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

BACKGROUND: The 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. METHODS: From 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 rate, technical success, bailout stenting, clinically-driven target lesion reintervention, improvement of ankle-brachial index (ABI), and Rutherford class. RESULTS: A 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. The mean length of these lesions 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%. CONCLUSIONS: ELA 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.

Prognostic Implications of Initial Focal Contrast Enhancement in Acute Type B Intramural Hematoma.

BACKGROUND: The prognostic implication of initial focal contrast enhancement (FCE), including focal intimal disruption (FID) and intramural blood pool (IBP), in acute type B intramural hematoma (IMH) remain unclear. OBJECTIVES: The purpose of this study was to compare the prognostic implications in IMH with or without FCE. METHODS: A total of 574 patients were enrolled. FID was defined as an intimal disruption with contrast-filled out-pouching from the aorta lumen with a communicating orifice of >3 mm, and IBP was defined as a localized contrast medium-filled pool inside the IMH. RESULTS: A total of 207 (36.1%) patients with initial FCE, including 132 (63.8%) FIDs and 75 (36.2%) IBPs, were identified. Patients with FCE accompanying IMH were more likely to have hypertension (P = 0.001), pleural effusion (P = 0.006), fewer aortic segments involved (P < 0.001), more adverse aortic events (AAEs) (P < 0.001), and fewer freedom from intervention (P = 0.002). Pleural effusion (HR: 1.79; 95% CI: 1.25-2.55; P = 0.001) and FCE (HR: 1.51; 95% CI: 1.12-2.02; P = 0.006) were identified to be the independent risk factors of AAEs. In the subgroup analysis, IMH with initial FID were more likely to progress than those with initial IBP (P < 0.001). FIDs located at the proximal descending aorta (HR: 2.95; 95% CI: 1.65-5.29; P < 0.001) were associated with AAEs. CONCLUSIONS: Patients with FCE accompanying IMH were more likely to progress, especially in those initial FID localized at the proximal descending aorta. (Nature course and predictors of progression of intramural hematoma: A retrospective, multicenter study; ChiCTR2300073829).

Towards biomechanics-based pre-procedural planning for thoracic endovascular aortic repair of aortic dissection.

BACKGROUND AND OBJECTIVE: Although thoracic aortic endovascular repair (TEVAR) has shown promising outcomes in the treatment of patients with complicated type B aortic dissection, complications still occur after TEVAR that can lead to catastrophic events. Biomechanical interactions between the stent-graft (SG) and the local aortic tissue play a critical role in determining the outcome of TEVAR. Different SG design may cause different biomechanical responses in the treated aorta, but such information is not known at the time of pre-procedural planning. By developing patient-specific virtual stent-graft deployment tools, it is possible to analyse and compare the biomechanical impact of different SGs on the local aorta for individual patients. METHODS: A finite element based virtual SG deployment model was employed in this study. Computational simulations were performed on a patient-specific model of type B aortic dissection, accounting for details of the SG design and the hyperelastic behaviour of the aortic wall. Based on the geometry reconstructed from the pre-TEVAR CTA scan, the patient-specific aortic dissection model was created and pre-stressed. Parametric models of three different SG products (SG1, SG2 and SG3) were built with two different lengths for each design. The SG models incorporated different stent and graft materials, stent strut patterns, and assembly approaches. Using our validated SG deployment simulation framework, virtual trials were performed on the patient-specific aortic dissection model using different SG products and varying SG lengths. CONCLUSION: Simulation results for different SG products suggest that SG3 with a longer length (SG3-long) would be the most appropriate device for the individual patient. Compared to SG1-short (the SG deployed in the patient), SG3-long followed the true lumen tortuosity closely, resulted in a more uniform true lumen expansion and a significant reduction in peak stress in the distal landing zone. These simulation results are promising and demonstrate the feasibility of using the virtual SG deployment model to assist clinicians in pre-procedural planning.

Predictors of Return to Work After Thoracic Endovascular Aortic Repair in Patients With Type B Aortic Dissection.

OBJECTIVE: Type B aortic dissection (TBAD) is a life-threatening condition, and it takes heavy burden to family and society. Return to work (RTW) not only means patients' physical health but also demonstrates their mental well-being. Thoracic endovascular aortic repair (TEVAR) has been successful in treatment of TBAD patients. However, less studies have addressed on the social functional recovery of TBAD after TEVAR, especially for RTW. METHODS: From January 1, 2017 to January 1, 2021, TBAD patients who underwent TEVAR and completed a 12-month follow-up were retrospectively enrolled. Primary outcome was RTW. Patients' demographic, sociological, and clinical characteristics, and so on were recorded to analyze and demonstrate independent risk factors for RTW. RESULTS: Four hundred thirty-two TBAD patients (388 males) were enrolled with a mean age of 48.3±8.9 years (ranged from 19 to 60 years). The 12-month cumulative RTW rate was 62.7% (95% confidence interval [CI]: 57.2%-67.8%). Age <50 years (odds ratio [OR]=3.675, 95% CI: 1.436-9.405) was identified as independent protective factors for RTW, while preoperative job as manual workers (OR=0.101, 95% CI: 0.029-0.353), average annual income, <30 000 Chinese Yuan (CNY) [<4400 US dollar], (OR=0.186, 95% CI: 0.054-0.637), complicated TBAD (malperfusion) (OR=0.246, 95% CI: 0.092-0.659), and distal stent graft-induced new entry (SINE) (OR=0.218, 95% CI: 0.083-0.575, p=0.002) were identified as independent risk factors. CONCLUSION: Approximately 64% of our patients were able to RTW in the 12 months post-TEVAR for TBAD. Younger patients, patients with less physically demanding jobs, and patients with less complex surgeries were more likely to RTW. Based on these results, more can be done to facilitate the patient's ability and willingness to RTW after TEVAR. CLINICAL IMPACT: Type B aortic dissection (TBAD) is a life-threatening condition that poses significant burden on both individuals and society. The ability to return to work (RTW) not only reflects the patient's physical health but also indicates their mental well-being. Therefore, identifying risk factors for RTW and promoting the reintegration of TBAD patients into the workforce is crucial in clinical practice.To our knowledge, this study is the first to elucidate and predict the RTW outcomes of TBAD patients who underwent thoracic endovascular aortic repair (TEVAR).

Long-term outcomes of endovascular treatment for aortic pseudoaneurysm in patients with Behçet's disease.

OBJECTIVES: Behçet's disease (BD) is a multisystem inflammatory disorder with unknown etiology, and its aneurysmal lesions are associated with high mortality due to the high risk of rupture. This study intended to further explore the long-term safety and efficacy of endovascular therapy for BD-related aortic pseudoaneurysm (BAP). METHODS: From January 2009 to May 2021, 17 BAP patients who underwent endovascular repair were retrospectively identified and enrolled. Adequate immunosuppressive treatment was instituted before and after endovascular treatment unless emergency surgery was required. The patients were followed up at 3, 6, and 12 months and yearly after the primary endovascular intervention by computed tomography angiography (CTA) examination. RESULTS: Nineteen BAPs were identified among 17 patients. BAPs located at the aortic arch were found in three patients (17.6%), descending thoracic aorta in 5 (29.4%), and abdominal aorta in 10 (58.8%; suprarenal abdominal aorta in 2 [11.8%], and infrarenal abdominal aorta in 8 [47.1%]). The mean ESR during admission was 56.5 ± 24.9 mm/h (range = 30.0-120.0 mm/h), which fell to 22.7 ± 18.4 mm/h (range = 2.0-74.0 mm/h) before the endovascular intervention (p < 0.001). The rate of favorable immunosuppressive control before intervention is 76.5% (13/17). Technical success was achieved in all patients. Median follow-up time was 57.0 months (interquartile range [IQR] = 21.3-67.3 months). Pseudoaneurysm recurrence was observed in four patients, type I endoleak in one, pseudoaneurysms sac dilation in one, and external iliac artery occlusion in 1. Two patients died of pseudoaneurysm rupture. Five-year accumulated overall rate, recurrence-free rate, and reintervention-free survival rate of BAP patients were 92.8%, 75.4%, and 71.8%, respectively. CONCLUSION: Endovascular treatment in BAP patients seemed to be associated with long-term safety and efficacy with a 5-year overall survival rate of 92.8%. Adequate immunosuppressive treatment was essential for BAP patients to prevent aortic pseudoaneurysm recurrence and improve the prognosis.

Outcomes of endovascular therapy for Stanford type B aortic dissection in patients with Marfan syndrome.

OBJECTIVE: To evaluate the mid-term outcomes of thoracic endovascular aorta repair (TEVAR) for Stanford type B aortic dissection (TBAD) in patients with Marfan syndrome (MFS). METHODS: Between January 2009 and December 2019, patients with MFS who underwent TEVAR for TBAD were enrolled. Demographic data, preoperative and perioperative clinical profiles, and follow-up data were collected and analyzed. The cumulative survival and freedom from reintervention rates were calculated with Kaplan-Meier analysis. RESULTS: A total of 26 patients were enrolled. The mean age was 38.5 ± 10.7 (range, 24-64 years). The in-hospital mortality was 0. The cumulative survival rate was 88.1% (95% confidence interval [CI], 67.5%-98.5%) at 5 years and 82.9% (95% CI, 60.2%-93.3%) at 10 years. Patients with a thrombosed false lumen (FL) along the length of the stent had a significantly higher cumulative survival rate (P < .05) and freedom from reintervention (P = .01) than patients with patent FL. The freedom from reintervention was 83.4% (95% CI, 61.4% to 93.4%) at 5 years and 50.3% (95% CI, 21.4%-97.3%) at 10 years. There was no significant difference freedom from reintervention in freedom from reintervention between patients with and those without a previous aortic root procedure (P = .46). CONCLUSIONS: TEVAR can be performed safely and effectively for TBAD in patients with MFS. Perioperative mortality and morbidity were low; however, lifelong close follow-up in the clinic and imaging are mandatory to prevent aortic rupture. Patients with a patent FL were at high risk of late death.

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

PURPOSE: 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. MATERIALS AND METHODS: 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. RESULTS: 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. CONCLUSION: 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.

Results of Excimer Laser Ablation Combined with Drug-Coated Balloon for Atherosclerotic Obliterans of Lower Extremity and Risk Factors for Loss of Primary Patency.

BACKGROUND: The results of excimer laser ablation (ELA) combining with drug-coated balloon (DCB) in the treatment for atherosclerotic obliterans (ASO) remains unclear. METHODS: Retrospectively enrolled patients who underwent ELA combined with DCB in 2 centers. The primary endpoint was primary patency, and secondary endpoints included technical success, procedure-related complications, major amputation, clinically driven target lesions reintervention (CD-TLR), measurements of ankle-brachial index (ABI), and quality of life (QoL). RESULTS: 102 patients were enrolled. The primary patency was 86.7% (95% confidence interval [CI]: 72.9%-89.0%) at 12 months and 82.6% (95% CI: 78.2%-92.1%) at 24 months. The freedom from reintervention was 87.8% (95% CI: 79.5%-92.9%) at 12 months and 86.6% (95% CI: 78.1%-92.0%) at 24 months. The ABI measurement and QoL were significantly improved at each follow-up point. Sixteen (15.7%) patients lost the primary patency. Patients losing the primary patency demonstrated higher Rutherford class (P = 0.004), worse runoff (P < 0.001), higher Peripheral Arterial Calcium Scoring System (PACSS) (P < 0.001), and smaller ratio of tube diameter to reference vessel diameter (TD/RVD) (P < 0.001) compared with patients without losing it. The run-off ≥7 (adjusted odds ratio [aOR]: 34.3; 95% CI: 2.9-398.3; P = 0.005) and TD/RVD <4.9 (aOR: 24.7; 95% CI: 1.7-359.5; P = 0.019) were independent risk factors for loss of primary patency. CONCLUSIONS: ELA combined with DCB seemed an effective and safe treatment for ASO of lower extremity, and it could not only reduce the implantation of stent but significantly improve QoL. The run-off ≥7 and TD/RVD <4.9 were independent risk factors for loss of primary patency.

Long-Term Outcomes of Chronic Type B Aortic Dissection Treated by Thoracic Endovascular Aortic Repair.

Background The treatment of chronic type B aortic dissection by thoracic endovascular aortic repair has some challenges, and its long-term outcomes remain unclear. This study aimed to analyze the 5-year clinical outcomes of thoracic endovascular aortic repair of chronic type B aortic dissection, compare the differences between patients with and without adverse aortic events (AAEs), and identify risk factors for AAEs. Methods and Results Patients who underwent thoracic endovascular aortic repair of chronic type B aortic dissection from January 2009 to June 2017 were retrospectively enrolled. The primary end points were AAEs, including aorta-related death, procedural complications, and disease progression requiring reintervention. Clinical outcomes were described at the 5-year follow-up visit. The secondary end point was the comparison of the results between patients with and without AAEs. Univariable and multivariable logistic analyses were used to identify potential risk factors for AAEs. A total of 214 patients were enrolled. AAEs occurred in 46 (21.5%) patients. Compared with patients without AAEs, those with AAEs had higher rates of residual type A aortic dissection (26.1% versus 4.2%, P<0.001) and aortic diameter ≥5.5 cm (69.6% versus 11.3%, P<0.001), and a lower rate of complete false lumen thrombosis (23.9% versus 89.9%, P<0.001). Meanwhile, the median interval from symptom onset to intervention was longer in patients with AAEs (26 months versus 12 months, P=0.004). Partial or no false lumen thrombosis (adjusted odds ratio [AOR], 14.71 [95% CI, 5.67-38.14; P<0.001]) and aortic diameter ≥5.5 cm (AOR, 10.16 [95% CI, 3.86-26.73; P<0.001]) were identified as independent risk factors for AAEs. Conclusions While thoracic endovascular aortic repair of chronic type B aortic dissection might be challenging in some cases, its long-term outcomes appeared promising as this treatment was effective in preventing catastrophic aortic events. Patients with AAEs showed higher rates of residual type A aortic dissection and aortic diameter ≥5.5 cm, a lower rate of complete false lumen thrombosis, and a longer median interval from symptom onset to intervention. Failure of complete false lumen thrombosis and an aortic diameter ≥5.5 cm were predictors of AAEs.

Excimer laser ablation combined with drug-coated balloon versus drug-coated balloon in the treatment of de novo atherosclerotic lesions in lower extremities (ELABORATE): study protocol for a real-world clinical trial.

BACKGROUND: The efficacy and validity of excimer laser ablation (ELA) in the in-stent restenosis (ISR) has been confirmed. However, its application in de novo atherosclerotic lesions of lower extremity artery disease (LEAD) has not been clearly defined and its procedure has not been standardized. METHODS: ELABORATE is a prospective, multicenter, real-world study designed to evaluate the efficacy and safety between ELA combined with drug-coated balloon (DCB) and DCB alone in de novo atherosclerotic lesions of LEAD. DISCUSSION: ELABORATE is a prospective, multicenter, real-world study designed to assess the efficacy and safety between ELA combined with drug-coated balloon (DCB) and DCB alone in patients with de novo atherosclerotic lesions of LEAD. According to the real-world situation, eligible patients will be allocated to ELA + DCB group (group E) and DCB group (group C). Baseline and follow-up information (at 3, 6, and 12 months) will be collected. The primary efficacy point is primary patency at 12-months, and the secondary efficacy points include clinically driven target lesion reintervention (CD-TLR), change of Rutherford class, ankle-brachial index and ulcer healing rate. These indexes will be assessed and recorded at 3, 6, and 12-month follow-up. Also, safety evaluation, including major adverse event, all-cause mortality through 30-day follow-up, unplanned major amputation, bailout stent and distal embolization, will also be evaluated by an independent core laboratory. All the data will be collected and recorded by the electric data capture system. This study will be finished in 3 years and the 12-month results will be available in 2023. All the patients will be followed for 5 years. Trial registration number Chinese Clinical Trial Registry (ChiCTR2100051263). Registered 17 September 2019. http://www.chictr.org.cn/listbycreater.aspx .

Material parameter identification of the proximal and distal segments of the porcine thoracic aorta based on ECG-gated CT angiography.

Vessel wall material parameters are important in biomechanical research. The purpose of this study was to identify the material parameters of two porcine thoracic aortic segments and verify the accuracy of the identification results with uniaxial tensile testing. Principal component analysis (PCA) was used to reduce the dimensionality of the stress matrix. Data points in PCA space were initially screened by K-means cluster analysis, and connection networks of two levels were constructed based on the distance between the data points. The material parameters corresponding to the data points were substituted, and pressure was applied to convert the diastolic models to systolic models to match those reconstructed from electrocardiographic (ECG) gated computed tomography angiography (CTA), and determine the optimal material parameters. The proximal and distal segments of the thoracic aorta were selected for uniaxial tensile testing, and the stress-strain curves obtained from numerical simulations and experiments were compared. The average distances between the simulated systolic proximal and distal segments and their corresponding systolic models reconstructed from the ECG-gated-CTA were 0.388 mm and 0.257 mm, respectively. The fit goodness of the stress-strain data obtained by two methods was 0.9953 and 0.9750, respectively, with equivalent elastic moduli differences of 1.08% and 0.36%. Thus, a material parameter screening method for different aortic segments was proposed and its accuracy was verified experimentally with good consistency. This method is expected to provide a theoretical basis for biomechanical studies of aortic diseases.

Single-Cell Sequencing of Immune Cells in Human Aortic Dissection Tissue Provides Insights Into Immune Cell Heterogeneity.

Background: Inflammation plays an important role in the progression of sporadic aortic dissection (AD). Immune cells, especially macrophages, infiltrate the aorta and secrete inflammatory cytokines and matrix metalloproteinases to cause degradation of the extracellular matrix, thereby contributing to the pathogenesis of AD. However, the cellular heterogeneity within these immune cells has not been fully characterized. Methods: We used single-cell RNA sequencing to profile the transcriptomes of all immune cells in AD tissue and normal aorta. Using magnetic-activated cell sorting gating on CD45, we obtained a higher resolution identification of the immune cell subsets in the aorta. Results: We observed significant differences in the proportion of major immune cell subpopulations between AD and normal aorta tissues. Macrophages accounted for a higher percentage in the normal aorta, while the proportions of T cells, B cells and natural killer (NK) cells were all increased in AD tissues. Macrophage clusters that expanded in AD tissues originated primarily from circulating monocytes and expressed genes encoding proinflammatory cytokines and molecules involved in tissue repair. T and NK cells in AD tissues exhibited enhanced cytotoxic properties. A cluster of CD4+ T cells that had expanded in AD tissues was Th17-like and might contribute to the pathogenesis of AD. Cell-cell interaction analysis highlighted the increased communication between macrophages and T cells, which primarily regulated the costimulation of T cells. Conclusions: Our study provides a comprehensive characterization of immune cells in the dissected aorta with an emphasis on the role of macrophages and T cells. The information from our study improves our understanding of immune mechanisms in AD formation and helps to identify additional useful targets for early diagnosis or therapy of AD.

Autologous Stem Cells Transplantation for No-Option Angiitis-Induced Critical Limb Ischemia: Recurrence and New Lesion.

Although satisfying outcomes have been demonstrated in terms of autologous stem cell transplantation in the treatment of angiitis-induced critical limb ischemia (AICLI), few studies have systematically reported the recurrence conditions. In the current study, we aimed to investigate recurrence conditions of a relatively large AICLI cohort in our center during a long-term follow-up period. From May 2009 to August 2020, 181 patients with AICLI received peripheral blood mononuclear cells (PBMNCs) or purified CD34+ cells (PCCs) transplantation. The main outcomes included recurrence and new lesions. Patient demographic data, ischemic limb characteristics, interventional characteristics, etc., were identified and analyzed. A logistic multivariable regression was performed to identify the independent risk factors for recurrence by a stepwise selection of variables. One hundred forty-eight patients were enrolled in this study. The mean follow-up period was 62.3 ± 37.4 months (range 12-144 months). The 5- and 10-year recurrence-free rates were 88.5% (95% confidence interval [CI] 3.1%-82.6%) and 71.7% (95% CI 7.6%-58.2%), respectively. The 5- and 10-year new lesion-free rates were 93.2% (95% CI 2.2%-89.0%) and 91.7% (95% CI 2.7%-86.6%), respectively. The finding of multiple limbs involved (OR 1.322 95% CI 1.123-12.549, P = .036) and ischemia relief period ≥5 months (OR 3.367 95% CI 1.112-10.192, P = .032) were demonstrated to be independent risk factors for recurrence in patients with AICLI who underwent cell transplantation. For patients with AICLI who responded to cell transplantation, the durability of this therapy was satisfactory, with 5- and 10-year recurrence-free rates of 88.5% and 71.7%, respectively. Multiple limbs involved at admission and ischemia relief period ≥5 months were demonstrated to be independent risk factors for recurrence after transplantation.

Return to work after cell transplantation in patients with angiitis-induced critical limb ischaemia and factors related: a single-centre retrospective cohort study.

BACKGROUND: Angiitis-induced critical limb ischaemia (AICLI) patients, who are usually young and have a high amputation rate, always lose their ability to return to the labour force. Return to work (RTW) not only indicates patients' physical health, showing that they could undertake the work, but also demonstrates their psychological well-being. While cell transplantation showed satisfactory efficacy in limb salvage, few studies of AICLI patients' RTW after transplantation have been reported. METHODS: From May 2009 to May 2021, AICLI patients who underwent cell transplantation and completed no less than 12 months of follow-up were retrospectively enrolled. The primary endpoint was RTW. Patient demographics and characteristics of the ischaemic limbs were reviewed to analyse independent risk factors for RTW. RESULTS: A total of 171 AICLI patients (170 males) were enrolled with a mean age of 41.9 ± 9.6 years (range: 20-57 years). The 12-month and 24-month RTW cumulative rates were 69.4% (95% confidence interval [CI] 61.6-75.6%) and 70.1% (95% CI 62.3-76.2%), respectively. Age < 40 years (odds ratio [OR] 2.659, 95% CI 1.138-6.719) and preoperative occupation as a mental worker (OR 8.930, 95% CI 2.665-42.847) were identified as independent protective factors for RTW. Perioperative limb infection with ulcer or gangrene (OR 0.250, 95% CI 0.075-0.779) was identified as an independent risk factor. CONCLUSION: AICLI patients who underwent cell transplantation usually had a satisfactory midterm RTW cumulative rate. AICLI patients < 40 years old with preoperative occupation as mental workers were more likely to return to work. Prevention of limb infection during the perioperative period is of great significance to RTW.

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-a randomized single-blinded non-inferiority trial.

BACKGROUNDS: Patients 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: NCT02089828) on peripheral blood mononuclear cells (PBMNCs) and purified CD34+ cells (PCCs) transplantation for treating angiitis-induced critical limb ischemia (AICLI). METHODS: A randomized single-blinded non-inferiority trial (Number: NCT02089828) 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. RESULTS: During 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). CONCLUSION: The 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 NCT02089828. Registered 14 March 2014, https://clinicaltrials.gov/ct2/show/record/NCT02089828 .

Prediction of 2-Year Major Adverse Limb Event-Free Survival After Percutaneous Transluminal Angioplasty and Stenting for Lower Limb Atherosclerosis Obliterans: A Machine Learning-Based Study.

BACKGROUND: The current scoring systems could not predict prognosis after endovascular therapy for peripheral artery disease. Machine learning could make predictions for future events by learning a specific pattern from existing data. This study aimed to demonstrate machine learning could make an accurate prediction for 2-year major adverse limb event-free survival (MFS) after percutaneous transluminal angioplasty (PTA) and stenting for lower limb atherosclerosis obliterans (ASO). METHODS: A lower limb ASO cohort of 392 patients who received PTA and stenting was split to the training set and test set by 4:1 in chronological order. Demographic, medical, and imaging data were used to build machine learning models to predict 2-year MFS. The discrimination and calibration of artificial neural network (ANN) and random forest models were compared with the logistic regression model, using the area under the receiver operating curve (ROCAUC) with DeLong test, and the calibration curve with Hosmer-Lemeshow goodness-of-fit test, respectively. RESULTS: The ANN model (ROCAUC = 0.80, 95% CI: 0.68-0.89) but not the random forest model (ROCAUC = 0.78, 95% CI: 0.66-0.87) significantly outperformed the logistic regression model (ROCAUC = 0.73, 95% CI: 0.60-0.83, P = 0.01 and P = 0.24). The ANN model the logistic regression model demonstrated good calibration performance (P = 0.73 and P = 0.28), while the random forest model showed poor calibration (P < 0.01). The calibration curve of the ANN model was visually the closest to the perfectly calibrated line. CONCLUSION: Machine learning models could accurately predict 2-year MFS after PTA and stenting for lower limb ASO, in which the ANN model had better discrimination and calibration. Machine learning-derived prediction tools might be clinically useful to automatically identify candidates for PTA and stenting.

Clinical features and outcomes after endovascular therapy for penetrating aortic ulcer and intramural hematoma.

OBJECTIVES: To identify the differences between clinical features and outcomes after endovascular therapy for penetrating aortic ulcer (PAU) and intramural hematoma (IMH). METHODS: From January 2009 to March 2020, patients who underwent endovascular therapy for PAU and IMH were enrolled. Information on patient demographics, presentation, PAU and IMH morphology, laboratory examination, and clinical follow-up information was collected and analyzed. Univariate analysis was performed to identify the differences between IMH and PAU, and Kaplan-Meier was used to calculate the cumulative survival rate and freedom from reintervention. RESULTS: A total of 114 patients were enrolled; 80 (70.2%) of them were diagnosed with PAU. Compared with PAU, patients with IMH were younger (p = 0.006), more likely to be admitted emergently (p = 0.001), had longer hospital stay (p = 0.028), and had higher levels of C-reactive protein (p = 0.030). Meanwhile, patients with IMH were more likely to be associated with hypertension (p = 0.020) and pleural effusion (p < 0.001) and less likely to have a history of acute coronary syndrome (p = 0.019) and prior cardiovascular intervention (p = 0.017). The five-year freedom from reintervention and cumulative survival rate were 94.2% (95% confidential interval, 88.9%-99.9%) and 87.8% (95% confidential interval, 79.5%-96.9%) in PAU patients and 89.6% (95% confidential interval, 75.8%-99.9%) and 85.1% (95% confidential interval, 68.0%-99.9%) in IMH patients, respectively. There was no significant difference in freedom from reintervention (p = 0.795) or cumulative survival rate (p = 0.817). CONCLUSIONS: IMH appeared to occur in younger patients with hypertension and usually had an acute onset, while PAU was more likely to be found incidentally in older patients with atherosclerosis. Endovascular therapy was effective in both IMH and PAU patients with encouraging outcomes.

Risk factors and treatment outcomes for type B aortic dissection with malperfusion requiring adjunctive procedures after thoracic endovascular aortic repair.

OBJECTIVE: To investigate the risk factors for unrelieved malperfusion after thoracic endovascular aortic repair (TEVAR) alone. METHODS: From January 2009 to December 2019, 86 patients with type B aortic dissection-induced malperfusion were enrolled. Demographics and clinical and imaging data, as well as treatment outcomes, were collected and compared between patients with malperfusion relieved by TEVAR alone (TR) or by TEVAR with adjunctive procedures (TA). RESULTS: Among the 86 enrolled patients, 17 (19.8%) had malperfusion requiring TA. Patients in the TA group were more likely to suffer lower limb ischemia (P = .004), present with severe ischemia (P = .003), and have more than one end-organ ischemia (P = .015). There were more involved vessels classified as the mixed type in the TA group (P = .002). Mixed ischemia was the only independent risk factor for malperfusion requiring TA (odds ratio, 4.7; 95% confidence interval [CI], 1.3-17.2; P = .017). The ischemia-related in-hospital mortality rate of the TA group was significantly higher than that of the TR group (P = .023), and malperfusion requiring TA was the only risk factor in the multivariate logistic regression (odds ratio, 14.6; 95% CI, 1.4-150.5; P = .025). The 5-year overall cumulative survival rates were 82.4% (95% CI, 66.1%-100.0%) in the TA group and 89.5% (95% CI, 81.6%-98.1%) in the TR group (P = .294). CONCLUSIONS: Type B aortic dissection-induced malperfusion requiring TA was associated with a higher ischemia-related in-hospital mortality rate. Mixed obstruction was an independent risk factor for unrelieved malperfusion after TEVAR alone, and early identification of potential patients requiring TA could thereby be achieved. Reasonable treatment strategies could contribute to the successful management of malperfusion requiring TA.