Activated recombinant factor VII to reverse oral anticoagulants for emergent cesarean delivery.
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Pregnancy after valve replacement has been considered hazardous because of maternal and fetal complications secondary to anticoagulant medication, in addition to basic myocardial problems. Of 229 females aged 15-45 years with prosthetic valve replacement, 37 (including 34 with Björk-Shiley valve and anticoagulants) subsequently had a total of 47 pregnancies. Fullterm delivery of a normal infant was achieved in 40 cases. There were three premature births, two spontaneous abortions, one stillbirth and one ectopic pregnancy. The fetal mortality was 8.5%. Valve thrombosis developed in two cases, but surgical treatment was successful. Oral anticoagulants (acenocoumarin and dipyridamole) were continued throughout pregnancy. Heparin was substituted before labour began, but discontinued after delivery, when effective oral anticoagulation was resumed. Our experience showed that pregnancy in women with mechanical heart valve prosthesis and continued oral intake of anticoagulants is safe and successful in most cases.
A hundred and fifty-two patients who were to undergo major orthopaedic surgery were divided into two groups in order to study the value of dextrans administered as adjuvants to oral anticoagulants in the prevention of deep venous thrombosis. The control group had oral anticoagulants only from the evening before the day of operation, aimed at the 15 per cent thrombotest level. The dextran group had peroperative and postoperative dextran infusions as well. Radionuclide venography was used for thrombosis detection. The dextran group had a lower incidence of thrombosis, but more haemorrhagic problems. The incidence of thrombosis was high in both groups.
The effect of either heparin-dihydergot or heparin-acenocoumarin on the incidence of deep-vein thrombosis in the legs was studied in 181 women undergoing Ender nailing for intertrochanteric fracture of the femur. All the patients were screened with the 125-I-fibrinogen uptake test, confirmed by a bilateral ascending venogram. Deep-vein thrombosis developed in 40 per cent of the heparin-dihydergot group and in 61 per cent of the heparin-acenocoumarin group (p less than 0.015).
We investigated the risk of heterotopic ossification (HO) after total hip arthroplasty in 67 patients, 16 of whom had diffuse idiopathic skeletal hyperostosis (DISH). DISH was diagnosed on chest, dorsolumbar and pelvic radiographs. HO was graded according to DeLee et al. (1976). After a 1.4 year follow-up, 21 patients had HO. The risk of HO was 5 times higher in DISH than in non-DISH patients, but lower in patients receiving antivitamin K than in those receiving other anticoagulant therapy (relative risk 0.2). Our findings lead us to recommend that DISH should be diagnosed preoperatively for preventive therapy. They also suggest a preventive effect of antivitamin K against heterotopic ossification after hip arthroplasty.
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BACKGROUND: The optimal duration of oral anticoagulant treatment after a first episode of pulmonary embolism remains uncertain. OBJECTIVE: To evaluate the long-term clinical benefit of extending a 3-month course of oral anticoagulant therapy to 6 months (pulmonary embolism associated with temporary risk factors) or to 1 year (idiopathic pulmonary embolism) in patients with a first episode of pulmonary embolism. DESIGN: Multicenter randomized study with independent, blinded assessment of the outcome events. SETTING: 19 Italian hospitals. PATIENTS: 326 patients who had had 3 months of oral anticoagulant therapy without experiencing recurrence or bleeding. MEASUREMENTS: The primary study outcome was recurrence of symptomatic, objectively confirmed venous thromboembolism. RESULTS: Among 165 patients assigned to extended anticoagulant therapy, 15 patients (9.1%) had a recurrence of venous thromboembolism (3.1% per patient-year; average follow-up, 34.9 months), as compared with 18 of 161 patients (11.2%) assigned to discontinue treatment (4.1% per patient-year; average follow-up, 32.7 months); the rate ratio was 0.81 (95% CI, 0.42 to 1.56). All but one of the recurrences occurred after anticoagulant treatment was discontinued. Nineteen recurrences (57.6%) were episodes of pulmonary embolism, two of which were fatal. Three major bleeding episodes were observed during extended anticoagulation (1.8%). Among patients with idiopathic venous thromboembolism, 11 of 90 patients assigned to extended anticoagulation and 11 of 91 patients assigned to discontinue treatment experienced a recurrence (relative risk, 0.99 [CI, 0.45 to 2.16]). CONCLUSION: Patients with pulmonary embolism have a substantial risk for recurrence after discontinuation of oral anticoagulation, regardless of treatment duration. Physicians should try to identify patients who are at high risk for recurrent venous thromboembolism and are therefore potential candidates for indefinite oral anticoagulant therapy.
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BACKGROUND: Control of oral anticoagulant treatment has been reported to be suboptimal, but previous studies suggest that patient self-management improves control. OBJECTIVE: To compare the quality of control and the clinical outcomes of oral anticoagulant treatment in self-managed patients versus patients following conventional management. DESIGN: Randomized, controlled trial. SETTING: University-affiliated hospital in Spain. PATIENTS: 737 patients with indications for anticoagulant treatment. INTERVENTION: The self-management group (n = 368) received simple instructions for using a portable coagulometer weekly and self-adjusting treatment dose. The conventional management group (n = 369) received usual care in an anticoagulation clinic (monthly measurement and control of international normalized ratio [INR], managed by hematologists). MEASUREMENTS: Percentage of INR values within the target range and major related complications. RESULTS: The median follow-up period was 11.8 months (range, 0.3 to 16.9 months). The unadjusted percentages of in-range INRs were 58.6% in the self-management group and 55.6% in the conventional management group (difference, 3.0 percentage points [95% CI, 0.4 to 5.4 percentage points]). Twenty-seven patients (7.3%) in the conventional management group and 8 (2.2%) in the self-management group had major complications related to anticoagulant treatment. The unadjusted risk difference for major complications between groups was 5.1 percentage points (exact 95% CI, 1.7 to 8.5 percentage points). Fewer patients had minor hemorrhages in the self-management group (14.9%) than in the conventional management group (36.4%). Fifteen patients (4.1%) in the conventional management group and 6 (1.6%) in the self-management group died (unadjusted risk difference, 2.5 percentage points [exact 95% CI, 0.0 to 5.1 percentage points]). LIMITATIONS: The trial was performed at only 1 center and was not blinded. The dropout rate in the intervention group was 21%. CONCLUSIONS: Compared with conventional management by an anticoagulation clinic, self-management of oral anticoagulant treatment achieved a similar level of control. Of note, major complications and minor hemorrhages were less common in the self-management group.