Suspended Lead Suits and Radiation Exposure in Interventional Echocardiographers

Key Findings▪Percutaneous left atrial appendage (LAA) occlusion has emerged as an alternative strategy to oral anticoagulants in selected patients with atrial fibrillation.▪The landmark trials comparing LAA occlusion to an oral anticoagulation strategy enrolled patients with no apparent contraindications to the use of warfarin.▪LAA occlusion has limited head-to-head comparison against the direct-acting oral anticoagulants.▪Observational data to date have generally shown specific adverse events after LAA occlusion in specific subgroups of patients (women, patients with kidney disease and heart failure, patients belonging to racial/ethnic subgroups and with advanced age), but further large-scale studies are necessary to elucidate reasons for increased adverse events associated with LAA occlusion in these subgroups of patients before recommending this modality as first-line therapy in all patient groups. ▪Percutaneous left atrial appendage (LAA) occlusion has emerged as an alternative strategy to oral anticoagulants in selected patients with atrial fibrillation.▪The landmark trials comparing LAA occlusion to an oral anticoagulation strategy enrolled patients with no apparent contraindications to the use of warfarin.▪LAA occlusion has limited head-to-head comparison against the direct-acting oral anticoagulants.▪Observational data to date have generally shown specific adverse events after LAA occlusion in specific subgroups of patients (women, patients with kidney disease and heart failure, patients belonging to racial/ethnic subgroups and with advanced age), but further large-scale studies are necessary to elucidate reasons for increased adverse events associated with LAA occlusion in these subgroups of patients before recommending this modality as first-line therapy in all patient groups.

Percutaneous left atrial appendage (LAA) occlusion (LAAO) is a procedure dominated by cardiologists. The aim of our study was to present the results of percutaneous LAAO performed solely by cardiac surgeons. Two hundred twenty-three consecutive patients with nonvalvular atrial fibrillation underwent percutaneous LAAO in two cardiac surgery sites. In the first center, all 84 LAAO procedures were performed with the endocardial LAA occluders: 60 cases with the Amulet and 24 cases with the LAmbre. In the second center, all 139 LAAO procedures were performed with the LARIAT epicardial device. The mean CHA2 DS2 -VASc-score was 3.7 ± 1.8 points, and mean HAS-BLED score was 3.6 ± 1.2 points. The procedure was successful in 97.3% of cases. Procedural or device-related adverse events were noted in 4.4% (n = 10) of cases: one periprocedural cardiac arrest, one aortic injury, one gastrointestinal bleeding, three cases of vascular access complications, and four cardiac tamponades. After a follow-up of 40.3 ± 17.3 months, 78.4% of patients were alive, with the annual mortality rate of 5.3%. Compared to the predicted risk, the observed incidence of thromboembolism was lower by 71%, and the bleeding incidence was lower by 69%. Percutaneous LAAO procedures can be safely performed by cardiac surgeons, with no cardiological assistance. LAAO done by surgeons is safe and effective, and periprocedural and long-term outcomes are excellent. Cardiac surgeons should be trained in both types of LAAO: endocardial and epicardial.

We studied the impact of the use of three-dimensional multidetector computed tomography (3D-MDCT) and fluoroscopy fusion on percutaneous left atrial appendage occlusion (LAAO) procedures in relation to procedure time, contrast volume, fluoroscopy time, and total radiation. This was a single-center, prospective, single-blinded, randomized control trial. Patients meeting criteria for LAAO were randomized to undergo LAAO with the WATCHMAN FLXTM device with and without 3D-MDCT-fluoroscopy fusion guidance using a prespecified protocol using computed tomography angiography for WATCHMAN FLXTM sizing, moderate sedation, and intracardiac echocardiography for procedural guidance. Overall, 59 participants were randomly assigned to the fusion (n = 33) or no fusion (n = 26) groups. The median (interquartile range) age was 79 (75-83) years, 24 (41%) were female, and 55 (93%) were Caucasian. The median CHA2 DS2 VASc and HASBLED scores were 5 (4-6) and 3 (3-4), respectively. At the time of the study, 51 (53%) patients were on a direct acting oral anticoagulant. There were no significant differences between the fusion and no fusion groups in procedure time (52.4 ± 15.4 vs. 56.8 ± 19.5 min, p = .36), mean contrast volume used (33.8 ± 12.0 vs. 29.6 ± 11.5 mls, p = .19), mean fluoroscopy time (31.3 ± 9.9 vs. 28.9 ± 8.7 min, p = .32), mean radiation dose (1177 ± 969 vs. 1091 ± 692 mGy, p = .70), and radiation dose product curve (23.9 ± 20.5 vs. 35.0 ± 49.1 Gy cm2 , p = .29). There was no periprosthetic leak in the two groups in the immediate 1-month postprocedure follow-up periods. There was no significant difference with and without 3D-MDCT-fluoroscopy fusion in procedure time, contrast volume use, radiation dose, and radiation dose product.

Percutaneous endocardial left atrial appendage occlusion (LAAO) is an alternative therapy for stroke prevention in patients with atrial fibrillation who are poor candidates for oral anticoagulants. Oral anticoagulation is generally discontinued 45 days following successful LAAO. Real-world data on early stroke and mortality following LAAO are lacking. Using International Classification of Diseases, Tenth Revision, Clinical-Modification codes, we performed a retrospective observational registry analysis to examine the rates and predictors of stroke, mortality, and procedural complications during index hospitalization and 90-day readmission among 42 114 admissions in the Nationwide Readmissions Database for LAAO between 2016 and 2019. Early stroke and mortality were defined as events occurring during index admission or 90-day readmission. Data on timing of early strokes post-LAAO were collected. Multivariable logistic regression modeling was used to ascertain predictors of early stroke and major adverse events. LAAO was associated with low rates of early stroke (0.63%), early mortality (0.53%), and procedural complications (2.59%). Among patients who had readmissions with strokes after LAAO, the median time from implant to readmission was 35 days (interquartile range, 9-57 days); 67% of readmissions with strokes occurred <45 days postimplant. Between 2016 and 2019, the rates of early stroke after LAAO significantly decreased (0.64% versus 0.46% P-for-trend <0.001), while early mortality and major adverse event rates were unchanged. Peripheral vascular disease and a history of prior stroke were independently associated with early stroke after LAAO. Early post-LAAO stroke rates were similar between low, medium, and high LAAO volume tertile centers. In this contemporary real-world analysis, the early stroke rate after LAAO was low, with the majority occurring within 45 days of device implantation. Despite an increase in LAAO procedures between 2016 and 2019, there with a significant decline in early strokes after LAAO during that period.

LEFT ATRIAL APPENDAGE OCCLUSION UNDER INTRACARDIAC ECHOCARDIOGRAPHIC GUIDANCE: IMPACT OF THE LEARNING CURVE ON PROCEDURAL RESULTS

Percutaneous left atrial appendage occlusion: A review of current devices, clinical evidence, patient selection, and post procedural antithrombotic management

AimsThis study was performed to compare the usability, efficiency, and safety of a modified angioplasty guidewire-assisted transseptal puncture (TSP) technique vs. the conventional approach in facilitating access into the left atrium during left atrial appendage occlusion (LAAO) procedures for the treatment of atrial fibrillation.Methods and resultsThe ADVANCE-LAAO trial (Angioplasty Guidewire-Assisted vs. Conventional Transseptal Puncture for Left Atrial Appendage Occlusion) was an investigator-initiated, prospective, multicentre, randomized controlled trial (NCT05125159). Patients with atrial fibrillation who underwent LAAO were prospectively enrolled from four centres and randomly assigned to an angioplasty guidewire-assisted TSP group (n = 131) or to a conventional Brockenbrough needle TSP group (n = 132). The primary endpoint was the one-time success rate of TSP. We also analysed the TSP procedure time, failure rate of the assigned TSP type, radiation dose, contrast dose, and procedural complications in both groups. All patients in the guidewire-assisted group underwent successful TSP, whereas five in the standard conventional group switched to the guidewire-assisted approach. The guidewire-assisted puncture improved the one-time success rate (92.4 vs. 77.3%, P = 0.001), shortened the TSP procedure time (109.2 ± 48.2 vs. 120.5 ± 57.6 s, P = 0.023), and tended to have a higher rate of good coaxial orientation of the sheath with the left atrial appendage during the LAAO procedure (66.4 vs. 54.5%, P = 0.059). No TSP-related complications occurred in the guidewire-assisted TSP group, whereas two complications occurred in the conventional TSP group. There was no significant difference in the failure rate of the assigned TSP type, the total procedure time, the total radiation dose, the rate of successful LAAO implantation, or the procedural complication rate between the two groups (all P > 0.05).ConclusionThis study confirmed that angioplasty guidewire-assisted puncture can effectively improve the success rate of TSP during LAAO procedures. This novel technique has high potential for application in interventional therapies requiring TSP.

PO-03-161 INTRA-PROCEDURAL CROSSOVER OF LEFT ATRIAL APPENDAGE OCCLUSION DEVICES, A SINGLE CENTER EXPERIENCE

Left atrial appendage occlusion (LAAO) devices have become a favorable alternative option among nonvalvular atrial fibrillation (AF) patients with long-term contraindication to anticoagulation. Real-world experience with postprocedural readmission rates and predictors of readmission in LAAO patients is limited. To assess all-cause 30-day readmission rate and predictors of readmission after LAAOprocedure in the United States. This retrospective observational study included all AF patients undergoing percutaneous LAAO procedures in the United States from January 1, 2016, and December 31, 2017, in the National Readmission Database. The primary outcome measure was all-cause 30-day readmission. A propensity score-matched analysis compared outcomes with a non-LAAO AF cohort. Among 14 024 LAAO procedures (age: 76 ± 8 years; 60.5% males), 9.4% were readmitted within 30-days and,0.2% died during their index hospitalization. The most frequent primary diagnosis during readmission among LAAO was gastrointestinal bleeding (12%). The incidence of LAAO procedures increased by 102%. In the multivariate model, gender and CHA2 DS2 -VASc failed to predict readmission. Age 55-64 years had lower odds (adjusted odds ratios [aOR]: 0.41; 95% confidence interval [CI]: 0.18-0.94), while drug abuse (aOR: 4.1; 95% CI: 1.34-12.54), and deficiency anemia (aOR: 1.88; 95% CI: 1.12-3.18) had higher odds of readmission. In propensity-matched cohort, compared to non-LAAO AF, LAAO patients had lower 30-day readmission (9.4% vs. 10.98%, p = .002) and all-cause in-hospital mortality (0.19% vs. 0.57%, p < .001). The readmission rate following the LAAO procedure is substantial (approximately 10%), and largely attributable to gastrointestinal bleeding. Factors such as drug abuse and anemia must be explored further to minimize readmission risk.

To investigate the rate and clinical impact of a persisting iatrogenic atrial septal defect (iASD) after percutaneous left atrial appendage occlusion (LAAO). Percutaneous LAAO is an alternative to oral anticoagulation (OAC) for the prevention of ischemic stroke and systemic embolism in patients with atrial fibrillation (AF). Data regarding incidence and persistence of iASD after LAAO procedures and its clinical relevance is scarce. We retrospectively analyzed 144 patients that underwent LAAO at our center between 2009 and 2020 who had at least one follow-up including transesophageal echocardiography (TEE). Baseline clinical, procedural data and echocardiographic characteristics in patients with and without evidence of an iASD were compared. We furthermore determined the rate of iASD persistence over time and evaluated outcomes of patients with and without spontaneous iASD closure. After a median of 92 days (IQR 75-108 days) after LAAO, 50 patients (50/144, 34.7%) showed evidence of an iASD. Patients with iASD had higher CHADS-VASc-scores (4.9±1.5vs 4.2±1.2, p=0.03), larger left atrial volumes (80.5±30.5ml vs 67.1±19.7ml, p=0.01) and were more likely to have relevant mitral regurgitation (≥° II) (46.0%vs 12.3%, p=0.001). LAAO procedures took longer (50.1±24.3vs 41.1±17.8min, p=0.06) in patients with a persisting iASD. Furthermore, larger device sizes were implanted (24.3±3.4mm vs 22.1±2.8mm, p=0.03). The presence of an iASD had no impact on RV dysfunction, thromboembolism or mortality. Spontaneous closure of an iASD was documented in 52.0% (26/50). Hereby, similar risk factors were identified for the persistence of an iASD in follow-up.

Percutaneous left atrial appendage (LAA) occlusion and novel pharmacological therapies are now available to manage stroke risk in patients with nonvalvular atrial fibrillation; however, the cost-effectiveness of LAA occlusion compared with dabigatran and warfarin in patients with nonvalvular atrial fibrillation is unknown. Cost-utility analysis using a patient-level Markov microsimulation decision analytic model with a lifetime horizon was undertaken to determine the lifetime costs, quality-adjusted life years, and incremental cost-effectiveness ratio of LAA occlusion in relation to dabigatran and warfarin in patients with nonvalvular atrial fibrillation at risk for stroke without contraindications to oral anticoagulation. The analysis was performed from the perspective of the Ontario Ministry of Health and Long Term Care, the third-party payer for insured health services in Ontario, Canada. Effectiveness and utility data were obtained from the published literature. Cost data were obtained from the Ontario Drug Benefits Formulary and the Ontario Case Costing Initiative. Warfarin therapy had the lowest discounted quality-adjusted life years at 4.55, followed by dabigatran at 4.64 and LAA occlusion at 4.68. The average discounted lifetime cost was $21 429 for a patient taking warfarin, $25 760 for a patient taking dabigatran, and $27 003 for LAA occlusion. Compared with warfarin, the incremental cost-effectiveness ratio for LAA occlusion was $41 565. Dabigatran was extendedly dominated. Percutaneous LAA occlusion represents a novel therapy for stroke reduction that is cost-effective compared with warfarin for patients at risk who have nonvalvular atrial fibrillation.

Introduction: Pre-procedure cardiac computed tomography (CT) or magnetic resonance imaging (MRI) prior to percutaneous left atrial appendage occlusion (LAAO) has many theoretical benefits but data on its association with periprocedural safety and effectiveness is limited. Hypothesis: Pre-procedure imaging has the potential to improve the safety and effectiveness of LAAO. Methods: We evaluated patients in the NCDR LAAO Registry who underwent LAAO between 1/2016 and 6/2021 to compare the safety and effectiveness of LAAO procedures by use vs. non-use of pre-procedural CT/MRI. Study outcomes included implant success (deployment and release of device), device success (device released with peri-device leak &lt;5mm), and procedure success [device released with peri-device leak &lt;5mm and no in-hospital MAE (major adverse effects)]. Multivariable logistic regression was used to assess the relationship between pre-procedure imaging and outcomes. Results: Pre-procedure CT/MRI was used for 18.2% (n=20,851) of the 114,384 procedures in this study and significant variability was noted by hospital ( Figure ). CT/MRI use was more common among government and university hospitals, larger hospitals, non-teaching hospitals, and hospitals in the Midwest and south, and was less common among patients with uncontrolled hypertension, abnormal renal function, and no prior thromboembolism. Overall rates of implant success, device success, and procedure success were 93.4%, 91.2%, and 89.4%. Pre-procedure CT/MRI was independently associated with an increased likelihood of implant success (OR 1.08, CI 1.00-1.17), device success (OR 1.10, CI 1.04-1.16), and procedural success (OR 1.07, CI 1.02-1.13) There was no significant difference in risk for MAE (OR 1.02, 0.92-1.12). Conclusions: Pre-procedure CT/MRI was used 1 in 5 LAAO procedures and was independently associated with higher likelihood of implant success, device success, and procedure success, but no difference in MAE.

PO-03-163 CONCOMITANT LAAO AND ATRIAL FIBRILLATION ABLATION VS. A STAGED APPROACH: INSIGHTS FROM THE NATIONWIDE READMISSIONS DATABASE

Short- and long-term outcomes of percutaneous left atrial appendage occlusion in cancer patients.

Association of Hospital Procedural Volume With Outcomes of Percutaneous Left Atrial Appendage Occlusion.