mode selection in pacemaker – evidence review
DESCRIPTION
Mode selection in pacemaker – Evidence review. Dr. Shreetal Rajan Nair SR, Department of Cardiology. Introduction. Aims of pacing Try to normalize cardiac output – heart rate and myocardial contractility Achieve chronotropic competence, AV and interventricular synchrony - PowerPoint PPT PresentationTRANSCRIPT
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Mode selection in pacemaker– Evidence review
Dr. Shreetal Rajan NairSR, Department of Cardiology
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Introduction Aims of pacing
- Try to normalize cardiac output – heart rate and myocardial contractility
- Achieve chronotropic competence, AV and interventricular synchrony
- Bring comorbidities associated with pacing to a minimum
- Improve exercise tolerance and quality of life.
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What are the options available ?
Single chamber – atrial , ventricularDual chamber Fixed rate vs rate adaptive
Physiologic pacing ?
Includes atrial as well as dual chamber pacing
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Indications
SNDA V conduction blockOther indications
- Neurocardiogenic syncope- Carotid Hypersensitivity
Syndrome- HCM- Long QTS
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Pacing in SNDSND is the most common indication for pacing.Patients with SND prone to develop AF and AV blockAV block in SND - 20% at the time of diagnosis - 3- 35% in pacemaker implanted patients during 5
year follow upAF in SND - 40 – 70% at the time of diagnosis - 3.9 – 22.3% during follow up in pacemaker implanted patients incidence of
AF influenced by pacing mode, duration of ventricular pacing and follow up duration
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Pacing modes in SND
Single chamber –AAI vs VVISingle vs dual - VVI vs DDD
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Evidence reviewMajor randomized trials
1. Danish study – SSS 2. PASE (Pacemaker Selection in the Elderly) – SSS + AVB3. MOST (Mode Selection Trial ) - SSS4. CTOPP (Canadian Trial of Physiologic Pacing ) - SSS +
AVB5. DANPACE (The Danish Multicenter Randomized Study
on Atrial Inhibited Versus Dual-Chamber Pacing in Sick Sinus Syndrome)– SSS
6. UKPACE (United Kingdom Pacing and Cardiovascular Events)- AVB
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HRS/ACCF expert consensus statement on pacemaker device and mode selection. J Am Coll Cardiol 2012;60:682–703
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HRS/ACCF expert consensus statement on pacemaker device and mode selection. J Am CollCardiol 2012;60:682–703
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Endpoints studied
All cause mortalityAF StrokeHeart failure Quality of lifePacemaker syndrome
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AFSignificant decrease in AF incidence in
Danish, CTOPP and MOST with relative risk reduction of 46%, 18% and 21% respectively.
Supported dual chamber and atrial pacing
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Stroke or thromboembolismDanish study showed a 57% risk reduction
with atrial based pacing Metaanalysis also showed a trend in favour of
atrial based and dual chamber pacing modes This effect may be due to less incidence of AF
as already described
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Heart failureDanish study : atrial pacing improved heart
failure statusMOST : 10% in DDDR group vs 12.3% in
VVIR group
Other studies failed to show a benefit for atrial based pacing
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Quality of life and functional statusCTOPP : overall there was no significant
effect of pacing mode on quality of life subgroup analysis showed improved quality
of life in those with high degree of pacing
MOST and PASE showed definite benefit of dual chamber pacing on quality of life
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Pacemaker syndrome Symptoms of PACEMAKER SYNDROME was
found to be more in ventricular only pacing vs DDDR or AAIR
improvement in quality of life reported earlier believed to be lower incidence of pacemaker syndrome
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Overall mortalityOnly the Danish study showed a benefit in
favour of atrial based and dual chamber pacing
Other studies and metaanalysis failed to prove any definite advantage for atrial or dual chamber pacing.
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The effect of RV pacingRV pacing associated with RV dysfunction
and interventricular dyssynchrony due to abnormal non physiologic activation sequence.
DDDR pacing associated with more dyssynchrony and decrease in EF when compared with AAIR pacing
MOST : increased incidence of HF and AF in DDDR vs AAIR
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Effect of RV pacingWhen compared with normal LV function vs
LV dysfunction , those with normal LV function fared better.
Factors influencing patient outcomes : 1. LV function2. Degree of RV pacing 3. Presence of structural heart disease
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Managed ventricular pacing (MVP)Long-term RV pacing causes a deterioration of LV function
through complex effects on regional ventricular wall strain and loading conditions
MVP searches for intrinsic conduction and avoid unnecessary ventricular pacing
Pacemakers can switch pacing mode from AAI(R) to DDD(R) in the Managed Ventricular Pacing (MVP) mode
The MVP mode provides functional AAI(R) pacing with the safety of dual-chamber ventricular support in the presence of transient or persistent loss of conduction
The criterion to switch to backup ventricular pacing is loss of AV conduction for two of the last four pacing cycles (the four most recent A-A intervals
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SAVE – PACe trial
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Results Minimal Vpacing algorithms showed
decrease in AF burden and progression to permanent AF.
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Single chamber atrial pacing vs dual chamber pacing DANPACE: DDDR better in SND than AAIR
only pacing - this finding was in contrary to the earlier studies – explanation was minimal ventricular pacing protocols were used in the DDDR group in DANPACE.
Very short and very prolonged AV intervals : increased AF burden on follow up.
DANPACE used moderately prolonged AV interval protocols which resulted in less AF burden
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Single chamber ventricular pacing vs dual chamber pacing
No trial showed any significant benefit of dual over ventricular pacing
Back up VVI pacing preferred in those not requiring frequent pacing
VVI pacing preferred in those with permanent and long standing persistent AF
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Rate adaptive pacingIndicated only for symptomatic chronotropic
incompetenceNo significant effect on quality of life or
exercise time though peak exercise heart rate increased
Increased frequency of heart failure, AF noted in dual chamber rate adaptive pacing vs those without
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Circulation 2006;114:11-17
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Circulation 2006;114:11-17
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Endpoint assessment – all cause mortalityHealey et al Randomized Trials of Pacing Mode: A Meta-Analysis; Circulation. 2006;114:11-17
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Endpoint assessment – AFHealey et al Randomized Trials of Pacing Mode: A Meta-Analysis; Circulation. 2006;114:11-17
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Endpoint assessment – STROKE
Healey et al Randomized Trials of Pacing Mode: A Meta-Analysis; Circulation. 2006;114:11-17
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Pacing and mode selection in SND
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AV BLOCK
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AV conduction diseaseIntermittent AV conduction abnormalities
progress to complete heart block on long term follow up
The minimum requirement is to prevent symptomatic bradycardia
The aim of pacing to establish AV synchrony without affecting ventricular synchrony
If there is no sinus node dysfunction then VDD mode will maintain AV synchrony and chronotropic competence
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Why AV synchrony is essentialPositive effect on cardiac outputIncreases stroke volume by 50% and
decrease LAP by 25%AV synchrony also helpful in diastolic
dysfunction
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Three randomized trials
PASEUKPACECTOPP
compared single vs dual chamber pacing in AV conduction disease
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3 randomized trialsMostly elderly ( 73-80 yrs )CTOPP and PASE had both patients with
sinus node and AV conduction disease.AV block as primary indication of pacing :
49% in PASE and 51% in CTOPPUK PACE had patients with AV conduction
disease only
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UKPACE 2005 - NEJMmulticenter, randomized, parallel-group trial2021 patients ; 70 years of age or older high-grade atrioventricular block randomly assigned to receive a single-chamber ventricular
pacemaker (1009 patients) or a dual-chamber pacemaker (1012 patients).
In the single-chamber group, patients were randomly assigned to receive either fixed-rate pacing (504 patients) or rate-adaptive pacing (505 patients).
The primary outcome was death from all causes. Secondary outcomes included atrial fibrillation, heart
failure and a composite of stroke, transient ischemic attack or other thromboembolism
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RESULTS The median follow-up period was 4.6 years for
mortality and 3 years for other cardiovascular events.
The mean annual mortality rate was 7.2 percent in the single-chamber group and 7.4 percent in the dual-chamber group (hazard ratio, 0.96; 95 percent confidence interval, 0.83 to 1.11).
no significant differences between single-chamber pacing and dual-chamber pacing in the rates of atrial fibrillation, heart failure or a composite of stroke, transient ischemic attack or thromboembolism.
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CONCLUSION In elderly patients with high-grade
atrioventricular block, the pacing mode does not influence the rate of death from all causes during the first five years or the incidence of cardiovascular events during the first three years after implantation of a pacemaker.
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pacing50
55
60
DANPACE
Pacing in the atrium: 58% in the AAIR group and 59% in the DDDR group; pacing in the ventricle: 65% in the DDDR group
Survival: similar between groups (29.6% vs. 27.3%, p = 0.53)
Paroxsymal atrial fibrillation ↑ with single-lead atrial pacing (28.4% vs. 23.0%, p = 0.024)
Need for reoperation: ↑ with single-lead atrial pacing (22.1% vs. 11.9%, p < 0.001)
Trial design: Patients with sick sinus syndrome were randomized to single-lead atrial (AAIR) pacing (n = 707) vs. dual-chamber (DDDR) pacing with an atrioventricular interval of ≤220 msec (n = 708). Mean follow-up was 5.4 years.
Results
Conclusions• Among patients with sick sinus syndrome,
dual-chamber pacing appears to be superior to single-lead atrial pacing
• Dual-chamber pacing resulted in reduced frequency of atrial fibrillation and need for reoperation
Nielsen JC, et al. Eur Heart J 2011;Feb 7:[Epub]
(p = NS)
AAIR DDDR
%
Pacing in the atrium
5859
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Effects of pacing modes on various parameters
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AFThose with AV block indication for pacing
were less likely to progress to permanent AF when compared to SND indication for pacing – CTOPP trial
UKPACE – annual event rates for developing AF were similar in both dual and single chamber groups
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Stroke , mortality and heart failure No difference between dual chamber or
single chamber pacing in the above parameters
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Exercise capacity and quality of life
CTOPP and some short term crossover studies showed increased exercise tolerance and improved quality of life by patient symptom scores with dual chamber rate adaptive pacing when compared to fixed rate ventricular pacing ( but statistical significance not attained)
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Effect of rate adaptive pacing
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Pacemaker syndromePASE - 26% of patients randomized to VVI mode had
severe symptoms attributable to pacemaker syndrome
– 50% of patients who were programmed to DDD from VVI mode had AV block
Whereas only 7% of patients in CTOPP needed a pacemaker revision over a 6 yr follow up period
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Pacing mode after AV junction ablationSingle chamber pacing is the preferred mode
of therapy for patients who have AV junction ablation for medically refractory AF
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Potential deleterious effects of ventricular pacing No randomized trials available Algorithms to minimize ventricular pacing
have not found to be useful in patients with AV block.
Some case reports have even reported to have deleterious effects
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VDD pacemaker in AV block
Single lead , dual chamberDecreases procedure time and costsRestore AV synchronyAtrial lead will be a floating bipole and its
sensing function may degrade over time needing revision
Useful in young patients with CCHB
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HYPERSENSITIVE CAROTID SINUS SYNDROME
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Evidence No large randomized clinical trials of pacing
mode have been conducted in this syndrome.AAI pacing alone has been shown to be
ineffective in this syndrome due to concomitant AV block during carotid sinus activation
Morley CA, et al. Carotid sinus syncope treated by pacing. Analysis of persistent symptoms and role of atrioventricular sequential pacing. Br Heart J 1982;47:411– 8
There is a potential benefit of dual-chamber pacing to minimize the impact of the vasodepressor response and prevent pacemaker syndrome.
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Evidence In a prospective randomized study of pacing
vs. no pacing therapy performed in 60 patients with carotid sinus syndrome, syncope recurred in 16 (57%) of the no-pacing group and in only 3 (9%) of the pacing group (p0.0002)
18 of 32 (56%) of the paced group received VVI devices and the remainder received DDD devices
Brignole M, et al. Long-term outcome of paced and nonpaced patientswith severe carotid sinus syndrome. Am J Cardiol 1992;69:1039 – 43
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Evidence comparisons made between VVI vs. DDDR vs. DDDR with rate
drop response in patients with carotid sinus syndrome without evidence of concomitant SND or AV block.
The primary endpoints of syncope or presyncope were significantly reduced after pacemaker implantation in all three groups
no significant differences in the primary outcomes were demonstrated among the three pacing modalities.
minor benefits of DDDR pacing was noted vs. baseline in the categories but no pacing mode was found to be superior.
Despite the physiological hemodynamic advantage of AV synchrony, the superiority of DDD pacing was not observed in this study
McLeod CJ, Trusty JM, Jenkins SM. Rea RF, Cha Y-M, Espinosa RA.Friedman PA, Hayes DL, Shen W-K. Method of pacing does not affect the recurrence of syncope in carotid sinus
syndrome. Pacing Clin Electrcrossover study
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NEUROCARDIOGENIC SYNCOPE
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Trial evidence
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Neurocardiogenic syncope role of permanent cardiac pacing for
neurocardiogenic syncope remains controversialThe Vasovagal Pacemaker Study II (VPS 2)
reported no significant reduction in the time to a first recurrence of syncope during dual-chamber pacing over 6 months of follow-up
The Vasovagal Syncope and Pacing Trial (SYNPACE) also reported that there was no significant difference between comparison groups
The subgroup of patients who had demonstrated asystole during tilt-table testing had a significant increase in time to first syncope recurrence compared with those with bradycardia alone (91 vs 11 days, respectively)
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PACING IN NEUROCARDIOGENIC SYNCOPEThe ISSUE II trial reported that permanent
pacing in patients with periods of asystole resulted in a significant reduction in the frequency of syncope.
In the Syncope and Falls in the Elderly Pacing and Carotid Sinus Evaluation (SAFE PACE) study, permanent pacing reduced falls, recurrent syncope and injuries in elderly patients with frequent nonaccidental falls and cardioinhibitory carotid sinus hypersensitivity.
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Hypertrophic cardiomyopathy
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M – PATHY trial48 patientsRandomized Double blind cross over studyDDD pacing vs AAI pacingThough outflow tract gradient decreased with
dual chamber pacing no much significance was found in the quality of life between the two groups.
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Long QT syndrome
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Long QT syndrome
No randomized trials availableIndicated in pause dependent VTAAI vs DDD vs VVI – direct comparisons not
availableDual chamber pacing better than single
chamber pacing
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Complications – evidence review
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Summary
Compared with ventricular pacing, the use of atrial-based pacing does not improve survival or reduce heart failure or cardiovascular death.
Atrial-based pacing reduces the incidence of atrial fibrillation and may modestly reduce stroke
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Thank you