Table 1 Summary of included studies

Bilanovic et al. (2013) [37]

Canada

Qualitative

To explore experiences of phantom shocks in ICD recipients

Quantitative

To describe psychosocial correlates of objective and phantom shocks

Mixed Methods

Qualitative

Interpretive phenomenology

Quantitative

Cross-sectional descriptive correlational quantitative

Purposive sampling

(17 participants)

9 ICD recipients with phantom shocks (PS) within the last 24 months

- all males

- mean age: 65.9 years

8 ICD recipients with objective shocks (OS) within the last 24 months

- all males

- mean age: 63.9 years

Qualitative

Phantom shock experiences

(8 participants, 1 refused to complete)

Quantitative

Psychosocial measurements of the level of:

- Post-traumatic stress disorder (PTSD)

- Depression & anxiety

- Disease-specific distress

- Social desirability

Qualitative

Semi-structured interview (face-to-face)

Quantitative

Instruments:

- PTSD Checklist – Civilian Version (PCL-C)

- Hospital Anxiety & Depression Scale (HADS)

- Cardiac Anxiety Questionnaire (CAQ)

- Socially Desirable Response Set (SDRS-5)

Qualitative

Theme 1: Phantom shock as a somatic experience

PS is strikingly similar to OS; Vivid physical sensation of ‘punch in middle of breast’

Theme 2: Emotional impact of phantom shock

Alarmed, confused, anxious, fear, helpless; Mistrust in ICD

Theme 3: Searching for meaning

Rationalize situation, trying to account for the cause of PS

Quantitative

- Both PS & OS ↑trauma & anxiety

- PS ↑psychological distress (depression, PSTD) & social desirability

- OS ↑heart-focused worry

Bolse et al. (2005) [15]

United States

To describe the perceptions of ICD recipients on their life situations

Descriptive phenomenology

(Dahlgren & Fallsberg’s approach)

Purposive sampling

with maximum variation sampling

(14 participants)

- 8 males, 6 females

- mean age: 55.71 years (range: 21–84 years)

- average 2 years with ICD

- 6 experienced shocks within the 1st year

Perceptions of life situations with ICD

Semi-structured interview (telephone call)

Category 1: Trust

- Trust in ICD → Security & confidence for future

Category 2: Adaptability

- Adapt to limitations in life; Obligated to accept restrictions; Changing habits; Resume routine

Category 3: Empowerment

- Support from family & healthcare staff; Overprotection, felt dependent

Carroll and Hamilton (2005) [16]

United States

To compare the QOL in those with ICD shock and those who did not receive shock during 1st year

Longitudinal, prospective, descriptive correlational quantitative

Convenience sampling

(59 participants; Initially 81 participants – 84% retention rate)

16 Shock group

- 13 males, 3 females

- mean age: 57.5 years

43 Non-shock group

- 29 males, 14 females

- mean age: 64.8 years

Collected at two time points (at implantation & 1 year after):

- Health status

- Psychological distress

- QOL

Collected at one time point (1 year after):

- Fear & concerns

Instruments:

- Ferrans & Powers QOL Index

- Medical Outcomes Study Short Form-36 (SF36)

- Profile of Mood States (POMS)

- Brodsky ICD Questionnaire

At 1 year,

- Shock group significantly ↓mental health & vitality score than non-shock group

- Shock group ↑anxiety, fatigue, psychological distress, & suffering than non-shock group

Carroll and Hamilton (2008) [45]

United States

To investigate the changes in health status, QOL and psychological state following ICD implantation 4 years later

Longitudinal, prospective, descriptive correlational quantitative

Convenience sampling

(41 participants; Initially 70 participants – 59% retention rate)

- 30 males, 11 females

- mean age: 60.4 years

Collected at six time points (at implantation, 6 months, 1 year, 2 years, 3 years, 4 years later):

- Health status

- Psychological distress

- QOL

Instruments:

- Quality of Life Index-Cardiac III (CQLI-3)

- Medical Outcomes Study Short Form-36 (SF36)

- Profile of Mood States (POMS)

- Mental health score improved

↑mental health & ↓psychological distress by 6 months post-ICD

- Physical score worsened

Physical sub-score significant ↑at 6 months but ↓functioning at 3 & 4 years

- Fewer negative moods

Total psychological distress score ↓significantly

Chair et al. (2011) [13]

Hong Kong

To examine the HRQL and its relation with ICD shock-related anxiety and ICD acceptance

Cross-sectional, descriptive correlational quantitative

Purposive sampling (85 participants)

- 65 males, 20 females

- mean age: 59.7 years

Collected at one time point:

- QOL

- ICD shock-related anxiety

- ICD acceptance

Instruments:

- Chinese (Hong Kong) SF-12 Health Survey Standard Version 1.0

- Florida Patient Acceptance Scale (FPAS)

- Florida Sock Anxiety Scale (FSAS)

- Physical component & mental component ↓than population norm

- MCS (-) correlated with shock anxiety

MCS (+) correlated with patient acceptance

- Shock anxiety (-) correlated with patient acceptance

- Age (+) associated with FPAS

Age (-) related with FSAS

- ICD shock (yes/no) does not but shock frequency (0, 1–2, ≥3) & gender significantly different on FSAS shock anxiety but not on MCS general mental functioning

Conelius (2015) [17]

United States

To describe the experiences of women with ICD implantation

Descriptive phenomenology

(Colaizzi’s approach)

Convenience sampling

(3 participants)

- all Caucasian women

- age range: 34–50 years

- average 1 year with ICD

- none experienced shocks

Experiences of living with ICD

Unstructured interview

(face-to-face)

Theme 1: Security blanket: If it keeps me alive, it’s worth it

Sense of security → ↓Worry about medical emergencies

Theme 2: A piece of cake: I do more than before

Stable/↑QOL after post-op period; ICD implantation process was easy

Theme 3: A constant reminder: I know it’s there

Constant reminder of ICD by others and self; Affect body image

Theme 4: Living on the edge: I do not want it to go off

Fear of shock in public; Uncertainty over how it feels

Theme 5: Catch 22: I’d rather not have it

Rather not have but it’s medically necessary; No choice, had to adjust to ICD

Flanagan et al. (2010) [18]

United States

To explore lived experiences of patients with 1–2 years post-ICD implantation

Descriptive phenomenology

(Van Manen’s hermeneutic phenomenology approach)

Purposive sampling

(14 participants)

- 8 males, 6 females

- median age: 55.7 years (range: 21–48 years)

- 10 for secondary prevention

- average 1–2 years with ICD

- 6 experienced shocks in 1st post-op year

Experiences of patients 1–2 years after ICD implantation

Unstructured interview

(telephone call)

Theme 1: Appreciation versus apprehension

Gratitude; Anxiety over uncertainty of shock

Theme 2: Maintaining structure & routine as a way to maintain sense of self

Strong need to maintain structured routine; Reassure family that someone is checking on them

Theme 3: Isolation & vulnerability

Desire to connect with ICD patients but not attend support groups; Overwhelmed by isolation from family

Theme 4: Being abandoned & still grieving

Resistance to accept help & isolation → significant loss around time of illness (lost most important person); Still grieving

Theme 5: Seeking advice, making decisions

Many unanswered queries on sexual function & fear shocking partner/drive to avoid job loss/altered memory concerns

Flemme et al. (2005) [28]

Sweden

- To describe theQOL and uncertainty in patients with ICD

- To predict QOL at long-term follow-up

Longitudinal, descriptive correlational quantitative

Convenience sampling

(35 participants; Initial 56 participants – 62.5% retention rate)

- 23 males, 12 females

- mean age: 58.7 years

Collected at four time points (pre-implantation, 1–10 months, 11–20months, ≥21 months average 6.9 years):

- QOL

- Uncertainty

Instruments:

- Quality of Life Index – Cardiac version (QLI-C)

- Mishel Uncertainty in Illness Scale Community (MUIS-C)

- Overall QOL & health/functioning remains unchanged over time; reasonably good at 6.9 years post-ICD

- Socioeconomic & psychologic/spiritual domains ↓in 1st year

- Baseline to long-term follow-up, family domain & uncertainty↓

- Uncertainty is a predictor of low QOL

Flemme et al. (2012) [27]

Sweden

- To describe the coping strategies and coping effectiveness 6–24 months post-implantation

- To explore the factors influencing coping strategies

Cross-sectional, descriptive correlational quantitative, multi-centred

Purposive sampling (147 participants; Initial 164 participants – 89% retention rate)

- 121 males, 26 females

- mean age: 63 years

- 77 for secondary prevention

- 38 experienced shocks

Collected at one time point:

- Anxiety & depression

- Perceived control

- QOL

- Coping strategies

Instruments:

- Jalowiec Coping Scale-60 (JCS-60)

- Quality of Life Index – Cardiac version (QLI-C)

- Hospital Anxiety and Depression Scale (HADS)

- Control Attitude Scale (CAS)

- Most seldom use coping strategies

Coping strategies used perceived as fairly helpful

- Perceive moderate control over condition

- Optimism is the most frequently used

Optimism is the most effective coping strategy

- Anxiety & gender account for 26% of the variance in coping strategies

- Female use more overall, optimistic, palliative & supportive coping

- ↑Depression, ↑evasive coping

↑Perceived control, ↓fatalistic coping

- Satisfied with QOL

Flemme et al. (2011) [28]

Sweden

To explore the concerns of patients living with ICD (6–24 months) and how they handle daily their lives

Grounded theory

(Constant comparative analysis)

Purposive sampling

(16 participants; data saturation at 13 participants)

- 9 males, 7 females

- median age: 57.6 years (range: 31–78 years)

- 12 for secondary prevention

- average 6–24 months with ICD

- 8 experienced shocks

Focus is not on acute phase near post-implantation:

- Experiences in daily life (had ICD for 6–24 months)

- Concerns

- Management of concerns

Unstructured interview

(face-to-face)

Core Category 1: Incorporating uncertainty in daily life

Restricting activities (Strategies)

Balance activity level with available resources → partly control life; Uncertain about activity level & type to prevent shock; Fear shock → restrictions & careful planning of activities of daily living (ADL)

Distracting oneself

Engage in other activity → ↓stress level, prevent thinking of negative aspects (denial & illusion)

Accepting being an ICD recipient

Accept – reality of condition/life situation (dependent on ICD & support from others but don’t mean accept helplessness)/body scar

Re-evaluating life

Reflective about life, changing values & expectations; Forced to live with uncertainty of future; Develop inner strength

Fluur et al. (2013) [11]

Sweden

To describe the ICD recipients’ experiences regarding battery replacement and end-of-life issues

Descriptive qualitative

Quota sampling with maximum variation sampling

(37 participants)

- 23 males, 14 females

- median age: 64 years (range: 29–88 years)

- average 4.5 years with ICD

- 21 for secondary prevention

- 9 experienced shock

- 8 with ICD replacement

Experiences with battery replacement & end-of-life issues

Semi-structured interview

(face-to-face)

Theme 1: Being part of an uncertain illness trajectory

Some had insight of their condition; some chose to ignore illness trajectory, live a day at a time

Category 1: Standing at a crossroads

Decision to replace ICD & when to discuss option

The unreflecting way

Replacing ICD a necessity; Offer protection from all causes of death; Adhere to doctor’s decision/ICD indication

The deliberate choice

Some disagreed with doctor’s advice to not replace, unless ICD no shock → unnecessary; Some are done with life

Category 2: Progressing from one phase to another

Anticipated preferences about ICD deactivation at end-stage

Avoiding decisions

The majority has no take on issue, difficulty talking about death; Unaware of deactivation option; Decide when the time come, live each day a time

Choosing life at all costs

Most kept it as long as possible, even with multiple shocks; Extend life; Misunderstanding of deactivation = immediate death/euthanasia

Facing finality

Some at end-stage reflected on mode of death; Few will make advance deactivation planning

Groeneveld et al. (2007) [19]

United States

- To measure and compare the QOL among primary & secondary

prevention

- To identify the predictive factors for QOL in each group

Cross-sectional, descriptive correlational quantitative

Purposive sampling

(120 participants)

45 Primary prevention group

- 28 males, 17 females

- mean age: 58 years

75 Secondary prevention group

- 60 males, 15 females

- mean age: 61 years

Collected at one time point:

- QOL

- ICD concerns

Instruments:

- Euro-QOL-5D (EQ-5D), Visual Analogue Scale (EQ-VAS),

- Health Utilities Index-Mark 3 HUI-3)

- Medical Outcomes Questionnaires Survey Short Form-12 (SF-12)

- Florida Patient Acceptance Survey (FPAS)

- No significant difference between both groups in all QOL scales

- Both groups view their devices favourably according to the FPAS scale, no significant difference

- Anxiety/concerns on:

Lifting (40%)

Sexual activity (19%)

Driving (14%)

Habibovic et al. (2011) [33]

Netherlands

To examine the effect of gender versus NYHA Class III/IV, ICD shock and Type D personality as determinantof anxiety & QOL using Cohen’s effect size estimates

Longitudinal, descriptive correlational quantitative, multi-centred

Purposive sampling

(718 Participants; Initial 1080 participants – 66% retention rate)

139 Female Group

- mean age: 58.3 years

579 Male Group

- mean age: 61.4 years

Collected at two time points (at implantation & 12 months after):

- Anxiety

- QOL

Instruments:

- Medical Outcomes Study Short Form-36 (SF36)

- Spielberger’s State Trait Anxiety Inventory (STAI)

- Type D Scale (DS14)

- No difference between men & women on mean anxiety scores

- QOL difference in 2 out of 8 subscales of SF-36, women poorer physical functioning & vitality than men

- In anxiety, effect size at baseline & 12 months for gender,

NYHA class & ICD shocks → small

Type D personality → large

- In QOL, effect size at baseline & 12 months,

Gender → small

NYHA class & Type D personality → moderate to large

Herman et al. (2013) [50]

Prag

To gain insight into patients’ opinions, attitudes and wishes regarding end-of-life decisions, ICD deactivation and their knowledge

Cross-sectional, descriptive quantitative

Convenience sampling

(109 participants; Initial 112 participants, 3 excluded due to incomplete questionnaire)

- 91 males, 18 females

- mean age: 67.6 years

- average 662.4 days with ICD

Collected at one time point:

Survey questionnaire on end-of-life decisions, ICD deactivation & overall understanding

Instruments:

- Self-developed survey questionnaire (qualitative questions – yes/no; quantitative questions – VAS)

- Felt safer with ICD (90.8%)

- Health status improved (60.6%)

- Discussed topic with doctor (7.3%)

- Never thought of ICD deactivation at end-of-life (45.9%)

- Wanted more information (40.1%)

- Refused additional information on the issue (25.7%)

41.7% from secondary prevention & 22.4% from primary prevention refused to speak of deactivation

- Deactivation a personal decision, won’t involve relatives (50.1%)

Humphreys et al. (2016) [42]

United Kingdom

- To explore the perceived concerns and benefits of ICD

- To explore the emotional responses to ICD and coping

Descriptive qualitative

Purposive sampling

(18 participants)

- 11 males, 7 females

- range 30–68 years

- 5 shock (1 out of 5 female)

- 13 non-shock (6 out of 11 female)

- 7 for secondary prevention

- all except 1 had ≤1 year with ICD

Emotions, concerns and coping of ICD recipients

Semi-structured interview

(face-to-face)

Theme 1: Physical consequences

Physically aware of device in body → reminds of disease; Physical encumbrance – (1) Larger size (2) Protrusion (3) Arm adjacent to implant painful, restricted movement

Theme 2: Emotional consequences

Vulnerable/Uncertain (Non-shock patients with

sudden cardiac arrests (SCA) episodes)

Traumatized; ↑awareness of fine line between life and death; Changed perspectives to appreciate life and work

Anxiety of receiving shocks

Fear of 1st shock & its feelings (in non-shock patients) – Male: Focus on medical implications of shocks, Female: Focus on pain & failure to attend work

Depression

Loss of confidence – (1) Inability to resume work (2) Disappoint employers & unable to support spouse → loss of status & male role (3) ↓financial security; Loss of independence; Loss of physical fitness

Theme 3: Coping with the ICD

Avoidant/restriction; Acceptance – (1) resigned acceptance (no choice) (2) Grateful acceptance; Set goals for ‘new self’

Jacq et al. (2009) [46]

France

To assess the point prevalence & severity of anxiety, depression & QOL using standardized scales on shock and non-shock patients

Cross-sectional, descriptive correlational quantitative

Purposive sampling

(65 participants)

40 Shock group

- 35 males, 5 females

- mean age: 60.18 years

- average 37.44 months with ICD

- average 7.8 shocks

25 Non-shock group

- 21 males, 4 females

- mean age: 59.40 years

- average 17.88 months with ICD

Collected at one time point:

- Anxiety & depression

- Health status

Instruments:

- Medical Outcomes Study Short Form-36 (SF36)

- Mini International Neuropsychiatric Interview according to DSM-IV (MINI)

- Hospital Anxiety and Depression Scale (HADS)

- ↑Point prevalence of anxiety disorders in shock group

(MINI shock: 37.5%, non-shock: 8%)

- ↑Depressive symptoms in shock group but point difference of depressive disorders is insignificant

- (+) correlation between the number of shocks & depressive symptoms

- (-) correlation between the number of shocks & SF-36 mental health sub-score

Johansson and Strömberg (2010) [12]

Sweden

To describe the perceptions of ICD recipients regarding driving & driving restrictions

Descriptive phenomenology

(Dahlgren and Fallsberg’s approach)

Strategic theoretical sampling

(20 participants)

- 14 males, 6 females

- Range: 43–82 years

- 16 for secondary prevention

- all had driving license – 16 driving & 4 ongoing restrictions

Perceptions of driving & driving restrictions

Unstructured interview

(face-to-face)

Category 1: Achieving adherence to driving restriction

Non-adherence when beliefs & preferences unaddressed/information unclear/given at inappropriate time

Information needs

Stress pre-implantation → less receptive to information; Lack discussion of consequences; Inconsistent information

Individual interpretations

Interpreted restriction as recommendation; Difficulty adapting – Driving whole life/2° prevention ban ~3 months; Blame restriction rather than condition

Willingness to adapt

Mutual understanding – Understood rationale, don’t think they are suitable/honour doctor’s agreement; Anxious of unable to do things as usual

Category 2: Emotional influence of driving restrictions

Wanted to keep driving privileges

Loss of independence

Losses – Social life changes/↓Independence/↓freedom → rely on others for ADL (felt useless/burden others/guilt)/limited;

Changed self-image

Perceived as physically-disabled; Less valuable; Lose personal identity; Altered self-image (dignity & self-respect)

Category 3: Altered views on driving

Importance of network

Family support → driven around; (+/-) Comfort receiving help

Influence on driving behaviour

Change driving pattern – avoid driving/partner drive/avoid heavy traffic/limit time & distance

Future perspectives

Anxiety of causing accident, unsuitable driver; Unwilling to check for arrhythmia as fear license revoked

Mert et al. (2012) [38]

Turkey

To describe the experiences of patients with ICD

Descriptive qualitative using focus group interview

Purposive sampling (19 participants)

- 15 males, 4 females

- mean age: 53.5 years

- average 15.4 months with ICD

- 13 experienced shock

Living with ICD:

- Attitudes

- Feelings

- Beliefs

- Reactions

- Experiences

Semi-structured interview guide (focus group)

Theme 1: Experiences in the regular activities of daily life

Restrict physical activity/quarrel/physical contact/shower alone → fear shock/ICD dislocation

Theme 2: Experiences related to social life

Cannot resume previous social activity; Cannot leave home → cellular phone phobia; Quit/change job

Theme 3: Familial relationships

↓Sexual activity, partner uncomfortable; Overprotection

Theme 4: Emotional changes

Fear, nervous, anxiety (shock > no shock), anger; Uncertainty over shock timing

Theme 5: Experiences related to ICD shocks

Prior shock symptoms; ‘Blow on chest’; Anxiety, fear of death, helplessness (multiple shocks more pain)

Theme 6: Patients’ experiences relating to receiving information/counselling from healthcare providers

Inadequate information on impacts & shock management; Advised on driving & conditions affecting ICD; No chance to clarify doubts; Contradictory information received

McDonough (2009) [20]

United States

- To describe the everyday experiences of younger adults (18–40 years) with ICD

- To describe the physiological and psychosocial issues of younger adults

- To identify the coping strategies

Descriptive qualitative

Purposive sampling with maximum variation sampling (20 participants)

- Young adults age 18–40 years

14 Internet group

- 6 males, 8 females

- mean age: 32.9 years

- average 4.1 years with ICD

- 6 experienced shock

6 Telephone group

- 2 males, 4 females

- mean age: 35.2 years

- average 3.4 years with ICD

- 3 experienced shock

- Experiences of living with ICD

- Physiological & psychosocial impacts of ICD

- Coping strategies

Semi-structured interview

Two methods of triangulation:

- Internet group via website (written interview, email correspondence)

- Telephone group via phone call (telephone interview)

Theme 1: A cautious transition to a new normal

Initial diagnosis: Anxiety and concern

Anxiety; Body image concerns; Anger with self; Resentment towards ICD; Depression

Caution, awareness and security: Daily life with ICD

Cautious; Security, trust, comfort in ICD

Childbearing: Passing my disease to my children

Concern of heredity cardiac conditions; Family planning – No kids/not more; Existing children – genetic testing/future preparations for ICD

Financial concerns

Out-of-pocket expenses; ↑Insurance premium; ICD & battery replacement costs; Job instability

Physiological and psychosocial

Physical restrictions; Pain, itching, scarring → embarrassment; Shock-related pain (female > male); Fear of shock in public; Body image & sexual concerns

Strategies to manage life with an ICD: Be positive and live life to the fullest

Positive; Adhere body cues; Healthy lifestyles; Online & social support; Educate others; Future planning

Morken, et al. (2010) [30]

Norway

To explore the experience of living with ICD in daily life and the long-term (a minimum of 10 months)

Grounded theory

(Strauss & Corbin’s approach)

Purposive sampling

With maximum variation sampling

(16 participants)

- mean age: 54 years (range: 25–80 years)

- average 4.5 years with ICD

Experiences of living with ICD:

- Daily life

- Long-term

Unstructured interview

(face-to-face)

Core Category 1: Reconstructing the unpredictability of living with an ICD

Category 1: Losing control (After shock)

Uncertainty associated with the triggering of the device

No pre-physical symptoms of arrhythmia; Unpredictability → depressing; ‘Struck by lightning’

Influence on the relationship with one’s partner

Afraid to be alone; Dependent on partner

Reduced physical activity

↓Physical activity to avoid shock/fear losing driving license for work → ↓well-being & sex life; Uncertainty over acceptable activity level; Most engage moderate daily exercise

Category 2: Regaining control

Being normal

Resume normal life & perceive life good (no new shock)

Learning to trust the ICD as a life saver

Shock → remind death & show device functioned; Lifesaver; Grateful for new chance

Category 3: Lacking support

Lack of continuity & appropriate support from healthcare professionals

Insufficient information on impacts & shock; Follow-up with different doctors; Consultation time limited

Category 4: Seeking support

Managing emotions

Empathy in listening to their feelings

Seeking guidance about physical activity

Inactive from physical discomfort

Morken et al. (2014) [31]

Norway

- To investigate the extent of shock anxiety & perceived support from healthcare professionals are related to PTSD symptoms

- To examine the extent of perceived support from healthcare professionals moderate relationship between shock anxiety & PTSD symptoms

Cross-sectional, descriptive correlational quantitative

Purposive sampling

(167 participants)

- 133 males, 34 females

- mean age: 64.4 years

- 106 for secondary prevention

- average 57 experienced shocks

Collected at one time point:

- PTSD

- Shock anxiety

- Social support from healthcare professionals

Instruments:

- Impact of Event Scale-Revised (IES-R)

- Florida Sock Anxiety Scale (FSAS)

- Patient Questionnaire on Empowerment

- Agree a little/strongly on constructive support (68.8%)

Agree a little on non-constructive support (12%)

- Experience moderate to severe PTSD symptoms (10–15%)

- Associations between shock anxiety & PTSD symptoms significantly moderated by perceived non-constructive support from healthcare professionals

↑Non-constructive support, ↑tendency for PTSD especially those with shock anxiety

Morken et al. (2014) [32]

Norway

To investigate the extent of perceived support from healthcare professionals and shock anxiety is related to device acceptance among ICD recipients

Cross-sectional, descriptive correlational quantitative

Purposive sampling

(167 participants)

- 133 males, 34 females

- mean age: 64.4 years

- 106 for secondary prevention

- average 57 experienced shocks

Collected at one time point:

- ICD acceptance

- Shock anxiety

- Social support from healthcare professionals

Instruments:

- Florida Patient Acceptance Scale (FPAS)

- Florida Sock Anxiety Scale (FSAS)

- Patient Questionnaire on Empowerment

- Experience high device acceptance (84.4%)

Experience device-related distress (4.8%)

- Constructive support from healthcare professionals ↑device acceptance & moderate (-) relationship between shock anxiety & device acceptance → prevent shock anxiety leading to poor device acceptance

Non-constructive support can ↓device acceptance

Myers and James (2008) [21]

United States

To examine the differences in ICD indicators, anxiety and social support between ICD recipients who seek support group and

those without

Cross-sectional, descriptive comparative quantitative

Convenience sampling

(150 participants)

73 Support Attendees group

- 55 males, 18 females

- mean age: 67.71 years

77 Support Non-Attendees group

- 65 males, 12 females

- mean age: 68.38 years

Collected at one time point:

- Anxiety

- Social support & social network

Instruments:

- Spielberger’s State Trait Anxiety Inventory (STAI)

- Sarason’s 6-item Social Support Questionnaire (SSQ)

- Support attendees higher trait anxiety than non-attendees

Support attendees less satisfied with social support than non-attendees

- Trait anxiety higher in those diagnosed with tachycardia

↑Satisfaction with support, ↓trait & state anxiety

- ↑Social network, ↓trait & state anxiety

↑Social network, ↑support satisfaction

Palacios- Ceña et al. (2011) [47]

Spain

To determine the experience of Spanish male ICD recipients

Descriptive phenomenology

(Giorgi approach)

Phase 1:

Purposive sampling

Phase 2:

Theoretical sampling

(22 participants, data saturation at 16)

- men above age 18 years

- average 44 months with ICD

- 17 for secondary prevention

- 10 experienced shocks

Experiences of living with ICD

Phase 1:

Unstructured interview to not condition or guide participant

(face-to-face)

Phase 2:

Semi-structured interview to elicit response on specific topics of interest

(face-to-face)

- Field notes

- 12 personal letters

- 4 diary extracts

Theme 1: Accepting the change

‘Changes (improves/restricts) in mobility & loss of independence’; ‘Changes in family & work status as advised to stop work’ – viewed (+) by senior positions/(-) by young & lower paying jobs

Theme 2: Developing strategies (To adapt to ICD/Illness)

‘Avoidance & evasiveness’ of ICD-related events, avoid contact & stay indoors; ‘Search for alternative information’

Theme 3: Rethinking their relationship with their partner & becoming emotionally more distant

‘Importance of wife’; ↓‘Frequency & length of sexual relations’, fear of harming partner → emotionally-distant

Theme 4: Giving up some of their independence

Family support; Overprotection → lose independence but tolerated

Theme 5: Transformed

Reflection on life, changes in outlook & priorities; ‘Internal change’ in work, relationship & living

Theme 6: With life insurance

Love-hate attitude towards ICD

Theme 7: Continual uncertainty & waiting

‘Discharge reminds that heart is deteriorating’; Waiting for discharges → uncertainty poorly-tolerated

Palacios- Ceña et al. (2011) [43]

Spain

To explore the experience of elderly Spanish men with ICD implantation

Descriptive phenomenology

(Giorgi’s approach)

- Purposive sampling

- Snowball sampling

(20 participants; Data saturation at 15 participants +5 participants for validation)

- Elderly men age 71–83 years

- average 52.7 months with ICD

- 15 for secondary prevention

- 13 experienced shocks/storm shocks

Experiences of living with ICD

Unstructured interview

(face-to-face)

- Field notes

- 6 personal letters

- 1 diary

Theme 1: Accepting changes

Limited functional capacity & autonomy from fear of shocks → ADL changes

Theme 2: Developing strategies to adapt to changes arising in all areas of the recipient’s life

Hide health & ICD-related information; Confidence in healthcare staff, never seek other information sources; Positive attitude

Theme 3: Living with someone

Love & support from family; Strengthen couple’s relationship; Worry about family & try to stop them from being around

Theme 4: Feel transformed

Reflection on meaning of life & desire to live in peace; ‘Waiting’ for the end; Resignation/predestination; New life outlook & priorities before it’s too late

Theme 5: Live feeling safe

ICD as protector & lifesaver; Expectation of future shocks → uncertainty

Pedersen et al. (2013) [34]

Netherlands

- To examine patients’ knowledge and willingness for information

- To identify the prevalence and correlates of favourable attitude towards deactivation

Cross-sectional, descriptive correlational quantitative

Convenience sampling (294 participants stratified into 3 groups)

- 110 Group 1:

De novo implanted

- 107 Group 2: Moderate experience

- 77 Group 3: Considerable experience

Collected at one time point:

- Patient’s knowledge about deactivation

- Wishes for information

Instruments:

- Self-developed survey questionnaire (qualitative questions – yes/no)

- Generalised Anxiety Disorder Scale

- Patient Health Questionnaire

- Type D Scale

- Most are aware ICD deactivation option (68%, 1/3 unaware)

- Important to inform patient of possibility (95%)

- Discussion of deactivation issues ↑anxiety (82%)

- When should discussion take place? (multiple responses):

Before implantation (49%)

During the dying process (26%)

Battery replacement (17%)

↓Life expectancy (55%)

- Made the decision for/against deactivation (246/84%)

In favour of deactivation (195/79%)

- ‘Wish for a worthy death – avoidance of shocks during dying’ independently associated with favourable attitude towards deactivation

Raphael et al. (2011) [49]

England

To examine when end-of-life & device deactivation issues should be discussed and how much patients wish to know at pre-implantation

Cross-sectional, descriptive quantitative

Purposive sampling

(54 participants)

29 Group 1: No shock group

- 20 males, 9 females

- mean age: 71 years

- average 3.6 years with ICD

- 18 for secondary prevention

25 Group 2: Shock group

- 23 males, 2 females

- mean age: 74 years old

- average 3.3 years with ICD

- 10 for secondary prevention

Collected at one time point:

- When end-of-life & device deactivation should be discussed

- How much patients wish to know at pre-implantation

Additional questions for Group 2 regarding deactivation & factors influencing decision

Instruments:

- Self-developed survey questionnaire (qualitative & quantitative questions)

- Poor understanding of ICD function

Aware that ICD can be deactivated without being explanted (38%)

- Want to be involved in deactivation decision (84%) All willing to address end-of-life issues, none found discussion distressing

- Never considered ICD deactivation (87%)

- When should discussion take place?

Prior implantation (52%)

Really ill (24%)

- Situations to consider deactivation:

Acutely unwell (82%)

Frequency of shocks (70%)

- Factors influencing deactivation decision:

Prognosis (85%)

‘Quick death’ (70%)

Saito et al. (2012) [14]

Japan

- To describe the experiences of living with arrhythmia & ICD

- To evaluate their post- implantation experiences regarding insights on obtaining appropriate care for their conditions

Descriptive qualitative

No sampling method specified

(22 participants)

- 20 males, 2 females

- mean age: 61.2 years old, (range: 35–79 years)

- average 14 months with ICD

- 8 experienced shocks

Experiences of living with arrhythmia & ICD

Semi-structured interview

(face-to-face)

Category 1: Bewilderment stemming from arrhythmia & ICD implant

Uncertainty about one’s own body

Uncertainty about fatal arrhythmia & necessity of ICD

Fear of arrhythmia ending my life

Anxiety related to ICD shock (without shock – anxious of unknown, with shock – anxious of recurrence)

Dissatisfaction with unforeseen results of ICD

Dissatisfaction regarding limitations of ICD & lifestyle restraints; Discomfort of having foreign object

Category 2: Facing reality of arrhythmia, the ICD & being able to continue life

Confirming & managing lifestyle activities

Permissible range of safe lifestyle activity; Concern on evaluating expansion of lifestyle activity

Facing reality of the ICD & being able to continue life

Objectification of themselves as being kept alive by machine

Category 3: Giving meaning to living with arrhythmia & ICD

Giving meaning to one’s illness

Giving meaning to the value of ICD; Coming to terms with own lifestyle, acceptance

Recognition of one’s disease

Objectification of disease (gaining knowledge & new outlook); Return to original lifestyle despite changes in ADLs

Salmoirago-Blotcher et al. (2012) [22]

United States

To evaluate if better spiritual well-being is associated with lower psychological distress in ICD outpatients

Cross-sectional, descriptive correlational quantitative

Convenience sampling

(46 participants)

- 32 males, 14 females

- mean age: 65 years

Collected at one time point:

- Psychological distress

- Spiritual well-being

Instruments:

- Hospital Anxiety and Depression Scale (HADS)

- Functional Assessment of Chronic Illness Therapy-Spiritual Well-being (FACIT-SWB)

- ↑HADS, ↓FACIT-SWB

- Spiritual well-being is independently associated with ↓psychological distress in ICD outpatients

Spiritual well-being could be a protective factor against psychological distress in these high-risk patients

Spindler et al. (2009) [39]

Denmark

- To examine if women are at greater risk of increased anxiety, depression, ICD concerns and lower device acceptance

- To examine if women have poorer QOL than men after adjusted for demographic and clinical factors

Cross-sectional, descriptive correlational quantitative

Convenience sampling

(535 participants)

97 Female Group

- mean age: 55.22 years

438 Male Group

- mean age: 62.94 years

Collected at one time point:

- Anxiety & depression

- QOL

- ICD concerns

- ICD acceptance

Instruments:

- Hospital Anxiety and Depression Scale (HADS)

- ICD Concerns Questionnaire (ICDC)

- Florida Patient Acceptance4 Survey (FPAS)

- Medical Outcomes Study Short Form-36 (SF36)

- Women ↑anxiety than men

Women ↑ICD concerns than men

Differences in depression insignificant

- ICD patients with shocks ↑anxiety

ICD patients with shocks ↑ICD concerns

- Significant gender differences for 3 out of 8 subscales of SF-36

Women reporting poorer HRQL on all 3 subscales

Starrenburg et al. (2014) [35]

Netherlands

To examine relationship between gender and patient-reported outcomes regarding general anxiety, device-related anxiety, depression and QOL

Longitudinal descriptive correlational quantitative

Purposive sampling

(300 participants)

53 Female group

- mean age: 59.8 years

247 Male group

- mean age: 62.9 years

Collected at 5 time points (pre-implant, 2mths, 5mths, 8mths, 12mths):

- Anxiety & depression

- Health-related quality of life (HRQOL)

- Shock-related anxiety

- ICD acceptance

Instruments:

- Hospital Anxiety and Depression Scale (HADS)

- Florida Shock Anxiety Scale (FSAS)

- Florida Patient Acceptance4 Survey (FPAS)

- Medical Outcomes Study Short Form-36 (SF-36)

- Women has higher anxiety & shock-related anxiety than men within a year

- On most HRQOL subscales, no gender differences except in physical functioning where women reported more improvement than men

- Gender is independently associated with poorer device-related acceptance

- Women expressing higher levels of concerns about body image than men

Steinke et al. (2005) [23]

United States

To explore the sexual activity of patients & their partners post-ICD implantation

Descriptive qualitative

Participants recruited from part of a larger quantitative study examining sexual issues & concerns from a diverse of samples of 2 support groups

Convenience sampling

(12 participants)

ICD Patients

- 10 males, 2 females

- mean age: 62 years

- average 5.3 years with ICD

- all except 1 sexually active – cease all sexual activity due to ICD discharge

- 5 experienced ICD discharge during sexual activity

Partners

- 1 male, 3 females

- mean age: 47 years

Post-ICD experiences:

- ICD impacts on relationship & sexual relationship

- Effect of ICD discharges on sexual activity

- Patient education & sexual counselling needs

- Preferred patient education

- Other sexual concerns

Semi-structured interview

(face-to-face)

Theme 1: Anxiety & apprehension

Concerns about resuming sex

Partner overprotectiveness

Attentiveness to patients’ needs

Fear of ICD firing with sexual activity

Fear & anxiety related to ↑heart rate → may signal impending shock; (-) past experiences; Change sexual frequency

Theme 2: Varying interests & pattern of sexual activity

Strong/↑sexual interest despite anxiety; Explore other ways of affection; ↓frequency; Backing off & waiting before resuming sex after ICD discharge

Theme 3: Powerfulness of ICD discharge

Patient – ‘thunder going off chest’; Partner – ‘bumping together hard’; ICD discharge unpredictable

Theme 4: A need for information & sexual counselling

Provider relationships

Preference of sharing sexual issues with healthcare staff based on knowledge level; Some staff indifferent/uncomfortable

Educational approaches

ICD support member with knowledge & experience; Need for information – most prefer sexual information provided pre-discharge, reinforce advice, answer queries, individualized

Information for sexual counselling

Lack of information on resuming sex

Strömberg et al. (2014) [29]

Sweden

- To describe the knowledge on ICD at the end-of-life in a large national cohort of ICD recipients

- To explore patient-related factors associated with insufficient knowledge regarding role of ICD in end-of-life

Cross-sectional, descriptive correlational quantitative

Convenience sampling

(3067 participants)

- 2438 males, 629 females

- mean age: 66 years

- average 5 years since ICD implantation

- 1957 for secondary prevention

- 1056 experienced shock

Collected at one time point:

- Knowledge about ethical aspects

- Knowledge differences by age & gender

- Impact of insufficient knowledge on deactivation/replacement attitudes

Instruments:

- EuroQol-5 Dimension (EQ-5D)

- Experiences, Attitudes & Knowledge of End-of-Life Issues in Implantable Cardioverter Defibrillator Patients (EOL-ICD) Questionnaire

- Few scored all correct in EOL-ICD

(3%; mean score: 6.6/11)

- Insufficient knowledge in EOL-ICD 25th percentile (29%)

~1/3 thought deactivation = euthanasia

Only 1 in 10 wants deactivation during terminal illness

- Insufficient knowledge is associated with greater indecisiveness to make decisions on ICD deactivation in end-of-life or make decision that may not achieve a high quality of end-of-life experience

e.g. favour replacing ICD even in seriously-ill/advanced age, keeping shock even in end-stage terminal illness

Svanholm et al. (2015) [48]

Denmark

To explore the experiences & thoughts of octogenarian with ICD/CRT-D with a battery replacement due

Descriptive phenomenology (Ricoeur’s reflective phenomenology & interpretive approach)

Purposive sampling

(11 participants)

- 9 males, 2 females

- mean age: 82.8 years (range: octogenarians 80–86 years

- mean year range of implantation: 2003

- 10 for secondary prevention

Experiences regarding:

- Everyday life

- Views on life & death issues

- Decision making

- Communication with healthcare professionals

Semi-structured interview

(face-to-face)

Theme 1: Feeling safe with the ICD

The ICD: A life keeper

ICD is a necessity to prolong life; Understood ICD hinder natural death → refuse replacement

The battery level is important

Even with remote follow-up, appreciate going down to reassure battery level

ICD shock – No problem

None had fear of shock; Some unsure if had shock – misunderstood knowledge

Theme 2: The physician is an authority

Being trustful

View physician role as treat actively → replace when battery low; Place lives in doctors’ hands, grateful & satisfied

Feeling fine knowing nothing

Surprised when told of possibility to deactivate ICD/Refuse replacement

Criminal act to deactivate the ICD or refuse ICD replacement

View as an illegal act for doctors

Thomas et al. (2009) [24]

United States, Canada & New Zealand

- To evaluate the changes in depression, anxiety and social support in heart failure patients who implanted ICD in SCD-HeFT

- To evaluate effects of ICD shocks on age and NYHA class on these changes

Longitudinal, descriptive correlational quantitative

Purposive sampling

(22 participants; Initial 57 participants – 38% retention rate)

- 47 males, 10 females

- all NYHA Class II/III heart failure

- mean age: 59.8 years

- 12 experienced shock

Collected at five time points (Initial, 6, 12, 18, 24 months):

- Depression

- Anxiety

- Social support

Instruments:

- Beck Depression Inventory-2 (BDI-II)

- Spielberger’s State Trait Anxiety Inventory (STAI)

- Social Support Questionnaire-6 (SSQ-6)

- Depression ↓significantly overtime overall but ↑in those with ICD shocks

- Anxiety higher in NYHA Class III than Class II,

↓in Class III but remained the same in Class II

- Amount of social support (-) related to age

Young, more social support

Social support ↓significantly over time but young ↓more

Vazquez et al. (2008) [25]

Australia & United States

To investigate the areas of adjustment across 3 age groups of women from multiple centres

Cross-sectional, descriptive correlational quantitative, multi-centred

Convenience sampling

(88 participants)

30 Young women group

- ≤50 years

25 Middle women group

- 50–64 years

32 Old women group

- ≥ 65 years

- average 3.1 years since ICD implantation

- 33% experienced shocks

Collected at one time point:

- Shock anxiety

- Death anxiety

- Body image concerns

Instruments:

- Florida Shock Anxiety Survey (FSAS)

- Multi-dimensional Fear of Death Scale (MFODS)

- Florida Patient Acceptance Survey (FPAS)

- Young women has higher rate of shock anxiety, death anxiety & body image concerns than middle & older women

Verkerk et al. (2015) [36]

Netherlands

- To investigate the impact on QOL in 1st year after ICD implantation for primary prevention of SCD among young adults between 18 and 50 years

- To compare the QOL scores with available population norms

Longitudinal, descriptive quantitative

Convenience sampling

(35 participants)

- 18 males, 17 females

mean age: 36.7 years

Collected at four time points (pre-implantation, 2, 6, 12 months):

- Depression

- Anxiety

- QOL

Instruments:

- Centre for Epidemiologic Studies Depression Scale (CED-D)

- Spielberger’s State Trait Anxiety Inventory (STAI)

- Medical Outcomes Study Short Form-36 (SF36)

- Self-designed questionnaire to explore impacts of receiving ICD

- 29% of patients’ pre-ICD depression score (CES-D) higher than cut-off score of 16.

After 2, 6 & 12 months → 23, 9 & 13% respectively

- 71% of patients pre-ICD anxiety score (STAI) higher than cut-off of 40

After 2, 6 & 12 months → 40, 32 & 34% respectively

- QOL significantly ↓ at pre-implantation & 2 months but improved with time & is comparable with population norms at 6 & 12 months

- Self-designed questionnaire 1: ICD…

Feel protected against cardiogenic condition (87%)

More negative than positive effects (11%)

Worry of ICD firing when nobody is around (22%)

Influences the way I dress (16%)

Can no longer do the things I enjoy (19%)

Lead a normal life like everyone else (52%)

- Self-designed questionnaire 2: Cardiogenic condition & ICD therapy have…

Negative influence on my professional career (34%)

Important influence on decision for children (36%)

- Of 29 patients with job at baseline:

28% had lost/changed their from their condition/ICD

17% temporarily can’t work

31% ↓working hours

Versteeg et al. (2010) [40]

Germany

- To examine if female ICD patients report more psychological distress than male patients

- To examine if somato-sensory amplification mediates this relationship

Cross-sectional, descriptive correlational quantitative

Convenience sampling

(241 participants)

80 Female group

- mean age: 55.04 years

161 Male group

- mean age: 60.29 years

Collected at one time point:

Instruments:

- Psychological distress

- Somatosensory amplification

Instruments:

- Symptom Checklist-90 (SCL-90)

- Somatosensory Amplification Scale (SSAS)

- Female has more anxiety, phobic anxiety, & somatic health complaints than men

Female has higher somatosensory amplification score than men

- Somatosensory amplification is associated with more anxiety, phobic anxiety, & somatic health complaints

- Somatosensory amplification mediated the association between gender & three domains of psychological distress

Williams et al. (2007) [44]

Australia

To explore the experiences, concerns & needs of ICD recipients and their caregivers

Descriptive qualitative

Purposive sampling

(22 participants)

Age range: 30–80 years

11 ICD recipients

- 8 males, 3 females

- number of years with ICD: 4 had less than 2 years, 5 had 2–3 years, 2 had more than 3 years

11 Caregivers

Experiences, concerns & needs of recipients and caregivers

Semi-structured interview

(face-to-face)

Theme 1: Physical & psychological adjustments stage

Physical difficulties; Psychological distress; Coping with reality of illness, uncertainty & insecurity of future – denial, avoidance of topic, & refusal to resume normal activities

Theme 2: Acceptance stage – Getting on with life

- ICD accepted, normal routine resume; Strong will power

- Play it down to people/avoid discussion

- Forget about ICD being there

- Reframe interpretation of personal situation, others less fortunate; ICD support group

- Reassess lifestyle, make changes