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Evidence Based Medicine The Need to Avoid Unnecessary Ventricular Stimulation for internal use only 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 for internal use only 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 for internal use only MOde Selection Trial (MOST) 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 Sweeney et al. Circulation, 2003; vol 107: 2932 - 2937 for internal use only MOST Objectives 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 for internal use only MOST Randomization, Characteristics • Pts with SND 1339 pts • QRSd < 120 ms • Median EF 55% • Mild or no CHF DDDR 707 pts VVIR 632 pts • > 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 for internal use only MOST Results for internal use only MOST DDDR Heart Failure Hospitalization proportion event free 40% VP > 40% VP months for internal use only proportion event free MOST DDDR 1st incidence of AF 40% VP 40-70% VP 70-90% VP months for internal use only 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 for internal use only DAVID Trial Sponsor, Reference 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 for internal use only David Trial Objectives, Hypothesis, End Points 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 for internal use only David Trial Design, Randomization, Typical Result design Single blinded, parallel-group, randomized clinical trial 506 pts randomization VVI-40 256 pts typical result for internal use only RV pacing 4 % DDDR-70 250 pts RV pacing 70% (no AV delay recommendation) DAVID Trial Endpoint: Death or 1st Hospitalization for New or Worsened CHF Cumulative Probability Relative Hazard (95% CI), 1.61 (1.06-2.44) 0.4 DDDR -70bpm 0.3 26.7% 0.2 16.1% VVI - 40bpm 0.1 0 No at Risk DDDR VVI for internal use only 0 6 250 256 159 158 Time, mo 12 18 76 90 21 25 DAVID Trial Conclusion 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 for internal use only DAVID Trial Clinical Implications 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 for internal use only David Sub-Analysis Objectives, Hypothesis, Remarks 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 for internal use only DAVID Sub-Analysis Endpoint: 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 126 195 59 for internal use only 70 118 35 26 47 16 3 5 4 DDDR > 40% VVI unpaced DDDR 40% Intrinsic RV Trial Sponsor, Reference Study Sponsor Boston Scientific CRM Reference Olshansky B al. Circ, 2007; vol 115: 9-16 for internal use only Intrinsic RV Trial Objectives, Hypothesis, End Points Study Objectives Compare DDDR with algorithm to avoid ventricular pacing with backup 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 for internal use only Intrinsic RV Trial Results DDDR with AVSH trends towards superiority compared to VVI P=0.072 for internal use only Intrinsic RV Trial (Death or HF Hospitalization) % of Patients with an Event Sub - Analysis 14% 8% 3% Cumulative % RV pacing for internal use only How Can We Avoid Unnecessary Ventricular Stimulation VIP for internal use only Ventricular Intrinsic Preference VIP Active Safety for internal use only VIP Active 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 for internal use only VIP Advanced Programmability for internal use only VIP Advanced 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 for internal use only VIP To Activate VIP for internal use only VIP AV Extension for internal use only VIP Search Interval for internal use only VIP Search Cycles for internal use only VIP Activation - Deactivation for internal use only VIP Activation 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 for internal use only VIP Deactivation Criteria VIP is deactivated when the consecutive number of VP events equals the number of programmed Search Cycles at the extended AV delay for internal use only VIP versus no VIP for internal use only Example: patient with intermittent complete AV block No VIP long fixed AV delay (e.g. 320 ms) to prevent VP VIP VIP induced AV delay extension to prevent VP AV conduction too long (e.g. 320 ms) fixed AV delay AV block for internal use only change to optimized AV delay (e.g. 195 ms) VIP Patient selection for internal use only VIP Patient 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 for internal use only VIP versus AAI DDD algorithms for internal use only VIP Patient 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 for internal use only VIP Patient 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) 1. 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 2. Van Mechelen R, et al. Risk of Managed Ventricular Pacing in a patient with heart block. Heart Rhythm 2006; 3(11): 1384-1385 for internal use only VIP Patient 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 2. Van Mechelen R, et al. Risk of Managed Ventricular Pacing in a patient with heart block. Heart Rhythm 2006; 3(11): 1384-1385 for internal use only VIP clinical benefits for internal use only VIP Clinical Benefits • Less risk of heart failure progression 3,4 • Less risk of developing AF 5 • Better QoL trough improved hemodynamics 6 3. 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. 4. 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. 5. Sweeny MO , et al. Minimizing ventricular pacing to reduce AF in sinus node disease. N Engl J Med 2007; 357: 1000 - 1008 6. Ovsyshcher E. Toward physiological pacing: optimization of cardiac hemodynamics by AV delay adjustment. PACE 1997; 20: 861 - 865 for internal use only VIP additional information for internal use only VIP Additional 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 for internal use only VIP Disabled 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 for internal use only VIP And 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 for internal use only VIP Summary • 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) for internal use only VIP to avoid unnecessary ventricular stimulation for internal use only for internal use only