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Harms and benefits of screening young people to prevent sudden cardiac death

BMJ 2016; 353 doi: https://doi.org/10.1136/bmj.i1156 (Published 20 April 2016) Cite this as: BMJ 2016;353:i1156

Rapid Response:

Re: Harms and benefits of screening young people to prevent sudden cardiac death. Answer to Assanelli’s rapid response.

Assanelli et al. make 2 major points. First, differences across health care systems in different countries may affect the impact of pre-participation screening. Second, they suggest that pre-participation screening may be cost-effective [1].

The dissimilarity in the cardiac conditions diagnosed in the SMILE study [2] in Europe versus Algeria is predominantly due to a remarkable high number of Wolff-Parkinson-White (WPW) syndromes detected in Algeria. Among 5,563 European screenees, 1 asymptomatic and 1 symptomatic WPW were detected. In Algeria, among 1,071 screenees they identified 12 asymptomatic and 11 symptomatic cases. The fact that at screening a high number of symptomatic WPWs are identified in Algeria can be explained by difference in the local health care system, as suggested by Assanelli et al. [2]. In western countries, most if not all of these symptomatic individuals, would have been identified and treated appropriately through standard medical care. As discussed in our report [3] the detection of asymptomatic WPW individuals has no impact on the mortality rate in screened athletes. Sudden cardiac death (SCD) is extremely rare as a presenting symptom in an individual with WPW and there is no consensus on how to prevent such devastating event in asymptomatic subjects. Some experts argue that asymptomatic people do not need to be treated. Others will proceed to catheter ablation or implantation of a defibrillator in selected individuals. They argue that, although it has not been shown that these interventions reduce the risk of SCD, there is a pathophysiological rationale for it. However, those treatment modalities have their proper mortality risk which may be of a similar magnitude of the SCD risk of asymptomatic affected individuals.

Our main objection against the assertion that pre-participation screening is cost-effective is that it has not been shown that such screening saves lives. On the contrary, overall harms may even exceed benefits. The absence of evidence of benefit of screening has recently been confirmed in a recommendation issued by the American Heart Association, stating that “Mandatory and universal mass screening with 12-lead ECGs in large general populations of young healthy people 12 to 25 years of age (including on a national basis in the United States) to identify genetic/congenital and other cardiovascular abnormalities is not recommended for athletes and nonathletes alike (Class III, no evidence of benefit; Level of Evidence C)” [4]. Also the UK National Screening Committee recommended in July 2015 not to screen 12 to 39 year olds to prevent SCD (http://legacy.screening.nhs.uk/suddencardiacdeath).

In the context of an uncertain clinical effectiveness, economic considerations can only provide additional arguments against screening. Assanelli’s comment nevertheless shows the importance of critically appraising the input variables and assumptions of economic evaluations before taking any decision based on their conclusions. The study of Wheeler et al. [5], that is often cited to support the cost-effectiveness of cardiovascular screening and the economic evaluation cited in Assanelli’s answer [1] provide good examples of this requirement. We conducted a systematic review of economic evaluations published up to December 2014 [3]. From this review, 5 economic evaluations were identified [5-9]. After having analysed their quality, it appears that those 3 that were in favour of pre-participation screening [5,6,9], incorrectly based their conclusion on the assumption that history-taking and physical examination (H&P) was the standard of care and therefore the comparator. Nevertheless, there is no evidence showing that H&P should be the current standard practice. If no screening was considered in the comparators, additional analyses performed in the study of Wheeler et al. showed that adding an ECG to H&P would give an ICER superior to $100 000/QALY. All other economic evaluations concluded against screening.

Moreover, all economic evaluations (including the study referred to in the letter [1]) based effectiveness parameters of their model on data extracted from the Veneto study [10]. We have discussed this point at great length, both in our paper and in the original Health Technology Assessment [3, 11]. The essential problem with this study is that it does not include a valid control population, i.e. young people who participate in competitive sports and who are not screened. This study does not allow making causal inferences. We simply do not know what would have happened with the SCD rate in Italy if there were no mandatory screening program.

Furthermore, in the study of Corrado et al. [10], a yearly screening is performed while in all economic evaluations, including the study referred to in the letter [1], a one-time screening is assessed only including the cost of one screening round (comprising screening tests and further examinations). All authors optimistically assumed that such a one-time screening has the same effect as a yearly screening. Most importantly, the study of Wheeler et al. [5] explored this in sensitivity analyses and showed that “annual screening of any kind, or extending screening to all middle and high school students, is highly unlikely to be cost-effective in terms of reduction of sudden cardiac death”.
Negative implications of a (false) positive screening result is also usually not taken into account (lifestyle restrictions and/or sport disqualification, long term side effects of nontrivial therapies and anxiety associated with living with a heart disease). Figure 1 illustrates the impact of a cardiovascular pre-participation screening with H&P and ECG in Belgium (for a prevalence of 0.3%, a sensitivity of 0.75 and a specificity between 0.70 and 0.95). From a medical point of view, there is a low prevalence of people at risk of SCD (yellow circle in the blue circle), a very high number of false-positives in the short term (orange circle – size depending on test-specificity), and a relatively high number of people being disqualified or treated (red circle) in relation to the real risk of SCD (small dot at the right). From an economic point of view, based on Belgian cost data from a health care payer perspective (including screening, diagnosis, and patient management costs in the long term), the balance between the very high costs and the uncertain treatment effect makes the intervention no good investment of limited resources. The visual representation in figure 1 might help physicians to explain to young asymptomatic athletes and their parents why it is better not to screen them for SCD.

References
1. Assanelli D, Levaggi R, Carre F, et al. Cost-effectiveness of pre-participation screening of athletes with ECG in Europe and Algeria. Internal and emergency medicine 2015;10(2):143-50.
2. Assanelli D, Ermolao A, Carre F, et al. Standardised pre-competitive screening of athletes in some European and African countries: the SMILE study. Internal and emergency medicine 2014;9(4):427-34.
3. Desomer A, Gerkens S, Vinck I, et al. Cardiovascular pre-participation screening in young athletes. Belgian Health Care Knowledge Centre (KCE), 2015. KCE Reports 241. https://kce.fgov.be/publication/report/cardiovascular-pre-participation-....
4. Maron BJ, Levine BD, Washington RL, et al. Eligibility and Disqualification Recommendations for Competitive Athletes With Cardiovascular Abnormalities: Task Force 2: Preparticipation Screening for Cardiovascular Disease in Competitive Athletes: A Scientific Statement From the American Heart Association and American College of Cardiology. Circulation 2015;132(22):e267-72.
5. Wheeler MT, Heidenreich PA, Froelicher VF, et al. Cost-effectiveness of preparticipation screening for prevention of sudden cardiac death in young athletes. Annals of internal medicine 2010;152(5):276-86.
6. Fuller CM. Cost effectiveness analysis of screening of high school athletes for risk of sudden cardiac death. Medicine and science in sports and exercise 2000;32(5):887-90.
7. Halkin A, Steinvil A, Rosso R, et al. Preventing sudden death of athletes with electrocardiographic screening: what is the absolute benefit and how much will it cost? J Am Coll Cardiol 2012;60(22):2271-6.
8. Leslie LK, Cohen JT, Newburger JW, et al. Costs and benefits of targeted screening for causes of sudden cardiac death in children and adolescents. Circulation 2012;125(21):2621-9.
9. Schoenbaum M, Denchev P, Vitiello B, et al. Economic evaluation of strategies to reduce sudden cardiac death in young athletes. Pediatrics 2012;130(2):e380-9.
10. Corrado D, Basso C, Pavei A, et al. Trends in sudden cardiovascular death in young competitive athletes after implementation of a preparticipation screening program. JAMA : the journal of the American Medical Association 2006;296(13):1593-601.
11. Van Brabandt H, Desomer A, Gerkens S, et al. Harms and benefits of screening young people to prevent sudden cardiac death. BMJ 2016;353:i1156.

Competing interests: No competing interests

01 August 2016
Sophie Gerkens
Health economist
Hans Van Brabandt, Anja Desomer, Mattias Neyt
Belgian health Care Knowlegde Centre (KCE)
Kruidtuinlaan 55 1000 Brussels Belgium