Introduction
The literature recommends against the use of fondaparinux in patients with kidney failure and dialysis as it may, with repeated dosing, accumulate and put patients at risk of bleeding. The management of patients with thrombosis in the presence of heparin-induced thrombocytopenia HIT requires the introduction of an alternative anticoagulant like bivalirudin or argatroban. When these drugs are not available, fondaparinux, remains the only alternative. In similar scenarios, there are few studies addressing how to administer it.
Methods
We developed a protocol for fondaparinux in patients with renal failure where pharmacokinetic parameters are altered, and levels changed only after hemodialysis or in cases of residual renal activity. Patients received a full first dose except for high risk of bleeding. We targeted a peak anti-factor Xa activity level of 0.6–1.3 units/ml and changed the subsequent dose accordingly. Furthermore, we monitored the patients for signs of bleeding, a drop in hemoglobin level, or clinical signs of thrombosis.
Discussion
We described 10 patients with kidney failure and suspected HIT taking fondaparinux. All the patients achieved therapeutic anti-factor Xa activity levels. However, one developed new-onset venous thromboembolism (VTE) despite therapeutic anti-factor Xa levels. Another patient experienced a bleeding episode. We believe that these two patients developed complications due to their medical conditions rather than the use of fondaparinux.
Conclusion
Fondaparinux can be safely used in kidney failure using our protocol. However, despite its safety profile and relative success, this case series was small. More robust studies need to be conducted prior to drawing conclusions.
Objective This study aims to identify the clinical variables which are predictive for the benefit of concomitant distal revascularization (DR) to prevent Chronic limb-threatening ischemia (CLTI) progression and the need for major limb amputation. Methods This is a retrospective cohort study of patients who presented with lower limb ischemia and required at least femoral endarterectomy (FEA), recruited over a period of 15 years (2002-2016). The patient cohort was divided into three groups based on the type of intervention: A (FEA alone), B (FEA + catheter-based intervention/(CBI)), and C (FEA + surgical bypass (SB)). The primary endpoint was to identify independent predictors for the use of concomitant DR (CBI or SB). Secondary endpoints were amputation rate, length of stay, mortality rate, postoperative ankle-brachial index and complications, readmission rate, re-intervention rate, resolution of symptoms and wound status. Results A total of 400 patients were included, 68.0% were males. Most presenting limbs were at Rutherford class (RC) III and WIfI stage 2, with an ankle-brachial index (ABI) of .47 ± .21 and a TASC II class C lesion. No significant differences were found in the primary-assisted and secondary patency rates between the three groups ( P > .05, in all). In the multivariate analyses, clinical variables associated with DR were hyperlipidemia (hazard ratio (HR) 2.1-2.2), TASC II D (HR 2.62), Rutherford class 4 (HR 2.3) and 5 (HR 3.7), as well as WIfI stage ≥3 (HR 1.48). Conclusions Femoral endarterectomy is sufficient to treat intermittent claudication. However, patients in whom rest pain, tissue loss or TASC II D anatomic lesion severity are present may benefit from concomitant distal revascularization. Taking into consideration the overall assessment of operative risk factors for each individual patient, proceduralists should have a lower threshold for performing early or concomitant distal revascularization to reduce CLTI progression including additional tissue loss and/or major limb amputation.
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