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You’ve Come Along Way Baby: Pacemakers and ICDsGLENDA S. DELL MSN, APRN ACNS-BC

TNP CONFERENCE

SEPTEMBER 8, 2018

Objectives

u Participants will learn the history of pacemakers and ICDs.

u Participants will identify MRI compatible pacemakers and ICDs.

u Participants will identify indications for wireless pacemakers and ICDs and implications for care.

u Participants will identify indications for HIS bundle pacing.

Disclosures:

u I have nothing to disclose.

Devices

History

Transcutaneous Pacemaker Portable Pacemaker

History

u October 8th 1958 first implantable pacemaker in Sweden by Senning and Elmvquist.

u Done by thoracotomy and 2 epicardial leads placed.

u Device lasts 3 hours.

u The recipient Arne Larsson survived until 2001(his cause of death was not related to his cardiac issues)

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History

u 1970s Nuclear pacemaker were developed.

u Pacemaker become non-invasively programmable in the mid 1970s.

u Dual chamber devices are developed in the late 1970s.

u The 1980s drug eluding steroid leads, rate response pacing developed.

u The 1990s micro-processor pacemakers appeared

u The 2000’s biventricular pacing introduced.

u 2015 HIS bundle pacing.

History

First pacemaker Pacemakers Today

History

u 1980 the first ICD was implanted by Michel Mirowski and his team.

u Was considered a treatment of last resort.

u Devices were large, performed by open chest surgery.

History

History

Trials MADIT [10] MUSTT [11] MADIT II [13] SCD-HeFT [28]

Sample size 196 704 1232 2521

DesignICD vs antiarrhythmic drugs as conventional therapy

EP-guided therapy vs placebo

ICD vs optimal pharmacological therapy

ICD vs optimal pharmacological therapy vs optimal pharmacological therapy + amiodarone

PatientsPrevious MI, EF ≤ 0.35, nsVT, positive findings on EPS

Coronary disease, EF ≤ 0.40, nonsustained VT, inducible VT at EPS

Prior MI, EF ≤ 0.30

Ischemic and nonischaemic cardiomyopathy, EF ≤ 0.35

Follow-up (months) 27 39 20 46

Results

Risk reduction with ICD 54% (P = 0.001) 51% (P = 0.001) 31% (P = 0.02) 23% (P = 0.007)

History

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History History

MRI Devices MRI Devices:

u MRI conditional devices contain a dedicated MRI pathway.

u Safety features include:

u System integrity checks, Asynchronous pacing, tachy detections disabled, increased output during the scan, return to preprogrammed state.

u Most MR conditional devices use 1.5T scans in “normal operating mode”

u If patient has abandoned or epicardial leads MRI is not recommended.

MRI Devices:

u Identify Patient has an MRI compatible device and leads.

u Verify patient has had the device at least 6 weeks.

u Scheduling will require coordination between radiology and cardiology.

u Device may cause image artifact.

MRI Devices:

u Once scheduled:

u Device clinic staff should be present to test and reprogram device prior to MRI.

u EKG and Pulse Oximetry monitoring should be done throughout the scan.

u Patient’s device should be checked post MRI.

u ILR(implantable loop recorder) should be interrogated pre-MRI.

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MRI Devices: MRI: Devices

MRI Devices:

u Contact information:

u Medtronic: 1-800-551-5544

u Boston Scientific: 1-800-227-3422

u ST Jude/Abbott: 1-800-722-3774

u Biotronik: 1-800-547-0394

MRI Devices: Medtronic

MRI Devices: Boston Scientific MRI: St Jude/Abbott

PacemakersAssurity 1272

Assurity 2272

Confirm implantable Cardiac Monitor.

1.5 T MRI image scans

ICDs/CRT-DEllipse VR

Ellipse DR

Fortify Assura VR

Fortify Assura DR

Quadra Assura CRT-D

1.5T MRI image scans

LeadsLPA1200M

7122Q

1458Q

1.5T MRI image Scans

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Leadless Devices Leadless Devices

u Eliminate/reduce pocket and lead complications seen with traditional pacemakers.

u Safe pacing option for those patients who have had a device infections.

Leadless Devices

u Delivered through a transcutaneous approach.

u 99.1% implant success rate.

u Low dislodgement rate(0.06%)

u Low infection rate (0.17%)

u Retrieval feature for acute retrieval.

u 87% relative risk reduction in system revisions. 54% fewer hospitalizations.

Leadless Devices

Leadless Devices: Leadless Devices:

u Preferred choice for:

u Patients 65 and younger who lead an active lifestyle.

u Have no venous access

u Are diagnosed with Channelopathies(LQT, Burguda, HCM)

u High risk for complications with TV-ICD.

u Have high risk of infections and history of endocarditis.

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Leadless Devices

u Benefits:

u Decreased time limits of range of motion restrictions( 2 weeks vs 4 weeks).

u Implant site reduces visible scarring.

u Reduced chance of infection.

u Less likely to receive inappropriate shock( a fib with rvr)

u Drawbacks:

u Twice as large as a traditional ICD.

u Very thin pt. will not be a candidate.

u NO standard pacing support

u No tachypacing support

Leadless Devices

HIS Bundle Pacing HIS Bundle Pacing

u Long term RV pacing can lead to structural and cellular changes.

u CRT with BIV pacing not always feasible.

u HIS pacing can prevent ventricular dyssynchrony and LV dysfunction.

u Has shown to restore conduction through the diseased HIS-Purkinje system.

HIS Bundle pacing

u Risk and complications:

u High threshold >2.5v/1.0ms (10-15%)

u Lead revisions (~ 3-6.7%)

u Ventricular undersensing

u Far-field atrial oversensing.

u Capturing the atrium

HIS Bundle Pacing

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HIS Bundle Pacing HIS Bundle Pacing

u No history of CAD / CABG / PCI / MI

u 2014: Diagnosed with CHFu TTE 5.15.14: LVEF ~ 35% + Moderate AS (mean PG = 33 mm Hg)

u ECG:

HIS bundle Pacing

u No history of CAD / CABG / PCI / MIu 2014: Diagnosed with CHF

u TTE 5.15.14: LVEF ~ 35% + Moderate AS (mean PG = 33 mm Hg)u ECG: LBBBu Cath (-)

u 2017: Worsening CHF + decreased exercise toleranceu TTE: LVEF ~ 35% + Severe AS (mean PG = 42 mm Hg)u Cath (-)

u TAVR 8.1.17u TTE 8.21.17: TAVR is good; LVEF ~ 35%

HIS Bundle Pacing

HIS Bundle Pacing

u TAVR 8.1.17

u TTE 8.21.17: TAVR is good; LVEF ~ 35%

u CRT-D implanted 9.21.17u TTE 9.22.17: LVEF ~ 40%

u TTE 1.8.18: LVEF = 55%

HIS Bundle Pacing

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HIS Bundle Pacing HIS Bundle Pacing

HIS Bundle Pacing

Patient is symptomatic with this. Next step?

What type of Pacemaker? What % of RV Pacing do you expect?

HIS Bundle Pacing

HIS Bundle Pacing Questions

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Helpful Websites:

u www.medtronicacademy.com

u www.bostonscientific.com

u www.sjm.com

References:

u Aquilina, O. (2006). A brief history of cardiac pacing. Images in Pediatric Cardiology, 8(2),17-81. Retrieved July 15, 2018, from pubmed.gov.

u Boston Scientific. (2017). Cardiac rhythm resource center. Retrieved from http://www.bostonscientific.com

u Chang, P. M., Doshi, R., & Saxon, L. A. (2014). Subcutaneous Implantable Cardioverter Defibrillator. Circulation,129(23), E644-E646. doi:doi.org/10.1161/CIRCULATIONAHA.113.006645

u El-Chami, M. F., MD, Johansen, J. B., MD, Zadai, A., MD, Faerestand, S., MD, Reynolds, D., MD, Garcia-Seara, J., Piccini, J. P., MD. (n.d.). Leadless Pacemaker Implant in Patients with Pre-Existing Infections: Results from the Micra Post-Approval Registry. Retrieved from http://www.medtronic academy.com, August 5, 2018.

u Ellenbogen, K. A., & Vijayaraman, P. (2015). His Bundle Pacing A New Promise in Heart Failure Therapy? Journal of American College of Cardiology, 1(6). doi:10.1016/j.jacep.2015.09.007

u Indik, J. H., Gimbel, J. R., Abe, H., Alkmim-Teixeira, R., Birgersdotter-Green, U., Clarke, G. D., Woodard, P. K. (2017). 2017 HRS expert consensus statement on magnetic resonance imaging and radiation exposure in patients with cardiovascular implantable electronic devices. Heart Rhythm, 14(7). doi:10.1016/j.hrthm.2017.04.025

References:

u Medtronic (2018). Corepace. Retrieved from http://www.medtronicconnect.com

u St. Jude Medical. (2017). Clinical discoveries for healthcare professionals. Retrieved from

http://www.clinical.sjm.com