Dr. David Yuh, chief of cardiac surgery at Yale University, New Haven, Conn., said that while he was not surprised by the split vote on risk-benefit, he voted positively on this question. "I did feel this was an effective monitoring device that did facilitate closer monitoring of these very difficult patients for heart failure cardiologists."
Dr. Valluvan Jeevanandam, chief of cardiac and thoracic surgery at the University of Chicago, was one of two panelists who were not convinced by efficacy in terms of reducing HF hospitalizations; however, he voted in favor of the risk-benefit profile because of what he considered the device’s value as a diagnostic tool, which he said he would find useful in "innumerable" patients.
"I just got paged for two people who need right-heart catheterizations tomorrow, who wouldn’t need them" if they had this device, he said.
Voting no on the effectiveness and risk-benefit questions, Dr. David Milan, a cardiac electrophysiologist at Massachusetts General Hospital, Boston, said he believed the device was safe, but there were not enough data on effectiveness. The data analyses presented by the company were not valid or convincing, and the company should have conducted another randomized controlled study, he said.
The FDA usually follows the recommendations of its advisory panels. Panelists have been cleared of potential conflicts of interest related to the topic of the meeting. If approved, CardioMEMS has planned a postapproval study that would prospectively follow the safety and effectiveness of the device in a real-world setting in about 1,200 patients, including 420 women.