Pre-clinical trial with external defibrillator
DOI:
https://doi.org/10.15448/1980-6108.2014.4.17538Keywords:
VENTRICULAR FIBRILLATION, EQUIPMENT, EXTERNAL DEFIBRILLATOR, SWINES, PRE-CLINICAL RESEARCHAbstract
AIMS: To evaluate the efficacy of defibrillation in response to induced ventricular fibrillation and to describe the macroscopic changes in porcine hearts after truncated exponential capacitive discharge shock applied by a prototype defibrillator produced in Brazil and a reference, international market leader defibrillator. METHODS: Sixteen pigs were divided into four groups of four animals each, to verify the effectiveness of the defibrillator in response to induced ventricular fibrillation by applying loads of 50 J to 100 J, and assess the safety of the defibrillator by macroscopic analysis of the skin and heart. Erythema, edema, blistering, fluid in the pericardial cavity, burns, and post-shock charred tissue were evaluated. RESULTS: All pigs, after one minute of inducing ventricular fibrillation, developed tachycardia and progressed to ventricular fibrillation. When used low energy, the prototype equipment obtained 25% of success, with one reversed pig, while the reference equipment has obtained a success rate of 50%, with two reversals. However, with energy 100 J, the prototype equipment reestablished sinus rhythm in three pigs (75%) and the reference product only made effective defibrillation in one (25%). The application of 100 J energy was associated with skin burns Grade II in only one pig with the prototype defibrillator and four pigs with the reference equipment. The heart tissue injuries occurred in equal numbers with both defibrillators. CONCLUSIONS: The prototype defibrillator, when applied with 100 J energy, was more effective in reversing ventricular fibrillation and showed less injury than the reference defibrillator with the same energy. This study may help to raise the technological standard and to increase the supply of qualified health equipment produced in Brazil, replacing and/or decreasing imports and providing a secure next-generation device.Downloads
References
Instituto Brasileiro de Ensaios de Conformidade. Apresentação do laboratório de Segurança Elétrica - Ensaio de Inspeção, Elétricos e Mecânicos aplicados a Equipamentos Eletromédicos [Internet]. Hortolândia; 2012. [cited 2012 Dec 12]. Available from: http://www.ibec.com.br/download/Apostila_SegEletrica.pdf
Food and Drug Administration. Why are animals used for testing medical products [Internet]. Silver Spring: FDA; [2012]. [cited 2012 Dec 12]. Available from: http://www.fda.gov/AboutFDA/Transparency/Basics/ucm194932.htm
Babbs CF, Tacker WA, VanVleet JF, Bourland JD, Geddes LA. herapeutic indices for transchest defibrillator shocks: effective, damaging, and lethal electrical doses. Am Heart J. 1980 Jun;99(6):734-8.
Koumbourlis AC. Electrical injuries. Crit Care Med. 2002 Nov;30(11 Suppl):S424-30.
Ku CS, Lin SL, Hsu TL, Wang SP, Chang MS. Myocardial damage associated with electrical injury. Am Heart J. 1989 Sep;118(3):621-4.
Osswald S, Trouton TG, O'Nunain SS, Holden HB, Ruskin JN, Garan H. Relation between shock-related myocardial injury and defibrillation efficacy of monophasic and biphasic shocks in a canine model. Circulation. 1994 Nov;90(5):2501-9.
Dahl CF, Ewy GA, Warner ED, Thomas ED. Myocardial Necrosis from Direct Current Countershock: Effect of paddle electrode size and time interval between discharges. Circulation. 1974 Nov;50(5):956-61.
Maccarthy T. Animal models in medical device development and qualification. Charles River Laboratories.1997;10(2).
Higgins SL, Herre JM, Epstein AE, Greer GS, Friedman PL, Gleva ML, Porterfield JG, Chapman FW, Finkel ES, Schmitt PW, Nova RC, Greene HL. A comparison of biphasic and monophasic shocks for external defibrillation. Physio-Control Biphasic Investigators. Prehosp Emerg Care. 2000 Oct-Dec;4(4):305-13.
Mittal S, Ayati S, Stein KM, Knight BP, Morady F, Schwartzman D, Cavlovich D, Platia EV, Calkins H, Tchou PJ, Miller JM, Wharton JM, Sung RJ, Slotwiner DJ, Markowitz SM, Lerman BB. Comparison of a novel rectilinear biphasic waveform with a damped sine wave monophasic waveform for transthoracic ventricular defibrillation. ZOLL Investigators. J Am Coll Cardiol. 1999 Nov 1;34(5):1595-601.
Schwarz B, Bowdle TA, Jett GK, Mair P, Lindner KH, Aldea GS, Lazzara RG, O'Grady SG, Schmitt PW, Walker RG, Chapman FW, Tacker WA. Biphasic shocks compared with monophasic damped sine wave shocks for direct ventricular defibrillation during open heart surgery. Anesthesiology. 2003 May;98(5):1063-9.
Link MS, Atkins DL, Passman RS, Halperin HR, Samson RA, White RD, Cudnik MT, Berg MD, Kudenchuk PJ, Kerber RE. Part 6: electrical therapies: automated external defibrillators, defibrillation, cardioversion, and pacing: 2010 American Heart Association Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Circulation. 2010 Nov 2;122(18 Suppl 3):S706-19.
Abordagem de vigilância sanitária de produtos para saúde comercializados no Brasil: desfibrilador externo. Bol Inf Tecnovigilância [Internet]. 2011 Jan/Mar;(1). [cited 2012 Dec 12]. Available from: http://www.anvisa.gov.br/boletim_tecno/boletim_tecno_fev2011/boletim_tecno.html.
Walker RG1, Melnick SB, Chapman FW, Walcott GP, Schmitt PW, Ideker RE. Comparison of six clinically used external defibrillators in swine. Resuscitation. 2003 Apr;57(1):73-83.
Mischke K, Schimpf T, Knackstedt C, Frechen D, Gramley F, Rana O, Saygili E, Meyer C, Kelm M, Schauerte P. Comparison of four clinically used external defibrillators for transesophageal defibrillation. Intensivmed. 2008; 45(2):76–81.
Li Y, Wang H, Cho JH, Didon JP, Bisera J, Weil MH, Tang W. Comparison of efficacy of pulsed biphasic waveform and rectilinear biphasic waveform in a short ventricular fibrillation pig model. Resuscitation. 2009 Sep;80(9):1047-51.
Zelinka M, Buić D, Zelinka I. Comparison of five different defibrillators using recommended energy protocols. Resuscitation. 2007 Sep;74(3):500-7.
Neal S1, Ngarmukos T, Lessard D, Rosenthal L. Comparison of the efficacy and safety of two biphasic defibrillator waveforms for the conversion of atrial fibrillation to sinus rhythm. Am J Cardiol. 2003 Oct 1;92(7):810-4.
Kim ML, Kim SG, Park DS, Gross JN, Ferrick KJ, Palma EC, Fisher JD. Comparison of rectilinear biphasic waveform energy versus truncated exponential biphasic waveform energy for transthoracic cardioversion of atrial fibrillation. Am J Cardiol. 2004 Dec 1;94(11):1438-40.
Huang J, KenKnight BH, Rollins DL, Smith WM, Ideker RE. Ventricular defibrillation with triphasic waveforms. Circulation. 2000 Mar 21;101(11):1324-8.
Thibodeau GA, Patton KT. Estrutura e funções do corpo humano. Barueri: Manole; 2002.
Ambler JJ, Deakin CD. A randomised controlled trial of the effect of biphasic or monophasic waveform on the incidence and severity of cutaneous burns following external direct current cardioversion. Resuscitation. 2006 Dec;71(3):293-300.
