PMID- 34019990
OWN - NLM
STAT- MEDLINE
DCOM- 20211220
LR  - 20221207
IS  - 1097-6809 (Electronic)
IS  - 0741-5214 (Linking)
VI  - 74
IP  - 5
DP  - 2021 Nov
TI  - PROMISE I: Early feasibility study of the LimFlow System for percutaneous deep 
      vein arterialization in no-option chronic limb-threatening ischemia: 12-month 
      results.
PG  - 1626-1635
LID - S0741-5214(21)00737-0 [pii]
LID - 10.1016/j.jvs.2021.04.057 [doi]
AB  - OBJECTIVE: We report the 6- and 12-month outcomes of the PROMISE I early 
      feasibility study after treatment of no-option chronic limb-threatening ischemia 
      (CLTI) with percutaneous deep vein arterialization (pDVA) using the LimFlow 
      System. METHODS: Thirty-two patients with no-option CLTI, previously offered 
      major amputation, were enrolled in this single-arm early feasibility study 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. RESULTS: Of 32 enrolled patients, 31 (97%) were 
      successfully treated with the LimFlow System at the time of the procedure, and 
      two (6.3%) were lost to follow-up. The 30-day, 6-month, and 12-month AFS rates 
      were 91%, 74%, and 70% respectively. The 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 3 months. The majority of reinterventions (n = 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. 
      CONCLUSIONS: The LimFlow pDVA System was utilized in treating patients with 
      no-option CLTI. A 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 that 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.
CI  - Copyright (c) 2021 The Authors. Published by Elsevier Inc. All rights reserved.
FAU - Clair, Daniel G
AU  - Clair DG
AD  - Department of Surgery, University of South Carolina, Columbia, SC. Electronic 
      address: daniel.clair@uscmed.sc.edu.
FAU - Mustapha, Jihad A
AU  - Mustapha JA
AD  - Advanced Cardiac and Vascular Amputation Prevention Centers, Grand Rapids, Mich.
FAU - Shishehbor, Mehdi H
AU  - Shishehbor MH
AD  - Harrington Heart & Vascular Institute, University Hospitals Cleveland Medical 
      Center and Case Western Reserve University School of Medicine, Cleveland, Ohio.
FAU - Schneider, Peter A
AU  - Schneider PA
AD  - Division of Vascular and Endovascular Surgery, University of California San 
      Francisco, San Francisco, Calif.
FAU - Henao, Steve
AU  - Henao S
AD  - Division of Vascular Surgery, New Mexico Heart Institute, Albuquerque, NM.
FAU - Bernardo, Nelson N
AU  - Bernardo NN
AD  - Medstar Washington Hospital Center, Washington, DC.
FAU - Deaton, David H
AU  - Deaton DH
AD  - Division of Vascular Surgery, University of Pennsylvania, Philadelphia, Pa.
LA  - eng
PT  - Clinical Trial
PT  - Journal Article
PT  - Multicenter Study
DEP - 20210518
PL  - United States
TA  - J Vasc Surg
JT  - Journal of vascular surgery
JID - 8407742
SB  - IM
MH  - Aged
MH  - Aged, 80 and over
MH  - Amputation, Surgical
MH  - *Blood Vessel Prosthesis
MH  - Blood Vessel Prosthesis Implantation/adverse effects/*instrumentation
MH  - Chronic Disease
MH  - Endovascular Procedures/adverse effects/*instrumentation
MH  - Feasibility Studies
MH  - Female
MH  - Humans
MH  - Ischemia/diagnostic imaging/physiopathology/*surgery
MH  - Limb Salvage
MH  - Lower Extremity/*blood supply
MH  - Male
MH  - Middle Aged
MH  - Peripheral Arterial Disease/diagnostic imaging/physiopathology/*surgery
MH  - Prospective Studies
MH  - Regional Blood Flow
MH  - Retreatment
MH  - *Stents
MH  - Time Factors
MH  - Treatment Outcome
MH  - United States
MH  - *Vascular Access Devices
MH  - Vascular Patency
OTO - NOTNLM
OT  - Amputation
OT  - Chronic limb-threatening ischemia
OT  - Critical limb ischemia
OT  - No-option chronic limb-threatening ischemia
OT  - Percutaneous deep vein arterialization
EDAT- 2021/05/22 06:00
MHDA- 2021/12/21 06:00
CRDT- 2021/05/21 20:16
PHST- 2020/03/30 00:00 [received]
PHST- 2021/04/17 00:00 [accepted]
PHST- 2021/05/22 06:00 [pubmed]
PHST- 2021/12/21 06:00 [medline]
PHST- 2021/05/21 20:16 [entrez]
AID - S0741-5214(21)00737-0 [pii]
AID - 10.1016/j.jvs.2021.04.057 [doi]
PST - ppublish
SO  - J Vasc Surg. 2021 Nov;74(5):1626-1635. doi: 10.1016/j.jvs.2021.04.057. Epub 2021 
      May 18.