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Aims Cryoballoon pulmonary vein isolation (PVI) is a safe and effective treatment for atrial fibrillation (AF). Current limitations include incomplete vein occlusion due to balloon rigidity and inconsistent electrogram recording, which impairs identification of isolation. We aimed to evaluate the acute safety and performance of a novel cryoballoon system. Methods and results The system includes a steerable sheath, mapping catheter, and a balloon that maintains uniform inflation pressure and size following initiation of ablation. Protocol-directed cryoablation was delivered for 180 s for isolation documented in ≤60 s, otherwise freeze duration was 240 s. Primary endpoints were acute safety and vein isolation. Pulmonary vein isolation was confirmed at ≥30 min post-isolation. Data were compared across vein locations. Thirty patients with paroxysmal AF were enrolled at two centres and underwent PVI. Pulmonary vein isolation was achieved with cryoablation only in 100% of veins (120/120). Nadir temperature was −53.1 ± 5.3°C. The number of applications to achieve PVI was 1.4 ± 0.4 per vein. Of the 120 veins, 89 were isolated with a single cryothermal application (10/30 patients required only 4 total cryoablations). There were no procedural- or device-related serious adverse events at 30 days post-procedure. A subset (24/30) of patients was followed for 1-year and 71% (17/24) remained free of atrial arrhythmias. Six patients with arrhythmia recurrence were remapped and three had durable PVI for all four veins. Conclusion In this first human experience, the novel cryoballoon platform was safe, efficacious, and demonstrated a high proportion of successful single ablation isolation.

Background Recently, a novel cryoballoon ablation catheter has demonstrated acute safety and efficacy in de novo pulmonary vein isolation (PVI) procedures in patients with paroxysmal atrial fibrillation (PAF). However, there are limited studies demonstrating the long-term efficacy. The aim of this study was to evaluate the long-term safety and efficacy of this novel cryoballoon in treating PAF. Methods This was a non-randomized, prospective, multicentre study enrolling 58 consecutive patients. Cryoablation was delivered for 180 s if time to isolation was ≤ 60 s. Otherwise a 240-s cryoablation was performed. One centre performed pre- and post-ablation high-density mapping (n = 9) to characterize lesion formation. After a 3-month blanking period, recurrence was defined as having any documented, symptomatic episode(s) of AF or atrial tachycardia. All patients were followed for 1 year. Results Acute PVI was achieved in 230 of 231 pulmonary veins (99.6%) with 5.3 ± 1.6 cryoablations per patient (1.3 ± 0.7 cryoablations per vein). Forty-three (77%) patients remained arrhythmia-free at 1-year follow-up. Four patients (6.9%) experienced phrenic nerve injury (3 resolved during the index procedure; 1 resolved at 6 months). One serious adverse device event was reported: femoral arterial embolism event occurring 2 weeks post-index procedure. For patients who underwent high-density mapping, cryoablation was antral with 50% of the posterior wall ablated. Conclusions Initial multicentre clinical experience with a novel cryoballoon has demonstrated safety and efficacy of PVI in patients with PAF. Ablation with this cryoballoon provides a wide, antral lesion set with significant debulking of the posterior wall of the left atrium.

Carotid bodies (CBs) are peripheral chemoreceptors, which are primary sensors of systemic hypoxia and their activation produces respiratory, autonomic, and cardiovascular adjustments critical for body homeostasis. We have previously shown that carotid chemoreceptor stimulation increases directly recorded cardiac sympathetic nerve activity (cardiac SNA) which increases coronary blood flow (CoBF) in conscious normal sheep. Previous studies have shown that chemoreflex sensitivity is augmented in heart failure (HF). We hypothesized that carotid chemoreceptor stimulation would increase CoBF to a greater extent in HF than control sheep. Experiments were conducted in conscious HF sheep and control sheep (n = 6/group) implanted with electrodes to record diaphragmatic electromyography (dEMG), flow probes to record CoBF as well as arterial pressure. There was a significant increase in mean arterial pressure (MAP), CoBF and coronary vascular conductance (CVC) in response to potassium cyanide (KCN) in both groups of sheep. To eliminate the effects of metabolic vasodilation, the KCN was repeated while the heart was paced at a constant level. In this paradigm, the increase in CoBF and CVC was augmented in the HF group compared to the control group. Pre-treatment with propranolol did not alter the CoBF or the CVC increase in the HF group indicating this was not mediated by an increase in cardiac sympathetic drive. The pressor response to CB activation was abolished by pre-treatment with intravenous atropine in both groups, but there was no change in the CoBF and vascular conductance responses. Our data suggest that in an ovine model of HF, carotid body (CB) mediated increases in CoBF and CVC are augmented compared to control animals. This increase in CoBF is mediated by an increase in cardiac SNA in the control group but not the HF group.

Background Recently, a novel cryoballoon (CB; POLARx) has been developed with increased steerability which maintains size and pressure throughout the ablation. Initial clinical data has demonstrated acute procedural safety and efficacy in de novo pulmonary vein isolation (PVI) procedures in patients with paroxysmal atrial fibrillation (AF). However, there are limited studies demonstrating the long-term efficacy of the CB. Purpose To evaluate the long-term safety and efficacy of the novel CB in treating paroxysmal AF. Methods This was a non-randomized, prospective, multi-center study. Fifty-eight consecutive patients with paroxysmal AF were enrolled at 4 centers for de novo PVI procedures. Cryoablation was delivered for 180s if time to isolation was ≤60s. Otherwise a 240s cryoablation was performed. PVI was confirmed with entrance and exit block testing. Patients were followed for 1 year with 24-hour Holter monitoring at 3, 6, and 12 months. After a 3-month blanking period, recurrence was defined as having any documented, symptomatic episode(s) of AF or atrial tachycardia. Results Acute isolation with the CB was achieved in 230 of 231 pulmonary veins (99.6%) with 5.2±1.5 cryoapplications per patient (1.3±0.6 cryoapplications per vein). There were 4 patients (6.9%) with phrenic nerve injury (3 resolved during the index procedure; 1 resolved at 6 months follow-up). One serious adverse device event was reported: femoral arterial embolism event occurring 2 weeks post index procedure (1.7%). Of the 56 patients that had complete 12-month follow-up, 43 (76.8%) were free from recurrent atrial arrhythmias. Conclusion Initial multicenter clinical experience with the novel CB has demonstrated long-term safety and efficacy of PVI in patients with paroxysmal AF. Further studies are underway to confirm these findings. Funding Acknowledgement Type of funding sources: Private company. Main funding source(s): Boston Scientific

This report describes the occurrence of desynchronization in a patient with a cardiac resynchronization device programmed with an active pacemaker-mediated tachycardia algorithm based on AV delay modification. Desynchronization was precipitated by sinus tachycardia and the abrupt return of the prevailing AV delay that followed the periodic prolongation of the AV delay mandated by activity of the algorithm. Prevention of desynchronization in this setting requires programming a right ventricular upper rate interval longer than the sum of the programmed ventriculoatrial interval and the AV delay.

The number of cardiac implantable electronic device (CIED) implantations has increased over recent years. Transvenous lead extraction (TLE), as a part of an overall lead management strategy, has also been increasing, not only as a consequence of this growth, but also because of increasing rates of infection, lead failure, awareness of indications for lead management, and development of extraction tools. Clinical research is essential for understanding efficacy and risks of TLE.

Introduction: More effective methods for characterizing 3D electrical activity in human left atrium (LA) are needed to identify substrates/triggers and microreentrant circuit for paroxysmal atrial fibrillation (PAF). We describe a novel wavelet-based approach and wave-front centroid tracking that have been used to reconstruct regional activation frequency and electrical activation pathways from non-contact multi-electrode array. Methods: Data from 13 patients acquired prior to ablation for PAF with a 64 electrode noncontact catheter positioned in the LA were analysed. Unipolar electrograms were reconstructed at 2048 locations across each LA endocardial surface. Weighted fine- and coarse-scale electrograms were constructed by wavelet decomposition and combined with peak detection to identify atrial fibrillation (AF) activation frequency and fractionated activity at each site. LA regions with upper quartile AF frequencies were identified for each patient. On the other hand, a wave-front centroid tracking approach was introduced for this first time to detect macro-reentrant circuit during PAF. Results: The results employing wavelet-based analysis on atrial unipolar electrograms are validated by the signals recorded simultaneously via the contacted ablation catheter and visually tracking the 3D spread of activation through the interest region. Multiple connected regions of high frequency electrical activity were seen; most often in left superior pulmonary vein (10/12), septum (9/12) and atrial roof (9/12), as well as the ridge (8/12). The wave-front centroid tracking approach detects a major macro circuit involving LPVs, PLA, atrial floor, MV, septum, atrial roof and ridge. The regions with high frequency by wave-front tracking are consistent with the results using wavelet approach and our clinical observations. Conclusions: The wavelet-based technique and wave-front centroid tracking approach provide a robust means of extracting spatio-temporal characteristics of PAF. The approach could facilitate accurate identification of pro-arrhythmic substrate and triggers, and therefore, to improve success rate of catheter ablation for AF.

Temporary DDD pacing offers significant hemodynamic benefits in emergency management of bradyarrhythmias but is underused because of its complexity (two leads) and unreliability. Single lead VDD pacing with atrial sensing via a floating dipole is feasible, but atrial pacing is limited by high thresholds and phrenic nerve stimulation (PNS). Overlapping biphasic impulse (OLBI) stimulation may avoid these problems. The authors designed a single lead balloon-tipped catheter for temporary transvenous DDD pacing, incorporating noncontact atrial dipoles for OLBI stimulation. This catheter was deployed using fluoroscopic guidance in 74 patients (43 men, 31 women) with mean age 56.9 +/- 17.0 years. Pacing parameters were assessed at implantation and follow-up. The median procedural time was 6.6 (range 1.2-25.0) minutes and fluoroscopy time 1.9 (range 0.2-7.8) minutes. Stable VDD pacing was achieved in all cases. Atrial capture was achieved in 73 of 74 cases with both modes at maximum output but was restricted by PNS at outputs below atrial capture threshold in 3 of 74 cases with OLBI and 10 of 74 cases with standard bipolar mode (P = 0.04). At outputs > or = 1.0 V above atrial threshold, reliable DDD pacing without PNS was achieved and maintained in 67 (91%) of 74 patients in OLBI compared to 53 (72%) of 74 patients in bipolar mode (P = 0.003). Pacing parameters were stable during follow-up (median 53 hours, range 6-168 hours). In conclusion, the single lead catheter with OLBI stimulation allows temporary VDD and DDD pacing without PNS to be achieved in > 90% of patients. This rapid and convenient approach should facilitate DDD pacing in emergency settings.

BackgroundRemote telemonitoring holds great potential to augment management of patients with coronary heart disease (CHD) and atrial fibrillation (AF) by enabling regular physiological monitoring during physical activity. Remote physiological monitoring may improve home and community exercise-based cardiac rehabilitation (exCR) programs and could improve assessment of the impact and management of pharmacological interventions for heart rate control in individuals with AF. ObjectiveOur aim was to evaluate the measurement validity and data transmission reliability of a remote telemonitoring system comprising a wireless multi-parameter physiological sensor, custom mobile app, and middleware platform, among individuals in sinus rhythm and AF. MethodsParticipants in sinus rhythm and with AF undertook simulated daily activities, low, moderate, and/or high intensity exercise. Remote monitoring system heart rate and respiratory rate were compared to reference measures (12-lead ECG and indirect calorimeter). Wireless data transmission loss was calculated between the sensor, mobile app, and remote Internet server. ResultsMedian heart rate (-0.30 to 1.10 b∙min-1) and respiratory rate (-1.25 to 0.39 br∙min-1) measurement biases were small, yet statistically significant (all P≤.003) due to the large number of observations. Measurement reliability was generally excellent (rho=.87-.97, all P