Amplatzer Amulet Device Research Articles

Systematic Review of Contiguous Vessel and Valve Injury Associated with Endocardial Left Atrial Appendage Occlusion Devices.

Endocardial LAAO has been increasingly utilized in atrial fibrillation (AF) patients who are not suitable for long term oral anticoagulation. While overall procedural complications have decreased, rare complications like contiguous vessel and valve injury may be more frequently seen in the future with increase in the procedure volume. We performed a systematic search using predefined terms which reviewed all cases published in literature of contiguous vessel (pulmonary artery, pulmonary vein and left circumflex artery) and mitral valve injury caused by LAAO devices. Our results showed that Amplatzer Cardiac Plug (ACP) and Amplatzer Amulet devices were the most commonly used devices. Pulmonary artery perforation was the most commonly seen collateral vessel injury associated with LAAO. Close proximity of left atrial appendage to pulmonary artery was noted in all cases of pulmonary artery injury. Pulmonary artery injury commonly manifests as pericardial tamponade with hemodynamic collapse and is often fatal. Most common denominator of all the reviewed cases was the presence of an oversized LAAO device. In conclusion, collateral vessels and valve injury can be seen after LAAO mostly with double lobe devices such as ACP or Amulet. Increased awareness by the operators along with proper imaging and investigations could potentially mitigate such rare complications associated with LAAO.

Incidence, Characterization, and Clinical Impact of Device-Related Thrombus Following Left Atrial Appendage Occlusion in the Prospective Global AMPLATZER Amulet Observational Study

ObjectivesThis study sought to report the incidence, characteristics, and clinical impact of device-related thrombus (DRT) following left atrial appendage occlusion (LAAO) with the AMPLATZER Amulet device (Abbott, Plymouth, Minnesota). BackgroundDRT is a potential serious complication of LAAO, but the incidence and clinical impact of DRTs in a real-world setting are not well characterized. MethodsA total of 1,088 patients were enrolled in a multicenter prospective study and followed for 1 year. All events were adjudicated by an independent committee, including the presence of DRT. Patients with DRT were reviewed for suboptimal device implantation and characterization of DRT formation. Multiple Cox regression was performed to identify predictors of DRT formation. ResultsDevice implantation was successful in 1,078 (99%) patients, with 1-year follow-up completed in 96.3% of patients. A total of 18 DRTs occurred in 17 patients (1.7%/year), as a second DRT developed following complete resolution of an initial DRT in 1 patient. The left upper pulmonary vein ridge was not covered by the Amulet disc in 82% of DRT patients, indicating suboptimal implantation, with most thrombus developing in the untrabeculated area of the LAA ostium between the pulmonary vein ridge and the upper edge of the disc. Three (18%) DRT patients had an ischemic stroke, all within 3 months of DRT diagnosis. Patients with a DRT were at a greater risk for ischemic stroke or transient ischemic attack compared with non-DRT patients (hazard ratio: 5.27; 95% confidence interval: 1.58 to 17.55; p = 0.007). Larger LAA orifice width was a predictor of DRT formation (hazard ratio: 1.09; 95% confidence interval: 1.00 to 1.19; p = 0.04). ConclusionsFollowing LAAO with the AMPLATZER Amulet device, DRT was observed infrequently. Although the presence of DRT was associated with an increased rate of ischemic stroke or transient ischemic attack as compared with patients without DRT, the large majority of DRT patients (82%) did not experience any ischemic neurologic events.

Left atrial appendage closure in patients with intracranial haemorrhage and atrial fibrillation

IntroductionThe use of oral anticoagulants in patients with a history of atrial fibrillation (AF) and intracranial haemorrhage (ICH) is controversial on account of the risk of haemorrhagic stroke recurrence. This study presents our experience regarding the safety and efficacy of percutaneous left atrial appendage closure (LAAC), an alternative to anticoagulation in these patients. MethodsWe conducted a retrospective, single-centre, observational study. LAAC was performed in patients with a history of ICH and non-valvular AF. Risk of ischaemic and haemorrhagic events was estimated using the CHA2DS2-VASc and HAS-BLED scales. We recorded periprocedural complications, IHC recurrence, cerebral/systemic embolism, mortality and use of antithrombotic drugs following the procedure. ResultsLAAC was performed in 9 patients (7 men, 2 women) using the AMPLATZER Amulet device in 7 cases and the AMPLATZER Cardiac Plug device in 2. Mean age was 72.7±8.2 years. Time between ICH and LAAC was less than one month in 5 patients and more than one month in 4 patients. Median CHA2DS2-VASc score was 4 (interquartile range of 2.5). Median HAS-BLED score was 3 (interquartile range of 0). No periprocedural complications were recorded. All patients received single anti-platelet therapy (clopidogrel in 5 patients, aspirin in 4) after the procedure; 5 patients received this treatment for 6 months and 4 received it indefinitely. No ischaemic or haemorrhagic events were recorded during follow-up (mean duration of 15 months). ConclusionsIn our series, LAAC was found to be safe and effective in patients with a history of ICH who required anticoagulation due to AF.

Comparison of transesophageal and intracardiac echocardiography in guiding percutaneous left atrial appendage closure with an Amplatzer Amulet device.

IntroductionPercutaneous occlusion of the left atrial appendage (LAAO) is becoming an extensively used method of stroke prevention in individuals with contraindications to oral anticoagulants. Transesophageal echocardiography (TOE) is the gold standard for LAAO guiding, but intracardiac echocardiography (ICE) appears to be a potential alternative.AimTo compare the LAAO procedure guided by TOE or ICE with respect to procedural success and safety.Material and methodsTOE-guided LAAO was performed in 12 patients and ICE-guided LAAO in 11 patients. ICE was performed using an 8F AcuNav probe and the ACUSON SC2000 system. For LAAO the Amplatzer Amulet was used. After 1 month TOE was performed.ResultsProcedural success was achieved in all patients in TOE and ICE groups. There was 1 complication (groin hematoma). The procedure time was significantly longer in the TOE group (43 to 80 min; median: 54 min) compared to the ICE group (28 to 67 min; median: 45 min), (p = 0.02) The time needed to puncture the interatrial septum and time needed to remove the sheath did not differ between groups. Fluoroscopic time was insignificantly longer in the ICE group (9.91 ±4.01s) compared to the TOE group (7.69 ±3.21s), and a significantly larger contrast media volume was used in the ICE group (30.00 ±6.67 ml vs. 40.45 ±23.18 ml, p = 0.03). There were no statistically significant differences in the results between TOE and ICE groups in follow-up assessments.ConclusionsLAAO using the Amplatzer Amulet may be successfully and safely guided by ICE. ICE offered shorter procedure time and similar results irrespectively of left atrial appendage anatomy compared to TOE guidance.

Nonvalvular atrial fibrillation in high-hemorrhagic-risk patients: state of the art of percutaneous left atrial appendage occlusion.

: Atrial fibrillation is the most common cardiac arrhythmia and its prevalence is constantly increasing. The main complications related to atrial fibrillation are death and major stroke. Oral anticoagulant therapy is the cornerstone of management of atrial fibrillation patients at increased stroke risk. Unfortunately, a significant proportion of patients do not receive adequate anticoagulant therapy due to increased or prohibitive hemorrhagic risk. The observation that most thrombi are generated in the left atrial appendage (LAA) had led to the consideration of surgical or percutaneous occlusion as an alternative. During recent years, the WATCHMAN percutaneous occlusion device has proven to be not inferior to anticoagulant therapy for the prevention of thromboembolic events, with the added benefit of a lower rate of hemorrhagic events. Numerous data showed the same results for the AMPLATZER cardiac plug and Amulet devices. Left atrial appendage occlusion (LAAO) often represents the only therapeutic strategy in this group of patients. We describe the current state of the art of percutaneous LAAO in atrial fibrillation patients with a high hemorrhagic risk.

Rationale and design for AMPLATZER Amulet Left Atrial Appendage Occluder IDE randomized controlled trial (Amulet IDE Trial)

The Amulet IDE Trial is an ongoing, prospective, randomized, multi-national trial, designed to evaluate the safety and effectiveness of the AMPLATZER Amulet Left Atrial Appendage Occluder for stroke prevention in comparison to the WATCHMAN Left Atrial Appendage Closure Device in patients with non-valvular atrial fibrillation. METHODS: Non-valvular atrial fibrillation patients at high risk of stroke (CHADS2 score ≥2 or a CHA2DS2-VASc score of ≥3) who are suitable candidates for left atrial appendage occlusion (LAAO) will be fully informed and requested to participate in the trial. A total of 1878 patients at up to 150 sites worldwide will be randomized in a 1:1 ratio between the AMPLATZER Amulet device (investigational) and the Boston Scientific WATCHMAN device (control). Each patient will be followed for 5 years, with follow-up assessments at discharge, 45 days, 3, 6, 9, 12, 18, and 24 months and then annually. The trial has three primary endpoints: A composite of procedure-related complications, or all-cause death, or major bleeding through 12 months (safety); a composite of ischemic stroke or systemic embolism through 18 months (effectiveness); and effective device LAAO, defined as residual jet around the device ≤5 mm at the 45-day visit (mechanism of action). SUMMARY: The Amulet IDE Trial is the first randomized head-to-head LAAO device trial and will provide data for the AMPLATZER Amulet occluder in a population with a high risk of stroke and bleeding.

Relation of left atrial appendage closure devices to topographic neighboring structures using standardized imaging by cardiac computed tomography angiography.

BackgroundAlthough left atrial appendage (LAA) anatomy and topographic relations are well understood, little is known about the impairment of neighboring structures (NBS) by an implanted left atrial appendage closure (LAAC) device. This prospective longitudinal observational study for the first time describes distances of implanted LAA closure (LAAC) devices to NBS using a standardized imaging protocol of cardiac computed tomography angiography (cCTA).HypothesiscCTA imaging is an eligible tool for post‐implantation evaluation of LAAC devices and their relation to neighboring structures.MethodscCTA data sets of consecutive patients 6 months after successful LAAC were acquired on a third generation dual‐source CT system and reconstructed with a slice thickness of 0.5 mm. The standardized multi‐planar reconstruction LAA occluder view for post‐implantation evaluation (LOVE) algorithm was used to measure the distances to NBS in relation to LAA morphology and implanted LAAC devices.ResultsA total of 48 patients (median age 80 years, 25% female) were included. Left upper pulmonary vein and circumflex artery were generally closest to occlusion devices (median 2.9 and 2.8 mm, respectively). AMPLATZER AMULET devices were closer to the mitral valve annulus than WATCHMAN devices (6.6 mm (inter quartile range [IQR] 4.9‐8.6) vs 10.9 mm (IQR 7.4‐14.0), P = 0.001). Distances to the left upper pulmonary vein were affected by LAA morphology, with cauliflower type having the closest proximity (1.7 mm [IQR 1.0‐3.4], P = 0.048).ConclusionA standardized cCTA imaging protocol is an eligible tool to accurately measure distances to NBS. Left upper pulmonary vein and circumflex artery are closest to LAAC devices and could thus be most prone to impairment.

Peridevice Leak After Left Atrial Appendage Closure: Incidence, Risk Factors, and Clinical Impact

BackgroundLimited studies reported the rate and clinical impact of peridevice leaks (PDL) after percutaneous left atrial appendage closure (LAAC). MethodsAll consecutive patients with a nonvalvular atrial fibrillation admitted for LAAC between November 2011 and October 2016 were prospectively enrolled. The follow-up included clinical, transesophageal echocardiography, and/or cardiac computed tomography angiogram (CCTA). PDL was defined by the presence of contrast within the left atrial appendage on CCTA, and Major Adverse Cardiac Event (MACE) included stroke, device-related thrombosis, and cardiovascular death. ResultsOverall, 77 patients (mean CHA2DS2-VASc score = 4.4 ± 1.5 and mean HAS-BLED = 3.4 ± 1.1) were implanted using Amplatzer Cardiac Plug (n = 24), Amulet (n = 37), or Watchman devices (n = 16). Indications were stroke recurrence despite adequate oral anticoagulation (OAC, n = 6) or contraindication to long-term OAC (n = 71). From 3-month to 12-month CCTA follow-up, the PDL rate decreased from 68.5% to 56.7% (P = 0.02), without any difference between the various devices. Patients with PDL were more often in permanent atrial fibrillation, and had a larger landing zone diameter, a lower ratio of device compression, and a more frequent off-axis position of the device. A device compression ratio < 10% was the only parameter associated with PDL occurrence. During follow-up (median 236 days) the MACE rate was 9.1%, with no statistically significant difference between patients with vs without PDL (12% vs 4.3%, P = 0.3). ConclusionsThe PDL rate detected by CCTA after LAAC was high, especially in cases with a low device compression ratio (< 10%), but decreased over time. The incidence of MACE was quantitatively greater with PDL, but the difference was not statistically significant. Larger studies are needed to determine the clinical importance of PDL.

Left atrial appendage occlusion with the AMPLATZER Amulet device: one-year follow-up from the prospective global Amulet observational registry.

Left atrial appendage occlusion (LAAO) is a stroke prevention therapy for patients with non-valvular atrial fibrillation (AF). This study reports one-year outcomes from patients enrolled in the prospective global Amulet registry. A total of 1,088 patients were recruited, aged 75±9 years; 65% of patients were male. The CHA2DS2-VASc and HAS-BLED scores were 4.2±1.6 and 3.3±1.1, respectively. Eighty-three percent (83%) of patients had contraindications to anticoagulation (OAC); 72% had a history of major bleeding. An AMPLATZER Amulet LAA occluder was successfully implanted in 99% of cases. Transoesophageal echocardiography one to three months after implant showed no residual flow or flow <3 mm in 98.4%. The observed ischaemic stroke rate was 2.9%/year. Device-related thrombus was noted in 1.7% of patients. There were ten cases between 0 and 90 days and eight cases between 91 and 365 days. Patients discharged without OAC (>80%), in particular those on single aspirin therapy, did not appear to have a higher risk of device-related thrombus. In the first year, major bleeding occurred at an annualised rate of 10.3%. All-cause mortality was 8.4% at one year. In the global prospective Amulet registry of patients at high risk of stroke and bleeding, the annualised ischaemic stroke rate was 2.9%. The LAA was sealed in 98.4% after one to three months and device-related thrombus was observed in 1.7% of cases with only a minority of all patients on anticoagulation treatment.

P4579Impact of left atrial appendage morphology on procedural characteristics: a two center experience with the Amplatzer Amulet Device

P4579Impact of left atrial appendage morphology on procedural characteristics: a two center experience with the Amplatzer Amulet Device

Intracardiac Versus Transesophageal Echocardiographic Guidance for Left Atrial Appendage Occlusion: The LAAO Italian Multicenter Registry

ObjectivesThis study sought to evaluate the feasibility, safety, and efficacy of intracardiac echocardiography (ICE)–guided versus transesophageal echocardiography (TEE)–guided left atrial appendage occlusion (LAAO) by the use of Amplatzer Cardiac Plug or Amulet devices included in a large Italian registry. BackgroundTEE is widely used for LAAO procedure guidance. ICE may be a potential alternative imaging modality in LAAO. MethodsData from 604 LAAO procedures performed in 16 Italian centers were reviewed. ICE-guided LAAO was performed in 187 patients, whereas TEE was used in 417 patients. Procedural success was defined as LAAO without occurrence of pericardial tamponade, stroke, systemic embolism with end organ damage, major bleeding, and device embolization. Stroke, transient ischemic attack, major bleeding, overall and cardiovascular death were analyzed. ResultsCHA2DS2-VASc (congestive heart failure, hypertension, age ≥75 years, diabetes mellitus, prior stroke or transient ischemic attack or thromboembolism, vascular disease, age 65 to 74 years, sex category) and HAS-BLED (hypertension, abnormal renal and liver function, stroke, bleeding, labile international normalized ratio, elderly, drugs or alcohol) scores were similar between the ICE and TEE groups. TEE implied lower procedural (delta 12 min) and fluoroscopy time (delta 5 min) when compared with ICE. Procedural success was similarly high (≥94%) between the TEE and ICE groups with a complication rate of 6.5% for TEE versus 4.2% for ICE (odds ratio: 1.468; 95% confidence interval: 0.681 to 3.166; p = 0.327). At median follow-up of 451 days (interquartile range: 162 to 899 days), the rate of cerebral ischemic events was similar between TEE-guided and ICE-guided procedures. ConclusionsICE-guided LAAO by means of Amplatzer devices may represent a second alternative imaging modality after an appropriate learning curve and bearing in mind that pre-procedural computed tomography imaging is mandatory. When comparing ICE with TEE, TEE remains the gold standard.

Left Atrial Appendage Perforation Does Not Always Mean Pericardial Effusion

An 81-year-old man was referred for left atrial appendage (LAA) closure because of nonvalvular atrial fibrillation and recurrent gastrointestinal bleeds with 2 direct oral anticoagulants. He had a CHA2DS2-VASc score of 4 and a HAS-BLED score of 3. A 25-mm Amplatzer Amulet device (St. Jude Medical,

Feasibility of intracardiac echocardiography imaging from the left superior pulmonary vein for left atrial appendage occlusion.

Intracardiac echocardiography (ICE) is considered an alternative imaging modality for left atrium appendage occlusion (LAAO) to avoid general anesthesia. However, the quality of ICE images obtained from right atrium can be suboptimal compared with transesophageal echocardiography (TEE) imaging. Although placing an ICE probe into left atrium can improve imaging quality, there are limited data regarding procedure outcomes of ICE-guided LAAO versus TEE-guided LAAO. One hundred forty four patients who underwent LAAO with Amplatzer Cardiac Plug, Amulet, or Watchman device were enrolled from two referral institutes. TEE-guided LAAO was performed under general anesthesia or deep sedation (n = 103), and ICE-guided LAAO was conducted under local anesthesia (n = 41). An ICE probe was placed into left superior pulmonary vein (LSPV) via transseptal approach. The procedure success and complication rates of the ICE-guided LAAO were comparable with the TEE-guided LAAO (100 vs. 97.1%, p = 1.0; 2.4 vs. 6.8%, p = 0.734, respectively). The procedure time and total radiation dose were significantly lower in ICE-guided group compared with TEE-guided group (58.0 [55.0, 61.0] min vs. 80.0 [58.0, 95.0] min, p < 0.001; 456.0 [359.0, 604.0] mGy vs. 625.0 [439.0, 1502.5] mGy, p < 0.001, respectively). In multivariate analysis, younger age, the last time period of procedure, and local anesthesia were independent factors affecting shorter procedure time. ICE imaging from the LSPV provided optimal views for LAAO procedure with a significant reduction of total procedure time through performing under local anesthesia. This approach can be very useful for LAAO procedure especially in patients who are ineligible for general anesthesia.

Percutaneous left atrial appendage occlusion in the prevention of stroke in atrial fibrillation: a systematic review.

Atrial fibrillation is commonly coexistent with heart failure, and the management of the heart failure patient would be incomplete without an appreciation for atrial fibrillation management. There are many complications associated with oral anticoagulation in the prevention of stroke related to atrial fibrillation. In recent years, the advent of several percutaneous left atrial appendage (LAA) occlusion/closure strategies has sought to provide an alternative treatment modality. Here, we systematically review the published literature to investigate the efficacy and safety of percutaneous LAA occlusion/closure devices. We searched PubMed, EMBASE, Cochrane database of systematic reviews, and the FDA Medical Devices database. Using prespecified criteria, we identified studies of the Amplatzer Cardiac Plug (St. Jude Medical), Amplatzer Amulet (St. Jude Medical), Lariat suture delivery device (SentreHeart), and Watchman device (Boston Scientific). We analyzed 2 randomized controlled trials (RCT) and 15 non-randomized registries that satisfied the study criteria. The two RCT both studied the Watchman device versus standard warfarin therapy; the studies indicate that the Watchman may be non-inferior to warfarin. Long-term efficacy outcomes for the Watchman device are promising. Data regarding the Amplatzer Cardiac Plug, Amplatzer Amulet, and Lariat suture delivery device are limited by the paucity of RCT data. High-quality prospective research is needed to directly compare LAA occlusion/closure strategies against one another as well as versus the direct oral anticoagulation medications. Data regarding the role of LAA occlusion in the heart failure population are lacking.

Does peri-device leak after left atrial appendage closure impact patient outcome?

Limited studies reported the rate and clinical impact of peri-device leaks (PDL) after percutaneous left atrial appendage closure (LAAC). All consecutive patients admitted for LAAC between November 2011 and October 2016 ( n = 83) were prospectively enrolled. LAAC was performed under sedation using fluoroscopy and trans-esophageal echocardiography (TEE) monitoring. The follow-up included clinical, TEE and/or cardiac computed tomography angiography (CCTA). PDL was defined by the presence of contrast within the LAA on CCTA, and MACE included stroke, device-related thrombosis and cardiovascular death. LAAC failures ( n = 3) and patients without imaging during follow-up were excluded ( n = 10). Overall, 70 patients (mean age 75 ± 8 years, mean CHA2DS2-VASc = 4.4 ± 1.5 and mean HAS-BLED 3.4 ± 1.1) were implanted using Amplatzer Cardiac Plug ( n = 24), Amulet ( n = 32) or Watchman devices ( n = 14). Indications were stroke recurrence under optimal treatment ( n = 7) or contraindication to anticoagulation ( n = 63). After LAAC, patients with a contraindication to anticoagulation received antiplatelet therapy alone (aspirin alone, n = 33). On CCTA at 3, 6 and 12 months, PDL was observed respectively in 70% (46/66), 64% (27/42) and 50% (13/26) of patients. Patients with PDL had a larger LAA diameter (21 ± 3 mm vs. 18 ± 3 mm, P = 0.01) and a lower prosthesis compression (13 ± 7% vs. 9 ± 7%, P = 0.02). During follow-up (median 261 days [147–399]), MACE were observed in 7.1% of patients including 2 strokes, 2 device-related thrombosis, and 1 cardiovascular death. The presence of a PDL was not associated with MACE. PDL is frequently observed (> 50%) after LAAC and tends to decrease over the time. No association is observed between PDL and MACE.

Left Atrial Appendages Occlusion: Current Status and Prospective.

Stroke continues to be a major cause of morbidity and mortality in atrial fibrillation (AF) patients. Oral anticoagulation (OAC) provides protection against stroke and peripheral embolization in AF but significant proportion of patients could not be started on anticoagulation because of bleeding complications. Left atrial appendage harbors clot in about 90% of nonvalvular AF. The advent of left atrial appendage occlusion (LAAO) techniques has provided these patients with alternative to OAC for stroke prophylaxis. Multiple LAAO devices are currently available with Watchman and Amulet being the most commonly used in clinical practice. Randomized studies are available for Watchman device only. Data on Amplatzer Cardiac Plug, Amulet and Lariat devices are limited by the paucity of randomized data. Long-term data on different LAAO techniques are showing promising results. Device related thrombosis continues to be a serious complication associated with LAAO. Future studies should look into comparative effectiveness between different LAAO techniques, optimal patient selection, risk of complications, and anticoagulant treatment after LAAO. This article aims to provide current available evidence on efficacy and safety of different LAAO devices and future prospective.

Left Atrial Appendage Occlusion with Amplatzer Cardiac Plug and Amplatzer Amulet: a Clinical Trials Update.

It has been over a decade since dedicated Amplatzer devices have been used for left atrial appendage occlusion (LAAO) in patients with atrial fibrillation. The first was the Amplatzer Cardiac Plug (ACP) that is now replaced in most countries by the Amplatzer Amulet device. Most of the clinical data for ACP come from the ACP multicenter registry that included 1047 patients from 22 sites, whereas the largest to date report on the Amplatzer Amulet is a recently published prospective multicenter study in 1088 patients from 64 sites. Two important randomized clinical trials the Amulet IDE trial and the STROKECLOSE trial are currently enrolling patients and expected to provide more data on LAAO with Amplatzer Amulet in the near future.

Combined left atrial appendage percutaneous closure and atrial fibrillation ablation: a single center experience

We evaluated long-term safety and efficacy of concomitant left atrial appendage (LAA) closure and atrial fibrillation (AF) ablation. From February 2013 to June 2017, all patients referred for AF ablation and LAA closure (group 1) were enrolled in the study and compared with a matched control group undergoing AF ablation only (group 2). Pulmonary vein isolation was achieved in all cases with radiofrequency or cryoballoon. LAA was occluded with Watchman or Amplatzer Cardiac Plug or Amulet (ACP) devices. All patients were treated with oral anticoagulation therapy for at least 3 months after the procedure ("blanking period"), and then switched to dual antiplatelet therapy with aspirin and clopidogrel for other 3 months, and then to single antiplatelet therapy with aspirin in case of LAA closure, while group 2 was treated with long-term oral anticoagulation therapy according to CHA2DS2-VASc score. Follow-up was performed with transesophageal echocardiography and clinical visit at 3, 6 and 12 months after the procedure. AF burden was evaluated by loop recorder or pacemaker interrogation in all patients. Overall, 42 patients were enrolled, 21 in each group. Mean age was 66.86 ± 10.35 years in group 1 vs 68.42 ± 10.61 in group 2 (p=NS); mean CHA2DS2-VASc score was 2.8 ± 1.22 in group 1 vs 2.01 ± 0.93 in group 2 (p=NS), mean HAS-BLED score was 3.2 ± 0.83 in group 1 vs 3.1 ± 0.95 in group 2 (p=NS). Persistent AF was present in 80% of patients in group 1 and in 85% in group 2. LAA closure was successful in all cases (14 Watchman, 7 ACP devices). Procedural and fluoroscopy times were shorter in group 2 (68 ± 17 vs 52 ± 15 min, p <0.05; 23 ± 5 vs 18 ± 3 min, p <0.05, respectively). No procedural complications were observed in group 2, while in group 1 one case of self-terminating pericardial effusion and one arteriovenous fistula were observed. At a mean follow-up of 14.93 ± 10.05 months, complete seal of LAA was documented in all patients, with neither dislocations nor thromboembolic events. Similarly, no long-term complications were observed in group 2. Maintenance of sinus rhythm was overlapping, with an AF relapse rate of 36% in group 1 vs 38% in group 2 (p=NS). Combined LAA percutaneous closure and AF ablation appears to be feasible in high-risk patients.

Left atrial appendage occlusion with the AMPLATZER Amulet device: periprocedural and early clinical/echocardiographic data from a global prospective observational study.

The global, prospective AMPLATZER Amulet observational study documents real-world periprocedural, transoesophageal echocardiographic (TEE) and clinical outcomes from left atrial appendage occlusion (LAAO) using the AMPLATZER Amulet device. The aim of this report is to describe the periprocedural and early clinical/TEE results from this study. This multicentre prospective real-world registry included 1,088 patients (75±8.5 years, 64.5% male, CHA2DS2-VASc: 4.2±1.6, HAS-BLED: 3.3±1.1) with non-valvular atrial fibrillation; 82.8% of patients were considered to have an absolute or relative contraindication to long-term anticoagulation and 72.4% had had a previous major bleeding. Periprocedural results, clinical outcomes up to the first three months and the available TEE results from the first scheduled follow-up (one to three months post implant) are reported. Successful device implantation was achieved in 99.0% of patients. During the procedure and index hospitalisation, major adverse events occurred in 3.2% of patients. Patients were discharged on a single antiplatelet agent (23.0%), dual antiplatelets (54.3%) or an oral anticoagulant (18.9%). TEE follow-up 67±23 days post procedure in 673 patients showed adequate (<3 mm jet) occlusion of the appendage in 98.2% of patients and device thrombus in 10 patients (1.5%), as evaluated by core laboratory analysis. This large real-world prospective registry of catheter-based LAAO using the AMPLATZER Amulet device reports a high implant success rate and a low periprocedural complication rate in a population with a high risk of stroke and bleeding. Transoesophageal echo data confirm good closure rates during follow-up and low rates of device-associated thrombus.

Cierre de orejuela en pacientes con hemorragia intracraneal y fibrilación auricular

IntroductionThe use of oral anticoagulants in patients with a history of atrial fibrillation (AF) and intracranial haemorrhage (ICH) is controversial on account of the risk of haemorrhagic stroke recurrence. This study presents our experience regarding the safety and efficacy of percutaneous left atrial appendage closure (LAAC), an alternative to anticoagulation in these patients. MethodsWe conducted a retrospective, single-centre, observational study. LAAC was performed in patients with a history of ICH and non-valvular AF. Risk of ischaemic and haemorrhagic events was estimated using the CHA2DS2-VASc and HAS-BLED scales. We recorded periprocedural complications, IHC recurrence, cerebral/systemic embolism, mortality and use of antithrombotic drugs following the procedure. ResultsLAAC was performed in 9 patients (7 men, 2 women) using the AMPLATZER Amulet device in 7 cases and the AMPLATZER Cardiac Plug device in 2. Mean age was 72.7±8.2 years. Time between ICH and LAAC was less than one month in 5 patients and more than one month in 4 patients. Median CHA2DS2-VASc score was 4 (interquartile range of 2.5). Median HAS-BLED score was 3 (interquartile range of 0). No periprocedural complications were recorded. All patients received single anti-platelet therapy (clopidogrel in 5 patients, aspirin in 4) after the procedure; 5 patients received this treatment for 6 months and 4 received it indefinitely. No ischaemic or haemorrhagic events were recorded during follow-up (mean duration of 15 months). ConclusionsIn our series, LAAC was found to be safe and effective in patients with a history of ICH who required anticoagulation due to AF.