Table 1.
Overview of the main studies assessing pulmonary artery pressure monitoring for heart failure.
| First Author | Year | PAP Monitoring Device | Study Design | Study Name | Study Population | Sample Size | Comparator | HFH Outcomes |
|---|---|---|---|---|---|---|---|---|
| Abraham | 2011 | CardioMEMS | RCT | CHAMPION | NYHA III HF and HFH < 12 months |
550 | Control group | HR 0.72; 95% CI 0.60–0.85; p = 0.0002 (6 months follow-up) HR 0.63; 95% CI 0.52–0.77; p < 0.0001) (15 months mean follow-up) |
| Abraham | 2016 | CardioMEMS | RCT | CHAMPION (extended follow-up) | NYHA III HF and HFH < 12 months |
347 | Control group and patient own historic control | HR 0.67; 95% CI 0.55–0.80; p < 0.0001 (18 months mean follow-up, compared to control group) HR 0.52; 95% CI 0.40–0.69; p < 0.0001 (13 months mean follow-up, compared to historic control) |
| Lindenfeld | 2021 | CardioMEMS | RCT | GUIDE-HF | NYHA II–IV HF and HFH < 12 months or elevated NT-proBNP/BNP |
1000 | Control group | HR 0.88; 95% CI 0.74–1.05; p = 0.16 (main analysis) HR 0.81; 95% CI 0.66–1.00; p = 0.049 (pre-COVID analysis) |
| Angermann | 2020 | CardioMEMS | Non-randomized trial and Post-marketing | MEMS-HF | NYHA III HF and HFH < 12 months |
236 | Patient own historic control | HR 0.38; 95% CI 0.31–0.48; p < 0.0001 (12 months post-implant versus 12 months pre-implant) |
| Shavelle | 2020 | CardioMEMS | Non-randomized trial and Post-marketing | CardioMEMS post-approval study | NYHA III HF and HFH < 12 months |
1200 | Patient own historic control | HR 0.43; 95% CI 0.39–0.47; p < 0.0001 (12 months post-implant versus 12 months pre-implant) |
| Heywood | 2022 | CardioMEMS | Non-randomized trial and Post-marketing | CardioMEMS post-approval study (extended follow-up) | NYHA III HF and HFH < 12 months |
710 | Patient own historic control | HR 0.30; 95% CI 0.25–0.35; p < 0.0001 (24 months post-implant versus 12 months pre-implant HR 0.62; 95% CI 0.56–0.69; p < 0.0001 (24 months post-implant versus 12 months post-implant) |
| Cowie | 2022 | CardioMEMS | Non-randomized trial | COAST (UK results) | NYHA III HF and HFH < 12 months |
100 | Patient own historic control | HR 0.18; 95% CI 0.12–0.28; p < 0.0001 (12 months post-implant versus 12 months pre-implant) |
| Desai | 2017 | CardioMEMS | Cohort study | … | HF patients with an implanted CardioMEMS and ≥6 months follow-up | 1114 | Patient own historic control | HR 0.55; 95% CI 0.49–0.61; p < 0.001 (6 months post-implant versus 6 months pre-implant) HR 0.66; 95% CI 0.57–0.76; p < 0.001 (12 months post-implant versus 12 months pre-implant) |
| Abraham | 2019 | CardioMEMS | Cohort study | … | HF patients with an implanted CardioMEMS and >12 months follow-up | 2174 | Matched control group | HR 0.76; 95% CI 0.65–0.89; p < 0.01 (12 months follow-up) |
| Kishino | 2022 | CardioMEMS | Cohort study | … | HF patients with an implanted CardioMEMS AND an HFH | 3763 | Matched control group | HR 0.75; 95% CI 0.63–0.89; p = 0.001 (30 days follow-up) HR 0.73; 95% CI 0.63–0.86 p < 0.001 (90 days follow-up) HR 0.80; 95% CI 0.71–0.91; p = 0.001 (180 days follow-up) |
| Milligan | 2022 | CardioMEMS | Cohort study | … | NYHA III HF and an implanted CardioMEMS | 53 | Patient own historic control | IRR 0.48; 95% CI 0.32–0.70; p < 0.001 (6 months post-implant versus 6 months pre-implant) IRR 0.56; 95% CI 0.41–0.76; p < 0.001 (12 months post-implant versus 12 months pre-implant) |
| Mullens | 2020 | Cordella | Non-randomized trial | SIRONA | NYHA III HF and HFH < 12 months |
15 | … | … |
| Sharif | 2022 | Cordella | Non-randomized trial | SIRONA 2 | NYHA III HF and HFH < 12 months or elevated NT-proBNP/BNP | 75 | … | 8 HFH (90 days follow-up) 11 HFH (6 months follow-up) |
HF: Heart Failure; HFH: Heart Failure-Related Hospitalization; NYHA: New York Heart Association; CardioMEMS: CardioMEMS HF system; Cordella: Cordella HF system; HR: Hazard Ratio; IRR: Incidence Rate Ratio; 95% CI: 95% Confidence Interval; RCT: Randomized Controlled Trial.