Hospitals are making great strides in reducing healthcare-associated infections. However, infection rates associated with cardiac implantable electronic devices (CIEDs), such as pacemakers and implantable cardioverter-defibrillators, are steadily increasing.
This articles is sponsored by Medtronic.
These infections cause serious health complications that are both difficult and expensive for hospitals to treat — the cost of which comes directly from a hospital's bottom line. As CMS requires hospitals to cover the cost of treating these infections under its Hospital Acquired Condition payment provision, it's more crucial than ever for healthcare facilities to adopt the right tools to prevent or reduce CIED infections.
Increasing CIED infections stem from a heightened use of CIEDs in the last 20 years. Grant Simons, MD, chief of cardiac electrophysiology at Englewood (NJ) Hospital and Medical Center, became involved in electrophysiology in 1997, when the prevalence of CIED insertions was low. At the time, Dr. Simons says “there were very few indications — or designated clinical conditions — for which physicians inserted implantable defibrillators, and biventricular devices had not yet been approved by the FDA.” That has changed.
"The first biventricular pacemaker was approved in 2001, followed by biventricular defibrillators. Even more importantly, the era of prophylactic defibrillators was just starting," he says. “From 2003 to 2010, clinical trials spurred new indications for primary prevention defibrillators, which changed treatment guidelines, Food and Drug Administration device labeling, and Medicare and commercial insurance policies for CIEDs,” according to Dr. Simons.
As physicians became more comfortable with these indications, they referred patients for CIED insertion more and more, which spurred a huge growth in CIED use over the last decade. Today, about 400,000 pacemakers and implantable cardioverter-defibrillators are implanted annually, and more than 3 million Americans have CIEDs in their bodies, according to a 2011 study published in Circulation.
"While we've seen a huge growth in the rate of implants, we've seen even larger growth in the rate of infections — roughly double," says Dr. Simons, meaning nationwide CIED infection rates have outpaced implementation rates. This article examines factors driving CIED infection rates, the financial costs of CIED infections on hospitals' bottom lines, as well as opportunities for reducing these infections.
CIED infection rates are rising
From 1993 to 2008, the rate of CIED infections jumped 210 percent, compared to the use of implants, which increased 96 percent over the same time period, according to a 2011 study published in the Journal of the American College of Cardiology. The study attributed the rise to several factors, including more patient comorbidities, an older patient population, and higher bacterial resistance.
“CIED infections are often related to bacteria entering the surgical site, either during an initial implant or subsequent revision or replacement procedure,” according to Dr. Simons. “If a patient has an infection somewhere else in the body, a secondary infection can spread through the bloodstream to the heart device, although this scenario is less common”, he says. CIED infections are difficult and time-consuming to treat, as they require additional surgery to remove and replace the infected device and leads. In the most severe cases, these infections can be life-threatening.
"Treatment is almost always removal of the foreign body,” says Dr. Simons. “Taking out recently implanted devices and leads — or wires that transfer energy from the CIED device to the heart muscle — is fairly easy and low-risk. However, chronically implanted leads become scarred to the veins over time, so removing them is complex and risky. The older the lead, the greater the risks associated with getting it out,” says Dr. Simons.
"One of the largest multicenter studies on the risk of taking out leads shows a 0.25 percent risk of death from the procedure," he says. "This sounds low if you say 0.25 percent, but it doesn't sound so low if you say 1 out of 400."
CMS added CIED infections as a condition subject to the Hospital Acquired Condition payment provision in Fiscal Year 2013, meaning Medicare does not reimburse hospitals for the cost of treating the infection if the patient acquired it in the hospital. As a result, "the economic consequences of CIED infections, including resource utilization, are substantial," according to a 2010 American Heart Association analysis published in Circulation.
Removing the infected hardware is a highly invasive procedure that requires a lot of resources and prolonged antibiotics. "In most cases, physicians eventually have to put in a new generator and leads once patients clear the infection," says Dr. Simons. "So hospitals are not only paying for the extraction procedure, but also covering the cost of repeating the initial surgery."
Infections typically cost a facility an average of ~$52,000, but may exceed well over $100,000, according to information from a 2011 study published in Archives of Internal Medicine and CMS' Inpatient Prospective Payment System final rule for Fiscal Year 2013.
How to help reduce CIED infections
Hospitals can use various techniques to help reduce CIED infections, such as pre-, peri-, and post-operative antibiotics, along with meticulous surgical technique and appropriate management of anticoagulation to minimize the risk of hematoma. However, one of the most effective tools Dr. Simons uses is the TYRX™ Absorbable Antibacterial Envelope.
"The TYRX Envelope is a very promising FDA-cleared technology that many clinicians in the heart rhythm community have adopted, myself included," says Dr. Simons.
The product, developed by Minneapolis-based Medtronic, is a large-pore mesh envelope, knitted from absorbable filaments, which is designed to hold an implantable cardiac device in place, thereby creating a stable environment. This stabilization helps reduce the chance for device migration, erosion, or Twiddler's Syndrome, which are additional complications of cardiac device procedures. The Envelope is coated by a bioabsorbable polyarylate polymer containing two antibiotics — minocycline and rifampin — which are eluted for a minimum of seven days post implantation to help reduce a wide range of bacterial infections. The mesh is fully absorbed by the body approximately nine weeks after the procedure, which leaves no foreign body nidus for infection and eliminates the need to modify surgical technique in future replacement or revision procedures.
In six peer-reviewed published clinical studies, conducted from 2011 to present, the TYRX Envelope has achieved a 70 percent to 100 percent reduction in CIED infections.
Researchers examined 1,129 high-risk patients undergoing ICD or CRT upgrade or replacement procedures with the TYRX Antibacterial Envelope in a 2017 large prospective cohort study published online in the Journal of the American College of Cardiology: Clinical Electrophysiology. Twelve months after surgery, patients demonstrated a significant reduction in the incidence of major CIED infection. On a relative scale, up to 90 percent fewer infections were reported in the TYRX cohort.
Fewer infections means more cost savings
Along with improved clinical outcomes, the TYRX Envelope can also help improve economic outcomes for healthcare facilities by reducing treatment costs.
Utilizing the same 1,129-patient cohort, researchers examined the economic benefits of using the TYRX Envelope in patients at high-risk for CIED infections undergoing replacement procedures with ICD and CRT devices.
Of 1,129 patients treated with the TYRX Envelope, only five had a major CIED infection one year after the surgery — 20 fewer infections than the control group treated without the TYRX Envelope. Researchers found this reduction in infection rate translated to significant cost savings for hospitals. The total costs associated with using TYRX Envelopes, roughly $1,129,000, was offset by a $1,644,975 reduction in total CIED infection-related hospital costs, for a total net savings of $515,975.
"Bottom line, we found hospitals could save $457 per patient," said Jessica Lopatto, a senior analyst of health economics at Medtronic who was involved with the analysis. "It's a great opportunity for hospitals to not only avoid the poor critical outcomes and patient experience associated with the CIED infections, but also spend less money in the process."
Conclusion
CIED infections represent a dangerous and costly healthcare complication unwanted by any patient or hospital. Hospitals must take diligent steps to help reduce these infections and carefully assess the risks and benefits of current infection reduction products on the market. Numerous clinical and economic studies demonstrate that the TYRX Antibacterial Envelope is a valuable clinical and economic tool physicians and hospitals can use to help reduce infections, improve patient outcomes, and achieve significant cost savings.