A patient was referred to a vascular surgeon to evaluate exertional leg pain relieved by rest, worse on the right than the left. Pertinent history included tobacco use and medically managed coronary artery disease, hypertension, and hyperlipidemia. The patient denied any history of chest pain.
On physical examination, the patient had an absent right femoral pulse, a diminished left femoral pulse, and no palpable pulses in the feet. The skin was pink without evidence of tissue loss. Noninvasive studies confirmed arterial occlusive disease bilaterally, worse on the right. A diagnostic arteriogram showed severe aortoiliac occlusive disease, with “coral reef-like projections” at the aortic bifurcation and occlusion of the right common iliac artery.
A discussion between the surgeon and the patient and family ensued. Options offered included extra-anatomic bypass and aortobifemoral bypass, which the surgeon recommended. After reviewing the risks of surgery, the patient agreed to the aortobifemoral bypass. The surgeon requested no preoperative clearance, and there was no discussion of endovascular options.
The surgery was performed 2 weeks later. Due to severe calcification at the aorta, the surgeon was unable to place a clamp, instead attempting to control the aorta with an intraluminal balloon catheter. During balloon inflation, the balloon ruptured. The patient experienced significant hemorrhage, suffering a cardiac arrest and requiring chest compressions. While control of bleeding was initially obtained, an attempt to place a prosthetic graft was ineffective due to tearing of the aortic adventitia. The patient again went into asystole and was subsequently pronounced dead in the operating room.
An autopsy showed the cause of death as “acute abdominal hemorrhage” and also identified 80% stenoses of the coronary arteries. It is worth noting that documentation of the patient’s admission history and physical exam did not take place until 2 months after the patient’s death.
Experts reviewing this case were critical of both preoperative and operative decision-making. Concerns included the lack of discussion about endovascular options and the surgeon’s failure to obtain preoperative cardiac clearance. Some also questioned the need for the procedure given the lack of limb-threatening ischemia. Some experts opined that once the surgeon determined the aorta could not be clamped, the surgery should have been aborted. Others suggested that the rupture of the balloon could have been predicted by the coral reef atheroma present in the aorta.
Some experts, however, did not have any concerns about the lack of a preoperative cardiac consultation in a patient without chest pain. They also commented that it was not known if an endovascular procedure would have been effective. Additionally, hemorrhage is a known complication of surgery. The claim was settled prior to trial.
“Three P” Analysis
The “Three Ps” refer to “prevent, preclude, and prevail"—the three key elements to reduce practitioner risk related to malpractice litigation.1
Prevent Adverse Events
- Patients presenting for vascular surgical evaluation should undergo a systematic review of what is typically a complex systemic disease. Subjective findings should be well documented, combining recognized signs and symptoms using the patient’s words and perspectives of the impact of their vascular disease when applicable. This is particularly true for lower extremity occlusive disease where similar levels of disease can cause varying degrees of disability (claudication to tissue loss) in different individuals.
- Objective data, such as physical findings and noninvasive testing, should also be assessed and well documented. Using objective data enables a data-driven approach to discussion and decision-making and may involve using available and well-recognized clinical trials for patients with asymptomatic disease, such as aneurysms or extracranial carotid occlusive disease.
- In many situations, surgeons are able to offer multiple acceptable treatment plans with varying degrees of efficacy, safety, and durability. This case, however, did not include documentation of the rationale used to select open reconstruction over an endovascular intervention or medical management, including smoking cessation and supervised exercise therapy.
- Central to the management of this matrix of information is the importance of shared decision making. Patients should be informed of uncertainty as well as the risks and benefits of treatments, guided by patients’ values and preferences and the availability of operative expertise.2 The decision to proceed with surgery should reflect a discussion of all elements, documenting the severity of the disease both subjectively and objectively and the alternatives to the chosen path forward.
- Open aortic surgery is a procedure with recognized risks and complications. Because decisions made intraoperatively when an adverse event occurs can always be questioned retrospectively, obtaining intraprocedural consultation from a partner or colleague can be helpful—not only to manage the complication, but also to verify findings and rationale for intraprocedural decision-making.
Preclude a Malpractice Case Despite an Adverse Event
- The value of timely and honest communication with the patient and family is consistently recognized.3 In the aftermath of an adverse event or undesirable outcome, responding quickly and compassionately to a patient’s or family’s communication needs is both ethical and advantageous for everyone involved.1
- When responding to an adverse event, follow your institution’s disclosure program, and seek support to guide conversations with patients and families. Conversations must conform to state laws governing disclosure and peer review protocols to ensure that disclosures are protected in court.4
Prevail in Lawsuits When a Claim Is Made
- Aortic surgery has inherent risks that can lead to a variety of undesired results—including death. As is always the case, doing the right thing for the right patient for the right reason is paramount. But these good intentions can only be speculated upon if they are not documented.
- With the ubiquity of the electronic health record (EHR), attention to documentation provides significant value:5 EHR systems, however, may not lend themselves well to tried-and-true principles of documentation, such as Subjective-Objective-Assessment-Plan (SOAP). Templates and drop-down menus, which are helpful for efficiency, may not allow the practitioner to identify pertinent negatives. Use free-text fields as necessary to supplement the EHR template.
- Including only a minimum of information in the record can create false impressions. By providing their thought process and rationale, practitioners can help eliminate speculation down the line on how decisions were reached.
- Delayed documentation, as well as what appeared to be the absence of a discussion of alternatives to open surgical reconstruction, made this case difficult to defend. While some experts supported the lack of a preoperative cardiac risk assessment in a patient without active chest pain, better documentation of pertinent negatives and the rationale for not obtaining a consult may have more effectively supported this decision-making.
