Table 1.
Overview of study characteristics and patient baseline variables of CardioMEMS studies.
| Study Characteristics | Patient Baseline Variables * | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| First Author | Year of Publication | Country | Follow-Up Duration | Number of Patients | Mean Age | Male (%) | Background HF Therapy (%) | |||
| Beta-Blockers | RAS-i | MRA | ||||||||
| Randomized controlled trials | ||||||||||
| CHAMPION trial | ||||||||||
| Open- access/extended period | Abraham 4 | 2016 | USA | 13 months | 347 ** | CM: 61.3 ± 13.0 Control: 61.8 ± 12.7 |
CM: 72 Control: 73 |
CM: 89 Control: 84 |
CM: 76 Control: 79 |
CM: 43 Control: 41 |
| Randomized access period | Abraham 5 | 2011 | USA | 6 months | 550 | CM: 61.3 ± 13.0 Control: 61.8 ± 12.7 |
CM: 72 Control: 73 |
CM: 90 Control: 91 |
CM: 76 Control: 79 |
CM: 43 Control: 41 |
| Non-randomized controlled studies | ||||||||||
| MEMS-HF | Angermann 6 | 2020 | DE/NL/IE | 12 months | 234 | 67.9 ± 10.7 | 78.2 | 88.9 | 85.5 | 72.2 |
| PAS | Shavelle 7 | 2020 | USA | 12 months | 1200 | 69 ± 12.0 | 62.3 | 88.1 | 56.9 | 44.1 |
| COAST | Cowie 8 | 2020 | UK | 6 months | 100 | 69 ± 12 | 70 | NA | NA | NA |
| Real-world studies | ||||||||||
| Desai 9 | 2017 | USA | 6 months | 1114 | 71.3 ± 10.8 | 63.8 | NA | NA | NA | |
| 12 months | 480 | 71.4 ± 11.4 | 62.5 | NA | NA | NA | ||||
| Abraham 10 | 2019 | USA | 12 months | 2174 | CM: 62.7 ± 10.2 Control: 72.9 ± 10.1 |
CM: 35.1 Control: 35.1 |
NA | NA | NA | |
| Assaad 14 | 2019 | USA | 6–18 months | 27 | 67 ± 12 | 52 | 92.6 | 77.8 | 33.3 | |
CHAMPION, CardioMEMS Heart Sensor Allows Monitoring of Pressure to Improve Outcomes in NYHA Class III Heart Failure Patients; COAST, CardioMEMS Post-Market Study; DE, Germany; IE, Ireland; NL, Netherlands; HF, heart failure; CM, CardioMEMS; MEMS-HF, CardioMEMS European Monitoring Study for Heart Failure; MRA, mineralocorticoid receptor antagonist; NA, not available; PAS, Post Approval Study; RAS-i, renin-angiotensin system inhibitors; UK, United Kingdom; USA, United States of America.* All studies were performed in patients suffering from chronic heart failure in NYHA class III across all ejection fraction ranges with a previous HF-related hospitalization. ** Primary efficacy analysis was performed in a subset of 347 from the 550 initially enrolled patients.