bluuebunny/crossref_metadata_2025 huggingface dataset:
Predictors of single shot pulmonary vein isolation with Heliostar radiofrequency balloon
Authors: Martinez Gomez E , Salgado Aranda R , Calvo Cuervo D , Gonzalez Ferrer J J , Canadas Godoy V , Filgueiras Rama D , Chavez Ortiz I , La Rosa G , Sanchez Vallejo C , Perez-Villacastin Dominguez J , Perez Castellano N
Published: November 2023

Introduction

Single shot pulmonary vein isolation techniques have emerged as an effective and safe alternative to point-by-point ablation, considerably reducing procedure times. The recent appearance on the market of the Heliostar® radiofrequency (RF) balloon offers a new option in this regard. The main predictors of single-shot isolation with this new device are unknown.

Objectives

Our objective was to evaluate as potential predictors of single-shot isolation the impedance drop, temperature rise and voltage reduction of the electrograms recorded by the balloon during radiofrequency application.

Methods

A total of 25 patients with paroxysmal (68%) or persistent (32%) symptomatic atrial fibrillation were prospectively included and underwent pulmonary vein isolation with Heliostar® RF balloon. Impedance and temperature parameters were collected from each of the applications performed in all veins. The voltage of the electrograms recorded by the Heliostar® RF balloon immediately before and after initiating the RF application in each vein was collected. The number of applications per vein was recorded and the single shot criterion was discriminated in each vein. A total of 92 veins were included for impedance and temperature analysis, and 59 veins for electrogram analysis (excluding veins in which the RF application was performed in atrial fibrillation). Impedance drop, temperature increase and electrogram voltage decrease during each application were analysed by logistic regression to correlate these parameters as potential predictors of single shot isolation.

Results

Single shot isolation was obtained in 64.1% of the veins. Applications that obtained persistent single shot isolation showed a higher impedance drop [22.5 ± 6.3 Ω vs 19 ± 5.3 Ω, p = 0.005] and a higher temperature rise [12.5 ± 4.4 ºC vs 10.3 ± 3.5 ºC, p = 0.008]. The voltage reduction of the electrograms collected by the balloon, on the other hand, did not differ significantly between the two groups [2.3 mV in single shot vs 2.2 mV in non-single shot applications, p = 0.4]. Univariate analysis by logistic regression showed impedance drop [OR per 1 Ω increase, 1.11, 95% CI 1.02-1.21, p = 0.007] and temperature increase [OR per 1°C increase, 1.15, 95% CI 1.02-1.3, p = 0.01] as significant predictors of single shot isolation.

Conclusions

Impedance drop and temperature rise during application were significant predictors of single shot isolation with Heliostar® RF balloon. The voltage reduction of the electrograms recorded by the balloon was not a predictor of single shot application.
Early pulmonary vein isolation in patients with heart failure
Authors: Toth P , Arnoth B , Komlosi F , Vamosi P , Szegedi N , Sallo Z , Perge P , Osztheimer I , Merkely B , Geller L , Nagy K V
Published: November 2023

Background

Atrial fibrillation (AF) and heart failure (HF) are often present simultaneously, leading to worse outcomes compared to the respective morbidity alone. Pulmonary vein isolation (PVI) is the most effective treatment modality and should be considered as first-line therapy, however, the optimal timing of the procedure is still unknown.

Purpose

We aimed to investigate the effect of early PVI on all-cause mortality and AF recurrence in patients with HF.

Methods

The data of 334 patients with symptomatic paroxysmal (n=118, 35.5%) or persistent (n=212, 63.5%) AF and HF with LVEF < 50% were analyzed, who underwent PVI using radiofrequency energy between 2010 and 2022. All available medical data of the patients were collected in a structured registry. Early PVI was defined as catheter ablation performed within 12 months of AF diagnosis. The median follow-up was 1524.5 [365.0-3939.0] days with a minimum of 365 days. Our primary endpoints were all-cause mortality and AF recurrence following 3-months blanking period.

Results

During the follow-up of the 334 patients, 164 (49.1%) experienced AF recurrence and 86 (25.8%) patients died. The median age was 64 [56.1-69.9] years. The median LVEF was 40% for early PVI and 38% for deferred PVI (p=0.057). Out of the 139 (41.6%) patients who underwent early PVI, 36 (25.9%) had AF recurrence and 83 (59.7%) were taking amiodarone. Patients who underwent early PVI had longer freedom from recurrence (median 1042.5 [474.8-1921.0] days for early PVI, median 424 [134.5-1153.0] days for deferred PVI). Early PVI predicted lower rate of AF recurrence (HR: 0.29, p<0.0001). Early ablation was not associated with mortality benefit. Among those who experienced AF recurrence, a repeat ablation was associated with better survival (HR: 0.29, p<0.0001).

Conclusions

Our study shows that early rhythm control therapy with catheter ablation may be more beneficial compared to deferred PVI in patients with AF and HF. A repeat ablation may be considered in case of arrhythmia recurrence in patients with AF and HF to reduce mortality.
Safety and efficacy of non-vitamin K antagonist oral anticoagulants compared to warfarin in patients with atrial fibrillation and end stage renal disease: a meta-analysis of randomized trials
Authors: Chao T , Lip G Y H , Chen S A
Published: November 2023

Background

Stroke prevention in patients with atrial fibrillation (AF) and end stage renal disease (ESRD) is difficult because of the lacking of high-quality evidence. Although there were few randomized trials comparing NOACs and warfarin in AF patients with ESRD, the small patient size prohibits these studies from making a conclusion. We aimed to perform a meta-analysis to evaluate currently available randomized trials in this special population.

Methods

We searched the literature for randomized clinical trials comparing NOAC to warfarin in AF patients with ESRD undergoing hemodialysis.

Results

A total of 3 randomized trials were identified from the literature (one for rivaroxaban [Valkyrie study] and two for apixaban [AXADIA-AFNET 8 and RENAL-AF]). About the principal efficacy outcome, NOACs did not decrease the risk compared to warfarin (relative risk [RR] 0.79, 95%CI 0.45-1.37) while a significant heterogeneity was noted (p = 0.03). In Valkyrie study, rivaroxaban had better efficacy outcome than warfarin (RR 0.57, 95%CI 0.43-0.75). For the safety outcome, the risk was similar between NOACs and warfarin (RR 0.81, 95%CI 0.52-1.27) without significant heterogeneity (p = 0.11)(Figure 1). The pooled event rate of 3 trials disclosed a high risk of all-cause mortality (39.9% for NOACs, 34.6% for warfarin) and cardiovascular mortality (10.1% for NOACs, 8.5% for warfarin) for AF patients with ESRD even on OACs (Figure 2).

Conclusions

This meta-analysis suggested that NOACs (rivaroxaban or apixaban) was at least as safe and effective as warfarin in AF patients with ESRD. Even on OACs, these patients remain at high risk of cardiovascular events and all-cause mortality. Integrated care and holistic management were important for this high-risk population.
Impact of bleeding events on mortality in patients with atrial fibrillation and silent left atrial thrombi: insight from the LAT trial
Authors: Okada M , Tanaka N , Tanaka K , Hirao Y , Harada S , Miyazaki N , Iwasa K , Egami Y , Masuda M , Inoue K , Sunaga A , Hikoso S , Sakata Y
Published: November 2023

Background

Thrombolytic therapy is important to prevent thromboembolism in patients with atrial fibrillation (AF) and left atrial (LA) thrombi. However, bleeding complications are a major concern.

Purpose

To investigate the incidence and prognosis of bleeding complications in patients with AF and silent LA thrombi.

Methods

An analysis was performed from the LAT trial, a multicenter observational study investigating outcomes of silent LA thrombi detected by trans-esophageal echocardiography (TEE) in AF patients. Of 17,436 patients who underwent TEE, 297 (median age, 70 years; 31% female, median CHA2DS2-VASc score of 4) were eligible for inclusion. Management of oral anticoagulants was at the physician’s discretion, and the follow-up period was set as 1-year. Major bleeding was defined as intracranial hemorrhage, bleeding requiring surgery or transfusion, or ≥4 g/dl decrease in hemoglobin level.

Results

Prescription rates of oral-anticoagulants at baseline and the final follow-up were 81.8% and 89.9%, respectively (p = 0.002). During a median follow-up of 385 (interquartile range, 365-411) days after the thrombi detection, the incidence of thromboembolism, major bleeding, and all-cause death was 5.7% (n = 17), 11.4% (n = 34) and 8.4 % (n = 25), respectively. Patients with thromboembolism were more likely experience subsequent death than those without thromboembolism (17.7% vs. 7.9%, log-rank p = 0.063). Similarly, patients with major bleeding more frequently experienced subsequent death than those without bleeding (20.6% vs. 6.8%, log-rank p = 0.002). Time-adjusted Cox regression analysis revealed a temporal association between major bleeding and subsequent death (hazard ratio, 3.72; 95% confidence interval 1.55–8.93; p = 0.003) as well as between thromboembolism and subsequent death (hazard ratio, 2.98; 95% confidence interval 0.89–9.99; p = 0.077).

Conclusions

In the LAT trial, about 10% of patients with AF and silent LA thrombi experienced major bleeding during 1-year follow-up. Not only thromboembolism but also major bleeding was strongly associated with subsequent death.
Oral anticoagulation among frail patients with atrial fibrillation: assessment of net clinical benefit in a nationwide cohort
Authors: Nielsen P B , Jensen M , Hoejen A A , Larsen T B , Lip G Y H , Ording A G , Soegaard M
Published: November 2023

Background

Frail patients with atrial fibrillation (AF) are often undertreated with oral anticoagulants (OAC), and evidence for the net clinical benefit of OAC is sparse.

Objectives

We examined the risk of thromboembolic events and major bleeding, and the association between age, frailty level, and net clinical benefit (NCB) of anticoagulation.

Methods

This was an observational cohort study based on Danish nationwide data. Frail patients aged ≥50 years with a Hospital Frailty Risk Score ≥5 and incident AF were identified from 2013-2018. Patients were categorized according to OAC therapy, and differences in thromboembolic events and major bleeding were studied after 1 year. The NCB of anticoagulation was assessed by the bivariate trade-off between thromboembolism and bleeding.

Results

We identified 36223 frail AF patients (median age 79 years, 50.5% female), of whom 61.8% started OAC therapy, while 38.2% were untreated despite indication for stroke prevention. At one year, the risk of thromboembolic events was 2.1% (95% CI 1.8 to 2.3%) among patients not receiving OAC versus 1.5% (95% CI 1.4 to 1.7%) in patients with OAC. The one-year bleeding risk was 3.2% (95% CI 2.9 to 3.5%) among patients without OAC and 3.5% (95% CI 3.2 to 3.8%) among anticoagulated patients. The NCB was 0.66% (95% CI 0.19% to 1.12%) suggesting a statistically significant benefit of OAC treatment.

Conclusion

Frail AF patients are often untreated with OAC in routine clinical care despite an indication for stroke prevention. The NCB when balancing thromboembolic events and major bleeding was in favor of anticoagulation but decreased with advancing age and increasing frailty.
Haemorrhagic stroke among patients with atrial fibrillation: preceding oral anticoagulation use and 30-day case fatality over 10 years
Authors: Tiili P , Putaala J , Halminen O , Lehtonen O , Haukka J , Niemi M O , Mustonen P , Linna M , Hartikainen J , Airaksinen K E J , Lehto M
Published: November 2023

Background and purpose

Oral anticoagulation (OAC) is the cornerstone of thromboprophylaxis in atrial fibrillation (AF) yet complicated by elevated bleeding risk. We examined the temporal evolution of OAC treatment on 30-day fatality in patients with AF and first-ever hemorrhagic stroke (HS).

Methods

We identified the study population from the nationwide registry-linking Finnish AntiCoagulation in Atrial Fibrillation (FinACAF) study. Patients were eligible if the incident AF was diagnosed between January 2009 and November 2017, with a subsequent first-ever HS (ICD-10 I60* or I61*) recorded in hospital or death registries before December 2018. OAC purchases in the previous 90 days were registered.

Results

Over the ten-year period, 1,890 patients experienced their first-ever HS (53% women, median age 79.5 [IQR 72.5-85.5]). Of these, 1,039 (55%) had a recent OAC purchase. The 30-day case fatality was 45.4% (n=858, 57% women) and did not vary by prior OAC purchase (warfarin 47%, Non-Vitamin K Antagonist Oral Anticoagulants 41%, none 45%). The proportion of patients without OAC decreased from 67% to 34%, while case fatality increased between 2009 and 2011 from 42% to 54% and then decreased from 54% to 43%.

Conclusions

Despite the near-doubled proportion of patients with AF exposed to OAC prior to their first-ever HS, their 30-day case fatality rate decreased slightly over 10 years. These results suggest that the recent evolution of OAC treatment is associated with improved outcomes in the AF population.
Effect of perceived and objectively-assessed frailty on outcomes in edoxaban-treated patients with atrial fibrillation: data from the ETNA-AF-Europe 4-year follow-up
Authors: Fumagalli S , Diemberger I , Bakhai A , Pecen L , Lamparter M , Kirchhof P , De Caterina R
Published: November 2023

Background

Frailty is common in patients with atrial fibrillation (AF). However, different definitions of frailty are used, and these may variably overlap with frailty perception among physicians. Long-term data on outcomes based on perceived versus objective frailty in patients with AF treated with a non-vitamin K antagonist oral anticoagulant are lacking.

Purpose

To assess the effect of perceived versus objective frailty on outcome events in patients with AF treated with edoxaban during the 4-year follow-up of the ETNA-AF-Europe registry (NCT02944019).

Methods

ETNA-AF-Europe is a multinational, multicentre, post-authorisation, observational study conducted in patients with AF receiving edoxaban. In this sub-analysis, patients were evaluated in terms of perceived or objective frailty status (yes or no categories). Perceived frailty was based on investigators’ own clinical binary judgement in each patient. Objective frailty was determined using a Modified Frailty Index, a simplified adaptation of the Rockwood’s Frailty Index. Patient demographics and characteristics were collected at baseline. The efficacy and safety outcomes are reported here comparing frailty status (yes versus no) among perceived or objectively classified patients.

Results

Among the 13,164 patients with 4 years of follow-up, the prevalence of perceived and objective frailty was 10.7% and 4.1%, respectively. Compared with the objectively frail group, those perceived as frail were older, with a lower proportion of males, had lower body weight and creatinine clearance values, yet lower CHA2DS2-VASC and modified HAS-BLED scores (Table 1). Further, patients with objective frailty tended to have more comorbidities (e.g., diabetes, heart failure, hypertension; Table 1). Those deemed frail were more likely to receive the reduced 30 mg edoxaban dose versus non-frail patients (p<0.001 for both groups), and non-recommended dosing regimens (60 or 30 mg) were more often prescribed in frail versus non-frail patients (p<0.0001 for all comparisons; Table 1). Patients perceived as frail had a significantly higher risk of all evaluated outcomes compared with non-frail patients (p-value range: <0.0001 – 0.0459; Figure 1). Similar data were seen for objectively frail patients, with the exception of no significant differences in the risk of intracranial haemorrhage (ICH, p=0.0918) or haemorrhagic stroke (p=0.1619; Figure 1).

Conclusions

Frailty was associated with an inappropriate dosing of edoxaban and an increased incidence of outcome events, quantitatively similar in the perceived and objective frailty groups. After 4 years of therapy, even if ICH risk was increased in frail subjects, its cumulative incidence was low.
Long-term effectiveness and safety of edoxaban in patients with atrial fibrillation: 4-year follow-up of more than 13,000 patients from the ETNA-AF-Europe study
Authors: Kirchhof P , Bakhai A , De Groot J R , Deharo J C , Levy P , Lopez-De-Sa E , Monteiro P , Steffel J , Waltenberger J , Fronk E M , Lamparter M , Laeis P , Smolnik R , De Caterina R
Published: November 2023

Background

Direct, non-vitamin K antagonist oral anticoagulants (DOACs/NOACs) have become the first-choice therapy for stroke prevention in patients with atrial fibrillation (AF) at risk of stroke. Data on long-term effectiveness and safety of NOACs are scarce and not available from randomised clinical trials.

Purpose

We analysed 4-year outcome data in 13,632 European patients with AF treated with the NOAC, edoxaban.

Methods

This is the first report of the four-year follow-up information collected in the ETNA-AF-Europe (NCT02944019) study. It is a prospective registry, conducted in 825 centres enrolling edoxaban-treated patients in 10 European countries. Design and follow-up were agreed with the European Medicines Agency as part of the post-approval safety assessment of edoxaban. Key efficacy and safety outcomes were adjudicated.

Results

13,164 patients (56.7% males) with AF treated with edoxaban (60 mg OD n=9617; 30 mg OD n=3042; missing dose n=505) were analysed: median (interquartile range [IQR]) age was 75 (68–80) years, weight 80 (70–90) kg, creatinine clearance (CrCl) 68.9 (52.7–87.9) mL/min, modified CHA2DS2-VASc and HAS-BLED scores 3 (2–4) and 2 (1–2), respectively in the overall population.

Annualised all-cause and cardiovascular deaths in the overall population were 4.1%/year and 1.0%/year, respectively; higher in the edoxaban 30 mg vs 60 mg cohort (Figure 1). Annualised rates of stroke, transient ischaemic attack and systemic embolic events rates were <1% (0.6%/year, 0.3%/year and 0.1%/year, respectively); these proportions were similar between the two dose cohorts (Figure 1). The time-to-first event curves for all-cause death, stroke and major bleeding were almost linear throughout the 4-year follow-up (Figure 2), irrespective of dose cohort.

Compared with patients receiving edoxaban 60 mg, those prescribed 30 mg were older (median [IQR] age: 80 [75–85] vs 73 [66–78] years), had greater frail proportion (27.0% vs 6.6%), a lower CrCl (46.1 [37.4–59.0] vs 75.9 [61.9–93.8] mL/min) and a higher CHA2DS2-VASc score (4 [3–5] vs 3 [2–4]). Annualised bleeding rate was 3.0%/year and higher in the 30 mg vs 60 mg cohort (Figure 1). Annualised major bleeding, intracranial haemorrhage (ICH) and major gastrointestinal (GI) bleeding rates were low (0.9%/year, 0.2%/year and 0.4%/year, respectively), with higher major bleeding and major GI bleeding rates in patients treated with edoxaban 30 mg OD (Figure 1). ICH rates were similar in both dose cohorts.

Conclusion

These findings illustrate the long-term effectiveness and safety of edoxaban. Treatment with edoxaban over 4 years in patients with AF is associated with a relatively low, linearly increasing rate of all-cause death and ischaemic stroke. Rates of bleeding and especially ICH rates were low.
Sex disparities in outcomes of left atrial appendage occlusion
Authors: Ahmed R , Ramphul K , Deshpande S A U R A B , Sawatari H , Sherif A , Wafa E I , Mohammed S , Padmanabhan D E E P A K , Veillet-Chowdhury M R , Benton S , Schuler B , Khanji M , Chahal A
Published: November 2023

Background

Atrial fibrillation (AF) is the most common arrhythmia in adults and is associated with an increased risk of embolic stroke. Left atrial appendage occlusion (LAAO), such as Watchman device, has demonstrated non-inferiority to anticoagulation in clinical trials for prevention of stroke in non-rheumatic AF. However, sex differences in outcomes of LAAO implantation have not been studied using a large real-world database.

Purpose

To identify the sex disparities in outcomes of LAAO

Methods

Data from the 2016-2020 National Inpatient Sample (NIS) were used to identify patients of ages ≥18 with a primary diagnosis of atrial fibrillation/flutter and a primary/secondary procedure code for LAAO. Various patient characteristics, comorbidities, and complications were also identified and compared. Propensity-matched cohorts were extracted after adjusting for multiple comorbidities and demographics.

Results

A total of 87,790 procedures of LAAO were performed between 2016-2020, with 58.4% males and 41.6% females. Whilst a yearly rise in the number of procedures was also observed, the trend was not statistically significant (ptrend=0.318) (Figure 1). Post-matching 6,842 males and 7,303 females were retained in our study. Females had a higher mean CHA2DS2-VASc score (4.6 vs.3.7, p<0.01) and longer length of stay than males (1.38 vs. 1.24 days, p<0.01). Furthermore, a higher incidence of cardiac tamponade (1.1% vs. 0.3%, p<0.01, aOR 3.642, 95% CI 2.231-5.946), need for mechanical ventilation (0.7% vs. 0.3%, p<0.01, aOR 1.994, 95% CI 1.168-3.401), and pericardial effusion (3.9% vs. 2.8%, p<0.01, aOR 1.359, 95% CI 1.124-1.643) were noted amongst females vs. males. Though post-procedure, females reported a higher incidence of acute kidney injury (2.2% vs. 1.9%, aOR 1.175, 95% CI 0.918-1.504, p=0.199), intra/post-operative haemorrhage (0.6% vs. 0.4%, aOR 1.635, 95% CI 0.981-2.726), and device failure (0.7% vs. 0.5%, aOR 1.118, 95% CI 0.692-1.806, p=0.650), this was not statistically significant. In addition, no differences were observed in the mean modified HAS-BLED score between the two groups (1.9 vs. 1.9, p=0.398) (Table 1).

Conclusions

By using a large propensity matched cohort of patients who have undergone LAAO procedure for AF, this study has demonstrated that length of stay, pericardial effusion, cardiac tamponade and need for mechanical ventilation are higher in females as compared to males. These findings necessitate the development of strategies to reduce the increased risk of adverse events for females.Figure 1
Safety and healthcare resource utilisation in patients undergoing left-atrial appendage closure - A nationwide analysis
Authors: Thevathasan T , Degbeon S , Paul J , Fuereder L , Gaul A L , Scheitz J F , Stadler G , Rroku A , Lech S , Buspavanich P , Huemer M , Reinthaler M , Landmesser U , Skurk C
Published: November 2023

Background

Percutaneous left-atrial appendage closure (LAAC) has emerged as a non-pharmacological alternative for stroke prevention in patients with atrial fibrillation (AF) not suitable for anticoagulation therapy. Real-world data on peri-procedural outcomes are limited.

Purpose

To analyse outcomes of peri-procedural in-hospital safety and healthcare resource utilisation after percutaneous LAAC.

Methods

The US National Inpatient Sample was utilised to identify AF patients undergoing LAAC from 2016 to 2019. Primary outcomes (safety) were in-hospital stroke or systemic embolism (SE), pericardial effusion (PE), major bleeding, device embolisation and mortality. Secondary outcomes (resource utilisation) were adverse discharge disposition, hospital length of stay (LOS) and treatment costs. Logistic and Poisson regression models were used to analye outcomes by adjusting for 10 confounders.

Results

11,240 adult patients (with 41.9% being female) with AF undergoing LAAC were included. SE decreased by 97% between 2016 and 2019 [95% Confidence Interval (CI) 0-0.24] (P=0.003), while a trend to lower numbers of other peri-procedural complications was determined. In-hospital mortality remained stable (0.14%). Hospital LOS decreased by 18% (0.78-0.87, P<0.001) and adverse discharge rate by 41% (95% CI 0.41-0.86, P=0.005) between 2016 and 2019, while hospital costs did not significantly change (P=0.2). Of note, female patients had a higher risk of PE (OR 2.86 [95% CI 2.41-6.39]) and SE (OR 5.0 [95% CI 1.28-43.6]), while patients with multiple comorbidities had higher risks of major bleeding (P<0.001), mortality (P=0.031), longer hospital LOS (P<0.001) and increased treatment costs (P=0.073). Male patients had the most peculiar decrease in adverse discharge rate between 2016 and 2019: OR 0.45 [95% CI 0.27-0.77]. Significant differences in all outcomes were observed between male and female patients across US regions (Figure). Subgroup analyses confirmed that female patients had a prolonged LOS and higher risk of adverse discharge disposition than male patients.

Conclusions

LAAC has become a safer and more efficient procedure. Significant sex differences existed across US regions. Careful considerations should be taken when performing LAAC in female and comorbid patients.
Left atrial appendage occlusion indicated by increased thrombotic risk versus increased bleeding risk: a comparison of the stroke despite anticoagulation (STR-OAC) and EWOLUTION cohorts
Authors: Aarnink E , Maarse M , Fierro N , Tondo C , Pracon R , De Backer O , Nielsen-Kudsk J , Benito-Gonzalez T , Nombela-Franco L , Arzamendi D , Alla V , Swaans M , Vireca E , Bergmann M , Boersma L
Published: November 2023

Background

Left atrial appendage occlusion (LAAO) provides mechanical cardioembolic protection, especially attractive for atrial fibrillation (AF) patients that cannot use oral anticoagulation therapy (OAC). Patients with prior stroke despite OAC are at high risk for recurrence and may also benefit from LAAO as (adjunctive) therapy.

Purpose

To investigate the efficacy of LAAO in AF patients with prior stroke on OAC compared to LAAO in AF patients with a contra-indication to OAC.

Methods

The STR-OAC LAAO is an international collaboration combining patients that underwent successful percutaneous LAAO because of a thrombo-embolic event or LAA thrombus on OAC from multiple LAAO registries (n=439). This cohort was compared to patients from the previously published EWOLUTION registry comprising of patients that successfully underwent LAAO because of a contra-indication for long-term OAC (n=1005). Thrombotic endpoints were prespecified and (non-procedural) major bleeding was defined as BARC score>2. Annualized event rates were calculated and compared to historical data based on individual patient risk scores.

Results

Both cohorts were comparable in terms of age and sex (Table 1). CHA2DS2-VASc and HAS-BLED scores were higher in the STR-OAC cohort. After LAAO indicated by a thrombotic event despite OAC, 33% of patients had a planned lifelong hybrid strategy approach of concomitant LAAO and OAC. Consequently, STR-OAC patients often continued OAC (with or without antiplatelet therapy), whereas EWOLUTION patients were more frequently discharged with antiplatelet therapy only. The annualized event rate (AER) for composite thrombotic events was slightly higher in the STROAC-LAAO compared to the EWOLUTION patients (4.2% versus 2.0%), possibly due to the higher thrombotic risk of this population. Major bleeding occurred more frequently in the EWOLUTION compared to STROAC-LAAO patients (AER 2.6% versus 1.1%, Table 2). In comparison to historically expected event rates, relative risk reduction (RRR) for thrombo-embolic events was 65% in the STR-OAC cohort, and 80% in the EWOLUTION cohort (Fig. 1). Annualized major bleeding rates were reduced with 81% and 46% in the STR-OAC-LAAO and EWOLUTION cohorts, respectively.

Conclusions

LAAO in AF patients with a thrombotic event despite OAC provides ischemic stroke protection similar to a guideline-recommended population with high bleeding risk. RRR for thrombotic events was more pronounced in the population contra-indicated for long-term OAC, while RRR for major bleeding was more pronounced in the patients that experienced a thrombotic event on OAC. Randomized trial data could endorse thrombotic event despite OAC as an indication for LAAO.Table 1&2Figure 1
Biatrial flutters: unique circuits requiring a customized ablation approach
Authors: Brito J , Valente Da Silva P , Alves Da Slva P , Martins A M , Nunes Ferreira A , Lima Da Silva G , Cunha N , Ricardo I A , Ribeiro J , Carpinteiro L , Cortez-Dias N , Pinto F J , Sousa J
Published: November 2023

Introduction

Atrial futters are macroreentrant tachycardias that typically involve several walls of a certain atrium, being the other atrium passively activated. Biatrial flutters (BAF) are peculiar macro-reentries associated with anterior/septal scars, involving both atria and using the interatrial connections.

Purpose

To characterize the mechanism of BAF a cohort of patients (pts) submitted to mapping and ablation.

Methods

Retrospective single-center study of pts with atypical atrial flutter submitted to ablation from 2015 to 2022. High resolution electroanatomical voltage and activation mapping were collected using Carto, Ensite or Rhythmia. Whenever the arrhythmia circuit was not fully displayed in a certain atrium, of the other atrium was mapped to fully characterize the reentrant circuit and establish the critical isthmus. Biatrial circuits were classified into 4 types: type 1, involving the mitral annulus and the tricuspid annulus, escaping the septal wall in both atria; type 2 using most of the mitral annulus and the right atrium (RA) septum; type 3, using both the left atrium (LA) and RA septum; and type 4, using most of the tricuspid annulus and the LA septum. Acute and long-term success was evaluated.

Results

From a total of 107 pts submitted to atypical flutter ablation, 5 pts presented BAF (3 male, median age: 55-yo), 4 of them previously submitted to cardiac surgery (CABG in 1, mitral valvuloplasty in 1, mitral+tricuspid valvuloplasty in 1 and surgical correction of aortic coarctation and ostium primum atrium septal defect in 1) and 1 had been previously submitted to pulmonary vein isolation (PVI), empirical roof line and cavotricuspid isthmus (CTI) ablation. A proximal-to-distal coronary sinus activation and extensive low-voltage areas at the septum were recognized in all these pts. The BAF mechanism was single loop in all of them, with a type 2 circuit in 2 pts, and types 1, 3 and 4 in one patient each. BAF types 1 and 4 were terminated with CTI ablation. BAF types 2 and 3 were terminated with linear ablations from the mitral annulus to the right superior PV, complemented with focal applications at Bachmann bundle insertion sites in the pts with type 2 BAF. Acute success was achieved in all pts. During a mean time of follow-up of 344±91 days, 1 pt had AFl recurrence.

Conclusion

BAF is a rare and complex arrhythmia, which is possible to ablate successfully by applying high-density mapping tools, a comprehensive analysis of the substrate/activation maps and a mechanism-tailored ablation strategy.
Predictive capacity of combined P-wave-indices-CHA2DS2-VASc Score in sinus node dysfunction patients without atrial fibrillation
Authors: Dong H , Zhang Y , Yang Y , Wang S , Wei Y , Liu F , Li Z , Zhang J , Xia Y , Yang X
Published: November 2023

Background and Aims

Isolated sinus node dysfunction (ISND) is sinus node dysfunction without atrial fibrillation. A high risk of ischemic stroke (IS) has been reported in western ISND populations, but its epidemiology in Chinese populations remains unknown. Moreover, anticoagulation therapy is not recommended in ISND management under current guidelines, partially due to the lack of a precise predictive score to evaluate IS risk. In Chinese ISND patients, IS incidence and IS-risk prediction capacity of a new score incorporating P-wave indices (PWIs) should be investigated.

Methods

In this longitudinal cohort study with prospective design, 1185 ISND patients were analyzed. Hazard ratios (HRs) and 95% CIs of PWIs for IS were estimated by Cox proportional hazards models. Based on HRs of significantly abnormal PWIs and CHA2DS2-VASc score, new score was constructed. IS prediction improvement was assessed by discrimination, calibration, and clinical effectiveness. The cutoff value of the new score was explored by restricted cubic spline analysis.

Results

124 (10.46%) ISND patients developed IS (yearly rate: 1.63%; 95% CI: 1.49%-1.78%) after a median follow-up time of 3.02 years. In them, P-wave terminal force in ECG-lead V1 (PTFV1) was the only significantly abnormal PWI (adjusted HR: 2.56; 95% CI: 1.72–3.80). We incorporated PTFV1 results with the CHA2DS2-VASc score to generate a P-combined score. For 5-year IS risk, P-combined score improved the area under the receiver operating characteristic curve (95% CI) from 0.647 (0.590-0.703) to 0.706 (0.652-0.760) and improved Harrell's C-statistic (95% CI) from 0.678 (0.618-0.738) to 0.716 (0.657-0.774). The categorical net reclassification improvement and the relative integrated discrimination improvement were 0.248 (0.120-0.363) and 0.021 (0.008-0.035), respectively. The calibration and decision curve analysis shown improvement at the same time. The cutoff value (P-combined score=3) by restricted cubic spline analysis was confirmed.

Conclusions

Chinese ISND patients have a higher IS risk than the general population. Incorporating PWIs into a P-combined score increased IS prediction capacity for ISND patients. Accurate stratification of IS risk should facilitate anticoagulation therapeutic strategies in ISND patients after further randomized trials with P-combined score-predicted high-risk ISND patients.Structured Graphical Abstract
Prevalence and awareness of vasovagal syncope in a large cohort study
Authors: Tajdini M , Bijar A R E F , Sadeghian S A E E D , Vasheghani-Frahani A L I , Bozorgi A L I , Mehrani M E H D I
Published: November 2023

Background

Despite the important nature of vasovagal syncope, the true prevalence of this disorder is not fully determined. Based on the limited data available in the literature, among young medical students less than 21 years, the prevalence of vasovagal syncope has been estimated to be 39%, increasing to 50% in life time for all subjects. There are no robust studies with adequately powered sample size to assess the prevalence of this disorder in the general population.

Purpose

In this study, we aimed to determine the prevalence of vasovagal syncope in a large general population by conducting a cross-sectional survey.

Methods

A systematic sampling method was used to enroll a representative sample of adults from all metropolitan areas. A total of 4,215 households including 9,170 adults over 35 years were invited for interviews and 8,296 individuals (90.5%) participated in the study. The participants were interviewed using comprehensive questionnaire, detailed history, 12 leads electrocardiogram and physical examination. Participants with a history of transient loss of consciousness were asked to complete detailed assessments based on the Calgary Syncope Symptom Score.

Results

Of the 8,296 subjects, 447 (5.4%) reported transient loss of consciousness and 406 (4.9%) had a score greater than -2 on the Calgary Syncope Symptom Score in favor of vasovagal syncope. The overall prevalence of vasovagal syncope was 4.9% (73.7% were female). The percentage was 2.9 and 6.5 in men and women respectively. Although 53% of the patients had 2 or more syncopal attacks in their lifetime and 23% of all attacks were traumatic, only 26 percent of patients were aware of the diagnosis and consulted a physician. The age distribution of vasovagal syncope in women after 25 years follows a decreasing pattern. In men, the prevalence of syncope increases until the age of 50 and decreases thereafter (Figure). There were no differences between patients with vasovagal syncope and other participants in terms of ECG findings and cardiovascular risk factors (Table).

Conclusions

Vasovagal syncope has a notable prevalence in the general population and women are mostly affected. Recurrences (even traumatic ones) happen but only a few of patients know their diagnosis and basic treatments such as life style modifications. This is the first study to report the prevalence of vasovagal syncope in the general population and population-based educational programs are strongly recommended given the high recurrence rate, risk of trauma and decreased quality of life.
Atrioventricular-synchronous leadless pacemakers: a single center experience
Authors: Reis Santos R , Gomes D , Cavaco D , Carmo J , Paiva M S , Lopes P M , Matos D , Rodrigues G R , Carvalho M S , Costa F M , Santos P G , Carmo P , Morgado F B , Adragao P
Published: November 2023

Background

Leadless pacemakers allow atrioventricular (AV) synchronous pacing using a new software to detect atrial contraction with a 3- axis accelerometer. Notwithstanding, evidence supporting its use is still scarce and only limited real-world data have been reported.

Aim

To evaluate the feasibility and to describe pacing outcomes of AV-synchronous leadless pacemakers.

Methods

Consecutive patients with AV block referred to leadless pacemaker MicraTM at single center between June 2020 and November 2022 were retrospectively included. Patients were evaluated at two distinct times during follow-up and parameters from sensed atrial tracking were calculated: tracking index (atrial mechanical sense followed by ventricular pace [AM-VP] divided by total VP) and total AV synchrony (sum of AM-ventricular sense [AM-VS], AM-VP, and AV conduction mode switch).

Results

A total of 43 patients (mean age 78 ± 11 years; 72% male) were included. Pacing indication was complete AV block in 29 patients (67%) and high-grade AV block in the remaining 14 (33%). Mean implantation and fluoroscopy times were 48 ± 22 minutes and 4.5 ± 3.9 minutes, respectively. One major peri-procedural complication was reported: a cardiac tamponade, treated with pericardiocentesis. The first outpatient visit occurred at a mean follow-up of 3.2 ± 4.1 months after the implantation procedure. Overall, at the first screening, 47% of patients required at least 50% pacing; mean tracking index was 65 ± 16% and mean total AV synchrony was 80 ± 18%. Specific pacemaker parameters were adjusted according to physician’s discretion, namely A3 and A4 thresholds and A3 window. Thirty-seven patients performed 2 follow-up visits, 8 ± 5 months after the first visit. In comparative analysis between both follow up times, mean total AV synchrony remained stable (80 ± 17% vs. 80 ± 15%, p=0.970) and there was a numerical improvement of tracking index by 6 ± 13% (65 ± 15% vs. 71 ± 16%, p=0,059). During the follow-up, 7 patients (16%) died, none related to the procedure nor the device.

Conclusions

Implantation of AV-synchronous leadless pacemakers is feasible and safe. In our cohort, there was a numerical increased of atrial tracking and a stability of AV synchrony during follow-up.
The number of screwing attempt and predictors for the success of left bundle branch area pacing : A multicenter experience with standard stylet-driven pacing leads
Authors: Kim T H , Yu G I , Yu H T , Uhm J S , Kim D , Joung B , Pak H N , Lee M H
Published: November 2023

Objectives

Although Left Bundle Branch Area Pacing (LBBAP) is emerging conduction system pacing modality, it is unclear which parameters are predictive of procedural success and how many screwing attempts are acceptable. This retrospective observational study sought to assess predictors of successful LBBAP, left bundle branch (LBB) capture, and factors associated with the number of screwing attempts.

Methods

We performed a multicenter retrospective analysis of 120 patients who underwent LBBAP with stylet driven lead. We analyzed factors affecting the number of screwing attempts and procedural success. Procedural, 12-lead ECG, echocardiographic parameters and clinical variables were used in multivariate analyses.

Results

LBBAP success rate was 95.8% (115/120), and LBB capture success rate was 86.1% (99/115). Few screwing attempts was associated with procedural success (2.1 ± 1.2, 2.7 ± 1.2, and 3.5 ± 1.3 in LBBAP with LBB capture, LBBAP without LBB capture and failed LBBAP group, respectively) (p for trends=0.03). 4 or more screwing attempt was independently associated with higher complication rate compared to fewer screwing attempt (n≤3) (p<0.05). The larger RA size (B = 1.901, 95% confidence interval [CI] 1.07 - 2.73, p <0.001), smaller RV size (B = -0.995, 95% CI -1.88 - -0.31, p = 0.007), and intraventricular conduction delay (IVCD) at pre-implant ECG were independently associated with more screwing attempts. Larger RA size (4th quartile) was associated with larger final sheath size and frequent sheath size change to larger sheath when compared to others.

Conclusions

More screwing attempts was associated with failed LBBAP procedure and failed LBB capture, and 4 or more screw attempts was associated with higher complication rate. Larger the RA size, smaller the RV size, and IVCD in pre-implant ECG are predictive of more screwing attempt.
Prediction of sinus tachycardia after cardioneuroablation: the utility of atropine test
Authors: Stiavnicky P , Haskova J , Peichl P , Stojadinovic P , Borisincova E , Jansova H , Cihak R , Kautzner J , Wichterle D
Published: November 2023

Background

Acceleration of sinus rhythm (SR) due to parasympathetic denervation of sinus note is a favourable sign during cardioneuroablation (CNA) for the treatment of functional bradyarrhythmias. On the contrary, a faster heart rate may be symptomatic in some patients.

Purpose

We investigated predictors of sinus tachycardia at the 3-month post-CNA visit.

Methods

An atropine test (2 mg IV) was performed before the procedure. The endpoint of CNA was complete denervation of the sinus node as assessed by extracardiac vagus nerve stimulation. Sinus tachycardia was defined as a sinus rate ≥100 bpm at the 3-month post-CNA outpatient visit. Factors independently associated with post-CNA SR were investigated by multivariate analysis. Using regression coefficients, a composite continuous-scale index (CCSI) estimating the post-CNA SR was constructed and used for sinus tachycardia prediction.

Results

The study included 160 patients aged 40 ± 12 years, 56% men, with baseline SR of 63 ± 15 bpm, post-atropine SR of 107 ± 21 bpm, and SR 3-month post-CNA SR of 83 ± 15 bpm. Nineteen patients had sinus tachycardia at a 3-month visit after CNA. Age, gender, baseline SR and post-atropine SR were significantly (and the latter two independently) associated with 3-month post-CNA SR. The CCSI (defined as 36 + 0.32 * baseline SR + 0.25 * post-atropine SR) correlated with 3-month post-CNA SR (Figure) and provided an area under the curve of 0.87 in the analysis of receiver operating characteristic. The CCSI >90 predicted the 3-month post-CNA sinus tachycardia with a sensitivity of 74% and specificity of 86%.

Conclusion

Sinus tachycardia at 3 months after CNA can be predicted by the baseline and post-atropine sinus rate. This can help to select patients who may benefit from less rigorous sinus nodal denervation to avoid potentially symptomatic sinus tachycardia after the CNA.
Homozygous or compound heterozygous variants in DSG2 are mainly causative of Japanese arrhythmogenic right ventricular cardiomyopathy
Authors: Sonoda K , Nagase S , Aiba T , Kato K , Fukuyama M , Kikuchi N , Shiga T , Horie M , Ohno S
Published: November 2023

Background

Arrhythmogenic right ventricular cardiomyopathy (ARVC) is an inherited cardiomyopathy mainly caused by desmosomal gene variants. Previously, we showed that the genetic backgrounds of ARVC in Japanese was different from those in Caucasian and that DSG2 was the most common causative gene.

Purpose

We aimed to confirm the inheritance mode of Japanese ARVC caused by pathogenic variants in DSG2. Furthermore, we reassessed the difference of phenotypes depending on the genotype.

Methods and results

Among 153 ARVC probands diagnosed with definite, borderline or possible by TFC2010 excluding the criteria of family history, 66 had one or more DSG2 variants (25 homozygous, 26 compound heterozygous, 11 multiple variants with unknown allele origin and 4 heterozygous). In the family screening, 62 relatives carried DSG2 variants (2 homozygous, 6 compound heterozygous, 54 heterozygous). All family members with a heterozygous DSG2 variant were not fulfilled ARVC diagnostic criteria. These results indicate that most of ARVC caused by DSG2 variants is an autosomal recessive disease. Therefore, 62 probands who have multiple DSG2 variants were included as pathogenic DSG2 variants carriers in following analysis. Figure A shows the genotypes in Japanese ARVC probands. We compared the clinical characteristics of the probands with DSG2 variants to those with PKP2 ones (N = 28). DSG2 variant carriers hospitalized for heart failure at younger age (42 ± 17 vs. 64 ± 13 years, P = 0.003) and had lower LVEF at diagnosis (51 [39 - 60] vs. 60 [55 - 65] %, P = 0.004). On the other hand, PKP2 variant carriers suffered atrial fibrillation more frequently (N = 7 (25%) vs. N = 5(8%), P = 0.04) and sustained VT at younger age though it was not statistically significant (38 ± 18 vs. 47 ± 15 years, P = 0.055). Finally, we analyzed the genotype effect on the incidence of lethal ventricular arrhythmia (LVA). The cumulative incidence in probands with each causative gene is shown in Figure B. Using multivariable analysis, we confirmed that PKP2 variant carriers had higher risk for LVA after adjusted by sex, medication, catheter ablation and device implantation (HR 2.904; 95% CI 1.530 – 5.513, P = 0.001).

Conclusion

DSG2 was the most common causative gene for ARVC in Japanese, and their mode of inheritance was mainly autosomal recessive. While DSG2 variants were associated with LV involvement and heart failure, PKP2 variants were risk for ventricular arrhythmia. Our findings would be helpful for diagnosis and prognosis for the ARVC patients.Genotype of Japanese ARVC probandsCumulative incidence of LVA