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Effectiveness of ultra-portable or pocket automated external defibrillators: a Scoping Review (BLS-2603) ScR

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Conflict of Interest Declaration

The ILCOR Continuous Evidence Evaluation process is guided by a rigorous ILCOR Conflict of Interest policy. The following Task Force members and other authors were recused from the discussion as they declared a conflict of interest: None.

The following Task Force members and other authors declared an intellectual conflict of interest and this was acknowledged and managed by the Task Force Chairs and Conflict of Interest committees: Ziad Nehme and Bridget Dicker.

CoSTR Citation

Debaty, G, Dainty K, Norii T, Perkins GD, T Olasveengen, Bray J on behalf of the International Liaison Committee on Resuscitation (insert) Life Support Task Force(s). Effectiveness of ultra-portable or pocket automated external defibrillator Consensus on Science with Treatment Recommendations [Internet] Brussels, Belgium: International Liaison Committee on Resuscitation (ILCOR) Advanced Life Support Task Force, 2024 January 8. Available from: http://ilcor.org

Methodological Preamble and Link to Published Scoping Review

As part of the continuous evidence evaluation process, the ILCOR Basic Life Support Task Force performed a scoping review of Effectiveness of ultra-portable or pocket automated external defibrillators. ILCOR has not previously examined this topic.

Scoping Review

Webmaster to insert the Scoping Review citation and link to Pubmed using this format when/if it is available.

PICOST

The PICOST (Population, Intervention, Comparator, Outcome, Study Designs and Timeframe)

Population: Adults and children who are in out-of-hospital cardiac arrest

Intervention: the use of an ultra-portable or pocket AED

Outcomes: all outcomes were accepted

Study Designs: Randomized controlled trials (RCTs) and non-randomized studies (non-randomized controlled trials, interrupted time series, controlled before-and-after studies, cohort studies, conference abstracts and trial protocols) are eligible for inclusion. Studies which describe the use of mobile AEDs associated with drone technology are excluded.

Timeframe: 2012 to October 31st 2023.

Search Strategies

The search strategy was developed with assistance from an information specialist from University of Toronto. After review from the ILCOR BLS Task Force, the search strategy was run on October 31st 2023. Articles for review were obtained through Ovid MEDLINE(R) and EMBASE from 2012 to October 31, 2023. We did not search grey literature.


Inclusion and Exclusion criteria

Included manuscripts described any studies related with ultraportable or pocket AED. Manuscripts that did not describe the use or the development of ultraportable or pocket AED were excluded. We also excluded manuscripts that were not in English.

The search strategy identified 66 studies to screen (Pubmed = 25, Embase = 27, with 19 duplicates). We identified 4 articles for full-text review. One was excluded due to wrong setting.

We included three articles in the final review.

Data tables: BLS 2603 Effectiveness of ultraportable or pocket AED Data table

Task Force Insights

1. Why this topic was reviewed.

This topic has not been reviewed before.

Early defibrillation is associated with a large increase in survival from out-of-hospital cardiac arrest.1-4 If defibrillation occurs within 3 to 5 min of collapse, survival rates as high as 50-70% have been reported.3,4 Emergency medical services response time rarely allow performing defibrillation in such a short time.5 Current strategies to decrease time to defibrillation in case of OHCA include, development of public access defibrillation, drone delivery of an AED and use of community volunteer responders dispatched by mobile app to perform early bystander CPR and defibrillation6-8.

Recently, several companies have started advertising "ultra-portable" or "pocket" AEDs for personal use or equipping community volunteer responders, aiming to improve AED availability. They advocate that, compared to standard AEDs, these devices offer a lower cost and weight, allowing for easier portability and availability in homes, where most out-of-hospital cardiac arrests (OHCA) occur. These devices may be limited to a certain number of shocks and lower energy outputs (e.g., restricted to up to 20 shocks and a maximum of 85 joules).

We aimed to review evidence supporting the potential effect on outcomes and the performance of these ultra-portable or pocket AEDs.

2. Narrative summary of evidence identified

Only three studies were identified in this scoping review. One study was a medico-economic simulation study, one is the study protocol of cluster randomized trial and one is an abstract with preliminary results of this trial (data table).

Health-economic simulation study (n=1)

A health-economic analysis modelled the impact of a SMall AED for Rapid Treatment of a Sudden Cardiac Arrest (SMART) strategy on a simulated patient database (n=600 000) at low, moderate, and high-risk for OHCA9. Their results suggest that a SMART approach to prevent fatalities related to OHCA is cost-effective in patients with elevated sudden cardiac arrest risk. They describe a smart phone enabled pocket AED, but as a simulation study they estimated the performance of the device from conventional AED studies.

Real world studies with use of pocket/ultraportable AED (n= 2)

Todd et al. described in a study protocol (FIRST trial) and an abstract with preliminary results of their study10,11 the use of smartphone activated (GoodSAM) first responders with an ultraportable AED to increase 30-day survival rates in OHCA. High frequency GoodSAM responders were cluster randomized to either a standard strategy (with retrieval of local AED if available) or an intervention strategy equipped with an ultraportable AED (CellAED , Rapid Response Revival Research Limited). In their abstract 1,788 alerts have been sent to CellAED participants, with 104 responders arriving before EMS. No data on the performance of the device or patient outcomes were reported.

3. Treatment recommendation

Urgent evaluation of the clinical effectiveness of ultra-portable or pocket AEDs is needed (Good Practice Statement).

4. Narrative Reporting of the task force discussions

There is insufficient evidence to recommend progression to a formal systematic review currently. There is a distinct lack of published research in this area.

Ultra-portable or pocket AEDs are a new generation of defibrillators characterized by a small size, lightweight and easy to carry on one’s person, and affordable for personal and home use.

We acknowledge that the development of ultra-portable or pocket and more affordable AEDs offer the unique opportunity to develop more efficient public access defibrillation or community volunteer responder programs, increase home AED availability and therefore improves outcomes.

Device registration with regulatory authorities alone does not provide evidence of device performance in real world settings. As the success of defibrillation is related to several factors including shock energy, transthoracic impedance, defibrillator pad size and anatomical location, diagnostic accuracy for shockable rhythms and the duration the person has been in cardiac arrest, further research is required to demonstrate the clinical efficacy of pocket/ ultraportable AEDs.

Knowledge Gaps

We found no evidence about the effect of ultra-portable or pocket AEDs use on critical and important clinical outcomes.

There are several other gaps in our knowledge on pocket/ultraportable AED use:

  • Lack of consensus on the definition ultraportable AED.
  • Lack of evidence of the clinical efficacy (i.e. whether the devices work in optimal settings) or clinical effectiveness (real world settings) of ultraportable AEDs.
  • The performance of defibrillation of ultraportable AEDs compared to standard AEDs? Such research should address process measures (e.g. time to defibrillation), evidence of efficacy (e.g. termination of fibrillation, return of organized rhythm, return of spontaneous circulation) and clinical effectiveness (e.g. survival with a favourable neurological outcome, survival to discharge).
  • The cost-effectiveness of ultraportable defibrillators in different contexts (e.g. at home, by community volunteer responder programs and in public locations).
  • How to organize and maintain ultraportable defibrillators.

References

1. Nakashima T, Noguchi T, Tahara Y, Nishimura K, Yasuda S, Onozuka D, Iwami T, Yonemoto N, Nagao K, Nonogi H, et al. Public-access defibrillation and neurological outcomes in patients with out-of-hospital cardiac arrest in Japan: a population-based cohort study. Lancet. 2019;394:2255-2262. doi: 10.1016/s0140-6736(19)32488-2

2. Kitamura T, Kiyohara K, Iwami T. Public-Access Defibrillation in Japan. N Engl J Med. 2017;376:e12. doi: 10.1056/NEJMc1700160

3. Caffrey SL, Willoughby PJ, Pepe PE, Becker LB. Public use of automated external defibrillators. N Engl J Med. 2002;347:1242-1247. doi: 10.1056/NEJMoa020932

4. Valenzuela TD, Roe DJ, Nichol G, Clark LL, Spaite DW, Hardman RG. Outcomes of rapid defibrillation by security officers after cardiac arrest in casinos. N Engl J Med. 2000;343:1206-1209. doi: 10.1056/nejm200010263431701

5. Gold LS, Fahrenbruch CE, Rea TD, Eisenberg MS. The relationship between time to arrival of emergency medical services (EMS) and survival from out-of-hospital ventricular fibrillation cardiac arrest. Resuscitation. 2010;81:622-625. doi: 10.1016/j.resuscitation.2010.02.004

6. Schierbeck S, Hollenberg J, Nord A, Svensson L, Nordberg P, Ringh M, Forsberg S, Lundgren P, Axelsson C, Claesson A. Automated external defibrillators delivered by drones to patients with suspected out-of-hospital cardiac arrest. Eur Heart J. 2022;43:1478-1487. doi: 10.1093/eurheartj/ehab498

7. Pollack RA, Brown SP, Rea T, Aufderheide T, Barbic D, Buick JE, Christenson J, Idris AH, Jasti J, Kampp M, et al. Impact of Bystander Automated External Defibrillator Use on Survival and Functional Outcomes in Shockable Observed Public Cardiac Arrests. Circulation. 2018;137:2104-2113. doi: 10.1161/circulationaha.117.030700

8. Ringh M, Rosenqvist M, Hollenberg J, Jonsson M, Fredman D, Nordberg P, Jarnbert-Pettersson H, Hasselqvist-Ax I, Riva G, Svensson L. Mobile-phone dispatch of laypersons for CPR in out-of-hospital cardiac arrest. N Engl J Med. 2015;372:2316-2325. doi: 10.1056/NEJMoa1406038

9. Shaker MS, Abrams EM, Oppenheimer J, Singer AG, Shaker M, Fleck D, Greenhawt M, Grove E. Estimation of Health and Economic Benefits of a Small Automatic External Defibrillator for Rapid Treatment of Sudden Cardiac Arrest (SMART): A Cost-Effectiveness Analysis. Front Cardiovasc Med. 2022;9:771679. doi: 10.3389/fcvm.2022.771679

10. Todd V, Dicker B, Okyere D, Smith K, Smith T, Howie G, Stub D, Ray M, Stewart R, Scott T, et al. A study protocol for a cluster-randomised controlled trial of smartphone-activated first responders with ultraportable defibrillators in out-of-hospital cardiac arrest: The First Responder Shock Trial (FIRST). Resusc Plus. 2023;16:100466. doi: 10.1016/j.resplu.2023.100466

11. Todd V, Dicker B, Okyere D, Smith K, Howie G, Smith T, Stub D, Ray M, Stewart R, Scott T, et al. The First Responder Shock Trial (FIRST): Can We Improve Cardiac Arrest Survival by Providing Community Responders With Ultraportable Automated External Defibrillators? Heart, Lung and Circulation. 2023;32. doi: 10.1016/j.hlc.2023.04.240

Basic Life Support
Defibrillation and Electrical Therapy
pocket, portable, external automated, defibrillators

Discussion

GUEST
Martin Fagan

(modified: )

The principal of ‘Personal defibrillators’ is valid. Whether Ultraportable devices are the answer is open for debate. There are traditional devices that will meet this need.

As a charity, we were interested in this area and have requested on many occasions over the past 18 months, and in Zoom/telephone/face to face meetings, for copies of clinical data to support the marketing claims being made. These have never been provided, whether by the manufacturer or their UK sales agents. What has been provided is marketing and sales documentation, with challengeable statements.

RCUK advise ‘caution’ over using this device due to the lack of performance data.

We do have concerns, that need addressing, before we can consider this device. Namely;

  • is 70J sufficient energy to overcome TTI?
  • Is having a max energy ⅔ that of other devices clinically effective?
  • Is the experimental dual exponential energy curve valid?
  • Is use on neonates dangerous for a community device, given their normal HR is 120-220 and some devices shock at 130 bpm, suggesting that a shock could be given to an otherwise normal baby?
  • What are the pads adhesion data?
  • The explanation in the manual over use on paediatrics seems to conflict with advice from elsewhere.
  • Is a cellphone type battery ⅓ that of a standard cell phone going to give sufficient energy for multiple shocks, and also what are the degradation studies on the battery over time?
  • What data is there to support the marketing claim of “equal or better than existing devices”?
  • How does the rescue data get transmitted to the hospital?

Until the basic questions are answered with peer reviews data, these types of product should be restricted in their use. We understand the FIRST trail is not looking at clinical efficacy, and therefore further evidence needs to be provided that shows efficacy, and in particular efficacy in relation to existing equipment that is available.

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