Effect of gait speed on clinical outcomes after crural and pedal bypass in patients with chronic limb-threatening ischemia.

OBJECTIVES: Many factors affect long-term outcomes after open bypass in patients with chronic limb-threatening ischemia (CLTI). Ambulatory status has been suggested to be associated with clinical outcomes, but there is limited knowledge on the effect of gait speed on outcomes. The purpose of this study is to evaluate the effect of gait speed assessed in a 6-min walk test (6MWT) on outcomes after crural and pedal bypass in patients with CLTI. METHODS: A retrospective analysis was performed in patients with CLTI who underwent a 6MWT at 1 month after crural and pedal bypass at a single center from 2014 to 2021. Comparisons were made between those with high gait speed (HG group, 6-min walk distance (6MWD) > 288 m) and those with low gait speed (LG group, 6MWD ≤288 m). The primary endpoint was survival, and the secondary endpoints were graft patency, limb salvage, wound healing, major adverse cardiovascular events (MACEs), and hospital outcomes. RESULTS: Of 104 patients with CLTI who underwent a 6MWT after crural and pedal bypass, 46 (44%) and 58 (56%) were placed in the HG and LG groups, respectively. The LG group was older (p < .001), had more female subjects (p = .006), and had a higher prevalence of cerebrovascular disease (p = .042) and tissue loss (p = .007). The median follow-up was 36 (22-57) months. The HG group had significantly higher 3-year primary patency (65% vs 42%, p = .013), 3-year secondary patency (87% vs 66%, p = .018), 3-year overall survival (89% vs 58%, p < .001), and 3-year freedom from MACE (79% vs 67%, p = .039). The 3-year limb salvage and 12-month wound healing rates did not differ between the groups. CONCLUSIONS: Gait speed in patients with CLTI after crural and pedal bypass was associated with survival, freedom from MACE, and graft patency but not with limb salvage and wound healing. A detailed study of walking ability in these patients may be needed in the future.

The effects of high quality team medicine on outcomes of chronic limb-threatening ischemia patients with infrapopliteal bypass.

OBJECTIVES: A team approach for treatment of patients with CLTI is used worldwide. However, the quality of team medicine is a concern. The Global Vascular Guidelines provide recommendations for high quality team medicine, but there is limited knowledge of the significance of team quality in CLTI treatment. The objective of this study is to evaluate the effects of team quality on clinical outcomes after infrapopliteal bypass. METHODS: A retrospective analysis was performed in 337 patients who underwent 414 infrapopliteal bypasses under a team medicine approach at a single center between 2009 and 2021. In 2017, team medicine was reorganized for improvement of quality. Comparisons were made between before (Group 1; 160 patients, 195 limbs) and after (Group 2; 177 patients, 219 limbs) reorganization. The primary endpoints were limb salvage and wound healing after infrapopliteal bypass. RESULTS: The patients included 227 males (67%) and had a median age of 76 [68-83] years. Diabetes mellitus was present in 67% and end-stage renal disease with hemodialysis in 37%. The follow-up rate was 96% in a mean follow-up period of 31±30 months. The 3-year limb salvage rate was significantly lower in Group 1 (before reorganization) than in Group 2 (after reorganization) (84% vs 95%, p = .001). The wound healing rates in the whole cohort were 72% at 6 months and 85% at 12 months, with no significant differences between the groups. In multivariate analysis, the risk factors for major amputation were treatment before reorganization (HR 2.68; p = .017), hemodialysis (HR 2.27; p = .017), and non-ambulatory status (HR 2.63; p = .005). CONCLUSIONS: A reorganized team approach with the goal of higher quality was independently associated with reduced major amputation for patients with CLTI treated with infrapopliteal bypass. This result indicates the importance of a high quality team approach for success of this treatment.

Effectiveness of Unsupervised Exercise Therapy After Endovascular Treatment for an Iliac Occlusive Lesion.

OBJECTIVE: Exercise therapy has acceptable outcomes for patients with intermittent claudication (IC), but there are few reports on the results of continuous unsupervised exercise therapy after endovascular treatment (EVT) for an iliac lesion. The aim of this study is to analyze the long-term outcomes of unsupervised exercise therapy for patients after EVT. MATERIAL AND METHODS: A retrospective analysis was performed in 76 patients (93 limbs) with IC who underwent iliac EVT from 2012 to 2020 at our hospital. Maintenance of unsupervised exercise therapy was evaluated at 6 months after EVT. Long-term outcomes such as primary patency, clinically driven target lesion revascularization (CD-TLR), survival, and major adverse cardiovascular events (MACE) were compared between patients who continued (cET group) or discontinued (dET group) unsupervised exercise therapy. RESULTS: A total of 28 patients (37%) continued unsupervised exercise therapy until 6 months after EVT for an iliac lesion. There were no differences in patient background and procedural details between the cET and dET groups. The follow-up rate was 96% in a median follow-up period of 35 [25 - 42] months. The mean exercise time in the cET group was 52 ± 18 minutes daily, with a mean frequency of 5.8 ± 1.1 days per week. The median step count in the cET group was 5559 ± 2908 steps daily. At 3 years, the cET group had significantly higher rates for primary patency (97% vs 71%, P = .002), and freedom from CD-TLR (97% vs 79%, P = .007); and a tendency for higher survival (100% vs 94%, P = .074), and higher freedom from MACE (89% vs 73%, P = .12). CONCLUSION: The findings of this study suggested superior long-term outcomes, including primary patency, freedom from CD-TLR, survival, and freedom from MACE, in patients who maintained continuous unsupervised exercise therapy after EVT.

Prognostic Significance of Preoperative Functional Independence Measure (FIM) on Long-Term Outcomes in Patients with Chronic Limb-Threatening Ischemia (CLTI).

BACKGROUND: The purpose of this study was to evaluate the effect of preoperative motor and cognitive activities of daily living (ADL) on long-term outcomes of patients with chronic limb-threatening ischemia (CLTI) after distal bypass. METHODS: A retrospective review was performed for patients who underwent distal bypass for CLTI from 2013 to 2019 at multiple centers in Japan. Comparisons were made among patients with high and low motor and cognitive ADL based on the functional independence measure (FIM). The primary endpoint was limb salvage and the secondary endpoints were survival, amputation free survival (AFS), major adverse limb events (MALE), readmission, and wound healing. RESULTS: A total of 226 distal bypasses were performed in 185 patients (169 males; median age, 76 years; diabetes mellitus, 70%; end-stage renal disease with hemodialysis, 40%). The patients were divided into high (n = 93, 50%) and low (n = 92, 50%) FIM-motor cases, and high (n = 157, 85%) and low (n = 28, 15%) FIM-cognitive cases. FIM-motor (high vs. low) and FIM-cognitive (high vs. low) were not significantly associated with limb salvage, freedom from MALE, freedom from readmission, and wound healing. The 1- and 3-year survival rates were significantly lower in low FIM-motor cases (93% vs. 70% at 1 year, 73% vs. 46% at 3 years, P = 0.0011); and in low FIM-cognitive cases (87% vs. 50% at 1 year, 63% vs. 45% at 3 years, P < 0.001). The 1- and 3-year AFS rates were significantly lower in low FIM-motor cases (92% vs. 67% at 1 year, 69% vs. 44% at 3 years, P < 0.001); and in low FIM-cognitive cases (85% vs. 49% at 1 year, 59% vs. 44% at 3 years, P < 0.001). In multivariate analysis, independent risk factors for survival were hemodialysis (HR = 2.17; 95% confidence interval (CI), 1.23-3.83; P = .0078), low FIM-cognitive (HR = 3.45; 95% CI, 1.78-6.71; P < 0.001), and ejection fraction (HR = 0.98; 95% CI, 0.95-0.99; P = 0.019). CONCLUSIONS: FIM-motor and FIM-cognitive were predictive factors for long-term survival and AFS of CLTI patients after distal bypass, but had no influence on limb salvage, MALE, readmission, and wound healing. These results suggest that the motor and cognitive status of ADL should be assessed using FIM before distal bypass for patients with CLTI.

Effectiveness of continuous unsupervised exercise therapy after above-knee femoropopliteal bypass.

OBJECTIVE: Exercise therapy has acceptable outcomes for patients with intermittent claudication, although few reports exist regarding the results of continuous exercise therapy after surgical reconstruction for intermittent claudication. This study aimed to analyze the long-term outcomes of unsupervised exercise therapy for patients after above-knee femoropopliteal bypass. MATERIAL AND METHODS: We retrospectively analyzed 69 patients (69 limbs, 69 grafts) who underwent above-knee femoropopliteal bypass from April 2009 to March 2018 in our hospital. At six months after above-knee femoropopliteal bypass, we evaluated the maintenance of unsupervised exercise therapy. Patients who continued unsupervised exercise therapy or discontinued unsupervised exercise therapy were assessed via 1:1 propensity matching. Long-term outcomes such as patency, survival, and major adverse cardiovascular events were compared between the groups after matching. We also analyzed the maintaining rate of unsupervised exercise therapy in a study cohort. RESULTS: Twenty-nine (42%) patients continued unsupervised exercise therapy until six months after above-knee femoropopliteal bypass. The discontinued unsupervised exercise therapy had higher proportions of female sex (p = 0.015) and cerebrovascular disease (p = 0.025) than did the continued unsupervised exercise therapy. The mean follow-up period was 65 ± 36 months. After propensity matching, the rates of the following factors were significantly higher in the continued unsupervised exercise therapy than in the discontinued unsupervised exercise therapy: primary patency (97% vs. 61%, p = 0.0041), secondary patency (100% vs. 69%, p = 0.0021), and freedom from major adverse cardiovascular events (61% vs. 24%, p = 0.0071) at five years. Both groups had a similar survival rate. The maintaining rate of unsupervised exercise therapy in the study cohort was 44% at six months, 41% at one year, 36% at three years, 25% at five years, and 25% at seven years. CONCLUSION: The findings of this study suggested superior long-term outcomes, including graft patency and freedom from major adverse cardiovascular events, with unsupervised exercise therapy after open bypass than with the usual therapy. Unsupervised exercise therapy may be recommended for the patients after open bypass.

Long-Term Results of Distal Bypass for Intermittent Claudication.

BACKGROUND: Distal bypass (DB) is the optimal treatment for patients with critical limb ischemia (CLI). However, effectiveness of DB for patients with intermittent claudication (IC) remains uncertain. This study aimed to analyze long-term results of DB for IC patients (IC-DB) compared with those of DB for CLI patients (CLI-DB). METHODS: Patients undergoing DB from January 2009 to July 2018 at a single institution were retrospectively reviewed. Operative details, primary and secondary patency, amputation free survival rate (AFS), and long-term exercise capacity using Barthel index were analyzed. RESULTS: Out of 302 DB (245 patients), 49 IC-DB were performed in 43 patients: 38 males, mean age 70.3 ± 8.0 years, diabetes mellitus 51%, chronic renal failure with hemodialysis 7%. The Great saphenous vein was used in 47 limbs, the small saphenous vein in 1, and the arm vein in 1. These grafts were bypassed in a non-reversed fashion for 35 limbs, in an in-situ fashion in 9, and in a reversed fashion in 5. The mean operative time was 173 min. The mean follow-up was 25 ± 26 months. Primary and secondary patency of IC-DB was 79% and 94% at 1 year, 71% and 90% at 3 years, 65% and 90% at 5 years, which were significantly higher than those of CLI-DB (primary patency: P = .007, secondary patency: P = .025). AFS of IC-DB and CLI-DB was 100% and 77% at 1 year, 93% and 52% at 3 years, and 90% and 43% at 5 years (IC-DB vs. CLI-DB, p < .0001). Barthel index of IC-DB unchanged at discharge (median 100) and at the last visit (median 100), showing daily activity was maintained adequately. CONCLUSIONS: DB could offer a promising approach for patients with IC because of durable graft patency, acceptable AFS, and maintenance of daily activity.