US EditionReport: UK's NHS Kept Using Deadly Heart Device Despite Safety Data
Analysis showed 45% mortality within two years for Medtronic HeartWare HVAD patients versus 15% for Abbott HeartMate III, yet UK hospitals used it until mid-2021.
- Hospitals continued implanting the Medtronic HeartWare HVAD despite NHS warnings as the Freeman Hospital, Newcastle, and Harefield Hospital, Harefield near west London, used the pump for years before its withdrawal for safety.
- Hospitals defended their choices by questioning the audit's reliability, saying they saw no clear grounds to deem the Medtronic device inferior and noting clinicians cited 'excellent outcomes' and suitability for smaller patients; several senior transplant clinicians had declared consulting ties to Medtronic, hospitals said.
- Detailed audit numbers reveal higher mortality and complications for the Medtronic pump, with 45% of 119 patients dying within two years versus 15% of 97 patients given the Abbott HeartMate III, and three patients may have died from pump malfunctions.
- Families and patient representatives are demanding answers, with Greg Marshall's family seeking clarity while the Freeman offers 'sincere condolences' and investigates, and Robbie Burns calls for an external probe.
- The Medicines and Healthcare products Regulatory Agency continued approvals despite lacking NHS data, while Royal Papworth Hospital, Cambridge stopped using the device in February 2018 after trials; half of NHS patients fitted with LVADs died within three years.
15 Articles
15 Articles
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