US Data Convey the Scope of Bleeding in Lower-Extremity Peripheral Interventions

The field of lower-extremity peripheral vascular intervention (PVI) is seeing rapid growth, but little is known about real-world practice patterns and outcomes. To tease out this information, researchers crunched numbers from the NCDR PVI Registry on more than 18,000 procedures done at 76 US hospitals over a 3-year period, with a focus on periprocedural bleeding.

What they found is the first step toward developing strategies to improve the care of patients with PAD, authors say.

“Although reducing periprocedural bleeding after percutaneous coronary intervention has been a major focus of efforts to improve procedural safety, less attention has been given to bleeding reduction after PVI,” Bhaskar Bhardwaj, MD (University of Missouri, Columbia), and colleagues point out in their paper published in the June 24, 2019, issue of JACC: Cardiovascular Interventions.

To TCTMD, senior author Adam C. Salisbury, MD (Saint Luke’s Mid America Heart Institute, Kansas City, MO), said the data set is reflective of what’s going on across the United States, thanks to its large size and diverse care settings. “The challenge in the peripheral vascular literature, especially in the past, has been you’re often looking at data from a small number of centers or a single-center experience,” he observed.

It’s always good to be able to identify leading centers, so that we can drill down on the processes that have been successful in reducing risks. Adam C. Salisbury

“It’s good to see national-level data on peripheral vascular interventions,” Manesh R. Patel, MD (Duke University Medical Center, Durham, NC), noted to TCTMD. “I think it just speaks to how nascent the field is, that we are just now starting to talk about the major bleed rates and the variability in [them]. We need to start thinking about modifiable factors, which include probably other access points, other technologies, other ways to think about taking care of these patients.”

A Snapshot

Bhardwaj et al looked at 18,289 PVI cases between 2014 and 2016. There were 744 major bleeds (4.1%), defined as any overt bleeding with a hemoglobin (Hb) drop ≥ 3 g/dL, any Hb decline ≥ 4 g/dL, or blood transfusion within 72 hours in patients with preprocedure Hb > 8 g/dL.

Bleeds most commonly occurred at the access site (58.4%), followed by retroperitoneal (22.6%), “other” (14.5%), gastrointestinal (3.1%), and genitourinary bleeding (1.4%).

In-hospital mortality was increased among patients who did versus did not develop major bleeding (6.6% vs 0.3%; adjusted HR 10.9; 95% CI 6.9-17.0). The death rate was highest in those who experienced overt bleeding (8.8%) or required transfusion (6.2%). Patients with a Hb drop ≥ 4 g/dL in the absence of overt bleeding had an in-hospital mortality rate of 3.1%.

Patients were more likely to experience bleeding if they were older or female, had prior heart failure, had preprocedural Hb < 12 g/dL, were undergoing nonelective PVI, or had presented with critical limb ischemia (CLI). Procedural characteristics tied to higher risk were nonfemoral vascular access, thrombolytic therapy, treatment in an aortoiliac segment, and treatment of multiple lesions. Use of closure devices, on the other hand, were linked to less bleeding.

Independent Predictors of Bleeding

“These insights can be incorporated into strategies to reduce periprocedural bleeding after PVI, the investigators conclude.

In an editorial, Douglas E. Drachman, MD (Massachusetts General Hospital, Boston), and Beau M. Hawkins, MD (University of Oklahoma Health Sciences Center, Oklahoma City), say the study’s main takeaway is “that bleeding is a significant complication of PVI and that bleeding confers 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.”

Retroperitoneal bleeding accounted for nearly a quarter of overt bleeding, they point out, and is a “potentially lethal complication.” But even “minor” bleeds that wouldn’t have been captured by the definition employed in this study “may have an impact on long-term prognosis in a population of patients with a high prevalence of coronary and other cardiovascular disease,” Drachman and Hawkins say.

Given the study’s “stringent” definition for major bleeding, the observed rate “is fairly substantial,” Patel commented. “It might miss other reasonable bleeds that might affect outcomes, such as significant femoral hematomas or other things that might not meet [the criteria].”

What’s also not captured in the NCDR PVI Registry are cases done in outpatient hospital settings, ambulatory surgical centers, and office-based labs (OBLs). These are on the rise thanks to a 2008 shift in US Centers for Medicare & Medicaid Services reimbursement. Many see potential advantages for physicians, patients, and the healthcare system as a whole. But, underlined by a recent TCTMD investigative report, there have been concerns about lack of oversight and accountability, leading experts in the field to discuss the best way ensure quality care.

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Hopefully, Patel said, bleeding rates would be lower in outpatient facilities due to healthcare providers risk-stratifying patients and tending to send higher-risk individuals to hospitals for treatment. But “this is all conjecture,” Patel cautioned. Providers, too, might be different among centers, “so you just don’t know.”

Salisbury agreed that these hospital-focused data don’t extend to outpatient facilities. “The patients treated in those settings are typically not as complicated. It’s hard to compare apples to apples, so to speak, when you’re looking at a more straightforward lesion in a more straightforward patient at an OBL versus a complex patient in a hospital setting,” he explained.

Asked whether hospital and provider characteristics are part of the NCDR PVI Registry, Salisbury said these haven’t yet been analyzed but are “important directions for future research.”

“When we’re trying to develop strategies to reduce any adverse outcome, it’s always good to be able to identify leading centers, so that we can drill down on the processes that have been successful in reducing risks,” he noted.

The most immediate task, Salisbury reported, is to develop a tool using the NCDR PVI Registry that can help predict a patient’s bleeding risk at the point of care, affect management, and improve outcomes. “If we know a patient is at high bleeding risk, what will that modify about what we do during the procedure? We might choose an alternative anticoagulant, maybe bivalirudin instead of heparin, or . . . choose to be particularly mindful of smaller sheaths and ultrasound-guided access and micropuncture access,” he concluded. “That’s the next step for us.”

Patel suggested that possible avenues for improvement are use of radial access as well as a “push to better understand how we take care of [people] in the outpatient holding areas,” for example, and exploration of different anticoagulation strategies.