Patient deaths blamed on user error, but Thoratec pump sales could fall

Thoratec has stopped short of recalling the new control unit for its HeartMate II left ventricular assist device (LVAD) after four deaths, saying that the problem was to do with patients operating the device incorrectly rather than equipment failure. Instead the company issued an urgent safety alert calling for patients to re-learn how to work the pump’s controls.

But doctors could be much more reluctant to recommend a device whose controls appear to be hard to master. Added to the increased risk of thrombosis with the HeartMate II which emerged three months ago, this could impinge on Thoratec’s sales (HeartWare buys CircuLite as Thoratec suffers from thrombosis, December 3, 2013).

New controller

As well as the four patient deaths the new device, called the Pocket Controller, has been linked with five cases of loss of consciousness or other symptoms of hypoperfusion. Thoratec says that eight of these nine events occurred in patients who had started to use the Pocket Controller after initially being trained on an earlier control device. The ninth patient had only ever used the Pocket Controller.

Two of the patients who died had attempted to switch from their primary controller to a backup system while alone and, in contravention of the labelling, without contacting a hospital first, Thoratec said. The company says it has investigated all reported adverse events with the Pocket Controller and found no malfunctions.

It advised patients with the new controller to contact their doctor immediately to be re-trained and to receive an updated manual. Updated labelling and training materials have also been issued to doctors.

The HeartMate II Pocket Controller was launched in the EU in August 2012, and in the US and Canada in May 2013. So far 2,142 patients have received the unit, either at the time of the implantation of the HeartMate II or as a replacement for an older control model.

Threat

The threat to sales is not as dire as it might be as some of the patients using Thoratec’s pump have no choice. The LVAD sold by Thoratec’s main rival, HeartWare, is only approved in the US for temporary use, but Thoratec’s can be used temporarily or permanently. It therefore has the monopoly in US patients too sick for a heart transplant, who can receive the pump as destination therapy – it is not removed until after the patient dies.

Still, many US cardiologists may opt for HeartWare’s device, called the HVAD, as destination therapy anyway given that the HVAD is approved for this use in Europe. And a reluctance to use Thoratec's device as bridge-to-transplant in US patients, and in all European patients, would be understandable.

As patients grow sicker, they may require something more than an LVAD: a full artificial heart, which replaces the native organ entirely.

French company Carmat is beginning to be active here, though development is very early. The first patient to receive one of Carmat's artificial hearts has just died, 74 days after the device was implanted. Though the term was short, this still counts as something of a success; end-stage heart failure is an “immediate life-threatening situation”, Carmat says, and under these circumstances survival for 30 days post-implant is considered “encouraging”.

What caused the 76-year-old patient’s death is not yet known. But the trial will continue, with implants planned in three more patients. If they survive for more than a month, Carmat will begin a trial of around 20 patients to evaluate the device’s effects on their quality of life. European approval for the device could come as early as next year, such is the demand.

In the LVAD space, though, much of the battle is between Thoratec and HeartWare, and the latter may be getting the upper hand.

To contact the writer of this story email Elizabeth Cairns in London at [email protected] or follow @LizEPVantage on Twitter

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