Safety Alert Or Field Safety Notices for Biological replacement pericardial aortic heart valve

Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and the United Kingdom.

This alert applies only to the Mitroflow ‘model LX’ valve which was marketed in the UK by Sorin between 2005 and 2014. Patients implanted with the smaller sizes of the Mitroflow LX model are more prone to early SVD (especially younger patients) and therefore should be prioritised for extra surveillance. It is estimated that less than 80 of these smaller sized valves have been sold in the UK in the last five years (and less than 1,300 in the last 10 years). Hence even allowing for some implants having taken place later on within their 5-year expiration period, the number of affected patients is expected to be comparatively low.An earlier version, the ‘model 12’ Mitroflow valve is not included in this alert, because it was last distributed in the UK in 2006. With a maximum shelf-life of 5 years, these valves will have been implanted no later than 2011, and so should already be subject to the increased surveillance recommended for all prosthetic valve patients from 5 years, in accordance with the European Society of Cardiology Guidelines. This alert essentially brings forward these follow-up recommendations to apply to all patients with the smaller size Mitroflow LX valve.The more recent version of the Mitroflow valve, the ‘model DL’ is not included in this alert, because there is currently no evidence that it is affected by a higher than expected incidence of early SVD. This may be linked to the introduction of a phospholipid reduction treatment for this model to reduce calcification. We intend to review the safety and performance of model DL once more clinical data becomes available.The recommendations in this alert are based on our review of a number of published papers on the Mitroflow series valves over the last few years in which we noted some consistent findings giving rise to concerns. In general, the concerns relate to a higher risk of SVD in patients with the smallest aortas, particularly in the presence of patient-prosthesis mismatch (PPM). Some of the more significant references and observations are listed below:A 2016 report by the National Institute for Cardiovascular Outcomes Research (NICOR), which used data from all National Health Service and private hospitals in England and Wales that submitted to the National Adult Cardiac Surgery Audit (NACSA) between 1998 and 2013. The report highlighted that the Sorin Mitroflow series displayed a larger hazard than expected with the 10-year overall freedom from re-intervention or death rate for the Mitroflow valve found to be 33.8%, compared with the overall average of 47.2% for all non-Sorin biological valves.
A 2014 report by the Odense University Hospital, Denmark3, revealed an increased risk of mortality and/or reoperation for Mitroflow valves VS a comparator valve.
A 2014 report by the Nantes University Hospital, France4 presented early SVD as frequent in Mitroflow valves (models 12A/LX), especially for small sizes (19 and 21 mm) with reduced overall survival.In response to the concerns raised by MHRA, the manufacturer is planning a targeted, post-market surveillance study in the UK to compare Mitroflow with all-comers, including the use of other stented tissue valves that require ancillary procedures such as aortic root enlargement. Over time this study intends to use existing NHS data, as well as data from the Hospital Episodes Statistics and Office for National Statistics to provide a more complete assessment of this SVD signal.