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.

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.

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.

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.

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.

A systematic review and meta-analysis of the cerebrovascular event incidence after transcatheter aortic valve implantation.

OBJECTIVE: Periinterventional stroke is one of the most feared potential complication, among patients treated with transcatheter aortic valve implantation (TAVI). The purpose of this review was to investigate the incidence of cerebrovascular events and the influence of postinterventional neurologic check-up in patients undergoing TAVI. METHODS: A systematic review and meta-analysis were conducted according to the PRISMA guideline. Three separate electronic searches of the public domains Medline and Clinicaltrials.gov were performed to identify the 30-day incidence of stroke within randomized controlled trials (RCTs) and registries for patients undergoing a TAVI procedure. A meta-analysis was conducted to evaluate the 30-day incidence of stroke within RCTs. Furthermore, we pooled the RCTs in which a scheduled neurological check-up was conducted or not to investigate the effect of this intervention. RESULTS: Twenty-three studies including 399,491 TAVI patients were included, 6370 from RCTs, 833 from cerebral-embolic protection device RCTs and 392,288 were adopted from registries. The mean 30-day incidence of stroke among all reviewed studies was 2.33%. In RCTs evaluating TAVI the pooled stroke incidence was 3.86%, among RCTs focused CEP the incidence was 6.36% and in registries the incidence was 2.29%. Ten RCTs conducted scheduled neurological check-ups, the incidence in these was 4.03% and among the remaining RCTs it was 2.47%. In the meta-analysis, the pooled 30-day stroke incidence was 3.61% (95% CI 2.57-4.79%). CONCLUSION: This systematic review demonstrates that the stroke incidences following TAVI differ strongly according to the study design and neurological follow-up. Intense neurological testing increases the incidence of a stroke after TAVI.

Real-world anticoagulatory treatment after percutaneous mitral valve repair using MitraClip: a retrospective, observational study on 1300 patients.

AIMS: This study sought to investigate current anticoagulatory treatment patterns and clinical outcome in patients undergoing transcatheter mitral valve repair (MitraClip). METHODS AND RESULTS: In a retrospective study of a German claims database (InGef research database), anticoagulatory treatment regimens were assessed using any drug prescription post discharge within the first 90 days after MitraClip procedure. Clinical events between 30 days and 6 months were examined by treatment regime. The study population comprised 1342 patients undergoing MitraClip procedure between 2014 and 2018. 22.4% received antiplatelet monotherapy, 20.8% oral anticoagulation (OAC) plus antiplatelet therapy, 19.4% OAC monotherapy, 11.7% dual antiplatelet therapy, 2.8% triple therapy and 21.0% did not receive any anticoagulatory drugs. 63% of patients with OAC received non-vitamin-K antagonist oral anticoagulants (NOAC). A total of 168 patients were newly prescribed OAC after MitraClip, of whom 12 patients (7.1%) had no diagnosis of atrial fibrillation or venous thromboembolism. 40% of patients with OAC prior to MitraClip did not have any OAC after MitraClip. The adjusted risk of all-cause mortality was significantly increased in patients with no anticoagulatory treatment (HR 3.84, 95% CI 2.33-6.33, p < 0.0001) when compared to antiplatelet monotherapy whereas the other regimes were not significantly different. CONCLUSIONS: This large real-world data analysis demonstrates a heterogeneous spectrum of prescriptions for anticoagulant therapies after MitraClip. Considering relevant differences in clinical outcome across treatment groups, major effort is warranted for controlled trials in order to establish evidence-based recommendations on anticoagulatory treatment after percutaneous mitral valve repair.