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

Clair, Daniel G.; Mustapha, Jihad; Shishehbor, Mehdi H.; Schneider, Peter A.; Henao, Steve; Bernardo, Nelson N.; Deaton, David N.

doi:10.1016/j.jvs.2021.04.057

Cited by 59 publications

(55 citation statements)

References 17 publications

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“…Notably, most patients were classified as Rutherford class 5 (87.5%) in the PROMISE I trial. 10 The current case series differs from those by Kum et al in that it represents a real-world cohort of patients with advanced end-stage SAD and a high percentage of patients classified as Rutherford class 6 (59.5%).…”

Section: Q14mentioning

confidence: 71%

“…The rates of reintervention were in line with those of the PROMISE I trial. 10 The clinical reasons for failure seem to revolve around wound care. Treating patients with CLTI with advanced tissue loss represents an area that requires a significant improvement.…”

Section: Q14mentioning

confidence: 99%

“…Early trials showed promising limb salvage and wound healing rates. [8][9][10][11] However, this system is not yet commercially available in the United States. We are awaiting the results of the second clinical trial phase, PROMISE II.…”

Section: Introductionmentioning

confidence: 99%

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Percutaneous Deep Venous Arterialization: Treatment of Patients with End-Stage Plantar Disease

Saab¹,

Mustapha²,

Ansari³

et al. 2022

Journal of the Society for Cardiovascular Angiography & Int

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Section: Q14mentioning

confidence: 71%

Section: Q14mentioning

confidence: 99%

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Percutaneous Deep Venous Arterialization: Treatment of Patients with End-Stage Plantar Disease

Saab¹,

Mustapha²,

Ansari³

et al. 2022

Journal of the Society for Cardiovascular Angiography & Int

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“…The valve lysis could be ameliorated with a new dedicated surgical antegrade valvulotome, such as the antegrade, over-the-wire valvulotome, recently proposed in the PROMISE I study. This trial represents an evolution of the first LimFlow experience [ 9 , 20 ], and also added self-expanding stent grafts specifically conceived to divert blood flow from the tibial artery into the tibial and pedal venous system with a reported procedural success of 75% and 30-day, 6-month, and 12-month amputation-free survival rates of 91%, 74%, and 70%, respectively [ 10 ].…”

Section: Discussionmentioning

confidence: 99%

“…Recently, endovascular deep vein arterialization of the foot has been attempted in multiple settings using “off-label” [ 8 ] and purpose-built products [ 9 , 10 ] with a standardized approach to treating CLTI, to improve limb salvage and mortality in the no-option population.…”

Section: Introductionmentioning

confidence: 99%

Duplex and Angiographic-Assisted Evaluation of Outcomes of Endovascular Embolization after Surgical Deep Vein Arterialization for the Treatment No-Option Critical Limb Ischemia Patients

Montelione¹,

Catanese²,

Gabellini

et al. 2022

Diagnostics

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Objective: To report early and mid-term outcomes of the arterialization of the deep venous system in no-option critical limb-threatening ischemia (CLTI) using duplex ultrasound and angiographic evaluation to improve limb perfusion. Methods: A single-center prospective study of patients with no-option CLTI treated with hybrid surgical arterialization of the deep venous circulation and staged endovascular embolization of the venous collateral. Embolization was performed using a controlled-release spiral, within two weeks after bypass surgery. Patients were assessed for clinical status, wound healing, median transcutaneous partial pressure of O2 (TcPO2), and post-operative duplex ultrasound evaluating peak systolic velocity (PSV), end diastolic velocity (EDV), and resistance index (RI) to assess foot perfusion and bypass features. Primary endpoint analysis was primary technical success, limb salvage, patency rates, and clinical improvement. Secondary endpoints were 30-day and long-term mortality, major cardiovascular events (MACE), including myocardial infarction or stroke, and serious adverse events (SAE). Results: Five patients with no-option CLTI were treated at our center using the hybrid deep vein arterialization technique. Clinical stage was grade 3 in one patient and grade 4 in the remaining four. Mean age was 65.8 years (range 49–76 years), and two patients were affected by Buerger’s disease. Primary technical success was achieved in all patients, and all the bypasses were patent at the angiographic examination. At 30-day and at average follow-up of 9.8 months (range 2–24 months), mortality, major cardiovascular events (MACE), and serious adverse events (SAE) were not reported, with a primary patency and limb salvage rates of 100%. Three patients required minor amputation. Clinical improvement was demonstrated in all patients with granulation, resolution of rest pain, or both. Median TcPO2 values rose from 10 mm Hg (range 4–25) before the procedure to 35 (range 31–57) after surgery, and to 59 mm Hg (range 50–76) after the staged endovascular procedure. Conclusions: In our initial experience, the arterialization of the deep venous circulation, with subsequent selective embolization of the venous escape routes from the foot, seems a feasible and effective solution for limb salvage in patients with no-option CLTI and those in the advanced wound, ischemia, and foot infection (WIfI) clinical stage.

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Endovascular Revascularisations: When and How

Patrone,

Zayed

2023

Management of Diabetic Foot Complications

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

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

Cited by 59 publications

References 17 publications

Percutaneous Deep Venous Arterialization: Treatment of Patients with End-Stage Plantar Disease

Percutaneous Deep Venous Arterialization: Treatment of Patients with End-Stage Plantar Disease

Duplex and Angiographic-Assisted Evaluation of Outcomes of Endovascular Embolization after Surgical Deep Vein Arterialization for the Treatment No-Option Critical Limb Ischemia Patients

Endovascular Revascularisations: When and How

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