Key result
In a European registry of patients receiving ICDs for primary prevention after myocardial infarction, 6% required device replacement over an average of 1.5 years of follow-up.
This editorial emphasizes the necessity and cost-effectiveness of ICDs for primary prevention after myocardial infarction with left ventricular dysfunction, despite reimbursement and implementation challenges in Europe.
Primary prevention remains a difficult enterprise, at least in European hands. 1 Even when ESC guidelines endorse primary prevention, physicians are not implementing what seems to be logical [implanting implantable cardioverter defibrillators (ICDs) in patients with a poor left ventricular function]. The reasons are multiple. The most visible one is that reimbursing authorities are reluctant to spend the money. This is the case, for example, in Belgium, where quota has been assigned, reducing the number of primary prevention indications and making it very tough for physicians to decide which patient is at the highest risk, in order to spend the budget as effective as possible. In other countries, local guidelines are preferred over European guidelines (which is contrasts with agreements that European guidelines should prevail). These guidelines are often much more restrictive towards primary prevention. This is due to agreements between scientists and professional societies, on the one hand, and authorities and/or insurance companies, on the other hand. It is not surprising that cardiologists do not always follow the European or US attitude. One of the most striking factors (according to me, watching the Dutch and the French scenes) is the (hopefully ancient) fight over the indications for resynchronization pacemaker vs. resynchronization defibrillator therapy as such. The Working Group on Heart Failure, the industry, and several scientists missed the opportunity to demonstrate that cardiac resynchronization and defibrillator therapies are complementary to each other. 2 Finally, companies took the profit, inhibiting us to collect scientific proof that ICDs were really useful in the subsets of heart failure patients who are resynchronized. 3 A real randomized trial has now become impossible, due to religion that had replaced science. Not unexpected, this fight has endorsed opinion makers in insuring authorities that the value of ICDs for heart failure patients can be debated. This is evidently true in part: New York Heart Association class II patients benefit more than those with more advanced heart failure. 4 Another problem is related to the implementation of primary prophylaxis after infarction. One trial was negative in patients who received their ICD within 30 days. 5 Retrospectively, this seems too early for primary prevention: patients were in the phase that the coronaries are still not completely quiet, with stents still requiring clopidogrel, and reocclusion as a major problem when the antiplatelet therapy is interrupted. Indeed, the outlook for patients after infarction has changed. Acute coronary stenting [percutaneous coronary stenting (PCI)] is widely available, and the pool of eligible patients could diminish (but only if a decline in the incidence of coronary artery disease becomes a reality). The long-term result of PCI will determine whether a patient becomes a primary prevention candidate. However, several patients still do not benefit from early intervention. This could finally bring the numbers again to the original forecast. Other important scientific reasons are raised to doubt whether ICD therapy should be widely used for primary prevention. One argument is that MADIT I and II were carried out in the era before PCI was available, and other pharmacological advances were not optimally used. 6 , 7 SCD-HeFT was a very nice confirmation of the MADIT II hypothesis and its results, leaving no doubt that in the course after myocardial infarction, primary prevention plays a role after a certain moment. Nevertheless, this requires a change in the attitude of several cardiologists, including interventional cardiologists, who still seem to believe that with PCI, all problems are solved and often rely on 1–2-year follow-up to believe that this is the truth. Efforts to improve the selection process early after infarction face difficulties, and the inclusion of eligible patients is difficult. 8 In contrast, some suggested to use other tools to stratify patients at high risk, re-introducing autonomic tone and variables in the repolarization as T-wave alternans. 9 This might overcome difficulties in the assessment of the left ventricular ejection fraction, which is a major inclusion criterion in the larger studies. If this is measured too early, or with an inappropriate technique, or just an estimate is used, its value becomes limited or even useless. This gives support to introduce other variables in an attempt to adapt or bypass the guidelines again. Another obstacle to more widespread use of primary prophylaxis is the recent wave of device recalls and hardware problems, with the Sprint Fidelis problem as the summit. 10 This recent change in appearances of software and hardware of arrhythmia management devices certainly undermined the willingness for a wide use of primary prevention in borderline patients. Therefore, it is interesting to read the results of a large European Registry, mainly performed in Italy and Germany analysing the adherence to guidelines, and how the patients were doing with respect to tachy- and bradyarrhythmias. 11 The authors stipulate that their patients were more ill than those included in MADIT II and they often received a resynchronization device. However, they had a similar time course after the infarction (7 years). It is nice to observe that morbidity is lower, despite unfavourable baseline data. Another interesting fact is that 6% had device replacement over 1.5 years of average follow-up, with only 27 recalls. This might be considered as a low number, but more objectively, this brings us back to the early eighties. It is a pity that no data are given on lead replacement, but it might be worthwhile to consider for the authors to do so in a further analysis. The number of patients receiving appropriate intervention was high enough to consider patient selection as adequate. In conclusion, the published data are confirming the concept of primary prevention after infarction. Given the numbers, primary prevention should probably be considered as a cost-effective procedure. This manuscript, on the background of a European health care system, contains very useful data to help us to convince those responsible in insurance companies and healthcare authorities from the benefits of primary prophylaxis. Conflict of interest: none declared.
No takes yet. Share an insight, caveat, or question.
Valk et al. (2008) conducted an editorial in myocardial infarction with left ventricular dysfunction. Implantable cardioverter defibrillators (ICDs) was evaluated. In a European registry of patients receiving ICDs for primary prevention after myocardial infarction, 6% required device replacement over an average of 1.5 years of follow-up.
Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context: