PROMISE I early feasibility study of the LimFlow System for percutaneous deep vein arterialization in no-option chronic limb-threatening ischemia 12-month results.

MedStar author(s):
Citation: Journal of Vascular Surgery. 2021 May 18PMID: 34019990Institution: MedStar Heart & Vascular InstituteForm of publication: Journal ArticleMedline article type(s): Journal ArticleSubject headings: IN PROCESS -- NOT YET INDEXEDYear: 2021Local holdings: Available online from MWHC library: 1995 - present, Available in print through MWHC library: 1999 - 2006ISSN:
  • 0741-5214
Name of journal: Journal of vascular surgeryAbstract: CONCLUSIONS: The LimFlow pDVA System was utilized in treating no-option patients with CLTI. High technical success rate was observed, with a significant percentage of patients surviving free of major amputation at 12 months. These results suggest early safety and provide an initial assessment of the efficacy of the LimFlow pDVA System which supports the expansion of carefully executed studies to determine whether this is a viable option that can be used in this critically disadvantaged and growing patient population. Copyright (c) 2021. Published by Elsevier Inc.METHODS: Thirty-two no-option CLTI patients, previously offered major amputation, were enrolled in this single-arm EFS of the LimFlow pDVA System. No-option CLTI was defined as being ineligible for surgical or endovascular arterial revascularization. Patients were assessed for clinical status, pain, wound healing, and duplex ultrasound at 30 days, 6 months, and 12 months post-treatment. Primary endpoint analysis was amputation-free survival (AFS) at 30 days and 6 and 12 months. AFS was defined as freedom from above-ankle amputation of the index limb and freedom from all-cause mortality. Secondary endpoints evaluated included technical success of the procedure, and wound healing at 6 and 12 months.OBJECTIVE: We report the 6 and 12-month outcomes of the PROMISE I early feasibility study (EFS) after treatment of no-option chronic limb-threatening ischemia (CLTI) with percutaneous deep vein arterialization (pDVA) using the LimFlow System.RESULTS: Of 32 enrolled patients, 31 (97%) were successfully treated with the LimFlow System at the time of the procedure, and 2 (6.3%) were lost to follow-up. The 30-day, 6-month, and 12-month AFS rates were 91%, 74%, and 70% respectively. Wound healing status of fully healed or healing was 67% at 6-months, and 75% at 12-months. Reintervention was performed in 16 patients (52%) with 14 (88%) of the maintenance reinterventions occurring within the first three months. The majority of reinterventions, 12 (75%), involved the arterial inflow tract proximal to the stented LimFlow circuit, and no in-stent stenoses were determined to have been the cause of reintervention.All authors: Bernardo NN, Clair DG, Deaton DH, Henao S, Mustapha JA, Schneider PA, Shishehbor MHFiscal year: FY2021Digital Object Identifier: Date added to catalog: 2021-06-28
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Item type Current library Collection Call number Status Date due Barcode
Journal Article MedStar Authors Catalog Article 34019990 Available 34019990

Available online from MWHC library: 1995 - present, Available in print through MWHC library: 1999 - 2006

CONCLUSIONS: The LimFlow pDVA System was utilized in treating no-option patients with CLTI. High technical success rate was observed, with a significant percentage of patients surviving free of major amputation at 12 months. These results suggest early safety and provide an initial assessment of the efficacy of the LimFlow pDVA System which supports the expansion of carefully executed studies to determine whether this is a viable option that can be used in this critically disadvantaged and growing patient population. Copyright (c) 2021. Published by Elsevier Inc.

METHODS: Thirty-two no-option CLTI patients, previously offered major amputation, were enrolled in this single-arm EFS of the LimFlow pDVA System. No-option CLTI was defined as being ineligible for surgical or endovascular arterial revascularization. Patients were assessed for clinical status, pain, wound healing, and duplex ultrasound at 30 days, 6 months, and 12 months post-treatment. Primary endpoint analysis was amputation-free survival (AFS) at 30 days and 6 and 12 months. AFS was defined as freedom from above-ankle amputation of the index limb and freedom from all-cause mortality. Secondary endpoints evaluated included technical success of the procedure, and wound healing at 6 and 12 months.

OBJECTIVE: We report the 6 and 12-month outcomes of the PROMISE I early feasibility study (EFS) after treatment of no-option chronic limb-threatening ischemia (CLTI) with percutaneous deep vein arterialization (pDVA) using the LimFlow System.

RESULTS: Of 32 enrolled patients, 31 (97%) were successfully treated with the LimFlow System at the time of the procedure, and 2 (6.3%) were lost to follow-up. The 30-day, 6-month, and 12-month AFS rates were 91%, 74%, and 70% respectively. Wound healing status of fully healed or healing was 67% at 6-months, and 75% at 12-months. Reintervention was performed in 16 patients (52%) with 14 (88%) of the maintenance reinterventions occurring within the first three months. The majority of reinterventions, 12 (75%), involved the arterial inflow tract proximal to the stented LimFlow circuit, and no in-stent stenoses were determined to have been the cause of reintervention.

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