Left Atrial Appendage Closure During Cardiac Surgery for Atrial Fibrillation: A Meta-Analysis

BackgroundLeft atrial appendage closure (LAAC) during cardiac surgery in atrial fibrillation (AF) patients has been investigated in multiple studies with variable safety and efficacy results.MethodsA comprehensive review was performed of all studies comparing LAAC and placebo arm during cardiac surgery in AF patients. A random-effect model was used to calculate risk ratios, mean differences, and 95% confidence intervals.ResultsFive randomized controlled trials and 22 observational studies were included with a total of 540,111 patients. The LAAC group had significantly decreased postoperative stroke/embolic events as compared to the no LAAC group with all cardiac surgeries (3.74% vs 4.88%, p = 0.0002), isolated valvular surgery (1.95% vs 4.48%, p = 0.002). However, CABG insignificantly favored the LAAC group for stroke/embolic events (6.72% vs 8.30%, p = 0.07). There was no difference between both groups in all-cause mortality in the perioperative period (p = 0.42), but was significantly lower in the LAAC arm after two years (14.1% vs 18.3%, p = 0.02). There was no difference in major bleeding, all-cause rehospitalizations, or cross-clamp time between both groups (p = 0.53 and p = 0.45). The bypass and the cross-clamp time were longer in the LAAC group (4 and 9 min, respectively).ConclusionIn AF patients, LAAC during cardiac surgery had a decreased risk of stroke and long-term all-cause mortality. Additionally, there was no difference in major bleeding, all-cause rehospitalizations, or cross-clamp time.     

Direct Oral Anticoagulant Versus Warfarin After Left Atrial Appendage Closure With WATCHMAN: Updated Systematic Review and Meta-analysis

In the pivotal WATCHMAN trials, warfarin was used for post-procedural anticoagulation in the first 45 days after left atrial appendage closure. We aimed to investigate the efficacy and safety of direct oral anticoagulant (DOAC) versus warfarin after WATCHMAN. We performed a literature search of 5 electronic databases to identify studies comparing DOAC with warfarin after WATCHMAN. We pooled outcomes for the efficacy (thromboembolism, device-related thrombus [DRT], peridevice leak [PDL] >5 mm) and safety endpoints (bleeding, mortality). Thromboembolism was defined as ischemic stroke, transient ischemic attack, or systemic embolism. We included 10 cohort studies with 2,440 patients, of whom 1,397 (57.3%) received DOAC. Concerning periprocedural outcomes (within 7 days following implantation), DOAC was associated with a reduction in major bleeding (Risk ratio [RR] 0.32; 95% confidence interval [CI] 0.11-0.92) compared with warfarin, without significant differences in all bleeding (RR 0.46; 95% CI 0.15-1.42) and thromboembolism (RR 0.93; 95% CI 0.21-4.16). On first follow-up transesophageal echocardiography, DRT (RR 0.79; 95% CI 0.39-1.60) and PDL>5 mm (RR 0.44; 95% CI 0.16-1.20) were comparable among groups. With a mean follow-up of 1.5-12 months, DOAC was associated with reductions in major bleeding (RR 0.52; 95% CI 0.30-0.89) and all bleeding (RR 0.38; 95% CI 0.25-0.58) compared with warfarin. The outcomes of thromboembolism (RR 0.79; 95% CI 0.36-1.73) and all-cause mortality (RR 0.49; 95% CI 0.19-1.28) were not significantly different between the 2 groups. Following WATCHMAN implantation, DOAC was associated with reductions in major bleeding and all bleeding compared with warfarin at mid-term follow-up. The outcomes of thromboembolism, all-cause mortality, DRT, and PDL >5 mm were comparable among groups.     

Conformal Left Atrial Appendage Seal Device for Left Atrial Appendage Closure: First Clinical Use

ObjectivesThe authors report the first clinical experience with the Conformal Left Atrial Appendage Seal (CLAAS) device.BackgroundThe CLAAS device was designed to address the limitations of first-generation left atrial appendage closure (LAAC) devices by providing an implant that is minimally traumatic, can be deployed in a noncoaxial fashion, and does not require postprocedural oral anticoagulation.MethodsPatients with atrial fibrillation at high stroke risk (CHA₂DS₂-VASc score ≥2) were recruited using standard selection criteria. The LAAC procedure was guided by transesophageal echocardiography with patients under general anesthesia. The CLAAS device is composed of a foam cup, with a Nitinol endoskeleton with an expanded polytetrafluoroethylene cover, delivered with a standard delivery system using a tether for full recapture. All patients received dual-antiplatelet therapy for 6 months, followed by aspirin alone. Transesophageal echocardiographic follow-up was scheduled for 45 days and 1 year.ResultsTwenty-two patients (63.7% with CHA₂DS₂-VASc scores ≥3, 76.2% with HAS-BLED scores ≥3) were enrolled. The device was successfully implanted in 18 patients and unsuccessfully in 4 patients. There were no serious procedural complications. On transesophageal echocardiography performed at 45 days, 1 significant leak (≥5 mm) was seen, which was due to a large posterior lobe not appreciated at the time of implantation, and 1 device-related thrombus was noted, which resolved on oral anticoagulation. There were no periprocedural strokes, major pericardial effusions, or systemic or device embolization.ConclusionsThis first-in-human study demonstrates the clinical feasibility of the CLAAS device for LAAC.     

Percutaneous Left Atrial Appendage Closure: Review of Anatomy,Imaging, and Outcomes

Current Treatment Options in Cardiovascular Medicine - Percutaneous left atrial appendage closure (LAAC) with WATCHMAN (Boston Scientific Inc.) has emerged as a viable non-pharmacological...     

Sex Differences in Clinical Outcomes Following Percutaneous Coronary Intervention of Unprotected Left Main Coronary Artery: A Systematic Review and Meta-Analysis

IntroductionPercutaneous coronary intervention (PCI) has emerged as a reasonable alternative to coronary artery bypass graft (CABG) surgery in well-selected patients with unprotected left main coronary disease (LMCD). We conducted a systematic review and meta-analysis with the aim of assessing the impact of sex on outcomes of PCI in patients with unprotected LMCD.MethodsA systematic search of PUBMED, EMBASE, Cochrane, and Google Scholar databases was performed to identify studies comparing the outcomes of men vs. women among patients undergoing PCI for unprotected LMCD. The primary outcome of interest was study defined major adverse cardiac events (MACE) and secondary outcomes were all-cause mortality, cardiac mortality, myocardial infarction (MI), target lesion revascularization (TLR), stent thrombosis and stroke. For all outcomes, pooled odds ratios (OR) with their corresponding 95% confidence intervals (CIs) were calculated using the DerSimonian-Laird random-effects model.ResultsSix studies with a total of 6515 individuals (4954 men, 1561women) with a mean follow up of 36 months were included in the analysis. MACE and MI were significantly higher in women with OR of 1.17 (95% CI 1.01–1.36; p = 0.03) and 1.42 (95% CI 1.07–1.87; p = 0.01) respectively. All-cause mortality, cardiac mortality, and TLR were similar among men and women.ConclusionOur meta-analysis suggests that women undergoing PCI for unprotected LMCD have higher rates of MACE and MI compared to men.     

5-Year Experience of In-Hospital Outcomes After Percutaneous Left Atrial Appendage Closure in Germany

ObjectivesThe aim of this study was to evaluate 5-year in-hospital trends and safety outcomes of left atrial appendage (LAA) closure in the German nationwide inpatient sample.BackgroundThe safety and efficacy of percutaneous LAA closure have been demonstrated in randomized trials and prospective cohort studies, but results from large samples are missing.MethodsData on patient characteristics and in-hospital safety outcomes for all percutaneous LAA closures performed in Germany between 2011 and 2015 were analyzed. Overall, 15,895 inpatients were included.ResultsThe annual number of LAA occlusions increased from 1,347 in 2011 to 4,932 in 2015 (β = 1.00; 95% confidence interval [CI]: 0.95 to 1.01; p < 0.001), with a nonsignificant uptrend of in-hospital mortality (from 0.5% in 2011 to 0.9% in 2015; β = 0.01; 95% CI: ?0.09 to 0.32; p = 0.271). Patient characteristics shifted toward older age and higher prevalence of comorbidities such as heart failure, chronic obstructive pulmonary disease, and chronic renal insufficiency over time. Important independent predictors of in-hospital mortality were cancer (odds ratio [OR]: 2.49; 95% CI: 1.00 to 6.12; p = 0.050), heart failure (OR: 2.42; 95% CI: 1.72 to 3.41; p < 0.001), stroke (OR: 5.39; 95% CI: 2.76 to 10.53; p < 0.001), acute renal failure (OR: 13.28; 95% CI: 9.08 to 19.42; p < 0.001), pericardial effusion (OR: 5.65; 95% CI: 3.76 to 8.48; p < 0.001), and shock (OR: 45.11; 95% CI: 31.01 to 65.58; p < 0.001).ConclusionsThe use of percutaneous LAA closure increased 3.6-fold from 2011 to 2015, with a nonsignificant uptrend of in-hospital mortality rate in this real-world setting. Important predictors of in-hospital death were acute renal failure, pericardial effusion, and ischemic stroke during hospitalization.     

Safety and Feasibility of Same-Day Discharge After Left Atrial Appendage Closure

Subacute or late complications > 24 hours after left atrial appendage closure (LAAC) are infrequent. We therefore created a clinical pathway to enable safe same-day discharge (SDD) after LAAC. Patients were assessed for overall physical conditioning, lack of significant frailty and comorbidities limiting physical abilities, good home support, and patient preference. Of 78 LAACs performed, 24 patients (30.8%) were discharged the same day: 21 were transesophageal echocardiography guided and 3 intracardiac echocardiography guided. SDD clinical pathway patients were discharged 395.4 ± 56.6 minutes after leaving the procedural room. There were no clinical complications at 1 month or in long-term follow-up. SDD is safe and feasible after LAAC, following a dedicated clinical pathway and surveillance in carefully selected patients.     

Peridevice Leak After Left Atrial Appendage Closure: Incidence,Risk Factors,and Clinical Impact

Background

Limited studies reported the rate and clinical impact of peridevice leaks (PDL) after percutaneous left atrial appendage closure (LAAC).

Changes in Left Atrial Appendage Dimensions Following Volume Loading During Percutaneous Left Atrial Appendage Closure

ObjectivesThis study sought to determine whether volume loading alters the left atrial appendage (LAA) dimensions in patients undergoing percutaneous LAA closure.BackgroundPercutaneous LAA closure is increasingly performed in patients with atrial fibrillation and contraindications to anticoagulation, to lower their stroke and systemic embolism risk. The safety and efficacy of LAA closure relies on accurate device sizing, which necessitates accurate measurement of LAA dimensions. LAA size may change with volume status, and because patients are fasting for these procedures, intraprocedural measurements may not be representative of true LAA size.MethodsThirty-one consecutive patients undergoing percutaneous LAA closure who received volume loading during the procedure were included in this study. After an overnight fast and induction of general anesthesia, patients had their LAA dimensions (orifice and depth) measured by transesophageal echocardiography before and after 500 to 1,000 ml of intravenous normal saline, aiming for a left atrial pressure >12 mm Hg.ResultsSuccessful implantation of LAA closure device was achieved in all patients. The average orifice size of the LAA at baseline was 20.5 mm at 90°, and 22.5 mm at 135°. Following volume loading, the average orifice size of the LAA increased to 22.5 mm at 90°, and 23.5 mm at 135°. The average increase in orifice was 1.9 mm (p < 0.0001). The depth of the LAA also increased by an average of 2.5 mm after volume loading (p < 0.0001).ConclusionsIntraprocedural volume loading with saline increased the LAA orifice and depth dimensions during LAA closure. Operators should consider optimizing the left atrial pressure with volume loading before final device sizing.     

Evaluating Gender-based Differences in Clinical Outcomes for Patients Undergoing Left Atrial Appendage Occlusion: A Single Centre Experience

There is emerging recent data that has shown women to be more prone to in-hospital major adverse events after trans catheter left atrial appendage occlusion. Institutional LAAO registry at West Virginia University (WVU) was reviewed from January 2016 to October 2021 to identify 271 women and 293 men who underwent successful LAAO device implantation. Patients were evaluated for gender-based differences in baseline characteristics, CHA?DS?-VASc Score, HAS-BLED score, procedural data, in-hospital, and follow-up outcomes. Compared to men, women had lower baseline comorbidities including coronary artery disease (135 (49.6%) vs 172 (58.7%), P = 0.03), myocardial infarction (MI) (56 (20.5%) vs 85 (29%), P = 0.02) and coronary artery bypass surgery (10 (3.6%) vs 27 (9.2%), P = 0.008). Women were noted to have a higher CHA?DS?-VASc Score (5.3 ± 1.4 vs 4.4 ± 1.4, P < 0.001), and left ventricular ejection fraction (57.9 ± 7.7 vs 52.7 ± 12.4, P < 0.001). Women were noted to have a significantly higher rate of in-hospital composite adverse events (74 (27.2%) vs 58 (19.8%), P = 0.03); bleeding events (38 (10.2%) vs 19 (6.4%), P = 0.003) and associated blood transfusion (6 vs 0, P = 0.001) compared with men. No statistically significant differences were noted between both genders regarding the follow-up outcome. Our single center study shows women to have higher in-hospital composite adverse events as well as higher bleeding events during the index hospital admission.