An implantable device has a clinically significant impact on hospitalizations, but its ultimate utility and value remain uncertain.
In May 2014, the FDA approved CardioMEMS, an implantable pulmonary artery (PA) pressure monitor intended to guide heart failure (HF) therapy for patients with New York Heart Association class III symptoms and a previous-year hospitalization for HF, based on results from CHAMPION, a single-blinded, 6-month follow-up trial. During FDA consideration, concerns were raised about communications in the study between the manufacturer/sponsor and investigational site staff regarding patients in the active treatment group. Now, a manufacturer-supported, follow-up study assesses longer-term outcomes.
In CHAMPION, 550 patients (mean age, 62; 73% men; 22% with left ventricular ejection fraction ≥40%) received the device and were randomized to have therap…
Reviewing Author
DisclosuresConsultant/Advisory BoardBristol Myers Squibb; CPC Clinical Research
Grant/Research SupportNational Heart, Lung, and Blood Institute
Editorial BoardsUpToDate; American College of Cardiology Self-Assessment Program (SAP)
Leadership Positions in Professional SocietiesAmerican College of Cardiology (Chair, Innovations Committee)
DisclosuresConsultant/Advisory BoardBristol Myers Squibb; CPC Clinical Research
Grant/Research SupportNational Heart, Lung, and Blood Institute
Editorial BoardsUpToDate; American College of Cardiology Self-Assessment Program (SAP)
Leadership Positions in Professional SocietiesAmerican College of Cardiology (Chair, Innovations Committee)