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HVAD to Heartmate 3 Device Exchange: A Society of Thoracic Surgeons Intermacs Analysis
Rebecca Cogswell1, Ryan S Cantor2, Esther Vorovich3
1Department of Medicine, Division of Cardiology, University of Minnesota, Minneapolis, Minnesota.
Insights
Exchanging the HeartWare Ventricular Assist Device (HVAD) to the HeartMate 3 shows increased mortality compared to continued HVAD support. However, for patients needing pump exchange, HeartMate 3 offers superior survival.
Area of Science:
- Cardiovascular Surgery
- Medical Device Technology
- Clinical Outcomes Research
Background:
- Medtronic announced the discontinuation of the HVAD left ventricular assist device in June 2021.
- This analysis focuses on surgical risks and survival outcomes related to HVAD device exchanges.
Purpose of the Study:
- To summarize surgical risks associated with exchanging the HVAD to a HeartMate 3 device.
- To compare survival rates after HVAD to HeartMate 3 exchange versus primary HVAD implantation.
- To compare survival outcomes between HVAD to HeartMate 3 and HVAD to HVAD exchange procedures.
Main Methods:
- Utilized The Society of Thoracic Surgeons Intermacs database to identify three patient cohorts.
- Cohorts included primary HVAD implant, HVAD to HeartMate 3 exchange, and HVAD to HVAD exchange.
- Modeled mortality after HVAD to HeartMate 3 exchange and compared it to continued HVAD support.
Main Results:
- HVAD to HeartMate 3 exchange was linked to significantly reduced survival compared to continued HVAD support (73.8% vs 79.0% at 6 months).
- Survival was higher after HVAD to HeartMate 3 exchange compared to HVAD to HVAD exchange at 1 year (85.9% vs 66.6%, P = .009).
Conclusions:
- Exchanging to HeartMate 3 from HVAD significantly increases mortality compared to continued HVAD support.
- For patients requiring pump exchange while on HVAD support, switching to HeartMate 3 demonstrated superior survival.
- Currently, there is insufficient evidence to recommend elective exchange from HVAD to HeartMate 3.
Background:
On June 3, 2021 Medtronic, Inc announced discontinuation of the HVAD left ventricular assist device. The purpose of this analysis was to provide summary data on surgical risks of HVAD to HeartMate 3 exchange and compare survival after HVAD to HeartMate 3 exchange to survival after primary HVAD implantation.
Methods:
Three cohorts within The Society of Thoracic Surgeons Intermacs database were identified: primary HVAD implant cohort (January 2017 to March 2021, n = 3797), HVAD to HeartMate 3 exchange cohort (December 2017 to March 2021, n = 45), and HVAD to HVAD exchange cohort (January 2017 to March 2021, n = 234). Mortality after HVAD to HeartMate 3 exchange was modeled and compared with the constant hazard phase for risk of mortality while on continued HVAD support. As a secondary analysis outcomes and survival were compared between patients who underwent HVAD to HeartMate 3 and HVAD to HVAD exchange.
Results:
HVAD to HeartMate 3 exchange was associated with significantly reduced survival compared with survival while remaining on HVAD support (6 months after exchange, 73.8% [70% confidence interval, 68.6-77.8] vs 79.0% [70% confidence interval, 78.3-79] for continued HVAD support). Compared with HVAD to HVAD exchange, survival was higher after replacement with HeartMate 3 (1 year: 85.9% [70% confidence interval, 79.5-90.5] vs 66.6% [70% confidence interval, 63.0-70.0], P = .009).
Conclusions:
Compared with continued support on HVAD, an exchange to HeartMate 3 was found to be associated with a significant increase in mortality. For patients who required pump exchange on HVAD support, exchange to HeartMate 3 demonstrated superior survival. Currently there is insufficient evidence to support elective exchange from an HVAD to HeartMate 3.
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