Single Day Observational Experience at High Volume Ablation Programs: What is the Impact to Practicing Electrophysiologists?

INTRODUCTION: Significant improvements in catheter technology, electro-anatomic (EA) mapping and techniques to reduce fluoroscopy during radiofrequency ablation (RFA) of atrial fibrillation (AF) are on-going.However, few educational opportunities are available post fellowship for Electrophysiologists (EPs) to understand and integrate them into their practice, preventing wide spread adoption. The impact of observational learning for adoption of new technologies and techniques in the field of cardiac electrophysiology has not been studied. We sought to report the impact of a visit to a high-volume center with experience in new technologies and fluoroscopy reductionto the clinical practice of EPs. METHODS: Between 8/2014 and 10/2017 a total of 150 EPs visited 3 hospitals that perform a high volume of AF RFAs. EPs observed a minimum of 4 RFAs, primarily AF. AF RFAs were performed without fluoroscopy, using Carto 3 Version 4 (Biosense Webster) and intracardiac Echocardiography. There was ample interaction and discussion between hosting and visiting EP. RESULTS: 73 EPs (48.6% of visitors) completed an electronic survey after the visit. The majority reported a significant reduction in fluoroscopy (>50%) and procedure (>20%).68% adopted a rigorous workflow and reported an increase in their confidence level with intracardiac echo (79%), continuous mapping (52%) and the Visitag module (61%). CONCLUSIONS: Observational experience can have an immense impact on the clinical practice of EPs. Further effort should be devoted to such programs and to study in a more systematic way their ultimate impact on patient care.

Gains in Paroxysmal Atrial Fibrillation Ablation Using a Standardized Workflow to Optimize Contact Force Technologies.

BACKGROUND: Catheter ablation technology has evolved rapidly in recent years. There is a need to understand the impact of these advances on efficiency, safety, and effectiveness in real-world populations. The objective of this study was to evaluate a standardized workflow that integrates a contact force (CF) catheter and stability module in an attempt to optimize efficiency and clinical outcomes of paroxysmal atrial fibrillation (PAF) ablation, and to compare the outcomes of this workflow with existing ablation technologies at a high-volume center. METHODS: Consecutive ablations for PAF from July 2013 - June 2016 were included. Radiofrequency (RF) ablations were performed with the ThermocoolSF Catheter (SF) through April 2014, after which a change was made to the ThermocoolSmarttouchCatheter (ST)with a standardized workflow. Cryoballoon ablations (CA) were performed with theArctic FrontAdvancebetween July 2013 and March 2016. Systematic collection of 12-month effectiveness data began in July 2014. Prior to that time, only acute outcomes and reablations were captured. RESULTS: Procedural data for 32 SF, 232 ST, and 59 CA procedures for PAF were available. Mean procedure times were similar across SF and CA, and moderately shorter with ST (p=0.0201). Fluoroscopy times were substantially reduced with ST (p<0.0001). Complication rates were low and similar across all cohorts (p=0.4744), whereas reablation rates were lowest in the ST cohort (p=0.0194). CONCLUSIONS: PAF ablation using integrated CF and catheter stability technology with a systematic ablation workflow maylead to improvements in both procedural efficiency and reablation rates, without compromising patient safety.

Interpreting changes in quality of life in atrial fibrillation: how much change is meaningful?

BACKGROUND: The Atrial Fibrillation Effect on QualiTy of Life (AFEQT) questionnaire is a novel quality of life (QOL) measure previously shown to be valid, reliable, and sensitive to clinical change in patients with atrial fibrillation (AF). The clinical relevance of a given change in the score is not known. The most useful "anchor" for a measure of meaningful change in QOL is patient-reported magnitude of change. OBJECTIVE: The aim of this study was to define the interpretability of changes in the AFEQT score from the patients' perspective. METHODS: With the use of the original validation study of AFEQT, in which 210 patients completed the questionnaire at baseline and at 3 months, we estimated the AFEQT score corresponding to a meaningful improvement in QOL using the patients' assessments of global change in QOL, AF symptoms from the Atrial Fibrillation Severity Scale (AFSS), and physicians' assessment of global QOL over the 3 months, as anchors. RESULTS: In patients with a moderate improvement in global QOL, the AFEQT scores increased from 51.9 ± 21.8 to 70.8 ± 17.4 (an increase of 18.9 ± 20.7), compared with an increase of 6.9 ± 16.9 units in patients with "unimportant change" in global QOL. Physicians' global assessment yielded a similar change in AFEQT score corresponding to a moderate change in global QOL (21.3 ± 20.2 units). Patients with moderate improvement in AF symptom severity using the AFSS scale had an increase of 17.9 ± 11.8 units on the AFEQT scale. A change in 19 units in the AFEQT score corresponded to a 0.9 SD unit change or greater than a minimal important difference from a distribution based method. CONCLUSIONS: A meaningful improvement in QOL in patients with AF can be measured from a change in the AFEQT score. These results can assist in monitoring patient progress and interpreting the effects of interventions in patients with AF.

Development and validation of the Atrial Fibrillation Effect on QualiTy-of-Life (AFEQT) Questionnaire in patients with atrial fibrillation.

BACKGROUND: Atrial fibrillation (AF) has a deleterious impact on health-related quality-of-life (HRQoL), but measuring this outcome is difficult. A comprehensive, validated, disease-specific questionnaire to measure the spectrum of QoL domains affected by AF and its treatment is not available. We developed and validated a 20-item questionnaire, Atrial Fibrillation Effect on QualiTy-of-life (AFEQT), in a 6-center, prospective, observational study. METHODS AND RESULTS: Factor analyses established 4 conceptual domains (Symptoms, Daily Activities, Treatment Concern, and Treatment Satisfaction) from which individual domain and global scores were calculated. Participants from 6 centers completed the AFEQT at baseline, at month 1, and at month 3. Psychometric analyses included internal consistency and known-group validity. Test-retest reliability was assessed by comparing 1-month changes in scores among those with no change in therapy. Effect size was used to assess responsiveness after intervention. Among 219 patients age 62±11.9 years, 94% completed the AFEQT at baseline and 3 months; 66% had paroxysmal, 24% persistent, 5% longstanding persistent, and 5% permanent AF. Internal consistency was >0.88 for all scales. Lower AFEQT scores were observed with increased AF severity, categorized as asymptomatic, mild, moderate and severe, respectively: 71.2±20.6, 71.3±19.2, 57.9±19.0, and 42.0±21.2. Intraclass correlations for Overall, Symptoms, Daily Activities, Treatment Concern, and Satisfaction scores were 0.8, 0.5, 0.8, 0.7, and 0.7, respectively. Changes in 3-month scores were larger after ablation than with pharmacological adjustments, and both were greater than those observed in stable patients. CONCLUSIONS: This initial validation of AFEQT supports its use as an outcome in studies and a means to clinically follow patients with AF.

Cardiac defibrillation and resynchronization therapies: principles, therapies, and management implications.

Patients with heart failure remain at high risk for sudden cardiac death (SCD) and death due to heart failure progression, despite the incorporation of pharmacologic agents into clinical practice that have been shown to decrease mortality in clinical trials. Most patients experience SCD as their first dysrrhythmic event. The implantable cardioverter defibrillator (ICD) effectively terminates ventricular tachycardia/fibrillation (VT/VF) aborting SCD. Cardiac resynchronization therapy (CRT) complements pharmacologic therapy improving cardiac performance, quality of life, functional status, and exercise capacity in patients with systolic dysfunction despite optimal medical therapy who have a prolonged QRS duration; furthermore, it decreases mortality when compared with optimal medical therapy alone. Implantation of a combination CRT and ICD device, a CRT-D, reduces mortality by aborting SCD and providing the functional benefits of CRT. This article discusses the evolution of CRT-D therapy, the mechanism of operation of a CRT-D device, and nursing implications.

Electrical characteristics of a split cathodal pacing configuration.

Several electrical configurations can be used for biventricular pacing to achieve cardiac resynchronization. Commercially approved biventricular pacing systems stimulate the RV with an endocardial lead and the LV with a unipolar lead positioned in the cardiac venous circulation using the tip electrodes of both leads linked as a common cathode. The distribution of current with this parallel circuit, split cathodal configuration is dependent on the separate impedances of the two leads. A total of 19 patients with left bundle branch block and congestive heart failure underwent implantation of a cardiac venous lead and standard bipolar right atrial and RV pacing leads. Stimulation thresholds and impedances were measured for the RV and LV in five electrical configurations: (1) unipolar LV from the cardiac venous lead; (2) bipolar LV using the tip electrode in the cardiac vein as the cathode and the ring electrode of the RV lead as the anode; (3) bipolar RV from the RV lead; (4) unipolar split cathodal stimulation of the cardiac venous and RV leads; and (5) bipolar split cathodal stimulation of the cardiac venous and RV leads. Repeat measurements of RV and LV thresholds were made from the pulse generator at 1-year follow-up. The LV stimulation threshold increased from 0.7 +/- 0.5 V in the unipolar configuration to 1.0 +/- 0.8 V in the unipolar split cathodal configuration (P = 0.01) and from 1.0 +/- 0.7 V in the bipolar configuration to 1.3 +/- 0.9 V in the bipolar split cathodal configuration (P < 0.001). The RV stimulation threshold increased from 0.3 +/- 0.2 V in the bipolar configuration to 0.5 +/- 0.2 V in the bipolar split cathodal configuration (P = 0.005). The bipolar impedance measured 874 +/- 299 Omega for the coronary venous lead, 705 +/- 152 for the RV lead, 442 +/- 87 in the split unipolar cathodal configuration, and 516 +/- 64 in the bipolar split cathodal configuration. At 1-year follow-up, the LV stimulation threshold was 1.8 +/- 1.6 in the unipolar split cathodal configuration and 2.4 +/- 1.6 in the bipolar split cathodal configuration (P = 0.003). The RV stimulation threshold at 1 year was 0.7 +/- 0.3 in the unipolar split cathodal configuration and 0.8 +/- 0.3 in the bipolar split cathodal configuration (P = 0.02). The split cathodal configuration significantly increases the apparent stimulation threshold for both the LV and the RV as compared with individual stimulation of either chamber alone. Programming to the bipolar split cathodal configuration further increases the apparent stimulation threshold. These observations support the development of pacing systems with separate LV and RV output circuits for resynchronization therapy.

Quality of life in the antiarrhythmics versus implantable defibrillators trial: impact of therapy and influence of adverse symptoms and defibrillator shocks.

BACKGROUND: Implantable cardioverter defibrillator (ICD) use reduces mortality in patients with serious ventricular arrhythmias compared with antiarrhythmic drug (AAD) use. However, the relative impact of these therapies on self-perceived quality of life (QoL) is unknown. METHODS AND RESULTS: Three self-administered instruments were used to measure generic and disease-specific QoL in Antiarrhythmics Versus Implantable Defibrillators trial participants. Generalized linear models were used to assess the relationships between self-perceived QoL and treatment (AAD versus ICD) and adverse symptoms and ICD shocks. To minimize the impact of missing data, only patients surviving 1 year were included in the primary analyses. Baseline characteristics among QoL participants (n=905) and nonparticipants (n=111) were similar, but participants who survived 1 year (n=800) were healthier at baseline than nonsurvivors (n=105). Of the 800 patients in the primary analysis, characteristics of those randomized to AAD (n=384) versus ICD (n=416) were similar. Overall, ICD and AAD use were associated with similar alterations in QoL. The development of sporadic shocks and adverse symptoms were each associated with reduced physical functioning and mental well-being and increased concerns among ICD recipients, whereas development of adverse symptoms was associated with reduced physical functioning and increased concerns among AAD recipients. CONCLUSIONS: ICD and AAD therapy are associated with similar alterations in self-perceived QoL over 1-year follow-up. Adverse symptoms were associated with reduced self-perceived QoL in both groups, and sporadic shocks were associated with reduced QoL in ICD recipients.