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Journal of Interventional Cardiac... Jun 2024Left atrial appendage closure (LAAC) is a treatment modality for stroke prevention in patients with atrial fibrillation (AF). One of the potential complications of LAAC... (Review)
Review
BACKGROUND
Left atrial appendage closure (LAAC) is a treatment modality for stroke prevention in patients with atrial fibrillation (AF). One of the potential complications of LAAC is a peri-device leak (PDL), which could potentially increase the risk of thromboembolism formation.
METHODS
This systematic review was done according to PRISMA guidelines. Using four databases, all primary studies through April 2022 that met selection criteria were included. Outcomes of interest were studies reporting on PDL characteristics, risk factors and management.
RESULTS
A total of 116 studies met selection criteria (97 original studies and 19 case reports/series). In the original studies (n = 30,133 patients), the weighted mean age was 72.0 ± 7.4 years (57% females) with a HAS-BLED and CHA2DS2-VASc weighted means of 2.8 ± 1.1 and 3.8 ± 1.3, respectively. The most common definition of PDL was based on size; 5 mm: major, 3-5 mm: moderate, < 1 mm minor, or trivial. Follow up time for PDL detection was 7.15 ± 9.0 months. 33% had PDL, irrespective of PDL severity/size, and only 0.9% had PDL of greater than 5 mm. The main risk factors for PDL development included lower degree of over-sizing, lower left ventricular ejection fraction, device/LAA shape mismatch, previous radiofrequency ablation, and male sex. The most common methods to screen for PDL included transesophageal echocardiogram and cardiac CT. PDL Management approaches include Amplatzer Patent Foramen Ovale occluder, Hookless ACP, Amplatzer vascular plug II, embolic coils, and detachable vascular coils; removal or replacement of the device; and left atriotomy.
CONCLUSION
Following LAAC, the emergence of a PDL is a significant complication to be aware of. Current evidence suggests possible risk factors that are worth assessing in-depth. Additional research is required to assess suitable candidates, timing, and strategies to managing patients with PDL.
Topics: Humans; Atrial Appendage; Atrial Fibrillation; Risk Factors; Postoperative Complications; Septal Occluder Device; Female; Stroke; Male; Left Atrial Appendage Closure
PubMed: 38182966
DOI: 10.1007/s10840-023-01729-z -
Journal of Thrombosis and Thrombolysis Feb 2024This meta-analysis compared the efficacy and safety of different antithrombotic regimens after left atrial appendage closure (LAAC). PubMed, Embase, Medline, Cochrane... (Meta-Analysis)
Meta-Analysis Review
This meta-analysis compared the efficacy and safety of different antithrombotic regimens after left atrial appendage closure (LAAC). PubMed, Embase, Medline, Cochrane Library databases were systematically searched from their inception to March 2023. Patients were divided into short-term oral anticoagulation (OAC) group and antiplatelet therapy (APT) group. The incidence of events were performed using RevMan 5.4. The events including device-related thrombus (DRT), ischemic stroke/systemic embolization (SE), major bleeding, any bleeding, any major adverse event and all-cause mortality. Subgroup analysis were based on OAC alone or OAC plus single antiplatelet therapy (SAPT) in OAC group. Oral anticoagulants include warfarin and direct oral anticoagulant (DOAC). Fourteen studies with 35,166 patients were included. We found that the incidence of DRT (OR = 0.49, 95% CI 0.36-0.66, P<0.0001) and all-cause mortality (OR = 0.71, 95% CI 0.57-0.89, P = 0.002) were significantly lower in OAC group than APT group. However, there was no statistical differences in the incidence rates of ischemic stroke/SE (OR = 0.77, 95% CI 0.49-1.20, P = 0.25), major bleeding (OR = 0.84, 95% CI 0.55-1.27, P = 0.84), any bleeding (OR = 0.83, 95% CI 0.56-1.22, P = 0.34) and any major adverse event (OR = 0.56, 95% CI 0.30-1.03, P = 0.06) in the two groups. Subgroup analysis found that the incidence of DRT, all-cause mortality and any major adverse event in OAC monotherapy were lower than that in APT group (P<0.05), but not statistically different from other outcome. The incidence of DRT, all-cause mortality, any major adverse event and any bleeding in DOAC were significantly better than APT group (P<0.05). While warfarin only has better incidence of DRT than APT (P<0.05), there was no statistical difference between the two groups in other outcome (P>0.05). The incidence of DRT was significantly lower than APT group (P<0.05), major bleeding were higher, and the rest of the outcome did not show any statistically significant differences(P>0.05) when OAC plus SAPT. Based on the existing data, short-term OAC may be favored over APT for patients who undergo LAAC. DOAC monotherapy may be favored over warfarin monotherapy or OAC plus APT, when selecting anticoagulant therapies.
Topics: Humans; Warfarin; Platelet Aggregation Inhibitors; Left Atrial Appendage Closure; Atrial Fibrillation; Treatment Outcome; Anticoagulants; Hemorrhage; Ischemic Stroke; Stroke; Atrial Appendage
PubMed: 38180590
DOI: 10.1007/s11239-023-02919-2 -
World Neurosurgery May 2024Flow diverters with surface modification (FDSM) are increasingly being used in the treatment of intracranial aneurysms (ANs). We aimed to evaluate the effectiveness and... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Flow diverters with surface modification (FDSM) are increasingly being used in the treatment of intracranial aneurysms (ANs). We aimed to evaluate the effectiveness and safety across different devices and antiplatelet therapies using a systematic review and meta-analysis.
METHODS
A systematic review was performed to identify original studies of ≥10 patients with intracranial ANs treated with FDSM from database inception through August 2023. Primary effectiveness outcome was the rate of complete AN occlusion at follow-up ≥6 months. Safety outcomes included ischemic stroke, hemorrhage, and in-stent thrombosis, and were stratified by FDSM devices and antiplatelet therapies. Certainty of evidence was evaluated following the Grading of Recommendations, Assessment, Development, and Evaluations approach.
RESULTS
Twenty-seven studies were included, yielding 2161 patients with 2373 ANs. A total of 70.5% of the ANs were located on the internal carotid artery (ICA). Total 10.3% were acutely ruptured. The complete AN occlusion rate was 72.3% at follow-up ≥6 months. Sensitivity analysis in the ICA AN cohort yielded comparable occlusion rates between Pipeline Flex Embolization Device-Shield (80.4%) and Phenox-hydrophilic polymer-coated (77.5%, P = 0.54), but a lower 66.2% rate for Flow Redirection Endoluminal Device-X (P = 0.02). The rate of in-stent thrombosis and stenosis tended to be higher in Phenox-hydrophilic polymer-coated (3.4%) and Flow Redirection Endoluminal Device-X (4.3%) versus Pipeline Flex Embolization Device-Shield (0.8%, P = 0.05).
CONCLUSIONS
FDSM were safe with satisfactory effectiveness for intracranial ANs. More specific investigations are warranted to explore their performance in ANs beyond the ICA and optimal antiplatelet therapy.
Topics: Humans; Intracranial Aneurysm; Stents; Endovascular Procedures; Embolization, Therapeutic; Treatment Outcome; Platelet Aggregation Inhibitors
PubMed: 38160909
DOI: 10.1016/j.wneu.2023.12.132 -
Clinical Neurology and Neurosurgery Jan 2024Intracranial mycotic or infectious aneurysms result from the infection of arterial walls, most caused by bacterial or fungal organisms. These infections can weaken the... (Meta-Analysis)
Meta-Analysis
INTRODUCTION
Intracranial mycotic or infectious aneurysms result from the infection of arterial walls, most caused by bacterial or fungal organisms. These infections can weaken the arterial wall, leading to the formation of an aneurysm, a localized dilation, or a bulge. The management can be conservative mainly based on antibiotics or invasive methods such as clipping or endovascular treatment.
PURPOSE
We performed a systematic review and meta-analysis of the current literature on endovascular treatment of mycotic aneurysms, analyzing the safety and efficacy associated with this procedure.
METHODS
We systematically searched on PUBMED, Cochrane Library, Embase, and Web of Science databases. Our search strategy was carefully crafted to conduct a thorough investigation of the topic, utilizing a comprehensive combination of relevant keywords. This meta-analysis included all studies that reported endovascular treatment of mycotic aneurysms. To minimize the risk of bias, studies with fewer than four patients, studies where the main outcome was not found, and studies with no clear differentiation between microsurgical and endovascular treatment were excluded.
RESULTS
In a comprehensive analysis of 134 patients, it was observed that all except one patient received antibiotics as part of their treatment. Among the patients, 56% (a total of 51 out of 90 patients) underwent cardiac surgery. Additionally, three patients required a craniotomy following endovascular treatment. 12 patients experienced morbidity related to the procedures performed, indicating complications arising from the interventions. Furthermore, four aneurysms experienced rebleeding while treatment. A pooled analysis of the endovascular treatment of the mycotic aneurysm revealed a good level of technical success, achieving a 100% success rate in 12 out of 14 studies (97-100%; CI 95%; I = 0%), as illustrated in Fig. 2. Similarly, the aneurysm occlusion rate demonstrated a notable efficacy, with a success rate of 97% observed in 12 out of 14 studies (97-100%; CI 95%; I = 0%), as depicted in Fig. 3.
CONCLUSION
The results strongly support the efficacy of endovascular treatment in achieving technical success, complete aneurysm occlusion, and favorable neurological outcomes. Additionally, the notably low incidence of complications and procedure-related mortality reaffirms the safety and benefits associated with this intervention.
Topics: Humans; Aneurysm, Infected; Intracranial Aneurysm; Treatment Outcome; Morbidity; Embolization, Therapeutic; Endovascular Procedures; Anti-Bacterial Agents
PubMed: 38064880
DOI: 10.1016/j.clineuro.2023.108068 -
Journal of Endovascular Therapy : An... Dec 2023Balloon angioplasty (BA), including drug-coated balloons (DCBs) and percutaneous transluminal angioplasty (PTA), has traditionally been used to treat femoral-popliteal... (Review)
Review
Efficacy and Safety of Atherectomy Combined With Balloon Angioplasty vs Balloon Angioplasty Alone in Patients With Femoro-Popliteal Lesions: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.
BACKGROUND
Balloon angioplasty (BA), including drug-coated balloons (DCBs) and percutaneous transluminal angioplasty (PTA), has traditionally been used to treat femoral-popliteal lesions. However, in recent years, atherectomy (ATH) has been proposed as a complementary approach. To assess the effectiveness of ATH compared with BA alone in patients with femoral-popliteal artery lesions, we conducted a systematic review and meta-analysis of randomized controlled trials (RCTs).
METHODS
We included RCTs that focused on patients with femoral-popliteal artery lesions and reported data on the use of ATH and BA therapy. Two reviewers conducted a literature search, refined the data, and assessed the risk of bias.
RESULTS
We included a total of 6 RCTs involving 399 patients with femoral-popliteal artery lesions. The use of ATH in combination with BA appeared to improve the patency rate at 12 months (odds ratio [OR]=2.04, 95% confidence interval [CI]=1.14-3.62). In addition, ATH with BA was associated with lower major amputation rates (MD=2.01, 95% CI=0.06-0.77, p=0.02) and a decreased likelihood of bailout stenting (OR=0.07, 95% CI=0.02-0.25, p=0.001). However, there were no statistically significant differences between the groups in terms of target lesion revascularization (TLR) at 12 months, major adverse cardiovascular events (MACEs), and distal embolization events. In addition, we performed subgroup analysis for different ATH devices and BA types.
CONCLUSIONS
Based on this meta-analysis, it can be concluded that the use of ATH in combination with BA is a safe and effective method for treating femoral-popliteal artery lesions. In addition, the patency rate at 1 year is superior to treatment with BA alone. Atherectomy also reduces the likelihood of amputation and bailout stenting. Clinicians should consider these findings when designing future RCTs and developing clinical practice guidelines.
CLINICAL IMPACT
This meta-analysis summarises a number of existing studies to advance understanding of the atherectomy devices and to reveal its potential. This new technique, when compared with drug coated balloon, shows the possibility of obtaining better clinical outcomes in femoro-popliteal lesions than drug-coated balloon alone, such as higher 12-month primary patency rates as shown in some studies. Currently, it is important to consider the appropriate technology applicable for individualised treatment. atherectomy devices seem to provide clinicians with additional options in clinical practice and to benefit patients in the future. This requires more high quality studies to explore the role and benefits of atherectomy devices in femoro-popliteal lesions.
PubMed: 38049942
DOI: 10.1177/15266028231215354 -
American Journal of Cardiovascular... 2023The first-generation Watchman 2.5 (W 2.5) presented several limitations, such as challenges in implantation within complex left atrial appendage (LAA) anatomies, higher... (Review)
Review
INTRODUCTION
The first-generation Watchman 2.5 (W 2.5) presented several limitations, such as challenges in implantation within complex left atrial appendage (LAA) anatomies, higher incidence of peri-device leak, device recapture, and device-related thrombus (DRT). The newer generation Watchman FLX (W-FLX) was introduced with a modified design aiming to overcome these limitations. The purpose of this meta-analysis is to conduct a comparative assessment of the safety and efficacy of the W-FLX and 2.5 devices in clinical practice.
METHOD
The meta-analysis was conducted according to the preferred reporting items for systematic review and meta-analysis protocols (PRISMA). Studies were located through a search strategy utilizing PubMed, Cochrane, Google scholar and MEDLINE from inception to March 2023, with a primary objective to compare the safety and efficacy of the W-FLX and W 2.5 devices. After applying the selection criteria, five studies were included in this analysis.
RESULTS
The analysis included five studies comprising 54,727 patients. The W-FLX is associated with an increase in procedural success (OR 7.49 [95% CI 1.98-28.26, P = 0.02; = 0%]), and a significant reduction in mortality (OR 0.52 [95% CI 0.51-0.54, P<0.01; = 0%], major bleeding 0.57 [95% CI 0.51-0.64, P<0.01; = 0%]), device embolism (OR 0.35 [95% CI 0.18-0.70, P = 0.02; = 0%]), and pericardial effusion (OR 0.33 [95% CI 0.26-0.41, P<0.01; = 0%]). The rates of DRT and stroke were similar between the two groups.
CONCLUSION
Compared to the W 2.5, the W-FLX was associated with a higher procedural success rate and significantly reduced adverse outcomes including mortality, major bleeding, device embolization, and pericardial effusion.
PubMed: 38026111
DOI: No ID Found -
Heart (British Cardiac Society) May 2024The use of cerebral embolic protection (CEP) during transcatheter aortic valve implantation (TAVI) has been studied in several randomised trials. We aimed to perform a... (Meta-Analysis)
Meta-Analysis
OBJECTIVES
The use of cerebral embolic protection (CEP) during transcatheter aortic valve implantation (TAVI) has been studied in several randomised trials. We aimed to perform a systematic review and Bayesian meta-analysis of randomised CEP trials, focusing on a clinically relevant reduction in disabling stroke.
METHODS
A systematic search was applied to three electronic databases, including trials that randomised TAVI patients to CEP versus standard treatment. The primary outcome was the risk of disabling stroke. Outcomes were presented as relative risk (RR), absolute risk differences (ARDs), numbers needed to treat (NNTs) and the 95% credible intervals (CrIs). The minimal clinically important difference was determined at 1.1% ARD, per expert consensus (NNT 91). The principal Bayesian meta-analysis was performed under a vague prior, and secondary analyses were performed under two informed literature-based priors.
RESULTS
Seven randomised studies were included for meta-analysis (n=3996: CEP n=2126, control n=1870). Under a vague prior, the estimated median RR of CEP use for disabling stroke was 0.56 (95% CrI 0.28 to 1.19, derived ARD 0.56% and NNT 179, I=0%). Although the estimated posterior probability of benefit was 94.4%, the probability of a was 0-0.1% under the vague and informed literature-based priors. Results were robust across multiple sensitivity analyses.
CONCLUSION
There is a high probability of a beneficial CEP treatment effect, but this is unlikely to be clinically relevant. These findings suggest that future trials should focus on identifying TAVI patients with an increased baseline risk of stroke, and on the development of new generation devices.
PROSPERO REGISTRATION NUMBER
CRD42023407006.
Topics: Humans; Transcatheter Aortic Valve Replacement; Embolic Protection Devices; Bayes Theorem; Aortic Valve Stenosis; Intracranial Embolism; Stroke; Risk Factors; Randomized Controlled Trials as Topic; Treatment Outcome
PubMed: 37996242
DOI: 10.1136/heartjnl-2023-323359 -
Circulation Mar 2024Device-detected atrial fibrillation (also known as subclinical atrial fibrillation or atrial high-rate episodes) is a common finding in patients with an implanted... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Device-detected atrial fibrillation (also known as subclinical atrial fibrillation or atrial high-rate episodes) is a common finding in patients with an implanted cardiac rhythm device and is associated with an increased risk of ischemic stroke. Whether oral anticoagulation is effective and safe in this patient population is unclear.
METHODS
We performed a systematic review of MEDLINE and Embase for randomized trials comparing oral anticoagulation with antiplatelet or no antithrombotic therapy in adults with device-detected atrial fibrillation recorded by a pacemaker, implantable cardioverter defibrillator, cardiac resynchronization therapy device, or implanted cardiac monitor. We used random-effects models for meta-analysis and rated the quality of evidence using the Grading of Recommendations Assessment, Development and Evaluation framework (GRADE). The review was preregistered (PROSPERO CRD42023463212).
RESULTS
From 785 citations, we identified 2 randomized trials with relevant clinical outcome data: NOAH-AFNET 6 (Non-Vitamin K Antagonist Oral Anticoagulants in Patients With Atrial High Rate Episodes; 2536 participants) evaluated edoxaban, and ARTESiA (Apixaban for the Reduction of Thrombo-Embolism in Patients With Device-Detected Sub-Clinical Atrial Fibrillation; 4012 participants) evaluated apixaban. Meta-analysis demonstrated that oral anticoagulation with these agents reduced ischemic stroke (relative risk [RR], 0.68 [95% CI, 0.50-0.92]; high-quality evidence). The results from the 2 trials were consistent (I statistic for heterogeneity=0%). Oral anticoagulation also reduced a composite of cardiovascular death, all-cause stroke, peripheral arterial embolism, myocardial infarction, or pulmonary embolism (RR, 0.85 [95% CI, 0.73-0.99]; I=0%; moderate-quality evidence). There was no reduction in cardiovascular death (RR, 0.95 [95% CI, 0.76-1.17]; I=0%; moderate-quality evidence) or all-cause mortality (RR, 1.08 [95% CI, 0.96-1.21]; I=0%; moderate-quality evidence). Oral anticoagulation increased major bleeding (RR, 1.62 [95% CI, 1.05-2.50]; I²=61%; high-quality evidence).
CONCLUSIONS
The results of the NOAH-AFNET 6 and ARTESiA trials are consistent with each other. Meta-analysis of these 2 large randomized trials provides high-quality evidence that oral anticoagulation with edoxaban or apixaban reduces the risk of stroke in patients with device-detected atrial fibrillation and increases the risk of major bleeding.
Topics: Humans; Administration, Oral; Anticoagulants; Atrial Fibrillation; Embolism; Hemorrhage; Ischemic Stroke; Pyridines; Stroke; Thiazoles; Treatment Outcome; Randomized Controlled Trials as Topic
PubMed: 37952187
DOI: 10.1161/CIRCULATIONAHA.123.067512 -
Neurosurgical Review Oct 2023Flow diversion with the pipeline embolization device (PED) is increasingly used to treat intracranial aneurysms with high obliteration rates and low morbidity. However,... (Meta-Analysis)
Meta-Analysis Review
Flow diversion with the pipeline embolization device (PED) is increasingly used to treat intracranial aneurysms with high obliteration rates and low morbidity. However, long-term (≥ 1 year) angiographic and clinical outcomes still require further investigation. The aim of this study was to compare the occlusion and complication rates for small (< 10 mm) versus large (10-25 mm) aneurysms at long-term following treatment with PED. A systematic review and meta-analysis were performed in compliance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses. We conducted a comprehensive search of English language databases including Ovid MEDLINE and Epub Ahead of Print, In-Process, and Daily, Ovid EMBASE, Ovid Cochrane Central Register of Controlled Trials, Ovid Cochrane Database of Systematic Reviews, and Scopus. Our studies included a minimum of 10 patients treated with PED for small vs. large aneurysms and with at least 12 months of follow-up. The primary safety endpoint was the rate of clinical complications measured by the occurrence of symptomatic stroke (confirmed clinically and radiographically), intracranial hemorrhage, or aneurysmal rupture. The primary efficacy endpoint was the complete aneurysm occlusion rate. Our analysis included 19 studies with 1277 patients and 1493 aneurysms. Of those, 1378 aneurysms met our inclusion criteria. The mean age was 53.9 years, and most aneurysms were small (89.75%; N = 1340) in women (79.1%; N = 1010). The long-term occlusion rate was 73% (95%, CI 65 to 80%) in small compared to 84% (95%, CI 76 to 90%) in large aneurysms (p < 0.01). The symptomatic thromboembolic complication rate was 5% (95%, CI 3 to 9%) in small compared to 7% (95%, CI 4 to 13%) in large aneurysms (p = 0.01). The rupture rate was 2% vs. 4% (p = 0.92), and the rate of intracranial hemorrhage was 2% vs. 4% (p = 0.96) for small vs. large aneurysms, respectively; however, these differences were not statistically significant. The long-term occlusion rate after PED treatment is higher in large vs. small aneurysms. Symptomatic thromboembolic rates with stroke are also higher in large vs. small aneurysms. The difference in the rates of aneurysm rupture and intracranial hemorrhage was insignificant. Although the PED seems a safe and effective treatment for small and large aneurysms, further studies are required to clarify how occlusion rate and morbidity are affected by aneurysm size.
Topics: Humans; Female; Middle Aged; Aneurysm, Ruptured; Intracranial Aneurysm; Intracranial Hemorrhages; Stroke; Angiography
PubMed: 37882896
DOI: 10.1007/s10143-023-02192-0 -
Langenbeck's Archives of Surgery Oct 2023Hospitalisation and surgery are major risk factors for venous thromboembolism (VTE). Intermittent pneumatic compression (IPC) and graduated compression stockings (GCS)... (Review)
Review
PURPOSE
Hospitalisation and surgery are major risk factors for venous thromboembolism (VTE). Intermittent pneumatic compression (IPC) and graduated compression stockings (GCS) are common mechanical prophylaxis devices used to prevent VTE. This review compares the safety and efficacy of IPC and GCS used singularly and in combination for surgical patients.
METHODS
Ovid Medline and Pubmed were searched in a systematic review of the literature, and relevant articles were assessed against eligibility criteria for inclusion along PRISMA guidelines.
RESULTS
This review is a narrative description and critical analysis of available evidence. Fourteen articles were included in this review after meeting the criteria. Results of seven studies comparing the efficacy of IPC versus GCS had high heterogeneity but overall suggested IPC was superior to GCS. A further seven studies compared the combination of IPC and GCS versus GCS alone, the results of which suggest that combination mechanical prophylaxis may be superior to GCS alone in high-risk patients. No studies compared combination therapy to IPC alone. IPC appeared to have a superior safety profile, although it had a worse compliance rate and the quality of evidence was poor. The addition of pharmacological prophylaxis may make mechanical prophylaxis superfluous in the post-operative setting.
CONCLUSION
IPC may be superior to GCS when used as a single prophylactic device. A combination of IPC and GCS may be more efficacious than GCS alone for high-risk patients. Further high-quality research is needed focusing on clinical relevance, safety and comparing combination mechanical prophylaxis to IPC alone, particularly in high-risk surgical settings when pharmacological prophylaxis is contraindicated.
Topics: Humans; Venous Thromboembolism; Intermittent Pneumatic Compression Devices; Stockings, Compression; Combined Modality Therapy; Risk Factors
PubMed: 37851108
DOI: 10.1007/s00423-023-03142-6