pacing in the ventricle MAX TRACKING RATE MAX TRACKING RATE MAX TRACKING RATE Using the programmed AV Delay and PVARP, the 2:1 Block Point will be 120 ppm this is the fastest that we can program the Maximum Tracking Rate PVARP = Post Ventricular Atrial Refractory Period 250 ms AV = AV Delay 250 ms TARP = AV Delay + PVARP 2:1 Block Point = 60,000 / TARP 250 ms ms = 500 ms 60,000 / 500 = 120 ppm

7 Timing Cycles Programming Solutions Extending the AV Delay to 400 ms changes the 2:1 Block Point to 92 ppm this is the fastest that we can now program the Maximum Tracking Rate PVARP = Post Ventricular Atrial Refractory Period 250 ms AV = AV Delay 400 ms TARP = AV Delay + PVARP 2:1 Block Rate = 60,000 / TARP 400 ms ms = 650 ms 60,000 / 650 = 92 ppm To increase the MTR from 92 ppm to 120 ppm (for example): 1. Change programming from Fixed PVARP to Dynamic PVARP 2. Change programming from Fixed AV Delay to Dynamic AV Delay Dynamic AV Delay = 400 ms Max and 290 ms Min Dynamic PVARP = 250 ms Max and 210 ms Min TARP = Min AV Delay + Min PVARP = 290 ms ms = 500 ms MTR can now accept programming up to 120 bpm again!! Minimum values used to calculate TARP

8 3 Conditions for VT Underdetection to occur 1. Dual chamber pacing mode DDx(R) 2. Patient is atrial pacing at a rate above the LRL (i.e. Rate Smoothing or Sensor Driven) at the time a stable VT occurs 3. Programming such that: Tachy rate threshold (ms) > MTR / MSR (ms) - AV Delay (ms) Will produce a YELLOW warning screen on the programmer when true Sensor Driven Rate AP AV Delay AP V-blank VRP V-blank VT (VT) VP (VT) (VT) VT

9 VT Under-detection warning

10 Key Takeaways for 400ms AV Delay 400ms AV Delays offer increased programmability for our customers and patients. With these advantages come programming and programmer interaction challenges. Timing cycle rules govern the interaction between MTR, AV Delay, and PVARP Conditions that work together to cause VT Underdetection: 1. DDx(R) pacing mode, AND 2. VT (ms) > Pacing rate (ms) AV delay, AND 3. Stable VT occurs while atrial pacing General tips and takeaways: 1. Consider using Dynamic AV Delay since the Minimum AV Delay value is used to calculate these interactions 2. Consider using Dynamic PVARP since, like Dynamic AV Delay, the Minimum PVARP is used in the interaction calculations Interactions on the programmer are all about trade-offs: increasing / decreasing a parameter value (AV Delays) will affect other parameters

11 Thank you!