Incidence, progression, and predictors of left atrial appendage sealing after Watchman FLX device implantation with computed tomographic assessment.

BACKGROUND: Limited data exists regarding incidence, progression, and predictors of left atrial appendage (LAA) sealing after transcatheter LAA closure. We aimed to evaluate the incidence, progression, and predictive factors associated with LAA sealing after LAA closure. METHODS: This study includes patients who underwent successful LAA closure with Watchman FLX device and had both pre- and postprocedural computed tomography (CT). Postprocedural CT was performed 45 days after LAA closure and used to evaluate residual LAA patency. Patient who had residual LAA patency at 45 days underwent 1-year follow-up CT. RESULTS: A total of 105 patients (mean age: 75.2 ± 9.6 years; 53.3% female) who underwent successful LAA closure with Watchman FLX device and had pre- and postprocedural CT at 45 days were included. Residual patency was observed in 35 (33.3%) patients: 21 (20.0%) patients showed complete contrast opacification in LAA (complete LAA patency) while 14 (13.3%) patients showed contrast opacification only in the distal LAA (distal LAA patency). Among patients with residual LAA patency at 45 days, the rate of LAA sealing at 1 year was significantly higher in the distal LAA patency group than in the complete LAA patency group (75.0% vs. 16.7%; p = 0.019). Increased depth oversizing was associated with both distal LAA patency and complete LAA patency. CONCLUSION: Postprocedural CT at 45 days detected patent LAA in one-third of patients after LAA closure. LAA sealing was more frequently observed at 1 year among the distal LAA patency group than the complete LAA patency group.

Percutaneous left atrial appendage occlusion in mitral valve disease: A Nationwide Readmission Database analysis.

BACKGROUND: Percutaneous left atrial appendage occlusion (LAAO) has emerged as a non-pharmacologic alternative to oral anticoagulation in reducing stroke risk in AF patients. However, patients with mitral valve disease (MVD), who are expected to have a significantly greater risk of left atrium (LA) thrombus formation and embolic stroke were excluded from randomized trials examining percutaneous LAAO. To address this gap, we present a national registry analysis of the use of LAAO among patients with MVD. METHODS: Using the National Readmissions Database, we performed a retrospective review of all hospitalizations for LAAO identified between September 2015 and November 2019. Of these, patients with ICD-10 codes for MVD were identified. Propensity matched (PSM) analysis was used to compare patients with MVD with a matched sample of patients undergoing LAAO with non-valvular AF. Outcomes examined included all-cause mortality, stroke, major bleeding, pericardial effusion (PE), and tamponade. RESULTS: 51,540 patients who underwent LAAO without a history of MVD and 3777 with a history of MVD were identified. Crude analysis demonstrated the odds of mortality, PE, and cardiac tamponade during index hospitalization to be higher in the MVD group. The length of stay and cost of index hospitalization were also slightly greater for the MVD group. A sample of 7649 patients (MVD: 3777 MVD and no MVD: 3872) were selected for PSM analysis with similar comorbidities across the two groups. In the PSM comparison, MVD was associated with higher risk of PE. The MVD group had a slightly higher rate of readmissions the association with PE remained at 30-day readmission (OR: 2.099 [1.360-3.238], p-value: <0.001). CONCLUSION: To our knowledge, this is the first study examining the use of LAAO among MVD patients. Our findings suggest that patients with MVD who underwent LAAO had a higher risk of post-procedural PE without an increase in mortality, stroke, or major bleeding. These results provide a rationale for considering LAAO as part of the stroke prevention strategy among patients with valvular AF.

Midterm follow-up after computed tomography angiography planned left atrial appendage closure.

BACKGROUND: While studies have shown the advantages of computed tomography angiography (CTA) over transesophageal echocardiography (TEE) in left atrial appendage closure (LAAC) preprocedural planning for WATCHMAN™ legacy and FLX devices, there has been no reported long-term data for this approach. OBJECTIVES: We sought to evaluate long-term outcomes using CTA-based preprocedural planning for LAAC using the WATCHMAN™ device. METHODS: A prospective analysis of 231 consecutive patients who underwent LAAC in a single, large academic hospital in the United States was conducted over a 5-year period. CTA-guided preprocedural planning was performed in all. Procedural success, adverse events, length of procedure, number of devices used, and length of stay were evaluated. Rates of death, cerebral embolism, systemic embolism, and major and minor bleeding were recorded. Adjusted predicted stroke and major bleeding rates were derived from CHA2DS2-Vasc and HAS-BLED scores, respectively. RESULTS: From January 26, 2017, to November 23, 2021, 231 patients underwent LAAC with CTA preprocedural planning by two operating physicians. The mean age of patients was 76.5 ± 8.4. 59.7% of patients were male. Mean CHA2DS2VASc and HAS-BLED scores were 4.5 ± 1.4 and 3.9 ± 0.9, respectively. All procedures were performed with intracardiac echo (100%). The procedural success rate was 99.1%. The CTA sizing strategy accurately predicted the implant size in 93.5% of patients. Mean number of devices used was 1.10 ± 0.3. Peri-procedural complication rate was 2.2%. 6 patients were lost to follow-up. Mean follow-up was 608.94 days with a total of 377.04 patient years. Median follow-up period of 368 days (interquartile range: 209-1067 days). There were 51 deaths from all causes (13.52 per 100 patient-years), 10 cases of cerebral embolism (2.65 per 100 patient-years), 2 cases of systemic embolism (0.53 per 100 patient-years), 17 cases of major bleeding (4.50 per 100 patient-years), and 31 cases of minor bleeding (8.2 per 100 patient-years). All-cause mortality at 1, 2, and 3 years was 12.7%, 20.9%, and 29.2%, respectively. CV event rates at 1, 2, and 3 years were 2.1%, 6.6%, and 10.5%, respectively. CONCLUSIONS: CTA-based preprocedural planning is accurate in predicting device size for LAAC and associated with excellent clinical outcomes at 5 years.

Amulet device implantation following incomplete left atrial appendage closure with Watchman legacy device.

Peri-device leak after left atrial appendage closure (LAAC) is often treated with endovascular coils, plugs, or second occluders. This is the first study reporting the Amulet device used for peri-device leak. An 80-year-old male with paroxysmal atrial fibrillation and recurrent falls with head trauma who underwent LAAC with a 24 mm Watchman 2.5 device 3 years ago at another institution was referred to our clinic for management of the peri-device leak. Transesophageal echocardiogram showed persistent residual peri-device leak with 5 mm width along the Coumadin ridge aspect of the device. Computed tomography (CT) also showed the peri-device leak with width of 6 mm and complete opacification of left atrial appendage (LAA). Importantly, CT demonstrated that the Watchman 2.5 device was deployed at distal LAA, leaving the proximal part of LAA with length of 10 mm from ostium. Under general anesthesia, a 22 mm Amulet device was deployed successfully with complete sealing of LAA. Procedure planning is the key to minimize the risk of peri-device leak or device-related thrombosis. Careful assessment of LAA anatomy using multimodality images for peri-device leak after LAAC helped optimal treatment strategy including second LAAC with different type of devices.

Trends and outcomes of combined percutaneous (TAVI+PCI) and surgical approach (SAVR+CABG) for patients with aortic valve and coronary artery disease: A National Readmission Database (NRD) analysis.

BACKGROUND: In patients with severe aortic stenosis (AS) and concomitant severe coronary artery disease (CAD), the relative merits of a combined percutaneous (transcatheter aortic valve implantation [TAVI] and percutaneous coronary intervention [PCI]] versus surgical approach (surgical aortic valve replacement [SAVR] and coronary artery bypass graft [CABG]) remain unknown. AIMS: To determine the utility of combined percutaneous versus surgical approaches in patients with severe AS and CAD. METHODS: The National Readmission Database (NRD) (2015-2019) was queried to identify all cases of TAVI+PCI and SAVR+CABG. The adjusted odds ratios (aOR) of mortality, stroke, and its composite (major adverse cardiovascular events [MACE]) were calculated using a propensity-score matched (PSM) analysis. RESULTS: A total of 89,314 (5358 TAVI+PCI, 83,956 SAVR+CABG) patients were included in the crude analysis. There was a gradual increase in the utilization of TAVI+PCI from 2016 to 2019 by 2%-4% per year. Using PSM, a subset of 11,361 (5358 TAVI+PCI, 6003 SAVR+CABG) patients with a balanced set of demographics and baseline comorbidities was selected. During index hospitalization, the adjusted odds of MACE (aOR 0.72, 95% confidence interval [CI] 0.62-0.83), and all-cause mortality (aOR 0.68, 95% CI 0.57-0.81) were significantly lower in patients undergoing TAVI+PCI compared with SAVR+CABG. However, patients undergoing TAVI+PCI had a higher incidence of MACE (aOR 1.40, 95% CI 1.05-1.87), and mortality (aOR 1.75, 95% CI 1.22-2.50) at 30-days. The risk of index-admission (aOR 0.82, 95% CI 0.62-1.09) and 30-day (aOR 0.88, 95% CI 0.51-1.51) stroke was similar between the two groups. CONCLUSION: In selected patients with severe AS and concomitant CAD, a combined percutaneous approach (TAVR+PCI) compared with SAVR+CABG may confer a lower risk of MACE and mortality during index admission but a higher incidence of 30-day complications.

Efficacy of 3D-multidetector computed tomography and fluoroscopy fusion for percutaneous left atrial appendage occlusion procedures.

INTRODUCTION: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: There was no significant difference with and without 3D-MDCT-fluoroscopy fusion in procedure time, contrast volume use, radiation dose, and radiation dose product.

Left Atrial Appendage Closure Outcomes in Patients With Cancer at a Single Tertiary Center.

Atrial fibrillation is the most common arrhythmia in patients with underlying malignancy. Patients with cancer have a higher risk of bleeding, and at the same time, carry an elevated risk of thromboembolism related to the hypercoagulable state, type of cancer, and anticancer treatment, rendering safe anticoagulation challenging in this population. Left atrial appendage closure is an alternative treatment option in patients with atrial fibrillation and high bleeding risk; however, the data on patients with cancer are limited. Our study aimed to compare the long-term outcomes in patients with cancer receiving left atrial appendage closure using the WATCHMAN device. This is a prospective, single-center study comparing outcomes in 389 patients who underwent percutaneous left atrial appendage closure using the WATCHMAN device over 5 years in a single, large academic hospital in the United States. The postprocedural outcomes of mortality, stroke, and major bleeding were evaluated in patients with and without cancer. Our study included 57 patients with cancer and 332 without cancer. The baseline characteristics were similar between the 2 groups. Metastatic disease was present in 16.4% of patients, and 25% were receiving active treatment at the time of the procedure. The median follow-up time was 354 (interquartile range 85 to 790) days. There was no difference in mortality (hazard ratio [HR] 1.3, 95% confidence interval [CI] 0.72 to 2.35, p = 0.38), major bleeding episodes (HR 1.2, 95% CI 0.45 to 3.33, p = 0.68), and stroke (HR 0.64, 95% CI 0.19 to 2.21, p = 0.49) at 3 years after the procedure in patients with and without cancer. There was no difference in the composite outcome (postprocedural mortality, stroke, and major bleeding) between the 2 groups (HR 1.25, CI 0.75 to 2.07, p = 0.38). Percutaneous left atrial appendage closure in patients with cancer appears to be safe and has a similar long-term risk compared with patients without cancer.

Platelet and Monocyte Activation After Transcatheter Aortic Valve Replacement (POTENT-TAVR): A Mechanistic Randomized Trial of Ticagrelor Versus Clopidogrel.

Background: Inflammation and thrombosis are often linked mechanistically and are associated with adverse events after transcatheter aortic valve replacement (TAVR). High residual platelet reactivity (HRPR) is especially common when clopidogrel is used in this setting, but its relevance to immune activation is unknown. We sought to determine whether residual activity at the purinergic receptor P2Y12 (P2Y12) promotes prothrombotic immune activation in the setting of TAVR. Methods: This was a randomized trial of 60 patients (enrolled July 2015 through December 2018) assigned to clopidogrel (300mg load, 75mg daily) or ticagrelor (180mg load, 90 mg twice daily) before and for 30 days following TAVR. Co-primary endpoints were P2Y12-dependent platelet activity (Platelet Reactivity Units; VerifyNow) and the proportion of inflammatory (cluster of differentiation [CD] 14+/CD16+) monocytes 1 day after TAVR. Results: Compared to clopidogrel, those randomized to ticagrelor had greater platelet inhibition (median Platelet Reactivity Unit [interquartile range]: (234 [170.0-282.3] vs. 128.5 [86.5-156.5], p < 0.001), but similar inflammatory monocyte proportions (22.2% [18.0%-30.2%] vs. 25.1% [22.1%-31.0%], p = 0.201) 1 day after TAVR. Circulating monocyte-platelet aggregates, soluble CD14 levels, interleukin 6 and 8 levels, and D-dimers were also similar across treatment groups. HRPR was observed in 63% of the clopidogrel arm and was associated with higher inflammatory monocyte proportions. Major bleeding events, pacemaker placement, and mortality did not differ by treatment assignment. Conclusions: Residual P2Y12 activity after TAVR is common in those treated with clopidogrel but ticagrelor does not significantly alter biomarkers of prothrombotic immune activation. HRPR appears to be an indicator (not a cause) of innate immune activation in this setting.

Surgical and transcatheter left atrial appendage closure in patients with atrial fibrillation and hypertrophic cardiomyopathy.

BACKGROUND: Patients with hypertrophic cardiomyopathy (HCM) and atrial fibrillation (AF) are at increased stroke risk in comparison to those with non-valvular AF not affected by HCM. OBJECTIVES: To investigate the role of left atrial appendage closure (LAAC) in patients with HCM and AF. METHODS AND RESULTS: We identified patients with HCM and AF using the National Readmission Dataset. Patients were stratified based on LAAC status. The primary efficacy outcome was a composite of ischaemic and haemorrhagic stroke, TIA, and all-cause mortality. The primary safety outcome was a composite of major bleeding and pericardial complications. Patients were matched using inverse probability of treatment weighting. Cox-proportional hazard regression was applied to calculate the hazard ratio (HR) with a 95% confidence interval (CI) on matched cohorts. We identified 71 980 patients with HCM and AF. 1351 (1.9%) patients underwent LAAC. Two hundred and eighty-seven (21.2%) underwent transcatheter LAAC. LAAC was associated with a lower risk of the primary efficacy outcome (2.5% vs. 5.4%, HR: 0.38; 95% CI: 0.17-0.88; P = 0.024), the primary safety outcome (2.9% vs. 6.8%, HR: 0.39; 95% CI: 0.23-0.66, P = 0.001), and reduced major bleeding. The LAAC group trended towards a lower risk of ischaemic stroke and all-cause mortality. CONCLUSION: Surgical and transcatheter LAAC was associated with a lower risk of haemorrhagic stroke and major bleeding.

Delayed Pericardial Effusion Following Left Atrial Appendage Closure: A 5-Year Single-Center Experience.

BACKGROUND: Though uncommon, pericardial effusion and cardiac tamponade are serious complications of left atrial appendage closure (LAAC). There are few data related to delayed pericardial effusions from this procedure. METHODS: This is a single-center prospective analysis of 369 patients who underwent LAAC from December 2016 to March 2022 at a large teaching hospital. We compared patients who developed effusion (n = 5) to patients who did not (n = 364) to determine if there were any factors that predispose patients to developing acute (AEs) or delayed pericardial effusions (DEs). We compared patient characteristics, procedural data, and complications. Unadjusted, stepwise multivariate logistic regression was performed. RESULTS: A total of 369 patients underwent LAAC. Of these, 5 patients (1.4%) developed pericardial effusion. Patients in both groups (pericardial effusion vs non-effusion) had similar patient and procedural characteristics. Patients in both groups were older (mean age, 78.4 ± 7.8 years in the effusion group vs 76.3 ± 8.5 years in the non-effusion group; P=.50) and white (60% in the effusion group vs 90.1% in the non-effusion group). CHA2DS2-VASc (4.2 ± 1.1 vs 4.5 ± 1.4; P=.67) and HAS-BLED (3.4 ± 0.5 vs 3.7 ± 0.9; P=.53) scores were similar in the effusion group vs the non-effusion group, respectively. Gastrointestinal bleeding was the most common procedural indication in both groups (80% in the effusion group vs 53.6% in the non-effusion group; P=.23). The majority of the patients in both groups had successful implantation in the first attempt, with the 27-mm device the most commonly used size. There was no significant difference in procedural duration (67 minutes in the effusion group vs 75 minutes in the non-effusion group; P=.16). Among patients who received the Watchman Legacy device, 2 patients developed AEs and no patients had DEs. Of those receiving the Watchman FLX device, 1 patient developed AE and 2 patients developed DEs. All of the patients with effusions had successful recovery. CONCLUSION: In this 5-year, single-center experience, DEs were uncommon and potentially related to LAA device anchor microperforation. No statistically significant risk factors predisposing patients to pericardial effusions were identified in our analysis.

Permanent Pacemaker Insertion Reduction and Optimized Temporary Pacemaker Management After Contemporary Transcatheter Aortic Valve Implantation With Self-Expanding Valves (from the Pristine TAVI Study).

Permanent pacemaker implantation (PPMI) reduction and optimal management of newly acquired conduction disturbances after transcatheter aortic valve implantation (TAVI) are crucial. We sought to evaluate the relation between transcatheter heart valve (THV) implantation depth and baseline and newly acquired conduction disturbances on PPMI after TAVI. This study included 1,026 consecutive patients with severe symptomatic aortic stenosis (mean age 79.7 ± 8.4 years; 47.4% female) who underwent TAVI with the newer-generation self-expanding THVs Primary outcomes were early and late PPMI defined as the need for PPMI during the index admission and between discharge and 30 days, respectively. Early and late PPMI was required for 115 (11.2%) and 21 patients (2.0%), respectively. Early PPMI rates decreased from 26.7% in 2015 and 2016 to 5.7% in 2021, and so did the mean THV depth from 4.4 ± 2.4 mm to 1.8 ± 1.6 mm. Receiver operator characteristics curve analyses showed THV depth had significant discriminatory value for early and late PPMI with cutoff values of 3.0 and 2.2 mm, respectively. Rates of early and late PPMI were significantly lower for patients with shallower compared with deeper implantations (5.1% vs 22.6% and 0.4% vs 4.1%, p <0.001 for both, respectively). Furthermore, rates of early PPMI were lower with shallower implantations in patients with new left bundle branch block after TAVI (2.4% vs 15.9%; p <0.001) and those with baseline right bundle branch block (7.5% vs 29.6%; p = 0.017). Lower rates of PPMI with shallower THV implantation were consistently observed, including in patients with baseline and newly acquired conduction disturbances. Our findings might help optimize the management of a temporary pacemaker after TAVI.

Predictors of successful same-day discharge and 1-year outcomes after left atrial appendage closure.

BACKGROUND: Same-day discharge (SDD) following left atrial appendage closure (LAAC) is increasingly common but predictors of successful SDD and 1-year clinical outcomes have not been described. OBJECTIVE: The purpose of this study was to explore predictors of successful SDD and report 1-year outcomes in patients undergoing LAAC with SDD. METHODS: A prospective analysis was performed over a 20-month period of 225 consecutive patients that underwent LAAC in a large, academic hospital. All patients included in the study underwent a SDD protocol. Baseline characteristics and 1-year outcomes of patients discharged same day of the procedure versus those that required at least one overnight stay were compared. Adverse events, procedural success, and procedure times were evaluated. RESULTS: One hundred and sixty-one patients (72%) of patients were discharged the same day and 64 patients (28%) required at least an overnight stay (non-SDD: NSDD). NSDD patients were older and more often female. Procedure time was also longer in the NSDD group than in the SDD (63.4 vs. 55.1 min; p = 0.01). While overall procedural success rates were similar between the SDD and NSDD groups (99.4% vs. 98.4%; p = 0.39), NSDD patients had more complications (9.4% vs. 0%; p = 0.01) and higher number of devices per procedure (1.2 vs. 1.0; p = 0.01) as compared to SDD. At 1 year, there were no significant difference between the SDD and NSDD groups in stroke (1.1% vs. 0%; log-rank p = 0.44) and all-cause mortality (3.9% vs. 4.7%; log-rank p = 0.70). CONCLUSION: In this single-center LAAC experience, female sex, older age, and longer procedure duration were associated with higher likelihood for need of overnight stay. At 1-year follow-up, there were no significant differences in stroke events and death rates between SDD and NSDD groups.