As physicians, our patients and their caregivers expect that we base clinical decisions about disease management and treatment on the best available evidence, following guidelines and recommendations based on randomized clinical trials (RCTs) and literature reviews. But there is not always evidence to guide every decision, opening the door to other influences: local practice patterns, professional culture, past experience, as well as industry marketing. , published this month in JAMA, illustrates the potential influence that payments from the medical device industry have on physician decision-making, specifically payments to interventional cardiologists and use of intravascular microaxial left ventricular assist devices (LVADs).
Intravascular Microaxial LVADs: A Controversial History
Intravascular microaxial LVADs are complex medical devices used to provide temporary mechanical circulatory support, most commonly among patients undergoing high-risk percutaneous coronary intervention (PCI) or experiencing cardiogenic shock. The first version of these devices received FDA through the 510(k) regulatory pathway, based primarily on similarity to nonroller cardiopulmonary bypass pumps. However, among patients undergoing high-risk PCI, PROTECT II, found no statistically significant difference in the primary endpoint of major adverse events at 30 days, despite superior hemodynamic support.
Over the subsequent years, use of these and similar devices increased substantially -- -- with in hospital uptake. Such uptake was not driven by clear evidence of benefit, as had no mortality benefit when used for patients with cardiogenic shock after acute myocardial infarction. In contrast, over the past 5 years, multiple leveraging administrative claims and registry data have found intravascular microaxial LVAD use to be associated with greater risk of death and severe bleeding among patients with cardiogenic shock.
Moreover, intravascular microaxial LVADs have been subject to more than by the FDA. The most serious recall was recently announced, in February 2024, after some models of the device were found to have perforated the walls of patients' left ventricles, associated with and 129 serious injuries.
In the context of these growing safety concerns, just 2 weeks ago, the on the safety and effectiveness of these devices was released. Conducted in Europe and requiring 10 years to recruit 360 severely ill patients with cardiogenic shock after ST-segment elevation myocardial infarction, intravascular microaxial LVAD use led to a lower risk of death from any cause at 180 days compared to standard care alone. However, the risks for several serious adverse events were higher among patients treated with these devices, including severe bleeding and the need for renal replacement therapy. No new RCT data have demonstrated clinical outcome benefit for patients undergoing high-risk PCI.
What's Motivating LVAD Use?
Given the paucity of RCT evidence for many years demonstrating clinical outcome benefits of intravascular microaxial LVADs, what has been motivating use? Certainly, some physicians have witnessed positive outcomes when using these devices for patients, which may have driven local practice patterns. However, our concern is that commercial interests may also be influencing use, even if only subtly or subconsciously.
First, from the greater reimbursement associated with intravascular microaxial LVAD use, which may have prompted some hospitals to establish these services at their facility.
Second is the role industry marketing and promotion may be playing. Medical device marketing commonly comes in the form of advertising to physicians through mailers and promotions at conferences. In healthcare, it also comes through offering payments and other articles of value (including meals) to physicians to allow detailing representatives into their office and to attend seminars and other promotional lectures.
The scale of these payments is extraordinary. From 2013 through 2022, $12.1 billion was paid by the pharmaceutical and medical device industry to physicians, and more than half of all physicians in the U.S. received payments over this period.
prior have that payments from pharmaceutical manufacturers to physicians are associated with greater use of their brand-name medications, often at the expense of generics or other less costly alternatives. The have been found true for medical device manufacturers, as most implantable cardioverter-defibrillator (ICD) placements were performed by physicians who had received payments from ICD manufacturers.
What About LVAD Manufacturer Payments?
Intravascular microaxial LVADs are manufactured by one company: Abiomed. To understand whether payments from the manufacturer were associated with device use, we linked Medicare claims data to the agency's Open Payment Programs data, which is a repository of all payments of $10 more, or $100 annually, by all manufacturers of FDA-regulated products to physicians, nurses, and academic medical centers in the U.S.
We identified more than 6,000 interventional cardiologists who performed PCIs for Medicare beneficiaries from 2016 through 2018, received payments from the intravascular microaxial LVAD manufacturer. We found that those who received payments were approximately twice as likely to place an intravascular microaxial LVAD in the year of the payment, as well as in the year following the payment. We also found that the highest use of these devices was among physicians who received the highest value of payments.
Should Payments From Industry to Physicians Be Allowed?
Physicians may not believe -- or want to believe -- that they are influenced by payments from industry. But payments clearly influence decision-making, both subtly through feelings of reciprocity and overtly through marketing and promotional materials. Should this be allowed? Or should the profession seek ways to mitigate the influence of industry in medicine?
Our strong preference is that we make clinical decisions about disease management and treatment for patients based on the best available evidence. Rather than tolerating a system where companies compete to influence the care of our patients through marketing and promotion, where payments are most commonly made to that are more expensive, potentially less safe, and no more effective than alternatives, we should foster a system where companies compete by conducting high-quality RCTs that demonstrate that their products are more effective and safe than alternatives or no device.
is an assistant professor of medicine at UCSF School of Medicine. MHS, is a professor of medicine and public health at Yale School of Medicine.
Disclosures
Dhruva receives support from the Department of Veterans Affairs and Arnold Ventures, and previously received research support from the Medical Device Innovation Consortium as part of the National Evaluation System for Health Technology (NEST).
Ross receives research support through Yale University from Johnson & Johnson to develop methods of clinical trial data sharing; from FDA for the Yale-Mayo Clinic Center for Excellence in Regulatory Science and Innovation (CERSI) program; from the Agency for Healthcare Research and Quality; and from Arnold Ventures. He previously received research support from the Medical Device Innovation Consortium as part of the National Evaluation System for Health Technology (NEST) and from the National Heart, Lung and Blood Institute of the NIH.