Summary of ‘real-world’ studies evaluating the CardioMEMS HF System
| Lead author | Journal, publication year | Study type | Main analysis | n | Main findings | Other considerations | Limitations |
| Heywood27 | Circulation Heart Failure, 2017 | Retrospective study | Reduction in mPAP using AUC method; transmission adherence | 2000 |
6-month AUC (mm Hg) CHAMPION control: 42.0±65.0 (228 pts) CHAMPION treatment: −150.1±71.0 (236 pts) General use cohort: −434.0±27.5 (1655 pts) Median time between transmissions at 6 months: 1.27 days | General use cohort had higher baseline mPAP (34.9±10.2 mm Hg vs 31.6±10.9 mm Hg) which may have exaggerated AUC differences | Heart failure hospitalisation information not available; limited baseline clinical characteristics available |
| Desai25 | JACC HF, 2017 | Retrospective study, Medicare beneficiaries | HFH rate/HFH cost | 1114 | Median HFH per patient (each patient served as their own historical control) 6 months pre: 0.92 6 months post: 0.37 HR: 0.55 (0.49–0.61); p<0.001 | Compared with CHAMPION trial cohort - Larger representation of women (40% vs 23%) - Larger patient cohort (1114 vs 550) | No formal clinical event adjudication |
| Abraham | Pending publication; presented at ACC 2018 in Orlando | Retrospective, propensity-matched control | Crude mortality and HFH | 1087 |
12-month mortality rate: HD mgmt: 0.22 deaths/patient-year Propensity-matched cohort: 0.30 deaths/patient-year HR: 0.7 (0.59 to 0.83) 12-month HF hospitalisation rate: HD mgmt: 0.65 HFH/patient-year Propensity-matched cohort: 0.88 HFH/patient-year HR: 0.76 (0.65 to 0.89) | ||
| Jermyn26 | Clinical Cardiology, 2017 | Prospective effectiveness analysis | NYHA class, HFH, 6MWT | 77 |
Treatment versus control: NYHA improvement ≥1 (Rx vs control): 61.8% vs 12.5% (p<0.001) 6MWT: 54.5 m increase in Rx group, no difference in control group HFH rate: 0.16 (0.06–0.35) HFH/patient-year vs 1.0 HFH/patient-year, p<0.001 | ||
| Vaduganathan32 | JAMA Cardiology, 2017 | Retrospective | Safety outcomes | 5500 | Total adverse events: 155 (2.8%) Deaths attributable to device implantation: 6 (0.1%) PA injury/haemoptysis: 28 (0.5%) resulting in 14 ICU stays, 7 intubations and 6 deaths Sensor failure, malfunction, migration: 46 (0.84%) Access site-related bleeding/infection: 15 (0.27%) | CHAMPION adverse events: Total (out of 575 implants): 15 (2.6%) Deaths: 2 (0.35%) PA injury: 1 (0.17%) |
All HR values are point estimate with 95% CI within parentheses.
6MWT, 6 min walk test; AUC, area under the curve; HD mgmt, haemodynamic management; HF, heart failure; HFH, heart failure hospitalisation; ICU, intensive care unit; mPAP, mean pulmonary artery pressure; NYHA, New York Heart Association; PA, pulmonary artery; pts, patients.