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  • 1
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    Online Resource
    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
    Springer Science and Business Media LLC ; 2022
    In:  BMC Cardiovascular Disorders Vol. 22, No. 1 ( 2022-12)
    Details
    In: BMC Cardiovascular Disorders, Springer Science and Business Media LLC, Vol. 22, No. 1 ( 2022-12)
    Abstract: 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 .
    Type of Medium: Online Resource
    ISSN: 1471-2261
    URL: Article
    DOI: 10.1186/s12872-022-02751-1
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2022
    detail.hit.zdb_id: 2059859-2
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  • 2
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    Long-Term Outcomes of Peripheral Blood Mononuclear Cells in the Treatment of Angiitis-Induced No-Option Critical Limb-Threatening Ischemia
    Elsevier BV ; 2021
    In:  SSRN Electronic Journal
    Details
    In: SSRN Electronic Journal, Elsevier BV
    Type of Medium: Online Resource
    ISSN: 1556-5068
    URL: Article
    DOI: 10.2139/ssrn.3896560
    Language: English
    Publisher: Elsevier BV
    Publication Date: 2021
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  • 3
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    Safety and Effectiveness of Excimer Laser Ablation Combined With Drug-Coated Balloon for Atherosclerotic Obliterans in the Lower Extremity
    SAGE Publications ; 2023
    In:  Journal of Endovascular Therapy Vol. 30, No. 5 ( 2023-10), p. 721-729
    Details
    In: Journal of Endovascular Therapy, SAGE Publications, Vol. 30, No. 5 ( 2023-10), p. 721-729
    Abstract: 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.
    Type of Medium: Online Resource
    ISSN: 1526-6028 , 1545-1550
    URL: Article
    DOI: 10.1177/15266028221092979
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2023
    detail.hit.zdb_id: 2049858-5
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  • 4
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    Outcomes of endovascular stent graft repair for penetrating aortic ulcers with or without intramural hematoma
    Elsevier BV ; 2021
    In:  Journal of Vascular Surgery Vol. 73, No. 5 ( 2021-05), p. 1541-1548
    Details
    In: Journal of Vascular Surgery, Elsevier BV, Vol. 73, No. 5 ( 2021-05), p. 1541-1548
    Type of Medium: Online Resource
    ISSN: 0741-5214
    URL: Article
    DOI: 10.1016/j.jvs.2020.10.022
    Language: English
    Publisher: Elsevier BV
    Publication Date: 2021
    detail.hit.zdb_id: 1492043-8
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  • 5
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    Return to work after cell transplantation in patients with angiitis-induced critical limb ischaemia and factors related: a single-centre retrospective cohort study
    Springer Science and Business Media LLC ; 2022
    In:  Stem Cell Research & Therapy Vol. 13, No. 1 ( 2022-12)
    Details
    In: Stem Cell Research & Therapy, Springer Science and Business Media LLC, Vol. 13, No. 1 ( 2022-12)
    Abstract: 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.
    Type of Medium: Online Resource
    ISSN: 1757-6512
    URL: Article
    DOI: 10.1186/s13287-022-02807-1
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2022
    detail.hit.zdb_id: 2548671-8
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  • 6
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    Outcomes of Excimer Laser Ablation Combined with Drug-coated Balloon in Atherosclerotic Lesions of the Popliteal Artery
    Elsevier BV ; 2024
    In:  Annals of Vascular Surgery ( 2024-3)
    Details
    In: Annals of Vascular Surgery, Elsevier BV, ( 2024-3)
    Type of Medium: Online Resource
    ISSN: 0890-5096
    URL: Article
    DOI: 10.1016/j.avsg.2023.12.091
    Language: English
    Publisher: Elsevier BV
    Publication Date: 2024
    detail.hit.zdb_id: 1473891-0
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  • 7
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    Autologous peripheral blood-derived stem cells transplantation for treatment of no-option angiitis-induced critical limb ischemia: 10-year management experience
    Springer Science and Business Media LLC ; 2020
    In:  Stem Cell Research & Therapy Vol. 11, No. 1 ( 2020-12)
    Details
    In: Stem Cell Research & Therapy, Springer Science and Business Media LLC, Vol. 11, No. 1 ( 2020-12)
    Abstract: Previous studies have demonstrated that no-option angiitis-induced critical limb ischemia (NO-AICLI) could be significantly improved by transplantation of peripheral blood-derived stem cells (PBDSCs). Additionally, a randomized controlled trial (RCT) recently conducted by us suggested that peripheral blood-derived purified CD34+ cells (PCCs) were not inferior to non-purified peripheral blood mononuclear cells (PBMNCs) at limb salvage in treatment of NO-AICLI. However, most of these clinical trials whether RCT or single-arm studies were characterized with a small sample size and absence of long-term outcomes. Methods To analyze long-term clinical outcomes of PBDSCs transplantation for NO-AICLI, we reviewed clinical data of patients with NO-AICLI receiving PBDSCs transplantation at our center during the past decade. Meanwhile, we first compared the long-term safety and efficacy of intramuscular transplantation of PCCs versus PBMNCs in a sizable number of patients with NO-AICLI. Results From May 2009 to December 2019, a total of 160 patients with NO-AICLI patients were treated by PBDSCs transplantation (82 with PCCs, 78 with PBMNCs) at our center. Baseline characteristics between two groups were similar. Up to June 2020, the mean follow-up period was 46.6 ± 35.3 months. No critical adverse events were observed in either group. There was one death during the follow-up period. A total of eight major amputations occurred. The cumulative major amputation-free survival (MAFS) rate at 5 years after PBDSCs transplantation was 94.4%, without difference between two groups ( P  = .855). Wound healing, rest pain, pain-free walking time, ankle-brachial index, transcutaneous oxygen pressure, and quality of life (QoL) also significantly improved after PBDSCs transplantation. Conclusions Autologous PBDSCs intramuscular transplantation could significantly decrease the major amputation rates and improve the QoL in patients with NO-AICLI. Long-term observation of a large sample of patients confirmed that the clinical benefits of PBDSCs transplantation were durable, without difference between the PCCs and PBMNCs groups.
    Type of Medium: Online Resource
    ISSN: 1757-6512
    URL: Article
    DOI: 10.1186/s13287-020-01981-4
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2020
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  • 8
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    Long‐Term Outcomes of Chronic Type B Aortic Dissection Treated by Thoracic Endovascular Aortic Repair
    Ovid Technologies (Wolters Kluwer Health) ; 2023
    In:  Journal of the American Heart Association Vol. 12, No. 1 ( 2023-01-03)
    Details
    In: Journal of the American Heart Association, Ovid Technologies (Wolters Kluwer Health), Vol. 12, No. 1 ( 2023-01-03)
    Abstract: 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.
    Type of Medium: Online Resource
    ISSN: 2047-9980
    URL: Article
    DOI: 10.1161/JAHA.122.026914
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2023
    detail.hit.zdb_id: 2653953-6
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  • 9
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    Three-year outcomes of peripheral blood mononuclear cells vs purified CD34+ cells in the treatment of angiitis-induced no-option critical limb ischemia and a cost-effectiveness assessment: A randomized single-blinded noninferiority trial
    Oxford University Press (OUP) ; 2021
    In:  Stem Cells Translational Medicine Vol. 10, No. 5 ( 2021-05-01), p. 647-659
    Details
    In: Stem Cells Translational Medicine, Oxford University Press (OUP), Vol. 10, No. 5 ( 2021-05-01), p. 647-659
    Abstract: For patients with angiitis-induced critical limb ischemia (AICLI), cell transplantation, such as purified CD34+ cells (PCCs) and peripheral blood mononuclear cells (PBMNCs), is gradually being used as a promising treatment. This was the first randomized single-blinded noninferiority trial (number: NCT 02089828) specifically designed to evaluate the therapeutic efficacies of the transplantation of PCCs vs those of PBMNCs for the treatment of AICLI. We aimed to compare the mid-term safety and efficacy between the two groups and determine their respective advantages. From April 2014 to September 2019, 50 patients with AICLI were equally allocated to the two groups, except for 1 lost patient, 1 amputee, and 1 patient who died of heart disease. The other 47 patients completed the 36-month follow-up. The endpoints were as follows: major amputation-free survival and total amputation-free survival at 6 months, which were 96.0% and 84.0% in the PBMNCs group and 96.0% and 72.0% in the PCCs group, respectively. These rates remained stable at 12, 24, and 36 months. The PCCs group had a significant higher probability of rest pain relief than the PBMNCs group, whereas earlier significant improvements in the Rutherford classification were observed in the PBMNCs group. Accordingly, PCCs would be preferred for patients with significant pain, whereas PBMNCs may be a good option for patients with two or more critically ischemic limbs. Concerning cost-effectiveness, PCCs are not more cost-effective than PBMNCs. These outcomes require verification from long-term trials involving larger numbers of patients.
    Type of Medium: Online Resource
    ISSN: 2157-6564 , 2157-6580
    URL: Article
    DOI: 10.1002/sctm.20-0033
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2021
    detail.hit.zdb_id: 2642270-0
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  • 10
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    Long-Term Outcomes of Peripheral Blood Mononuclear Cells in the Treatment of Angiitis-Induced No-Option Critical Limb-Threatening Ischemia
    Frontiers Media SA ; 2021
    In:  Frontiers in Cardiovascular Medicine Vol. 8 ( 2021-12-6)
    Details
    In: Frontiers in Cardiovascular Medicine, Frontiers Media SA, Vol. 8 ( 2021-12-6)
    Abstract: Background: Peripheral blood mononuclear cells (PBMNCs) showed encouraging short outcomes in the treatment of angiitis-induced no-option critical limb-threatening ischemia (AICLTI) in the pilot study. This study aimed to demonstrate the long-term outcomes of this treatment. Methods: From May 2014 to December 2018, patients diagnosed with AICLTI and treated by autotransplantation of PBMNCs in our center were enrolled and analyzed. The primary endpoint was major amputation-free survival (MAFS), the secondary endpoints included peak pain-free walking time (PPFWT), Wong-Baker FACES pain rating scale score (WFPRSS), labor recovery, ankle-brachial index (ABI), transcutaneous partial oxygen pressure (TcpO2), and SF-36v2 scores. Results: A total of 58 patients were enrolled. During a minimal follow-up of 36 months, the MAFS was 93.1% and the labor competence restored rate was 62.1%. The WFPRSS was decreased from 8.7 ± 1.6 to 1.6 ± 3.2, and PPFWT was significantly improved from 2.9 ± 4.2 min to 16.6 ± 6.9 min. The quality of life was also significantly improved at each follow-up point. Perfusion evaluating parameters, such as ABI and TcPO2, were also significantly improved. No critical adverse event was observed during the treatment and follow-up period. Conclusions: The treatment of AICLTI by autotransplantation of PBMNCs demonstrated encouraging long-term results. It could not only restore labor competence, improve the quality of life, but also significantly reduce the major amputation rate.
    Type of Medium: Online Resource
    ISSN: 2297-055X
    URL: Article
    DOI: 10.3389/fcvm.2021.769472
    Language: Unknown
    Publisher: Frontiers Media SA
    Publication Date: 2021
    detail.hit.zdb_id: 2781496-8
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