Invasive Medical and Surgical Procedures Need More Research

One of the hardest things to study in medicine and surgery are invasive procedures, like putting stents into arteries that line the heart or cleaning out debris from an arthritic knee. Two main problems arise trying to evaluate if such procedures are actually helpful. First, what is the control condition? When we study medications, we often compare them to a placebo pill, but what kind of placebo is there for a surgical intervention? Second, even if we can come up with some kind of control conditions, how do we keep everyone involved in the research blind as to whether the patient received the procedure under study or the control? Unlike the medication and placebo situation, it is very difficult–but no impossible, as we will see– to keep people involved in studying invasive procedures blind to what is actually done  to the patient, and this then introduces the possibility of biased assessments.

What is troubling is that when research on invasive procedures is conducted, we often get surprising results indicating that the procedure is either being done for patients who don’t really need it or that the procedure doesn’t actually work. Three recent examples illustrate this problem.

Coronary Artery Stents Are Placed Too Often

According to an analysis published last October by the  Lown Institute, 22% of stents put in the arteries that surround the heart—the coronary arteries—in the U.S. are unnecessary. The study found that U.S. hospitals placed an unnecessary stent in a patient every seven minutes between 2019 and 2021, costing the U.S. healthcare system about $2.4 billion. The Lown Institute study was based on an  analysis of Medicare claims for 1,773 hospitals and outpatient facilities and used criteria for determining what is an unnecessary stent placement that were based on the most recent scientific evidence. The Lown report has received pushback  from some cardiologists who dispute the Lown Institute’s criteria for overuse.

Procedure for Shoulder Tendinitis Doesn’t Work

 A second example of what may be an ineffective procedure involves infusing saline into shoulders that are calcified. This is a painful condition called calcific tendinopathy and in recent years a procedure of washing out the shoulder joint (i.e., lavage) with salt water (i.e., saline) and injecting steroids into the shoulder under ultrasound guidance has been used on the assumption that this would relieve the pain by clearing out the calcium and reducing inflammation. However, investigators in Norway performed a randomized study in which they were able to both find a reasonable control condition and to keep some of the people involved in making the assessments blind to study condition. In their study, patients with painful shoulder tendinitis received either lavage plus steroids or a sham procedure in which no lavage was performed plus steroids or a sham procedure without lavage or steroids. Four months after the procedure, they found there was no difference in outcomes among the three conditions; that is, there was no evidence that the lavage plus steroid condition works. In this study, the researchers kept the patients and follow-up assessors blind to which condition the patient had been assigned.  In a commentary about the study,  John Genver wrote “Theirs is just the latest rigorous study to cast doubt on a common orthopedic procedures…Increasingly it seems that many such therapies rely primarily on the placebo effect for benefit…”

Are We Doing Too Many Atherectomies?

Perhaps most disturbing of all–and controversial–is an analysis published by  ProPublica last month of procedures called atherectomies, used to treat vascular disease caused by a buildup of atherosclerotic plaque in the arteries. This can cause pain, which can become severe, and interfere with functions like walking.  The article from ProPublica explains that during the atherectomy procedure, doctors “use a laser or bladed catheter to remove plaque from the patient’s vessel walls…Experts recognize atherectomies are appropriate for severe vascular disease, but they told ProPublica that the majority of patients with milder symptoms like leg pain while walking, a condition known as claudication, should start with treatments like medication and exercise.” The authors of the ProPublica report analyzed Medicare records and found that “nearly 1 in 4 patients underwent the invasive procedure after only a diagnosis for claudication, indicating an early stage of vascular disease.” The article is controversial because doctors whom ProPublica singled out for performing too many atherectomies insisted that the diagnosis of claudication does in fact include people who have tried and failed to respond to less invasive procedures and who do have severe pain and impairment. So, the question becomes whether the method used to identify unnecessary atherectomies by ProPublica provides an accurate estimate of the number of unnecessary atherectomies. Still, the article raises a clear concern as voiced by Dr. Caitlin Hicks, described in the article as “an associate professor of surgery at Johns Hopkins University School of Medicine and a leading researcher on procedure overuse,” who is quoted as saying “’It’s concerning that we may be doing unnecessary procedures and spending unnecessary health care dollars…We know that aggressive interventions for claudication may give short-term relief, but in the long term, patients are the same as they started or even worse.’”

These three are only examples of reports that we may be doing too many invasive procedures. Some of the procedures in question are effective for some patients but are used too often for patients with milder forms of disease who could be treated with less invasive interventions. Others don’t seem to work at all. Because every invasive procedure carries some risk, it is important that we limit our use of them to people who really stand to benefit.

Furthermore, unnecessary procedures waste enormous amounts of money. The U.S. system of healthcare finance pays more for physicians to do procedures than to counsel patients about the best ways to maintain health and prevent disease. There is a concerning incentive, then, for doctors to do procedures rather than spend the time recommending and monitoring less invasive interventions like diet, exercise, and medications.

For individuals facing the prospect of an elective, invasive procedure it might be best to take a step back and ask the question, what is the evidence supporting the benefits to me of this procedure? Unfortunately, it is likely that in many instances there still aren’t much data to help us decide how useful a procedure is going to be. What we need then are two things: more research of invasive procedures like the randomized trial performed in the case of shoulder tendinitis noted above and greater attention paid to the research that we do have. None of this applies, of course, to emergency situations when interventions may be urgently needed and lifesaving. And in many cases elective procedures will indeed benefit more than harm. Unfortunately, we are short on following existing data and producing new evidence to tell us everything we need to know about which elective procedures are indeed necessary.