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Patient Reported Outcomes for Peripheral Vascular Interventions For Claudication: Correlation with Traditional Outcome Measures
Daniel Nguyen, BS, Scott S. Berman, MD, Megon Berman, BS.
Pima Heart and Vascular, Oro Valley, AZ, USA.

Objective: Measure patient reported outcomes (PRO) for patients with claudication undergoing peripheral vascular intervention (PVI) and determine if there is a relationship between PRO, ankle-brachial index (ABI) and clinical frailty score (CFS). Methods: We prospectively collected CFS, ABI and PRO data (using the SF-6 claudication tool) for patients undergoing PVI for claudication between October 2019 and March 2023 using our VQI PVI module with hashtags for CFS, ABI and SF-6 scores prior to intervention (PRE), at early follow-up (POM1) (4-6 weeks) and long-term follow-up (LTFU) (POY1) (9-21 months). PRO data was collected by administering the SF-6 survey to the patient at the time of their appointment at each interval by the clinical staff. Statistical comparisons between the PRE, POM1 and POY1 data were performed using t-tests and ANOVA. Results: During the period of review, 450 patients underwent PVI for claudication, of which 63% were male and 37% female. The interventions were performed in the office-based lab in 87%, hospital outpatient in 10% and hospital inpatient in 3%. No patient suffered a major complication or required amputation related to the index procedure or during the follow-up period. Data analysis revealed significantly greater PRO score at POM1 compared with PRE (12.7 ± 4 vs. 18 ± 4; P < 0.0001, clinically meaningful difference = 0.81). POM1 ABI was significantly greater than that recorded at PRE (0.93 ± 0.14 vs. 0.68 ± 0.20; P < 0.0001). Frailty score (CFS) significantly improved (decreased in value) from PRE to POM1 (3.5 ± 0.7 vs. 3.3 ± 0.7; P = 0.068, clinically meaningful difference = 0.14 ). Post hoc tests revealed PRO score to be significantly higher at POM1 compared to PRE (19 ± 5 vs. 13 ± 4; P = 0.001), and POY1 (18 ± 5) compared to PRE (P = 0.0009). There was no significant difference between PRO scores at POM1 and POY1 (P = 0.642). LTFU in 322 limbs showed success in 239 (74%) and failure requiring re-intervention in 83 (26%). Conclusions: Patient’s perception of a positive outcome of therapy as measured by PRO correlated with improvement in ABI at one month and was sustained at one year. Further work is necessary to see if these outcomes are durable beyond 1 year follow-up.


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