bluuebunny/crossref_metadata_2025_split huggingface dataset:
Insertion procedure assessment, sensing and detection performance of a novel miniaturized implantable cardiac monitor with a long sensing vector
Authors: Reinsch N , Fueting A , Hoewel D , Neven K 
Published: May 2022

Abstract

Funding Acknowledgements
Type of funding sources: Private grant(s) and/or Sponsorship. Main funding source(s): unrestricted grant by Biotronik

Background
The Biotronik BioMonitor III (BM III) is a novel implantable cardiac monitor (ICM) with a miniaturized profile, long sensing vector and simplified implantation technique.

Objective
We assessed insertion procedure, reliability of sensing quality and detection performance of the BM III.

Methods
The ICM was implanted in the left parasternal region between the suprasternal notch and the nipple, preferentially at a 45° angle to the sternum. R-wave amplitude was recorded immediately post implantation and at day 1. Follow-up was after 3 months or an event. All episodes, R-wave amplitude and noise burden were documented. The anatomical ICM position was determined at day 1 and after 3 months. A patient questionnaire on pain after implantation, prolonged paresthesia, restriction of daily activity, handling of the HomeMonitoring system and overall satisfaction was conducted after 3 months.

Results
In 30 patients (age 67 years, 40% male) a BM III was successfully inserted, without complications. Indications were: unexplained syncope (80%), suspected AF (3%) and cryptogenic stroke (17%). Median implantation time was 6 min. Mean R-wave amplitude was 0.73 mV at insertion, 0.77 mV at day 1 (p=0.59) and 0.81 mV after 107 days (p=0.39). At day 1 and at follow-up visit, an anatomically stable device position was demonstrated. Vertical distance from fossa jugularis to the lowest part of the ICM was 14.5 cm at implantation and 14.5 cm at follow-up (p=0.94). The horizontal cranial sternal-to-device distance was 4.4 cm and 4.3 cm at follow-up (p=0.87). The horizontal caudal sternal-to-device distance was 6.0 cm and 5.7 cm at follow-up (p=0.7). Median time to first event was 12 days. In 13 (43%) patients, true episodes were detected. False arrhythmia alerts were detected in 12 (40%) patients, in 7/12 false AF alerts due to recurrent premature atrial contractions (PAC) were recorded. Total number of false detections was low. Patient-satisfaction rate was high, with very few limitations in daily activity.

Conclusion
Insertion of the novel Biotronik BioMonitor III ICM is fast, uncomplicated and keeps an anatomically stable position of the device over time. Initial sensing values are good and remain stable over time. False arrhythmia alert, mainly due to PACs, occurred in 40% of patients, with a low total number of false detections.
Circulating adipokines involved in atrial fibrillation and obesity: a comprehensive scoping review
Authors: Meulendijks E , Krul SPJ , Baalman SW , Wesselink R , Al-Shama RF , Ernault CCE , Limpens J , Kawasaki M , Vries TAC , Neefs J , De Groot JR 
Published: May 2022

Abstract

Funding Acknowledgements
Type of funding sources: Private company. Main funding source(s): Received research grants (through institution) from Atricure Inc, Bayer, Boston Scientific, Daiichi Sankyo, Johnson&Johnson, Medtronic Received honoraria/speaker/consultancy fees from Abbott, AtriaN Medical, Atricure Inc, Bayer, Biotronik, CVOI, Daiichi Sankyo, IPP Med, Itreas, Medtronic, Novartis, Servier

Background
Obesity increases the risk of atrial fibrillation (AF). Obesity may induce or facilitate AF via adipokines, proteins secreted by metabolically active adipose tissue (AT). These adipokines potentially affect atrial electrical and structural remodeling. Therefore, adipokines could be targets in the management of AF.

Purpose
Here, we aim to give a comprehensive overview of circulating adipokines, defined as proteins expressed in adipose tissue, associated with pre-existing or new-onset AF as well as their relationship with obesity.

Methods
A systematic, explorative primary search was conducted for studies reporting corrected odds and hazard ratios (ORs, HRs) of adipokines in pre-existing AF, and in new-onset AF. Adipokine-ratios were aggregated into processes involved in AF substrate formation. Next, a secondary search was performed to investigate the association between the identified adipokines and obesity.

Results
Sixty-three distinct adipokines were identified, 49 in pre-existing AF (78 corrected ORs), and 34 in new-onset AF (76 corrected HRs). These included adipocyte specific adipokines as FABP4, and adipokines expressed by both adipocytes and other cells residing in the fat, as interleukin 6 (IL-6). The majority of identified adipokines were involved in inflammatory and fibrotic pathways. Most inflammatory adipokines were significantly increased in pre-existing AF (20/33ORs), and half in new-onset AF (14/28 HRs). Approximately half of the fibrotic adipokines were increased in pre-existing AF (12/25 ORs) and in new-onset AF (8/17 HRs). The secondary search showed that in obesity, most (33) of the 63 identified adipokines in AF were increased, including IL-6. Twenty-four were not affected, and 6 were decreased. Candidate pro-arrhythmogenic inflammatory, and fibrotic adipokines increased in both AF and obesity are shown in the figure.

Conclusion
Most pro-inflammatory and fibrotic circulating adipokines, associated with AF pathology, were either increased or showed a strong trend towards increased levels in both pre-existing and new-onset AF, as well as in obesity. Our review provides insight into the effect of obesity on circulating adipokines involved in AF substrate formation.
Dipole charge density mapping integrated in robotic ablation: first-in-human experience
Authors: Gagyi R , Noten AME , Wijchers S , Yap SC , Bhagwandien R , Hoogendijk M , Szili-Torok T 
Published: May 2022

Abstract

Funding Acknowledgements
Type of funding sources: None.

Background
Remote magnetic navigation (RMN) provides increased precision and catheter stability. Its atraumatic catheter design has a superior safety profile. Formerly, only the CARTO 3D mapping system was integrated in the RMN system. Recently, a novel high-resolution non-contact mapping system (AcQMap) can be used in combination with RMN robotics (AcQMap-RMN).

Purpose
To assess safety, efficiency and efficacy of dipole charge density mapping in RMN guided catheter ablation (CA) procedures.

Methods
All CA procedures using the AcQMap-RMN system were analyzed in 147 consecutive patients. Procedural efficiency was characterized by procedure time, total ablation time, radiation times and doses. Acute success was defined by arrhythmia source elimination. Efficacy data are based on 12-month follow up and number of redo procedures. Procedural safety was evaluated by intra- and post-procedural complications.

Results
Seventy-one out of 147 patients had atrial fibrillation (AF) (24 PAF, 47 persAF). Five AF patients underwent re-isolation-only procedure, 42 patients had AcQMap based substrate ablation, and the remaining 24 patients converted to atrial tachycardia/atrial flutter (AT/AFL) during ablation. Seventy-six patients were referred for supraventricular tachycardia, including 8 patients with perinodal AT, 3 patients with inappropriate sinus tachycardia and 65 patients with AT/AFL. Thirty-eight patients were mapped with de novo, 22 with post-PVI, and 5 with post-MAZE AT/AFL. The mean procedure time was 167.6±56.5 min, mean ablation time 1228.0 (IQR 562.2-2007.2) s, mean radiation time 21.5±9.6 min, and dose was 160.0(IQR 102.0-302.0) mGy. Acute success was achieved in 137 procedures (93.1%). Twenty-three patients with PAF (95.8%), and 34 patients with persAF (72.3%) were AF-free at the end of the follow-up period. Four de novo AT/AFL patients (10.5%) and 3 post-PVI/post-MAZE AT/AFL patients (11.1%) had documented recurrence at the end of the follow-up period. Nine patients were referred for redo procedures. Minor complications were reported in 5 patients (4 groin hematomas and 1 transient ischemic attack).

Conclusion
AcQMap-RMN integration provides high acute and long-term success rates, without negative impact on the safety profile. It allows mapping of a broad spectrum of arrhythmias.
UK multi-centre retrospective study of the learning curve and relative performance of the rhythmia high density mapping system for atrial ablation
Authors: Bates A , Naseer MZ , Taylor M , Denham N , Yue A , Das M , Morris GM , Ullah W 
Published: May 2022

Abstract

Funding Acknowledgements
Type of funding sources: Public hospital(s). Main funding source(s): University Hospital Southampton

Background
Rhythmia HDx® is a novel ultra-high density electroanatomical mapping system using an innovative 64 electrode basket catheter. A learning curve is a recognised phenomenon for any new technology and was examined in this study.

Purpose
Comparison of performance, long-term success, and complications using Rhythmia for atrial ablation in the UK.

Methods
Retrospective data collection from three centres across the UK from the introduction of Rhythmia. Patients were matched with controls who had undergone ablation using the well-established Carto3 mapping system. Assessed were: fluoroscopy, radiofrequency ablation and procedure times; acute and long term success, and complications.

Results
253 study patients with 253 controls were included. Significant correlations existed between procedural efficiency metrics and centre experience for de novo atrial fibrillation (AF) ablation (procedure time, Spearman’s ρ = -0.624; ablation time, ρ = -0.795), and de novo atrial flutter (AFlut) ablation (ablation time, ρ = -0.566; fluoroscopy time, ρ = -0.520). No such correlations existed for redo AF, redo AFlut, de novo atrial tachycardia (AT), or redo AT cases. For de novo AF and AFlut, procedural efficiency metrics were significantly improved after 10 procedures in each centre, (procedure time [AF only, p = 0.001], ablation time [AF, p &lt; 0.0005; AFlut p &lt; 0.0005] and fluoroscopy time [AFlut only, p = 0.0022]), and became comparable to controls (Figures 1 and 2). Acute success and long-term success did not see significant improvement with experience but were comparable to the control group. There was no relationship between experience and complications, which were comparable to Carto3 (3.6% in both groups).

Conclusion
A short learning curve exists with the use of Rhythmia HDx for standardised procedures (de novo AF / AFlut). Procedural performance improves and becomes comparable to Carto3 following 10 cases at each centre. Clinical outcomes at 6 and 12 months, and complications are not affected by this learning curve and remain comparable with controls.
Acute results of a novel flexible tip radiofrequency catheter incorporating contact force sensing
Authors: Nair D , Martinek M , Colley J , Sundaram S , Sharma S , Morales G , Sommer P , Healy S , Siddiqui U , Williams C , Sarver A , Lo M 
Published: May 2022

Abstract

Funding Acknowledgements
Type of funding sources: Private company. Main funding source(s): Abbott

Background
Catheter ablation is an established therapy for paroxysmal atrial fibrillation (PAF). The TactiFlex Ablation Catheter, Sensor-Enabled (TactiFlex SE) is a next-generation radiofrequency ablation catheter incorporating highly accurate fiber optics-based contact force sensing technology with a flexible, laser-cut tip. This is the first report of results from the TactiFlex IDE clinical study.

Purpose
To demonstrate that ablation with TactiFlex SE is safe and effective for the treatment of drug refractory, symptomatic PAF.

Methods
The TactiFlex IDE (NCT04356040) is a prospective, non-randomized, multi-center clinical study which enrolled 305 subjects worldwide in the main study. Enrollment in the main study began on June 26, 2020 and completed on June 8, 2021. Subjects underwent de novo Pulmonary Vein Isolation (PVI) and, if indicated, a Cavotricuspid Isthmus ablation (CTI line) for CTI-dependent atrial flutter.

Results
Acute procedural success was achieved in 98.6% (274/278) of the main study cohort who underwent an ablation procedure using the TactiFlex SE. First pass success, defined as isolation of all pulmonary veins (PVs) confirmed after a minimum 20 min waiting period was achieved in 89.6% (249/278) of subjects. This was a significant improvement versus the TactiSense IDE trial (TactiCath Ablation Catheter, Sensor-Enabled). Significant decreases were also seen in total procedure time (123 min [101.0, 163.5]), total PV ablation time (55.5 min [35.0, 81.0]), total fluoroscopy time (6.0 min [0.0, 13.0]) and irrigation fluid volume (450.0 mL [346.0, 636.0]) (values given as Median [Q1, Q3]), see FIGURE. All subjects have completed at least 90 days of follow-up. Only 2.6% (7/271) of subjects required a repeat procedure during the 90-day blanking period. The primary safety and effectiveness endpoints will be evaluated at 12-months. At 90 days, 4.3% (12/281) subjects had experienced a primary safety endpoint event.

Conclusions
The acute data from the TactiFlex IDE clinical study demonstrate safety and effectiveness of the TactiFlex SE catheter in the treatment of PAF. Ablation procedures performed using the next-generation TactiFlex SE catheter were shorter and had improved acute clinical effectiveness outcomes versus the TactiSense IDE. It is anticipated these results will also be reflected in the 12-month safety and effectiveness endpoints.
Biophysical parameters and time to isolation of pulmonary veins with a novel cryoballoon: results of POLAR ICE study
Authors: Martin C , Tilz RR , Anic A , Defaye P , Luik A , Asmundis C , Champ-Rigot L , Iacopino S , Sommer P , Albrecht E , Raybuck JD , Wehrenberg S , Cielen N , Yap SC 
Published: May 2022

Abstract

Funding Acknowledgements
Type of funding sources: Private company. Main funding source(s): Boston Scientific

Introduction
Low nadir temperatures and long thaw times with cryoballoon ablation are associated with successful pulmonary vein isolation (PVI). Recently, a system that maintains uniform pressure and size has been introduced to improve catheter stability during cryoballoon ablation. The present results examine the relationship between cryoballoon time to isolation (TTI) and other biophysical parameters; time to -40ºC (TT-40), nadir temperature, time to thaw (TT0), and first pass isolation success in patients with paroxysmal AF (PAF).

Methods
POLAR ICE, a prospective, non-randomized, multicenter (international) registry (NCT04250714), enrolled 400 patients across 19 centers, between Aug 2020 and May 2021. This study included any patients indicated for treatment of PAF with the POLARx cryoablation system. Cryodosing regimen was left to the operator and not specified by study protocol. Procedural characteristics, such as time to isolation (TTI), cryoablations per pulmonary vein, nadir temperature, and occlusion grade were recorded. PVI was confirmed via entrance block. Biophysical parameters for ablations longer than 120s were evaluated.

Results
Data on 389 PVI procedures (n=2303 ablations) were collected. Of those ablations, 1914 (83%) had a duration of at least 120s and were included in this analysis. Isolation was attempted using the CB alone. TTI was reported in 1335 ablations with the majority (64%) occurring within 60s. Biophysical parameters and single shot success rates were examined based on TTI. Ablations with TTI&lt;60s had significantly faster TT-40 (30.6±7.4s), lower nadir temperatures (-58.3±5.8ºC), longer thaw times (21.1±6.7s), and a greater proportion of grade 4 occlusions (88%) than longer TTIs or ablation with no TTI reported (Table 1). In TTIs&lt;60s single shot success was 95%, significantly greater than TT≥60s, or No TTI. Procedure-related complications included: phrenic nerve palsy (0.5%), tamponade (0.5%), AV block (0.3%), stroke (0.3%), and transient ischemic attack (0.3%).

Conclusions
These data suggest a correlation between cryoballoon biophysical parameters and single shot success. Good occlusion likely drives faster freeze and lower nadir temperatures, resulting in longer thaw times with this novel cryoballoon. Future research should examine the relationship between these parameters to drive optimization of cryoablation techniques and provide guidance toward improved workflow.
Benefit of sleep study in all patients with atrial fibrillation and BMI&gt; 28,0 Kg/m2 before catheter ablation
Authors: Antunes Coelho R , Parreira L , Farinha J , Esteves A , Pinheiro A , Ferreira J , Quintal J , Amador P , Marinheiro R , Mesquita D , Caria R 
Published: May 2022

Abstract

Funding Acknowledgements
Type of funding sources: None. Main funding source(s): None

Background
Sleep apnea is a known risk factor for atrial fibrillation recurrence after catheter ablation. Despite this, in recent atrial fibrillation guidelines, it is unclear in which patients to test sleep apnea before catheter ablation.

Purpose
Evaluate if body mass index (BMI) has a good discriminative power to predict sleep apnea in patients with atrial fibrillation proposed to catheter ablation.

Methods
We retrospectively studied 160 consecutive patients undergoing catheter ablation of paroxysmal or persistent atrial fibrillation in our institution. We evaluated recurrence of atrial fibrillation after catheter ablation and analysed diagnosis of sleep apnea, body mass index, treatment with CPAP, echocardiographic findings (indexed volume of left atrium and left ventricular ejection fraction), cardiovascular risk factors and other comorbidities and clinical characteristics. Receiver operator characteristics (ROC) curve and area under the curve (AUC) were obtained to determine the discriminative power of body mass index as predictor of sleep apnea. Optimal cut-point value was obtained (Youden index) and patients were divided according to this value.

Results
During a mean follow-up time of 22,8 ± 19,9 months, 46 patients (28,8%) had atrial fibrillation recurrence and none died. The recurrence was associated with hypertension, alcohol habits and untreated sleep apnea (HR 3,74; 95% CI 1,89-7,42; p &lt;0,001). Optimal cut-point value for predicting sleep apnea in patients with atrial fibrillation proposed to catheter ablation was BMI of 28,0 Kg/m2 (AUC 0,733, p = 0,001, 95% CI 0,640-0,827). The group of patients with BMI of 28,0 Kg/m2 had a 4-fold increased risk of sleep apnea (OR 3,95, 95% CI 1,85-8,42, p =0,001) and 2-fold risk of atrial fibrillation recurrence (HR 1,96; 95% CI 1,10-3,51; p = 0,023).

Conclusions
In this group of patients undergoing catheter ablation of atrial fibrillation, a BMI ≥ 28,0 Kg/m2 was independent predictor of sleep apnea and recurrence of atrial fibrillation after catheter ablation. In patients with atrial fibrillation proposed to catheter ablation and BMI ≥ 28,0 Kg/m2 is reasonable to do a sleep study before catheter ablation.
Ambulatory pulmonary vein isolation workflow using suture-mediated vascular closure devices: a prospective observational cohort study
Authors: Fabbricatore D , Mileva N , Valeriano C , Buytaert D , Paolisso P , Paolisso P , Geelen P , Geelen P , De Potter T 
Published: May 2022

Abstract

Funding Acknowledgements
Type of funding sources: Private grant(s) and/or Sponsorship. Main funding source(s): Cardiovascular Abbott D. Fabbricatore is supported by a research grant from the CardioPaTh PhD Program

Background
Pulmonary vein isolation (PVI) for the treatment of atrial fibrillation (AF) is an increasingly performed procedure worldwide, presenting an attractive opportunity for performing it in a day care setting.[1] The main reason for delayed discharge are the potential vascular complications that may occur.[2–5] There is still a lack of knowledge considering the usage of vascular closure devices in the electrophysiological field.

Purpose
The aim of the study was to evaluate feasibility, safety, and efficacy of a suture-mediated vascular closure device in ambulatory management after PVI.

Methods
Prospective single-centre cohort study on 50 patients admitted for PVI from January 2020 to May 2021. At the end of the procedure, a suture-mediated vascular closure system was used for each vascular access. The feasibility of an ambulatory PVI strategy was assessed as the percentage of patients being able to be discharged the same day of the procedure. Outcomes were defined as acute rate of vascular device closure performance, postprocedural time to haemostasis, time to ambulation and time to discharge. Vascular complications, analysed on the total number of patients enrolled, were assessed during the 30-days follow-up.

Results
A total of 48/50 (96%) patients were discharged at the same day of the procedure. Haemostasis was reached within 1 minute after the deployment of the device in 30 patients (60%). During the post-operative stay, two patients had minor bleeding without necessity of intervention and one patient was kept in supine position until an ultrasound evaluation resulted negative. Mean and median time to be deemed suitable for discharge in the 48 patients who reached the primary endpoint were 4:55 (±00:54) and 4:48 (2:50-7:30) hours respectively. Mean and median time to discharge were 5:48 (± 1:03) and 5:51 (3:38-7:57) hours respectively. Patient satisfaction was queried and resulted excellent. No major vascular complications were observed during 30-days follow up. Minor complications occurred in 4 patients and were three minor superficial haematomas (&lt;6 cm) and one transient access site related nerve injury.

Conclusion
The use of a closure device for femoral venous accesses after PVI led to a safe discharge of patients within 6 hours from the intervention in 96% of the population. The ambulatory management described in the abstract could be useful for minimizing the overcrowding of healthcare facilities and reduce the post-operative recovery time and management. Additionally, patients were satisfied with the treatment received. Randomised trials are needed for further evaluate the efficacy of this approach.