Incidence, implications, and management of sense-B-noise failure in subcutaneous cardioverter-defibrillator patients: insights from a large multicentre registry.

AIMS: Subcutaneous implantable cardioverter-defibrillators (S-ICDs) offer potentially distinct advantages over transvenous defibrillator systems. Recent randomized trials showed significantly lower lead failure rates than transvenous ICD. Still, S-ICDs remain associated with the risk of inappropriate shocks (IAS). While previous studies have reported varying causes of IAS, this study explores a rare cause of IAS, referred to as 'sense-B-noise.' It was recently described in case series, but its incidence has not been studied in a large cohort of S-ICD patients. METHODS AND RESULTS: We retrospectively reviewed data from patients implanted with S-ICD models 1010, A209, and A219 between October 2009 and July 2023 across nine centres in Europe and the USA. The analysis concentrated on determining the incidence and understanding the implications of sense-B-noise events. Sense-B-noise represents a rare manifestation of distinct electrogram abnormalities within the primary and alternate sensing vectors. Data were collected from medical records, device telemetry, and manufacturer reports for investigation. This registry is registered on clinicaltrials.gov (NCT05713708). Subcutaneous implantable cardioverter-defibrillator devices of the 1158 patients were analysed. The median follow-up time for all patients was 46 (IQR 23-64) months. In 107 patients (9.2%) ≥1 IAS was observed during follow-up. Sense-B-noise failure was diagnosed in six (0.5 and 5.6% of all IAS) patients, in all patients, the diagnosis was made after an IAS episode. Median lead dwell time in the affected patients was 23 (2-70) months. To resolve the sense-B-noise defect, in three patients reprogramming to the secondary vector was undertaken, and two patients underwent system removal with subsequent S-ICD reimplantation due to low amplitude in the secondary vector. In one patient, the secondary vector was initially programmed, and subsequently, an S-ICD system exchange was performed due to T-wave-oversensing IAS episodes. CONCLUSION: This multicentre analysis' findings shed light on a rare but clinically highly significant adverse event in S-ICD therapy. To our knowledge, we provide the first systematic multicentre analysis investigating the incidence of sense-B-noise. Due to being difficult to diagnose and limited options for resolution, management of sense-B-noise is challenging. Complete system exchange may be the only option for some patients. Educating healthcare providers involved in S-ICD patient care is crucial for ensuring accurate diagnosis and effective management of sense-B-noise issues.

Occurrence of premature battery depletion in a large multicentre registry of subcutaneous cardioverter-defibrillator patients.

AIMS: Subcutaneous implantable cardioverter-defibrillators (S-ICDs) have become established in preventing sudden cardiac death, with some advantages over transvenous defibrillator systems, including a lower incidence of lead failures. Despite technological advancements, S-ICD carriers may suffer from significant complications, such as premature battery depletion (PBD), that led to an advisory for nearly 40 000 patients. This multicentre study evaluated the incidence of PBD in a large set of S-ICD patients. METHODS AND RESULTS: Data from patients implanted with S-ICD models A209 and A219 between October 2012 and July 2023 across nine centres in Europe and the USA were reviewed. Incidence and implications of PBD, defined as clinically observed sudden drop in battery longevity, were analysed and compared to PBD with the definition of battery depletion within 60 months. Prospectively collected clinical data were obtained retrospectively from medical records, device telemetry, and manufacturer reports. This registry is listed on ClinicalTrials.gov (NCT05713708). Of the 1112 S-ICD devices analysed, 547 (49.2%) were equipped with a potentially affected capacitor linked to PBD occurrence, currently under Food and Drug Administration advisory. The median follow-up time for all patients was 46 [inter-quartile range (IQR) 24-63] months. Clinically suspected PBD was observed in 159 (29.1%) of cases, with a median time to generator removal or replacement of 65 (IQR 55-72) months, indicative of significant deviations from expected battery lifespan. Manufacturer confirmation of PBD was made in 91.7% of devices returned for analysis. No cases of PBD were observed in devices that were not under advisory. CONCLUSION: This manufacturer-independent analysis highlights a notable incidence of PBD in patients equipped with S-ICD models under advisory, and the rate of PBD in this study corresponds to the rate currently estimated by the manufacturer. To the best of our knowledge, this provides the largest contemporary peer-reviewed study cohort investigating the actual incidence of PBD in S-ICD patients. These findings emphasize the importance of post-market registries in collaboration between clinicians and the manufacturer to optimize safety and efficacy in S-ICD treatment.

Balloon technologies for pulmonary vein isolation-12-month outcome and comparison of the novel radiofrequency balloon with the cryoballoon in patients with paroxysmal atrial fibrillation.

BACKGROUND: The cryoballoon (CB) has become a standard tool for pulmonary vein isolation (PVI), but the technology is limited in certain ways. A novel RF-balloon (Heliostar™, Biosense Webster, CA, USA) promises the advantages of a balloon technology in combination with 3D mapping. METHODS: To assess procedural data and outcome, all patients undergoing RF-balloon PVI were included and compared with data from consecutive patients undergoing CB PVI for paroxysmal AF. RESULTS: A total of 254 patients (63 ± 13 years, 54% male) were included: 30 patients undergoing RF-balloon and 224 patients CB PVI. Baseline parameters were comparable. Procedure duration (104.3 ± 35.3 min vs. 69.9 ± 23.1 min; p ≤ 0.001) and fluoroscopy time (16.3 ± 7.1 min vs. 11.6 ± 4.9 min; p ≤ 0.001) were longer using the RF-balloon; ablation time (43.5 ± 17.9 vs. 36.4 ± 15.6; p = 0.08) did not differ, and time-to-isolation (TTI) was shorter (18.2 ± 7.0 s vs. 62.8 ± 35.1 s; p ≤ 0.001). Second-generation RF-balloon cases showed shorter ablation time and TTI at comparable procedure duration and fluoroscopy time. One pericardial effusion occurred with the RF-balloon due to complicated transseptal access. During CB PVI in 4/224 patients (1.8%), a phrenic nerve palsy was observed. After 12 months, 78% of patients after RF-balloon and 81% of patients after CB PVI (p = 0.5) were free from atrial arrhythmias. CONCLUSION: The RF-balloon was safe and effective. Compared with the CB, TTI was shorter, but procedure durations and fluoroscopy times were longer. This can be attributed to a learning curve and the initial necessity for separate 3D map preparation. Considering the results with the second-generation RF-balloon, more experience is needed to determine the potential benefits.

The omnipolar mapping technology-a new mapping tool to overcome "bipolar blindness" resulting in true high-density maps.

BACKGROUND: Omnipolar mapping (OT) is a novel tool to acquire omnipolar signals for electro-anatomical mapping, displaying true voltage and real-time wavefront direction and speed independent of catheter orientation. The aim was to analyze previously performed left atrial (LA) and left ventricular (LV) maps for differences using automated OT vs. standard bipolar settings (SD) and HD wave (HDW) algorithm. METHODS: Previously obtained SD and HDW maps of the LA and LV using a 16-electrode, grid-shaped catheter were retrospectively analyzed by applying automated OT, comparing voltage, point density, pulmonary vein (PV) gaps, and LV scar area. RESULTS: In this analysis, 135 maps of 45 consecutive patients (30 treated for LA, 15 for LV arrhythmia) were included. Atrial maps revealed significantly higher point densities using OT (21471) vs. SD (6682) or HDW (12189, p < 0.001). Mean voltage was significantly higher using OT (0.75 mV) vs. SD (0.61 mV) or HDW (0.64 mV, p < 0.001). OT maps detected significantly more PV gaps per patient vs. SD (4 vs. 2), p = 0.001. In LV maps, OT revealed significantly higher point densities (25951) vs. SD (8582) and HDW (17071), p < 0.001. Mean voltage was significantly higher for OT (1.49 mV) vs. SD (1.19 mV) and HDW (1.2 mV), p < 0.001. Detected scar area was significantly smaller using OT (25.3%) vs. SD (33.9%, p < 0.001). CONCLUSION: OT mapping leads to significantly different substrate display, map density, voltage, detection of PV gaps, and scar size, compared to SD and HDW in LA and LV procedures. Successful CA might be facilitated due to true HD maps.

Comparison of pulsed-field ablation versus very high power short duration-ablation for pulmonary vein isolation.

BACKGROUND: The newly introduced nonthermal pulsed field ablation (PFA) is a promising technology to achieve fast pulmonary vein isolation (PVI) with high acute success rates and good safety features. However, previous studies have shown that very high power short duration ablation (VHPSD) is also highly effective and fast to achieve PVI with potentially less arrhythmia recurrence compared to conventional radiofrequency ablation. Data comparing PFA to VHPSD-PVI is lacking. OBJECTIVE: This study compared procedural and outcome data for PFA-PVI to VHPSD-PVI in patients with paroxysmal or persistent atrial fibrillation (PAF/persAF). METHODS: Consecutive patients undergoing de novo PVI (PFA or VHPSD) were included in this analysis. For PFA-PVI a pentaspline 20 electrode catheter was used. For VHPSD-PVI an enhanced irrigated catheter with a power setting of 70 W/7 s (70 W/5 s at posterior wall) was employed in conjunction with electro-anatomical mapping. All procedures were performed in deep analgo-sedation. RESULTS: A total of n = 114 patients (n = 57[50%] PFA, n = 17[30%] PAF; n = 40[70%] persAF) were included in this analysis. PVI was successful in all patients. The PFA group revealed a significantly shorter procedure duration (65 ± 17 min vs. 95 ± 23 min, p < 0.01) but longer fluoroscopy time (PFA 15 ± 5 min and VHPSD 12 ± 3 min; p < 0.001). At follow-up after median 125 days (interquartile range: 109-162) n = 46 PFA (80.7%) and n = 44 VHPSD pts (77.2%) were free from atrial arrhythmia after a single procedure (p = 0.819). Two tamponades occurred in the PFA while in VHPSD two pts suffered groin bleedings. One clinically nonsignificant PV stenosis occurred in the VHPSD group. CONCLUSION: Pulsed-field ablation and VHPSD-PVI seem to be highly effective and safe to achieve PVI in the setting of PAF and persAF with comparable arrhythmia-free survival. However, procedure duration for PFA PVI is significantly shorter and therefore may be of potential benefit. Compared to PFA VHPSD-PVI might ensure information on left atrial substrate allowing to target concomitant secondary tachycardias.

Comparison of pulsed field ablation and cryoballoon ablation for pulmonary vein isolation.

INTRODUCTION: Pulmonary vein isolation (PVI) remains the cornerstone in the treatment of atrial fibrillation (AF). PVI using cryoballoon (CB) technology has emerged as a standard procedure in many centers. Recently, pulsed field ablation (PFA) has been introduced and used to achieve PVI. First data show high acute and favorable long-term outcomes. So far, data comparing these new "single shot" devices are sparse. We sought to compare procedural and outcome data for first time PFA users versus CB in patients undergoing de novo PVI. Furthermore, potentially postprocedural discomfort and affection of autonomic ganglia were assessed. METHODS AND RESULTS: A retrospective analysis and comparison of all de novo PVIs with PFA and CB was performed. Furthermore, PFA PVI learning curve was evaluated. During follow-up, repeat outpatient visits and Holter electrocardiogram were performed to analyze arrhythmia-free survival. Discomfort analysis was obtained by prescribed analgesic medication within first 48 h after PVI. Potential changes in heart rate (HR) between baseline and at 3-month follow-up were evaluated. A total of 108 patients (54 PFA and 54 CB; PFA; 33 (30%) female) with paroxysmal and persistent AF were analyzed. Type of AF was comparable (Patients suffering from PAF: PFA: 16 (30%), CB: 17 (31%), p = 1.0). In 107 (99%) patients, successful PVI was achieved. Transient phrenic palsy omitted complete PVI in one CB patient. A trend for a shorter overall procedure duration was observed in the PFA group (PFA: 64.5 ± 17.5 min; CB: 73.0 ± 24.8 min; p = 0.07). Excluding LA mapping time (first 14 cases), procedure time was significantly shorter using PFA (PFA: 58.0 ± 12.5 min, CB: 73.0 ± 24.8 min, p = 0.0001). Fluoroscopy time was significantly longer for PFA (PFA: 15.3 ± 4.7 min, CB: 12.3 ± 5.3 min; p = 0.001), but significantly less contrast medium was used (PFA: 12 ± 6 mL; CB: 51 ± 29 mL, p < 0.0001). Subgroup analysis of the PFA group revealed a significant shortening of procedure duration over time (first tertile: 72.7 ± 13.5 min, second tertile: 67.3 ± 21.7 min, third tertile: 53.4 ± 9.8 min, first vs. third tertile p < 0.0001). Two cardiac tamponades occurred in the PFA group (p = 0.495), of which one was most likely related to complex transseptal puncture. In the first 48 h after PVI, the number of prescribed analgesics due to postprocedural pain was equal between both groups (PFA: 7 (13%) patients, CB: 10 (19%) patients, p = 0.598). After a FU of 273 ± 129 days, 35 of 47 patients (74%) after PFA and 36 of 50 patients (72%) after CB PVI were free of any atrial arrhythmia (HR: 0.98, p = 0.88). Only in the PFA group, a significant increase in HR 3 months after PVI was observed (pre-PVI: 61 ± 8 beats/min, post-PVI: 65 ± 9 beats/min, p = 0.008). CONCLUSION: The new PFA technology is equally effective and safe as compared to CB for complete PVI with potentially shorter procedure time and significantly less contrast medium. However, AF recurrence rates after PFA PVI seem to be comparable to CB PVI.

Implementation and first outcomes of a novel standard operating procedure for preprocedural transoesophageal echocardiography screening in course of atrial arrhythmia ablation.

AIMS: Preprocedural transoesophageal echocardiography (TEE) screening for left atrial (LA) thrombi is the standard of care in many centres performing atrial fibrillation (AF) ablation. However, TEE imposes procedural risks for patients and is often challenging to implement in daily practice, besides causing patient discomfort. At our centre, a novel standard operating procedure (SOP) was implemented, aiming to identify patients that can be exempt from TEE screening. We aimed to assess whether this screening approach may reduce preprocedural TEEs without imposing patients of higher risks for cerebrovascular events (CVEs). METHODS AND RESULTS: Data of 1874 consecutive patients treated by catheter ablation of LA arrhythmias between 2018 and 2022 were retrospectively analysed. A cohort of 937 patients, where decision to perform TEE screening was based on a new SOP (considering rhythm at admission, CHA2DS2-VASc score, and sufficient anticoagulation), was compared to a matched cohort receiving TEE before every procedure. Number of performed TEEs and incidences of CVEs were compared. Implementation of the new SOP led to a 67% reduction in TEEs performed (old SOP: 933 vs. new SOP: 305). No significant differences between the groups were detected regarding transitory ischaemic attack (old SOP: 5 vs. new SOP: 3; P = 0.48) and stroke (no events). No solid thrombi were detected during TEE screening. CONCLUSION: The number of preprocedural screening TEEs before AF ablation procedures can be safely reduced by applying risk stratification based on rhythm at admission and CHA2DS2-VASc score, if anticoagulation was performed properly.

First long-term outcome data for the MicraVR™ transcatheter pacing system: data from the largest prospective German cohort.

AIMS: The MicraVR™ transcatheter pacing system (TPS) has been implemented into clinical routine for several years. The primary recipients are patients in need for VVI pacing due to bradycardia in the setting of atrial fibrillation (AF). Implantation safety and acute success have been proven in controlled studies and registries. So far only few long-term real-life data on TPS exist. We report indication, procedure and outcome data from two high-volume implanting German centers. METHODS: Between 2016 and 2019, 188 (of 303) patients were included. During follow-up (FU), TPS interrogation was performed after 4 weeks and thereafter every 6 months. RESULTS: Indication for TPS implantation in 159/188 (85%) patients was permanent or intermittent AV block III° in the setting of atrial fibrillation. The mean procedure duration was 50 min [35.0-70.0]. The average acute values after system release were: thresholds: 0.5V [0.38-0.74]/0.24ms; R-wave sensing: 10.0mV [8.1-13.5]; impedance: 650 Ohm [550-783]; RV-pacing demand: 16.9% [0.9-75.9]; and battery status: 3.15 V [3.12-3.16]. During FU of 723.4 ± 597.9 days, neither pacemaker failure nor infections were reported. Long-term FU revealed: thresholds: 0.5V [0.38-0.63]/0.24 ms; sensing: 12.3mV [8.9-17.2]; impedance: 570 Ohm [488-633]; RV-pacing demand: 87.1% [29.5-98.6]; and battery status 3.02 V [3.0-3.1]. Forty-three patients died from not-device-related causes. CONCLUSION: This to date largest German long-term dataset for MicraVR™ TPS implantation revealed stable device parameter. Foremost, battery longevity seems to fulfill predicted values despite a significant increase in RV-pacing demand over time and even in patients with consecutive AV-node ablation. Of note, no infections or system failure were observed.

Pulmonary vein isolation for atrial fibrillation using true high-power short-duration vs. cryoballoon ablation.

AIMS: Pulmonary vein isolation (PVI) is achievable and effective using radiofrequency (RF) catheter (CA) or cryoballoon (CB) ablation. The newly introduced high RF-power short-duration ablation (HPSD) technique has shown promising results. Data comparing HPSD- to CB-PVI is sparse. We sought to investigate success rates and procedural differences of HPSD-PVI vs. CB-PVI in patients undergoing ablation for PAF and persAF. METHODS: Consecutive patients undergoing de novo PVI (HPSD or CB) were included. A power setting of 70W/7 s (70W/5 s at posterior wall) using a flexible tip catheter with enhanced irrigation was considered as true HPSD. Follow-up consisted of out-clinic pts visits, tele-consultation, 48-h Holter ECG, app-based telemonitoring and cardiac implanted electronic devices (CIED) interrogation. RESULTS: 721 patients (46 HPSD, 675 CB) were analyzed. In all HPSD (27 persAF [59%]) and CB patients (423 persAF [63%]), PVI was successfully achieved. Procedure duration was significantly longer for HPSD (91 ± 19 min vs. 72 ± 18 min, p < 0.01). Ablation time was similar in both groups (HPSD: 44 ± 19 min vs. CB: 40 ± 17 min; p = 0.347). No major complications occurred in HPSD. For CB-PVI, in 25 (3.7%; p = 0.296) patients, complications occurred. At a follow-up of 290 ± 135 days, arrhythmia-free survival using HPSD was non-inferior to CB-PVI in the Kaplan-Meier survival analysis (p = 0.096). CONCLUSION: PVI using HPSD is equally effective and safe to CB-PVI. This analysis revealed a similar arrhythmia-free survival after HPSD and CB with low complication rates. Procedure duration for CB was significantly shorter while LA dwell time excluding mapping was equal. Currently, a prospective trial is conducted to corroborate these findings.

Impact of ventricular arrhythmia management on suboptimal biventricular pacing in cardiac resynchronization therapy.

BACKGROUND: Reduced biventricular pacing (BiVP) is a common phenomenon in cardiac resynchronization therapy (CRT) with impact on CRT-response and patients' prognosis. Data on treatment strategies for patients with ventricular arrhythmia and BiVP reduction is sparse. We sought to assess the effects of ventricular arrhythmia treatment on BiVP. METHODS: In this retrospective analysis, the data of CRT patients with a reduced BiVP ≤ 97% due to ventricular arrhythmia were analyzed. Catheter ablation or intensified medical therapy was performed to optimize BiVP. RESULTS: We included 64 consecutive patients (73 ± 10 years, 89% male, LVEF 30 ± 7%). Of those, 22/64 patients (34%) underwent ablation of premature ventricular contractions (PVC) and 15/64 patients (23%) underwent ventricular tachycardia (VT) ablation while 27/64 patients (42%) received intensified medical treatment. Baseline BiVP was 88.1% ± 10.9%. An overall increase in BiVP percentage points of 8.8% (range - 5 to + 47.6%) at 6-month follow-up was achieved. No changes in left ventricular function were observed but improvement in BiVP led to an improvement in NYHA class in 24/64 patients (38%). PVC ablation led to a significantly better improvement in BiVP [9.9% (range 4 to 22%) vs. 3.2% (range - 5 to + 10.7%); p = < 0.001] and NYHA class (12/22 patients vs. 4/27 patients; p = 0.003) than intensified medical therapy. All patients with VT and reduced BiVP underwent VT ablation with an increase of BiVP of 16.3 ± 13.4%. CONCLUSION: In this evaluation of ventricular arrhythmia treatment aiming for CRT optimization, both medical therapy and catheter ablation were shown to be effective. Compared to medical therapy, a higher increase in BiVP was observed after PVC ablation, and more patients improved in NYHA class. CLINICAL TRIAL REGISTRATION: The study was registered at clinical trials.org in August 2019: NCT04065893.

Dipole Density Guided Catheter Ablation versus Conventional Substrate Modification for Repeat Catheter Ablation of Persistent Atrial Fibrillation.

AIMS: The optimal ablation strategy for recurrent persistent atrial fibrillation (persAF) after initially successful catheter ablation (CA) remains debatable. Dipole density (DD) guided CA using the AcQMap system has been proven to be feasible and effective in patients with persAF. So far, long-term outcome data for DD-guided CA in patients with recurrence of persAF are sparse. This study sought to assess long-term outcome data in patients undergoing a DD-guided CA for recurrence of persAF after previous CA in comparison to conventional repeat CA. METHODS AND RESULTS: Patients undergoing DD-guided CA for recurrence of persAF after previous ablation were compared to patients undergoing conventional substrate modification (CSM). A total of 64 patients (32 DD-guided and 32 CSM) were included in this analysis. Procedure duration (DD: 236 ± 61 min; CSM: 198 ± 59 min; p = 0.004) and fluoroscopy time (DD: 36 ± 15 min; CSM: 20 ± 11 min; p = 0.0001) were significantly longer in the DD group. After a long-term median follow-up (FU) of 27 months (interquartile range 12.8-34.3), DD-guided CA was inferior to CSM regarding overall arrhythmia-free survival (DD: 6 patients (19%), CSM: 11 patients (34%); HR 1.47; p = 0.04). Freedom from AF did not differ between both groups (DD: 16 patients (50%); CSM: 18 patients (56%), HR 0.99, p = 0.47). During FU, more patients underwent repeat CA after DD-guided ablation (DD: 16 patients (50%), CSM: 7 patients (22%), p = 0.04). No major complications occurred overall. CONCLUSIONS: Dipole density-guided CA is equally safe but associated with longer procedure duration compared to conventional substrate modification for treatment of recurrent persAF after previous CA. Of note, long-term arrhythmia-free survival is significantly worse after DD-guided ablation, and more patients undergo redo procedures.

Procedural and outcome impact of obesity in cryoballoon versus radiofrequency pulmonary vein isolation in atrial fibrillation patients.

PURPOSE: Cryoballoon (CB) ablation and radiofrequency (RF) ablation are the most common techniques for pulmonary vein isolation (PVI) in patients with symptomatic atrial fibrillation (AF). An increasing number of patients undergoing PVI are obese. To address the paucity of data on outcomes of CB- vs. RF-based PVI in relation to body mass index (BMI) of AF patients. METHODS: All patients undergoing de novo PVI between 01/2018 and 08/2019 at University Hospital Cologne were included in this retrospective analysis. Patients of each group (CB-PVI vs. RF-PVI) were analyzed based on their BMI. Hereafter, procedural characteristics and AF recurrence rate were compared regarding different BMI groups. RESULTS: A total of 526 patients (62% male, 65±11 years) underwent successful de novo PVI (320 CB and 206 RF). In obese patients, two differences in procedural characteristics were noted: A significantly increased contrast medium volume in CB group and a lower fluoroscopy dose in RF group: contrast medium: CB 50 [40-80] vs. RF 20 [20-30], p<0.001; fluoroscopy dose: CB 392.4 [197.9-995.9] vs. RF 282.5 [139.8-507.2], p<0.001. The complication rate was equal throughout all BMI groups, regardless of CB or RF usage. For obese patients, a trend toward a higher AF recurrence rate was revealed after RF-PVI as compared to CB-PVI. In line with previous studies, the overall procedure time was significantly shorter with CB-PVI regardless of BMI. CONCLUSION: For obese patients, CB-PVI is similarly safe and effective as RF-PVI. The significantly shorter procedure time for CB-PVI may minimize potential obesity-related complications. However, the lower contrast medium quantity and fluoroscopy dose in RF-PVI must be considered. AF recurrence rates were comparable between CB-PVI and RF-PVI.

First transcatheter leadless pacemaker implantation in a pediatric patient with a genetic disease.

A pediatric patient suffering from Marden-Walker syndrome, a rare genetic disease, was referred to the authors' hospital for syncope due to bradycardia. Since this disease is associated with severe joint contractures, a transcatheter leadless pacing system (TPS) was chosen. Despite the small body size and complex anatomy, TPS implantation was feasible, demonstrating that it is a safe alternative in difficult venous access compared to a conventional pacemaker with increased risk of lead complications in these patients.

Porous tip contact force-sensing catheters for pulmonary vein isolation: performance in a clinical routine setting.

PURPOSE: In catheter ablation of atrial fibrillation (AF), contact force (CF)-sensing catheters with an irrigated tip are used to deliver radiofrequency (RF) energy to the tissue. The ThermoCool® Smarttouch™ Surroundflow catheter (STSF) integrates CF-sensing technology and a new porous tip for advanced external cooling. The aim was to evaluate the performance and safety of STSF in a clinical setting of pulmonary vein isolation (PVI) in comparison with standard contact force-sensing catheter (ST). METHODS: We assigned consecutive patients (n = 80, prospectively, open-label, non-randomized) with symptomatic AF to either PVI with STSF (n = 60) or ST (n = 20). RESULTS: Total ablation time to achieve PVI was significantly shorter in STSF compared to that in ST (STSF, 1556 ± 435 s vs. ST, 1922 ± 961 s; p = 0.045). Ablation time to achieve loss of pace capture of left pulmonary veins was shorter using STSF (left veins, 155 ± 140 s vs. 291 ± 188 s; p = 0.01; right veins, 208 ± 196 s vs. 369 ± 306 s; p = 0.09). Furthermore, administered irrigation fluid was significantly reduced in STSF (241.4 ± 79.6 ml vs. 540.3 ± 229.5 ml; p < 0.01). CF was lower during ablation of left pulmonary veins. One steam pop occurred in STSF, which did not lead to pericardial effusion (vs. no steam pop in ST). The Kaplan-Meier estimate 12-month AF recurrence was 34.3% and 37.7% (p = 0.8). CONCLUSIONS: Integrating CF technology and the porous tip technology enables effective energy transfer to the tissue resulting in shorter ablation time and less irrigation fluid administration. In our cohort, PVI using the STSF was not associated with an increased complication rate or AF recurrence rate after 12-month follow-up when compared with the ST.

Incidence of myopotential induction in subcutaneous implantable cardioverter-defibrillator patients: Is the oversensing issue really solved?

BACKGROUND: The subcutaneous implantable cardioverter-defibrillator (S-ICD) has established its role in the prevention of sudden cardiac death in a defined population. Inappropriate shocks and device malfunction in S-ICD therapy may be caused by myopotential (MP) oversensing. OBJECTIVE: The purpose of this study was to systematically evaluate a cohort of consecutive S-ICD patients for MP inducibility. METHODS: After S-ICD implantation, all vectors (primary [PrimV], secondary [SecV], alternative [AltV]) were analyzed during isometric chest press (ICP), lifting and holding a 20-kg weight, and side plank exercise (SPE), supporting the body weight on the left arm. When MPs were induced, signal classification was assessed: adequate noise detection, induced undersensing (R waves classified as noise), and oversensing (noise annotated as R waves). In case of noise induction in the current vector, device reprogramming to a noise-free vector was done. RESULTS: We systematically assessed 41 patients. In nearly all patients (90.2%), MPs were inducible. ICP was the most potent inductor of MPs. Whereas SecV (70.7%) and AltV (75.6%) were most vulnerable during ICP, PrimV was most affected during SPE (51.2%). In only a few cases did the S-ICD software distinguish correctly between MPs and QRS. MPs predominantly led to undersensing (up to 65.9%), but in up to 22% of patients MP-induced oversensing occurred but did not lead to tachycardia detection. No relation was seen between S-ICD lead and generator position and MP inducibility. CONCLUSION: Induction of MPs during physical exercise was observed frequently. Although in most cases MP noise led to undersensing, oversensing events were commonly observed.

The use of a high-resolution mapping system may facilitate standard clinical practice in VE and VT ablation.

BACKGROUND: First experiences using a 64-electrode mini-basket catheter (BC) paired with an automatic mapping system (Rhythmia™) for catheter ablation (CA) of ventricular ectopy (VE) and ventricular tachycardia (VT) have been reported. OBJECTIVES: We aimed to evaluate (1) differences in ventricular access for the BC and (2) benefit of this technology in the setting of standard clinical practice. METHODS: Patients (pts) undergoing CA for VE or VT using the Intellamap Orion™ paired with the Rhythmia™ automated-mapping system were included in this study. For LV access, transseptal and retrograde access were compared. RESULTS: All 32 pts (29 men, age 63 ± 15 years) underwent CA for VE (17 pts) or VT (15 pts). For mapping of VE originating from the left ventricle (LV) in 10 out of 13 pts, a transaortic access was feasible. The predominant access for CA of VT was transaortic (5/7). Feasibility and safety seem to be equal. The total procedure time was 179.1 ± 21.2 min for VE ablation and 212.0 ± 71.7 min for VT ablation (p = 0.177). For VE, an acquisition of 1602 ± 1672 map points and annotation of 140 ± 98 automated mapping points sufficed to abolish VE in all pts. During a 6-month follow-up (FU) after CA for VE, a VE burden reduction from 18.5 ± 2.1% to 2.8 ± 2.2% (p = 0.019) was achieved. In VT pts, one patient showed recurrence of sustained VT episodes during FU. CONCLUSION: Use of a high-resolution mapping system for VE/VT CA potentially facilitates revelation of VE origin and VT circuits in the setting of standard clinical practice. Feasibility and safety of a venous, transaortic, transseptal, or a combined approach seem to be equal.

Remote vs. conventional navigation for catheter ablation of atrial fibrillation: insights from prospective registry data.

BACKGROUND: Robotic (RNS) or magnetic navigation systems (MNS) are available for remotely performed catheter ablation for atrial fibrillation (AF). OBJECTIVE: The present study compares remotely assisted catheter navigation (RAN) to standard manual navigation (SMN) and both systems amongst each other. METHODS: The analysis is based on a sub-cohort enrolled by five hospitals from the multicenter German ablation Registry. RESULTS: Out of 2442 patients receiving catheter ablation of AF, 267 (age 61.4 ± 10.4, 69.7% male) were treated using RAN (RNS n = 187, 7.7% vs. MNS n = 80, 3.3%). Fluoroscopy time [RNS median 17 (IQR 12-25) min vs. MNS 22 (16-32) min; p < 0.001] and procedure duration [RNS 180 (145-220) min vs. MNS 265 (210-305) min; p < 0.001] were significantly different. Comparing RAN (11%) to SMN (89%) fluoroscopy time (RAN 19 (13-27) min, vs. SMN 25 (16-40) min; p < 0.001), energy delivery (RAN 3168 (2280-3840) s vs. SMN 2640 (IQR 1799-3900) s; p = 0.008) and procedure duration [RAN 195 (150-255) min vs. SMN 150 (120-150) min; p = 0.001] differed significantly. In terms of acute and 12 months outcome, no differences were seen between the two systems or in comparison to SMN. CONCLUSION: AF ablation can be performed safely, with high acute success rates using RAN. RNS results in less fluoroscopy burden and shorter procedure durations. Compared to SMN, a reduced fluoroscopy burden, prolonged procedure and ablation duration were observed using RAN. Overall, the number of RAN procedures is small suggesting low impact on clinical routine of AF ablation.

Effects of propofol sedation on pacing thresholds : Results from an observational cohort study.

BACKGROUND: Propofol is one of the most commonly used intravenous anaesthetic drugs for surgical procedures. The use of propofol for sedation is also common practice during endoscopic procedures, electrophysiology studies, and ablation procedures, as well as pacemaker and defibrillator implantation. It was found that propofol alters the electrophysiologic properties of the heart and its conduction system. The effects of propofol on pacing thresholds are unknown and could have implications for pacemaker (PM) and defibrillator (ICD) implantation procedures, as well as sedation and anaesthesia in PM and ICD patients in general. OBJECTIVES: We sought to investigate the effects of propofol sedation on atrial and right ventricular pacing thresholds in PM and ICD patients. MATERIALS AND METHODS: A total of 50 patients with PM, ICD, or cardiac resynchronization therapy (CRT) undergoing propofol sedation for electrophysiology (EP) investigation, transesophageal echocardiography (TEE), electrocardioversion (ECV), or bronchoscopy were included prospectively. Pacing thresholds, impedance, and sensing were assessed by device interrogation immediately prior to sedation and after the desired sedation depth was achieved by the administration of propofol. RESULTS: Mean atrial (0.68 V vs 0.77 V, p = 0.136) and mean right ventricular thresholds (0.90 V vs 0.93 V, p = 0.274) remained unchanged. Impedances and sensing remained unaffected in all patients. CONCLUSIONS: Propofol sedation did not affect pacing thresholds of atrial and right ventricular leads in this cohort of PM and ICD patients.