Bleeding Complications Common and Costly After Transcatheter Therapies With Large-Bore Catheters

Patients who require transcatheter cardiovascular interventions in which large-bore catheters are used have a high incidence of bleeding complications, which in turn are associated with greater risk of death, longer hospital stays, and higher costs. Additionally, about one in seven patients with bleeding after large-bore procedures will require a blood transfusion, according to a large analysis.

“It’s worrisome, because all the new transcatheter therapies require large-bore catheters. Obviously TAVR devices are getting smaller, but overall it’s still a large catheter,” senior author Philippe Généreux, MD (Gagnon Cardiovascular Institute, Morristown Medical Center, NJ), told TCTMD. “Our goal was to show where we can improve ourselves when doing these procedures. Bleeding is frequent, and it is not benign when it occurs.”

Approximately 18% of all patients in the study experienced a hemorrhage, hematoma, or the need for percutaneous or surgical reintervention to control the bleeding event—30.2% of TAVR patients, 13.4% of EVAR patients, and 25.8% of those being implanted with percutaneous left ventricular assist devices (PVADs).

Généreux added that identifying bleeding and the risk for bleeding early as well as using bleeding-avoidance strategies are important takeaways for operators.

Impact on Death, Length of Stay, and Cost

Published online March 18, 2017, in JAMA Cardiology, the study, led by Björn Redfors, MD, PhD (Cardiovascular Research Foundation, New York, NY), looked at 17,672 patients from the Healthcare Cost and Utilization Project’s National Inpatient Sample who underwent procedures involving TAVR, EVAR, or PVAD implant from 2012 through 2013.

For patients with bleeding, in-hospital mortality was about three times higher than for those with no bleeding events (adjusted OR 2.70; 95% CI 2.27-3.22). Additionally, their median hospital stay was 7 days compared with just 2 days for those with no bleeding complications, and median hospital costs were about 47% higher ($48,663 vs $29,968; P < 0.001).

The majority of patients with a bleeding complication (80.7%) required at least one blood transfusion. The proportion who required more than one transfusion was higher for the PVAD implant group, followed by EVAR and TAVR. Compared with patients not requiring transfusion, those who needed one or more had increased in-hospital mortality, length of stay, and healthcare costs, all of which rose further if additional transfusions were needed.

Although the study did not analyze the impact of operator volume on bleeding, both Généreux and Redfors said it likely plays a role.

To TCTMD, Redfors said that while the study to some extent is a “look in the rearview mirror” based on its time frame, the very high rates of bleeding highlight the need for better methods for preventing and identifying bleeding even as the techniques and devices evolve and operators gain experience.

“We are seeing very rapid progress, especially in TAVR, over the last few years, and so we would expect the numbers possibly to be a little lower today than what we saw in this study,” Redfors noted. “But that being said, the considerable bleeding risk with these procedures and the impact of it remains an issue.”

Note: Redfors is an employee of the Cardiovascular Research Foundation, the publisher of TCTMD. Généreux is a faculty member of the organization, as are study co-authors Roxana Mehran, MD, and Ajay J. Kirtane, MD.