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