bluuebunny/crossref_metadata_2025 huggingface dataset:
AV-node isolation in atrial fibrillation vs AV-node ablation by pace and ablate strategy
Authors: Essmann L , El Hamriti M , Braun M , Khalaph M , Baridwan N , Bante H , Eitz T , Bergau L , Sohns C , Sommer P , Imnadze G
Published: May 2021

Funding Acknowledgements

Type of funding sources: None.

Introduction

AV-node ablation (AVNA) is a common therapy option for rate control strategy of permanent atrial fibrillation. However, this therapy has numerous side-effects as bundle branch blocks and absence of escape rhythm. We have invented a new technique that isolates the AV node instead of ablation.

Methods

Our study includes 60 patients with 40 being treated with AVNA and 20 being treated with AV-node isolation (AVNI). In AVNI patient´s AV-node region was mapped using 3D navigation system. Ablation was performed around the previously mapped HIS-cloud regions isolating the atrium from the AV-node. In all cases in AVNI group ablation was performed with irrigated tip ablation catheter.  Procedure time, ablation points, fluoroscopy time and total DAP, escape rhythm and delta QRS among other data were measured and compared in these two methods. Statistical analysis was performed by SPSS software 27.0.

Results

No complications appeared in this study. In the AVNI group more ablation points were used (p < 0.01) but there was no significant difference in total procedure time (p = 0.730). With AVNI highly significantly less fluoroscopy time (1.4 vs. 4.7 minutes) and total DAP (40.75 vs. 382.85 µGym²) was achieved (p < 0.01). Moreover, the median change in QRS width was 0 ms in the AVNI group vs. 26 ms in the AVNA group (p < 0.01). Immediately postoperative the escape rhythm of the AVNI group was significantly higher than in the AVNA group (MRang = 37.38 vs. MRang = 27.06, p = 0.023).

Conclusion

AV-node isolation using 3D navigation mapping system is a safe and effective alternative to classic AVNA procedure with less radiation exposure and potential preservation of escape rhythm, which is a major benefit in case of a pacemaker failure.

Figure 1. 3D Navigation pictures after successful AVNI with NavX-System (left panel) and CARTO 3-System (right panel). His cloud with yellow points. The Tricuspid annulus could be defined with different color (green on the left panel) or with the tag points (white points on the right panel). Modified left lateral to posterior view. Abstract Figure.
Efficacy and safety of 50-60 Watt high-power short-duration radiofrequency catheter ablation of atrial fibrillation: A propensity score matching study
Authors: Pak HN , Yang SY , Kim M , Yu HT , Kim TH , Uhm JS , Joung BY , Lee MH , Park JW
Published: May 2021

Funding Acknowledgements

Type of funding sources: None.

Introduction

Although high-power short-duration (HPSD) radiofrequency (RF) energy is commonly utilized in atrial fibrillation (AF) catheter ablation (CA), its efficacy, safety, and autonomic neural effects have not yet been evaluated in a large patient number. We compared HPSD-AFCA and conventional power (ConvP)-AFCA after propensity score matching.

Methods

Among 3,221 consecutive AF ablation patients, we included 1,720 patients (74.4% male, 59 ± 10 years old, 56.5% paroxysmal type) who underwent AFCA after propensity score matching: 430 in 50∼60W HPSD group vs. 1,290 in the ConvP group. We evaluated the procedural factors, complication risk, rhythm outcome, and 3-month heart rate variability (HRV) between the two groups and subgroups.

Results

Procedure times were significantly shorter in the HPSD group (p < 0.001), but the complication rate (p = 0.088) and the 3rd-month HRV did not differ between the two groups. At the 12-month follow-up, rhythm outcomes did not differ between the two groups (Overall, Log-rank p = 0.212; anti-arrhythmic drug off Log rank p = 0.246). These efficacy and safety outcomes were consistently similar regardless of the AF type or ablation lesion set. In the Cox regression analysis, the left atrium volume index measured by computed tomography (HR 1.009 [1.003-1.015]), p = 0.005) and extra-pulmonary vein triggers (HR 1.587 [1.033-2.440], p = 0.035) were independently associated with 1-year clinical recurrence, while the HPSD strategy was not (HR 1.188 [0.903-1.564], p = 0.218).

Conclusions

HPSD-AFCA significantly shortened the procedure time with similar rhythm outcomes, complication risks, and autonomic neural effects as ConvP-AFCA, regardless of the AF type or ablation lesion set. Abstract Figure.
Is there a change in P wave parameters following pulmonary vein isolation (PVI) using radiofrequency ablation (RF) vs. cryoballoon ablation (CRYO) for paroxysmal atrial fibrillation (PAF)?
Authors: Antoun I , Bharat S , Mavilakandy A , Pooranachandran V , Ng GA
Published: May 2021

Funding Acknowledgements

Type of funding sources: None.

Pulmonary vein isolation (PVI) is an effective and established therapy for paroxysmal atrial fibrillation (PAF) . PVI can be performed using point by point ablation with radiofrequency (RF) or with single shot techniques such as cryoballoon (CRYO). As P waves represent atrial depolarization, we aimed to study whether P wave metrics may change after PVI and if there are differences between RF and CRYO approaches.

Methods

We studied 88 matched patients who had PVI for PAF between January 2017 and December 2018 (RF = 44, CRYO = 44). Each patient was in sinus rhythm (SR) prior to ablation. Patients on amiodarone and those who had additional linear ablation were excluded. Patients had continuous ECG monitoring using Labsystem Pro (Boston Scientific Inc). Sampled at 1kHz during the procedure. One-minute recordings before and after PVI were exported and analysed using custom-written software using MatLab (v2018, bandpass 1-50Hz) to annotate P wave onset, peak and end. P wave duration was heart rate corrected (PWDc) by using the Hodges formula and P wave amplitude (PWA).

Results

P wave metrics were comparable before PVI between both cohorts. Successful PVI was achieved in all patients.

There was a trend towards an increase in PWDc in some ECG leads with either RF or CRYO but no significant difference in P wave metrics as a result of PVI ablation or between both ablation modalities.

Conclusion

In this study, there was no significant change seen in PVI with RF or CRYO and no difference between the 2 ablation modalities. P wave metrics comparison, RF vs CRYO PWDc (ms) PRE, RF (n = 44) POST, RF (n = 44) P PRE, CRYO (n = 44) POST CRYO (n = 44) P P (RF vs CRYO) I 134.7 ± 32 133.5 ± 35 0.813 131.9 ± 36 132.7 ± 39 0.9 0.81 II 140.9 ± 34 144.1 ± 37 0.56 139.4 ± 42 134.4 ± 40 0.51 0.41 III 131.5 ± 31 143.3 ± 37 0.04 132.8 ± 41 130.6 ± 36 0.68 0.074 AVF 137 ± 32 144.7 ± 36 0.15 137.5 ± 42 127.4 ± 37 0.11 0.141 V1 143.9 ± 33 151.8 ± 37 0.17 133.6 ± 37 143.8 ± 38 0.09 0.745 PWA (mV) PRE, RF (n = 44) POST, RF (n = 44) P PRE, CRYO (n = 44) POST CRYO (n = 44) P P (RF vs CRYO) I 0.125 ± 0.08 0.09 ± 0.06 0.002 0.13 ± 0.08 0.14 ± 0.09 0.59 0.076 II 0.238 ± 0.1 0.238 ± 0.1 0.98 0.232 ± 0.1 0.278 ± 0.2 0.1 0.212 III 0.149 ± 0.1 0.153 ± 0.1 0.83 0.189 ± 0.1 0.187 ± 0.1 0.97 0.86 AVF 0.195 ± 0.1 0.196 ± 0.1 0.92 0.197 ± 0.1 0.247 ± 0.1 0.066 0.132 V1 0.122 ± 0.1 0.151± 0.1 0.05 0.138 ± 0.1 0.193 ± 0.2 0.002 0.543 PWDc and PWA comparison following RF vs CRYO.
Early mortality and complications associated with catheter ablation of atrial fibrillation: analysis of the entire procedure in Korea from 2007 to 2016
Authors: Yang PS , Byun JH , Sung JH , Joung B
Published: May 2021

Funding Acknowledgements

Type of funding sources: None.

Background

There is limited data regarding the early mortality and adverse outcomes from catheter ablation of atrial fibrillation (AF) in Korea. The aim of this study was to examine the early mortality and frequency of adverse outcomes associated with AF catheter ablation from 2006 to 2016 in Korea.

Methods

From 2006 to 2016 in the Korean National Health Insurance Service database, 11,893 individuals underwent catheter ablation for AF. We investigated the frequency of complications and early mortality associated with AF ablation and comorbidities that led to adverse outcomes after AF ablation.

Results

Out of all 11,893 procedures, early mortality occurred in 38 cases (0.32%). Annual trends in AF procedural complications occurring during index admission for AF ablation decreased from 9.25% in 2006 to 6.49% in 2016 (P for trend = 0.004). The early mortality rate after AF ablation had remained unchanged between 2006 and 2016. After adjustment for age, comorbidities, and medication, procedural complications (adjusted odds ratio[aOR]: 16.1; P < 0.001), age (aOR: 1.25; P = 0.024), history of hemorrhagic stroke (aOR: 4.74; P = 0.019), and less experience with AF ablation of the hospital (aOR: 2.85; P = 0.024) were associated with early mortality. Among procedural complications, atrioesophageal fistula (aOR: 199.8; P < 0.001), access site complications (aOR: 6.08; P = 0.005), complete heart block (aOR: 11.3; P = 0.029), pneumothorax (aOR: 62.0; P < 0.001), and procedure related pneumonia (aOR: 39.0; P < 0.001) were associated with early mortality.

Conclusions

Procedural complications, history of hemorrhagic stroke, and less experience with AF ablation of the hospital were predictors of early mortality. Out of all complications, atrioesophageal fistual, procedure related pneumonia, and in-hospital stroke were related to early mortality. Adequate management of complications may contribute to reducing the number of early mortalty rates following AF ablation. Abstract Figure. Trend of early mortality after ablation
Safety and efficacy of cryoballoon-ablation for atrial fibrillation performed at local hospitals: results of the german register on cryoballoon-ablation in local hospitals (REGIONAL)
Authors: Michaelsen J , Parade U , Bauerle H , Winter K-D , Rauschenbach U , Mischke K , Schaefer C , Gutleben K-J , Rana OR , Willich T , Schloesser M , Roetzer A , Breithardt O-A , Middendorf S , Waldecker B
Published: May 2021

Funding Acknowledgements

Type of funding sources: None.

OnBehalf

REGIONAL

Background

Pulmonary vein isolation (PVI) using cryoballoon ablation (CBA) has become an established procedure for the treatment of symptomatic paroxysmal and persistent atrial fibrillation (AF). The safety and efficacy of PVI at community hospitals with low to moderate case numbers is unknown.

Aim

To determine safety and efficacy of PVI using CBA performed at community hospitals with limited annual case numbers.

Methods

1004 PVI performed consecutively between 01/2019 and 09/2020 at 20 community hospitals (each <100 PVI using CBA/year) for symptomatic paroxysmal AF (n = 563) or persistentAF (n= 441) were included in this registry. CBA was performed considering local standards. Procedural data, efficacy and complications were determined.

Results

Mean number of PVI using CBA/year was 59 ± 26. Mean procedure time was 90.1 ± 31.6 min and mean fluoroscopy time was 19.2 ± 11.4 min. Isolation of all pulmonary veins could be achieved in 97.9% of patients, early termination of CBA due to phrenic nerve palsy was the most frequent reason for incomplete isolation. There was no in-hospital death. 2 patients (0.2%) suffered a clinical stroke. Pericardial effusion occurred in 6 patients (0.6%), 2 of them (0.2%) required pericardial drainage. Vascular complications occurred in 24 patients (2.4%), in 2 of these patients (0.2%) vascular surgery was required. In 48 patients (4.8 %) phrenic nerve palsy was noticed which persisted up to hospital discharge in 6 patients (0.6%).

Conclusions

PVI for paroxysmal or persistent AF using CBA can be performed at community hospitals with high efficacy and low complication rates despite low to moderate annual procedure numbers.
Evaluation of atrial complexity of patients undergoing atrial fibrillation ablation: a clinical computational study
Authors: Sanchez De La Nava AM , Gonzalez-Torrecilla E , Gonzalez-Mansilla A , Soto N , Avila P , Datino T , Bermejo J , Arenal A , Fernandez-Aviles F , Atienza F
Published: May 2021

Funding Acknowledgements

Type of funding sources: Public grant(s) – EU funding. Main funding source(s): Supported in part by the Instituto de Salud Carlos III (PI16/01123, DTS16/0160, PI17/010559, PI17/01106 and PI20/01618); Spanish Ministry of Science and Innovation (CIRBER CV); and cofound by FEDER: Fondo Europeo de Desarrollo Regional. EITHealth 19600 AFFINE.

Background

Pulmonary veins (PV) electrical isolation is the cornerstone of atrial fibrillation (AF treatment), but other proarrhythmic areas of the atria may trigger or sustain AF.

Objective

We used computer simulations to analyze AF complexity measured using non-invasive electrocardiographic imaging (ECGi).

Methods

We included 30 patients that underwent PVI. Personalized simulations using biatrial anatomies segmented from MRI images and an automata model for modeling the electrical activity were compared with ECGi results to evaluate the long-term outcome of AF ablation.

Results

Simulation maps closely correlated with the rotors histogram obtained from patients´ ECGi: high entropy areas from simulations matched the areas with higher density of rotor presence on the ECGi. Simulations revealed that successful ablations occurred in patients with rotors mainly located at the PV area, while unsuccessful ablations presented an increased number of high entropy foci, greater distribution of rotors along the atria and lower number of PV rotors. The number of rotors attached to the PV was significantly higher in patients with favorable long-term ablation outcome (1-year AF Freedom: 1.61 ± 0.21 vs. AF: 1.40 ± 0.20; p-value = 0.018).

Conclusion

This simulation approach could improve patient screening and ablation design prior to the intervention providing information of the complexity of the atria. Abstract Figure. Rotor maps, ACM and ACB for 3 patients
Why is neuromodulation effect of pulmonary vein isolation not same in all cases?
Authors: Aksu T , Yalin K , Gopinathannair R
Published: May 2021

Funding Acknowledgements

Type of funding sources: None.

Background

Cardiac ganglionated plexi (GPs) of the autonomic system are primarily located in major epicardial fat pads adjacent to the left atrium and pulmonary vein junctions. These structures may play a central role in both the initiation and maintenance of atrial fibrillation (AF). Previous studies reported modification of GPs during pulmonary vein isolation (PVI) may increase rate of sinus node and AF-free survival. However, a deficiency certainly existed why is modification of GPs observed in some patients during PVI but not in others?

Purpose

We aimed to evaluate ratio of ablation points within classical antral circumferential ablation lines for PVI and distribution of 4 major atrial ganglionated plexus.

Methods

Thirty-eight consecutive patients undergoing ablation of GP for vagally mediated bradyarrhythmias were evaluated. All GP sites were detected by using previously defined fragmented electrogram based strategy which is a validated tool when compared with a combination of spectral analysis and high frequency stimulation to detect GPs. Estimated ablation lines for antral circumferential ablation was defined as a circumferential isolation line performed ≥1 cm away from the pulmonary vein ostium as identified by 3D electroanatomical reconstruction (Figure 1). The total number of ablation points in each GP sites and ratio of ablation points within estimated antral circumferential ablation lines were recorded.

Results

The great majority of ablation points were detected at the insertion of the right pulmonary veins. Number of ablation points in each GP site in descending order is as follows: (1) the right superior GP = 13.6 ± 6; (2) the left superior GP = 10.5 ± 5; (3) the right inferior GP = 5.9 ± 4; and (4) the left inferior GP = 2.5 ± 3. The ratio of ablation points within estimated antral circumferential ablation lines was higher in right-sided GPs (50.5%±24 for the right superior GP and 30.2%±31 for the right inferior GP vs 18.3%±24 for the left superior GP and 11.6%±26 for the left inferior GP. Figure 2 demonstrates total number of ablation points and the ratio of ablation points within estimated antral circumferential ablation lines in each GP site.

Conclusions

The present study shows that individual variability of distribution of GPs and how antral ablation was done during PVI might be the main contributors of neuromodulation effect. Further randomized, controlled and multicenter studies should be performed to confirm these findings. Abstract Figure 1
Catheter ablation as initial therapy for symptomatic atrial fibrillation- a meta analysis
Authors: Abdul Razzack A , Gopar Franco WX , Rocha Castellanos DM , Patel N , Patel V , Adeel Hassan S , Pothuru S , Yasmin F , Kumar Ochani R , Mandava S , Theja Reddy K , Mustafa A , Mehmood Lak H
Published: May 2021

Funding Acknowledgements

Type of funding sources: None.

Background

 The current guidelines recommend a trial of antiarrhythmic drugs (AAD) before ablation is considered. However, the concept "first do no harm" plays an integral role in the management of atrial fibrillation. Little is known about ablation as first line therapy for untreated patients with symptomatic atrial fibrillation.

Methods

 Electronic databases (Medline, Scopus, Embase) were searched until 25th November 2020. Unadjusted odds ratios (OR) were calculated from dichotomous data using Mantel Haenszel (M-H) random-effects with statistical significance to be considered if the confidence interval excludes 1 and p < 0.05. Randomised controlled trials (RCTs) evaluating catheter ablation vs AAD as first line therapy were included. The primary outcome of interest was recurrence of any atrial tachyarrhythmia (symptomatic/asymptomatic, atrial fibrillation, atrial flutter and atrial tachycardia). Secondary outcomes included recurrence of symptomatic atrial tachyarrhythmia, major adverse events and cardiovascular adverse events.

Results

 A total of five studies with 986 (Ablation = 496; AAD = 490) participants were included. Patients receiving ablation were less prone to experience any type of atrial tachyarrhythmia when compared to patients receiving anti-arrhythmic drugs (OR 0.42; 95%CI 0.31 to 0.55; p < 0.00001; I²=0) The incidence of symptomatic atrial tachyarrhythmia was also higher in the AAD arm (OR 0.33; 95%CI 0.18-0.62; p = 0.0006; I²=59%). There were no statistically significant differences for major(OR1.30; 95%CI0.85 to 1.98; p = 0.22; I²=0)and cardiovascular adverse events (OR 1.13; 95%CI 0.69-1.86; p = 0.64 I²=0) respectively.

Conclusion

 Catheter ablation was associated with a significantly lower rate of tachyarrhythmia recurrence than conventional anti-arrhythmic drugs, but may also cause adverse events Abstract Figure.
Antiplatelets in patients with atrial fibrillation: a systematic review and meta-analysis of randomized clinical trials
Authors: Benz A , Johansson I , Dewilde W , Lopes RD , Mehran R , Sartori S , Sarafoff N , Yasuda S , Mcintyre WF , Healey JS , Shoamanesh A , Eikelboom JW , Connolly SJ
Published: May 2021

Funding Acknowledgements

Type of funding sources: Private grant(s) and/or Sponsorship. Main funding source(s): Dr. Benz reports a personal research grant from the German Heart Foundation (Deutsche Herzstiftung e.V.). Dr. Johansson reports personal unrestricted research grants from Swedish Heart-Lung Foundation (Hjärt-Lungfonden) and from Stockholm County Council (Region Stockholm). Dr. McIntyre holds a fellowship award from the Canadian Institutes for Health Research (CIHR). Dr. Shoamanesh reports funding support from the Marta and Owen Boris Foundation and the Heart and Stroke Foundation of Canada.

Background/Introduction: There is an ongoing controversy surrounding the efficacy and safety of antiplatelet agents in patients with atrial fibrillation (AF).

Purpose

We aimed to systematically assess the effects of antiplatelets on stroke and other outcomes in patients with AF, both receiving oral anticoagulation or not.

Methods

We searched MEDLINE, Embase and CENTRAL up until September 2020 to identify randomized trials allocating patients with AF to aspirin or a P2Y12 inhibitor, versus control. Where applicable, we obtained unpublished data from study authors. Random-effects models were applied for meta-analysis.

Results

Based on 21,518 patients from 18 randomized trials, there was no reduction in stroke with antiplatelet therapy (risk ratio [RR] 0.89, 95% confidence interval [CI] 0.76-1.04). There was a significant qualitative interaction according to whether patients were receiving concomitant oral anticoagulation or not (p < 0.001). Without concomitant anticoagulation, antiplatelets reduced stroke (RR 0.77, 95% CI 0.69-0.86), while they appeared to increase stroke with it (RR 1.33, 95% CI 0.98-1.79). A similar pattern emerged for ischaemic stroke. Antiplatelets increased major bleeding (RR 1.54, 95% CI 1.35-1.77) and intracranial haemorrhage (RR 1.64, 95% CI 1.20-2.24), and reduced myocardial infarction (RR 0.79, 95% CI 0.65-0.94), consistently and irrespective of concomitant anticoagulation. Antiplatelets had a neutral effect on mortality (RR 1.02, 95% CI 0.89-1.17).

Conclusions

Antiplatelet therapy did not reduce stroke and increased major bleeding in patients with AF. Antiplatelets did not affect mortality. Subgroup analysis suggests a reduction in stroke with antiplatelets in patients without concomitant oral anticoagulation, and a corresponding signal for harm in those with it. Abstract Figure.
Is transesophageal echocardiogram mandatory for patients undergoing ablation for right atrial flutter with uninterrupted anticoagulants? A prospective single registry
Authors: Suzat A , Da Costa A , Guichard JB , Pierrard ROMAIN , Benali K , Yvorel C , Bayard G , Isaaz K
Published: May 2021

Funding Acknowledgements

Type of funding sources: None.

Background. Limited data exist regarding the prevalence of left atrial appendage (LAA) thrombi and spontaneous echocardiographic contrast (SEC) in patients with atrial flutter (AFL). Objectives. Our prospective single-center observational study sought to evaluate the prevalence of LAA thrombi in patients referred for AFL ablation, compared to those requiring atrial fibrillation (AFib) ablation during the same time period, as well as to determine the predictive factors of LAA thrombi in terms of arrhythmia etiology. Methods and Results. From July 2019 to August 2020, 321 consecutive patients who were referred for either AFib ablation (n = 229) or AFL ablation (n = 92) were included in the study, with a thrombus detected by transesophageal echocardiography (TEE) in 3.22% (12/321). Prior to ablation under anticoagulants, the percentage of thrombi was similar between patients referred for AFL ablation and those referred for AFib ablation (5.4% [n = 5/92] vs. 3.1% [n = 7/229]; p = 0.3). In the overall population, patients with LAA thrombi had a higher CHA²DS²-VASc score (3 ± 2 vs. 2 ± 1.5; p = 0.048) and a higher presence of valvular prothesis (25% vs. 4.9%; p = 0.003), with relevant left atrial remodeling  more often observed, such as demonstrated by a higher left atrium (LA) volume (57 ± 19 vs. 46 ± 17 ml/m²; p = 0.04), a lower LAA velocity (0.41 ± 0.3 vs. 0.55 ± 0.2; p = 0.04) and a more severe LAA echo contrast (83.3% vs. 3.2%; p <0.0001). In the subset of patients with right AFL, patients with LAA thrombi had a higher CHA²DS²-VASc score (4.4 ± 1 vs. 2.5 ± 1.5; p = 0.008), had more often hypertension (100% vs. 53%; p = 0.04) and more often diabetes mellitus (60% vs. 18.4%; p = 0.03), and a more severe LAA echo contrast (80% vs. 5.7%; p <0.0001). Predictive factors of atrial thrombi evaluated by crude odds ratios were the presence of valvular prosthesis (OR = 6.53; [1.60, 26.65] ; p = 0.009), the CHA²DS²-VASc score (OR = 1.41 [0.99, 2.01] ; p = 0.05), the LAA velocity (cm/s) (OR = 0.03; [0.001, 0.79]; p = 0.04) and presence of severe LAA contrast (OR = 188 ; [35.32, 1002.02] ; <0.0001) rather than the atrial arrhythmia itself. Conclusions. Patients referred for ablation with right AFL have a similar risk of LAA thrombi, compared to those with AFib. The risk of LAA thrombi is better related to the presence of valvular prosthesis, CHA²DS²-VASc score and LA remodelling than the atrial arrhythmia itself. Accordingly, TEE should be recommended before right AFL ablation, especially in case of a valvular prosthesis, high CHA²DS²-VASc score or LA alteration.
Periprocedural anticoagulation management in edxoaban patients undergoing catheter-based cardiovascular procedures: analyses of the noninterventional global EMIT study
Authors: Vanassche T , Colonna P , Santamaria A , Chen C , Von Heymann C , Jin J , Saxena M , Jiang W , Unverdorben M
Published: May 2021

Funding Acknowledgements

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

Background

 The optimal periprocedural management of direct oral anticoagulants (DOAC), including edoxaban, in patients undergoing catheter-based cardiovascular procedures is unknown, and mainly based on physician opinion and experience.

Purpose

To assess real-world management of edoxaban in patients undergoing cardiovascular procedures, and to report their clinical events.

Methods

Global EMIT-AF/VTE is a prospective study of periprocedural management in edoxaban-treated patients undergoing diagnostic and therapeutic procedures. We report the data from patients undergoing cardiovascular procedures. Timing and duration of edoxaban interruption were at the treating physician’s discretion. Outcomes were collected from 5 days before until 30 days post procedure. Primary outcome was the incidence of major bleeding (MB); secondary outcomes included incidence of clinically relevant non-major bleeding (CRNMB) and acute thromboembolic events (ATE).

Results

Data was collected from 301 and 311 procedures with arterial or venous access, respectively. Baseline characteristics are shown in Table 1. Edoxaban was not interrupted in 36.9% of arterial and 52.7% of venous procedures. Edoxaban was interrupted pre-procedure in 41% of arterial and 32.8% of venous procedures. The median periprocedural interruption was 2 days. The overall incidence of bleeding was very low. Any bleeding was reported in 8 patients undergoing arterial and 10 patients undergoing venous procedures (2.7% and 3.2%). MB or CRNMB occurred in 2 arterial and 3 venous procedures (0.7% and 1.0%) and ATE occurred in 5 arterial and 1 venous procedure (1.7% and 0.3%, Table 1).

Conclusions

In this study, the periprocedural risks of bleeding and thrombotic events were low. About a third of arterial access procedures and half of venous access procedures were performed without edoxaban interruption. Arterial(n = 301) Venous(n = 311) Baseline characteristics Age, year, mean (SD)Male, n (%)Weight (kg), mean (SD) 71.9 (8.5)211 (70.1%)80.8 (16.7) 64.6 (11.1)215 (69.1%)84.1 (17.4) CrCL (mL/min), mean (SD) CHA2DS2-VASc score, mean (SD)HAS-BLED score, mean (SD) 73.5 (29.8) 3.3 (1.5)2.0 (1.0) 88.9 (35.5) 2.2 (1.5)1.3 (1.0) Edoxaban 60 mg / 30 mg, % 73% / 26% 88% / 26% Coronary heart disease, n (%) Congestive heart failure, n (%) 101 (33.6%) 58 (19.3%) 51 (16.4%) 33 (10.6%) Interruption of edoxaban, n (%) No interruption Pre-procedure only Post-procedure only Pre- and post-procedure 111 (36.9%)125 (41.5%)12 (4.0%)53 (17.6%) 164 (52.7%)102 (32.8%)8 (2.6%)37 (11.9%) Clinical events, n (%) MB or CRNMBACSStroke/Transient ischemic attackCV mortalityAll-cause mortality 2 (0.7%)2 (0.7%)3 (1.0%)1 (0.3%)2 (0.7%) 3 (1.0%) 01 (0.3%)00
Ophthalmic complications in patients with nonvalvular atrial fibrillation and type 2 diabetes prescribed rivaroxaban or warfarin
Authors: Costa O , Ho K , Caranfa JT , Vardar B , Abdelgawwad K , Brescia CW , Coleman CI
Published: May 2021

Funding Acknowledgements

Type of funding sources: Private company. Main funding source(s): Bayer AG Berlin, Germany

INTRODUCTION

Patients with type 2 diabetes (T2D) are at an increased risk of ophthalmic complications compared to those without. Ophthalmic complications in T2D patients with comorbid nonvalvular atrial fibrillation (NVAF) may include ophthalmic bleeding and/or diabetic retinopathy.

PURPOSE

We sought to evaluate ophthalmic complications in patients with NVAF and T2D prescribed rivaroxaban or warfarin for stroke prevention.

METHODS

Optum® de-identified electronic health record (EHR) data from 11/2010-3/2020 were utilized. Adults with NVAF and T2D, newly started on rivaroxaban or warfarin and with ≥12 months of prior EHR activity were included. Patients were excluded if they received any oral anticoagulation in the prior 12 months, had valvular disease or pre-existing diabetic retinopathy. Our primary outcome was the incidence rate of any ophthalmic complication including non-traumatic bleeding (choroidal, intraocular, retinal, vitreous) or diabetic retinopathy.  Ophthalmic bleeds typically associated with trauma (hyphema, orbital) were excluded from our outcomes.  Hazard ratios (HR) with 95% confidence intervals (CIs) were calculated using propensity score-overlap weighted Cox regression.

RESULTS

We included 26,537 rivaroxaban and 61,690 warfarin patients. The average age of patients was 69 ± 9 years, CHA2DS2VASc score was 4.1 ± 1.5 and HASBLED 1.5 ± 0.9. Thirty-two percent of patients had an a1c ≥7.0 and 16% an a1c≥8.0. Rivaroxaban was associated with a 15% (95%CI = 8-21%) relative hazard reduction of any ophthalmic complication (incidence rate = 1.25 vs. 1.46%/year) (Table), driven by reductions in both ophthalmic bleeding (HR = 0.80) and diabetic retinopathy (HR = 0.85).

CONCLUSIONS

Rivaroxaban was associated with a reduction in ophthalmic complications compared to warfarin. Table. Ophthalmic Complications Outcome Rivaroxaban, %/yearN = 26,537 Warfarin, %/yearN = 61,690 PS OLW HR (95%CI) Any Ophthalmic Complication 1.25 1.46 0.85 (0.79-0.92) Any Ophthalmic Bleed 0.15 0.19 0.80 (0.63-1.00) Choroidal Bleed 0.003 0.005 0.59 (0.11-3.17) Intraocular Bleed 0.01 0.01 0.75 (0.26-2.13) Retinal Bleed 0.08 0.09 0.93 (0.68-1.28) Vitreous Bleed 0.07 0.10 0.66 (0.47-0.92) Any Type of Diabetic Retinopathy 1.15 1.34 0.85 (0.79-0.93) Diabetic Retinopathy, non-proliferative 0.35 0.44 0.80 (0.69-0.93) Diabetic Retinopathy, proliferative 0.09 0.12 0.79 (0.59-1.05) Diabetic Retinopathy, unspecified 0.82 0.94 0.87 (0.79-0.97) CI = confidence interval; HR = hazard ratio; OLW = overlap weighted; PS = propensity score
Periprocedural safety and efficacy after left atrial appendage closure in a large UK tertiary centre: 10-year experience
Authors: Briosa E Gala A , Pope MTB , Monteiro C , Leo M , Betts TR
Published: May 2021

Funding Acknowledgements

Type of funding sources: None.

Introduction

Left atrial appendage (LAA) thrombus is responsible for up 90% of atrial fibrillation (AF) related ischaemic strokes. Mechanical closure of the LAA is an alternative stroke prevention strategy in patients with non-valvular AF who are at a high risk of bleeding. LAA morphology is highly variable which may affect acute procedural success rates.

Purpose

This study sought to examine the periprocedural safety and efficacy, and short-term outcomes in patients undergoing left atrial appendage occlusion (LAAO) device implantation in a large UK tertiary centre.

Methods

This retrospective study included all patients listed for a LAAO device in our institution from January 2010 to December 2020. Medical notes, procedural and imaging reports were reviewed and adverse event rates were calculated at discharge, 30 and 90 days. A Cox regression model was used for multivariable analysis with pre-specified covariates to assess outcomes at 90 days.

Results

Of 237 patients listed for a LAAO device, 8 (3.4%) had a LAA thrombus and the procedure was abandoned (4 had a successful implant at a later date). In 225 (94.9%) patients a LAAO device was implanted and 4 (1.7%) had unsuitable anatomy precluding device deployment. Seventy-two percent were male, age 74 ± 8 years, BMI 27 ± 6 kg/m2, CHA2DS2-VASc score 4.4 ± 1.2, HASBLED score 3.2 ± 0.8 and at high risk of stroke (98 ischaemic strokes and 129 haemorrhagic strokes) and bleeding (151 major or life-threatening bleeding episodes).  The mean procedural and fluoroscopy time were 52.5 ± 30.5 and 8.0 ± 5.9 minutes, respectively. Three different LAAO devices were used (136 Watchman, 54 Watchman FLX and 35 Amplatzer Cardiac Plug) with no significant difference in acute procedural success (97.8%, 98.2% and 94.4%, p = 0.41, respectively). Complete seal was achieved in 202 (92%) patients with only 1 (0.4%) moderate leak. Procedure-related mortality was 1.3% and non-fatal serious adverse events occurred in 5 (2.1%) patients. At 90 days, 28 patients experienced an adverse event (KM 12.5%; 95% CI, 8%-16.1%) and 16 patients suffered a serious adverse event (KM 7.1%; 95% CI, 3.7%-10.4%). In a covariate-adjusted Cox model, CHA2DS2-VASc score less than 4 had hazard ratio of 0.21 (95% CI, 0.06 -0.71, p = 0.01) for serious events at 90 days.

Conclusion

The acute procedural success rate was high (97%) with a low number of periprocedural complications. Serious adverse events at both 30 and 90-days were low in keeping with other published registries. Abstract Figure.
Long-term outcomes in patients with non-valvular atrial fibrillation and left atrial appendage closure in a large UK tertiary centre: 10-year experience
Authors: Briosa E Gala A , Pope MTB , Monteiro C , Leo M , Betts TR
Published: May 2021

Funding Acknowledgements

Type of funding sources: None.

Introduction

Left atrial appendage occlusion (LAAO) is a well-established stroke prevention strategy in patients with non-valvular atrial fibrillation (AF) and high risk of bleeding or contra-indication to oral anticoagulation (OAC). Despite encouraging randomised control trial and international registry safety and efficacy data, long-term outcome data remains sparce.

Purpose

This study sought to evaluate the long-term outcomes in ‘real-world’ AF patients undergoing left atrial appendage occlusion in a large UK tertiary centre.

Methods

This retrospective study included all patients that had a LAAO device implanted in our institution from January 2010 to December 2020. Medical notes, electronic patient records, procedural and imaging reports were reviewed. Annual bleeding risk was extrapolated from the Swedish National Cohort study according to CHA2DS2-VASc and HASBLED score.

Results

During the study period a total of 225 patients underwent LAAO device implant. Seventy-two percent were male, age 74 ± 8 years, BMI 27 ± 6 kg/m2, CHA2DS2-VASc score 4.4 ± 1.2, HASBLED score 3.2 ± 0.8 and at high risk of stroke (98 ischaemic strokes and 129 haemorrhagic strokes) and bleeding (151 life-threatening bleeding episodes). Three different LAAO devices were used: 136 Watchman, 54 Watchman FLX and 35 Amplatzer Cardiac plugs. Three patients (1.3%) had fatal complications related to the procedure. At discharge, 10% were taking single antiplatelet (ATP), 79% dual-antiplatelet (DAPT), 1.4% OAC, 3.6% ATP and OAC, 3.1% DAPT and OAC, 1.3% were not taking any anti-thrombotic. Nine (4%) patients had device-related thrombus on follow-up transoesophageal echocardiography with no significant difference between devices (5.0%, 2.8% and 6.7% p = 0.8, respectively) and anticoagulation strategy (p = 0.7). Over a total follow-up of 889 patient-years (mean follow-up 3.9 ± 3.7 years), 24 (10.4%) patients died, 55 patients (6.2/100 patient-years) suffered an adverse event, 15 ischaemic strokes (1.7/100 patient-years) and 20 non-procedural major bleeding episodes (2.3/100 patient-years) occurred. Compared to estimated annual stroke and bleeding risk adjusted for CHA2DS2-VASc and HASBLED score, our cohort had a 79% and 65% relative risk reduction in ischaemic stroke and major bleeding, respectively.

Conclusion

In this cohort of "real-world" high-risk patients, major bleeding and thromboembolic rate remained low on long-term follow-up. Abstract Figure 1
A new inherited syndrome causing sudden cardiac death with specific ECG changes and idiopathic left ventricular hypertrophy
Authors: Swojanowsky P , Von Korn H , Basso C , Pilichou K , Stefan V , Muenzel T
Published: May 2021

Funding Acknowledgements

Type of funding sources: None.

Introduction

 Sudden cardiac death (SCD) is a serious threat. In individuals under the age of 35 years sudden arrhythmic death is the most frequent cause. In younger persons, genetically determined cardiac diseases (e.g., cardiomyopathies, ion-channel diseases) account for an important proportion of these cases.

Purpose

We discovered a unusual combination of ECG changes and left ventricular hypertrophy that lead to a cumulation of sudden cardiac death in a single family. We therefore did a scientific work-up of this finding.

Methods

We investigated the case of a 23 year-old male with SCD, specific ECG changes and left ventricular hypertrophy (Figure 1). Family history was significant for SCD in the paternal line. A precise analysis was performed by an international multidisciplinary expert panel including autopsy of the index patient’s heart, molecular autopsy, whole exome sequencing, analysis of the pedigree and examination of available family members (Figure 2).

Results 

Three cases of SCD were  reported in paternal relatives. The index patient exhibited specific ECG changes (ST-depression), which were also found in five paternal relatives and the brother of the index Patient (Figure 3). Post-mortem analysis of the heart yielded mild idiopathic concentric hypertrophy without myocardial disarray.

 The genetic analysis of the index patient showed two nucleotide variations in two different genes (ANK2: c.11791G > A , MYO18B: c.3761G > A), which were also expressed in five relatives. Two family members had showed all indicators of the inherited syndrome including specific ECG changes, genetic changes and left ventricular hypertrophy.

Conclusions

We described a distinct inheritable syndrome causing SCD, characterized by specific ECG changes, idiopathic left ventricular hypertrophy and mutations of ANK2 and MYO18. As far as we know this is the first description of this syndrom. We hypothesize that if all features (ECG-changes, described genetic mutations, left ventricular hypertrophy) are positive, the risk for SCD may be considerably increased. Abstract Figure. ECG of index patient and pedigree
Heterogeneity of right ventricular refractory period: a novel prognostic predictor in type-1 Brugada
Authors: Teresi L , Rossi A , Giannoni A , Nesti M , Castiglione V , Solarino G , Mirizzi G , Russo V , Panchetti L , Startari U , Ripoli A , Santoro A , Casolo G , Emdin M , Piacenti M
Published: May 2021

Funding Acknowledgements

Type of funding sources: None.

Risk stratification in Brugada syndrome (BrS) is needed especially for the choice of an Implantable Cardiac Defibrillator (ICD). To date the predictive value of either clinical or conventional electrophysiological indexes in type 1 electrocardiographic pattern BrS is rather low.

We aimed to evaluate the eventual prognostic significance of refractoriness heterogeneity of right ventricular outflow tract, an emergent relevant pathophysiological substrate, at electrophysiological study (EPS) in patients with BrS.

From 5 centers 348 patients were retrospectively selected (age 44 ± 15 years, males 68%). Eighty-five (24%) patients had an ICD. EPS was proposed in patients with spontaneous type-1 ECG pattern regardless of symptoms, or in patients with drug-induced type-1 ECG pattern with symptoms (n = 174). The difference in the refractory period between the right ventricular outflow tract and the apex (ΔRPRVOT-apex) at EPS was evaluated as a prognostic factor. The optimal ΔRPRVOT-apex cutpoint for prognosis prediction was calculated through a P-spline hazard ratio analysis. Thus, ΔRPRVOT-apex  was compared through different statistical analyses to other other clinical or conventional electrophysiological prognostic indexes previosly described in literature. 

During a 36-month median follow-up (range 6-228) 3 SCD and 10 appropriate ICD shocks (aborted SCD, aSCD) occurred. Fifty patients (29%) had a positive EPS (induction of sustained ventricular tachycardia, VT, or ventricular fibrillation, VF, during the procedure). At multivariable logistic analysis, only ΔRPRVOT-apex  and late potentials remained independent predictors of a positive EPS. At Cox Proportional Hazard analysis, family history of SCD, history of syncope, VT/VF inducibility and a ΔRPRVOT-apex >60 ms were all univariate predictors of SCD/aSCD. At bivariate analysis, a ΔRPRVOT-apex >60 ms remained an independent predictor of SCD/aSCD even when adjusted the other univariate predictors. At C-Statistic analysis, the strongest predictive model was the one using ΔRPRVOT-apex >60 ms as covariate with a C-statistics (95% CI) of 0.72 (0.51-0.93). At Kaplan-Meyer curves, ΔRPRVOT-apex >60 ms was confirmed a strong predictor of SCD/aSCD and another very interesting observation was possible: patients with positive EPS, but a ΔRPRVOT-apex < 60 ms, had a similar risk to SCD/aSCD compared to patients with a negative EPS, while those with a positive EPS and a ΔRPRVOT-apex > 60 ms were found to be at a higher risk of events.

Refractory period heterogeneity of the right ventricle defined as ΔRPRVOT-apex > 60 ms at EPS is a strong and independent predictor of SCD/aSCD in patients with BrS, beyond VT/VF inducibility at EPS and common clinical predictors. Abstract Figure.
Time-efficient three-dimensional transmural scar assessment provides relevant substrate characterization for ventricular tachycardia features and long-term recurrences in ischemic cardiomyopathy
Authors: K Gutierrez L , Merino-Caviedes S , Alfonso-Almazan JM , Sanz-Estebanez S , Cordero-Grande L , G Quintanilla J , Sanchez-Gonzalez J , Marina-Breysse M , Peinado R , Merino JL , Perez-Villacastin J , Martin-Fernandez M , Perez-Castellano N , Alberola-Lopez C , Filgueiras-Rama D
Published: May 2021

Funding Acknowledgements

Type of funding sources: Public grant(s) – National budget only. Main funding source(s): - Ministerio de Ciencia e Innovación and the ProCNIC Foundation - Grant TEC2017-82408-R

Background

 We aimed to validate a 3D methodology for transmural scar assessment using time-efficient upsampled models from 2D delayed gadolinium-enhanced cardiac magnetic resonance (LGE-CMR) sequences and determine the clinical implications in ischemic cardiomyopathy-related ventricular tachycardia (VT) episodes. 

Methods

 Translational study including 10 pigs with myocardial infarction and 15 patients with spontaneous VT episodes and underlying infarct-related scar. Pigs underwent 3D LGE-CMR sequences to test 3D transmural-based scar assessment using several downsampled resolutions from the original images. Validation in patients included 3D and 2D LGE-CMR studies performed within the same protocol. Transmural-based scar areas were used for correlation analyses with the cycle length (CL) of VT episodes. Scar volumes were used as a benchmark comparison. 

Results

 In pigs, 3D transmural-based scar areas showed interclass correlation coefficients >0.94 between original 3D high-resolution- and downsampled-derived models. In patients, scar area quantification in myocardial regions with 3D transmurality <0.2 (for upsampled 2D-derived models) and <0.1 (for 3D-derived models) showed direct correlation with the CL of spontaneous VT episodes (r = 0.69; p < 0.01 and r = 0.79; p < 0.01, respectively) (See Abstract Figure). After ablation, patients with VT recurrences showed lower scar areas on 3D and upsampled 2D models using <0.1 and <0.2 transmurality criteria, respectively, than patients without VT recurrences (48.5 [37.7, 67.5] vs. 91.5 [84.3, 117.3] cm2, respectively, for 3D-derived models; p = 0.004, and 64.0 [43.5, 69.5] vs. 83.0 [70.2, 99.7] cm2, respectively, for upsampled 2D models; p = 0.04). Conversely, time-consuming scar volume reconstructions from 2D or 3D LGE-CMR sequences did not show significant differences between patients with and without VT recurrences.  

Conclusions

 Three-dimensional transmural scar assessment in upsampled 2D-LGE-CMR-derived models provides time-efficient characterization of infarct-related myocardial substrates associated with the CL of spontaneous VT episodes and VT recurrences after ablation. Abstract Figure
Zero fluoroscopy PVC ablation
Authors: Pena Mellado J , Sanchez Millan P , Gutierrez Ballesteros G , Tercedor L , Alvarez Lopez M
Published: May 2021

Funding Acknowledgements

Type of funding sources: None.

Premature ventricular complex(PVC) catheter ablation is required in a wide spectrum of the population.Ionizing radiation exposure in this procedure carries health risks,especially in young patients.

In this prospective observational study we included 18 patients,submitted to PVC ablation without fluoroscopy between October 2018 and December 2020.Baseline characteristics of the population,acute success and complications derived from the procedure were evaluated,as well as recurrence rate during follow-up.

Median age was 49.5 years. Most often cause of ablation were palpitations(77.8%),followed by reduced LVEF(16.7%) and dyspnoea(5.6%).33.3% had a cardiopathy,the most common was tachycardiomyopathy(66.7%).PVC burden pre-ablation was 25 ± 12.6%.The most frequent PVC origin was RVOT(66.7%)followed by LVOT(22.2%),mitral annulus(5.6%) and papillary muscles(5.6%).

We used a 3D electroanatomical navigation system in all cases,intracardiac echocardiography in 88.9% and a contact force catheter for mapping(61%) and ablation(88.9%).The mean maximum radiofrequency power applied was 35 ± 5.7W(236.5s median time).Median number of applications was 5.5 and mean total procedural time was 198.6 ± 67.5 minutes.Median best prematurity was 28ms.We used isoprenaline in order to induce PVC in 77.8% of cases and suppression of PVC was achieved in 88.9%.There was only one complication(pericardial effusion without the need for pericardiocentesis).Median follow-up of 5 months,17.6% of recurrences(<80% reduction of PVC burden at 3 months),all them(3) from RVOT.

In conclusion, the PVC ablation without fluoroscopy is a safe procedure with no major complications and good rates of success and recurrence in our experience. Baseline characteristics of the patientsMale6(33.3%)Female12(66.7%)Median age-yr.(range)49.5 (23-71)HTA6(33.3%)DM2(11.1%)Dyslipidemia3(16.7%)Smoking6(33.3%)LVEF median-(%)56.5%Treatment pre-ablationBeta blockers11(61.1%)No treatment6(33.3%)BB + flecainide/propafenone1(5.6%)1st column: Characteristics /2nd column: Patients included (N = 18) Abstract Figure 1