Risk of thromboembolic events after percutaneous left atrial appendage ligation in patients with atrial fibrillation: Long-term results of a multicenter study.

BACKGROUND: Percutaneous left atrial appendage (LAA) occlusion with Lariat has emerged as a viable alternative to oral anticoagulation (OAC) to prevent thromboembolic (TE) events in patients with atrial fibrillation. OBJECTIVE: We evaluated the long-term TE risk in post-Lariat patients. METHODS: Consecutive patients undergoing LAA ligation with the Lariat device at multiple centers with at least 1-year follow-up were included in the analysis. Transesophageal echocardiography (TEE) was performed at 4 weeks, 6 months, and 12 months to assess the completeness of LAA occlusion. OAC was discontinued if 4-week TEE revealed no device-related thrombus and complete closure of the appendage. Patients remained on 81 mg of aspirin per day after discontinuation of the blood thinner. RESULTS: A total of 306 patients were included in the study (mean age 68.8 ± 11.0 years; mean CHA2DS2-VASc score 3.6 ± 1.7). Four-week TEE revealed leaks in 81 patients (26.5%); all leaks were less than 5 mm in diameter. At 6-month TEE, spontaneous closure of the leak was demonstrated in 21 patients (25.9%), 26 patients (32%) underwent a successful leak closure procedure, and the remaining 34 (42%) patients were placed on OAC. At the median follow-up period of 15.9 ± 9.2 months, 9 TE events (2.9%) were reported: 7 with persistent leak and 2 without any detectable leaks on 2-dimensional TEE (P < .001). CONCLUSION: Complete occlusion of the LAA with the Lariat device was associated with the low rate of TE events at long-term follow-up. However, residual leaks were common after Lariat closure and the stroke rate was significantly higher in patients with incomplete occlusion, even with small leaks.

Clinical outcomes in patients with atrial fibrillation receiving amiodarone on NOACs vs. warfarin.

PURPOSE: Amiodarone is a potent inhibitor of the CYP450:3A4 and inhibitor of the P-glycoprotein, both of which metabolize new oral anticoagulants (NOACs). Patients who are on NOACs and are concomitantly treated with amiodarone may have a higher risk of major bleeding according to recent retrospective trials. Whether this increased risk outweighs the benefits of NOACs compared to warfarin is unknown. We aimed to compare clinical outcomes between NOACs and warfarin in patients with atrial fibrillation (AF) being treated with amiodarone. METHODS: We performed a systematic review of MEDLINE, Cochrane, and Embase for randomized controlled trials that compared NOACs to warfarin for prophylaxis of ischemic stroke/thromboembolic events (TEs) in patients with AF and reported outcomes on TE, major bleeding, and intracranial bleeding (ICB). Risk ratio (RR) and 95% confidence intervals were measured using the Mantel-Haenszel method. Fixed effects model was used, and if heterogeneity (I2) was > 25%, effects were analyzed using a random model. RESULTS: A total of four studies comparing NOACs to warfarin were included in the analysis. The total number of patients on amiodarone was 6197. Mean follow up was 23 ± 5 months. No statistically significant difference for TE prevention (RR, 0.73; 95% CI 0.50-1.07), major bleeding (RR, 1.02; 95% CI 0.68-1.53), or ICB outcomes (RR, 0.58; 95% CI 0.22-1.51) between patients on NOACs + amiodarone when compared to patients on warfarin + amiodarone. CONCLUSION: Among patients with AF taking amiodarone, there is no increased risk of stroke, major bleeding, or ICB with NOACs compared to warfarin.

Use of antimicrobial agent pocket irrigation for cardiovascular implantable electronic device infection prophylaxis: Results from an international survey.

PURPOSE: Survey the usage and application protocol of antimicrobial agent pocket irrigation for cardiovascular implantable electronic device (CIED) infection prophylaxis. BACKGROUND: Local antibiotic usage for CIED infection prophylaxis, in particular pocket irrigation, is a well-known strategy but with little data on its clinical effectiveness. METHODS: An anonymous voluntary online survey was sent to a total of 2,092 arrhythmia-oriented cardiologists in 51 countries (1,490 from the United States). RESULTS: There were 487 responses (response rate 23.3%: U.S. 28.2%, outside of the U.S. 11.1%). Eighty-seven percent of respondents use intraoperative antimicrobial agent pocket irrigation and/or an antimicrobial eluting pouch to reduce CIED infection. Fifty-four percent of respondents believe that it is effective to use an antimicrobial agent pocket irrigation to reduce CIED infection; 33% of respondents are uncertain; a few consider this strategy ineffective (13%) or offered no opinion. Significant differences exist in the practice patterns and beliefs between the U.S. and non-U.S. countries (P < 0.05). Ninety-eight percent of respondents report using the same pocket irrigation protocol for permanent pacemaker versus implantable cardioverter defibrillator. Bacitracin (48%), vancomycin (39%), and a cephalosporin (29%) are the most commonly chosen antibiotics. A majority of the respondents are unaware of the cost of using antimicrobial agent pocket irrigation (69%) and neither are they concerned (67%). CONCLUSION: This international survey suggests that, while there are little clinical data to support or discourage such practice, the usage of antimicrobial agent pocket irrigation for CIED infection prophylaxis is widely used in current practice.

Clinical Implications of Leaks Following Left Atrial Appendage Ligation With the LARIAT Device.

OBJECTIVES: The aim of this study was to evaluate the incidence and clinical implications of leaks (acute incomplete occlusion, early and late reopenings) following LAA ligation with the LARIAT device. BACKGROUND: Percutaneous LAA ligation with the LARIAT device may represent an alternative for stroke prevention in high-risk patients with atrial fibrillation with contraindications to oral anticoagulation. METHODS: This was a retrospective, multicenter study of 98 consecutive patients undergoing successful LAA ligation with the LARIAT device. Leaks were defined as the presence of flow as evaluated by transesophageal echocardiography (TEE). TEE was performed during the procedure, at 6 and 12 months, and after thromboembolic events. RESULTS: Leaks were detected in 5 (5%), 14 (15%), and 19 (20%) patients at the 3 time points. During follow-up, 5 patients developed neurological events (4 strokes and 1 transient ischemic attack). Two occurred early (1 fatal stroke and 1 stroke with multiple recurrences in the following months), and TEE was not repeated after the events. The remaining 3 occurred late (after 6 months) and were associated with small leaks (<5 mm). In 2 of 3 cases, such a small leak was missed by the standard evaluation on 2-dimensional TEE, being evident only with the aid of 3-dimensional imaging. CONCLUSIONS: Incomplete occlusion of the LAA after LARIAT ligation is relatively common and may be associated with thromboembolic events. Proper long-term surveillance with careful TEE should be considered to detect leaks, which can be managed with either resumption of oral anticoagulation or percutaneous transcatheter closure.

Referral Patterns for Primary Prophylaxis Implantable Cardioverter Defibrillator Therapy for an Urban US Population.

Implantable cardioverter defibrillators (ICDs) have been demonstrated to improve survival for both primary and secondary prevention of sudden cardiac arrest. However, studies suggest that ICD therapy is underused in appropriate candidates. Sex and racial disparities in ICD use have been suggested. We sought to characterize the referral patterns of high-risk patients for the primary prophylaxis of sudden cardiac arrest at a tertiary academic medical center serving a diverse population in an urban US setting. Electronic hospital databases were retrospective reviewed for patients meeting criteria for prophylactic ICD implantation. We evaluated the association of gender, age, race, and primary language with the referral and subsequent implantation of an ICD. We identified 1,055 patients satisfying prophylactic ICD criteria: 600 men, mean age 62.6 years, 27.6% black, 19.3% white, 23.3% Hispanic, and 49.8% primary language of English. Of the 673 patients (63.7%) referred for ICD evaluation, 345 underwent implantation, 125 declined, and 203 had significant co-morbidities that precluded implantation. Gender, race, and primary language were not associated with referral for ICD or with decision to proceed with implantation. Patients of increased age were less likely to be referred for ICD and were more likely to refuse implantation. ICD therapy was not considered in 146 patients eligible for prophylactic implantation. In conclusion, referral rates for ICD consideration were higher at our institution than in previous reports. Nonetheless, 14% of appropriate patients were not considered. This argues for the importance of increased education for patients and referring physicians.

Characteristics of ventricular tachycardia arising from the inflow region of the right ventricle.

INTRODUCTION: Ventricular tachycardia (VT) arising from the right ventricular inflow (RVI) region is uncommon. There is minimal literature on the clinical and electrocardiographic characteristics of RVI VT. METHODS: A retrospective analysis of patients with RVI VT who underwent electrophysiology study between 2006 and 2011 was performed. Patients with structural heart disease (including arrhythmogenic right ventricular dysplasia) were excluded. RESULTS: Seventy patients underwent an electrophysiology study for VT arising from the right ventricle during the study period. Nine patients (13%) met the inclusion criteria for RVI VT and were the subject of this analysis. The median age was 46 years (range, 14-71), and VT cycle length was 295 milliseconds (range, 279-400 milliseconds). All VTs had an left bundle-branch block morphology. An inferiorly directed QRS axis was noted in 7 (78%) of 9 patients and a left superior axis in 2 (22%) of 9 patients. A QS or rS pattern was noted in all patients in aVR and V(1). A transition from S to R wave occurred in V(3) to V(5) in all patients, with 78% of the patients transitioning in V(4) or V(5). Ablation was attempted in 8 (89%) of 9 patients and was successful in 6 (67%) of 9 patients. Ablation was limited in all unsuccessful patients due to the proximity to the His and risk of complete heart block. CONCLUSIONS: Electrocardiographic findings of a left bundle-branch block with a normal QRS axis, QS or rS patterns in aVR and V(1), and late S to R transition (V(4)/V(5)) are commonly found in RVI VT. Because of the proximity to the His, ablation of RVI VT may be more challenging than that of right ventricular outflow tract VT.

The psychological impact of implantable cardioverter-defibrillator recalls and the durable positive effects of counseling.

BACKGROUND: It is known that patients with lifesaving devices such as implantable cardioverter-defibrillators (ICDs) may be alarmed and worried by recalls or alerts related to their ICDs. OBJECTIVES: This study aimed to determine whether counseling has any short- or long-term benefits, and to look for characteristics that identify those most worried and those most in need of counseling. METHODS: Among 100 patients with recall or alert ICDs, 14 were pacer dependent; 50 had ICDs for 1 degrees prevention and 22 were women. Patients completed a survey indicating how worried they were on learning of the recall or alert (0-10 scale). After counseling and advice in accordance with manufacturer guidelines, patients were asked to indicate their level of worry, and were again asked after 6 months. RESULTS: For all patients, the "worry level" at the initial interview was 5.0+/-3.7, falling to 2.2+/-3.0 after counseling (P < 0.001) and 1.4+/-2.3 after 6 months (P < 0.001 vs both earlier levels). There were no significant differences between those implanted for 1 degrees versus 2 degrees prevention or for pacer dependency. Women were initially more worried than men, but not for the long term. The 49 patients whose ICDs could be managed by reprogramming or software fix had significant reduction in worry after counseling and at 6 months compared to others. The 18 patients recommended for operative intervention remained more concerned after counseling (3.5+/-3.3 vs 1.9+/-2.9, P = 0.043). CONCLUSIONS: Patients' concerns resulting from ICD recalls or alerts can be reduced by appropriate counseling. Those patients whose ICDs could be reprogrammed to safer parameters had the most reduction in worry levels.

Intravenous sedation for cardiac procedures can be administered safely and cost-effectively by non-anesthesia personnel.

AIMS: Primary: to determine the safety and efficacy of intravenous sedation for cardiac procedures administered by non-anesthesia personnel. Secondary: to assess cost effectiveness of such sedation. METHODS: Anesthesiologists trained non-anesthesia personnel, and established our sedation protocol, which was then used in 9,558 patients who had cardiac procedures with sedation by non-anesthesia personnel, recorded on a computerized database. Most sedation used was midazolam (MID) and morphine (MOR). Complications and problems were derived from the database and quality assurance committee records. Doses were based on desired level of sedation and procedure duration; highest dose used: MID 78 mg, MOR 84 mg. RESULTS: Data included catheterization (n = 3,819) and transesophageal echo procedures (n = 260); and overall electrophysiology (n = 5,479) and selected subsets. There were complications or problems in only 9 patients (0.1%), a strong safety statement. There were 3 deaths in electrophysiology related procedures, 2 deaths in catheterization related procedures, all in very sick patients and not definitely related to sedation; 4 others developed clinical instability (hives, hypotension and heart failure-all with no sequellae), 2 of which needed reversal medications. Three patients (<0.03%) proved difficult to sedate, and their procedures were completed with help from the anesthesia department; by protocol this was not a complication. A total of $5,365,691 was saved during the last decade on cardiac procedures performed with conscious sedation. CONCLUSION: Non-anesthesia personnel can administer intravenous sedation for cardiac procedures in cardiac settings, with safety and cost-effectiveness demonstrated over many years. Anesthesia services are still appropriate for selected cases.

Atrial fibrillation ablation: reaching the mainstream.

INTRODUCTION AND AIMS: Ablation of atrial fibrillation (AF) has evolved rapidly in the decade since its inception. We aimed to review the results of this evolution as reflected in the published literature. METHODS: Publications through 2005 were reviewed, and data included if there was information on the technique used, and follow-up of at least 6 months. RESULTS: More than 23,000 patients met criteria for inclusion. There has been a steady improvement in reported outcomes (P<0.001). Variations on radiofrequency catheter ablation for pulmonary vein isolation result in apparent elimination ("cure") or improvement of AF in 75%, and surgical techniques are even better. CONCLUSIONS: Catheter ablation of AF is now a mainstream procedure. Continuing technical advances are needed to achieve better results with more uniformity and reduced procedure times.