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The Impact Of Compliance After Revascularization On The Outcomes Of Patients Treated For CLTI
Gathe Kiwan, Alaa Mohamedali, Tanner Kim, MD, Haoran Zhuo, Yawei Zhang, Carlos Mena-Hurtado, MD, Hamid Mojibian, MD, Jonathan Cardella, MD, Raul Guzman, MD, Cassius Iyad Ochoa-Chaar, MD.
Yale University, New Haven, CT, USA.

OBJECTIVE: Compliance with follow up after lower extremity revascularization (LER) for chronic limb threatening ischemia (CLTI) is important for monitoring patency and prevention of amputation. However, optimal compliance has not been studied. This study analyzes the impact of compliance on the outcomes of patients undergoing LER for CLTI.
METHODS: The electronic medical records of patients with CLTI undergoing open or endovascular LER from 2013-2015 were reviewed. Patients were stratified according to their compliance with follow up. Compliance after revascularization was defined as adherence to follow up with a vascular specialist at least once for the first 3 months and a second time in the following period up to 15 months after the index procedure. Patient characteristics and outcomes were compared between compliant and non-compliant patients.
RESULTS: There were 359 patients and 219 (61%) were compliant. There was no significant difference in baseline demographics, comorbidities, or medications prior to treatment. At 30 days, both groups had comparable morbidity and mortality. (Table) After a mean follow up of 2.7 years, compliant patients had a significantly higher rate of ipsilateral reintervention (48.9% vs 22.6%, P=.004) and higher mean number of ipsilateral reinterventions (2.2 1.8 vs 1.6 1.1, P =.02) compared to non-compliant patients. Moreover, compliant patients were more likely to undergo LER of the contralateral leg as reflected by higher overall reintervention rate (61.2% vs 44.3%, P=.002) and increased mean total number of LER (2.7 2.3 vs 2.1 1.6) compared to non-compliant patients. However, there was no difference between the 2 groups in major amputation or mortality.
Conclusion: Compliant patients after LER for CLTI are subjected to increased reinterventions compared to non-compliant patients. However, the additional reinterventions do not seem to impact survival or limb salvage. Additional research to define the ideal follow up time line and optimal threshold for reintervention is needed.
Table 1. Demographics, comorbidities, and outcomes among compliant and non-compliant patients with critical limb ischemia undergoing lower extremity revascularization

Non-compliant
N=140
Compliant
N=219
p-value
Demographics
Age70.1 11.868.9 12.80.335
Male90 (64.3%)126 (57.5%)0.203
Smoking0.078
Former55 (39.6%)110 (50.2%)
Current35 (25.2%)54 (24.7%)
Nonsmoker49 (35.3%)55 (25.1%)
Race0.947
White94 (68.6%)146 (67.9%)
African American28 (20.4%)43 (20.0%)
Other15 (11.0%)26 (12.1%)
BMI29.5 6.528.3 6.80.091
Comorbidities
Diabetes96 (68.6%)142 (64.8%)0.494
Chronic renal insufficiency38 (27.1%)48 (22.0%)0.268
ESRD13 (9.3%)32 (14.6%)0.137
Hypertension124 (88.6%)191 (87.2%)0.702
Hyperlipidemia88 (62.9%)126 (57.5%)0.316
Coronary artery disease57 (41.0%)105 (48.0%)0.199
Congestive heart failure32 (22.9%)38 (17.4%)0.199
Stroke21 (15.00%)22 (10.1%)0.159
Hypercoagulable2 (1.4%)0 (0.0%)0.153
History of cancer20 (14.3%)35 (16.0%)0.663
Prior endovascular intervention17 (12.1%)35 (16.0%)0.313
Prior open surgery15 (10.7%)32 (14.6%)0.286
Serum creatinine1.6 1.91.7 1.90.944
Medications
Aspirin86 (61.4%)143 (65.9%)0.390
P2Y12 inhibitor48 (34.3%)61 (27.9%)0.196
Anticoagulation22 (15.7%)46 (21.0%)0.212
Statin87 (62.1%)145 (66.5%)0.398
30-day outcomes
Hematoma3 (2.2%)4 (1.9%)1.000
Pseudoaneurysm2 (1.5%)1 (0.5%)0.561
Bleeding10 (7.4%)19 (8.8%)0.646
Wound infection7 (5.2%)19 (8.8%)0.213
Pneumonia3 (2.2%)1 (0.5%)0.159
Urinary tract infection1 (0.8%)3 (1.4%)1.000
Thrombosis2 (1.5%)2 (0.9%)0.639
Deep venous thrombosis3 (2.2%)5 (2.3%)1.000
Stroke0 (0.00%)1 (0.5%)1.000
Acute renal failure8 (5.9%)11 (5.1%)0.729
Acute/new HD1 (0.7%)4 (1.8%)0.653
Return to Operating room14 (10.5%)36 (16.6%)0.110
Major amputation5 (3.7%)8 (3.7%)0.993
Any morbidity33 (23.6%)58 (26.5%)0.619
Mortality2 (1.5%)0 (0.0%)0.146
Long-term outcomes
Follow-up time (mean years SD)2.8 2.02.6 1.60.202
Reintervention rate (any leg)62 (44.3%)134 (61.2%)0.002*
Mean number of reinterventions (any leg)2.1 1.62.7 2.30.033*
Ipsilateral reintervention rate47 (22.6%)107 (48.9%)0.004*
Mean number of ipsilateral reinterventions1.6 1.12.2 1.80.020*
Major amputation16 (11.4%)40 (18.3%)0.082
Mortality56 (40.6%)76 (35.0%)0.291


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