bluuebunny/crossref_metadata_2025 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

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

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

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

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 < 0.0005; AFlut p < 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

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

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<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<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> 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

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 <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

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 (<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.
Influence of atrial cycle length and site of origin on the peak frequency of bipolar electrograms to discriminate isthmus conduction in atrial scar
Authors: Merino JL , Kim S , Relan J , Sanroman M , Castrejon S , Carton A , Cervantes C , Martinez Cossiani M , De La Vieja Alarcon JJ , Molina P , Rivero Santana B
Published: May 2022

Funding Acknowledgements

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

Background

Peak frequency (PF) of conventional bipolar electrograms is a novel parameter which may distinguish between near-field (NF) and far-field (FF) signals. However, the influence of activation rate and the direction of the activation front on it is unknown.

Purpose

1. To study the influence of atrial cycle length and wavefront origin on PF to detect residual conduction in a well-defined model of narrow isthmus of conduction such as subacute pulmonary vein (PV) reconnection following atrial fibrillation ablation. 2. To compare this influence with that found for Bipolar voltage (BiV).

Methods

Baseline maps were acquired in redo PV isolation (PVI) procedures with a 16-pole grid catheter (HD-Grid) during low rate sinus rhythm (SR), low rate coronary sinus pacing at 500 ms cycle length (CSLR) and high rate coronary sinus pacing at 300 ms cycle length (CSHR). PFs were retrospectively computed. PVI sites requiring ≤3 radiofrequency applications were included, with EGMʼs ≤1cm from the PVI site classified as GAP (vs >1cm, No-GAP).

Results

28 GAPs were found in 12 of 14 consecutive patients in the study. 3976 EGMʼs (1547 GAP vs 2429 No-GAP) were analyzed. In both GAP and No-GAP, PF was similar in SR vs CSLR (GAP: 363±132 Hz -SR vs 345±135 Hz -CSLR, P=NS ; No-GAP: 196±110 Hz -SR vs 181±116 Hz -CSLR, P=NS). PF was slightly higher for CSLR vs CSHR. (GAP: 345±135 Hz -CSLR vs 317±154 Hz -CSHR, P<0.001; No-GAP 181±116 mV -CSLR vs 162±129 mV -CSHR, P<0.01). (Panel A). BiV was significantly higher in SR vs CS pacing but similar between CSLR and CSHR (GAP: 1.86±2.11 mV -SR vs 0.87±1.19 mV -CSLR vs 0.74±0.92 mV -CSHR, P= NS, No-GAP: 0.62±1.22 mV -SR vs 0.33±0.68 mV - CSLR vs 0.27±0.48 mV - CSHR, P=NS. (Panel B). ROC GAP discrimination for PF was similar between SR and CSLR (AUCʼs: 0.86-SR, 0.84-CSLR) and slightly lower for CSHR (AUC: 0.81) with optimal cutoffs of 260, 240 and 220 Hz, respectively. ROC GAP discrimination for BiV was lower vs PF in all rhythm modes (AUCʼs: 0.77-SR, 0.74-CSLR, 0.75-CSHR), with optimal cutoffs of 0.3, 0.2 and 0.15 mV, respectively.

Conclusion

ROC gap discrimination was significantly higher for all rhythm modes with PF vs BiV. PF showed slightly decreasing cutoff values for SR, CSLR and CSHR respectively, whereas BiV showed a greater relative decrease in cutoffs for SR, CSLR and CSHR.
Comparison of safety and efficacy between POLARx and Arctic Front cryoballoon ablation
Authors: Rehman M , Adiyaman A , Smit JJJ , Manfai B , Elvan A
Published: May 2022

Funding Acknowledgements

Type of funding sources: None.

Introduction

Pulmonary vein isolation (PVI) remains the cornerstone of atrial fibrillation (AF) ablation. The POLARx cryoballoon, which maintains a constant balloon pressure during ablation, was recently introduced for the treatment of AF. We present a comparison of acute and follow-up efficacy and safety outcomes between POLARx and Arctic Front, a frequently used second-generation used cryoballoon.

Methods

251 consecutive patients who underwent first-time cryoballoon AF ablation with POLARx (n=118) or Arctic Front (n=133) with a follow-up of at least 6 months, were retrospectively included.

Results

Of the total 251 patients who were included, mean age was 63 ± 9 years and 161 (64%) participants were male. The majority of the patients suffered from paroxysmal atrial fibrillation (95%). Follow-up success rates did not significantly differ between the POLARx (79%) and Artic Front (75%) groups at 6 months. Antiarrhythmic drug-use after the blanking period of 3 months was 9% for the POLARx group. Complication rates, excluding groin complications, were low in both study groups and were not significantly different (4% in POLARx vs 3% in Arctic Front). Procedure times (71 ± 23 minutes vs. 120 ± 36 minutes) and fluoroscopy times (20 ± 10 minutes vs. 33 ± 18 minutes) were both more favourable in the POLARx group. Lastly, nadir balloon temperatures were significantly lower (-57 ± 7 ºC vs -51 ± 7 ºC) for the POLARx group for all pulmonary veins (p<0.001).

Conclusion

Cryoballoon AF ablation with the POLARx cryoballoon results in similar success and complication rates at 6 months, in comparison with Arctic Front. Procedure and fluoroscopy times are shorter and balloon nadir temperatures are significantly lower for the POLARx cryoballoon. This can lead to optimal logistics and thus cost-effective use of lab and personnel.
Pre-clinical evaluation of a third generation absorbable antibacterial envelope
Authors: Christie M , Love C , Hanna I , Thomas G , Greenspon A , Chen S , Sanders M , Bauer C , Christopherson M , Balaji V , Skulsky S , Sohail M
Published: May 2022

Funding Acknowledgements

Type of funding sources: Private company. Main funding source(s): Medtronic

Background

An absorbable antibacterial envelope (TYRX), which stabilizes cardiac implantable electronic devices (CIEDs) was shown to significantly reduce infections in a large randomized controlled trial (WRAP-IT). A 3rd generation envelope (T3) is being developed to improve the implanter experience and enable smoother device insertion with a redesigned, multifilament mesh, an enhanced form factor, and identical polymer coating and antibiotic concentrations as the currently available 2nd generation envelope (T2).

Purpose

To compare drug elution profiles of T3 vs T2 and evaluate the efficacy of T3 against bacteria commonly known to be associated with CIED infections.

Methods

The T3 drug elution profile was assessed in vitro by evaluating the amount of each drug, minocycline and rifampin, released at a given timepoint using an accelerated dissolution method. For comparative analysis with T2, elution curve equivalency was based on similarity factor values (f2) of ≥50 per FDA guidance. An in vivo elution study was also conducted (per the Principles of Laboratory Animal Care [NIH Publication no. 85-23 revised 1985]) to ensure drug concentrations met the minimal inhibitory concentration (MIC) through 7 days. Substantial equivalence was defined as rifampin and minocycline concentrations above MIC at 2hr post-implant and sustained through 7 days. In a further animal model, 12 pockets were created in 6 rabbits, for CIED insertion with and without T3 envelopes, to evaluate efficacy against gram+ and gram- bacteria. At day 7, implant sites were evaluated for signs of infection via macroscopic observations and microbial recovery procedures. A Fisher’s Exact Test was used for comparisons.

Results

The T3 envelope showed a similar elution profile to T2 in vitro (Figure) with f2 >50 (range 76-84). In the in vivo assessment, the T3 envelope eluted both antibiotics above the MIC at 2hr post-implant with sustained elution through 7 days, consistent with historical T2 performance. Further bacterial challenge studies in vivo showed a statistically significant reduction (p<0.05) in infections with 0/6 infected pockets in the CIED + T3 group vs 6/6 infected pockets in the CIED only group consistent with T2 performance (Table).

Conclusion

The 3rd generation absorbable antibacterial envelope demonstrated equivalent pre-clinical performance compared to the 2nd generation envelope as antibiotic elution curves were equivalent, elution was sustained at concentrations above MIC for 7 days, and infection rates were significantly reduced compared to no envelope. These results suggest equivalent clinical performance could be expected with the newly designed envelope.
Endurance training increases the risk of atrial fibrillation in women: a matched-cohort study
Authors: Drca N , Larsson SC , Jensen-Urstad M
Published: May 2022

Funding Acknowledgements

Type of funding sources: Foundation. Main funding source(s): This work was supported by research grants from Kvinnor och Hälsa and The Swedish Research Council for Sport Science (to Nikola Drca).

Objective

Previous studies have found that vigorous physical activity, mainly related to endurance sport participation, increases the risk of atrial fibrillation (AF) in men. However, it remains unclear whether vigorous physical activity also influences the risk of AF in women. We aimed to examine whether endurance sport participation may affect AF risk in women.

Methods

We conducted a matched-cohort study of top Swedish female endurance athletes (n=228 marathon runners, cyclist, and 10 000-meters track runners) active between 1979-1991 and reference individuals (n=1 368) from the general population individually matched by sex, year of birth, and area of living with a 6:1 ratio to the female athletes. The athlete cohort was created by combining all Swedish women who ran the Stockholm Marathon faster than 3.25 hours in any of the races between 1979 and 1991 with all Swedish women competing in the Swedish athletic national championship in 10 000-meter track running and the top-ranked Swedish bicyclist during the same period. Participants were followed up from study entry until AF diagnosis, death, emigration, or December 31, 2017, whichever occurred first. We used the Swedish National Patient Register to determine whether the participants were diagnosed with AF and other covariables. Cox proportional hazards regression models were used for analysis.

Results

Baseline characteristics are presented in Table 1. Mean age at study entry was 32 (SD ± 8.5) years. During follow-up (mean 28.8 years; SD ± 4.4), 33 cases of AF were diagnosed, including 10 (4.4%) among athletes and 23 (1.7%) among references. Endurance training was associated with an increased AF risk (Figure 1). The hazard ratio for female athletes compared with the reference population was 2.56 (95% confidence interval 1.22 to 5.37) in the univariable model and 3.67 (95% confidence interval 1.71 to 7.87) after adjustment for hypertension.

Conclusion

High level of endurance sport training is associated with an increased risk of AF in women.
Advanced vascular aging in patients with paroxysmal atrial fibrillation - Data from RACE V
Authors: Weberndoerfer V , Van De Lande ME , Artola Arita VA , Nguyen BO , Elvan A , Hemels MEW , Tieleman RG , De Melis M , Mihl C , Schotten U , Van Gelder IC , Rienstra M , Linz D , Crijns HJGM , Kroon AA
Published: May 2022

Funding Acknowledgements

Type of funding sources: Foundation. Main funding source(s): Dutch Heart Foundation, Medtronic

Background

The incidence of atrial fibrillation (AF) increases exponentially with age. To which extend vascular aging is part of this process is unknown. Pulse wave velocity and carotid intima-media thickness are established markers for vascular aging and have been combined in a vascular aging index as published before(1).

Purpose

We aim to investigate if vascular age exceeds chronological age in our cohort with paroxysmal AF and if yes to which extend.

Methods

In this substudy from RACE V we included 295 patients with paroxysmal AF in which carotid-femoral pulse wave velocity (cfPWV) and carotid intima-media thickness (IMT) were measured. To calculate vascular aging we used a logarithmic formula derived from the Malmö-Cancer-and-Diet study which yields a vascular age index derived from cfPWV, cIMT and chronological age. This vascular aging index (VAI) is a strong predictor of cardiovascular events. (1). All patients underwent cardiac echocardiography and had a native cardiac CT scan in which fat around the heart and coronary calcium were quantified. In 121 patients Agatston scores from the ascending aortic artery were also measured.

Results

Patients in this study had a mean chronological age of 63.8 ± 10.1 years and a vascular age of 71.4 ± 11.7 years. Vascular age was on average 9.3 ± 10.2 years higher than chronological age. Vascular age correlated significantly with markers for diastolic dysfunction, vascular calcification in the coronary arteries as well as the aorta and the amount of epicardial and pericardial fat (table 1).

Conclusions

In patients with PAF vascular age was on average 9.3 years higher than chronological age in our cohort. Advanced vascular age is represented by vascular and myocardial remodeling related to fibrosis, calcification and fat accumulation. The results suggest that in patients with AF enhanced inflammation is leading to fibrosis and calcification. Whether AF is a marker, a mechanism or both in advanced vascular aging warrants further study.
Prognostic impact of vascular disease in patients with atrial fibrillation: Insights from The Loire Valley Atrial Fibrillation Project
Authors: Fawzy AM , Langouet Q , Bisson A , Bodin A , Lip GYH , Fauchier L
Published: May 2022

Funding Acknowledgements

Type of funding sources: None.

Background

Vascular disease which comprises peripheral artery disease, significant coronary artery disease and aortic disease is associated with both an increased risk of atrial fibrillation (AF) and ischaemic stroke in AF patients.

Purpose

We investigated the effect of vascular disease on the prognosis of AF patients.

Methods

In this retrospective analysis, all patients with AF were identified and classified into 2 groups depending on the presence of vascular disease. 3 patients were excluded due to missing data. Primary outcome was a composite of death, stroke and thromboembolic events. Secondary outcomes included all-cause mortality, stroke or systemic embolism (SSE), ischaemic stroke, haemorrhagic stroke and major bleeding.

Results

A total of 8962 patients were included; 3021 with vascular disease and 5941 without vascular disease and followed up over a mean period of 929±1082 days. On the univariate analysis, patients with vascular disease were at a higher risk of all-cause mortality hazard ratio (HR) 1.728 ((confidence interval (CI)1.549-1.928), SSE HR HR 1.477 (CI 1.274-1.714), ischaemic stroke HR 1.441 (CI 1.202-1.727), major bleeding HR 1.488 (CI 1.292-1.713) and a composite of death and SSE HR 1.643 (CI 1.489-1.812), compared to patients without vascular disease. On a multivariate analysis, after adjusting for components of the CHA2DS2VASc score, oral anticoagulation (warfarin) use and antiplatelet use, the increased risk of all-cause mortality HR 1.460 (CI 1.285-1.658), SSE HR 1.226 (CI 1.030-1.458) and major bleeding HR 1.186 (CI 1.005-1.400) remained statistically significant, but the risk of ischaemic stroke was no longer significant, HR 1.187 (CI 0.960-1.469). Compared to those without vascular disease, patients with vascular disease were at a lower risk of haemorrhagic strokes but this was not significant.

Conclusion

AF patients with vascular disease are at a higher risk of all-cause mortality, SSE and major bleeding compared to patients without vascular disease, indicating that patients with this combination require careful and holistic management in terms of risk factor control and treatment. Additional research is required to further characterise the relationship between the two.
Electrocardiographic parameters and the risk of new-onset atrial fibrillation in the general population
Authors: Geurts S , Tilly MJ , Kors JA , Deckers JW , Stricker BHC , De Groot NMS , Ikram MA , Kavousi M
Published: May 2022

Funding Acknowledgements

Type of funding sources: Public Institution(s). Main funding source(s): The Rotterdam Study is funded by Erasmus Medical Center and Erasmus University, Rotterdam, Netherlands Organization for the Health Research and Development (ZonMw), the Research Institute for Diseases in the Elderly (RIDE), the Ministry of Education, Culture and Science, the Ministry for Health, Welfare and Sports, the European Commission (DG XII), and the Municipality of Rotterdam. This study is further supported by the Senior Scientist Grant from Dutch Heart Foundation (03-004-2021-T050).

Background

The (shape of the) association and sex-differences between electrocardiographic parameters and new-onset atrial fibrillation (AF) remain incompletely understood.

Purpose

To investigate the association between electrocardiographic parameters and new-onset atrial fibrillation among men and women in the general population.

Methods

12,212 participants free of AF from a large population-based cohort study were included. Up to five repeated measurements of electrocardiographic parameters including PR, QRS, QT, QT corrected for heart rate (QTc), JT, RR interval, and heart rate were assessed at baseline and follow-up examinations. Cox proportional hazards models and joint models, both adjusted for cardiovascular risk factors, were used to determine the (shape of) association between baseline and longitudinal electrocardiographic parameters with new-onset AF. Additionally, we evaluated potential sex-differences.

Results

During a median follow-up of 9.3 years, 1,282 incident AF cases occurred among 12,212 participants (mean age 64.9 years, 58.2% women). Penalized cubic splines revealed that associations between baseline electrocardiographic measures and risk of new-onset AF were generally U-shaped (Figure 1). Sex-differences in terms of the shape of the various associations were most apparent for baseline PR, QT, QTc, RR, and heart rate in relation to new-onset AF. Longitudinal measures of PR (hazard ratio (HR), 95% confidence interval (CI), 1.43, 1.02-2.04, p=0.0393), and QTc interval (HR, 95% CI, 5.23, 2.18-12.45, p=0.0002) were significantly associated with new-onset AF. Sex-stratified analyses showed that the longitudinal associations were more prominent among men.

Conclusions

Baseline electrocardiographic measures and risk of new-onset AF were generally U-shaped. Longitudinal electrocardiographic measures of PR, and QTc interval were significantly associated with new-onset AF, more pronounced in men. Our findings imply that different thresholds of electrocardiographic parameters might translate to a differential risk of AF among men and women, and that treatment options targeting specific electrocardiographic parameters might prevent AF in the general population, in particular in men.
Atrial fibrillation and stroke risk of patients with hypertrophic cardiomyopathy in denmark from 2005-2018: a nationwide cohort study
Authors: Zoerner CR , Pallisgaard J , Schjerning AM , Toennesen J , Jensen MK , Gislason G , Hansen ML
Published: May 2022

Funding Acknowledgements

Type of funding sources: Public hospital(s). Main funding source(s): Internal funding: Herlev-Gentofte Cardiovascular Research Department.

Background

Hypertrophic cardiomyopathy (HCM) can be associated with serious complications such as heart failure, atrial fibrillation (AF) and sudden cardiac death. The treatment of AF in HCM patients can be challenging since AF often aggravates symptoms. Previous studies have suggested that HCM patients with AF have an elevated risk of thromboembolism and stroke compared to AF patients without HCM regardless of their CHA2DS2VASc score.

Purpose

To determine the risk of AF and stroke in HCM patients.

Methods

Through the Danish National Registers all patients aged 16 or older diagnosed with HCM between the 1st of January 2005, and the 31st of December 2018 were included in the analysis. The association between HCM, AF, and stroke was investigated using multivariable Cox proportional-hazard analysis adjusted for gender, age, atrial fibrillation, ischemic heart disease, chronic obstructive pulmonary disease, chronic kidney disease and hypertension. Cumulative incidence of AF and stroke was calculated using the Aalen-Johansen estimator, taking death as a competing risk into account.

Results

A total of 3856 patients were included, 2060 (53,4%) were male and median age of 67,8 (IQR 56 and 77,8) years. During the study period, 384 (10%) patients were diagnosed with AF. The risk of AF was significantly lower in males (HR 0,72 (0,59–0,90), p-value = 0.003) and for patients below 60 years (HR 0,18 (0,12–0,27), p-value = <0.001). (Figure 1)

157 (4,1%) of the HCM patients developed stroke. The risk of developing stroke was significantly decreased for patients aged under 60 (HR 0,32 (0,2–0,52), p-value = <0.001). There was no increased risk of stroke comparing genders.

Stroke risk was further analyzed in patients with known AF at time of inclusion, 656 (17%) in total. Compared to patients without AF and adjusted for age, gender and co-morbidities, there was no significant difference in stroke risk between these groups (HR 1.2 (0,81-1,76), p-value = 0.36). (Figure 2)

Conclusion

AF and stroke are common complications in HCM. Women are more susceptible to developing AF than men, and age over 60 at the time of diagnosis was associated with significantly higher risk of AF and stroke. HCM patients with previously known AF did not have a significantly elevated risk of stroke. More research will be needed to further explore these connections.
Pre-diabetes increases the risk of heart failure among patients with nonvalvular atrial fibrillation
Authors: Huang J , Lip YHG , Wu MZ , Ren QW , Tse HF , Yiu KH
Published: May 2022

Funding Acknowledgements

Type of funding sources: None.

Background

Heart failure (HF) is common in patients with nonvalvular atrial fibrillation (NVAF) which is associated with excess morbidity and mortality. Notably, the presence of diabetes increases risk of HF in patients with NVAF. The association between pre-diabetes and risk of HF was nonetheless unexplored in this population.

Purpose

The present study aimed to evaluate whether pre-diabetes was associated with an increased risk of HF in patients with NVAF.

Methods

Using a previously validated territory-wide electronic health record database, patients with newly diagnosed NVAF from 2010 to 2018 were included to evaluate for risk of HF upon competing risk regression with Cox proportional-hazard model adjustment. Patients were divided into 3 groups according to their baseline glycemic status: (1) type 2 diabetes, (2) pre-diabetes, and (3) normoglycemia. In the pre-diabetes group, the subsequent risk of HF was further evaluated according to the changes of glycemic status at two years following index date.

Results

Among 65,994 NVAF patients (mean age 75.7 years, 48.5% female), 27,706 (42.0%) were normoglycemic, 10,926 (16.6%) had pre-diabetes, and 27,312 (41.4%) had diabetes at baseline. Over a median follow-up of 7.1 years, 7,203 (26%) normoglycemic patients, 3,168 (29%) pre-diabetic patients, and 8,745 (32%) diabetic patients developed HF (Log rank test, P<0.001). Pre-diabetes was associated with an increased risk of HF compared with normoglycemic patients (subdistribution Hazard Ratio (SHR) = 1.09, 95% confidence interval (CI): 1.04-1.14) and diabetes conferred the highest risk amongst three groups (SHR=1.19, 95%CI: 1.15-1.24). In patients with pre-diabetes at baseline, 873 (8.0%) progressed to diabetes and 1204 (11%) resolved to normoglycemia at 2 years. Compared to those who remained pre-diabetic, patients who progressed to diabetes had a higher risk of HF (SHR = 1.23, 95% CI :1.05-1.44), whereas those who resolved to normoglycemia incurred a lower risk (SHR = 0.80, 95% CI :0.68-0.94).

Conclusion(s)

Pre-diabetes was independently associated with an increased risk of HF in patients with NVAF. Pre-diabetic patients who progressed to diabetes at 2 years experienced an increased risk of HF, whereas those who resolved to normoglycemia reduced risk of HF, as compared to those who remained pre-diabetic. These findings highlight the importance of strict blood glucose control in reducing the risk of HF in patients with atrial fibrillation.