Length of stay following percutaneous left atrial appendage occlusion: Data from the prospective, multicenter Amplatzer Amulet Occluder Observational Study

Aims To evaluate factors influencing the length of stay in patients undergoing percutaneous left atrial appendage occlusion (LAAO). Methods and results Patient characteristics, procedural data and the occurrence of serious adverse events were analyzed from the AmplatzerTM AmuletTM Occluder Observational Study. Patients were divided into three groups: same day (S, 0day, n = 60, 5.6%) early (E, 1day, n = 526, 48.9%), regular (R, 2-3days, n = 338, 31.4%) and late (L, ≥4days, n = 152, 14.1%) discharge and followed up for 60 days. Procedure and device related SAE during the in-hospital stay (S: 0.0% vs. E: 1.0% vs. R: 2.1% vs. L: 23%, p<0.0001) were a major trigger for a prolonged in-hospital stay. Of the 37 subjects in the late discharge group with an SAE prior to discharge, cardiac or bleeding complications were the most common underlying conditions, occurring in 26 subjects. Multinomial logistic analysis only identified HAS-BLED score as an independent influencing factor (p = 0.04) for a late discharge. After 60 days, mortality tended to be greatest in the late discharge group (S: 0.0% vs. E: 1.0% vs. R: 1.2% vs. L: 3.3%, p = 0.1066). Conclusion Over half of the subjects receiving an Amplatzer Amulet occluder were discharged within 1 day of the implant procedure. Serious adverse events were a major trigger for a late discharge after LAAO. Increased HAS-BLED score was associated with a prolonged in-hospital stay.

Download Full-text

Comparative data on left atrial appendage occlusion efficacy and clinical outcomes by age group in the Amplatzer™ Amulet™ Occluder Observational Study

EP Europace ◽

10.1093/europace/euaa262 ◽

2020 ◽

Author(s):

Xavier Freixa ◽

Boris Schmidt ◽

Patrizio Mazzone ◽

Sergio Berti ◽

Sven Fischer ◽

...

Keyword(s):

Observational Study ◽

Ischaemic Stroke ◽

Left Atrial ◽

Left Atrial Appendage ◽

Atrial Appendage ◽

Serious Adverse Events ◽

Left Atrial Appendage Occlusion ◽

Increased Risk ◽

The Impact

Abstract Aims Left atrial appendage occlusion (LAAO) may be considered for patients with non-valvular atrial fibrillation (NVAF) and a relative/formal contraindication to anticoagulation. This study aimed to summarize the impact of aging on LAAO outcomes at short and long-term follow-up. Methods and results We compared subjects aged <70, ≥70 and <80, and ≥80 years old in the prospective, multicentre Amplatzer™ Amulet™ Occluder Observational Study (Abbott, Plymouth, MN, USA). Serious adverse events (SAEs) were reported from implant through a 2-year post-LAAO visit and adjudicated by an independent clinical events committee. Overall, 1088 subjects were prospectively enrolled. There were 265 subjects (24.4%) <70 years old, 491 subjects (45.1%) ≥70 and <80 years old, and 332 subjects (30.5%) ≥80 years old, with the majority (≥80%) being contraindicated to anticoagulation. As expected, CHA2DS2-VASc and HAS-BLED Scores increased with age. Implant success was high (≥98.5%) across all groups, and the proportion of subjects with a procedure- or device-related SAE was similar between groups. At follow-up, the observed ischaemic stroke rate was not significantly different between groups, and corresponding risk reductions were 62, 56, and 85% when compared with predicted rates for subjects <70, ≥70 and <80, and ≥80 years old, respectively. Major bleeding and mortality rates increased with age, while the incidence of device-related thrombus tended to increase with age. Conclusions Despite the increased risk for ischaemic stroke with increasing age in AF patients, LAAO reduced the risk for ischaemic stroke compared with the predicted rate across all age groups without differences in procedural SAEs.

Download Full-text

Clinical outcomes of patients undergoing percutaneous left atrial appendage occlusion in general anaesthesia or conscious sedation: data from the prospective global Amplatzer Amulet Occluder Observational Study

BMJ Open ◽

10.1136/bmjopen-2020-040455 ◽

2021 ◽

Vol 11 (3) ◽

pp. e040455

Author(s):

Kerstin Piayda ◽

Katharina Hellhammer ◽

Jens Erik Nielsen-Kudsk ◽

Boris Schmidt ◽

Patrizio Mazzone ◽

...

Keyword(s):

Observational Study ◽

General Anaesthesia ◽

Left Atrial ◽

Left Atrial Appendage ◽

Conscious Sedation ◽

Structural Heart Disease ◽

Atrial Appendage ◽

Serious Adverse Events ◽

Left Atrial Appendage Occlusion ◽

Procedure Duration

Objective To evaluate the safety and efficacy of percutaneous left atrial appendage occlusion (LAAO) using conscious sedation (CS). Background Several percutaneous structural heart disease interventions are safely and efficiently performed using CS instead of general anaesthesia (GA). This concept has not been evaluated in a large multicenter cohort of patients undergoing LAAO. Methods Patients from the prospective, global Amplatzer Amulet Occluder Observational Study were divided into two groups (GA vs CS). Baseline information, periprocedural and postprocedural efficacy and complications, as well as outcomes through 7 days post implant were compared. Results Patients undergoing transesophageal-guided implants were categorised by GA (n=607, 64%) or CS (n=342, 36%) usage. Mean age was 75 years in both groups. LAAO technical success was achieved in 99% of both groups. The procedure duration (GA: 35±22 min vs CS: 27±19 min, p<0.001), total amount of contrast medium (GA: 105±81 mL vs CS: 86±66 mL, p<0.001) and fluoroscopic time (GA: 13±9 min vs CS: 12±13 min, p<0.001) were less in CS cases. Procedure-related or device-related serious adverse events during the first 7 days were numerically higher in the CS group (GA: 4.9% vs CS: 7.6%, p=0.114). Peridevice residual flow was absent or ≤5 mm 1–3 months after the procedure in 99.7% of the GA and in 100% of the CS group (p=1.000). Conclusions In a large global study, LAAO with the Amplatzer Amulet occluder is safe and feasible using CS. Procedure duration and total amount of contrast were less with CS than GA cases. Trial registration number NCT02447081; Results.

Download Full-text

Abstract 17419: Gender Differences in Outcomes With Patients Undergoing Percutaneous Left Atrial Appendage Occlusion: Insights From the NCDR LAAO Registry

Circulation ◽

10.1161/circ.142.suppl_3.17419 ◽

2020 ◽

Vol 142 (Suppl_3) ◽

Author(s):

Douglas J Darden ◽

Thao Duong ◽

Mohamad B Munir ◽

Frederick Han ◽

Ryan Reeves ◽

...

Keyword(s):

Atrial Fibrillation ◽

Adverse Events ◽

Hospital Stay ◽

Left Atrial ◽

Left Atrial Appendage ◽

Atrial Appendage ◽

Uncontrolled Hypertension ◽

Major Bleed ◽

Left Atrial Appendage Occlusion ◽

Data Registry

Introduction: Left atrial appendage occlusion (LAAO) has emerged as an alternative to anticoagulation in select patients with atrial fibrillation (AF), however women are underrepresented in trial data and sex-specific sub analyses are limited. Hypothesis: Women will be more likely than men to experience adverse events following left atrial appendage occlusion (LAAO) procedure. Methods: Using the National Cardiovascular Data Registry LAAO Registry, patients undergoing Watchman implantation between January 2016 and December 2018 were included. Unadjusted and multivariable adjusted logistic regression analyses were performed to assess the association between gender and in-hospital outcomes, including any complication, major adverse events (pericardial effusion, major bleeding, stroke, and device embolization), hospital stay > 1 day, and mortality. Results: A total of 20,388 (41.3%) women and 28,969 (58.7%) men underwent Watchman implantation. Compared with male patients, women were older (76.5 vs 75.8 years, p<0.001) with a higher CHA2DS2-VASc score (1.5 vs 1.4, p<0.001), and higher prevalence of paroxysmal atrial fibrillation (59.0% vs 50.0%, p<0.001), prior stroke (27.5% vs 26.7%, p=0.003) and uncontrolled hypertension (29.3% vs 26.7%, p<0.001). Women had a lower prevalence of congestive heart failure (34.5% vs 39.7%, p<0.001), diabetes (34.8 vs 39.7%, p<0.001), and coronary artery disease (35% vs 55.7%, p<0.001). There were no differences with increased thromboembolic risk or history of major bleed, while women were more likely to have a high fall risk (39.8% vs 33.5%, p<0.001) and labile INR (9.1% vs 8.3%, p=0.003) as an indication for occlusion. After multivariable adjustment, women were more likely to have any complication (OR 1.62, 95% CI 1.62 - 1.77, p<0.001), major adverse event (OR 1.81, 95% CI 1.61 - 2.04, p<0.001), hospital stay >1 day (OR 1.46, 95% CI 1.38 - 1.54, p<0.001), and higher mortality (2.01, 95% CI 1.31 - 3.09, p=0.001). Conclusion: Women have a significantly higher risk than men of in-hospital adverse events and mortality following Watchman implantation. Further examination of the risk-benefit relationship of LAAO in women is warranted.

Download Full-text

Outcome of left atrial appendage occlusion in high-risk patients

Heart ◽

10.1136/heartjnl-2017-312383 ◽

2017 ◽

Vol 104 (7) ◽

pp. 594-599 ◽

Cited By ~ 7

Author(s):

Ahmed Masoud ◽

Stefano Bartoletti ◽

Timothy Fairbairn ◽

Ayush Khurana ◽

Periaswamy Velavan ◽

...

Keyword(s):

Atrial Fibrillation ◽

Adverse Events ◽

Stroke Prevention ◽

Left Atrial ◽

Left Atrial Appendage ◽

Atrial Appendage ◽

Complication Rates ◽

Serious Adverse Events ◽

Risk Patients

ObjectivePercutaneous left atrial appendage (LAA) occlusion can be an interventional alternative to oral anticoagulation for stroke prevention in patients with atrial fibrillation.MethodsWe delivered LAA occlusion therapy using a standardised approach to patient referral, multidisciplinary team assessment, implant criteria, imaging and follow-up. We analysed patient characteristics, efficacy and safety of the implant procedure, and 12-month outcomes.ResultsOf 143 referrals from October 2014 to December 2016, 83 patients (age 76±8years, 32.5% female, mean CHAD2S2-VASc score 4 ±1) were offered LAA occlusion. Eighty (95.3%) had previous major bleeding (intracranial in 59%). LAA occluder implantation with an Amulet device was successful in 82 (98.8%), with periprocedural major adverse events occurring in 5 (6.0%) patients (2 device embolisations including 1 death, 2 major bleeds). Cardiac imaging in 75 (94%) patients 2months following implant showed device-related thrombus in 1 case (1.3%) and minor (<5mm) device leaks in 13 (17.1%). Over a median 12-month follow-up, 3 (3.8%) ischaemic strokes, 2 (2.5%) haemorrhagic strokes and 5 (6.3%) major extracranial bleeds occurred. All-cause mortality was 10%, with most deaths (7, 87.5%) due to non-cardiovascular causes.ConclusionsLAA occlusion may be a reasonable option for stroke prevention inhigh-risk patients with atrial fibrillation ineligible for anticoagulation. However, procedural complication rates are not insignificant, and patients remain at risk of serious adverse events and death even after successful implant.

Download Full-text

Left atrial appendage morphology, echocardiographic characterization, procedural data and in-hospital outcome of patients receiving left atrial appendage occlusion device implantation: a prospective observational study

BMC Cardiovascular Disorders ◽

10.1186/s12872-016-0200-z ◽

2016 ◽

Vol 16 (1) ◽

Cited By ~ 8

Author(s):

Christian Fastner ◽

Michael Behnes ◽

Benjamin Sartorius ◽

Mustafa Yildiz ◽

Kambis Mashayekhi ◽

...

Keyword(s):

Observational Study ◽

Left Atrial ◽

Prospective Observational Study ◽

Left Atrial Appendage ◽

Atrial Appendage ◽

Hospital Outcome ◽

Left Atrial Appendage Occlusion ◽

Device Implantation ◽

Occlusion Device

Download Full-text

Left atrial appendage occlusion with the Amplatzer™ Amulet™ device: full results of the prospective global observational study

European Heart Journal ◽

10.1093/eurheartj/ehaa169 ◽

2020 ◽

Vol 41 (30) ◽

pp. 2894-2901 ◽

Cited By ~ 15

Author(s):

David Hildick-Smith ◽

Ulf Landmesser ◽

A John Camm ◽

Hans-Christoph Diener ◽

Vince Paul ◽

...

Keyword(s):

Adverse Events ◽

Ischaemic Stroke ◽

Major Bleeding ◽

Left Atrial ◽

Left Atrial Appendage ◽

Cardiovascular Death ◽

Atrial Appendage ◽

Stroke Rate ◽

Left Atrial Appendage Occlusion

Abstract Aims To evaluate the safety and efficacy of left atrial appendage occlusion (LAAO) with the Amplatzer™ Amulet™ occluder. Methods and results Patients with atrial fibrillation eligible for LAAO were recruited to a prospective global study. Implant procedures were undertaken with echocardiographic guidance. Transoesophageal echocardiography (TOE) was undertaken 1–3 months post-LAAO. Implant and follow-up TOEs were evaluated by a CoreLab. The primary endpoint was a composite of ischaemic stroke and cardiovascular death at 2 years. Serious adverse events were adjudicated by an independent clinical events committee. A total of 1088 patients were enrolled, aged 75.2 ± 8.5 years; 64.5% were male. CHA2DS2-VASc and HAS-BLED scores were 4.2 ± 1.6 and 3.3 ± 1.1, respectively. A total of 71.7% had prior major bleeding, and 82.8% had contraindications to oral anticoagulants. Implant success was 99.1%. Major adverse events (≤7 days post-procedure) occurred in 4.0%, including death (0.3%), stroke (0.4%), major vascular (1.3%), and device embolization (0.2%). A total of 80.2% of patients were discharged on antiplatelet therapy alone. Peridevice flow was <3 mm in 98.4% at follow-up TOE. Device-related thrombus (DRT) was seen in 1.6% of cases. Cardiovascular death or ischaemic stroke occurred in 8.7% of patients at 2 years. The ischaemic stroke rate was 2.2%/year—a 67% reduction compared to the CHA2DS2-VASc predicted rate. Major bleeding (Bleeding Academic Research Consortium type ≥ 3) occurred at rates of 10.1%/year (year 1) and 4.0%/year (year 2). Conclusion Following LAAO with the Amplatzer Amulet device, the ischaemic stroke rate was reduced by 67% compared to the predicted risk. Closure was complete in 98.4% of cases and DRT seen in only 1.6%.

Download Full-text

Periprocedural safety and efficacy after left atrial appendage closure in a large UK tertiary centre: 10-year experience

EP Europace ◽

10.1093/europace/euab116.282 ◽

2021 ◽

Vol 23 (Supplement_3) ◽

Author(s):

A Briosa E Gala ◽

MTB Pope ◽

C Monteiro ◽

M Leo ◽

TR Betts

Keyword(s):

Adverse Event ◽

High Risk ◽

Adverse Events ◽

Left Atrial ◽

Left Atrial Appendage ◽

Atrial Appendage ◽

Serious Adverse Events ◽

Safety And Efficacy ◽

Tertiary Centre ◽

Procedural Success

Abstract Funding Acknowledgements Type of funding sources: None. Introduction Left atrial appendage (LAA) thrombus is responsible for up 90% of atrial fibrillation (AF) related ischaemic strokes. Mechanical closure of the LAA is an alternative stroke prevention strategy in patients with non-valvular AF who are at a high risk of bleeding. LAA morphology is highly variable which may affect acute procedural success rates. Purpose This study sought to examine the periprocedural safety and efficacy, and short-term outcomes in patients undergoing left atrial appendage occlusion (LAAO) device implantation in a large UK tertiary centre. Methods This retrospective study included all patients listed for a LAAO device in our institution from January 2010 to December 2020. Medical notes, procedural and imaging reports were reviewed and adverse event rates were calculated at discharge, 30 and 90 days. A Cox regression model was used for multivariable analysis with pre-specified covariates to assess outcomes at 90 days. Results Of 237 patients listed for a LAAO device, 8 (3.4%) had a LAA thrombus and the procedure was abandoned (4 had a successful implant at a later date). In 225 (94.9%) patients a LAAO device was implanted and 4 (1.7%) had unsuitable anatomy precluding device deployment. Seventy-two percent were male, age 74 ± 8 years, BMI 27 ± 6 kg/m2, CHA2DS2-VASc score 4.4 ± 1.2, HASBLED score 3.2 ± 0.8 and at high risk of stroke (98 ischaemic strokes and 129 haemorrhagic strokes) and bleeding (151 major or life-threatening bleeding episodes). The mean procedural and fluoroscopy time were 52.5 ± 30.5 and 8.0 ± 5.9 minutes, respectively. Three different LAAO devices were used (136 Watchman, 54 Watchman FLX and 35 Amplatzer Cardiac Plug) with no significant difference in acute procedural success (97.8%, 98.2% and 94.4%, p = 0.41, respectively). Complete seal was achieved in 202 (92%) patients with only 1 (0.4%) moderate leak. Procedure-related mortality was 1.3% and non-fatal serious adverse events occurred in 5 (2.1%) patients. At 90 days, 28 patients experienced an adverse event (KM 12.5%; 95% CI, 8%-16.1%) and 16 patients suffered a serious adverse event (KM 7.1%; 95% CI, 3.7%-10.4%). In a covariate-adjusted Cox model, CHA2DS2-VASc score less than 4 had hazard ratio of 0.21 (95% CI, 0.06 -0.71, p = 0.01) for serious events at 90 days. Conclusion The acute procedural success rate was high (97%) with a low number of periprocedural complications. Serious adverse events at both 30 and 90-days were low in keeping with other published registries. Abstract Figure.

Download Full-text