The value of wearable cardioverter defibrillator in adult patients with recent myocardial infarction: Economic and clinical implications from a health technology assessment perspective.

AIMS: Sudden cardiac death (SCD) causes high mortality and substantial societal burdens for healthcare systems (HSs). The risk of SCD is significantly increased in patients with reduced left ventricular ejection fraction after myocardial infarction (MI). Current guidelines recommend re-evaluation of cardioverter-defibrillator implantation 40 days post-MI, earliest. Medical therapy alone does not provide sufficient protection against SCD, especially in the first month post-MI, and needs time. Consequently, there is a gap in care of high-risk patients upon hospital discharge. The wearable cardioverter defibrillator (WCD) is a proven safe, effective therapy, which temporarily protects from SCD. Little information on WCD cost-effectiveness exists. We conducted this research to demonstrate the medical need of the device in the post-MI setting defining WCD cost-effectiveness. METHODS & RESULTS: Based on a randomized clinical trials (RCTs) and Italian and international data, we developed a Markov-model comparing costs, patient survival, and quality-of-life, and calculated the Incremental Cost-Effectiveness Ratio (ICER) of a WCD vs. current standard of care in post-MI patients. The rather conservative base case analysis - based on the RCT intention-to-treat results - produced an ICER of €47,709 per Quality Adjusted Life Year (QALY) gained, which is far lower than the accepted threshold of €60,000 in the Italian National HS. The ICER per Life Year (LY) gained was €38,276. CONCLUSION: WCD utilization in post-MI patients is clinically beneficial and cost-effective. While improving guideline directed patient care, the WCD can also contribute to a more efficient use of resources in the Italian HS, and potentially other HSs as well.

Usability study of two common defibrillators reveals hazards.

STUDY OBJECTIVE: This usability study evaluates the user interface of 2 common monitor-defibrillators, the Lifepak10 and Lifepak12, to identify use-related hazards. METHODS: Fourteen paramedics familiar with both devices completed 4 EMS simulator scenarios using each device. The scenarios involved "quick look" and monitoring, defibrillation, synchronized cardioversion, and replacing paper. Qualitative and quantitative data were collected, including both participant self-evaluation (scored 1 to 9) and expert observer evaluation (scored 0 to 4). RESULTS: Participant ratings demonstrated that for performing a quick look, the Lifepak10 was easier to use (mean 8.0 versus 7.1), and for synchronized cardioversion the Lifepak12 was easier (mean 6.7 versus 5.3). Participants performed better on the Lifepak12 than the Lifepak10 for synchronized cardioversion (mean 3.1 versus 1.6) and replacing paper (mean 3.0 versus 2.1). One participant did not complete the final questionnaire. Of the remaining 13, 11 (85%) participants preferred the Lifepak12 for use on a regular basis. Eight (62%) paramedics thought that the Lifepak12 would be more effective in an emergency; 9 (69%) believed that the Lifepak10 is quicker to learn. Paramedics reported difficulty using the devices with gloves and confusion in "sync" mode. Of note, 50% of participants inadvertently delivered an unsynchronized countershock for supraventricular tachycardia. CONCLUSION: Although the Lifepak10 is easier to learn, the Lifepak12 is perceived as easier to use and more effective in emergencies. The high failure rate in synchronized cardioversion indicates a need to reevaluate the user interface design for this function. Limitations of this study include the use of simulation.

Fully automatic external defibrillators in acute care: Clinicians' experiences and perceptions.

BACKGROUND: Fully automatic external defibrillators (FAEDs) reduce the time to defibrillation [Martinez-Rubio A, Kanaan N, Borggrefe M, Block M, Makijarvi M, Fedele F, et al. Advances in treating in-hospital cardiac arrest: safety and effectiveness of a new automatic external cardioverter-defibrillator. J Am Coll Cardiol 2003;41(4):627-32; Mattioni T, Kanaan N, Riggio D, Bahu M, Lin D, Welch S, et al. Performance of an automatic external-cardioverter-defibrillator algorithm in the discrimination of supraventricular from ventricular tachycardia. Am J Cardiol 2003;91:1323-6] and improve outcomes [Martinez-Rubio A, Kanaan N, Borggrefe M, Block M, Makijarvi M, Fedele F, et al. Advances in treating in-hospital cardiac arrest: safety and effectiveness of a new automatic external cardioverter-defibrillator. J Am Coll Cardiol 2003;41(4):627-32]. There is, however, no guidance or standard about their use in the UK. This paper presents the results of a study, which explored clinicians' experiences and perceptions of using FAEDs in acute care in the UK. AIMS: This study sought to understand clinicians' experiences and perceptions of the use of FAEDs in acute care and their impact on decision making. METHODS: Using a qualitative approach, 43 nurses and four physicians were included in a trial of FAEDs in a Coronary Care Unit (CCU) and cardiology ward during 2004. Semi-structured interviews were conducted with nurses and physicians prior to and following the trial. Data were analysed using thematic analysis [Attride-Stirling J, Thematic networks: an analytic to research. Qual Res 2001;1(3):385-405]. RESULTS: Decision control, safety, a lack of confidence in the technology, previous experience and concerns about the psychological affect on patients affected clinicians' decision making and limited the use of the FAED. CONCLUSION: Despite reported benefits of the FAED [Martinez-Rubio A, Kanaan N, Borggrefe M, Block M, Makijarvi M, Fedele F, et al. Advances in treating in-hospital cardiac arrest: safety and effectiveness of a new automatic external cardioverter-defibrillator. J Am Coll Cardiol 2003;41(4):627-32; Mattioni T, Kanaan N, Riggio D, Bahu M, Lin D, Welch S, et al. Performance of an automatic external-cardioverter-defibrillator algorithm in the discrimination of supraventricular from ventricular tachycardia. Am J Cardiol 2003;91:1323-26], personal and contextual issues affected the clinicians' decision making. More and better understanding about how FAEDs and their context of use may challenge established practice is required in order that it is utilised in the most effective way.