心臟起搏器培訓資料：G EEnhancing Patient Safety

1、. . . . . . . . . . . . . . . . . . . Enhancing Patient Safety Vitatron series G86 (suppl):104K-110K . . . . . . . . . . . . . . . . . . . Benefits of automaticity Enhances patient safety Simplifies pacemaker programming and follow-up Device surveillance More rapid adjustments in device performance,

2、 no longer dependent on scheduled office visits Increases quality of life Extends battery life Marck Schoenfeld, Toby Markowitz. Device Follo-up in the Age of Automacity. PACE 2000; Vol 23. 803-806 . . . . . . . . . . . . . . . . . . . Enhancing Patient Safety Implant Detection . . . . . . . . . . .

3、 . . . . . . . . Safety at implant Clinical Rationale At implant we need to Avoid mistakes Be fast, save time The feature “Implant Detect” helps the TC, supporting an IPG implant . . . . . . . . . . . . . . . . . . . Implant Detection 30-minute period, beginning at lead connection Automatic configur

4、ation of polarity of connected leads At the end of 30 min, automatic features are activated . . . . . . . . . . . . . . . . . . . Pacemaker measures the Lead Impedance with every delivered pace pulse The IPG can “detect” that it has been implanted, by a change of pace impedance, and automatically st

5、arts setting itself up This is called Implant Detection Safety at Implant . . . . . . . . . . . . . . . . . . . Implant Detection Automatic configuration of polarity of connected leads Post implant period for confirmation of lead stability Start at lead connect DDD Mode Duration: 30 minutes Complete

6、d by activating of automatic features . . . . . . . . . . . . . . . . . . . Implant Detect Pre implant In box Stimulation, both in bipolar and unipolar configuration Stimulation Impedance 4 KW No lead connected During implant stimulation Impedance 4 KW lead connected Start of configuration of the po

7、larities . . . . . . . . . . . . . . . . . . . Implant Detect Configuration Sequence of polarity 05 min30 minTime Connection Of Leads Verification of Bipolar Lead Final Verification of Bipolar Lead Confirmation Bipolar lead Phase 1Phase 2 Configuration of polarity . . . . . . . . . . . . . . . . . .

8、 . Unipolar Backup Bi-polar Impedance 4 KW - no need for unipolar backup. Bipolar Impedance 4 KW Unipolar Backup Pacing U N I U N I B I B I 122 us 122 us Bipolar Unipolar . . . . . . . . . . . . . . . . . . . End of Phase 1 (5minutes) Pacemaker delivers 3 test paces at asynchronous magnet rate. If B

9、ipolar impedance is 4 kOhm Unipolar When this happens 2 of 3 times: pacemakers will remain operating in unipolar mode If Bipolar impedance is between 200 and 4000 Ohm When this happens 2 of 3 times: pacemakers will remain operating in bipolar mode Phase 2 starts . . . . . . . . . . . . . . . . . . .

10、 End of Phase 2 (25 minutes) If phase 1 concluded Unipolar: Continuous unipolar pacing If phase 1 concluded Bipolar: During 25 minutes (Phase 2): If 8 of 16 paces are out of range: change into Unipolar After 25 minutes: reconfirmation Pacemaker delivers 3 test paces at asynchronous magnet rate. When

11、 2 of 3 paces are determined as Bipolar: operating is set to Bipolar (or adaptive, depending on programming) When 2 of 3 paces are determined as Unipolar: operating is set to Unipolar End of implant detect and activation of automatic features . . . . . . . . . . . . . . . . . . . Implant Detection A

12、utomatic features activated after 30 min Adaptive sensitivity settings (Sensing Assurance) Rate Responsive Pacing, including adaptive rate profile optimization Adaptive Pacing Output settings for threshold management (Output Management) Diagnostic data collection . . . . . . . . . . . . . . . . . .

13、. Implant Detection . . . . . . . . . . . . . . . . . . . Enhancing Patient Safety Sensing Thresholds . . . . . . . . . . . . . . . . . . . Amplitude of P- and R-waves are not stable, but vary with: Lead maturation Myocardial infarction Anti-arrhythmia medications 1 Arrhythmias Exercise Sensing Thre

14、sholds Clinical Rationale 1 1. Castro A. Liebold A, Vincente J, et al. Evaluation of autosensing as an automatic means of maintaining a 2:1 sensing safety margin in an implanted pacemaker. Autosensing Investigation Team. PACE. 1996;19(pt. II):1708-1713. 2. Frohlig G, Schwerdt H, Schieffer H, et al.

15、Atrial signal variations and pacemaker malsensing during exercise: a study in the time and frequency domain. J Am Coll Cardiol. 1988;11:806-813. . . . . . . . . . . . . . . . . . . . Programming sensitivity with a safety margin based on P- and R wave measurement while in sinus rhythm may not be adeq

16、uate for sensing during tachycardia3 100% safety margin based on a single P-wave measurement provided reliable atrial sensing in only 72% of the patients with a Dual Chamber device4 Sensing Thresholds Clinical Rationale 2 3. Wood MA, Moskovljevic P, Stambler BS, et al. Comparison of bipolar atrial e

17、lectrogram amplitude in sinus rhythm, atrial fibrillation, and atrial flutter. PACE. 1996;19:150-156. 4. Boute W, Albers BA, Giele V. Avoiding atrial undersensing by assessment of P wave amplitude histogram data. PACE. 1994;17(pt. II):1878-1882. . . . . . . . . . . . . . . . . . . . Sensing Threshol

18、ds Clinical Rationale 3 The result of inappropriate sensing can be: Unreliable pace timing Unreliable MS Unreliable diagnostic data collection Accurate arrhythmia detection is necessary to help guide therapy decisions . . . . . . . . . . . . . . . . . . . Ensuring Appropriate Sensing Devices solutio

19、n Sensing Assurance Measures every intrinsic P- and R-wave Adapts Sensitivity based on target safety margins Reduces the chance for undersensing atrial and ventricular tachyarrhythmias Nominally programmed On . . . . . . . . . . . . . . . . . . . “Adequate” “High” “Low” 2.8 mV Sensing Assurance Func

20、tion Programmed Sensitivity (Current) 8.0 mV 11.2 mV 2.8 x Sensitivity 4 x Sensitivity example for R wave -sensing . . . . . . . . . . . . . . . . . . . Chamber and Sensing Polarity Safety Margin Maintained Atrial Bipolar4.0 5.6 times the programmed value Atrial Unipolar or Ventricular Unipolar or Ventricular Bipolar 2.8 4.0 times the programmed valu