Project description:AimsLeft atrial appendage (LAA) imaging is critical during percutaneous occlusion procedures. 3D-intracardiac echocardiography (ICE) features direct visualization of LAA from multiple cross-sectional planes at a time. We aimed at reporting procedural success of 3D-ICE-guided LAA occlusion and the correlation between pre-procedural transoesophageal echocardiography (TEE) and intraprocedural 3D-ICE for LAA sizing.Methods and resultsAmong 274 patients undergoing left atrial appendage occlusion (LAAO) with a Watchman FLX, periprocedural ICE guidance was achieved via a commercially available 2D-ICE catheter (220 patients) or a novel (NUVISION™) 3D-ICE one (54 patients). Primary endpoint was a composite of procedural success and LAA sealing at follow-up TEE. Secondary endpoint was a composite of periprocedural device recapture/resizing plus presence of leaks ≥ 3 mm at follow-up TEE. 3D-ICE measurements of maximum landing zone correlated highly with pre-procedural TEE reference values [Pearson's: 0.94; P < 0.001; bias: -0.06 (-2.39, 2.27)]. The agreement between 3D-ICE-based device selection and final device size was 96.3% vs. 79.1% with 2D-ICE (P = 0.005). The incidence of the primary endpoint was 98.1% with 3D-ICE and 97.3% with 2D-ICE (P = 0.99). 2D-ICE patients had a trend towards a higher incidence of periprocedural device recapture/redeployment (31.5% vs. 44.5%; P = 0.09). The secondary endpoint occurred in 31.5% of 3D-ICE patients vs. 45.9% of 2D-ICE ones (P = 0.065).ConclusionIntracardiac echocardiography-guided LAAO showed a very high success, with no major adverse events. A very high level of agreement for LAA sizing was found between pre-procedural TEE and periprocedural 3D-ICE. 3D-ICE performed significantly better than 2D-ICE for FLX size selection and may provide better guidance during device deployment.
Project description:Background Accumulated clinical studies utilized intracardiac echocardiography (ICE) to guide percutaneous left atrial appendage occlusion (LAAO). However, its procedural success and safety compared to traditional transesophageal echocardiography (TEE) remained elusive. Therefore, we performed a meta-analysis to compare efficacy and safety of ICE and TEE for LAAO. Methods We screened studies from four online databases (including the Cochrane Library, Embase, PubMed, and Web of Science) from their inception to 1 December 2022. We used a random or fixed-effect model to synthesize the clinical outcomes and conducted a subgroup analysis to identify the potential confounding factors. Results A total of twenty eligible studies with 3,610 atrial fibrillation (AF) patients (1,564 patients for ICE and 2,046 patients for TEE) were enrolled. Compared with TEE group, there was no significant difference in procedural success rate [risk ratio (RR) = 1.01; P = 0.171], total procedural time [weighted mean difference (WMD) = −5.58; P = 0.292], contrast volume (WMD = −2.61; P = 0.595), fluoroscopic time (WMD = −0.34; P = 0.705; I2 = 82.80%), procedural complications (RR = 0.82; P = 0.261), and long-term adverse events (RR = 0.86; P = 0.329) in the ICE group. Subgroup analysis revealed that ICE group might be associated with the reduction of contrast use and fluoroscopic time in the hypertension proportion <90 subgroup, with lower total procedure time, contrast volume, and the fluoroscopic time in device type subgroup with multi-seal mechanism, and with the lower contrast use in paroxysmal AF (PAF) proportion ≤50 subgroup. Whereas, ICE group might increase the total procedure time in PAF proportion >50 subgroup and contrast use in multi-center subgroup, respectively. Conclusion Our study suggests that ICE may have comparable efficacy and safety compared to TEE for LAAO.
Project description:BackgroundIntracardiac echocardiography (ICE)-guided left atrial appendage occlusion (LAAO) is increasingly common. Patients with previous atrial septal defect closure constitute a significant challenge for transseptal access.Case summaryA 49-year-old man with persistent atrial fibrillation, hypertension, and reduced left ventricular function was considered for LAAO after a life-threatening intrathoracic bleeding while on oral anticoagulation. Percutaneous atrial septal defect closure was performed 15 years before with a 34 mm Amplatzer Septal Occluder. Preprocedural cardiac computed tomography demonstrated the atrial septal occluder device with a small native interatrial septum at the inferior margin. The left atrial appendage landing zone measured 17 × 22 mm. The LAAO was performed under local analgesia. A steerable sheath was used to guide the transseptal puncture, and the ICE probe was traced along a guidewire across the atrial septum. A 12-F Amulet delivery sheath was advanced through the same transseptal hole. Under ICE and fluoroscopy guidance, a 25 mm Amplatzer Amulet was deployed. Follow-up imaging showed a well-positioned device with a small peridevice leak at the disc.DiscussionThis case report illustrates the feasibility of LAAO performed with ICE guidance from the left atrium in a patient with a large Amplatzer Septal Occluder with a small native interatrial septum. It demonstrates that prior atrial septal defect closure should not be considered as a contraindication for LAAO but warrants careful preprocedural planning.
Project description:BackgroundIntracardiac echocardiography (ICE) is an alternative to transesophageal echocardiography to guide left atrial appendage occlusion (LAAO). However, 2-dimensional ICE has important limitations that hinder its adoption in routine practice.ObjectivesThis prospective multicenter study (NCT04569734) investigated the feasibility and safety of ICE-guided LAAO with Watchman FLX using a novel 3-dimensional ICE catheter (VeriSight Pro, Philips).MethodsA total of 100 patients undergoing LAAO with the Watchman FLX device were recruited. All cases were performed under moderate sedation. A simplified 2 orthogonal view ICE imaging protocol was adopted to assess PASS (position, anchoring, sizing, and sealing) criteria. The feasibility endpoint was successful implantation of the FLX device and adequate seal (peri-device leak <5 mm) at 45 days. The safety endpoint was the incidence of major complications at 7 and 45 days. Physician experience and imaging quality scores were collected (1 = lowest, 5 = highest).ResultsThe mean age was 77.0 ± 8.1 years, and 39 (39%) were women. CHA2DS2-VASc score was 4.8 ± 1.5 and HAS-BLED score was 3.2 ± 1.1. Total procedural time was 54 ± 25 minutes. Mean contrast volume was 41 ± 46 ml, with no contrast used in 16 patients. The feasibility endpoint was achieved in 95 patients (95%); 4 patients were not implanted due to unsuitable anatomy, and 1 patient had a leak >5 mm at 45 days. There was 1 periprocedural stroke and 2 gastrointestinal bleeds requiring transfusion at 7 days with no other major complications. Physicians' rating of overall ICE imaging quality was 4.6 ± 0.6.ConclusionsThe novel 3-dimensional ICE VeriSight Pro Probe can safely and effectively guide LAAO with Watchman FLX using a simplified imaging protocol.
Project description:BackgroundIntracardiac echocardiography (ICE) appears to be a potential alternative for percutaneous left atrial appendage occlusion (LAAO) to transesophageal echocardiography (TEE). Thus, a meta-analysis was performed comparing ICE vs. TEE for LAAO guidance.MethodsA comprehensive literature search was performed using MEDLINE, Scopus and Web of Science electronic databases from their inception to November 2023.Results18 studies (124,230 patients) were included. Technical success was higher in ICE- compared to TEE-guidance (OR: 1.36, 95% CI 1.14 to 1.63, p = 0.006) and fewer devices employed (SMD: -0.22, 95% CI -0.43 to -0.01, p = 0.04, I2 = 62%). ICE guidance related with more pericardial effusion/tamponade and iatrogenic residual shunts (logRR: 0.62, 95% CI 0.36 to 0.89, p < 0.001 and RR: 1.53, 95% CI 1.12 to 2.09, p = 0.02, I2 = 1%, respectively). More vascular complications were noted in ICE group (logRR: 0.45, 95% CI 0.11 to 0.78, p = 0.009).ConclusionICE-guided imaging is an effective alternative to TEE in LAAO, as it shows better efficacy than TEE, considering technical success. However, the higher rates of adverse events should be carefully considered.
Project description:Prevention of stroke represents a goal of primary importance in health systems due to its associated morbidity and mortality. As several patient groups with increased stroke rates have been identified, multiple approaches have been developed and implemented: oral anticoagulation (OAC) for patients with atrial fibrillation, surgical and percutaneous revascularisation in patients with carotid disease, device closure for patients with patent foramen ovale, and now, left atrial appendage occlusion (LAAO) for selected patients with non-valvular atrial fibrillation (NVAF). The latter group of patients are the focus of this review which evaluates the pathophysiology, selection of patients, procedural performance, outcomes of treatment both during and post-procedure, adjunctive therapy, complications, and longer-term outcomes.
Project description:BackgroundLeft atrial appendage closure (LAAC) is usually performed under the guidance of transesophageal echocardiography (TEE). Data on the safety of intracardiac echocardiogram (ICE)-guided LAAC from a real-world population in the United States remain limited. In this study, the aim was to evaluate the trends and outcomes of ICE-guided LAAC procedures using the US National Inpatient Sample.MethodsThis study used the National Inpatient Sample database from quarter 4 of 2015 to 2019. We used a propensity-matched analysis and adjusted odds ratios for in-hospital outcomes/complications. A P value of <.05 was considered significant.ResultsWe identified 61,995 weighted LAAC cases. Of these, 1410 patients had ICE-guided LAAC with a lower median age than the patients who had TEE-guided LAAC (75 vs 77 years; P ≤ .01). The use of ICE-guided LAAC increased from 1.7% in 2015 to 2.2% in 2019 (P trend = .75). Major, cardiovascular, neurologic, and pulmonary complications were similar for ICE-guided and TEE-guided LAAC on adjusted analysis. On propensity-matched analysis, the overall vascular complication rates were similar. However, retroperitoneal bleeding remained significantly higher (0.7% vs 0%) with ICE. Gastrointestinal bleeding complications were more frequent in TEE-guided LAAC (3.5% vs 2.1%). The length of stay was similar for both groups (median = 1 day; P = .23); however, ICE was associated with $1769 excess cost of hospitalization ($25,112 vs $23,343; P = .04).ConclusionsICE-guided LAAC is safer than TEE-guided LAAC, with similar rates of major complications. However, ICE use was associated with lower rates of gastrointestinal bleeding and higher rates of retroperitoneal bleeding. In addition, ICE-guided LAAC is associated with a similar length of stay but higher costs of hospitalization.