Wearable Defibrillators

Frequency and implications of ischemia prior to ventricular tachyarrhythmia in patients treated

with a wearable cardioverter defibrillator following myocardial infarction
David E. Kandzari is an employee of Zoll Medical Corporation
- treated for VT/VF over 6 yr period while wearing WCD following acute MI with EF < 35% from
5/2008 to 5/20014
- ST-segment changes > 0.1 before VT/VF compared to ST-segment changes during the fitting
- 273 patients fulfilling study criteria
- 15.4% had ischemia prior to VT/VF. ST segment depression present in 86%.
- termination of VT/VF by WCD treatment approximated 96% in both groups
- survival 24 hrs post-treatment was 88% and 84% (p=0.54) for patients with and without
ischemic VT/VF
- 30 day cumulative survival for those with and without ischemic VT/VF was 77% and 70%
(p=0.57)
- ECG recordings analyzed by ZOLL ECG technician
- EF average of 27.6 and 25.5% in patients with and without ischemic VT/VF
- revascularization performed in 79% of patients with ischemic VT/VF and 69% of patients
without ischemic VT (p=0.2)
- >20% had prior MI in addition to the index MI for which the WCD was prescribed
- index MI to WCD prescription was 4 days
- median daily use of 23.7 hours in patients with ischemic VT/VF and 23.6 hrs in patients with
nonischemic VT/VF
- median time from index MI to first shock was 18 days (5-126 days) in patients with ischemic
VT/VF compared to 16 days in patients with nonischemic VT/VF
- 42 ischemic VT/VF had 47 shock events during which they received 106 appropriate shocks;
103 successfully terminated VT/VF and the remaining 3 were unsuccessful with shock
conversion success rate of 97%
- For those with unsuccessful shocks, 2 converted to slower rhythm spontaneously and third
received additional resuscitation from bystanders. All 3 patients survived > 24 hrs post
treatment.
- For group of 42 with ischemic VT/VF, 56% of shocks delivered when the rhythm prior to
treatment was sustained VT and remaining shocks treated VF rhythmAverage number of
shocks per patient 2.5, range 1-19 with 47% of patients treated by > 2 shocks. 37/42 patients
survived > 24 hrs post treatment with survival rate of 88%
- 231 patients without ischemic VT/VF had 243 shock events, received 490 appropriate
shocks, 472 successfully terminated VT/VF, 8 were unsuccessful, 4 led to asystole, and
treatment outcomes unknown in 6, with shock conversion success rate of 96% in group
(p=0.67). For the 8 patients with unsuccessful shocks, 5 received advanced resuscitation
from emergency responders, 2 had device disconnected, 1 spontaneously converted to a
slower rhythm. 5 of the 8 patients survived > 24 hrs post treatment. 52% of the shocks
delivered was sustained VT (p=0.47). Average number of shocks per patient 2.1 per hour
post treatment 24 hr survival rate of 84% (195 of 231) (p=0.54)
- Reasons for WCD end of use in ischemic VT/VF group included icd therapy (59.5%), death
(28.5%) and other (12%). Among patients who died, median time from start of WCD use to
death was 12.5 days (3-120)
- Reasons for WCD end of use in nonischemic VT/VF group included 135 pts received ICD
(58.5%), 59 patients died (25.5%), other 37 (16%). Median time to death was 17 days (1-195
days)
- Survival evaluated in first 30 days. In 30 day interval, cumulative survival 77% and 70%
respectively (p=0.57)
- Electrical storm > 3 WCD shocks in 24 hr time period associated with lower survival OR 0.32
(0.12-0.9, p=0.03)

Other facts
- VALIANT or Valsartan in acute MI rate of SCD 2.3% within 30 days following an MI
- DINAMIT and IRIS trials early ICD following MI had neutral survival impact because reduced
risk of SC was offset by an increased risk of nonarrhythmic mortality
- ICD implantation waiting periods of 40 days after MI if no revascularization is performed or 90
days when revascularization is performed
- 1.6% of 8543 patients wearing WCD received treatment for life-threatening ventricular
arrhythmias and shocks occurred at a rate of 0.006 per patient month of use
- In VALIANT, 105 autopsied subjects, 28 (26%) died of recurrent MI, 13 (12%) died of cardiac
rupture, 3 (2.8%) died due to index MI, remaining 54 (51%) presumably due to arrhythmia

Study limitations
- retrospective
- did not evaluate other arrhythmias as a cause of death
- current analyses derived from the manufacturer’s datbase
- ischemia evaluated using 2-lead orthogonal system
- “ischemia may have been the trigger of VT/VF even without visible ST-segment changes”
- “ST-segment changes may occur without true ischemia”
- deaths not tracked after WCD was taken off of the patient
- “The authors express their gratitude to Steven J. Szymkiewicz, MD, and Robin Lynn, EMT-P,
of ZOLL Medical Corporation for edits to an earlier version of the manuscript and analysis of
electrocardiographic recordings, respectively
- No comment on deaths in patients who were not using the WCD

Early Risk of Mortality after Coronary Artery Revascularization in Patients with Left Ventricular
Dysfunction and Potential Role of the Wearable Cardioverter Defibrillator
Edwin T. Zishiri
- mortality hazard higher among 4149 patients discharged without a debrillator compared to
809 with WCDs (90 day mortality post cabg 7% vs 3% p=0.03; post-PCI 10% vs 2%
p<0.0001
- WCD use associated with adjusted lower risks of long termmortality in total cohort (35%,
p<0.0001) in post-cabg (38%, [=0.048_ and post-PCI (57%, p<0.0001) cohorts (mean f/u 3.2
yrs)
- WCD use remained associated with lower mortality (58% post CABG p=0.002; 67% post PCI
p<0.0001)
- only 1.3% of WCD group had documented appropriate therapy
- retrospective observational parallel cohort study; obtained from prospectiely collected
registries of all patients who undergo cardiac surgery and PCI at Cleveland Clinic and from
national database of all patients issued WCD post-market release in US. Study period for
inclusion 8/1/2002 to 12/31/2009
- No WCD revascularization subjects - included if they underwent CABG/PCI, had EF < 35%,
survived to hospital discharge. Exclusionary criteria included preexisting ICD, ICD
implantation before discharge after CABG or PCI, WCD issued at discharge, absence of
social security number to determine social security death index mortality status.
- WCD revascularization subjects all post cabg or PCI
- mean duration of use 79 days after cabg
- mean duration of use 81 days after PCI
- 1480/4958 subjects (30%) died (follow up 3.2 years, median 2.8 years)
- In the No WCD group, 1399/4149 subjects (34%) died; 81/809 (10%) died in WCD group.
- In the PCI cohorts, 763/1951 (39%) no wcd and 31/288 (11%) wcd patients died
- In CABG cohorts 636/2198) no wcd and 19/226 (8.4%) wcd patients died
- 90 day mortality 324/4149 (7.8%) in no wcd and 18/809 (2.2%) in wcd patients p<0.0001
- In PCI cohorts 90 day mortality was 189/1951 (9.7%) in no wcd and 5/288 (1.7%) in wcd
patients p < 0.0001
- In cabg cohorts 90 day mortality was 135/2198 (6.1%) in no wcd and 7/226 (3.1%) in wcd
patients p = 0.064
- WCD use associated with 38.6% lower risk of long term mortality with HR 0.601 ci
0.476-0.957
- other predictors of long-term mortality included age, dm, female gender, lower ef
- HR 0.54 in first 90 days comparing WCD to No WCD group
- Mortality at 90 days was 2% in WCD and 7% in No WCD group
- HR 0.74 ci 0.57-0.97 p = 0.027 in 90 day mortality group
- In cabg patients, HR 0.596 ci 0.372-0.957 p = 0.03, 1st 90 days HR 0.61, ci 0.39-0.97, p=0.03
- in pci group, HR 0.405 p < 0.0001; wcd compared to no wcd in first 90 days HR 0.45 ci
0.31-0.66, p<0.0001
- 18 appropriate defibrillations occurred in 11 patients (1.3% of WCD group) for VT/VF;
defibrillations successful in 12/18 shocks; one patient required 8 shocks for 2 separate VT
episodes; inappropriate shocks numbered 13 (42% of total therapies) 3 for afib/aflutter, one
for sinus tach at 180 bmp and 9 for sensing channel noise
- Of 3 asystolic events, 2 were fatal
- surviving patient had a transient self-terminating 10 second episode
- 1st patient who died had VT at 150-170 bmp under VT detection criterion programmed at 180
bpm
- second patient had idioventricular rhythm at 55 that slowed down to asystolie
- In the wcd database, 32% of cabg and 30% of PIC underwent ICD implantation

Limitations
- those that wear WCD may have better medical care or insurance
- WCD patients were younger (63 vs 66), had lower EF’s (EF 24 vs 27), had more diabetes
- Times since 1/1/2002 to index revascularization procedures longer in WCD groups
- Patients willing to have an WCD may be more adherent to medical treatment
- No mention of patients who died not wearing the WCD

Other
- In 348,341 cabg patients > 65 years old, mortality 7.6% at 30 days, 18.5% at 1 year in
patients with EF < 30%

American heart association

- “Because there is a paucity of prospective data supporting the use of the WCD, particularly
the absence of any published, randomized, clinical trials, the recommnedations provided in
this advisory are not intended to be prescriptive or to suggest an evidence-based approach to
the management of patients with FDA-approved indications for use. Instead, these
recommendations are offered to provide clinicians direction when discussing this therapy with
 patients. It is our opinion that the final decision on the use of the WCD should be based on
shared decision making, which would include a frank risk benefit discussion between the
clinician and the patient that acknowledges the uncertainty surrounding the efficacy and
safety of the WCD.”
- Indications for ICD: LVEF < 0.35 combined with NYHA class II-III despite long-term medical
therapy or prior MI and EF < 0.3, NYHA functional class IV, absence of severe heart failure, >
40 days from MI
- After revascularization and medical management, 50% of patients post MI improve after 3
months; 50% improve by 10% in patients with nonischemic cardiomyopathy after medical
management
- Immediate Risk Stratification Improves Survival (IRIS) mandated EF < 40% and resting HR >
90 bpm or NSVT > 150 bpm on Holter monitoring
- No RCT’s have compared early ICD implantation with standard medical therapy in
nonischemic cardiomyopathy
- SCD-HEFT excluded patients with cardiomyopathy of < 3 months who had not received
guideline directed medical therapy
- In VALIANT, EF < 0.3 after MI followed median of 24.7 mo, 21T of SCD occurred within 30
days after MI (51% were possibly arrhythmic)
- Cardiomyopathy trial (CAT) patients with recently diagnosed dilated cardiomyopathy EF < 0.3
had no measureable benefit from ICD
- RCT trial of AED in home failed to provide any survival benefit
- Adverse event rates associated with ICD implantation range 1.3-11% including bleeding, lead
dislodgement, PTX, cardiac perforation, acute infection, and death (0.4%-1.2%), long term
morbidity include component failure, lead dysfunction, inappropriate shocks, vascular
occlusion, infection, lead longevity 85% at 5-10 years after implantation
- subcutaneous ICD has issues with lead dislodgement (2.5%), skin erosion (1.7%), infection
(5.9%), 13% incidence of inappropriate shocks, unclear of subq ICD better than intracardiac

WCD: JACC
- consists of wearable garment and battery powered monitor defibrillator
- garment sized to the patient’s chest circumference and weight, is worn underneath the skin
- contains sensing and defibrillation electrodes
- 4-electrode 2-lead system located in belt of garment, used to record surface ECGs for
morphology analysis and detection of arrhythmia
- WCD use analog and digital filters, algorithms, to recognize electromagnetic interference and
other sources of noice, exhibit a sensitivity of 80-100% and specificity of 98-99%
- inappropriate shock rates in early studies were 1-2%
- once detection has occurred, device initiates patient responsiveness testing, incorporates
vibratory, audible, and visual alerts. If pt presses response button, episode is aborted
- if no patient response is recorded, defib electrodes discharge gel onto skin and ultimately
deliver a shock via an apex-posterior vector
- detection to shock can take between 25-60 seconds
- WCD shock energies range between 75 and 150 J biphasic
- shock efficacy rates between 69% and 99%
- able to deliver up to 5 shocks
- once device has treated an episode of arrhythmia, garment and electrodes must be replaced
- relative contraindications: patients with unipolar pacing (atrial or ventricular) cannot use WCD
because large amplitude pacing stimuli can interfere with arrhythmia detection, patients who
cannot detect or respond to patient responsiveness testing stimuli
- limitations: no pacing capabilities, uncomfortable, difficult to fit obese patients, open chest
wounds make it difficult, compliance
- pain and cutaneous burns related to shock
- “no completed randomized trials of WCD therapy” “Thus, no definitive data area available on
comparative efficacy versus alternative (or no) treatment.”
- Pts instructed to wear their device at all times except when showering or bathing
- discontinuation rates as high as 22% have been reported, resulting from patient comfort and
lifestyle concerns
- in largest observational series to date, daily use was > 90% in more than half of the cohort,
device discontinuation rate was 14%
- VEST prevention of early sudden death trial and registry still pending RCT patients within 7
days of MI with EF < 0.35
- IIa, C indications: waiting for heart transplantation, ICD removed due to infection
- IIb, C indications: waiting for ICD s/p revascularization, nonischemic dilated cardiomyopathy
in patients starting guideline directed medical therapy or secondary cardiomyopathy in which
underlying cause is potentially treatable (tachycardia mediated, thyroid mediated)
- IIb, C, no mortality benefit, but shown to decrease SCD, within 40 days of MI
- III not to be used when nonarrhythmic risks exceed risks of arrythmia, when patient’s
prognosis poor, < 6 mo
- consider if high-grade ventricular ectopy or NSVT
- infection of ICD 1-2%
- cost of care: 1% may benefit, so if it costs $10,000, requires $1 million

WEARIT and BIROAD

- wearable defibrillator investigative trial and bridge to ICD in patients at risk of arrhythmic
death or WEARIT and BIROAD study
- WEARIT study: enrolled patients with symptomatic heart failure NYHA class III-IV and LVEF <
0.3, considered high risk, but did not meet eligibility requirements for an ICD
- BIROAD study enrolled patients who were perceived to be at high risk for sudden death and
within 4 months of MI or surgical revascularization; specific reasons for consideration of WCD
included, but no limited to VT/VF within 48 hrs of CABG, EF < 0.3 after cabg, syncope after
cabg, patient refusal of ICD
- Enrolled 289 patients, 6/8 WCD defibrillation attempts were successful
- 12 deaths, sudden, half of which occurred in patients who wear not wearing the device as
instructed
- 25% or 68/289 discontinued wearing the device due to discomfort or adverse reactions

Manufacturer registry 2002-2006

- 2002-2006 manufacturer registry 3569 pts wore wcd for 1 day, WCD discontinuation occurred
in 14%
- indications for WCD included ICD explantation (23%), ventricular arrhythmia before planned
ICD implantation (16%), recent MI (16%), post cabg status (9%) and recent diagnosis of
cardiomyopathy with EF < 0.35 (28%)
- total of 143643 patient years, 80 sustained VT/VF events in 59 patients (1.7%/patient-year)
- most events occurred in patients with explanted device
- first-shock efficacy was 99% (79 of 80) and post VT/VF survival was 90% (72 of 80)
- Many sudden cardiac arrests attributable to non-VT/VF events (25%) including 23 asystole
events
- compared with single center cohort of patients receiving ICDs (1996-2004), mortality rate of
3.6% vs 4.4% at 3 months p=0.256
- 2% of WCD patients received inappropriate shock rate of 1.4%/mo
- reasons for inappropriate shocks: signal noise (68%), svt (27%), nsvt (6%), oversensing of
normal cardiac signals (4%), ECG signal loss (4%) failure to activate response button
- inappropriate shock rate can reach 1.9% to 5.9% within 2-3 mo
- ICD shock rates demonstrated to be 13% over 41 months
- 8453 patients within 90 days of MI (median time from AMI 16 days; 62% of patients
revascularized, 77% with EF < 0.3), 1.6% patients received appropriate shocks

Peripartum cardiomyopathy
- mortality rates 2-56%, half of events occurring within 12 weeks of delivery
- recovery of ventricular function occurs in 30-50% of patients, often within 6 mo of diagnosis
- however, SCD prevalence in this population not well described

Other
- myocarditis, stress cardiomyopathy, tachycardia mediated, thyroid mediated, trastuzumab,
anemia related, recovery is relatively likely and role of WCDs may be limited to patients with
high risk features or in secondary prevention
- alcohol, methamphetamine cardiomyopathies: may consider WCD to assess adherence
- WCD may be helpful in patients with difficult to assess prognosis, if able to survive > 1
year ,and additional time may clarify expectations for future survival and quality of life
- ICD on hold given noncardiac co-morbidities, WCD may allow more time to understand the
severity and reversibility of such comorbidity (anoxic brain injury, acute kidney injury, copd
exacerbation, cancer)
- some patients may need time before considering ICD

Limitations
- “Although WCD therapy is increasingly used in clinical practice, at present only preliminary
data exist on the actual effectiveness of this intervention in improving survival among patients
who are at risk for SCD. Accordingly, this science advisory provides a tentative interim
framework to assist in decision making until more definitive studies are available.”

Wearable Cardioverter-Defibrillator use in patients perceived to be at high risk early post-

myocardial infarction Journal of ACC Vol 62 Nov 21 13
- “recent MI with EF 35%” or ICD-9 code of acute MI
- between 9/2005 and 7/2011
- 8453 patients mean age 62.7, 73% male
- 133 patients (1.6%) received 309 appropriate shocks during 149 shock events; 252
successfully terminated VT/VF, 9 led to asystole, 41 unsuccessful, 1 each resulted in nsvt and
svt, rhythm outcomes unknown in 5
- of those shocked 91% resuscitated from ventricular arrhythmia
- For shocked patients, LVEF 30% in 106, 30-35% in 17 , > 36% in 8, and not reported in 2
patients
- Of 38% of patients not revascularized, 84% had LVEF 30%, of 62% patients revascularized,
77% had EF 30%
- median time from index MI to WCD therapy was 16 days; from MI to prescription 9 days
- Of treated patients, 75% received treatment in 1st month, 96% within first 3 mo of use
- Shock success resulting in survival was 84% in nonrevascularized and 95% in revascularized
patients (duration of survival unclear)
- database includes indications, baseline demographics, compliance, end of use reasons,
events
- WCD consists of 3 defibrillation electrode pads, 4 sensing electrodes, vibration box,
defibrillation unit
- threshold rates programmable with VF zone programmable between 120 and 250 beats/min
and VT zone programmable between 120 beats/min and VF detection rate
- when arrhythmia detected and after 10 second delay, escalating alarm sequence starts with
vibrational pulses against skin and proceeds to add audible alerts and voice prompts
- ir response buttons not pressed, up to 5 150 J biphasic shocks delivered and EKG stored
- shocks deemed appropriate if they occurred during sustained > 30 s VT/VF
- cause of inappropriate detection and reason for lack of proper response button use reviewed
- all appropriate shocks occurring within 24 hr period considered 1 event (“shock event”) and
same with inappropriate shocks
- WCD prescribed for 8,678 patients post mi; 225 (2.6%) were not fitted with device or did not
wear it due to death, deteriorating condition, insurance noncoverage, implantation of icd, for
unknown reasons, leaving 8453 patients who were fitted with WCD and wore it for at least 15
min
- mean length of use was 69 days, median daily use was 21.8 hours
- 252 (2.9%) successful terminations in 8453 patients
- 84530000/252 = $335437
- 84530000/146 shock events = $578973
- 134 appropriate shocks occurred in 121 patients that resulted in survival (conscious at time
after shock); 12 patients did not survive (92% survival per event, 91% per patient) of these
initial survivors, 3 died within 2 days after shock delivery, and 41 died at a time remote from
shock delivery (>3 days) leading to a 78 (0.9%) patients ultimately being saved from lifevest
- $1,083,717 per life saved
- Average number of shocks per event: 2
- VT not consistently detected in 2 events due to rate falling below VT threshold; neither patient
survived
- A 3rd VT/VF event not detected due to signal artifact; patient died
- Bradycardia or asystole events not associated with VT/VF responsible for 34 additional
deaths (0.4% of patients)
- 99 patients received 114 inappropriate shocks, which did not induce arrhythmias, or lead to
burns; only caused pain; occurred in 102 shock events; in combination with universal lack of
proper response button use to prevent shock, were due to electrical oversensing (15), noise
artifact (62), detection of svt (21), nsvt (3), other causes (1)
- inappropriate shock rate 0.006 shocks per patient month of use
- for those who received appropriate shock, mean length of WCD use 31 days and length of
use after appropriate shock was 8 days, average time from WCD prescription to first shock
delivery was 22 days, 75% of first shock occurring in first 30 days and 96% occurring in first
90 days; after time from index MI to first treatment 30 days and from revascularization to first
treatment 26 days; time from MI to WCD was 7 days for both nonrevascularized and
revascularized patients
- after time from WCD start to death was 202 days; 1st treatment to death was 175 days
- Follow up time to assess for mortality for those not dead was 900 days
- 3, 6, 12 mo survival rates were 96%, 94%, 93%
- shocked patients who survived initial event had 1 year survival of 71%
- overall mortality rate 4% at 3 mo
- mortality 1 year after treatment 29%

Valiant study
- 14,703 patients randomized to receive valsartan, aptopril, or both after MI complicated by
heart failure, low LVEF, or both
- 7% died suddenly or were resuscitated from cardiac arrest at median time of 180 days during
median follow up of 24.7 mo
- cumulative event rate 1.4% (19% of events in trial) in first 30 days, 2.5% between 1 and 6
months
- Of those resuscitated in 1st month, 74% were alive 1 year later
- risk of death 4-6 times higher than those without heart failure
- 51 patients had specific findings of recurrent MI (31) or cardiac rupture (13) that otherwise
their death would have been considered from arrhythmia

Dinamit
- EF35%
- randomized to OMT with or without an ICD
- survival identical
- annual mortality rate for both control and icd groups 7.2% or 1.8% in first 3 mo (using linear
extrapolation)
- index MI to randomization 18 days and average of 6 more days to ICD implantation (24 days)
- mortality 30% at 1 year

IRIS study
- patients with Ef 40% and HR > 90 beats/min with or without NSVT 5-31 days post MI on OMT
randomized to receive ICD or not
- no survival benefit
- 11.6% died during first year of follow up or 2.9% in first 3 mo (using linear extrapolation)
- 91.1% of patients who received ICD did so in index hospitalization

MADIT II trial
- 1 mo post MI waiting period and 3 mo if revascularized, icd benefit only occurred 9 mo after
radnomization in the trial
- at 3 mo following enrollment, 4% of patient had died in both ICD and medical therapy group
- survival curves only began to diverge at 9 mo
- in longterm follow-up only if implantation occurred > 18 months from last MI was ICD benefit
apparent
- mortality 20% 1 year after appropriate therapy

REFINE: LVEF improvement 18% at 8 weeks

HEART: 66% patients had improvement in LVEF by day 90

Chunt et al on WCD
- 3569 patients wearing device, daily use 19.9 hours and >90% of the day in 52% of the
patients
- Although first-shock success 100%, 8 pts died after successful shock therapy
- asystole occurred in 23 patients (0.6%) of whom 17 died, PEA occurred in 2, respiratory
arrest occurred in 1. Represented 24.5% of SCAs
AED
- 75% of cardiac arrest occur at home and most without witness to deploy device
- home AED did not improve overall survival

Limitations
- unclear how many patients were nonadherent to treatment
- cost effectiveness could not be assessed
- key information such as management and outcomes of patients resuscitated by the WCD
were not known