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Severe Post Traumatic Stress Disorder As A Consequence of Pacemaker/Defibrillator Dysfunction Due to Sprint Fidelis
Lead Fracture - Case Report and Literature Review of ICD-induced Post Traumatic Stress Disorder
Dr. Frank W Meissner MD1,Dr. Cynthia Garza, JD, MD2, Dr. Henry Wiseman, MD3
1TTUHSC Paul L. Foster School of Medicine, PGY-2 Psychiatry Resident, El Paso TX
2TTUHSC Paul L. Foster School of Medicine, PGY-3 Psychiatry Resident, El Paso TX
3TTUHSC Paul L. Foster School of Medicine, Residency Program Director Psychiatry, El Paso TX
No Conflicts Of Interest
AIMS
Defibrillator therapy revolutionized the management of Heart Failure
with Reduced EF (HFrEF) by reducing the numbers of deaths due to
Sudden Cardiac Death (SCD). However this reduction in mortality can be
accompanied by a dramatic reduction in the implanted patient’s quality of
life if even a single clinically inappropriate defibrillator discharge occurs.
Two illustrative case of dramatic defibrillator dysfunction causing ICD
storm are presented. In spite of the similar course of the patient’s ICD
storm; in one case, the patient was left with a debilitating and treatment
resistant case of PTSD, while in the second case, the patient was entirely
without long term stigmata as a consequence of his ICD storm. A focused
literature review of defibrillator- induced PTSD is presented and
discussed and an expository model of adjustment to ICD storm is
presented,
Methods
Literature search of PubMed over the years 1980 - April 2017 was accomplished
with use of the following search terms: ICD, implant*, cardiover*, PTSD . The
resulting 41 papers could be organized in the following fashion: [case reports (5)],
[technical solutions to reduce symptoms - RF Abalation (1) vs SubQ ICD
Implantation (1) vs bilateral cardiac sympathetic denervation (1) vs lipophilic beta-
blocker therapy (1)], [target population incidence/prevalence rates - Pediatric (2),
Gender-based (1), Non-pediatric, Non-gender Based (6)], [screening for detection
of existing PTSD in ICD patients (2)], [analysis of psychosocial factors associated
with development of PTSD in ICD patients (5)], [therapy modalities for treatment of
ICD induced PTSD [(2 CBT (Randomized Trials), (1 EMDR), (1 ad hoc
interventions), (1 Psychotherapeutic Treatment),(1 Crisis Intervention)], [impact of
PTSD development on overall mortality of ICD patients (2)], [‘Phantom shocks’ (2)],
[Systematic Reviews (2)], [Subjective Patient Reports (2)], [Practice Guidelines (2
both in German)].
Results
In one case our patient was in his 8th decade of life, Caucasian, college-educated, well
traveled, financially well off, agnostic, who retired from a professional career as an electrical
engineer, and was on track to live out an average life span given his advanced age at the
time of ICD implantation. The contrasting case, was young, Hispanic, high-school educated,
not at all traveled, financially dependent on working 40-hr weeks, a devout Catholic, who had
an expectation of a dramatically reduced life-span.
What factors could have been in play that protected the second patient from PTSD and
failed to protect the first patient from the life altering effects of his ICD storm? The available
literature details pre-morbid risk factors which play a factor in predicting the occurrence of
PTSD in patients with an ICD storm.
The side panel entitled ‘Humanistic Model of Medicine’ makes the point that any medical
therapy, even one as highly sophisticated as ICD function and ICD - human interactions must
be interpreted in the context of the patient’s culture, the availability of technological solutions
and the patient’s individualistic concepts of spirit and spirituality as well as the more classical
bio-social-psychological factors seen in medical practice.
Perhaps no medical device or therapy emphasizes the relationships between a patient’s
concepts of mortality and his/hers acceptance or rejection of mankind intrinsic time limits/
length of liife.
Pre-implantation personality characteristics have been shown to be important in
predicting a subsequent risk of PTSD development, for example the presence of the so-
called Type D personality. However, although authors have claimed that identification of
these types of patients is important pre-implantation and they have recommend personalized
support to those at risk (the young, the depressed, and the Type D personality) no study has
demonstrated that aggressive pre-implantation interventions result in a different clinical
trajectory for patient’s with and without the markers of increased risk for development of
post-implantation PTSD.
However within the context of this case, non-psychological factors may have had a
deterministic impact on these two patients diametrical clinical trajectories.
Specifically, Patient B’s ICD storm was a direct consequence of poor device programming
and once corrected the patient held a defensible belief that he would not be further troubled
by ICD storm. The other patient had a uniquely troubling ICD storm based on lead failure
combined with AV node modification/ablation, with a high probability of persistent problems
without technical modification of the device and its leads.
Patient B as a consequence of his strong religious faith had an accepting but hopeful
orientation to his cardiac disease(s); he was in brief able to endure with heroic equanimity
the ‘slings and arrows of outrageous fortune.’ Patient A, had a psychological worldview best
characterized as cynical, unaccepting, and pessimistic.
Furthermore, his ICD storm experiences were socially isolated in ways Patient B’s never
were. Patient B had a wide circle of supportive friends and relatives. Patient A had outlived
all his close friends and his wife was herself in tenuous health.
Patient A ’s etiology for HF was due to progressive coronary artery disease, patient’s B
pathologically reduced EF less clearly defined and in fact was never definitively determined.
Conclusions
1. A multitude of dynamic interacting factors (psychological, physiological, social, spiritual, and
technological) resulted in divergent clinical outcomes in spite of near identical clinical circumstances
as determined by the technical analysis of the devices functioning. Given the enhanced
understanding of the interplay of all factors noted in our conceptual model, we are able to rationalize
the observed differences in the psychological responses to CBT of Patient A and Patient B.
2. In accounting and/or accurately predicting divergent responses to therapies aimed at reducing the
likelihood of PTSD post-implantation consideration of all relevant factors (as outlined in our
conceptual model) is necessary.
A 70 year old Caucasian male underwent dual chamber ICD
implantation three years prior to his emergency clinical evaluation by
the principle author. He had a Sprint Fidelis lead implanted in
combination with his Meditronic Dual Chamber ICD done in
combination with AV nodal ablation, making him pacemaker
dependent. According to Medtronic follow up data, the Fidelis lead
failure probabilities transition at 3 years from an exponential to linear
pattern, with a stabilized probability of lead failure of 4.5% per year.
Our patient presented to the Emergency Department since his
fractured lead resulted in false sensing of biological myotonic
electrical signals and the embedded defibrillator logic interpreted the
myotonic electrical activity as ventricular fibrillation. Consequently
defibrillator shock was delivered and his ICD subsequently paced
asynchronously at 60 beats per minute at maximum electrical output
for the 1st minute post defibrillator shock.
Once the period of asynchronous pacing was completed the
device then looked for evidence of spontaneous QRS complexes, it
then mischaracterized the self same myoclonic potentials as
spontaneous heart beats and so stopped pacing the patient inducing
severe dizziness and near syncope due to the failure of his
spontaneous atrial beats to traverse the ablated A-V node. His
syncope was then punctuated by another defibrillator discharge as the
ICD again misclassified the situation.
This terrifying cycle of complex mutually exclusive
misinterpretations of the lead failure resulted in more than one hour of
alternating near syncope followed in short order by full discharge
cardiac defibrillation.
Once in the Emergency Department, Cardiology was called and
the device placed into asynchronous pacing mode at 70 beats per
minute and the defibrillator function inactivated. However, as a
consequence of the greater than 30 defibrillation events the patient
was left with a highly resistant case of post traumatic stress disorder.
A 30 year old Hispanic male with idiopathic cardiomyopathy
and a LVEF less than 30% underwent prophylactic ICD
implantation. He continued to work as a security guard in a grade
school.
Shortly after implantation of the defibrillator, he responded to a
altercation involving two eighth graders. The implanting
Electrophysiologist for unknown reasons programmed the device
threshold for defibrillation at any heart rate > 100 bpm. While
running to respond to the altercation his heart rate understandably
and predictably exceeded 100 bpm.
He subsequently experienced the rapid delivery of
approximately 30 full energy defibrillator shocks (40 joules
delivered energy) over the course of 15 minutes.
The excess number of defibrillator shocks occurred because
the pain from the defibrillator events kept his heart rate greater
than 100 bpm.
After device reprogramming to a threshold of 180 bpm, he
experienced no further defibrillator shocks. He never complained
of or experienced any post ICD storm PTSD symptoms and
retained a cheerful and positive outlook to his life.
Case #1
Case #2
Medtronic Sprint Fidelis lead (268,000 implanted
worldwide) underwent a FDA Class I device recall 15 Oct
2007 due to excessive lead fracture rates.
Specifically, chronic conductor fractures have occurred
involving Sprint Fidelis leads: 1) the distal portion of the
lead, affecting the anode (ring electrode) and 2) near the
anchoring sleeve tie-down, predominantly affecting the
cathode (helix tip electrode), and occasionally the high
voltage conductor.
High voltage conductor fractures resulted in inability to
deliver defibrillation therapy. Anode or cathode conductor
fractures (at either location) presents clinically as increased
impedance, oversensing (as in our case), increased interval
counts, multiple inappropriate shocks, and/or loss of pacing
output.
Based on Medtronic surveillance information as of Y2007,
there were identified five patient deaths in which a Sprint
Fidelis lead fracture were a possible or likely contributing
factor. Additionally, 665 chronic fractures were seen in
returned leads. Approximately 90% of these fractures
occurred in the anode or cathode conductors, while 10%
occurred in the high voltage conductors.
Considering the ICD as a system of systems, the lead is
the weakest link, since failure of the generator (software and
battery and circuit board) occurs at much lower rate than
lead failures. The average ICD lead while a miracle of
materials engineering may incorporate a total of 30
subcomponents in its manufacture.
Given the complexity of Defibrillator lead design and
construction, failure mode analysis may result in the ICD
being considered a ‘wicked problem’ , i.e., a problem that is
difficult or impossible to solve because of incomplete,
contradictory, and changing requirements that are often
difficult to recognize. This concept may well be extended to
include the individual psychological responses to ICD
‘storm.’
.
.
In Classical Conditioning theory repeated shocks
given by the ICD may be paired with previously
neutral environmental or behavioral stimuli
resulting in a conditioned response, i.e., anxiety
or fear.
In Learned Helplessness theory, ICD patents
feel they have no control over the delivery of
painful & disruptive shocks & develop
hopelessness & depression.
In cognitive appraisal theory, ICD shocks
represent a ‘sickness scorecard’ in which
presence of shocks represent a forecast of future
health. Under this last theory, higher levels of
shocks, such as ICD storm, are interpreted as
indicators of impending catastrophe and leads to
heightened anxiety & avoidance behavior.1
1 Understanding Implantable Cardioverter Defibrillator Shocks and Storms: Medical and
Psychosocial Considerations For Research and Clinical Care. S.F. Sears & J.B. Conti.
Clin. Cardiol. 26, 107–111 (2003)
2 Quality Of Life And Psychological Functioning Of ICD Patients. S.F. Sears & J.B.
Conti. Heart 2002;87:488–493
3. Posttraumatic stress and anxiety in patients with an implantable cardioverter
defibrillator: Trajectories and vulnerability factors.Habibović M, Denollet J, Pedersen
SS; WEBCARE investigators. Pacing Clin Electrophysiol. 2017 Apr 22.
4. Posttraumatic stress and quality of life with the totally subcutaneous compared to
conventional cardioverter defibrillator systems. Köbe J, Hucklenbroich K, Geisendörfer
N, Bettin M, Frommeyer G, Reinke F, Dechering D, Burgmer M, Eckardt L. Clin Res
Cardiol. 2017 May;106(5):317321.
5. Implementation of a Screening Program for Patients at Risk for Posttraumatic Stress
Disorder. Roberts CR, Wofford JE, Hoy HM, Faddis MN. Clin Med Insights Cardiol.
2016 Aug 8;10:12937.
6. Cognitive Behavioral Treatment of Posttraumatic Stress†in Patients With Implantable
Cardioverter Defibrillators: Results From a Randomized Controlled Trial. Ford J,
Rosman L, Wuensch K, Irvine J, Sears SF. J Trauma Stress. 2016 Aug;29(4):38892.
7. Left Ventricular Ejection Fraction Predicts Severity of Posttraumatic Stress Disorder
in Patients With Implantable Cardioverter Defibrillators. Sawatari H, Ohkusa T,
Rahamawati A, Ishikawa K, TsuchihashiMakayaM, Ohtsuka Y, Nakai M, Miyazono M,
Hashiguchi N, Chishaki H, Sakurada H, Mukai Y, Inoue S, Sunagawa K, Chishaki A.
Clin Cardiol. 2016 May;39(5):2638.
8. Cognitive behavioral therapy (CBT) in a Patient with Implantable Cardioverter
Defibrillator (ICD) and Posttraumatic stress disorder(PTSD). Ansari S, Arbabi M. Iran J
Psychiatry. 2014 Jul;9(3):1813.
9. Factors influencing psychological status and quality of life in patients with implantable
cardioverter defibrillators. Kajanová A, Bulava A, Eisenberger M. Neuro Endocrinol Lett.
2014;35 Suppl 1:548. Review.
10. Position paper on the importance of psychosocial factors in cardiology: Update
2013. Ladwig KH, Lederbogen F, Albus C, Angermann C, Borggrefe M, Fischer D,
Fritzsche K, Haass M, Jordan J, Jünger J, Kindermann I, Köllner V, Kuhn B, Scherer M,
Seyfarth M, Völler H, Waller C, HerrmannLingen C. Ger Med Sci. 2014 May 7;12:
11. Psychiatric functioning and quality of life in young patients with cardiac rhythm
devices. Webster G, Panek KA, Labella M, Taylor GA, Gauvreau K, Cecchin F,
Martuscello M, Walsh EP, Berul CI, DeMaso DR. Pediatrics. 2014 Apr;133(4):e96472
12. Synergistic application of cardiac sympathetic decentralization and comprehensive
psychiatric treatment in the management of anxiety and electrical storm. Khalsa SS,
Shahabi L, Ajijola OA, Bystritsky A, Naliboff BD, Shivkumar K. Front Integr Neurosci.
2014 Jan 2;7:98.
13. A randomized controlled trial of cognitive behavior therapy tailored to psychological
adaptation to an implantable cardioverter defibrillator. Irvine J, Firestone J, Ong L,
Cribbie R, Dorian P, Harris L, Ritvo P, Katz J, Newman D, Cameron D, Johnson S,
Bilanovic A, Hill A, O'Donnell S, Sears SJr. .Psychosom Med. 2011 Apr;73(3):22633.
14. Chronic posttraumatic stress and its predictors in patients living with an implantable
cardioverter defibrillator. von Känel R, Baumert J, Kolb C, Cho EY, Ladwig KH. J Affect
Disord. 2011 Jun;131(13): 34452.
15. Gender disparities in quality of life and psychological disturbance in patients with
implantable cardioverterdefibrillators. Rahmawati A, Chishaki A, Sawatari H,
TsuchihashiMakaya M, Ohtsuka Y, Nakai M, Miyazono M, Hashiguchi N, Sakurada H,
Takemoto M, Mukai Y, Inoue S, Sunagawa K, Chishaki H. Circ J. 2013;77(5):115865.
16. Posttraumatic stress 18 months following cardioverter defibrillator implantation:
shocks, anxiety, and personality. Habibović M, van den Broek KC, Alings M, Van der
Voort PH, Denollet J.
Health Psychol. 2012 Mar;31(2):18693.
17. Psychopathology in patients with ICDs over time: results of a prospective study.
Kapa S, RotondiTrevisan D, Mariano Z, Aves T, Irvine J, Dorian P, Hayes DL. Pacing
Clin Electrophysiol. 2010 Feb;33(2):198208.
18. Posttraumatic stress symptoms and predicted mortality in patients with implantable
cardioverterdefibrillators: results from the prospective living with an implanted
cardioverter defibrillator study. Ladwig KH, Baumert J, MartenMittag B, Kolb C, Zrenner
B, Schmitt C. Arch Gen Psychiatry. 2008 Nov;65(11):132430.
.
General Theories - Psychological
Adjustment to ICD Shock/‘Storm’
Cognitive Map of ICD Behavior on Psychological Function2
Psych
Social
Bio Spiritual
C
u
l
t
u
r
e
Technology
A Humanistic Model of Medicine
Select References From Literature Search

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Barcelona Case presentation

  • 1. Severe Post Traumatic Stress Disorder As A Consequence of Pacemaker/Defibrillator Dysfunction Due to Sprint Fidelis Lead Fracture - Case Report and Literature Review of ICD-induced Post Traumatic Stress Disorder Dr. Frank W Meissner MD1,Dr. Cynthia Garza, JD, MD2, Dr. Henry Wiseman, MD3 1TTUHSC Paul L. Foster School of Medicine, PGY-2 Psychiatry Resident, El Paso TX 2TTUHSC Paul L. Foster School of Medicine, PGY-3 Psychiatry Resident, El Paso TX 3TTUHSC Paul L. Foster School of Medicine, Residency Program Director Psychiatry, El Paso TX No Conflicts Of Interest AIMS Defibrillator therapy revolutionized the management of Heart Failure with Reduced EF (HFrEF) by reducing the numbers of deaths due to Sudden Cardiac Death (SCD). However this reduction in mortality can be accompanied by a dramatic reduction in the implanted patient’s quality of life if even a single clinically inappropriate defibrillator discharge occurs. Two illustrative case of dramatic defibrillator dysfunction causing ICD storm are presented. In spite of the similar course of the patient’s ICD storm; in one case, the patient was left with a debilitating and treatment resistant case of PTSD, while in the second case, the patient was entirely without long term stigmata as a consequence of his ICD storm. A focused literature review of defibrillator- induced PTSD is presented and discussed and an expository model of adjustment to ICD storm is presented, Methods Literature search of PubMed over the years 1980 - April 2017 was accomplished with use of the following search terms: ICD, implant*, cardiover*, PTSD . The resulting 41 papers could be organized in the following fashion: [case reports (5)], [technical solutions to reduce symptoms - RF Abalation (1) vs SubQ ICD Implantation (1) vs bilateral cardiac sympathetic denervation (1) vs lipophilic beta- blocker therapy (1)], [target population incidence/prevalence rates - Pediatric (2), Gender-based (1), Non-pediatric, Non-gender Based (6)], [screening for detection of existing PTSD in ICD patients (2)], [analysis of psychosocial factors associated with development of PTSD in ICD patients (5)], [therapy modalities for treatment of ICD induced PTSD [(2 CBT (Randomized Trials), (1 EMDR), (1 ad hoc interventions), (1 Psychotherapeutic Treatment),(1 Crisis Intervention)], [impact of PTSD development on overall mortality of ICD patients (2)], [‘Phantom shocks’ (2)], [Systematic Reviews (2)], [Subjective Patient Reports (2)], [Practice Guidelines (2 both in German)]. Results In one case our patient was in his 8th decade of life, Caucasian, college-educated, well traveled, financially well off, agnostic, who retired from a professional career as an electrical engineer, and was on track to live out an average life span given his advanced age at the time of ICD implantation. The contrasting case, was young, Hispanic, high-school educated, not at all traveled, financially dependent on working 40-hr weeks, a devout Catholic, who had an expectation of a dramatically reduced life-span. What factors could have been in play that protected the second patient from PTSD and failed to protect the first patient from the life altering effects of his ICD storm? The available literature details pre-morbid risk factors which play a factor in predicting the occurrence of PTSD in patients with an ICD storm. The side panel entitled ‘Humanistic Model of Medicine’ makes the point that any medical therapy, even one as highly sophisticated as ICD function and ICD - human interactions must be interpreted in the context of the patient’s culture, the availability of technological solutions and the patient’s individualistic concepts of spirit and spirituality as well as the more classical bio-social-psychological factors seen in medical practice. Perhaps no medical device or therapy emphasizes the relationships between a patient’s concepts of mortality and his/hers acceptance or rejection of mankind intrinsic time limits/ length of liife. Pre-implantation personality characteristics have been shown to be important in predicting a subsequent risk of PTSD development, for example the presence of the so- called Type D personality. However, although authors have claimed that identification of these types of patients is important pre-implantation and they have recommend personalized support to those at risk (the young, the depressed, and the Type D personality) no study has demonstrated that aggressive pre-implantation interventions result in a different clinical trajectory for patient’s with and without the markers of increased risk for development of post-implantation PTSD. However within the context of this case, non-psychological factors may have had a deterministic impact on these two patients diametrical clinical trajectories. Specifically, Patient B’s ICD storm was a direct consequence of poor device programming and once corrected the patient held a defensible belief that he would not be further troubled by ICD storm. The other patient had a uniquely troubling ICD storm based on lead failure combined with AV node modification/ablation, with a high probability of persistent problems without technical modification of the device and its leads. Patient B as a consequence of his strong religious faith had an accepting but hopeful orientation to his cardiac disease(s); he was in brief able to endure with heroic equanimity the ‘slings and arrows of outrageous fortune.’ Patient A, had a psychological worldview best characterized as cynical, unaccepting, and pessimistic. Furthermore, his ICD storm experiences were socially isolated in ways Patient B’s never were. Patient B had a wide circle of supportive friends and relatives. Patient A had outlived all his close friends and his wife was herself in tenuous health. Patient A ’s etiology for HF was due to progressive coronary artery disease, patient’s B pathologically reduced EF less clearly defined and in fact was never definitively determined. Conclusions 1. A multitude of dynamic interacting factors (psychological, physiological, social, spiritual, and technological) resulted in divergent clinical outcomes in spite of near identical clinical circumstances as determined by the technical analysis of the devices functioning. Given the enhanced understanding of the interplay of all factors noted in our conceptual model, we are able to rationalize the observed differences in the psychological responses to CBT of Patient A and Patient B. 2. In accounting and/or accurately predicting divergent responses to therapies aimed at reducing the likelihood of PTSD post-implantation consideration of all relevant factors (as outlined in our conceptual model) is necessary. A 70 year old Caucasian male underwent dual chamber ICD implantation three years prior to his emergency clinical evaluation by the principle author. He had a Sprint Fidelis lead implanted in combination with his Meditronic Dual Chamber ICD done in combination with AV nodal ablation, making him pacemaker dependent. According to Medtronic follow up data, the Fidelis lead failure probabilities transition at 3 years from an exponential to linear pattern, with a stabilized probability of lead failure of 4.5% per year. Our patient presented to the Emergency Department since his fractured lead resulted in false sensing of biological myotonic electrical signals and the embedded defibrillator logic interpreted the myotonic electrical activity as ventricular fibrillation. Consequently defibrillator shock was delivered and his ICD subsequently paced asynchronously at 60 beats per minute at maximum electrical output for the 1st minute post defibrillator shock. Once the period of asynchronous pacing was completed the device then looked for evidence of spontaneous QRS complexes, it then mischaracterized the self same myoclonic potentials as spontaneous heart beats and so stopped pacing the patient inducing severe dizziness and near syncope due to the failure of his spontaneous atrial beats to traverse the ablated A-V node. His syncope was then punctuated by another defibrillator discharge as the ICD again misclassified the situation. This terrifying cycle of complex mutually exclusive misinterpretations of the lead failure resulted in more than one hour of alternating near syncope followed in short order by full discharge cardiac defibrillation. Once in the Emergency Department, Cardiology was called and the device placed into asynchronous pacing mode at 70 beats per minute and the defibrillator function inactivated. However, as a consequence of the greater than 30 defibrillation events the patient was left with a highly resistant case of post traumatic stress disorder. A 30 year old Hispanic male with idiopathic cardiomyopathy and a LVEF less than 30% underwent prophylactic ICD implantation. He continued to work as a security guard in a grade school. Shortly after implantation of the defibrillator, he responded to a altercation involving two eighth graders. The implanting Electrophysiologist for unknown reasons programmed the device threshold for defibrillation at any heart rate > 100 bpm. While running to respond to the altercation his heart rate understandably and predictably exceeded 100 bpm. He subsequently experienced the rapid delivery of approximately 30 full energy defibrillator shocks (40 joules delivered energy) over the course of 15 minutes. The excess number of defibrillator shocks occurred because the pain from the defibrillator events kept his heart rate greater than 100 bpm. After device reprogramming to a threshold of 180 bpm, he experienced no further defibrillator shocks. He never complained of or experienced any post ICD storm PTSD symptoms and retained a cheerful and positive outlook to his life. Case #1 Case #2 Medtronic Sprint Fidelis lead (268,000 implanted worldwide) underwent a FDA Class I device recall 15 Oct 2007 due to excessive lead fracture rates. Specifically, chronic conductor fractures have occurred involving Sprint Fidelis leads: 1) the distal portion of the lead, affecting the anode (ring electrode) and 2) near the anchoring sleeve tie-down, predominantly affecting the cathode (helix tip electrode), and occasionally the high voltage conductor. High voltage conductor fractures resulted in inability to deliver defibrillation therapy. Anode or cathode conductor fractures (at either location) presents clinically as increased impedance, oversensing (as in our case), increased interval counts, multiple inappropriate shocks, and/or loss of pacing output. Based on Medtronic surveillance information as of Y2007, there were identified five patient deaths in which a Sprint Fidelis lead fracture were a possible or likely contributing factor. Additionally, 665 chronic fractures were seen in returned leads. Approximately 90% of these fractures occurred in the anode or cathode conductors, while 10% occurred in the high voltage conductors. Considering the ICD as a system of systems, the lead is the weakest link, since failure of the generator (software and battery and circuit board) occurs at much lower rate than lead failures. The average ICD lead while a miracle of materials engineering may incorporate a total of 30 subcomponents in its manufacture. Given the complexity of Defibrillator lead design and construction, failure mode analysis may result in the ICD being considered a ‘wicked problem’ , i.e., a problem that is difficult or impossible to solve because of incomplete, contradictory, and changing requirements that are often difficult to recognize. This concept may well be extended to include the individual psychological responses to ICD ‘storm.’ . . In Classical Conditioning theory repeated shocks given by the ICD may be paired with previously neutral environmental or behavioral stimuli resulting in a conditioned response, i.e., anxiety or fear. In Learned Helplessness theory, ICD patents feel they have no control over the delivery of painful & disruptive shocks & develop hopelessness & depression. In cognitive appraisal theory, ICD shocks represent a ‘sickness scorecard’ in which presence of shocks represent a forecast of future health. Under this last theory, higher levels of shocks, such as ICD storm, are interpreted as indicators of impending catastrophe and leads to heightened anxiety & avoidance behavior.1 1 Understanding Implantable Cardioverter Defibrillator Shocks and Storms: Medical and Psychosocial Considerations For Research and Clinical Care. S.F. Sears & J.B. Conti. Clin. Cardiol. 26, 107–111 (2003) 2 Quality Of Life And Psychological Functioning Of ICD Patients. S.F. Sears & J.B. Conti. Heart 2002;87:488–493 3. Posttraumatic stress and anxiety in patients with an implantable cardioverter defibrillator: Trajectories and vulnerability factors.Habibović M, Denollet J, Pedersen SS; WEBCARE investigators. Pacing Clin Electrophysiol. 2017 Apr 22. 4. Posttraumatic stress and quality of life with the totally subcutaneous compared to conventional cardioverter defibrillator systems. Köbe J, Hucklenbroich K, Geisendörfer N, Bettin M, Frommeyer G, Reinke F, Dechering D, Burgmer M, Eckardt L. Clin Res Cardiol. 2017 May;106(5):317321. 5. Implementation of a Screening Program for Patients at Risk for Posttraumatic Stress Disorder. Roberts CR, Wofford JE, Hoy HM, Faddis MN. Clin Med Insights Cardiol. 2016 Aug 8;10:12937. 6. Cognitive Behavioral Treatment of Posttraumatic Stress†in Patients With Implantable Cardioverter Defibrillators: Results From a Randomized Controlled Trial. Ford J, Rosman L, Wuensch K, Irvine J, Sears SF. J Trauma Stress. 2016 Aug;29(4):38892. 7. Left Ventricular Ejection Fraction Predicts Severity of Posttraumatic Stress Disorder in Patients With Implantable Cardioverter Defibrillators. Sawatari H, Ohkusa T, Rahamawati A, Ishikawa K, TsuchihashiMakayaM, Ohtsuka Y, Nakai M, Miyazono M, Hashiguchi N, Chishaki H, Sakurada H, Mukai Y, Inoue S, Sunagawa K, Chishaki A. Clin Cardiol. 2016 May;39(5):2638. 8. Cognitive behavioral therapy (CBT) in a Patient with Implantable Cardioverter Defibrillator (ICD) and Posttraumatic stress disorder(PTSD). Ansari S, Arbabi M. Iran J Psychiatry. 2014 Jul;9(3):1813. 9. Factors influencing psychological status and quality of life in patients with implantable cardioverter defibrillators. Kajanová A, Bulava A, Eisenberger M. Neuro Endocrinol Lett. 2014;35 Suppl 1:548. Review. 10. Position paper on the importance of psychosocial factors in cardiology: Update 2013. Ladwig KH, Lederbogen F, Albus C, Angermann C, Borggrefe M, Fischer D, Fritzsche K, Haass M, Jordan J, Jünger J, Kindermann I, Köllner V, Kuhn B, Scherer M, Seyfarth M, Völler H, Waller C, HerrmannLingen C. Ger Med Sci. 2014 May 7;12: 11. Psychiatric functioning and quality of life in young patients with cardiac rhythm devices. Webster G, Panek KA, Labella M, Taylor GA, Gauvreau K, Cecchin F, Martuscello M, Walsh EP, Berul CI, DeMaso DR. Pediatrics. 2014 Apr;133(4):e96472 12. Synergistic application of cardiac sympathetic decentralization and comprehensive psychiatric treatment in the management of anxiety and electrical storm. Khalsa SS, Shahabi L, Ajijola OA, Bystritsky A, Naliboff BD, Shivkumar K. Front Integr Neurosci. 2014 Jan 2;7:98. 13. A randomized controlled trial of cognitive behavior therapy tailored to psychological adaptation to an implantable cardioverter defibrillator. Irvine J, Firestone J, Ong L, Cribbie R, Dorian P, Harris L, Ritvo P, Katz J, Newman D, Cameron D, Johnson S, Bilanovic A, Hill A, O'Donnell S, Sears SJr. .Psychosom Med. 2011 Apr;73(3):22633. 14. Chronic posttraumatic stress and its predictors in patients living with an implantable cardioverter defibrillator. von Känel R, Baumert J, Kolb C, Cho EY, Ladwig KH. J Affect Disord. 2011 Jun;131(13): 34452. 15. Gender disparities in quality of life and psychological disturbance in patients with implantable cardioverterdefibrillators. Rahmawati A, Chishaki A, Sawatari H, TsuchihashiMakaya M, Ohtsuka Y, Nakai M, Miyazono M, Hashiguchi N, Sakurada H, Takemoto M, Mukai Y, Inoue S, Sunagawa K, Chishaki H. Circ J. 2013;77(5):115865. 16. Posttraumatic stress 18 months following cardioverter defibrillator implantation: shocks, anxiety, and personality. Habibović M, van den Broek KC, Alings M, Van der Voort PH, Denollet J. Health Psychol. 2012 Mar;31(2):18693. 17. Psychopathology in patients with ICDs over time: results of a prospective study. Kapa S, RotondiTrevisan D, Mariano Z, Aves T, Irvine J, Dorian P, Hayes DL. Pacing Clin Electrophysiol. 2010 Feb;33(2):198208. 18. Posttraumatic stress symptoms and predicted mortality in patients with implantable cardioverterdefibrillators: results from the prospective living with an implanted cardioverter defibrillator study. Ladwig KH, Baumert J, MartenMittag B, Kolb C, Zrenner B, Schmitt C. Arch Gen Psychiatry. 2008 Nov;65(11):132430. . General Theories - Psychological Adjustment to ICD Shock/‘Storm’ Cognitive Map of ICD Behavior on Psychological Function2 Psych Social Bio Spiritual C u l t u r e Technology A Humanistic Model of Medicine Select References From Literature Search