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Journal of Vascular Surgery Jun 2022Vascular complications remain a prevalent and devastating complication of extracorporeal membrane oxygenation (ECMO). Risks for vascular complications have risen as the...
BACKGROUND
Vascular complications remain a prevalent and devastating complication of extracorporeal membrane oxygenation (ECMO). Risks for vascular complications have risen as the volume and medical complexity of ECMO cases has rapidly increased in recent years. This study assesses occurrence and clinical impact of vascular complications across all ECMO modes and cannulation methods in a high-volume academic center.
METHODS
A retrospective single-institution review was performed of all ECMO cannulations for central or peripheral venovenous (VV) or venoarterial (VA) ECMO in 2019-2020. Patients who expired during cannulation were excluded. Primary outcomes of vascular consultation rates at or after ECMO placement, limb loss, and mortality were assessed during index hospitalization.
RESULTS
A total of 229 patients were identified during the 2-year study period. VA ECMO was used in the majority of patients (n = 137, 60%), with 83% (N = 114) undergoing peripheral cannulation. Vascular surgery was consulted in 54 (23.6%) patients. Complication rates ranged from 33.9% in peripheral VA cannulation to 7% in jugular VV cannulation. Overall, 65% of vascular consults required operative intervention; interventions were highest in peripheral VA ECMO (n = 30 of 114, 26.3%). Across all ECMO types, acute limb ischemia (ALI) was the most common complication (n = 38, 16.5%), with rates ranging from 26.1% in central VA ECMO to 4.8% in jugular VV ECMO. Distal antegrade perfusion catheters (DPCs) were employed in n = 68 of 114 (59.6%) of all peripheral VA ECMO cases. Prophylactic DPCs were found to be incorrectly placed in 10.2% (n = 7 of 68) of cases, which obscured the ability to fully evaluate the effect of prophylactic DPCs on reducing rates of ALI. Major amputation (Below Knee Amputation/Above Knee Amputation) occurred in six peripheral VA patients (5.3%), two central VA patients (8.65), and two femoral-femoral VV patients (4%). Patients with ALI experienced significantly lower rates of in-hospital survival in Kaplan-Meier analysis (32.5% vs 54%, log-rank = 0.023).
CONCLUSIONS
This study highlights the prevalence of vascular complications, and their associated mortality impact, across all modes of ECMO and additionally identifies several areas for institutional performance improvement. ALI was the most common complication across all cohorts and was associated with decreased in-hospital survival. The impact of DPC on ALI was difficult to elucidate due to nonstandardized placement patterns and selective use. In the care of these medically complex patients on multidisciplinary teams, review of outcomes and group discussions targeting areas for improvement are critical to success; in this study, findings resulted in the development of a lower extremity perfusion management protocol.
Topics: Cardiovascular Diseases; Catheterization, Peripheral; Extracorporeal Membrane Oxygenation; Femoral Artery; Humans; Ischemia; Retrospective Studies; Risk Factors
PubMed: 35090988
DOI: 10.1016/j.jvs.2022.01.078 -
Journal of Cardiothoracic Surgery Apr 2021Determine if shortening the covered section of a self-expanding bidirectional arterial cannula, can enhance retrograde flow and thus reduce the risk of lower limb...
OBJECTIVES
Determine if shortening the covered section of a self-expanding bidirectional arterial cannula, can enhance retrograde flow and thus reduce the risk of lower limb ischemia.
METHODS
Outlet pressure vs flow rate was determined for three cannulas types: a 15F self-expanding bidirectional cannula having a covered section of 90 mm, the same cannula but with a shorter covered section of 60 mm, and a Biomedicus cannula as control. The performances of all the cannulas were compared using a computerized flow-bench with calibrated sensors and a centrifugal pump. Water retrograde flow was determined using a tank timer technique. Anterograde and retrograde flow rate versus outlet pressure were determined at six different pump speed.
RESULTS
For each of the six pump speed, both bidirectional cannulas, 60-mm covered and 90-mm covered respectively, showed higher performance than Biomedicus cannula control, as demonstrated by higher flow rate and lower pressure. We also observed that for the bidirectional cannula with shorter covered section, i.e. 60 mm coverage, provides enhanced performance as compared to a 90-mm coverage. Finally, the flow rate and the corresponding pressure can be consistently measured by our experimental set-up with low variability.
CONCLUSIONS
The new configuration of a shorter covered section in a bidirectional self-expanding cannula design, may present an opportunity to overcome lower leg ischemia during extra-corporal life support with long term peripheral cannulation.
Topics: Cannula; Cardiac Surgical Procedures; Equipment Design; Extracorporeal Membrane Oxygenation; Humans; Ischemia; Leg; Perfusion
PubMed: 33902666
DOI: 10.1186/s13019-021-01500-3 -
International Journal of Environmental... Jan 2023Critical ischemia of the lower limbs refers to the last stages of peripheral arterial disease. It is characterized by resting discomfort or trophic disorders such as...
BACKGROUND
Critical ischemia of the lower limbs refers to the last stages of peripheral arterial disease. It is characterized by resting discomfort or trophic disorders such as ulceration, skin necrosis, or gangrene in the lower limbs. Critical ischemia corresponds to Leriche-Fontaine (LF) stages III-IV and Rutherford stages 4-6. The purpose of this study was to observe the patency and postoperative complications of patients who have had infra-inguinal surgical revascularization and compare the results based on the kind of graft utilized.
METHODS
The present study was designed as an observational retrospective cohort study, including all patients from 2018 to 2019 diagnosed with severe ischemia of the lower limbs who were hospitalized at the Vascular Surgery Clinic of the County Emergency Clinical Hospital of Targu Mures.
RESULTS
Patients with a polytetrafluoroethylene (PTFE) graft had a higher incidence of chronic obstructive pulmonary disease ( = 0.01), stage III LF (70.41% vs. 55.29%), = 0.03), and a lower incidence of stage IV LF (29.95% vs. 44.71%, = 0.03). As for complications, the PTFE group showed a lower incidence of bypass thrombosis (29.59% vs. 44.71%; = 0.03) and graft infection (9.18% vs. 21.18%; = 0.02), but no statistical significance in the event of bleeding ( = 0.40). Regarding the outcomes, no statistical significance was seen for below-the-knee amputations or death. However, the PTFE group had a lower incidence of above-the-knee amputations (11.22% vs. 24.71%; = 0.01). At multivariate analysis, the PTFE graft is an independent predictor of primary patency at 6, 12, and 24 months (OR: 2.15, = 0.02; OR: 1.84, = 0.04; and OR: 1.89, = 0.03), as well as a protective factor against bypass thrombosis (OR: 0.52; = 0.03), graft infection (OR: 0.37; = 0.02), and above-the-knee amputation (OR: 0.38; = 0.01).; Conclusions: According to this study's findings, there were minor differences regarding the long-term patency, bypass thrombosis, graft infections, and above-the-knee amputations. In addition, the PTFE graft group had a higher incidence of primary patency at 6, 12, and 24 months, as well as a lower incidence of bypass thrombosis, graft infection, and above-the-knee amputations.
Topics: Humans; Polyethylene Terephthalates; Blood Vessel Prosthesis; Blood Vessel Prosthesis Implantation; Chronic Limb-Threatening Ischemia; Femoral Artery; Retrospective Studies; Vascular Patency; Ischemia; Postoperative Complications; Polytetrafluoroethylene; Treatment Outcome
PubMed: 36673997
DOI: 10.3390/ijerph20021235 -
Journal of Vascular Surgery Jul 2020Endovascular tibial interventions for chronic limb-threatening ischemia are frequent, but the implications of early failure (≤30 days) of an isolated tibial...
BACKGROUND
Endovascular tibial interventions for chronic limb-threatening ischemia are frequent, but the implications of early failure (≤30 days) of an isolated tibial intervention are still unclear. The aim of this study was to examine the patient-centered outcomes after early failure of isolated tibial artery intervention.
METHODS
A database of patients undergoing lower extremity endovascular interventions between 2007 and 2017 was retrospectively queried. Patients with chronic limb-threatening ischemia (Rutherford classes 4, 5, and 6) were selected, and failures within 30 days were identified. Lack of technical success at the time of the procedure was an exclusion. Intention-to-treat analysis by patient was performed. Patient-oriented outcomes of clinical efficacy (absence of recurrent symptoms, maintenance of ambulation, and absence of major amputation), amputation-free survival (survival without major amputation), and freedom from major adverse limb events (MALEs; above-ankle amputation of the index limb or major reintervention [new bypass graft, jump or interposition graft revision]) were evaluated.
RESULTS
There were 1779 patients (58% male; average age, 65 years; 2898 vessels) who underwent tibial intervention for chronic limb-threatening ischemia; 284 procedures (16%) were early failures. In the early failure group, 124 cases (44%) were considered immediate (<24 hours), and 160 cases (56%) failed within the first 30 days after intervention. The two modes of failure were hemodynamic failure (47%) and progression of chronic limb-threatening ischemia (53%). Bypass after early failure was successful in patients with adequate vein, target vessel of ≥3 mm, and good inframalleolar runoff. Progression of symptoms was associated with major amputation in patients with Rutherford class 5 and class 6 disease. Presentation with diabetes and end-stage renal disease were identified as independent clinical predictors for early failure. Lesion calcification, reference vessel diameter <3 mm, lesion length >300 mm, and poor inframalleolar runoff were identified as independent anatomic predictors for early failure and increased MALEs. Early failure was predictive of poor long-term clinical efficacy (11% ± 9% vs 39% ± 8% at 5 years, mean ± standard error of the mean, early vs no early failure; P = .01) and amputation-free survival (16% ± 9% vs 47% ± 9% at 5 years, mean ± standard error of the mean, early vs no early failure; P = .02).
CONCLUSIONS
Both clinical and anatomic factors can predict early failure of endovascular therapy for isolated tibial disease. Early failure significantly increases 30-day major amputation and 30-day MALEs and is associated with poor long-term patient-centered outcomes.
Topics: Aged; Aged, 80 and over; Amputation, Surgical; Chronic Disease; Databases, Factual; Disease Progression; Endovascular Procedures; Female; Humans; Ischemia; Limb Salvage; Male; Middle Aged; Peripheral Arterial Disease; Retrospective Studies; Risk Factors; Tibial Arteries; Time Factors; Treatment Failure
PubMed: 32035771
DOI: 10.1016/j.jvs.2019.11.035 -
Journal of Vascular Surgery Sep 2023There is a relative lack of comparative effectiveness research on revascularization for patients with chronic limb-threatening ischemia (CLTI). We examined the...
OBJECTIVE
There is a relative lack of comparative effectiveness research on revascularization for patients with chronic limb-threatening ischemia (CLTI). We examined the association between lower extremity bypass (LEB) vs peripheral vascular intervention (PVI) for CLTI and 30-day and 5-year all-cause mortality and 30-day and 5-year amputation.
METHODS
Patients undergoing LEB and PVI of the below-the-knee popliteal and infrapopliteal arteries between 2014 and 2019 were queried from the Vascular Quality Initiative, and outcomes data were obtained from the Medicare claims-linked Vascular Implant Surveillance and Interventional Outcomes Network database. Propensity scores were calculated on 15 variables using a logistic regression model to control for imbalances between treatment groups. A 1:1 matching method was used. Kaplan-Meier survival curves and hierarchical Cox proportional hazards regression with a random intercept for site and operator nested in site to account for clustered data compared 30-day and 5-year all-cause mortality between groups. Thirty-day and 5-year amputation were subsequently compared using competing risk analysis to account for the competing risk of death.
RESULTS
There was a total of 2075 patients in each group. The overall mean age was 71 ± 11 years, 69% were male, and 76% were white, 18% were black, and 6% were of Hispanic ethnicity. Baseline clinical and demographic characteristics in the matched cohort were balanced between groups. There was no association between all-cause mortality over 30 days and LEB vs PVI (cumulative incidence, 2.3% vs 2.3% by Kaplan Meier; log-rank P-value = .906; hazard ratio [HR], 0.95; 95% confidence interval [CI], 0.62-1.44; P-value = .80). All-cause mortality over 5 years was lower for LEB vs PVI (cumulative incidence, 55.9% vs 60.1% by Kaplan Meier; log-rank P-value < .001; HR, 0.77; 95% CI, 0.70-0.86; P-value < .001). Accounting for competing risk of death, amputation over 30 days was also lower in LEB vs PVI (cumulative incidence function, 1.9% vs 3.0%; Fine and Gray P-value = .025; subHR, 0.63; 95% CI, 0.42-0.95; P-value = .025). There was no association between amputation over 5 years and LEB vs PVI (cumulative incidence function, 22.6% vs 23.4%; Fine and Gray P-value = .184; subHR, 0.91; 95% CI, 0.79-1.05; P-value = .184).
CONCLUSIONS
In the Vascular Quality Initiative-linked Medicare registry, LEB vs PVI for CLTI was associated with a lower risk of 30-day amputation and 5-year all-cause mortality. These results will serve as a foundation to validate recently published randomized controlled trial data, and to broaden the comparative effectiveness evidence base for CLTI.
Topics: Aged; Aged, 80 and over; Female; Humans; Male; Middle Aged; Chronic Limb-Threatening Ischemia; Endovascular Procedures; Ischemia; Limb Salvage; Lower Extremity; Medicare; Peripheral Arterial Disease; Retrospective Studies; Risk Factors; Treatment Outcome; United States; Comparative Effectiveness Research
PubMed: 37207790
DOI: 10.1016/j.jvs.2023.05.015 -
Journal of Vascular Surgery Apr 2023Hypercoagulability is common in severe acute respiratory syndrome coronavirus 2 and has been associated with arterial thrombosis leading to acute limb ischemia (ALI)....
OBJECTIVE
Hypercoagulability is common in severe acute respiratory syndrome coronavirus 2 and has been associated with arterial thrombosis leading to acute limb ischemia (ALI). Our objective was to determine the outcomes of concurrent coronavirus disease 2019 (COVID-19) infection and ALI, particularly during the Delta variant surge and the impact of vaccination status.
METHODS
A retrospective review was performed of patients treated at a single health care system between March 2020 and December 2021 for ALI and recent (<14 days) COVID-19 infection or who developed ALI during hospitalization for the same disease. Patients were grouped by year as well as by pre and post Delta variant emergence in 2021 based on the World Health Organization timeline (January to May vs June to December). Baseline demographics, imaging, interventions, and outcomes were evaluated. A control cohort of all patients with ALI requiring surgical intervention for a 2-year period prior to the pandemic was used for comparison. Primary outcomes were in-hospital mortality and amputation-free survival. Kaplan-Meier survival and Cox proportional hazards analysis were performed.
RESULTS
Forty acutely ischemic limbs were identified in 36 patients with COVID-19, the majority during the Delta surge (52.8%) and after the wide availability of vaccines. The rate of COVID-19-associated ALI, although low overall, nearly doubled during the Delta surge (0.37% vs 0.20%; P = .09). Intervention (open or endovascular revascularization vs primary amputation) was performed on 31 limbs in 28 individuals, with the remaining eight treated with systemic anti-coagulation. Postoperative mortality was 48%, and overall mortality was 50%. Major amputation following revascularization was significantly higher with COVID-19 ALI (25% vs 3%; P = .006) compared with the pre-pandemic group. Thirty-day amputation-free survival was significantly lower (log-rank P < .001). COVID-19 infection (adjusted hazard ratio, 6.2; P < .001) and age (hazard ratio, 1.1; P = .006) were associated with 30-day amputation in multivariate analysis. Severity of COVID-19 infection, defined as vasopressor usage, was not associated with post-revascularization amputation. There was a higher incidence of re-thrombosis in the latter half of 2021 with the Delta surge, as reintervention for recurrent ischemia of the same limb was more common than our previous experience (21% vs 0%; P = .55). COVID-19-associated limb ischemia occurred almost exclusively in non-vaccinated patients (92%).
CONCLUSIONS
ALI observed with Delta appears more resistant to standard therapy. Unvaccinated status correlated highly with ALI occurrence in the setting of COVID-19 infection. Information of limb loss as a COVID-19 complication among non-vaccinated patients may help to increase compliance.
Topics: Humans; COVID-19; Endovascular Procedures; Ischemia; Limb Salvage; Lower Extremity; Peripheral Arterial Disease; Retrospective Studies; Risk Factors; SARS-CoV-2; Treatment Outcome; Vaccines; COVID-19 Vaccines
PubMed: 36526086
DOI: 10.1016/j.jvs.2022.12.002 -
Journal of Vascular Surgery Apr 2023The WIfI (Wound, Ischemia, foot Infection) stage measures the extent of wounds, ischemia, and foot infection in patients with chronic limb threatening ischemia (CLTI)... (Randomized Controlled Trial)
Randomized Controlled Trial
OBJECTIVE
The WIfI (Wound, Ischemia, foot Infection) stage measures the extent of wounds, ischemia, and foot infection in patients with chronic limb threatening ischemia (CLTI) and has been associated with the risk of major amputation. Patients with CLTI have impaired health-related quality of life (HRQoL), which can be multifactorial. We hypothesized that the severity of the limb threat (WIfI stage) would be associated with poor HRQoL among patients with CLTI presenting for revascularization.
METHODS
The dataset of the BEST-CLI (best endovascular versus best surgical therapy in patients with CLTI) trial, a prospective, randomized trial comparing open and endovascular revascularization strategies, was queried for HRQoL assessments at patient enrollment. The HRQoL assessments included (1) Vascular Quality of Life; (2) 12-item short form survey (SF-12), containing the utility index score (short-form six-dimension R2 utility index, incorporating physical, emotional, and mental well-being) and mental and physical components; and (3) the EQ-5D. Multivariable regression analysis was used to identify the independent associations with the baseline HRQoL assessments.
RESULTS
A total of 1568 patients with complete WIfI data were analyzed, of whom 71.5% were men. The WIfI distribution was 35.5% with stage 4, 29.6% with stage 3, 28.6% with stage 2, and 6.3% with stage 1. Patients presenting with WIfI stage 4, compared with stage 1 to 3, were more often men (74.9% vs 69.6%) and current smokers (25.4% vs. 17.6%), had had end-stage renal disease (13.3% vs 8.5%) and diabetes (83.6% vs 60.2%), were not independently ambulatory (56.8% vs 38.5%), and had had higher median morbidity scores (4 vs 3; P < .05 for all). On multivariable analysis, WIfI stage 4, compared with stage 1 to 3, was associated with lower SF-12 mental component scale scores (estimate, -2.43; 95% confidence interval, -3.73 to -1.13; P < .001) and short-form six-dimension R2 utility index scores (estimate, -0.02; 95% confidence interval, -0.03 to 0.001; P = .04). The WIfI stage was not independently associated with the baseline Vascular Quality of Life, SF-12 physical component scale, or EQ-5D assessments.
CONCLUSIONS
WIfI stage was independently associated with poorer quality of life because of mental, rather than physical, health for patients with CLTI. Clinicians should be aware of the burden of mental stress borne by those with the greatest limb impairment.
Topics: Male; Humans; Female; Limb Salvage; Quality of Life; Risk Factors; Prospective Studies; Treatment Outcome; Peripheral Arterial Disease; Ischemia; Chronic Limb-Threatening Ischemia; Retrospective Studies; Endovascular Procedures
PubMed: 36435274
DOI: 10.1016/j.jvs.2022.11.050 -
Journal of Vascular Surgery Dec 2022The traditionally reported outcomes for patients with ischemic wounds have centered on amputation-free survival. However, that discounts the importance of other...
BACKGROUND
The traditionally reported outcomes for patients with ischemic wounds have centered on amputation-free survival. However, that discounts the importance of other patient-centered outcomes such as the wound healing time (WHT) and wound-free period (WFP). We evaluated the long-term wound outcomes of patients treated for chronic limb-threatening ischemia at our institution.
METHODS
From 2014 to 2017, we identified all patients with chronic limb-threatening ischemia and ischemic wounds using symptomatic and hemodynamic criteria. The primary data included the wound size, wound location, WIfI (wound, ischemia, foot infection) grade, WHT, WFP, minor and major amputation, and death. Wounds were not considered healed if the patient had required a major amputation or had died before wound healing. The WHT was calculated as the interval in days between the diagnosis and determination of a healed wound. The WFP was calculated as the interval in days between a healed wound and wound recurrence, major amputation, death, or the end of the study period. A comparison of the wound healing parameters stratified by revascularization status was performed using the Student t test. A generalized linear model adjusted for age, sex, initial wound size, and WIfI grade was used to evaluate the risk of wound healing with and without revascularization.
RESULTS
A total of 256 patients had presented with 372 wounds. Of the 256 patients, 48% had undergone revascularization. During the study period, 97 minor amputations and 100 major amputations had been required, and 132 patients had died. The average wound size was 13.9 ± 52.0 cm; however, for the 155 wounds that had healed, the average size was only 4.0 ± 9.6 cm (P = .002). No differences were found in the wound size when stratified by revascularization status (P = .727). Adjusted for the initial wound size, the risk of wound healing was not different when stratified by revascularization (risk ratio, 1.22; 95% confidence interval, 0.80-1.87; P = .354). For those whose wounds had healed, the average WHT and WFP were 173 ± 169 days and 775 ± 317 days, respectively. The WHT was not faster for the revascularized group (155 days vs 188 days; P = .221). When stratified by revascularization status, the rate of wound recurrence was 4.6 vs 8.9 wounds per 100 person-years for the revascularized and nonrevascularized groups, respectively (P = .125).
CONCLUSIONS
In our study, we found that, except for patients who presented with severe ischemia, revascularization was not associated with improved rates of wound healing. Among the wounds that healed, regardless of the initial ischemia grade, revascularization was not associated with a faster WHT or longer WFPs.
Topics: Humans; Limb Salvage; Chronic Limb-Threatening Ischemia; Treatment Outcome; Risk Factors; Time Factors; Retrospective Studies; Ischemia; Peripheral Arterial Disease
PubMed: 35810955
DOI: 10.1016/j.jvs.2022.05.025 -
The Cochrane Database of Systematic... Jul 2022Peripheral arterial disease is a major health problem, and in about 1% to 2% of patients, the disease progresses to critical limb ischaemia (CLI), also known as critical... (Review)
Review
BACKGROUND
Peripheral arterial disease is a major health problem, and in about 1% to 2% of patients, the disease progresses to critical limb ischaemia (CLI), also known as critical limb-threatening ischaemia. In a substantial number of individuals with CLI, no effective treatment options other than amputation are available, with around a quarter of these patients requiring a major amputation during the following year. This is the second update of a review first published in 2011.
OBJECTIVES
To evaluate the benefits and harms of local intramuscular transplantation of autologous adult bone marrow mononuclear cells (BMMNCs) as a treatment for CLI.
SEARCH METHODS
We used standard, extensive Cochrane search methods. The latest search date was 8 November 2021.
SELECTION CRITERIA
We included all randomised controlled trials (RCTs) of CLI in which participants were randomly allocated to intramuscular administration of autologous adult BMMNCs or control (either no intervention, conventional conservative therapy, or placebo).
DATA COLLECTION AND ANALYSIS
We used standard Cochrane methods. Our primary outcomes of interest were all-cause mortality, pain, and amputation. Our secondary outcomes were angiographic analysis, ankle-brachial index (ABI), pain-free walking distance, side effects and complications. We assessed the certainty of the evidence using the GRADE approach.
MAIN RESULTS
We included four RCTs involving a total of 176 participants with a clinical diagnosis of CLI. Participants were randomised to receive either intramuscular cell implantation of BMMNCs or control. The control arms varied between studies, and included conventional therapy, diluted autologous peripheral blood, and saline. There was no clear evidence of an effect on mortality related to the administration of BMMNCs compared to control (risk ratio (RR) 1.00, 95% confidence interval (CI) 0.15 to 6.63; 3 studies, 123 participants; very low-certainty evidence). All trials assessed changes in pain severity, but the trials used different forms of pain assessment tools, so we were unable to pool data. Three studies individually reported that no differences in pain reduction were observed between the BMMNC and control groups. One study reported that reduction in rest pain was greater in the BMMNC group compared to the control group (very low-certainty evidence). All four trials reported the rate of amputation at the end of the study period. We are uncertain if amputations were reduced in the BMMNC group compared to the control group, as a possible small effect (RR 0.52, 95% CI 0.27 to 0.99; 4 studies, 176 participants; very low-certainty evidence) was lost after undertaking sensitivity analysis (RR 0.52, 95% CI 0.19 to 1.39; 2 studies, 89 participants). None of the included studies reported any angiographic analysis. Ankle-brachial index was reported differently by each study, so we were not able to pool the data. Three studies reported no changes between groups, and one study reported greater improvement in ABI (as haemodynamic improvement) in the BMMNC group compared to the control group (very low-certainty evidence). One study reported pain-free walking distance, finding no clear difference between BMMNC and control groups (low-certainty evidence). We pooled the data for side effects reported during the follow-up, and this did not show any clear difference between BMMNC and control groups (RR 2.13, 95% CI 0.50 to 8.97; 4 studies, 176 participants; very low-certainty evidence). We downgraded the certainty of the evidence due to the concerns about risk of bias, imprecision, and inconsistency.
AUTHORS' CONCLUSIONS
We identified a small number of studies that met our inclusion criteria, and these differed in the controls they used and how they measured important outcomes. Limited data from these trials provide very low- to low-certainty evidence, and we are unable to draw conclusions to support the use of local intramuscular transplantation of BMMNC for improving clinical outcomes in people with CLI. Evidence from larger RCTs is needed in order to provide adequate statistical power to assess the role of this procedure.
Topics: Adult; Amputation, Surgical; Bone Marrow; Humans; Ischemia; Peripheral Arterial Disease; Randomized Controlled Trials as Topic; Transplantation, Autologous
PubMed: 35802393
DOI: 10.1002/14651858.CD008347.pub4 -
Minerva Anestesiologica Nov 2023
Topics: Humans; Peripheral Nerves; Ischemia; Anesthesia, Conduction
PubMed: 37194242
DOI: 10.23736/S0375-9393.23.17439-6