Peripheral Arterial Disease Clinical Trial
Official title:
Impact of Multidisciplinary Critical Limb Ischemia Team on the Utilization of Vascular Studies, Patient Management, AMPutation and Long-term Outcomes: The CLI-AMP Registry
Single-center, observational registry study with a prospective and retrospective arm to evaluate the impact of multidisciplinary CLI teams and protocol on amputation rates, vascular studies, revascularization, in-hospital and long-term outcomes.
It is well known from large Medicare and National Inpatient Sample databases that vascular
evaluations in patients with critical limb ischemia (CLI) and at risk for amputations remains
extremely low. However, this data is largely pulled from the early 2000s with a scarcity in
studies from this recent decade. A recent study showed that Medicare patients from 2011
showed that 23% of patients received primary major amputation. In a recent retrospective
analysis preformed at this institution, all amputation patients from 2011-2017 were evaluated
for vascular work up and long-term mortality. This cohort included 698 patients with 1009
amputated specimens (major and minor). This means that this institution is preforming around
140 amputations per year, which can be considered unacceptably high. Only 50% received any
form of vascular study (ankle-brachial index, doppler ultrasound, and computed tomography
angiography) within the year prior to amputation. Furthermore, only 30% of patients received
an angiogram within the year prior to amputation. In addition, all major amputations received
histopathological analysis, which confirmed that 62% the specimens were graded with severe
atherosclerosis. Even in this present decade, with the knowledge that CLI patients are not
receiving proper evaluation and treatment leading to amputation which is associated with
extreme mortality rates and a large economic burden, health care facilities are not improving
their care.
Multidisciplinary teams are a recommendation from the American Heart Association/American
College of Cardiology guidelines for managing peripheral vascular disease. Multidisciplinary
team approaches in other cardiovascular diseases, such as structural heart disease, has long
been validated. Literature regarding the implementation of "CLI Teams" remains scarce and not
widely adopted. However, institutions that have implemented a CLI Team that engages with
specialists from multiple disciplines have shown successful decrease in amputation rates and
increases in vascular evaluations and revascularization in these patients. The goal for this
study is to establish a hospital-based, physician and nurse led, multidisciplinary team to
deliver comprehensive care to CLI patients. We believe it is important to document the
experience of building a CLI Team and care protocols to provide insight and validated data
for other programs to implement. The multidisciplinary team will include vascular
interventionalists, hospitalists, podiatry, wound care, infectious disease, nephrology,
orthopedics, pharmacists, emergency department physicians, mid-level providers, nursing
staff, and vascular technologists. The ultimate goal is amputation prevention and wound
healing through comprehensive vascular care and data driven patient outcomes.
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