Follow-up Transesophageal Echocardiography Research Articles

Safety and efficacy of catheter-based left atrial appendage closure in patients with contraindications for long-term anticoagulation.

Percutaneous left atrial appendage closure (LAAC) and the role of postinterventional anticoagulation often evokes controversy in daily practice. This study aimed to evaluate LAAC in patients with non-rheumatic atrial fibrillation, high thromboembolic risk and contraindications for long-term anticoagulation in a clinical scenario. Between 2010-2015, LAAC was attempted in 118 patients (47 women). Devices were successfully implanted in 95% (Watchman™ device: N.=97; Amplatzer™ Cardiac Plug/Amulet: N.=14; Amplatzer PFO Occluder: N.=1). Mean age was 75±8.35 years. Mean HAS-BLED and CHA2DS2VASc scores were 4.3 and 4.9, respectively. Median follow-up was 447 days (IQR: 183-789 days). The primary safety endpoint was defined as major bleeding according to the International Society on Thrombosis and Hemostasis. The combined efficacy endpoint included ischemic strokes, transitory ischemic attacks (TIA) and systemic embolisms. Procedural complication rate was 3.4%. After successful intervention, either a therapy with anticoagulants (N.=62) or dual antiplatelet therapy (DAPT, N.=50) was prescribed temporarily. Medication was reduced if implantation proved satisfying in a 6-week follow-up transesophageal echocardiography, which was the case in 79% of these patients. During follow-up, one patient suffered a TIA (0.6%/year). No other efficacy event was observed. Eleven major bleedings occurred (6.6%/year): one each under DAPT plus phenprocoumon, DAPT plus rivaroxaban, acetylsalicylic acid (ASA) plus rivaroxaban, two under DAPT, two under ASA plus low molecular weight heparin, and four under ASA only. In the present study, catheter-based LAA occlusion prevented thromboembolisms with high efficacy. Major bleedings were however common in patients with, but also without anticoagulation, independent from time course.

Twelve-month follow-up of left atrial appendage occlusion with Amplatzer Amulet.

The Amplatzer Amulet (St. Jude Medical, Minneapolis, MN, USA) is a second gen-eration Amplatzer device for left atrial appendage (LAA) occlusion (LAAO) for stroke prophylaxis in patients with atrial fibrillation. This research sought to assess the clinical performance of the Amplatzer Amulet device and in follow up for 12 months. In this single-center registry patients with atrial fibrillation and contraindication to oral anticoagulation underwent LAAO with the Amplatzer Amulet device. Follow-up was performed before discharge, by transesophageal echocardiography (TEE) after 6 weeks and telephone interview after 3, 6 and 12 months. Between October 2014 and August 2015 50 patients (76.1 ± 8.3 years; 30 male) were en-rolled. Procedural success was achieved in 49 (98%) patients. Major periprocedural adverse events were observed in 4 (8%) of patients: 1 device embolization, 2 pericardial effusions requiring pericardiocente-sis and 1 prolonged hospital stay due to retropharyngeal hematoma from the TEE probe. Follow-up TEE was available in 38 of 50 patients showing complete LAA sealing in all. 2 device-related thrombi were also documented. At 12-month follow-up 7 patients had died unrelated to the device. Ischemic stroke occurred in 3 patients. According to neurological examination two were classified as microangiopathic and not cardio-embolic. The other one could not be classified. Bleeding complications (5 minor, 3 major) were documented in 8 patients. Although minimizing procedure-related complications remains challenging, LAAO with the Amplatzer Amulet device showed high procedural success and excellent LAA sealing. (Cardiol J 2017; 24, 2: 131-138).

Risk Factors of Aortic Plaque Progression Evaluated by Long-Term Follow-Up Data With Transesophageal Echocardiography

There are few longitudinal data regarding aortic plaque. This study aimed to examine chronological changes in aortic plaques with transesophageal echocardiography (TEE), and to clarify the risk factors of aortic plaque progression. Among 2,675 consecutive patients who underwent TEE, we retrospectively investigated 252 patients who underwent follow-up TEE with an interval >3years. The thickness and morphology of aortic plaques were examined. Chronological changes in aortic plaques were investigated by comparing baseline and follow-up TEE. Clinical factors, laboratory data, and medications were evaluated. Among 252 study patients, the grade of aortic plaques was unchanged in 213 (group U), but progression was observed in 32 (group P) and regression in 7 patients (group R). Patients in group P were older; they had a higher prevalence of coronary artery disease, hypertension, smoking habit, and moderate or severe plaque at baseline TEE; more patients were using statins and no warfarin; and they had higher creatinine levels than those in group U. In multivariate analysis, moderate or severe plaques at baseline TEE were the strongest predictor of plaque progression. Among 50 patients who showed moderate or severe plaque at baseline TEE, smoking habit and no anticoagulation therapy were predictors of plaque progression. In conclusion, aortic plaques should be followed up using TEE in patients with moderate or severe plaque at baseline TEE.

Incidence and Clinical Impact of Device-Associated Thrombus and Peri-Device Leak Following Left Atrial Appendage Closure With the Amplatzer Cardiac Plug

ObjectivesRoutine device surveillance after successful left atrial appendage closure is recommended to evaluate for intermediate to late complications. The aim of this study was to assess the incidence and clinical impact of these complications on cardiovascular events. MethodsCenters participating in the Amplatzer Cardiac Plug multicenter study were requested to submit their post-procedural transesophageal echocardiograms for independent adjudication. Thirteen of 22 centers contributed all their post-procedural echocardiograms, which included 344 from 605 consecutive patients. These images were submitted to a core laboratory and reviewed by 2 independent experts for peri-device leak, device-associated thrombus, device embolization, device migration, left atrial appendage thrombus, and left atrial thrombus. Clinical events were prospectively collected by each center. ResultsOf the 344 transesophageal echocardiograms, 339 were deemed analyzable. Patients’ mean age was 74.4 ± 7.5 years, and 67.3% were men. The mean CHADS2 score was 2.7 ± 1.3, the mean CHA2DS2-VASc score was 4.3 ± 1.5, and the mean HAS-BLED score was 3.0 ± 1.2. Amplatzer Cardiac Plug implantation was successful in all patients. Periprocedural major adverse events occurred in 2.4%. Median clinical follow-up duration was 355 days (range 179 to 622 days). Follow-up transesophageal echocardiography was performed after a median of 134 days (range 88 to 227 days). Device-associated thrombus was observed in 3.2% and peri-device leak in 12.5% (5.5% minimal, 5.8% mild, 0.6% moderate, 0.6% severe). Neither device-associated thrombus nor peri-device leak was associated with an increased risk for cardiovascular events. Independent predictors of device-associated thrombus were smoking (odds ratio: 5.79; p = 0.017) and female sex (odds ratio: 4.22; p = 0.027). ConclusionsFollowing successful left atrial appendage closure with the Amplatzer Cardiac Plug, the presence of peri-device leak was relatively low, and device-associated thrombus was infrequent. Neither was associated with increased risk for thromboembolism.

Prosthetic Valve Thrombosis in the Acute Phase of the Stroke: Relevance of Detection and Follow-Up

Stroke may be the first symptom of prosthetic valve thrombosis (PVT); therefore, rapid diagnosis and therapy are crucial. We aimed to evaluate the prevalence, main predictors, and long-term clinical evolution of patients with PVT in the acute phase of stroke. We studied consecutive acute ischemic stroke patients with prosthetic heart valves who underwent emergent transesophageal echocardiography (TEE) during a 5-year period. Two groups were defined depending on the presence of PVT (PVT or non-PVT groups). Baseline characteristics, TEE findings, and international normalized ratios (INRs) at the stroke event were registered. Follow-up visits and TEE control examinations were performed. Sixty-seven patients were registered. TEE was performed within the first week in 85% of patients (n = 57). PVT was diagnosed in 41.8% of cases (n = 28). Clinical severity and baseline INR level showed no differences when the PVT and non-PVT groups were compared. The presence of PVT was associated with the mitral valve location as compared with the aortic valve location (75% versus 25%, P = .003), the presence of spontaneous echocontrast (64.3% versus 35.9%, P = .022), and low ejection fraction (66.7% versus 32.7%, P = .019). The PVT group showed a trend toward higher percentage of recurrence (10.7% versus 2.5%, P = .102) in the follow up period (mean follow-up 25 months). The detection of PVT in the acute stroke phase was relevant, as the stroke recurrence rate was considerable. Therefore, all patients with prosthetic heart valve should undergo emergent TEE.

Rosuvastatin prevents aortic arch plaque progression and improves prognosis in ischemic stroke patients

Objectives: Complicated aortic arch plaques (CAP) and their progression are important for recurrent ischemic stroke (IS) and its prognosis. We investigated the effects and clinical benefits of rosuvastatin therapy on this pathophysiology. The purpose of this study was to investigate whether rosuvastatin prevention of aortic arch plaque progression improved the prognosis of IS patients.Methods: Ninety-seven consecutive acute cerebral embolism patients were retrospectively surveyed. All had transesophageal echocardiography (TEE) to assess the presence or absence of CAP, defined as aortic wall thickness ≥4 mm or plaque ulceration. Patients received conventional antithrombotic therapy as clinically indicated. All patients with CAP were recommended to receive 5 mg rosuvastatin/day, administered by their attending physicians; not all physicians followed this recommendation. Six-month follow-up TEEs were performed in patients with CAP who received rosuvastatin. Major adverse cerebrovascular events (MACEs) comprised recurrent IS and death.Results: CAP was detected in 39 patients (40%), and MACEs in 15. Multivariate regression analysis showed that patients with CAP not taking rosuvastatin was an independent risk factor for MACEs (odds ratio = 18.044; 95% confidential interval = 2.089–155.846, p < 0.01). When patients were divided into three groups: those with CAP taking rosuvastatin, those with CAP not taking rosuvastatin, and those without CAP, Kaplan–Meier analysis demonstrated that patients with CAP not taking rosuvastatin had significantly more MACEs than those in the other two groups (long-rank test; χ2 = 6.553, p < 0.05). Six-month TEE follow-ups in the 26 patients with CAP taking rosuvastatin showed significant improvement in CAP diameter with improved lipid profiles; 88% (23/26 patients) showed no morphological CAP progression; 15 of these showed CAP regression.Discussion: Rosuvastatin therapy prevented aortic arch plaque progression in IS patients with CAP, and may also have long-term clinical benefits.

Transcatheter Aortic Valve Thrombosis: Incidence, Predisposing Factors, and Clinical Implications

BackgroundThere are limited data on the incidence, clinical implications, and predisposing factors of transcatheter heart valve (THV) thrombosis following transcatheter aortic valve replacement (TAVR). ObjectivesThe authors assessed the incidence, potential predictors, and clinical implications of THV thrombosis as determined by contrast-enhanced multidetector computed tomography (MDCT) after TAVR. MethodsAmong 460 consecutive patients who underwent TAVR with the Edwards Sapien XT or Sapien 3 (Edwards Lifesciences, Irvine, California) THV, 405 (88%) underwent MDCT in addition to transthoracic and transesophageal echocardiography 1 to 3 months post-TAVR. MDCT scans were evaluated for hypoattenuated leaflet thickening that indicated THV thrombosis. ResultsMDCT verified THV thrombosis in 28 of 405 (7%) patients. A total of 23 patients had subclinical THV thrombosis, whereas 5 (18%) patients experienced clinically overt obstructive THV thrombosis. THV thrombosis risk did not differ among different generations of THVs (8% vs. 6%; p = 0.42). The risk of THV thrombosis in patients who did not receive warfarin was higher compared with patients who received warfarin (10.7% vs. 1.8%; risk ratio [RR]: 6.09; 95% confidence interval [CI]: 1.86 to 19.84). A larger THV was associated with an increased risk of THV thrombosis (p = 0.03). In multivariable analysis, a 29-mm THV (RR: 2.89; 95% CI: 1.44 to 5.80) and no post-TAVR warfarin treatment (RR: 5.46; 95% CI: 1.68 to 17.7) independently predicted THV thrombosis. Treatment with warfarin effectively reverted THV thrombosis and normalized THV function in 85% of patients as documented by follow-up transesophageal echocardiography and MDCT. ConclusionsIncidence of THV thrombosis in this large study was 7%. A larger THV size may predispose to THV thrombosis, whereas treatment with warfarin appears to have a protective effect. Although often subclinical, THV thrombosis may have important clinical implications.

Device-associated thrombus after percutaneous left atrial appendage closure: a case report and literature review

Introduction. In the setting of atrial fibrillation (AF), left atrial appendage (LAA) closure using the Watchman TM device (WD) was proven to effectively prevent stroke, systemic embolism and cardiovascular death when compared with warfarin therapy. However, this procedure is potentially associated with the risk of complications, including device-attached thrombus formation. Case presentation. We report a case of a 65-year-old woman with permanent non-valvular AF, a history of ischemic stroke on warfarin treatment, hypertension, diabetes mellitus, heart failure with preserved left ventricular ejection fraction, labile values of the international normalized ratio, enlarged left atrium (LA) and spontaneous echo contrast in echocardiography, who was qualified for percutaneous LAA closure using the WD. The pre-procedural patient assessment indicated high thromboembolic (CHA 2 DS 2 -Vasc Score = 5) and bleeding risk (HAS-BLED Score = 4), and optimal morphology of LAA in transesophageal echocardiography (TEE). After a successful procedure using a 30 mm-sized WD, and despite appropriate antiplatelet and anticoagulation therapy, 6-month follow-up TEE revealed a mobile thrombus (2.4 cm × 0.6 cm) at the atrial side of the WD. Therapy with intravenous heparin was started. However, a control TEE examination after one week revealed progression of the thrombus size (4.2 cm × 0.7 cm) and its protrusion across the mitral valve orifice into the left ventricle. Although the patient remained asymptomatic, cardiosurgical excision of the thrombus was performed due to high risk of thrombus embolization. Conclusions. Late device-associated thrombus formation after implantation of the WD remains a rare but severe complication. Formal recommendations regarding prevention and management of device-related thrombosis are still lacking. In this complex clinical setting, we suggest: 1) careful long-term echocardiographic monitoring after percutaneous LAA closure, especially in patients with permanent AF, high thromboembolic risk, large LA and dense spontaneous echo contrast in echocardiography, and 2) an individualized treatment approach.

A randomized, prospective pilot comparison of 3 atrial appendage elimination techniques: Internal ligation, stapled excision, and surgical excision

BackgroundElimination of the left atrial appendage (LAA) attempts to reduce stroke in patients with atrial fibrillation (AF). A retrospective review suggests that various surgical techniques are often unsuccessful and may leave a stump or gap. In a pilot study, we prospectively evaluated 3 surgical techniques with long-term follow up to define effectiveness. MethodsAt a single institution, 28 patients undergoing concomitant AF surgery were randomized prospectively into 1 of 3 techniques of LAA elimination: internal suture ligation (IL), external stapled excision (StEx), and surgical excision (SxEx). The success of LAA elimination was assessed by transesophageal echocardiography (TEE) in all patients at the time of surgery. Failure of LAA closure consisted of either a stump (residual appendage tissue >1 cm in maximum length) or a gap (persistent flow between the left atrium [LA] and the LAA). Failure was treated intraoperatively when recognized. Late follow-up was obtained using a TEE at a mean of 0.4 years in 21/28 (75%) of patients. ResultsEarly failure was recognized and treated in 1 patient in the IL group (13%), 6 patients in the StEx group (60%), and 2 patients in the SxEx group (20%) (P = .06). On follow-up TEE, 4 of 7 patients in the IL group (57%) had developed gaps, 3 of whom (43%) with greater than mild flow. No patients in the StEx or SxEx groups had a gap (P = .03). In late follow-up, 1 of 7 patients in the IL group (14%) had a stump, compared with 2 of 8 (25%) in the StEx group and 3 of 6 (50%) in the SxEx group (P = .35). The overall failure rate was 57%: 5 of 8 (63%) in the IL group, 6 of 10 (60%) in the StEx group, and 5 of 10 (50%) in the SxEx group (P = .85). No patient had a stroke at any time during follow-up. ConclusionsLAA elimination is often incomplete and goes undetected. If the LAA is eliminated at the time of surgery, then TEE should be used intraoperatively to assess effectiveness and reintervention performed if warranted. Late assessment for completeness of closure should be considered before cessation of anticoagulation until more effective LAA techniques can be developed.

Short and long-term outcomes of percutaneous left atrial appendage suture ligation: Results from a US multicenter evaluation

Published studies of epicardial ligation of left atrial appendage (LAA) have reported discordant results. The purpose of this study was to delineate the safety and efficacy of LAA closure with the LARIAT device. This is a multicenter registry of 712 consecutive patients undergoing LAA ligation with LARIAT at 18 US hospitals. The primary end point was successful suture deployment, no leak by intraprocedural transesophageal echocardiography (TEE), and no major complication (death, stroke, cardiac perforation, and bleeding requiring transfusion) at discharge. A leak of 2-5 mm on follow-up TEE was the secondary end point. LARIAT was successfully deployed in 682 patients (95.5%). A complete closure was achieved in 669 patients (98%), while 13 patients (1.8%) had a trace leak (<2 mm). There was 1 death related to the procedure. Ten patients (1.44%) had cardiac perforation necessitating open heart surgery, while another 14 (2.01%) did not need surgery. The risk of cardiac perforation decreased significantly after the introduction of a micropuncture (MP) needle for pericardial access. Delayed complications (pericarditis requiring >2 weeks of treatment with nonsteroidal anti-inflammatory drugs/colchicine and pericardial and pleural effusion after discharge) occurred in 34 (4.78%) patients, and the risk decreased significantly with the periprocedural use of colchicine. Follow-up TEE (n = 480) showed a leak of 2-5 mm in 6.5% and a thrombus in 2.5%. One patient had a leak of >5 mm. LARIAT effectively closes the LAA and has acceptable procedural risks with the evolution of the use of the micropuncture needle for pericardial access and the use of colchicine for mitigating the postinflammatory response associated with LAA ligation and pericardial access.

An Approach to Improve the Negative Predictive Value and Clinical Utility of Transthoracic Echocardiography in Suspected Native Valve Infective Endocarditis

In patients with suspected native valve infective endocarditis, current guidelines recommend initial transthoracic echocardiography (TTE) followed by transesophageal echocardiography (TEE) if clinical suspicion remains. The guidelines do not account for the quality of initial TTE or other findings that may alter the study's diagnostic characteristics. This may lead to unnecessary TEE when initial TTE was sufficient to rule out vegetation. The objective of this study was to determine if the use of a strict definition of negative results on TTE would improve the performance characteristics of TTE sufficiently to exclude vegetation. A retrospective analysis of patients at a single institution with suspected native valve endocarditis who underwent TTE followed by TEE within 7days between January 1, 2007, and February 28, 2014, was performed. Negative results on TTE for vegetation were defined by either the standard approach (no evidence of vegetation seen on TTE) or by applying a set of strict negative criteria incorporating other findings on TTE. Using TEE as the gold standard for the presence of vegetation, the diagnostic performance of the two transthoracic approaches was compared. In total, 790 pairs of TTE and TEE were identified. With the standard approach, 661 of the transthoracic studies had negative findings (no vegetation seen), compared with 104 studies with negative findings using the strict negative approach (meeting all strict negative criteria). The sensitivity and negative predictive value of TTE for detecting vegetation were substantially improved using the strict negative approach (sensitivity, 98% [95% CI, 95%-99%] vs 43% [95% CI, 36%-51%]; negative predictive value, 97% [95% CI, 92%-99%] vs 87% [95% CI, 84%-89%]). The ability of TTE to exclude vegetation in patients is excellent when strict criteria for negative results are applied. In patients at low to intermediate risk with strict negative results on TTE, follow-up TEE may be unnecessary.

Differential Diagnosis of a Left Atrial Mass after Surgical Excision of Myxoma: a Remnant or a Thrombus?

Echocardiographic diagnosis of atrial myxoma may not always be straightforward, and the distinction between myxoma and thrombi is not easy, especially when we observe a mass after successful surgery. Our report describes a 72-year-old woman who presented with right upper limb hemiparesis and was subsequently diagnosed as having transient ischemic attack due to a left atrial myxoma. One month after successful surgical resection of the tumor, the patient developed left-sided weakness. Echocardiography revealed a left atrial mass attached to the interatrial septum. Intravenous heparin was administered as a therapeutic trial for postoperative thrombi, which resulted in a decrease in mass size within a week. Anticoagulation with warfarin was continued, and complete resolution was demonstrated on a 4-month follow-up transesophageal echocardiography. This case highlights the fact that thrombus formation at the surgical site should be considered an unusual but potential complication after surgical resection of left atrial myxomas.

Catheter-based closure of residual leaks after percutaneous occlusion of the left atrial appendage.

The purpose of this study was to evaluate safety and efficacy of catheter-based occlusion of residual leaks after percutaneous closure of the left atrial appendage (LAA). All cases of LAA closure at our center were reviewed to identify secondary interventions for residual leaks. Leaks with a width of more than 3 mm by transesophageal echocardiography (TEE) were considered relevant. In a case-specific approach, depending on the respective morphology of the defect, either an LAA occlusion device or an Amplatzer Vascular Plug was implanted under TEE and fluoroscopic guidance. Between June 2003 and December 2013, 12 patients underwent residual leak closure. All procedures were technically successful and without complications. In 10 cases (83%), complete sealing was confirmed at TEE follow-up. In 2 patients, minimal gaps (2-3 mm) persisted and anticoagulation was continued. None of the patients had strokes during the follow-up period. Percutaneous residual leak closure after attempted LAA occlusion can be done safely and with high procedural success rates. © 2015 Wiley Periodicals, Inc.

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.

Left Atrial Appendage Ligation in Nonvalvular Atrial Fibrillation Patients at High Risk for Embolic Events With Ineligibility for Oral Anticoagulation: Initial Report of Clinical Outcomes

ObjectivesThis study sought to assess long-term clinical outcomes in adults with nonvalvular atrial fibrillation (AF) who are ineligible for oral anticoagulation therapy and underwent left atrial appendage (LAA) ligation with the Lariat device. BackgroundLAA exclusion has been used to prevent thrombus formation within the LAA in AF patients and is believed to decrease the risk of cardioembolic events. MethodsLAA ligation with the Lariat device was performed in 139 patients with nonvalvular AF. LAA closure was verified during the procedure by LA angiography and transesophageal echocardiography. A follow-up transesophageal echocardiography was performed at 30 to 45 days post-procedure. After the procedure, patients received aspirin only, clopidogrel only, aspirin plus clopidogrel, or no antithrombotic drugs. Patients did not receive transition oral anticoagulation therapy post-LAA ligation. Patients were followed for LAA closure and adverse events, including stroke, systemic events, and death. ResultsAcute closure was accomplished in 138 of 139 treated patients (99%). In 1 patient, a posterior lobe was partially closed. At the day-30 to day-45 transesophageal echocardiography (n = 127), 114 (90%) had complete LAA closure, and 13 (10%) had a 2- to 4-mm leak. There were no leaks ≥5 mm. The periprocedural adverse event rate was 11.5%, including 2 cardiac perforations and 1 death due to pulmonary embolus. Over a mean follow-up of 2.9 ± 1.1 years, the event rate for the composite endpoint of stroke and systemic embolism was 1.0% per year (n = 4). The combined stroke, embolism, and death of any cause event rate was 2.8% (n = 11) per year. ConclusionsThe findings from this analysis of post-procedure event rates suggest that LAA ligation with the Lariat device effectively closes the LAA and may be a beneficial approach to reduce the risk of embolic events in AF patients ineligible to oral anticoagulation therapy. However, future randomized clinical trials are needed to verify these results and to determine device and procedural safety.

Transcatheter Left Atrial Appendage Closure Using Intracardiac Echocardiographic Guidance From the Left Atrium

BackgroundMost commonly, left atrial appendage (LAA) occlusion procedures are performed using transesophageal echocardiography (TEE) guidance and general anaesthesia. Intracardiac echocardiography (ICE) offers potential advantages over TEE, however, ICE-guided LAA occlusion experience is limited and has been typically performed from a right-sided location where LAA visualization might be suboptimal. We sought to evaluate the efficacy and safety of percutaneous LAA occlusion using ICE guidance performed from the left atrium. MethodsThirty-seven patients with atrial fibrillation, significant risk for stroke, and long-term contraindication to anticoagulation underwent LAA closure with the Amplatzer Cardiac Plug (St Jude Medical, Inc, St Paul, MN) with mild sedation and ICE guidance. The ICE catheter was introduced in the left atrium through a second transseptal puncture. Patients underwent preprocedural TEE to rule out thrombus and 3-month follow-up TEE to assess occlusion grade. Patient characteristics, procedural data, effectiveness of ICE imaging, quality of occlusion, and complications were prospectively recorded. ResultsProcedural success was achieved in 36 of 37 patients (97%). Closure was complete or near complete (grade ≥3 according to ICE and angiography) in all cases where the device was released. In all cases, ICE imaging yielded good LAA and surrounding structure visualization and adequate procedural guidance. Three major procedural or in-hospital complications occurred. Median length of stay was 1 day. Follow-up TEE documented the absence of any residual peri-device leak in all but 1 (29 of 30) case. ConclusionInitial experience suggests LAA occlusion with the Amplatzer Cardiac Plug using ICE guidance from the left atrium is feasible, reproducible, and safe.

Abstract T MP117: Rosuvastatin May Have Long-Term Clinical Benefits by Causing Plaque Regression and Improving Aortic Stiffness in Ischemic Stroke Patients

Background: Complicated aortic arch plaque (CAP) is important in recurrent ischemic stroke (IS) and prognosis. Keying on the reduced occurrence of IS observed in the large-cohort JUPITER Study, the current investigation assessed clinical benefits and pathophysiology of statin therapy. Methods: Of 112 consecutive acute cerebral embolism patients, 97 gave informed consent for our retrospective survey and were analyzed. All had transesophageal echocardiography (TEE) to assess presence or absence of CAP, defined as aortic wall thickness &gt;4mm or plaque ulceration. Also assessed were aortic stiffness parameter β (Aoβ) and aortic arch wall motion velocity (WMV) evaluated by tissue Doppler imaging. Patients received appropriate conventional antithrombotic therapy as clinically indicated, and in addition we recommended that all patients with CAP receive 5 mg rosuvastatin/day. Patients were divided into 3 groups: those with CAP taking rosuvastatin (Group A, n=26, 68±7 years), those with CAP not taking rosuvastatin (Group B, n=13, 71±9 years), and those without CAP (Group C; n=58, 62±12 years). Follow-up TEE was performed at 6 months in Group A. In these 3 groups recurrent stroke and death were defined as major adverse cerebrovascular events (MACE). Results: Study duration was 710±405 days. CAP was detected in 39 patients (40%), and MACE occurred in 15 (15%). Kaplan-Meier analysis demonstrated that Group B had significantly higher MACE compare to other 2 groups (long-rank test; X2=6.553, p&lt;0.05), while Group A did not differ from Group C despite being significantly older (p&lt;0.05). Group A patients with a follow-up TEE at 6 months showed significant improvement in CAP diameter, Aoβ and peak WMV during the diastolic phase of contraction (5.8±2.0 vs. 4.9±1.9 mm, p&lt;0.01; 19.5±14.6 vs. 12.9±6.5, p&lt;0.05; 1.5±0.4 vs. 1.7±0.4 cm/s, p&lt;0.01, respectively). In addition, CAP were morphologically improved in 15 patients, unchanged in 8, and worsened in 3. Conclusions: Rosuvastatin therapy causes plaque regression and improved aortic arch stiffness in IS patients with CAP, and may also have long-term clinical benefits.

PERCUTANEOUS LEFT ATRIAL APPENDAGE OCCLUSION UNDER INTRA-CARDIAC ECHOCARDIOGRAPHY GUIDANCE FROM THE LEFT ATRIUM

Percutaneous left atrial appendage (LAA) occlusion is commonly performed under general anesthesia and trans-esophageal echocardiography (TEE) guidance. Experience is limited with LAA occlusion under intra-cardiac echocardiography (ICE) guidance. Previously ICE guidance for LAA occlusion has been performed from the right atrium or coronary sinus where visualization of the LAA anatomy is uncertain. Our goal was to evaluate the feasibility, efficacy and safety of LAA occlusion using ICE guidance from the left atrium (LA) under local anesthesia and conscious sedation. Twenty-three consecutive patients (mean age 75 IQR 65-85) with atrial fibrillation, high risk of thromboembolic complications (CHA2DS2VASc score ≥ 2) and long term contra-indication to anticoagulation underwent LAA closure with the Amplatzer Cardiac Plug (ACP)TM (St.Jude Medical Inc.) under conscious sedation and ICE guidance. The ICE catheter (8-Fr Acunav, Biosense Webster Inc.) and ACP delivery sheath were advanced into the LA through separate transseptal punctures. Baseline patient characteristics, procedural and follow-up data were prospectively recorded. Clinical and TEE follow-up was performed 3 months after the procedure. Procedural success was defined as the implantation of the closure device at the intended delivery site with adequate occlusion (grade 3 or more by angiography and ICE). Mean CHADSVASC and HASBLED scores were respectively 4.4±1.4 and 3.5±0.8. Procedural success was achieved in 22 of 23 patients (96%) with a mean procedural time was 105±27 minutes. There were no major procedural complications. The only failure was due to challenging “chicken wing” LAA anatomy where an adequate device position could not be secured. Median hospital stay was 1 day. In all cases, ICE provided adequate procedural guidance, closure assessment and LAA and device visualization, including their relation with adjacent structures (figure 1). Best appreciation of the LAA anatomy was achieved with the ICE catheter placed in a mid-LA location or just above the mitral plane. There were no lost to follow-up. Two patients died of causes not related to the procedure or device. Three-month TEE (n = 20) showed complete LAA exclusion in all but one patient. Initial experience suggests LAA occlusion with the Amplatzer Cardiac PlugTM under ICE guidance from the left atrium in conscious patients is feasible, reproducible and safe.

Early Safety and Efficacy of Percutaneous Left Atrial Appendage Suture Ligation: Results From the U.S. Transcatheter LAA Ligation Consortium

BackgroundTranscatheter left atrial appendage (LAA) ligation may represent an alternative to oral anticoagulation for stroke prevention in atrial fibrillation. ObjectivesThis study sought to assess the early safety and efficacy of transcatheter ligation of the LAA for stroke prevention in atrial fibrillation. MethodsThis was a retrospective, multicenter study of consecutive patients undergoing LAA ligation with the Lariat device at 8 U.S. sites. The primary endpoint was procedural success, defined as device success (suture deployment and <5 mm leak by post-procedure transesophageal echocardiography), and no major complication at discharge (death, myocardial infarction, stroke, Bleeding Academic Research Consortium bleeding type 3 or greater, or cardiac surgery). Post-discharge management was per operator discretion. ResultsA total of 154 patients were enrolled. Median CHADS2 score (congestive heart failure, hypertension, age ≥75 years, diabetes mellitus, prior stroke, transient ischemic attack, or thromboembolism [doubled]) was 3 (interquartile range: 2 to 4). Device success was 94%, and procedural success was 86%. A major complication occurred in 15 patients (9.7%). There were 14 major bleeds (9.1%), driven by the need for transfusion (4.5%). Significant pericardial effusion occurred in 16 patients (10.4%). Follow-up was available in 134 patients at a median of 112 days (interquartile range: 50 to 270 days): Death, myocardial infarction, or stroke occurred in 4 patients (2.9%). Among 63 patients with acute closure and transesophageal echocardiography follow-up, there were 3 thrombi (4.8%) and 13 (20%) with residual leak. ConclusionsIn this initial multicenter experience of LAA ligation with the Lariat device, the rate of acute closure was high, but procedural success was limited by bleeding. A prospective randomized trial is required to adequately define clinical efficacy, optimal post-procedure medical therapy, and the effect of operator experience on procedural safety.

Rosuvastatin Improves Plaque Morphology in Cerebral Embolism Patients with Normal Low-Density Lipoprotein and Severe Aortic Arch Plaque

The effect of rosuvastatin was investigated on complicated aortic arch plaque (CAP) morphology and lipid profiles in acute cerebral embolism (CE) patients with normal low-density lipoprotein-cholesterol (LDL-c) levels. Transesophageal echocardiography (TEE) studies were performed in 56 consecutive CE patients with LDL-c less than 140 mg/dL who were not taking lipid-lowering agents at baseline. CAP observed by TEE was defined as the presence of greater than 4-mm diameter, ulcerated, or mobile aortic plaque. Patients were divided into those with CAP versus without CAP (group A, n=24, age 69±8 years) and without CAP (group B, n=32, age 62±10 years). Of the 24 group A patients, 18 received 5 mg/d of rosuvastatin for 6 months and had follow-up TEE studies. In Group A, the baseline values of high-density lipoprotein-cholesterol (HDL-c) and apolipoprotein A-1 (ApoA-1) were significantly lower than in Group B (44±15 versus 55±15 mg/dL, P=.0059; 103±19 versus 137±25 mg/dL, P=.0006, respectively) and age and serum high-sensitivity C-reactive protein concentration were significantly higher (69±8 vs. 62±10 years, P=.0080; 2.34±3.05 vs. 0.67±1.00 mg/dL, P=.0054, respectively). By multivariate logistic regression analysis, ApoA-1 was shown to be an independent predictor of CAP (odds ratio=.894, 95% confidence intervals .800-.996, P=.0483). In the 18 group A patients receiving rosuvastatin for 6 months, aortic arch plaque diameter and serum LDL-c were significantly decreased (5.8±2.2 to 5.1±2.1 mm, P=.0377; 110±23 to 81±23 mg/dL, P=.0008, respectively), whereas serum HDL-c and ApoA-1 concentrations were significantly increased (42±8 to 52±9 mg/dL, P=.0002; 109±22 to 135±15 mg/dL, P=.0002, respectively). Plaques were morphologically improved in 11 patients, unchanged in 6, and worsened in 1. These data suggest that rosuvastatin improves plaque morphology concomitant with improving lipid profiles in CE patients with normal LDL-c levels.