High-Output Mechanical Circulatory Support in Left Main Interventions: The Magenta Elevate High-Risk PCI First-in-Human Study
Authors' conclusion
In this first-in-human study, use of the Magenta Elevate low-profile, high-output catheter during HR-PCI was safe and provided substantial cardiac support. During prolonged interventional LM occlusions, the system unloaded the LV, maintaining a normal MAP and dΔPAoLV.
Study context
- Population
- Patients undergoing high-risk percutaneous coronary intervention (HR-PCI), including prolonged unprotected left main balloon occlusions8 with LM occlusions
- Participants
- 14 patients
- Outcome
- Major device-related adverse events (primary safety endpoint)
Main finding
As reported in the abstract
- No major device-related adverse events
Further findings
| Outcome | Change (mm Hg) (CI) | P value | |
|---|---|---|---|
| Haemodynamic change during prolonged LM occlusions (20 occlusions)During occlusionvs Before occlusionSystolic aortic pressure | −35 (−46 to −23) | P < 0.0001 | |
| Haemodynamic change during prolonged LM occlusions (20 occlusions)During occlusionvs Before occlusionDiastolic pressure | 7 (4–10) | P < 0.0055 | |
| Haemodynamic change during prolonged LM occlusions (20 occlusions)During occlusionvs Before occlusionMAP; remained in normal range | −7 (−13 to −2) | P < 0.001 | |
| Haemodynamic change during prolonged LM occlusions (20 occlusions)During occlusionvs Before occlusiondΔPAoLV; remained in normal range | −2 (−5 to 4) | P = 0.51 | |
| −60−40−20020Difference, mm Hg (linear scale) |
- Haemodynamic change during prolonged LM occlusions (20 occlusions) — Ventriculo-arterial uncoupling
- 13 of 20 LM balloon occlusions
Mortality · 30 days
- No mortality at 30 days
Parts of this Brief are withheld: the automatic checks could not confirm them against the abstract.
Original publication
High-Output Mechanical Circulatory Support in Left Main Interventions: The Magenta Elevate High-Risk PCI First-in-Human Study. JACC Cardiovasc Interv. Published 23 December 2024. doi:10.
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