FondaKIDS II: Long-term follow-up data of children receiving fondaparinux for treatment of venous thromboembolic events

2014 ◽  
Vol 134 (3) ◽  
pp. 643-647 ◽  
Author(s):  
Richard H. Ko ◽  
Carlo Michieli ◽  
Jessica L. Lira ◽  
Guy Young
2019 ◽  
Vol 8 (12) ◽  
pp. 2158
Author(s):  
Pei-Hsun Sung ◽  
Yao-Hsu Yang ◽  
Hsin-Ju Chiang ◽  
John Y. Chiang ◽  
Hon-Kan Yip ◽  
...  

Previous data have shown patients with osteonecrosis of the femoral head (ONFH) have increased lifelong risk of unprovoked venous thromboembolic events (VTE) as compared with the general population, according to sharing common pathological mechanism of endothelial dysfunction. However, whether the risk of VTE increases in those ONFH patients undergoing major hip replacement surgery remains unclear. This is a retrospective nationwide Asian population-based study. From 1997 to 2013, a total of 12,232 ONFH patients receiving partial or total hip replacement for the first time and revision surgeries were retrospectively selected from Taiwan Health Insurance surgical files. By 1:1 matching on age, sex, surgical types, and socioeconomic status, 12,232 subjects without ONFH undergoing similar hip surgery were selected as non-ONFH group. The incidence and risk of post-surgery VTE, including deep venous thrombosis (DVT) and pulmonary embolism (PE), were compared between the ONFH and non-ONFH groups. Results showed that 53.8% of ONFH patients were male and the median age was 61.9 years old. During the mean follow-up period of 6.4 years, the incidences of VTE (1.4% vs. 1.2%), DVT (1.1% vs. 0.9%), and PE (0.4% vs. 0.4%) were slightly but insignificantly higher in the ONFH than in the non-ONFH group undergoing the same types of major hip replacement surgery (all p-values > 0.250). Concordantly, we found no evidence that the risk of VTE was increased in the ONFH patients as compared with the non-ONFH counterparts (adjusted HR 1.14; 95% CI 0.91–1.42; p = 0.262). There were also no increased risks for DVT and PE in the ONFH subgroups stratified by comorbidities, drug exposure to pain-killer or steroid, and follow-up duration after surgery, either. In conclusion, hip arthroplasty in Asian patients with ONFH is associated with similar rates of VTE as compared to patients with non-ONFH diagnoses.


2013 ◽  
Vol 2 (2) ◽  
pp. 105
Author(s):  
Chao Tze-Fan ◽  
Chiang Chern-En ◽  
Chen Shih-Ann ◽  
◽  
◽  
...  

The incidence of atrial fibrillation (AF) was around 1.5 per 1000 person-years in Taiwan. Systemic thromboembolism is the most severe complication of AF. Risk stratification and adequate thromboembolism prophylaxis is the cornerstone of treatment in AF patients. The CHA2DS2-VASc score is powerful in selecting “truly low-risk” patients who are not necessary to receive anticoagulation therapies. It is also useful in predicting thromboembolic events and mortality for patients undergoing AF ablation. Recently, more and more biomarkers and imaging parameters were reported to be associated with adverse events in AF patients. How could these biomarkers and imaging tools change the current strategy of stroke prevention in AF deserves further investigations.


Circulation ◽  
2015 ◽  
Vol 132 (suppl_3) ◽  
Author(s):  
Carola Gianni ◽  
Luigi Di Biase ◽  
Sanghamitra Mohanty ◽  
Chintan Trivedi ◽  
Yalçin Gökoglan ◽  
...  

Introduction: The objective of this retrospective multicenter study is to report the initial long-term performance results after percutaneous exclusion of the LAA with the endo-epicardial Lariat device to prevent AF-related thromboembolic events. Methods and results: Patients with successful LAA ligation and at least 1-year follow-up were analyzed (N=355). At 1 year, TEE follow-up was present in 172 patients. A leak was defined as presence of flow into the LAA as assessed by TEE. At 6 months, 19 (11%) patients had a leak; 2 strokes occurred: 1 in a patient without a leak and 1 associated with mesenteric ischemia in a patient without a known acute leak, who died before repeat TEE could be performed. At 12 months, 34 (20%) patients had a leak; 6 patients developed a neurological event (5 strokes and 1 TIA), 4 in patients with a leak, 2 in patients without a leak. 3% were followed-up for more than one 1 year (with a mean of 21±9 months). 1 additional thromboembolic event (TIA) occurred 14 months post-implant in a patient without anticoagulation and with a partially excluded LAA (stump), although no leak or thrombus were detected on standard TEE. Among patients with a leak (36% of those with long-term follow-up), 75% were on long-term anticoagulation and no additional TE events were detected. Out of 355 patients, 9 (2.5%) patients had a neurological event: 4 with a leak, 4 without a leak and 1 in a patient where TEE was not repeated. Considering those with known LAA status, thromboembolic events were more common in patients with a leak (4/34 vs 4/136; RR 4, 95% CI 1.1-15.4). Conclusion: In this multicenter experience with the Lariat device, the rate of leaks was high (20% of those with TEE follow-up at 1 year). Thromboembolic events were not rare (overall, 2.5%), and occurred more frequently in patients with a leak (RR 4).


Blood ◽  
2012 ◽  
Vol 120 (21) ◽  
pp. 1151-1151
Author(s):  
Vivek Kesari ◽  
Maithili Shethia ◽  
Xiao Zhou ◽  
Michael Overman ◽  
Saroj Vadhan-Raj

Abstract Abstract 1151 Background: Patients (pts) with pancreatic cancer are at high risk for venous thromboembolic events (VTE) and the occurrence of VTE can adversely affect prognosis. However, it is unclear if the type of VTE such as symptomatic vs incidental, deep vein thrombosis (DVT) vs pulmonary embolism (PE), the location of VTE [DVT of extremities vs visceral veins (abdominal/pelvic veins)] or the timing of VTE from diagnosis can influence the survival. The purpose of this study was to evaluate the incidence of different types of VTE, the impact of types and timing of VTE (early vs late) on survival. Methods: Medical records of 260 pts with pancreatic cancer, newly referred to MDACC in 2006, were reviewed for cancer diagnosis, patient demographics (age, gender), presence of metastasis, the date of diagnosis of VTE, timing of VTE, type of VTE, the site of VTE, the incidence of VTE during 2 years of follow up from the date of diagnosis. Clinical and laboratory parameters predictive for survival were also reviewed. All VTE episodes, including symptomatic as well as incidental VTEs were confirmed by the radiological studies using CT ANGIO, CT scan, Doppler compression ultrasound or V/Q perfusion scans. The survival time was calculated from the date of cancer diagnosis to the date of last follow up. Survival analysis was conducted using Kaplan-Meier method and Cox proportional hazard models. The stepwise selection method was employed to build a multivariate model using variables with p<0.15 in univariate analysis. Results: Of the 260 pts referred, 235 were confirmed to have the diagnosis of pancreatic carcinoma. During the 2-year follow-up, 80 pts (34%) had 109 episodes of VTE, including symptomatic and incidental episodes. The median age of the pts with VTE was 59 years (range: 28–86) and 51% were males. Of the 80 pts with VTE, 21 (26%) had PE, 18 (23%) had DVT of extremities, 28 (35%) had DVT of visceral veins and 13 (16%) had concurrent PE/DVT (diagnosed on the same day). Of the 80 pts, 25 (31%) had 29 recurrent episodes. Kaplan-Meier survival analysis, as shown in the table below, indicated that the pts who had early VTE (defined as VTE diagnosed within 30 days from the date of diagnosis of pancreatic cancer) vs late VTE (> 30 days) and pts with metastasis vs no metastasis had statistically poor 1 year survival (log-rank test). Conclusions: These findings suggest that timing of VTE is an important indicator of prognosis, regardless of whether symptomatic or incidental. Patients with VTE within 30 days of diagnosis have shorter survival. Disclosures: No relevant conflicts of interest to declare.


2018 ◽  
Vol 46 (4) ◽  
pp. 1685-1689 ◽  
Author(s):  
Kun Chu ◽  
Qing Zhang ◽  
Ningxia Sun ◽  
Haixia Ding ◽  
Wen Li

Laparoscopic unwinding of adnexal torsion has been proposed for decades. However, this technique is still controversial regarding the concern of thromboembolic events. We present two cases of conservative laparoscopic management of adnexal torsion. In the first case, a 16-year-old adolescent with serous cystadenoma was successfully managed by untwisting and cystectomy. We followed up this patient for 17 years with regular re-examinations in our hospital. To the best of our knowledge, this is the longest follow-up reported of this condition. In the second case, a 32-year-old infertile woman who received oocyte retrieval 3 days before being admitted to hospital was referred to hospital with right ovarian torsion. We treated her successfully based on our long-term follow-up experience, and she is now asymptomatic and in her 7th month of pregnancy.


2017 ◽  
Vol 10 (6) ◽  
pp. 560-565 ◽  
Author(s):  
Nicholas K Cheung ◽  
Albert HY Chiu ◽  
Andrew Cheung ◽  
Jason D Wenderoth

BackgroundStent assisted coil embolization (SACE) of bifurcation aneurysms is challenging. Heterogeneous results have been achieved to date, but largely for laser cut stents. While braided stents offer multiple technical advantages, their long term efficacy has yet to be validated.ObjectiveTo report the first long term 18 month results for the durability of bifurcation aneurysms treated with braided stents.Materials and methodsOver a 4 year period, 59 consecutive patients with 60 bifurcation aneurysms underwent elective braided SACE across three Australian neurovascular centers. 17 of these aneurysms underwent T- or Y-shaped stent constructs. All patients had immediate, 6 month and 18 month clinical and radiological follow-up. Radiological assessment was made on modified Raymond–Roy occlusion scores while clinical assessment was based on the modified Rankin Scale. Subgroup analysis of 17 aneurysms treated with multi-stent constructs was conducted.Results6 month follow-up data were available for 59 aneurysms and 18 month follow-up data for 58 aneurysms. Satisfactory aneurysm occlusion was achieved in 97% at inception and at 6 months, and 98% at 18 months. Good neurological outcomes were achieved in 95% at 18 months. Similar satisfactory results were achieved with the multi-stent construct cohort. Intraprocedural thromboembolic events were recorded in 5% and delayed events in 2%. Technical complications were found in 5%. All complication rate was 13%.ConclusionBraided SACE was safe, efficacious, and durable at the long term 18 month follow-up, including for multi-stent constructs. Preliminary results indicate favorable clinical and radiological outcomes compared with laser cut stents.


Blood ◽  
2012 ◽  
Vol 120 (21) ◽  
pp. 3415-3415 ◽  
Author(s):  
Richard Har Ko ◽  
Carlo Michieli ◽  
Laura Bernardini ◽  
Guy Young

Abstract Abstract 3415 Background: The incidence of venous thrombotic events (VTE) in children has risen substantially over the past decade, resulting in increasing use of anticoagulants and making it imperative that pharmacokinetic (PK) and pharmacodynamic studies be performed in children. Fondaparinux has several advantages over low molecular weight heparins including once-daily dosing, no risk for heparin-induced thrombocytopenia, and possibly reduced effects on bone mineral metabolism. A PK, dose-finding, and safety study of fondaparinux was published; however it only studied relatively short-term outcomes and adverse effects. The purpose of this study was to investigate the long-term safety, dosing, and efficacy of fondaparinux in children. Methods: The study included all children 1–18 years (yrs) old treated consecutively with fondaparinux in a single institution between September 1, 2007 and June 20, 2011. The following data were abstracted from the medical records: demographics, location of initial VTE, fondaparinux dosing and levels, bleeding events, other adverse events, status of VTE at each subsequent imaging study (complete resolution, partial resolution, no change, or progression), and VTE recurrence. Descriptive statistics are used to describe the patients and the outcomes. Results: Data from 22 patients were collected and all were available for the safety analysis while 19 were analyzed for dosing (1 excluded due to only receiving 2 doses secondary to an allergic reaction and 2 excluded for ineligible diagnoses) and 16 for efficacy (1 excluded due to allergic reaction, 1 because fondaparinux was given as prophylaxis, and 4 due to ineligible diagnoses/insufficient data). There were 11 females (F) and 11 males (M) (10 F and 9 M analyzed for dosing; 9 F and 7 M for efficacy). The mean age of the patients was 9 yrs (median: 10 yrs; range: 1–17 yrs). The mean duration of treatment with fondaparinux was 377 days (d) (median: 171 d; range: 6–1566 d). The mean dose of fondaparinux was 0.1 mg/kg/dose (median: 0.1 mg/kg/dose; range: 0.07–1.4 mg/kg/dose). Nine of 16 evaluable patients (56.3%) had complete resolution of their thrombus while 6/16 (37.5%) had partial resolution, and 1/16 (6.3%) had no change in their thrombus. Thus, 15/16 (93.8%) patients had either a complete or partial response and 0/16 had progression. The mean time to best outcome from initiation of fondaparinux was 110.5 d (median: 63 d; range: 4–487 d). Seven patients needed a total of 12 dose adjustments (one subject with 3 adjustments and one with 4) to achieve therapeutic levels. Three patients (18.8%) (2 had prior complete resolution of the initial VTE) had a recurrent VTE. Two patients were on fondaparinux at the time of recurrence and 1 was on warfarin. There were 2 major (intracranial hemorrhage- occurred prior to initiation of fondaparinux and subretinal hemorrhage) and 3 minor (all with blood in stool) bleeding events. One patient had an allergic reaction after starting fondaparinux. Conclusions: In this long-term follow-up study on children treated with fondaparinux for VTE, 95% of patients had either complete or partial resolution while the recurrence rate was in line with previous studies. There were 5 bleeding events (2 major and 3 minor), though only 1 event required the discontinuation of fondaparinux. Given the advantages of fondaparinux over other anticoagulants, this study suggests that fondaparinux could be considered a safe and effective alternative for the management of VTE in children. Disclosures: Off Label Use: fondaparinux: anti-coagulation for the treatment of venous thromboembolic events in children. Young:Biogen Idec: Research Funding; Baxter: Consultancy, Honoraria; Novo Nordisk: Consultancy, Honoraria, Research Funding.


Blood ◽  
2013 ◽  
Vol 122 (21) ◽  
pp. 4643-4643 ◽  
Author(s):  
Mouhab Ayas ◽  
Khawar Siddiqui ◽  
Abdulrahman Al-Musa ◽  
Hassan El-Solh ◽  
Abdullah Al-Jefri ◽  
...  

Post-transplant erythrocytosis is an ominous complication of kidney transplantation, occurring in the first 8 to 24 months after surgery in 10% to 15% of transplant recipients; this is frequently associated with significant thromboembolic events and sometimes death. In patients undergoing allogeneic hematopoietic cell transplantation (HCT), erythrocytosis has not been previously well described. At our institution, we observed that some aplastic anemia (AA), and Fanconi anemia (FA) patients developed progressively increased hemoglobin (HB), hematocrit (HCT) and RBC readings on long term follow up. Thus, this study was conducted to assess the validity of this observation in AA/FA patients post HCT, and its impact on their health. Patients and Methods From January 1993 until December 2011, 144 pediatric patients underwent successful allogeneic HCT for AA or FA; median age at HCT 11.6 years (range, 6.6 -15). All patients included were alive at the time of the analysis, and had sustained engraftment; all have had a follow up time of ≥ 12 months. For those who underwent more than one HCT, only events after the last HCT were included. We retrospectively examined the HB levels as an indicator for erythrocytosis (Corresponding RBC, HCT, WBC, and platelet counts were also collected). HB values of 150, and 160 gm/l were considered the trigger value in females and males, respectively. Patients who reached this value were studied for higher values on follow up, and only those whose HB persisted for at least 3 months above trigger value were included in the analysis; 29 patients (15 females, 14 males) were identified after causes of secondary erythrocytosis were ruled out. Erythrocytosis was defined as HB ≥ 160 gm/l in females, a HB ≥ 170 gm/l in males. Results Median time to trigger HB was 51.4 months (range, 15-121) in females, and 65 months (range, 23.3-114) in males, and median age at trigger HB was 14.7 years (range, 8.6-21.4) in females, and 16.9 years (range, 13.4-20.6) in males. Median highest HB reached was 160 gm/l (range, 151-162) in females, and 172 gm/l (range, 164-189) in males, with a median time of 67 months (range, 17-164) in females, and 103 months (range, 23.3-206) in males; the median age at highest HB was 16 years (range, 9.7-24.8) in females, and 20.2 years (range, 13.4-27.4) in males. Upon follow up, the HB fell below the trigger level in 16 patients (9 females, 7 males) (55.2%), at a median time of 37.2 months from the trigger value (range, 3.6-104). Seventeen patients qualified for the diagnosis of erythrocytosis (12%); 8 females, and 9 males. In all 8 females and in 4 males, HB fell below the erythrocytosis value upon follow up. All HB values correlated positively with HCT and RBC, no correlation was detected with platelet count or WBC. On univariate analysis, patients with older age at HCT (≥ 10 years) appeared to be more likely to develop elevated HB (P=0.003); and those who had radiation in the conditioning regimen were less likely to develop elevated HB (P=0.008). Three of the males with persistent erythrocytosis were tested further and all 3 had normal erythropoietin levels and were negative for JAK-2 mutations. None of the 29 patients had any adverse clinical symptoms during the follow up visits, and no thromboembolic events were reported. Conclusion A proportion of patients with AA/FA who undergo HCT may experience elevated HB on long term follow up; 12% subsequently qualifying as erythrocytosis, with the highest reading requiring between 1.5-2 years to evolve. Unlike erythrocytosis post renal transplant, the phenomenon we are describing in our patient cohort does not appear to be associated with any adverse symptoms, or any increased risk of thrombosis. More in depth investigation to study the potential pathophysiology behind it is currently underway at our institution, together with further exploration of this observation in patients with other illnesses undergoing allogeneic HCT. Disclosures: No relevant conflicts of interest to declare.


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