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Who benefits from precautionary implanted defibrillators? EU promotes Europe-wide study with 6 million Euros

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Start for Europe-wide and only fully publicly funded ICD- patient study EU CERT ICD with significant participation of DZHK partners: UMG heart center coordinates.

Up to this point, implantable cardioverter defibrillators (ICD) were considered a life insurance against sudden cardiac death for people with cardiac arrhythmia. According to older studies, about one third of all patients with a particular risk for cardiac arrhythmias are at an advantage if their heart is supported by such a “shock-pacemaker”. Preventive medical implantation is routine. But recent findings question the results of previous studies.

Which patients with cardiac arrhythmias benefit from the precautionary treatment with an implantable cardioverter defibrillator (ICD) and does it explicitly protect against sudden cardiac death? This question is now to be clarified by a large European study that is to present current findings. One of the study’s goal is to review the guidelines for the treatment with ICDs and to bring these up for discussion. The EU-CERT-ICD-Study (Comparative Effectiveness Research to Assess the Use of Primary ProphylacTic Implantable Cardioverter Defibrillators in Europe) is coordinated by the Heart Center at the University Medical Center Göttingen (UMG). The European Union (EU) promotes the project for four years with a total of 6 million Euros. So far, the study is the only ICD- patient study which is funded entirely by public funds.

19 institutions from 14 European countries are involved in the study. Included are four partner institutions of the German Centre for Cardiovascular Research (DZHK), the Charité in Berlin as well as the LMU and TU in Munich. Coordinator of the project is Prof. Dr. Markus Zabel, head of Clinical Electrophysiology at the Department of Cardiology and Pneumology, Heart Center at the University of Göttingen. The project secretariat is headed by Dr. Joachim Seeger, specialist for cardiology at the Heart Center Göttingen.

“This study is one of the currently most important European cardiovascular studies and I am very pleased that once again the coordination of a large European health study is located at the Heart Center Göttingen“, says Prof. Dr. Gerd Hasenfuß, director of the Department of Cardiology and Pneumology, chairman of the Heart Center Göttingen and Board Member of the German Centre for Cardiovascular Research (DZHK).

Every year, an estimated 500,000 people in the European Union die from sudden cardiac death. Main causes are malignant, life-threatening cardiac arrhythmias of the ventricles. Previous studies have shown that high-risk patients with implantable cardioverter-defibrillators have an advantage for survival of 31 percent compared to high-risk patients without ICD. The preventive ICD- implantation in patients at risk has since then been destined by international guidelines of professional societies and is anchored in the medical routine.

“The reasons for a reassessment of the international guidelines and the medical and medical practice are manifold. Dangerous cardiac arrhythmias are treatable today directly through improved drug therapies and other cardiological treatment principles. Therefore today, potential implantation candidates suffer less frequently from life-threatening ventricular fibrillation than ten years ago”, says Prof. Dr. Markus Zabel, coordinator of the Europe-wide study.

Recent studies also suggest that certain patients today do not have survival advantages, because they were provided with a prophylactic ICD. Two thirds of the prophylactically implanted ICD will never be used. And not every situation that leads to a “shock” of the ICD would have ended in sudden cardiac death if the patient hadn’t had an ICD. “The examples show that the available data on the effectiveness of prophylactic ICDs need an urgent update. Also, updating the selection criteria for patients who should benefit from prophylactic ICD therapy is absolutely necessary”, says Prof. Zabel.

The study aims to provide reliable, current data on risk factors of sudden cardiac death. Of importance is the question of whether and to what extent the sudden cardiac death can actually be prevented by precautionary ICD implantation given the lower shock frequencies. The new findings will also help to assess the socio-economic effects of the treatment. The results will be discussed with patients, patient organizations, health insurances, physicians and actors in health policy. A final result is the re-evaluation of current guidelines for the use of ICDs and their possible adaptation.

With three approaches the scientists want to obtain current data. Prospectively collected data of 2,500 patients without cardiac arrhythmias that were preventively supplied with a defibrillator allow conclusions about mortality rate as well as the frequency of correct and faulty ICD shocks. Another important point is the evaluation of life quality with and without ICD. For this, within the framework of EU-CERT-ICD, Europe’s largest registry of patients with prophylactic ICD-treatment is in the making. 6,000 already existing patient records are merged therein and provide important information about event frequencies. As a third source of data the scientists will sum up and analyze results of already published ICD-studies. Furthermore, they use all results for the analysis of health economics within the project.

ICD therapy in the EU
Currently over 100,000 defibrillators are implanted annually in the EU, the costs for the implantation alone amount to over two billion Euros each year. Implantation rates and acceptance of current guidelines for the use of ICDs differ across the EU, sometimes considerably. In Germany for example approximately 300 devices per year and per one million inhabitants are implanted whereas in the UK and Spain it’s only 80.

Universitätsmedizin Göttingen, Georg-August-Universität
Herzzentrum Göttingen
Klinik für Kardiologie und Pneumologie
Prof. Dr. Markus Zabel
Telefon 0551 / 39-10265