heartware vad malfunction details theheart.org

HeartWare VAD malfunction and subsequent ICH prompts hospital to suspend implantations

Milwaukee, WI (updated) - A patient implanted with the HeartWare ventricular assist device (VAD) (HeartWare, Framingham, MA) suffered an intracranial hemorrhage after being treated for a clot that caused a device malfunction, Reuters is reporting [1].

According to the report, which is based on statements from someone close to the case, the incident has prompted the implanting center, Aurora St Luke's Medical Center in Milwaukee, to stop implanting the VAD, a small centrifugal flow pump that can generate a flow of up to 10 L/min. The patient was treated with tissue plasminogen activator (tPA) to resolve a clot that triggered a device malfunction, according to the report. The patient then suffered an intracranial hemorrhage outside of the hospital. An earlier version of this article suggested that the device played a causative role in the intracranial hemorrhage, but the exact cause of the hemorrhage has not been identified. Intracranial hemorrhage is a long-recognized potential complication of treatment with thrombolytic agents such as tPA.

Sources
Clarke T and Sherman D. Leading US hospital suspends HeartWare device-source. Reuters, February 23, 2011. Available here.
HeartWare. HeartWare International reports fourth quarter 2010 revenues of $20.9 million; 71% increase from $12.2 million in fourth quarter 2009 [press release]. February 24, 2011. Available here.

The hospital would not comment on the case. A HeartWare spokesperson told heartwire that information from any one trial site is confidential, but that events are reported to the FDA "as appropriate." He also pointed out that over 50 US centers are active in the HeartWare trials.

During its February 24 quarterly-earnings call, HeartWare CEO Doug Godshall said, "Our goal is to get as close to zero on all complications as we possibly can," noting that the company is working on further improvements to the surfaces inside the device that will reduce the risk of thrombus formation. Godshall suggested that it is difficult to estimate how common this type of thrombus event is, because it is not tracked specifically in the INTERMACS registry or previous controlled VAD trials. "There's never a standalone pump-thrombus definition, in part because they are often dealt with medically, and if medical management was not possible, then it could lead to a pump exchange that appears in the adverse-event table."

HeartWare recently received FDA approval to add 94 patients to the 108 already approved for the continued access protocol for its ADVANCE trial of HeartWare as a bridge to transplant. In December, the company submitted six-month results from the 140-patient, 30-center ADVANCE trial to the FDA to support a bridge-to-transplant indication for the device. Results of the ADVANCE trial, reported at the American Heart Association conference in Chicago in November, showed that the incidence of stroke with the HeartWare VAD was higher than expected for a device this small.

The company has also enrolled about 80 patients at 30 centers in a destination-therapy study planned for 450 patients at 50 centers, according to HeartWare's most recent earnings statement [2].

The HeartWare VAD is commercially available in Europe.