Valvular & structural heart diseaseMeta-analysis
Quality and transparency of evidence for implantable cardiovascular medical devices assessed by the CORE-MD consortium
- Systematic review of prospective clinical studies
- pre-specified search strategies
Authors' conclusion
The quantity and quality of publicly available data from prospective clinical investigations across selected categories of cardiovascular devices, before and after CE approval during the period 2000-21, were deemed insufficient.
Study context
- Population
- Published prospective studies of 71 high-risk CV devices in 7 classes (bioresorbable coronary scaffolds, LAAO devices, TAVI systems, transcatheter mitral repair/replacement, surgical aortic and mitral valves, leadless pacemakers, subcutaneous ICD), 2000–21
- Participants
- 97,886 participants · 308 studies
- Comparison
- Studies published before vs after CE-mark approval; RCTs vs non-randomised trials
- Non-randomized clinical trialsn = 251
- Randomized clinical trialsn = 57
Pooled result
As reported in the abstract
Quantity and quality of published prospective clinical evidence for 71 high-risk CV devices, by CE-mark timing
- Devices with ≥1 prospective clinical trial
- 70% (50/71)
- Eligible prospectively designed studies (473 reports)
- 308
- Individuals enrolled
- 97 886
- Prospective non-randomized clinical trials
- 81% (251/308)
- RCTs
- 19% (57/308)
- Pre-registered study protocol
- 49% (150/308)
- Peer-reviewed publicly available protocol
- 16% (48/308)
- Device-related adverse events evaluated
- 82% (253/308)
- Outcome adjudication process reported
- 39% (120/308)
- RCTs published before CE-mark approval
- 0
- Non-randomized trials published after CE-mark approval
- 89%, 224/251
Further pooled results
Sample size, by trial design
P < 0.001
Sample size, published before vs after CE-mark approval
individuals
- Median sample size before CE-mark approval
- 31
- Median sample size after CE-mark approval
- 135
- P < .001
Trials with larger samples (>50 individuals) or longer recruitment
- More likely published after CE-mark approval; more frequent in 2016-21
Original publication
Quality and transparency of evidence for implantable cardiovascular medical devices assessed by the CORE-MD consortium. Eur Heart J. Published 28 August 2023. doi:10.1093/eurheartj/ehad567
Summarised from the published abstract; every number is checked against it