Variance in annual volumes of endovascular lower-extremity revascularization (eLER) procedures does not influence in-hospital mortality for patients suffering from critical limb ischemia (CLI), but could impact limb preservation, according to a new registry analysis.
Published online Monday and in the Sept. 13 issue of JACC: Cardiovascular Interventions, the study noted that despite the fact that CLI has a poor prognosis and is associated with high amputation and mortality rates, and the fact that revascularization for CLI – such as eLER – has been shown to improve major amputation-free survival, there is a scarcity of data on the relationship between hospital procedural volume and outcomes of eLER for CLI.
Led by Ayman Elbadawi, MD, from the Baylor College of Medicine, Houston, the team analyzed data from more than 140,000 patients – finding that there was no difference in in-hospital mortality after eLER for CLI, according to annual hospital volume of eLER.
However, compared with low-volume hospitals, eLER for CLI at high-volume hospitals was associated with lower rates of in-hospital major or minor amputation and lower rates of 30-day major adverse limb events (MALE).
Elbadawi and colleagues analyzed data from the Nationwide Readmissions Database (2013-2015) for hospitalized patients who underwent eLER for CLI. Hospitals were divided into tertiles according to annual eLER volume: low volume (<100 eLER procedures), moderate volume (100-550 eLER procedures) and high volume (>550 eLER procedures), and stepwise multivariable regression models were used. The main outcomes were in-hospital mortality and 30-day readmission with MALE, defined as the composite of amputation, acute limb ischemia or repeat revascularization.
They noted that among 145,785 hospitalizations for eLER for CLI, 5,199 (3.6%) were at low-volume eLER hospitals, 27,857 (19.1%) at moderate-volume eLER hospitals, and 112,728 (77.3%) at high-volume eLER hospitals.
On multivariable analysis, there was no difference with regard to in-hospital mortality among moderate-volume hospitals (adjusted odds ratio [OR]: 0.78; 95% CI: 0.60-1.01) and high-volume hospitals (adjusted OR: 0.84; 95% CI: 0.64-1.05) compared with low-volume hospitals, said Elbadawi and colleagues.
However, they noted a lower risk of in-hospital major amputation (adjusted OR: 0.82; 95% CI: 0.70-0.96) and minor amputation at high- versus low-volume hospitals.
“The length of hospital stay was shorter and discharges to nursing facilities were fewer among moderate- and high-volume hospitals compared with low-volume hospitals,” the team added, noting that compared with low-volume hospitals, eLER for CLI at high-volume hospitals had a lower risk for 30-day readmission with MALE (adjusted OR: 0.83; 95% CI: 0.70-0.99).
The team added that further analyses – with longer follow-up – may now be useful in providing additional insights regarding operator and hospital volume and experience in treating CLI.
Does volume matter?
Writing in an accompanying editorial, Debabrata Mukherjee, MD, MS, from the Texas Tech University Health Sciences Center, El Paso, and Saurav Chatterjee, MD, from North Shore-Long Island Jewish Medical Centers and the Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, noted that CLI is the most severe sequelae of peripheral arterial disease, affecting nearly 2 million people in the United States.
They added that patients with CLI are at increased risk of amputation, MALE and major cardiovascular ischemic events, and that all patients with CLI should be evaluated for potential revascularization and wound-healing therapies alongside pharmacological therapies to prevent cardiovascular ischemic events.
The editorialists noted that prior studies have also investigated the association of volume and outcomes in CLI – reporting that the rates of major amputation were inversely associated with distance from the index hospital, but rates of both major amputation and mortality were inversely associated with lower extremity revascularization volume, “suggesting that regionalization of CLI care into centers of excellence with higher volumes may potentially improve outcomes for these patients.”
“Although the lack of in-hospital survival benefit and the lack of large absolute differences in amputation rates among different hospital volumes may suggest that performing endovascular interventions among small and moderate endovascular peripheral volume hospitals remains tenable, the lower incidence of in-hospital major amputation, minor amputation, discharge to nursing facility, and 30-day readmission with major adverse limb events at higher-volume hospitals should be factored in decision making,” suggested the expert commentators.
Elbadawi A, Elgendy IY, Rai D, et al. Impact of Hospital Procedural Volume on Outcomes After Endovascular Revascularization for Critical Limb Ischemia. JACC Cardiovasc Interv 2021;14:1926-1936.
Mukherjee D, Chatterjee S. Endovascular Revascularization and Outcomes in Critical Limb Ischemia: Does Hospital Volume Matter? JACC Cardiovasc Interv 2021;14:1937-1939.
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