Lessons From My Medical-Legal Experience in Vascular Surgery

More people die of vascular disease in the USA (51%) than all other diseases combined. As such it tends to feature heavily in cases of medical malpractice. It is often a silent disease until complications arise; and it’s well known how sudden a heart attack, a stroke, or a ruptured aneurysm can be. Since vascular disease is often silent, it is the responsibility of the primary physician to look for the disease; particularly when the risk factors are there.

The presence of the disease is relatively easy to detect on history and physical examination. The most common risk factors include age, high blood pressure, high cholesterol or triglycerides, smoking, diabetes, family history. In the review of symptoms, the physician should ask if the patient has had chest pain, angina, brain attack, transient neurological symptoms, abdominal pain, claudication (calf pain on exertion), forefoot pain at rest, and non-healing ulcers. Physical examination should include feeling the peripheral and aorta pulses, as well as listening for a carotid bruit. If a pulse is not palpable, the patient likely has vascular disease, the most common killer in the USA. Asymmetry of blood pressure in one arm versus the other can also suggest that the disease is present.

All of these tests are easy to do; however, a patient dying of an 8 cm aortic aneurysm that was not diagnosed is not infrequent. A physician could be considered negligent if the presence of these risk factors did not prompt a careful abdominal examination. Within the broader umbrella of vascular disease, Aortic Aneurysm rupture is the 13th cause of death in the USA. An 8cm aneurysm is hard to miss. In many cases, a doctor can tell just by looking at the abdomen, which pulsates like in the “Alien” movie – unless the patient is morbidly obese. However, even If the patient is too fat to feel the aorta, the physician can still be held responsible; CMS will pay for ultrasound of the aorta to look for aneurysm if the appropriate risk factors are present.

In terms of treatment, most Arterial Vascular Surgery is reconstructive. Unlike extirpative surgery (i.e. removing an organ), reconstructive surgery has many subtle steps required to get a good result.

However, in 2016, the trend continues where the hands-on experience of surgeons during training is not as deep as it used to be. The hospital costs of surgery ($80-$100/minute), and the liability concerns during surgery, often curtail the time a senior surgeon may offer the resident/fellow to do the dissection and/or the reconstruction. Graduating residents and fellows are less confident and experienced than in the past; despite 5-7 years of residency and 2 years of fellowship.

The advent of catheter based procedures has also reduced their comfort with “open” vascular surgery. As such, when an open procedure is needed, these young vascular surgeons are required to intervene outside their level of expertise. In these situations, they can call upon a more senior surgeon, if available, or transfer the patient. Sometimes they may opt for a less complex solution, like amputation in the case of chronic limb threatening ischemia in lieu of a complex bypass graft. Sometimes, due to local circumstances, these surgeons may have to perform procedures they have limited to no experience performing.

Regardless of the approach selected, any intervention starts with a rationale for doing the procedure. Most Arterial procedures fall under “medical necessity,” and most vascular surgeons operate within this definition. However, whether by ignorance, or financial pressure to pay the bills, or desire to show “being busy,” some physicians opt to “widen” the definition of medical necessity. Examples include invasively treating minimally disabling non-limb threatening ischemia, or a small non-symptomatic aortic aneurysm, or moderate asymptomatic carotid stenosis.

If there is a complication of significance (such as limb loss, death, or stroke) a lawsuit may follow. In addition, catheter technologies have broadened the scope of clinicians that have the skill to treat Vascular Disease to include interventional radiologists, cardiologists, general surgeons, cardiac surgeons, and interventional nephrologists.

Not all of these clinicians adhere to the same guidelines as vascular surgeons. “Drive-by” angioplasties of non-coronary vessels during a coronary catheterization are notorious. If an angioplasty were without risk and, forever durable, this would be fine. However, the reality is one may simply be exchanging the slow disease of atherosclerosis for the complications of neointimal hyperplasia and restenosis following angioplasty. Neointimal hyperplasia is the scarring inside the artery at the site of angioplasty/surgery, and it progresses rapidly compared to atherosclerosis.

As an example, many “Drive-by” renal artery stents were placed until research documented risk with minimal benefit. The most common over-treated artery today, in my opinion, is the superficial femoral artery in the setting of non-disabling claudication.

Complications are inevitable as most of vascular intervention is “palliative”: there is no cure for atherosclerosis or most vasculitis. To get a good outcome, one would prefer the intervention to have good inflow, good outflow, a good conduit, good rheology, and a tolerant coagulation system. However, most of our patients are elderly, have other issues that affect those requirements, have impaired immune systems, and have significant co-morbidities. Some continue their bad habits (e.g. tobacco use) after intervention, or do not comply with their medical regimen. Blood clots may form. As mentioned above, biological processes such as neointimal hyperplasia arise.

In addition, atherosclerosis over time can undo the good work. Complications (death, limb loss, non healing wounds, infection) in the hands of an experienced vascular surgeon operating with informed consent under true “medical necessity” is not usually malpractice. Many would say that dealing with atherosclerosis is the most technically demanding of all fields, particularly when it comes to open surgery.

The guidelines for what we do in the operating room/interventional suite change as technology and more information becomes available. An expert in Vascular Surgery has to be current in knowledge and clinical practice.

As an expert, I zero in on indications for the procedure, as well as the timeline. The timeline is important – vascular emergencies are true emergencies. Waiting until the next day to treat acute limb ischemia, or a symptomatic aortic aneurysm, or acute visceral ischemia, will often lead to limb loss or death. Conversely, rushing a patient to the operating room for stents and angioplasty who has calf pain after walking 2 blocks (claudication) without a trial of risk factor modification and programmed exercise exposes the patient to the risk of limb loss.

Another example of poor judgement is revascularizing the limb of a non-functional 90 year old stroke patient with contractures to heal a non-healing large pressure ulcer with osteomyelitis (amputation is the preferred option). Technical complications rise to malpractice due to errors of omission (e.g. failure to anticoagulate during carotid endarterectomy can precipitate a stroke), to errors of commission (operating on the wrong side or the wrong indication). I have witnessed complications from non-indicated procedures rise from malpractice to medicare fraud to assault.

There are also grey zones. For instance, a catheter based cerebral angiogram following a quality non-invasive cerebrovascular CT angiogram would expose the patient to a 1% risk of stroke. Absent any rationale (except generating income), that complication would be basis for a malpractice suit (not a grey zone). However, the grey zone exists when both technologies are readily available, and a 4 vessel cerebral angiogram is performed using a catheter in lieu of the non-invasive CTA, and the patient gets a procedure related stroke. It is “grey” because both procedures are indicated, and until 10 years ago, cerebral angiogram was the standard of care. CT angiography has advanced as a technology, gives more information, and has become the safe study of choice. Cerebral angiography by catheter is now performed to clarify an issue when the CT is not optimal or to treat a lesion with a catheter based intervention.

As you can see, there are many nuances. Some advice on preparing your cases:

1. Get all the records. I have had instances defending physicians and hospitals, where the defense became apparent only upon review of the older records.
2. Get the CTA or MRA images sent on a DVD. Printed interpretations do not necessarily identify important nuances vascular surgeons rely on. The printed interpretations are by diagnostic physicians who have no experience “wrestling” with the disease in the operating room daily.
3. In court, make a motion that the expert be allowed to usual visual aids. The juries typically have no understanding, the expert usually does speak “lay medicine”, and the time is limited. Pictures are worth a thousand words.
4. If you feel uncomfortable with the medicine, let your expert answer open ended questions if possible.
5. DO NOT START taking depositions until you have an expert review the case. This sounds intuitive, but I have seen this error first hand, in situations where there was no case (for the plaintiff), or there was a case, but the appropriate questions were not asked in deposition.
6. While the computerized disk form of the medical record is convenient, it takes much more time to review. On a laptop, one cannot efficiently negotiate the text to cross reference corroborative data from labs, nursing notes, studies etc. If the record is sent by disk or email, please make sure the file is searchable, editable, and indexed. Or to send both the disk and the paper record. One hour extra of review would certainly be more expensive than copying the text and sending.

In conclusion, most adverse events are complications, not malpractice. Vascular disease is managed from head to toe by algorithms. I define the best doctor as the one who can correctly predict his outcome 100% of the time; based on initial conditions and boundary conditions, and the appropriate algorithms.

However, the reality is that no doctor can tell a patient that there is a 100% likelihood of achieving the desired outcome. Most of us do the best we can. Problems arise when the physician is performing outside his level of expertise, or outside of prudence. With that being said, there are plenty of instances when a physician will extend the health care system to manage his/her patient in the face of high risk, and/or outside the norm, to heroically try to save a bad situation. The FDA gives us latitude to use our judgement in the face of situations where the standard of care or treatment is not well defined.