Frederick T. Han

Percutaneous left atrial appendage suture ligation using the LARIAT device in patients with atrial fibrillation: initial clinical experience.

OBJECTIVES The purpose of the study was to determine the efficacy and safety of left atrial appendage (LAA) closure via a percutaneous LAA ligation approach. BACKGROUND Embolic stroke is the most devastating consequence of atrial fibrillation. Exclusion of the LAA is believed to decrease the risk of embolic stroke. METHODS Eighty-nine patients with atrial fibrillation were enrolled to undergo percutaneous ligation of the LAA with the LARIAT device. The catheter-based LARIAT device consists of a snare with a pre-tied suture that is guided epicardially over the LAA. LAA closure was confirmed with transesophageal echocardiography (TEE) and contrast fluoroscopy immediately, then with TEE at 1 day, 30 days, 90 days, and 1 year post-LAA ligation. RESULTS Eighty-five (96%) of 89 patients underwent successful LAA ligation. Eighty-one of 85 patients had complete closure immediately. Three of 85 patients had a ≤ 2-mm residual LAA leak by TEE color Doppler evaluation. One of 85 patients had a ≤ 3-mm jet by TEE. There were no complications due to the device. There were 3 access-related complications (during pericardial access, n = 2; and transseptal catheterization, n = 1). Adverse events included severe pericarditis post-operatively (n = 2), late pericardial effusion (n = 1), unexplained sudden death (n = 2), and late strokes thought to be non-embolic (n = 2). At 1 month (81 of 85) and 3 months (77 of 81) post-ligation, 95% of the patients had complete LAA closure by TEE. Of the patients undergoing 1-year TEE (n = 65), there was 98% complete LAA closure, including the patients with previous leaks. CONCLUSIONS LAA closure with the LARIAT device can be performed effectively with acceptably low access complications and periprocedural adverse events in this observational study.

Genetic Deficiency of Inducible Nitric Oxide Synthase Reduces Atherosclerosis and Lowers Plasma Lipid Peroxides in Apolipoprotein E–Knockout Mice

Background—Inducible nitric oxide synthase (iNOS) is expressed by leukocytes and smooth muscle cells in atherosclerotic lesions. To test whether NO produced by iNOS deficiency affects atherosclerosis, we studied apoE/iNOS–double knockout (dKO) and apoE-knockout (KO) control animals fed a “Western-type” diet. Methods and Results—After 16 weeks of Western-type diet, the aortic lesion area in apoE/iNOS-dKO males and females was significantly reduced, by 22% and 21%, respectively, compared with apoE-KO males and females. This effect was more pronounced after 24 weeks of Western-type diet, after which lesion formation in male and female dKO mice was reduced by 38% and 40%, respectively. Plasma levels of lipoperoxides in apoE/iNOS-dKO mice (2.0±0.23 &mgr;mol/L) were significantly lower than in apoE-KO control animals (3.2±0.44 &mgr;mol/L;P =0.02). To test whether substrate deficiency plays a role in the proatherogenic actions of iNOS, we administered l-arginine to apoE-KO animals for 16 and 24 weeks. l-Arginine treatment did not affect lesion formation in apoE-KO animals fed a Western-type diet. Conclusions—Genetic deficiency of iNOS decreases diet-induced atherosclerosis and lowers plasma levels of lipoperoxides, a marker for oxidative stress, in apoE-KO animals. Reduction in iNOS-mediated oxidative stress could partly explain protection from lesion formation in dKO animals. l-Arginine supplementation did not change lesion area in apoE-KO mice, indicating that substrate deficiency is not a likely cause for iNOS-mediated injury in this model of atherosclerosis.

Results of a Minimally Invasive Surgical Pulmonary Vein Isolation and Ganglionic Plexi Ablation for Atrial Fibrillation Single-Center Experience With 12-Month Follow-Up

Background—The Cox Maze procedure for treatment of medically refractory atrial fibrillation (AF) is limited by its complexity and requirement for cardiopulmonary bypass. Long-term follow-up and success using criteria established by the Heart Rhythm Society/European Heart Rhythm Association/European Cardiac Arrhythmia Society consensus statement have not been reported for surgical AF ablation. We describe the results of using a thorascopic approach and radiofrequency energy to perform bilateral pulmonary vein isolation and left atrial ganglionic plexi ablation for treatment of AF. Methods and Results—Forty-five (33 paroxysmal; 12 persistent) consecutive patients underwent thorascopic bilateral radiofrequency pulmonary vein isolation, ganglionic plexi ablation, ligament of Marshall ablation, and left atrial appendage exclusion by a single surgeon. Forty-three patients were prospectively followed without antiarrhythmic drugs for a minimum of 1 year with a 30-day continuous event monitor or pacemaker interrogation at 6 and 12 months. Failure was defined as any atrial tachyarrhythmia of >30 seconds’ duration occurring >90 days after surgery. Mean follow-up was 516±181 days (202 to 858 days). Twenty-eight (65%) patients had no atrial tachyarrhythmia >30 seconds by 1 year, and 15 (35%) patients had atrial tachyarrhythmia recurrences by 1 year. Eight of 15 patients with recurrent AF had catheter ablation resulting in elimination and/or reduction of AF episodes in 7 of 8 patients. Four of 15 patients had AF elimination or reduction with antiarrhythmic drugs alone. Three patients did not benefit from surgery and received rate control only. There were no deaths; 1 phrenic nerve injury and 2 pleural effusions were the only major complications. Conclusions—The single procedure success at 1-year follow-up for surgical pulmonary vein isolation and ganglionic plexi ablation is 65%. Atrial tachyarrhythmia recurrences after surgery are usually responsive to catheter ablation and/or antiarrhythmic drugs.

The effects of LAA ligation on LAA electrical activity.

BACKGROUND The arrhythmic role of the left atrial appendage (LAA) has been implicated in the maintenance of persistent atrial fibrillation. LAA isolation with catheter ablation has been successful but is limited by the risk of tamponade and electromechanical dissociation with the potential for LAA thrombus formation. OBJECTIVE To assess whether LAA ligation results in LAA electrical isolation. METHODS A total of 68 patients with contraindication or intolerance to oral anticoagulation therapy underwent LAA ligation with the LARIAT suture delivery device. Patients had unipolar [n = 30(44%)] or bipolar [n = 38(56%)] voltage measurements pre- and post-LAA ligation. RESULTS All 68 patients underwent successful LAA ligation. There was a statistically significant reduction in the mean LAA voltage from pre-ligation (unipolar pre-ligation voltage 1.1 ± 0.53 mV; bipolar pre-ligation voltage 4.7 ± 2.83 mV) to post-ligation (unipolar post-ligation voltage 0.3 ± 0.38 mV; bipolar post-ligation voltage 0.6 ± 0.27 mV). Ninety-four percent of the patients had a reduction in the LAA voltage after the closure of the snare, with 10 of 30 (33%) of the patients having complete elimination of LAA voltage with the initial tightening of the suture. Pacing from the LAA after the closure of the snare resulted in lack of capture of the left atrium in 28 of 31 patients. CONCLUSIONS The snare closure of the LAA using the LARIAT device produces an acute reduction in the LAA voltage and inhibits the capture of the left atrium during LAA pacing. Future studies are needed to determine whether LAA ligation affects atrial fibrillation burden.

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.

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.

Management of Recurrent Atrial Arrhythmias After Minimally Invasive Surgical Pulmonary Vein Isolation and Ganglionic Plexi Ablation for Atrial Fibrillation

BACKGROUND Minimally invasive thoracoscopic procedures have evolved for surgical treatment of atrial fibrillation (AF). The spectrum and management of arrhythmias after minimally invasive epicardial radiofrequency ablation of the pulmonary vein (PV) antrum have not been well studied. OBJECTIVE The aim of this study was to describe the spectrum and treatment of recurrent atrial tachyarrhythmias (AT) after minimally invasive AF surgery. METHODS Fifty patients underwent bipolar radiofrequency (RF) ablation of the PV antrum, parasympathetic ganglionated plexi, and ligament of Marshall. Twenty patients (40%) had recurrent AT, and 13 underwent electrophysiology study 100 to 948 days postoperatively (mean 383 +/- 234). RESULTS Fourteen arrhythmias were identified in 13 patients 90 to 666 days (mean 214 +/- 162) after AF surgery. The most common arrhythmias were AF (N = 8) and atrial flutter (N = 3). Of 44 PVs examined, 22 (50%) had reconnected. Seven of 8 patients with recurrent AF had either 2 or 3 veins reconnected, and 6 of 8 had reconnection of the left superior PV. On average, 25.6% of each PV reconnected and showed conduction delay between the left atrium and PV. Two of 4 postoperative atrial flutters were due to isthmus-dependent re-entry. After catheter ablation, 2 patients had symptomatic recurrence of AT. CONCLUSION Recurrent AT occurs in up to 40% of patients after minimally invasive thoracoscopic AF surgery during a minimal follow-up of 12 months. PV reconnection accounts for most recurrences. Postoperative AT appears amenable to catheter ablation, often in conjunction with medical therapy, with high intermediate-term success.

Effect of Electrode Orientation on Lesion Sizes Produced by Irrigated Radiofrequency Ablation Catheters

Background: Irrigated radiofrequency (RF) ablation catheters may produce different lesion sizes dependent upon the electrode orientation to the tissue. This study examined the effect of irrigated electrode orientation on the lesion size and explores a potential mechanism for this effect.

Sequential Percutaneous LAA Ligation and Pulmonary Vein Isolation in Patients with Persistent AF: Initial Results of a Feasibility Study

Left atrial appendage (LAA) ligation results in LAA electrical isolation and a decrease in atrial fibrillation (AF) burden. This study assessed the feasibility of combined percutaneous LAA ligation and pulmonary vein isolation (PVI) in patients with persistent AF.

Direct Measurement of the Lethal Isotherm for Radiofrequency Ablation of Myocardial Tissue

Background—The lethal isotherm for radiofrequency catheter ablation of cardiac myocardium is widely accepted to be 50°C, but this has not been directly measured. The purpose of this study was to directly measure the tissue temperature at the edge of radiofrequency lesions in real time using infrared thermal imaging. Methods and Results—Fifteen radiofrequency lesions of 6 to 240 seconds in duration were applied to the left ventricular surface of isolated perfused pig hearts. At the end of radiofrequency delivery, a thermal image of the tissue surface was acquired with an infrared camera. The lesion was then stained and an optical image of the lesion was obtained. The thermal and optical images were electronically merged to allow determination of the tissue temperature at the edge of the lesion at the end of radiofrequency delivery. By adjusting the temperature overlay display to conform with the edge of the radiofrequency lesion, the lethal isotherm was measured to be 60.6°C (interquartile ranges, 59.7° to 62.4°C; range, 58.1° to 64.2°C). The areas encompassed by the lesion border in the optical image and the lethal isotherm in the thermal image were statistically similar and highly correlated (Spearman &rgr;=0.99, P<0.001). The lethal isotherm temperature was not related to the duration of radiofrequency delivery or to lesion size (both P>0.64). The areas circumscribed by 50°C isotherms were significantly larger than the areas of the lesions on optical imaging (P=0.002). Conclusions—By direct measurement, the lethal isotherm for cardiac myocardium is near 61°C for radiofrequency energy deliveries <240 seconds in duration. A 50°C isotherm overestimates lesion size. Accurate knowledge of the lethal isotherm for radiofrequency ablation is important to clinical practice as well as mathematical modeling of radiofrequency lesions.