Medtronic (NYSE:MDT) today touted stroke data from the Lateral trial of its HeartWare HVAD left ventricular assist device involving implantation via thoracotomy instead of open surgery.
With a thoracotomy implantation, surgeons insert the pump via a small, lateral incision between the left ribs and make a second small incision to accommodate the pump’s outflow graft. Fridley, Minn.-based Medtronic said Lateral results presented at the annual meeting of the American Society for Artificial Internal Organs showed that 95% of thoractomy patients were free from disabling stroke at two years.
Adverse events were more likely in the first 30 days after implantation and declined significantly after that, as measured by events per patient year. Bleeding events moved from 1.53 to 0.51 per patient year; arrhythmia events slid from 3.22 to 0.26; and from 0.51 to 0.12 for stroke between the 30- and 180-day marks, the company said.
The risk of late stroke was 0.05 EPPY in years one to two post-implant and the survival rate was 87% at two years, according to Medtronic.
“These data give us more comprehensive information showing low adverse event and stroke rates for end-stage heart failure patients who receive the HVAD system,” cardiac rhythm & heart failure CMO Dr. Rob Kowal said in prepared remarks.
“Remembering my earliest experiences with the very first HVAD system implant in patient more than 15 years ago, I’ve seen both the significant benefits and also the risks for patients who receive a ventricular assist device. These new data are impressive,” added study investigator Dr. Georg Wieselthaler of UC San Francisco. “Many of us have dedicated our lives’ work to improving this therapy, including minimizing adverse events. The HVAD pump’s small size lends itself to the less-invasive surgical approach, and to see 95% freedom from disabling stroke at two years with the HVAD system implanted via thoracotomy reinforces that we are making dramatic strides in this therapy.”
Medtronic also said it plans to launch a global registry study of thoracotomy implantations in bridge-to-transplant and destination therapy patients.