One in Five Patients Receive Opioids After CIED Procedures

Patrice Wendling

October 22, 2019

New research shows that 20% of patients are discharged with an opioid prescription after a pacemaker or implantable cardioverter defibrillator (ICD) procedure and that more than a third receive high-dose opioids.

Although 80% of patients were opioid-naïve, meaning they had not taken opioids in the 90 days before their procedure, nearly one in 10 refilled their opioid prescription (9.4%), according to results published online October 20 in Heart Rhythm.

"The main goal of this study is to bring attention toward opioid medications after procedures, and then the next step would be to look into different techniques we can use to reduce these medications," lead study author Justin Z. Lee, MD, Mayo Clinic, Phoenix, told theheart.org | Medscape Cardiology.

Prescription opioids contribute to the surge in opioid abuse and deaths in the United States, with more people now dying from opioid overdose than from cocaine or heroin.

Opioid prescribing after cardiac implantable electronic device (CIED) procedures has not been studied before, Lee explained. Studies in other specialties, however, have shown opioid prescription rates of only 5.4% after interventional radiology procedures, but 59% after endovascular aneurysm repair and 77% after hand surgery.

"So our 20% is small, but then again our procedure in terms of pacemaker implantation is not as major as the rest, so there's definitely room for improvement there," Lee said.

"It's eye-opening," Kenneth Ellenbogen, MD, chair of cardiology, VCU School of Medicine, Richmond, Virginia, who was not involved in the study, commented to theheart.org | Medscape Cardiology. "I think it's important because putting in a pacemaker or a defibrillator is not a major, open-heart procedure."

"We were always taught to err on the side of, 'Oh, make sure the patient has what they need to be comfortable when they go home,' but now we realize that by giving people narcotics, what we're really doing has some important implications for the patients' health down the road."

In the study, patients who were prescribed opioids had higher 30-day readmission rates than those not receiving opioids (9.5% vs 7.7%; P < .001)

Moreover, new prolonged opioid use was reported in 250 patients who were opioid-naïve and 678 patients given opioids became opioid-tolerant.

"That's a lot of people you're creating a problem for; it's just too much," observed Ellenbogen.

The study involved 16,517 patients who underwent CIED procedures from January 2010 to March 2018 at the Mayo Clinic in Minnesota, Arizona, and Florida. The average patient age was 70 years and 36% were female.

Patients who underwent subcutaneous ICD implantation had the highest rate of opioid prescription (25%), followed by new implants (23.2%), lead revision or replacement (22.4%), device upgrade (18.3%), and generator change (11.6%; P < .001).

Their average oral morphine equivalents (OMEs) were 194.0, 244.6, 215.7, 254.9, and 249.7, respectively.

Overall, the average OME was 243.2, and 38.8% of patients prescribed opioids received a high-dose prescription (OME >200).

"This is an important study" and "shows that the use of opioids after devices is substantial," John Mandrola, MD, Baptist Health, Louisville, Kentucky, who was not involved in the study, told theheart.org | Medscape Cardiology via email.

"I am struck by the large proportion of patients who receive more than 200 OME. That's approximately 30 to 40 standard hydrocodone tablets. That's a lot — for any kind of device. Plus, nearly one in 10 patients who received opioids had a refill. That, too, is an outlier," he said.

New opioid users were significantly younger than those not prescribed opioids (63.7 vs 72.1 years), more likely to be female (39.7% vs 35.4%), and had fewer comorbidities, including coronary artery disease (61.9% vs 64.1%). These patients may have a lower pain threshold or, because they are generally more active, the prescriber may have had a lower threshold for prescribing opioids so patients could return to their baseline activity level, Lee hypothesized.

Although a single or even repeat opioid refill does not necessarily signal addiction or dependence, patient refill rates were likely underestimated, as opioid refills outside the Mayo healthcare system were not captured, the authors note. Data were also not captured on use of nonopioid analgesic medications or intraprocedural medications.

Regional Variation

Similar to data from the Centers for Disease Control and Prevention, data from the three tertiary referral centers shows higher opioid prescribing rates in Florida, where it reached a whopping 56.6%. This compares with rates of 17.2% in Arizona and 15.7% in Minnesota, the authors report.

However, the average OME among patients who received opioids was 255, 267, and 204 in Minnesota, Arizona, and Florida, respectively. The rate of opioid refills among previously opioid-naïve patients was 8.1%, 12.1%, and 10.0%, respectively.

These differences may be due to "variations in patient populations, hospital protocols, and provider practice patterns," the authors write. Administration of local anesthesia and intraprocedural opioids were at the discretion of the provider, although beginning in 2014, it was common for the Mayo Clinic Rochester practice to administer liposomal bupivacaine (Exparel, Pacira Pharmaceuticals) for all subcutaneous ICD implants.

The team did not systematically compare opioid prescribing by provider type, but a survey across the three states showed a great deal of variation in prescribing from the physician performing the procedure to the nurse practitioner discharging the patient or a separate discharge team when the patient was an inpatient, Lee said.

Overall, opioid prescribing trended higher from 2010 to 2015, when it peaked at 25.9%. It fell to 14.6% in 2018 (P ≤ .001); however, the rate for subcutaneous ICD cases continued to increase to 39.1% in 2018.

Although nonopioid medications may be inadequate for pain control in some cases, there is also a need to educate patients to give nonopioids more of a chance before proceeding to an opioid prescription, Lee said. Also, recent work suggests that alternatives, like gabapentin given 1 to 2 hours before a procedure, may reduce postoperative pain.

"In general proceduralists, and even our research evidence and publications, are focused toward improving the procedure, but sometimes postoperative things are less looked into," he said. "So this is just a call for more research, for more comprehensive care of the patient."

Ellenbogen agreed more research is needed and that patients need to be counseled preoperatively to expect adequate pain control to function but not to eliminate pain all together.

"Ultimately, we need to think about ways we can provide patients comfort or prevent them from developing discomfort without using opioids," he said. "There are other ways to do that — using nerve blocks before a procedure and more potent doses of other pain medications like nonsteroidals — rather than just going to narcotics."

Mandrola said he routinely prescribed low-dose, short-duration opioids after most cardiac device procedures, thinking that they were safe and the benefits outweighed the risks, but that his practice changed significantly beginning around 2016 and that he rarely does so now.

"This change occurred in large part because I and my colleagues underappreciated the issue of opioid dependence," he said. "Even small doses of opioids over the short run can cause dependence issues. I have learned to (greatly) fear these drugs."

"We should be telling our patients that pain is normal after surgery. And that it will improve quickly and it is a sign to let your body heal. I now tell my patients that there is some pain afterwards but it will be neither severe nor long-lasting."

"How the medical profession was duped by industry, and how the policy of pain-as-a-fifth-vital sign harmed patients, should be a history lesson taught in all medical and nursing schools," Mandrola concluded.

The authors, Ellenbogen, and Mandrola report no relevant conflicts of interest. Mandrola is a regular contributor to theheart.org | Medscape Cardiology.

Heart Rhythm. Published online October 20, 2019. Abstract

Follow Patrice Wendling on Twitter: @pwendl. For more from theheart.org | Medscape Cardiology, join us on Twitter and Facebook.

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