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 | ||||
| Age | 70.1 ± 11.8 | 68.9 ± 12.8 | 0.335 | |
| Male | 90 (64.3%) | 126 (57.5%) | 0.203 | |
| Smoking | 0.078 | |||
| Former | 55 (39.6%) | 110 (50.2%) | ||
| Current | 35 (25.2%) | 54 (24.7%) | ||
| Nonsmoker | 49 (35.3%) | 55 (25.1%) | ||
| Race | 0.947 | |||
| White | 94 (68.6%) | 146 (67.9%) | ||
| African American | 28 (20.4%) | 43 (20.0%) | ||
| Other | 15 (11.0%) | 26 (12.1%) | ||
| BMI | 29.5 ± 6.5 | 28.3 ± 6.8 | 0.091 | |
| Comorbidities | ||||
| Diabetes | 96 (68.6%) | 142 (64.8%) | 0.494 | |
| Chronic renal insufficiency | 38 (27.1%) | 48 (22.0%) | 0.268 | |
| ESRD | 13 (9.3%) | 32 (14.6%) | 0.137 | |
| Hypertension | 124 (88.6%) | 191 (87.2%) | 0.702 | |
| Hyperlipidemia | 88 (62.9%) | 126 (57.5%) | 0.316 | |
| Coronary artery disease | 57 (41.0%) | 105 (48.0%) | 0.199 | |
| Congestive heart failure | 32 (22.9%) | 38 (17.4%) | 0.199 | |
| Stroke | 21 (15.00%) | 22 (10.1%) | 0.159 | |
| Hypercoagulable | 2 (1.4%) | 0 (0.0%) | 0.153 | |
| History of cancer | 20 (14.3%) | 35 (16.0%) | 0.663 | |
| Prior endovascular intervention | 17 (12.1%) | 35 (16.0%) | 0.313 | |
| Prior open surgery | 15 (10.7%) | 32 (14.6%) | 0.286 | |
| Serum creatinine | 1.6 ± 1.9 | 1.7 ± 1.9 | 0.944 | |
| Medications | ||||
| Aspirin | 86 (61.4%) | 143 (65.9%) | 0.390 | |
| P2Y12 inhibitor | 48 (34.3%) | 61 (27.9%) | 0.196 | |
| Anticoagulation | 22 (15.7%) | 46 (21.0%) | 0.212 | |
| Statin | 87 (62.1%) | 145 (66.5%) | 0.398 | |
| 30-day outcomes | ||||
| Hematoma | 3 (2.2%) | 4 (1.9%) | 1.000 | |
| Pseudoaneurysm | 2 (1.5%) | 1 (0.5%) | 0.561 | |
| Bleeding | 10 (7.4%) | 19 (8.8%) | 0.646 | |
| Wound infection | 7 (5.2%) | 19 (8.8%) | 0.213 | |
| Pneumonia | 3 (2.2%) | 1 (0.5%) | 0.159 | |
| Urinary tract infection | 1 (0.8%) | 3 (1.4%) | 1.000 | |
| Thrombosis | 2 (1.5%) | 2 (0.9%) | 0.639 | |
| Deep venous thrombosis | 3 (2.2%) | 5 (2.3%) | 1.000 | |
| Stroke | 0 (0.00%) | 1 (0.5%) | 1.000 | |
| Acute renal failure | 8 (5.9%) | 11 (5.1%) | 0.729 | |
| Acute/new HD | 1 (0.7%) | 4 (1.8%) | 0.653 | |
| Return to Operating room | 14 (10.5%) | 36 (16.6%) | 0.110 | |
| Major amputation | 5 (3.7%) | 8 (3.7%) | 0.993 | |
| Any morbidity | 33 (23.6%) | 58 (26.5%) | 0.619 | |
| Mortality | 2 (1.5%) | 0 (0.0%) | 0.146 | |
| Long-term outcomes | ||||
| Follow-up time (mean years ± SD) | 2.8 ± 2.0 | 2.6 ± 1.6 | 0.202 | |
| Reintervention rate (any leg) | 62 (44.3%) | 134 (61.2%) | 0.002* | |
| Mean number of reinterventions (any leg) | 2.1 ± 1.6 | 2.7 ± 2.3 | 0.033* | |
| Ipsilateral reintervention rate | 47 (22.6%) | 107 (48.9%) | 0.004* | |
| Mean number of ipsilateral reinterventions | 1.6 ± 1.1 | 2.2 ± 1.8 | 0.020* | |
| Major amputation | 16 (11.4%) | 40 (18.3%) | 0.082 | |
| Mortality | 56 (40.6%) | 76 (35.0%) | 0.291 | |
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