Management of complications associated with percutaneous left atrial appendage closure with or without ablation: experience from 512 cases over a 4-year period.

Background: Percutaneous left atrial appendage closure (LAAC) serves as an alternative prophylactic strategy for patients with non-valvular atrial fibrillation (AF) who cannot undergo anti-coagulation therapy. Proper management of associated complications is crucial to enhancing the procedure's success rate and mitigating perioperative risks and adverse events during follow-up. Aims: This study aims to summarize our center's experience and strategies in managing procedural-related complications encountered in 512 cases of LAAC with or without ablation for AF conducted from January 2020 to December 2023. Results: We identified 11 significant intervention-requiring complications associated with LAAC with or without Ablation procedure. These included three cases of intraoperative thrombosis, three instances of pericardial effusion or tamponade, one case of device-related thrombosis, one peri-device leak, one systemic embolism, one bleeding episode, and one additional device-related complication. The categorization of intraoperative thrombosis was as follows: one patient exhibited heparin resistance; one experienced thrombosis due to prolonged device implantation during the LAAC with ablation procedure; and one had unexplained intraoperative thrombosis. The pericardial effusion or tamponade likely resulted from damage to the atrial appendage during LAAC device insertion. Two patients encountered device-related thrombosis and systemic embolism events possibly caused by non-standard postoperative antithrombotic medication use; one patient's peri-device leak may have resulted from incomplete endothelialization of the occluder post-surgery; one patient experienced postoperative bladder bleeding; and one patient's device-related complications occurred due to a dislodged strut frame that damaged the left atrial appendage, leading to pericardial effusion. Our proactive interventions enabled all patients with these surgical-related complications to be safely discharged, with subsequent follow-ups showing no adverse events. Conclusion: Implementing targeted interventions for immediate procedural-related complications during the LAAC with or without ablation procedures enhances procedural success rates, diminishes postoperative mortality and patient disability, and bolsters stroke prevention efforts. This approach underscores the importance of a strategic response to complications, affirming the procedure's viability and safety in managing non-valvular AF in patients contraindicated for anticoagulation.

Staged hybrid ablation in left atrial appendage aneurysm a rare cause of refractory atrial tachyarrhythmia-a case report.

Background: Left atrial appendage aneurysm (LAAA) is a rare cardiac anomaly, which can be congenital or acquired in origin. Because most cases are asymptomatic, it is typically diagnosed incidentally in the second to third decades of life. We present a case of a 28-year-old male with refractory atrial tachyarrhythmias and significantly reduced exercise tolerance. The informed consent was given by patient for this manuscript. Case summary: We present a case of a 28-year-old male with refractory atrial tachyarrhythmias and significantly reduced exercise tolerance after an episode of COVID respiratory infection. He was referred by primary care physician for management of atrial fibrillation (AF) with CHA2DS2Vasc score zero. He had documented AF and atrial flutter (AFL) resistant to both chemical and electrical cardioversions. Initial portable focused transthoracic echocardiography documented borderline reduced left ventricular ejection fraction in context of AFL. Electrophysiological study confirmed the diagnosis of typical AFL. Successful radiofrequency ablation of cavo-tricuspid isthmus resulted in bidirectional isthmus conduction block. However, patient developed AF, which was electrically cardioverted at the end of procedure. Patient was discharged on bisoprolol, ramipril, and apixaban, and outpatient cardiac MRI was organized to look for post-COVID myocardial scarring. Patient had recurrence of symptoms, and this time it was due to AF. Multimodal imaging led to discovery of LAAA, in which after discussion in multidisciplinary meeting, he was accepted for and managed with surgical resection of LAAA with concomitant Cox-Maze IV procedure. On 9 months post-operative follow up, patient is maintaining sinus rhythm and has completely returned to baseline activities. Discussion: A young patient with refractory atrial arrhythmia should be referred for multimodal cardiovascular imaging to rule out any structural heart disease. Left atrial appendage aneurysm is rare and can be managed conservatively, but surgical excision is most reported and appears to favour arrhythmia-free survival.

Interventional closure of an iatrogenic LAA-perforation by means of a PFO-occluder.

Atrial fibrillation (AF) is the most common rhythm disorder with a high risk for cardioembolic strokes. Interventional occlusion of the left atrial appendage (LAA) is an alternative to the widely established stroke prevention with oral anticoagulation. Complications through LAA closure (LAAC) are rare and usually occur periinterventional. We present a case of an 87-year-old patient who presents for elective LAAC. After placement of the LAA occluder (Amplatzer Amulet device 25 mm) in the LAA and partial resheathing, the patient developed a pericardial effusion (PE), became hemodynamically unstable and went into cardiac arrest with the need for cardiopulmonary resuscitation (CPR). After drainage of the PE, we closed the causative LAA-perforation using a persistent foramen ovale (PFO)-occluder device (Amplatzer Talisman, 25 mm). Thereby we were able to successfully seal the perforation and stabilize the patient. The patient was monitored at our intensive care unit for 2 days and left the hospital in good condition a few days after. Procedural complications during interventional LAAC are rare but can be serious. The most common complication, PE, requires percutaneous drainage and often cardiac surgery. We present a case in which a perforation and following PE with hemodynamic relevance and need for CPR was resolved with an interventional strategy through implantation of a PFO-occluder into the perforation. With this approach we were able to show that in the right setting even serious complications can be treated by interventional measures, thereby not only saving the patient's life, but also avoiding cardiac surgery.

Left main coronary artery disease treated with beating heart surgery: 10-year single center results.

Introduction: Left main (LM) coronary disease is believed to represent a complex, advanced, and potentially life-threatening atherosclerotic syndrome that can be treated by either percutaneous or surgical interventions. Despite its satisfactory results, the declined number of off-pump coronary artery bypass grafting (OPCAB) is observed. Aim: To compare 10-year survival and point out possible mortality risk factors in patients referred for left main and multivessel OPCAB surgery followed by transit time bypass measurements. Material and methods: There were 159 patients (128 (81%) men and 31 (19%) women) in a median age of 66 (60-70) years enrolled in retrospective analysis who were referred to surgical intervention due to left main (51, 32%) and multivessel (108, 68%) disease. The regression analysis for long-term mortality risk and the Kaplan-Meyer survival curve were analyzed. Results: Multivariable analysis pointed female sex (HR = 1.08, 95% CI: 1.03-1.14, p = 0.001) and diabetes mellitus (HR = 6.33, 95% CI: 1.86-21.52, p = 0.003) as possible risk factors for 10-year mortality risk. There was no significant difference in Kaplan-Meyer 10-year mortality comparison between left main and multivessel disease patients treated by off-pump surgical revascularization (HR = 0.93, 95% CI: 0.40-2.13, p = 0.86). Conclusions: Off-pump surgery in the left main disease, compared to multivessel disease, represents a safe surgical technique with satisfactory long-term results. The female sex and diabetes mellitus were found as possible risk factors for 10-year mortality risk in multivariable analysis.

Prognostic impact of increase in left atrial volume following left atrial appendage closure: Insights from the OCEAN-LAAC registry.

Background: Percutaneous left atrial appendage closure (LAAC) is an effective therapy to prevent thromboembolic events among patients with atrial fibrillation (AF). However, since the left atrial appendage (LAA) contributes to left atrial volume and serves as a buffer for increasing left atrial pressure, this procedure may impair left atrium (LA) compliance, enlarge LA, and deteriorate diastolic function. In this study, we sought to investigate the change in left atrial volume index (LAVI) following LAAC and its effect on prognosis. Methods and Results: We analyzed 225 patients from the OCEAN-LAAC registry, an ongoing, multicenter Japanese study. Comparing LAVI measurements at baseline and 6 months after LAAC, no significant increase was observed (55.0 [44.0, 70.0] ml/m2 vs. 55.0 [42.0, 75.6] ml/m2; P = 0.31). However, some patients underwent LAVI increase. Particularly, a smaller LAVI (odds ratio [OR]: 0.98 [95 % confidence interval (CI): 0.97-0.996]) and elevated tricuspid regurgitation pressure (TRPG) at baseline (OR: 1.04 [95 % CI: 1.00 - 1.08]) were significantly related to the increase in LAVI at 6-month follow-up. In addition, a 5 ml/m2 increase in LAVI was significantly associated with subsequent heart failure hospitalization (HFH) (hazard ratio: 3.37 [95 % CI: 1.18-9.65]). This association, however, was not observed in patients with lower baseline LAVI (≤55 ml/m2) but was only seen in those with a baseline LAVI over 55 ml/m2. Conclusion: Our study demonstrated an increase in LAVI after LAAC was related to smaller LAVI or elevated TRPG at baseline. The LAVI increase was significantly associated with subsequent HFH.

Left atrial appendage closure for stroke prevention in atrial fibrillation: current status and perspectives.

Atrial fibrillation (AF) is associated with an increased risk of stroke and systemic embolism, and the left atrial appendage (LAA) has been identified as a principal source of thromboembolism in these patients. While oral anticoagulation is the current standard of care, LAA closure (LAAC) emerges as an alternative or complementary treatment approach to reduce the risk of stroke or systemic embolism in patients with AF. Moderate-sized randomized clinical studies have provided data for the efficacy and safety of catheter-based LAAC, largely compared with vitamin K antagonists. LAA device iterations, advances in pre- and peri-procedural imaging, and implantation techniques continue to increase the efficacy and safety of LAAC. More data about efficacy and safety of LAAC have been collected, and several randomized clinical trials are currently underway to compare LAAC with best medical care (including non-vitamin K antagonist oral anticoagulants) in different clinical settings. Surgical LAAC in patients with AF undergoing cardiac surgery reduced the risk of stroke on background of anticoagulation therapy in the LAAOS III study. In this review, we describe the rapidly evolving field of LAAC and discuss recent clinical data, ongoing studies, open questions, and current limitations of LAAC.

Systematic review and meta-analysis of left atrial appendage closure's influence on early and long-term mortality and stroke.

Objective: Left atrial appendage closure (LAAC) concomitant to heart surgery in patients with underlying atrial fibrillation (AF) has gained attention because of long-term reduction of thromboembolic complications. As of mortality benefits in the setting of non-AF, data from both observational studies and randomized controlled trials are conflicting. Methods: On-line databases were screened for studies comparing LAAC versus no LAAC concomitant to other heart surgery. End points assessed were all-cause mortality and stroke at early and longest-available follow-up. Subgroup analyses stratified on preoperative AF were performed. Risk ratios (RR) with 95% CIs served as primary statistics. Results: Electronic search yielded 25 studies (N = 660 [158 patients]). There was no difference between LAAC and no LAAC in terms of early mortality. In the overall population analysis, LAAC reduced long-term mortality (RR, 0.86; 95% CI, 0.74-1.00; P = .05; I 2 = 88%), reduced early stroke risk by 19% (RR, 0.81; 95% CI, 0.72-0.93; P = .002; I 2 = 57%), and reduced late stroke risk by 13% (RR, 0.87; 95% CI, 0.84-0.90; P < .001; I 2 = 58%). Subgroup analysis showed lower mortality (RR, 0.85; 95% CI, 0.72-1.01; P = .06; I 2 = 91%), short-, and long-term stroke risk reduction only in patients with preoperative AF (RR, 0.81; 95% CI, 0.71-0.93; P = .003; I 2 = 71% and RR, 0.87; 95% CI, 0.84-0.91; P < .001; I 2 = 70%, respectively). No benefit of LAAC in patients without AF was found. Conclusions: Concomitant LAAC was associated with reduced stroke rates at early and long-term and possibly reduced all-cause mortality at the long-term follow-up but the benefits were limited to patients with preoperative AF. There is not enough evidence to support routine concomitant LAAC in non-AF settings.

Case Report: Successful retrieval of a migrated left atrial appendage occluder through the synergistic use of a guidewire and a gooseneck snare.

Left atrial appendage occluder (LAAO) dislodgement with embolization is a rare occurrence. If the LAAO migrates into the left atrium or ventricle, it can lead to acute heart failure or even death in a person, necessitating urgent surgical intervention. Currently, most cases of LAAO dislodgement are managed through open-heart surgery, while percutaneous retrieval of the LAAO has been reported only in a few cases with limited associated experience. This article reports a case of a patient in whom a migrated LACbes device was successfully retrieved using a catheter-based approach, demonstrating an innovative and minimally invasive treatment strategy.

Migration of the left atrial appendage closure device to the aorta.

Percutaneous closure of the left atrial appendage may be indicated in patients with contraindications to anticoagulation therapy, for example, after recurrent gastrointestinal bleeding. It is an effective and safe procedure but is not without complications. We present a patient who presented with severe aortic insufficiency due to migration of the left atrial appendage closure device, which required urgent cardiac surgery for its removal.

Surgical treatment of atrial fibrillation in mitral valve surgery: a narrative review.

Background and Objective: Atrial fibrillation (AF) is one of the most common arrhythmias in clinical practice, which leads to cardiac decompensation, cardiovascular and cerebrovascular infarction, and other thromboembolic diseases. AF is one of the most common comorbidities of valvular heart disease, especially in mitral valve disease. At the time of their mitral valve surgery, 20-42% of patients have AF. It is beneficial to maintain postoperative sinus rhythm and minimize complications when AF surgery is performed concurrently with mitral valve surgery. This review describes the surgical management of AF in mitral valve surgery, including AF surgical route, surgical ablation technology and surgical approaches. The aim of this review is to enable more patients with AF to receive more appropriate and individualised treatment. Methods: A narrative review was conducted on the literature on PubMed, Embase including all relevant studies published until November 2023. Key Content and Findings: This review focuses on the surgical management of AF during mitral valve surgery, including AF surgical route, surgical ablation technology and surgical approaches. Conclusions: Mitral valve surgery combined with AF surgery facilitates the maintenance of postoperative sinus rhythm in patients, reduces the risk of postoperative stroke, and improves survival. Advances in ablation technology have reduced the difficulty of the procedure, making it possible for more patients to undergo surgical ablation. In the future, it will be possible to tailor specific lesion sets and ablation modalities for individual patients. This would make surgical treatment of AF more effective and applicable to a larger population of patients with AF and mitral valve disease.

Is it a thrombus or a tumor? An imaging dilemma for clinicians.

Atrial fibrillation, the most common cardiac arrhythmia in the Western world, confers a 5-fold increase in stroke, mainly due to thrombus formation in the left atrial appendage. Early rhythm control is often beneficial in reducing adverse cardiovascular events in higher-risk populations. Here, we present a patient who was found to have a 1 cm stalk-like lesion in the left atrial appendage on transesophageal echocardiogram prior to electrical cardioversion. Using multiple cardiac imaging modalities, including cardiac magnetic resonance imaging and computed tomography, the mass was eventually determined to be a chronic resolving thrombus.

A rare case of left atrial appendage aneurysm.

BACKGROUND: Left atrial appendage aneurysm is a rare cardiac mass, with only a few cases reported. There are usually no specific symptoms, and a few patients visit the doctor with symptoms. CASE PRESENTATION: A 20-year-old male presented to our hospital with a "pericardial cyst found by medical evaluation in another hospital for 2 years." Cardiac ultrasound performed at clinics of our hospital suggested a cystic dark area in the left ventricular lateral wall and the anterior lateral wall, consistent with a pericardial cyst and mild mitral regurgitation. After further relevant examinations and ruling out contraindications, an excision of the left atrial appendage aneurysm was performed under general anesthesia and cardiopulmonary bypass with beating-heart. The postoperative pathological results identified that: (left atrial appendage) fibrocystic wall-like tissue with a focal lining of the flat epithelium, consistent with a benign cyst. CONCLUSION: Left atrial appendage aneurysms are rare and insidious. They are usually found by chance during medical evaluations. If the location is not good or the volume is too large, then compression symptoms or arrhythmia, thrombosis and other concomitant symptoms will occur. Surgical resection is presently the only effective radical cure for a left atrial appendage aneurysm.

Outcomes of patients with cardiac amyloidosis undergoing percutaneous left atrial appendage occlusion.

BACKGROUND: There is limited data on the safety and efficacy of left atrial appendage occlusion (LAAO) devices in patients with cardiac amyloidosis. We examined the outcomes of patients with cardiac amyloidosis undergoing LAAO device implantation in a nationally representative cohort of patients. METHODS: The National Readmissions Database (NRD) was analyzed from 2016 to 2019 to identify patients ≥ 18 years old with atrial fibrillation (AF) undergoing LAAO. Patients were divided into those with cardiac amyloidosis and those without cardiac amyloidosis. A multivariable logistic regression model was utilized to assess the independent association of cardiac amyloidosis with in-hospital, 30-day/90-day/180-day outcomes after adjusting for confounders. RESULTS: Our cohort included 54,900 LAAO implantation procedures, of which 220 (0.4%) had cardiac amyloidosis. Patients with cardiac amyloidosis had a lower proportion of women and a lower prevalence of comorbidities including anemia, obesity, diabetes, and peripheral vascular disorders but a higher prevalence of stroke, as compared to those without cardiac amyloidosis. On multivariable analysis, cardiac amyloidosis was associated with significantly higher odds of peri-procedural major adverse events (adjusted odds ratio [aOR]: 2.69; 95% confidence interval [CI]: 1.41-5.14; p<0.01) and neurological complications (aOR: 5.48; 95% CI: 2.47-12.8; p<0.01). There was no difference in the odds of other peri-procedural complications, in-hospital mortality, hospital resource utilization, and 30/90/180-day all-cause/bleeding/stroke-related readmissions between both groups. CONCLUSION: Patients with cardiac amyloidosis undergoing LAAO device implantation have an increased risk of peri-procedural complications without any difference in bleeding/stroke-related readmissions. These hypothesis-generating findings need validation in future prospective studies.

Prophylactic Left Atrial Appendage Ligation During Coronary Artery Bypass Graft Surgery Allows Safe Avoidance of Anticoagulation Regardless of Postoperative Atrial Fibrillation.

Background New-onset postoperative atrial fibrillation (POAF) is the most common arrhythmia following cardiac surgery. POAF increases the risk of thromboembolism and stroke, as well as morbidity and mortality more generally. Despite evidence from the landmark PROTECT-AF and PREVAIL trials, left atrial appendage ligation (LAAL) is not routinely performed for thromboembolism prophylaxis in POAF, and anticoagulation remains the standard of care along with dual antiplatelet therapy. This study evaluated the efficacy of concomitant LAAL in eliminating the need for postoperative anticoagulation, regardless of POAF development, in patients undergoing coronary artery bypass grafting (CABG). Methods Between 2019 and 2021, 130 patients were selected to undergo concomitant LAAL while undergoing CABG surgery. Patients were then monitored for the incidence of new-onset POAF, and anticoagulation was strictly avoided for this indication. Demographic and outcome data were collected, with endpoints including transient ischemic attack (TIA) or stroke, death, and readmission within one year, as well as the length of hospital and intensive care unit (ICU) admissions. Results POAF occurred in 37 patients (28.5%), consistent with previous reports. However, none of the POAF patients experienced TIA or stroke during the one-year follow-up period, compared to 2 (2.15%) in the non-POAF group, a typical rate of postoperative stroke in such a patient population. No significant differences were observed between POAF and non-POAF cohorts in one-year stroke, all-cause mortality, readmission rates, or total hospital stay. Interestingly, the POAF cohort had a significantly longer mean ICU stay (4.24 vs 3.37 days, p = 0.0219), possibly due to the time required for arrhythmia control before discharge. The study population had a high mean CHA2DS2-VASc score (2.81), indicating an increased risk of thromboembolism, and a high mean HAS-BLED score, suggesting an elevated bleeding risk with anticoagulation. Conclusions LAAL appears to be an effective adjunct to CABG for thromboembolism prophylaxis in POAF. Formal anticoagulation was avoided in this study, with no significant differences in adverse events between POAF and non-POAF groups, suggesting that LAAL may be a suitable alternative to anticoagulation, especially in high-risk patients (e.g., those with elevated CHA2DS2-VASc or HAS-BLED scores). The safety and efficacy of this approach should be corroborated by larger randomized studies, such as the ongoing LeAAPS trial. LAAL during CABG may help reduce the risk of bleeding complications associated with anticoagulation while maintaining protection against thromboembolic events in patients who develop POAF.

Feasibility study on atrial fibrillation ablation with pulsed field ablation and concomitant occlusion of the left atrial appendage.

AIMS: Atrial fibrillation (AF) ablation and left atrial appendage occlusion (LAAO) are increasingly performed as individual procedures. Pulsed field ablation (PFA) has significantly reduced procedure duration and may be advantageous for the combined approach. METHODS AND RESULTS: We have launched a programme for simultaneous AF ablation using PFA and LAAO for patients qualifying for both treatments and excluding those with a complex anatomy. We compare procedure duration and fluoroscopy time against individual procedures (either AF ablation or LAAO alone), all performed by the same operators and using consistent technologies. We performed the combined procedure in 10 patients (50% males; median age 70 years) and excluded 2 patients (17%) because of a complex left atrial appendage anatomy. No death, stroke, or major bleeding events, including pericardial effusion, occurred. For single-procedure comparison, 207 AF ablation procedures and 61 LAAO procedures were available. The total median procedure duration was 79 min (range 60-125) for the combined procedure, 71 min (25-241) for individual AF ablation (51 min without and 78 min with 3-dimensional electroanatomic mapping), and 47 min (15-162) for individual LAAO. The respective fluoroscopy times were 21 (15-26), 15 (5-44), and 10 (3-50) min. For the combined procedure, femoral vein access to last PFA application lasted 49 min (34-93) and LAAO added 20 min (15-37). CONCLUSION: Simultaneous PFA-based AF ablation and LAAO in carefully selected patients is feasible and safe and can be executed within a short overall procedure duration.

Single-Operator Left atrial appendage Occlusion utilizing Conscious sedation TEE, Lack of Outpatient pre-imaging, and Same-day Expedited discharge (SOLO-CLOSE): A comparison with conventional approach.

BACKGROUND: Left atrial appendage occlusion (LAAO) with WATCHMAN currently requires preprocedural imaging, general anesthesia, and inpatient overnight admission. We sought to facilitate simplification of LAAO. AIMS: We describe and compare SOLO-CLOSE (single-operator LAA occlusion utilizing conscious sedation TEE, lack of outpatient pre-imaging, and same-day expedited discharge) with the conventional approach (CA). METHODS: A single-center retrospective analysis of 163 patients undergoing LAAO between January 2017 and April 2022 was conducted. The SOLO-CLOSE protocol was enacted on December 1, 2020. Before this date, we utilized the CA. The primary efficacy endpoint was defined as successful LAAO with ≤5 mm peri-device leak at time of closure. The primary safety endpoint was the composite incidence of all-cause deaths, any cerebrovascular accident (CVA), device embolization, pericardial effusion, or major postprocedure bleeding within 7 days of the index procedure. Procedure times, 7-day readmission rates, and cost analytics were collected as well. RESULTS: Baseline characteristics were similar in both cohorts. Congestive heart failure (37.5% vs. 11.1%) and malignancy (28.8% vs. 12.5%) were higher in SOLO-CLOSE. Median CHA2D2SVASc score was 5 in both cohorts. The primary efficacy endpoint was met 100% in both cohorts. Primary safety endpoint was similar between cohorts (p = 0.078). Mean procedure time was 30 min shorter in SOLO-CLOSE (p < 0.01). Seven-day readmissions for SOLO-CLOSE was zero. After SOLO-CLOSE implementation, there was a 188% increase in positive contribution margin per case. CONCLUSIONS: The SOLO-CLOSE methodology offers similar efficacy and safety when compared to the CA, while improving clinical efficiency, reducing procedural times, and increasing economic benefit.

Displacement of occluder after left atrial appendage closure: A case report.

Key Clinical Message: Atrial fibrillation is closely associated with thrombotic events. In non-valvular atrial fibrillation, 90% of thrombi are formed by the left atrial appendage. Left atrial appendage occlusion (LAAC) can effectively prevent the detachment of left atrial appendage thrombus during atrial fibrillation, thereby reducing the risk of long-term disability or death caused by thromboembolic events. However, the identification and management of complications in LAAC are also very important. Abstract: The efficacy and safety of left atrial appendage occlusion (LAAC) in preventing non-valvular atrial fibrillation stroke have been confirmed by multiple randomized controlled and registered studies, and have been recommended by several guidelines for stroke prevention in patients with atrial fibrillation at high-risk of stroke. We reported an 80-year-old male patient with persistent atrial fibrillation. The patient underwent left atrial appendage closure surgery due to high risk of embolism and bleeding. On the second day after surgery, echocardiography showed displacement of the left atrial appendage occluder. Immediately perform removal of left atrial appendage occlude and left atrial appendage occlusion on the same day, and the patient was discharged on the fifth day after surgery without any special circumstances. This case demonstrates the feasibility and important clinical significance of using interventional surgery to remove the left atrial appendage occluder after displacement in clinical practice.

Combining echocardiography and fluoroscopy imaging in real time for left atrial appendage occlusion - single center experience from Poland.

Introduction: Atrial fibrillation (AF) presents a growing health concern, often requiring stroke prevention measures, primarily through oral anticoagulation (OAC). Surgical interventions such as left atrial appendage occlusion (LAAO) offer alternatives when OAC is contraindicated. In recent years, percutaneous procedures have gained traction as minimally invasive options, demanding precise anatomical insights. Fusion imaging (FI), which combines transesophageal echocardiography (TEE) and fluoroscopy, has emerged as a potential game-changer in transcatheter interventions. Aim: This study introduces FI to LAAO procedures in Poland, assessing its role in guiding interventions, highlighting advantages, and exploring its potential to reshape cardiovascular interventions. Material and methods: We conducted a retrospective study involving LAAO procedures from March 2015 to December 2018, all utilizing FI. Patient indications, procedural specifics, and safety metrics were collected and analyzed. Follow-ups were conducted at 3 and 6 months. Results: A cohort of 83 patients (mean age: 72.1 ±8.4 years) underwent successful LAAO procedures. FI provided precise device placement and anatomical assessment. Mean procedure time was 54.9 ±34.3 min, contrast medium usage averaged 33.7 ±22.7 ml, and creatinine levels remained stable. Patients were discharged in about 4.2 ±3.4 days. Adverse effects were rare, including minimal bleeding and cardiac tamponade. Follow-ups demonstrated favorable outcomes with low adverse event rates. Conclusions: This study marks the inaugural application of FI in Polish LAAO procedures. FI, offering enhanced visualization and reduced procedure times, holds promise in improving patient safety and treatment efficacy. We recommend its consideration as a standard visualization technique for LAAO procedures.

The left atrial appendage closure by surgery 2 trial: statistical analysis plan for a randomized multicenter trial exploring if the closure of the left atrial appendage during open-heart surgery reduces stroke irrespective of patients' stroke risk and preoperative atrial fibrillation status.

BACKGROUND: Surgical left atrial appendage (LAA) closure concomitant to open-heart surgery prevents thromboembolism in high-risk patients. Nevertheless, high-level evidence does not exist for LAA closure performed in patients with any CHA2DS2-VASc score and preoperative atrial fibrillation or flutter (AF) status-the current trial attempts to provide such evidence. METHODS: The study is designed as a randomized, open-label, blinded outcome assessor, multicenter trial of adult patients undergoing first-time elective open-heart surgery. Patients with and without AF and any CHA2DS2-VASc score will be enrolled. The primary exclusion criteria are planned LAA closure, planned AF ablation, or ongoing endocarditis. Before randomization, a three-step stratification process will sort patients by site, surgery type, and preoperative or expected oral anticoagulation treatment. Patients will undergo balanced randomization (1:1) to LAA closure on top of the planned cardiac surgery or standard care. Block sizes vary from 8 to 16. Neurologists blinded to randomization will adjudicate the primary outcome of stroke, including transient ischemic attack (TIA). The secondary outcomes include a composite outcome of stroke, including TIA, and silent cerebral infarcts, an outcome of ischemic stroke, including TIA, and a composite outcome of stroke and all-cause mortality. LAA closure is expected to provide a 60% relative risk reduction. In total, 1500 patients will be randomized and followed for 2 years. DISCUSSION: The trial is expected to help form future guidelines within surgical LAA closure. This statistical analysis plan ensures transparency of analyses and limits potential reporting biases. TRIAL REGISTRATION: Clinicaltrials.gov, NCT03724318. Registered 26 October 2018, https://clinicaltrials.gov/study/NCT03724318 . PROTOCOL VERSION: https://doi.org/10.1016/j.ahj.2023.06.003 .