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Evidence Based Medicine

The Need to Avoid Unnecessary Ventricular Stimulation. Evidence Based Medicine. ESC Guidelines. Guidelines for cardiac pacing and CRT therapy Published by task force for cardiac pacing and CRT of the ESC in collaboration with European Heart Rhythm Association

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Evidence Based Medicine

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  1. The Need to Avoid Unnecessary Ventricular Stimulation Evidence Based Medicine

  2. ESC Guidelines • Guidelines for cardiac pacing and CRT therapy • Published by task force for cardiac pacing and CRT of the ESC in collaboration with European Heart Rhythm Association • European Heart Journal (2007) 28, 2256-2295

  3. ESC Guidelines • For patients with Sinus Node Disease and AV block a DDDR pacemaker with options to minimize ventricular pacing is indicated • Class I, evidence level C indication • Class I: evidence and/or general agreement that a given treatment or procedure is beneficial, useful and effective • Level of evidence C: expert opinion and/or small studies, retrospective studies and registries • EVITA: Evaluation of VIp feaTure in pacemaker pAtients

  4. Adverse Effect of Ventricular Pacing On Heart Failure and Atrial Fibrillation Among Patients With Normal Baseline QRS Duration in a Clinical Trial of Pacemaker Therapy for Sinus Node Dysfunction MOde Selection Trial (MOST) Sweeney et al. Circulation, 2003; vol 107: 2932 - 2937

  5. Study the effect of Cumulative % of Ventricular Pacing in DDDR and VVIR mode on Heart Failure Hospitalization and AF in Sinus Node Disease Pts with QRS duration < 120 ms MOST Objectives

  6. 1339 pts DDDR 707 pts VVIR 632 pts MOSTRandomization, Characteristics • Pts with SND • QRSd < 120 ms • Median EF 55% • Mild or no CHF • > 50% history of A-tachycardia • PR interval < 200 ms or mildly prolonged • DDDR and VVIR: lower rate  60, upper rate  110 bpm • DDDR: AV delay between 120 – 200 ms • 90% Ventricular Pacing in DDDR: due to AV < PR • 58% Ventricular Pacing in VVIR

  7. MOSTResults

  8. MOSTDDDR Heart Failure Hospitalization  40% VP proportion event free > 40% VP months

  9. MOST DDDR 1st incidence of AF  40% VP proportion event free 40-70% VP 70-90% VP months

  10. MOST DDDR Results • Risk of Heart Failure Hospitalization (HFH) for VP > 40% is 2.6 times risk compared with VP < 40% • Early, sustained and increasing incidence of HFH for VP > 40% compared with VP < 40% • The risk of AF increased by 1% for each % increase in percentage VP (up to 85%) • Early, sustained and increasing incidence of AF with increasing percentage of VP

  11. Study Sponsor St. Jude Medical. The sponsor had no role in protocol, data collection/management, statistical analysis, manuscript (except review) Reference Wilkoff BL et al. JAMA, Dec 2002; vol 288: 3115 - 3123 DAVID TrialSponsor, Reference

  12. Study Objectives Compare dual chamber with back-up single chamber pacing in pts with standard ICD indication (LVEF < 40%, no pacing indication) Hypothesis DDD(R) 70 bpm is superior to VVI 40 bpm End points 1. time to death 2. time to 1st hospitalization for congestive heart failure David TrialObjectives, Hypothesis, End Points

  13. 506 pts VVI-40 256 pts DDDR-70 250 pts David TrialDesign, Randomization, Typical Result • Single blinded, parallel-group, randomized clinical trial • design • randomization • RV pacing 70% (no AV delay recommendation) • typical result • RV pacing 4 %

  14. 0.4 0.3 Cumulative Probability 0.2 0.1 0 0 6 12 18 Time, mo No at Risk DDDR VVI 250 256 159 158 76 90 21 25 DAVID TrialEndpoint: Death or 1st Hospitalization for New or Worsened CHF Relative Hazard (95% CI), 1.61 (1.06-2.44) DDDR -70bpm 26.7% VVI - 40bpm 16.1%

  15. In patients with: standard ICD indication no pacing indication LVEF  40% DDDR-70 (no AV delay recommendation) versus VVI-40 offers: no clinical advantage may be detrimental by increasing the combined endpoint of death or hospitalization for heart failure DAVID TrialConclusion

  16. DDDR-70 may be detrimental compared to VVI-40 Is this rate related (70  40 bpm): no DAVID II (late braking trial HRS 2007) no difference in endpoint comparing AAI 70 with VVI 40 Is % RV pacing important: yes DAVID Sub-Analysis Sharma et al. Heart Rhythm 2005; 2: 830-834 DAVID TrialClinical Implications

  17. Study Objectives Evaluate the effect of % RV apical pacing on endpoint Endpoint: death or CHF hospitalization Study design Pts: DAVID pts, with 3 months follow-up, that did not reach endpoint % RV pacing at 3 month follow-up was examined Remarks There was a clear separation between DDDR pts with shipped settings of paced / sensed AV delay (180 – 150 ms) and an increased AV delay David Sub-AnalysisObjectives, Hypothesis, Remarks

  18. 126 195 59 70 118 35 26 47 16 3 5 4 DAVID Sub-AnalysisEndpoint: Death or 1st Hospitalization for New or Worsened CHF • best separation for predicting endpoints was between DDDR > 40% and DDDR  40% pacing • DDDR < 40% RV pacing patients were similar or better than VVI patients No at Risk DDDR > 40% VVI unpaced DDDR  40%

  19. Study Sponsor Boston Scientific CRM Reference Olshansky B al. Circ, 2007; vol 115: 9-16 Intrinsic RV TrialSponsor, Reference

  20. Study Objectives Compare DDDR with algorithm to avoid ventricular pacing with back-up single chamber pacing in pts with ICD indication Hypothesis DDD(R) + AV delay algorithm is not inferior to VVI-40 bpm End points 1. all-cause mortality 2. hospitalization for onset or worsening of CHF Intrinsic RV TrialObjectives, Hypothesis, End Points

  21. Intrinsic RV TrialResults • DDDR with AVSH trends towards superiority compared to VVI P=0.072

  22. Intrinsic RV TrialSub - Analysis 14% 8% % of Patients with an Event (Death or HF Hospitalization) 3% Cumulative % RV pacing

  23. How Can We Avoid Unnecessary Ventricular Stimulation VIP Ventricular Intrinsic Preference

  24. VIPActive Safety

  25. VIPActive Safety • Monitors the heart’s intrinsic conduction • Avoids unnecessary pacing • Provides pacing when needed • Activates and deactivates beat-by-beat • AV extension dynamically self-adjusts

  26. VIPAdvanced Programmability

  27. VIPAdvanced Programmability VIP value • extension of paced / sensed AV-delay • Off - 200 ms, max paced / sensed AV delay 350 ms Search Interval • how often does the pm search for intrinsic rhythm • 30 sec, 1, 3, 5, 10 or 30 min Search Cycles • the amount of cycles the AV-delay extension remains in effect while searching for intrinsic conduction • 1, 2, 3

  28. VIPTo Activate VIP

  29. VIPAV Extension

  30. VIPSearch Interval

  31. VIPSearch Cycles

  32. VIPActivation - Deactivation

  33. VIPActivation Criteria • One R-wave is sensed during the Search Interval • 3 consecutive R-waves occur within programmed AV delay but outside the Search Interval • 30 seconds after programming

  34. VIPDeactivation Criteria VIP is deactivated when the consecutive number of VP events equals the number of programmed Search Cycles at the extended AV delay

  35. VIPversus no VIP

  36. long fixed AV delay (e.g. 320 ms) to prevent VP VIP induced AV delay extension to prevent VP too long (e.g. 320 ms) fixed AV delay change to optimized AV delay (e.g. 195 ms) No VIP VIP Example:patient with intermittent complete AV block AV conduction AV block

  37. VIPPatient selection

  38. VIPPatient Selection • VIP most beneficial • Intermittent AV block • Mild prolongation of AV conduction • VIP not beneficial • Complete permanent AV block • Marked 1st degree AV block • If CRT therapy is indicated

  39. VIPversus AAI  DDD algorithms

  40. VIPPatient Type: 1st Degree AV block • VIP provides immediate ventricular support at the appropriate AV delay, avoiding inappropriately long AV delay • AAI  DDD will continue in AAI mode with an inappropriately long AV delay until block occurs

  41. VIPPatient Type: Intermittent 2nd Degree AV block • VIP provides immediate ventricular support • VIP allows switch to extended AV delay (avoid VP) after 30 seconds • ______________________________________________________ • AAI  DDD will continue in AAI mode with a (too) long AV delay until block occurs • AAI  DDD allows for repeated ventricular pauses (can cause pause dependent VTs 1,2) • Grey C, et al. Inappropriate application of “Managed Ventricular Pacing” in a patient with Brugada syndrome leading to polymorphic VT and ICD shocks. Heart Rhythm 2006; 3(5): S137 • Van Mechelen R, et al. Risk of Managed Ventricular Pacing in a patient with heart block. Heart Rhythm 2006; 3(11): 1384-1385

  42. VIPPatient Type: High Grade 2nd Degree, Intermittent 3rd Degree AV Block • VIP provides immediate ventricular support at the first blocked ventricular event • AAI  DDD occurs only after block, creates long ventricular intervals (can cause pause dependent VTs 2) • AAI  DDD will not occur if ventricular escape rhythm during block is sufficiently fast: sustained AV dissociation • Van Mechelen R, et al. Risk of Managed Ventricular Pacing in a patient with heart block. Heart Rhythm 2006; 3(11): 1384-1385

  43. VIPclinical benefits

  44. VIPClinical Benefits • Less risk of heart failure progression 3,4 • Less risk of developing AF 5 • Better QoL trough improved hemodynamics 6 • Wilkoff BL, et al. DAVID investigators. Dual chamber pacing or ventricular back-up pacing in patients with an implantable ICD. JAMA 2002; 288(24): 3115 – 3123. • Olshansky B, et al. Is dual chamber programming inferior to single chamber programming in an ICD? Results of the INTRINSIC RV Study. Circulation 2007; 115: 9 – 16. • Sweeny MO , et al. Minimizing ventricular pacing to reduce AF in sinus node disease. N Engl J Med 2007; 357: 1000 - 1008 • Ovsyshcher E. Toward physiological pacing: optimization of cardiac hemodynamics by AV delay adjustment. PACE 1997; 20: 861 - 865

  45. VIPadditional information

  46. VIPAdditional Information • PVCs have no effect on the timing of the VIP algorithm • If paced AV delay = 350ms: VIP is off • If rate responsive paced / sensed AV delay is enabled and active, the VIP AV delay extension will be added to the shortened paced / sensed AV delay

  47. VIPDisabled When: • programmed base rate  110 bpm in DDD(R) or VDD(R) • paced / sensed atrial rate  110 bpm • Negative AV hysteresis / search is programmed On • Advanced Hysteresis Response is initiated • A magnet is applied

  48. VIPAnd AutoCapture • When AutoCapture is On the VIP parameter needs to be  100 ms (VIP + paced AV delay  350 ms) • VIP is cancelled during AutoCapture Threshold Search and Loss of Capture recovery

  49. There is a need to avoid unnecessary ventricular pacing VIP helps to avoid unnecessary ventricular pacing Advanced programmability: VIP, Search Intervals, Search Cycles Immediate ventricular support at the appropriate AV delay Provide necessary pacing with optimized AV delay To pace (with QuickOpt) or not to pace (with VIP) VIPSummary

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