Women Face Higher Risks of Heartmate II Complications: Study

A new study suggests that women may be more likely than men to face complications from the Thoratec HeartMate II left ventricular assist system (LVAS), which is a mechanical heart pump that has recently been linked to a potential risk of blood clots and other problems.  

Researchers from the Cleveland Clinic published a retrospective analysis in the Journal of the American College of Cardiology online on December 11, indicating that being female increased the risk of bleeding, stroke and blood clots among patients who received a HeartMate II implant.

According to the findings, advanced age, a higher body mass index, and some other health factors appeared to increase the risk of some of the Thoratec HeartMate II complications, but women faced increased risks across the board.

“The striking finding is that female sex was a risk factor for all four events,” wrote Dr. Samer S. Najjar in an editorial that accompanied the study. “Identifying the additional demographic and clinical factors that modulate the risks of bleeding and thrombosis will enhance our ability to risk-stratify patients with LVADs. The hope is that by integrating this information, the anticoagulation and antiplatelet strategies could be tailored to balance the bleeding and thrombotic profiles of a given patient.”

HeartMate II Health Concerns

The Thoratec HeartMate II LVAS is a coronary implant given to patients whose hearts are too weak to efficiently pump blood. Former Vice President Dick Cheney is perhaps the most famous recipient, but they have been widely used among individuals with advanced heart disease who are waiting for a heart transplant or are too weak to undergo such a procedure.

This study comes less than a month after researchers from the Cleveland Clinic first sounded a warning bell about the potential risk of blood clot problems with the HeartMate II. In a study published last month in the New England Medical Journal researchers indicated that the heart pump may increase the risk of blood clots by a factor of four among patients who had received the device since March 2011.The blood clot complications resulted in the deaths of at least 19 patients since that time.

The numbers found a sharp increase in reports of HeartMate II injuries in recent years, even though the device had been on the market for years. Researchers were at a loss as to why blood clot problems with the device suddenly skyrocketed.

For HeartMate II pumps implanted before March 2011, the risk of pump thrombosis was at about 2.2% after three months. By January 2013 that rate had increased to 8.4%, leaving some researchers to question whether Thoratec has changed the devices’ design without informing the medical community or the FDA.

Thoratec HeartMate II Investigation

The FDA has announced it is investigating the findings of that study. A number of product liability lawyers are also reviewing the possibility of whether individuals who experienced problems may be eligible to pursue a claim through a Thoratec HeartMate lawsuit.

At least one group representing shareholders is also warning investors about a potential class action against Thoratec, noting that the company’s stocks dropped significantly in value after the HeartMate II concerns came to light.

On December 13, Shareholders Foundation noted that at least one law firm was investigating Thoratec Corporation over potential securities laws violations, in connection with financial statements the company had made. The investigation is focusing on whether the company made a series of statements about its business that were materially false and misleading.

The Foundation notes that Thoratech shares reached a 2013 high of $43.30 as of November 15 of this year. But following the November 27 announcement by the Cleveland Clinic the shares began dropping, and were down to $35.68 per share by December 13.