- Email: [email protected]
Headline: First report of true “Public Access Defibrillation”
Resuscitation 84 (2013) 137–138
Contents lists available at SciVerse ScienceDirect
Resuscitation journal homepage: www.elsevier.com/locate/resuscitation
Editorial
Headline: First report of true “Public Access Defibrillation”
Twenty or so years ago my wife, Linda, and I sat at our kitchen table. I explained to her the fact that soon any person able to acquire or find a defibrillator and use it could save the life of another person in cardiac arrest. I told her I needed a name that could be used to encompass the concept, somewhat like “Cardiopulmonary Resuscitation.” We came to “Public Access Defibrillation”. To this day as a former teacher, she reminds me that it is bad grammar to eliminate the adverb! The name was adopted by the American Heart Association.1 Finally, 12 years after the US FDA cleared the use of AEDs (Automated External Defibrillators) by non-healthcare or EMT trained individuals and 5 years after the US agency allowed sales of AEDs without a prescription, we have the first report of the use of such devices purchased by an adult “over the counter” without a prescription, or required training or registration. We now have a report of lives saved by true “Public Access Defibrillation.”2 In the report in this issue of Resuscitation2 the use of AEDs purchased “over the counter,” is reported by company employees and prominent members of the academic emergency medicine community. The corporation sought voluntary registration of all AEDs so purchased and surveyed those registered as to use of the AED. Since the company was the only source for defibrillation pad replacement, use of the AED was also identified in this second manner. When use was identified, the owner was interviewed to describe the event and result. Various other sources were assessed to determine survival to hospital discharge. Nearly all of the used devices were exchanged for a new device. Thus, the recording of the pre and post shock ECG in the devise could be displayed and analyzed for appropriateness, timing and results of each shock. The most important results of the study relate to the 25 cases where the device was employed after cardiac arrest. In 19 cases the arrest was witnessed and 12 patients were shocked. Of these 12, 8 (66%) survived to leave the hospital alive. This percent survival is similar to the survival reported for 90 patients with witnessed arrests with an initial rhythm of ventricular fibrillation reported by Valenzuela et al.3 from Las Vegas casino’s with use of AEDs by security guards (59%), and the 55% of 18 who survived after airport arrest with VF in Chicago. This high survival rate can be compared with similar arrests where the patient with witnessed arrest and a shockable rhythm awaits EMS arrival for defibrillation.4 Survival to hospital discharge is about half5,6 (30–40%) for quality EMS systems. Quality EMS also aids survival for patients with bystander AED use.7 Also of importance, again in this report, there was no report of harm caused by the device or its improper use. The paper cites, case by case, all applications found with improper use. Most of the
0300-9572/$ – see front matter © 2012 Elsevier Ireland Ltd. All rights reserved. http://dx.doi.org/10.1016/j.resuscitation.2012.11.020
devices were applied to individuals in distress but not in arrest and even a patient with known atrial fibrillation who placed it on himself, just to test the device operation. This lack of harm is similar to many reports of use of these devises where efforts are made to prospectively identify harm from these devices.5,6,8,9 This does contrast with reports to the US FDA of harm where in general there was little effort to verify the claim.10,11 These reports have formed the basis for an advisory committee recommendation to upgrade the classification of AEDs.11 Should upgrading occur it will likely result in the need for more rigorous premarket testing and potentially greater cost to purchase. It is of significant interest that proper and effective use of these devises occurred despite 68% of the users having no formal medical training and the majority learning to use the AED from the training video that accompanied the device when purchased. In 14 shock cases, where the time from turning on the device to shock was determined, the delay was 21 s (range 15–53 s). All 14 shocks terminated VF and 43% of the patients required more than one shock. Only one survivor is reported to have poor neurological outcome. Eighteen of the 25 uses occurred in the home12 and the remainder in public locations.13 However, the report is not comprehensive. There is no information as to the employment or use of all devices sold in this manner or a representative sample. Also there are no “denominators” reported such as how many devises were sold in this manner or how many registered, or how many responded to the survey. There may have been single uses where the pads were not replaced. Of considerable importance is the fact that the FDA is not the only agency of government to place restrictions on “Public Access Defibrillation.” In the US, state governments have authority to provide immunity from legal risk for users of AEDs via the “Good Samaritan” laws. Related or additional to these “Good Samaritan” provisions, US states frequently require AED registration with the EMS system, require specific training of specific number of volunteer users, and require appropriate maintenance. This is true in the state where I live, Maryland. With others and led by a courageous state Senator Nancy Jacobs there are efforts to encourage training, registration and maintenance but without the legal standard. One must recognize that these legislative bodies are largely composed of lawyers. If the legislature were filled with health professionals, who have seen the impact of sudden death on our society and families, or such family members or AED survivors, they would certainly diminish all legal barriers to AED availability and use. Voluntary AED registration may soon be of considerable value. Modern GPS and EMS tracking systems are now beginning to mate the AED, a willing volunteer and the location of the victim when
138
Editorial / Resuscitation 84 (2013) 137–138
cardiac arrest is reported to the 911 call system.14 This is the forefront of Public Access Defibrillation: monitor a patient at risk, transmit via cell phone the ECG signal diagnosed automatically as VT/VF, identify the location of the victim from the GPS in the cell, automatically call the cell of the nearest volunteer located by the GPS in the volunteer’s cell and finally audibly direct the volunteer to the AED and the victim through GPS tracking. This process would bring the ability to save lives in line with our ability to find the nearest gas station or restaurant! References 1. Weisfeldt ML, Kerber RE, McGoldrick RP, et al. Public access defibrillation: a statement for healthcare professionals from the American Heart Association Task Force on Automatic External Defibrillation. Circulation 1995; 92:2763. 2. Jorgenson DB, Yount TB, White RD, Liu PY, Eisenberg MS, Becker LB. Impacting sudden cardiac arrest in the home: a safety and effectiveness study of privatelyowned AEDs. Resuscitation 2012;84:149–53. 3. 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;343:1206–9. 4. Caffrey SL, Willoughby, Pepe PE, Becker LB. Public use of automated external defibrillators. N Engl J Med 2002;347:1242–7. 5. Investigators PAD. Public-access defibrillation and survival after out-of-hospital cardiac arrest. N Engl J Med 2004;351:637–46. 6. Weisfeldt ML, Sitlani CM, Ornato JP, et al. Survival after application of automatic external defibrillators before arrival of the emergency medical system: evaluation in the resuscitation outcomes consortium population of 21 million. J Am Coll Cardiol 2010;55:1713–20. 7. Rea TD, Olsufka M, Bemis B, et al. A population-based investigation of public access defibrillation: role of emergency medical services care. Resuscitation 2010;81:163–7.
8. Bardy GH, Lee KL, Mark DB, et al. Home use of automated external defibrillators for sudden cardiac arrest. N Engl J Med 2008;358:1793–804. 9. Peberdy MA, Van Ottingham L, Groh WJ, et al. PAD Investigators. Advesrs events associated with lay emergency response programs: The public access defibrillation trial experience. Resuscitation 2006;70:59–65. 10. 515 (I) Regulatory Classification of Automated External Defibrillators http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeeting Materials/MedicalDevices/MedicalDevicesAdvisoryCommittee/Circulatory SystemDevicesPanel/UCM240579.pdf 11. Summary from the Circulatory Systems Devices Panel Meeting – January 25, 2011. http://www.fda.gov/downloads/AdvisoryCommittees/Committees MeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/ CirculatorySystemDevicesPanel/UCM241780.pdf 12. Swor RA, Jackson RE, Compton S, et al. Cardiac arrest in private locations: different strategies are needed to improve outcome. Resuscitation 2003;58:171–6. 13. Weisfeldt ML, Everson-Stewart S, Sitlani C, et al. Ventricular tachyarrythmias after cardiac arrest in public versus at home. N Engl J Med 2011;364:313–21. 14. Rea T, Blackwood J, Damon S, Phelps R, Eisenberg M. A link between emergency dispatch and public access AEDs: potential implications for early defibrillation. Resuscitation 2011;82:995–8.
Myron L. Weisfeldt ∗ Department of Medicine, Johns Hopkins Medicine, Baltimore, MD 21287, United States ∗ Correspondence address: Johns Hopkins Medicine, 1830 E. Monument St., Suite 9026, Baltimore, MA 21287, United States. Tel.: +1 410 955 6642; fax: +1 410 614 8510. E-mail address: [email protected]
19 November 2012
Contents lists available at SciVerse ScienceDirect
Resuscitation journal homepage: www.elsevier.com/locate/resuscitation
Editorial
Headline: First report of true “Public Access Defibrillation”
Twenty or so years ago my wife, Linda, and I sat at our kitchen table. I explained to her the fact that soon any person able to acquire or find a defibrillator and use it could save the life of another person in cardiac arrest. I told her I needed a name that could be used to encompass the concept, somewhat like “Cardiopulmonary Resuscitation.” We came to “Public Access Defibrillation”. To this day as a former teacher, she reminds me that it is bad grammar to eliminate the adverb! The name was adopted by the American Heart Association.1 Finally, 12 years after the US FDA cleared the use of AEDs (Automated External Defibrillators) by non-healthcare or EMT trained individuals and 5 years after the US agency allowed sales of AEDs without a prescription, we have the first report of the use of such devices purchased by an adult “over the counter” without a prescription, or required training or registration. We now have a report of lives saved by true “Public Access Defibrillation.”2 In the report in this issue of Resuscitation2 the use of AEDs purchased “over the counter,” is reported by company employees and prominent members of the academic emergency medicine community. The corporation sought voluntary registration of all AEDs so purchased and surveyed those registered as to use of the AED. Since the company was the only source for defibrillation pad replacement, use of the AED was also identified in this second manner. When use was identified, the owner was interviewed to describe the event and result. Various other sources were assessed to determine survival to hospital discharge. Nearly all of the used devices were exchanged for a new device. Thus, the recording of the pre and post shock ECG in the devise could be displayed and analyzed for appropriateness, timing and results of each shock. The most important results of the study relate to the 25 cases where the device was employed after cardiac arrest. In 19 cases the arrest was witnessed and 12 patients were shocked. Of these 12, 8 (66%) survived to leave the hospital alive. This percent survival is similar to the survival reported for 90 patients with witnessed arrests with an initial rhythm of ventricular fibrillation reported by Valenzuela et al.3 from Las Vegas casino’s with use of AEDs by security guards (59%), and the 55% of 18 who survived after airport arrest with VF in Chicago. This high survival rate can be compared with similar arrests where the patient with witnessed arrest and a shockable rhythm awaits EMS arrival for defibrillation.4 Survival to hospital discharge is about half5,6 (30–40%) for quality EMS systems. Quality EMS also aids survival for patients with bystander AED use.7 Also of importance, again in this report, there was no report of harm caused by the device or its improper use. The paper cites, case by case, all applications found with improper use. Most of the
0300-9572/$ – see front matter © 2012 Elsevier Ireland Ltd. All rights reserved. http://dx.doi.org/10.1016/j.resuscitation.2012.11.020
devices were applied to individuals in distress but not in arrest and even a patient with known atrial fibrillation who placed it on himself, just to test the device operation. This lack of harm is similar to many reports of use of these devises where efforts are made to prospectively identify harm from these devices.5,6,8,9 This does contrast with reports to the US FDA of harm where in general there was little effort to verify the claim.10,11 These reports have formed the basis for an advisory committee recommendation to upgrade the classification of AEDs.11 Should upgrading occur it will likely result in the need for more rigorous premarket testing and potentially greater cost to purchase. It is of significant interest that proper and effective use of these devises occurred despite 68% of the users having no formal medical training and the majority learning to use the AED from the training video that accompanied the device when purchased. In 14 shock cases, where the time from turning on the device to shock was determined, the delay was 21 s (range 15–53 s). All 14 shocks terminated VF and 43% of the patients required more than one shock. Only one survivor is reported to have poor neurological outcome. Eighteen of the 25 uses occurred in the home12 and the remainder in public locations.13 However, the report is not comprehensive. There is no information as to the employment or use of all devices sold in this manner or a representative sample. Also there are no “denominators” reported such as how many devises were sold in this manner or how many registered, or how many responded to the survey. There may have been single uses where the pads were not replaced. Of considerable importance is the fact that the FDA is not the only agency of government to place restrictions on “Public Access Defibrillation.” In the US, state governments have authority to provide immunity from legal risk for users of AEDs via the “Good Samaritan” laws. Related or additional to these “Good Samaritan” provisions, US states frequently require AED registration with the EMS system, require specific training of specific number of volunteer users, and require appropriate maintenance. This is true in the state where I live, Maryland. With others and led by a courageous state Senator Nancy Jacobs there are efforts to encourage training, registration and maintenance but without the legal standard. One must recognize that these legislative bodies are largely composed of lawyers. If the legislature were filled with health professionals, who have seen the impact of sudden death on our society and families, or such family members or AED survivors, they would certainly diminish all legal barriers to AED availability and use. Voluntary AED registration may soon be of considerable value. Modern GPS and EMS tracking systems are now beginning to mate the AED, a willing volunteer and the location of the victim when
138
Editorial / Resuscitation 84 (2013) 137–138
cardiac arrest is reported to the 911 call system.14 This is the forefront of Public Access Defibrillation: monitor a patient at risk, transmit via cell phone the ECG signal diagnosed automatically as VT/VF, identify the location of the victim from the GPS in the cell, automatically call the cell of the nearest volunteer located by the GPS in the volunteer’s cell and finally audibly direct the volunteer to the AED and the victim through GPS tracking. This process would bring the ability to save lives in line with our ability to find the nearest gas station or restaurant! References 1. Weisfeldt ML, Kerber RE, McGoldrick RP, et al. Public access defibrillation: a statement for healthcare professionals from the American Heart Association Task Force on Automatic External Defibrillation. Circulation 1995; 92:2763. 2. Jorgenson DB, Yount TB, White RD, Liu PY, Eisenberg MS, Becker LB. Impacting sudden cardiac arrest in the home: a safety and effectiveness study of privatelyowned AEDs. Resuscitation 2012;84:149–53. 3. 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;343:1206–9. 4. Caffrey SL, Willoughby, Pepe PE, Becker LB. Public use of automated external defibrillators. N Engl J Med 2002;347:1242–7. 5. Investigators PAD. Public-access defibrillation and survival after out-of-hospital cardiac arrest. N Engl J Med 2004;351:637–46. 6. Weisfeldt ML, Sitlani CM, Ornato JP, et al. Survival after application of automatic external defibrillators before arrival of the emergency medical system: evaluation in the resuscitation outcomes consortium population of 21 million. J Am Coll Cardiol 2010;55:1713–20. 7. Rea TD, Olsufka M, Bemis B, et al. A population-based investigation of public access defibrillation: role of emergency medical services care. Resuscitation 2010;81:163–7.
8. Bardy GH, Lee KL, Mark DB, et al. Home use of automated external defibrillators for sudden cardiac arrest. N Engl J Med 2008;358:1793–804. 9. Peberdy MA, Van Ottingham L, Groh WJ, et al. PAD Investigators. Advesrs events associated with lay emergency response programs: The public access defibrillation trial experience. Resuscitation 2006;70:59–65. 10. 515 (I) Regulatory Classification of Automated External Defibrillators http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeeting Materials/MedicalDevices/MedicalDevicesAdvisoryCommittee/Circulatory SystemDevicesPanel/UCM240579.pdf 11. Summary from the Circulatory Systems Devices Panel Meeting – January 25, 2011. http://www.fda.gov/downloads/AdvisoryCommittees/Committees MeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/ CirculatorySystemDevicesPanel/UCM241780.pdf 12. Swor RA, Jackson RE, Compton S, et al. Cardiac arrest in private locations: different strategies are needed to improve outcome. Resuscitation 2003;58:171–6. 13. Weisfeldt ML, Everson-Stewart S, Sitlani C, et al. Ventricular tachyarrythmias after cardiac arrest in public versus at home. N Engl J Med 2011;364:313–21. 14. Rea T, Blackwood J, Damon S, Phelps R, Eisenberg M. A link between emergency dispatch and public access AEDs: potential implications for early defibrillation. Resuscitation 2011;82:995–8.
Myron L. Weisfeldt ∗ Department of Medicine, Johns Hopkins Medicine, Baltimore, MD 21287, United States ∗ Correspondence address: Johns Hopkins Medicine, 1830 E. Monument St., Suite 9026, Baltimore, MA 21287, United States. Tel.: +1 410 955 6642; fax: +1 410 614 8510. E-mail address: [email protected]
19 November 2012