Safety and Effectiveness of Implants for Cerebral Aneurysms Substantiated by Very Poor Evidence

ROTTERDAM the Netherlands - In recent years, many new devices have come on the market to treat an aneurysm in the brain: a bulge of a blood vessel. Neurosurgeon Victor Volovici of Erasmus MC, University Medical Center Rotterdam the Netherlands, noticed that many of these devices are labeled "safe and effective," while solid evidence for these claims is lacking.

No control group
With an international team (including representatives from the Mayo Clinic, The Barrow Neurological Institute, University Hospitals Cleveland Medical Center, Case Western Reserve University, and University of South Carolina), Volovici searched through 1,356 scientific studies that reported on the safety and effectiveness of new treatment methods for brain aneurysm in more than 400,000 patients. Volovici was shocked by the results. ‘The quality of the studies is poor. In 80 percent of the studies, no control group is used to provide a benchmark for the results of the new implant. The claim 'safe and effective' is therefore improperly substantiated from a scientific standpoint. There is often no difference in complications or even mortality between studies that conclude a device is safe and those that say it is not. Researchers seem to be cutting corners when it comes to good science.'

The problems in the evidence base occur mainly with the newer devices for endovascular treatment. These devices came on the market as a successor to two treatments for which the evidence is solid: brain surgery during which the skull is opened, called clipping. Or filling the aneurysm with platinum spirals via a blood vessel in the groin, called coiling. The goal of both treatments is to seal off the aneurysm.

Sepideh Amin-Hanjani, MD,  a collaborator on the study and Director of Cerebrovascular and Skull Base Surgery at University Hospitals Cleveland Medical Center, said,  “Although novel technologies and devices are a crucial aspect of advances to patient care, this study highlights how there can be a premature rush to acceptance; the newest thing is not always the better option, and as clinicians treating patients we should collectively expect and strive for more critical and objective appraisal of outcomes.

Evidence is lacking
In recent years, the industry has developed new devices for treatment, such as so-called WEB devices and flow-diverting stents. 'These implants are presented in practice as innovative treatments, which are even better than coiling and clipping. But evidence for this that stems from high-quality studies with a control group is lacking,' Volovici said. The same, he says, applies to new surgical techniques. 'I am at least as critical of those as I am of the endovascular studies.'

Volovici emphasizes that doctors should carefully make the choice of treatment together with other specialists during a multidisciplinary consultation. Then this choice should be discussed with the patient or the patient's family. 'If surgery and endovascular treatment are both possible, several factors play a role in making the choice. We consider, for example, the patient's age and preference and the shape and location of the aneurysm.'

Patients treated with a new device in the Netherlands need not worry, says Volovici. 'All patients are monitored regularly, and we have an extensive system of quality control in Europe before a new medical device enters the market. There is not enough evidence that the new implants are better than coiling or clipping, but there is also no evidence that they are worse.’

Tighten policies
Volovici is critical towards authors, peer reviewers and editors of scientific journals who call a new treatment safe and effective when no robust study has been done. 'Conducting and publishing studies of questionable quality must stop. Doctors, patient associations and the industry should say: from now on, we’ll only conduct studies with enough patients from multiple hospitals and with a control group representing the current standard of care.'

Volovici expects regulatory agencies, such as the FDA in the United States, to tighten medical device approval policies. He is also hopeful that the Dutch nationwide research consortium CONTRAST-2, in which nine centers in the Netherlands are investigating the safety and effectiveness of various stroke treatment methods, will change clinical practice for the better.

What is an aneurysm in the brain?
A cerebral aneurysm is a weakness or bulge in a blood vessel in the brain. Doctors do not currently know what causes an aneurysm. High cholesterol, high blood pressure or hereditary predisposition play a role. Most people do not notice they have an aneurysm. Others develop neurological symptoms or the aneurysm is discovered by chance during a scan.

If a cerebral aneurysm ruptures, it creates a life-threatening situation. One-third of patients die from it. Every year in the Netherlands, about 1,000 patients suffer a brain hemorrhage due to an aneurysm. Also, 200 to 300 people are treated before the aneurysm has burst. Treatment can be surgical or through a blood vessel in the groin (endovascular).

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