A Cohort Study Of 15,912 Patients On The Long-Term Quality Of Vka Therapy After Extreme Overanticoagulation

Blood ◽  
2013 ◽  
Vol 122 (21) ◽  
pp. 2384-2384
Author(s):  
Hilde A.M. Kooistra ◽  
Nakisa Khorsand ◽  
Hanneke C. Kluin-Nelemans ◽  
Nic J.G.M. Veeger ◽  
Margriet Piersma ◽  
...  

Abstract Introduction Many patients are on long-term vitamin K antagonists (VKA) for atrial fibrillation (AF) or recurrent venous thromboembolism (VTE). This therapy proved highly effective for the prevention of stroke and recurrence of venous thrombosis. However, due to intra-individual variations in the dose-response relationship it can be difficult to keep the International Normalized Ratio (INR) within the therapeutic range. As underanticoagulation increases the thrombotic risk and overanticoagulation the bleeding risk, the efficacy and safety of VKA depend on the individual time in the therapeutic range (iTTR). Although patients on stable VKA therapy tend to stay stable over time, a proportion develops extreme overanticoagulation. It is well known that the iTTR is lowered directly after overanticoagulation. However, it is unclear whether such patients will subsequently restabilize. For that reason, we analyzed in a large cohort of AF and VTE patients the course of VKA therapy during the 3 months after extreme overanticoagualation. Material and Methods We selected from a consecutive cohort of 15,912 AF and VTE patients all patients who were on ‘stable VKA therapy’ during the 3 months ‘screening period’. The screening period started for the individual patient at the first INR between January 2009 and January 2012 that was measured ≥3 month after treatment initiation. Stable VKA therapy was defined by a maximum interval of 56 days between INR-measurements and the absence of extreme overanticoagulation (INR≥ 8.0 or unscheduled supplementation of vitamin K). End of follow-up was June 2012. In patients with extreme overanticoagulation (EO), we compared the 3 months before with the 3 months after EO. Patients with EO were also compared with the total group of selected patients. The primary outcome was inadequate iTTR (iTTR <65%), as we know from previous studies that the majority of major bleeds and thrombo-embolic events occurs in this relatively small group. Secondary outcomes were: time under and above the therapeutic range, iTTR (linear), and frequency of INR-measurements. Target INR was 2.0-3.5 according to Dutch guidelines. The iTTR was calculated for each individual patient using linear interpolation. INRs within 7 days before or after EO were not taken into account. Results We selected 14,417 stable patients: 11,194 AF and 3,223 VTE patients. During a total follow-up of 25,848 patient-years, 885 patients (3.4/100 patient-years) experienced EO. After EO, 731 (83%) patients continued VKA treatment. In the 3 months before EO, 50.0% of patients had an iTTR<65%. This increased with 16.6% (95% CI 14.3 – 19.2) to 66.7 % after EO. In patients who continued VKA treatment, the mean iTTR decreased with 7.1% (95%CI 4.6 – 9.6) from 64.2 to 57.2 after EO. The mean time above the therapeutic range only slightly decreased (3.9%, 95%CI 1.5 – 6.3) from 22.4% to 18.5%. Interestingly, the time below the therapeutic range almost doubled as it increased with 11.0% (95%CI 8.7 – 13.3) to 24.3%. The frequency of INR-measurements increased from a mean time interval of 18.4 to 14.0 days. In the total cohort of 14,417 patients, 18% of patients had an iTTR<65%. The mean time below, within and above the therapeutic range was 10.4%, 77.3% and 12.3%, respectively. Therefore, the RR risk of inadequate VKA therapy was 2.8 (95%CI 2,6 – 3.0) before and 3.7 (95%CI 3.5 – 4.0) after EO, compared to the total group. Conclusion Patients with EO had a significantly higher risk of inadequate VKA therapy compared to the total group of patients already in the 3 months before EO. After EO, the time below the therapeutic range increased, which could be caused by a counter reaction. This resulted in further deterioration of the iTTR. Thus, even with more frequent INR-measurements, adequate VKA therapy was not achieved for most of these patients. Although an episode of EO does alert staff, this does not lead to better control. These patients might be better candidates for one of the new oral anticoagulants. Disclosures: No relevant conflicts of interest to declare.

2021 ◽  
Vol 23 (Supplement_2) ◽  
pp. ii50-ii51
Author(s):  
R M Emad Eldin ◽  
K M Abdel Karim ◽  
A M N El-Shehaby ◽  
W A Reda ◽  
A M Nabeel ◽  
...  

Abstract BACKGROUND Glomus Jugulare tumors are benign but locally aggressive ones that represent a therapeutic challenge. Previous studies about the use of Gamma Knife Radiosurgery (GRS) in those tumors have documented good results that needed larger number of patients and longer follow up periods to be confirmed. MATERIAL AND METHODS Between August 2001 and December 2017, 70 patients with glomus jugulare tumors were treated at the Gamma Knife Center, Cairo. They were 46 females and 24 males. The mean age was 48 years (16–71 years). Nineteen of these patients were previously operated, 5 were partially embolized, 3 underwent embolization and subsequent surgery and 43 had gamma knife as their primary treatment. Volume-staged gamma knife radiosurgery was used in 10 patients and single-session in 60 patients, with a total of 86 sessions. The mean target volume was 12.7 cm3 (range 0.2 to 34.5 cm3). The mean tumor volume was 15.5 cm3 (range 0.2 to 105 cm3). The mean prescription dose was 14.5 Gy (range 12 to 18 Gy). RESULTS The mean follow up period was 60 months (range 18 to 206 months), and by the time of the data analysis, two of the patients were dead (66 and 24 months after GK treatment). The tumor control was 98.6% (69/70). Thirty-two tumors became smaller and 37 were unchanged. The symptoms improved in 36 patients, were stable in 32 patients, and worsened in 2 patients who developed a transient facial palsy and worsened hearing. Symptomatic improvement began before any reduction in tumor volume could be detected, where the mean time to clinical improvement was 7 months whereas the mean time to tumor shrinkage was 18 months. CONCLUSION This study about the long term follow up of the GKR for the intracranial glomus jugulare tumors confirmed that this is a highly effective and safe treatment. This data shows that the clinical improvement is not correlated with the radiological volume reduction.


2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Jiayu Yan ◽  
Yanlong Duan ◽  
Tingting Liu ◽  
Jianlin Guo ◽  
Chunhui Peng ◽  
...  

Abstract Background Whether surgery can improve the prognosis of patients with primary pediatric gastrointestinal lymphoma (PPGL) who experienced bowel perforation remains controversial. This study aimed to evaluate the prognosis of such patients. Methods Nine patients pathologically diagnosed with PPGL who experienced perforation at our center between January 2010 and December 2020 were enrolled and divided into two groups: those with perforation during (n = 4) and before (n = 5) chemotherapy. Their medical records were reviewed, and long-term follow-up was conducted by telephone in February 2021. Results All patients with perforation during chemotherapy were diagnosed with PPGL in the outpatient department. The mean time from outpatient visit to chemotherapy was 17.3 ± 6.1 days. Two patients experienced perforation during the first chemotherapy regimen and received conservative treatment, while the others developed perforation after multiple chemotherapy regimens and underwent surgery. All of the patients received regular chemotherapy and survived for a mean follow-up time of 3.8 ± 1.9 years. No patient with perforation before chemotherapy had a definite diagnosis in the outpatient department. Among these patients, 4 experienced perforation and underwent surgery, of whom 3 developed perforation-related complications and died; the other recurred after chemotherapy. Only the patient who received conservative treatment was diagnosed with PPGL before chemotherapy, received regular chemotherapy, and survived without a recurrence for 1.0 year. Conclusion Prompt diagnosis and chemotherapy improve the prognosis of PPGL. Surgery does not affect the prognosis of patients with perforation during chemotherapy but may accelerate disease progression in patients with perforation before chemotherapy.


2021 ◽  
Vol 10 (13) ◽  
pp. 2950
Author(s):  
Cécile Chung ◽  
Sébastien Bommart ◽  
Sylvain Marchand-Adam ◽  
Mathieu Lederlin ◽  
Ludovic Fournel ◽  
...  

Diffuse pulmonary neuroendocrine cell hyperplasia (DIPNECH) is a rare pre-invasive disease whose pathophysiology remains unclear. We aimed to assess long-term evolution in imaging of DIPNECH, in order to propose follow-up recommendations. Patients with histologically confirmed DIPNECH from four centers, evaluated between 2001 and 2020, were enrolled if they had at least two available chest computed tomography (CT) exams performed at least 24 months apart. CT exams were analyzed for the presence and the evolution of DIPNECH-related CT findings. Twenty-seven patients, mostly of female gender (n = 25/27; 93%) were included. Longitudinal follow-up over a median 63-month duration (IQR: 31–80 months) demonstrated an increase in the size of lung nodules in 19 patients (19/27, 70%) and the occurrence of metastatic spread in three patients (3/27, 11%). The metastatic spread was limited to mediastinal lymph nodes in one patient, whereas the other two patients had both lymph node and distant metastases. The mean time interval between baseline CT scan and metastatic spread was 70 months (14, 74 and 123 months). Therefore, long-term annual imaging follow-up of DIPNECH might be appropriate to encompass the heterogeneous longitudinal behavior of this disease.


2020 ◽  
Vol 35 (Supplement_3) ◽  
Author(s):  
Sophia Lionaki ◽  
Ilias Makropoulos ◽  
Konstantinos Panagiotellis ◽  
Ioannis Gavalas ◽  
George Vlahopanos ◽  
...  

Abstract Background and Aims Advances in immunosuppressants, used for kidney transplantation (KTx) have significantly improved outcomes in this field. We aimed to compare the long-term results of KTx in recipients with IgAN, as cause of end stage kidney disease (ESKD), with those of patients, with non-glomerular causes of renal failure, during the modern era of immunosuppression for KTx. Method This is a retrospective, case control study, in which were included patients who received a KTx after 2000. Patients were eligible to be included, if they had IgAN in a native kidney biopsy specimen and follow up longer than 1 year after KTx. IgAN patients were compared to a control-group of patients with non-glomerular primary causes of ESKD matched for age, gender, date of KTx and donor source. Graft biopsies were performed by clinical indication. Patients with ABO incompatible KTx, preemptive KTx, re-KTx, PRA&gt;50%, major surgical complications during the 1st post-KTx month or non-compliance were excluded from the analysis of outcome. Primary outcomes of interest included graft function, patient and graft survival at end of follow up. The rate of IgAN recurrence in the graft and its impact in renal function and survival were also recorded. Computed GFR was calculated using the Modification of Diet in Renal Disease formula. Results A total of 102 KTx recipients with biopsy-proven IgAN, were compared to 204 controls with non-glomerular causes of ESKD. The mean age of patients with IgAN was 43.2(±10.15) years and 68(66.7%) were men. The mean time in dialysis was 50.2(±48.7) months and 59(57.8%) of them received a graft from a living donor. The mean cold ischemia time was 17.5(±6.7) hours, while 22(21.6%) of patients experienced delayed graft function. 97.05% of patients received induction therapy with an anti-CD25 inhibitor and 99.3% were maintained with a triple immunosuppressive regimen consisted of a mycophenolate mofetil formulation, a calcineurin inhibitor and glucocorticoids. The mean serum creatinine and eGFR at end of follow up were significantly lower for the IgAN group (p=0.001 and p=0.02 respectfully) with no difference in the frequency of acute rejection. However, graft and patient survival were not different even after controlling for follow up longer than one decade. During a mean follow up time of 120.8(±49.1) months, IgAN recurrence in the graft was documented in 23(22.5%) patients. The mean time to recurrence was 47.8(41.8) months, with a mean serum creatinine 1.83(±0.52) mg/dl and eGFR of 43.45(±18.4) ml/min/1.73m2 at the end of follow up. Within the IgAN group, although graft function was significantly lower in patients with disease recurrence, compared with that of patients without recurrence (p=0.003), graft loss remained not different between these two subgroups (p=0.49). Conclusion In the newer era of immunosuppression, long-term outcomes of KTx in patients with IgAN, as primary disease, appear significantly improved, and although graft function was significantly lower in patients with IgAN at the end of follow up, graft and patient survival was not different, compared to patients with non-glomerular causes of ESKD. Recurrence of IgAN in the graft was documented in 22.5% of patients and was associated with significantly lower eGFR at end of follow up compared to patients without recurrence but it did not impact graft survival in this time period.


2018 ◽  
Vol 17 (2) ◽  
pp. 43-48 ◽  
Author(s):  
B. A. Rudenko ◽  
D. A. Feshchenko ◽  
A. S. Shanoian ◽  
О. М. Drapkina ◽  
N. Е. Gavrilova ◽  
...  

Aim. To assess the safety and efficacy of radiofrequency denervation of pulmonary artery (PA) with the Simplicity system in patients with residual pulmonary hypertension (PH) after the thromberarterectomy surgery.Material and methods. To the study, 12 patients included, with the signs of residual PH (by echocardiography data, mean PH pressure ≥25 mmHg), who had undergone surgery (thrombendarcterectomy) for chronic thromboembolic PH. Mean time interval between the diagnosis of PH and pulmonary denervation was 8,5 years. After catheterization of the right chambers of the heart and tensiometry in small circle circulation, the spot circular radiofrequency denervation performed of the right and left PH at the area of ostia, with ablation catheter Simplicity. The success was defined by decrease of mean PA pressure >10 mmHg, absence of complications, exercise tolerance increase after the procedure immediately and in 12 months.Results. At long term period after the intervention there was significant decrease of mean PA pressure from 58±6 to 33±4 mmHg (p<0,01), of pulmonary vascular pressure from 8,6±2,1 to 3,2±1,4 mmHg (p<0,01) and increase of exercise tolerance from 321±19 m to 487±29 m (p<0,01). During the follow up period, 1 patient died in 8 months after inclusion due to severe gastrointestinal bleeding. The rest did not present with adverse events or non­planned hospitalizations. Nine patients noted significant improvement of general health, decrease of dyspnea and fatigue, 3 patients had discontinued sildenafil. There were no complications at PA radiofrequency ablation procedure (death, arrhythmias, PA perforation, acute PA thrombosis in the place of access, bleeding).Conclusion. Utilization of the Simplicity system in PA denervation is safe and effective. Further randomized studies in need to confirm clinical benefits from the procedures in PH patients.


Author(s):  
Hasan Öncül ◽  
Mehmet Fuat Alakuş

Purpose: The aim of this study is to determine the problems occurring during the COVID-19 pandemic period in patients treated with intravitreal (IV) injection for diabetic retinopathy, and to provide recommendations for treatment management in these patients. Methods: Twenty-nine eyes of 17 patients were included in this prospective, observational study. The frequency of hospital visits, treatments performed, and detailed ophthalmological examination findings, including optical coherence tomography findings and glycated haemoglobin (HbA1c) values, were recorded in the period before the COVID-19 pandemic. During the COVID-19 pandemic period, the detailed ophthalmological examination findings and HbA1c values were noted after the patients who had delayed their routine control time (>90 days) applied to the hospital. New treatments were planned according to the current situation. Results: Seventeen patients who were diagnosed with diabetic macular edema were included in the study; 10 were female (58.8%) and seven were male (41.2%). The mean time interval between following visits was 45.52±5.85 days during the pre-pandemic period, but it increased to 110.41±13.47 days during the COVID-19 pandemic period (p<.001). Visual acuity (LogMAR) was 0.44±0.36 in the pre-pandemic period and 0.76±0.48 during the COVID-19 pandemic period (p=.003). Central macular thickness was 300.10±85.56 µm in the pre-pandemic period and it increased to 387.10±144.48 µm during the COVID-19 pandemic period (p=.007). In three patients, complications of diabetic retinopathy that could not be cured by medical treatment developed and surgical treatment was recommended. Conclusions: Delays in the treatment of diabetic retinopathy may cause permanent impairment in visual functions. The COVID-19 pandemic has caused an increase in the hospital visit intervals of patients, and this situation has resulted in disruptions in the follow-up and treatment of patients with diabetic retinopathy. Alternative diagnosis and treatment practices are needed in order to manage these and similar processes smoothly.


Neurosurgery ◽  
2005 ◽  
Vol 56 (6) ◽  
pp. 1271-1278 ◽  
Author(s):  
David Kadrian ◽  
James van Gelder ◽  
Danielle Florida ◽  
Robert Jones ◽  
Marianne Vonau ◽  
...  

Abstract OBJECTIVE: To describe the short-term operative success and the long-term reliability of endoscopic third ventriculostomy (ETV) for treatment of hydrocephalus and to examine the influence of diagnosis, age, and previous shunt history on these outcomes. METHODS: We retrospectively analyzed 203 consecutive patients from a single institution who had ETV as long as 22.6 years earlier. Patients with hydrocephalus from aqueduct stenosis, myelomeningocele, tumors, arachnoid cysts, previous infection, or hemorrhage were included. RESULTS: The overall probability of successfully performing an ETV was 89% (84–93%). There was support for an association between the surgical success and the individual operating surgeon (odds ratios for success, 0.44–1.47 relative to the mean of 1.0, P = 0.08). We observed infections in 4.9%, transient major complications in 7.2%, and major and permanent complications in 1.1% of 203 procedures. Age was strongly associated with long-term reliability. The longest observed reliability for the 13 patients 0 to 1 month old was 3.5 years. The statistical model predicted the following reliability at 1 year after insertion: at 0 to 1 month of age, 31% (14–53%); at 1 to 6 months of age, 50% (32–68%); at 6 to 24 months of age, 71% (55–85%); and more than 24 months of age, 84% (79–89%). There was no support for an association between reliability and the diagnostic group (n = 181, P = 0.168) or a previous shunt. Sixteen patients had ETV repeated, but only 9 were repeated after at least 6 months. Of these, 4 procedures failed within a few weeks, and 2 patients were available for long-term follow-up. CONCLUSION: Age was the only factor statistically associated with the long-term reliability of ETV. Patients less than 6 months old had poor reliability.


2019 ◽  
pp. 112070001989466 ◽  
Author(s):  
Inari Laaksonen ◽  
Vincent P Galea ◽  
James W Connelly ◽  
Sean J Matuszak ◽  
Luca Marega ◽  
...  

Background: Despite the large number of studies assessing adverse local tissue reaction (ALTR) in metal-on-metal (MoM) hip implants, there is still a lack of knowledge about the natural progression of ALTR. The aims of this study were to describe the natural course of changes in ALTR at mid- to long-term follow-up for patients treated with metal-on-metal hip arthroplasty and to determine possible risk factors associated with change in ALTR. Methods: A total of 158 patients (158 hips), 109 MoM hip resurfacing arthroplasties (HRAs) and 49 MoM total hip arthroplasties (THAs), with 2 clinical follow-ups including MARS-MRIs were included. The mean time from index operation to the first visit was 7.6 years (range 3.4–11.4 years), and the mean time between the 2 visits was 1.0 year (range 0.7–1.6 years). Results: The proportion of patients with moderate or severe ALTR did not increase significantly between the first and second visit for the MoM HRA group (14.7–15.6%; p = 0.850) or the MoM THA group (32.7–36.7%; p = 0.671). 8 (7.3%) HRA patients and 9 (18.4%) THA patients progressed in ALTR grade. None of the collected clinical variables was sensitive or specific in identifying patients with ALTR progression. Conclusions: Although ALTR prevalence was high in our cohort, clinically significant ALTR progression was rare. We were unable to find any predictors associated with ALTR change. This indicates that MARS-MRI remains a valuable tool in the follow-up of patients treated with MoM hip devices in identifying patients who may need revision surgery.


2020 ◽  
Vol 66 (4) ◽  
pp. 6-8
Author(s):  
Andrzej Żyluk

AbstractThe incidence of recurrence Dupuytren’s disease after surgery is estimated up to 50% in relation to progression of the disease, treatment modality and time of the follow-up. The objective of this study was an analysis of the causes and frequency of recurrences among 67 patients following surgery for recurrent Dupuytren’s disease in the author’s institution in the years 2016–2018. The 67 patients comprised 56 men (83%) and 11 women (17%) at a mean age of 59 years (range 40–81), of which 27 patients (40%) had undergone a 2nd operation to the same hand, 22 patients (33%) had undergone a 3rd operation, 14 (21%) had undergone a 4th operation, and the remaining 4 patients had each undergone more than 5 operations on the same hand. The defined rate of recurrence in the analysed period was 20%. The mean time interval from the last operation and the appearance of signs of a relapse was 14 months; in 42 patients (63%) it was less than 1 year (3–12 months) and in the remaining 25 (37%) 1–4 years. Progressing contracture of the previously operated finger and contracture of the adjacent finger which was not involved at the 1st operation, was the most frequently observed pattern of recurrence, found in 29 patients; it was a combination of true recurrence and extension of the disease. The number of operations performed in a given patient was found to be a statistically significant risk factor of recurrence.


2019 ◽  
Vol 24 (5) ◽  
pp. 549-557
Author(s):  
Malia McAvoy ◽  
Heather J. McCrea ◽  
Vamsidhar Chavakula ◽  
Hoon Choi ◽  
Wenya Linda Bi ◽  
...  

OBJECTIVEFew studies describe long-term functional outcomes of pediatric patients who have undergone lumbar microdiscectomy (LMD) because of the rarity of pediatric disc herniation and the short follow-up periods. The authors analyzed risk factors, clinical presentation, complications, and functional outcomes of a single-institution series of LMD patients over a 19-year period.METHODSA retrospective case series was conducted of pediatric LMD patients at a large pediatric academic hospital from 1998 to 2017. The authors examined premorbid risk factors, clinical presentation, physical examination findings, type and duration of conservative management, indications for surgical intervention, complications, and postoperative outcomes.RESULTSOver the 19-year study period, 199 patients underwent LMD at the authors’ institution. The mean age at presentation was 16.0 years (range 12–18 years), and 55.8% were female. Of these patients, 70.9% participated in competitive sports, and among those who did not play sports, 65.0% had a body mass index greater than 25 kg/m2. Prior to surgery, conservative management had failed in 98.0% of the patients. Only 3 patients (1.5%) presented with cauda equina syndrome requiring emergent microdiscectomy. Complications included 4 cases of postoperative CSF leak (2.0%), 1 case of a noted intraoperative CSF leak, and 3 cases of wound infection (1.5%). At the first postoperative follow-up appointment, minimal or no pain was reported by 93.3% of patients. The mean time to return to sports was 9.8 weeks. During a mean follow-up duration of 8.2 years, 72.9% of patients did not present again after routine postoperative appointments. The total risk of reoperation was a rate of 7.5% (3.5% of patients underwent reoperation for the same level; 4.5% underwent adjacent-level decompression, and one patient [0.5%] ultimately underwent a fusion).CONCLUSIONSMicrodiscectomy is a safe and effective treatment for long-term relief of pain and return to daily activities among pediatric patients with symptomatic lumbar disc disease in whom conservative management has failed.


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