device future generation
TRANSCRIPT
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Device – Future Generation
Craig Swygman, CEPS
Heart Rhythm Center
Providence St. Vincent Medical Center
Portland, Oregon USA
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Overview
Subcutaneous ICD
Lead-less Pacemaker
Devices for heart failure monitoring
Devices for ischemia monitoring
New pacing features
– New leads
– MRI-compatible
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Subcutaneous ICD
Subcutaneous
No venous access
No Fluoroscopy
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Subcutaneous ICD
Limitations
– No brady pacing
– No anti-tachycardia pacing
– No atrial pacing/diagnostics
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Subcutaneous ICD
HRS 2012 report
– 330 pts at 33 sites
– Complication-free rate at 180 days = 99%
– 109 episodes in 16 patients were 100%
successfully treated
– Similar rate of inappropriate shocks as
transvenous ICDs
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Leadless Pacemakers
At lease three companies developing
leadless technology
– Avoid leads and their problems
– No Surgery (implanted through sheath)
– More cosmetic
– No connections
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Leadless Pacemakers
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? Smartphone
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EBR Systems
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Nanostim
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Leadless Pacmakers
Issues:
– Single chamber
– Communication with other
leads/components
– Longevity
– Repositioning
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Future?
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Devices for CHF/Hemodynamics
Currently use:
– Intra-thoracic impedance
– HRV
– Activity level
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LA Pressure
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Ischemia/MI Detection from IC Signals • CIED implantations have increased dramatically
• ICEGM have been used almost exclusively for
rhythm detection
• ECG and ICEGM contain similar information
o Medical community has invested a very long
time in learning how to recognize patterns of
ECG
• Possible uses of ICEGM could include:
o Ischemia/MI detection
o Detection of Electrolyte imbalances
o QT measurement
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Ischemia/MI Detection from IC Signals
Mendenhall, …, Saba et al. Europace 2012
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Surface ECG Reconstruction from ICEGM
Mendenhall and Saba, Europace 2010
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Pitfalls of 12-Lead Surface ECG
Reconstruction from ICEGM
Stability of reconstruction transformation over:
– Time
– Ranges of heart rate
– Changes in rhythm patterns (ectopic beats, arrhythmias, etc…)
– Changes in body position
– Changes in breathing patterns
– Changes in body habitus
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Ischemia/MI Detection from IC Signals Current CIED apply a HPF of 2.5-3 Hz to detected signal
This would distort the low frequency components of the
cardiac cycle (ST-T wave)
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Ischemia/MI Detection from IC Signals AngelMed Guardian Device:
1 IC vector (can-RV)
Phase I trials included 37 patients in US and Brazil – 4 patients had detected ST shifts and coronary
intervention
Currently being tested in the US (ALERTS II)
ALERTS II Clinical Study: – 75 Centers (~1020 patients)
– Randomization 1:1 for Alert ON vs. OFF for 6 months then all are ON
– Endpoints:
1. Safety endpoint, >90% free from complications
2. Efficacy composite endpoint, reduction in: » Cardiac or unexplained death
» New Q-wave MI
» Time of Sx-to-door > 2 hours for coronary occlusion
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Ischemia/MI Detection from IC Signals Fortify® ST device has a ST
monitoring feature (ST MF) with the ability to detect ST shifts and to record and store the associated high fidelity EGMs
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Ischemia/MI Detection from IC Signals
Analyze ST Study (SJM):
– N=5228 patients at 200
centers
– Patients with CAD and ICD
indication
– New ICD implantation or
change-out
– Endpoints:
» Safety
» Efficacy
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New Lead Design
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Quadripolar CRT Lead
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MRI and Devices
Historically:
– Inhibition/Triggering of pacing
– Reprogramming of device
– Leads may heat and stimulate tissue
– Until recently, all devices considered MRI-
unsafe
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MRI and Devices
2008 First MRI-compatible pacemaker
– Redesigned generator and lead
– Less magnetic material
– Improved circuitry protection
– Programming algorithm turned on before
scanning
– MRI magnetic field < 1.5 T
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MRI and Devices
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MRI and Devices
In US, first MRI-conditional pacemaker
approved in 2011 (Medtronic)
In Europe, SJM and Biotronik have
approved pacemakers
In Europe, Biotronik has approved ICD
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Conclusion
Cardiac rhythm device technology is
evolving rapidly
Historical challenges in devices may be
reduced
Better patient care should be aim of
improved device technology
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감사합니다