Limb salvage in diabetic patients with no-option critical limb ischemia: outcomes of a specialized center experience

Paola, Luca Dalla; Cimaglia, Paolo; Carone, Anna; Scavone, Giuseppe; Boscarino, Giulio; Bernucci, Davide; Sbarzaglia, Paolo; Censi, Stefano; Ferrari, Roberto; Campo, Gianluca

doi:10.1080/2000625x.2019.1696012

Cited by 21 publications

(20 citation statements)

References 20 publications

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“…Similarly, there were fewer patients with ischemic heart disease (41% vs. 66%) and dialysis (14% vs. 34%) in the population described by Uccioli et al, in comparison to our data [ 12 ]. A recent study by Dalla Paola et al reported approximately 8% of NO-CLI patients among 1024 subjects, although fewer patients with ischemic heart disease (approximately 55%) and hemodialysis (19%) were observed in comparison to our sample [ 13 ].…”

Section: Discussioncontrasting

confidence: 59%

Characteristics and Outcome for Persons with Diabetic Foot Ulcer and No-Option Critical Limb Ischemia

Meloni

Izzo

Ros

et al. 2020

JCM

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The study aimed to evaluate clinical and vascular characteristics, as well as outcomes, for diabetic persons with foot ulceration and no-option critical limb ischemia (CLI). The study group included a sample of patients admitted to our diabetic foot unit because of a new diabetic foot ulcer and CLI. All subjects were managed using a limb salvage protocol which includes lower-limb revascularization. According to whether or not the revascularization procedure was a success, patients were respectively divided into two groups: successfully treated CLI patients (ST-CLI) and no-option CLI patients (NO-CLI). Failed revascularization was considered in the case of technical recanalization failure of occluded vessels (inability to overcome the obstruction) and/or absence of arterial flow to the foot. Limb salvage, major amputation, and death after 1 year of follow-up were evaluated and compared between the two groups. Overall, 239 patients were included, 74.9% belonging to ST-CLI and 25.1% to NO-CLI. NO-CLI patients reported more cases of ischemic heart disease (80 vs. 62.1, p = 0.008), heart failure (63.3 vs. 32.4%, p < 0.0001), and end-stage renal disease (ESRD) (60 vs. 25.7%) than ST-CLI patients. In addition, more vessels were affected in the NO-CLI group (5.2 ± 1.6 vs. 4 ± 1.5, p < 0.0001), and there was more involvement of tibio-peroneal trunk (50 vs. 30.2%, p = 0.006), anterior tibial (93.3 vs. 82.7, p = 0.03), posterior tibial (93.3 vs. 73.7%, p = 0.0005), peroneal (70 vs. 48%, p = 0.002), and below-the-ankle arteries (73.3 vs. 39.1%, p < 0.0001) than ST-CLI. The 1 year outcomes for the whole population were 69.9% limb salvage, 10.9% major amputation, and 19.2% death. The outcomes for NO-CLI and ST-CLI were, respectively, as follows: limb salvage (13.8 vs. 73.4%, p < 0.0001), amputation (30 vs. 4.5%, p = 0.0001), and mortality (50 vs. 8.9%, p < 0.0001). NO-CLI patients showed a more severe pattern of peripheral arterial disease (PAD) with distal arterial lesions and worse outcomes than ST-CLI.

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Section: Discussioncontrasting

confidence: 59%

Characteristics and Outcome for Persons with Diabetic Foot Ulcer and No-Option Critical Limb Ischemia

Meloni

Izzo

Ros

et al. 2020

JCM

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“…When DFU develops, the healing process can be, in most of the cases, slow and challenging. Lower extremity amputation after a DFU can be devastating for the patient, affecting quality of life and lead to a poor prognosis, 13,14 despite Wukich et al having published data about improved quality of life after transtibial amputation in diabetic patients. 22 Peripheral arterial disease is detected in 50% to 60% of patients affected by foot ulceration with a noninvasive vascular assessment.…”

Section: Discussionmentioning

confidence: 99%

“…If the amputation takes place as complication of diabetes, morbidity and mortality rates are extremely high; a 5-year mortality rate after an amputation is higher than 45%. [1][2][3][5][6][7][8][9][10][11][12][13][14] In diabetic patients with critical limb ischemia (CLI), a successful revascularization (percutaneous transluminal angioplasty [PTA] or peripheral bypass grafts) reduces the major amputation rates. 11 In some cases, revascularization is not possible, so the term "no-option critical limb ischemia" was born.…”

Section: Introductionmentioning

confidence: 99%

“…These patients became a real challenge because of the high risk of major amputation and mortality rate they are carrying. [11][12][13][14][15][16] Today the percentage of patients experiencing a failure in lower limb revascularization has decreased, despite being still present. The management of these patients is very difficult, and frequently major amputation is considered the only therapeutic option available.…”

Section: Introductionmentioning

confidence: 99%

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Use of Integra Dermal Regeneration Template for Limb Salvage in Diabetic Patients With No-Option Critical Limb Ischemia

Paola

Cimaglia

Carone

et al. 2020

The International Journal of Lower Extremity Wounds

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We have analyzed in a retrospective study of consecutive diabetic patients affected by no-option critical limb ischemia (CLI) the efficacy of the dermal substitute Integra Dermal Regeneration Template for treatment of complicated foot lesions. The primary end point was limb salvage and 1-year amputation-free survival. The secondary end point was healing time of surgical site. Between October 2014 and October 2017, 1024 patients with diabetic foot ulcer (DFU) and CLI were admitted. In 84 patients (8.2%), there was a failure in distal revascularization with a persistent CLI after the procedure. Despite the persistent CLI, a group of 26 patients of this cohort obtained complete wound healing. Among them, 13 patients were treated with surgical debridement or open amputations and application of dermal substitute Integra Dermal Regeneration Template and the other 13 patients were treated without any dermal substitute. The Integra group healed within a mean time of 83.5 days, and the control group healed within a mean of 139 days ( P = .028). No major amputation was carried out at 1-year follow-up in the Integra group versus 15% in the control group. A conservative foot surgery or an approach with minor amputation in diabetic patients with no-option CLI may achieve limb salvage. The use of Integra Dermal Regeneration Template in patients with DFU and no-option CLI may be a useful option in a limb salvage program.

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“…Outcomes of patients with no-option CLTI who do not undergo revascularization are poor, with rates of limb loss up to 46% at 1 year. 3,13–18 These patients also suffer from a low quality of life and higher rates of mortality relative to other patients with CLTI. 17 These results reflect real-world studies of patients with no-option CLTI.…”

Section: Natural History Of Nonrevascularized Severe Cltimentioning

confidence: 99%

A Review and Proposed Classification System for the No-Option Patient With Chronic Limb-Threatening Ischemia

2020

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A growing, but poorly defined subset of patients with chronic limb-threatening ischemia (CLTI) have “no option” for revascularization. One notable subgroup includes patients with severe ischemia and advanced pedal artery occlusive disease, termed “desert foot,” who are at high risk for major amputation due to a lack of conventional revascularization options. Although new therapies are being developed for no-option patients with desert foot anatomy, this subgroup and the broader group of no-option patients are not well defined, limiting the ability to evaluate outcomes. Based on a systematic review, a classification of the no-option CLTI patient was constructed for use in clinical practice and studies. Several no-option conditions were identified, including type I—severe and pedal occlusive disease (desert foot anatomy) for which there is no accepted method of repair; type II—lack of suitable venous conduit for bypass in the setting of an acceptable target for bypass; type III—extensive tissue loss with exposure of vital structures that renders salvage impossible; type IV—advanced medical comorbidities for which available revascularization options would pose a prohibitive risk; and type V—presence of a nonfunctional limb. While type I and type II patients may have no option for revascularization, type III and type V patients have wounds, infection, comorbidities, or functional status that may leave them with few options for revascularization. As treatment strategies continue to evolve and novel methods of revascularization are developed, the ability to identify no-option patients in a standardized fashion will aid in treatment selection and assessment of outcomes.

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Limb salvage in diabetic patients with no-option critical limb ischemia: outcomes of a specialized center experience

Cited by 21 publications

References 20 publications

Characteristics and Outcome for Persons with Diabetic Foot Ulcer and No-Option Critical Limb Ischemia

Characteristics and Outcome for Persons with Diabetic Foot Ulcer and No-Option Critical Limb Ischemia

Use of Integra Dermal Regeneration Template for Limb Salvage in Diabetic Patients With No-Option Critical Limb Ischemia

A Review and Proposed Classification System for the No-Option Patient With Chronic Limb-Threatening Ischemia

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