Generalized anxiety is a predictor of impaired quality of life in patients with atrial fibrillation: Findings from the prospective observational ARENA study.

OBJECTIVE: Atrial fibrillation (AF) is associated with impaired health-related quality of life (HRQoL), an increased risk of morbidity, and mortality. Traditional AF-related outcomes (e.g., AF recurrence) primarily demonstrate the physiological benefits of AF management but do not focus on the benefits experienced subjectively by the patient (i.e., patient-reported outcomes), which have been suggested as optimal endpoints in AF intervention studies. The aim of this study is to identify medical and psychological factors associated with impaired HRQoL at 1-year follow-up. METHODS: Using data from the prospective observational multicenter ARENA study in patients with AF, we analyzed associations between medical factors, anxiety, and HRQoL at 1-year follow-up assessed using 5-level EuroQoL-5D. RESULTS: In 1353 AF patients (mean age 71.4 ± 10.3 years, 33.8% female), none of the medical predictors (e.g., heart disease) or history of cardioversion were associated with HRQoL at the 1-year follow-up. Higher generalized anxiety (ß = -0.114, p < .001) but not cardiac anxiety (ß = -0.006, p = .809) at baseline predicted decreased HRQoL, independent of confounding variables and patients' medical status. Furthermore, the worsening of patients' generalized anxiety was associated with decreased HRQoL (ß = -0.091, p < .001). In contrast, the improvement of generalized anxiety over time predicted higher HRQoL (ß = 0.097, p < .001). Finally, the worsening of patients' cardiac anxiety over time was associated with decreased HRQoL (ß = -0.081, p < .001). CONCLUSION: Our results highlight the importance of anxiety as a predictor of future HRQoL in patients with AF. Additional studies to examine the impact of anxiety treatment on HRQoL in this population are needed. CLINICAL TRIAL REGISTRATION: The investigators registered on ClinicalTrials.gov (NCT02978248) on November 30, 2016 https://clinicaltrials.gov/ct2/show/NCT02978248.

Long-term follow-up of coronary venous bypass graft lesions treated with a new generation drug-eluting stent with bioabsorbable polymer.

BACKGROUND: To date, no published data are available regarding long-term follow-up of new generation DES implanted in coronary artery bypass graft (CABG) lesions. OBJECTIVES: To assess the long-term clinical outcome of patients receiving the new generation Biolimus A9-coated drug-eluting stent (DES) with biodegradable polymer in saphenous vein grafts (SVG). METHODS: Three thousand sixty-seven patients were included in the NOBORI 2 registry: 71 patients with a total of 117 lesions received at least 1 biolimus A9 DES in SVG lesions and 2,959 patients received percutaneous coronary intervention in other lesions. Clinical follow-up was performed at 1, 6, and 12 months, and annually up to 3 years. RESULTS: Compared to the non-CABG group, patients with CABG lesions were older (P < 0.001), had a higher Charlson Comorbidity Index (P = 0.004), and presented more often with acute coronary syndrome (P = 0.02). At 3-year follow-up, cardiac death occurred in 9.7% versus 2.1% (P < 0.001), myocardial infarction (MI) in 8.3% versus 3.0% (P = 0.02), target lesion failure in 13.9% versus 6.4% (P = 0.03), and major adverse cardiac event in 18.1% versus 8.6% (P = 0.01). No differences were observed in TV-MI and TLR, nor stent thrombosis (ST) which was generally low in both groups (1.4% vs 0.8%, P = NS). CONCLUSION: Albeit 3-year outcomes were less favorable in the CABG group, the higher cardiac mortality was apparently not driven by ST, target vessel MI, or TLR, but is likely due to advanced disease and age as well as comorbidity. The low TLR rate as well as the absence of late and very late ST suggest that BES are safe and effective for the treatment of CABG lesions.

Differences in clinical and echocardiographic parameters between paroxysmal and persistent atrial flutter in the AURUM 8 study: targets for prevention of persistent arrhythmia?

PURPOSE: Cavotricuspid isthmus-dependent atrial flutter (AFL) can occur in a paroxysmal or persistent pattern. The aim of this study was to identify clinical, echocardiographic, and electrophysiological risk factors independently associated with persistence of AFL. METHODS: Patients of the recently published AURUM 8 study with paroxysmal versus persistent AFL were compared with respect to clinical and echocardiographic baseline characteristics as well as procedural parameters. The AURUM 8 study is a randomized, multicenter clinical trial comparing the efficacy and safety of gold versus platinum-iridium 8-mm-tip ablation. AFL was paroxysmal in 218 patients and persistent in 210 patients. RESULTS: Univariate analysis revealed that patients with persistent AFL had higher New York Heart Association class (P = 0.002), shorter time since 1st AFL episode (median 0.18 vs 0.34, P = 0.037), a higher prevalence of previous coronary artery bypass grafting surgery (17% vs 9%, P = 0.02), left ventricular hypertrophy (17% vs 8%, P = 0.005), dyspnea during AFL (P < 0.001), mitral regurgitation (P = 0.002), tricuspid regurgitation (P = 0.049), and pulmonary hypertension (P = 0.01). Palpitations during AFL were less frequent in patients with persistent AFL (P = 0.001). Multivariate analysis revealed that age, weight, AFL diagnosis after initiation of class IC or III antiarrhythmic drugs for atrial fibrillation, history of left ventricular hypertrophy, dyspnea during AFL and mitral regurgitation on echocardiography were significant independent variables associated with persistent AFL. A history of atrial fibrillation and palpitations during AFL were independently associated with paroxysmal AFL. CONCLUSIONS: We were able to identify clinical and echocardiographic risk factors associated with persistence of typical AFL. Treatment of these risk factors can potentially not only prevent the transition from paroxysmal to persistent AFL, but maybe also the development or initiation of AFL in general.

"Largest amplitude ablation" is the optimal approach for typical atrial flutter ablation: a subanalysis from the AURUM 8 study.

INTRODUCTION: The recently proposed "maximum voltage-guided" (MVG) technique for radiofrequency catheter ablation of atrial flutter targets high-voltage electrograms along cavotricuspid isthmus (CTI) to ablate the functionally important anatomic muscle bundles alone, without drawing a complete anatomic line across the CTI. This innovative approach may shorten ablation time and procedure duration. METHODS AND RESULTS: Within the multicenter AURUM 8 study, which compared 8-mm gold- and Pt-Ir-tip catheters in atrial flutter ablation, we made a post hoc comparison of procedural data from 72 patients treated with MVG technique with data from 281 patients undergoing anatomic CTI ablation (unmatched) and with data from 72 patients selected from among those 281 patients such that they were matched with the MVG group with respect to selected baseline parameters and catheter type (matched). The MVG technique markedly reduced (P < 0.001) ablation time (mean 6.9 minutes vs 10.9/9.7 minutes [unmatched/matched]), number of lesions (8.3 vs 13.7/12.9), fluoroscopy time (9.5 minutes vs 20.6/17.9 minutes), procedure duration (59 minutes vs 93/86 minutes), and energy delivered (19 kJ vs 34/30 kJ) compared with anatomic CTI ablation. The incidence of charring was higher for MVG than for anatomic ablation technique (31.9% vs 18.5/15.3%, P < 0.05), where Pt-Ir tip catheters were 6-fold more susceptible to charring than gold-tip catheters (P < 0.001), likely because of a lower thermal conductivity of the Pt-Ir material. The acute success rate was slightly better for MVG than for anatomic ablation technique (97.2% vs 92.2/91.7%, P = n.s.). CONCLUSION: Major procedural parameters are remarkably improved with MVG technique. Gold-tip catheters are substantially less susceptible to charring and may therefore be preferred over Pt-Ir-tip catheters for MVG ablation technique.

Symptom Severity and Health-Related Quality of Life in Patients with Atrial Fibrillation: Findings from the Observational ARENA Study.

BACKGROUND: Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia and is associated with impaired health-related quality of life (HRQoL), high symptom severity, and poor cardiovascular outcomes. Both clinical and psychological factors may contribute to symptom severity and HRQoL in AF. METHODS: Using data from the observational Atrial Fibrillation Rhine-Neckar Region (ARENA) trial, we identified medical and psychosocial factors associated with AF-related symptom severity using European Heart Rhythm Association symptom classification and HRQoL using 5-level EuroQoL- 5D. RESULTS: In 1218 AF patients (mean age 71.1 ± 10.5 years, 34.5% female), female sex (OR 3.7, p < 0.001), preexisting coronary artery disease (CAD) (OR 1.7, p = 0.020), a history of cardioversion (OR 1.4, p = 0.041), cardiac anxiety (OR 1.2; p < 0.001), stress from noise (OR 1.4, p = 0.005), work-related stress (OR 1.3, p = 0.026), and sleep disturbance (OR 1.2, p = 0.016) were associated with higher AF-related symptom severity. CAD (ß = -0.23, p = 0.001), diabetes mellitus (ß = -0.25, p < 0.001), generalized anxiety (ß = -0.30, p < 0.001), cardiac anxiety (ß = -0.16, p < 0.001), financial stress (ß = -0.11, p < 0.001), and sleep disturbance (ß = 0.11, p < 0.001) were associated with impaired HRQoL. CONCLUSIONS: Psychological characteristics, preexisting CAD, and diabetes may play an important role in the identification of individuals at highest risk for impaired HRQoL and high symptom severity in patients with AF.

Gold vs. platinum-iridium tip catheter for cavotricuspid isthmus ablation: the AURUM 8 study.

AIMS: Gold electrodes have the theoretical advantage of creating bigger lesions than platinum-iridium (Pt-Ir) electrodes. We performed a prospective randomized study to compare the clinical efficacy of standard 8 mm Pt-Ir tip catheter (control) and 8 mm gold-tip catheters in the ablation of the cavotricuspid isthmus (CTI)-dependent atrial flutter. METHODS AND RESULTS: A total of 463 patients undergoing CTI ablation in 19 clinical centres were randomized to receive the treatment by gold-tip or control catheter. The primary endpoint was cumulative radiofrequency (RF) application duration until achieving bidirectional CTI block. It did not differ significantly for the two catheters. The gold-tip catheter was, however, associated with a higher ablation success rate (94.3 vs. 89.0%, P = 0.042) and a substantially lower incidence of char and coagulum formation (4.8 vs. 37.9%, P < 0.001), which required exchange of 1 gold-tip (0.4%) and 10 control catheters (4.6%, P = 0.005). The gold-tip catheter delivered more mean power (52 ± 12 W) than the control catheter (48 ± 13 W, P < 0.001). Both mean and maximum temperatures measured by the thermocouple integrated in the catheter tip were statistically significantly lower in the gold (mean: 53.2 ± 4.7°C, max: 68.7 ± 6.6°C) than in the control catheter (54.3 ± 5.2 and 70.2 ± 7.0°C, respectively, P < 0.05). Fluoroscopy time, procedure duration, procedural-related complications, and arrhythmia recurrence during 6 months of follow-up did not differ between the two catheters. CONCLUSION: Owing to a higher primary ablation success rate and reduced incidence of char/coagulum formation, gold may be preferred over Pt-Ir as electrode material for 8 mm tip catheters for CTI ablation. ClinicalTrials.gov: NCT00326001 (http://clinicaltrials.gov/ct2/show/NCT00326001).

Embolic events in patients with atrial fibrillation and effective anticoagulation: value of transesophageal echocardiography to guide direct-current cardioversion. Final results of the Ludwigshafen Observational Cardioversion Study.

OBJECTIVES: The primary objective was to evaluate the usefulness of transesophageal echocardiography (TEE)-guided cardioversion to prevent thromboembolic complications in patients with atrial fibrillation (AF) and effective anticoagulation (International Normalized Ratio of 2 or 3) at least three weeks before cardioversion. BACKGROUND: Transesophageal echocardiography has been proposed as a method of screening patients for left atrial thrombi before direct-current cardioversion of AF. The usefulness of TEE as a screening tool has always been evaluated in patients without long-term anticoagulation before cardioversion. METHODS: This prospective, single-center, observational study, performed on an intention-to-cardiovert basis, comprised 1,076 consecutive, unselected patients with AF. The initial two years were designed to be the control phase, during which the conventional approach was used. After that, cardioversion guided by TEE was performed in consecutive patients. RESULTS: The prevalence of left atrial thrombi was 7.7% in patients with persistent AF and effective anticoagulation. During the first four weeks after electrical cardioversion, six thromboembolic complications were observed in patients in whom the TEE-guided approach was employed (6 [0.8%] of 719 patients), compared with three thromboembolic complications in patients in whom the conventional approach was used (3 [0.8%] of 357 patients). None of the patients in whom electrical cardioversion was not performed experienced an embolic event. CONCLUSIONS: There were no differences in the rate of embolic events between the two treatment groups. In patients with AF and effective anticoagulation, TEE-guided electrical cardioversion does not reduce the embolic risk. However, TEE revealed left atrial thrombi in 7.7% of patients with AF and effective anticoagulation, before direct-current cardioversion.

Prospective, multi-center evaluation of a silicon carbide coated cobalt chromium bare metal stent for percutaneous coronary interventions: two-year results of the ENERGY Registry.

BACKGROUND: Novel bare metal stents with improved stent design may become a viable alternative to drug-eluting stents in certain patient groups, particularly, when long-term dual antiplatelet therapy should be avoided. PURPOSE: The ENERGY registry aimed to assess the safety and benefits of a cobalt-chromium thin strut bare metal stent with a passive coating in a large series of patients under real-world conditions. METHODS AND MATERIALS: This prospective registry recruited 1016 patients with 1074 lesions in 48 centers from April to November 2010. The primary endpoint was the rate of major adverse cardiac events (MACEs), a composite of cardiac death, myocardial infarction and clinically driven target lesion revascularization. RESULTS: More than half of the lesions (61.0%) were type A/B1 lesions, mean lesion length was 14.5±6.5mm and mean reference vessel diameter 3.2±0.5mm. MACE rates at 6, 12 and 24months were 4.9%, 8.1% and 9.4%, target lesion revascularization rates 2.8%, 4.9% and 5.4% and definite stent thrombosis rates 0.5%, 0.6% and 0.6%. Subgroups showed significant differences in baseline and procedural characteristics which did not translate into significantly different clinical outcomes. Specifically, MACE rates at 24months were 13.5% in diabetics, 8.6% in small stents and 9.6% in acute coronary syndrome patients. CONCLUSION: The population of ENERGY reflects real-world conditions with bare metal stents being mainly used in simple lesions. In this setting, percutaneous coronary intervention using a cobalt-chromium thin strut bare metal stent with a passive coating showed very good results up to 24months. (ClinicalTrials.gov:NCT01056120) SUMMARY FOR ANNOTATED TABLE OF CONTENTS: The ENERGY international registry evaluated the safety and benefits of a cobalt-chromium thin strut bare metal stent with passive coating in 1016 patients under real-world conditions until 2years. Results were encouraging with a low composite rate of cardiac death, myocardial infarction and clinically driven target lesion revascularization, even in the pre-defined high risk groups of diabetes, stents ≤2.75mm and acute coronary syndrome.

Potential value of automated daily screening of cardiac resynchronization therapy defibrillator diagnostics for prediction of major cardiovascular events: results from Home-CARE (Home Monitoring in Cardiac Resynchronization Therapy) study.

AIM: To investigate whether diagnostic data from implanted cardiac resynchronization therapy defibrillators (CRT-Ds) retrieved automatically at 24 h intervals via a Home Monitoring function can enable dynamic prediction of cardiovascular hospitalization and death. METHODS AND RESULTS: Three hundred and seventy-seven heart failure patients received CRT-Ds with Home Monitoring option. Data on all deaths and hospitalizations due to cardiovascular reasons and Home Monitoring data were collected prospectively during 1-year follow-up to develop a predictive algorithm with a predefined specificity of 99.5%. Seven parameters were included in the algorithm: mean heart rate over 24 h, heart rate at rest, patient activity, frequency of ventricular extrasystoles, atrial-atrial intervals (heart rate variability), right ventricular pacing impedance, and painless shock impedance. The algorithm was developed using a 25-day monitoring window ending 3 days before hospitalization or death. While the retrospective sensitivities of the individual parameters ranged from 23.6 to 50.0%, the combination of all parameters was 65.4% sensitive in detecting cardiovascular hospitalizations and deaths with 99.5% specificity (corresponding to 1.83 false-positive detections per patient-year of follow-up). The estimated relative risk of an event was 7.15-fold higher after a positive predictor finding than after a negative predictor finding. CONCLUSION: We developed an automated algorithm for dynamic prediction of cardiovascular events in patients treated with CRT-D devices capable of daily transmission of their diagnostic data via Home Monitoring. This tool may increase patients' quality of life and reduce morbidity, mortality, and health economic burden, it now warrants prospective studies. ClinicalTrials.gov NCT00376116.

Noncontact mapping of ectopic atrial tachycardias: different characteristics of isopotential maps and unipolar electrogram.

The success rate for catheter ablation of ectopic atrial tachycardia (AT) has been limited by the inherent difficulty in localizing the site of origin within the complex three-dimensional structures of the atria. The objective of the study was to determine the usefulness of a noncontact mapping system for catheter ablation of AT. Radiofrequency ablation of 25 ATs was performed using a noncontact mapping system. Three different characteristics of isopotential maps and unipolar electrogram morphologies were observed: Group 1: Isopotential maps displayed a narrow, sharp ring of colors around a white, center spot. Unipolar electrograms revealed a Q-S morphology with a rapid dV/dt. Group 2: Isopotential maps displayed a broad ring of colors with little or no white spot in the center. Unipolar electrograms revealed a low amplitude, broad and smooth Q-S morphology in front of a second component with a rapid dV/dt. Group 3: Isopotential maps displayed a broad ring of colors. Unipolar electrogams revealed a low amplitude and fractionated waveform followed by endocardial breakthrough with a gradual dV/dt. Radiofrequency catheter ablation was successful in all ATs of groups 1 and 2, and failed in two of three ATs in group 3. The overall success rate was 92%. No severe complications were observed. Noncontact isopotential mapping is helpful to identify and characterize the origin of ectopic AT. Ablation success is associated with the characteristics of isopotential maps and unipolar electrogram morphologies. The overall success rate was 92%.

Catheter ablation of chronic atrial fibrillation with noncontact mapping: are continuous linear lesions associated with ablation success?

Catheter-based, right and left atrial compartmentalization procedure was evaluated using a noncontact mapping (NCM) system. Its usefulness to identify and close discontinuities in linear lesions in both atria was evaluated. The impact of linear lesion continuity on ablation success of chronic AF was also investigated. Nineteen patients with symptomatic, drug refractory chronic AF were studied. Right atrial ablation with three predefined lines was attempted in all patients. In 18 patients, left atrial ablation was performed with four linear lesions. During a follow-up of 12 +/- 3 months, 6 of 19 patients remained in sinus rhythm (SR) without antiarrhythmic agents (AAs). In addition, four patients were maintained in SR with AA. Thirteen of 14 patients with gaps identified during off-line analysis had recurrence of AF. Only one patient with a gap was free of recurrence without AAs. In the remaining five patients without recurrence of AF, no gap was observed during off-line analysis. In all four patients who were free of AF with additional treatment of AAs, two gaps had been identified. In the remaining nine patients with chronic AF recurrence, a mean of 4.9 gaps were identified. Excluding the initial learning period (first five patients) the success rate increased to 43% (6/14 patients) without and to 71% (10/14 patients) with AA. NCM identifies discontinuities in lines of ablation. Successful ablation of chronic AF is associated with continuity of linear lesions and good clinical technique demands a vigilant search for and closure of every gap.