Surgical Removal of a Migrated WATCHMAN Device.

The WATCHMAN™ atrial appendage closure device is designed to reduce the risk of stroke in patients with nonvalvular atrial fibrillation who are not suitable candidates for long-term oral anticoagulation therapy. However, the device also carries small risks, including procedural complications such as device migration, embolization, or pericardial effusion. We describe a case of WATCHMAN device migration requiring surgical retrieval.

Catheter ablation alone versus catheter ablation with combined percutaneous left atrial appendage closure for atrial fibrillation: a systematic review and meta-analysis.

BACKGROUND: Combined catheter ablation (CA) with percutaneous left atrial appendage closure (LAAC) may produce comprehensive treatment for atrial fibrillation (AF) whereby rhythm control is achieved and stroke risk is reduced without the need for chronic oral anticoagulation. However, the efficacy and safety of this strategy is still controversial. METHODS: This meta-analysis was reported according to the Preferred Reporting Items for Systematic Review and Meta-Analyses guidelines. Medline, Scopus, and Cochrane Central Register of Controlled Trials were systematically searched to identify relevant studies. The risk of bias was assessed using the Modified Newcastle-Ottawa scale and Cochrane risk of bias tool. Eligible studies reported outcomes in patients with AF who underwent combined CA and LAAC vs CA alone. Studies performing CA without pulmonary vein isolation were excluded. RESULTS: Eight studies comprising 1878 patients were included (2 RCT, 6 observational). When comparing combined CA and LAAC vs CA alone, pooled results showed no difference in arrhythmia recurrence (risk ratio (RR) 1.04; 95% confidence interval (CI) 0.82-1.33), stroke or systemic embolism (RR 0.78; 95% CI 0.27-2.22), or major periprocedural complications (RR 1.28; 95% CI 0.28-5.89). Total procedure time was shorter with CA alone (mean difference 48.45 min; 95% CI 23.06-74.62). CONCLUSION: Combined CA with LAAC for AF is associated with similar rates of arrhythmia-free survival, stroke, and major periprocedural complications when compared to CA alone. A combined strategy may be as safe and efficacious for patients at moderate to high risk for bleeding events to negate the need for chronic oral anticoagulation.

Reproducibility of Cardiac Computed Tomography Classifications of Hypoattenuated Thickening and Peridevice Leak Following Left Atrial Appendage Closure.

AIMS: To assess the reproducibility of interpreting hypoattenuated thickening (HAT) and peridevice leak (PDL) using cardiac computed tomography (CT) imaging following Watchman FLX left atrial appendage closure (LAAC). METHODS AND RESULTS: In this multicenter retrospective reproducibility study, 100 anonymized post-LAAC cardiac CT scans were evaluated within the same cardiac phase by an experienced and a novice rater blinded to prior evaluations. All scans were evaluated twice by each rater, assessing overall HAT and PDL categories as well as specific associated findings based on suggested algorithms for post-LAAC interpretation. Inter- and intra-rater agreement and reliability were evaluated using absolute agreement, Cohen's kappa and Kendall's tau for categorical variables, and mean difference, Bland-Altman plots, limits of agreement and intraclass correlation coefficients (ICC) for continuous variables.Within overall categories of both HAT and PDL, substantial agreement (kappa >0.61) and reliability (Kendall's tau-b  > 0.75) were observed. Specifically, identifying high-grade HAT (kappa >0.78) and distal patency (kappa >0.85) displayed the highest agreement within HAT and PDL interpretation. Meanwhile, measuring the height of the proximal screw hub cove represented the least reliable HAT assessment among both inter- and intra-rater comparisons (ICC<0.75), while suspected leak mechanism represented the least reproducible PDL measure. CONCLUSION: Despite only minimal training of one rater, overall high levels of inter- and intra-rater agreement and reliability were observed across the chosen algorithms for interpretation of HAT and PDL following Watchman FLX LAAC. Prognostic implications of the included variables are to be explored in future trials and registries.

Antithrombotic Therapy in Patients Undergoing Percutaneous Left Atrial Appendage Occlusion.

Percutaneous left atrial appendage closure (LAAC) is a valid alternative to oral anticoagulation to prevent ischemic stroke in patients with atrial fibrillation.The devices approved in Europe and United States for percutaneous LAAC contain metal and temporary antithrombotic therapy is strongly recommended following implantation to prevent thrombus formation on the atrial device surface. There is still uncertainty regarding to the optimal antithrombotic drug regimen after device implantation for several reasons. Thus, this review aims at summarizing the available evidence and the remaining challenges related to the management of antithrombotic therapy in the context of LAAC procedure.

Preprocedural cardiac computed tomography versus transesophageal echocardiography for planning left atrial appendage occlusion procedures.

The heterogeneous anatomy of the left atrial appendage (LAA) necessitates preprocedural imaging essential for planning of percutaneous LAA occlusion (LAAO) procedures. While transoesophageal echocardiography (TOE) remains the gold standard, cardiac computed tomography (CT) is becoming increasingly popular. To address the lack of consensus on the optimal imaging modality, we compared the outcomes of preprocedural TOE versus CT for LAAO procedure planning. A retrospective single-center cohort study of all LAAO procedures was performed to compare the outcomes of patients receiving preprocedural TOE versus those receiving CT. The primary outcome was procedural success and rate of major adverse events. The secondary outcomes were total procedure time, rate of device size change, and maximum landing zone diameter. A total of 64 patients was included. Of these, 25 (39.1%) underwent TOE and 39 (60.9%) underwent CT. There was no significant difference in the procedural success rate (96.0% vs. 100%, P = 0.39) or major adverse event rate (4.0% vs. 5.1%, P > 0.99) between TOE and CT patients. Compared with TOE, CT was associated with significantly shorter median procedure time (103 min vs. 124 min, P = 0.02) and a lower rate of device size change (7.7% vs. 28.0%, P = 0.04). Compared to CT, TOE was associated with a significantly smaller mean maximum landing zone diameter (20.8 mm vs. 25.8 mm, P < 0.01) and a higher rate of device upsizing (24.0% vs. 2.6%, P = 0.01). No significant difference in detected residual leak rates was found between TOE and CT (50.0% vs. 52.2%, P > 0.99). Planning of LAAO procedures with CT is associated with a shorter total procedure time and a lower rate of device size change and is less likely to underestimate the maximum landing zone diameter.

The presence of spontaneous echo contrast didn't increase the risk for left atrial appendage closure: A propensity score matching analysis based on the CLACBAC study.

Background: Left atrial appendage closure (LAAC) was effective in preventing thromboembolic events and stroke in patients with atrial fibrillation (AF). However, whether left atrial spontaneous echo contrast (LA-SEC) poses a higher risk for thromboembolism is contradictory. We aimed to investigate whether LA-SEC is a risk factor for thromboembolic events in patients who underwent LAAC. Methods: 258 consecutive patients who underwent successful LAAC were enrolled and divided according to the presence or absence of LA-SEC detected by transesophageal echocardiography (TEE). Propensity score matching (PSM) was used to eliminate covariate imbalances. Baseline characteristics, periprocedural details, and clinical outcomes were compared between LA-SEC and non-LA-SEC groups and PSM-matched groups. Results: Of the 258 patients enrolled, mean age was 71.8 ± 8.3 years and 59.3 % were male. LA-SEC group had a higher percentage of persistent AF and worse cardiac function. No significant difference in peri-procedure parameters was found. Through follow-up of 38.1 ± 10.7 months, the total incidence of thromboembolic events and stroke was 7.8 % and 6.6 %, respectively. Though the event-free survival rate of thromboembolic events (Log-Rank P = 0.042) and stroke (Log-Rank P = 0.010) was significantly lower in the LA-SEC group, multivariable COX regression analysis showed LA-SEC was not an independent predictor of thromboembolic events (Hazard ratio 2.073, 95 % Confidence interval 0.845-5.082, P = 0.111). Further survival analysis between PSM-matched groups with comparable baseline characteristics presented no significant difference in survival free from thromboembolic events (Log-Rank P = 0.616) and stroke (Log-Rank P = 0.312). Conclusion: Patients with LA-SEC had worse condition, while LA-SEC per se did not increase the incidence of thromboembolic events and stroke for patients who underwent LAAC.

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.

Surgical explantation of the WATCHMAN device and right atrial thrombus: a case report.

A 74-year-old male with a history of cardioembolic stroke, chronic atrial fibrillation, and cerebral hemorrhage, who had undergone left atrial appendage closure using the WATCHMAN device 1 year prior, was diagnosed with a 25-mm intra-cardiac mass in the right atrium. The patient underwent the surgical removal of the right atrial mass and the explantation of the WATCHMAN device. The WATCHMAN device was explanted with an external incision at the base of the left atrial appendage, facilitating the removal of the device and the closure of the appendage through direct suturing. The pathological examination confirmed the right atrial mass to be a thrombus. The patient was discharged on postoperative Day 13. From the perspectives of simplicity and radicality, the external approach could be a good option.

Safety and feasibility of atrial fibrillation ablation after left atrial appendage closure: A single-center experience of the left atrial appendage closure first strategy.

Background: Patients with atrial fibrillation (AF) who are not suitable for long-term anticoagulant therapy undergo percutaneous left atrial appendage closure (LAAC). The safety and feasibility of left atrial catheter ablation (CA) procedures after LAAC remain unclear. This study aimed to clarify the feasibility and safety of CA after LAAC, including in the early phase within 180 days. Methods: Characteristics and clinical outcomes of 46 patients with AF who had undergone both CA and LAAC within 2 years (mean age, 72 years; 29 men) were compared between those who had undergone CA-first (31 patients) and LAAC-first (15 patients). Results: The mean CHA2DS2-VASc and HAS-BLED scores were 4.8 and 3.3 points, respectively. The LAAC-first strategy was often used in patients with prior major bleeding and LAA thrombosis or sludge. In the LAAC-first group, the mean duration between both procedures was 212 days, and all LAAC-first patients, including seven patients in the early phase, could undergo CA without LAAC device-related complications; moreover, no cardiovascular adverse events were reported after both procedures (mean periods: 420 days). After CA post-LAAC, no device-related adverse events (device-related thrombosis, new peri-device leak appearance, peri-device leak increase, or device dislodgement) were observed, whereas, after LAAC post-CA, 3 new peri-device leak appearance events and 1 peri-device leak increase event were observed, especially patients who underwent LAAC in the early phase post-CA. Conclusion: Based on single-center experience, left atrial CA in the presence of an LAAC device implanted including the early phase was safe and feasible.

Position Statement on Cardiac Computed Tomography Following Left Atrial Appendage Occlusion.

Left atrial appendage occlusion (LAAO) is rapidly growing as valid stroke prevention therapy in atrial fibrillation. Cardiac imaging plays an instrumental role in preprocedural planning, procedural execution, and postprocedural follow-up. Recently, cardiac computed tomography (CCT) has made significant advancements, resulting in increasing use both preprocedurally and in outpatient follow-up. It provides a noninvasive, high-resolution alternative to the current standard, transesophageal echocardiography, and may display advantages in both the detection and characterization of device-specific complications, such as peridevice leak and device-related thrombosis. The implementation of CCT in the follow-up after LAAO has identified new findings such as hypoattenuated thickening on the atrial device surface and left atrial appendage contrast patency, which are not readily assessable on transesophageal echocardiography. Currently, there is a lack of standardization for acquisition and interpretation of images and consensus on definitions of essential findings on CCT in the postprocedural phase. This paper intends to provide a practical and standardized approach to both acquisition and interpretation of CCT after LAAO based on a comprehensive review of the literature and expert consensus among European and North American interventional and imaging specialists.

Watchman vs. Amulet for Left Atrial Appendage Closure: Current Evidence and Future Perspectives.

Left atrial appendage closure (LAAC) is a crucial intervention for stroke prevention in patients with non-valvular atrial fibrillation who are unsuitable for long-term anticoagulation. Amulet and Watchman are the most implanted devices worldwide for performing LAAC, and the aim of this review is to provide a comprehensive comparison focusing on their efficacy, safety, and short- and long-term outcomes. The Watchman device, the first to gain FDA approval, has been extensively studied and demonstrates significant reductions in stroke and systemic embolism rates. The Amulet device, a newer alternative, promises enhanced design features for more efficient appendage sealing. Current data highlight that both devices offer similar efficacy and safety for LAAC. While the two devices differ in terms of intraprocedural complication rates, they offer similar short- to long-term outcomes in terms of peri-device leaks, device-related thrombosis, and mortality. Both devices are indicated for patients who are unable to tolerate OAC, given their similar risk and safety profiles. Newer clinical studies are directed at establishing the efficacy of both devices as the primary method for stroke prevention in AF as an alternative to OAC.

Steerable Delivery Sheath for Left Atrial Appendage Closure in Patients With Severely Enlarged Left Atria.

Background: Enlarged left atrium (LA) is frequently identified in patients who undergo left atrial appendage closure (LAAC) and negatively affects the device's final position and intervention results. Steerable delivery sheath (SDS) could represent an option to overcome these difficulties. We aimed to assess the feasibility of SDS-assisted procedures and compare their efficacy to the standard sheath strategy. Methods: This study analyzed patients from our institution's LAAC registry who had severe LA enlargement on CT scan (index LA volume >90 mL/m2) and underwent AMULET device implantation between January 2019 and March 2023. The patients underwent postprocedural CT scan to assess the device's position, residual LAA filling, and peridevice leaks. Results: A total of 195 consecutive patients were screened and 47 (24%) met the inclusion criteria (n = 22 SDS group; n = 25 standard group). There was no difference in baseline clinical, anatomical, or procedural characteristics. The procedural technical success (96%) and complication rates (9% vs 4%; P = .59) were comparable in both groups. Post-LAAC CT scans were obtained in 19 SDS group and 22 standard group patients. We observed significantly lower incidences of residual patent LAA (26% vs 72%; P = .005), peridevice leaks (16% vs 64%; P = .004), and off-axis device position (0% vs 27%; P = .02) in SDS compared to the standard group, suggesting a better LAA sealing. Conclusions: Severe LA enlargement was frequent among LAAC candidates. In this situation, the use of SDS appears feasible and safe, leading to more efficient closures on follow-up imaging without a higher risk of periprocedural complications.

What characterizes device-related thrombosis following LAAC, if ejection fraction fails to shine?

Cardiac compartmental size depends on sex, with smaller values found in (healthy) women compared to a matched group of men. Various types of heart disease may cause dilation of the affected chamber. For example, atrial fibrillation (AF) is associated with enlarged left atrial (LA) size, often also implying increased left ventricular (LV) size. Sex-specific differences appear to persist during disease states. Thus, chamber volumes depend on both sex and the severity of the underlying disorder, and require quantification to evaluate the effect of interventions. Often, we rely on the popular performance metric ejection fraction (EF) which refers to the ratio of the minimum and maximum LV or LA volumetric values observed during the cardiac cycle. Here we discuss a sex stratified analysis of LVEF and LAEF in AF patients as treated by LA appendage closure, while comparing those with or without device-related thrombosis. Also, an alternative analysis based on primary data is presented while emphasizing its attractiveness. In any event, age- and sex-specific reference values as broadly documented for various imaging modalities should be applied to LA and LV.

Safety and effectiveness of left atrial appendage closure in atrial fibrillation patients with different types of heart failure.

BACKGROUND: Both atrial fibrillation (AF) and heart failure (HF) are common cardiovascular diseases. If the two exist together, the risk of stroke, hospitalization for HF and all-cause death is increased. Currently, research on left atrial appendage closure (LAAC) in patients with AF and HF is limited and controversial. This study was designed to investigate the safety and effectiveness of LAAC in AF patients with different types of HF. METHODS: Patients with non-valvular atrial fibrillation (NVAF) and HF who underwent LAAC in the First Affiliated Hospital of Army Medical University from August 2014 to July 2021 were enrolled. According to left ventricular ejection fraction (LVEF), the study divided into HF with reduced ejection fraction (LVEF < 50%, HFrEF) group and HF with preserved ejection fraction (LVEF ≥ 50%, HFpEF) group. The data we collected from patients included: gender, age, comorbid diseases, CHA2DS2-VASc score, HAS-BLED score, NT-proBNP level, residual shunt, cardiac catheterization results, occluder size, postoperative medication regimen, transthoracic echocardiography (TTE) results and transesophageal echocardiography (TEE) results, etc. Patients were followed up for stroke, bleeding, device related thrombus (DRT), pericardial tamponade, hospitalization for HF, and all-cause death within 2 years after surgery. Statistical methods were used to compare the differences in clinical outcome of LAAC in AF patients with different types of HF. RESULTS: Overall, 288 NVAF patients with HF were enrolled in this study, including 142 males and 146 females. There were 74 patients in the HFrEF group and 214 patients in the HFpEF group. All patients successfully underwent LAAC. The CHA2DS2-VASc score and HAS-BLED score of HFrEF group were lower than those of HFpEF group. A total of 288 LAAC devices were implanted. The average diameter of the occluders was 27.2 ± 3.5 mm in the HFrEF group and 26.8 ± 3.3 mm in the HFpEF group, and there was no statistical difference between the two groups (P = 0.470). Also, there was no statistically significant difference in the occurrence of residual shunts between the two groups as detected by TEE after surgery (P = 0.341). LVEF was significantly higher in HFrEF group at 3 days, 3 months and 1 year after operation than before (P < 0.001). At 45-60 days after surgery, we found DRT in 9 patients and there were 4 patients (5.4%) in HFrEF group and 5 patients (2.3%) in HFpEF group, with no significant difference between the two groups (P = 0.357). One patient with DRT had stroke. The incidence of stroke was 11.1% in patients with DRT and 0.7% in patients without DRT (P = 0.670). There was one case of postoperative pericardial tamponade, which was improved by pericardiocentesis at 24 h after surgery in the HFpEF group, and there was no significant difference between the two groups (P = 1.000). During a mean follow-up period of 49.7 ± 22.4 months, there were no significant differences in the incidence of stroke, bleeding, DRT and HF exacerbation between the two groups. We found a statistical difference in the improvement of HF between HFrEF group and HFpEF group (P < 0.05). CONCLUSIONS: LAAC is safe and effective in AF patients with different types of HF. The improvement of cardiac function after LAAC is more pronounced in HFrEF group than in HFpEF group.

Efficacy of four different left atrial appendage closure techniques during cardiac surgery-A transesophageal echocardiography follow-up study.

Objective: Closure of the left atrial appendage (LAA) is a routine part of atrial fibrillation ablation surgery and significantly reduces stroke rates. Different LAA-closure techniques are used in cardiac surgery with variable results reported. We therefore evaluated the efficacy of 4 different LAA-closure techniques in patients undergoing cardiac surgery. Methods: In total, 149 patients who underwent concomitant LAA closure during cardiac surgery between 2015 and 2019 were included in this retrospective transesophageal echocardiography study. Four different LAA-closure techniques were evaluated: LAA clipping (n = 62), suture ligation (n = 28), stapler resection (n = 30), and surgical LAA excision (n = 29). Successful LAA closure was defined as absence of LAA perfusion and absence of a stump greater than 10 mm. Results: The mean patients age was 68.7 ± 9.4 years; 61.7% were male. No complications related to LAA closure were observed. Mean follow-up was 36.5 ± 8 months. Transesophageal echocardiography follow-up showed the following LAA closure success rates: LAA clip 98.4%, surgical excision 93.1%, stapler resection 76.6%, and suture ligation 39.2%. Suture ligation resulted in a high rate of recanalization (50%) and residual stumps (10.8%), whereas stapler resection resulted in a high rate of residual stumps (23.4%). Overall, 4 patients (2.7%) had a stroke during follow-up. In detail, 2 of 27 (7.4%) patients with unsuccessful LAA closure had a stroke, whereas 2 of the 122 (1.6%) patients with successful LAA closure had a stroke. Conclusions: In our study, LAA clipping and surgical LAA excision proved to be both successful LAA-closure methods. External LAA ligation and stapler resection resulted in low rates of successful LAA closure and should be avoided.

Left Circumflex Fistula After Watchman Implantation: A Case Report of Left Atrial Appendage Closure Complication.

Left atrial appendage closure devices reduce the risk of stroke in patients with nonvalvular atrial fibrillation while avoiding the risks associated with therapeutic anticoagulation. This significant value comes with additional unique risks associated with device implantation or surgical closure. We discuss an uncommon complication of Watchman device (Boston Scientific) implantation wherein an asymptomatic fistulous connection developed between the left atrial appendage and the left circumflex artery. Additionally, we review other documented cases of left atrial appendage fistulas and current management approaches for iatrogenic fistulous connections associated with procedural left atrial appendage closure.