Major Amputation-free Survival Research Articles

Outcomes of Excimer Laser Ablation Combined with Drug-coated Balloon in Atherosclerotic Lesions of the Popliteal Artery

BackgroundThe treatment of atherosclerotic lesions in the popliteal artery is challenging. This study aims to investigate the efficacy and safety of excimer laser ablation (ELA) combined with drug-coated balloon (DCB) for these lesions. MethodsFrom June 2019 to December 2021, data of patients who underwent ELA combined with DCB in the popliteal artery were retrospectively reviewed. Demographics, lesion characteristics, periprocedural complications and follow-up information were analyzed. The primary endpoint was primary patency. Secondary endpoints included major amputation-free survival (MAFS) rate, technical success, bailout stenting, clinically-driven target lesion reintervention (CD-TLR), improvement of ankle-brachial index (ABI) and Rutherford class. ResultsA total of 61 patients were enrolled. The mean age was 73.4 ± 11.7 years. 20 (32.8%) patients had stenotic lesions while 41 (67.2%) patients had chronic total occlusions (CTOs). The mean length of these lesion was 7.3 ± 2.8 cm. Procedure technical success rate was 95.1%. Bailout stent was performed in 3 (4.9%) patients. Intraprocedural distal embolization occurred in 3 (4.9%) patients, while flow limiting dissections occurred in 3 (4.9%) patients. The mean ABI was significantly improved from 0.45 ± 0.13 at baseline to 0.90 ± 0.12 after ELA, 0.88 ± 0.11 at 6 months and 0.85 ± 0.12 at 12 months. during the follow-up period. The median follow-up time was 28.2 ± 6.1 months. Reintervention was performed in 5 (8.2%) patients. The 2-year primary patency was 83.5%. ConclusionELA combined with DCB is a safe and effective strategy in the treatment of popliteal artery atherosclerotic lesions with low rates of bail-out stenting and high primary patency.

Multidisciplinary management of diabetic foot infection associated with improved 8-year overall survival

AimsDiabetic foot syndrome is a global challenge best managed through multidisciplinary collaboration. This study aimed to investigate the effect of a systematic multidisciplinary team (MDT) on the overall survival and major amputation-free survival of hospitalized patients with diabetic foot infection (DFI). MethodsThis retrospective cohort study was conducted at Tampere University Hospital. Cohorts of hospitalized patients with DFI before and after the initiation of multidisciplinary wound ward were compared after an 8-year follow-up. ResultsKaplan-Meier analysis revealed significantly higher overall survival in the post-MDT cohort (37.8 % vs 22.6 %, p < 0.05) in 8-year follow-up. Similarly, major amputation-free survival was superior in this cohort (31.8 % vs 16.9 %, p < 0.05). Additionally, early major amputation was associated with inferior overall survival (35.1 % vs 12.0 %, p < 0.05). In a multivariable Cox-regression analysis cohort (hazard ratio [HR] 1.38, 95 % confidence interval [CI95%] 1.01–1.87), early amputation (HR 1.64, CI95% 1.14–2.34) and diagnosed peripheral artery disease (HR 2.23, CI95% 1.61–3.09), congestive heart failure (HR 2.13, CI95% 1.47–3.08), or moderate kidney disease (HR 1.95, CI95% 1.34–2.84) were identified as significant risk factors affecting overall survival. ConclusionsAfter systematic MDT approach we found improved long-term overall and major amputation-free survival. Multidisciplinary approach is therefore highly recommended for managing patients hospitalized for DFI.

Risk Factors for Major Lower Limb Amputation and Effect of Endovascular Revascularization in Patients with Diabetic Foot Wound.

Major lower extremity amputation (LEA) such as below-knee or above-knee amputations can result in more physical disabilities and poorer socioeconomic functions than minor LEAs in diabetic foot ulcer (DFU). Therefore, identification of risk factors for major LEA and investigation of effectiveness of endovascular revascularization are critical for prevention and better prognosis of DFU patients. From January 2014 to December 2017, a total of 125 patients with DFU treated with any level of amputation were included in this study. Demographic, diabetes-related, DFU-related and -relevant laboratory information were investigated to predict major amputation. To identify risk factors for major amputation, logistic regression analysis was performed for each variable. The effectiveness of endovascular revascularization treatment was analyzed using Kaplan-Meier survival curves. Major amputation was performed for 22 of 125 patients. Multivariate logistic regression analysis indicated that DM duration, peripheral arterial occlusive disease (PAOD) previous amputation, abscess, Wagner grade, CRP and albumin were significant risk factors for major amputation in DFU patients. PAOD was the most important risk factor. Major amputation-free survival rate at 5years was 97.4% in a non-PAOD group, 58.3% in a PAOD without revascularization group, and 88.0% in a PAOD with revascularization group, showing statistically significant differences among them. The duration of DM, PAOD, previous amputation, abscess, Wagner grade, CRP and albumin were major risk factors for major LEA in DFU patients. The most valuable and critical finding was that revascularization in diabetic foot patients with PAOD significantly improved major amputation-free survival rates.

Association of Preulcerative Foot Care and Outcomes of Diabetic Foot Ulceration.

The purpose of this study was to determine the association of preulcerative foot care and outcomes of diabetic foot ulcerations (DFUs). This retrospective cohort study using the Mariner all-payers claims data set included participants with a new DFU from 2010 to 2019. Patients were stratified into two cohorts (foot care and control) based on whether they had received any outpatient foot care within 12 months before DFU. Adjusted comparison was performed by propensity matching for age, sex, and the Charlson Comorbidity Index (1:2 ratio). Kaplan-Meier estimates and logistic regression examined the association between foot care and outcomes of DFUs. Of the 307,131 patients in the study cohort, 4.7% (n = 14,477) received outpatient preulcerative foot care within the 12-month period before DFU. The rate of major amputation was 1.8% (foot care, 1.2%), and 9.0% of patients had hospitalizations for foot infection within 12 months after DFU (foot care, 7.8%). In the study cohort, patients who received pre-DFU foot care had greater major amputation-free survival (P < .001) on Kaplan-Meier estimate. In both the study and matched cohorts, multivariable analysis demonstrated that foot care was associated with lower odds of major amputation for both study (odds ratio [OR], 0.56; 95% confidence interval [CI], 0.48-0.66) and matched (OR, 0.61; 95% CI, 0.51-0.72) cohorts, and lower odds of hospitalizations for a foot infection in both study (OR, 0.91; 95% CI, 0.86-0.96) and matched (OR, 0.88, 95% CI, 0.82-0.94) cohorts. Among patients with a new DFU, those who received outpatient preulcerative foot care within 12 months of diagnosis had lower risks of major amputation and hospitalizations for foot infection.

Acupoint transplantation versus non-acupoint transplantation using autologous peripheral blood mononuclear cells in treating peripheral arterial disease.

Numerous studies have discussed the therapeutic outcomes of using cell therapy or acupuncture to treat peripheral artery disease (PAD). However, there are no long-term studies on the safety and efficacy of transplanting peripheral blood mononuclear cells (PBMNCs) via acupoints to treat PAD. We first reviewed the short-term and long-term clinical results of PAD patients treated with PBMNCs through intramuscular non-acupoint transplantation (control group; n = 45) or intramuscular acupoint transplantation (acupoint group; n = 45) at a single university hospital general medical center between December 2002 and September 2022. Pain intensity (assessed with the verbal rating scale [VRS] score) in the acupoint group was considerably lower than that in the control group at month 1 (mean ± standard deviation [SD]: 1.29 ± 0.96 vs 1.76 ± 0.82; P = 0.016) and month 3 (mean ± SD: 1.27 ± 0.90 vs 1.61 ± 0.86; P = 0.042). We observed significant improvement of VRS score (P < .001 for all) and ankle-brachial index (ABI; P < .001 for all) from baseline in both groups at months 1, 3, 6, 12, 36, and 60. The 10-year cumulative rate of major amputation-free survival (MAFS) was higher in the acupoint group as compared to the control group (81.9%, 95% confidence interval [CI]: 71.3%-94.1% vs 78.5%, 95% CI: 66.7%-92.3%; P = 0.768). Compared with the routine injection method, intramuscular transplantation of PBMNCs via selected acupoints could significantly decrease the short-term pain intensity in patients with PAD, which remains an option for consideration.

Abstract 18185: A Multicenter Prospective Trial of Therapeutic Angiogenesis Using Bone Marrow-Derived Mononuclear for Patients With Critical Limb-Threatening Ischemia Caused by Thromboangiitis Obliterans

Background: Thromboangiitis obliterans (TAO) can develop critical limb-threatening ischemia (CLTI). Despite conventional treatments, such as smoking cessation or revascularization, young patients require limb amputation. Therapeutic angiogenesis using bone marrow-derived mononuclear cell (BM-MNC) implantation has demonstrated long-term efficacy and safety in patients with CLTI, particularly those with TAO. To expand BM-MNC implantation in clinical practice, further evidence is required in CLTI patients with TAO. We aimed to determine the efficacy of BM-MNC implantation in a prospective trial. Methods: This multicenter, prospective, interventional trial was performed under an advanced medical care program. We enrolled 22 patients with CLTI and skin perfusion pressure (SPP) &lt;30 mmHg; they underwent BM-MNC implantation within 28 days (Figure.1). The follow-up period was 180 days, and the primary endpoint was an improvement in the SPP value in the affected target limb 180 days after the implantation. One patient dropped out from the follow-up. Results: The mean age was 47.6 years (male: 90.5%, Fontaine classification IV: 57.1%). The SPP value significantly improved on day 180 (p&lt;0.001) (Figure. 2). The secondary endpoints, i.e., numerical rating scale scores and transcutaneous oxygen pressure values significantly improved within day 180. The 3-year major amputation-free and overall survival probability in the safety analysis set were 95.5% and 89.5%, respectively (Figure. 3). No severe adverse events occurred. Conclusions: We believe that the BM-MNC implantation will likely become a feasible and safe therapy for CLTI patients caused by TAO.

Impact of Optimal Medical Therapy on Reintervention and Survival Rates after Endovascular Infrapopliteal Revascularization.

Within this single-center cohort study, we investigated the impact of optimal medical therapy on all-cause mortality, major amputation-free survival and clinically driven target lesion revascularization (CD TLR) in 552 patients with peripheral arterial disease (PAD) undergoing endovascular infrapopliteal revascularization. From the overall cohort, 145 patients were treated for intermittent claudication (IC) and 407 were treated for critical limb ischemia (CLI). Optimal medical therapy (OMT) was defined as the presence of at least one antiplatelet agent, statin and ACE inhibitor or AT-2 antagonist based on guideline recommendations. About half (55.5%) of all patients were prescribed OMT at discharge, with a higher proportion in claudicants (62.1%) versus CLI patients (53.2%). Over three years of follow-up, survival was significantly better in patients with IC (80.6 ± 3.8% vs. 59.9 ± 2.9%; p < 0.001). There was a signal towards better survival in those patients receiving OMT (log-rank p = 0.09). Similarly, amputation-free survival (AFS) was significantly better in patients with IC (p = 0.004) and also in patients receiving OMT (78.8 ± 3.6%) compared to that in those without OMT (71.5 ± 4.2%; p = 0.046). Freedom from CD TLR within three years was significantly better in the IC group (p = 0.002), but there were no statistically significant differences for CD TLR dependent on the presence of OMT (p = 0.79). In conclusion, there is still an important underuse of OMT in patients undergoing infrapopliteal interventions, which is even more pronounced in CLI despite a signal for its benefit regarding all-cause mortality and major amputation-free survival.

The Role of Targeted Infra-popliteal Endovascular Angioplasty to Treat Diabetic Foot Ulcers Using the Angiosome Model: A Systematic Review

Atherosclerotic disease significantly impacts patients with type 2 diabetes, who often present with recalcitrant peripheral ulcers. The angiosome model of the foot presents an opportunity to perform direct angiosome-targeted endovascular interventions to maximise both wound healing and limb salvage. A systematic review was performed, with 17 studies included in the final review. Below-the-knee endovascular interventions present significant technical challenges, with technical success depending on the length of lesion being treated and the number of angiosomes that require treatment. Wound healing was significantly improved with direct angiosome-targeted angioplasty, as was limb salvage, with a significant increase in survival without major amputation. Indirect angioplasty, where the intervention is applied to collateral vessels to the angiosomes, yielded similar results to direct angiosome-targeted angioplasty. Applying the angiosome model of the foot in direct angiosome-targeted angioplasty improves outcomes for patients with recalcitrant diabetic foot ulcers in terms of primary wound healing, mean time for complete wound healing and major amputation-free survival.

Women are Not at Higher Risk for Reintervention or Major Amputation after Lower Extremity Atherectomy for Peripheral Artery Disease

Our objective was to compare short- and long-term differences in reintervention-free and major amputation-free survival between female and male patients undergoing lower extremity atherectomy for peripheral artery disease (PAD). We analyzed lower extremity atherectomy procedures performed on 294 patients between January 2014 and September 2019. Reintervention was defined as either open bypass or endovascular procedure to the same region following the index operation. Kaplan Meier (KM) survival analysis was performed to compare reintervention-free and major amputation-free survival between sexes. Multivariate logistic regression analyses were performed to determine the adjusted odds of reintervention and major amputation based on sex. We conducted subgroup analyses by anatomic region (femoropopliteal vs. tibial), indication (claudication vs. chronic limb-threatening ischemia (CLTI)), and balloon type (drug-coated balloon (DCB) vs. plain balloon angioplasty (POBA)) across sexes. Of the 294 patients, 125 (42.5%) were female. Compared to men, women receiving atherectomy were more likely to be Black (28.0% vs 16.6%; P=0.018), a nonsmoker (44.8% vs. 21.3%; P < 0.001), and present with CLTI (55.2% vs. 43.2%; P=0.042). There were no differences in atherectomy region, lesion type, or balloon type between sexes. KM analysis showed similar 4-year reintervention-free survival (68.8% vs. 75.1%; P=0.88) and major amputation-free survival (97.6% vs. 97.6%; P = 0.41) between sexes. Women and men had similar reintervention-free survival when grouped by femoropopliteal (67.9% vs. 70.8%; P=0.69) or tibial (76.2% vs. 83.9%; P=0.68) atherectomy region. Indication (claudication vs. CLTI) did not affect reintervention-free survival in either women (64.5% vs. 69.6%; P=0.28) or men (68.5% vs. 76.7%; P=0.84). KM curves for DCB vs. POBA were also similar between sexes and showed an early benefit in reintervention rate favoring DCB, which dissipated in both women (65.4% vs 72.7%; P=0.61) and men (75.5% vs. 78.4%; P=0.18) by 3 years. Compared to men, women demonstrate commensurate benefit from atherectomy for lower extremity revascularization. There were no differences seen in long-term reintervention or major amputation between sexes.

Interruption of Insurance Coverage and the Risk of Amputation in Patients with Pre-Existing Commercial Health Insurance and Peripheral Artery Disease

Peripheral artery disease (PAD) is linked with an increased risk of lower extremity amputation and multiple socioeconomic factors attenuate this risk. Prior studies have demonstrated increased rates of amputation in PAD patients with suboptimal or no insurance coverage. However, the impact of insurance loss in PAD patients with pre-existing commercial insurance coverage is unclear. In this study, we evaluated the outcomes of PAD patients who lose commercial insurance coverage. The Pearl Diver all-payor insurance claims database was used to identify adult patients (>18years) with a PAD diagnosis from 2010 to 2019. The study cohort included patients with pre-existing commercial insurance and at least 3years continuous enrollment after diagnosis of PAD. Patients were stratified based on whether they had an interruption of commercial insurance coverage over time. Patients who transitioned from commercial insurance to Medicare and other government-sponsored insurance during follow up were excluded. Adjusted comparison (1:1 ratio) was performed using propensity matching for age, gender, the Charlson Comorbidity Index (CCI), and relevant comorbidities. The main outcomes were major amputation and minor amputation. Cox proportional hazards ratios and Kaplan-Meier estimate were used to examine the association between loss of insurance and outcomes. Among the 214,386 patients included, 43.3% (n=92,772) had continuous commercial insurance coverage and 56.7% (n=121,614) had interruption of coverage (transition to uninsured or Medicaid coverage) during follow up. In the crude cohort and matched cohort, interruption of coverage was associated with lower major amputation-free survival on Kaplan Meier estimate (P<0.001). In the crude cohort, interruption of coverage was associated with 77% increased risk of major amputation (OR 1.77, 95% CI 1.49-2.12) and a 41% high risk of minor amputation (OR 1.41, 95% CI 1.31-1.53). In the matched cohort, interruption of coverage was associated with 87% increased risk of major amputation (OR 1.87, 95% CI 1.57-2.25) and a 104% increased risk of minor amputation (OR 1.47, 95% CI 1.36-1.60). Interruption of insurance coverage in PAD patients with pre-existing commercial health insurance was associated with increased risks of lower extremity amputation.

Label extension, single-arm, phase III study shows efficacy and safety of stempeucel® in patients with critical limb ischemia due to atherosclerotic peripheral arterial disease

BackgroundPeripheral arterial disease (PAD) of lower extremities comprises a clinical spectrum that extends from asymptomatic patients to critical limb ischemia (CLI) patients. 10% to 40% of the patients are at the risk of primary amputation. This study was planned in “no-option” patients of CLI due to atherosclerotic PAD to assess the efficacy and safety of pooled, allogeneic, adult human bone marrow-derived mesenchymal stromal cells which is already approved for marketing in India for CLI due to Buerger’s disease.MethodsThis was a single-arm, multi-centric, phase III study where mesenchymal stromal cells was injected as 2 million cells/kg body weight in the calf muscle and around the ulcer. Twenty-four patients of lower extremity CLI due to PAD with Rutherford III-5 or III-6 and ankle–brachial pressure index ≤ 0.6 and having have at least one ulcer with area between 0.5 and 10 cm2 were included in the study. These patients were evaluated over 12 months from drug administration.ResultsOver a period of 12 months, statistical significant reduction of rest pain and ulcer size along with improvement in ankle–brachial pressure index and ankle systolic was observed. The quality of life of patients improved together with increase in total walking distance and major amputation-free survival time.ConclusionMesenchymal stromal cells may be a feasible option to treat “no-option” patients with atherosclerotic PAD.Trial registration This study is registered prospectively in National Institutes of Health and Clinical Trials Registry—India (CTRI) website: CTRI/2018/06/014436. Registered 6th June 2018. http://ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=24050&EncHid=&userName=stempeutics.

Trends and outcomes associated with intravascular ultrasound use during femoropopliteal revascularization in the Vascular Quality Initiative

ObjectiveIntravascular ultrasound (IVUS) use in lower extremity interventions is growing in popularity owing to its imaging in the axial plane, superior detail in imaging lesion characteristics, and its enhanced ability to delineate lesion severity and extent compared with catheter angiograms. However, there are conflicting data regarding whether IVUS affects outcomes. The purpose of this study was to assess the effect associated with IVUS implementation in femoropopliteal interventions. MethodsThis retrospective cohort study used Vascular Quality Initiative data. Patients undergoing an index endovascular femoropopliteal revascularization from 2016 to 2021 were included. Patients were differentiated by whether or not IVUS was used to assess the femoropopliteal segment during intervention (no IVUS, IVUS). Propensity score matching, based on preoperative demographics and measures of disease severity was used. Primary outcomes were major amputation-free survival (AFS), femoropopliteal reintervention-free survival (RFS), and primarily patent survival (PPS) at 12 months. ResultsIVUS use grew steadily throughout the study period, comprising 0.6% of interventions in 2016 and increasing to 8.2% of interventions by 2021; growth was most dramatic in ambulatory surgical center or office-based laboratory settings where IVUS use grew from 4.4% to 43% to 47% of interventions. In unmatched cohorts, patients receiving interventions using IVUS tended to have lower prevalence of multiple cardiovascular comorbidities (eg, congestive heart failure, hypertension, diabetes, and dialysis dependence) and presented more often with claudication and less often with chronic limb-threatening ischemia (CLTI). Intraoperatively, IVUS was used more often in complex femoropopliteal lesions (Transatlantic Intersociety grade D vs A), and more often in conjunction with stenting and/or atherectomy. IVUS use was associated with improved AFS, but similar RFS and PPS at 12 months. However, in multivariable analysis IVUS was not associated with any of the primary outcomes independently; rather, all outcomes were influenced primarily by CLTI, dialysis dependence, and prior major amputation status; technical outcomes (ie, RFS and PPS loss) were further driven by complexity of lesion (worse in Transatlantic Intersociety grade D vs A lesions) and treatment setting (ie, ambulatory surgical center or office-based laboratory setting associated with increased hazard for RFS and PPS loss). ConclusionsIVUS implementation in femoropopliteal interventions is growing, with rapid adoption among interventions in ambulatory surgical centers and office-based laboratories. IVUS was not associated with an effect on technical outcomes at 12 months; improvement in major AFS was observed; however, multivariable analysis suggests this finding may be an effect of confounding by multiple factors highly associated with IVUS use, namely, in patients with lower prevalence of CLTI, dialysis dependence, and prior major amputations, thus conveying baseline lower risk for major amputation and death.

Retrospective cohort study of long-term outcomes and prognostic factors for survival after lower extremity amputation in patients with diabetes

AimsLower extremity amputation (LEA) is a pivotal event for patients with diabetes. This study aimed to provide updated data on the outcomes and prognostic factors after LEA for patients with diabetes. MethodsThis retrospective cohort study included all LEAs (n = 1081) performed at Tampere University Hospital between February 2007 and September 2020. Overall survival (OS) and major amputation-free survival were evaluated. ResultsIndex amputation level was below ankle in 65 % (n = 704) of patients, below knee in 14 % (n = 154) of patients, and above knee in 21 % (n = 223) of patients. In the whole population, OS was 75.8 % (CI 95 %: 73.3–78.3) at one year and 38.3 % (CI 95 %: 34.7–41.7) at five years. Higher age, peripheral artery disease (PAD), more proximal amputation level, and lower glomerular filtration rate (GFR) reduced OS. Multiple amputations and diagnosed dyslipidemia or hypertension associated with improved OS. Further, age, PAD, and GFR were identified as significant factors for major amputation free survival. ConclusionsOS after LEA is poor. After major amputation, the risk for death is higher compared to minor amputation. Recurrent amputation is associated with improved OS. Further, ischemia and renal disease are significant factors for inferior OS.

Application value of excimer laser ablation combined with drug-coated balloon in non-stent atherosclerotic lesions of lower extremity arteries

Objective: To examine the effect of excimer laser ablation (ELA) combining with drug-coated balloon (DCB) for atherosclerotic lesions in no-stenting zones (NSZ) of the lower extremity. Methods: From June 2019 to December 2021, 46 patients who underwent ELA combining with DCB in lesions of NSZ at Zhongshan Hospital, Fudan University and Jinshan Hospital, Fudan University were retrospectively enrolled, including 29 males and 17 females. The age was (72.5±11.7) years (range: 42 to 93 years). Among them, 44 lesions (95.7%, 44/46) were in popliteal artery and 2 lesions (4.3%, 2/46) were in common femoral artery. Chronic total occlusion (CTO) was observed in 31 patients (76.4%, 31/46), and stenotic lesions were observed in 15 patients (32.6%, 15/46). The length of lesions was (7.3±2.7) cm (range: 3.0 to 13.2 cm). Patients were followed at 6, 12 months after surgery and every year thereafter, and they underwent Doppler and CT angiography examination at each follow-up point. The primary endpoint was primary patency. The secondary endpoints included major amputation-free survival (MAFS) rate, technical success, bailout stent, ankle-brachial index (ABI), target lesion reintervention (TLR). Student t test was applied to compare the difference between ABI of 6 or 12 months after surgery and the baseline. Primary patency, freedom from TLR, and MAFS rate were calculated by Kaplan-Meier method. Results: The technical success rate was 91.3% (42/46). The rate of procedure-related complication was 6.5% (3/46), and all the complications were distal embolization. The rate of flow-limiting dissection was 8.7% (4/46). ABI was significantly increased at 6 and 12 months compared to preoperatively (0.90±0.10 vs. 0.42±0.10, t=-4.48, P<0.01; 0.87±0.12 vs. 0.42±0.10, t=-5.21, P<0.01). The follow-up time[M(IQR)] was 22.5 (8.8) months (range: 6 to 32 months). TLR was performed in 4 patients (4/46, 8.7%). The 2-year primary patency was 86.2% (95%CI: 71.8% to 93.5%). The 2-year freedom from TLR and MAFS rate were 90.7% (95%CI: 77.0% to 96.4%) and 97.8% (95%CI: 85.6% to 99.7%), respectively. Conclusion: ELA combining with DCB can be applied to treat atherosclerotic lesions in NSZ.

Cancer should not contravene the revascularization of chronic limb-threatening ischaemia.

This study aimed to examine the frequency of cancer among patients with chronic limb-threatening ischaemia (CLTI) due to peripheral artery disease (PAD) and to determine how active cancer affected outcomes after open or endovascular revascularization. In addition, we aimed to investigate all-cause mortality and cause of death in the PAD population. Observational single-centre cohort study based on a retrospective analysis of prospectively entered registry data. All consecutive patients treated for CLTI due to PAD at a single university centre between the 1st of January 2011 and the 31st of December 2015 were included. Data from the Danish Vascular Registry (Karbase) regarding demographics, surgical procedure, and complications were linked with data from the Danish Cancer Registry and Cause of Death Registry. The primary endpoint was major amputation-free survival. Secondary endpoints were postoperative complications within 30 days, cancer-free survival, all-cause mortality and cause of death in the cohort. Major amputation-free survival, cancer-free survival and mortality were described with Kaplan-Meier (KM) survival estimates. We included 920 patients, of which 116 (13%) were in the active cancer group at the time of revascularization. There was no difference in amputation-free survival between those with cancer (86.8% 1-year KM estimate) and those without cancer (85.2% 1-year KM estimate) (p = 0.50). Likewise, we found no difference in 30-day postoperative complication rate. The risk of developing cancer in the included CLTI cohort was similar to the age-matched background population (6.1% vs 6.4%) (p = 0.69). All-cause mortality was higher in CLTI patients with cancer, mainly due to cancer, compared with CLTI patients without cancer who mainly died from cardiovascular disease. Three-year KM survival estimates were 48.3% (95% CI 40.0%-58.3%) and 64.4% (95% CI 61.2%-67.8%) (p = 0.014) for cancer and non-cancer patients, respectively. Although cancer in patients with CLTI is related to higher medium- to long-term mortality, active cancer per se should not contravene revascularization, as postoperative complications and risk of amputation are not overrepresented.

Women Are Not at Higher Risk for Reintervention or Major Amputation After Lower Extremity Atherectomy for Peripheral Arterial Disease

Our objective was to compare short- and long-term differences in reintervention-free and major amputation-free survival between female and male patients undergoing lower extremity atherectomy for peripheral arterial disease.

Adherence to General Diabetes and Foot Care Processes, with Prompt Referral, Are Associated with Amputation-Free Survival in People with Type 2 Diabetes and Foot Ulcers: A Scottish National Registry Analysis.

Aims To compare different packages of care across care providers in Scotland on foot-related outcomes. Methods A retrospective cohort study with primary and secondary care electronic health records from the Scottish Diabetes Registry, including 6,845 people with type 2 diabetes and a first foot ulcer occurring between 2013 and 2017. We assessed the association between exposure to care processes and major lower extremity amputation and death. Proportional hazards were used for time-to-event univariate and multivariate analyses, adjusting for case-mix characteristics and care processes. Results were expressed in terms of hazard ratios with 95% confidence intervals. Results 2,243 (32.7%) subjects had a major amputation or death. Exposure to all nine care processes at all ages (HR = 0.63; 95% CI: 0.58-0.69; p < .001) and higher foot care attendance in people aged >70 years (HR = 0.88; 0.78-0.99; p = .03) were associated with longer major amputation-free survival. Waiting time ≥ 12 weeks between ulceration and clinic attendance was associated with worse outcomes (HR = 1.59; 1.37-1.84; p < .001). In people > 70 years, minor amputations were associated with improved major amputation-free survival (HR = 0.69; 0.52-0.92; p = .01). Conclusions Strict adherence to a standardised package of general diabetes care before foot ulceration, timely foot care after ulceration, and specific treatment pathways were associated with longer major amputation-free survival among a large cohort of people with type 2 diabetes in Scotland, with a larger impact on older age groups.

Safety and Effectiveness of Excimer Laser Ablation Combined With Drug-Coated Balloon for Atherosclerotic Obliterans in the Lower Extremity.

To evaluate the safety and effectiveness of excimer laser ablation (ELA) combined with drug-coated balloon (DCB) for atherosclerotic obliterans (ASO) of the lower extremities. From June 2019 to December 2020, all eligible patients were enrolled. Demographics, characteristics of lesions, complications, and follow-up information were collected and analyzed. The primary endpoint was major amputation-free survival (MAFS). Secondary endpoints included technical success, primary patency, bailout stent, distal embolization, target lesion reintervention (TLR), and ulcer healing rate. Major amputation-free survival and primary patency were calculated by Kaplan-Meier analysis. A total of 71 patients were enrolled. Forty-eight (81.7%) patients presented critical limb ischemia (CLI) and 48.6% of them was calcification class 4 according to Peripheral Arterial Calcium Scoring System (PACSS). Chronic totally occluded (CTO) disease was the most common lesion in 66.0% of them and superficial femoral artery (SFA) was the most common segment in 59.6%. Technical success rate was 93.0%. One-year follow-up was finished in 25 (35.2%) patients. The primary patency and MAFS were 92.0%±27.6% and 96.0%±20.0% at 12 months, respectively. During the mean follow-up of 9.4±4.3 months, clinically-driven TLR occurred in 2 (2.8%) patients, and major and minor amputation occurred in 2 (2.8%) and 1 (1.4%) patient, respectively. The early results demonstrated that ELA was an effective treatment in de novo, in-stent restenosis (ISR) and CTO lesions. Meanwhile, ELA could prepare the lumen for the use of DCB and reduce the implantation of stents, especially in segments unsuitable for stenting. Mid-term and long-term results need to be awaited.

The peripheral blood mononuclear cells versus purified CD34+ cells transplantation in patients with angiitis-induced critical limb ischemia trial: 5-year outcomes and return to work analysis\u2014a randomized single-blinded non-inferiority trial

BackgroundsPatients with AICLI constitute a considerable proportion of NO-CLI patients and cannot be treated with surgical or endovascular treatment. Although cell therapy has shown satisfactory results in treating AICLI, research comparing the efficacy of treatment with the 2 kinds of cell products is rare. The aim of this study was to report the 5-year outcomes of a randomized single-blinded noninferiority trial (Number: NCT 02089828) on peripheral blood mononuclear cells (PBMNCs) and purified CD34+ cells (PCCs) transplantation for treating angiitis-induced critical limb ischemia (AICLI).MethodsA randomized single-blinded non-inferiority trial (Number: NCT 02089828) was performed. Fifty patients were randomized 1:1 to the PBMNCs and PCCs groups. Efficacy outcomes, safety outcomes and patients’ work conditions were analyzed. The primary efficacy outcomes included major amputation and total amputation over 60 months.ResultsDuring the 60-month follow-up, 1 patient was lost to follow-up, 1 died, and 2 underwent major amputation. The major amputation-free survival rate (MAFS) was 92.0% (95% confidence interval [CI] 82.0%-100.0%) in the PBMNCs group and 91.7% (95% CI 81.3%-100.0%) in the PCCs group (P = 0.980). Compared with the PCCs group, the PBMNCs group had a significantly higher 5-year new lesion-free survival rate (100.0% vs. 83.3% [95% CI 69.7–99.7%], P = 0.039). All patients lost their ability to work before transplantation, and the 5-year cumulative return to work (RTW) rates were 88.0% in the PBMNCs group and 76.0% in the PCCs group (P = 0.085).ConclusionThe long-term follow-up outcomes of this trial not only demonstrated similar efficacy and safety for the 2 types of autoimplants but also showed a satisfactory cumulative RTW rate in AICLI patients who underwent cell transplantation.Trial registration: ClinicalTrials.gov, number NCT 02089828. Registered 14 March 2014, https://clinicaltrials.gov/ct2/show/record/NCT02089828.

Angiosome-Guided Endovascular Revascularization for Treatment of Diabetic Foot Ulcers with Peripheral Artery Disease

Because diabetic foot ulcers (DFUs) are difficult to heal and cause huge economic losses to the society, accelerating their healing has become extremely important. The purpose of this study was to evaluate the effect of revascularization based on the angiosome concept on DFU. Between January 2018 and July 2020, 112 consecutive legs with DFUs, in 111 patients who were discharged from the vascular surgery department of our hospital were retrospectively evaluated. The legs were assigned to two groups depending on whether direct arterial flow to the foot ulcer based on the angiosome concept was achieved. Comparisons of the ulcer healing rate, mean time to ulcer healing, major amputation rate, survival rate, and major amputation-free survival rate between the angiosome direct revascularization (DR) and angiosome indirect revascularization (IR) groups were performed. DR was achieved in 71 legs (63%) compared with IR in 41 legs. The ulcer healing rate (70.4% in the DR group versus 34.1% in the IR group, P<0.01), the mean time to ulcer healing (7.01±4.26months versus 10.09±3.24months, P<0.01), the survival rate (90.1 vs. 53.7%, P<0.01), and the major amputation-free survival rate (81.7 vs. 48.8%, P<0.01) were significantly higher in the DR group than in the IR group. Undergoing DR did not significantly reduce the major amputations rate compared to IR (13.4 and 34.1%, respectively, P=0.15), but there might be a trend. In multivariate models, DR remained a significant predictor for ulcer healing (HR, 7.07; 95% confidence interval (CI), 6.54-7.60, P<0.01). Opening multiple infrapopliteal arteries in the DR group compared with restoring only one infrapopliteal artery did not significantly improve the ulcer healing rate (P=0.59), the mean time to ulcer healing (P=0.70), major amputation rate (P=0.83), the survival rate (P=0.31), and the major amputation-free survival rate (P=0.40). Attaining a direct arterial flow based on the angiosome concept may be important for ulcer healing, survival, and amputation-free survival in diabetic foot patients. Opening multiple infrapopliteal arteries in DR patients may not improve the ulcer healing, survival, major amputation or amputation-free survival compared with single DR vessel patency.