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1.
Ann Surg Oncol ; 2024 Sep 10.
Article in English | MEDLINE | ID: mdl-39256312

ABSTRACT

BACKGROUND: Isolated limb infusion (ILI) treats unresectable extremity malignancies with high-dose regional chemotherapy limited to the limb. This study assessed long-term outcomes after ILI for limb-threatening sarcomas. METHODS: A retrospective review analyzed patients with an extremity sarcoma who underwent ILI with melphalan and dactinomycin from 2008 to 2023 at a single institution. RESULTS: The study identified 61 patients (52.5% female; median age, 73 years; range, 20-94 years). Of these patients, 68.9% had lower-extremity disease. The median follow-up period was 6.9 years. The overall response rate was 48.3% (complete response [CR], 21.7%; partial response [PR], 26.7%), and the disease control rate (DCR: CR + PR + stable disease [SD]) was 65%. The median progression-free survival (PFS) for the patients with CR/PR/SD/progressive disease (PD) was respectively 16.8/9.6/4.8/2.4 months (P < 0.0001). The responders (CR + PR) had significantly longer PFS than the non-responders (SD + PD) (hazard ratio [HR], 6.3; 95% confidence interval [CI], 3.1-12.9; P < 0.001). The median in-field PFS times for CR/PR/SD/PD were respectively 16.8/12/4.8/2.4 months (P < 0.001). The responders had a significantly longer risk of in-field PFS than the non-responders (HR, 5.9; 95% CI 2.9-12.0; P < 0.001). The median distant relapse PFS for CR/PR/SD/PD was not reached (NR)/NR/44.4/40.8 months (P = 0.02). The responders had a significantly longer distant relapse PFS than the non-responders (HR, 2.7; range, 1.1-6.8; P = 0.04). The median overall survival (OS) was 8.6 years for the responders and 4.1 years for the non-responders (P = 0.02). The disease-specific survival (DSS) rates were 87% at 1 year, 71% at 3 years, and 64% at 5 years. The median DSS was not reached for the responders and was 4.1 years for the non-responders (P = 0.003). The limb salvage rates at 6 months were 85% at 1 year, 80% at 3 years, and 70% at 5 years. The patients with PD had a higher risk of requiring amputation than the patients with CR + PR + SD (HR, 3.0; 95% CI 1.0-8.7; P = 0.04). CONCLUSIONS: The 5-year limb salvage rates after ILI are notably high, reaching 70%. After ILI, the responders had significantly better in-field and distant relapse PFS, OS, and DSS.

2.
J Vasc Surg ; 79(6): 1447-1456.e2, 2024 Jun.
Article in English | MEDLINE | ID: mdl-38310981

ABSTRACT

OBJECTIVE: Inadequate vein quality or prior harvest precludes use of autologous single segment greater saphenous vein (ssGSV) in many patients with chronic limb-threatening ischemia (CLTI). Predictors of patient outcome after infrainguinal bypass with alternative (non-ssGSV) conduits are not well-understood. We explored whether limb presentation, bypass target, and conduit type were associated with amputation-free survival (AFS) after infrainguinal bypass using alternative conduits. METHODS: A single-center retrospective study (2013-2020) was conducted of 139 infrainguinal bypasses performed for CLTI with cryopreserved ssGSV (cryovein) (n = 71), polytetrafluoroethylene (PTFE) (n = 23), or arm/spliced vein grafts (n = 45). Characteristics, Wound, Ischemia, and foot Infection (WIfI) stage, and outcomes were recorded. Multivariable Cox proportional hazards and classification and regression tree analysis modeled predictors of AFS. RESULTS: Within 139 cases, the mean age was 71 years, 59% of patients were male, and 51% of cases were nonelective. More patients undergoing bypass with cryovein were WIfI stage 4 (41%) compared with PTFE (13%) or arm/spliced vein (27%) (P = .04). Across groups, AFS at 2 years was 78% for spliced/arm, 79% for PTFE, and 53% for cryovein (adjusted hazard ratio for cryovein, 2.5; P = .02). Among cases using cryovein, classification and regression tree analysis showed that WIfI stage 3 or 4, age >70 years, and prior failed bypass were predictive of the lowest AFS at 2 years of 36% vs AFS of 58% to 76% among subgroups with less than two of these factors. Although secondary patency at 2 years was worse in the cryovein group (26% vs 68% and 89% in arm/spliced and PTFE groups; P < .01), in patients with tissue loss there was no statistically significant difference in wound healing in the cryovein group (72%) compared with other bypass types (72% vs 87%, respectively; P = .12). CONCLUSIONS: In patients with CLTI lacking suitable ssGSV, bypass with autogenous arm/spliced vein or PTFE has superior AFS compared with cryovein, although data were limited for PTFE conduits for distal targets. Despite poor patency with cryovein, wound healing is achieved in a majority of cases, although it should be used with caution in older patients with high WIfI stage and prior failed bypass, given the low rates of AFS.


Subject(s)
Amputation, Surgical , Limb Salvage , Peripheral Arterial Disease , Saphenous Vein , Wound Healing , Humans , Male , Retrospective Studies , Female , Aged , Saphenous Vein/transplantation , Risk Factors , Time Factors , Peripheral Arterial Disease/surgery , Peripheral Arterial Disease/physiopathology , Peripheral Arterial Disease/mortality , Middle Aged , Risk Assessment , Polytetrafluoroethylene , Aged, 80 and over , Chronic Limb-Threatening Ischemia/surgery , Blood Vessel Prosthesis , Vascular Grafting/adverse effects , Vascular Grafting/mortality , Vascular Grafting/methods , Vascular Patency , Blood Vessel Prosthesis Implantation/adverse effects , Blood Vessel Prosthesis Implantation/instrumentation , Blood Vessel Prosthesis Implantation/mortality , Progression-Free Survival , Cryopreservation , Treatment Outcome
3.
J Vasc Surg ; 2024 May 31.
Article in English | MEDLINE | ID: mdl-38823529

ABSTRACT

OBJECTIVE: Occlusive disease of the common femoral artery can generate profound lower extremity ischemia as the normal collateral pathways from the profunda to the superficial femoral artery cannot adequately develop. In patients with lifestyle-limiting claudication, isolated common femoral endarterectomy (CFE) is highly effective. Because CFE does not provide direct, in-line flow to the plantar arch, it has been felt to provide inadequate revascularization to patients with chronic limb-threatening ischemia (CLTI). The purpose of this retrospective clinical study was to report and assess the natural history of selected patients with CLTI treated with isolated CFE (without concomitant infrainguinal revascularization). METHODS: Consecutive CFEs performed in a large, urban hospital for CLTI between 2014 and 2021 were reviewed. Patient characteristics, limb, and anatomical stages using the Wound, Ischemia, foot Infection (WIfI) and Global Limb Anatomic Staging System were tabulated. Limb-specific and survival-related end points were analyzed. RESULTS: Fifty-eight patients presenting with CLTI underwent isolated CFE (mean age, 74 ± 10 years; 62% male, 90% current or prior smoker). Comorbidities included diabetes (52%), coronary artery disease (55%), congestive heart failure (22%), and end-stage renal failure on hemodialysis (5%). Patients presented with either rest pain (36%) or tissue loss (64%); the latter group exhibited advanced limb threat (68% in WIfI stage 3 or 4). The majority of patients had associated severe infrainguinal disease (50% Global Limb Anatomic Staging Systems 3). After a median follow-up of 17 months (range, 10-29 months), vascular reintervention was required in 7 patients (12%). One patient (2%) required major limb amputation after presentation in WIfI stage 4 (W3I3fI0). Indeed, WIfI stage 4 was a significant univariate predictor of the need for subsequent infrainguinal bypass (P = .034). CONCLUSIONS: Isolated CFE as primary therapy in highly selected patients with CLTI was safe and effective. Index limb stage is predictive of the need for associated infrainguinal revascularization in this complex population.

4.
J Vasc Surg ; 80(2): 515-526, 2024 Aug.
Article in English | MEDLINE | ID: mdl-38604318

ABSTRACT

OBJECTIVE: Annual trends of lower extremity amputation due to end-stage chronic disease are on the rise in the United States. These amputations are leading to massive expenses for patients and the medical system. In Oklahoma, we have a high-risk population because access to care is low, the number of uninsured is high, cardiovascular health is poor, and our overall health care performance is ranked 50th in the country. But we know little about Oklahomans and their risk of limb loss. It is, therefore, imperative to look closely at this population to discover contemporary rates, trends, and state-specific risk factors for amputation due to diabetes and/or peripheral arterial disease (PAD). We hypothesize that state-specific groups will be identified as having the highest risk for limb loss and that contemporary trends in amputations are rising. To create implementable solutions to limb preservation, a baseline must be set. METHODS: We conducted a 12-consecutive-year observational study using Oklahoma's hospital discharge data. Discharges among patients 20 years or older with a primary or secondary diagnosis of diabetes and/or PAD were included. Diagnoses and amputation procedures were identified using International Classification of Disease-9 and -10 codes. Amputation rates were calculated per 1000 discharges. Trends in amputation rates were measured by annual percentage changes (APC). Prevalence ratios evaluated the differences in amputation rates across demographic groups. RESULTS: Over 5,000,000 discharges were identified from 2008 to 2019. Twenty-four percent had a diagnosis of diabetes and/or PAD. The overall amputation rate was 12 per 1000 discharges for those with diabetes and/or PAD. Diabetes and/or PAD-related amputation rates increased from 8.1 to 16.2 (APC, 6.0; 95% confidence interval [CI], 4.7-7.3). Most amputations were minor (59.5%), and although minor, increased at a faster rate compared with major amputations (minor amputation APC, 8.1; 95% CI, 6.7-9.6 vs major amputation APC, 3.1; 95% CI, 1.5-4.7); major amputations were notable in that they were significantly increasing. Amputation rates were the highest among males (16.7), American Indians (19.2), uninsured (21.2), non-married patients (12.7), and patients between 45 and 49 years of age (18.8), and calculated prevalence ratios for each were significant (P = .001) when compared within their respective category. CONCLUSIONS: Amputation rates in Oklahoma have nearly doubled in 12 years, with both major and minor amputations significantly increasing. This study describes a worsening trend, underscoring that amputations due to chronic disease is an urgent statewide health care problem. We also present imperative examples of amputation health care disparities. By defining these state-specific areas and populations at risk, we have identified areas to pursue and improve care. These distinctive risk factors will help to frame a statewide limb preservation intervention.


Subject(s)
Amputation, Surgical , Peripheral Arterial Disease , Humans , Oklahoma/epidemiology , Amputation, Surgical/trends , Amputation, Surgical/statistics & numerical data , Risk Factors , Male , Middle Aged , Female , Aged , Peripheral Arterial Disease/surgery , Peripheral Arterial Disease/epidemiology , Peripheral Arterial Disease/diagnosis , Time Factors , Risk Assessment , Retrospective Studies , Treatment Outcome , Limb Salvage/trends , Adult , Aged, 80 and over , Young Adult , Diabetic Foot/surgery , Diabetic Foot/epidemiology , Diabetic Foot/diagnosis , Databases, Factual
5.
J Vasc Surg ; 79(6): 1438-1446.e2, 2024 Jun.
Article in English | MEDLINE | ID: mdl-38401777

ABSTRACT

OBJECTIVE: Major adverse limb event-free survival (MALE-FS) differed significantly by initial revascularization approach in the BEST-CLI randomized trial. The BEST-CLI trial represented a highly selected subgroup of patients seen in clinical practice; thus, we examined the endpoint of MALE-FS in an all-comers tertiary care practice setting. METHODS: This is a single-center retrospective study of consecutive, unique patients who underwent technically successful infrainguinal revascularization for chronic limb-threatening ischemia (2011-2021). MALE was major amputation (transtibial or above) or major reintervention (new bypass, open bypass revision, thrombectomy, or thrombolysis). RESULTS: Among 469 subjects, the mean age was 70 years, and 34% were female. Characteristics included diabetes (68%), end-stage renal disease (ESRD) (16%), Wound, Ischemia, and foot Infection (WIfI) stage 4 (44%), Global Limb Anatomic Staging System (GLASS) stage 3 (62%), and high pedal artery calcium score (pMAC) (22%). Index revascularization was autogenous vein bypass (AVB) (30%), non-autogenous bypass (NAB) (13%), or endovascular (ENDO) (57%). The composite endpoint of MALE or death occurred in 237 patients (51%) at a median time of 189 days from index revascularization. In an adjusted Cox model, factors independently associated with MALE or death included younger age, ESRD, WIfI stage 4, higher GLASS stage, and moderate-severe pMAC, whereas AVB was associated with improved MALE-FS. Freedom from MALE-FS, MALE, and major amputation at 30 days were 90%, 92%, and 95%; and at 1 year were 63%, 70%, and 83%, respectively. MALE occurred in 144 patients (31%) and was associated with ESRD, WIfI stage, GLASS stage, pMAC score, and index revascularization approach. AVB had superior durability, with adjusted 2-year freedom from MALE of 72%, compared with 66% for ENDO and 51% for NAB. Within the AVB group, spliced vein conduit had higher MALE compared with single-segment vein (hazard ratio, 1.8; 95% confidence interval, 0.9-3.7; P = .008 after inverse propensity weighting), but there was no statistically significant difference in major amputation. Of the 144 patients with any MALE, the first MALE was major reintervention in 47% and major amputation in 53%. Major amputation as first MALE was associated with non-AVB index approach. Indications for major reintervention were symptomatic stenosis/occlusion (54%), lack of clinical improvement (28%), asymptomatic graft stenosis (16%), and iatrogenic events (3%). Conversion to bypass occurred after 6% of ENDO cases, two-thirds of which involved distal bypass targets at the ankle or foot. CONCLUSIONS: In this consecutive, all-comers cohort, disease complexity was associated with procedural selection and MALE-FS. AVB independently provided the greatest MALE-FS and freedom from MALE and major amputation. Compared with the BEST-CLI randomized trial, MALE after ENDO in this series was more frequently major amputation, with relatively few conversions to open bypass.


Subject(s)
Amputation, Surgical , Limb Salvage , Peripheral Arterial Disease , Humans , Male , Female , Retrospective Studies , Aged , Risk Factors , Time Factors , Peripheral Arterial Disease/surgery , Peripheral Arterial Disease/mortality , Peripheral Arterial Disease/diagnostic imaging , Middle Aged , Risk Assessment , Chronic Limb-Threatening Ischemia/surgery , Progression-Free Survival , Aged, 80 and over , Endovascular Procedures/adverse effects , Endovascular Procedures/mortality , Treatment Outcome
6.
J Vasc Surg ; 2024 Sep 18.
Article in English | MEDLINE | ID: mdl-39303863

ABSTRACT

OBJECTIVE: Poor glycemic control in the perioperative period has been reported to be associated with early and late major adverse limb events (MALE). However, these studies were mostly from large databases or lacked long-term outcomes. We examined the long-term effects of high hemoglobin A1c (HbA1c) level on patency, MALE, limb salvage (LS) and survival after lower extremity revascularization procedures in diabetic patients. METHODS: Patients with diabetes who had revascularization for Rutherford class 3-6 ischemia between May 2002 and December 2018 were identified. Patients with HbA1c≤7% were compared to HbA1c>7% for patency, MALE, survival, LS and amputation-free survival (AFS). RESULTS: Of 706 patients, 699 had HbA1c data (775 limbs), with 311 (357 limbs) in HbA1c≤7%, and 388 (418 limbs) in HbA1c>7% groups. Patients with HbA1c>7% were younger (69.9±10.2 vs 71.7±9.5, P=0.011), had higher lipid levels, insulin use (70% vs 49%, P<0.01), ASA 4, and had lower prevalence of chronic kidney disease (CKD) (32%vs41%, P=0.023). HbA1c>7% patients were more likely to present with chronic limb-threatening ischemia (CLTI) (79% vs 72%,P=0.019) and undergo infrapopliteal interventions (49% vs 42%, P=0.005), with no difference in anatomic complexity (TASC C/D, 75% vs 77%, p=0.72) or type of revascularization (24% vs 18% Open, 66% vs 70% EV, 10% vs 12% Hybrid, p=0.236). Patency and freedom from MALE were significantly lower in patients with HbA1c>7% for infra-inguinal revascularizations, whereas AFS and overall survival were similar. In patients with CLTI, LS rates at five years were significantly lower in patients undergoing open revascularization (HbA1c>7%: 64%±6%vs HbA1c<7%:86%±5%, P=0.020), whereas it was similar after endovascular interventions (HbA1c>7%:79%±4% vs HbA1c<7%:77%±3%, p=0.631). Seventy patients with HbA1c>7% lost limbs vs 38 patients with HbA1c≤7% (P=0.007). In multivariate analysis, HbA1c was significantly associated with primary patency. HbA1c, insulin use, level of intervention, and ACEI use were associated with MALE. CONCLUSIONS: Perioperative HbA1c>7% is associated with poorer patency rates, and increased MALE especially at the infra-inguinal level revascularization in diabetics, with no significant impact on survival. Limb salvage is impacted after open, but not after endovascular revascularization.

7.
J Vasc Surg ; 80(3): 792-799.e1, 2024 Sep.
Article in English | MEDLINE | ID: mdl-38649101

ABSTRACT

OBJECTIVE: This study aimed to compare the influence of inframalleolar (IM) P0/P1 on wound healing in bypass surgery vs endovascular therapy (EVT) in patients with chronic limb-threatening ischemia (CLTI). METHODS: We retrospectively analyzed the multicenter data of patients who underwent infra-inguinal revascularization for CLTI between 2015 and 2022. IM P represents target artery crossing into foot, with intact pedal arch (P0) and absent or severely diseased pedal arch (P1). The endpoints were wound healing, limb salvage (LS), and postoperative complications. RESULTS: We analyzed 66 and 189 propensity score-matched pairs in the IM P0 and IM P1 cohorts, respectively. In the IM P0 cohort, the 1-year wound healing rates were 94.5% and 85.7% in the bypass surgery and EVT groups, respectively (P = .092), whereas those in the IM P1 cohort were 86.2% and 66.2% in the bypass surgery and EVT groups, respectively (P < .001). In the IM P0 cohort, the 2-year LS rates were 96.7% and 94.1% in the bypass surgery and EVT groups, respectively (P = .625), and those in the IM P1 cohort were 91.8% and 81.5% in the bypass surgery and EVT groups, respectively (P = .004). No significant differences were observed between the bypass surgery and EVT in terms of postoperative complication rates in either the IM P0 or P1 cohorts. CONCLUSIONS: Bypass surgery facilitated better wound healing and LS than EVT in patients with IM P1. Conversely, no differences in wound healing or LS were observed between groups in patients with IM P0. Bypass surgery should be considered a better revascularization strategy than EVT in patients with tissue loss and IM P1 disease.


Subject(s)
Chronic Limb-Threatening Ischemia , Endovascular Procedures , Limb Salvage , Peripheral Arterial Disease , Wound Healing , Humans , Male , Female , Retrospective Studies , Aged , Endovascular Procedures/adverse effects , Treatment Outcome , Middle Aged , Peripheral Arterial Disease/physiopathology , Peripheral Arterial Disease/therapy , Peripheral Arterial Disease/surgery , Peripheral Arterial Disease/diagnostic imaging , Time Factors , Chronic Limb-Threatening Ischemia/surgery , Risk Factors , Aged, 80 and over , Postoperative Complications/etiology , Vascular Grafting/adverse effects , Risk Assessment , Ischemia/physiopathology , Ischemia/surgery , Ischemia/therapy
8.
J Surg Res ; 301: 62-70, 2024 Sep.
Article in English | MEDLINE | ID: mdl-38917575

ABSTRACT

INTRODUCTION: The Best Endovascular versus Best Surgical Therapy in Patients with Critical Limb Ischemia (BEST-CLI) trial results suggest that in patients with chronic limb-threatening ischemia (CLTI) and adequate single-segment great saphenous vein (SSGSV) by preoperative duplex ultrasonography, a surgical-first treatment strategy is superior to an endovascular-first strategy. However, the utilization of vein mapping prior to endovascular-first revascularization for CLTI in actual clinical practice is not known. METHODS: Data from a multicenter clinical data warehouse (2008-2019) were linked to Medicare claims data for patients undergoing endovascular-first treatment of infra-inguinal CLTI. Only patients who would have otherwise been eligible for enrollment in BEST-CLI were included. Adequate SSGSV was defined as healthy vein >3.0 mm in diameter from the groin through the knee. Logistic regression was used to estimate associations between preprocedure characteristics and vein mapping. Survival methods were used to estimate the risk of major adverse limb events and death. RESULTS: A total of 142 candidates for either surgical or endovascular treatment underwent endovascular-first management of CLTI. Ultrasound assessment for SSGSV was not performed in 76% of patients prior to endovascular-first revascularization. Of those who underwent preprocedure vein mapping, 44% had adequate SSGSV for bypass. Within one year postprocedure, 12.0% (95% confidence interval 7.4-18.0%) of patients underwent open surgical bypass and 54.7% (95% confidence interval 45.3-62.4%) experienced a major adverse limb event or death. CONCLUSIONS: In a real-world cohort of BEST-CLI-eligible patients undergoing endovascular-first intervention for infra-inguinal CLTI, three-quarters of patients had no preprocedure ultrasound assessment of great saphenous vein conduit. Practice patterns for vein conduit assessment in the real-world warrant reconsideration in the context of BEST-CLI trial results.


Subject(s)
Endovascular Procedures , Saphenous Vein , Humans , Female , Male , Endovascular Procedures/methods , Aged , Aged, 80 and over , Saphenous Vein/surgery , Saphenous Vein/diagnostic imaging , Practice Patterns, Physicians'/statistics & numerical data , Ultrasonography, Doppler, Duplex , Chronic Limb-Threatening Ischemia/surgery , Retrospective Studies , Ischemia/surgery , Ischemia/diagnostic imaging , Ischemia/therapy , Preoperative Care/methods , United States
9.
J Endovasc Ther ; : 15266028241266211, 2024 Aug 06.
Article in English | MEDLINE | ID: mdl-39105588

ABSTRACT

PURPOSE: To describe a novel bailout technique to approach below-the-ankle (BTA) chronic total occlusions or plantar-arch severe disease where the balloon/catheter is unable to follow the crossing guidewire and no other described recanalization approach is feasible. TECHNIQUE: When facing a complex BTA revascularization, if the guidewire crosses but the balloon cannot progress due to a lack of pushability, an antegrade puncture of the infrapopliteal vessel where the tip of the guidewire lays is performed. The guidewire is then carefully navigated through this distal BTA vessel into the needle to achieve its rendezvous and externalization. A low-profile balloon is inserted through the femoral access and advanced till the non-crossable point of the BTA vessels. A torque device is then attached to the proximal hub of the balloon, and the through-and-through guidewire is subsequently pulled from the new distal access, allowing the balloon to be dragged across the lesion together with the wire. CONCLUSION: The below-the-ankle antegrade teleferic (BAT) technique may be considered for highly complex BTA revascularization procedures where the wire crosses the lesion, but no other device can be tracked over it. CLINICAL IMPACT: The clinical impact of this article lies in the description of a bailout technique for BTA revascularization where the guidewire crosses, but no device can be advanced. This technique can be helpful in scenarios where failure to achieve success could result in limb loss. The BAT technique provides a solution in extremely challenging cases, enhancing technical success, improving outcomes and potentially preserving the limbs of patients who would otherwise face amputation, if not revascularized.The video shows the BAT technique performed with a support catheter under fluoroscopy: antegrate puncture of the DP, advancement of the support catheter over the wire, rendezvous of the guidewire in the catheter and subsequent externalization of the wire.

10.
J Endovasc Ther ; : 15266028241234506, 2024 Mar 05.
Article in English | MEDLINE | ID: mdl-38441118

ABSTRACT

CLINICAL IMPACT: When the standard endovascular crossing maneuvers have failed during CLTI recanalization procedures and the distal below-the-knee or proximal below-the-ankle retrograde access is not possible due to chronic occlusion of the vessels, mastering the more distal and complex retrograde BTA punctures may be advantageous.There are scanty reports regarding the retrograde puncture of the mid and forefoot vessels. The aim of this article is to review different tips and tricks related to these techniques to help operators to apply them in specific scenarios to eventually improve procedural success rate.

11.
Eur J Vasc Endovasc Surg ; 67(3): 468-479, 2024 Mar.
Article in English | MEDLINE | ID: mdl-37931680

ABSTRACT

OBJECTIVE: Biomimetic stents are peripheral infrainguinal self expanding stents that mimic the anatomy of the vasculature and artery movement. They are indicated for use in infrainguinal arteries. This research aimed to synthesise all current evidence on the use of biomimetic stents as adjuncts for endovascular treatment of infrainguinal peripheral arterial disease (PAD), helping to guide clinical decision making. DATA SOURCES: MEDLINE, Embase, CINAHL and Cochrane databases. REVIEW METHODS: Random effects meta-analysis following PRISMA guidelines (PROSPERO registration CRD42022385256). Study quality was assessed using the Joanna Briggs Institute critical appraisal tools checklist, and certainty assessment through the Grading of Recommendations, Assessment, Development and Evaluation (GRADE). Endpoints included primary patency, target lesion revascularisation, stent fracture, secondary patency, and Death at one year. RESULTS: In total, 37 studies were included in the meta-analysis (33 cohort studies, two case series, and two randomised controlled trials [RCTs]), representing 4 480 participants. Of these, 34 studies included data on the Supera (81.5% of participants) and three studies reported data on the BioMimics 3D (18.5% of participants) stents. The pooled primary patency rate of 33 studies at one year follow up was 81.4% (95% confidence interval [CI] 78.7 - 83.9%), and the pooled target lesion revascularisation rate of 18 studies at one year was 12.2% (95% CI 9.6 - 15.0%). The certainty of evidence outcome rating as qualified by GRADE was very low for both. Only one study reported a positive stent fracture rate at one year follow up of 0.4% with a certainty of evidence outcome of low. CONCLUSION: Using biomimetic stents for infrainguinal PAD may be associated with acceptable one year primary patency and target lesion revascularisation rates, with a near negligible one year stent fracture rate. Their use should be considered in those presenting with infrainguinal PAD undergoing endovascular revascularisation. A RCT is necessary to determine their clinical and cost effectiveness.


Subject(s)
Endovascular Procedures , Peripheral Arterial Disease , Humans , Biomimetics , Peripheral Arterial Disease/surgery , Stents , Treatment Outcome , Vascular Patency
12.
Article in English | MEDLINE | ID: mdl-39260766

ABSTRACT

OBJECTIVE: In peripheral arterial disease, patency, limb salvage, and survival rates are mostly reported using Kaplan-Meier analyses. When comparing different revascularisation techniques, these methods have limitations in analysing complex patient flows over time. This study aimed to present, illustrate, and discuss new concepts based on multistate models of analysing outcome parameters in peripheral arterial disease. METHODS: Previously published data from a single centre, randomised controlled trial (RCT) with 218 cases that underwent either vein bypass surgery (bypass group, n = 109) or nitinol stent angioplasty (stent group, n = 109) of long femoropopliteal lesions were re-analysed using non-homogeneous Markov models. A step by step description of the concepts of states, state space, definitions, and illustration of transition probability curves as well as the benefits of multistate models is given. The RCT was registered at ISRCTN.com (ISRCTN18315574). RESULTS: Transition probability curves over time showed similar patterns in the bypass and stent groups. Significant differences in the transition probabilities were found for transitions from primary patency as well as secondary patency to end of patency. The transition probability for patients with preserved primary patency at 24 months who moved to end of patency at 48 months was 19.9% in the stent group vs. 6.4% in the bypass group (p < .001). CONCLUSION: The proposed method can answer important questions, such as: Did patients after femoropopliteal stenting with preserved primary patency at two years lose their patency more quickly within the following years compared with bypass surgery? and Did stent patients after a re-intervention to maintain patency at one year lose their patency more quickly compared with bypass surgery within the following years? Completely new research questions can now be raised and answered to optimise treatment and follow up strategies; this might lead to better identification of subgroups at higher risk of clinical deterioration following revascularisation procedures.

13.
Ann Vasc Surg ; 2024 Sep 28.
Article in English | MEDLINE | ID: mdl-39349239

ABSTRACT

INTRODUCTION: Diabetes is strongly correlated with the development of critical limb ischemia (CLI), with a predilection for below-the-knee and below-the-ankle patterns of arterial disease. The angiosome concept, described as a potential framework for targeted revascularization in CLI, has generated divergent opinions over the last decades. This study aims to evaluate the implication of angiosome targeted revascularization in wound healing in diabetic patients. MATERIALS AND METHODS: This is a single-center retrospective study including diabetic patients with ischemic ulcers admitted for invasive vascular study and revascularization between January and December 2019. The primary outcome was to evaluate the impact of angiosome-targeted revascularization in wound healing. Limb-based patency and amputation-free survival according to GLASS stage and revascularization procedures were considered secondary outcomes. RESULTS: Data from 117 limbs of 114 diabetic patients with neuroischemic diabetic foot were evaluated. There was no significant difference between targeted and non-targeted angiosome-revascularization in wound healing at 12 months. However, angiosome targeted revascularization was associated with shorter healing times. The severity of the infection was the only variable with an impact on healing time. Endovascular surgery did not show inferior patency to open surgery, even in patients with more complex arterial disease (GLASS III). CONCLUSION: Although angiosome-guided revascularization did not demonstrate significantly higher healing rates at 12 months, there appears to be a trend towards faster healing.

14.
BMC Musculoskelet Disord ; 25(1): 567, 2024 Jul 20.
Article in English | MEDLINE | ID: mdl-39033278

ABSTRACT

BACKGROUND: Limb salvage surgery is an important method for treating malignant tumors of the bone involving the adjacent parts of the major joints in children. This technique allows for preservation of limb function, especially in the lower limb. However, the reconstruction of the proximal end of the tibia after removing the tumor mass with a rational scale to preserve the total knee joint and reduce limb length discrepancy presents a challenge. CASE PRESENTATION: We present a case of osteosarcoma of the proximal tibia. After being treated with an extended tumor resection, the proximal tibia of the child was restructured using endoprosthetic replacement with epiphyseal preservation. This procedure preserves the entire articular surface and growth plate of the knee joint of the affected limb and provides a feasible alternative protocol for retaining the function and growth potential of the affected limb. The patient remained disease-free and normal limb motor function was observed during the 3.5 year follow-up since the initial surgery. CONCLUSIONS: Preservation of the epiphysis enabled our patient to perform better limb function after limb-saving surgery as a result of his undamaged knee joint and minimized limb-length discrepancy. We believe that endoprosthetic replacement with preservation of the epiphysis can provide the best strategy for reconstruction after resection of focal malignant tumors in long bones without epiphytic involvement.


Subject(s)
Bone Neoplasms , Epiphyses , Limb Salvage , Osteosarcoma , Tibia , Humans , Osteosarcoma/surgery , Tibia/surgery , Tibia/diagnostic imaging , Bone Neoplasms/surgery , Epiphyses/surgery , Male , Limb Salvage/methods , Child , Plastic Surgery Procedures/methods , Knee Joint/surgery , Knee Joint/diagnostic imaging , Knee Joint/physiopathology , Treatment Outcome
15.
Vascular ; : 17085381241263909, 2024 Jun 19.
Article in English | MEDLINE | ID: mdl-38896848

ABSTRACT

OBJECTIVES: The 2019 Global Vascular Guidelines recommended open bypass for patients at average risk with greater limb severity and anatomical complexity. However, the outcomes of tibial and pedal bypass (TPB) are inferior to those of above-the-knee surgical revascularization. This may be due to the technical difficulty and need for development of skills to perform TPB. However, there is a limited knowledge on the learning curve in TPB. Thus, the aim of the study is to assess this learning curve in a single-center retrospective analysis. METHODS: Cases treated with TPB with an autologous vein conduit in patients with chronic limb-threatening ischemia (CLTI) at a Japanese single center from 2009 to 2022 were analyzed retrospectively. The primary endpoint was the learning curve for TPB. RESULTS: The study included 449 TPB procedures conducted by a single main surgeon in patients with CLTI (median age, 75 years; 309 males; diabetes mellitus, 73%; end stage renal failure with hemodialysis, 44%). The operative time decreased significantly as the number of cases accumulated (p < .001). Using the cumulative sum (CUSUM) operative time, the learning curve was estimated to be phase 1 (initial learning curve) for 134 cases (1-134); phase 2 (competent period) for 179 cases (135-313); and phase 3 (mastery and challenging period) for 136 cases (314-449). The mean follow-up period was 34 ± 31 months. The 1- and 3-year limb salvage rates of 97% and 96% in phase 3 were significantly higher than those in phases 1 and 2 (p < .001, p = .029). Major adverse limb events (MALE) occurred in 117 (26%) patients, and the 1- and 3-year MALE rates of 10% and 17% in phase 3 were significantly lower than those in phases 1 and 2 (p < .001, p = .009). CONCLUSIONS: In the study, vascular surgeon required a learning curve of 134 TPB cases to Overcoming the learning curve for bypass was associated with improvement of medium-term outcomes for limb salvage and freedom from MALE.

16.
J Hand Surg Am ; 2024 Jan 12.
Article in English | MEDLINE | ID: mdl-38219089

ABSTRACT

PURPOSE: Chronic pain and functional limitations secondary to nerve injuries are a major barrier to optimal recovery for patients following high-energy extremity trauma. Given the associated skeletal and soft tissue management challenges in the polytraumatized patient, concomitant nerve injuries may be overlooked or managed in delayed fashion. Whereas previous literature has reported rates of peripheral nerve injuries at <10% in the setting of high-energy extremity trauma, in our experience, the incidence of these injuries has been much higher. Thus, we sought to define the incidence, pain sequelae, and functional outcomes following upper extremity peripheral nerve injuries in the combat-related limb salvage population. METHODS: We performed a retrospective review of all patients who underwent limb salvage procedures to include flap coverage for combat-related upper extremity trauma at a single institution between January 2011 and January 2020. We collected data on patient demographics; perioperative complications; location of nerve injuries; surgical interventions; chronic pain; and subjective, patient-reported functional limitations. RESULTS: A total of 45 patients underwent flap procedures on 49 upper extremities following combat-related trauma. All patients were male with a median age of 27 years, and 96% (n = 47) of injuries were sustained from a blast mechanism. Thirty-three of the 49 extremities (67%) sustained associated nerve injuries. The most commonly injured nerve was the ulnar (51%), followed by median (30%) and radial/posterior interosseous (19%). Of the 33 extremities with nerve injuries, 18 (55%) underwent surgical intervention. Nerve repair/reconstruction was the most common procedure (67%), followed by targeted muscle reinnervation (TMR, 17%). Chronic pain and functional limitation were common following nerve injury. CONCLUSIONS: Upper extremity peripheral nerve injury is common following high-energy combat-related trauma with high rates of chronic pain and functional limitations. Surgeons performing limb salvage procedures to include flap coverage should anticipate associated peripheral nerve injuries and be prepared to repair or reconstruct the injured nerves, when feasible. TYPE OF STUDY/LEVEL OF EVIDENCE: Therapeutic IV.

17.
Microsurgery ; 44(7): e31241, 2024 Oct.
Article in English | MEDLINE | ID: mdl-39301713

ABSTRACT

BACKGROUND: Adequate vascular anatomy and perfusion status are essential for successful lower extremity free tissue transfer. Computed tomography angiography (CTA) is widely available, minimally invasive, and enables visualization of soft tissues and bones. Angiography permits temporal evaluation of flow, identifies potential needs for concurrent endovascular interventions, and enhances visibility in the setting of hardware. Despite widespread availability of these imaging modalities, no standardized algorithm for preoperative imaging prior to lower extremity free flap reconstruction exists. METHODS: Current Procedural Terminology (CPT) codes identified patients undergoing free flap reconstruction of the lower extremity over an 18-year period (2002-2020). Electronic medical records were reviewed for patient, treatment, and imaging characteristics, and pre- and post-imaging laboratory values. Outcomes included imaging findings and related complications and surgical outcomes. RESULTS: In total, 405 patients were identified, with 59% (n = 238) undergoing preoperative imaging with angiography, 10% (n = 42) with CTA, 7.2% (n = 29) with both imaging modalities, and 24% (n = 96) with neither performed. Forty percent (122 of 309) of patients who underwent preoperative imaging had less than 3-vessel runoff. Four patients developed contrast-induced nephropathy (CIN) after angiography only and one after having both CTA and angiography. Vessel runoff on CTA and angiography demonstrated moderate correlation. CONCLUSION: Most patients undergoing lower extremity free tissue transfer underwent preoperative imaging with angiography and/or CTA, 40% of which had less than 3-vessel runoff. Both angiography and CTA had low complication rates, with no statistically significant risk factors identified. Specifically, the incidence of CIN was not found to be significant using either modality. We discuss our institutional algorithm to aid in decision-making for preoperative imaging prior to lower extremity free flap reconstruction. Specifically, we recommend angiography for patients with peripheral vascular disease, internal hardware, or distal defects secondary to trauma.


Subject(s)
Computed Tomography Angiography , Free Tissue Flaps , Lower Extremity , Plastic Surgery Procedures , Preoperative Care , Humans , Free Tissue Flaps/blood supply , Male , Female , Middle Aged , Preoperative Care/methods , Plastic Surgery Procedures/methods , Lower Extremity/blood supply , Lower Extremity/surgery , Computed Tomography Angiography/methods , Retrospective Studies , Adult , Aged
18.
J Wound Care ; 33(1): 22-27, 2024 Jan 02.
Article in English | MEDLINE | ID: mdl-38197281

ABSTRACT

Patients with diabetes who undergo a kidney transplant are at a great risk of undergoing amputations, usually associated with severe infection and necrosis. The treatment of severe diabetic foot necrosis is challenging in clinic, and the function of the limb is often hugely compromised. A 74-year-old male who had been diagnosed with severe post-renal transplant diabetic foot necrosis refused the option of below-knee amputation from previous surgeons, and requested to keep his left foot. The patient was treated with integrated traditional Chinese medicine (TCM) and Western medicine, with positive results. TCM therapeutic principles included 'clearing heat, removing toxicity, regulating Qi, resolving dampness, activating stagnant blood and nourishing yin as well as tonifying Qi and blood'. Treatment with Western medicine included wound debridement, internal fixation or joint fusion, and use of insulin, antibiotics and vasodilators. The patient was treated with a staged and diverse approach (i.e., a combination of TCM and Western medicine, surgical management and education for diabetic foot care), which ultimately helped the patient achieve limb salvage and regain normal function. A combination therapy of Western medicine and TCM may be a promising approach to heal diabetic foot ulcers.


Subject(s)
Diabetes Mellitus , Diabetic Foot , Aged , Humans , Male , Combined Modality Therapy , Diabetic Foot/surgery , Foot , Treatment Outcome , Medicine, Chinese Traditional
19.
J Wound Care ; 33(2): 118-126, 2024 Feb 02.
Article in English | MEDLINE | ID: mdl-38329832

ABSTRACT

OBJECTIVE: Current guidelines do not recommend the use of antibiotics to treat clinically uninfected ulcers. However, physicians continue to prescribe antibiotics for clinically uninfected ulcers with the rationale 'better to be safe than sorry'. Yet, antibiotic resistance is increasing, side-effects are common and treatment costs are rising. Evidence is needed to identify whether antibiotic treatment for clinically uninfected ulcers can be justified or we should stop prescribing them. The aim of this study was to evaluate whether antibiotic treatment in cases of clinically uninfected ulcers improved ulcer healing compared to treatment without antibiotics. METHOD: Consecutive patients treated in the outpatient clinic for clinically uninfected diabetic foot ulcer both in 2015 and in 2017 were retrospectively analysed. Primary outcome was ulcer healing at one year. Secondary outcomes were limb salvage, freedom from any amputation, amputation-free survival (AFS) and survival. RESULTS: A total of 102 ulcers of 91 patients were included for final analyses. The non-antibiotics and antibiotics groups both consisted of 51 ulcers. Ulcer healing at one year was 77.3% in the non-antibiotics group and 74.7% in the antibiotics group (p=0.158). No difference was found for limb salvage (93.8% versus 95.9%, respectively; p=0.661), freedom from any amputation (85.6% versus 85.6%, respectively; p=1.000), AFS (85.4% versus 79.1%, respectively; p=0.460) or survival (89.6% versus 83.7%, respectively; p=0.426). CONCLUSION: In this study, no benefits of antibiotic treatment over non-antibiotic treatment for clinically uninfected ulcers were identified. The findings of this study emphasise the recommendation of current guidelines to not treat clinically uninfected ulcer with antibiotics.


Subject(s)
Diabetes Mellitus , Diabetic Foot , Humans , Diabetic Foot/drug therapy , Anti-Bacterial Agents/therapeutic use , Wound Healing , Retrospective Studies , Limb Salvage , Diabetes Mellitus/drug therapy
20.
J Wound Care ; 33(Sup3): S51-S58, 2024 Mar 01.
Article in English | MEDLINE | ID: mdl-38457307

ABSTRACT

DECLARATION OF INTEREST: The authors have no conflicts of interest to declare.


Subject(s)
Polyurethanes , Wound Healing , Humans
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