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The Journal of Innovations in Cardiac... Jun 2024Atrial fibrillation (AF) is a prevalent cardiac arrhythmia marked by irregular and frequent tachycardic rhythms in the atria, affecting 1%-2% of the general population.... (Review)
Review
Comparative Profiles of the WATCHMAN™ and Amplatzer™ Cardiac Plug/Amplatzer™ Amulet™ Devices for Left Atrial Appendage Closure in Non-valvular Atrial Fibrillation: A Comprehensive Systematic Review and Meta-analysis.
Atrial fibrillation (AF) is a prevalent cardiac arrhythmia marked by irregular and frequent tachycardic rhythms in the atria, affecting 1%-2% of the general population. The WATCHMAN™ device from Boston Scientific (Marlborough, MA, USA) and the Amplatzer™ Amulet™ device from Abbott (Chicago, IL, USA) are two devices used globally for left atrial appendage closure (LAAC) in non-valvular AF. A systematic search was conducted in PubMed, the Cochrane Library, and Elsevier's ScienceDirect literature databases to identify studies comparing the WATCHMAN™ procedure with Amulet™ device implantation for LAAC in patients with AF. The analyses were conducted using the random-effects model. A total of 20 studies were identified, with 18 falling into the category of observational studies and 2 being randomized controlled trials. A total of 6310 participants were included in this meta-analysis, with 3198 individuals (50.68%) assigned to the WATCHMAN™ procedure group and 3112 individuals (49.32%) allocated to the Amplatzer™ Cardiac Plug (ACP) group. The analysis revealed a higher risk of stroke associated with the WATCHMAN™ technique (relative risk [RR], 1.14), albeit without statistical significance. Conversely, the WATCHMAN™ approach led to a significantly lower risk of cardiac death (RR, 0.44; = .04). Notably, the risks of all-cause mortality (RR, 0.89; 95% confidence interval [CI], 0.73-1.08; = 0%; = .25) and major bleeding (RR, 0.93; 95% CI, 0.65-1.33; = 31%; = .70) were clinically reduced with the WATCHMAN™ procedure, although statistical significance was not achieved. Compared to Amulet™ device implantation, WATCHMAN™ device implantation decreased the risk of cardiac mortality, while the risks of stroke, systemic embolism, all-cause mortality, and major bleeding were not statistically significant.
PubMed: 38948665
DOI: 10.19102/icrm.2024.15061 -
Turkish Neurosurgery 2024To compare endovascular coiling and surgical clipping for the evaluation of clinical outcomes in patients with unruptured intracranial aneurysms. (Meta-Analysis)
Meta-Analysis
AIM
To compare endovascular coiling and surgical clipping for the evaluation of clinical outcomes in patients with unruptured intracranial aneurysms.
MATERIAL AND METHODS
We searched MEDLINE, EMBASE, the Cochrane Library and three Chinese domestic electronic databases, namely, Wanfang, CNKI and VIP for studies published between January 1990 and January 2018. We included controlled clinical studies comparing clinical outcomes between surgical clipping and endovascular coiling treatments. Two researchers extracted the data and assessed the quality of the studies, and a meta-analysis was performed using RevMan 5 software.
RESULTS
We analysed a total of 23 controlled clinical studies including 117,796 cases. Meta-analysis demonstrated similar ischaemia rates between clipping and coiling with an odds ratio [OR] of 1.36 (95% CI: 0.77?2.40). The occlusion rate and bleeding risk were higher with clipping than coiling; the pooled ORs were 5.31 (95% CI: 3.07?9.19) and 2.39 (95% CI: 1.82?3.13), respectively. In addition, clipping resulted in a longer hospital stay (OR = 2.90, 95% CI: 2.14?3.65) than coiling did. Patients who underwent clipping had a higher short-term mortality (OR = 1.99, 95% CI: 1.70?2.33) and neurological deficit rate (OR = 2.05, 95% CI: 1.73? 2.44) compared with those who underwent coiling. However, 1 year mortality and deficit rate were similar for both clipping and coiling, with pooled ORs of 0.75 (95% CI: 0.41?1.38) and 0.94 (95% CI: 0.53?1.67), respectively. Funnel plots did not demonstrate a publication bias, with the exception of ischaemic outcome, and sensitivity analysis showed consistent results.
CONCLUSION
Our study demonstrates that coiling is associated with a lower rate of occlusion, shorter hospital stay, lower bleeding risk and lower short-term mortality and morbidity compared with clipping. In terms of ischaemic risk, 1 year mortality and morbidity, coiling and clipping bear a similar risk. In addition, we speculate that surgical clipping may have a better outcome than endovascular coiling in the long term especially in young patients. Further research is needed to confirm our conclusion.
Topics: Humans; Intracranial Aneurysm; Endovascular Procedures; Treatment Outcome; Surgical Instruments; Neurosurgical Procedures; Embolization, Therapeutic
PubMed: 38650551
DOI: 10.5137/1019-5149.JTN.23729-18.1 -
Neurosurgical Review Apr 2024Cerebral aneurysm is a life-threatening condition, which requires high precision during the neurosurgical procedures. Increasing progress of evaluating modern devices in... (Review)
Review
Cerebral aneurysm is a life-threatening condition, which requires high precision during the neurosurgical procedures. Increasing progress of evaluating modern devices in medicine have led to common usage of robotic systems in many fields, including cranial aneurysm operations. However, currently no systematic review describes up-to date knowledge of this topic. Following PRISMA guidelines, we have independently screened and extracted works from seven databases. Only studies fulfilling inclusion criteria were presented in this study. Device used, operation time, complications, aneurysm type and patient demographics were extracted from each work. We identified a total of 995 articles from databases. We have found six original works and one supplementary article eligible for this synthesis. Majority of works (4/6) have implemented CorPath GRX in cerebral aneurysm procedures. The procedures involved diverse aneurysm locations, utilizing flow diverters, stents, or coiling. One study described implementation of robot-assist on 117 patients and compared results to randomized clinical trials. One work with a small patient cohort described use of the magnetically-controlled microguidewire in the coiling procedures, without any complications. Additionally, one case-series study described use of a robotic arm for managing intraoperative aneurysm rupture. Currently, robotical devices for cerebral aneurysm treatment mainly lack jailing and haptic feedback feature. Further development of these devices will certainly be beneficial for operators and patients, allowing for more precise and remote surgeries.
Topics: Humans; Intracranial Aneurysm; Robotics; Robotic Surgical Procedures; Treatment Outcome; Embolization, Therapeutic; Endovascular Procedures; Stents; Retrospective Studies
PubMed: 38600417
DOI: 10.1007/s10143-024-02400-5 -
Cureus Feb 2024Inferior vena cava (IVC) filters have been used successfully in high-risk patients to prevent thromboembolism. The filters are widely created as retrievable devices, but... (Review)
Review
Inferior vena cava (IVC) filters have been used successfully in high-risk patients to prevent thromboembolism. The filters are widely created as retrievable devices, but complication rates progressively increase during IVC filter retrieval. This study aims to analyze IVC filter retrieval cases and associated complications during and following the procedures regarding dwell times, specific filter types, filter positioning, and advanced retrieval techniques. This review followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines to select and analyze relevant articles. A literature search for articles was performed on September 23, 2023, through three research databases: PubMed, ProQuest, and ScienceDirect. The keywords used to identify relevant publications were "IVC Filter retrieval AND complications" and "IVC filter removal AND complications". The articles before 2012 were excluded. Relevant articles were selected based on the inclusion and exclusion criteria. In total, 20,435 articles were found: 812 from PubMed, 15,635 from ProQuest, and 3,988 from Science Direct. Among the exclusions were 18,462 articles, which were excluded in the automatic screening process, leaving 1,973 for manual screening. The manual screening of articles was conducted based on title, abstract, article type, duplicates, and case reports, where 1,918 articles were excluded. Ultimately, 55 articles were included in this review. This study demonstrates that IVC filter retrievals have significant complication rates. Many complications have a common theme: prolonged dwell time and lost follow-up appointments. Therefore, importance should be placed on patient education and implementing strict protocols regarding the timelines of IVC filter removals.
PubMed: 38550500
DOI: 10.7759/cureus.55052 -
Singapore Medical Journal Mar 2024Prolonged cardiac monitoring after cryptogenic stroke or embolic stroke of undetermined source (ESUS) is necessary to identify atrial fibrillation (AF) that requires...
INTRODUCTION
Prolonged cardiac monitoring after cryptogenic stroke or embolic stroke of undetermined source (ESUS) is necessary to identify atrial fibrillation (AF) that requires anticoagulation. Wearable devices may improve AF detection compared to conventional management. We aimed to review the evidence for the use of wearable devices in post-cryptogenic stroke and post-ESUS monitoring.
METHODS
We performed a systematic search of PubMed, EMBASE, Scopus and clinicaltrials.gov on 21 July 2022, identifying all studies that investigated the use of wearable devices in patients with cryptogenic stroke or ESUS. The outcomes of AF detection were analysed. Literature reports on electrocardiogram (ECG)-based (external wearable, handheld, patch, mobile cardiac telemetry [MCT], smartwatch) and photoplethysmography (PPG)-based (smartwatch, smartphone) devices were summarised.
RESULTS
A total of 27 relevant studies were included (two randomised controlled trials, seven prospective trials, 10 cohort studies, six case series and two case reports). Only four studies compared wearable technology to Holter monitoring or implantable loop recorder, and these studies showed no significant differences on meta-analysis (odds ratio 2.35, 95% confidence interval [CI] 0.74-7.48, I 2 = 70%). External wearable devices detected AF in 20.7% (95% CI 14.9-27.2, I 2 = 76%) of patients and MCT detected new AF in 9.6% (95% CI 7.4%-11.9%, I 2 = 56%) of patients. Other devices investigated included patch sensors, handheld ECG recorders and PPG-based smartphone apps, which demonstrated feasibility in the post-cryptogenic stroke and post-ESUS setting.
CONCLUSION
Wearable devices that are ECG or PPG based are effective for paroxysmal AF detection after cryptogenic stroke and ESUS, but further studies are needed to establish how they compare with Holter monitors and implantable loop recorder.
PubMed: 38449074
DOI: 10.4103/singaporemedj.SMJ-2022-143 -
The Journal of Invasive Cardiology Apr 2024Atrial septal abnormalities are common congenital lesions that remain asymptomatic in many patients until adulthood. Adults with atrial septal defects (ASD) most...
Atrial septal abnormalities are common congenital lesions that remain asymptomatic in many patients until adulthood. Adults with atrial septal defects (ASD) most commonly have ostium secundum ASD. Transcatheter closure has become increasingly popular in recent years as a successful alternative method to surgery for treating ASD and patent foramen ovale (PFO). The overall rate of ASD transcatheter closure device embolization has been reported to be less than 1%; however, retrieving the device via surgery or by trans-catheter route can be necessary. The current manuscript describes a systematic review of the techniques used to retrieve ASD closure devices, as well as their success rates, complications, and limitations. A comprehensive search was performed covering various databases including PubMed, MEDLINE, SCOPUS, Google Scholar, and Cochrane Library from inception until April 2022 for English-published case reports, case series, and experimental studies investigating the indications, safety, and limitations of ASD closure and ASD device retrieval by trans-catheter approaches. Finally, 20 studies were included in our review. Our findings showed that most of the studies used a single snare technique; of these, all but one reported 100% success. Double tool retrieval methods (snare plus snare, snare plus bioptome, or snare plus forceps) and the gooseneck snare technique yielded 100% success. One study that used the lasso technique reported unsuccessful retrieval and the need for surgical intervention. More recently, the novel "coronary wire trap technique" was introduced, which provides a simpler method for embolized device removal by trapping the device for retrieval using coronary wire.
Topics: Adult; Humans; Foramen Ovale, Patent; Treatment Outcome; Cardiac Catheterization; Septal Occluder Device; Heart Septal Defects, Atrial; Cardiac Catheters
PubMed: 38412436
DOI: 10.25270/jic/23.00290 -
PloS One 2024In patients with non-valvular atrial fibrillation (NVAF), mechanical occlusion of the left atrial appendage (LAA) using a permanently implanted device may be an... (Meta-Analysis)
Meta-Analysis
Safety and efficacy of percutaneous Watchman 2.5 device versus Amplatzer Amulet for left atrial appendage closure in patients with non-valvular atrial fibrillation: A systematic review and study-level meta-analysis.
INTRODUCTION
In patients with non-valvular atrial fibrillation (NVAF), mechanical occlusion of the left atrial appendage (LAA) using a permanently implanted device may be an effective alternative to oral anti-coagulants (OAC). To facilitate left atrial appendage closure (LAAC), multiple percutaneous devices have been proposed. Watchman Generation 2.5 and Amplatzer Amulet are the two most popular used devices for preventing stroke in patients with NVAF. We sought to compare safety and efficacy outcomes between Watchman 2.5 and Amplatzer Amulet in patients undergoing LAAC procedure.
METHODS
We carried out a comprehensive and systematic search of the databases PubMed and Scopus, for all studies that compared the safety and efficacy of Watchman 2.5 and Amplatzer Amulet devices, from inception, till June 2023. We performed the statistical analysis using Review Manager (V.5.4.1 Cochrane Collaboration, London, United Kingdom). The safety outcomes of interest included device success, device-related thrombus, device embolization perioperatively and at follow-up, perioperative pericardial perfusion events, and perioperative cardiac tamponade events. Efficacy outcomes were all-cause mortality perioperatively and at follow-up, cardiovascular (CV) mortality at follow-up, stroke, major and minor bleeding events at follow-up, transient ischemic attack (TIA) in follow-up period, thromboembolic events in follow-up period, and peri-device leakage in perioperative period. All data was analysed using a random-effects model, and presented as risk ratios (RRs) with 95% confidence intervals (95%CIs).
RESULTS
Regarding safety outcomes, device success was non-significantly reduced in Watchman group when compared with Amulet (RR 0.99, p = 0.57; I2 = 34%). In contrast, device-related thrombus was non-significantly increased in Watchman 2.5 group in comparison to Amulet (RR 1.44, p = 0.11; I2 = 0%). There was no significant difference between the devices in terms of device embolization in the perioperative (RR 0.36, p = 0.38; I2 = 22%) and follow-up (RR 2.24, p = 0.13; I2 = 0%) periods. Likewise, there was no significant difference in the risks of pericardial effusion (RR 0.98, p = 0.98; I2 = 0%), and cardiac tamponade (RR 0.65, p = 0.76; I2 = 62%) perioperatively. Regarding efficacy outcomes, no significant difference was observed in all-cause mortality between devices perioperatively (RR 0.51, p = 0.32; I2 = 0%) and at follow-up (RR 1.08, p = 0.56; I2 = 0%). CV-mortality was non-significantly reduced in Watchman group when compared with Amulet (RR 0.57, p = 0.20; I2 = 0%). The Amulet device was not superior to the Watchman device in terms of stroke at follow-up (RR 1.13, p = 0.63; I2 = 0%). Sub-group analysis showed comparable ischaemic and haemorrhagic stroke events between two devices. Furthermore, at follow-up, there was no significant difference in major (RR 1.06, p = 0.63; I2 = 0%) and minor bleeding events (RR 1.81, p = 0.17; I2 = 0%) between the two devices. No difference was observed for trans-ischemic attack (RR 1.89, p = 0.24; I2 = 0%) and thromboembolic events (RR 0.96, p = 0.96; I2 = 0%) at follow-up. No significant difference was observed between devices for peri-device leakage in perioperative period (RR 2.16, p = 0.05; I2 = 0%).
CONCLUSION
The data suggested that LAAC is safe and efficacious procedure irrespective of device used, with generally low complication rates. Watchman generation 2.5 remains non-superior to Amplatzer Amulet in terms of safety and efficacy outcomes.
Topics: Humans; Atrial Fibrillation; Left Atrial Appendage Closure; Cardiac Tamponade; Treatment Outcome; Atrial Appendage; Stroke; Thrombosis; Cardiac Catheterization
PubMed: 38354181
DOI: 10.1371/journal.pone.0295804 -
Cardiology and Therapy Jun 2024Transcatheter aortic valve implantation (TAVI) plays a vital role in patients with symptomatic aortic stenosis. Despite the mortality benefit of TAVI, embolic stroke...
INTRODUCTION
Transcatheter aortic valve implantation (TAVI) plays a vital role in patients with symptomatic aortic stenosis. Despite the mortality benefit of TAVI, embolic stroke remains a feared complication. As a result, transcatheter cerebral embolic protection (TCEP) devices have been developed to reduce this risk. Given the ongoing debate of TCEP in TAVI, we performed a systematic review and meta-analysis of all randomized controlled trials to date to identify outcomes of periprocedural stroke using the Sentinel™ cerebral protection system (CPS).
METHODS
MEDLINE, Cochrane, and Scopus databases were utilized from inception until 12/2023. PRISMA criteria was utilized. Keywords included "cerebral embolic protection", "sentinel cerebral protection system", "transcatheter aortic valve implantation", and "transcatheter aortic valve replacement". Primary outcome was periprocedural stroke. Secondary outcomes included periprocedural disabling and non-disabling stroke, all-cause mortality, transient ischemic attack, delirium, acute kidney injury, vascular complications, bleeding, and pacemaker implantation. Risk ratios (RR) were measured via Mantel-Haenszel method with fixed analysis. Heterogeneity was assessed via chi-squared and Higgin's I test.
RESULTS
Four trials with 3528 patients were assessed. SAPIEN 3 was the most common bioprosthetic valve used. The average age was 79.4 years with 41.9% of the sample size being females. The most prevalent comorbidities were hypertension, diabetes mellitus, and coronary artery disease. There was no difference in periprocedural stroke in patients who underwent TAVI with the Sentinel™ CPS compared to no TCEP (RR 0.75, P = 0.12). Periprocedural disabling strokes were less likely in those who underwent TAVI with the Sentinel™ CPS compared to no TCEP (RR 0.41, P = 0.02) with a number needed to treat (NNT) of 123. All other outcomes did not reach statistical significance.
CONCLUSIONS
In our analysis, there was no difference between TAVI with the Sentinel™ CPS compared to TAVI without TCEP in regard to risk of periprocedural stroke; however, it was associated with a decreased risk of periprocedural disabling stroke.
PubMed: 38340292
DOI: 10.1007/s40119-024-00359-4 -
Acta Neurochirurgica Jan 2024Pipeline embolization device (PED) is widely used in intracranial aneurysms, and the scope of applications for the PED, which is frequently used to treat cerebral... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND AND PURPOSE
Pipeline embolization device (PED) is widely used in intracranial aneurysms, and the scope of applications for the PED, which is frequently used to treat cerebral aneurysms, is also growing. It has some effect on branching vessels as a result of its inherent properties. The effects of PED on the complications rate and branching vessels blockage have not yet been thoroughly investigated.
OBJECTIVE
We conducted a systematic review searching reports from multiple databases on PED use for intracranial aneurysms, and analyzed the influence of PED on the occlusion rate of different branching vessels, and the influence of the amount of PED on the occlusion rate of branching vessels by meta-analysis.
METHODS
We searched the literature using PUBMED, Web of Science, and OVID databases until August 2023. Inclusion criteria were that the study used only PED, included at least 10 patients, and recorded branching vessels occlusion rates, mortality, and neurological complications.
RESULTS
Nine studies were analyzed consisting of 706 patients with 986 side branches. The results of the meta-analysis showed that application of more than one PED did not significantly elevate the rate of branching vessels occlusion compared to application of one PED (OR = 0.70; 95% CI: 0.34 to 1.43; P = 0.33). In the comparison of branching vessels occlusion rates in the anterior circulation, the anterior cerebral artery (ACA) had a significantly higher occlusion rate compared to the ophthalmic artery (OphA) (OR = 6.54; 95% CI: 3.05 to 14.01; P < 0.01), ACA also had a higher occlusion rate compared to the anterior choroidal artery (AchA) (OR = 15.44; 95% CI: 4.11 to 57.94 P < 0.01), ACA versus posterior communicating artery (PcomA) occlusion rate difference was not statistically significant (OR = 2.58; 95% CI: 0.63 to 12.82; P = 0.17), OphA versus AchA occlusion rate difference was not statistically significant (OR = 2.56; 95% CI: 0.89 to 7.38; P = 0.08), and the occlusion rate was significantly higher for PcomA compared to AchA (OR = 7.22; 95% CI: 2.49 to 20.95; P < 0.01) and lower for OphA compared to PcomA (OR = 0.33; 95% CI: 0.19 to 0.55; P < 0.01).
CONCLUSION
The meta-analysis shows that use of multiple PEDs did not significantly increase the occlusion rate of branching vessels, and the larger the diameter of branching vessels covered by PED, the higher the occlusion rate of branching vessels. However, the incidence of complications is low after branching vessels occlusion in anterior circulation, which is related to the collateral circulation compensation of the branching vessels.
Topics: Humans; Intracranial Aneurysm; Vascular Diseases; Collateral Circulation; Anterior Cerebral Artery; Blood Vessel Prosthesis
PubMed: 38200390
DOI: 10.1007/s00701-024-05895-5 -
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