Efficacy and safety of left atrial appendage closure in non-valvular atrial fibrillation in patients over 75 years

Yu, Jianghong; Chen, Hongwu; Post, Felix; Muenzel, Manuela; Keil, Thorsten; Hou, Cody R.; Zhao, Mingzhong; Meng, Zhen; Jiang, Liang

doi:10.1007/s00380-019-01428-8

Cited by 10 publications

(12 citation statements)

References 26 publications

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“…However, the success rate of implantation and rate of severe complications during the peri-procedural period were comparable between the two groups. These were in line with conclusions from recent research in which advanced age, higher CHA 2 DS 2 -VASc score or HAS-BLED score, and critically-ill conditions did not seem to in uence implantation success, procedure-related adverse events within 7 days, and clinical outcomes [19][20][21]. In our cohort, the total rate of severe complications in the peri-procedural period within 7 days was 2.9%, with 2.9% in the bleeding group and 2.9% in the nonbleeding group, which was lower than the severe adverse events over 7 days of periprocedural period (4.0%) in the EWOLUTION registry study [22], and that (6.5%) reported by Renou et al in patients with previous intra-cerebral hemorrhage [23] respectively.…”

Section: Discussionsupporting

confidence: 91%

Influence of Prior Major Bleeding on the Safety and Effectiveness of Left Atrial Appendage Closure in Non-Valvular Atrial Fibrillation Patients: A Single-Center Study

Zhao

Hou

Xiao-lin

et al. 2021

Preprint

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Purpose: Left atrial appendage closure (LAAC) may present an alternative to anticoagulation in patients with non-valvular atrial fibrillation (NVAF). However, evidence regarding benefit of LAAC in patients with prior major bleeding is limited. We evaluate whether a previous bleeding factor influences the safety and effectiveness of LAAC. Methods: A total of 377 consecutive patients scheduled for LAAC were categorized into a bleeding group (n=137) and non-bleeding group (n=240). The implantation success and prevalence of severe peri-procedural complications, and efficacy/ safety endpoints during follow-up were investigated. Results: The bleeding group had more patients ≥75 years old (P=0.044), higher CHA2DS2-VASc (P=0.029) and HAS-BLED scores (P=0.001) than the non-bleeding group. Implantation success and severe peri-procedural complications were similar. During an average 2 years’ follow-up, major bleeding events (P=0.917), all-cause death (P=0.313), co-primary efficacy events (P=0.063), and the cumulative survival ratio (P=0.828) were comparable. However, the incidence of thromboembolism was lower in the bleeding group (P=0.031). The observed thromboembolism rate was reduced by 86.1% (P<0.005) and 43.9% (P<0.05) and the observed bleeding rate was decreased by 39.0% (P<0.05) and 34.8% (P<0.05) in the bleeding and non-bleeding groups, respectively. The extent of relative risk reduction in thromboembolism was significantly higher in the bleeding group (86.1% vs. 43.9%, P<0.01). Conclusion: LAAC may provide a safe and effective alternative to long-term antithrombotic therapy in NVAF patients with or without prior bleeding. The efficacy of LAAC in reducing thromboembolism instead of major bleeding seems to be higher in patients with versus without prior bleeding.

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Section: Discussionsupporting

confidence: 91%

Influence of Prior Major Bleeding on the Safety and Effectiveness of Left Atrial Appendage Closure in Non-Valvular Atrial Fibrillation Patients: A Single-Center Study

Zhao

Hou

Xiao-lin

et al. 2021

Preprint

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“…Eighteen studies were excluded because no outcomes of interest were provided. Finally, 12 articles—11 observational studies and 1 analysis matched on propensity scores—were used in our study [ 14 , 15 , 16 , 17 , 20 , 21 , 22 , 23 , 24 , 25 , 26 , 27 ]. The characteristics of the study are shown in Table 1 .…”

Section: Resultsmentioning

confidence: 99%

“…Although only one study in our included study found a greater risk of death in the elderly group [ 14 ], this study was excluded by sensitive analysis, and the statistical results remained statistically significant. Only one study clearly gave the cause of death: one procedure-related death occurred the next day [ 17 ]. Other studies did not explain the specific cause of death.…”

Section: Discussionmentioning

confidence: 99%

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Left Atrial Appendage Closure for Atrial Fibrillation in the Elderly >75 Years Old: A Meta-Analysis of Observational Studies

et al. 2022

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Background: Left atrial appendage closure (LAAC) is an established therapy for patients with atrial fibrillation (AF); however, there is a limited understanding of LAAC in elderly patients (≥75 years old). We conducted a meta-analysis to investigate the procedural complications and long-term outcomes after LAAC in the elderly versus the non-elderly. Methods: We screened PubMed, EMBASE, Cochrane Library, and Web of Science. Procedural endpoints of interest included successful implantation LAAC rates, in-hospital mortality, major bleeding events, pericardial effusion/tamponade, stroke, and vascular access complications related to LAAC. Long-term outcomes included all-cause mortality, major bleeding events, and stroke/transient ischemic attack (TIA) during follow-up. Results: Finally, 12 studies were included in the analysis; these included a total of 25,094 people in the elderly group and 36,035 people in the non-elderly group. The successful implantation LAAC rates did not differ between the groups, while the elderly patients experienced more periprocedural mortality (OR 2.62; 95% CI 1.79–3.83, p < 0.01; I2 = 0%), pericardial effusion/tamponade (OR 1.39; 95% CI: 1.06–1.82, p < 0.01; I2 = 0%), major bleeding events (OR 1.32; 95% CI 1.17–1.48, p < 0.01; I2 = 0%), and vascular access complications (OR 1.34; 95% CI 1.16–1.55, p < 0.01; I2 = 0%) than the non-elderly patients. The long-term stroke/TIA rates did not differ between the elderly and the non-elderly at least one year after follow-up. Conclusions: Even though successful implantation LAAC rates are similar, elderly patients have a significantly higher incidence of periprocedural mortality, major bleeding events, vascular access complications, and pericardial effusion/tamponade after LAAC than non-elderly patients. The stroke/TIA rates did not differ between both groups after at least one-year follow-up.

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“…In NVAF, the majority of thrombi leading to cardioembolic events derive from the LAA. Increasing clinical data, including our previous study, demonstrated that LAAC was a valid alternative to oral anticoagulation therapy for preventing from stroke or systemic embolisms [23][24][25]. However, the effects of sex-related differences on the clinical outcomes of LAAC in NVAF patients remain unknown.…”

Section: Discussionmentioning

confidence: 97%

Impact of sex differences on outcomes in patients with non-valvular atrial fibrillation undergoing left atrial appendage closure: A single-center experience

Zhao¹,

Post²,

Muenzel³

et al. 2021

Int. J. Med. Sci.

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Female patients affected by non-valvular atrial fibrillation (NVAF) have a higher risk of stroke compared with male patients. Left atrial appendage (LAA) closure has been demonstrated as a reasonable alternative to warfarin therapy for stroke prevention in patients with NVAF. However, the impact of sex-related differences on outcomes in patients undergoing LAA closure (LAAC) remains unclear. Our study investigated the differences in LAAC efficacy and safety endpoints between sexes. 387 consecutive patients undergoing WATCHMAN device implantation were enrolled and stratified by sex. Baseline clinical characteristics, procedural data, severe peri-procedural complications and long-term outcomes were compared between men and women. Measurements of LAA width and depth, device implantation success rate, and the frequency of severe peri-procedural complications were comparable between the two groups. After an average follow-up length of two years post LAAC, no significant differences were observed in the risks for composite thromboembolic events (P = 0.096), major bleeding (P = 0.129), and combined primary (co-primary) efficacy events (P = 0.231) between sexes, but the risk of all-cause death decreased significantly in women compared with men (P = 0.045). After performing propensity matching adjustment for residual confounders, the sex-related differences in the cumulative ratio of freedom from all-cause death did not reach statistical significance (P = 0.062), as was also observed with the cumulative ratio of freedom from composite thromboembolic events (P = 0.104), major bleeding (P = 0.134), and co-primary efficacy events (P = 0.241). The observed annual rate of thromboembolic events was significantly decreased by 67.1% (P < 0.01) and 52.5% (P < 0.05) and the observed annual rate of bleeding was reduced by 33.6% (P < 0.05) and 43.5% (P < 0.05) in men and women when compared with the predicted risk based on CHA2DS2VASc score and HAS-BLED score, respectively. LAAC can be considered as an effective and safe strategy in preventing thromboembolic events and decreasing bleeding risks in NVAF patients, regardless of sex. LAAC appears to normalize the sex-specific differences in NVAF patients both in terms of safety and efficacy.

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Efficacy and safety of left atrial appendage closure in non-valvular atrial fibrillation in patients over 75 years

Cited by 10 publications

References 26 publications

Influence of Prior Major Bleeding on the Safety and Effectiveness of Left Atrial Appendage Closure in Non-Valvular Atrial Fibrillation Patients: A Single-Center Study

Influence of Prior Major Bleeding on the Safety and Effectiveness of Left Atrial Appendage Closure in Non-Valvular Atrial Fibrillation Patients: A Single-Center Study

Left Atrial Appendage Closure for Atrial Fibrillation in the Elderly >75 Years Old: A Meta-Analysis of Observational Studies

Impact of sex differences on outcomes in patients with non-valvular atrial fibrillation undergoing left atrial appendage closure: A single-center experience

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