Noel G. Boyle, MD PhD

UCLA Cardiac Arrhythmia Center

Los Angeles, California.

Brazilian Congress of Cardiac

Arrhythmias,

Nov 22nd, 2019

Pacemaker and ICD Interrogations in the

Coroner’s Department

Campus photo courtesy : S. Tateshima MD

Presentation Outline

• Four cases from Los Angeles Coroner’s Office

• Summary of CIED interrogations form LA Coroner’s office (2001-2016)

• San Francisco Coroner’s- UCSF Study (2015)

• Baltimore - Johns Hopkins University Study (2016)

• Berlin -Charitē University Hospital Study (2018)

• Meta-analysis of International Studies (1996-2008)

• Summary

Note: CIED =Cardiac ImplantedElectronic Device

i.e. Pacer or ICD or CRT

• CASE HISTORY I

• A 58 year old man fell and hit his head while coaching basketball and lost consciousness.

• Substrate- ischemic CM, EF=25%; St Jude ICD

• CT head at a local hospital showed bilateral subarachnoid hemorrhage, subdural hematoma and cerebral swelling. The patient was transferred to Neurosurgery Center, but subsequently died.

• ICD interrogation post mortem showed an 11 second episode of polymorphic VT successfully terminated by ICD shock (#2), but which did not prevent syncope, recorded at time the fall and head trauma occurred.

• CASE HISTORY 2

• A 21 year old woman lost control of her car while driving and crashed into a tree. The paramedics found initial rhythm of asystole and the patient could not be resuscitated.

• Substrate- congenital complete heart block

• Permanent pacemaker implanted at age 10 years

• Pacemaker interrogation post mortem showed the device battery was completely exhausted.

• 17 months prior to this event, the patient’s pacemaker was checked and found to have a battery life of 6 months – however the patient did not follow-up for battery replacement.

• CASE HISTORY 3

• An elderly woman was found dead in her apartment 8 days after being last seen alive. The deceased patient’s identity was confirmed by dental records.

• Autopsy evaluation showed moderate coronary atherosclerosis

• Permanent pacemaker implanted 2 years prior

• Pacemaker interrogation showed a Guidant model 1296 with battery capacity of 4.5 years

• Device log showed an episode of ventricular tachycardia which occurred 4 days prior to the patient being found dead and was most likely cause of death.

• CASE HISTORY 4

• An elderly man was found down on the street and taken to local hospital where he was pronounced dead. There was no identifying information on the decreased patient (and no pacer ID card).

• Fingerprinting performed at autopsy was not useful as no prior record

• A pacemaker was removed at autopsy.

• Pacemaker interrogation revealed the patient’s name, and the name implanting physician and date device implanted -allowing positive identification of deceased patient

Patient Name here

(MEASURED AFTER LEAD CUT)

Los Angeles Coroner Device Data 2001-2016

• 2001-2016: 66,244 autopsies performed in 15 year period

• 43 cases referred for device interrogation post autopsy (0.65%)

• Cases were referred only if cause of death was unknown after autopsy or there was concern re device malfunction contributing to death

• Mean age 67 years (72% male)

• Devices examined: Pacemakers 27(63%), ICDs 14 (32%), CRT-D 2 (5%)• Normal device function: 36 (84%); • Some type of device system malfunction: 7 (16%)

Los Angeles Coroner Device Data 2001-2016

• Arrhythmia diagnosis in 19 cases (44%)• Ventricular tachycardia 14/19 (74%)

• Ventricular fibrillation 1/19 (5%)

• Supraventricular Tachycardia 3/19 (16%)

• Undetermined 1/19(5%)

• ICD delay or failure to shock in 2 cases (5%)• Patient lost consciousness (prior to shock delivery) and died due to motor vehicle

accident (Case 1)

• VT misclassified by ICD as SVT and no shock delivered

• Complete battery depletion in 3/43 cases (7%)

• Lead Malfunction: 2/43 (5%) – one lead fracture, one insulation break

Likely cause of patient’s death

JAMA Internal Medicine 2015: 175:1342-50

San Francisco Coroner /UCSF Study 2015

Tseng Z et al. JAMA Internal Medicine 2015: 175:1342-50

22 of 517 sudden deaths had CIED

• Prospective study to determine cause of Sudden Death in CIED patients in San Francisco over 3 years (2011-2014)

• 22 of 517 sudden deaths had CIED device (4.3%)

• 6 of 14 pacemaker sudden deaths and 7 of 8 ICD sudden deaths were due to ventricular tachycardia or fibrillation

• Device issues were found with 4 pacemakers and 7 ICDs – total 11/22 of patients with sudden death and implanted devices – 50%

• Problems included rapid battery depletion(1), lead fractures(3) ventricular tachycardia undersensing by ICDs(5) and VT missed due to ICD programming(1)

San Francisco Coroner /UCSF Study

Tseng Z et al. JAMA Internal Medicine 2015: 175:1342-50

22 of 517 sudden deaths had CIED

AEGM

VEGM

MARKERS

EXAMPLE of ICD failing to sense VF:Top: Atrial electrogram (AEGM)Middle: Ventricular Electrogram (VEGM)Bottom: Device markersFailure to sense – red arrowheads – associated with specific manufacturer delay decay algorithm – device incorrectly concludes “Return to Sinus” and no shock was delivered.

San Francisco Coroner /UCSF Study

Sinha S et al. JACC 2016; 68: 1255-64.

Baltimore – Johns Hopkins University Study 2016

Sinha S et al. JACC 2016; 68: 1255-64.

• Registry analysis from Johns Hopkins University, Baltimore, to determine utility of post mortem CIED analysis over a 6 year period (2009-2015)

• 84 devices (37 pacemakers and 47 ICDs) were analyzed out of 2025 autopsies (4.1%)

• 43 classified as sudden deaths, 41 as non sudden deaths

• Significant Clinical alerts (sustained tachycardias or elevated fluid volume index) in 63% of sudden death and 20% of non sudden death cases

• Manufacturer analysis identified 1 case of early battery depletion and 1 device ‘hard reset’ as due to cold exposure!

Baltimore – Johns Hopkins University Study

Sinha S et al. JACC 2016; 68: 1255-64.

Baltimore – Johns Hopkins University Study

Sinha S et al. Clinical Inferences of CIED Analysis at Autopsy. JACC 2016; 68: 1255-64.

Baltimore – Johns Hopkins University Study

Berlin – Charite University Hospital Study 2018

• 150 CIEDs (109 pacemakers, 35 ICDs and 7 Loop recorders (ILRs) were evaluated) in 5368 autopsy exams from 2012-2107 at the ChariteUniversity Hospital in Berlin [2.8%]

• In 40 cases the time of death could not be established – device interrogation established this in 28/40 (70%)

• In 51 cases the cause of death could not be established – device interrogation established this in 31/51 (61%)

• Concerns re device function identified in 9 cases (6%) – 3 hardware, 4 programming an 2 algorithm issues.

Lacour P at al. Circulation 2018; 137:2730-40.

Berlin – Charite University Hospital Study 2018

• 150 CIEDs [2.8%](109 pacemakers, 35 ICDs and 7 Lop recorders (ILRs) were evaluated) in 5368 autopsy exams from 2012-2107 at the ChariteUniversity Hospital in Berlin

• In 40 cases the time of death could not be established – device interrogation established this in 28 (70%)

• In 51 cases the cause of death could not be established – device interrogation established this in 31 (61%)

• Concerns re device function identified in 9 cases (6%) – 3 hardware, 4 programming an 2 algorithm issues.

Lacour P at al. Circulation 2018; 137:2730-40.

(far field EGM) Artifact Sensing

Under-sensing post shock

VT rate (193) below cutoff (200)

Under-sensing VF

Three examples of device problems: 1.

2.

3.

Berlin – Charite University Hospital Study 2018

• 12 studies on post-mortem interrogation of CIEDs – reported from 1996 – 2018

San Francisco

Baltimore

Berlin

Dyrbus M. et al. Int. Heart Journal 2019;280:89-94

MAIN FINDINGS

• 12 studies reviewed – reported from 1996 – 2018• 11 studies retrospective; 1 study prospective (San Francisco/UCSF) • Number of devices interrogated ranged from 19-320 (mostly pacers

and ICDs; rare loop recorders-ILRs)

• Studies assessed utility of post mortem interrogation and possible determination of cause of sudden death

• Stored rhythms analyzed in 31-100% of devices• Complete autopsies obtained in 4 studies; limited cases in 4 studies;

no autopsies in 4 studies

Dyrbus M. et al. Int. Heart Journal 2019;280:89-94

Possible Causes of Death found at Post-mortem CIED Interrogation in 12 Studies

Review: Possible Findings from Cardiac Device Interrogation at Post-Mortem

• Identify deceased patient

• Clarify time of death

• Identify terminal rhythm from stored electrograms

• Establish device battery status

• Confirm device programming

• Confirm if device therapy was delivered and if it was effective

• Identify possible lead malfunction with impedance changes

Role of the Cardiac

Electrophysiology Consultant

Noel G. Boyle, MD, PhD, FACC, FRCPI, FRCP, Christopher

Rogers, MD, MBA2 and Lakshmanan Sathyavagiswaran, MD,

FRCP(C), FACP, FCAP3

1UCLA Cardiac Arrhythmia Center, University of California, Los Angeles, CA, United States 2 Los Angeles County Department of Medical Exa111iner-Corone1; Los

Angeles, CA, United States 3 Los Angeles County Chief Medical Examiner-Coroner/Director (Retired), Los Angeles, CA,

United States

INTRODUCTIONIn the period from 1993 to 2006, 2.4 million people received pacemakers and a

further 0.8 million implantable cardioverter defibrillators (ICDs) in the United

States, so these devices are now commonly encountered by the pathologist at

autopsy (Kurtz et al., 2010; Saint-Martin et al., 2008). Since the first pacemaker

implantation in 1958, and the first ICD implantation in 1981, there has been a

rapid technological development in these devices with smaller and more program-

mable devices which can now store large amounts of information about the patient

and their cardiac rhythm history. While in most cases the device information and

interrogation may not be relevant to the questions arising at autopsy, in selected

cases, it may provide critical information to the forensic pathologist in identifying

the patient and the time and mode of death.

The earliest discussions of pacemaker evaluation from the postmortem stand point

of the pathologist were from Raasch in the 1970s (Raasch, 1977, 1978). He

advocated that the pathologist "examine the pacemaker and its lead as an integral

part of an autopsy." He posed three questions to be addressed: Was there a signal?

Was it effective? Could anything have altered it? In a 1974 analysis of deaths in

pacemaker patients, Siddons found that 9 of 145 deaths in patients with

pacemakers were related to pacemaker malfunctions, with failure to pace in six

and "speeding pacemaker" in three; however, this study predates the advent of

stored electrograms and modern highly reliable pacemakers.

Advances in pacemaker and ICD battery and lead technology in recent decades

now mean that device failure is a very rare finding, particularly for pace makers,

although occasionally it still occurs with ICDs (Guidant device). However, lead

function in ICDs remains an Achilles heel of even modern ICD devices (Fidelis,

Riata leads).Publication from Los Angeles County Coroner’s Office - 2018

SUMMARY

• Currently CIED post mortem analysis is rarely conducted internationally (1-4% of cases)

• Device interrogation can provide multiple findings relative to the coroner’s forensic post-

mortem examination – all studies reported were performed in selected cases with CIEDs

• In patients with CIEDs where there is uncertainty in time or cause of death, CIED

interrogation can provide additional useful forensic data in ~50% of cases

– time of death in ~60% of patients (Berlin study)

– manner of death (if arrhythmia related) in ~70% of cases (Berlin study)

• While device malfunctions are rare overall, device concerns arose in 50% of cases with

ICD and sudden death in San Francisco study – much less in other studies – 16% in our

Los Angeles Coroner’s Dept. study.

Cardiomyopathy & Transplantation:

Ali Nsair MD

Tamara Horwich MDDaniel Cruz MDArnold Baas MDMario Deng MD

Gregg C. Fonarow MD

ACHD:

Jamil Aboulhosn MD

Jeannette Lin MD

Gentian Lluri MD PhD

Jeremy Moore MD

Leigh Reardon MD

Kevin Shannon MDPamela Miner RN NP

Cardiac Surgery:

Reshma Biniwale MD

Hillel Laks MD

Murray Kwon MD

Richard Shemin MD

Peyman Benharash MD

Jeffrey L. Ardell PhD (Dir)

J. Andrew Armour MD PhD

John Tompkins PhD

Maria Jordan MD

Amiksha Gandhi BS

Cardiac Pathology:

Michael C. Fishbein MD

Gregory A. Fishbein MD

EP Nurse Practitioners:

Shelly Cote RN MN NP

Jean Gima RN MN NP

Geraldine Pavez RN MN NP

Armineh Gorkian RN MN NP

Research Administration:

Julie M. Sorg RN MSN

Radiology:

J. Paul Finn MD PhD

Stephen J. Kee MD

John Moriarty MDStefan Ruehm MD

Administrative:

Cecilia Flores

Carmen Mora Sanchez

Gilma Rodriguez

Walter Flores Coto

Belinda DeLeon

Center Director

Kalyanam Shivkumar MD PhD

Co-Directors

Noel G. Boyle MD PhD

Jeffrey Ardell PhD

Specialized Program for AF & EP Labs

Eric F. Buch MD, MS (Dir)

Specialized Program for VT

Jason Bradfield, MD (Dir)

Implanted Devices Clinic

Osamu Fujimura MD (Dir)

Cardiac EP, UCLA Olive View

Carlos Macias, MD (Dir)

Clinical & Translational Research

Marmar Vaseghi MD PhD (Dir)Specialized Program for Clin Autonomics:

Olujimi A. Ajijola MD PhD (Dir)

Electrophysiology Faculty:

Zenaida Feliciano MD (Dir, Wes LA VAMC EP)

Malcolm Bersohn MDJanet Han MD

Houman Khakpour MD

Yuliya Krokhaleva MD

EP Fellows/trainees:

Duc Do MD MS

Justin Hayase MD

Aron Bender MD

Peter S. Hanna MD

Ching Zhu MD

Pradeep Rajendran BS (MSTP/PhD)

Cardiac Anesthesia:

Komal Patel MD

Reed Harvey MD

Jonathan Ho MD

Health System:

Erick Ascencio CVT

Coach John R. Wooden 1910-2010

COMPREHENSIVE CARDIAC

NEURAL MAPPING &

COMPUTATIONAL SUPERGROUP