for internal use only evidence based medicine the need to avoid unnecessary ventricular stimulation

for internal use only

Evidence Based Medicine

The Need to AvoidThe Need to AvoidUnnecessaryUnnecessary

Ventricular StimulationVentricular Stimulation


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


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


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


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


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


MOST ResultsResults


MOST DDDR Heart Failure DDDR Heart Failure HospitalizationHospitalization

40% VP

> 40% VP

months

pro

po

rtio

n e

ven

t fr

ee


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


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


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


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


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


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%


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


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


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


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%


Intrinsic RV TrialSponsor, ReferenceSponsor, Reference

Study Sponsor

Boston Scientific CRM

Reference

Olshansky B al. Circ, 2007; vol 115: 9-16


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


Intrinsic RV Trial ResultsResults

P=0.072

DDDR with AVSH trends towards superiority compared to VVI


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%


How Can We AvoidHow Can We AvoidUnnecessaryUnnecessary

Ventricular StimulationVentricular Stimulation

VIP Ventricular Intrinsic Preference


VIP

Active SafetyActive Safety


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


VIP

Advanced ProgrammabilityAdvanced Programmability


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


VIPTo Activate VIPTo Activate VIP


VIPAV ExtensionAV Extension


VIPSearch IntervalSearch Interval


VIPSearch CyclesSearch Cycles


VIP

Activation - DeactivationActivation - Deactivation


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


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


VIP

versus no VIPversus no VIP


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)


VIP

Patient selectionPatient selection


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


VIP

versus AAI versus AAI DDD algorithms DDD algorithms


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


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


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


VIP

clinical benefitsclinical benefits


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


VIP

additional informationadditional information


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


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


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


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)


VIPto avoid unnecessary ventricular stimulation

for internal use only evidence based medicine the need to avoid unnecessary ventricular stimulation

Documents

internal use

pts dddr

vvir slide

ms slide

dddr pacemaker

bpm dddr

prolonged dddr

percentage vp