for internal use only evidence based medicine the need to avoid unnecessary ventricular stimulation
TRANSCRIPT
for internal use only
Evidence Based Medicine
The Need to AvoidThe Need to AvoidUnnecessaryUnnecessary
Ventricular StimulationVentricular Stimulation
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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
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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
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MOde Selection Trial (MOST)
Adverse Effect of Ventricular PacingOn
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
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MOST ObjectivesObjectives
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
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MOST Randomization, CharacteristicsRandomization, Characteristics
1339 pts
DDDR707 pts
VVIR632 pts
•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
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MOST ResultsResults
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MOST DDDR Heart Failure DDDR Heart Failure HospitalizationHospitalization
40% VP
> 40% VP
months
pro
po
rtio
n e
ven
t fr
ee
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MOST DDDR 1DDDR 1stst incidence of AF incidence of AF
40% VP
40-70% VP
months
pro
po
rtio
n e
ven
t fr
ee
70-90% VP
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MOST DDDR ResultsDDDR 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
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DAVID TrialSponsor, ReferenceSponsor, 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
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David TrialObjectives, Hypothesis, End PointsObjectives, Hypothesis, End Points
Study ObjectivesCompare dual chamber with back-up single chamber pacing in pts with standard ICD indication (LVEF < 40%, no pacing indication)
HypothesisDDD(R) 70 bpm is superior to VVI 40 bpm
End points1. time to death2. time to 1st hospitalization for congestive heart
failure
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David TrialDesign, Randomization, Typical Design, Randomization, Typical ResultResult
design
RV pacing 70% (no AV delay recommendation)
Single blinded, parallel-group, randomized clinical trial
randomization
typical result
RV pacing 4 %
506 pts
VVI-40256 pts
DDDR-70250 pts
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Relative Hazard (95% CI), 1.61 (1.06-2.44)
VVI - 40bpm
250256
159158
7690
2125
No at RiskDDDR
VVI
0 6 12 18Time, mo
Cu
mu
lati
ve P
rob
ab
ility 0.4
0.3
0.2
0.1
0
DAVID TrialEndpoint: Death or 1st Hospitalization for New or Worsened CHF
DDDR -70bpm
26.7%
16.1%
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DAVID TrialConclusionConclusion
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
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DAVID TrialClinical ImplicationsClinical 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
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David Sub-AnalysisObjectives, Hypothesis, RemarksObjectives, 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
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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
12619559
7011835
264716
354
No at RiskDDDR > 40%VVI unpacedDDDR 40%
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Intrinsic RV TrialSponsor, ReferenceSponsor, Reference
Study Sponsor
Boston Scientific CRM
Reference
Olshansky B al. Circ, 2007; vol 115: 9-16
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Intrinsic RV Trial Objectives, Hypothesis, End PointsObjectives, Hypothesis, End Points
Study ObjectivesCompare DDDR with algorithm to avoid ventricular pacing with back-up single chamber pacing in pts with ICD indication
HypothesisDDD(R) + AV delay algorithm is not inferior to VVI-40 bpm
End points1. all-cause mortality
2. hospitalization for onset or worsening of CHF
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Intrinsic RV Trial ResultsResults
P=0.072
DDDR with AVSH trends towards superiority compared to VVI
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Intrinsic RV TrialSub - AnalysisSub - Analysis
% o
f P
ati
en
ts w
ith
an
Even
t
(Death
or
HF
Hosp
italiza
tion
)
Cumulative % RV pacing
8%
3%
14%
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How Can We AvoidHow Can We AvoidUnnecessaryUnnecessary
Ventricular StimulationVentricular Stimulation
VIP Ventricular Intrinsic Preference
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VIP
Active SafetyActive Safety
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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
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VIP
Advanced ProgrammabilityAdvanced Programmability
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VIPAdvanced ProgrammabilityAdvanced Programmability
VIP valueextension of paced / sensed AV-delayOff - 200 ms, max paced / sensed AV delay 350 ms
Search Intervalhow 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
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VIPTo Activate VIPTo Activate VIP
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VIPAV ExtensionAV Extension
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VIPSearch IntervalSearch Interval
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VIPSearch CyclesSearch Cycles
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VIP
Activation - DeactivationActivation - Deactivation
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VIPActivation CriteriaActivation 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
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VIPDeactivation CriteriaDeactivation Criteria
VIP is deactivated when the consecutive number of VP events equals the number of programmed Search Cycles at the extended AV delay
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VIP
versus no VIPversus no VIP
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Example:Example: patient with intermittent complete AV patient with intermittent complete AV
blockblock
AV conducti
on
AV block
No VIP VIP
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)
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VIP
Patient selectionPatient selection
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VIPPatient SelectionPatient 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
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VIP
versus AAI versus AAI DDD algorithms DDD algorithms
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VIPPatient Type: 1Patient Type: 1stst Degree AV block 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
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VIPPatient Type: Intermittent 2Patient Type: Intermittent 2ndnd Degree AV Degree AV blockblock
•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
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VIP Patient Type: High Grade 2Patient Type: High Grade 2ndnd Degree, Degree, Intermittent 3Intermittent 3rdrd Degree AV Block 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
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VIP
clinical benefitsclinical benefits
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VIPClinical BenefitsClinical 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
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VIP
additional informationadditional information
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VIPAdditional InformationAdditional 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
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VIPDisabled When: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
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VIPAnd AutoCaptureAnd 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
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VIPSummarySummary
• 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)
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VIPto avoid unnecessary ventricular stimulation
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