One-year limb salvage and quality of life following mechanical aspiration thrombectomy in patients with acute lower extremity ischemia.

OBJECTIVE: Lower extremity acute limb ischemia (LE-ALI) is associated with high morbidity and mortality rates, and a burden on patient quality of life (QoL). There is limited medium- to long-term evidence on mechanical aspiration thrombectomy (MT) in patients with LE-ALI. The STRIDE study was designed to assess safety and efficacy of MT using the Indigo Aspiration System in patients with LE-ALI. Thirty-day primary and secondary endpoints and additional outcomes were previously published. Here, we report 365-day secondary endpoints and QoL data from STRIDE. METHODS: STRIDE was a multicenter, prospective, single-arm, observational cohort study that enrolled 119 patients across 16 sites in the United States and Europe. Patients were treated first-line with MT using the Indigo Aspiration System (Penumbra, Inc). The study completed follow-up in October 2023. Secondary endpoints at 365 days included target limb salvage and mortality. Additionally, the VascuQoL-6 questionnaire, developed for evaluating patient-centered QoL outcomes for peripheral arterial disease, was assessed at baseline and follow-up through 365 days. RESULTS: Seventy-three percent of patients (87/119) were available for 365-day follow-up. Mean age of these patients was 65.0 ± 13.3 years, and 44.8% were female. Baseline ischemic severity was classified as Rutherford I in 12.6%, Rutherford IIa in 51.7%, and Rutherford IIb in 35.6%. In general, baseline and disease characteristics (demographics, medical history, comorbidities, target thrombus) of these patients are similar to the enrolled cohort of 119 patients. The secondary endpoints at 365 days for target limb salvage was 88.5% (77/87) and mortality rate was 12.0% (12/100). VascuQoL-6 improved across all domains, with a median total score improvement from 12.0 (interquartile range, 9.0-15.0) at baseline to 19.0 (interquartile range, 16.0-22.0) at 365 days. CONCLUSIONS: These 365-day results from STRIDE demonstrate that first-line MT with the Indigo Aspiration System for LE-ALI portray continued high target limb salvage rates and improved patient-reported QoL. These findings indicate Indigo as a safe and effective therapeutic option for LE-ALI.

Multilevel thrombotic or embolic burden and its role in sex-related outcomes in acute limb ischemia.

OBJECTIVE: The impact of sex upon outcomes in acute limb ischemia (ALI) remains disputed. We aim to quantify the effect of sex upon amputation-free survival (AFS) after a percutaneous-first approach for ALI. METHODS: This was a two-center retrospective review of ALI managed via a percutaneous-first approach. Demographics, comorbidities, and clinical characteristics were analyzed. The Kaplan-Meier and Cox regression were used to estimate AFS, limb salvage, and overall survival. RESULTS: Over 9 years, 170 patients (n = 87, 51% males; median age, 67 [interquartile range (IQR), 59-77 years) presented with ALI. Rutherford classification was I in 56 (33%); IIa in 85 (50%); IIb in 20 (12%), and III in 9 (5%). Thirty-day mortality, major amputation rate, and fasciotomy rates were 8% (n = 13); 6.5% (n = 11), and 4.7% (n = 8), respectively. Among revascularized limbs, 92% were patent at 30 days. Length of stay was 7 days (IQR, 3-11 days). Complications included 13 bleeding episodes (8%), four cases of atrial fibrillation (2%), and three re-thrombosis/clot extension events (1.7%). No differences were noted in complication rates when stratified by sex. Females were older than males (median age, 70 [IQR, 62-79] vs 65 [IQR, 56-76 years]; P = .02) and more likely to present with atrial fibrillation (20.5% vs 8%; P = .02) and hyperlipidemia (72% vs 57%; P = .04). Females also more frequently presented with multi-level thrombotic/embolic burden compared with males (56% vs 43%; P = .03) and required both aspiration thrombectomy and thrombolysis (27% vs 14%; P = .02). Kaplan-Meier estimated median AFS, limb salvage, and overall survival were 425 days (IQR, 140-824 days); 314 days (IQR, 72-727 days); and 342 days (IQR, 112-762 days). When stratified by sex, females had worse survival (median, 270 days [IQR, 92-636 days] vs 406 days [IQR, 140-937 days]; P = .005) and limb salvage (median, 241 days [IQR, 88-636 days] vs 363 days [IQR, 49-822 days]; P = .04) compared with males. Univariate Cox regression showed female sex (hazard ratio [HR], 1.46; 95% confidence interval [CI], 1.04-2.05; P = .03), multi-level thrombotic/embolic burden (HR, 1.64; 95% CI, 1.17-2.31; P = .004), and Rutherford class (HR, 1.37; 95% CI, 1.08-1.73; P = .009) predicted major amputation/death. By multivariable Cox regression, multi-level thrombotic/embolic burden (HR, 1.54; 95% CI, 1.09-2.17; P = .01), Rutherford class (HR, 1.34; 95% CI, 1.07-1.69; P = .01), and female sex (HR, 1.45; 95% CI, 1.03-2.05; P = .03) were each independently predictive of major amputation/death. CONCLUSIONS: A percutaneous-first strategy is safe and efficacious in the overall ALI population. Similar to prior works, female vs male patients with ALI in our cohort have higher rates of mortality and major amputation. In our multivariable model, multi-level thrombotic/embolic burden was independently associated with a greater than 45% increased hazard of major amputation/death at last follow-up. Further prospective analysis is warranted to elucidate the underlying factors contributing to the higher prevalence of multi-level thrombotic/embolic burden in female patients with ALI, and to further define the optimal percutaneous-first approach for ALI in consideration of patient sex and extent of clot burden.

Safety and efficacy of mechanical aspiration thrombectomy for patients with acute lower extremity ischemia.

OBJECTIVE: Acute limb ischemia (ALI) is associated with high rates of amputation and consequent morbidity and mortality. The objective of this study is to report on the safety and efficacy of aspiration thrombectomy using the Indigo Aspiration System in patients with lower extremity (LE) ALI. METHODS: The STRIDE study was an international, multicenter, prospective, study that enrolled 119 participants presenting with LE-ALI. Patients were treated firstline with mechanical thrombectomy using the Indigo Aspiration System, before stenting or angioplasty, or other therapies as determined by treating physician. The primary end point was target limb salvage at 30 days after the procedure. Secondary end points within 30 days included technical success, defined as core laboratory-adjudicated Thrombolysis in Myocardial Infarction (TIMI) 2/3 flow rate immediately after the procedure, changes in modified Society for Vascular Surgery runoff score, improvement of Rutherford classification compared with before the procedure, patency, rate of device-related serious adverse events, and major periprocedural bleeding. Secondary end points that will be evaluated at 12 months include target limb salvage and mortality. RESULTS: Of the 119 participants enrolled at 16 sites, the mean age was 66.3 years (46.2% female). At baseline (n = 119), ischemic severity was classified as Rutherford I in 10.9%, Rutherford IIa in 54.6%, and Rutherford IIb in 34.5%. The mean target thrombus length was 125.7 ± 124.7 mm. Before the procedure, 93.0% (of patients 107/115) had no flow (TIMI 0) through the target lesion. The target limb salvage rate at 30 days was 98.2% (109/111). The rate of periprocedural major bleed was 4.2% (5/119) and device-related serious adverse events was 0.8% (1/119). Restoration of flow (TIMI 2/3) was achieved in 96.3% of patients (105/109) immediately after the procedure. The median improvement in the modified Society for Vascular Surgery runoff score (before vs after the procedure) was 6.0 (interquartile range, 0.0-11.0). Rutherford classifications also improved after discharge in 86.5% of patients (83/96), as compared with preprocedural scores. Patency at 30 days was achieved in 89.4% of patients (101/113). CONCLUSIONS: In the STRIDE (A Study of Patients with Lower Extremity Acute Limb Ischemia to Remove Thrombus with the Indigo Aspiration System) study, aspiration thrombectomy with the Indigo System provided a safe and effective endovascular treatment for patients with LE-ALI, resulting in a high rate (98.2%) of successful limb salvage at 30 days, with few periprocedural complications.

Healing rates and outcomes following closed transmetatarsal amputations: A systematic review and random effects meta-analysis of proportions.

Transmetatarsal amputation (TMA) is a common surgical procedure for addressing severe forefoot pathologies, such as peripheral vascular disease and diabetic foot infections. Variability in research methodologies and findings within the existing literature has hindered a comprehensive understanding of healing rates and complications following TMA. This meta-analysis and systematic review aims to consolidate available evidence, synthesising data from multiple studies to assess healing rates and complications associated with closed TMA procedures. Following Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) guidelines, a systematic search of Medline, Embase, and Cochrane databases was conducted for articles published from January 1st, 1988, to June 1st, 2023. Inclusion criteria comprised studies reporting healing rates in non-traumatic transmetatarsal amputation patients with more than 10 participants, excluding open TMAs. Two independent reviewers selected relevant studies, with disagreements resolved through discussion. Data extracted from eligible studies included patient demographics, healing rates, complications, and study quality. Among 22 studies encompassing 1569 transmetatarsal amputations, the pooled healing rate was 67.3%. Major amputation rates ranged from 0% to 55.6%, with a random-effects pooled rate of 23.9%. Revision rates varied from 0% to 36.4%, resulting in a pooled rate of 14.8%. 30-day mortality ranged from 0% to 9%, with a fixed-effects pooled rate of 2.6%. Post-operative infection rates ranged from 3.0% to 30.7%, yielding a random-effects pooled rate of 16.7%. Dehiscence rates ranged from 1.7% to 60.0%, resulting in a random-effects pooled rate of 28.8%. Future studies should aim for standardised reporting and assess the physiological and treatment factors influencing healing and complications.

Contemporary Medical Management of Peripheral Arterial Disease.

PURPOSE: Peripheral arterial disease (PAD) is characterized by atherosclerotic arterial occlusive disease of the lower extremities and is associated with an increased risk of major adverse cardiovascular events (MACE) in addition to disabling clinical sequelae, including intermittent claudication and chronic limb-threatening ischemia (CLTI). Given the growing burden of disease, knowledge of modern practices to prevent MACE and major adverse limb events (MALE) is essential. This review article examines evidence for medical management of PAD and its associated risk factors, as well as wound prevention and care. METHODS: A thorough review of the literature was performed, with attention to evidence for the management of modifiable atherosclerotic risk factors, claudication symptoms, wound prevention, and wound care. RESULTS: Contemporary management of PAD requires a multi-faceted approach to care, with medical optimization of smoking, hypertension, hyperlipidemia, and diabetes mellitus. The use of supervised exercise therapy for intermittent claudication is highlighted. The anatomic disease patterns of smoking and diabetes mellitus are discussed further, and best practices for diabetic foot ulcer prevention, including offloading footwear, are described. Quality wound care is essential in this patient population and involves strategic use of debridement, wound-healing adjuncts, and skin substitutes, when appropriate. CONCLUSION: The objective of medical management of PAD is to reduce the risk of MACE and MALE. Atherosclerotic risk factor optimization, appropriate wound care, and management of diabetic foot ulcers, foot infections, gangrene, and chronic, non-healing wounds are critical components of PAD care. Interdisciplinary care is essential to coordinate care, leverage expertise, and improve outcomes.

Potential applications of artificial intelligence and machine learning on diagnosis, treatment, and outcome prediction to address health care disparities of chronic limb-threatening ischemia.

Chronic limb-threatening ischemia (CLTI) is the most advanced form of peripheral artery disease. CLTI has an extremely poor prognosis and is associated with considerable risk of major amputation, cardiac morbidity, mortality, and poor quality of life. Early diagnosis and targeted treatment of CLTI is critical for improving patient's prognosis. However, this objective has proven elusive, time-consuming, and challenging due to existing health care disparities among patients. In this article, we reviewed how artificial intelligence (AI) and machine learning (ML) can be helpful to accurately diagnose, improve outcome prediction, and identify disparities in the treatment of CLTI. We demonstrate the importance of AI/ML approaches for management of these patients and how available data could be used for computer-guided interventions. Although AI/ML applications to mitigate health care disparities in CLTI are in their infancy, we also highlighted specific AI/ML methods that show potential for addressing health care disparities in CLTI.

Transplant Renal Vein Thrombosis Rescued in a Pediatric Patient Using Suction Thrombectomy.

Renal vein thrombosis after kidney transplant is a rare but potentially graft-threatening event. As sequelae of this complication can range from brief acute kidney injury to total graft failure, it is necessary to maintain close clinical observation postoperatively. If posttransplant renal vein thrombosis does occur, recanalization may be attempted with mechanical thrombectomy, suction thrombectomy, or explantation and reimplantation of the allograft. This is a novel report of the successful use of suction thrombectomy to treat renal vein thrombosis in a pediatric kidney transplant.

Rivaroxaban in patients with symptomatic peripheral artery disease after lower extremity bypass surgery with venous and prosthetic conduits.

BACKGROUND: Patients with peripheral artery disease (PAD) requiring lower extremity revascularization (LER) have a high risk of adverse limb and cardiovascular events. The results from the VOYAGER PAD (efficacy and safety of rivaroxaban in reducing the risk of major thrombotic vascular events in subjects with symptomatic peripheral artery disease undergoing peripheral revascularization procedures of the lower extremities) trial have demonstrated that rivaroxaban significantly reduced this risk with an overall favorable net benefit for patients undergoing surgical revascularization. However, the efficacy and safety for those treated by surgical bypass, including stratification by bypass conduit (venous or prosthetic), has not yet been described. METHODS: In the VOYAGER PAD trial, patients who had undergone surgical and endovascular infrainguinal LER to treat PAD were randomized to rivaroxaban 2.5 mg twice daily or placebo on top of background antiplatelet therapy (aspirin 100 mg to be used in all and clopidogrel in some at the treating physician's discretion) and followed up for a median of 28 months. The primary end point was a composite of acute limb ischemia, major amputation of vascular etiology, myocardial infarction, ischemic stroke, and cardiovascular death. The principal safety outcome was major bleeding using the TIMI (thrombolysis in myocardial infarction) scale. The index procedure details, including conduit type (venous vs prosthetic), were collected at baseline. RESULTS: Among 6564 randomized patients, 2185 (33%) had undergone surgical LER. Of these 2185 patients, surgical bypass had been performed for 1448 (66%), using a prosthetic conduit for 773 patients (53%) and venous conduit for 646 patients (45%). Adjusting for the baseline differences and anatomic factors, the risk of unplanned limb revascularization in the placebo arm was 2.5-fold higher for those receiving a prosthetic conduit vs a venous conduit (adjusted hazard ratio [HR], 2.53; 95% confidence interval [CI], 1.65-3.90; P < .001), and the risk of acute limb ischemia was three times greater (adjusted HR, 3.07; 95% CI, 1.84-5.11; P < .001). The use of rivaroxaban reduced the primary outcome for the patients treated with bypass surgery (HR, 0.78; 95% CI, 0.62-0.98), with consistent benefits for those receiving venous (HR, 0.66; 95% CI, 0.49-0.96) and prosthetic (HR, 0.87; 95% CI, 0.66-1.15) conduits (Pinteraction = .254). In the overall trial, major bleeding using the TIMI scale was increased with rivaroxaban. However, the numbers for those treated with bypass surgery were low (five with rivaroxaban vs nine with placebo; HR, 0.55; 95% CI, 0.18-1.65) and not powered to show statistical significance. CONCLUSIONS: Surgical bypass with a prosthetic conduit was associated with significantly higher rates of major adverse limb events relative to venous conduits even after adjustment for patient and anatomic characteristics. Adding rivaroxaban 2.5 mg twice daily to aspirin or dual antiplatelet therapy significantly reduced this risk, with an increase in the bleeding risk, but had a favorable benefit risk for patients treated with bypass surgery, regardless of conduit type. Rivaroxaban should be considered after lower extremity bypass for symptomatic PAD to reduce ischemic complications of the heart, limb, and brain.

Guillotine Transmetatarsal Amputations With Staged Closure Promote Early Ambulation and Limb Salvage in Patients With Advanced Chronic Limb-Threatening Ischemia.

PURPOSE: Transmetatarsal amputation (TMA) with primary closure has long been an option for limb salvage in patients with advanced chronic limb-threatening ischemia (CLTI) with extensive tissue loss of the forefoot. However, TMA healing and closure techniques are challenging, specifically in high-risk patients. Guillotine transmetatarsal amputations (gTMA) with staged closure may provide an alternative treatment in this population. We report long-term outcomes of such technique. MATERIALS AND METHODS: A single-center retrospective cohort study of CLTI patients undergoing gTMA between 2017 and 2020 was performed. Limb salvage, wound healing, and survival rates were quantified using Kaplan-Meier (KM) analysis. Multivariate regression was used to identify the effect of patient characteristics on the outcomes. RESULTS: Forty-four gTMA procedures were reviewed. Median follow-up was 381 (interquartile range [IQR], 212-539.75) days. After gTMA, 87.8% (n=36) of the patients were able to ambulate after a median interval of 2 (IQR, 1-3) days. Eventual coverage was achieved in a personalized and staged approach by using a combination of skin substitutes (88.6%, n=39) ± split thickness skin grafts (STSG, 61.4%, n=27). KM estimates for limb salvage, wound healing, and survival were 84.1%, 54.5%, and 88.6% at 1 year and 81.8%, 63.8%, and 84.1% at 2 years. Wound healing was significantly associated with STSG application (p=0.002, OR=16.5, 95% CI 2.87-94.81). CONCLUSION: gTMA resulted in high limb salvage rates during long-term follow-up in CLTI patients. Adjunctive STSG placement may enhance wound healing at the gTMA site, thus leading to expedited wound closure. Surgeons may consider gTMA as an alternative to reduce limb loss in CLTI patients at high risk of major amputation. CLINICAL IMPACT: Currently, the clinical presentation of CLTI is becoming more complex to deal with due to the increasing comorbidities as the society becomes older. The data shown in this article means for clinicians that when facing diffused forefoot gangrene and extensive tissue loss, limb preservation could still be considered instead of major amputation. Guillotine transmetatarsal amputations in the setting of an aggressive multidisciplinary group, can be healed by the responsibly utilization of dermal substitutes and skin grafts leading to the preservation of the extremity, allowing mobility, avoiding of sarcopenia, and decreasing frailty. This will equate to maintenance of independent living and preservation of lifespan.

Early experience with venous arterialization for limb salvage in no-option patients with chronic limb-threatening ischemia.

OBJECTIVE: Chronic limb-threatening ischemia (CLTI) is associated with adverse limb outcomes and increased mortality. However, a small subset of the CLTI population will have no feasible conventional methods of revascularization. In such cases, venous arterialization (VA) could provide an alternative for limb salvage. The objective of the present study was to review the outcomes of VA at our institution. METHODS: We performed a single-institution review of 41 patients who had been followed up prospectively and had undergone either superficial or deep VA. The data collected included patient demographics, comorbidities, VA technique (endovascular vs hybrid), and WIfI (wound, ischemia, and foot infection) limb staging. Data were collected at 1-month, 6-month, and 1-year intervals and included the following outcomes: patency, wound healing, major adverse limb events, major amputation, and death. Descriptive statistics were used for analysis. RESULTS: The study group included 41 patients who had undergone successful open hybrid superficial or deep endovascular VA; 21 (51.2%) had undergone a purely endovascular procedure and 20 (48.8%), hybrid VA. The WIfI clinical stage was as follows: stage 4, 33 (80.5%); stage 3, 6 (14.6%); and stage 2, 1 (2.4%). Of the 41 patients, 24 (58.5%) had completed follow-up at 6 months and 16 (39%) at 1 year. At 1 year, the VA primary patency was 28.6% (95% confidence interval [CI], 0.15%-0.43%), primary assisted patency was 44.3% (95% CI, 0.27%-0.60%), and secondary patency was 67% (95% CI, 0.49%-0.80%). The complete wound healing rate was 2.7% (n = 1) at 1 month, 62.5% (n = 15) at 6 months, and 18.8% (n = 3) at 1 year. Overall wound healing at 1 year was 46.3% (n = 19). The number of major adverse limb events at 1 year was 15 (36.5%) and included 8 reinterventions (19.5%) and 7 major amputations (17%). The number of deaths was zero (0%) at 1 month and four (19%) at 6 months. Two deaths (9.5%) were attributed to COVID-19 (coronavirus disease 2019). No further deaths had occurred within 1 year. The limb salvage survival probability at 1 year was 81%. CONCLUSIONS: These findings suggest that for a select subset of CLTI patients presenting with a high WIfI clinical limb stage and no viable options for conventional open or endovascular arterial revascularization, superficial and deep VA are feasible options to achieve limb salvage.

Analysis of a Machine Learning-Based Risk Stratification Scheme for Chronic Limb-Threatening Ischemia.

Importance: Valid risk stratification schemes are key to performing comparative effectiveness research; however, for chronic limb-threatening ischemia (CLTI), risk stratification schemes have limited efficacy. Improved, accurate, comprehensive, and reproducible risk stratification models for CLTI are needed. Objective: To evaluate the use of topic model cluster analysis to generate an accurate risk prediction model for CLTI. Design, Setting, and Participants: This multicenter, nested cohort study of existing Project of Ex Vivo Vein Graft Engineering via Transfection (PREVENT) III clinical trial data assessed data from patients undergoing infrainguinal vein bypass for the treatment of ischemic rest pain or ischemic tissue loss. Original data were collected from January 1, 2001, to December 31, 2003, and were analyzed in September 2021. All patients had 1 year of follow-up. Exposures: Supervised topic model cluster analysis was applied to nested cohort data from the PREVENT III randomized clinical trial. Given a fixed number of clusters, the data were used to examine the probability that a patient belonged to each of the clusters and the distribution of the features within each cluster. Main Outcomes and Measures: The primary outcome was 1-year CLTI-free survival, a composite of survival with remission of ischemic rest pain, wound healing, and freedom from major lower-extremity amputation without recurrent CLTI. Results: Of the original 1404 patients, 166 were excluded because of a lack of sufficient feature and/or outcome data, leaving 1238 patients for analysis (mean [SD] age, 68.4 [11.2] years; 800 [64.6%] male; 894 [72.2%] White). The Society for Vascular Surgery Wound, Ischemia, and Foot Infection grade 2 wounds were present in 543 patients (43.8%), with rest pain present in 645 (52.1%). Three distinct clusters were identified within the cohort (130 patients in stage 1, 578 in stage 2, and 530 in stage 3), with 1-year CLTI-free survival rates of 82.3% (107 of 130 patients) for stage 1, 61.1% (353 of 578 patients) for stage 2, and 53.4% (283 of 530 patients) for stage 3. Stratified by stage, 1-year mortality was 10.0% (13 of 130 observed deaths in stage 1) for stage 1, 13.5% (78 of 578 patients) for stage 2, and 20.2% (105 of 521 patients) for stage 3. Similarly, stratifying by stage revealed major limb amputation rates of 4.2% (5 of 119 observed major limb amputations in stage 1) for stage 1, 10.8% (55 of 509 patients) for stage 2, and 18.4% (81 of 440 patients) for stage 3. Among survivors without a major amputation, the rates of CLTI recurrence were 9.2% (11 of 119 observed recurrences in stage 1) for stage 1, 24.9% (130 of 523 patients) for stage 2, and 29.6% (132 of 446 patients) for stage 3. Conclusions and Relevance: The topic model cluster analysis in this cohort study identified 3 distinct stages within CLTI. Findings suggest that CLTI-free survival is an end point that can be accurately and reproducibly quantified and may be used as a patient-centric outcome.

The shifting care and outcomes for patients with endangered limbs - Critical limb ischemia (SCOPE-CLI) registry overview of study design and rationale.

BACKGROUND: Critical limb ischemia (CLI), the most severe form of peripheral artery disease, is associated with pain, poor wound healing, high rates of amputation, and mortality (>20% at 1 year). Little is known about the processes of care, patients' preferences, or outcomes, as seen from patients' perspectives. The SCOPE-CLI study was co-designed with patients to holistically document patient characteristics, treatment preferences, patterns of care, and patient-centered outcomes for CLI. METHODS: This 11-center prospective observational registry will enroll and interview 816 patients from multispecialty, interdisciplinary vascular centers in the United States and Australia. Patients will be followed up at 1, 2, 6, and 12 months regarding their psychosocial factors and health status. Hospitalizations, interventions, and outcomes will be captured for 12 months with vital status extending to 5 years. Pilot data were collected between January and July of 2021 from 3 centers. RESULTS: A total of 70 patients have been enrolled. The mean age was 68.4 ± 11.3 years, 31.4% were female, and 20.0% were African American. CONCLUSIONS: SCOPE-CLI is uniquely co-designed with patients who have CLI to capture the care experiences, treatment preferences, and health status outcomes of this vulnerable population and will provide much needed information to understand and address gaps in the quality of CLI care and outcomes.ClinicalTrials.gov identifier (NCT Number): NCT04710563 https://clinicaltrials.gov/ct2/show/NCT04710563.

The Society for Vascular Surgery Objective Performance Goals for Critical Limb Ischemia are attainable in select patients with ischemic wounds managed with wound care alone.

BACKGROUND: To set therapeutic benchmarks, in 2009 the Society for Vascular Surgery defined objective performance goals (OPG) for treatment of patients with chronic limb threatening ischemia (CLTI) with either open surgical bypass or endovascular intervention. The goal of these OPGs are to set standards of care from a revascularization standpoint and to provide performance benchmarks for 1 year patency rates for new endovascular therapies. While OPGs are useful in this regard, a critical decision point in the treatment of patients with CLTI is determining when revascularization is necessary. There is little guidance in the comprehensive treatment of this patient population, especially in the nonoperative cohort. Guidelines are needed for the CLTI patient population as a whole and not just those revascularized, and our aim was to assess whether CLTI OPGs could be attained with nonoperative management alone. METHODS: Our cohort included patients with an incident diagnosis of CLTI (by hemodynamic and symptomatic criteria) at our institution from 2013-2017. The primary outcome measured was mortality. Secondary outcomes were limb loss and failure of amputation-free survival. Descriptive statistics were used to define the 2 groups - patients undergoing primary revascularization and patients undergoing primary wound management. The risk difference in outcomes between the 2 groups was estimated using collaborative-targeted maximum likelihood estimation. RESULTS: Our cohort included 349 incident CLTI patients; 60% male, 51% white, mean age 63 +/- 13 years, 20% Rutherford 4, and 80% Rutherford 5. Most patients (277, 79%) underwent primary revascularization, and 72 (21%) were treated with wound care alone. Demographics and presenting characteristics were similar between groups. Although the revascularized patients were more likely to have femoropopliteal disease (72% vs. 36%), both groups had a high rate of infrapopliteal disease (62% vs. 57%). Not surprisingly, the patients in the revascularization group were less likely to have congestive heart failure (34% vs. 42%), complicated diabetes (52% vs. 79%), obesity (19% vs. 33%), and end stage renal disease (14% vs. 28%). In the wound care group, 2-year outcomes were 65% survival, 51% amputation free survival, 19% major limb amputation, and 17% major adverse cardiac event. The wound care cohort had a 13% greater risk of death at 2 years; however, the risk of limb loss at 2 years was 12% less in the wound care cohort. CONCLUSIONS: A comprehensive set treatment goals and expected amputation free survival outcomes can guide revascularization, but also assure that appropriate outcomes are achieved for patients treated without revascularization. The 2-year outcomes achieved in this cohort provide an estimate of outcomes for nonrevascularized CLTI patients. Although multi-center or prospective studies are needed, we demonstrate that equal, even improved, limb salvage rates are possible.