PMID- 29180909
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20240327
IS  - 1179-1470 (Print)
IS  - 1179-1470 (Electronic)
IS  - 1179-1470 (Linking)
VI  - 10
DP  - 2017
TI  - Wearable cardioverter defibrillators for the prevention of sudden cardiac arrest: 
      a health technology assessment and patient focus group study.
PG  - 257-271
LID - 10.2147/MDER.S144048 [doi]
AB  - AIM: To summarize the evidence on clinical effectiveness and safety of wearable 
      cardioverter defibrillator (WCD) therapy for primary and secondary prevention of 
      sudden cardiac arrest in patients at risk. METHODS: We performed a systematic 
      literature search in databases including MEDLINE via OVID, Embase, the Cochrane 
      Library, and CRD (DARE, NHS-EED, HTA). The evidence obtained was summarized 
      according to GRADE methodology. A health technology assessment (HTA) was 
      conducted using the HTA Core Model((R)) for rapid relative effectiveness 
      assessment. Primary outcomes for the clinical effectiveness domain were all-cause 
      and disease-specific mortality. Outcomes for the safety domain were adverse 
      events (AEs) and serious adverse events (SAEs). A focus group with cardiac 
      disease patients was conducted to evaluate ethical, organizational, patient, 
      social, and legal aspects of the WCD use. RESULTS: No randomized- or 
      non-randomized controlled trials were identified. Non-comparative studies (n=5) 
      reported AEs including skin rash/itching (6%), false alarms (14%), and 
      palpitations/light-headedness/fainting (9%) and discontinuation due to 
      comfort/lifestyle issues (16-22%), and SAEs including inappropriate shocks 
      (0-2%), unsuccessful shocks (0-0.7%), and death (0-0.3%). The focus group results 
      reported that experiencing a sense of security is crucial to patients and that 
      the WCD is not considered an option for weeks or even months due to expected 
      restrictions in living a "normal" life. CONCLUSION: The WCD appears to be 
      relatively safe for short-to-medium term, but the quality of existing evidence is 
      very low. AEs and SAEs need to be more appropriately reported in order to further 
      evaluate the safety of the device. High-quality comparative evidence and 
      well-described disease groups are required to assess the effectiveness of the WCD 
      and to determine which patient groups may benefit most from the intervention.
FAU - Ettinger, Sabine
AU  - Ettinger S
AD  - Ludwig Boltzmann Institute for Health Technology Assessment, Vienna, Austria.
FAU - Stanak, Michal
AU  - Stanak M
AD  - Ludwig Boltzmann Institute for Health Technology Assessment, Vienna, Austria.
FAU - Szymanski, Piotr
AU  - Szymanski P
AD  - Institute of Cardiology, Warsaw, Poland.
FAU - Wild, Claudia
AU  - Wild C
AD  - Ludwig Boltzmann Institute for Health Technology Assessment, Vienna, Austria.
FAU - Tandara Hacek, Romana
AU  - Tandara Hacek R
AD  - Department for Development, Research and Health Technology Assessment, Agency for 
      Quality and Accreditation in Health Care and Social Welfare, Zagreb, Croatia.
FAU - Ercevic, Darija
AU  - Ercevic D
AD  - Department for Development, Research and Health Technology Assessment, Agency for 
      Quality and Accreditation in Health Care and Social Welfare, Zagreb, Croatia.
FAU - Grenkovic, Renata
AU  - Grenkovic R
AD  - Department for Development, Research and Health Technology Assessment, Agency for 
      Quality and Accreditation in Health Care and Social Welfare, Zagreb, Croatia.
FAU - Huic, Mirjana
AU  - Huic M
AD  - Department for Development, Research and Health Technology Assessment, Agency for 
      Quality and Accreditation in Health Care and Social Welfare, Zagreb, Croatia.
LA  - eng
PT  - Journal Article
DEP - 20171114
PL  - New Zealand
TA  - Med Devices (Auckl)
JT  - Medical devices (Auckland, N.Z.)
JID - 101566041
PMC - PMC5697444
OTO - NOTNLM
OT  - cardioverter defibrillator
OT  - external
OT  - patient involvement
OT  - sudden cardiac arrest
OT  - ventricular fibrillation
OT  - ventricular tachycardia
OT  - wearable
COIS- Disclosure The authors report no conflicts of interest in this work.
EDAT- 2017/11/29 06:00
MHDA- 2017/11/29 06:01
PMCR- 2017/11/14
CRDT- 2017/11/29 06:00
PHST- 2017/11/29 06:00 [entrez]
PHST- 2017/11/29 06:00 [pubmed]
PHST- 2017/11/29 06:01 [medline]
PHST- 2017/11/14 00:00 [pmc-release]
AID - mder-10-257 [pii]
AID - 10.2147/MDER.S144048 [doi]
PST - epublish
SO  - Med Devices (Auckl). 2017 Nov 14;10:257-271. doi: 10.2147/MDER.S144048. 
      eCollection 2017.