scholarly journals Wenxin Keli versus Sotalol for Paroxysmal Atrial Fibrillation Caused by Hyperthyroidism: A Prospective, Open Label, and Randomized Study

2015 ◽  
Vol 2015 ◽  
pp. 1-9 ◽  
Author(s):  
Zhaowei Meng ◽  
Jian Tan ◽  
Qing He ◽  
Mei Zhu ◽  
Xue Li ◽  
...  

We aimed to compare effectiveness of Wenxin Keli (WK) and sotalol in assisting sinus rhythm (SR) restoration from paroxysmal atrial fibrillation (PAF) caused by hyperthyroidism, as well as in maintaining SR. We randomly prescribed WK (18 g tid) or sotalol (80 mg bid) to 91 or 89 patients. Since it was not ethical not to give patients antiarrhythmia drugs, no control group was set. Antithyroid drugs were given to 90 patients (45 in WK group, 45 in sotalol group);131I was given to 90 patients (46 in WK group, 44 in sotalol group). Three months later, SR was obtained in 83/91 or 80/89 cases from WK or sotalol groups(P=0.762). By another analysis, SR was obtained in 86/90 or 77/90 cases from131I or ATD groups(P=0.022). Then, we randomly assigned the successfully SR-reverted patients into three groups: WK, sotalol, and control (no antiarrhythmia drug was given) groups. After twelve-month follow-up, PAF recurrence happened in 1/54, 2/54, and 9/55 cases, respectively. Log-Rank test showed significant higher PAF recurrent rate in control patients than either treatment(P=0.06). We demonstrated the same efficacies of WK and sotalol to assist SR reversion from hyperthyroidism-caused PAF. We also showed that either drug could maintain SR in such patients.

Author(s):  
S. V. Zemskov

Pancreatic cancer (PC) is associated with high risk of thromboembolism (TE). However, the question of out-patient thromboprophylaxis and its feasibility in patients with PC is still disputable. The purpose of the study was to evaluate the efficacy of enoxaparin application as as thromboprophylaxis based on Khorana index in patients with unresectable PC on chemotherapy. Out-patients with PC on chemotherapy were retrospectively consecutively included in the study. Main and control group included 43 patients each. Patients of the main group were treated with 40mg of enoxaparin daily if Khorana index was >3 for at least 7 days or until Khorana index went <3. No thromboprophylaxis was applied in control group. Follow up time was 24 weeks and coincided with chemotherapy period. The rate TE in control group was 37.2 % (16 of 43) and 14 % (6 of 43) in the main group. The difference in event-free survival when calculated by log-rank test was statistically considerable (p=0.02). No massive bleeding was detected in the main group. Thromboprophylaxis with enoxaparin based on Khorana index in PC patients on chemotherapy may decrease the rate of TE.


Circulation ◽  
2014 ◽  
Vol 130 (suppl_2) ◽  
Author(s):  
Luigi Di Biase ◽  
Rodney Horton ◽  
Chintan Trivedi ◽  
Prasant Mohanty ◽  
Sanghamitra Mohanty ◽  
...  

Introduction: Radiofrequency catheter ablation of atrial fibrillation is performed under fluoroscopic guidance and therefore carries radiation risk exposure for the both the patient and the operator. Three-dimensional mapping systems and newer technologies to allow non-fluoroscopic catheter visualization together with intracardiac echo have reduced but not abolished the fluoroscopy exposure. We aim to demonstrate the feasibility, the safety and the efficacy of catheter ablation for atrial fibrillation without the use of fluoroscopy. Methods: A totally fluoro-less approach was developed for AF ablation at our Institution. 94 consecutive AF patients underwent zero fluoroscopy catheter ablation for atrial fibrillation. In the zero fluoroscopy cases, the fluoroscopy arm was kept far away from the patient table. Access including double trans-septal, mapping with the Carto 3 system and ablation were all performed without fluoroscopy with the use of ICE and the Carto 3 system. These 94 patients were compared with 94 control patients matched for age, sex and type of AF who underwent AF ablation by the same operator with the use of fluoroscopy. Results: Baseline characteristics were similar between fluoroless (N=94, Age=64.5 ± 10.1, 75.5% male, 48% paroxysmal) and control (N=94, Age=65.1 ± 9.9, 72.3% male, 50% paroxysmal) group. Non-PV triggers were detected and ablated in 51 (54.3%) and 56 (59.6%) patients in fluoroless and control group respectively (p=0.5). Average fluoro time in control group was 10.1 ± 4.7 minutes. Procedure duration was comparable (120.4 ± 25.8 vs. 122.2 ± 28.7, p =0.6). After the short term median follow-up of 4.5 (4 – 6.5) months, 10 (10.6 %) patients in flourless and 9 (9.6%) patients in control group experienced recurrences (p=0.8).One pericardial effusion requiring pericardiocenteis occurred in the fluoroless group. Conclusions: Our series show that zero fluoroscopy ablation of atrial fibrillation with the use of newer technologies is feasible, safe and efficacious at the short term follow up. Importantly in our series the double transeptal was performed without fluoroscopy and the ablation was not limited to the pulmonary veins only but included ablation of the posterior wall, the coronary sinus and the left atrial appendage.


2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 5520-5520 ◽  
Author(s):  
Myong Cheol Lim ◽  
Suk-Joon Chang ◽  
Heong Jong Yoo ◽  
Byung-Ho Nam ◽  
Robert Bristow ◽  
...  

5520 Background: Cytoreductive surgery followed by taxane and platinum-based chemotherapy is standard treatment for advanced ovarian cancer. We compared results of randomly allocated HIPEC in primary advanced epithelial ovarian cancer who have optimal cytoreductive surgery in this prospective randomized multicenter trial. The study endpoint is to evaluate progression free survival (PFS) and overall survival (OS). Methods: 184 patients staged III and IV were randomly allocated to trial arm (HIPEC, cisplatin 75 mg/m2, 90 min) or control arm (no HIPEC), intraoperatively based on residual tumor (size <1cm) from July 2010 to January 2016. The groups were well balanced according to the age, body mass index, performance status, stage, histology, serum CA125 level, and use of neoadjuvant chemotherapy (NAC) at study entry. Results: 184 pts (HIPEC, 92; control, 92) were included in this preplanned analysis. No mortality after surgery ± HIPEC was identified in both groups. Postoperative outcomes including extent of surgery, estimated blood loss, residual tumor, and hospitalization day were not different between both group, except operation time (487 vs. 404 min, p<0.001) due to HIPEC procedure. The most common adverse event was anemia: 67.4% in HIPEC and 50% in control group (p=0.025). The other toxicity common in HIPEC group is the elevation of creatinine (15.2% vs. 4.3%, p=0.026). There were no differences between both groups for transfusion (35.9 vs. 29.3, p=0.432), neutropenia (19.6 vs. 10.9%, p=0.151), and thrombocytopenia (9.8 vs. 3.3%, p=0.136). Two-year PFS was 43.2% and 43.5% and 5-year PFS was 20.9% and 16.0% in HIPEC and control group, respectively (p=0.569). Five-year OS was 51.0% and 49.4% in HIPEC and control group, respectively (p=0.574). In women who received NAC, the median PFS for HIPEC and control group were 20 and 19 months, respectively (log-rank test, p = 0.137) and the median OS for HIPEC and control group were 54 and 51 months, respectively (log-rank test, p = 0.407). In the subgroup with NAC, 2-year PFS was 37.2% in HIPEC group and 29.5% in control group and 5-year OS was 47.9% in HIPEC group and 27.7% in control group. After 20 months in PFS and 30 months in OS, two survival curves in women who received NAC showed the trend of gradual distinction, favoring HIPEC group. Conclusions: No mortality was identified and postoperative morbidities were not statistically different between two groups except anemia and creatinine elevation in HIPEC group. The survival analysis did not show the statistical superiority of the HIPEC arm. More follow-up is required to confirm the impact of HIPEC on long-term survival outcome in ovarian cancer, especially in NAC group. Clinical trial information: NCT01091636.


Author(s):  
Brooke E. Wilson ◽  
Michelle B. Nadler ◽  
Alexandra Desnoyers ◽  
Eitan Amir

Background: Censoring due to early drug discontinuation (EDD) or withdrawal of consent or loss to follow-up (WCLFU) can result in postrandomization bias. In oncology, censoring rules vary with no defined standards. In this study, we sought to describe the planned handling and transparency of censoring data in oncology trials supporting FDA approval and to compare EDD and WCLFU in experimental and control arms. Methods: We searched FDA archives to identify solid tumor drug approvals and their associated trials between 2015 and 2019, and extracted the planned handling and reporting of censored data. We compared the proportion of WCLFU and EDD between the experimental and control arms by using generalized estimating equations, and performed logistic regression to identify trial characteristics associated with WCLFU occurring more frequently in the control group. Results: Censoring rules were defined adequately in 48 (59%) of 81 included studies. Only 14 (17%) reported proportions of censored participants clearly. The proportion of WCLFU was higher in the control group than in the experimental group (mean, 3.9% vs 2.5%; β-coefficient, −2.2; 95% CI, −3.1 to −1.3; P<.001). EDD was numerically higher in the experimental arm in 61% of studies, but there was no statistically significant difference in the proportion of EDD between the experimental and control groups (mean, 21.6% vs 19.9%, respectively; β-coefficient, 0.27; 95% CI, −0.32 to 0.87; P=.37). The proportion of EDD due to adverse effects (AEs) was higher in the experimental group (mean, 13.2% vs 8.5%; β-coefficient, 1.5; 95% CI, 0.57–2.45; P=.002). WCLFU was higher in the control group in studies with an active control group (odds ratio [OR], 10.1; P<.001) and in open label studies (OR, 3.00; P=.08). Conclusions: There are significant differences in WCLFU and EDD for AEs between the experimental and control arms in oncology trials. This may introduce postrandomization bias. Trials should improve the reporting and handling of censored data so that clinicians and patients are fully informed regarding the expected benefits of a treatment.


2021 ◽  
Vol 42 (Supplement_1) ◽  
Author(s):  
J.F Alderete Martinez ◽  
S Shizuta ◽  
F Yoneda ◽  
S Nishiwaki ◽  
M Tanaka ◽  
...  

Abstract Background Radiofrequency catheter ablation (RFCA) for atrial fibrillation (AF) is becoming a routine procedure to treat patients with drug-refractory symptomatic AF. However, data regarding very long-term clinical outcomes is limited. The aim of the present study was to evaluate the 10-year clinical outcomes of patients who underwent RFCA for paroxysmal and persistent AF. Methods We retrospectively enrolled 503 consecutive patients (mean age 66,9±9,51 years; 71,6% male) who underwent RFCA for drug-refractory symptomatic AF between February 2004 and June 2011. Follow-up information was obtained using medical records and/or telephonic interviews with the patient, relatives and/or referring physicians. Results Among 503 patients enrolled in this study, 362 had paroxysmal atrial fibrillation (PAF) and 141 had persistent atrial fibrillation (PeAF) (72% and 28%, respectively). Mean follow-up was 8,84±3,05 years. The 10-year event-free rate for recurrent atrial tachyarrhythmia (AT) after the first procedure was 44,5% (49,4% for PAF vs 31,9% for PeAF; p=0,002 by log-rank test) and 81,9% after the last procedure (87,3% for PAF and 67,9% for PeAF; p≤0,001 by log-rank test). AT recurrence was observed most commonly during the first 12 months of the initial procedure (56%), with only 18% of them occurring after 60 months. Multivariate analysis revealed that persistent AF (hazard ratio=1,366; 95% confidence interval 1,058–1,76; p=0,017) and duration of AF &gt;5 years (hazard ratio=1,357; 95% confidence interval 1,064–1,732; p=0,005) were independent risk factors for AT recurrence. Regarding adverse events, there were 24 (4,8%) hospitalizations for acute decompensated heart failure, 20 (4%) ischemic strokes and 14 (2,8%) bleeding complications requiring hospital admissions. Patients taking oral anticoagulation and antiarrhythmic drugs at the end of the study accounted for 32,8% and 16,7% respectively. Conclusions RFCA for AF provided favorable results in terms of arrhythmia event-free survival in long-term follow-up with better results in patients with paroxysmal AF. Persistent AF and long-standing AF (beyond 5 years) were associated with AT recurrence. Despite the large number of patients who discontinued oral anticoagulation, thromboembolic adverse events were rare. FUNDunding Acknowledgement Type of funding sources: None.


EP Europace ◽  
2019 ◽  
Vol 21 (12) ◽  
pp. 1802-1808
Author(s):  
Tosho Balabanski ◽  
Josep Brugada ◽  
Elena Arbelo ◽  
Cécile Laroche ◽  
Aldo Maggioni ◽  
...  

Abstract Aims Monitoring of patients after ablation had wide variations in the ESC-EHRA atrial fibrillation ablation long-term (AFA-LT) registry. We aimed to compare four different monitoring strategies after catheter AF ablation. Methods and results The ESC-EHRA AFA-LT registry included 3593 patients who underwent ablation. Arrhythmia monitoring during follow-up was performed by 12-lead electrocardiogram (ECG), Holter ECG, trans-telephonic ECG monitoring (TTMON), or an implanted cardiac monitoring (ICM) system. Patients were selected to a given monitoring group according to the most extensive ECG tool used in each of them. Comparison of the probability of freedom from recurrences was performed by censored log-rank test and presented by Kaplan–Meier curves. The rhythm monitoring methods were used among 2658 patients: ECG (N = 578), Holter ECG (N = 1874), TTMON (N = 101), and ICM (N = 105). A total of 767 of 2658 patients (28.9%) had AF recurrences during follow-up. Censored log-rank test discovered a lower probability of freedom from relapses, which was detected with ICM compared to TTMON, ECG, and Holter ECG (P < 0.001). The rate of freedom from AF recurrences was 50.5% among patients using the ICM while it was 65.4%, 70.6%, and 72.8% using the TTMON, ECG, and Holter ECG, respectively. Conclusion Comparing all main electrocardiographic monitoring methods in a large patient sample, our results suggest that post-ablation recurrences of AF are significantly underreported by TTMON, ECG, and Holter ECG. The ICM estimates AF ablation recurrences most reliably and should be a preferred mode of monitoring for trials evaluating novel AF ablation techniques.


Circulation ◽  
2008 ◽  
Vol 118 (suppl_18) ◽  
Author(s):  
Isabel Deisenhofer ◽  
Tilko Reents ◽  
Heidi L Estner ◽  
Stephanie Fichtner ◽  
Christian von Bary ◽  
...  

Introduction: Segmental pulmonary vein isolation (PVI) leads to elimination of paroxysmal atrial fibrillation (AF) in approximately 75% of patients. Ablation of complex fractionated atrial electrograms (CFAE) is an alternative ablation strategy. In this prospective randomized study the long-term effect of PVI alone is compared to the effect of combined PVI and CFAE ablation in paroxysmal AF. Methods: 98 patients with paroxysmal AF (57±10 years, 74 male) were randomly assigned to PVI (48 patients) or PVI+CFAE ablation (50 patients). Additional CFAE ablation was performed in the PVI+CFAE group if AF was still inducible after PVI. Follow-up results were assessed with repetitive 7 days Holter ECG and clinical evaluation including repeat ablations. Results: Additional CFAE ablation was performed in 30/50 (60%) patients of the PVI+CFAE group with still inducible AF after PVI. In each group, 2 patients were lost to long term follow-up. In the intention-to-treat analysis at 3 months and after 19±8 months, there was no significant difference between both groups (36/48 [75%] and 34/46 [74%] patients in the PVI and 37/50 [73%] and 40/48 [83%] of patients in the PVI+CFAE ablation group in sinus rhythm [p=0.32]). In subgroup analysis, patients actually treated with the combined PVI+CFAE ablation approach had a significantly better long-term success (25/28; 89%) than patients with still inducible AF who underwent PVI only (22/30;73%; p=0.02). In both groups repeat ablations were performed in 31% (PVI group; 15/48 patients) and 35% (PVI+CFAE group; 17/48 patients) (p=n.s). After 9 months, significantly more patients in the PVI+CFAE group experienced sustained regular atrial tachycardia than in the PVI group (6/44 versus 1/39 patients, P=0.02). Conclusion: The combination of PVI and CFAE ablation was equally effective than PVI alone in reaching freedom of AF in the intention-to-treat analysis. During long-term follow-up, patients actually treated with combined PVI+CFAE ablation had a significantly better outcome (89% vs. 73%). However, the rate of ablation-induced regular atrial tachycardias is inreased.


2016 ◽  
Vol 2016 ◽  
pp. 1-6 ◽  
Author(s):  
Wei Liu ◽  
Jianrong Wang ◽  
Miaomiao Zhang ◽  
Yuan Tao ◽  
Yan Sun

Background. To compare the efficacy of needle revision with 5-fluorouracil (5-FU) and mitomycin C (MMC) on dysfunctional filtration blebs shortly after trabeculectomy.Methods. It is a prospective randomized study comparing needle revision augmented with MMC or 5-FU for failed trabeculectomy blebs.Results. To date 71 patients (75 eyes) have been enrolled, 40 eyes in the MMC group and 35 in the 5-FU group. 68 patients (72 eyes) have completed 12-month follow-up, 38 eyes in the MMC group and 34 in the 5-FU group. The mean IOP before and that after needle revision in the MMC group were26.5±4.3 mmHg and11.3±3.4 mmHg, respectively (P<0.05), and in the 5-FU group were27.1±3.8 mmHg and10.9±3.4 mmHg, respectively (P<0.05). At 12-month follow-up, complete success rates were 57.5% for MMC group and 34.3% for 5-FU group (P=0.042; log-rank test) and 75% and 60% (P=0.145; log-rank test), respectively, for the qualified success. Complication rates between the two groups were not statistically different (P>0.05).Conclusions. Needle revision and subconjunctival MMC injection were more effective than needling and subconjunctival 5-FU injection for early dysfunctional filtration blebs after trabeculectomies.


2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
T Nakano ◽  
K Suenari ◽  
K Suruga ◽  
H Takemoto ◽  
Y Hashimoto ◽  
...  

Abstract Background Currently, cryoballoon ablation (CBA) has proven to be highly effective in achieving free from atrial fibrillation (AF), especially paroxysmal AF. However, the optimal freezing protocol for each patient to achieve successful pulmonary vein isolation by only CBA is still uncertain. The aim of this study was to evaluate the clinical implications of a reduction in the freezing duration (<180s) during CBA guided by the time to target temperature. Methods From November 2015 to August 2018, 286 consecutive paroxysmal AF patients undergoing CBA were enrolled. We compared 107 patients undergoing a tailor-made CBA procedure (Group A; August 2017-August 2018) to 179 patients with a standard CBA procedure (Group B; November 2015–July 2017). In Group A, the freezing duration was reduced to 150s when the temperature reached ≤−40°C within 40s. Furthermore, we reduced it to 120s when it reached ≤−50°C within 60s. In the other patients, the freezing time was 180s except for excessive freezing over −60°C and/or emergent situations while monitoring the esophageal temperature and for phrenic nerve injury as in Group B. Results The baseline clinical characteristics were similar between two groups. In Group A, 89 patients (83%) underwent CBA with a reduction in the freezing time. The rate of having reduction time in left inferior PV (LIPV) and right inferior PV (RIPV) was lower compared with left superior PV (LSPV) and right superior PV (RSPV) (respectively 17%, 29%, 56%, and 63.5%). However, for right inferior PV, in 31 patients having the reduced freezing time, none of them required touch-up ablation. Although the procedure time and frequency of touch-up ablation did not differ between the 2 groups, total freezing time for each PV was significantly shorter in Group A than Group B as shown in figure (LSPV: 164±28s vs. 216±67s; p<0.001, LIPV: 187±44s vs. 218±69s; p<0.001, RSPV: 147±31s vs. 192±51s; p<0.001, RIPV: 180±50 vs. 218±73s; p<0.001). The AF free survival rate during the follow-up period (356±167 days) was similar between the 2 groups (log-rank test, p=0.38). Furthermore, the complication rate was similar 2 groups. The freezing time for each PV Conclusion The safety and efficacy of the new tailor-made CBA strategy were non-inferior to the standard procedure. This study showed that the unnecessary freezing time could be reduced in most of paroxysmal AF patients.


2018 ◽  
Vol 12 (1) ◽  
pp. 952-959
Author(s):  
Carmine Verrusio ◽  
Mirko Medaglia ◽  
Roberto Lo Giudice ◽  
Francesco Puleio ◽  
David Rizzo ◽  
...  

Objective: The aim of this study is to compare the efficacy of rotary instruments vs hand scalers in non-surgical periodontal therapy, studying the variation of periodontal health indexes. Materials and Methods: Forty patients (age between 30 and 70 years) with advanced chronic periodontitis, that were recruited for the study, were divided into two groups; control group and test group. Control patients were treated with hand scalers while test group patients were treated with rotary instruments. Periodontal indexes were evaluated at baseline and after 3 months. Results: Nonsignificant differences were found at 12 weeks follow up for all the parameters between test and control groups. Conclusions: Within their limits, the results indicate that different instruments can be effective in removing calculus and endotoxins. This requisite is mandatory for a proper periodontal healing. The reasons for clinicians to use diamond-coated instruments are related to a faster procedure, and the clinical evidence of a smooth root surface. The clinicians’ ability remains one of the most important variables that could affect periodontal therapy.


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