Research Letter
April 10, 2024
Intravascular Microaxial Left Ventricular Assist Device Manufacturer Payments to Cardiologists and Use of Devices
Sanket S. Dhruva, Joseph S. Ross, Michael A. Steinman, et al
JAMA. Published online April 10, 2024. doi:10.1001/jama.2024.4682
Mechanical circulatory support devices are increasingly used by physicians for patients receiving percutaneous coronary intervention (PCI).1 Use of intra-aortic balloon pumps (IABPs) has decreased, whereas use of intravascular microaxial left ventricular assist devices (LVADs) grew from 4.1% to 9.8% of all PCIs for acute myocardial infarction complicated by cardiogenic shock from 2015 to 2017,1 despite limited evidence demonstrating safety or clinical effectiveness2,3 and higher cost. Payments—even relatively small payments—from industry to physicians have been associated with greater likelihood of brand-name drug prescribing and medical device use.4,5 We examined whether payments from the LVAD manufacturer to cardiologists performing PCI were associated with any use of LVADs.
Methods
This cross-sectional study used data from the Open Payments program database linked to Part B claims for a 20% sample of Medicare fee-for-service beneficiaries to identify cardiologists performing at least 1 PCI in any year from 2016 to 2018 at hospitals capable of placing both LVADs and IABPs. Institutional review board approval was obtained at the University of California, San Francisco. Informed consent was not required given the use of publicly available data.
We used descriptive statistics to characterize industry payments from the single LVAD manufacturer (LVAD payments) to cardiologists, excluding research and royalty payments. We then used multivariable Poisson regression analyses with robust SEs to assess association between receiving LVAD payments vs not receiving payments and use of any LVAD (vs no LVAD use) in the same year and, in separate models, use of any LVAD in the year after payment. Payments in the same year as use may reflect physicians’ being rewarded by industry, whereas payments the following year may reflect payment influence on physician use. We also conducted these analyses among physicians who received their first payment during a year in the study (after not previously receiving payments) to assess whether new payments were associated with LVAD use and stratified by tertile of payment value among physicians who received LVAD payments to assess whether higher payments were associated with LVAD use. Covariates (physician demographics, PCI volume, placement of any IABPs, and payments from IABP manufacturers) and methodological details are provided in the eMethods in Supplement 1.
Statistical significance was defined as 2-sided 95% CIs not including 1. We performed analyses with SAS 9.4 and Stata 18.
Results
The cohort included 6398 cardiologists (median age, 52 years [IQR, 43-60 years]; 4.1% female), comprising 17 558 cardiologist-year observations. Of these cardiologists, 3796 (59.3%) placed at least 1 mechanical circulatory support device and 1871 (29.2%) at least 1 LVAD. Overall, 3586 (56.0%) received LVAD payments (median value, $164; IQR, $64-$451).
Among the 17 558 cardiologist-year observations, 6336 cardiologists received LVAD payments in individual years. Of these cardiologists, 1470 (23.2%) performed at least 1 LVAD, whereas among the 11 222 cardiologists not receiving LVAD payments, 1068 (9.5%) performed at least 1 LVAD (Table 1).
In multivariable analyses, receipt of LVAD payments (vs no receipt) was associated with any LVAD use in the year of payment (adjusted risk ratio [ARR], 2.04; 95% CI, 1.89-2.20) and in the subsequent year (ARR, 1.90; 95% CI, 1.74-2.07) (Table 2). Results were consistent among cardiologists who received their first LVAD payment after not receiving payment, and the highest ARR was observed in the highest tertile of LVAD payment values.
Discussion
Intravascular microaxial LVAD manufacturer payments (often modest) to cardiologists were associated with increased use of LVADs by cardiologists who perform PCIs. It is concerning that payments from the manufacturer to cardiologists may be associated with increased use of more expensive medical devices not demonstrated to be more safe or effective.2,3
Study limitations include observational design and inability to determine causality; cardiologists preferentially placing LVADs may seek opportunities to receive payments. Use of a 20% Medicare fee-for-service data sample means other Medicare beneficiaries and those with other insurance were not included. Although attention has been paid to marketing of pharmaceuticals,4,6 marketing payments to physicians for medical devices, including LVADs, warrant further scrutiny, given potential risk and high cost.
