scholarly journals A Randomized Comparison of Delivered Energy in Cardioversion of Atrial Fibrillation: Biphasic Truncated Exponential versus Pulsed Biphasic Waveforms

Diagnostics ◽  
2021 ◽  
Vol 11 (6) ◽  
pp. 1107
Author(s):  
Elina Trendafilova ◽  
Elena Dimitrova ◽  
Jean-Philippe Didon ◽  
Vessela Krasteva

A few randomized trials have compared impedance-compensated biphasic defibrillators in clinical use. We aim to compare pulsed biphasic (PB) and biphasic truncated exponential (BTE) waveforms in a non-inferiority cardioversion (CVS) study. This was a prospective monocentric randomized clinical trial. Eligible patients admitted for elective CVS of atrial fibrillation (AF) between February 2019 and March 2020 were alternately randomized to treatment with either a PB defibrillator (DEFIGARD TOUCH7, Schiller Médical, Wissembourg, France) or a BTE high-energy (BTE-HE) defibrillator (LIFEPAK15, Physio-Control Inc., Redmond, WA, USA). Fixed-energy protocol (200–200–200 J) was administered. CVS success was accepted if sinus rhythm was restored at 1 min post-shock. The study design considered non-inferiority testing of the primary outcome: cumulative delivered energy (CDE). Seventy-three out of 78 randomized patients received allocated intervention: 38 BTE-HE (52%), 35 PB (48%). Baseline characteristics were well-balanced between groups (p > 0.05). Both waveforms had similar CDE (mean ± standard deviation, 95% confidence interval): BTE-HE (253.9 ± 120.2 J, 214–293 J) vs. PB (226.0 ± 109.8 J, 188–264 J), p = 0.31. Indeed, effective PB shocks delivered significantly lower energies by mean of 25.6 J (95% CI 24–27.1 J, p < 0.001). Success rates were similar (BTE-HE vs. PB): 1 min first-shock (84.2% vs. 82.9%), 1 min CVS (97.4% vs. 94.3%), 2 h CVS (94.7% vs. 94.3%), 24 h CVS (92.1% vs. 94.3%), p > 0.05. Safety analysis did not find CVS hazards, reporting insignificant changes of myocardial-specific biomarkers, transient and rare ST-segment deviations, and no case of harmful tachyarrhythmias and apnea. Cardioversion of AF with fixed-energy protocol 200–200–200 J was highly efficient and safe for both PB and BTE-HE waveforms. These similar performances were achieved despite differences in the waveforms’ technical design, associated with significantly lower delivered energy for the effective PB shocks. Clinical Trial Registration: Registration number: NCT04032678, trial register: ClinicalTrials.gov.

Heart ◽  
2018 ◽  
Vol 104 (15) ◽  
pp. 1292-1299 ◽  
Author(s):  
Dragos Vinereanu ◽  
Alice Wang ◽  
Hillary Mulder ◽  
Renato D Lopes ◽  
Petr Jansky ◽  
...  

ObjectiveTo assess stroke/systemic embolism, major bleeding and other outcomes, and treatment effect of apixaban versus warfarin, in patients with atrial fibrillation (AF) and different types of valvular heart disease (VHD), using data from the Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation trial.MethodsThere were 14 793 patients with known VHD status, categorised as having moderate or severe mitral regurgitation (MR) (n=3382), aortic regurgitation (AR) (n=842) or aortic stenosis (AS) (n=324); patients with moderate or severe mitral stenosis were excluded from the trial. Baseline characteristics, efficacy and safety outcomes were compared between each type and no significant VHD. Treatment effect was assessed using an adjusted model.ResultsPatients with MR or AR had similar rates of stroke/systemic embolism and bleeding compared with patients without MR or AR, respectively. Patients with AS had significantly higher event rates (presented as rate per 100 patient-years of follow-up) of stroke/systemic embolism (3.47 vs 1.36; adjusted HR (adjHR) 2.21, 95% CI 1.35 to 3.63), death (8.30 vs 3.53; adjHR 1.92, 95% CI 1.41 to 2.61), major bleeding (5.31 vs 2.53; adjHR 1.80, 95% CI 1.19 to 2.75) and intracranial bleeding (1.29 vs 0.51; adjHR 2.54, 95% CI 1.08 to 5.96) than patients without AS. The superiority of apixaban over warfarin on stroke/systemic embolism was similar in patients with versus without MR (HR 0.69, 95% CI 0.46 to 1.04 vs HR 0.79, 95% CI 0.63 to 1.00; interaction P value 0.52), with versus without AR (HR 0.57, 95% CI 0.27 to 1.20 vs HR 0.78, 95% CI 0.63 to 0.96; interaction P value 0.52), and with versus without AS (HR 0.44, 95% CI 0.17 to 1.13 vs HR 0.79, 95% CI 0.64 to 0.97; interaction P value 0.19). For each of the primary and secondary efficacy and safety outcomes, there was no evidence of a different effect of apixaban over warfarin in patients with any VHD subcategory.ConclusionsIn anticoagulated patients with AF, AS is associated with a higher risk of stroke/systemic embolism, bleeding and death. The efficacy and safety benefits of apixaban compared with warfarin were consistent, regardless of presence of MR, AR or AS.Clinical trial registrationARISTOTLE clinical trial number NCT00412984.


2020 ◽  
Vol 57 (6) ◽  
pp. 1154-1159
Author(s):  
Jahangir A Khan ◽  
Jari O Laurikka ◽  
Otto H Järvinen ◽  
Niina K Khan ◽  
Kati M Järvelä

Abstract OBJECTIVES Postoperative atrial fibrillation is the most frequent complication after cardiac surgery, and the use of statins in preventing them is being extensively studied. The aim of this study was to investigate whether a pause in the administration of statins affects the occurrence of atrial fibrillation after cardiac surgery in a prospective randomized and controlled setting. METHODS A total of 301 patients without chronic atrial fibrillation with prior statin medication scheduled for elective or urgent cardiac surgery involving the coronary arteries and/or heart valves were prospectively recruited and randomized for statin re-initiation on either the first (immediate statin group) or the fifth (late statin group) postoperative day, using the original medication and dosage. The immediate statin group comprised 146 patients and the late statin group 155 patients. Except for a somewhat higher rate of males (85% vs 73%, P = 0.016) in the immediate statin group, the baseline characteristics and the distribution of procedures performed within the groups were comparable. The occurrence of postoperative atrial fibrillation and the clinical course of the patients were compared between the groups. RESULTS The incidence of atrial fibrillation was 46% and the median delay after surgery before the onset of atrial fibrillation was 3 days in both groups (P = NS). No differences were observed in the frequency of the arrhythmia in any subgroup analyses or in other major complications or clinical parameters. No adverse effects related to early statin administration were detected. CONCLUSIONS Early re-initiation of statins does not appear to affect the occurrence of postoperative atrial fibrillation. Clinical trial registration European Union Drug Regulating Authorities Clinical Trials Database (EudraCT)—2016-001655-44.


2020 ◽  
pp. bjophthalmol-2020-316414
Author(s):  
Zelin Zhao ◽  
Siteng Wu ◽  
Weina Ren ◽  
Qinxiang Zheng ◽  
Cong Ye ◽  
...  

AimsTo compare the efficacy of compression sutures combined with intracameral air injection (CSAI) and thermokeratoplasty (TKP) for the management of acute corneal hydrops in keratoconus.MethodsIn this multi-centre randomised clinical trial, 20 patients with keratoconus (20 eyes) with acute corneal hydrops were enrolled and randomised to receive either CSAI or TKP and followed-up for a period of 6 months.ResultsThere were no significant differences in patient demographics, severity of corneal hydrops and preoperative duration of symptoms between the two groups. In both groups, corneal oedema resolved within 2 weeks. The maximum thickness of the corneal scars following CSAI and TKP was not significantly different. Best spectacle-corrected visual acuity was superior in the CSAI group at 6-month follow-up (CSAI vs TKP, 0.52 (0.37, 0.85) vs 0.96 (0.70, 1.34) LogMAR, p=0.042). CSAI resulted in greater corneal endothelial cell density (CSAI vs TKP, 2677.8±326.7 vs 1955.3±298.1 cells/mm2, p<0.001) and flatter corneal curvature (CSAI vs TKP: mean keratometry value, 52.13±4.92 vs 63.51±5.83D, p<0.001; maximum keratometry value, 65.21±7.42 vs 77.13±12.01D, p=0.016) at the 6-month follow-up.ConclusionAlthough both CSAI and TKP resulted in resolution of acute corneal hydrops in keratoconus, CSAI was associated with superior clinical outcomes in this study.Chinese Clinical trial registration numberChiCTR-IOR-17013764


2020 ◽  
pp. 174749302093829
Author(s):  
Wen-Yi Huang ◽  
Meng Lee ◽  
Sheng-Feng Sung ◽  
Sung-Chun Tang ◽  
Kuo-Hsuan Chang ◽  
...  

Background Enhancing detection of unrecognized atrial fibrillation among acute ischemic stroke patients is crucial for secondary stroke prevention. Aim To evaluate whether the detection rate of new atrial fibrillation in acute ischemic stroke patients without known atrial fibrillation could be improved by doing serial 12-lead electrocardiograms once daily for five days, compared with conventional 24-h Holter monitoring (24-h Holter). Methods We conducted a randomized clinical trial to compare the detection rates of paroxysmal atrial fibrillation between serial electrocardiograms versus 24-h Holter from October 2015 to October 2018 at six hospitals. Eligible participants were acute ischemic stroke patients with aged ≥65 years, with neither atrial fibrillation history nor any presence of atrial fibrillation on baseline electrocardiogram at admission. The primary outcome was newly detected electrocardiogram in the serial electrocardiograms and 24-h Holter group. Results Among 826 patients, baseline characteristics were similar between both groups. In the intention-to-treat analysis, there was no statistical difference between serial electrocardiograms versus 24-Holter to detect atrial fibrillation (8.4% vs. 6.9%; adjusted odds ratio 1.17, 95% confidence interval 0.69–2.01). Stepwise multivariate logistic regression revealed age ≥80 years and history of heart failure were associated with detection of paroxysmal atrial fibrillation whereas patients with lacunar infarction had lower odds for detection of paroxysmal atrial fibrillation. Conclusions Serial electrocardiograms had comparable detection rate of paroxysmal atrial fibrillation compared with 24-h Holter and might be a viable alternative to 24-h Holter as a first-line approach to survey for potential paroxysmal atrial fibrillation among elderly patients with acute ischemic stroke. Clinical Trial Registration: URL https://clinicaltrials.gov/ct2/show/NCT02578979 Unique Identifiers: NCT02578979


2011 ◽  
Vol 19 (5) ◽  
pp. 1063-1071 ◽  
Author(s):  
Luiz Carlos Ribeiro Lamblet ◽  
Edilson Sant'Anna Meira ◽  
Silvana Torres ◽  
Barbara Carvalho Ferreira ◽  
Sergio Dias Martucchi

This clinical trial aimed at comparing the intensity of pain and bruising by subcutaneous and intramuscular injections using and retractable fixed syringes and needles and syringes with no needles combined, at a public hospital in Sao Paulo, for six months. We evaluated the perception of pain in case of intramuscular (n=1000) and subcutaneous injections (n=240). In subcutaneous application, bruise formation was also verified. Pain and bruising scores were higher in the group with no needles combined (p<0.001) and (p<0.029), respectively. The test power in relation to the pain scale of was 0.98. The use of retractable fixed needles is recommended in the application of subcutaneous and intramuscular injections. Clinical trial registration number: NCT01271608.


2020 ◽  
Author(s):  
Long Chen ◽  
Yaowu Liu ◽  
Didi Zhu ◽  
Jinbo Yu ◽  
Chunlei Yu ◽  
...  

Abstract Background: The burden of atrial fibrillation (AF) has been attractive recently and may be associated with stroke risk and mortality. Remote ischemic conditioning could reduce the incidence, inducibility and sustainability of AF. But the effects of chronic remote ischemic conditioning (CRIC) on atrial fibrillation burden in patients with pacemaker implanted are still unknown.Design: This was a single‑center, prospective, randomized, open-labeled clinical study.Methods: Sixty-six patients with permanent pacemakers were randomly divided into CRIC group and control group after 4 weeks screening. CRIC treatment was performed twice a day for 12 weeks. A remote ischemic conditioning protocol consisted of 4 × 5 min inflation/deflation of the blood pressure cuff applied in the upper arm to create intermittent arm ischemia. Pacemaker programming was performed for four times: before screening (-4-week), after screening and before randomization (0-week, baseline), 4-week and 12-week follow-up. Data including AF burden, longest duration of AF and cumulative numbers of atrial high-rate episodes (AHREs) were collected.Results: Sixty-one patients (31 patients in CRIC group and 30 patients in control group) completed the study. CRIC was well-tolerated by patients after 12 weeks treatment. The burden of AF in CRIC group was decreased significantly at 4-week compared with that at 0-week (14.7%±18.5% vs 17.0%±20.7%, p < 0.001), which further decreased at 12-week compared with that at 0-week (8.6%±10.2% vs 17.0%±20.7%, p < 0.001) and that at 4-week (8.6%±10.2% vs 14.7%±18.5%, p < 0.001), which was not observed in the control group. AF burden also reduced significantly after 12-week CRIC compared with that in control group (8.6%±10.2% vs 17.6%±19.5%, p = 0.013). Repeated measurement ANOVA showed that the changes of AF burden was associated with CRIC instead of time (p < 0.01). In addition, there were trends that longest duration of AF and cumulative numbers of AHREs were reduced after 12-week CRIC.Conclusions: This study suggests that a 12-week course of CRIC treatment could reduce AF burden in patients with permanent pacemakers, supporting widespread use of CRIC in the daily lives of these patients, which need to be verified in the future.Clinical Trial RegistrationRegistration name: Effects of remote ischemic conditioning on atrial fibrillation burden in patients with paroxysmal atrial fibrillationRegistration number: ChiCTR-IOR-17012666Registered 14 September 2017; URL: www.chictr.org.cn/showproj.aspx?proj=21591


2021 ◽  
Vol 8 ◽  
Author(s):  
Chen Zhao ◽  
Li Li ◽  
Wei Yang ◽  
Wenliang Lv ◽  
Jian Wang ◽  
...  

Background: Previous research suggested that Chinese Medicine (CM) Formula Huashibaidu granule might shorten the disease course in coronavirus disease 2019 (COVID-19) patients. This research aimed to investigate the early treatment effect of Huashibaidu granule in well-managed patients with mild COVID-19.Methods: An unblinded cluster-randomized clinical trial was conducted at the Dongxihu FangCang hospital. Two cabins were randomly allocated to a CM or control group, with 204 mild COVID-19 participants in each cabin. All participants received conventional treatment over a 7 day period, while the ones in CM group were additionally given Huashibaidu granule 10 g twice daily. Participants were followed up to their clinical endpoint. The primary outcome was worsening symptoms before the clinical endpoint. The secondary outcomes were cure and discharge before the clinical endpoint and alleviation of composite symptoms after the 7 days of treatment.Results: All 408 participants were followed up to their clinical endpoint and included in statistical analysis. Baseline characteristics were comparable between the two groups (P &gt; 0.05). The number of worsening patients in the CM group was 5 (2.5%), and that in the control group was 16 (7.8%) with a significant difference between groups (P = 0.014). Eight foreseeable mild adverse events occurred without statistical difference between groups (P = 0.151).Conclusion: Seven days of early treatment with Huashibaidu granule reduced the likelihood of worsening symptoms in patients with mild COVID-19. Our study supports Huashibaidu granule as an active option for early treatment of mild COVID-19 in similar well-managed medical environments.Clinical Trial Registration:www.chictr.org.cn/showproj.aspx?proj=49408, identifier: ChiCTR2000029763.


2019 ◽  
Vol 19 (1) ◽  
Author(s):  
Ying Wang ◽  
Chang-Sheng Ma ◽  
Xin Du ◽  
Liu He ◽  
Jie Li ◽  
...  

Abstract Background Several studies have reported on atrial fibrillation (AF) outcomes, including thromboembolism in patients with paroxysmal and non-paroxysmal AF; however the findings still remain controversial on whether risks differ between these clinical subtypes and limited data are available in Asian cohorts. Methods We compared the risk of thromboembolism between paroxysmal and persistent AF patients, in a large contemporary Chinese cohort study. A total of 8529 non-valvular atrial fibrillation (NVAF) patients from the Chinese Atrial Fibrillation Registry (CAFR) study were enrolled. The study subjects were divided into two groups: paroxysmal AF (PaAF, defined as AF lasting within 7 days, n = 4642) and persistent AF (PeAF, lasting over 7 days, n = 3887) groups. Results In non-anticoagulated patients, PeAF group demonstrated a higher risk of stroke, all-cause death, cardiac/ non-cardiac death and composition of stroke/ transient ischemic attack (TIA)/peripheral thromboembolism (PT)/all-cause death, compared to the PaAF group. No significant difference was found in anticoagulated subjects. On multivariate analysis in non-anticoagulated patients, age ≥ 75 years (P = 0.046) and prior stroke/TIA/PT (P = 0.018) but not AF type (P = 0.63) were significantly associated with the risk of stroke/TIA/PT events. Conclusions Stroke, all-cause death and cardiac/non-cardiac death in Chinese NVAF population was increased in non-anticoagulated PeAF patients compared with PaAF group, but same between anticoagulated PeAF and PaAF patients. After adjustment, AF type was not an independent predictor of thromboembolism in NVAF patients. Clinical trial registration Chinese Clinical Trial Registry ChiCTR-OCH-13003729. Registered 22 October 2013.


2020 ◽  
Vol 54 (23) ◽  
pp. 1416-1422 ◽  
Author(s):  
Mark Matthews ◽  
Michael Skovdal Rathleff ◽  
Andrew Claus ◽  
Tom McPoil ◽  
Robert Nee ◽  
...  

ObjectivesTo test (i) if greater foot pronation (measured as midfoot width mobility) is associated with better outcomes with foot orthoses treatment, compared with hip exercises and (ii) if hip exercises are superior to foot orthoses, irrespective of midfoot width mobility.MethodsA two-arm parallel, randomised superiority clinical trial was conducted in Australia and Denmark. Participants (18–40 years) were included who reported an insidious onset of knee pain (≥6 weeks duration); ≥3/10 numerical pain rating, that was aggravated by activities (eg, stairs, squatting, running). Participants were stratified by midfoot width mobility (high ≥11 mm change in midfoot width) and site, randomised to foot orthoses or hip exercises and blinded to objectives and stratification. Success was defined a priori as much better or better on a patient-perceived 7-point scale at 12 weeks.ResultsOf 218 stratified and randomised participants, 192 completed 12-week follow-up. This study found no difference in success rates between foot orthoses versus hip exercises in those with high (6/21 vs 9/20; 29% vs 45%, respectively) or low (42/79 vs 37/72; 53% vs 51%) midfoot width mobility. There was no association between midfoot width mobility and treatment outcome (Interaction effect p=0.19). This study found no difference in success rate between foot orthoses versus hip exercises (48/100 vs 46/92; 48% vs 50%).ConclusionMidfoot width mobility should not be used to help clinicians decide which patient with patellofemoral pain might benefit most from foot orthoses. Clinicians and patients may consider either foot orthoses or hip exercises in managing patellofemoral pain.Trial registration numberACTRN12614000260628.


PLoS ONE ◽  
2021 ◽  
Vol 16 (3) ◽  
pp. e0248644
Author(s):  
Sunyoung Jang ◽  
Oluseye Ogunmoroti ◽  
Di Zhao ◽  
Oluwaseun E. Fashanu ◽  
Martin Tibuakuu ◽  
...  

Background Emerging evidence has implicated that inflammation contributes to the pathogenesis of atrial fibrillation (AF). GlycA is a novel marker of systemic inflammation with low intra-individual variability and high analytic precision. GlycA has been associated with incident cardiovascular disease (CVD) independent of other inflammatory markers. However, whether GlycA is associated with AF, specifically, has yet to be established. We examined the association between GlycA and AF in a multi-ethnic cohort. Methods We studied 6,602 MESA participants aged 45–85, with no clinical CVD at baseline, with data on GlycA and incident AF. We used multivariable-adjusted Cox models to evaluate the association between GlycA and incident AF. We also examined other inflammatory markers [high-sensitivity C-reactive protein (hsCRP), interleukin-6 (IL6) and fibrinogen] and incident AF for comparison. Results The mean (SD) age was 62 (10) years, 53% women. The mean plasma GlycA was 381 (62) μmol/L. Over median follow-up of 12.9 years, 869 participants experienced AF. There was no statistically significant association between GlycA and incident AF after adjusting for sociodemographics, CVD risk factors, and other inflammatory markers [Hazard Ratio (95% CI) per 1 SD increment in GlycA: 0.97 (0.88–1.06)]. Neither hsCRP nor fibrinogen was associated with incident AF in same model. In contrast, IL-6 was independently associated with incident AF [HR 1.12 per 1 SD increment (1.05–1.19)]. Conclusions Although GlycA has been associated with other CVD types, we found that GlycA was not associated with AF. More research will be required to understand why IL-6 was associated with AF but not GlycA. Clinical trial registration MESA is not a clinical trial. However, the cohort is registered at: URL: https://clinicaltrials.gov/ct2/show/NCT00005487 Unique identifier: NCT00005487.


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