Results from a single-center analysis show the outpatient setting met SVS objective performance goals.
A retrospective study of endovascular interventions performed for chronic limb-threatening ischemia (CLTI) in an office-based lab (OBL) associated with a large New York City medical center across seven years determined that carefully selected patients may be treated safely in the outpatient setting.
Researchers from NYU Langone Medical Center report that 44.8% of the 230 patients included in the study required ipsilateral reintervention, with 30.4% warranting inpatient reintervention; and 20.4% required ipsilateral amputation, with 9.1% undergoing major amputation. All-cause mortality was 16.5% at three-year follow-up. This is set against Society for Vascular Surgery (SVS) objective performance goals for revascularization carried out for CLTI of 55% freedom from reintervention, 84% limb salvage and 80% survival at one year.
The data, from September 2016–February 2023, are to be presented at the 2024 annual meeting of the Eastern Vascular Society (EVS) in Charleston, South Carolina (Sept. 19–22), by Moira McGevna, a medical student at Rutgers Robert Wood Johnson Medical School in New Brunswick, New Jersey, who worked on the project during a research year at NYU under the senior authorship of Thomas Maldonado, MD, NYU Langone professor of surgery.
Acknowledging the controversy that often surrounds the role of the OBL in the treatment of vascular disease, Maldonado notes in an interview with Vascular Specialist ahead of EVS 2024, “we found that despite not being adjoined or adjacent to a hospital, the OBL plays an important role, even in patients with critical limb ischemia [or CLTI].”
The tendency with CLTI patients, often bearing the risk of limb loss, is to treat them “in-house,” he says. “When we looked at our experience of 230 patients over seven years who had a minimum of one year of follow up—we had a mean follow up of 3.1 years—in these patients we found really very favorable outcomes with respect to major amputation, for instance, of only 9.1%. This compares very favorably to the SVS performance goals, which suggest limb salvage at 84, 85%.”
The key, Maldonado says, is in patient selection. “I think what we’re taking from this is that the OBL has a role to play even in patients who have more advanced comorbidities, with higher risk of limb loss, and may be an appropriate place to treat these patients, understanding that we only have a 9.1% risk of major amputation in this cohort. We feel that the OBL may be an appropriate setting in select patients with critical limb ischemia. Like anything we do in vascular surgery, patient selection and good judgment are paramount. Despite the OBL being a setting that is not in the context of a hospital with all its support, I still believe it has an important role, even with patients with critical limb ischemia who have higher comorbidities.”
To this end, the analysis showed that patients who underwent amputation were more likely to have diabetes (79.2% vs. 58.2%). “When we looked at comorbidities, diabetic patients in particular were more likely to have amputation after out patient endovascular procedures for CLTI—not particularly surprising for this higher-risk cohort of patients is at increased susceptibility to infection, wound complications, etc.,” says Maldonado.
“But again, that speaks to proper patient selection and understanding that these patients need to be vetted and properly worked up to make sure that their comorbidities have been optimized and well managed before attempting something like this in the outpatient setting.”
Future research directions will look at cost implications of OBL use for CLTI patients, Maldonado continues. “Anytime you use the hospital infrastructure for taking care of these sick patients, there is an associated cost. Future studies should examine the health economics associated with caring for a patient with critical limb ischemia in the inpatient versus outpatient setting.
“Our present study has shown that over 70% of these patients do not require inpatient reinterventions. We can keep them out of the hospital and that may be beneficial, not just for the patient but it also may be economic from a cost-savings standpoint.”
Maldonado also points toward likely gains in terms of patient quality of life and overall satisfaction.
“There’s no doubt that patients coming into the hospital, often resulting in an overnight stay or longer, can result in decreased patient satisfaction and negatively impact their quality of life,” he adds.
