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Impact of prior endovascular interventions on outcomes of lower limb bypass surgery: A systematic review and meta-analysis.

ABSTRACT: The aim of this meta-analysis was to evaluate the mortality, amputation and complication rates in patients with peripheral lower limb arterial disease undergoing bypass surgery with or without a prior history of endovascular operation. A systematic literature screen was performed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines on four academic databases, Medline, Scopus, Embase and Cochrane Central Register of Controlled Trials. Out of 1,072 records, six articles involving 11,420 patients (mean age, 68.1±2.0 years) met the inclusion criteria. The findings presented a 2b level of evidence (i.e. overall evidence represents data from individual cohort study or low quality randomized controlled trials) and suggested lower mortality, amputation and complication rates for patients undergoing bypass surgery without any history of endovascular operation, compared with those with a history of prior endovascular operation. Moreover, a random-effect meta-analysis suggested a small, positive reduction in mortality (Hedge's g=0.08), amputation (Hedge's g=0.18) and complication rates (Hedge's g=0.05) for patients undergoing bypass surgery without any history of endovascular operation. Nevertheless, owing to the scarcity of high-quality data, further studies and randomized clinical trials are needed to confirm these effects.

SUBMITTER: Xin H

PROVIDER: S-EPMC7668154 | biostudies-literature | 2020 Dec

REPOSITORIES: biostudies-literature

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Impact of prior endovascular interventions on outcomes of lower limb bypass surgery: A systematic review and meta-analysis.

Xin Hai H Li Yongxin Y Guan Xiaomei X Wang Yuewei Y Liu Junjun J Liu Xukui X Wang Jinping J Niu Liyuan L Li Jun J

Experimental and therapeutic medicine 20201027 6

The aim of this meta-analysis was to evaluate the mortality, amputation and complication rates in patients with peripheral lower limb arterial disease undergoing bypass surgery with or without a prior history of endovascular operation. A systematic literature screen was performed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines on four academic databases, Medline, Scopus, Embase and Cochrane Central Register of Controlled Trials. Out of 1,072 records ...[more]

PMID: 33209124

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Project description:Although open surgical bypass remains the standard revascularization strategy for patients with critical limb ischemia (CLI), many centers now perform peripheral endovascular intervention (PVI) as the first-line treatment for these patients. We sought to determine the effect of a prior ipsilateral PVI (iPVI) on the outcome of subsequent lower extremity bypass (LEB) in patients with CLI.A retrospective cohort analysis of all patients undergoing infrainguinal LEB between 2003 and 2009 within hospitals comprising the Vascular Study Group of New England (VSGNE) was performed. Primary study endpoints were major amputation and graft occlusion at 1 year postoperatively. Secondary outcomes included in-hospital major adverse events (MAE), 1-year mortality, and composite 1-year major adverse limb events (MALE). Event rates were determined using life table analyses and comparisons were performed using the log-rank test. Multivariate predictors were determined using a Cox proportional hazards model with multilevel hierarchical adjustment.Of 1880 LEBs performed, 32% (n = 603) had a prior infrainguinal revascularization procedure (iPVI, 7%; ipsilateral bypass, 15%; contralateral PVI, 3%; contralateral bypass, 17%). Patients with prior iPVI, compared with those without a prior iPVI, were more likely to be women (32 vs 41%; P = .04), less likely to have tissue loss (52% vs 63%; P = .02), more likely to require arm vein conduit (16% vs 5%; P = .001), and more likely to be on statin (71% vs 54%; P = .01) and beta blocker therapy (92% vs 81%; P = .01) at the time of their bypass procedure. Other demographic factors were similar between these groups. Prior PVI or bypass did not alter 30-day MAE and 1-year mortality after the index bypass. In contrast, 1-year major amputation and 1-year graft occlusion rates were significantly higher in patients who had prior iPVI than those without (31% vs 20%; P = .046 and 28% vs 18%; P = .009), similar to patients who had a prior ipsilateral bypass (1 year major amputation, 29% vs 20%; P = .022; 1 year graft occlusion, 33% vs 18%; P = .001). Independent multivariate predictors of higher 1-year amputation and graft occlusion rates were prior iPVI, prior ipsilateral bypass, dialysis dependence, prosthetic conduit and distal (tibial and pedal) bypass target.Prior iPVI is highly predictive for poor outcome in patients undergoing LEB for CLI with higher 1-year amputation and graft occlusion rates than those without prior revascularization, similar to prior ipsilateral bypass These findings provide information, which may help with the complex decisions surrounding revascularization options in patients with CLI.

Project description:OBJECTIVE:Lower extremity bypass (LEB) has traditionally been the "gold standard" in the treatment of critical limb ischemia (CLI). Infrainguinal endovascular intervention (IEI) has become more commonly performed than LEB, but comparative outcomes are limited. We sought to compare rates of major adverse limb events (MALEs) and major adverse cardiovascular events (MACEs) after LEB and IEI in a propensity score-matched, national cohort of patients with CLI. METHODS:The National Surgical Quality Improvement Program (NSQIP) vascular targeted files (2011-2014) for LEB and IEI were merged. CLI patients were identified by ischemic rest pain or tissue loss. Patients were matched on a 1:1 basis for propensity to undergo LEB or IEI. Primary outcomes were 30-day MALEs and MACEs. Within the propensity-matched cohort, multivariate logistic regression was used to identify independent predictors of MALEs and MACEs. RESULTS:A total of 13,294 LEBs and IEIs were identified, with 8066 cases performed for CLI. Propensity matching identified 3848 cases (1924 per group). There were no differences in preoperative variables between the propensity-matched LEB and IEI groups (all P > .05). At 30 days, rates of MALEs were significantly lower in the LEB group (9.2% LEB vs IEI 12.2%; P = .003). On multivariate logistic regression, bypass with single-segment saphenous vein vs IEI (odds ratio [OR], 0.7; 95% confidence interval [CI], 0.54-0.92; P = .01), bypass with alternative conduit (prosthetic, spliced vein, or composite) vs IEI (OR, 0.7; 95% CI, 0.56-0.98; P = .04), antiplatelet therapy (OR, 0.8; 95% CI, 0.58-1.00; P = .049), and statin therapy (OR, 0.8; 95% CI, 0.62-0.99; P = .04) were protective against MALEs, whereas infrageniculate intervention (OR, 1.4; 95% CI, 1.09-1.72; P = .01) and a history of prior bypass of the same arterial segment (OR, 1.8; 95% CI, 1.41-2.41; P <. 0001) were predictive. Rates of 30-day MACEs were not significantly different (4.9% LEB vs 3.7% IEI; P = .07) between the groups. Independent predictors of MACEs included age (OR, 1.02; 95% CI, 1.01-1.04; P = .01), steroid use (OR, 1.8; 95% CI, 1.08-2.99; P = .03), congestive heart failure (OR, 1.7; 95% CI, 1.00-1.96; P = .02), beta blocker use (OR, 1.6; 95% CI, 1.09-1.43; P = .01), dialysis (OR, 2.3; 95% CI, 1.55-3.45; P < .0001), totally dependent functional status (OR, 3.1; 95% CI, 1.25-7.58; P = .02), and suboptimal conduit for LEB compared with IEI (OR, 1.6; 95% CI, 1.08-2.36; P = .02). CONCLUSIONS:Within this large, propensity-matched, national cohort, LEB predicted lower risk-adjusted 30-day MALE rate compared with IEI. Furthermore, there was no difference in 30-day MACE rate between the groups despite higher inherent risk with open surgical procedures. Therefore, this study supports the effectiveness and primacy of LEB for revascularization in CLI.

Project description:Outcomes of endovascular lower extremity interventions (eLEIs) have been recently linked to provider specialty; however, the indication for intervention was not examined. We sought to compare outcomes between specialties performing eLEI for different indications, in a recent statewide inpatient discharge dataset.The Florida hospital discharge data from 2005 to 2009 were reviewed for patients with LEI during hospitalization. We assigned provider specialty as interventional radiology (IR), interventional cardiology (IC), or vascular surgery (VS) based on provider-associated procedures. Clinical indication was claudication or critical limb ischemia (CLI). We limited our analysis to patients without concomitant open surgery during hospitalization. We compared mortality, length of stay (LOS), major use of intensive care unit (ICU), discharge disposition, and total charges between specialties with regression models, both unadjusted and adjusted for demographic and clinical characteristics.A total of 15,398 patients (47% with CLI) had an eLEI. Clinical indication was significantly associated with provider type (P < .001) and outcomes. VS and IR were more likely than IC to treat CLI patients (VS 59%, IR 65%, IC 26%; P < .001). IC performed the majority of procedures on claudicants (VS 30%, IC 57%, IR 13%; P < .001), while VS performed the majority of procedures on CLI patients (VS 50%, IC 23%, IR 27%; P < .001). Adjusted analyses demonstrated no difference in mortality rates between the three specialties (odds ratio [OR] VS: reference, IR: 1.24, IC: 0.79; P = NS for both). However, compared with VS, IR-treated patients were less likely to be discharged home (OR, 0.74; P < .001), LOS was longer (?, 1.16 days; P < .001), major ICU use was more common (OR, 1.49; P < .001), and total charges were higher (?, $341; P = .001). CLI predicted poorer results for all outcomes: death (OR, 4.19; P < .001), discharge home (OR, 0.50; P < .001), increased LOS (?, 3.26 days; P < .001), major ICU use (OR, 1.95; P < .001), and total charges (?, $18,730; P < .001).The majority of eLEI done by VS are for CLI, whereas the majority of patients treated by IC are claudicants. Although provider specialty does correlate with several clinical results, the clinical indication for eLEI is a stronger predictor of adverse outcomes. Future analyses of eLEI should adjust for clinical indication.

Project description:To determine whether diabetes mellitus has an independent impact on major limb outcomes at 1 year after endovascular treatment of lower extremity peripheral artery disease (PAD).The study involved 1906 consecutive patients (mean age 66 years; 1469 men) enrolled in the observational Excellence in Peripheral Artery Disease (XLPAD) registry ( ClinicalTrials.gov identifier NCT01904851) between January 2005 and October 2015 after undergoing index endovascular procedures in 2426 limbs for arterial occlusive disease. Patient outcomes included 12-month target limb amputation (above ankle) and target limb revascularization as well as all-cause death. Kaplan-Meier analysis and adjusted Cox proportional hazard models were used for time-to-event analysis of outcomes for the entire study sample as well as for the critical limb ischemia (CLI) and claudication subgroups. Results of the Cox regression models are reported as the hazard ratio (HR) and 95% confidence interval (CI).Diabetics undergoing endovascular procedures had higher rates of comorbid conditions (p<0.001), CLI (p<0.001), heavily calcified lesions (p=0.002), multivessel disease (p=0.030), and fewer infrapopliteal runoff vessels (p<0.001). Regression analysis after adjusting for confounders revealed significantly higher target limb major amputation in diabetics compared with nondiabetics (HR 5.02, 95% CI 1.44 to 17.56, p=0.011). However, repeat revascularization rates were similar. When considering CLI and claudication subgroups, diabetes was associated with a nonsignificant increased risk of 12-month major amputation only for patients presenting with CLI (HR 3.48, 95% CI 0.97 to 12.51, p=0.056). Diabetes was also associated with an increased risk of 12-month all-cause mortality in the overall study sample (HR 4.64, 95% CI 2.01 to 10.70, p<0.001) and in the CLI subgroup (HR 14.15, 95% CI 3.16 to 63.32, p<0.001) but not in the claudication subgroup (HR 1.42, 95% CI 0.45 to 4.54, p=0.552).Diabetes increases the risk of major amputation and all-cause death at 12 months following endovascular revascularization in patients with symptomatic PAD. These risks are especially heightened in patients presenting with CLI.

Project description:ObjectiveAlthough an increasing number of patients with peripheral arterial disease undergo multiple revascularization procedures, the effect of prior interventions on outcomes remains unclear. The purpose of this study was to evaluate perioperative outcomes of bypass surgery in patients with and those without prior ipsilateral treatment.MethodsPatients undergoing nonemergent infrainguinal bypass between 2011 and 2014 were identified in the National Surgical Quality Improvement Program Targeted Vascular module. After stratification by symptom status (chronic limb-threatening ischemia [CLTI] and claudication), patients undergoing primary bypass were compared with those undergoing secondary bypass. Within the secondary bypass group, further analysis compared prior bypass with prior endovascular intervention. Multivariable logistic regression analysis was used to establish the independent association between prior ipsilateral procedure and perioperative outcomes.ResultsA total of 7302 patients were identified, of which 4540 (62%) underwent primary bypass (68% for CLTI), 1536 (21%) underwent secondary bypass after a previous bypass (75% for CLTI), and 1226 (17%) underwent secondary bypass after a previous endovascular intervention (72% for CLTI). Prior revascularization on the same ipsilateral arteries was associated with increased 30-day major adverse limb event in patients with CLTI (9.8% vs 7.4%; odds ratio [OR], 1.4 [95% confidence interval (CI), 1.1-1.7]) and claudication (5.2% vs 2.5%; OR, 2.1 [95% CI, 1.3-3.5]). Similarly, secondary bypass was an independent risk factor for 30-day major reintervention (CLTI: OR, 1.4 [95% CI, 1.1-1.8]; claudication: OR, 2.1 [95% CI, 1.3-3.5]), bleeding (CLTI: OR, 1.4 [95% CI, 1.2-1.6]; claudication: OR, 1.7 [95% CI, 1.3-2.4]), and unplanned reoperation (CLTI: OR, 1.2 [95% CI, 1.0-1.4]; claudication: OR, 1.6 [95% CI, 1.1-2.1]), whereas major amputation was increased in CLTI patients only (OR, 1.3 [95% CI, 1.01-1.8]). Postoperative mortality was not significantly different in patients undergoing secondary compared with primary bypass (CLTI: 1.7% vs 2.2% [P = .22]; claudication: 0.4% vs 0.6% [P = .76]). Among secondary bypass patients with CLTI, those with prior bypass had higher 30-day reintervention rates (7.8% vs 4.9%; OR, 1.5 [95% CI, 1.0-2.2]) but fewer wound infections (7.3% vs 12%; OR, 0.6 [95% CI, 0.4-0.8]) compared with patients with prior endovascular intervention.ConclusionsPrior revascularization, in both patients with CLTI and patients with claudication, is associated with worse perioperative outcomes compared with primary bypass. Furthermore, prior endovascular intervention is associated with increased wound infections, whereas those with prior bypass had higher reintervention rates. The increasing prevalence of patients undergoing multiple interventions stresses the importance of the selection of patients for initial treatment and should be factored into subsequent revascularization options in an effort to decrease adverse events.

Project description:IntroductionChronic limb-threatening ischemia (CLTI) is the end stage of peripheral arterial disease (PAD) and is associated with high amputation rates, mortality and disease-related health care costs. In infrapopliteal arterial disease (IPAD), endovascular revascularization should be considered for the majority of anatomical and clinical subgroups of CLTI. However, a gap of high-quality evidence exists in this field. The aim of the Dutch Chronic Lower Limb-Threatening Ischemia Registry (THRILLER) is to collect real world data on popliteal and infrapopliteal endovascular interventions.MethodsTHRILLER is a clinician-driven, prospective, multicenter, observational registry including all consecutive patients that undergo a popliteal or infrapopliteal endovascular intervention in seven Dutch hospitals. We estimate that THRILLER will include 400-500 interventions annually. Standardized follow-up visits with wound monitoring, toe pressure measurement and duplex ultrasonography will be scheduled at 6-8 weeks and 12 months after the intervention. The independent primary endpoints are primary patency, limb salvage and amputation free survival. Patients must give informed consent before participation and will be included according to predefined reporting standards. A data log of patients who meet the inclusion criteria but are not included in the registry will be maintained. We intend to conduct the first interim analysis two years after the start of inclusion. The results will be published in a scientific journal.DiscussionDespite innovations in medical therapy and revascularization techniques, patients with CLTI undergoing endovascular revascularization still have a moderate prognosis. Previous prospective cohort studies were hampered by small sample sizes or heterogeneous reporting. Randomized controlled trials (RCTs) have high costs, potential conflicts of interest and give a limited reflection of daily practice. THRILLER aims to provide the largest prospective well phenotyped up-to-date dataset on treatment outcomes in CLTI patients to answer multiple underexplored research questions regarding diagnostics, medication, patient selection, treatment strategies and post intervention follow-up.

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Impact of prior endovascular interventions on outcomes of lower limb bypass surgery: A systematic review and meta-analysis.

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Impact of prior endovascular interventions on outcomes of lower limb bypass surgery: A systematic review and meta-analysis.

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