Researchers find that bleeding after minimally invasive peripheral artery disease (PAD) treatments can increase the risk of death, Major bleeding occurs in about 4 percent of surgical procedures to treat blockages in the arteries of the lower leg and an increased risk of in-hospital deaths, according to a new study published in JACC: Cardiovascular Interventions.
According to the researchers, the study found several risk factors that increase the chance of bleeding, which they say can guide future efforts to reduce bleeding complications. This study is the first published research using NCDR PVI Registry data.
\”This is the first large-scale study to describe the frequency of bleeding in patients undergoing lower extremity peripheral vascular interventions (PVI),\” said Adam C. Salisbury, M.D., MSc, a cardiologist with St. Luke\’s Health System in Kansas City, Missouri, and the study\’s lead author, in a June 17 statement announcing the publication of the article. \”Bleeding has been well studied in coronary artery procedures but not in vascular procedures involving the lower extremities,\” he says.
The researchers say that PVI is a minimally invasive outpatient procedure used to treat PAD, which causes plaque buildup in the arteries leading to the intestines, head, arms and most commonly the legs. PAD affects approximately 8 million Americans, they note.
Limited Studies Taking Look at PVI Outcomes
PVI procedure, using a balloon-tipped catheter and/or stents to open blockages from inside the vessel, are used to restore the flow of blood to the lower extremities, eliminating pain, numbness or need for amputation. Since 1999, a growing number of physicians are using PVI for the treatment of PAD, but there have been a limited number of studies taking a look at the safety outcomes of the popular medical procedure in a routine clinical practice, Salisbury said.
From 2014 to 2016, the study’s researchers studied patients undergoing PVI at 76 hospitals in the NCDR PVI Registry. Among 18,289 PVI procedures performed, major bleeding occurred in 744 (4.1 percent). The in-hospital death rate was higher in patients who experienced bleeding compared with those who did not (6.6 percent versus 0.3 percent).
The researchers found patient characteristics associated with bleeding specifically, age, female sex, heart failure and anemia. Patients with resting leg pain or ulcerations due to poor blood flow were also at higher risk, they say.
The study’s findings indicate that certain surgical strategies were associated with bleeding, such as placing the catheter in an artery other than the femoral artery. The use of thrombolytic (\”clot-busting\”) therapy was also associated with an increased risk of bleeding, say the researchers.
\”The findings suggest we can use different procedural strategies, such as using different access points for the catheter, alternative blood thinners or different sizes of equipment, to reduce the risk of bleeding,” says Salisbury, noting that these findings can identify factors and create research models to predict who is at higher risk of bleeding. In these patients, we need to be especially careful to avoid doing anything that could increase the risk of bleeding,\” he adds.
Time to Establish Best Practices
In an editorial accompanying the published study, Douglas E. Drachman, M.D., of Massachusetts General Hospital and Beau M. Hawkins, M.D., of the University of Oklahoma Health Sciences Center, wrote that the study \”demonstrates that bleeding is a common complication of PVI and that bleeding confers significant clinical risk. For clinicians engaged in the care of patients with lower extremity PAD, this represents an opportunity to establish best practices and improve patient outcomes: it is time to stop the bleeding.\”