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Commentary: The value of nonrandom and uncontrolled.
David Blitzer1, Hannah Copeland2,3
1Division of Cardiovascular Surgery, Department of Surgery, Columbia University, New York, New York, USA.
Journal of Cardiac Surgery
|April 1, 2022
Summary
This study compared HeartMate 3 (HM3) left ventricular assist device implantation before and after FDA approval. Post-approval patients were sicker, requiring HM3 as a bridge to transplant, highlighting real-world clinical practice differences from clinical trials.
Area of Science:
- Cardiovascular Surgery
- Medical Device Technology
- Clinical Outcomes Research
Background:
- The HeartMate 3 (HM3) left ventricular assist device received FDA approval in 2018.
- Real-world clinical data is crucial for understanding device performance beyond initial trials.
Purpose of the Study:
- To evaluate the clinical experience with HeartMate 3 implantation before and after its FDA approval.
- To compare patient characteristics and outcomes in a real-world setting.
Main Methods:
- A single-center review of 82 patients implanted pre-FDA approval and 92 patients implanted post-FDA approval.
- Analysis of patient demographics, preoperative conditions, and surgical strategy.
Main Results:
- The post-approval group was younger and had higher preoperative INR.
- Patients receiving HM3 post-approval were more likely to be bridged to transplant and have prior mechanical support.
- The post-approval cohort included more patients with higher INTERMACS profiles.
Conclusions:
- Randomized controlled trials may not fully represent clinical practice realities.
- Real-world studies are essential for a comprehensive understanding of medical interventions like the HM3 device.
Keywords:
transplant
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