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Pr Haran BurriUnité d’électrophysiologieService de Cardiologie
The latest in cardiac pacing and defibrillation therapy
– what’s there to stay?
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Disclosures
• Biotronik, Boston Scientific, Liva Nova, Medtronic, St-Jude Medical
- institutional fellowship support, researchcontracts, consulting or speaker fees
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News in Pacing and ICD and CRT
• Pacemakers- Leadless- LV septal
• ICD - programming- DFT testing- S-ICD
• CRT- Multipoint LV pacing (MPP)- LV endocardial pacing- OptimizationArrh
ythmia
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Cardiovasc Med 2016
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Reddy, NEJM 2015; 373(12): 1125-35
Successful implant in 504/526 pts (94.8%)
SAE in 6.7% of the patients:- cardiac perforation (1.3%),- dislodgement with percutaneous retrieval (1.7%), - pacing-threshold elevation with retrieval (1.3%)
Primary cohort:Primary efficacy endpoint at 6 months:thresholds of pacing (≤2.0 V/0.4 msec) and sensing(R ≥5.0 mV) in 270/300 (90%) pts
Primary safety endpoint:Absence of SAE in 280/300 (93%) of pts
Total cohort:
Total procedure time 46.5±25.3minFluoroscopy: 13.9±9.1min7 successfull retrievals
2 procedure-related deaths (0.4%)
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Reynolds et al. NEJM 2015
719/725 (99.2%) successful implants
1 death (metabolic acidosis)9 perforations (1.6%)No dislodgements1 device retrieval (high threshold)
AF (64.0%SSS (17.5%),AVB(14.8%),
Procedure time 34.8 ± 24.1 minFluoro time 8.9 ± 16.6min
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No lead issues
No pocket issues
No venous access issues
MRI conditional (1.5/3T)
Limited extractability
Risk of perforation
No remote monitoring
Price
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Leadless PMs
• 1 system (Micra) commercialized in CH
• Indications? - age >70 ans- VVI(R) pacing- preserved LVEF (no CRT indication)- venous access issues- at risk for pocket issues
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RV Leadless
pacemaker
LV Leadless
pacemaker
RA Leadless
pacemaker
Next steps
S-ICD
P. Mabo
Extraction tools
Leadless PM + S-ICD
Leadless DDD?
Leadless CRT-D?
Energy management?
Remote monitoring?Arrhyth
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News in Pacing and ICD and CRT
• Pacemakers- Leadless- LV septal
• ICD - programming- DFT testing- S-ICD
• CRT- Multipoint LV pacing (MPP)- LV endocardial pacing- OptimizationArrh
ythmia
Summit B
asel
Circ Arrhythm Electrophysiol. 2016
10 patients with DDD PM and SSS
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Mafi-Rad Circ Arrhythm Electrophysiol. 2016
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News in Pacing and ICD
• Pacemakers- Leadless- LV septal
• ICD - programming- DFT testing- S-ICD
• CRT- Multipoint LV pacing (MPP)- LV endocardial pacing- OptimizationArrh
ythmia
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Inappropriate therapy Death
High-rate and delayed therapy: 3% inappropriate shocksNo difference in first episode of syncope
HR high rate vs Conv. = 0.45; P = 0.01HR delayed vs Conv = 0.56; P = 0.06
1500 primary prevention ICD pts randomized to conventional vs. high rate vs delay. Primary endpoint: first occurrence of inappropriate therapy
N Engl J Med 2012;367:2275-83
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MADIT-RIT
Moss AJ et al. N Engl J Med 2012
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SuggestedICD programming
DelayedICD Therapy
High-rateICD Therapy
VT zone:
monitoring only
≥170 bpm
VF zone:
≥200 bpm, 2.5 s
ATP 1x + shocks
VT1 zone:
≥170 bpm, 60 s
dual chamber detection
ATP (4 bursts, 4 ramps)
+ shocks
VT2 zone:
≥200 bpm, 12 s
dual chamber detection
ATP (4 bursts, 4 ramps)
+ shocks
VF zone:
≥250 bpm, 2.5 s
ATP 1x + shocks
VT1 zone:
≥170 bpm
monitoring only
VT2 zone:
≥200 bpm, 12 s
dual chamber detection
ATP :3 bursts (3 ramps)
+ shocks
VF zone:
≥250 bpm, 2.5 s
ATP 1x + shocks
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Online Appendix
Programmingrecommendations for all major companies
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Heart Rhythm2015;12:926–936
2790 patients
1.5% inappropriate shock @ 1yr 2.5% inappropriate shock @ 1yr
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News in Pacing and ICD
• Pacemakers- Leadless- LV septal
• ICD - programming- DFT testing- S-ICD
• CRT- Multipoint LV pacing (MPP)- LV endocardial pacing- OptimizationArrh
ythmia
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Single-blind,, randomised non-inferiority trialn=2’500 standard ICD indications (not right-sided)72% primary prevention
Lancet 2015; 385: 785–91
P=0.33
“….for most new ICD and resynchronization ICD implants, a strategy of implantation without routine DFT should be preferred”
BSc devices only
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EHJ (2015) 36, 2500-7
Prospective randomized non-inferiority
n= 1077 standard ICD indicationNot HCM, ARVC82% primary prevention
Biotronik devices only
First shock efficacy
“…supports the hypothesis that if 40 J devices are used, DF testing does not improve DF efficacy during follow-up.”
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DFT testing.
• No DFT required unless:
- right-sided - S-ICD- generator replacement?- leads under advisory- suspicion of lead fracture/erosion- suboptimal electrical parameters- HCM, LQTS,Brugada…(underrepresented/excluded from trials)
Wilkof et al. 2015 HRS/EHRA consensus on ICD programming
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News in Pacing and ICD
• Pacemakers- Leadless- LV septal
• ICD - programming- DFT testing- S-ICD
• CRT- Multipoint LV pacing (MPP)- LV endocardial pacing- OptimizationArrh
ythmia
Summit B
asel
S-ICD
80J biphasic shock
Post-shock pacing only
7.3 yrs longevityRemote monitoring
MRI conditional (soon)
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Dayal, Burri, Sticherling, Aurrichio,Cardiovasc Med 2016 (in press)
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ECG screening
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Shock efficacy: comparison S-ICD with T-ICD
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Complications882 pts from IDE and EFFORTLESSPooled 2-year follow-up
Burke JACC 2015;65:1605–15
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7% inappropriate shocks
N=472
Eur Heart J. 2014 Jul 1;35(25):1657-65
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JCE 2015; 26:417-423
Retrospective analysis with new algorithm
40% reduction in inappropriate shocks due to TWOS
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S-ICD
• Improvement in rate of complications (erosion/infection, inappropriate shocks)
• Large size, shorter longevity, less diagnostics and programming options
• Indications: - venous access issues- high risk of infection (dialysis…)- no brady pacing or CRT indication- no indication for ATP
• Widening of indications in the future (especially if coupled to a leadless pacemaker)?
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News in Pacing and ICD
• Pacemakers- Leadless- LV septal
• ICD - programming- DFT testing- S-ICD
• CRT- Multipoint LV pacing (MPP)- LV endocardial pacing- OptimizationArrh
ythmia
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Quadripolar (IS-4) LV leads
Rinaldi, Burri et al, Europace 2015; 17(1):7-17
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Heart Rhythm2015;12:751–758
1124/1055 (95%) procedures with successfull quadripolar LV lead implantation1.4% lead dislodgment (0.3% with straight lead)
Capture threshold <2.5V and no PNS at programmed output
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Heart Rhythm2015;12:975–981
29 CRT patientsdP/dT measurementsConventional (bipolar distal and proximal)MPP: D1 + P4Pacing from different veins
90% of pts had improved dP/dT with MPP
Mean QRS : 17118 MPP vs 17516 ms conv. (P= 0.003), Arrh
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Heart Rhythm 2015;12:2449–245716 CRT ptsBiV vs single vein MPP vs dual vein MPPElectro-antomical mapping with EnsiteResponse > 10% ↑ LV dP/dT
n=9 n=7
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Responder
Non-responder
Intrinsic Single LV Dual-vein MPP Single-vein MPPEnsitemapping
*Strauss criteria Sohal Heart Rhythm 2015;12:2449–2457
Dotted lines = 10th / 90th % activation
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Sohal Heart Rhythm 2015;12:2449–2457
Alternative site LV pacing was ineffective
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Europace 2016 (in press)
LV dP/dT > 10%
16 ptsLV free wall scar (MRI)BiV and MPP (3P: distal + mid + prox) over scar region
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Europace (2013) 15, 984–991
19 ptsLV dP/dT
MPP
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44 CRT pts randomized to conventional CRT vs MPP guided by PV loops
Heart Rhythm. 2015 Jun;12(6):1250-8.
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MORE CRT MPP
• Prospective, randomized controlled double blind study
• 1898 pts (enrollment complete)
• NYHA III/IV, LVEF<35%, QRS>120ms
• CRT echo non-responders at 6 months
• Randomization 1:1 BiV vs MPP
• Primary endpoint: percentage of non-responders converted (LVESV ↓ >15%) at 1yrArrh
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Multipoint LV pacing• No benefit of dual vein vs single-vein LV MPP
• No significant additional benefit in acute responders to BiV
• Improvement in dP/dT in ~50% in acute non-responders
• May improve response in LV free-wall scar
• Acute HD data from small series (< 20pts)
• Uncertain optimal programming (D1 – P4?)
• Limited long-term follow-up (MORE-CRT MPP ongoing)
• Tradeoff: impact on battery longevity
• Feature on SJM and MDT devices only (may use anodalcapture if not available)
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News in Pacing and ICD
• Pacemakers- Leadless- LV septal
• ICD - programming- DFT testing- S-ICD
• CRT- Multipoint LV pacing (MPP)- LV endocardial pacing- OptimizationArrh
ythmia
Summit B
asel
EHJ 2016 (in press)
138 pts with failed or CRT non-responders (23%)89% implant successINR 2-4
3830 lead
Fu 17±10mo10.6% stroke/TIA17% mortality (not related to LV lead)59% improved NYHA, 55% LVEDV ↓>15%No mitral valve issues5 infections requiring uneventful explantation
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News in Pacing and ICD and CRT
• Pacemakers- Leadless- LV septal
• ICD - programming- DFT testing- S-ICD
• CRT- Multipoint LV pacing (MPP)- LV endocardial pacing- OptimizationArrh
ythmia
Summit B
asel
CRT: Effects of varying the AV delay
LV filling LV contraction
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JCE 2010;21(11):1226-32
SAVopt=AS-Pend+40 PAVopt=AP-Pend+30
n=63Echo AV optimization by iterative method
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Circ Arrhythm Electrophysiol 2012;5:544-552.
24 canine hearts with LBBBdP/dT measurements at different AVDVectrocardography in the frontal planeVector amplitude halfway between LBBB and max. LV capture predicted best dP/dT
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CONCLUSION:Higher % of synchronized LV pacing (sLVP) was independently associated with superior clinical outcomes. In patients with normal AV conduction, aCRTprovided mostly sLVP (7325%) and demonstrated better outcomes compared to echo-optimized BVP.
CONCLUSION:Use of the aCRT algorithm is associated with a significant reduction in the probability of a 30-day readmission after both HF hospitalizations (-59%) and all-cause hospitalizations (-46%).
% Normal AV Patients with Improved Packer CCS at 6 months
p=0.041
81%
69%
aCRT
echo
CONCLUSION:Patients receiving aCRT experienced a reduced risk of AF compared to conventional CRT, potentially through a more physiological therapy that minimizes RV pacing.
Sub-analyis of Adaptive CRT RCT
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LV fusion pacing
• Hemodynamic benefit: profits from intrinsicconduction, avoids A-wave truncation
• Encouraging initial data for improved CRT response
• Ongoing AdaptResponse RCT (3’000 pts withLBBB and normal AV conduction): mortality + HFH
• Longer battery longevity
• Currently only available from 1 company, but others are on their way….
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