Left Atrial Appendage Occlusion Devices Research Articles

Comparison of peri-device sealing and procedural outcome after LAA closure in patients with and without isolated left atrial appendage

Abstract Background Catheter-based electrical isolation of the left atrial appendage (LAA) is increasingly performed in patients with symptomatic atrial fibrillation (AF) not responding to pulmonary vein isolation (PVI). Since the electrically isolated LAA is known to be susceptible to thromboembolism, endovascular LAA occlusion (LAAO) is increasingly being used. Objective We performed a procedural and clinical outcome analysis over 12 months in patients receiving two different LAAO device systems and compared those with versus those without LAA isolation (LAAI). Methods Between 08/2021 and 10/2022 we enrolled 83 consecutive patients (median age 73.2 years; median CHA2DS2-VASc Score 3.0; 51 men [61%]) of whom 59 (71%) had LAAI and 24 (29%) no LAAI. All patients had a least one previous catheter ablation procedure of AF. LAAO was done 6 weeks after the last ablation procedure. The main indication for LAAO was the implementation of electrical LAAI. In the no-LAAI group, all patients had lost persistent LAAI. Implanted devices were Watchman FLXTM (n=30) and LAmbreTM (n=53). Pertinent procedural data, periprocedural complications, as well as peri-device leaks (PDL) at 45 days were assessed according to device type. The composite endpoints (death, TIA/stroke, device thrombus, bleeding) and the clinical impact after switch of anticoagulation therapy were assessed at 12 months follow-up. Results The distribution of LAAI/No LAAI were found in 21[70%]/9 patients treated with the Watchman device and in 38[72%]/15 patients treated with the LAmbre device (p=0.87). PDL on follow-up (f/u) TEE was observed in 13/54 LAAI patients (24%) and 10/23 No-LAAI patients (43%, p=0.089). Leak distribution (<3mm/3-5mm/>5mm/no leak) at f/u was different between LAAI groups (LAAI: 12/1/0/41; No LAAI: 5/4/1/13; p=0.027) but not between device types. The mechanisms of leaks according to device type are listed in Table 1. Procedural complications were observed in 6/59 LAAI patients and 0/24 No-LAAI patients (p=0.11). The composite endpoint of death, stroke, severe bleeding, device-related thrombus and thromboembolism was reached by a total of 2 patients (both LAAI with LAmbre device). In 9/13 LAAI-group patients (69%) with PDL (all <6 mm) the sealing effect was assumed to be incomplete with perfusion of the LAA. Post procedural anticoagulation therapy was switched after the control TEE from NOAC/VKA (8/1) to aspirin alone. None of these patients reached the composite endpoint after 12 months. Conclusions LAAO can be performed safely and efficaciously in patients with LAAI. Compared with patients without LAAI after LAAO, the occurrence of minor leaks, periprocedural complications, and composite endpoint events was not different between the two patient groups. Despite the presence of incomplete sealing with perfusion of LAA in the LAAI group, the switch in post-procedural anticoagulation seems to be safe regarding the composite endpoint after 12 months.Mechanism of PDL of the LAmbre DeviceMechanism of PDL between the LAAO types

B-38 | Propensity Matched In-Hospital Outcomes of Left Atrial Appendage Occlusion Devices in Younger vs Older Patients

B-38 | Propensity Matched In-Hospital Outcomes of Left Atrial Appendage Occlusion Devices in Younger vs Older Patients

(1193) - Percutaneous Left Atrial Appendage Occlusion Devices and Continuous Flow LVAD Thrombosis: An Occult Source of VAD Thrombosis?

(1193) - Percutaneous Left Atrial Appendage Occlusion Devices and Continuous Flow LVAD Thrombosis: An Occult Source of VAD Thrombosis?

Safety of Amulet Left Atrial Appendage Occluder and Watchman Device for Left Atrial Appendage Closure in Patients With Atrial Fibrillation.

Left atrial appendage (LAA) closure is an alternative to chronic anticoagulation for stroke prevention in patients with nonvalvular atrial fibrillation. Multiple devices were used for LAA closure, with the Amplatzer Amulet LAA Occluder (Abbott,Chicago, IL, USA) and Watchman device (Boston Scientific,Marlborough, MA, USA) being the most commonly used in clinical practice. In August 2021, the FDA approved the use of the Amplatzer Amulet LAA Occluder. There is still a knowledge gap in the safety profile of the Amplatzer Amulet LAA Occluder device in comparison to the Watchman device. The aim of this study was to assess and compare the safety profile peri-procedure and post-procedure between the Amplatzer Amulet LAA Occluder and Watchman devices. Patients who underwent LAA closure using Watchman or Amulet devices from July 2015 to August 2020 at the American University of Beirut Medical Center were included in the analysis. Primary endpoints included peri-operative and post-procedural complications (thromboembolic events, bleeding complications, vascular access complications, pericardial effusion/tamponade, device positional complications and in-hospital death). The study included 37 patients (21 had Watchman devices, 16 had Amplatzer Amulet LAA Occluder devices, and 28 were men, mean age 76.57 ± 9.3 years). Seven patients developed post-procedural iatrogenic atrial septal defects (four in the Watchman group vs three in the Amulet group, p-value=0.982). Three patients developed pericardial effusion (one in the Watchman vs two in the Amulet group, p-value=0.394). Only one patient developed peri-device leak (one in the Watchman group vs none in the Amulet group, p-value=0.283). One device could not be deployed (one in the Amulet group vs none in the Watchman group, p-value=0.191). None of the patients developed in-hospital death, cardiac tamponade, device embolism, device thrombosis, stroke/transient ischemic attack (TIA), cranial bleeding, or arrhythmias after the procedure. The rate of peri-operative complications was similar between both groups. Both groups displayed low rates of adverse events in the peri-operative and post-operative periods. There was no significant difference in the safety profile of Amplatzer Amulet LAA Occluders and Watchman devices. There was a low incidence of peri-operative and post-operative adverse events with the implanted devices.

Patient Characteristics Associated With Using Transcatheter Left Atrial Appendage Occlusion Versus Oral Anticoagulants for Atrial Fibrillation.

Transcatheter left atrial appendage occlusion (LAAO) is an alternative to oral anticoagulants (OACs) for stroke prevention in patients with atrial fibrillation, but the predictors of LAAO use in routine care are unclear. We aimed to assess the utilization trends of LAAO and compare the change in characteristics of LAAO users versus OACs since its marketing. Using the US Medicare claims database (March 15, 2015, to December 31, 2020), we identified patients with atrial fibrillation, ≥65 years, and CHA2DS2-VASc score ≥2 (men) or ≥3 (women), with either first implantation of an LAAO device or initiation of OACs, including apixaban, dabigatran, rivaroxaban, edoxaban, or warfarin. Patient characteristics, measured 365 days before the first LAAO or OAC use date, were compared using logistic regression. There were 30 058 LAAO recipients (mean age, 77.74 years; female, 42.1%) and 792 600 OAC initiators (mean age, 78.48; female, 53.3%). In 2020, patients had higher odds of initiating LAAO use than in 2015 (0.52 versus 9.32%; adjusted odds ratio [aOR], 13.64 [95% CI, 12.56-14.81]). Old age (ie, >85 versus 65-75 years; aOR, 0.84 [95% CI, 0.80-0.88]), female sex (aOR, 0.74 [95% CI, 0.71-0.76]), Black race (aOR, 0.63 [95% CI, 0.58-0.68]) versus White race, and Medicaid eligibility (aOR, 0.61 [95% CI, 0.58-0.64]) were associated with lower odds of receiving LAAO. Among clinical characteristics, frailty, cancer, fractures, and venous thromboembolism were associated with lower odds of LAAO use, while history of intracranial and extracranial bleeding, coagulopathy, and falls were associated with higher odds of receiving LAAO. Among patients with atrial fibrillation receiving stroke-preventive therapy, LAAO use increased rapidly from 2015 to 2020 and was positively associated with the risk factors for OAC complications but negatively associated with old age, advanced frailty, and cancer. Black race and female sex were associated with a lower likelihood of receiving LAAO.

The use of percutaneous left atrial appendage occluder device in a patient with prior surgical ligation with incomplete exclusion: a case report

Abstract Background Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia, and the most common cause of cardioembolic stroke. The left atrial appendage (LAA) is the main source of thrombus formation in patients with AF. Therapies include use of percutaneous LAA closure devices, or surgical LAA occlusion (LAAO). Despite these options, complete closure of the LAA is not always achieved, and residual communication between the LAA and atrium may result in increased thrombus formation. Although studies have analysed the use of percutaneous measures such as coils, plugs, or second occluder device deployment in LAA with peri-device leak (PDL), use of percutaneous occlude devices in surgically occluded LAA is far less studied. Case summary We present a case of a 79-year-old female patient who underwent LAAO device deployment within a surgically occluded LAA with PDL. She underwent 27 mm LAAO device (WATCHMANTM) deployment and all the P.A.S.S. (Position, Anchor, Size, and Seal) criteria were satisfied. Only 1.4 mm PDL was present. She was continued on apixaban and aspirin post-operatively. Post-operative transoesophageal echocardiogram at 6 weeks demonstrated trivial PDL measuring 1.49 mm. Patient was continued on aspirin and clopidogrel, with discontinuation of apixaban. Discussion Percutaneous LAAO device deployment in previously surgically ligated LAA with incomplete exclusion is a potential therapeutic option for patients with AF and a high bleeding risk seeking a minimally invasive strategy, in an attempt to de-escalate anticoagulation therapy.

First-in-Human Percutaneous Removal of Left Atrial Appendage Occlusion Devices With a Novel Retrieval System

First-in-Human Percutaneous Removal of Left Atrial Appendage Occlusion Devices With a Novel Retrieval System

Development of an in vitro platform for transesophageal echocardiographic and color Doppler hemodynamic assessments of left atrial appendage occlusion devices

Abstract Introduction Device-related thrombus (DRT) remains a significant complication after left atrial appendage occlusion (LAAO) and is associated with device position. Clinical prospective study of the influence of device position on DRT is cumbersome. Purpose To establish an in vitro bench test platform that allows visual, transesophageal echocardiographic and color Doppler hemodynamic assessments of left atrial appendage occlusion devices. Methods Based on a mock circulatory system, an in vitro platform was developed to create pathophysiological environment and left atrium wall motion under atrial fibrillation condition. Results LAAO devices could be visualized in the left atrium phantom model using transesophageal echocardiography and color Doppler measurement of local blood velocity at LAAO devices were proven to be capable. Deep implantations resulted in uncovered left upper pulmonary vein ridges. In comparison to ostium-fitted device positions, deep implantations were associated with reduced velocity of blood and the local velocity in the "cul-de-sac" remained lower than the critical threshold of 0.2 m/s. Conclusions An in vitro platform was developed that allows transesophageal echocardiographic and color Doppler hemodynamic assessments of left atrial appendage occlusion devices.

In-hospital safety of catheter based left atrial appendage closure in Germany 2016 - 2020

Abstract Background New catheter based left atrial appendage (LAA) occlusion devices were introduced in the past decade. Catheter based LAA occlusion can be performed through a permanently implanted intracardiac LAA occlusion device or a loop stitch around the base of the LAA via an additional pericardial access. Knowledge about recent in-hospital safety trends and center volume dependent outcomes is limited. Methods Catheter based LAA closures in Germany were identified via ICD and OPS codes from 2016 - 2020. Adjusted risk differences for loop stitch procedures were calculated using an inverse probability weighting approach taking into account 17 predefined baseline characteristics. Center volume dependent outcomes were calculated using a risk adjusted logistics regression analysis taking into account the same predefined baseline characteristics. Results 28 039 permanently intracardiac implanted LAA occlusion device procedures and 213 loop stitch LAA occlusions were performed from 2016 - 2020. Numbers of permanently implanted occlusion device procedures increased from 5 259 in 2016 to 5 917 in 2020 (p = 0.020) without a significant trend for in-hospital safety parameters. Risk adjusted logistic regression analysis of center volume depended MACCE and pericardial puncture for permanently implanted occlusion devices did not show a significant trend. Patients receiving the loop stitch procedure were younger (76.17 +/- 8.16 vs. 73.16 +/- 8.99, p < 0.001), had a lower comorbidity index (2.29 +/- 1.93 vs. 1.92 +/- 1.64, 0.005) and less previous myocardial infarctions (7.82 % vs. 3.29 %, p = 0.014) or cardiac surgeries (12.34 % vs. 6.57 %, p = 0.011). Adjusted risk difference of pericardial effusion (8.04 %; 95% CI: 3.01 % – 13.08 %; p = 0.002) and pericardial puncture (6.60 %; 95% CI: 3.85 % – 9.35 %; p < 0.001) was higher for the LAA loop stitch procedure, while risk of bleeding (-1.85 %; 95% CI: -3.01 % to -0.69 %; p = 0.002), intracerebral bleeding (-0.37 %; 95% CI: -0.59 % to -0.15 %; p = 0.001) and shock (-1.41 %; 95% CI: -2.44 % to -0.39 %; p = 0.007) was lower. No significant difference was observed for in-hospital MACCE. Conclusions Permanently implanted occlusion devices were the major catheter based LAA closure procedure in Germany without improvements in in-hospital safety from 2016 – 2020. Center volumes did not influence in-hospital MACCE and pericardial puncture for the permanently implanted LAAC devices. LAA loop stitch occlusion was used much less frequently and was associated with a higher risk of pericardial effusion and pericardial puncture, a lower risk of bleeding and shock and no significant risk difference in MACCE.

Effect of left atrial appendage occlusion device type and position on potential determinants of device-related thrombus

Abstract Introduction Device-related thrombus (DRT) after left atrial appendage occlusion (LAAO) is potentially linked to adverse events. Clinical reports suggest an association between the device type/position and the DRT risk, in-depth studies of its mechanistic basis are needed. Purpose To generate in silico model with precise geometry of LAAO devices and assess the impact of device type and position on local hemodynamics and surrogate markers of DRT risk. Methods Watchman (plug-type device) and Amulet (pacifier device) LAAO devices were modeled with precise geometry and virtually implanted in different positions into a patient-specific left atrium. Using computational fluid dynamics, the following surrogate markers of thrombogenicity were quantified: residual blood, wall shear stress (WSS) and endothelial cell activation potential (ECAP). Results In comparison to ostium-fitted device positions, deep implantations were associated with more residual blood surrounding the device (after six cardiac cycles: plug-type device 12% vs 8%; pacifier device 6% vs 5%). Furthermore, deep implantations resulted in lower average WSS that indicates increased risk in platelet adhesion (plug-type device 0.21 vs. 0.26 Pa; pacifier device 0.30 vs 0.35 Pa) and higher ECAP that represents higher potential in endothelial dysfunction (plug-type device 2.23 vs. 0.85 Pa-1; pacifier device 0.16 vs 0.10 Pa-1). For plug-type device, an off-axis orientation towards mitral valve resulted in even more residual blood (15% vs. 8%), higher ECAP (1.10 vs. 0.85 Pa-1) and a similar average WSS as compared to an ostium-fitted device position. In addition, the precise geometry of the LAAO device models allowed indication of residual blood accumulation on the device’s atrial surface surrounding the threaded insert as well as on the lateral device surface and on the left atrium tissue around the device landing zone. Similarly, low WSS and high ECAP were mostly found in these areas, suggesting an increased risk for potential thrombus in these areas, which corresponds to the clinical observational series. Conclusions This study demonstrated the effect of LAAO device type and position on potential DRT risk factors. In comparison to the plug-type device, the pacifier device showed lower blood stasis, platelet adhesion and endothelial dysfunction and, therefore, lower DRT risk. For both device types, deep implantations are associated to higher surrogate markers of DRT compared to ostium-fitted device positions. In addition, an off-axis device position of plug-type device were associated with higher DRT risk.

One-year clinical outcomes and the impact of procedural configurations in patients with left atrial appendage occlusion

Abstract Background To evaluate the long-term clinical performance, the impact of procedural configurations and post-procedure medications in atrial fibrillation patients with percutaneous left atrial appendage occlusion (LAAO). Methods The RECORD study was a prospective, all-comers registry conducted in 39 Chinese centers that consecutively enrolling patients who received LAAO between 1st April 2019 and 31st October 2020 with minimum inclusion and exclusion criteria. Events including any death, any stroke, systemic embolism and bleeding event were collected at 1 year and adjudicated by an independent clinical event committee. Cox proportional hazard models with multivariable adjustments were applied to estimate hazard ratios (HRs) for each outcome. Results Of the 3,096 participants, 3,082 successfully received an LAAO implant and 3,013 (97.8%) completed the 1-year follow-up. Participants had a high risk of stroke (mean CHA2DS2-VASc score of 4.0) and a moderate-to-high risk of bleeding (mean HAS-BLED score of 2.4). Local anesthetic was performed in 1,287 (41.6%) patients and fluoroscopy guidance in 492 (16.0%) patients. In 1295 (42.0%) cases, one-stage combination procedures of LAAO and radiofrequency ablation or cryoablation (CA) were performed. At 1 year, the composite ischemic endpoint of death, stroke, and systemic embolism occurred in 133 (4.51%) patients. Any life-threatening, disabling or major bleeding events occurred in 71 (2.36%) patients. There was no significant association between the type of anesthesia (general versus local), modality of image guidance (TEE, ICE, or fluoroscopy) with the ischemic or bleeding events. Combination procedures of LAAO plus CA was associated with a significantly lower rate of death, stroke, or systemic embolism than performing LAAO only (3.5% versus 5.2%, HRadjusted:0.69, 95%CI:0.48-0.98, P=0.041). The commonest antithrombotic strategy was OAC | APT | APT (38.1%; corresponded to medication prescribed at discharge | 45 days | 6 months), followed by OAC | OAC | APT (27.0%). Compared with OAC | APT | APT, the OAC | OAC | APT group was associated with a higher risk of life-threatening, disabling or major bleeding (1.2% versus 2.5%, HRadjusted:0.50, 95%CI: 0.25-0.99, P=0.47); whereas the risk of death, stroke and SE was numerically similar (2.9% versus 3.0%, HRadjusted:1.05, 95%CI: 0.61-1.78, P=0.867). There was no significant difference between OAC | APT | APT and OAC+APT | APT | APT groups regarding ischemic events; however, in patients with HAS-BLED ≥ 3, OAC | APT | APT was associated with lower rates of life-threatening, disabling or major bleeding events (1.1% versus 4.8%, HRadjusted:4.55, 95%CI: 1.31-15.81, P=0.017). Conclusion In Chinese centers, patients with a WATCHMAN LAAO device had low rates of ischemic and bleeding events at 1 year. One-stage combination procedures of LAAO and catheter ablation was associated with a significantly lower rate of ischemic events than performing LAAO only.Procedural configurations to outcomesPost-LAAO antithrombotic medications

Embolization of percutaneous left atrial appendage closure devices: timing, management and associated clinical outcomes

Abstract Background Percutaneous left atrial appendage occlusion (LAAO) is a good option to mitigate stroke risk in patients with atrial fibrillation. Device embolization is infrequent but a serious complication. Objectives We aim to describe timing, management and clinical outcomes of device embolization in an international multi-center registry. Methods Patient characteristics, imaging findings, procedure and follow-up data were collected retrospectively. Device embolizations were categorized according to 1) timing 2) management and 3) clinical outcomes. Results Sixty-seven centers contributed data on 125 patients who underwent LAAO and experienced device embolization at an embolization rate between 0 and 3.9 % per 100 person-years. Device embolization within the first 24 hours post-procedural occurred in 69.4% of cases. The device was left in place in three (2.8%) patients, a percutaneous retrieval was attempted in 83 (76.1%) and surgery was preferred in 23 (21.1%) patients. In 27/83 (32.5%) patients with an initial percutaneous retrieval attempt a second, additional procedure was performed, which was associated with a high mortality (death first attempt: 2.7% vs. second attempt: 18.5%, p<0.001[HS1] ). The primary outcome (bailout surgery, cardiogenic shock, and/or death) occurred in 43 (38.7%) patients. Major complications related to LAAO device embolization occurred in 39 (35.1%) patients. Conclusions The majority of device embolizations after LAAO occurs early. The percutaneous approach is often the preferred method for a first rescue attempt. Major adverse event rates, including death, are high particularly if the first retrieval attempt was not successful.

Abstract 16107: Post-Cardioversion Device-Related Thrombus in a Patient With Left Atrial Appendage Occlusion Device on Apixaban

Introduction and Importance: Current guidelines recommend against pre-procedural transesophageal echocardiogram (TEE) prior to cardioversion in atrial fibrillation patients compliant with oral anticoagulants for at least 3 weeks. The relevance of these guidelines remain unclear in those undergoing repeat cardioversion. Case Presentation: 66-year-old male with a history of atrial fibrillation and an implanted left atrial appendage occlusion device(LAAO), compliant with apixaban, presented with dyspnea and lightheadedness. He was cardioverted into sinus rhythm 10 days prior to symptom onset with TEE unremarkable for thrombus. Vitals were remarkable for tachycardia and electrocardiogram revealed that the patient converted back into atrial fibrillation. Patient was then scheduled for cardioversion. At the patient’s request, a TEE was obtained which revealed a new thrombus in the left atrium located on his WATCHMAN device. Cardioversion was canceled and patient was admitted for coumadin initiation with lovenox bridge along with neurological monitoring due to increased stroke risk. Clinical Discussion: Restoration of sinus rhythm after cardioversion can lead to thrombus formation due to atrial stunning, a transitory dysfunction of the atrial appendage and atrium.Atrial stunning occurs immediately after cardioversion and can persist for several weeks. Time-span of preceding atrial fibrillation, presence of structural cardiovascular disease, and atrial size impact severity of atrial stunning and duration of anticoagulation needed.While anticoagulation decreases the risk of thrombus formation, it does not completely eliminate it, especially in those with increased stroke risk factors. Conclusion: Atrial fibrillation patients are susceptible to thrombus formation after cardioversion.Further studies should be done to assess the need for routine TEE after cardioversion in those with increased risk for stroke on anticoagulants or who have LAAO.

Abstract 18213: Predictors of Left Atrial Appendage Occlusion Device-Related Thrombus

Background: Left atrial appendage (LAA) occlusion (LAAO) is preformed to prevent LAA thrombus and cardioembolic stroke in patients with atrial fibrillation (AF). There is however up to 4% risk of device related thrombus (DRT) on the left atrial (LA) side of LAAO device that is a cause for stroke. Predicting which patients are at high risk of DRT would enable more aggressive anticoagulation strategies and closer surveillance to prevent stroke post LAAO. Objective: To develop a risk score to predict DRT. Methods: From the LAAO registry at University of Kansas Medical Center we identified 26 patients with DRT. We chose 3 controls per case at random from other LAAO recipients without DRT. Predictor variables were obtained from transesophageal echocardiogram (TEE) reports and images, transthoracic echocardiogram reports and detailed clinical chart review. LAAO device depth was measured from the center of the device to the peak of the left atrial ridge in 45° TEE view. Results: We analyzed 26 DRT patients (age 77.7±9.7 yr, 34.6% female) and 78 controls. Univariate predictors of DRT included history of venous thromboembolism (VTE, 23.1% vs 5.1%, P=0.01), presence of spontaneous LA echocontrast (SEC) on TEE (26.9% vs 7.7%, p=0.02), implant depth >2 cm (34.6% vs 12.8%, p=0.02) and rhythm at implant being AF (50.0 % vs 11.5%, p=0.0001). Using a multivariate model with these variables we devised a risk score with 1 point each factor except 2 points for AF rhythm. A total score of ≥3 had odds ratio 13.6 (95% CI 3.8-48.4, p<0.0001) of DRT (see Tables). Discussion: We present a DRT risk score comprising history of VTE, LA SEC, implant depth >2 cm (1 point each) and AF rhythm (2 points). Score of ≥3 identified patients at high risk of DRT. This score needs to be validated in an independent dataset.

Frailty and associated outcomes in patients undergoing percutaneous left atrial appendage occlusion: findings from the NCDR LAAO registry.

Frailty is associated with significant morbidity and mortality and may have clinical implications in an advanced age population with atrial fibrillation undergoing left atrial appendage occlusion (LAAO). We sought to develop a novel frailty scale to predict worse outcomes in patients undergoing LAAO. Patients in the NCDR LAAO Registry between 2016 and 2021 receiving percutaneous LAAO devices were categorized as non-frail (0 points), pre-frail (1-3 points), or frail (4-5 points) based on a 5-point scale representing multiple domains of frailty: hemoglobin <13.0 g/dL in male, <12.0 g/dL in female; creatinine ≥1.2 mg/dL; albumin <3.5 g/dL; body mass index <20 kg/m2; and increased risk of falls. Of 57,728 patients, 44,360 (76.8%) were pre-frail and 7693 (13.3%) were frail. Compared to non-frail, pre-frail and frail patients were older, had a higher burden of co-morbidities, and more disability based on the Modified Rankin Scale. Compared to non-frail patients after adjustment, frail patients were at higher risk of in-hospital major complication (OR 1.29, 95% 1.02-1.62, p = 0.01), any complication (OR 1.29, 95% CI 1.09-1.52, p = 0.0005), and death (OR 5.79, 95% CI 1.75-19.17, p = 0.001), while no difference was observed in pre-frail patients. At 45-day follow-up, there was no difference in the risk of complications in frail patients as compared to non-frail, although mortality was significantly higher (OR 3.01, 95% CI 1.97-4.85, p < 0.0001). A simple and practical frailty scale accurately predicts adverse events in patients undergoing LAAO. The 13% of patients considered frail were at significantly higher risk of in-hospital adverse events and 45-day mortality.

Intracardiac vs Transesophageal Echocardiography for Left Atrial Appendage Occlusion With Watchman FLX in the U.S.

BackgroundIntraprocedural imaging is critical for device delivery in transcatheter left atrial appendage occlusion (LAAO). Although pivotal trials of LAAO devices were conducted using transesophageal echocardiography (TEE), intracardiac echocardiography (ICE) is an emerging imaging modality. ObjectivesThis study compared outcomes after ICE- and TEE-guided Watchman FLX implantation in the SURPASS (SURveillance Post Approval AnalySiS Plan) nationwide LAAO registry. MethodsBaseline characteristics were compared using chi-square and t-tests. Outcomes were reported in unadjusted and adjusted comparisons via propensity weighting. ResultsBetween August 2020 and September 2021, LAAO was attempted in 39,759 patients at 698 sites, including 2,272 cases (5.7%) with ICE and 31,835 (80.0%) with TEE. ICE and TEE patients had similar baseline characteristics and mean procedural times (ICE 82 minutes vs TEE 78 minutes). ICE patients were less likely to receive general anesthesia (54% vs 98%, P < 0.01). Successful device implantation (98.3% vs 97.6%) and complete seal rates at 45 days were similar (n = 25,280; 83% vs 82%). Most adverse event rates were similar; unadjusted mortality rates at 45 days were 1.1% for ICE vs 0.8% for TEE (P = 0.14), and 1.0% vs 0.7% (P = 0.27) in adjusted analyses. Even after adjustment, pericardial effusion rates requiring intervention were significantly higher with ICE at 45 days (1.0% vs 0.5%; P = 0.02). This rate decreased as operators performed more ICE-guided procedures, although 82% of operators had performed <10 ICE-guided procedures overall. ConclusionsIn the largest comparison to date, ICE use was infrequent. ICE and TEE both achieved high rates of complete LAAO. ICE was associated with significantly higher rates of pericardial effusion requiring intervention.

Clinical Implications of CT-detected Hypoattenuation Thickening on Left Atrial Appendage Occlusion Devices.

Background At follow-up CT after left atrial appendage occlusion (LAAO), hypoattenuation thickening (HAT) on the atrial aspect of the device is a common finding but the clinical implications require further study. Purpose To assess the association of HAT grade at follow-up CT with clinical characteristics and outcomes in patients who underwent LAAO. Materials and Methods This prospective study included consecutive participants with atrial fibrillation and who were at high risk for stroke (CHA2DS2-VASc score ≥4) who underwent LAAO and were administered pacifier or nonpacifier devices at two French medical centers between January 2012 and November 2020. Postprocedure CT images were evaluated by two radiologists in consensus and device-specific interpretation algorithms were applied to classify HAT as low grade (low suspicion of thrombosis) or high grade (high suspicion of thrombosis). The association between HAT grade and clinical characteristics was assessed using multinomial logistic regression, and variables associated with risk of stroke were assessed using a Cox proportional hazard model. Results This study included 412 participants (mean age, 76 years ± 8 [SD]; 284 male participants) who underwent follow-up CT at a mean of 4.2 months ± 1.7 after LAAO. Low-grade and high-grade HAT were depicted in 98 of 412 (23.8%) and 21 of 412 (5.1%) participants, respectively. High-grade HAT was associated with higher odds of antithrombotic drug discontinuation during follow-up (odds ratio, 9.5; 95% CI: 3.1, 29.1; P < .001), whereas low-grade HAT was associated with lower odds of persisting left atrial appendage patency (odds ratio, 0.46; 95% CI: 0.27, 0.79; P = .005). During a median follow-up of 17 months (IQR, 11-41 months), stroke occurred in 24 of 412 (5.8%) participants. High-grade HAT was associated with stroke (hazard ratio, 4.6; 95% CI: 1.5, 14.0; P = .008) and low-grade HAT (P = .62) was not. Conclusion Low-grade HAT was a more common finding at CT performed after LAAO CT (24%) than was high-grade HAT (5%), but it was associated with more favorable outcomes than high-grade HAT, which was associated with higher stroke risk. © RSNA, 2023 Supplemental material is available for this article. See also the editorial by Choe in this issue.

Quality and transparency of evidence for implantable cardiovascular medical devices assessed by the CORE-MD consortium.

The European Union Medical Device Regulation 2017/745 challenges key stakeholders to follow transparent and rigorous approaches to the clinical evaluation of medical devices. The purpose of this study is a systematic evaluation of published clinical evidence underlying selected high-risk cardiovascular medical devices before and after market access in the European Union (CE-marking) between 2000 and 2021. Pre-specified strategies were applied to identify published studies of prospective design evaluating 71 high-risk cardiovascular devices in seven different classes (bioresorbable coronary scaffolds, left atrial appendage occlusion devices, transcatheter aortic valve implantation systems, transcatheter mitral valve repair/replacement systems, surgical aortic and mitral heart valves, leadless pacemakers, subcutaneous implantable cardioverter-defibrillator). The search time span covered 20 years (2000-21). Details of study design, patient population, intervention(s), and primary outcome(s) were summarized and assessed with respect to timing of the corresponding CE-mark approval. At least one prospective clinical trial was identified for 70% (50/71) of the pre-specified devices. Overall, 473 reports of 308 prospectively designed studies (enrolling 97 886 individuals) were deemed eligible, including 81% (251/308) prospective non-randomized clinical trials (66 186 individuals) and 19% (57/308) randomized clinical trials (31 700 individuals). Pre-registration of the study protocol was available in 49% (150/308) studies, and 16% (48/308) had a peer-reviewed publicly available protocol. Device-related adverse events were evaluated in 82% (253/308) of studies. An outcome adjudication process was reported in 39% (120/308) of the studies. Sample size was larger for randomized in comparison to non-randomized trials (median of 304 vs. 100 individuals, P < .001). No randomized clinical trial published before CE-mark approval for any of the devices was identified. Non-randomized clinical trials were predominantly published after the corresponding CE-mark approval of the device under evaluation (89%, 224/251). Sample sizes were smaller for studies published before (median of 31 individuals) than after (median of 135 individuals) CE-mark approval (P < .001). Clinical trials with larger sample sizes (>50 individuals) and those with longer recruitment periods were more likely to be published after CE-mark approval, and were more frequent during the period 2016-21. The quantity and quality of publicly available data from prospective clinical investigations across selected categories of cardiovascular devices, before and after CE approval during the period 2000-21, were deemed insufficient. The majority of studies was non-randomized, with increased risk of bias, and performed in small populations without provision of power calculations, and none of the reviewed devices had randomized trial results published prior to CE-mark certification.

Impact of Device Implant Depth After Left Atrial Appendage Occlusion

BackgroundDevice-related thrombus (DRT) remains one of the main concerns after left atrial appendage occlusion (LAAO). Several risk factors have been proposed, but most cannot be modulated. A modifiable factor such as device implantation depth is a potential target to adjust the risk for DRT. ObjectivesThe aim of this study was to assess the impact of LAAO device implantation depth as a predisposing factor for DRT. MethodsThe study included patients who underwent successful LAAO at 9 centers in Europe and Canada. Patients were classified into 2 groups: proximal device implantation (covered pulmonary ridge [PR] in the lobe and disc cohort or <5 mm from the PR in the single-lobe cohort) and distal device implantation (uncovered PR in the disc and lobe cohort and ≥5 mm in the single-lobe cohort). ResultsA total of 1,317 patients were included. Among these, proximal and distal device implantation was achieved in 732 (55%) and 585 (45%) patients, respectively. No differences in procedural outcomes were observed between the groups. At follow-up, patients with proximal implantation had a lower incidence of DRT (2.3%) than those with distal implantation (12.2%) (P < 0.001). Deeper device implantation and a larger uncovered left atrial appendage area were associated with a higher incidence of DRT (P < 0.001), regardless of device type. In multivariable analysis, distal implant (HR: 5.92; 95% CI: 3.39-10.36) and no or single antiplatelet therapy (HR: 1.62; 95% CI: 0.99-2.62) emerged as independent predictors of DRT. ConclusionsLAAO device implantation depth is an independent risk factor for DRT. Deeper device implantation and larger uncovered left atrial appendage areas were associated with a higher incidence of DRT.

Mechanisms, predictors, and evolution of severe peri-device leaks with two different left atrial appendage occluders.

Incomplete left atrial appendage occlusion (LAAO) due to peri-device leak (PDL) is a limitation of the therapy. The Amulet IDE trial is the largest randomized head-to-head trial comparing the Amulet and Watchman 2.5 LAAO devices with fundamentally different designs. The predictors and mechanistic factors impacting differences in PDLs within the Amulet IDE trial are assessed in the current analysis. An independent core lab analysed all images for the presence or absence of severe PDL (>5 mm). The incidence, mechanistic factors, predictors using propensity score-matched controls, and evolution of severe PDLs through 18 months were assessed. Of the 1878 patients randomized in the trial, the Amulet occluder had significantly fewer severe PDLs than the Watchman device at 45 days (1.1 vs. 3.2%, P < 0.001) and 12 months (0.1 vs. 1.1%, P < 0.001). Off-axis deployment or missed lobes were leading mechanistic PDL factors in each device group. Larger left atrial appendage (LAA) dimensions including orifice diameter, landing zone diameter, and depth predicted severe PDL with the Watchman device, with no significant anatomical limitations noted with the Amulet occluder. Procedural and device implant predictors were found with the Amulet occluder attributed to the learning curve with the device. A majority of Watchman device severe PDLs did not resolve over time through 18 months. The dual-occlusive Amplatzer Amulet LAA occluder provided improved LAA closure compared with the Watchman 2.5 device. Predictors and temporal observations of severe PDLs were identified in the Amulet IDE trial. https://clinicaltrials.gov Unique identifier NCT02879448.