Influence of monitoring and atrial arrhythmia burden on quality of life and health care utilization in patients undergoing pulsed field ablation: A secondary analysis of the PULSED AF trial.

BACKGROUND: Freedom from atrial arrhythmia (AA) recurrence ≥30 seconds after pulsed field ablation (PFA) in patients with atrial fibrillation (AF) was reported in PULSED AF (Pulsed Field Ablation to Irreversibly Electroporate Tissue and Treat AF; ClinialTrials.gov Identifier: NCT04198701). AA burden may be a more clinically meaningful endpoint. OBJECTIVE: The purpose of this study was to determine the influence of monitoring strategies on AA detection and AA burden association with quality of life (QoL) and health care utilization (HCU) after PFA. METHODS: Patients underwent 24-hour Holter monitoring at 6 and 12 months and weekly, and symptomatic transtelephonic monitoring (TTM). AA burden post-blanking was calculated as the greater of (1) percentage of AA on total Holter time; or (2) percentage of weeks with ≥1 TTM with AA out of all weeks with ≥1 TTM. RESULTS: Freedom from all AAs varied by >20% when differing monitoring strategies were used. PFA resulted in zero burden in 69.4% of paroxysmal atrial fibrillation (PAF) and 62.2% of persistent atrial fibrillation (PsAF) patients. Median burden was low (<9%). Most PAF and PsAF patients had ≤1 week of AA detection on TTM (82.6% and 75.4%) and <30 minutes of AA per day of Holter monitoring (96.5% and 89.6%), respectively. Only PAF patients with <10% AA burden averaged a clinically meaningful (>19 point) QoL improvement. PsAF patients experienced clinically meaningful QoL improvements irrespective of burden. Repeat ablations and cardioversions significantly increased with higher AA burden (P <.01). CONCLUSION: The ≥30-second AA endpoint is dependent on the monitoring protocol used. PFA resulted in low AA burden for most patients, which was associated with clinically relevant improvement in QoL and reduced AA-related HCU.

Hemodynamic Doppler echocardiographic evaluation of permanent His bundle and biventricular pacing after AV nodal ablation.

placing after atrioventricular (AV) nodal ablation for permanent atrial fibrillation (AF) may include cardiac resynchronization therapy (CRT) with either His bundle pacing (HBP) or biventricular pacing (BVP), or conventional single site right ventricular apical pacing (RVAP). To determine the relationship between pacing method and hemodynamic outcome, we used Doppler echocardiographic methods to evaluate left ventricular (LV) hemodynamics after AV nodal ablation and either HBP, BVP, or RVAP. Method: 20 patients were evaluated > 6 months after AV nodal ablation, 10 each with chronic HBP or BVP, and all with RVAP lead. Doppler echocardiography was used to measure 3 parameters indicative of CRT: 1) LV dP/dt, 2) the LV pre-ejection interval, and 3) myocardial performance index, relative to intra-patient RVAP. Results: Primary endpoint of LV dP/dt on average improved by > 17% with both HBP and BVP, compared to RVAP. HBP but not BVP, had improvement across all three parameters. Conclusion: HBP provides LV electromechanical synchrony across multiple echo Doppler parameters. Both HBP and BVP were hemodynamically superior to RVAP following AV nodal ablation.

Detection of previously undiagnosed atrial fibrillation in patients with stroke risk factors and usefulness of continuous monitoring in primary stroke prevention.

The detection of undiagnosed atrial tachycardia/atrial fibrillation (AT/AF) among patients with stroke risk factors could be useful for primary stroke prevention. We analyzed newly detected AT/AF (NDAF) using continuous monitoring in patients with stroke risk factors but without previous stroke or evidence of AT/AF. NDAF (AT/AF >5 minutes on any day) was determined in patients with implantable cardiac rhythm devices and ≥1 stroke risk factors (congestive heart failure, hypertension, age ≥75 years, or diabetes). All devices were capable of continuously monitoring the daily cumulative time in AT/AF. Of 1,368 eligible patients, NDAF was identified in 416 (30%) during a follow-up of 1.1 ± 0.7 years and was unrelated to the CHADS(2) score (congestive heart failure, hypertension [blood pressure consistently >140/90 mm Hg or hypertension treated with medication], age ≥75 years, diabetes mellitus, previous stroke or transient ischemic attack). The presence of AT/AF >6 hours on ≥1 day increased significantly with increased CHADS(2) scores and was present in 158 (54%) of 294 patients with NDAF and a CHADS(2) score of ≥2. NDAF was sporadic, and 78% of patients with a CHADS(2) score of ≥2 with NDAF experienced AT/AF on <10% of the follow-up days. The median interval to NDAF detection in these higher risk patients was 72 days (interquartile range 13 to 177). In conclusion, continuous monitoring identified NDAF in 30% of patients with stroke risk factors. In patients with NDAF, AT/AF occurred sporadically, highlighting the difficulty in detecting paroxysmal AT/AF using traditional monitoring methods. However, AT/AF also persisted for >6 hours on ≥1 days in most patients with NDAF and multiple stroke risk factors. Whether patients with CHADS(2) risk factors but without a history of AF might benefit from implantable monitors for the selection and administration of anticoagulation for primary stroke prevention merits additional investigation.

Complete pulmonary vein isolation using balloon cryoablation in patients with paroxysmal atrial fibrillation.

Electrical isolation of the pulmonary veins and disconnection of the left atrial musculature from their arrhythmogenic effects is the cornerstone of definitive and curative treatment in patients with symptomatic recurrent paroxysmal atrial fibrillation that is refractory to antiarrhythmic therapy. The type of lesion produced by balloon cryoablation is such that the tissue architecture is preserved and thrombus formation and the risk of pulmonary vein stenosis are reduced. We report on immediate outcomes in the first five patients who underwent treatment. These cases represent initial experience with the technique in Spain. A total of 20 pulmonary veins were treated and complete acute electrical isolation was achieved in all cases (100%). Patients were discharged from hospital within 72 hours of the procedure, and there were no complications. In conclusion, balloon cryoablation of the pulmonary veins is a practical, safe and effective technique for achieving the electrophysiologic goal of acute pulmonary vein isolation in patients with paroxysmal atrial fibrillation.

Aislamiento circunferencial completo de venas pulmonares por crioablación con catéter-balón en pacientes con fibrilación auricular paroxística / Complete pulmonary vein isolation using balloon cryoablation in patients with paroxysmal atrial fibrillation

El aislamiento de las venas pulmonares y la desconexión del músculo auricular izquierdo de la actividad arritmogénica de éstas son la piedra angular del tratamiento definitivo y curativo en pacientes con fibrilación auricular paroxística recurrente y sintomática refractaria a tratamiento antiarrítmico. La lesión producida por frío con catéter-balón preserva la arquitectura tisular, disminuye la formación de trombos y el riesgo de estenosis venosa pulmonar. Presentamos los resultados inmediatos conseguidos en los primeros 5 pacientes, que constituyen la experiencia inicial en España. Se trataron un total de 20 venas pulmonares, y se demostró aislamiento eléctrico agudo completo en todas (100%). Los pacientes fueron dados de alta dentro de las primeras 72 h del procedimiento, sin complicaciones. En conclusión, la crioablación con catéter-balón de las venas pulmonares es una técnica factible, segura y eficaz para conseguir el objetivo final electrofisiológico de aislamiento agudo de ellas en pacientes con fibrilación auricular paroxística (AU)

Electrical isolation of the pulmonary veins and disconnection of the left atrial musculature from their arrhythmogenic effects is the cornerstone of definitive and curative treatment in patients with symptomatic recurrent paroxysmal atrial fibrillation that is refractory to antiarrhythmic therapy. The type of lesion produced by balloon cryoablation is such that the tissue architecture is preserved and thrombus formation and the risk of pulmonary vein stenosis are reduced. We report on immediate outcomes in the first five patients who underwent treatment. These cases represent initial experience with the technique in Spain. A total of 20 pulmonary veins were treated and complete acute electrical isolation was achieved in all cases (100%). Patients were discharged from hospital within 72 hours of the procedure, and there were no complications. In conclusion, balloon cryoablation of the pulmonary veins is a practical, safe and effective technique for achieving the electrophysiologic goal of acute pulmonary vein isolation in patients with paroxysmal atrial fibrillation (AU)

Utility of adjunctive single oral bolus propafenone therapy in patients with atrial defibrillators.

AIMS: Previous studies have demonstrated that ambulatory atrial defibrillation shocks delivered by an implantable cardioverter-defibrillator (ICD) are safe and effective, but poorly tolerated. Separate studies have demonstrated the utility of single oral bolus propafenone for conversion of recent-onset atrial fibrillation (AF); however, most patients were hospitalized, had no structural heart disease, were taking no other antiarrhythmic drugs, and were not exposed to concomitant shock. We hypothesized that a single oral bolus dose of propafenone given early after onset would be a safe and effective adjunct to ICD-based AF therapy and improve overall therapy tolerance. METHODS AND RESULTS: A randomized three-way crossover study design was used to compare three strategies, deployed in the ambulatory setting early after AF episode onset in 35 ICD patients with advanced, drug refractory episodic/persistent syndromes, many of whom had structural heart disease and were taking other antiarrhythmic drugs: (i) single oral bolus propafenone (600 mg), followed by ICD shock if necessary; (ii) single oral bolus placebo, followed by ICD shock if necessary; and (iii) no oral bolus therapy and ICD shock if necessary (no bolus). Antiarrhythmic efficacy, defined by the restoration of sinus rhythm within 24 h, was similar during propafenone (81%) and no-bolus strategies (84%); both were significantly higher than during placebo strategy (62%). Propafenone was well tolerated and not associated with proarrhythmia. Shock use was significantly lower during propafenone strategy (19%) than during no-bolus strategy (55%); this was correlated with improved patient tolerance. CONCLUSION: Adjunctive use of single oral bolus propafenone is safe and effective in patients with an ICD and improves patient tolerance of device-based AF therapy.

Understanding atrial symptom reports: objective versus subjective predictors.

BACKGROUND: Atrial fibrillation (AF) is the most common cardiac arrhythmia and is associated with a variety of symptoms such as dizziness, palpitations, shortness of breath, and other signs of heart failure, which in turn impact quality of life (QOL). Implantable cardioverter defibrillators with atrial therapies (ICDs-ATs) have been shown to reduce AF symptoms and improve QOL in select AF samples. METHOD: This study examined the strength of relationships between objective (device-detected AF events) versus subjective (emotional symptoms) data and AF symptoms (number) reported as part of the Patient Atrial Shock Survey of Acceptance and Tolerance Study (N = 96, 72% men, M age = 65, SD = 12). Depression and anxiety were assessed via the Center for Epidemiological Studies--Depression Scale and the-State Trait Anxiety Inventory. AF disease burden was measured via a number of device-detected AF episodes and the Atrial Tachyarrhythmia Symptom Severity Scale. RESULTS: Hierarchical multiple regression analysis indicated that negative emotions accounted for a significant 13.2% of unique variance in AF symptom score (F change (1, 54) = 9.625, P = 0.003). On the other hand, the number of device-detected AF episodes accounted for non-significant 8.2% of unique variance in the AF symptom score (P = 0.167). The full model explained 25.7% of the variance in AF symptom score (F(6, 54) = 3.110, P = 0.011). Specifically, greater number of treated AF episodes (beta= 0.251, P = 0.043) and higher levels of negative emotions (beta= 0.369, P = 0.003) predicted greater number of reported AF symptoms. CONCLUSION: Therefore, psychological distress may be a significant confounding factor affecting patient's report of AF symptoms rather than the actual experience of recurrent AF episodes.

Performance of a new cardiac cryoablation system in the treatment of cavotricuspid valve isthmus-dependent atrial flutter.

We sought to evaluate prospectively the safety and efficacy of cryothermal energy to ablate typical atrial flutter (AFL). Ablation of cardiac tissue using cryothermal energy has recently been developed as an alternative to radiofrequency energy, which may offer certain advantages in the treatment of AFL. This prospective, multicenter nonrandomized study of a new catheter-based system for the treatment of cavotricuspid isthmus (CTI)-dependent AFL enrolled patients between 18 and 75 years of age. The CTI dependence of AFL was confirmed at electrophysiologic study with activation mapping and/or entrainment. Patients with atrial septal defect, recent myocardial infarction, left ventricular ejection fraction <0.30, or prior AFL ablation were excluded. Cryoablation of AFL was performed in 48 patients from 11 centers. The procedure was immediately successful in 45 patients (94%), and effective in 30 of 40 patients with complete data available at 6 months. Cryoablation is a promising new treatment of CTI-dependent AFL refractory to medical therapy. Further improvements in catheter design and intravascular sheaths will be tested in a larger multicenter trial.

Transvenous catheter cryoablation for treatment of atrial fibrillation: results of a feasibility study.

Pulmonary vein (PV) isolation using radiofrequency (RF) ablation can induce PV stenosis. Cryoablation may offer a safer alternative energy source for PV isolation. PV isolation with cryoablation was attempted in 31 patients with paroxysmal atrial fibrillation (AF). Event monitors were used to measure the AF episode burden. Serial spiral CT scans were obtained to monitor PV stenosis pre- and postcryoablation. Cryoablation was immediately successful for PV isolation in 29 of 31 patients (94%), with 5.9 +/- 1.2 months of follow-up. Additional RF ablation was performed for AF recurrences in seven patients. The remaining 22 patients with a single cryoablation procedure demonstrated a time-dependent, long-term reduction in the frequency of AF episodes. At 6 months of follow-up, 18 of 22 of cryo-treated only patients (82%) were free of symptomatic AF episodes, and antiarrhythmic drugs were discontinued in 12 of 22 patients. Serial spiral CT scans demonstrated no change in the cryo-treated PV ostial diameter. PV cryoablation was effective to control paroxysmal AF in most patients. Early recurrences of AF postcryoablation were common, though tended to resolve within 6 months postablation, consistent with a process of reverse atrial remodeling. Cryoablation of the PVs did not cause PV stenosis or other serious adverse events.

Nitrous oxide sedation reduces discomfort caused by atrial defibrillation shocks.

An implantable cardioverter defibrillator with atrial therapies (ICD-ATs) is an effective therapy to manage atrial tacharrhythmias. Acceptance of this therapy is limited by atrial shock related anxiety and discomfort. Inhaled nitrous oxide (N2O) is a potent sedative-analgesic-anxiolytic agent that may mitigate shock discomfort and anxiety and improve patient ICD-AT acceptance. ICD-AT patients with more than one ambulatory atrial shock within 12 months were enrolled and grouped by ICD-AT shock method; awake (n = 9) or asleep (n = 4) when ambulatory ICD-AT shock is delivered. A baseline questionnaire assessed the most recent ambulatory ICD-AT shock (3 +/- 3 months). A 65% N2O/35% O2 mixture was inhaled for 4 minutes followed by an ICD-AT test shock (18 +/- 8 J). The test shock mimicked the awake shock method. The test shock experience during N2O was evaluated via questionnaire immediately following and 24 hours after the shock. Shock related anxiety, intensity, pain, and discomfort were assessed using a ten-point rank scale. Baseline test shock scores were similar between the shock method groups. In the awake shock method group, N2O greatly reduced preshock anxiety by 48% (6.4 +/- 2.4 to 3.3 +/- 2.0, or), and shock related intensity (5.9 +/- 3.1 to 3.3 +/- 2.5), pain (5.0 +/- 2.6 to 2.0 +/- 2.1), and discomfort (5.6 +/- 2.4 to 1.3 +/- 1.4) from baseline values by 45%, 60%, and 78% (P < 0.05), respectively. The asleep shock method group reported no changes in shock related anxiety, intensity, pain, or discomfort. Atrial shock concern, assessed via a five-point rank scale (5 = extreme concern) was improved by N2O but only in the awake group (3.1 +/- 1.0 baseline to 1.6 +/- 0.5 N2O, P = 0.008). There were no adverse events with N2O and patients fully recovered within 5 minutes after N2O. In conclusion, 65% N2O greatly reduced shock related pain and discomfort, and significantly reduced atrial shock concern but only in the awake shock method group. The benefits of N2O therapy may expand the use and acceptability of ICD-AT therapy into a larger atrial fibrillation cohort.

Do patients accept implantable atrial defibrillation therapy? Results from the Patient Atrial Shock Survey of Acceptance and Tolerance (PASSAT) Study.

INTRODUCTION: The Medtronic Jewel AF 7250 is an implantable cardioverter defibrillator with atrial and ventricular therapies (ICD-AT). The ICD-AT is effective in managing atrial tachyarrhythmias (atrial fibrillation [AF]), but patient acceptance remains an issue. This aim of this study was to measure ICD-AT acceptance. METHODS AND RESULTS: ICD-AT acceptance was evaluated in 96 patients enrolled in the "Jewel AF-AF-Only Study" for > or =3 months of follow-up (mean 19 months). Patients were mostly men (72%; age 65 +/- 12 years). Clinical data and a written survey (75% response rate) were used to quantify demographics, AF frequency and symptoms, atrial defibrillation therapy, quality of life (QOL), psychosocial distress, and ICD-AT therapy acceptance. From implant to survey, AF symptom and severity scores decreased by 18% (P < or = 0.05), and QOL (SF-36) scores increased by 15% to 50% (P < or = 0.05). ICD-AT therapy acceptance was high, with 71.3% of patients scoring in the 75th percentile on the Florida Patient Acceptance Survey. ICD-AT acceptance was correlated with the Physical Component Scale and Mental Health Component Scale scores of the SF-36 (r = 0.28 and 0.35, respectively). ICD-AT acceptance was negatively correlated with depressive symptomatology (r =-0.59), trait anxiety (r =-0.48), illness intrusiveness (r =-0.55), and AF symptom and severity scores (r =-0.26). ICD-AT acceptance did not correlate with preimplant cardioversions, number of atrial shocks, AF episodes detected by the device, or device implant duration. CONCLUSION: Most patients accepted ICD-AT therapy. Patients were more likely to accept ICD-AT if they had less psychosocial distress, greater QOL, and lower AF symptom burden.

Sleep quality among patients treated with implantable atrial defibrillation therapy: effect of nocturnal shock delivery and psychological distress.

INTRODUCTION: The Medtronic ICD-AT has atrial/ventricular therapies, which can be programmed to deliver atrial defibrillation during sleep, intended to potentially decrease shock anxiety/pain and lifestyle disruption. However, these shocks may diminish sleep quality. This study examined atrial shock characteristics (i.e., mode, frequency), AF symptoms, and psychological factors as determinants of sleep quality. METHODS AND RESULTS: The 96 ICD-AT patients were mostly men (72%; M age 65 +/- 12 years) and implanted for 1.6 years (SD = 0.8 years). Patients were divided into shock groups based on the proportion of mode (> or =90%) of total atrial shocks received. Patients were grouped into either automatic-nocturnal shock group (8 P.M.-8 A.M.; n = 35) or manual-awake shock group (n = 42). Psychological measures included Pittsburgh Sleep Quality Index (PSQI), Center for Epidemiology Studies-Depression Scale, State-Trait Anxiety Inventory, and Illness Intrusiveness Rating Scale. Atrial fibrillation disease burden was assessed via atrial symptom score and atrial shock use. PSQI global scores were similar between manual (7.67 +/- 2.53) and automatic shock (8.20 +/- 2.93) groups. A multiple hierarchical regression analysis indicated that no atrial shock variables were predictive of sleep quality; yet, both AF symptom (B = 0.226, P = 0.040) and depression (B = 0.392, P = 0.034) scores predicted diminished sleep quality, accounting for 42% of the variance in global sleep quality (P < 0.001). CONCLUSION: These results suggest that atrial defibrillation therapy does not have a deleterious impact on sleep. However, the significance of AF symptoms and depression indicate that comprehensive care of both physical and psychological symptomatology may improve sleep quality in ICD-AT patients.

Early recurrence of atrial fibrillation after ambulatory shock conversion.

OBJECTIVES: We sought to gain insights into the early recurrence of atrial fibrillation (ERAF) after cardioversion shocks delivered by permanently implanted rhythm management systems. BACKGROUND: Several reports have characterized ERAF, but these reports used a limited definition and did not evaluate an association between clinical or device variables and ERAF. METHODS: A total of 144 patients with recurrent, drug-resistant, symptomatic atrial fibrillation (AF) underwent implantation of an atrial rhythm management system (Medtronic Jewel AF, Model 7250, Minneapolis, Minnesota). The device was programmed to deliver cardioversion shocks automatically and/or on patient command. The incidence of ERAF was evaluated after 1,092 successful shocks among 97 patients. Three different ERAF definitions were used: recurrence within 1 min, 1 h or 1 day. Multiple clinical and device variables were assessed for their relationship with ERAF. RESULTS: The per-patient incidences of ERAF were 44%, 61% and 70% for ERAF within 1 min, 1 h and 1 day, respectively. The per-episode incidences of ERAF were 17%, 30% and 43% for ERAF within 1 min, 1 h and 1 day, respectively. Variables that were independently associated with ERAF included AF duration <3 h before termination, more than one shock required to cardiovert and the absence of a previous myocardial infarction. The most potent variable was AF duration <3 h, associated with a threefold increase in the incidence of ERAF. CONCLUSIONS: Recurrence of AF early after ambulatory shock cardioversion is common. In this retrospective study, both clinical and device variables were predictive.