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Delayed Yet Successful Mechanical Thrombectomy for Phlegmasia Cerulea Dolens in a Limb with Severe Arterial Disease and May-Thurner Syndrome.

ABSTRACT: Phlegmasia cerulea dolens (PCD) is a rare but life-threatening complication of acute deep venous thrombosis that lacks consensus regarding the approach to management. We present a case of PCD developing shortly after a spinal surgery and manifesting as acute swelling and discoloration in a leg with existing severe atherosclerotic arterial disease. The patient's critical limb ischemia was completely and rapidly reversed by percutaneous mechanical thrombectomy using the ClotTriever device despite a delay in treatment. An underlying iliac vein compression "May-Thurner" syndrome was discovered using intravascular ultrasound and treated with angioplasty. This case identifies mechanical thrombectomy using the ClotTriever system as a possible effective and safe treatment for PCD.

PROVIDER: S-EPMC7652628 | BioStudies |

REPOSITORIES: biostudies

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Project description:<h4>Purpose</h4>Intra-arterial mechanical thrombectomy combined with appropriate patient selection (image-based selection of acute ischaemic stroke patients with large artery occlusion) yields improved clinical outcomes. We conducted a systematic review and meta-analysis, with trial sequential analysis to understand the benefits, risks and impact of new trials reporting in 2016 on the magnitude/certainty of the estimates for clinical effectiveness and safety of mechanical thrombectomy.<h4>Method</h4>Random effects' models were conducted of randomised clinical trials comparing mechanical thrombectomy (stent retriever or aspiration devices) with/without adjuvant intravenous thrombolysis with intravenous thrombolysis and other forms of best medical/supportive care in the treatment of acute ischaemic stroke. Study inclusion and risk of bias were assessed independently by two reviewers. Functional independence (modified Rankin Scale 0-2) and mortality at 90 days, including symptomatic intracranial haemorrhage rate were extracted. Trial sequential analysis established the strength of the evidence derived from the meta-analyses.<h4>Findings</h4>Eight trials of mechanical thrombectomy with a total sample size of 1841 (916 patients treated with mechanical thrombectomy and 925 treated without mechanical thrombectomy) fulfilled review inclusion criteria. The three most recent trials more precisely defined the effectiveness of mechanical thrombectomy (modified Rankin Scale 0 to 2; OR?=?2.07, 95% CI?=?1.70 to 2.51 based on data from eight trials versus OR?=?2.39, 95% CI?=?1.88 to 3.04 based on data from five trials). Meta-analyses showed no effect on mortality (OR?=?0.81, 95% CI?=?0.61 to 1.07) or symptomatic intracranial haemorrhage (OR?=?1.22, 95% CI?=?0.80 to 1.85) as found in analysis of first five trials. Trial sequential analysis indicated that the information size requirement was fulfilled to conclude the evidence for mechanical thrombectomy is robust.<h4>Discussion</h4>The impact of three recent trials on effectiveness and safety of mechanical thrombectomy was a more precise pooled effect size for functional independence. Trial sequential analysis demonstrated sufficient evidence for effectiveness and safety of mechanical thrombectomy.<h4>Conclusion</h4>No further trials of mechanical thrombectomy versus no mechanical thrombectomy are indicated to establish clinical effectiveness. Uncertainty remains as to whether mechanical thrombectomy reduces mortality or increases risk of symptomatic intracranial haemorrhage.

Project description:<h4>Background</h4>The beneficial effects of endovascular treatment with new-generation mechanical thrombectomy devices compared with intravenous thrombolysis alone to treat acute large-artery ischemic stroke have been shown in randomized controlled trials (RCTs). This study aimed to estimate the cost utility of mechanical thrombectomy compared with the established standard of care.<h4>Methods</h4>We developed a Markov decision process analytic model to assess the cost-effectiveness of treatment with mechanical thrombectomy plus intravenous thrombolysis versus treatment with intravenous thrombolysis alone from the public payer perspective in Canada. We conducted comprehensive literature searches to populate model inputs. We estimated the efficacy of mechanical thrombectomy plus intravenous thrombolysis from a meta-analysis of 5 RCTs, and we used data from the Oxford Vascular Study to model long-term clinical outcomes. We calculated incremental cost-effectiveness ratios (ICER) using a 5-year time horizon.<h4>Results</h4>The base case analysis showed the cost and effectiveness of treatment with mechanical thrombectomy plus intravenous thrombolysis to be $126?939 and 1.484 quality-adjusted life-years (QALYs), respectively, and the cost and effectiveness of treatment with intravenous thrombolysis alone to be $124?419 and 1.273 QALYs, respectively. The mechanical thrombectomy plus intravenous thrombolysis strategy was associated with an ICER of $11?990 per QALY gained. Probabilistic sensitivity analysis showed that the probability of treatment with mechanical thrombectomy plus intravenous thrombolysis being cost-effective was 57.5%, 89.7% and 99.6% at thresholds of $20?000, $50?000 and $100?000 per QALY gained, respectively. The main factors influencing the ICER were time horizon, extra cost of mechanical thrombectomy treatment and age of the patient.<h4>Interpretation</h4>Mechanical thrombectomy as an adjunct therapy to intravenous thrombolysis is cost-effective compared with treatment with intravenous thrombolysis alone for patients with acute large-artery ischemic stroke.

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Delayed Yet Successful Mechanical Thrombectomy for Phlegmasia Cerulea Dolens in a Limb with Severe Arterial Disease and May-Thurner Syndrome.

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