Transcript Document

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