Watchman Left Atrial Appendage Closure Research Articles

Left atrial appendage closure in conjunction with radiofrequency ablation: Effects on left atrial functioning in patients with paroxysmal atrial fibrillation.

In the present study, we investigated the impact of left atrial appendage closure (LAAC) following catheter ablation (CA) on the left atrial structure and functioning of patients with paroxysmal atrial fibrillation (AF). Patients with paroxysmal AF were enrolled in this single-center prospective cohort study between April 2015 and July 2021; 353 patients received CA alone, while 93 patients received CA in combination with Watchman LAAC. We used age, gender, CHA2DS2-VASc, and HAS-BLED scores as well as other demographic variables to perform propensity score matching. Patients with paroxysmal AF were randomly assigned to the CA combined with Watchman LAAC group (combined treatment group) and the simple CA group, with 89 patients in each group. The left atrial structure, reserve, ventricular diastole, and pump functions and their changes in patients were assessed using routine Doppler echocardiography and 2D speckle tracking echocardiography over the course of a 1-year follow-up. At 1-week follow-up, the reserve, ventricular diastole, and pump functions of the left atrium (LA) increased in both groups; these functions were gradually restored at the 1- to 3-month follow-up; they were close to or returned to their pre-operative levels at the 3-month follow-up; and no significant differences were found compared with the pre-operative levels at the 12-month follow-up. In the first 3 months, the reserve (Ƹ, SRs) and pump functions (SRa) in the combined treatment group decreased significantly when compared with the simple CA group, and the differences were statistically significant. Patients with paroxysmal AF may experience a short term, partial effect of LAAC on LA reserve and pump functions, which are gradually restored and the effect disappears by 12 months.

Watchman device migration and embolization: A report from the NCDR LAAO Registry.

Incomplete anchoring of the Watchman left atrial appendage closure (LAAO) device can result in substantial device migration or device embolization (DME) requiring percutaneous or surgical retrieval. We performed a retrospective analysis of Watchman procedures (January 2016 through March 2021) reported to the National Cardiovascular Data Registry LAAO Registry. We excluded patients with prior LAAO interventions, no device released, and missing device information. In-hospital events were assessed among all patients and postdischarge events were assessed among patients with 45-day follow-up. Of 120 278 Watchman procedures, the in-hospital DME rate was 0.07% (n = 84) and surgery was commonly performed (n = 39). In-hospital mortality rate was 14% among patients with DME and 20.5% among patients who underwent surgery. In-hospital DME was more common: at hospitals with a lower median annual procedure volume (24 vs. 41 procedures, p < .0001), with Watchman 2.5 versus Watchman FLX devices (0.08% vs. 0.04%, p = .0048), with larger LAA ostia (median 23 vs. 21 mm, p = .004), and with a smaller difference between device and LAA ostial size (median difference 4 vs. 5 mm, p = .04). Of 98 147 patients with 45-day follow-up, postdischarge DME occurred in 0.06% (n = 54) patients and cardiac surgery was performed in 7.4% (n = 4) of cases. The 45-day mortality rate was 3.7% (n = 2) among patients with postdischarge DME. Postdischarge DME was more common among men (79.7% of events but 58.9% of all procedures, p = .0019), taller patients (177.9 vs. 172 cm, p = .0005), and those with greater body mass (99.9 vs. 85.5 kg, p = .0055). The rhythm at implant was less frequently AF among patients with DME compared to those without (38.9% vs. 46.9%, p = .0098). While Watchman DME is rare, it is associated with high mortality and frequently requires surgical retrieval, and a substantial proportion of events occur after discharge. Due to the severity of DME events, risk mitigation strategies and on-site cardiac surgical back-up are of paramount importance.

Abstract WP168: Percutaneous Left Atrial Appendage Closure Device For Patients With Atrial Fibrillation In New York

Introduction: Trials have shown that WATCHMAN left atrial appendage closure (LAAC) for stroke is noninferior to oral anticoagulation (OAC) for stroke prevention in patients with atrial fibrillation (AF). Since the approval of WATCHMAN, real world clinical outcome of LAAC is still limited. We performed a state wide analysis to evaluate clinical outcomes for AF patients undergo LAAC. Methods: Using the Healthcare Cost and Utilization Project (HCUP) State Inpatient Database, we included New York state adult patients, who had AF diagnosis with and without LAAC procedure from 2011 to 2017. Patients who had acute ischemic stroke (AIS) or history of AIS prior or during index admission were excluded. AF, AIS and other diagnosis were identified based on standard ICD-9 CM and ICD-10 CM codes. We compared rates of AIS, intracranial hemorrhage (ICH) and death between patients with and without LAAC. We also constructed a Cox regression model to determine hazard ratios (HR) of LAAC associated with each outcome. Results: Of the 627,972 patients with AF admitted, the mean age was 75.8 and 33.1% were female, and 773 (0.1%) underwent LAAC. AIS readmission occurred in 0.030% of AF patients without LAAC while it occurred in 0.012% of patients underwent LAAC. In the Cox regression model, LAAC had similar AIS readmission (HR 0.84, 95% CI 0.44-1.62, P = 0.602) and ICH readmission (HR 1.688, 95% CI 0.63-4.50, P = 0.296), but LAAC was associated with less death (HR 0.295, 95% CI 0.20-0.43, P &lt; 0.001). These outcomes remained the same despite adjustment with common risk factors and insurance type, or adjustment with CHADS 2 VASC 2 scores. In sensitivity analysis, after restricting to patients that had ICH prior to index admission, LAAC again had similar AIS readmission (HR 1.884, 95% CI 0.26-13.46, P = 0.528) compared to non-LAAC group but still marginally associated with less death (HR 0.289, 95% CI 0.07-1.16, P = 0.080). Conclusion: In New York state, AF patients underwent LAAC procedural are less likely to have death during follow up despite adjustment of common risk factors or CHADS 2 VASC 2 score, while AIS and ICH readmission appears to be similar. However, given potential underlying confounding by treatment indication, these findings need confirmation by ongoing randomized control trials.

Multicenter registry of the Watchman left atrial appendage closure device for patients with atrial fibrillation in Japan: The TERMINATOR registry

Abstract Funding Acknowledgements Type of funding sources: Private grant(s) and/or Sponsorship. Main funding source(s): Boston Scientific Japan Background Transcatheter left atrial appendage closure (LAAC) provides an alternative to oral anticoagulation for thromboembolic risk reduction in patients with nonvalvular atrial fibrillation (AF). A meta-analysis of previous two randomized trials reported improved rates of hemorrhagic stroke, cardiovascular/unexplained death, and nonprocedural bleeding compared to warfarin (1). Recently, the next-generation LAAC device, the Watchman FLX system, became available, and showed a low incidence of adverse events and a high incidence of anatomic closure (2). This transcatheter stroke prevention has already been approved in Asian countries. However, there is little data of LAAC in Asian population. Purpose This study sought to assess efficacy and safety of LAAC for patients with nonvalvular AF in Asia. Methods The TERMINATOR (Transcatheter Modification of Left Atrial Appendage by Obliteration with Device) registry is a multicenter nonrandomized study in Japan. This enrolled patients who underwent LAAC in 23 Japanese institutions. The LAAC was indicated for patients with nonvalvular atrial fibrillation in whom oral anticoagulation is required, but who have a risk of bleeding (history of BARC type 3 bleeding or HAS-BLED score ≥3 points). Baseline patient and procedural characteristics and clinical outcomes were evaluated. Results A total of 729 patients were enrolled between September 2019 and November 2021. The mean age was 74.9±8.8 years and the mean CHA2DS2-VASc score was 4.7±1.5. The Watchman generation 2.5 and FLX system were used in 469 (64.3%) and 260 patients (35.7%), respectively. Procedural success was achieved in 722 patients (99.0%). In-hospital adverse events were as follows; 6 tamponades (0.8%), 3 pericardial effusion (0.4%), 2 device embolization (0.3%), no stroke (0%), and no death (0%). During follow-up, device-related thrombus and all-cause death were reported in 16 (2.2%) and 23 patients (3.2%), respectively. Conclusions LAAC with the Watchman system provides compatible efficacy and safety outcomes in Asian population.

Sex-specific Long-term Outcomes of Watchman Left Atrial Appendage Closure for Stroke Prevention in Atrial Fibrillation

<h2>Abstract</h2><h3>Background</h3> A recent analysis of a large registry showed differences in periprocedural outcomes of the Watchman left atrial appendage closure device in males compared with females. The objective of our study was to investigate the 5-year event rate in males and females enrolled in the Watchman device premarket clinical studies submitted for US Food and Drug Administration review. <h3>Methods</h3> We conducted a patient-level meta-analysis of 2256 patients from 4 studies: the PROTECT AF (Embolic Protection in Patients with Atrial Fibrillation) and PREVAIL (Prospective Randomized Evaluation of the Watchman Left Atrial Appendage Closure Device in Patients with Atrial Fibrillation vs Long-Term Warfarin Therapy) randomized controlled trials and their continued-access registries—CAP1 (Continued Access to PROTECT AF) and CAP2 (Continued Access to PREVAIL). The outcomes evaluated were ischemic stroke (IS), IS/systemic embolism, hemorrhagic stroke (HS), and all-cause mortality. Mixed-effects Cox regression models and statistical testing for treatment-by-sex interaction were used to compare left atrial appendage closure vs warfarin in males and females. Hazard ratios adjusted (aHRs) for CHADS₂ scores were generated using the same model with CHADS₂ score as a covariate. Time-to-event end points were evaluated using the Kaplan-Meier method and log-rank test. <h3>Results</h3> For Watchman vs warfarin in the 2 randomized controlled trials, there was no significant interaction between sex and treatment for IS, IS/systemic embolism, HS, and all-cause mortality (<i>P</i> > .05); both males and females in the Watchman group had a lower aHR for HS than that in the warfarin group, which was statistically significant for males (aHR, 0.163; 95% CI, 0.045-0.593). In addition, there were no differences in outcomes between females and males treated with the Watchman device when pooling all studies. <h3>Conclusions</h3> These data suggest that sex does not significantly affect the long-term safety and effectiveness of the Watchman device in patients with nonvalvular atrial fibrillation; however, further studies are needed.

Performing transcatheter left atrial appendage closure: Techniques and challenges.

The left atrial appendage (LAA) has been demonstrated to be the major source of thromboemboli in patients with atrial fibrillation.1 The rationale of LAA closure is based on eliminating LAA continuity with the left atrium (LA), thereby reducing stroke risk. Indeed, left atrial appendage occlusion (LAAO) procedures play an important role in anticoagulation-intolerant patients who are at risk for atrial fibrillation–related stroke. Based on the PROTECT AF (Watchman Left Atrial Appendage System for Embolic PROTECTion in Patients With Atrial Fibrillation)2 and PREVAIL (Prospective Randomized Evaluation of the WATCHMAN LAA Closure Device in Patients With Atrial Fibrillation [AF] Versus Long Term Warfarin Therapy)3 studies, the Food and Drug Administration (FDA) approved use of the Watchman (Boston Scientific, Marlborough, MA) device in 2015, with an updated generation of device subsequently ratified in 2020 following the PINNACLE-FLX (Protection Against Embolism for Nonvalvular AF Patients: Investigational Device Evaluation of the Watchman FLX LAA Closure Technology) study.

Watchman device migration and embolization: a report from the NCDR LAAO registry

Abstract Background Incomplete anchoring of the Watchman left atrial appendage closure (LAAO) device can result in substantial device migration or device embolization requiring percutaneous or surgical retrieval. Purpose To report rates and characteristics of in-hospital and post-discharge Watchman device migration and embolization events in the United States. Methods We performed a retrospective analysis of Watchman procedures (January 2016 through March 2021) reported to the National Cardiovascular Data Registry LAAO Registry. We excluded patients with prior LAAO interventions, no device released, and missing device information. In-hospital events were assessed among all patients and post-discharge events were assessed among patients with 45-day follow-up. Results Of 120,278 Watchman procedures, device migration or embolization occurred in 0.07% of patients (n=84) during the index hospitalization and surgery was performed in 39 patients. The in-hospital mortality rate was 14% among patients with device migration or embolization and 20.5% among patients who underwent surgery. In-hospital migration or embolization was more common: at hospitals with a lower median annual procedure volume (24 vs. 41 procedures, p&amp;lt;0.0001), with first-generation Watchman versus next-generation Watchman FLX devices (0.08% vs. 0.04%, p=0.0048), with larger LAA ostia (median 23 mm vs. 21 mm, p=0.004), and with a smaller difference between device and LAA ostial size (median difference 4 mm vs. 5 mm, p=0.04). There were no differences by age, sex, hospital type, hospital size, or teaching versus non-teaching status. Of 98,147 patients with 45-day follow-up, device migration or embolization after discharge occurred in 0.06% (n=54) patients and cardiac surgery was performed in 7.4% (n=4) of cases. The 45-day mortality rate was 3.7% (n=2) among patients with post-discharge device migration or embolization. Post-discharge migration or embolization was more common among men (79.7% of events but 58.9% of all procedures, p=0.0019), taller patients (177.9 cm vs. 172 cm, p=0.0005), and those with greater body mass (99.9 kg vs. 85.5 kg, p=0.0055); in contrast to in-hospital events, there were no differences in hospital volume, device characteristics, or LAA characteristics. Conclusions Watchman device migration or embolization is rare but associated with high mortality (Figure 1) and frequently requires surgical retrieval. A substantial proportion of all device migration or embolization cases occur after discharge and different patient and procedure characteristics are associated with in-hospital versus post-discharge cases. Given the morbidity and mortality associated with device migration or embolization, risk mitigation strategies and on-site cardiac surgical back-up are of paramount importance. Funding Acknowledgement Type of funding sources: Public grant(s) – National budget only. Main funding source(s): National Institutes of Health

Decreased device related thrombus and enhanced neo-endocardial tissue maturation with a new generation left atrial appendage closure (LAAC) device. An anticoagulation and antiplatelet free canin study

Abstract Introduction Device related thrombus (DRT) has been reported in up to 7% of patients post LAAC even while on anticoagulation. Clinical predictors of DRT are poorly understood and may be related to patient, procedural and device factors. A next generation WATCHMAN LAAC device (NG) is identical in shape and geometry to the current WATCHMAN FLX device (CW) but has a device coating designed to make it hemocompatible and less thrombogenic. Objective To evaluate the incidence and burden of WM surface thrombus formation as detected longitudinally by TEE and at necropsy in a canine model implanted with the NG device. Methods The study included 12 canine (6 implanted with CW and 6 implanted with NG) that underwent serial TEE follow up at 14, 28 and 45 days to evaluate surface thrombus on WM face. This was a challenged canine model designed to induce thrombus with no anticoagulation or antiplatelet use throughout the study. D-dimer levels were measured at 7 days and 45 days and compared to baseline measurements. Results All devices were successfully implanted. TEE follow up at 14 days showed noticeably reduced thrombus burden on the NG device compared to CW (fig.1) with even further diminution by 28 days in the NG (6/6) as compared to only in 1/6 in the CW group (fig.2). After 45 days in-life, the post-fixation trim en-face images show a smooth, glistening neoendocardial covering (absence of acute thrombus material) in all (6/6) NG compared to only 2/6 in the CW (fig.3). The CW had 3/6 devices with exuberant, bulging calcified thrombus mass one of which was considered to be a mobile DRT. D Dimer levels at 7 and 45 days were significantly lower relative to baseline in the NG compared to CW. Conclusion The NG device compared to the CW device was associated with markedly less thrombus formation at 14 days and no thrombus formation at 28 days post implant on no anticoagulant and no antiplatelet therapy along with a more mature uniform tissue coverage at 45 days. The WATCHMAN FLX Pro device coating is a promising step to reduce DRT even without the use of anticoagulation and antiplatelets and merits further investigation in human studies. Funding Acknowledgement Type of funding sources: Private company. Main funding source(s): Boston Scientific

Left atrial appendage occlusion should be offered only to select atrial fibrillation patients.

Left atrial appendage occlusion should be offered only to select atrial fibrillation patients.

Impact of Peridevice Leak on 5-Year Outcomes After Left Atrial Appendage Closure

BackgroundIn the U.S. Food and Drug Administration (FDA) clinical trials of left atrial appendage (LAA) closure, a postimplantation peridevice leak (PDL) of ≤5 mm (PDL≤5) was accepted as sufficient LAA “closure.” However, the clinical consequences of these PDLs on subsequent thromboembolism are poorly characterized. ObjectivesWe sought to assess the impact of PDL≤5 on clinical outcomes after implantation of the Watchman device. MethodsUsing combined data from the FDA studies PROTECT-AF (Watchman Left Atrial Appendage System for Embolic Protection in Patients With Atrial Fibrillation), PREVAIL (Evaluation of the Watchman Left Atrial Appendage Closure Device in Patients With Atrial Fibrillation vs Long Term Warfarin Therapy), and CAP2 (Continued Access to PREVAIL), we assessed patients with successful device implantation for PDL by means of protocol-mandated transesophageal echocardiograms (TEEs) at 45 days and 1 year. Five-year outcomes were assessed as a function of the absence or presence of PDL≤5. ResultsThe cohort included 1,054 patients: mean age 74 ± 8.3 years, 65% male, and CHA2DS2-VASc 4.1 ± 1.4. TEE imaging at 45 days revealed 634 patients (60.2%) without and 404 (38.3%) with PDL≤5, and 1-year TEE revealed 704 patients (71.6%) without and 272 (27.7%) with PDL≤5. The presence of PDL≤5 at 1 year, but not at 45 days, was associated with an increased 5-year risk of ischemic stroke or systemic embolism (adjusted HR: 1.94; 95% CI: 1.15-3.29; P = 0.014), largely driven by an increase in nondisabling stroke (HR: 1.97; 95% CI: 1.03-3.78; P = 0.04), while disabling or fatal stroke rates were similar (HR: 0.69; 95% CI: 0.19-2.46; P = 0.56). PDL≤5 was not associated with an increased risk of cardiovascular or unexplained death (HR: 1.20; P = 0.45) or all-cause death (HR: 0.87; P = 0.42). ConclusionsPDL≤5 at 1 year after percutaneous LAA closure with the Watchman device are associated with increased thromboembolism, driven by increased nondisabling stroke, but similar mortality. (Watchman Left Atrial Appendage System for Embolic Protection in Patients With Atrial Fibrillation [PROTECT-AF; NCT00129545]; Evaluation of the Watchman Left Atrial Appendage Closure Device in Patients With Atrial Fibrillation vs Long Term Warfarin Therapy [PREVAIL; NCT01182441]; Continued Access to PREVAIL [CAP2; NCT01760291])

Comparison between Amplatzer and Watchman Left Atrial Appendage Closure Devices for Stroke Prevention in Atrial Fibrillation: A Systematic Review and Meta-Analysis

Introduction: The Amplatzer and Watchman left atrial appendage closure (LAAC) devices are the two most frequently used devices for LAAC devices worldwide. This meta-analysis aimed to compare the safety and efficacy of the two devices. Methods: We searched the PubMed, EMBASE, and the Cochrane Library for studies up to February 6, 2022 that compared the safety and efficacy of the Amplatzer and Watchman devices. Results: Fifteen studies including 2,150 patients in randomized controlled trials and 2,526 patients in observational studies were included in the meta-analysis. Amplatzer device was associated with higher rates of major procedure-related complications (odds ratio [OR]: 1.99, 95% confidence interval [CI]: 1.45–2.74, p < 0.0001) and device embolization (OR: 1.99, 95% CI: 1.09–3.64, p = 0.03). However, Amplatzer device had lower rates of total peridevice leak (PDL) (OR: 0.48, 95% CI: 0.27–0.83, p = 0.009), significant PDL (OR: 0.27, 95% CI: 0.12–0.57, p = 0.0007) and device-related thrombus (DRT) (OR: 0.67, 95% CI: 0.48–0.95, p = 0.02). No statistical differences were observed between the two devices in other safety and efficacy endpoints, such as pericardial effusion, cardiac tamponade, air embolism, vascular complications, ischemic stroke/transient ischemic attack (TIA), hemorrhagic stroke, all-cause death, cardiovascular death, and bleeding. Conclusions: Amplatzer LAAC device was associated with higher rates of major procedure-related complications, especially in device embolization. Watchman LAAC device was associated with higher rates of PDL and DRT. There were no significant differences between two devices in ischemic stroke/TIA, hemorrhagic stroke, all-cause death, cardiovascular death, and bleeding.

Impact of Left Atrial Appendage Closure Combined with Catheter Ablation on Endocrine and Mechanical Cardiac Function in Patients with Atrial Fibrillation.

Background The combined procedure of left atrial appendage closure (LAAC) and catheter ablation (CA) is a safe and feasible therapy to treat patients with atrial fibrillation (AF). However, the effect of the combined procedure on cardiac function remains unclear. This study aimed to investigate the changes in endocrine and mechanical function of the heart following the combined procedure. Methods This retrospective study included 62 consecutive patients who underwent the combined procedure of AF ablation and WATCHMAN LAAC and 62 sex and age-matched patients who only received AF ablation. During follow-up, patients were examined for brain natriuretic peptide (BNP) levels to represent endocrine cardiac function. Mechanical cardiac function was assessed during echocardiographic examination by means of the LA ejection fraction, LA strain (Ƹ), and LA strain rate (SR). Results (1) The BNP levels decreased acutely after the procedure, rose at day 3 postoperation, but trended downwards at 3 months postoperation in both groups. No significant difference was observed between the two groups. (2) LA ejection fraction, LA Ƹ, and SR exhibited a continuous upward trend over a 3-month follow-up in both groups. There was no significant difference in LA ejection fractions, SRe (the parameter of LA conduit function), and SRa (the parameter of LA booster pump function) between the two groups. However, the Ƹ and SRs (the parameters of LA reservoir function) improved in patients treated with CA alone. Conclusions The combined procedure of LAAC and CA significantly improved the endocrine and mechanical function of the heart. Compared to simple CA, based on CA with LAAC intervention, it does not significantly change LA endocrine function but may lead to a decline in the LA reservoir function.

A Comparative Study of Three Imaging Modalities for Size Selection of a Watchman Left Atrial Appendage Closure Device.

PurposeTo compare the results of computed tomography angiography (CTA), transesophageal echocardiography (TEE), and digital subtraction angiography (DSA) measurements and analyze their accuracy, correlation, and consistency in patients who have successfully undergone left atrial appendage closure (LAAC).Materials and MethodsA total of 157 non-valvular atrial fibrillation (AF) patients who underwent LAAC with Watchman devices were included in the study. The maximum diameter and depth of LAA were recorded using CTA, TEE, and DSA. Correlations and agreements were compared.ResultsThe LAAC procedure was performed successfully in all patients using the Watchman device. There was no significant difference between DSA and TEE measurements of the diameter of the LAA ostium. LAA ostium diameter obtained by CTA, however, was greater than that from DSA and TEE. Correlations were good between LAA ostium diameter measured by TEE, CTA, and DSA and Watchman device size. DSA measurements and actual device size showed the widest limits of agreement, followed by TEE; CTA measurements showed the narrowest limits of agreement. For LAA depth measurements, mean CTA measurements were higher than those of TEE and DSA. There was no significant difference in depth measurements among the three imaging modalities.ConclusionCTA, TEE, and DSA measurements exhibited good correlations with Watchman device size. The ostium diameter and depth of the LAA measured by CTA were greater than those measured by TEE and DSA. The relevance and concordance of CTA measurements were the strongest.

Comparison between Amulet and Watchman left atrial appendage closure devices: A real-world, single center experience.

BackgroundData reporting a head-to-head comparison between Amulet and Watchman devices are scarce. The aim of this study was to compare the Watchman™ versus Amulet™ left atrial appendage closure (LAAC) devices in a consecutive, industry-independent registry.MethodsPatients who underwent LAAC using Watchman or Amulet devices from January 2014 to December 2019 at the University Heart Center Lübeck, Lübeck, Germany were included in the present analysis. Primary endpoints included periprocedural complications (in-hospital death, pericardial tamponade, device embolization, stroke, major bleeding and vascular access complications), and complications during long-term follow-up (ischemic stroke, hemorrhagic stroke, thromboembolism, device thrombus, bleeding and death).ResultsAfter matching the patients for age (±5 years), gender, CHA2DS2Vasc score (±1) and HASBLED score (±1), each of the Watchman and the Amulet groups included 113 patients. Patients in the Amulet group had significantly more periprocedural complications (2.7% vs 10.6%, p = 0.029; respectively) and more major bleeding complications (0% vs 5.3%, p = 0.029; respectively). During long-term follow-up, the rate of events was comparable between the Watchman and Amulet groups (18.3% versus 20.8%, p = 0.729; respectively).ConclusionAmulet LAAC device was associated with increased periprocedural complications as compared to Watchman LAAC device. On long-term follow-up, both devices showed comparable efficacy and safety.

Value of detecting peri-device leak and incomplete endothelialization by cardiac CT angiography in atrial fibrillation patients post Watchman LAAC combined with radiofrequency ablation.

ObjectivesTo explore the value of detecting the peri‐device leak (PDL) and device endothelialization after left atrial appendage closure (LAAC) by cardiac computed tomography (CT) in patients with atrial fibrillation (AF), who underwent Watchman LAAC combined with radiofrequency ablation of atrial fibrillation (AFCA).MethodsPatients with symptomatic drug‐refractory atrial fibrillation at high risk of stroke (CHA2DS2‐VASc Score ≥ 2), who underwent Watchman LAAC combined with AFCA in our center from March 2017 to December 2018 were enrolled. Maximum diameter of LAA orifice was determined by preoperative CCTA. A standardized view of Watchman device was obtained by postoperative CCTA multiplannar reconstruction to evaluate the PDL and device endothelialization.ResultsApproximately 84 patients post successful LAAC and AFCA were enrolled in this study. The satisfactory LAA occlusion rate was 100%. There was no death, bleeding, stroke, and device‐related thrombus (DRT) events. At 6‐month postprocedure, CCTA images evidenced complete endothelialization in 44 patients (no contrast enhancement in LAA); contrast enhancement in LAA and visible PDL in 33 patients; contrast enhancement in LAA but without PDL in seven patients (incomplete device endothelialization). Maximum diameter of LAA orifice could independently predict the occurrence of PDL (odds ratio, 1.31; 95% confidence interval, 1.11–1.55; p = .002), sensitivity was 69.7% and specificity was 80.4% with the cutoff value of maximum diameter of LAA orifice more than 28.2 mm on predicting PDL.ConclusionsCCTA is feasible to evaluate PDL and device endothelialization after LAAC. The maximum diameter of LAA orifice derived from CT can independently predict the occurrence of post‐LAAC PDL.

Impact of conscious sedation and general anesthesia on periprocedural outcomes in Watchman left atrial appendage closure.

Transcatheter left atrial appendage closure (LAAC) is performed either in conscious sedation (CS) or general anesthesia (GA), and limited data exist regarding clinical outcomes for the two approaches. The aim of the study was to analyze the effect of CS versus GA on acute outcomes in a large patient cohort undergoing LAAC with a Watchman occluder. A cohort of 521 consecutive patients underwent LAAC with Watchman occluders at two centers (REGIOMED hospitals, Germany) between 2012 and 2018. One site performed 303 consecutive LAAC procedures in GA, and the other site performed 218 consecutive procedures in CS. The safety endpoint was a composite of major periprocedural complications and postoperative pneumonia. The efficacy endpoint was defined as device success. After a 1:1 propensity score matching, 196 (CS) vs. 115 (GA) patients could be compared. In 5 (2.6%) cases CS was converted to GA. The primary safety endpoint (3.5% [CS] vs. 7.0% [GA], p = 0.18) and its components (major periprocedural complications: 2.5% vs. 3.5%, p = 0.73; postoperative pneumonia: 2.6% vs. 4.3%, p = 0.51) did not differ between the groups. Also, device success was comparable (96.9% vs. 93.9%, p = 0.24). In patients undergoing LAAC with the Watchman device, conscious sedation and general anesthesia showed comparable device success rates and safety outcomes. The type of anesthesia for LAAC may therefore be tailored to patient comorbidities, operator experience, and hospital logistics.

MAUDE Database Analysis of Post-Approval Outcomes following Left Atrial Appendage Closure with the Watchman Device

Left atrial appendage closure (LAAC) is an important strategy to reduce stroke risk in patients with non-valvular atrial fibrillation (AF) who are at high risk of bleeding on long-term anticoagulation. Real-world assessments of the safety of the Watchman LAAC device remain limited. The objective of this study was to determine the frequency and timing of adverse events associated with Watchman LAAC device implants performed after FDA approval. Adverse events associated with Watchman LAAC implants performed between March 2015 and March 2019 were identified through a search of the FDA Manufacturer and User Facility Device Experience (MAUDE) database. During the study period, 3,652 unique adverse events were identified. An estimated 43,802 Watchman implants were performed in the United States during the study period. The overall adverse event rate was 7.3% and the mortality rate was 0.4%. Of the 159 unique types of adverse events identified, pericardial effusion was most common (1.4%). Most adverse events (73%) occurred intraoperatively (59%) or within 1 day of the procedure (15%). However, 19% of deaths, 24% of strokes and 27% of device embolizations occurred >1 month after implantation. The rates of most Watchman-related adverse events reported in the MAUDE database were comparable to those observed in clinical trials. A majority of adverse events occurred within 1 day of implant. In conclusion, while the absolute event rates were low, a significant proportion of device embolizations, strokes, and deaths occurred >1 month after Watchman implant.

Effect of Left Atrial Appendage Closure in Combination With Catheter Ablation on Left Atrial Function for Persistent Atrial Fibrillation.

Background: A single procedure combining left atrial appendage closure (LAAC) plus catheter ablation (CA) has been proven to be safe and feasible for treating atrial fibrillation (AF). However, the influence of treatment modality on left atrial (LA) function is not thoroughly explained.Objective: We aimed to investigate the changes of LA function in persistent AF patients undergoing concomitant LAAC and CA.Methods: The study population comprised 65 patients who underwent combined AF ablation and Watchman LAAC (combined therapy group) in our center, and 65 participants of the AF simple ablation group who were matched based on sex, age, CHA2DS2-VASc score and HAS-BLED score using propensity score matching. During the 1-year follow-up period, two-dimensional echocardiography and speckle tracking echocardiography were performed to assess LA reservoir, conduit, and contractile function.Results: The combined therapy was associated with a significant improvement in the LA reservoir function with increased expansion index and strain indices, including strain and strain rate (SR) during ventricular systole. Conduit function with SR during early ventricular diastole was also improved, as was contractile function with active atrial emptying fraction and SR during atrial systole. Similarly, LA reservoir and contractile function indices all improved continuously during follow-up after catheter ablation alone. At 3 months follow-up LA reservoir and conduit function with strain indices had a tendency to improve only in the simple procedure group. At 1-year follow-up there was no significant difference in either LA volumes or strain indices between the two groups.Conclusion: Both the combined therapy group and the simple ablation group demonstrated significant improvement in LA function. Based upon the fact that LA function was improved in both groups it might be concluded that most of the effects appeared to result from ablation, not LAAC; furthermore the additional LAAC procedure did not affect the improvement of LA function after CA.

Feasibility and perioperative safety of the combined procedure of catheter ablation and watchman left atrial appendage closure

Objective: We aimed to explore the feasibility and perioperative safety of performing catheter ablation and left atrial appendage closure (LAAC) in a single (one-stop) session in patients with atrial fibrillation (AF). Methods: This study is an observational study. Consecutive AF patients who underwent the combined procedure of catheter ablation and LAAC with Watchman device of Xinhua Hospital in Shanghai between March 2017 and May 2019 were prospectively enrolled. Baseline, intra-and peri-procedural parameters were evaluated. Results: A total of 358 AF patients (189 males, (69.0±8.0) years) underwent the one-stop procedure. The CHA2DS2-VASc score was 3.2±1.5 and HAS-BLED score was 2.4±1.1, respectively in this patient cohort. Pulmonary vein isolation was achieved in all patients, while additional linear ablation was applied in 180 (50.3%) patients, yielding immediate success rate of 99.7%. Successful Watchman implantation was achieved in all patients. The perioperative serious adverse event occurred in 14 cases (3.9%). including 6 pericardial effusions (1.7%), 1 stroke (0.3%) and 5 vascular complications (1.4%), yielding procedure-related complication rate of 3.4%. In addition, 2 (0.6%) new-onset heart failures occurred postoperatively. There was no major bleeding or death during the perioperative period. Conclusions: Combined catheter ablation and LAAC can be successfully and safely performed in AF patients with high stroke risk. Follow-up data are needed to evaluate the outcome of this one-stop procedure.

Transesophageal Echocardiographic Guidance in the Implantation of a Watchman Left Atrial Appendage Closure Device.

Transesophageal Echocardiographic Guidance in the Implantation of a Watchman Left Atrial Appendage Closure Device.