Various heart patients have had a heart device forced on them by Zwolle cardiologists in recent years. Hospital Isala recognizes this in response to four cases that NRC submitted. The patients contacted NRC after a series of publications about the ongoing corruption investigation into five Zwolle cardiologists and a German heart equipment manufacturer. One of the complaints of patients is that they were put under (time) pressure to have a pacemaker or implantable defibrillator fitted in the short term.
Isala says that the treatment of the patients “clearly does not” meet the standards for a procedure. “A patient should never feel pressure to choose a particular treatment. We can therefore imagine that these patients look back on their experiences with regret.” One of the patients has her defibrillator (ICD) removed for medical reasons.
In the past, Isala cardiologists also placed innovative wireless pacemakers in patients as part of scientific research. These devices turned out to have many flaws. For example, parts became loose and the battery sometimes drained very quickly. Since October 2016, the American manufacturer Abbott has advised doctors to monitor patients monthly if they wear the device for more than two years. Isala does not follow this advice for unclear reasons and applies a term of three months. The hospital says that the doctors consider “on the basis of the individual medical situation” whether “this extra check” is necessary.
Inserted too many ICDs
Zorginstituut Nederland, a regulator, warned this month that cardiologists across the Netherlands too often implant ICDs in patients without improving their chances of survival. An ICD delivers a shock in the event of a life-threatening cardiac arrhythmia, so that sudden death can be prevented. Cardiologists are instructed by the Zorginstituut to install the devices less quickly, to inform patients better and to work more carefully.
Isala places the largest number of ICDs of all Dutch hospitals, also in relation to the size of the patient population. The board of directors previously investigated the reason for this, but found out empty-handed: Zwolle doctors act within the liberal European rules that allow patients to quickly receive a preventive ICD. “That is our struggle,” CEO Rob Dillmann said earlier NRC. “If you are in a discussion with a professional group, but you have acted within the guideline, then you are done talking as a director.”
One of the patients tells NRC that Zwolle doctors in a clinic in Indonesia insisted on a pacemaker. After the placement, he never received a call for a check-up. Cardiologists from Isala have been working at the Cinere clinic in Jakarta for at least twenty years, in which the cardiology partnership of Isala has invested financially. Many heart devices have been placed under their supervision. The hospital declines all responsibility for this. “Isala has never had any involvement in activities that individual cardiologists from Zwolle carried out there. Therefore, patients treated there are not known in Isala, so they could not be checked at Isala.”
Also read the experiences of the patients: Cardiologist? ‘It felt like it was a kitchen vendor’
The patients in Jakarta did receive a hospital card with the name Isala after the pacemaker was placed. The hospital now says that there must have been “improper use of items”. The hospital emphasizes that there are no more contacts with Indonesia from the department of cardiology.
The cardiologists say they are unable to respond due to medical confidentiality.
All cardiological scientific research over the past twenty years has been done outside Isala, via a commercial company of cardiologists, the company Diagram. Last year, the Fiscal Investigation Service (FIOD) raided this place because of the suspicion that Zwolle medical specialists were bribed by the German manufacturer of heart devices Biotronik. Five cardiologists associated with Diagram have also been identified as suspects. The hospital management subsequently demanded more information from Diagram about the money flows. Because there was insufficient response to this, the hospital cut ties with Diagram. “Isala will from now on carry out all cardiological scientific research itself.”
A version of this article also appeared in the newspaper of February 13, 2023