Industry gifts may influence which cardiac device is used in common lifesaving procedure

UNIVERSITY OF PITTSBURGH

PITTSBURGH, April 10, 2024 — Physicians who received payments from the manufacturer of a specific set of cardiac devices are more likely to use those devices, often during a common procedure to unblock coronary arteries, according to a research letter published today in JAMA authored by researchers from the University of Pittsburgh, University of California, San Francisco, Yale University and the University of Connecticut.

The devices, known as the intravascular microaxial left ventricular assist devices (LVADs), were developed to provide cardiac support, often during percutaneous coronary intervention (PCI) procedures, and have been scrutinized in recent years for concerns about the evidence supporting their safety and effectiveness. The Food and Drug Administration issued a correction on instructions for LVADs last month. The research letter raises questions about how industry payments influence the use of medical devices, which can include high-risk procedures as well as high costs.

Using the national disclosure program Open Payments, the authors examined marketing-related payments from the LVAD manufacturer to cardiologists from 2016 to 2018, then linked these data to Medicare claims to determine which devices were subsequently used in beneficiaries. The team found that physicians who received payments from the manufacturer of LVADs were approximately twice as likely to use the device that year as well as in the following year, suggesting a lasting effect.

Senior author Timothy Anderson, M.D., M.A.S., a primary care physician, health services researcher and assistant professor of medicine at Pitt, explained that their findings align with previous studies showing that even small marketing payments may influence clinical care, but that most prior studies focus on prescription drugs. This study is one of the first to expand to medical devices and raises concern given that intravascular microaxial LVADs are more expensive but not shown to be more safe or effective than alternatives.

“These marketing relationships are very different from research partnerships between academia and industry, which are often beneficial in developing new innovations,” said Anderson. “If free meals and gifts to doctors might influence what device is used during a cardiac emergency, it is time to rethink whether these relationships are acceptable.”

Other authors on the study were Sanket Dhruva, M.D., M.H.S., of UCSF, Joseph S. Ross, M.D., M.H.S., of Yale; Michael Steinman, M.D., and Siqi Gan, M.P.H., of UCSF; and Sruthi Muluk, M.D., of University of Connecticut.

This research was supported by Veterans Affairs Health Services Research & Development (#1IK2HX003357) and National Institutes of Health/National Institute on Aging (#K76AG074878, #2K24AG049057, #P30 AG044281).

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About the University of Pittsburgh School of Medicine

As one of the nation’s leading academic centers for biomedical research, the University of Pittsburgh School of Medicine integrates advanced technology with basic science across a broad range of disciplines in a continuous quest to harness the power of new knowledge and improve the human condition. Driven mainly by the School of Medicine and its affiliates, Pitt has ranked among the top recipients of funding from the National Institutes of Health since 1998. In rankings released by the National Science Foundation, Pitt is in the upper echelon of all American universities in total federal science and engineering research and development support.

Likewise, the School of Medicine is equally committed to advancing the quality and strength of its medical and graduate education programs, for which it is recognized as an innovative leader, and to training highly skilled, compassionate clinicians and creative scientists well-equipped to engage in world-class research. The School of Medicine is the academic partner of UPMC, which has collaborated with the University to raise the standard of medical excellence in Pittsburgh and to position health care as a driving force behind the region’s economy. For more information about the School of Medicine, see www.medschool.pitt.edu.

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JOURNAL

JAMA

METHOD OF RESEARCH

Data/statistical analysis

SUBJECT OF RESEARCH

Not applicable

ARTICLE TITLE

Intravascular Microaxial Left Ventricular Assist Device Manufacturer Payments to Cardiologists and Use of Devices

ARTICLE PUBLICATION DATE

10-Apr-2024

COI STATEMENT

Disclosures: Dr. Dhruva currently receives research funding from the Department of Veterans Affairs and Arnold Ventures and reports serving as a member of the Institute for Clinical and Economic Review California Technology Assessment Forum. Drs. Dhruva and Ross report serving on the Medicare Evidence Development and Coverage Advisory Committee. Dr. Ross currently receives research support through Yale University from Johnson and Johnson to develop methods of clinical trial data sharing, from the Food and Drug Administration for the Yale-Mayo Clinic Center for Excellence in Regulatory Science and Innovation (CERSI) program (U01FD005938), from the Agency for Healthcare Research and Quality (R01HS022882), and from Arnold Ventures; formerly 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 National Institutes of Health (NIH) (R01HS025164, R01HL144644); and in addition, Dr. Ross was an expert witness at the request of Relator’s attorneys, the Greene Law Firm, in a qui tam suit alleging violations of the False Claims Act and Anti-Kickback Statute against Biogen Inc. that was settled September 2022. Dr. Anderson reports grant support from the American College of Cardiology, American Heart Association, and US Deprescribing Research Network outside of the submitted work. Dr. Anderson also reports consulting fees from the American Medical Student Association and personal fees from the American Medical Association. Dr. Steinman reports grant support from the National Institute on Aging and receives royalties from UpToDate and honoraria from the American Geriatrics Society.