Safety and efficacy study of the wound care 360° SiteSeal® vascular closure device in percutaneous cardiac catheterization procedures.

OBJECTIVES: Vascular access site complications after percutaneous transfemoral cardiovascular procedures remain a common cause of morbidity and mortality. We evaluated the SiteSeal® VCD for achieving hemostasis following diagnostic cardiac catheterization. METHODS: We conducted a prospective case control single center study to assess the safety and efficacy of SiteSeal® VCD compared to standard manual compression following diagnostic cardiac catheterization. Forty patients were enrolled in study to receive either SiteSeal® device or manual compression (20 in each group). RESULTS: Patients in the SiteSeal® group achieved hemostasis in a significantly shorter time (4 ± 2.4 vs. 19 ± 2.4 min, P < 0.001), had shorter time from hemostasis to ambulation (95 ± 44 vs. 388 ± 63 min, P < 0.001) and significantly earlier device deployment to discharge time compared to the manual compression group (4.7 ± 1.1 vs. 8.9 ± 4.8 h, P = 0.001). There was one non-major bleeding event in the SiteSeal® group which occurred >24 h after discharge from the hospital and was managed conservatively. In the remaining device patients, there was no clinical or Doppler ultrasound evidence of major or minor vascular complication with good overall patient comfort at discharge, 7 days and 30 days follow-up. CONCLUSIONS: In this first clinical experience, the SiteSeal® VCD achieved safe and efficient hemostasis, allowed for earlier ambulation and faster discharge compared to manual compression.

Vascular complications associated with percutaneous left ventricular assist device placement: A 10-year US perspective.

BACKGROUND: Over the last decade, there has been a significant increase in the use of percutaneous left ventricular assist devices(p-LVADs). p-LVADs are being increasingly used during complex coronary interventions and for acute cardiogenic shock. These large bore percutaneous devices have a higher risk of vascular complications. We examined the vascular complication rates from the use of p-LVAD in a national database. METHODS: We conducted a secondary analysis of the National In-patient Sample (NIS) dataset from 2005 till 2015. We used the ICD-9-CM procedure codes 37.68 and 37.62 for p-LVAD placement regardless of indications. We investigated common vascular complications, defining them by the validated ICD 9 CM codes. χ2 test and t test were used for categorical and continuous variables, respectively for comparison. RESULTS: A total of 31,263 p-LVAD placements were identified during the period studied. A majority of patients were male (72.68%) and 64.44% were white. The overall incidence of vascular complications was 13.53%, out of which 56% required surgical treatment. Acute limb thromboembolism and bleeding requiring transfusion accounted for 27.6% and 21.8% of all vascular complications. Occurrence of a vascular complication was associated with significantly higher in-hospital mortality (37.77% vs. 29.95%, p < .001), length of stay (22.7 vs. 12.2 days, p < .001) and cost of hospitalization ($ 161,923 vs. $ 95,547, p < .001). CONCLUSIONS: There is a high incidence of vascular complications with p-LVAD placement including need for vascular surgery. These complications are associated with a higher in-hospital, LOS and hospitalization costs. These findings should be factored into the decision-making for p-LVAD placement.

Impact of short term oral steroid use for intravenous contrast media hypersensitivity prophylaxis in diabetic patients undergoing nonemergent coronary angiography or interventions.

OBJECTIVES: Oral steroids are routinely administered in the United States for prophylaxis of iodinated contrast media hypersensitivity (ICMH). We studied the impact of short-term steroid use in diabetic patients with ICMH undergoing nonemergent coronary angiography. METHODS: We retrospectively analyzed records of diabetic patients with and without ICMH who underwent nonemergent coronary angiography at our center. Primary study endpoint was 30-day major adverse cardiac events (MACE) and secondary endpoints were pre- and postprocedure fasting blood glucose (FBG), highest in hospital blood glucose, pre- and postprocedure systolic blood pressure (SBP), and use of intravenous insulin and antihypertensive medications. RESULTS: A total of 88 diabetics with ICMH (study group) and 76 diabetics without ICMH (control group) undergoing angiography were enrolled. Demographics and hemoglobin A1c values were similar in both groups. Preprocedural FBG was significantly higher in the study group. The study group had significantly higher post angiography FBG (239.93 + 96.88 mg/dl vs. 156.6 + 59.88 mg/dl) and greater use of intravenous (IV) insulin (67.27% vs. 32.43%). Further, those who received steroids had significantly higher systolic SBP postprocedure (146.16 + 25.35 mmHg vs. 130.8 + 21.59 mmHg), a higher incidence of severe hypertension and use of IV antihypertensive medications (80.95% vs. 19.05%) periprocedurally. There were no differences in 30-day MACE between groups. CONCLUSION: Short-term steroid use for ICMH results in a significant increase in surrogate markers for adverse clinical events after coronary procedures. Study findings highlight the need for better periprocedural management of these patients and to limit steroid prophylaxis to those with only true ICMH.

Prognostic significance, angiographic characteristics and impact of antithrombotic and anticoagulant therapy on outcomes in high versus low grade coronary artery ectasia: A long-term follow-up study.

OBJECTIVES: To assess the prognostic significance of high vs. low grade coronary artery ectasia (CAE) and the impact of antithrombotic or anticoagulant therapy on adverse cardiac outcomes. BACKGROUND: There is paucity of knowledge on the impact of angiographic characteristics in CAE or that of antithrombotic or anticoagulant therapy on outcomes. METHODS AND RESULTS: In this retrospective study, we reviewed angiograms and medical records of all cases of confirmed CAE (2001-2011). Extent of CAE was categorized using the Markis classification. Types 1 and 2 were categorized as high-grade and types 3 and 4 as low-grade CAE. Angiographic flow was recorded as normal or sluggish (

Safety profiles of percutaneous left atrial appendage closure devices: An analysis of the Food and Drug Administration Manufacturer and User Facility Device Experience (MAUDE) database from 2009 to 2016.

BACKGROUND: Percutaneous left atrial appendage closure (LAAC) is a viable option for AF patients who are unable to tolerate long-term oral anticoagulation (OAC). OBJECTIVE: We sought to assess the safety of two commonly used percutaneous devices for LAA closure in the United States by analysis of surveillance data from the FDA Manufacturer and User Facility Device Experience (MAUDE) database. METHODS: The MAUDE database was queried between May 1, 2006 and May 1, 2016 for LARIAT® (SentreHEART Inc., Redwood City, CA, USA) and WATCHMAN™ (Boston Scientific Corp., Marlborough, MA, USA) devices. Among 622 retrieved medical device reports, 356 unique and relevant reports were analyzed. The cumulative incidence of safety events was calculated over the study period and compared between the two devices. RESULTS: LAAC was performed with LARIAT in 4,889 cases. WATCHMAN was implanted in 2,027 patients prior to FDA approval in March 2015 and 3,822 patients postapproval. The composite outcome of stroke/TIA, pericardiocentesis, cardiac surgery, and death occurred more frequently with WATCHMAN (cumulative incidence, 1.93% vs. 1.15%; P = 0.001). The same phenomenon was observed when comparing the WATCHMAN pre- and postapproval experiences for the composite outcome, as well as device embolization, cardiac surgery, and myocardial infarction. CONCLUSIONS: MAUDE-reported data show that postapproval, new technology adoption is fraught with increased complications. Improved collaboration between operators, device manufacturers, and regulators can better serve patients through increased transparency and practical postmarket training and monitoring mechanisms.

Anatomical and electrical remodeling with incomplete left atrial appendage ligation: Results from the LAALA-AF registry.

BACKGROUND: The anatomical, electrical, and clinical impact of incomplete Lariat left atrial appendage ligation remains unclear. METHODS: We studied LAA anatomy pre- and postligation using contrast enhanced-computed tomography (CT) scans in 91 patients with atrial fibrillation (AF) who subsequently underwent catheter ablation (CA). RESULTS: Eleven patients had an incomplete exclusion (12%) with a central leak ranging from 1 to 5 mm. Despite incomplete ligation; the LAA volume were reduced by 67% postprocedurally when compared to preprocedure. In 7 patients with a leak between 1 and 3 mm, there was a 77% reduction in LAA volume beyond the ligation site suggestive of remodeling of the LAA. In 4 patients with larger (4-5 mm) leak the LAA remnants (LAARs) were slightly larger than those with smaller leaks on follow-up CT scan. Three out of the 4 demonstrated LAA electrical activity during CA and underwent isolation of the LAA ostium. Follow-up imaging showed two of these LAARs completely sealed with no communication with the left atrium. There was no significant difference in the AF recurrence rates between the patients who had a leak versus those with complete ligation (4 of 11 [36%] vs. 22 of 80 [27%]; P  =  0.6). Oral anticoagulation was discontinued in all patients with small leaks and 2 patients with large leaks that sealed completely upon follow-up imaging. There were no strokes or TIAs at 12 months. CONCLUSION: Despite incomplete LAA ligation by Lariat device there is significant anatomical and electrical remodeling that resulted in reduction in LAA size, volume, and electrical activity.

Safety and Feasibility of Rotational Atherectomy in Elderly Patients With Severe Aortic Stenosis.

BACKGROUND: Percutaneous coronary intervention (PCI) followed by transcatheter aortic valve replacement (TAVR) is an alternative to surgery in patients with severe aortic stenosis (AS) and coronary artery disease (CAD). In many, the coronary arteries are severely calcified and best treated with rotational atherectomy (RA). However, RA is not routinely performed in severe AS patients due to safety concerns. There is a paucity of data on the safety of RA in severe AS patients with calcific CAD. METHODS: We retrospectively analyzed the medical records of 29 patients with severe AS who underwent elective RA-facilitated PCI at our center between January 1, 2011 and December 31, 2015. RESULTS: Twenty-nine patients (mean age, 79.8 ± 8.8 years) were enrolled. Mean aortic valve area was 0.71 ± 0.20 cm², mean aortic valve gradient was 40.32 ± 9.88 mm Hg. All PCIs were successful (mean diameter stenosis, 86.3 ± 7.6%; mean burr size, 1.62 ± 0.19 mm). Nineteen patients (65.5%) required temporary pacemaker. Eight patients (27.6%) required vasopressors during PCI. There was a significant reduction in systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP), and heart rate (HR) during RA, but without clinical events. No procedure was aborted and there were no deaths or clinical myocardial infarctions. CONCLUSION: RA-facilitated PCI can be safely performed in elderly patients with severe AS and severely calcified CAD with low risk of complications. There was a significant but transient drop in SBP, DBP, MAP, and HR during RA. However, this was not associated with clinically significant adverse events.

Use of non-warfarin oral anticoagulants instead of warfarin during left atrial appendage closure with the Watchman device.

BACKGROUND: In the stroke prevention trials of left atrial appendage closure with the Watchman device (Boston Scientific), a postimplantation antithrombotic regimen of 6 weeks of warfarin was used. OBJECTIVE: Given the clinical complexity of warfarin use, the purpose of this study was to study the relative feasibility and safety of using non-warfarin oral anticoagulants (NOACs) instead of warfarin during the peri- and initial postimplantation periods after Watchman implantation. METHODS: This was a retrospective multicenter study of consecutive patients undergoing Watchman implantation and receiving peri- and postprocedural NOACs or warfarin. Transesophageal echocardiography or chest computed tomography was performed between 6 weeks and 4 months postimplant to assess for device-related thrombosis. Bleeding and thromboembolic events also were evaluated at the time of follow-up. RESULTS: In 5 centers, 214 patients received NOACs (46% apixaban, 46% rivaroxaban, 7% dabigatran, and 1% edoxaban) in either an uninterrupted (82%) or a single-held-dose (16%) fashion. Compared to a control group receiving uninterrupted warfarin (n = 212), the rates of periprocedural complications, including bleeding events, were similar (2.8% vs 2.4%, P = 1). At follow-up, the rates of device-related thrombosis (0.9% vs 0.5%, P = 1), composite of thromboembolism or device-related thrombosis (1.4% vs 0.9%, P = 1), and postprocedure bleeding events (0.5% vs 0.9%, P = .6) also were comparable between the NOAC and warfarin groups. CONCLUSION: NOACs proved to be a feasible peri- and postprocedural alternative regimen to warfarin for preventing device-related thrombosis and thromboembolic complications expected early after appendage closure with the Watchman device, without increasing the risk of bleeding.

Intravenous Adenosine Infusion is Safe and Well Tolerated During Coronary Fractional Flow Reserve Assessment in Elderly Patients With Severe Aortic Stenosis.

BACKGROUND: This study assessed the safety of intravenous adenosine infusion during fractional flow reserve (FFR) evaluation of intermediate coronary lesions in severe aortic stenosis (AS). In severe AS, the extent of underlying coronary artery disease (CAD) can be an important determinant for deciding between surgical aortic valve replacement (SAVR) and transcatheter aortic valve replacement (TAVR). Hemodynamic assessment of coronary lesion severity using FFR may reduce the extent of revascularization needed and make TAVR more feasible in higher-risk patients (compared with coronary artery bypass surgery with SAVR). METHODS AND RESULTS: We retrospectively analyzed the demographic, clinical, and hemodynamic parameters of 72 patients with severe AS who underwent FFR procedure with intravenous adenosine infusion for hemodynamic assessment of intermediate coronary artery lesions. Severe AS patients were elderly, predominantly male, and had a high prevalence of peripheral arterial disease, prior myocardial infarction, left ventricular hypertrophy, and chronic kidney disease. Mean aortic valve area in these patients was 0.71 ± 0.24 cm². No patient with severe AS required discontinuation of the adenosine and all patients tolerated the infusion well. We observed a statistically significant reduction in systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP), and heart rate (HR) during adenosine infusion compared with the baseline values. However, no clinically significant adverse events occurred. CONCLUSION: In elderly patients with severe AS, adenosine infusion is safe and well tolerated during FFR evaluation of intermediate coronary lesions. There was a significantly greater drop in SBP, DBP, MAP, and HR with adenosine infusion as compared with baseline values. This, however, was not associated with clinically significant adverse events.

Impact of Periprocedural Colchicine on Postprocedural Management in Patients Undergoing a Left Atrial Appendage Ligation Using LARIAT.

INTRODUCTION: Left atrial appendage (LAA) can be effectively and safely excluded using a novel percutaneous LARIAT ligation system. However, due to pericardial catheter manipulation and LAA ligation and subsequent necrosis, postprocedural course is complicated by pericarditis. We intended to evaluate the preprocedural use of colchicine on the incidence of postprocedural pericardial complications. METHODS AND RESULTS: In this multicenter observational study, we included all consecutive patients who underwent LARIAT procedure at the participating centers. Many patients received periprocedural colchicine at the discretion of the physician. We compared the postprocedural outcomes of patients who received prophylactic periprocedural colchicine (colchicine group) with those who did not receive colchicine (standard group). A total of 344 consecutive patients, 243 in the "colchicine group" and 101 in the "standard group," were included. The mean age, median CHADS2VASc score, and HASBLED scores were 70 ± 11 years, 3 ± 1.7, and 3 ± 1.1, respectively. There were no significant differences in major baseline characteristics between the two groups. Severe pericarditis was significantly lower in the "colchicine group" compared to the "standard group" (10 [4%] vs. 16 [16%] P<0.0001). The colchicine group, compared to the standard group, had lesser pericardial drain output (186 ± 84 mL vs. 351 ± 83, P<0.001), shorter pericardial drain duration (16 ± 4 vs. 23 ± 19 hours, P<0.04), and similar incidence of delayed pericardial effusion (4 [1.6%] to 3 [3%], P = 0.42) when compared to the standard group. CONCLUSION: Use of colchicine periprocedurally was associated with significant reduction in postprocedural pericarditis and associated complications.

Electrolyte and hemodynamic changes following percutaneous left atrial appendage ligation with the LARIAT device.

PURPOSE: The left atrial appendage (LAA) is a well-known source of atrial natriuretic peptide (ANP) and therefore plays an important role in homeostasis. The neurohormonal impact of epicardial exclusion of the LAA with the LARIAT procedure is unknown. In this proof-of-concept study, we postulated that LAA exclusion would impact homeostasis as evidenced by changes in electrolytes and blood pressure (BP). METHODS: A total of 76 patients who underwent successful LAA exclusion were enrolled in this retrospective observational study utilizing a prospective registry. Electrolytes, BP, and heart rate (HR) were monitored before LARIAT and post-LARIAT (24 and 72 h and 6 months). RESULTS: There was a significant reduction of systolic BP (mmHg) at 24 h (113.3 ± 16.0; p < 0.0001) and 72 h (119.0 ± 18.4 mmHg; p < 0.0001) post-LARIAT when compared with pre-LARIAT BP (138.2 ± 21.3). The reduction in systolic BP persisted at 6-month follow-up (128.8 ± 17.3; p = 0.0005). There was significant reduction in serum sodium (mmol/L) at 24 h (135.4 ± 3.6; p < 0.0001) and 72 h (136.3 ± 3.7; p < 0.001) post-LARIAT when compared to pre-LARIAT (138.7 ± 3.2). The reduction in sodium was not persistent at 6-month follow-up (138.4 ± 3.3; p = 0.453). CONCLUSIONS: LAA exclusion results in an early and persistent decrease in systolic BP. Additionally, there is an early decline in serum sodium, which normalizes at long-term follow-up. The underlying mechanism leading to these changes is not entirely clear; however, it is likely related to neurohormonal changes post LAA exclusion.

Endocardial (Watchman) vs epicardial (Lariat) left atrial appendage exclusion devices: Understanding the differences in the location and type of leaks and their clinical implications.

BACKGROUND: Watchman and Lariat left atrial appendage (LAA) occlusion devices are associated with LAA leaks postdeployment. OBJECTIVE: The purpose of this study was to compare the incidence, characteristics, and clinical significance of these leaks. METHODS: We performed a multicenter prospective observational study of all patients who underwent LAA closure. Baseline, procedural, and imaging variables along with LAA occlusion rates at 30-90 days and 1-year postprocedure were compared. RESULTS: A total of 478 patients (219 with the Watchman device and 259 with the Lariat device) with successful implants were included. Patients in the Lariat group had a higher CHADS2 (congestive heart failure, hypertension, age >74 years, diabetes, stroke) score and a larger left atrium and LAA. A total of 79 patients (17%) had a detectable leak at 1 year. More patients in the Watchman group had a leak compared with those in the Lariat group (46 [21%] vs 33 [14%]; P = .019). All the leaks were eccentric (edge effect) in the Watchman group and concentric (gunny sack effect) in the Lariat group. The size of the leak was larger in the Watchman group than in the Lariat group (3.10 ± 1.5 mm vs 2.15 ± 1.3 mm; P = .001). The Watchman group had 1 device embolization requiring surgery and 2 pericardial effusions requiring pericardiocentesis. In the Lariat group, 4 patients had cardiac tamponade requiring urgent surgical repair. Three patients in each group had a cerebrovascular accident and were not associated with device leaks. CONCLUSION: The Lariat device is associated with a lower rate of leaks at 1 year as compared with the Watchman device, with no difference in rates of cerebrovascular accident. There was no correlation between the presence of residual leak and the occurrence of cerebrovascular accident.

Characterization of pleural effusion after left atrial appendage exclusion using the Lariat procedure.

BACKGROUND: The Lariat procedure is increasingly used for the exclusion of the left atrial appendage (LAA) in atrial fibrillation (AF) patients. There are anecdotal reports of pleural effusions after the Lariat procedure. However, the incidence, demographics, and pathophysiology of these effusions are largely unknown. OBJECTIVE: Characterization of pleural effusions in patients who underwent LAA exclusion using the Lariat procedure. METHODS: We report the incidence, demographics, and clinical and laboratory characteristics of patients from a multicenter prospective registry who underwent the Lariat procedure and subsequently developed pleural effusions. RESULTS: A total of 10 out of 310 (3.2%) patients developed significant pleural effusions after the Lariat procedure. The mean age of these patients was 67 ± 9, ranging from 52 to 78 years and included 5 (50%) males. Nine patients had persistent AF with median CHADS2 score of 2.7 ± 1.2. The LAA was successfully ligated in all these patients. Post-Lariat procedure, 6 patients developed bilateral and 4 patients developed left-sided pleural effusions. Pleural tap revealed transudative in 2 and exudative in 6 patients. The remaining 2 patients responded to active diuresis and behaved clinically like transudative effusions. There is a statistically significant difference between the onset of pleural effusion after the Lariat procedure between tPLE versus ePLE groups (14 ± 1.2 vs. 6 ± 6, P = 0.05). CONCLUSION: Incidence of clinically significant pleural effusion is uncommon after the Lariat procedure and can be either exudative or transudative in nature depending on the underlying mechanisms. More prospective studies are needed to study the pathophysiologic basis of development of pleural effusions after the Lariat procedure.

Left Atrial Appendage Ligation and Ablation for Persistent Atrial Fibrillation: The LAALA-AF Registry.

OBJECTIVES: This study was intended to evaluate the impact of adding the left atrial appendage (LAA) closure system (LARIAT) procedure to conventional atrial fibrillation (AF) ablation in patients with persistent AF. BACKGROUND: Percutaneous endoepicardial LARIAT may result in both mechanical and electrical exclusion of the LAA and aid in improving the outcomes of catheter ablation by eradicating the LAA triggers and altering the substrate. METHODS: We performed a prospective observational study of patients with persistent AF referred for AF ablation. Patients underwent LAA ligation with LARIAT procedure before undergoing AF ablation (LARIAT group). Age- and sex-matched persistent AF patients undergoing AF ablation during the same time frame were included in the control group (ablation-only group). RESULTS: A total of 138 patients were included in the study, with 69 patients in the LARIAT group. The mean age of the population was 67 ± 10 years, with 96 (70%) men. Left atrial (LA) size, CHADS2, CHADSVasc, and HAS-BLED scores were higher in the LARIAT group when compared with the ablation-only group. There were no differences in the type of lesions during AF ablation between the groups. The primary outcome of freedom from AF at 1 year off antiarrhythmic therapy after 1 ablation procedure was higher in the LARIAT group (45 [65%] vs. 27 [39%]; p = 0.002). More patients in the ablation-only group underwent repeat ablation because of AF recurrence (11 [16%] vs. 23 [33%]; p = 0.018). CONCLUSIONS: In patients with persistent AF, addition of LAA ligation with the LARIAT device to conventional ablation appears to improve the success rate of AF ablation.

Left Atrial Appendage Tachycardia Termination With A LARIAT Suture Ligation.

Left atrial appendage (LAA) is a known trigger for left atrial tachycardia (AT). The use of LARIAT epicardial suture for termination of AT arising from LAA is not yet reported. A 66-year-old female had a history of hypertension, diabetes, sick sinus syndrome, labile INR, and symptomatic persistent AF. She underwent radiofrequency ablation after failed cardioversion and multiple antiarrhythmics. She was in AT originating from LAA on activation map. Radiofrequency endocardial LAA isolation was performed. However, the AT recurred with increased burden and symptoms. Due to her multiple hospitalization for spontaneous bleeds and labile INR, a Lariat epicardial suture ligation of her LAA was performed. With application of the Lariat suture, electrical isolation was achieved and the AT terminated. She remained AT free at 18 months. Our case is the first to illustrate the utility of LARIAT suture in electrical isolation of the LAA in addition to its mechanical exclusion.

Impact of left atrial appendage exclusion using an epicardial ligation system (LARIAT) on atrial fibrillation burden in patients with cardiac implantable electronic devices.

BACKGROUND: The left atrial appendage (LAA) is a well-known source of atrial arrhythmia and atrial fibrillation (AF). OBJECTIVE: The purpose of this study was to determine whether LAA exclusion using the LARIAT device would decrease AF burden. METHODS: A total of 50 patients with AF and cardiac implantable electronic devices who underwent successful LAA exclusion were enrolled in this prospective observational study. AF burden before LAA exclusion (baseline) and 3 and 12 months after exclusion was assessed by device interrogation. RESULTS: AF burden at 3-month follow-up (42% ± 34%) was significantly lower compared to baseline (76% ± 33%, P < .0001). The reduction in AF burden was sustained at 12 months (59% ± 26%, P < .001). Subgroup analysis revealed that AF burden at 3-month follow-up was similarly reduced in both paroxysmal AF (n = 19) and nonparoxysmal AF (n = 31). However, there was no reduction in AF burden in patients with paroxysmal AF at 12 months. AF burden in patients with known AF triggers in the LAA (n = 9) was significantly reduced at 3 months (52% ± 35%) and 12 months (42% ± 19%) compared to respective baseline (84 ± 31%, P < .0001). CONCLUSION: LAA exclusion appears to reduce AF burden. The presence of AF triggers in the LAA appears to be the strongest predictor of AF reduction. The study underscores the role of the LAA in arrhythmogenesis for AF and highlights the complementary role of LAA exclusion in restoration of normal sinus rhythm.

Initial experience with post Lariat left atrial appendage leak closure with Amplatzer septal occluder device and repeat Lariat application.

BACKGROUND: Left atrial appendage (LAA) ligation with the Lariat device is a therapeutic option to prevent thromboembolic stoke in patients with nonvalvular atrial fibrillation (AF) at high risk for systemic thromboembolization and bleeding related to use of anticoagulation. In rare cases, this procedure could leave the LAA incompletely ligated with continued risk of stroke. OBJECTIVE: The purpose of this study was to investigate the incidence and characteristics of LAA leak following ligation using the Lariat device and the feasibility of leak closure with the Amplatzer septal occluder device or a repeat Lariat application. METHODS: Seventy-one consecutive patients who underwent LAA ligation by the Lariat device were followed-up with transesophageal echocardiography to evaluate for the presence of appendage leaks, characterization of the leaks, and the presence of any thrombus. Patients with LAA leaks underwent definite closure of the leak. RESULTS: Six patients had LAA leaks with a mean leak size of 4.3 ± 0.6 mm. All leaks were concentric in nature. None of the patients had LAA thrombus. Leaks in 5 of these patients were successfully closed using an Amplatzer septal occluder device (St. Jude Medical); the leak in the sixth patient was closed using a repeat Lariat procedure. CONCLUSION: LAA leaks from incomplete ligation of the LAA following the Lariat procedure are not uncommon and could be successfully closed with an Amplatzer septal occluder device or a repeat Lariat procedure.

Embryology and Anatomy of the Left Atrial Appendage: Why Does Thrombus Form?

The left atrial appendage (LAA) is a long tubular structure that opens into the left atrium. In patients with atrial fibrillation, the LAA develops mechanical dysfunction and fibroelastotic changes on the endocardial surface. The complex anatomy of the LAA makes it a good site for relative blood stasis. In addition, systemic factors exacerbate the hypercoagulable state, eventually resulting in endothelial dysfunction, release of tissue factor, and production of inflammatory cytokines and oxidative free radicals, and eventually initiating the coagulation cascade. Thus, the LAA is susceptible to thrombus formation and is the most common source of systemic thromboembolism.