It is called the risk that keeps on giving. PCI-related bleeding events potentially carry a host of unwanted consequences, including cascading complications, increased costs and even deaths. By adopting bleeding avoidance strategies and personalized approaches, interventional cardiologists can stanch the problem in the short and long term.
Early vigilance pays off
About three years ago, a bump in the major bleeding rate for PCIs at St. Vincent Health in Indianapolis set its cardiovascular thoracic council’s performance improvement process in motion. After all, even this blip first spotted in its monthly report could have an impact on patient safety. For instance, an analysis of the National Cardiovascular Data Registry (NCDR) CathPCI Registry found that PCI patients with major bleeding events had higher in-hospital mortality compared with patients with no bleeding complications, at 5.26 percent vs. 1.87 percent (JAMA 2013;309:1022-1029). The researchers estimated that 12.1 percent of deaths were related to bleeding complications.
The blip also potentially could affect costs, patient satisfaction and quality measures. Bleeding complications can add two to six days to the hospital length of stay and tag $6,000 to $8,000 or more onto hospital costs. PCI bleeding is one component in a 100-point score card by one of St. Vincent’s payers and is a metric reported on the NCDR. That prompted a root-cause analysis that identified “a multitude of things that we subsequently dealt with,” says Edward T. A. Fry, MD, chair of St. Vincent’s cardiology division.
Some were straightforward fixes, such as revising the training of personnel who remove sheaths to improve their competency. They didn’t stop there, though. Instead the team made PCI bleeding a priority project. “It more recently encouraged us to look at an overall strategy of identifying those who are at higher risk of bleeding and applying the risk score and periprocedurally modifying the procedural approach or the procedural drug therapy,” Fry says.
Rate of femoral or radial access according to predicted risk of transfemoral vascular access complications. Patients with higher predicted risk of complications via the transfemoral approach were less likely to receive a transradial approach. Source: J Am Heart Assoc. 2013;2:e000174
Interventional cardiologists continually try to find the sweet spot between safety and efficacy when treating patients who undergo PCIs and managing them after the procedure. The therapies that decrease ischemic risk typically increase bleeding risk, making that spot more of a dot, and a moving dot at that. “The strategies one uses to avoid bleeding are different between the periprocedural time period and the long-term events,” observes Robert W. Yeh, MD, MBA, co-director of the chronic total occlusion intervention program at Massachusetts General Hospital in Boston. “As a physician, one has to constantly be updating in one’s mind what one thinks the patient’s bleeding risk is at any given time.”
The St. Vincent group adopted a risk stratification model that allowed interventional cardiologists to categorize patients at high, intermediate or low risk and apply evidence-based strategies for reducing the bleeding risk. Low-risk included elective cases with stable angina; intermediate-to-high risk were urgent cases with non-STEMI and unstable angina; and high risk were emergent with STEMI. A decision tree assigned anticoagulant and antiplatelet therapy by risk category followed by the option of transradial or transfemoral access. Patients who underwent transfemoral access PCIs and who had a high risk of bleeding received the direct thrombin inhibitor bivalirudin (Angiomax, Medicines Company) as an anticoagulant rather than unfractionated heparin.
Fry characterizes the dozen interventional cardiologists at St. Vincent as early adopters but credits the group’s newer members and fellows for championing radial PCI, which is shown to lower bleeding rates but also has a learning curve. “[Physicians] say, ‘Patients like this; they don’t bleed as much; they can go home the same day; and it is not really that hard once you get over the hump,’” he says. “The barriers came down and it became a lot easier.”
In an analysis that compared PCIs between July 1 and Dec. 31, 2013, to St. Vincent’s historical data, PCI-associated major bleeding decreased 59 percent and the use of transradial PCI jumped from 19 percent to 43 percent. The use of bivalirudin remained relatively