Summary Safety Review - Trifecta Heart Valve - Assessing the Potential Risk of Early Wear

August 15, 2016

Product

Trifecta heart valve manufactured by St. Jude Medical

Potential Safety Issue

Early wear (structural valve deterioration)

Key Messages

• Trifecta is an artificial valve that is placed in the heart (an implanted device) when patients require replacement of a diseased, damaged, or malfunctioning aortic heart valve.
• Health Canada's safety review was triggered by a published report that described the wearing out (structural valve deterioration) of a patient's Trifecta valve approximately 3 years after it was placed in the heart, which is earlier than expected.
• In carrying out this safety review, Health Canada determined that there was not enough long-term evidence available to make changes to the product information at this time. Health Canada will continue to monitor safety information including the manufacturer's 10-year long patient studies and other patient safety reports on an annual basis regarding the Trifecta heart valve.

Overview

After reviewing an article about the wearing out of the Trifecta heart valve 34 months after it was implanted in a patient^{Footnote 1}, Health Canada carried out a safety review of related patient reports both in Canada and internationally. When a heart valve implant does not function properly it can place stress on the heart and a patient typically has to undergo surgery or an invasive procedure to have the valve repaired or replaced.

Use in Canada

• The Trifecta heart valve is an artificial aortic heart valve (pericardial aortic, supra annular, stented tissue valve) that has been designed to closely resemble the same valve in a human. It is made, in part, from pig and cow heart tissue that has been prepared for human use.
• This device is meant to be a replacement for a diseased, damaged, or malfunctioning aortic heart valve or as a replacement for a previously implanted aortic prosthetic heart valve.
• The Trifecta valve was first licensed in Canada in October 2010 and is manufactured by St. Jude Medical. From January 2010 to August 2015, over 125,000 of these valves were sold worldwide and 3,500 of these were sold in Canada.

Safety Review Findings

• At the time of the review, Health Canada had received a total of 13 case reports related to the wearing out (structural valve deterioration) of the Trifecta valve.  The reports describe patients that had the device implanted in their heart for 1.5 to 6 years. Information received from the manufacturer describes 117 cases of potential structural valve deterioration of this device from January 2010 to August 2015, world-wide. The number of complaints of early wear for the Trifecta valve (about 1 report for every 1,000 valves implanted) is comparable to valves of the same type.
• The scientific literature explains that, when implanted in patients older than 65 years, artificial heart valves made of animal tissues are generally expected to last approximately 10 to 15 years.^{Footnote 2},^{Footnote 3}
• There is limited information about the long-term durability of the Trifecta valve because the product has only been on the market in Canada since 2010. The manufacturer started two long-term studies to monitor the safety of this valve in a group of patients. The "Trifecta Durability Study" has been ongoing since 2011 and will conclude in 2021 and the "Long Term Follow-up Study of the St. Jude Medical Trifecta Valve" started in 2012 and will conclude in 2020. The studies will monitor patients for ten years to determine how frequently structural valve deterioration occurs.
• The current Canadian product information for the Trifecta valve mentions the potential for "structural deterioration". The Warnings section of this document provides a list of factors that may place patients at greater risk of having their Trifecta valve wear down because of calcium build-up (calcific degeneration). 
• At the time of the review, the product information did not include specific guidelines for when or how healthcare professionals should follow-up with patients, and did not state how long the device should last. The American Heart Association/American College of Cardiology Guideline for the Management of Patients with Valvular Heart Disease provides recommendations^{Footnote 4} for following up with patients that have prosthetic heart valve implants.

Conclusions and Actions

• As a result of a safety review, Health Canada considered updating the product information for the Trifecta valve regarding the potential of early wear. However, given longer-term studies are ongoing Health Canada will await these results before finalizing any updates to the product information.
• Health Canada will monitor safety information regarding the durability of the Trifecta heart valve as it becomes available, including the manufacturer's 10-year long patient studies and other patient safety reports on an annual basis. Health Canada will take appropriate and timely action if and when any new health risks are identified.

Additional Information

The analysis that contributed to this safety review included scientific and medical literature, Canadian and international safety information and what is known about the use of this device both in Canada and internationally.

For additional information, contact the Marketed Health Products Directorate.

References