The scandal surrounding the use of the “Cardioband” heart valve implant at the University Hospital of Zürich (USZ), Zürich, Switzerland, continues to spread. After the report by the independent investigative commission, released at the end of April, suggested that under former hospital director Francesco Maisano, there were over 70 unexpected deaths between 2016 and 2020, the public prosecutor’s office has launched an investigation. Following the publication of the commission’s report, the hospital board filed a complaint — specifically regarding 11 deaths and 13 instances of medical device use. 

Now, the University Hospital of Bern (Inselspital Bern), Bern, Switzerland, also intends to have the use of the Cardioband system at its hospital reviewed. The investigation will encompass all Cardioband treatments performed at Inselspital, and the aim of the review is to comprehensively analyze the indications, treatment processes, and clinical outcomes, the Insel Group announced in its press release. The release states: “According to current information, there is no evidence of safety problems with the procedures performed at Inselspital. Nevertheless, the Insel Group considers an independent review of the treatments performed and the decision-making processes to be appropriate. It wants to ensure that the findings from Zurich are carefully and independently analyzed, also with regard to its own practices.”

Also Used in German Hospitals

The Cardioband system was also used in German hospitals. As Lena Bösch, head of corporate communications, University Medical Center Göttingen (UMG), Göttingen, Germany, reported in response to an inquiry from Medscape, the selection of patients to be treated with the Cardioband system was carefully evaluated. “Not all patients were eligible, which is why the number of these patients over a 5-year period — more specifically, between 2016 and 2021 — was very low,” Bösch reported. Since mid-2021, the procedure has no longer been used at UMG. “The reason for this was the professional assessment by our specialists that, on average, better results could be achieved with less effort using other established procedures,” explained Bösch.

According to Bösch, there were no significant complications related to the Cardioband system. Patients treated with a Cardioband received the necessary cardiologic follow-up care. Some of the patients are cared for at the UMG, while others are treated by private-practice cardiologists and, if necessary, referred back to UMG.

“Our experts are, of course, closely monitoring the latest developments and reports regarding the Cardioband system. Whether this will result in a need for further action for individual patients will be assessed — as is always the case with new safety-related findings — based on the current scientifically proven state of knowledge and the individual situation of each patient,” said Bösch.

The Rhön-Klinikum Campus Bad Neustadt and the Zentralklinik Bad Berka (German hospitals) have used the Cardioband system exclusively for individual patients with significant tricuspid valve regurgitation whose treatment was particularly complex, emphasized Heike Ochmann, spokesperson for Rhön-Klinikum AG. “In our practice, the use of the Cardioband was always based on a case-by-case decision following discussion within an interdisciplinary HeartTeam. It was only performed when the other two procedures — repair with a clip or replacement of the heart valve with a prosthesis — were not medically possible or were not promising for the patient,” explained Ochmann.

According to Ochmann, in Bad Neustadt and Bad Berka, more than 3250 catheter-based heart valve procedures were performed between 2021 and 2024. “Patients were successfully treated with a Cardioband on 18 occasions. We have not experienced any problems resulting from its use,” reported Ochmann. The patients are enrolled in structured semi-annual or annual follow-up examinations; so far, there have been no abnormalities, according to Ochmann.

At Ulm University Hospital (UKU), Ulm, Germany, the procedure was previously used at the Department of Internal Medicine II of the UKU “in a very limited patient population as part of treatment that complied with the guidelines and clinical trials of the time using the approved product,” stated Philip Hertle, press officer at UKU, in response to an inquiry.

Certification Expired

Due to reports on the findings of the commission’s report, many people with an implanted Cardioband have contacted the German Heart Foundation with concerns, the foundation stated. It cannot comment on the incidents in Zurich, “as we do not have further information on the matter.” In a recent commentary on the website of the German Heart Foundation, Volker Rudolph, Director of the Department of General and Interventional Cardiology/Angiology, and Jan Gummert, Director of the Department of Thoracic and Cardiovascular Surgery, both at the Heart and Diabetes Center NRW in Bad Oeynhausen, Germany, explained the principle of the Cardioband system and clarified whether additional measures are now required.

With over 6000 procedures performed annually in Germany, the “clip” repair is by far the most commonly used procedure. The Cardioband and prosthetic replacement each account for between 100 and 200 procedures per year, although the Cardioband has not been in use since 2024 because the company did not renew its European Conformity (CE) certification, according to the German Heart Foundation.

The Cardioband is inserted via the femoral vein using a K-wire and secured with several screw anchors in the heart muscle tissue of the annulus of the tricuspid valve. The band is then tightened via a catheter — effectively gathering the valve — causing the individual leaflets of the valve to move toward one another. This restores the valve’s seal.

Complications Occurred in the Early Phase

Reports on the use of the system at the USZ revealed cases of anchor disengagement, in which the band’s screw anchors detached from the heart muscle. This detachment of the anchors from the heart muscle tissue represents a terrifying scenario, Rudolph and Gummert emphasized. However, all available data indicated that these detachments typically occur during or shortly after implantation and are then detected by the implanting clinic. “In the vast majority of patients, the data show a sustained, safe reduction in valve regurgitation following implantation of a Cardioband,” wrote Rudolph and Gummert.

The cardiologists emphasized that the described complications primarily stem from the early phase of use of the Cardioband system. Since the band was the first available system of its kind, experience with catheter-based treatment of the tricuspid valve was limited overall. Compared to the initial phase, however, imaging — especially ultrasound of the valve and catheters — has “advanced considerably,” the two cardiologists emphasized. For example, it was not recognized during the early phase of the Cardioband that there are various degrees of severity and forms of tricuspid valve regurgitation. In the meantime, however, these have been clearly defined. This and many other findings have, according to Rudolph and Gummert, led to Cardioband implantations recently being performed more safely and efficiently than in the early phase.

Nevertheless, the initial experiences have also led to a certain degree of reluctance toward the system within the medical community. Further scientific studies of the significantly advanced Cardioband system did not result in approval, because the implantation procedure was still considered complicated. Further widespread adoption of the therapy thus seemed unlikely, so the distributing company did not renew the CE certification; the Cardioband is no longer available and is no longer used as a treatment option. There are, however, other approaches from different companies that, in the broadest sense, are testing similar procedures. Whether these will ever be used clinically is currently unclear, according to the German Heart Foundation.

Regular Checkups Are Sufficient

Patients with an implanted Cardioband who are clinically stable should — like all heart patients following valve surgery — undergo regular cardiologic follow-up examinations. If there is a problem with the Cardioband, it can be detected by an ECG. If the imaging shows that everything is normal, there is no need for further measures. Should a suspicious finding arise, the patient is usually referred to the clinic that performed the implantation. 

Emergencies are the absolute exception. The experts noted that the current reporting does not indicate any need for acute or unscheduled measures. The routinely recommended cardiologic follow-up is sufficient. Every patient with a Cardioband should undergo regular cardiologic examinations.

This story was translated from Medscape’s German edition.