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.

Left atrial appendage closure in a patient previously implanted with an interatrial shunt device: a case report.

Patients with previous interatrial shunt device (IASD) implantation may face greater challenges during future left atrial interventional procedures. Herein, we report the first case of left atrial appendage closure (LAAC) in a patient with previous IASD implantation. The patient successfully underwent LAAC using the LAmbre device without complications.

Novel computed tomography angiography-based sizing methodology for WATCHMAN FLX device in left atrial appendage closure.

BACKGROUND: While there is recent data suggesting an advantage of computed tomography angiography (CTA) over transesophageal echocardiography (TEE) for preprocedural left atrial appendage closure (LAAC) planning, there is limited published experience for sizing strategies. Device sizing for LAAC may be challenging and noninvasive algorithms that improve this selection process are warranted. OBJECTIVES: We sought to evaluate the safety and the feasibility for the implementation of a novel CTA-based sizing methodology for WATCHMAN™ FLX device in a series of patients undergoing LAAC using the TruPlan™ software package. METHODS: A prospective analysis of 136 consecutive patients who underwent LAAC over a 12-month period in a single, large academic hospital in the United States was conducted. CTA-guided preprocedural planning and intracardiac echocardiography (ICE) was performed in all. Procedural success, adverse events, length of procedure, number of devices used, and length of stay were evaluated. RESULTS: A total of 136 patients who underwent LAAC procedure with WATCHMAN™ FLX platform between October 1, 2020 until September 30, 2021 were included. The pre-specified protocol using CTA and ICE was implemented in all patients (100%). Mean CHA2 DS2 VASc score was 4.4 ± 1.3 and the mean HAS-BLED score was 3.9 ± 0.8. ICE-guided 100% transseptal puncture success rate was 100% with 98.5% of overall procedural success rate. Preprocedural CTA sizing strategy accurately predicted the implanted size in 91.1% of patients. Ten patients (7.4%) required another sized device and 2 cases were aborted. At 45-day follow-up, only 1 patient (0.7%) had significant peri-device leak (≥5 mm) on TEE. CONCLUSIONS: CTA-based preprocedural sizing methodology for WATCHMAN™ FLX in LAAC was safe, feasible and associated with excellent procedural outcomes. Further studies are warranted to confirm if the features specific to TruPlan™ may reduce the number of deployment attempts, the number of devices utilized in the procedure, and the risk of complications.

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.

Incidence and temporal evolution of delayed peridevice leak after left atrial appendage closure.

BACKGROUND: Peridevice leak (PDL) after left atrial appendage closure (LAAC) portends adverse outcomes. OBJECTIVE: The purpose of this study was to assess the incidence, predictors, clinical implications, and temporal evolution of PDL after LAAC. METHODS: This single-center retrospective study included all patients who underwent LAAC with Watchman FLX and had no PDL detected at the time of implantation. The primary end point was the incidence of new PDL at initial imaging. The composite secondary end point included continued oral anticoagulation after initial imaging, device-related thrombus, stroke or transient ischemic attack, major bleeding, and need for PDL closure at longest follow-up. Temporal evolution of PDL was assessed in patients with available surveillance imaging. RESULTS: Of the 355 patients who completed imaging at 47 days (interquartile range [IQR] 44-50 days), 139 (39%) had new PDL with a mean leak size of 3.2 ± 1.4 mm (median 3.0 mm; IQR 2.0-4.0 mm; range 1.0-9.0 mm). Multiple deployment attempts and larger device size were positive predictors of PDL, while increased contrast volume administration was a negative predictor of PDL. The composite secondary end point occurred in 42 (30%) patients with PDL and 33 (15%) patients without PDL (P < .001). Of the 139 patients with PDL, 43 (31%) had surveillance imaging where the leak size regressed from 3.7 ± 1.8 mm at 46 days (IQR 44-51 days) to 1.7 ± 2.0 mm at 189 days (IQR 158-285 days) (P < .001). The leak size regressed in 33 (77%), remained stable in 4 (9%), and progressed in 6 (14%) cases. CONCLUSION: Despite design improvements, LAAC with Watchman FLX demonstrates a significant incidence of PDL with meaningful clinical implications. Regardless of initial size, most leaks regressed over time.

Should the Left Atrial Appendage Closure (LAAC) Technique Be the Main Form of Stroke Prevention in Patients With Long-Standing Persistent or Permanent Atrial Fibrillation?

Currently, oral anticoagulants are considered the gold standard for stroke prevention in patients with atrial fibrillation. Despite the efficacy of oral anticoagulants in reducing stroke incidence, patients are at risk of developing adverse reactions such as excessive bleeding and bruising, and can also have drug-drug interactions. In the early 2000s, a minimally invasive technique called the left atrial appendage closure emerged as an alternative for stroke prevention in atrial fibrillation patients who could not tolerate oral anticoagulants. Despite the success of the left atrial appendage closure, practitioners still opt for medication therapy and are reluctant to advocate for this procedure. Given the adverse effects of oral anticoagulants, physicians should question if this is the appropriate method of stroke prevention in long-standing persistent or permanent atrial fibrillation patients. This case report investigates an 82-year-old Middle Eastern male in the United States with long-standing persistent atrial fibrillation who underwent a left atrial appendage closure due to recurrent bleeding on oral anticoagulants. In addition, there will be further discussion on the appropriate method of stroke prevention in similar patients.

Tissue oedema following pulsed field ablation recognized during a concomitant left atrial appendage closure procedure: a case report.

Background: In patients with non-valvular atrial fibrillation (AF), at high stroke risk, and who are ineligible for long-term oral anticoagulation, the left atrial appendage closure (LAAC) could be an alternative to anticoagulation. Pulsed field ablation (PFA) is a new non-thermal method for cardiac ablation modality based on high-voltage electrical energy for irreversible electroporation. We first report a case of a concomitant PFA pulmonary vein isolation (PVI) and LAAC. Case summary: A 74-year-old female patient was referred to our department for PVI for persistent AF (CHA2DS2-VASc score 5). A concomitant percutaneous LAAC was proposed because of a history of previous cerebellar transient ischaemic attack despite continuous oral anticoagulation therapy. Pulmonary vein isolation was achieved with a pentaspline PFA catheter, and LAAC was performed with a WATCHMAN FLX™ device (Boston Scientific, Plymouth, MN, USA). After PVI, a swelling of the left atrial ridge was observed, yet a 27 mm LAAC device was successfully implanted. The follow-up transesophageal echo (TEE) after 6 weeks showed complete resolution of the oedema, no device-related thrombus, but a slight proximal tilting of the LAAC device without leakage could be observed. The 6-month follow-up demonstrated a stable sinus rhythm, no stroke, or bleeding events were recorded. Discussion: In this case of synchronous PFA-PVI procedure in AF and WATCHMAN FLX™ device implantation, the electroporation created an acute oedema at the ridge level which at the TEE follow-up after 6 weeks was resolved. This resulted in a slightly tilted WATCHMAN device position which was nevertheless stable and showed no leakage.

The effect of two different methods of planning landing zone for left atrial appendage closure by cardiac computed tomography angiography: a comparative study.

Background: To explore the value of 2 different methods for planning landing zone for left atrial appendage closure (LAAC) by cardiac computed tomography angiography (CCTA). Methods: A retrospective analysis was performed on the clinical data of patients who successfully underwent LAAC with the Watchman device at The Affiliated Taizhou People's Hospital of Nanjing Medical University from August 2020 to February 2022. Two different methods were used to plan the landing zone and measure the longest diameter, average diameter, depth, and perimeter of the landing zone. The difference between the 2 methods and the correlation between their measurements and occluder size were analyzed. Results: A total of 66 patients undergoing LAAC were included, with an average age of 69.35±7.1 years, of whom 30 (45.5%) were women. The mean error between the longest diameter measured by the traditional method and the actual value was 2.90±2.83 mm, and the mean absolute error (MAE) was 2.71 (1.17, 4.38) mm. The mean error between the longest diameter measured by the new method and the actual value was 0.9 (-0.13, 2.50) mm, and its MAE was 1.4 (0.40, 2.53) mm. The error of the longest diameter measured by the traditional method was larger than that measured by the new method (P<0.001). The mean error between the depth measured by the traditional method and the actual value was 1.40±3.45 mm, and the MAE was 2.36 (0.74, 4.58) mm. The mean error between the depth measured by the new method and the actual value was 0.10 (-1.33, 1.95) mm, and the MAE was 1.55 (0.60, 3.10) mm. Likewise, the depth error measured by the traditional method was larger than that measured by the new method (P<0.05). The correlation between the perimeter and the size of the occluder was the strongest (r=0.919, P<0.001). Conclusions: With CCTA, the new method is more accurate in planning landing zone than the traditional method. It is particularly important to select the occluder size for the patients with flat oval landing zone ostium.

A Case of Unintentional Release of the Watchman FLX Device During Implantation: A Cautionary Tale.

Atrial fibrillation (AF) is a common heart rhythm disorder that increases the risk of stroke and other cardiovascular complications. The Watchman FLX device is a percutaneous device used for the closure of the left atrial appendage in patients with atrial fibrillation and prevents blood clots from forming, thereby decreasing the risk of stroke. However, device dislodgement during the procedure can occur and compromise the effectiveness of the device. In this case report, we present the experience of an 86-year-old man with a history of atrial fibrillation, coronary artery disease, hypertension, and recent gastrointestinal bleeding due to diverticulosis. During the procedure, the device became dislodged prior to the planned release from the shaft due to the difficult anatomy of the appendage, which caused the operator to over-torque and kink the delivery sheath. The kinked sheath prevented the transmission of torque to the appropriate region of the sheath and caused the device to unscrew prematurely. Fortunately, the device was self-deployed in a satisfactory position, and no further intervention was required. The patient did not experience any complications prior to discharge and follow-up echocardiography showed proper positioning of the device. This case highlights the importance of careful technique during the Watchman FLX procedure and the need to replace the delivery sheath if kinking is noted to prevent unintentional dislodgement of the device. In addition, the case was written with the aid of the artificial intelligence-powered language model ChatGPT and demonstrates its benefits as well as calls for caution while using it for medical writing.

Prediction model based on machine learning for short- and long-term adverse events in left atrial appendage closure.

Background: At present, the prediction of adverse events (AE) had practical significance in clinic and the accuracy of AE prediction model after left atrial appendage closure (LAAC) needed to be improved. To identify a good prediction model based on machine learning for short- and long-term AE after LAAC. Methods: In this study, 869 patients were included from the Department of Cardiovascular Medicine of Shanghai University of Medicine and Health Sciences Affiliated Zhoupu Hospital during 2017 and 2021. Univariate and multivariate analyses were conducted for short-term AE after LAAC to determine possible risk factors related with AE. We compared 8 machine learning algorithms for prediction short-term AE, and XGBoost was found to have the best performance. In addition, Cox-regression was used for long-term AE to find out the risk factors and establish a prediction model. Results: In univariate and multivariate analysis, body mass index (BMI) [odds ratio (OR) =0.91], congestive heart failure, hypertension, age ≥75 years, diabetes, stroke2 attack (CHADS2) score (OR =0.49) and bleeding history or predisposition, labile international normalized ratio (INR), elderly, drug/alcohol usage (BLED) score (OR =1.71) were shown to be significant risk factors for short-term AE. The XGbosst algorithm was used to predict short-term AE based on 15 possible risk factors. For long-term AE, Cox regression was used for the prediction. The CHADS2 score [hazard ratio (HR) =1.43], hypertension (HR =2.18), age more than 75 (HR =0.49), diabetes (HR =0.57), BLED score (HR=0.28), stroke (HR =19.8), hepatopathy (HR =3.97), nephropathy (HR =2.93), INR instability (HR =4.18), drinking (HR =2.67), and drugs (HR =2.36) were significant risk factors for long-term AE. The XGBoost had a good receiver operating characteristic (ROC) curve and area under the curve (AUC) was 0.85. The accuracy of the XGBoost model stayed at nearly 0.95. Conclusions: In short- and long-term AE, CHADS2 score and BLED score were the most obvious risk factors. Several other risk factors also played roles in AE of LAAC. The incidence of long-term AE is under 15% and LAAC is effective and safe. The XGBoost model had good prediction accuracy and ROC curve.

Long Term Impact of Epicardial Left Atrial Appendage Ligation on Systemic Hemostasis: LAA HOMEOSTASIS-2.

BACKGROUND: Recent data suggest that epicardial left atrial appendage closure (LAAC) is associated with several short-term neurohormonal effects. However, the long-term effects are currently unknown. OBJECTIVE: To investigate the effects of percutaneous epicardial left atial appendage (LAA) exclusion using LARIAT on neurohormonal profiles at long-term follow-up. METHODS: In a prospective single centre study, 60 patients with long-standing, persistent atrial fibrillation (AF) LARIAT were treated. The major hormones of the adrenergic system, renin-angiotensin-aldosterone system (RAAS), and natriuretic peptides were assessed before the intervention and at regular intervals during the following two years. RESULTS: In patients with epicardial LAAC, atrial natriuretic peptide (ANP) levels were significantly increased from baseline at 24 h and decreased at 7 days, 1 month, and 3 months, while remaining unchanged at 12 and 24 months. Noradrenaline levels were significantly lower at 24 h, 7 days, 1 month, 6 months, 12 months, and 24 months, while epinephrine levels decreased significantly at 1 month, 6 months, 12 months, and 24 months. Plasma renin activity significantly decreased at 7 days, 1 month, 6 months, 12 months, and 24 months, while aldosterone levels significantly decreased at 6 months, 12 months, and 24 months. Endothelin-1 and vasopressin showed a significant increase and decrease, respectively, at 24 h, 7 days, 1 month, 6 months, 12 months, and 24 months. There was also a significant decrease in systolic and diastolic blood pressure at 3 months, 6 months, 1 year, and 2 years after the intervention. CONCLUSIONS: Epicardial LAAC in AF patients is associated with persistent neurohormonal changes favouring blood pressure reduction.

Latest outcomes of transcatheter left atrial appendage closure devices and direct oral anticoagulant therapy in patients with atrial fibrillation over the past 5 years: a systematic review and meta-analysis.

Left atrial appendage closure (LAAC) are emerging treatment for patients with atrial fibrillation (AF). However, data on the safety, efficacy, and medications for LAAC devices in patients with AF are lacking. We aimed to investigate the incidence of all-cause mortality, stroke, and major bleeding in AF patients with LAAC devices and DOACs. Moreover, we aimed to investigate the incidence rate of device-related thrombus (DRT) and the medications used in the management of AF patients with LAAC devices to gain insights into achieving better outcome. Based on a literature search using PubMed, EMBASE, Cochrane Library, and Web of Science databases between January 2015 and December 2020, eight LAAC device studies that used WATCHMAN and Amulet, and three DOAC studies that used rivaroxaban, with a total of 24,055 AF patients (LAAC devices, n = 2855; DOAC, n = 21,200), were included. A random-effects model was used to incorporate heterogeneity among studies. The pooled incidence of events per person-years were as follows: all-cause mortality, 0.06 (95% confidence interval [CI] 0.02-0.10) for WATCHMAN, 0.04 (95% CI 0.00-0.14) for Amulet, and 0.03 (95% CI 0.01-0.04) for rivaroxaban; stroke; 0.02 (95% CI 0.00-0.04) for WATCHMAN, 0 for Amulet, and 0.01 (95% CI 0.01-0.02) for rivaroxaban; major bleeding, 0.04 (95% CI 0.02-0.06) for WATCHMAN, 0.02 (95% CI 0.00-0.06) for Amulet, and 0.02 (95% CI 0.01-0.03) for rivaroxaban. The incidence rate of DRT was 2.3%, and complications were reported in 9%. The incidence of all-cause mortality, stroke, and major bleeding were similar between LAAC devices and DOACs. The rate of complications was acceptable, and those of DRT were lower than the average incidence reported in previous studies. However, further follow-up is needed. Concomitant anticoagulant and antiplatelet therapies should be further evaluated to find the optimal regimen for AF patients with LAAC devices.

Embolic Cerebrovascular Accident Secondary to Device-Related Thrombus Post WATCHMAN Device Implantation.

Atrial fibrillation (AF) is one of the most common cardiac arrhythmias encountered. Aggressive and appropriate management, along with identification and modification of risk factors, remains at the forefront of evidence-based practice. Thrombus formation (primarily in the left atrial appendage) and consequent thromboembolism are risks associated with AF. Anticoagulation is utilized to prevent and reduce AF-induced complications such as stroke, heart failure, and death. However, in instances when the risk of bleeding from anticoagulation outweighs the benefits of stroke prevention, other modalities such as left atrial appendage closure (LAAC) devices like the WATCHMAN device (Boston Scientific, MA) are utilized. LAAC devices, such as the WATCHMAN device, are also not without significant risks, one of them being device-related thrombus (DRT) formation. We present a case of device-related thrombus formation post WATCHMAN implantation and a subsequent embolic cerebrovascular accident (CVA).

The feasibility and safety of "one-stop" left atrial appendage closure and percutaneous coronary intervention in atrial fibrillation patients with significant coronary artery disease (PCI-LAAC study).

BACKGROUND: The anti-thrombotic strategy for patients with atrial fibrillation (AF) who have undergone percutaneous coronary intervention (PCI) for coronary artery disease (CAD) is a common and difficult challenge. This pilot study aimed to assess the feasibility and safety of "one-stop" left atrial appendage closure (LAAC) combined with PCI as an alternative stroke prophylaxis strategy. METHODS: From March 2017 to October 2019, AF patients with elevated bleeding risk and significant stable CAD requiring PCI were recruited to undergo LAAC as alternative stroke prophylaxis in Fuwai Hospital, Beijing, China. LAAC was performed either in the same setting with PCI (i.e. "one-stop" LAAC/PCI), or as staged procedure after PCI. Dual antiplatelet therapy was given for all patients after LAAC. Peri-procedural and intermediate-term clinical outcomes were assessed through hospital clinical records review and standardized telephone interviews. RESULTS: A total of 24 patients were recruited including 13 (54.2%) underwent stage procedure and 11 (45.8%) underwent "one-stop" procedure respectively. The mean CHA2DS2-VASc and HAS-BLED scores were 4.5±1.4 and 3 (IQR 3,4) respectively. Six patients (46.1%) in the staged procedure cohort were treated with triple anti-thrombotic following PCI, with 2 developed minor bleeding before LAAC. One patient ("one-stop" cohort) had gastrointestinal bleeding 1 day after procedure. Otherwise, there was no device related complication or peri-procedural stroke/myocardial infarction. After a mean 19±5.4 months follow-up, there was no death, myocardial infarction, stroke and systemic embolization detected. CONCLUSIONS: In this pilot study, "one-stop" LAAC with PCI was shown to be efficacious with no stroke, MI, VARC-2 major bleeding or CV death reported over a mean follow-up of 19 months, and safe with no major peri-procedural bleeding or device related complications.

Leaks after left atrial appendage ligation with Lariat device: Incidence, pathophysiology, clinical implications and methods of closure- A case based discussion.

Catheter based left atrial appendage (LAA) closure techniques are emerging as a promising alternative for stroke prevention in patients who cannot tolerate oral anticoagulation. Lariat procedure involves percutaneous catheter based epicardial ligation of the LAA with a suture via an endo-epicardial hybrid approach. It offers the advantage of not leaving behind a focus for thrombus formation or embolization. Similar to surgical ligation of the left atrial appendage, Lariat ligation is limited by leaks in a small percentage of patients. The incidence of leaks is variable and can be seen in the immediate post procedure period or during follow up. The electrical and mechanical implications of leaks are still under debate. In this review, we discuss the incidence, pathophysiology, clinical implications and methods of closure of leaks after Lariat. In the end, we present a case of a Lariat leak closed with an Amplatzer septal occluder.