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Vascular Specialist is the official newspaper of the Society for Vascular Surgery and provides the vascular specialist with timely and relevant news and commentary about clinical developments and about the impact of healthcare policy. Content for Vascular Specialist is provided by BIBA Publishing. Content for the News From SVS is provided by the Society for Vascular Surgery. | The ideas and opinions expressed in Vascular Specialist do not necessarily reflect those of the Society or the Publisher. The Society for Vascular Surgery and BIBA Publishing will not assume responsibility for damages, loss, or claims of any kind arising from or related to the information contained in this publication, including any claims related to the products, drugs, or services, or the quality or endorsement of advertised products or services, mentioned herein. | The Society for Vascular Surgery headquarters is located at 9400 W. Higgins Road, Suite 315, Rosemont, IL 60018. | POSTMASTER: Send changes of address (with old mailing label) to Vascular Specialist, Subscription Services, 9400 W. Higgins Road, Suite 315, Rosemont, IL 60018. | RECIPIENT: To change your address, e-mail subscriptions@bibamedical.com | For missing issue claims, e-mail subscriptions@bibamedical. com. | Vascular Specialist (ISSN 1558-0148) is published monthly for the Society for Vascular Surgery by BIBA Publishing. | Printed by Vomela Commercial Group | ©Copyright 2022 by the Society for Vascular Surgery
No time like the present: The moral imperative for advocacy in vascular surgery
By Chelsea Dorsey, MD, Luka Pocivavsek, MD, and Ross Milner, MD
“I’m so sorry but we have to cancel your surgery”—10 words any warm-blooded surgeon dreads uttering. This time around, it was not for the typical reasons. Our patients’ blood pressure wasn’t sky high in pre-op, and our case wasn’t being bumped for the trauma du jour. Regrettably, Medicaid unexpectedly denied approval of an investigational thoracic endovascular repair (TEVAR) for this 65-year-old Black male with a known history of a complicated type B aortic dissection (TBAD) two weeks prior to his planned intervention. Though insurance denials are not uncommon for “out-of-network patients” at our institution (an issue ripe for a follow-up editorial at a later date), our team was both surprised and devastated to find that this patient’s “in-network” procedure was denied because cardiovascular trial devices were not covered under his Illinois Medicaid insurance policy—with no exceptions. Our surgical plan was not only toast, but this man’s hopes of obtaining a cutting-edge thoracic repair were gone simply because of his reliance on state medical aid.
Like so many of our vulnerable patients on the underserved South Side of Chicago, this man’s path towards a repair was anything but linear. The patient was originally diagnosed in 2015 but was lost to follow-up for several years. He re-presented to our institution in March 2022 as a victim of gun violence in an altercation where he suffered an injury to his left arm—his wife and son were killed in the incident. A trauma pan-scan at the time showed that his TBAD had grown significantly and therefore met criteria for repair. The dissection remained distal to the left subclavian, and the aneurysmal portion was predominantly in the descending thoracic aorta. The patient had, in the intervening seven years, also suffered a stroke and myocardial infarction. Given that his multiple comorbidities also included morbid obesity and diabetes, the patient was not an optimal candidate for an open thoracoabdominal repair. Furthermore, the patient was anatomically not a candidate for a TEVAR with or without traditional debranching to allow for landing in zone 1 or 2. Given these findings, the patient was enrolled in the Nexus-ENDOSPAN trial for an arch device with zone 0 landing.
The patient was seen multiple times preoperatively, and the trial was explained to him in detail. He was eager to participate, something not always encountered given the under-
Top to bottom: Chelsea Dorsey, Luka Pocivavsek and Ross Milner
standable mistrust of the research process often seen in Black patients. His anatomy was evaluated by the review board, and he was found to be an excellent candidate for the investigative device. The patient was scheduled for the two-part surgery in early August. After being notified of the denial, we participated in a lengthy peer-to-peer conversation with a physician representative from the patient’s Medicaid provider, but our efforts failed. The procedure was canceled. And there we were—highly trained surgeons technically able to offer all options to the patient but handcuffed to an open approach, which carried with it a much higher morbidity and mortality for this particular patient.
The investigational process is well regulated by both federal (Food and Drug Administration, or FDA) and institutional (IRB) oversight committees. The oversight and approval process has been in place for many years, and, at its core, has the safety of patients in mind. Clinical trials provide safe access to novel devices for select patients with complex problems.
As for “select”— this is an interesting word choice in this context. Typically, patients must meet specific eligibility criteria to be enrolled in a clinical trial. The criteria commonly include such factors as a minimum and maximum age. In addition, specific anatomic characteristics are assessed as part of the trial design and vary based on the investigational device. As a frequent site for clinical trials, our institution commonly uses such standards in our decision-making on who is safe to be treated and who is not. Noticeably absent from this algorithm is the categorization of patients based on their insurance status. This is an appropriate omission given that uniformly that data point is irrelevant in deciding whether a patient should or should not be entered into a trial. In other words, patients should never be “selected” or excluded due to their insurance status. This unfair decision specifically targets an already marginalized group of patients. Clinical trials should be available to all patients. This fact is highlighted by the paradoxical elimination of a high-risk patient as seen in this scenario. The reality is that this is a patient who unequivocally needs our care the most.
As practicing vascular surgeons on the South Side of Chicago, we treat individuals from our local community and from all over the Midwest. It is reasonable to surmise that most physicians who find themselves in this particular corner of the city chose to work here to plant roots at an innovative medical institution with the ability to provide outstanding care to all patients regardless of race, ethnicity, gender, sexual orientation, and insurance status. To deny us the ability to do so feels like a dereliction of duty and a contradiction to the Hippocratic oath we all
