Abbott's recent recall of its new $30,000 heart valve repair device called the MitraClip led to an intensive educational campaign to retrain surgeons in proper implantation techniques. The speedy action will likely prevent thousands of injuries.
But the voluntary action has also renewed concerns by patient safety advocates that some new devices are being thrown on the market without sufficient clinical testing or adequate training.
The rapid response by Abbott and the Food and Drug Administration comes at a time when quality and safety researchers are increasingly concerned about the cascade of new medical devices and equipment being introduced into day-to-day practice. In this case, it was only intensive post-market surveillance that highlighted the training problem.
A few months after the CMS ordered the procedures and outcomes for every Medicare patient who received the MitraClip be entered in a registry, physicians told the FDA and Abbott that the clip was becoming entangled or the device malfunctioned during the percutaneous procedure, which uses catheters and is less invasive than open-heart surgery. The device is intended for patients who do not qualify for open-heart surgery.
That meant that in cases where the catheter procedure went awry, the patients ended up needing an open-heart emergency operation to pull the device from inside their chests and to repair the mitral valve.
While just nine incidents were reported to Abbott — an incidence rate of around one in 400 procedures — at least one patient died.
Abbott reached all surgeons within a few weeks of February's initial field notice. The company distributed updated instructions to reinforce proper procedures, according to Jonathon Hamilton, a company spokesman. It did not need to retrieve any of the 3,534 devices currently on the market.
Experts say that even with the best training, there's always a learning curve. In this gray zone of medical practice, real-world outcomes often do not match the pre-market study outcomes, which were done on carefully selected patients in restrictive clinical trial environments.
“You want the people doing them to be your most proficient...not someone who just met the minimal standard,” said Dr. Michael Carome, director of Public Citizen's Health Research Group.
In testimony to an FDA advisory committee before the device was approved, Public Citizen argued there was lack of sufficient evidence about the device's effectiveness for the intended patient population. The group noted serious risks were present in the pre-approval clinical trials.
Dr. Robert Kipperman, a principal investigator for the MitraClip trial site at Morristown Medical Center in New Jersey, said during a 2011 interview with the medical technology site Medgadget that surgeons participating in the clinical trial would be best prepared to use the device.
He expressed concern about community-based intervention cardiologists needing additional training on the device and on the special issues involved in structural heart diseases like leaky heart valves. “This last group will likely be the most problematic,” he said at the time, “as the training won't be readily available in many places.” Kipperman was unavailable to comment for this story.
Dr. Jason Rogers, director of interventional cardiology at University of California-Davis Medical Center, works with Abbott to teach other physicians to use the device.
Rogers, who was contacted independently of Abbott, said the company has a “substantial training pathway,” including a two-day course involving didactic slides, training videos, case studies and hands-on instruction. As a condition of approval for the MitraClip, the federal government required that clinicians using the device participate in a registry set up to track outcomes.
The registry, run by the Society of Thoracic Surgeons and the American College of Cardiology, currently has 420 participating facilities in 48 states, the District of Columbia and Puerto Rico. The registry's website boasts its ability to let physicians benchmark their performance and outcomes against others in the study.
Abbott's spokesman said the company was made aware of the events directly from hospitals and not through the registry.
Modern Healthcare found at least six incidents that were reported to the FDA's Manufacturer and User Facility Device Experience, or MAUDE, database. In one incident, the patient died when “the clip became entangled in the left atrial appendage.” Attempted release of the clip resulted in “left atrial appendage laceration that required emergency open heart surgery.”
Other complaints involved the device malfunctioning or injuring the patient.
In one incident, the device release cables fractured, and despite multiple maneuvers and extensive discussions with Abbott representatives, the device could not be used. The procedure was “converted to open heart surgery to retrieve the retained wire.” The patient had to be sent to intensive care for recovery.
Rogers, who was involved in the clinical trials and has performed over 100 MitraClip procedures, said the retraining took just five to ten minutes. He said he will now stress Abbott's new instructions in his teaching.
While the clip itself isn't particularly difficult to insert, the number of steps can make it more challenging than other cardiac procedures. “When you do the procedure you do have to be meticulous and follow all the instructions,” Rogers said.
Some safety leaders say the MitraClip device recall is also raising questions about patient safety at low-volume centers. Studies link low surgical volumes to higher mortality and complication rates.
The MitraClip incident also highlights the need for "human factors" usability testing before products hit the market. Abbott is generally regarded for having a well-qualified department of human factors and usability engineers, said Dr. Terry Fairbanks, director of Medstar's National Center for Human Factors in Healthcare.
It's too late to fix usability design problems after the fact, Fairbanks said.
“Then the only option is to remedy the problem with training,” he said. “And this is a compromise because training is often less effective and not sustainable over time.”