Long term follow up after percutaneous closure of PFO in 357 patients with paradoxical embolism: Difference in occlusion systems and influence of atrial septum aneurysm.

BACKGROUND: Percutaneous transcatheter closure of patent foramen ovale (PFO) in cryptogenic stroke or TIA is an alternative to medical therapy especially in patients with atrial septal aneurysm (ASA). The differences in time to complete occlusion for various closure devices in PFO alone and PFO plus ASA are of natural interest. METHODS AND RESULTS: Between January, 1st 1998 and November, 30th 2006 percutaneous PFO closure was performed in 357 patients with a history of > or =1 paradoxical embolism using three different devices: Amplatzer PFO-(n=199), Starflex-(n=48) and Helex Occluder (n=110). All patients were assigned to a post-interventional protocol with contrast-enhanced transesophageal echocardiography (TOE) at 1 and 6 months and every 6 to 12 months in case of incomplete closure. Definite closure was confirmed in at least two consecutive TOE studies. The closure time curves between the three devices were significantly different (p=0.0072). Devices of 25 mm or less had a better occlusion rate. The difference between the closure time curves of PFO and PFO+ASA concerning each device type was significant for Helex (p=0.006) and Starflex (p=0.030). In regard to the occlusion time for large devices Helex succeeded later than Amplatzer and Starflex (p=0.0029). Concerning the cumulative follow up period of 1265 patient years the recurrence/re-event rate of cerebral and peripheral thromboembolic events was 0.7% per patient year. No relation to residual PFO shunting or to thrombus formation was seen. There were no peri-interventional technical complications. In five patients of the Starflex group thrombi were detected in the four week TOE controls. CONCLUSION: The closure rate is dependent on occluder size and type plus the occurrence of an atrial septum aneurysm.

[Prevention of thromboembolism with low molecular weight heparin (Dalteparin-Na) in risk pregnancy]. / Thromboembolieprophylaxe mit niedermolekularem Heparin (Dalteparin-Na) bei Risikoschwangerschaften.

BACKGROUND: Venous thrombotic events still remain the leading cause of maternal morbidity and mortality. During pregnancy as well as post partum, hemostasis changes also in normal pregnant women. Coagulation is activated and fibrinolysis suppressed, the concentration of particular coagulation factors is increased, while inhibitor potential is decreased. Additionally, the venous blood stream is mechanically hampered by the gravid uterus. As a result of these physiologic changes, the risk of thromboembolism is elevated. The risk increases frequently in women with previous thromboembolic episodes, a family history of thromboembolism, hereditary or acquired thrombotic disorders as well as the appearance of additional exposure prothrombogenic factors such as immobilization, inflammation, and operation. Simultaneous presence of combined prothrombogenic factors conducts a potentiation of the risk of thromboembolism. To avoid thromboembolism or rethromboembolism during pregnancy or puerperium, an individual risk-adapted heparin prophylaxis is indicated. PATIENTS AND METHODS: 17 pregnant women with inherited and/or acquired prothrombogenic disorders, eleven of them with previous thromboembolism episodes, were treated with low molecular weight heparin (LMWH; dalteparin-Na). The daily dose of 5,000-10,000 IU LMWH was applied subcutaneously by self-injection during pregnancy and up to 8 weeks post partum. Every 4 weeks clinical and laboratory monitoring was performed. Basic parameters as well as the special coagulation marker TAT (thrombin-antithrombin complex) and D-dimer were analyzed. RESULTS: Under the therapy with LMWH (dalteparin-Na), no thromboembolic events during pregnancy or post partum could be observed. No serious bleeding complications, except small subcutaneous local hematomas, occurred. Bolus applications of LMWH by self-injection were easy to practice, gained a good acceptance and high compliance. Increased TAT values above normal at the actual state of pregnancy could be suppressed to normal values by raising the LMWH dose. CONCLUSION: The individual thromboembolic prophylaxis with LMWH represents an effective and safe therapy in risk pregnancy with previous thromboembolic events and/or thrombotic disorders. TAT seems to be an effective marker for monitoring of the coagulation activity during pregnancy and puerperium. Under this management, thromboembolic prophylaxis can be optimized.