DUBLIN - February 27, 2020 -
Medtronic is committed to providing therapeutic options for the sickest heart failure patients who otherwise have limited treatment options. Patients implanted with the Medtronic HeartWare HVAD™ system have been studied in six completed, prospective, global trials supporting the safety and efficacy of the device. Since the approval of the HVAD system for patients requiring support to survive until heart transplant, or among those who are too sick to receive a heart transplant, Medtronic has continued to enroll patients in a post-market surveillance study (DT-PAS) that has shown consistent safety with ongoing follow up of this important patient population.
We appreciate the efforts of the STS INTERMACS annual report authors to describe trends in the care of patients receiving these life-saving devices. The report demonstrates important changes in patient profile, policy and device utilization over time. However, we have strong concerns that the report’s comparison of left ventricular assist devices (LVADs) and related patient outcomes remains scientifically flawed and misleading.
The STS INTERMACS annual report does not account for the significant variability in practice patterns and patient selection observed among VAD centers. In fact, baseline data depicted in the supplemental materials shows more than 20 individual factors known to be dramatic predictors of mortality that are not adjusted for in the analysis. These data reveal that patients in the registry who received an HVAD pump are much sicker and at greater risk of dying based on a higher rate of known surgical and medical risk factors present prior to implant (including, but not limited to, having prior heart surgery, cancer, severe diabetes, alcohol and/or drug abuse, right ventricular dysfunction and critical cardiogenic shock, e.g., INTERMACS 1 classification), which could lead to the differences in outcomes reported between devices when device types are compared without adequately adjusting for these risk factors.
The STS INTERMACS is a voluntary database from participating hospitals that includes patients who receive mechanical circulatory support devices. This observational registry shows important trends and high variability in patient profiles by device utilization and selection, but is not designed to compare medical devices. In fact, the authors acknowledge, ‘… direct comparisons between centrifugal flow devices are premature.’
In general, we support the use of registries because they can inform the medical community on the real-world use of technology. However, non-randomized registries have well-known limitations, particularly in comparing one device to another when known risk factors are not balanced or adjusted.
We are proud of our long-standing partnership with clinicians, scientists and engineers to pioneer and demonstrate the safety and effectiveness of centrifugal, continuous-flow LVAD technology. Globally, more than 18,000 patients with advanced heart failure – whose hearts have ceased to work well enough for them – have benefited from a Medtronic HeartWare HVAD System, which saved and extended their lives.
Medtronic is committed to patient safety, and to evidence-based decision making. We will continue to review the STS INTERMACS data along with other relevant scientific data. The Medtronic HVAD System is the most extensively studied centrifugal LVAD, with published data on patients who have successfully relied on HVAD support for more than seven years. To continue to improve outcomes for these patients, we are committed to partnering with STS INTERMACS and others to bring reliable, actionable data to physicians that advances the field of mechanical circulatory support.