The safety and efficacy of third- and fourth-generation cryoballoons for atrial fibrillation: a systematic review and meta-analysis
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SUBMITTER: Zhang M
PROVIDER: S-EPMC11345166 | biostudies-literature | 2024 Jan
REPOSITORIES: biostudies-literature
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Project description:BackgroundEvidence on the efficacy and safety of anticoagulation in preventing stroke and thromboembolic events in people with thyrotoxic atrial fibrillation is scarce.ObjectiveWe evaluated the efficacy and safety of anticoagulation in people with thyrotoxic atrial fibrillation.MethodsOur study protocol was published in the International Prospective Register of Systematic Reviews (registration no. CRD42020222782). Four databases and two systematic review registers were searched through 25 November 2020 for interventional and observational studies comparing anticoagulation therapy with active comparators, placebo, or no treatment in people with thyrotoxic atrial fibrillation. Random-effects meta-analysis and sensitivity analysis were performed. Quality of evidence was described using the GRADE framework.ResultsIn the study, 23,145 records were retrieved. One randomized controlled trial and eight cohort studies were ultimately included. Effect estimates on the efficacy and safety of anticoagulation were extracted. Meta-analysis using the inverse variance and random-effects methods was conducted on four cohort studies with 3443 participants and 277 events. Anticoagulation in people with thyrotoxic atrial fibrillation reduced the risk of ischemic stroke and systemic thromboembolism by 3% (95% CI: 1-6%). Warfarin may prevent ischemic stroke in people with thyrotoxic atrial fibrillation if the CHA2DS2-VASc score exceeds 1 and when atrial fibrillation persists beyond 7 days. Direct oral anticoagulants may be associated with fewer bleeding events than warfarin.ConclusionsAnticoagulation prevents ischemic stroke and systemic thromboembolism in people with thyrotoxic atrial fibrillation. Direct oral anticoagulants may be associated with fewer bleeding events.
| S-EPMC9175610 | biostudies-literature
Project description:BackgroundGrowing evidence suggests that second-generation cryoballoon ablation (2G-CB) is effective in patients with persistent atrial fibrillation (PerAF). The cornerstone of atrial fibrillation (AF) ablation is pulmonary vein isolation (PVI). The purpose of this study was to summarize the available data on the safety and mid-term (≥ 12 months) effectiveness of a 'PVI-only' strategy vs. a 'PVI-plus' strategy using 2G-CB in patients with PerAF.MethodsWe searched the PubMed, EMBASE and Cochrane library databases for studies on 2G-CB for PerAF. Group analysis was based on the ablation approach: 'PVI-only' versus 'PVI-plus', the latter of which involved PVI plus other substrate modifications. Studies showing clinical success rates at a follow-up (FU) of ≥ 12 months were included. Complication rates were also assessed. Data were analyzed by applying a fixed effects model.ResultsA total of 879 patients from 5 studies were analyzed. After a mid-term FU of 27 months, the overall success rate of 2G-CB for PerAF was 66.1%. In the 'PVI-plus' group, the success rate was 73.8%. In the 'PVI-only' group, the success rate was 53.6%. No heterogeneity was noted among studies (I2 = 0.0%, P = 0.82). Complications occurred in 5.2% of patients (P = 0.93), and the rate of phrenic nerve (PN) injury was 2.8% (P = 0.14). Vascular assess complications were the most frequent at 1.6% (P = 0.33). No death or myocardial infarction was reported.Conclusion'PVI-plus' involving 2G-CB seems to be safe and effective for treating PerAF.
| S-EPMC6201921 | biostudies-literature
Project description:Conventionally, patients have been admitted overnight after atrial fibrillation (AF) catheter ablation. Several centers have recently adopted a same-day discharge (SDD) protocol for patients undergoing AF catheter ablation. We aimed to systematically review the current evidence for the safety and efficacy of SDD after AF catheter ablation. A systematic search was performed in PubMed, Embase, Scopus, Web of Science, and the Cochrane library until August 21, 2021. The risk of bias was assessed with the "Methodological Index for Non-Randomized Studies" (MINORS). The pooled efficacy rate of SDD protocol (defined as the proportion of patients discharged the same day of ablation among the patients who were planned for SDD) was calculated. Meanwhile, pooled major complication rates and early readmission or emergency department (ED) visit rates were evaluated in successful and planned SDD groups separately. Overall, 12 observational studies consisting of 18,065 catheter ablations were included, among which 7320 (40.52%) were discharged the same-day after ablation. The pooled efficacy was 90.3% (95% confidence interval [CI] [82.7-96.0]). The major complication rates were 1.1% (95%CI [0.5-1.9]), and 0.7% (95% CI [0.0-3.1]) in planned SDD and successful SDD groups, respectively. In addition, readmission/ED visit rate were 3.0% (95%CI [0.9-6.1]), and 3.1% (95% CI [0.8-6.5]) in the same groups. There were no significant differences between planned SDD and overnight groups with respect to major complication rate (risk ratio = 0.70, 95%CI [0.35-1.42], p-value = .369). The available data indicates that SDD after AF ablation is safe and efficient. Further prospective and randomized studies are warranted to elucidate the safety of SDD after AF ablation and develop a standardized SDD protocol.
| S-EPMC8860483 | biostudies-literature
Project description:Background: The benefits and risks of starting anticoagulation therapy, such as direct oral anticoagulations (DOACs) or warfarin, in atrial fibrillation (AF) patients with a history of intracranial hemorrhage (ICH) remain controversial. We performed a systematic review and meta-analysis to compare the safety and efficacy of starting oral anticoagulation (OAC) and non-oral anticoagulation in these patients. Methods: PubMed, Cochrane Library, and Embase were searched from inception to 01 May 2022 for randomized controlled trials and cohort studies, reporting effectiveness and safety outcomes for anticoagulation therapy in atrial fibrillation patients with intracranial hemorrhage. The Newcastle-Ottawa Scale (NOS) and the Cochrane Collaboration tool were used to evaluate bias risks for all randomized controlled trials (RCTs) and cohort studies. An effects model was applied to calculate adjusted hazard ratios (aHRs) for randomized controlled trials and cohort studies. Results: We analyzed data from two randomized controlled trials (304 patients) and seven Cohort studies (17,477 patients). Compared to non-oral anticoagulation, starting oral anticoagulation therapy reduced the risk of Ischemic Stroke/Systemic Embolism (SE) (aHR: 0.64, 95% CI: 0.55–0.57) and all-cause death (aHR: 0.53, 95% CI: 0.35–0.80) in atrial fibrillation patients and a prior history intracranial hemorrhage. Starting oral anticoagulation therapy did not increase the risk of recurrent intracranial hemorrhage (aHR: 1.07, 95% CI: 0.66–1.74), but increased the risk of major bleeding (aHR: 1.38, 95% CI: 1.00–1.91) than no oral anticoagulation therapy. The DOACs had a lower risk of Ischemic Stroke/SE (aHR: 0.84, 95% CI: 0.70–1.00), recurrent intracranial hemorrhage (aHR: 0.63, 95% CI: 0.49–0.82), and all-cause death (aHR: 0.65, 95% CI: 0.48–0.88) compared to warfarin. According to subgroup analyses, starting oral anticoagulation therapy have a higher risk of recurrent intracranial hemorrhage than non-oral anticoagulation therapy (aHR: 1.57, 95% CI: 1.36–1.81) for Asians. Conclusion: After intracranial hemorrhage in atrial fibrillation patients, restarting or initiating oral anticoagulation therapy decreased the risk of Ischemic Stroke/SE and all-cause death but did not increase the risk for recurrent intracranial hemorrhage. Direct oral anticoagulations have better efficacy and safety than warfarin if oral anticoagulation therapy is started. However, starting oral anticoagulation increases the risk for recurrent intracranial hemorrhage in the Asian region.
| S-EPMC10033967 | biostudies-literature
Project description:BackgroundAtrial fibrillation (AF) is the most common cardiac arrhythmia associated with high morbidity and mortality. AF treatment is guided by a patient-provider risk-benefit discussion regarding drug versus ablation or combination. Thermal ablation has a high rate of adverse events compared to pulsed field ablation (PFA). In this systematic review, we aimed to determine the safety and efficacy of PFA.MethodsThe electronic search for relevant articles in English was completed in PubMed, PubMed Central, Cochrane library, Scopus, and Embase databases till July 2022. The screening was completed via the use of Covidence software. The risk of bias assessment and data extraction from the included studies was performed, and the narrative synthesis was performed accordingly.ResultsA total of six studies were selected for review and 1897 patients receiving PFA were involved in these studies. Our review was focused on pulmonary vein isolation success, major adverse events, and arrhythmia recurrence. Successful pulmonary vein isolation (PVI) was completed in 100% of cases except in two studies. In one of them, six out of seven patients (86%) in the epicardial cohort had successful PVI. In the MANIFEST-PF survey, the acute PVI success rate was 99.9%. The major complications were rare and included pericardial tamponade, vascular complications requiring surgery, and stroke. The atrial arrhythmia recurrence was higher in the thermal group than in the PFA group (39% vs. 11%).ConclusionsThe success rate of PVI by PFA is high, and major adverse events are low. PFA is found to decrease the recurrence of atrial arrhythmia compared to thermal ablation. Substantial randomized controlled trials (RCTs) are needed to validate the efficacy and safety of PFA over conventional methods.
| S-EPMC9861350 | biostudies-literature
Project description:Background: Edoxaban is a novel oral anticoagulant which may decrease the risk of stroke and systemic embolism in patients suffering from atrial fibrillation (AF). However, the decreased efficacy of edoxaban versus warfarin for the avoidance of stroke and systemic embolism in AF with creatinine clearance (CrCl) > 95 mL/min has been reported. The purpose of this meta-analysis is to further clarify the safety (major bleeding) and efficacy (stroke or systemic embolism) of edoxaban for AF patients with various CrCl. Methods: A systematic search of studies on edoxaban and warfarin in AF patients related to renal function was conducted in PubMed, Medline, Web of Science databases, EBSCO, Embase, and the Cochrane Central Register of Controlled Trials. In this meta-analysis (protocol number: PROSPERO CRD 42021245512), we included studies that provide specific data on three outcomes: ischemic stroke or systemic embolism (S/SE), bleeding, and all-cause mortality. Results: This meta-analysis enrolled two randomized controlled trials (RCTs) studies and two retrospective studies that enrolled 28,065 patients. According to CrCl, subjects are divided into three groups (CrCl 30−50 mL/min, CrCl 50−95 mL/min, CrCl > 95 mL/min). In AF patients with CrCl 30−50 mL/min, edoxaban 30 mg daily is similar to warfarin in the prevention of ischemic S/SE and all-cause mortality, resulting in lower bleeding rate and better net clinical outcome (ischemic S/SE: hazard ratio (HR), 0.85, 95% confidence interval (CI), 0.19−1.87; all-cause mortality: HR, 0.65, 95% CI, 0.35−1.19; bleeding: HR, 0.75, 95% CI, 0.60−0.93; net clinical outcome: HR, 0.75, 95% CI, 0.63−0.90). In the group of CrCl 50−95 mL/min, the net clinical outcome was more favorable with edoxaban 60 mg daily than warfarin (HR, 0.81, 95% CI: 0.68−0.96), and there was no significant difference between edoxaban 60 mg daily and warfarin in terms of prevention of bleeding, ischemic S/SE, and all-cause mortality. For AF patients with CrCl > 95 mL/min, there was a statistically significant difference in lower bleeding rate between edoxaban 60 mg daily and warfarin (bleeding: HR: 0.70, 95% CI: 0.58−0.84). There was no differential safety in ischemic S/SE, all-cause mortality, and net clinical outcome. Conclusion: Overall, edoxaban was superior to warfarin in terms of net clinical outcome in various groups of CrCl with AF patients. Although there was no significant difference in net clinical outcome between edoxaban and warfarin for AF patients with CrCl > 95 mL/min, edoxaban is not inferior to warfarin in safety and effectiveness in the various levels of CrCl. Edoxaban may be a more effective and safe treatment than warfarin for patients with chronic kidney disease (CKD) who require anticoagulation. More high-quality and long-term clinical research are needed to further estimate the effects of edoxaban.
| S-EPMC9861612 | biostudies-literature
Project description:BackgroundPulsed-field ablation (PFA) has emerged as an innovative alternative to radiofrequency (RF) and cryoablation because it selectively targets myocardial tissue. Thus, we aim to estimate the efficacy and safety of PFA versus thermal ablation for atrial fibrillation (AF) ablation.MethodsA systematic review and meta-analysis were retrieved from PubMed, WOS, SCOPUS, EMBASE, and CENTRAL through September 2023. We used RevMan V. 5.4 to pool dichotomous data using risk ratio (RR) and continuous data using mean difference (MD) with a 95% confidence interval (CI). PROSPERO ID: CRD42023480321.ResultsWe included 17 studies with a total of 2255 patients. PFA was significantly associated with a decreased incidence of AF recurrence (RR: 0.66 with 95% CI [0.51, 0.87], p = .003). However, there was no significant difference between PFA and thermal ablation in arrhythmia recurrence (RR: 0.92 with 95% CI [0.74, 1.46], p = .42). PFA was significantly associated with decreased total procedure time (MD: -15.15 with 95% CI [-20.23, -10.07], p < .00001), decreased heart rate change (MD: -7.39 with 95% CI [-12.16, -2.62], p = .002), decreased phrenic nerve palsy (RR: 0.38 with 95% CI [0.15, 0.98], p = .05), and reduced esophageal lesions (RR: 0.09 with 95% CI [0.01, 0.69], p = .02). On the contrary, PFA was significantly associated with increased pericardial tamponade (RR: 6.14 with 95% CI [1.43, 26.33], p = .01).ConclusionPFA was significantly associated with decreased AF recurrence, total procedure time, heart rate change, phrenic nerve palsy, esophageal lesion, and increased incidence of pericardial tamponade compared with thermal ablation.
| S-EPMC11474578 | biostudies-literature
Project description:Abstract Background and Aim Pulse field ablation (PFA) has emerged as a safe alternative to other catheter ablation energy sources for patients. Although early results are encouraging, secondary data about outcomes are lacking. Herein, we aimed to assess the safety and efficacy of the novel technique. Methods We searched PubMed, Ovid, Google Scholar, Web of Science, and Scopus databases and several major scientific conferences for studies reporting results regarding PFA. Results Sixteen studies were included, reporting 485 patients with atrial fibrillation who underwent pulsed field operations. Patients averaged 60 years of age. The total duration of the procedure is 94 min. The average Fluoro procedure takes 17 min. Isolation of all pulmonary veins was 100% with a 95% confidence interval (CI) (p > 0.05). Overall, the recurrence rate of arrhythmia in the participants was 2.84% (95% CI) (p > 0.05). Complications were detected during or after the PFA procedure at a rate of 2.23% (p < 0.05), with 95% CI indicating the high safety of the PFA procedure Conclusion Using pulsed‐field ablation as a new treatment for atrial fibrillation has proven safe and effective.
| S-EPMC9852677 | biostudies-literature
Project description:ObjectiveThis study incorporates the results of subgroup analyses of currently published randomized controlled trials (RCTs) and real-world cohort studies to compare the effectiveness and safety of new direct oral anticoagulants (NOACs) and warfarin among nonvalvular atrial fibrillation patients with diabetes.MethodsThe PubMed, Embase, Cochrane Library, Web of Science and ClinicalTrials.gov databases were searched. Five retrospective cohort studies and four subgroup analyses of RCTs were included in this meta-analysis.ResultsA meta-analysis of the data of 26,7272 patients showed that for patients with nonvalvular atrial fibrillation and diabetes, NOACs can significantly reduce the incidence of stroke/systemic embolism (SSE), ischaemic stroke, and haemorrhagic stroke compared with warfarin, with no significant difference in major bleeding and all-cause mortality. Additionally, NOACs were superior to warfarin in the incidence of intracranial bleeding, gastrointestinal bleeding, myocardial infarction, and vascular death.ConclusionsAmong nonvalvular atrial fibrillation patients with diabetes, NOACs were associated with a lower risk of SSE versus warfarin, with no significant difference in major bleeding. Therefore, NOACs may be a better clinical choice.
| S-EPMC9524066 | biostudies-literature
Project description:BackgroundData on different direct oral anticoagulants (DOACs) in atrial fibrillation (AF) patients with renal impairment are insufficient. We aimed to perform pairwise and network meta-analysis comparing oral anticoagulants (OACs) in AF patients with renal impairment, including advanced chronic kidney disease (CKD) with creatinine clearance <30 mL/min.MethodsPubMed, Embase, Cochrane Database, and references of related articles were searched up to April 2021. We included randomized trials and non-randomized studies using propensity-score or multivariable-model adjustments that compared clinical outcomes among OACs. Hazard ratios (HRs) for stroke or thromboembolism, major bleeding, and all-cause death were pooled using random-effects model.ResultsFrom 19 studies, 124,628 patients were included. In patients with AF and CKD, DOACs presented significantly lower risks of stroke or thromboembolism [HRpooled = 0.78, 95% confidence interval (CI) = 0.73-0.85, I2 = 16.6%] and major bleeding [HRpooled = 0.76 (0.64-0.89), I2 = 85.7%] when compared with warfarin, regardless of the severity of renal impairment. Results were consistent in advanced CKD patients for stroke or thromboembolism [HRpooled = 0.60 (0.43-0.85), I2 = 0.0%] and major bleeding [HRpooled = 0.74 (0.59-0.93), I2 = 30.4%]. In the network meta-analysis, edoxaban and apixaban presented the highest rank probability to reduce the risk of stroke or thromboembolism (edoxaban, P-score = 94.5%) and major bleeding (apixaban, P-score = 95.8%), respectively. Apixaban remained the safest OAC with the highest rank probability for major bleeding (P-score = 96.9%) in patients with advanced CKD.ConclusionDOACs, particularly apixaban and edoxaban, presented superior efficacy and safety than warfarin in AF patients with CKD. Apixaban was associated with the lowest risk of major bleeding among OACs for patients with advanced CKD.Systematic review registration[PROSPERO], identifier [CRD42021241718].
| S-EPMC9226375 | biostudies-literature