View
6
Download
0
Category
Preview:
Citation preview
Device – Future Generation
Craig Swygman, CEPS
Heart Rhythm Center
Providence St. Vincent Medical Center
Portland, Oregon USA
Overview
Subcutaneous ICD
Lead-less Pacemaker
Devices for heart failure monitoring
Devices for ischemia monitoring
New pacing features
– New leads
– MRI-compatible
Subcutaneous ICD
Subcutaneous
No venous access
No Fluoroscopy
Subcutaneous ICD
Limitations
– No brady pacing
– No anti-tachycardia pacing
– No atrial pacing/diagnostics
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
Leadless Pacemakers
At lease three companies developing
leadless technology
– Avoid leads and their problems
– No Surgery (implanted through sheath)
– More cosmetic
– No connections
Leadless Pacemakers
? Smartphone
EBR Systems
Nanostim
Leadless Pacmakers
Issues:
– Single chamber
– Communication with other
leads/components
– Longevity
– Repositioning
Future?
Devices for CHF/Hemodynamics
Currently use:
– Intra-thoracic impedance
– HRV
– Activity level
LA Pressure
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
Ischemia/MI Detection from IC Signals
Mendenhall, …, Saba et al. Europace 2012
Surface ECG Reconstruction from ICEGM
Mendenhall and Saba, Europace 2010
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
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)
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
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
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
New Lead Design
Quadripolar CRT Lead
MRI and Devices
Historically:
– Inhibition/Triggering of pacing
– Reprogramming of device
– Leads may heat and stimulate tissue
– Until recently, all devices considered MRI-
unsafe
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
MRI and Devices
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
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
감사합니다
Recommended