Heartfelt with Dr Melissa Walton-ShirleyView all posts »
"Consent the stent" campaign--long overdue!May 9, 2012 22:05 EDT
CARDIO DAILY HEADLINE NEWS
70-year-old with probable glioblastoma receives DES—delays diagnosis for weeks!
Uninsured smoker receives Cypher: SAT 3 weeks later—SURVIVES!
Patient with multiple myeloma requiring quarterly bone marrow biopsy receives DES: ONCOLOGIST SCREAMING!
80-year-old on warfarin receives DES: Bleeds buckets!
Although these were real events that occurred in my practice in the first few years following the advent of drug-eluting-stent (DES) implantation and interventionalists are doing a better job overall with stent selection, our efforts as cardiologists in general are still lacking. This blog was inspired by actual statements made in our THO forum on the topic. Issues affecting stent selection are as important to the medical-legal aspects of performing a procedure as the pericath risks we've all recited thousands of times. Admittedly, trials like Berne-Rotterdam that studied the Xience and Promus stents demonstrated a lower 1.4% risk of subacute thrombosis (SAT) when thienopyridines were discontinued, but we still can't rest on our laurels. There are scores of patients who face a real and unnecessary risk of bleeding from poor stent selection because we never had the "stent-selection" conversation.
In my 20-year history of performing cath work, my usual cath paragraph recitation went something like this: "There is a 2% risk of stroke, heart attack, death, allergic reaction, kidney failure, bleeding, blood vessel injury, and rhythm disturbance." When one of my patients got a moderate-sized groin hematoma and had to go to the OR for an uncomplicated and successful debridement due to skin necrosis, I realized my consent form was inadequate. The groin tissue was culture negative, but I added to my laundry list of possible complications the words "and infection" in my consent spiel nearly 12 years into my life as an invasive cardiologist. When bare-metal stents came on the market, I morphed it to include, "If you receive a stent, it will require extra blood thinner to be given for several months or indefinitely, depending upon your course and the findings at cath". When primary PCI without surgery on-site came to our facility, I morphed it yet again to include the words, "Off-site surgical backup is at Jewish Hospital in Louisville, KY, and if you were to experience a life- threatening complication, transport to that facility would be required."
After the above headliners actually occurred in my patient population as a result of poor stent selection, I added this final caveat to my routine consent talk: "Is there any surgery planned for you, or do you have a history of bleeding that might influence our stent selection?" So many times, the answer is yes. I've heard everything from "I have a face-lift planned next month" to "getting my knee fixed in June, doc" to "I can't afford clopidogrel, I have no insurance" and even things like "just had a unit of blood for aplastic anemia last month," with no mention of any of these plans or maladies on the intake history at the hospital admission or as a new patient to my office practice. My routine conversation with patients about cardiac cath, surgery, or intervention now includes a paragraph about stent selection. Furthermore, I suggest the following paragraph be included in every written consent form:
"I understand that I may require a heart artery stent that requires blood thinners, which help protect stents from clotting but can also increase the risk of bleeding. I understand it is my responsibility to inform my physician of my bleeding risks or any planned noncardiac surgery."
In addition, we need to add the "Do you have a risk of bleeding?" question to all intake or "get-to-know-you" conversations. The excuse that "patients are sedated and can't help us make a decision" no longer flies. Their family members aren't sedated, (well, not usually) and though we are always in a hurry to beat the 60 to 90 minute clock with STs up, the patients weren't sedated when they got into the ambulance or when they came flying through our emergency-department door. At every point of care, the potential cath patient deserves this conversation. It is an essential and most basic part of any history-taking process that is often neglected. With very little effort we can most certainly beef up our consent forms for stent implant and no doubt will avoid future headlines like these in our communities:
Cardiologist neglects to have stent selection conversation—Patient bleeds unnecessarily!
and whether we really want to admit it or not, one of the scariest headlines of all:
Starting a real "consent-the-stent" campaign will help prevent both.