Amplatzer Cardiac Plug Research Articles

MitraClip® and Amplatzer® cardiac plug implantation in a single procedure: A reasonable approach?

BackgroundPercutaneous mitral valve repair using MitraClip® (MC) is a well-established method for a subset of patients with severe mitral regurgitation (MR) and high risk for surgical intervention. Amplatzer® Cardiac Plug (ACP) occludes left atrial appendage and allows the discontinuation of oral anticoagulation and prevention of thromboembolic stroke. Due to the need for femoral and transseptal access in both procedures, a single approach could lead to minor risk of further complications and shorter cumulative intervention time. MethodsWe systematically analysed all four patients who underwent a combined procedure with MC and ACP in our heart-centre. All procedures were performed under fluoroscopic as well as echocardiographic guidance, and follow-up controls in a midterm period were carried out. ResultsIn all patients (2 male/female; age 73–88years), MC (1–2 Clips) and ACP (size 18-28mm) were successfully implanted in one procedure (mean total time: 114±17min). At least moderate MR was achieved and two patients had no complications and therefore were discharged early. In a third patient, a dislocation of ACP occurred 2h after the implantation. The oldest patient developed a respiratory insufficiency due to cardiac decompensation and further complications. ConclusionA combination of MC and ACP in a single procedure was feasible in this first case series of patients without a significant extension of procedure time. However, it might be important to select patients carefully. The location of optimal transseptal puncture may be challenging in regard to ACP placement, even in experienced hands and subsequent complications can occur.

138-02: One-year permeability rate of LAA closure devices : high incidence of peridevice leak and lack of endothelialization

Purpose: Percutaneous occlusion of the left atrial appendage (LAAO) is an alternative for patients with atrial fibrillation (AF) and contraindication to anticoagulants. Very few data are available in man regarding the residual permeability rate and endothelialization of implants, both conditions that may be associated to persistent embolic risk. The objectives of this study were to assess and compare the residual permeability rate by CT-scan and transesophageal echocardiography (TEE)in order to determine the causes of this permeability: peri-device leak or delayedendothelialization. Methods: Thirty-five patients were prospectively included in two French lefts (CHU Montpellier and Nimes) from July 2013 to April 2015. The judgments criteria were permeability of LAA at 12 months (contrast enhancement on CT-scan and color flow on TEE); presence of peri-device leak; endothelialization of the prosthesis. The permeability rate was compared in both type of prosthesis Watchman and Amplatzer Cardiac Plug (ACP), Summary: Patients had a mean age of 74.9 ± 6.4 years with a CHA2DS2-VASC score of 4.3 ± 1.4. The permeability rate on CT-scan at 10 ± 6 months was 70% (n = 21). Among them, a peri-device leak was noted in 5 patients (24%). Endothelialization at least partial was present in 19 (63.3%) patients. Sensitivity of TEE to diagnose permeability was 90.48% and specificity 88.89% compared to CT-scan. The LAA permeability rate on CT-scan was 83.33% for Watchman device, 61.11% for ACP (p = 0.1468). Conclusion: Our study shows that over a 10 ± 6 month-follow-up after LAAO, the LAA remains permeable in 70% of patients on CT-scan. In most cases the cause seems to be delayed endothelialization, only 24% of these patients have peri-device leak. Clinical implications are still unknown and new imaging processing techniques remain to be developed in order to provide a more accurate evaluation of the endothelialization process.

Left atrial appendage closure: patient, device and post-procedure drug selection.

Left atrial appendage closure (LAAC), a device-based therapy for stroke prevention in patients with atrial fibrillation, is considered an alternative to oral anticoagulation therapy, particularly for patients at high risk of bleeding. Proof of concept has been demonstrated by the PROTECT AF and PREVAIL trials which evaluated the WATCHMAN device (Boston Scientific, Marlborough, MA, USA) versus warfarin, showing favourable outcome for the device group. The most commonly used devices for LAAC are the WATCHMAN and its successor, the WATCHMAN FLX (Boston Scientific) and the AMPLATZER Cardiac Plug and more recently the AMPLATZER Amulet device (both St. Jude Medical, St. Paul, MN, USA). The procedure is typically performed via a transseptal puncture under fluoroscopic and echocardiographic guidance. Technically, it is considered quite demanding due to the anatomic variability and fragility of the appendage. Careful material manipulation, adequate operator training, and good cardiac imaging and device sizing allow a safe, uneventful procedure. Post-procedure antithrombotic drug selection is based on the patient's history, indication and quality of LAAC.

Amplatzer Cardiac Plug for Stroke Prevention in Patients with Atrial Fibrillation and Bigger Left Atrial Appendix Size.

Left atrial appendage (LAA) dimensions have been shown as an independent predictor of higher risk for stroke in AF patients. Little data exist on the outcomes after LAA closure in patients with nonvalvular atrial fibrillation (NVAF) who have relatively bigger LAA size. This study aims to evaluate the results associated with LAA closure with the Amplatzer cardiac plug (ACP, AGA, St. Jude Medical, Minneapolis, MN) in bigger LAA size. A total of 25 patients with NVAF underwent LAA closure with the ACP device. All patients received short-term (up to 3 months) dual-antiplatelet therapy (clopidogrel and aspirin) after the procedure and aspirin only thereafter. A transesophageal echocardiography was performed in all patients at the 3- and 6-month follow-ups. No patient was lost to follow-up (≥ 12 months in all patients). The mean age, CHA2DS2-VASc score, and HAS-BLED score were 66.2 ± 8.79 years; 3.2 ± 1.46 and 2.4 ± 1.0, respectively. The average sizes of the LAA landing zone and ostium were 23.08 ± 5.0 and 24.9 ± 4.4 mm, respectively. The procedure was successful in 23 (92%) patients and was canceled in 2 (8%) patients due to huge LAA dimensions. In 56% of the patients "pull and release" technique is needed to appropriately implant the ACP. During a mean follow-up of 12 months, no cases of periprocedural stroke and no mortality were observed. In patients with NVAF at high risk of cardioembolic events and big LAA size, LAA closure using the ACP device is safe and effective.

Left atrial appendage occlusion with the Amplatzer Cardiac Plug could improve survival and prevent thrombo-embolic and major bleeding events in atrial fibrillation patients with increased bleeding risk

Aims Literature suggests a beneficial effect of percutaneous left atrial appendage occlusion (LAAO) to prevent thrombo-embolic events in patients with non-rheumatic atrial fibrillation (AF). We compared outcome of LAAO versus ‘suboptimal standard’ treatment in AF patients with high bleeding risk.Methods and results Patients with sufficient follow-up data (n = 125) who underwent LAAO with the Amplatzer Cardiac Plug (ACP) were selected from the Belgian ACP database. AF patients who survived intracranial haemorrhage were recruited from the Leuven Neurosurgical Registry (LNR, n = 113). After propensity score adjustment, the outcome of both groups was compared for the combined end point (death, stroke, transient ischaemic attack, systemic emboli, and major bleeding event). The LAAO group did not differ from the LNR group for mean age and gender (74 ± 7 versus 75 ± 10 years, P= 0.29; female 39% versus 48%, P= 0.18). However, the CHA2DS2-VASc and HAS-BLED scores were both higher in the LAAO group (4.8 ± 1.7 versus 3.9 ± 1.7, P= 0.0001; 3.5 ± 1.4 versus 3.2 ± 1.4, P= 0.036). After propensity score adjustment, the risk for the primary end point was significantly higher for the LNR group (HR 2.012, 95% CI 1.113-3.638).Conclusion LAAO with ACP seems to improve the combination of survival and the prevention of thrombo-embolic and major bleeding events in patients with atrial fibrillation and increased bleeding risk.

0501 : Left atrial remodeling after percutaneous left atrial appendage closure

The importance of the left atrial appendage (LAA) on left atrial (LA) hemodynamics is unknown. We sought to evaluate the effect of LAA percutaneous closure (LAAPC) on left atrial remodeling in patients with paroxymal atrial fibrillation (AF) and permanent AF. All patients refered for LAAPC with Amplatzer Cardiac Plug (ACP) and Watchman device were enrolled. Cardiac computed tomography (CT) for LA volume measurement and transthoracic echocardiography (TTE) for diastolic function assessment were performed at baseline and 3 months after LAAPC. An average of 3 consecutives measurements were performed for TTE parameters in all patients. Sixty-three patients (mean age 73±9 years) were included. 38% (n=24) was in sinus rythm at baseline and 55% (n=35) in permanent AF. Patients in SR at baseline and permanent AF at 3 months were exclued (n=4, 7%). The mean CHA2DS2-VASc score was 4,3±1,3. The procedure was successful in all patients.There was no significant difference in the functionnal status (p=0,74) and BNP (155,6 ± 107 baseline vs 155±150,6 pg/ml at 3 months ; p=0,85). Left atrial volume excluding the LAA (14±55ml baseline vs 144±50 cm3 at 3 months; p=0,30) showed no significant change after 3 months in the overall population, neither in the SR (99,7 ± 19,1 baseline vs 103,8±21 cm3 at 3 months ; p=0,32) or the permanent AF groups (173,2±54 baseline vs 171,7±48,6 cm3 at 3 months ; p=0,59).MV peak E-wave (84,2 ± 22,7 ; 86,7±26 cm/s, p=0,62) and A-wave velocities (65,4±14,4 ; 68,5 ± 22,2 cm/s, p=0,66) did not differ between baseline and three months. E/E’ ratio was higher in the overall population and there was a trend to higher E/E’ ratio in the SR group. There's no evidence for early LA remodeling after LAAPC. LV pressure loading might be slighlty more elevated after LAA closure suggesting the potential reservoir role of the LAA. Further studies are warranted to confirm these prelimary results. The author hereby declares no conflict of interest

Left atrial appendage occlusion with the AMPLATZER Amulet device: an expert consensus step-by-step approach.

This document aims to describe a standardised methodology for performing left atrial appendage occlusion (LAAO) using the AMPLATZER Amulet device, and to provide useful tips and tricks for operators with different levels of experience. Physicians who are experts in LAAO and had personal clinical experience with the AMPLATZER Amulet device were asked to contribute in the preparation of this consensus document. Twenty-seven physicians (20 interventional cardiologists and 7 electrophysiologists) from 14 different countries reviewed the manuscript. A step-by-step approach, simulating a real case, was followed. Starting with patient selection and planning, related cardiac imaging is discussed, followed by vascular access - transseptal puncture optimisation. Then, angiographic calibration/sizing and the required fluoroscopy views are explained and a device sizing strategy is proposed. Device preparation and de-airing is briefly described, followed by sheath exchange, device deployment steps, evaluation of device stability and decision for final release. The way to recapture and change a device is then shown, together with some additional tips on how to deal with challenging anatomies like "chicken wing" left atrial appendage. Finally, for operators who are switching from AMPLATZER Cardiac Plug to Amulet, the main differences between the two devices with respect to implantation technique are presented. In conclusion, this document reflects a consensus approach by expert implanters on the steps of LAAO technique and best practices for implantation of the AMPLATZER Amulet device, along with some practical tips to minimise the complication rate.

Left atrial appendage occlusion for stroke prevention in atrial fibrillation: multicentre experience with the AMPLATZER Cardiac Plug.

To investigate the safety, feasibility, and efficacy of left atrial appendage occlusion (LAAO) with the AMPLATZER Cardiac Plug (ACP) for stroke prevention in patients with atrial fibrillation (AF). Data from consecutive patients treated in 22 centres were collected. A total of 1,047 patients were included in the study. Procedural success was 97.3%. There were 52 (4.97%) periprocedural major adverse events. Follow-up was complete in 1,001/1,019 (98.2%) of successfully implanted patients (average 13 months, total 1,349 patient-years). One-year all-cause mortality was 4.2%. No death at follow-up was reported as device-related. There were nine strokes (0.9%) and nine transient ischaemic attacks (0.9%) during follow-up. The annual rate of systemic thromboembolism was 2.3% (31/1,349 patient-years), which is a 59% risk reduction. There were 15 major bleedings (1.5%) during follow-up. The annual rate of major bleeding was 2.1% (28/1,349 patient-years), which is a 61% risk reduction. Patients with single LAAO on aspirin monotherapy or no therapy and longer follow-up had fewer cerebral and fewer bleeding events. In this multicentre study, LAAO with the ACP showed high procedural success and a favourable outcome for the prevention of AF-related thromboembolism. Modification in antithrombotic therapy after LAAO may result in reduction of bleeding events.

Percutaneous left atrial appendage occlusion in patients with non-valvular atrial fibrillation: implantation and up to four years follow-up of the AMPLATZER Cardiac Plug.

Percutaneous left atrial appendage occlusion (LAAO) may be considered for stroke prophylaxis in patients with non-valvular atrial fibrillation (NVAF). Data on device implantation safety and feasibility and long-term follow-up are limited. LAAO was performed using the AMPLATZER Cardiac Plug (ACP) device in 134 NVAF patients with long-term OAC contraindication, with median (interquartile range) CHA2DS2-VASc and HAS-BLED scores of four (3-5) and three (2-3.75), respectively. Follow-up data were collected over a mean follow-up period of 680 days (range: 42 days to 4.3 years) comprising a total implant experience of 238 patient-years. Device implantation was successful in 95.5% of the procedures and associated with a rate of major procedural complications of 2.2%. At the most recent follow-up, almost all patients were receiving antiplatelet therapy. Ischaemic stroke was observed at an annual rate of 0.8% and the annual rate of any thromboembolic (TE) event was 2.5%. Major bleeding during follow-up occurred at an annual rate of 1.3%. LAAO is a safe and effective stroke prevention therapy in a high-risk NVAF cohort, both at implantation and over longer follow-up periods. The long-term assessed ischaemic stroke rate in patients treated with LAAO is markedly reduced compared to the expected rate based on the patients' risk scores.

Long-term invasive follow-up of the everolimus-eluting bioresorbable vascular scaffold: five-year results of multiple invasive imaging modalities.

Invasive imaging modalities have shown restoration of vasomotion, prevention of restenosis and, most importantly, increase in lumen area between six months and two years after first-generation everolimus-eluting bioresorbable vascular scaffold (Absorb BVS) implantation. Our aim was to assess whether these positive findings were sustained in the long term. Patients included in the ABSORB cohort A from the Thoraxcenter Rotterdam cohort underwent coronary catheterisation including angiography, intravascular ultrasound (IVUS), virtual histology, optical coherence tomography (OCT) and vasomotion testing at five years. Eight out of 16 patients underwent catheterisation and scaffold assessment with multiple imaging modalities. A trend towards an increase in minimum luminal diameter was observed between two and five years by angiography (1.95±0.37 mm vs. 2.14±0.38 mm; p=0.09). IVUS data showed an increase in mean lumen area at five years (6.96±1.13 mm2) compared to six months (6.17±0.74 mm2; p=0.06) and two years (6.56±1.16 mm2; p=0.12), primarily due to a persistent reduction in plaque area size between six months and five years (9.17±1.86 mm2 vs. 7.57±1.63 mm2; p=0.03). The necrotic core area was reduced at five years compared to post-procedural results. In OCT, an increase in mean and minimal luminal area was observed. Moreover, no scaffold struts could be identified and a smooth endoluminal lining was observed. The scaffolded coronary segment did not show signs of endothelial dysfunction with acetylcholine testing. At five years, the Absorb BVS is no longer discernible by any invasive imaging method and endothelial function is restored. Late luminal enlargement persists up to five years of follow-up without adaptive vessel remodelling.

The novel application of intraprocedural cardiac computed tomography for left atrial appendage occlusion

A 67-year-old woman with persistent atrial fibrillation (CHA2DS2VASc: 6 and HAS BLED: 4) who experienced recurrent stroke and intracranial bleeding on Apixaban was considered for left atrial appendage (LAA) occlusion with Amplatzer Cardiac Plug (ACP). An angiography shared multi-detector computed tomography system (MDCT) was applicable in this procedure ( Panels A …

Impact of chronic kidney disease on left atrial appendage occlusion for stroke prevention in patients with atrial fibrillation

BackgroundLeft atrial appendage occlusion (LAAO) using the Amplatzer cardiac plug (ACP) is a preventive treatment of atrial fibrillation related thromboembolism. AimTo assess the safety and efficacy of LAAO in patients with chronic kidney disease (CKD). MethodsAmong the ACP multicentre registry, 1014 patients (75±8yrs) with available renal function were included. ResultsPatients with CKD (N=375, CHA2DS2-VASc: 4.9±1.5, HASBLED: 3.4±1.3) were at higher risk than patients without CKD (N=639, CHA2DS2-VASc: 4.2±1.6, HASBLED: 2.9±1.2; p<0.001 for both). Procedural (97%) and occlusion (99%) success were similarly high in all stages of CKD. Peri-procedural major adverse events (MAE) were observed in 5.1% of patients, 0.8% of death, with no difference between patients with and those without CKD (6.1 vs 4.5%, p=0.47). In patients with complete follow-up (1319 patients years), the annual stroke+transient ischaemic attack (TIA) rate was 2.3% and the observed bleeding rate was 2.1% (62 and 60% less than expected, similarly among patients with and those without CKD). Kaplan–Meier analysis showed a lower overall survival (84 vs 96% and 84 vs 93% at 1 and 2yrs. respectively; p<0.001) among patients with an eGFR <30ml/min/1.73m2. ConclusionLAAO using the ACP has a similar procedural safety among CKD patients compared to patients with normal renal function. LAAO with ACP offers a dramatic reduction of stroke+TIA rate and of bleeding rate persistent in all stages of CKD, as compared to the expected annual risk.

0095: Evaluation of peri device leaks after percutaneous left atrial appendage closure using cardiac computed tomography

Peridevice leaks after left atrial appendage (LAA) closure with the Amplatzer® Cardiac Plug (ACP) have been reported using trans oesophageal Echocardiography (TOE), but this evaluation is challenging, and the few available data are inconsistent. There are currently few data regarding the evaluation of cardiac CT (CT) for peridevice leaks detection. We aimed to assess the incidence and the related factors of ACP peridevice leaks using CT. Cardiac-CT using a multi-phase protocol and a second-generation dual-source-CT-system was performed in 45 patients with non-valvular atrial fibrillation 24h before the procedure and 3 months after LAA closure with ACP. Peridevice leak was defined as a presence of opacification of the LAA by the contast agent. Fourty three patients were included, aged 73±9.4 years. ACP size compared to mean diameter of the landing zone measured by CT was oversized by 2.7±2.2mm. Peridevice leaks were found on CT in 18 patients (41.9%). The rate of peridevice leaks was lower among patients in whom the ACP oversizing was <3mm based on CT measurements compared to an oversizing of the device >3mm, 23.5% and 55% respectively, p=0.052. The size of the LAA landing zone did not correlate significantly with the presence of peridevice leak (20.6±3.7 vs 21.5±4.2mm, p=0.47). The shape of the LAA was not associated with peridevice leaks (p=0.39). Clinical outcome with a mean follow-up 14.7 months was similar in both groups with 1 stroke in the peride-vice leak group and 2 in the other group (5.5% and 8% respectively). Cardiac CT scan is an accurate technique for peridevice leaks detection. Important oversizing of the device is not associated with absence of residual leaks. There is a trend toward more residual leaks in the biggest LAAs. No adverse outcome were related with a residual leak.

Successful Left Atrial Appendage Occlusion with the New Generation Amulet® Device after Late-Occurring Embolization of an Amplatzer® Cardiac Plug in a Patient with Repetitive Strokes.

The Amplatzer Cardiac Plug (ACP) is one of the most commonly used devices for percutaneous left atrial appendage (LAA) closure in order to prevent a stroke in patients with atrial fibrillation and contraindication for long-term oral anticoagulation therapy. We have previously described a patient who had experienced an embolization of the ACP device about 12 months after implantation and the device could be percutaneously retrieved. A few years later, he suffered from a posterior stroke and a stroke located in the brainstem as well as a transischemic attack (TIA). In order to protect him from further cardioembolic events a reocclusion of the LAA with the new generation of ACP device, the Amplatzer Amulet, was performed. A stable position of the device within follow-up period could be confirmed and the patient was free of additional strokes/TIA or bleeding events. This case stresses the importance of proper LAA sizing in order to prevent device embolization and notes that LAA size is not static. Moreover, it demonstrates that repeated implantation of an LAA occlusion device was still possible; one should be aware of undersizing the LAA dimensions and that the modifications of new generation LAA occlusion devices may overcome limitations of first-generation devices in order to prevent a cardioembolic stroke.

0290: Left atrial remodeling after percutaneous left atrial appendage closure

The importance of the left atrial appendage (LAA) on left atrial (LA) hemodynamics is unknown. We sought to evaluate the effect of LAA percutaneous closure (LAAPC) on left atrial remodeling in patients with paraxysmal atrial fibrillation (AF) and permanent AF. All patients refered for LAAPC with Amplatzer Cardiac Plug (ACP) and Watchman device were enrolled. Cardiac computed tomography (CT) for LA volume measurement and transthoracic echocardiography (TTE) for diastolic function assessment were performed at baseline and 3 months after LAAPC. An average of 3 consecutives measurements were performed for TEE parameters in all patients. Sixty-three patients (mean age 73±9 years) were included. 38% (n=24) in sinus rythm (SR) at baseline and 55% (n=35) in permanent AF. Patients in SR at baseline and permanent AF at 3 months were excluded (n=4,7%).The mean CHA2DS2-VASc score was 4,3±1,3. There was non significant difference in the functionnal status and BNP level (155,6±107 vs ±150,7pg/mL; p=0,85) between baseline and 3 months follow-up. Left atrial volume excluding the LAA (145 ±55cm 3 baseline vs 144±50cm 3 at 3 months; p=0,30) showed no significant change after 3 months in overall population, neither in the SR (99,7±19,1 vs 103,8±21cm 3 ; p=0,32) or the permanent AF groups (173,2±54 vs 171,7±48,6cm 3 ; p=0,59). MV peak E-wave (84,2±22,7 vs 86,7±26cm/s; p=0,62) and A-wave velocities (65,4±14,4; 68,5±22,2cm/s; p=0,66) dit not differ between baseline and follow-up but E/E’ ratio was increased in the overall population after LAAPC (7,9±2,1 vs 9,1±3,6cm/s; p=0,038) and there was trend to higher E/E’ ratio in the SR group (7,7±1,6 vs 9±3,3cm/s, p=0,46). There’s no evidence for early LA remodeling after LAAPC, but diastolic function might be negatively influenced by LAAPC suggesting the potential role of LAA in atrial function. Further studies are warranted to confirm the prelimary results.

0094: Left atrial appendage sizing for percutaneous occlusion with Amplatzer cardiac plug: a multimodality imaging approach

The morphology of the LAA is extremely heterogeneous. Acurate sizing of the landing zone is crucial for the optimal choice of the device diameter. Cardiac CT has been shown to provide acurate measurement of the LAA. TOE and selective LAA angiography can provide discordant results during the procedure, and there is no consensus about the most reliable imaging modality. Compare the sizing of the LAA using a multimodality imaging approach. We retrospectively included 45 patients (aged 67.6±6.2 years) who underwent LAA occlusion using the Amplatzer® cardiac plug (ACP). Mean diameter of the landing zone was determined using the different imaging modalities: MPR for cardiac-CT and 3D TOE, multiple angle view at 0, 45, 90 and 120° using 2D TOE, and monoplanar projection (RAO30° cranial 20°) for angiography. High intra and inter observer reproductibility were found for diameter (r=0.93 and 0.87, p<0.01 respectively with mean difference of –0.1mm [–1.9; +1.8] and –0.2mm [–2.9; +2.5] respectively) and area measurement (r 0.94 and 0.88, p<0.01 respectively, with a mean difference of 0cm 2 [–0.15; +0.16] and 0cm 2 [–0.9; +0.9], respectively)of the landing zone by CT. 2D TEE mean diameter was underestimated compared to CT (–2.6mm [–3.1; +8.3]) that was reduced to –1.8mm [–3.6; + 7.1] when a 120° view was available. 3D TEE also underestimated LAA diameter (-2mm [–2.7; +6.7]). Angiographic diameter was weakly correlated with CT (r=0.35, –1.4mm [–5.7; +8.5]). We found significant variability in the sizing of the LAA landing zone, using different imaging modalities. 3D data set provided by Cardiac-CT and 3D TOE looks interesting to get a complete overview of LAA anatomy. Multiple angle view from 0 to 120° are mandatory when using 2D TOE. Monoplanar LAA selective angiography seems not acurate for LAA sizing and may be avoided when non invasive imaging modalities are available. Abstract 0094 - Figure: Mutimodality imaging apporach

Left atrial appendage closure monitoring without sedation: a pilot study using intracardiac echocardiography through the oesophageal route.

We evaluated the safety and feasibility of an intracardiac echocardiography probe through the oesophageal route (ICE-TEE) for the monitoring of left atrial appendage (LAA) closure to avoid general anaesthesia. The study included 16 consecutive patients (75±7 years) in atrial fibrillation with high embolism (CHADS-VASc=5±1.4) and bleeding risk (HAS-BLED=4±0.9) referred for LAA closure (Amplatzer Cardiac Plug [ACP]). Standard TEE was performed before device implantation for LAA analysis. During the procedure, ICE-TEE was used under local anaesthesia to determine LAA size and monitor ACP positioning. Maximum and minimum LAA diameter by standard TEE averaged 21±3 mm and 18±1 mm, respectively. Eccentricity index (1.1±0.2) increased with LAA diameter (r=0.73, p=0.001). Maximum LAA size (21±3 mm) obtained by ICE-TEE during the procedure closely correlated with standard TEE measurement (r=0.9, p<0.0001). LAA closure was successfully performed in 15 patients without complication (one failed despite testing three ACP). Implanted ACP size averaged 25±3 mm (range 22-30 mm) and correlated with the size predicted by ICE-TEE (r=0.89) and standard TEE (r=0.57). Procedure duration (62±27 min) correlated with LAA size by ICE-TEE (r=0.71, p=0.002) and eccentricity index (r=0.58, p=0.02). An ICE-TEE probe through the oesophageal route without general anaesthesia may be used for the monitoring of ACP device implantation.

Rapid Fire Abstract session: usefulness of CT and radionuclide imaging in different clinical scenarios378Improving the cost-effectiveness of chest pain investigations using single photon emission computed tomography379Is autonomic nervous dysfunction severity associated to less benefit from cardiac resynchronization therapy?380Validation of stress Thallium-201/Rest Technetium-99m sequential dual isotope high-speed myocardial perfusion imaging against fractional flow reserve for the detection of the extent of

Rapid Fire Abstract session: usefulness of CT and radionuclide imaging in different clinical scenarios378Improving the cost-effectiveness of chest pain investigations using single photon emission computed tomography379Is autonomic nervous dysfunction severity associated to less benefit from cardiac resynchronization therapy?380Validation of stress Thallium-201/Rest Technetium-99m sequential dual isotope high-speed myocardial perfusion imaging against fractional flow reserve for the detection of the extent of

Moderated Posters session: complementary role of imaging techniquesP184Submillisievert computed tomography with model-based iterative reconstruction before pulmonary veins radiofrequency catheter ablation of atrial fibrillation: impact on radiation exposure and outcomeP185Calcium score and CT coronary angiography can be a low cost strategy for the investigation of patients with chest pain with low and intermediate predicted riskP186Impact of imaging modality on the heritability

Moderated Posters session: complementary role of imaging techniquesP184Submillisievert computed tomography with model-based iterative reconstruction before pulmonary veins radiofrequency catheter ablation of atrial fibrillation: impact on radiation exposure and outcomeP185Calcium score and CT coronary angiography can be a low cost strategy for the investigation of patients with chest pain with low and intermediate predicted riskP186Impact of imaging modality on the heritability

Safety and Efficacy of Left Atrial Appendage Closure with the Amplatzer Cardiac Plug in Very High Stroke and Bleeding Risk Patients with Non-Valvular Atrial Fibrillation.

IntroductionLimited data exist on the outcomes after left atrial appendage closure (LAAC) with the Amplatzer™ Cardiac Plug (ACP; St. Jude Medical, Minneapolis, MN, USA) in patients with atrial fibrillation (AF) with very high stroke and bleeding risks, the subset expected to benefit most from this procedure. The objective of this study was to report clinical outcomes after LAAC with the ACP device in a very high stroke and bleeding risk cohort of patients with non-valvular AF and contraindications to oral anticoagulation (OAC).MethodsLAAC using the ACP device was performed in 96 patients with AF who had median CHA2DS2-VASc and HAS-BLED scores of 5 and 3, respectively. Post-procedure, patients received dual antiplatelet therapy for 6 months. A transesophageal echocardiography (TEE) was scheduled at 6 months.ResultsProcedural success was 100%. Procedural-related complications occurred in 7.3% (pericardial effusion, 4.2%; thromboembolic events, 2.1%; device embolization, 1.0%). Additional thromboembolic events occurred in three patients during follow-up (92.7% follow-up). After 93.4 patient-years of follow-up, the annual rates of thromboembolic and major bleeding events were 3.2% and 1.1%, respectively. In those with TEE follow-up (70%), complete LAAC with no leaks was observed. Thrombus formation on the device was noted on TEE in two patients.ConclusionLAAC using the ACP device was associated with an acceptable low rate of embolic and bleeding events after a median follow-up of 9 months in a cohort of patients with AF who were amongst the highest stroke and bleeding risks reported so far in LAAC trials.Electronic supplementary materialThe online version of this article (doi:10.1007/s40119-015-0053-z) contains supplementary material, which is available to authorized users.