2. Introduction
• Chronic limb Threatening ischemia is a mayor public health problem.
Lack of public awareness and the
frequent failure to make an early
diagnosis
Broad variation in vascular aproach
Limited evidence base to guide
daily practice
Rapidly evolving
technologies in:
• Diagnostic
• Devices
• Drugs
• Techniques
• Biologics
Global vascular guidelines on the management of chronic limb-threatening ischemia
3. Non revascularizable ischemia
The majority of CLTI patients are anatomically suitable for
revascularization.
Dependent
on clinical
context.
Lack of a target artery
crossing the ankle and
absence of a suitable pedal
or plantar artery target.
WIfI stages 3 and 4.
Global vascular guidelines on the management of chronic limb-threatening ischemia
4. Options
Spinal cord stimulation
Lumbar sympathectomy
Intermittent pneumatic compression
Prostanoids
Hyperbaric oxygen therapy
Venous arterialization
Global vascular guidelines on the management of chronic limb-threatening ischemia
5. Spinal cord stimulation
• Five randomised and one controlled clinical trial
• 444 patients
• Primary end point: limb salvaje
• Limb salvage rates were found to be significantly higher in the SCS group (RR:
0.71; 95% CI, 0.56-0.90)
• The SCS grup required less analgesia
• No significant effect on ulcer healing
• Complication rate 17%
TASC II
ESVS
• insufficient evidence to
recommend its use in
the treatment of CLTI.
Global vascular guidelines on the management of chronic limb-threatening ischemia
6. lumbar sympathectomy
Randomised controlled trials have failed to identify any objective benefits for lumbar sympathectomy
Improvements in symptoms for patients with critical leg ischemia in approximately 60% of patients
symptomatic patients with critical leg ischaemia as an alternative to amputation in patients with
otherwise viable limbs
TASC II
ESVS
• Dont mention it as a
treatment to prevent
amputation but can be
considered to relieve
simptoms
Global vascular guidelines on the management of chronic limb-threatening ischemia
7. Intermitent compresion
• Systematic review (RCT, NRCT, CBA)
• 8 studies included
• Primary outcomes: All cause mortality, MACE, limb amputation, QoL, wound healing, adverse events and
complications rate.
• There is a lack of experimental studies examining the clinical effectiveness of IPC.
• Results from studies indicate that the treatment may be associated with improved limb salvage, wound
healing and pain management, but theres high risk of bias.
• Insufficient data to identify the optimal compression parameters to use.
No guidelines
Global vascular guidelines on the management of chronic limb-threatening ischemia
8. prostanoids
• Update of a review first published in 2010.
• RCTs describing the efficacy and safety of prostanoids compared with placebo or other
pharmacological control treatments for patients presenting with CLI without chance of
rescue or reconstructive intervention.
• 33 randomised controlled trials with 4477 participants
• There is no strong evidence on the efficacy and safety of prostanoids in patients with CLTI
on the basis of a high-quality meta-analysis of homogeneous, long-term RCTs
No clear difference in the incidence of cardiovascular mortality between
patients receiving prostanoids and those given placebo (RR 0.81, 95% CI 0.41
to 1.58).
No effect on the incidence of total amputations when compared with placebo
(RR 0.97, 95% CI 0.86 to 1.09).
Adverse events were more frequent with prostanoids than with placebo (RR
2.11, 95% CI 1.79 to 2.50).
Prostanoids reduced rest-pain (RR 1.30, 95% CI 1.06 to 1.59) and promoted
ulcer healing (RR 1.24, 95% CI 1.04 to 1.48) when compared with placebo
low-
quality
evidence
high-quality
evidence
moderate-
quality
evidence
moderate-
quality
evidence
TASC II
• Improved healing of
ischemic ulcers
• No benefit for
amputation
Global vascular guidelines on the management of chronic limb-threatening ischemia
9. Hiperbaric oxygen
12 trials and 577 patients
HBOT increased the rate of ulcer healing
in DFUs at 6 weeks but not at longer term
follow-up, with no significant difference in
the risk of major amputation.
• There may be a role for the use of HBOT to accelerate ulcer healing in
diabetic patients with nonhealing neuropathic ulcers and low-grade
ischemia who have failed to respond to conventional wound care.
• HBOT does not prevent major limb amputation and should not be
used as an alternative to revascularization in patients with CLTI.
TASC II
• Selected patients who have
not responded to
revascularization
Global vascular guidelines on the management of chronic limb-threatening ischemia
10. Venous arterialization
• 15 papers were included in this systematic review, 768 patients.
• The primary outcome measure was post-operative limb salvage at 12 months.
• Secondary outcome measures were 30 day or in-hospital mortality, survival,
patency, technical success, and wound healing.
• Venous arterialisation could be a valuable treatment option in patients facing
amputation of the affected limb; however, the current evidence is of low quality
Limb salvage rate at one year was 75% (0.75, 95% CI 0.70-
0.81).
Thirty day or in-hospital mortality ranged from 0 to 10%.
Overall survival ranged from 54% to 100% with a mean
follow-up ranging from 5 to 60 months.
Patency of the venous arterialisations was of 59-71% at 12
months.
Global vascular guidelines on the management of chronic limb-threatening ischemia
Represents the end stage of peripheral artery disease; Definition: PAD + Rest pain, gangrene, or lower limb ulceration > 2 weeks.
High morbiity: Significant mortality, limb loss, pain and diminished quality of life
The GVG where initiative was created to improve quality of care and to identify key research priorities
establishing direct inflow to the foot is the primary technical goal inflow
Non-reconstructable CLI, defined as CLI with no peripheral run-off vessels that could be treated through bypass or angioplasty approaches;
In some cases it is sufficient to get better inflow, like in rest pain or patients presenting minor degrees of tissue loss (WIFi 2)
The definition of a no-option anatomic pattern of disease is dependent on clinical context.
(eg, GLASS P2 modifier)
Angiography may occasionally fail to detect a patent distal artery target, and there are reports of successful tibial and pedal bypass grafting based on exploration of an artery identified on Doppler ultrasound examination that was not identified on contrast arteriography
SCS: Electrodes are implanted in the lumbar epidural space and connected to a generator to stimulate sensory fibers that promotes activation of cell signaling pathways that cause the release of vasodilatory molecules, leading to a decrease in vascular resistance and relaxation of smooth muscle cells.
LS: LS increases blood flow to the lower limb by inducing vasodilation of the collateral circulation and shunting of blood through cutaneous arteriovenous anastomoses by its reduction of sympathetic tone
IPC: increase in the arteriovenous pressure gradient, which stimulates the endothelial vasodilators, thus suspending the venoarteriolar reflex and stimulating collateral artery growth.
Prostanids: Prostanoids are inflamatory mediators, act by inhibiting the activation of platelets and leukocytes, by inhibiting the adhesion and aggregation of platelets, and by promoting vasodilation and vascular endothelial cytoprotection through antithrombotic and profibrinolytic activities
HBOT: increase oxygen transport capacity of plasma (independent of red blood corpuscle number and function), improved function of the leukocyte oxygen-dependent peroxidase system, reduced tissue edema due to the osmotic effect of oxygen, stimulation of progenitor stem cell mobilization and angiogenesis, and improved fibroblast function.
Also inhibits bacterial growth (particularly anaerobes), generates free radicals that destroy bacterial cellular structures, and improves the oxygen-dependent transport of antibiotics
VA: the use of the disease free venous bed as an alternative conduit for perfusion of the peripheral tissues with arterial blood.
Study of 2013
Complications: implantation problems 9%, reintervention for changes in stimulation 15%, infection 3%
Conclusions: pain relief and an 11% reduction in the amputation rate but high cost and possible complications
higher in the SCS group by $8824
$111,705 per limb saved and $312,754 per quality-adjusted life-year gained. SCS is not a cost-effective treatment of CLTI.
Systematic review with 13 papers that represented the best evidence
Lumbar sympathectomy is a minimally invasive procedure with a low complication rate.
MACE: 37% at 4.5 years versus 68% of patients with pramary amputation at 4.5 years.
The only study to include a comparison group found a large, statistically significant effect in favour of IPC treatment.
Improve of quality of life
No mayor adverse event, being abrasion the most commun (10%) with a compliance above 90%
Objectives: To determine the effectiveness and safety of prostanoids in patients with CLI unsuitable for rescue or reconstructive intervention.
21 compared different prostanoids versus placebo, seven compared prostanoids versus other agents, and five conducted head-to-head comparisons using two different prostanoids.
he most commonly reported adverse events were headache, nausea, vomiting, diarrhoea, flushing, and hypotension
although these small beneficial effects were diluted when we performed a sensitivity analysis that excluded studies at high risk of bias
A subgrup suggested that iloprost appeared to reduce major amputation (RR, 0.69; 95% CI, 0.52-0.93) and fared better with rest pain (RR, 1.54; 95% CI, 1.19-1.99) and ulcer healing (RR, 1.80; 95% CI, 1.29-2.50).
first published by Halstead and Vaughan in 1912, review of 2016
Multiple papers about this topic continue coming out so I hope soon there will be better evidence and maybe this will be the standar of care for non revascularizable chronic limb threating ischemia
The LimFlow system is the only registered device to perform a to perform a total percutaneous DVA