September 20, 2017JAMA Cardiology
Postmarketing Adverse Events Related to the CardioMEMS HF System
Key result
During the first 3 years after FDA approval, there were 155 adverse event reports (2.8%) among approximately 5,500 CardioMEMS HF System implants, including 22 deaths (0.4%).
Population
Patients with the CardioMEMS HF System (wireless pulmonary artery sensor)
Design
Cohort
Authors
Discussion
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Member takes
Implication
Postmarketing surveillance indicates low device-related risk in heart failure; leaves open need for comparative long-term safety studies.
Structured PICO
P
Population
Approximately 5,500 patients who received the CardioMEMS HF System in the United States over a 3-year period following FDA approval.
E
Exposure
CardioMEMS HF System (wireless pulmonary artery sensor)
O
Outcome
Adverse eventssafety
Postmarketing data indicates an adverse event rate of approximately 2.8% associated with the CardioMEMS HF System.
Limitations
- Incomplete patient profiling
- Underreporting, delayed reporting, or selective reporting
- Lack of quality control or event adjudication
- Cannot be used to establish definitive event rates
Cite This Study
Vaduganathan et al. (2017) conducted a letter in Heart Failure (n=5,500). CardioMEMS HF System was evaluated on Adverse events. During the first 3 years after FDA approval, there were 155 adverse event reports (2.8%) among approximately 5,500 CardioMEMS HF System implants, including 22 deaths (0.4%).