rivaroxaban and Hematoma--Epidural--Spinal

Pregnancy is a known risk factor for spontaneous spinal epidural hematoma. During cesarean section or vaginal delivery, the unstable hemodynamic status that may occur owing to fluctuation of intra-abdominal pressure increases the possibility of spontaneous spinal epidural hematoma. During labor and the postpartum period, neurologic symptoms may be masked by labor pain or anesthesia block, which makes early diagnosis difficult, especially in the obstetric clinic without a neurologist or neurosurgeon.. A 28-year-old woman who had a normal spontaneous delivery under epidural anesthesia developed bilateral lower limb flaccid paralysis and loss of sensation 12.5 hours after delivery. Magnetic resonance imaging showed a 5.2 × 0.9 × 2 cm spinal epidural hematoma with severe spinal cord stenosis at the T2-T5 level with no evidence of a vascular anomaly. After emergent evacuation of the spinal epidural hematoma, lower limb muscle power improved from 0/5 to 1/5, and sensation gradually returned to bilateral lower limbs 22 days postoperatively. Deep vein thrombosis developed at 35 days postoperatively, and an inferior vena cava filter was implanted with urokinase infusion for thrombolytic therapy. She was discharged on day 52 after admission, and lower limb muscle power returned to normal after 3 months.. Clinicians should observe postpartum women for signs of myelopathy or back tenderness and closely monitor neurologic function until anesthesia has run its course. A prompt diagnosis can enable prompt intervention.

Topics: Adult; Analgesia, Epidural; Anesthesia, Epidural; Decompression, Surgical; Delivery, Obstetric; Factor Xa Inhibitors; Female; Fibrinolytic Agents; Hematoma, Epidural, Spinal; Humans; Hypesthesia; Laminectomy; Lower Extremity; Magnetic Resonance Angiography; Magnetic Resonance Imaging; Paraplegia; Postoperative Complications; Pregnancy; Puerperal Disorders; Recovery of Function; Rivaroxaban; Spinal Cord Compression; Thrombolytic Therapy; Urokinase-Type Plasminogen Activator; Vena Cava Filters; Venous Thrombosis

Within the past 5 years, the oral anticoagulants rivaroxaban, apixaban, and dabigatran etexilate have been approved for the prevention of venous thromboembolism in adult patients after elective hip or knee arthroplasty in the European Union and many other countries worldwide. These agents differ from the previously available anticoagulants because they selectively and directly inhibit a single factor in the coagulation cascade-rivaroxaban and apixaban inhibit Factor Xa, and dabigatran inhibits Factor IIa (thrombin)-potentially enhancing the predictability of their anticoagulant effect. Currently, although some guidelines provide recommendations for the use of rivaroxaban, dabigatran etexilate, and apixaban in clinical practice, there are still questions regarding the optimal practical management of patients receiving these agents. This article briefly reviews the practical limitations associated with conventional anticoagulants, discusses potential issues with the practical management of the newer oral anticoagulants, and provides clinical experience from a single institution where rivaroxaban and dabigatran etexilate have been used within their approved indications.

Topics: Anti-Inflammatory Agents, Non-Steroidal; Anticoagulants; Arthroplasty, Replacement, Hip; Arthroplasty, Replacement, Knee; Benzimidazoles; Blood Coagulation Tests; Clinical Trials, Phase III as Topic; Contraindications; Dabigatran; Drug Administration Schedule; Drug Interactions; Drug Monitoring; Hematoma, Epidural, Spinal; Humans; Morpholines; Platelet Aggregation Inhibitors; Postoperative Complications; Postoperative Hemorrhage; Postoperative Nausea and Vomiting; Practice Guidelines as Topic; Pyrazoles; Pyridines; Pyridones; Rivaroxaban; Thiophenes; Venous Thromboembolism

The use of pharmacological thromboprophylaxis in the perioperative period may conflict with regional anesthetic techniques in which maintaining hemostatic integrity is essential. Recently, new anticoagulants have been developed with more efficacy and a better safety profile. This article reviews the basis for the actual recommendations and the current status and management of these new drugs.. Recent studies have outlined that the risk of epidural hematoma after neuraxial anesthesia may be higher than estimated. Therefore, it is imperative to follow the published recommendations. The use of new anticoagulant drugs may take into account the pharmacological profile of each one to safely perform regional anesthesia, mainly the time to reach peak plasma level and half-life.. When new anticoagulant drugs are used for thromboprophylaxis in orthopedic surgery, the performance of neuraxial anesthetic techniques should be based on their pharmacology. If a peripheral blockade is chosen, these recommendations should be followed when a block is performed in a noncompressible area.

Topics: Anesthesia, Epidural; Anesthesia, Spinal; Anticoagulants; Benzimidazoles; Dabigatran; Hematoma, Epidural, Spinal; Humans; Morpholines; Nerve Block; Platelet Aggregation Inhibitors; Pyrazoles; Pyridines; Pyridones; Rivaroxaban; Thiophenes

The oral direct Xa inhibitor rivaroxaban (Xarelto) shows great promise for prevention of venous thromboembolic events after major elective orthopedic surgery. Its consistent and predictable pharmacokinetics and pharmacodynamics across a wide range of patient populations allow administration with fixed dosing and with no coagulation monitoring. In 4 orthopaedic surgery clinical trials (12,700 patients), 10mg postoperative (6-10 hours after the end of surgery) dose, once daily, of oral rivaroxaban, achieved superior efficacy and similar safety to enoxaparin, whatever the dose of enoxaparin. Indeed, 40 mg once a day in Europe and 30 mg bid in US of enoxaparin were compared to the same dose of 10mg once daily of rivaroxaban. Furthermore, there is no difference according to liver enzymes elevation and cardio-vascular adverse events. Although the risk of spinal haematoma after neuraxial anaesthesia is rare, it is increased by concomitant use of anticoagulants. In orthopedic surgery trials with rivaroxaban to date, complications such as spinal haematoma have not been reported. The pharmacokinetic profile of rivaroxaban suggests that concurrent use with neuraxial anaesthesia should require no further precautions than currently necessary with low-molecular-weight heparin.

Topics: Administration, Oral; Anticoagulants; Clinical Trials, Phase II as Topic; Clinical Trials, Phase III as Topic; Double-Blind Method; Enoxaparin; Factor Xa Inhibitors; Fibrinolytic Agents; Hematoma, Epidural, Spinal; Hemorrhage; Heparin, Low-Molecular-Weight; Humans; Morpholines; Postoperative Complications; Preanesthetic Medication; Rivaroxaban; Thiophenes; Thromboembolism

BACKGROUND Spinal hematomas can be post-traumatic, iatrogenic, or spontaneous. A spontaneous spinal hematoma is a rare finding, but one with very serious clinical implications. There are some risk factors linked to its occurrence, e.g. arteriovenous malformations, lumbar puncture, coagulopathy, neoplasms, or therapeutic anticoagulation. At present, only a few cases of spontaneous spinal hematoma (SSH) associated with new oral anticoagulants (NOACs) have been described, three of which were linked with rivaroxaban. CASE REPORT We report the case of an 82-year-old Caucasian woman with persistent atrial fibrillation treated with rivaroxaban, who presented to the Urology Department with acute-onset back pain which was thought to be due to urolithiasis. No kidney stones were found, but her creatinine serum level was elevated, so she was transferred to our clinic for further treatment. During hospitalization she quickly developed paraplegia with urine and stool retention. MRI was performed, and demonstrated an acute epidural hemorrhage in her thoracic and lumbar spine. The neurosurgeons disqualified this patient from surgical intervention due to the extent of the hematoma and its location. The patient was referred to the Neurology Department for treatment and rehabilitation, but, to the best of our knowledge, she did not recover her motor function. CONCLUSIONS Although rivaroxaban has been shown to be more effective than warfarin in stroke prevention in patients with atrial fibrillation, physicians must remember that its use also carries the risk of major bleeding. SSH occurrence should be taken into account in a patient taking NOACs who develops paraplegia, even if there is no history of trauma prior to admission.

Topics: Aged, 80 and over; Anticoagulants; Atrial Fibrillation; Female; Hematoma, Epidural, Spinal; Humans; Lumbar Vertebrae; Magnetic Resonance Imaging; Paraplegia; Rivaroxaban; Thoracic Vertebrae

In this case report, we describe a case of epidural hematoma following epidural analgesia in a patient with recent cessation of a direct oral anticoagulant (DOAC).. An 89-year-old woman requiring upper abdominal surgery presented with multiple comorbidities, including a prior cerebrovascular accident resulting in a left-sided hemiparesis and atrial fibrillation requiring anticoagulation with rivaroxaban. In accordance with our departmental guidelines at the time of procedure, rivaroxaban was discontinued 4 days preoperatively. A thoracic epidural was placed at T8/9 immediately prior to induction. Venous thromboembolism prophylaxis was provided with compression devices, and every-12-hour unfractionated heparin initiated 5.5 hours after epidural placement. On postoperative day 2, the patient was noted to have a bilateral motor block, and imaging demonstrated a thoracic epidural hematoma extending from T6 to T11. Preexisting neurological deficits may have delayed detection. With patient agreement, neurosurgery recommended observation rather than surgical decompression because the patient was a poor surgical candidate and limited neurologic recovery was expected. The patient had modest motor recovery over the next few months.. Guidelines for cessation of DOACs prior to neuraxial techniques are based on pharmacologic half-lives rather than accumulated experience. This case adds to the experience of neuraxial analgesia complications while following these guidelines. Patient risk may be increased by the combination of recent cessation of a DOAC, as well as the cumulative effect of multiple small risk factors. Continued vigilance and reporting of cases of epidural hematomas will enhance our understanding and ultimately improve patient care. Elderly patients and/or patients with prior neurological deficits may present further challenges for early detection and require frequent assessments with comparison to baseline status.

Topics: Aged, 80 and over; Analgesia, Epidural; Drug Administration Schedule; Factor Xa Inhibitors; Female; Hematoma, Epidural, Spinal; Humans; Motor Activity; Rivaroxaban

Spinal hematomas (SHs) are rare yet potentially debilitating causes of acute back pain. Although spontaneous SHs have been described in the setting of anticoagulation with warfarin or enoxaparin, few cases of spontaneous SH on direct oral anticoagulants (DOACs) have been reported.. We report a case of spontaneous spinal epidural hematoma in a patient on rivaroxaban. A 72-year-old man on rivaroxaban and aspirin presented with a 4-day history of nontraumatic back pain. In the emergency department he developed lower-extremity weakness and numbness, followed by urinary incontinence. Magnetic resonance imaging revealed spinal epidural hematoma at T11-L2. The patient underwent emergent decompression and hematoma evacuation and was discharged home 8 days later with complete resolution of symptoms. WHY SHOULD AN EMERGENCY PHYSICIAN BE AWARE OF THIS?: Early recognition and surgical intervention for SHs with neurologic compromise is key to favorable outcome. Optimal timing of surgery in patients on DOACs requires an assessment of the risk of intraoperative or postoperative bleeding, an assessment of the patient's symptom progression, as well as an understanding of the pharmacokinetics of the DOAC used and possible reversal options available. We also review all published cases of spontaneous SHs in patients on DOACs and report on their management and outcomes.

Topics: Aged; Analgesia, Epidural; Aspirin; Back Pain; Emergency Service, Hospital; Factor Xa Inhibitors; Hematoma, Epidural, Spinal; Humans; Male; Pain Management; Platelet Aggregation Inhibitors; Rivaroxaban

The authors report a case of a 69-year-old woman who presented with a spontaneous spinal epidural hematoma (SSEH) 10 days after a total hip arthroplasty. The patient had been receiving 10 mg/d of rivaroxaban for 5 days for venous thromboembolism prophylaxis. She had a sudden onset of severe neck pain, followed by quadriplegia below C4. A dorsal SSEH was revealed by computed tomography. While preparing for the emergency evacuation of the SSEH, the neurological symptoms resolved spontaneously in 4 hours. The 1-month follow-up magnetic resonance imaging confirmed that the SSEH had completely resolved. The pathogenesis of SSEH is unclear, but anticoagulant therapy is a known risk factor. It is a relatively rare disorder. Only 1 case of SSEH has been reported, and that patient was receiving a nonsteroidal anti-inflammatory drug besides rivaroxaban, which is another known risk factor for bleeding disorders. [Orthopedics. 2016; 39(3):e558-e560.].

Topics: Aged; Anticoagulants; Arthroplasty, Replacement, Hip; Female; Hematoma, Epidural, Spinal; Humans; Magnetic Resonance Imaging; Neck Pain; Rare Diseases; Risk Factors; Rivaroxaban; Tomography, X-Ray Computed; Venous Thromboembolism

Topics: Anticoagulants; Arthroplasty, Replacement, Knee; Female; Hematoma, Epidural, Spinal; Humans; Middle Aged; Morpholines; Polyradiculopathy; Reoperation; Rivaroxaban; Thiophenes; Treatment Outcome

New oral anticoagulants (NOAC) are becoming available as alternatives to warfarin to prevent systemic embolism in patients with non-valvular atrial fibrillation and for the treatment and prevention of venous thromboembolism. An in-depth understanding of their pharmacology is invaluable for appropriate prescription and optimal management of patients receiving these drugs should unexpected complications (such as bleeding) occur, or the patient requires urgent surgery. The Australasian Society of Thrombosis and Haemostasis has set out to inform physicians on the use of the different NOAC based on current available evidence focusing on: (i) selection of the most suitable patient groups to receive NOAC, (ii) laboratory measurements of NOAC in appropriate circumstances and (iii) management of patients taking NOAC in the perioperative period, and strategies to manage bleeding complications or 'reverse' the anticoagulant effects for urgent invasive procedures.

Topics: Administration, Oral; Anticoagulants; Atrial Fibrillation; Benzimidazoles; beta-Alanine; Blood Coagulation Tests; Blood Loss, Surgical; Contraindications; Dabigatran; Drug Interactions; Drug Monitoring; Drug Substitution; Elective Surgical Procedures; Emergencies; Hematoma, Epidural, Spinal; Hemorrhage; Humans; Kidney Diseases; Liver Diseases; Morpholines; Patient Selection; Pyrazoles; Pyridones; Rivaroxaban; Stroke; Thiophenes; Thrombophilia

We report on a 61-year-old female patient who developed a spontaneous spinal epidural haematoma (SSEH) after being treated by rivaroxaban, a new agent for the prevention of venous thromboembolic events in orthopaedic surgery. Although the pathogenesis of SSEH is unclear, anticoagulant therapy is a known risk factor. The patient sustained a sudden onset of severe back pain in the thoracic spine, followed by paraplegia below T8, 2 days after proximal tibial osteotomy and rivaroxaban therapy. Magnetic resonance imaging (MRI) of the whole spine demonstrated a ventral SSEH from C2 to T8. Whilst preparing for the emergency evacuation of the SSEH, the neurological symptoms recovered spontaneously 4 h after onset without surgery. After monitored bed rest for 48 h the MRI was repeated and the SSEH was no longer present. This rare condition of spinal cord compression and unusually rapid spontaneous recovery has not previously been reported following rivaroxaban therapy.

Topics: Anticoagulants; Factor Xa Inhibitors; Female; Hematoma, Epidural, Spinal; Humans; Middle Aged; Morpholines; Rivaroxaban; Thiophenes; Venous Thromboembolism