bluuebunny/crossref_metadata_2025 huggingface dataset:
Comparison of complications during catheter ablation of atrial fibrillation between radiofrequency and cryoballoon ablation: insights from a nation-wide claims-based database
Authors: Miyamoto K , Tonegawa-Kuji R , Murata S , Takegami M , Nishimura K , Kusano K
Published: October 2024

Background

Few large-scale, real-world studies have compared the safety of radiofrequency (RF) catheter ablations (CA) with that of cryoballoon ablations of atrial fibrillation (AF), especially in east Asian countries.

Methods

This retrospective, cross-sectional study used a nationwide administrative claims database, to compare complication-incidence rates between patients who underwent RFCA and cryoballoon ablation of AF. We used data from Medical Data Vision Co., Ltd, that is derived from the health claims, Diagnosis Procedure Combination (DPC) system, and flat-fee payment system in Japan. We first extracted hospitalization records with CA with diagnosis of AF. Exclusion criteria were 1) records with diagnoses of atrial flutter or atrial tachycardia, 2) patients aged <20 years old, 3) CA of AF performed other than RFCA or cryoballoon, 4) records with insufficient clinical data, and 5) patients who were prescribed both direct oral coagulants and warfarin. Complications were defined using the following ICD-10 diagnosis codes: major bleeding (I31.9, I97.1, J98.5, J048, J0021); thromboembolism (H342, I24, I269, I740, I741, I744, I748, I749, K550, K868, N280, or T790); ischemic stroke (G45, or I63); cardiac tamponade (I31.9, I97.1, or J98.5); and vascular access complications (hematoma: S701, S801, T140 or T810; and/or pseudoaneurysms: I72.4). Logistic regression analyses were performed to estimate odds ratios and 95% confidence intervals (CI) for major bleeding, systemic thromboembolism, ischemic stroke, and cardiac tamponade.

Results

Among the 32,797,540 records between June 2011 and August 2020 from 426 hospitals, 41,347 records who underwent CA of AF (Median 68 [60–74] years old, 30.2 % women) were included in the study. A total of 36,729 RFCA (88.8%) and 4,618 cryoballoon ablation (11.2%) cases were included in the cohort. Major bleeding, systemic thromboembolism, ischemic stroke, cardiac tamponade, and vascular access complications occurred in 194 (0.5%), 193 (0.5%), 116 (0.3%), 414 (1.0%) and 115 (0.3%) patients, respectively. As a result of logistic regression analysis, when cryoballoon ablation was used as a reference, RFCA was associated with higher risk of cardiac tamponade (OR 1.54, 95% CI 1.09–2.25, P = 0.02), while it was not associated with higher or lower risk of other complications (major bleeding OR [95% CI ]1.21 [0.77–2.04]; thromboembolism 1.74 [1.03–3.22]; ischemic stroke 1.88 [0.94–4.47]; vascular access complication; 1.00 [0.58–1.87]).

Conclusion

Compared to cryoballoon ablations, RFCA was associated with higher risk of cardiac tamponade, using nationwide administrative claims database.
The efficacy and safety of NOAC in very elderly atrial fibrillation patients; data from the Korean national health insurance cohort registry
Authors: Choi S , Baek Y S , Lee Y C , Yoon G S
Published: October 2024

Background

Data regarding efficacy and safety on anticoagulation in very elderly atrial fibrillation patients are relatively sparse.

Purpose

We investigated the clinical benefit of anticoagulation with NOAC in very elderly AF patients through national healthcare insurance registry.

Methods

Clinical data of 862,935 patients who were diagnosed with AF from 2015 to 2020 were collected for analysis. Patients under the age of 85, prior history of ICH, GI bleeding and prior prescription days of aspirin, warfarin and NOAC exceeding 90 along with follow up period less than 90 days were excluded.

Results

A total of 10,625 patients were eligible for analysis. Patients with OAC (HR: 0.60, 95% CI 0.53-0.69), p<0.001) showed higher efficacy regarding systemic embolism compared to aspirin (HR: 0.84, 95% CI 0.74-0.95, p=0.008) and no treatment group. Individual comparison of NOAC and aspirin via propensity score matching showed that patients with NOAC (HR: 0.71, 95% CI 0.61-0.85), p<0.001) showed higher event free survival regarding systemic embolism compared to aspirin. Bleeding risk was also higher for NOAC (HR: 1.28, 95% CI 1.07-1.56, p=0.006) group but did not result in commensurate increase in mortality (HR:0.60, 95% CI 0.45-0.81, p<0.001).

Conclusions

Anticoagulation with NOAC in very elderly patient showed higher event free survival regarding systemic embolism. Despite having higher event rate of bleeding, eventual death did not show any association with NOAC.
Impact of body weight and body mass index on clinical outcomes of edoxaban therapy in atrial fibrillation patients included in the ETNA-AF-Global registry
Authors: Boriani G , Souza J , Steffel J , Koretsune Y , Chao T F , Weiss T , Zaremba-Pechman L , Borrow A P , Unverdorben M , De Caterina R
Published: October 2024

Background

In atrial fibrillation (AF) patients (pts) receiving non-vitamin K antagonist oral anticoagulant therapy, extreme body weights, both obesity and low body weight, may impact clinical outcomes.

Purpose

To determine the impact of body weight and body mass index (BMI) on clinical outcomes in AF pts receiving edoxaban from the Global ETNA program (Europe [NCT02944019], Japan [UMIN000017011], Korea/Taiwan [NCT02951039], Hong Kong [NCT03247582] and Thailand [NCT03247569]).

Methods

ETNA-AF-Global, a multinational, prospective, observational study collected demographic and clinical outcomes data for AF pts receiving edoxaban. In this subanalysis, pts were categorised into the following body weight groups: ≤60kg, >60 to 80kg (reference body weight), >80 to ≤100kg and >100kg; and BMI groups: <18.5kg/m², ≥18.5 to <25.0kg/m² (reference BMI), ≥25.0 to <30.0kg/m², ≥30.0 to <40.0kg/m² and ≥40.0kg/m². Clinical outcomes at 2-year follow-up were compared across body weight and BMI groups.

Results

26,805 pts were included in this analysis. Mean ± standard deviation body weight was 72.2 ± 18.1kg and mean BMI was 26.4 ± 5.0kg/m². 43.7% of pts were categorised into the >60 to 80kg reference body weight group. [other groups: ≤60kg, 28.1%; >80 to ≤100kg, 21.7%; >100kg, 6.5%] and 40.0% of pts into the ≥18.5 to <25.0kg/m² reference BMI group [other groups: <18.5kg/m², 3.0%; ≥25.0 to <30.0kg/m², 37.3%; ≥30.0 to <40.0kg/m², 18.0%; ≥40.0kg/m², 1.7%].

Clinical outcomes are shown in Fig. 1 as unadjusted hazard ratios vs. reference group according to weight and in Fig. 2 according to BMI. Among body weight groups, pts weighing ≤60kg had the highest annualised rates of any stroke or systemic embolic event (SEE; 1.24%), ischemic stroke (0.97%), all-cause death (3.96%), major bleeding events (1.49%), and major bleeding or clinical-relevant non-major (CRNM) bleeding events (3.45%). Pts in the reference body weight group had the lowest annualised rates of all-cause death (2.81%).

Annualised rates of major bleeding, major bleeding or CRNM bleeding events and any stroke or SEE were lowest in pts weighing >100kg.

Among BMI groups, annualised rates of all effectiveness and safety outcomes were highest in pts with a BMI <18.5kg/m². Pts in the ≥25.0 to <30.0kg/m² BMI group had the lowest annualised rates of all-cause death (2.85%) and pts in the ≥18.5 to <25.0kg/m² BMI group had the lowest annualised rates of CV death (0.73%).

Conclusions

In the Global ETNA-AF program, clinical outcomes varied between different body weight and BMI subgroups. These findings highlight the need to consider the clinical implications of low body weight and/or low BMI, as AF pts who belong to these categories may be at higher risk of adverse outcomes during long-term anticoagulant treatment.Figure 1.Figure 2.
Temporal trends in initiation of oral anticoagulants and stroke-free survival among elderly and very elderly patients with new onset atrial fibrillation - a 20-year perspective.
Authors: Larsen S , Elmegaard M , Binding C , Hartwell Garred C , Sindet-Pedersen C , Loldrup Fosboel E , Holt A , Nouhravesh N , Lamberts M , Christensen D , Koeber L , Bjerring Olesen J , Schou M
Published: October 2024

Background

Oral anticoagulants (OACs) significantly reduce the risk of ischemic stroke in patients with atrial fibrillation (AF). However, evidence regarding efficacy of OACs are lacking in the very elderly patients.

Aim

To examine temporal trends in initiation of OACs and five-year stroke-free survival in the very elderly patients with new onset AF over a time span of 20 years.

Methods

From the Danish nationwide registries, we identified patients ≥ 65 years of age with new onset AF from 1999 to 2018. The index date was defined as the day of AF diagnosis for outpatients and as the day of discharge for inpatients. Patients with a prescription of OAC, history of bleeding events, or history of stroke/transient ischemic attack prior to index were excluded. Patients were divided into two age groups based on their age at index: 1) 65-84 years (elderly); and 2) ≥ 85 years (very elderly). Patients were further divided into four calendar year groups from 1999-2018, based on the year of inclusion. We investigated the initiation of OACs and calculated the absolute five-year probability of stroke-free survival in both age groups.

Results

We included 167,122 patients with new-onset AF between January 1st, 1999, and December 31st, 2018. Among the patients, 23.1 % were aged 85 years or older, 48 % were male and 80.5 % had a CHA2DS2-VASc score equivalent to 2 or higher for men and 3 or higher for women. Initiation of OACs increased in both age groups after the guideline implementation of DOACs in 2010 (Figure 1). In the elderly age group, the proportion of patients receiving OACs increased from 50% in 2010 to almost 90% in 2018. In the very elderly age group, the proportion increased from 25% in 2010 to almost 90% in 2018. The probability of the five-year stroke-free survival improved by approximately 15% from 1999 to 2018 in the elderly age group, with no significant changes in the very elderly age group.

Conclusion

The proportion of elderly AF patients receiving OAC has increased markedly in the last 20 years. Even so, stroke-free survival remains the same among the very elderly patients.Five-year stroke-free survival
Incidence and predictors of 2-year mortality following percutaneous left atrial appendage occlusion in the EWOLUTION tria
Authors: Aarnink E , Ince H , Kische S , Pokushalov E , Schmidt B , Gori T , Meincke F , Betts T , Mazzone P , Grygier M , Sievert H , De Potter T , Vireca E , Bergmann M W , Boersma L V A
Published: October 2024

Background and aims

Sufficient survival time following left atrial appendage occlusion (LAAO) is essential for ensuring the efficacy and cost-effectiveness of this strategy for stroke prevention. Understanding prognostic factors for early mortality after LAAO could optimize patient selection. In the current study we perform an in-depth analysis of 2-year mortality after LAAO, focusing particularly on potential predictors.

Methods

The EWOLUTION registry is a real-world cohort comprising 1020 patients that underwent LAAO. Endpoint definitions were prespecified and death was categorized as cardiovascular, non-cardiovascular, or of unknown origin. Mortality rates were calculated from Kaplan-Meier estimates. Patient characteristics and event rates were compared between deceased and alive patients by unpaired T-tests or Chi-squared test, as appropriate. Baseline characteristics significantly associated with death in univariate Cox regression analysis were incorporated into the multivariate analysis. All multivariate predictors were included in a risk model.

Results

2-year mortality rate was 16.4% (CI: 14.0-18.7%), with 50% of patients dying from a noncardiovascular cause. Deceased patients had more comorbities and more often had a major bleeding after LAAO (20.6% vs 3.3%, p<0.001). Multivariate baseline predictors of 2-year mortality included age (HR 1.05, CI: 1.03-1.08, per year increase), heart failure (HR 1.73, CI: 1.24-2.41), vascular disease(HR 1.47, CI: 1.05-2.05), valvular disease (HR 1.63 CI: 1.15-2.33), abnormal liver function (HR 1.80 CI: 1.02-3.17) and abnormal renal function (HR 1.58, CI: 1.10-2.27). Mortality rate exhibited a gradual rise as the number of risk factors increased, reaching 46.1% in patients presenting with five or six risk factors.

Conclusion

One in six patients died within 2 years after LAAO. We were able to identify six independent predictors of mortality. When combined, this model showed a gradual increase in mortality rate with a growing number of risk factors, which may guide appropriate patient selection for LAAO.
Anticoagulation status and left atrial appendage occlusion indications in hospitalized cardiology patients with atrial fibrillation: a Hellenic Cardiorenal Morbidity Snapshot (HECMOS) sub-study
Authors: Tsioufis P , Tsiachris D , Botis M , Doundoulakis I , Antoniou C K , Kordalis A , Argiriou N , Laina A , Dimitriadis K , Koutsopoulos G , Gatzoulis K , Tsioufis K
Published: October 2024

Background

Proper use of oral anticoagulants is crucial in the management of non-valvular atrial fibrillation (NVAF) patients. Left atrial appendage occlusion (LAAC) may be considered for stroke prevention in patients with NVAF and contraindications for long-term anticoagulant treatment.

Purpose

We aimed to assess the anticoagulation status and LAAC indications in patients with NVAF from HECMOS (Hellenic Cardiorenal Morbidity Snapshot) survey.

Methods

HECMOS was a nationwide snapshot survey of cardiorenal morbidity in hospitalized cardiology patients. HECMOS used an electronic platform to collect demographic and clinically relevant information from all patients hospitalized on March 3, 2022, in 55 different cardiology departments. In this substudy, we included patients with known AF without mechanical prosthetic valves and moderate to severe mitral valve stenosis. Patients with poor adherence to anticoagulants, high bleeding risk, previous major bleeding, and previous stroke were considered candidates for LAAC.

Results

Two hundred fifty-six patients (mean age 76.6±11.7, 148 males) were included in our analysis. Most of them (n=159; 62%) suffered from persistent AF. Mean CHA 2 DS 2 - VASc score was 4.28±1.7, while mean HAS-BLED score was 1.47±0.9. Three out of 3 patients with a CHA 2 DS 2 -VASc 0 or 1 (female) received improperly anticoagulants. Sixteen out of 18 patients with a CHA 2 DS 2 -VASc 1 or 2 (female) received anticoagulants. Thirty-three out of 235 patients with a CHA 2 DS 2 -VASc > 1 or 2 (for female) did not receive improperly anticoagulants. Among 221 under anticoagulant therapy, 191 (86.4%) received non-vitamin K antagonist oral anticoagulants (NOACs) and 30 (13.6%) received vitamin K antagonists. Relative indications for LAAC were present in 77 patients with NVAF (53 had only one risk factor, while 22 had two and 2 patients had three concurrent risk factors). In detail, 15 reported poor or no adherence to the anticoagulant therapy, 17 patients had a history of major bleeding, 36 had a prior stroke and 35 had a HAS-BLED score ≥3. No LAAC treatment was recorded.

Conclusion

Αnticoagulation status was nearly optimal in a high thromboembolic risk population of cardiology patients, mainly treated with NOACs. Three out of ten AF patients should be screened for LAAC.Anticoagulation by thrombotic riskPotential LAAC candidates
The occurrence of atrioventricular nodal reentrant tachycardia requires not only the electrophysiological substrate but also the electro-anatomical characteristics in the triangle of Koch
Authors: Mine T , Terao S , Sugitani M , Kogame T , Fukuhara E , Ishihara M
Published: October 2024

Background

Some patients do not develop atrioventricular nodal reentrant tachycardia (AVNRT) clinically despite having the electrophysiological substrate for AVNRT; however, the cause remains unclear. Recently, the conduction to the slow pathway has been reported to be visualized using high-density mapping in the triangle of Koch (ToK) during sinus rhythm.

Purpose

To investigate whether the conduction to the slow pathway is associated with the occurrence of AVNRT.

Methods

We studied 83 patients (55 males, 67 ± 13 years, 10 with typical AVNRT, 66 atrial fibrillation; AF, 5 atrioventricular reentrant tachycardia; AVRT, and 2 Atrial Flitter) who received electrophysiological test and high-density mapping in the ToK during sinus rhythm. The conduction pattern to the slow pathway, rotating around the end (pivot point: PP) of the functional block line (FBL), was evaluated using the Advisor HD Grid mapping catheter.

Results

10 out of 10 AVNRT (100%), 17 of 66 AF (26%), and 1 of 4 AVRT showed PP and FBL (p<0.0001). 21 out of 21 (10 AVNRT and 11 AF) with the jump-up phenomenon in atrioventricular conduction indicated PP and FBL (100%), meanwhile 7 of 62 without jump-up phenomenon showed PP and FBL (11%) (p<0.0001). Among patients (10 AVNRT and 9 AF) who had the electrophysiological substrate for AVNRT (jump-up phenomenon and retrograde ventriculoarterial conduction), patients with AVNRT had a longer distance from PP to the tricuspid annulus; TA (16.9mm vs, 13.4mm, p=0.0116) than patients with non-AVNRT. There were no differences in the length of FBI, distance and conduction time from His to PP, distance and conduction time from PP to CS ostial, and the area size of ToK. All AVNRT patients underwent linear ablation from PP to TA and showed loss of atrial potential in the region between PP, TA, and His, AVNRT was no longer provoked, and in 8 out of 10 patients, a jump-up phenomenon disappeared.

Conclusion

Patients with AVNRT showed a functional block line and a longer distance from the pivot point to the tricuspid annulus. The occurrence of AVNRT requires not only the electrophysiological substrate but also the electro-anatomical characteristics, especially in the triangle of Koch.
Sex-specific syncope characteristics in the early diagnosis of cardiac syncope
Authors: Kaplan E , Du Fay De Lavallaz J , Zimmermann T , Lopez-Ayala P , Strebel I , Badertscher P , Nestelberger T , Miro O , Christ M , Cullen L , Than M , Martin-Sanchez F J , Manka R , Breidthardt T , Mueller C
Published: October 2024

Background

The Lancet women and cardiovascular disease commission requested evaluating sex-specific approaches in the diagnosis and management of acute cardiovascular disease.

Purpose

We aimed to explore 1) the utility of sex-specific syncope characteristics in the early diagnosis of cardiac syncope 2) sex-related differences in the management and outcomes of patients with a cardiac syncope.

Methods

Thirty-one syncope characteristics were prospectively assessed in women and men presenting with syncope to the emergency department (ED) in an international multicenter study. The final diagnosis of cardiac syncope was centrally adjudicated by two independent cardiologists. Sex-specific differences in the prevalence of syncope characteristics and their positive likelihood ratio (pLR) for cardiac syncope were the primary diagnostic endpoints. Sex-specific differences in hospital admission, diagnostic procedures performed in patients with a cardiac syncope and adverse events in patients directly discharged from the ED during one-year follow-up were secondary endpoints.

Results

Among 2661 patients (median age 71 years, 1099 women and 1562 men), 14.6% of women and 18.2% of men (p=0.02) were adjudicated to have a cardiac syncope. Eleven syncope characteristics showed diagnostic utility (statistically significant pLRs) in assessing cardiac syncope in the overall population. However, none of the syncope characteristics demonstrated significant sex interaction. Women adjudicated as having a cardiac syncope were as likely to be hospitalized as men (OR 1.12; 95% CI: 0.61-2.08, p=0.7) and to receive telemetry (40% vs 41%, p=0.9), ergometry (3.1% vs 6.3%, p=0.4), a holter (21% vs 17%, p=0.3), a loop recorder (0.6% vs 3.9%, p=0.06) and an echocardiogram (69% vs 65%, p=0.4). Among the 591 women and 796 men directly discharged from the ED, 18 women (3%) and 36 men (5%) were finally adjudicated as cardiac syncope. Noteworthy, within this cardiac syncope subgroup, 28% of women experienced major adverse cardiac events (MACE) during the 365-day follow-up period, in comparison to 67% men (OR 0.20; 95% CI: 0.06-0.68, p=0.011, Figure).

Conclusion

Syncope characteristics contributed to the early diagnosis of cardiac syncope, however, none had a significant sex interaction. Women with a cardiac syncope had a similar likelihood of being hospitalized and receiving diagnostic testing. Compard to men, women had a significantly decreased risk of MACE when not hospitalized after a cardiac syncope.Kaplan-Meier curves for 1 year MACE
Early discharge following cardiac implantable electronic device implantation: a systematic review and meta-analysis
Authors: Devesa Neto V , Costa G , Teixeira R , Costa A , Santos L F
Published: October 2024

Background

As the demand for cardiac implantable electronic device (CIED) placement rises, healthcare expenses, including the post-procedure hospital stay costs, have been on the increase. This systematic review and meta-analysis were undertaken to evaluate the safety and viability of same-day discharge (SDD) following cardiac device implantations.

Methods

We conducted a systematic searched of PubMed, Embase and Cochrane database during November 2023 for studies comparing SDD versus discharge after overnight stay (OS) after CIED. Outcomes included all-cause mortality and complications after the procedure (lead/device dislodgment, re-hospitalization, pneumothorax, local hematoma and wound complications). Data from each study were combined using the random-effects model to calculate pooled odds ratio (OR) with 95% confidence interval (CI).

Results

Eleven studies, including two randomized clinical trials, were incorporated, with a total of 64,646 patients, providing 918 pooled death events (74 in SDD and 844 in OS). The meta-analysis revealed that SDD was associated with a significantly lower risk of all-cause mortality compared to OS (pooled HR 0.72; 95% CI: 0.55-0.93; I2=0%) and no difference was found regarding re-hospitalization (pooled HR 0.96; 95% CI: 0.88-1.05; I2 55%). SSD was not associated with higher lead/device dislodgement (pooled HR 0.93; 95% CI: 0.50-1.71; I2=0%), pneumothorax (pooler HR 1.04; 95% CI: 0.31-3.50; I2 0%) and wound complications (pooled HR 0.65; 95% CI 0.22-1.01; I2 0%). SSD was associated with more episodes of local hematoma (pooled HR 0.31; 95% CI 0.09-1.05; I2 0%).

Conclusion

Our meta-analysis suggests that SDD is associated with a decreased all-cause mortality compared to OS. Although associated with more episodes of local hematoma, SDD was not significantly different regarding lead/device dislodgment, pneumothorax, re-admissions and wound complications. SDD after CIED appears to be a safe and feasible alternative.
Clinical evidence of pacemaker implantation during gestation: a case series
Authors: Smagulova A , Ainabekova B , Albaev R , Abdrakhmanova Z H , Suleymen Z H , Abdrakhmanov A
Published: October 2024

Background

Although recommended avoid any intervention during gestation in cases of poor tolerance to high degree atrioventricular block, pacemaker implantation may be necessary in pregnant women.

Purpose

To present outcomes of pacemaker implantation during gestation.

Methods

This prospective, single center study included 10 cases of pacemaker implantation during gestation (median age of patient - 26 years old at 18 weeks of gestation). We evaluated the further course of gestation and obstetric outcomes after implantation in comparison with pregnant with tachyarrythmias (n=111).

Results

Among 121 pregnant women with varying arrhythmias high degree atrioventricular block was detected in 10 cases (8,3%). In 6 cases this bradyarrhythmia diagnosed for the first time in gestation (60%). All pregnant with high degree atrioventricular block had clinical signs: dizziness and weakness (100%), syncope (70%), episodes of low blood pressure (100%). Pacemaker implantation performed due to hemodynamic instability and poor tolerance of bradyarrhythmia in all cases. Using electroanatomical mapping (Ensite Precision system)and echocardiographic guidance helped to reduce fluoroscopy time. For one pregnant implanted leadless pacemaker (Micra) with achieved more than 80% atrio-ventricular synchronization. Outcomes: further course of gestation characterized by increased incidence of uterine contractile activity (30%) in cases of high degree atrioventricular block, that was significantly higher than in pregnant with tachyarrhythmias (2%) (p=0.007). There were no differences in the rate of other complication: uterine blood flow violation (20% vs 12%, p=0.520), placental abraption (10% vs 5%, p=0.237) and preeclampsia (10% vs 5%, p=0.237). Vaginal type of delivery was in the majority of cases in both groups (70% vs 86%, p=0.553). Neonatal outcomes characterized with normal range of fetal birth weight (median 3163 vs 3212 grams, p=0.981) and 5 minute Apgar score (median 8.6 vs 8.7, p=0.564). There was no incidence of maternal and fetal mortality. In 12 month follow-up all patient have optimal electrical parameters of devise and remained stable over time.

Conclusions

High degree atrioventricular block in pregnant characterized by increased rate of uterine contractile activity. Pacemaker implantation during gestation can be effectively performed and associated with benign outcomes.
Prognostic parameters predict cardiac events in Brugada syndrome: a meta-analysis
Authors: Siranart N , Pajareya P , Roongphornchai P , Rattanamanoonporn S , Chokesuwattanaskul R
Published: October 2024

Background

Brugada syndrome (BrS) is recognized as a cause of sudden cardiac death (SCD), ventricular tachycardia or ventricular fibrillation (VT/VF). However, the prognosis varies among the patients with Brugada electrocardiograph (ECG) pattern. Furthermore, there is no prognostic tool to predict the worsening cardiac outcomes in BrS.

Objectives

Primary outcome was to assess the association between risks including patient history, ECG pattern, electrophysiology study (EPS) findings and cardiac events which is identified as VT/VF or SCD.

Method

We performed a meta-analysis of prospective and retrospective cohort studies which assessed the risks and cardiac events in patients with BrS. Pooled hazard ratios (HRs) was analyzed by using Random-effect model.

Result

A total of 27 studies involving 15,990 BrS patients. Of these, 17 were retrospective studies and 10 were prospective studies. In univariate analysis, the risks including male, aborted SCD, QRS duration≥120 msec, fragmented QRS (multiple spikes within the QRS complex in lead V1-V3), late potential (positive terminal filtered QRS complex of signal-averaged ECG), sinus node dysfunction or inducibility of ventricular tachyarrhythmias during EPS associated with a higher risk of cardiac events in BrS. In multivariate analysis, higher risks of cardiac events were associated in BrS patients with history of syncope (HR 2.65, 95% confidence interval (CI): 1.68-4.19, I2 = 54 %, p-value <0.001), family history of SCD (HR 2.64, 95%CI:1.39-5.01, I2 = 0%, p-value = 0.003), prior VF (HR 14.52, 95%CI: 3.36-62.84, I2 = 62%, p-value <0.001), type 1 Brugada ECG pattern (HR 2.07, 95%CI: 1.13-3.79, I2 = 0%, p-value = 0.018), spontaneous type 1 ECG pattern (HR 1.91, 95%CI: 1.01-3.61, I2 = 58%, p-value = 0.046), early repolarization pattern (HR 2.78, 95%CI: 1.9-4.07, I2 = 0%, p-value < 0.001) and history of atrial fibrillation before BrS diagnosis (HR 1.82, 95%CI: 1.03-3.23, I2 = 49%, p-value = 0.039) (Table 1).

Conclusion

Our findings suggest that patient history, ECG pattern, EPS findings can predict the cardiac events. Introducing a risk prediction model could aid in early management of BrS.
Right ventricular outflow tract arrhythmias in patients with obstructive sleep apnea- electrophysiological insights
Authors: Negru A , Crisan S , Vacarescu C , Mihaicuta S , Frentz S M , Luca S A , Gaita D I , Luca C T , Bebec D L , Milko D , Iovanovici D , Cherif M , Fatmi H , Ivanica A E
Published: October 2024

Background

Obstructive sleep apnea (OSA) was associated with atrial fibrillation and heart failure. Furthermore, the arrhythmic sudden death during sleep in patients with OSA raises serious concerns. Non-ischemic ventricular arrhythmias arise frequently from the right ventricular outflow tract (RVOT). The involvement of obstructive sleep apnea in the genesis of arrhythmia (premature ventricular contraction or tachycardia) originating specifically in the RVOT is not yet coherently established.

Purpose

This study aims to demonstrate the possible relationship between untreated obstructive sleep apnea and the occurrence of RVOT arrhythmia and to follow the electrophysiological features and outcomes after radiofrequency catheter ablation (RFA) in patients carrying this double burden.

Methods

One-hundred-twelve (112) consecutive asymptomatic and symptomatic patients admitted with RVOT arrhythmia ((PVCs and VTs) underwent a sleep study (polysomnography). Apnea was set out as the cessation of breathing and hypopnea was defined as shallow, slow, and restricted breathing occurring in episodes of ten seconds or more. The patients had normal left and right ventricle ejection fractions and no structural cardiovascular disease or other known extracardiac arrhythmia predisposing conditions. No significantly elevated systolic pressure in the pulmonary artery was assessed at echocardiography. Every patient was investigated by electrophysiologic study (EPS) and RFA of the clinical ventricular arrhythmia was immediately performed. Practicing and former professional athletes were excluded.

Results

Seventy-eight (69 %) of the included patients had an apnea-hypopnea index > 10/h. The included patients had the following characteristics: mean age 52 ± 8 years, 62% males, 81% had a BMI >30kg/m². The cardiac electrophysiologic study did not induce sustained VTs. The distribution of the PVCs and non-sustained VTs evidenced a predilection for the superior, septal and anterior (68%) and also superior and anterolateral aspects of the RVOT (23%). Radiofrequency catheter ablation (RFA) guided by activation mapping, precocity (the site of earliest activation > 30 ms before the setting of the QRS complex) and pace-mapping were performed in all patients. Immediate success was obtained in 98 patients (88%). After a mean follow-up of 24± 6 months, 28 patients (28%) from the success arm had a recurrence of the PVCs or the non-sustained VTs, 22 patients (22%) with and 6 patients (6%) without sleep apnea.

Conclusions

RVOT arrhythmia genesis and relapse after successful RFA seem highly associated with sleep apnea. Furthermore, patients with sleep apnea are more prone to have recurrent arrhythmias after radiofrequency catheter ablation in the absence of appropriate control of OSA.
In-hospital outcomes of ventricular tachycardia catheter ablation in the presence of intra-cardiac thrombus
Authors: Margolis G , Aviad C , Barel M , Kazatsker M , Kobo O , Roguin A , Leshem E
Published: October 2024

Background

Ventricular tachycardia (VT) catheter ablation in the presence of intracardiac thrombi was evaluated in very few studies.

Objectives

To investigate in-hospital outcomes of VT ablation in the presence of an intracardiac thrombus, in a large inpatient US registry.

Methods

Using the National Inpatient Sample (NIS) database, patients who underwent non-elective VT catheter ablations in the US between 2016 and 2019 were identified using ICD-10 codes. Sociodemographic, clinical data, in-hospital procedures and outcomes as well as in-hospital mortality were collected. In-hospital outcomes were compared using propensity score (PS) matching analysis with a 1:3 ratio between patients with and without intracardiac thrombus.

Results

A weighted total of 15,725 admissions for non-elective VT ablation were included in the study, of which 190 (1.2%) had a discharge diagnosis of intracardiac thrombus. Patients with intracardiac thrombus had a higher comorbidity burden and were more likely to have ischemic cardiomyopathy and a diagnosis of cardiac aneurysm. In PS analysis, the presence of intracardiac thrombus was significantly associated with higher rates of any in-hospital complications (42.1% vs 19.3%, P<0.009), driven by higher periprocedural cerebrovascular accident and vascular injury events. In-hospital mortality rates were not significantly different between the groups.

Conclusions

In patients undergoing non-elective VT ablation, intracardiac thrombus was associated with higher rates of in-hospital complications, but not higher in-hospital mortality. These findings suggest that intracardiac thrombus should not contraindicate VT ablation when deemed necessary, while efforts should be made to decrease potential complications.
Beat-to-beat measurement of R-wave peak time for left bundle branch area pacing: man versus machine using a novel automated algorithm
Authors: Spadotto A , Paamand R , Leonard O , Firth K , Burri H
Published: October 2024

Background

Assessment of stimulation spike to R-wave peak time (RWPT) in V6 and in aVL, and V6-V1 interpreak interval, may be used to evaluate presence of conduction system capture during left bundle branch area pacing (LBBAP). This is performed by manual measurements which is tedious and requires a skilled operator to limit variability in the measurements. Automatic beat-to-beat measurement of these intervals may streamline workflow during implantation, but such an algorithm has never been tested so far.

Purpose

To test the feasibility of performing beat-to-beat automatic measurement of RWPT using an algorithm designed to measure the interval between the stimulation spike and the peak positive voltage, and to compare the results with manual measurements.

Methods

ECG recordings from 50 patients (28% female, mean age 81.5 ± 9.0 years) undergoing LBBAP implantation were evaluated on a electrophysiology recording system by manually measuring RWPT in V6 and in aVL and the V6-V1 interpeak intervals . A single operator performed offline measurements on 10 consecutive beats in each patient. The same beats were subjected to the same measurements using an automatic algorithm after signal conditioning in a novel EP recording System. The correlation between manual and automatic measurements was calculated. Variability of the measurements (evaluated by standard deviation) in the 10 consecutive beats was also compared.

Results

Of the 500 beats measured, 3 were excluded due to obvious morphological differences affecting the interval measurement (e.g. due to fusion beats). The algorithm was unable to make a measurement in V6 in 20 beats and manual assessment of aVL was not possible in one patient, meaning that 1461/1500 (97.4%) measurements were compared between the manual and automatic methods. The results are shown in the figure. There was excellent correlation between manual and automatic measurements, with lower variability using the latter method.

Conclusion

Beat-to-beat automatic measurement of RWPT is feasible and provides excellent correlation with manual measurements, with less variability in the values. This algorithm may streamline the measurements during implantation. However, prospective evaluation is required to confirm operation of the algorithm in the clinical setting to include challenges such as electrical noise.
Electrical performance of a novel extravascular temporary pacing lead system
Authors: Burke M C , Doshi S , Ebner A , Husby M , Marcovecchio A , Sanghera R , Scheck D , O'connor M , Knops R E
Published: October 2024

Background

An investigational extravascular (EV) cardiac temporary pacing system has been developed that includes a parasternally-positioned temporary pacing lead within the anterior mediastinum. The pacing lead is inserted using a custom delivery tool through a parasternal skin incision. This novel system may provide clinical advantages over existing device alternatives that require intravascular, endocardial, or epicardial contact.

Objective

The purpose of this study was to evaluate electrical performance of an EV temporary pacing lead over 48 hours.

Methods

In this single-center study, patients who underwent a transvenous (TV) permanent pacemaker implant or replacement were simultaneously implanted with the investigational EV temporary pacing lead. Electrical performance was evaluated through analysis of capture thresholds, impedance, and R-wave amplitudes during multiple times on the day of the procedure and on the subsequent 2 days of follow-up.

Results

Lead insertions with acute capture were successful in all 8 patients (40% female, 71 ± 8 years, BMI 27 ± 3 kg/m2). Mean acute measurements for pacing capture threshold at 1.5 ms, impedance and R-wave amplitude were 6.2 mA, 1396 Ω, 5.4 mV, respectively. Pacing capture was maintained in 100% of assessments conducted over 3 days (Figure 1). There were no serious complications during insertion, removal or chronic use of the lead.

Conclusions

Results support that the investigational EV temporary pacing lead is capable of safely providing temporary pacing with thresholds typically well below the maximum output of temporary pacemakers.
Routine chest X-ray post cardiac implantable electronic device implantation: is it really required? Experience from a tertiary centre
Authors: Tan J , Maclean E , Wang R B O , Yick M C T , Vyas R , Sporton S , Creta A
Published: October 2024

Introduction

The 2021 EHRA expert consensus statement on pacemaker (PPM) and transvenous implantable cardioverter defibrillator (ICD) implant technique proposes a chest X-ray (CXR) prior to hospital discharge in all patients. This recommendation serves the dual purpose of excluding pneumothorax following subclavian or axillary access (SAA) and documenting lead position.

Purpose

Given that cephalic venous access (CA) precludes pneumothorax, the utility of CXR as a tool for identifying early lead displacement (LD) in these patients warrants further examination. We studied the yield of post implant CXR, device interrogation (DI), or both for the identification of pneumothorax and LD in patients undergoing transvenous PPM or ICD implant via SAA or CA.

Methods

4,051 consecutive PPM or ICD devices were implanted at a tertiary centre between 2016-2019. Lead position was documented fluoroscopically on conclusion of all procedures. A subsequent post implant CXR was performed in cases of SAA, plus in those CA patients requiring imaging for another indication (e.g. pulmonary oedema). Post implant DI was only performed in patients with a high anticipated burden of ventricular pacing (e.g. high-grade atrioventricular block). All patients underwent clinical review with repeat DI at 30 days post implant. LD was defined as a clinically significant translocation of a lead requiring repositioning or reprogramming.

Results

For the whole cohort, the incidence of LD at 30 days was 2.2% (n=89), and the incidence of pneumothorax (within the SAA group) was 0.9% (n=11). The venous access method used, post implant investigations, and the incidence of LD is shown in Figure 1.

1,282 patients (31.6%) required SAA; CXR was performed in all, and 9 LDs were identified (0.7%). However, four patients (0.3%) with ‘normal’ CXRs had evidence of LD on inpatient DI, and a further 17 LDs (1.3%) were confirmed on the 30 day DI despite a ‘normal’ CXR.

2,769 patients (68.4%) underwent CA; 309 (11%) required CXR. This identified LD in four patients (1.3%), with three further patients (1%) found to have LD on subsequent inpatient DI despite a ‘normal’ CXR. A further four LDs (1.3%) were diagnosed at 30 day DI.

The majority (89%, n=2,460) of CA patients were discharged without CXR. 30% (n=825) of these patients required inpatient DI; this identified 13 LDs (1.6%). Accordingly, 59% (n=1,635) of CA patients had no post procedural investigations; 24 (1.5%) were found to have LD at 30 day DI.

Conclusions

In patients who developed LD within 30 days of a PPM or ICD implant, a post implant CXR identified this in only 32% of cases (n=13/41), and the overall sensitivity of CXR for LD was low (50%). Additionally, the majority of LDs (54%) occurred after hospital discharge. We suggest that the utility of post implant CXR for identifying LD is limited, and that CXR should not be considered an essential investigation in CA device implants.Figure 1
Microbial specturm and antibiotic sensitivity of pocket swabs in ICD patients undergoing device replacement or lead revision surgery- findings from a ICD registry observational study
Authors: Mousavi B , Kouraki K , Strauss M , Mohammad O , Wenz A , Weisse U , Werling C , Sack F , Zahn R , Kleemann T
Published: October 2024

Introduction

Infection is a serious complication of implantable cardioverter defibrillator (ICD) therapy, necessitating effective preventive measures during implantation or revision surgery. The intraoperative use of antibacterial envelopes containing rifampicin and minocycline has shown promising results in reducing infection, yet, it is expensive and not cost-effective. Gentamicin sponges might be an alternative to the antibacterial envelope, however its efficacy on targeting the specific microbial spectrum found in device infection must be further investigated. Aim of the study was to identify the bacterial species obtained from pocket swabs of ICD patients undergoing revision surgery, and assess their sensitivity to gentamicin, rifampicin and minocycline.

Methods

A total of 459 intraoperative pocket swabs were collected from consecutive ICD patients who underwent elective device replacement, system upgrade or lead revision between 2017 and 6/2023. The baseline characteristics were similar in both groups (Table 1).

Results

Out of the 459 swabs analysed: 416 (90.6%) were negative for microbial growth. The remaining 43 swabs (9.4%) were tested positive for microbial growth (Table 2). Coagulase-negative- staphylococci (CoNS) were the most commonly isolated bacteria, accounting for 56% of cases. Bacteria with available antibiograms exhibited a sensitivity of 92% to gentamicin, 96% to rifampicin and 96% to Minocycline (Table 2).

Conclusion

The antibiotic sensitivity of the bacteria obtained from the pocket swabs to gentamycin, rifampicin and minocycline was similar. Thus, gentamicin sponges might be an alternative to the antibacterial envelope in patients with ICD undergoing generator replacement or revision surgery.
Extraction of old His bundle pacing leads and coronary sinus leads - an analysis of 3897 lead extraction procedures including 27 His and 253 coronary sinus lead removals
Authors: Kutarski A , Jachec W , Stefanczyk P , Dabrowski P , Glowniak A , Nowosielecka D , Tulecki L
Published: October 2024

Background

The lumen-less the Medtronic 3830 lead is most popular for His bundle pacing (HBP) and experience with such lead extraction are very limited especially for leads older than 4 years.

Methods

Analysis of 3898 transvenous lead extraction (TLE) procedures (including 27 HBP and 253 LVP lead extraction) was performed.

Results

The HBP was used usually in the CRT-D system (72.4%) and EF and NYHA class were better than patients with LVP extracted leads. Age of extracted HBP or LVP lead did not differ significantly (54.5 vs 50.2 months). Extraction of "old" HBP leads extraction was longer than in case of "young HBP leads (8,6 and 3.8 min). Mechanical dilatation was necessary in 63 and 100% extracted HBP leads. Unexpected procedure difficulties appeared (14,3%) and utility of second line / advanced tools had been utilised (28,6%) only when "old" HBP lead were extracted. Difficulties in extracting HBP leads were comparable to those encountered in the extraction of LVP leads of similar age. There was no extracted 3830 extracted lead break and no major complication, necessity of rescue cardiac surgery and procedure related death when HBP and LVP leads were extracted. The length of the FU period for those still alive patients was shorter for patients with removed leads for HBP as this technique was introduced significantly later than LVP. However, the 1-month mortality rate of patients with LVP lead removed is higher than in the HBP and control groups.

Conclusions

1. HBP most frequently is utilised in the CRT-D system for resynchronisation of failing heart (72.4%) 2. Extraction of HBP leads is performed most frequently due to non-infective indications (59,3%) and most often because of lead dysfunction (33,3%). 3. Extraction of "old" (>40 mth) HBP leads is twice longer than younger ones (3.8 and 8,6 min) and mechanical dilatation is necessary frequently. 4. Extraction of "old" (>40 mth) HBP leads is more difficult than younger ones due to appearance unexpected procedure difficulties (14,3%) and necessity utility of second line / advanced tools (28,6%) but it does not entail the risk of major complications and procedure related death. 5. Difficulties in extracting HBP leads comparable to those encountered in the extraction of LVP leads of similar age. 6. Survival after HBP and LVP lead extraction was comparable, but shorter than after removal of other leads.
Complications after cardiac implantable electronic devices in patients with severe mental illness: a Danish nationwide study
Authors: Wood-Kurland H , Storgaard Noerskov A , Nordgaard J , Porsborg Andersen M , Torp-Pedersen C , Bang C N F
Published: October 2024

Background

Patients with mental illness experience higher rates of postoperative complications and mortality across several types of surgery, but knowledge is lacking in relation to cardiac implantable electronic device (CIED) implantations.

Purpose

Our study aimed to investigate the 7-day, 30-day, and 90-day postoperative complication rate and mortality in patients with severe mental illness compared to the general population.

Methods

All adult patients in Denmark with a first-time pacemaker or ICD implantation during the study period from July 1995 to December 2022 were identified using the Danish nationwide registers. Severe mental illness was defined as having a preexisting diagnosis of schizophrenia and other non-affective psychotic disorders, bipolar affective disorders or major depressive disorder. Postoperative complications were obtained as diagnosis codes possibly relating to device implantation and categorized into seven types of complications: arterial thrombosis, venous thrombosis, pneumothorax, bleeding, infection, device function problem, and death. Stratified logistic regression analyses adjusted for sex and age were used to calculate the odds of postoperative complications within 7, 30, and 90 days of device implantation.

Results

Among 108,790 patients who had a de novo pacemaker or ICD implantation the mean age was 73.5 (± 12.8), 37.5% were women and 3,393 (3.1%) of the patients had preexisting severe mental illness. In total, 10,690 (9.8%) patients had one or more complications within 90 days. The number of patients with severe mental illness who experienced a complication were 407 (12.0%) while it was 10,283 (9.8%) of those without severe mental illness. Odds of death (OR 1.57, 95% CI: 1.03-2.29) were higher in patients with severe mental illness 7 days postoperatively, and 30 days postoperatively odds of venous thromboembolism (OR: 1.69, 95% CI: 1.05-2.56) and death (OR: 1.62, 95% CI: 1.29-2.01) were higher in patients with severe mental illness. 90 days postoperatively odds of venous thrombosis (OR: 1.95, 95% CI: 1.37-2.70), infection (OR: 1.45, 95% CI: 1.16-1.79), and death (OR: 1.40, 95% CI: 1.19-1.65) were higher in patients with severe mental illness compared to patients without severe mental illness, while the odds of pneumothorax were lower at all three time points for patients with severe mental illness (OR 7-days: 0.49, 95% CI: 0.21-0.95). The odds of arterial thrombosis, bleeding and device function problems were similar between the two groups at all three time points.

Conclusion

Severe mental illness was associated with increased risk of several types of complications and death following CIED implantation. This indicates that further care and attention is needed to ensure adequate treatment of patients with severe mental illness suffering from cardiac arrhythmias.Forest plot, SMI: severe mental illness