bluuebunny/crossref_metadata_2025_split huggingface dataset:
Should we implant cardioverter defibrillators in asymptomatic patients with Brugada syndrome?
Authors: Brankovic N , Radovanovic NN , Kircanski B , Pavlovic SU , Vujadinovic N , Sajic V , Milasinovic A , Bisenic V , Zivkovic M , Milasinovic G 
Published: May 2022

Abstract

Funding Acknowledgements
Type of funding sources: None.

Background
Implantable cardiverter defibrillators (ICD) represent the only effective treatment in prevention of sudden cardiac death (SCD) in patients with Brugada syndrome (BrS). However, according to current ESC Guidelines, ICD implantation is recommended only in secondary prevention, while it should be considered in patients with a spontaneous diagnostic type I ECG pattern and history of syncope.

Purpose
We aimed to determine the frequency of ventricular tachyarrhythmias during the long-term follow-up among patients with BrS and ICDs implanted in primary or secondary prevention.

Methods
This retrospective, observational study was conducted in a tertiary center among adult patients with BrS that underwent single or dual chamber ICD implantation from January 2008 to December 2017. The study group was devided into subgroups depending on weather the patients at the time of ICD implantation had documented sustained ventricular tachycardia (VT) or ventricular fibrillation (VF) regardless of the ECG type of BrS (group I), had BrS type I and history of syncope (group II) or had BrS type I and were asymptomatic but assessed as in high risk of SCD due to non-sustained VT episodes, younger age or history of SCD in close family members (group III). We used patients medical records for collecting the data about VT and VF episodes during the follow-up period.

Results
In the course of ten-year period, ICDs were implanted in 21 adult patients with BrS (66.7% were male). Mean age at the ICD implantation time was 40.3 ± 14.9 years. We analyzed 8 patients from group I, 7 patients from group II, and 6 patients from group III. Mean follow-up period was 82.5 ± 33.3 months. During the obsereved period, VT/VF episodes were appropriately detected in 7 patients from group I (87.5%), in 3 patients from group II (42.86%) and in one patient from group III (16.67%). Kruskal-Wallis test showed that there was a statistically significant difference in the occurrence of ventricular tachyarrhythmias among at least one pair of observed groups (p = 0.031). Using Dunn-Bonferroni post hoc analysis we found statistically significant difference between the patients with malignant arrhythmias and asymptomatic patients (p = 0.03), but not between the other pairs.

Conclusion
Although asymptomatic patients with BrS are at significantly lower risk of SCD, it is important to identify high-risk patients in the low-risk group. Therefore, creating a tool for calculating the risk of SCD among these patients might be helpfull in everyday clinical practice.
The impact of SMARTpass algorithm status on inappropriate shock rates in the UNTOUCHED Study
Authors: Boersma LVA , Aasbo J , Knops RE , Lambiase PD , Bongiorni MG , Deharo JC , Russo AM , Burke MC , Shakir A , Huang DT , Appl U , Brisben A , Carter N , El-Chami MF , Gold MR 
Published: May 2022

Abstract

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

Background
The current Subcutaneous ICD (S-ICD) model incorporates SMART Pass (SP) to improve sensing and discrimination capabilities to reduce inappropriate shocks (IAS). SP status is programmable but may also be disabled automatically in the setting of low amplitude signals or low heart rate in order to avoid under-sensing of VT/VF.

Objective
To evaluate SP impact on IAS, appropriate shocks (AS), complications and mortality in the UNTOUCHED S-ICD trial.

Methods
Primary prevention patients (pts, n=1111) with ejection fraction ≤35% and no pacing requirement were followed for up to 18 months. SP status during a study visit was programmed ON or OFF and status between visits was either consistently OFF, ON, or automatically disabled (DIS). The impact of SP status on pt outcomes was evaluated using Kaplan-Meier (K-M) analysis. Multivariable proportional hazard analysis identified predictors of IAS and SP disable events.

Results
Percent of pts with SP always ON, always OFF, ON with DIS, and OFF then ON with no DIS were 56, 16, 15, and 13%, respectively. At least one SP DIS occurred in 177 pts, but only 13% had 2 or more, mostly due to PVCs and low EGM amplitudes. Significant multivariable predictors of SP disable events are history of atrial fibrillation (hazard ratio (HR) 2.49, odds ratio (OR) (1.49-4.16); p=.0005), only one passing vector at S-ICD screening, (HR 1.85, OR (1.10-3.10; p=.0202) and lower left ventricular ejection fraction (HR 1.05, OR (1.01-1.08); p=.0074). K-M IAS rates were highest for pts experiencing DIS (fig 1) and lowest for SP ON. While neither AS (p=0.58) nor complication (p=0.58) rates varied significantly according to SP status, mortality was lower for pts with SP ON during any duration of time (p=0.044) by univariate analysis. Further analysis is planned to better understand the relationship between SP status and mortality.

Conclusion
Patients in the UNTOUCHED trial with SMART Pass (SP) consistently ON had significantly fewer inappropriate shocks, with no impact on appropriate therapy for VT/VF. Patients with history of atrial fibrillation, lower left ventricular ejection fraction, and only one passing vector at S-ICD screening are at higher risk of SP disable events; therefore, care should be taken for these patients to assess SP status and their higher risk for inappropriate shocks.
Real-world survival of model-3501 subcutaneous implantable defibrillator lead
Authors: Viani S , Segreti L , Ottaviano L , Biffi M , Nigro G , Ricciardi G , Francia P , D’onofrio A , Bisignani G , Dello Russo A , De Filippo P , Solimene F , Scalone A , Botto G , Migliore F 
Published: May 2022

Abstract

Funding Acknowledgements
Type of funding sources: None.

Background
In December 2020, the subcutaneous implantable cardioverter-defibrillator (S-ICD) lead model-3501 was subject to a safety notification because of increased risk of fracture at a location just distal to the proximal sense ring. The manufacturer’s product performance report currently reports a lead survival probability of 98.8% at 45 months. However, no multicenter long-term performance information exists for this lead.

Purpose
Our aim was to assess the longevity of model-3501 leads and to compare it with that of the previous model-3401.

Methods
This analysis included consecutive patients who received an S-ICD with a model-3501 or a model-3401 lead at 66 Italian participating centers of the Rhythm Detect registry. A lead failed if it required extraction/replacement because of abnormalities suggestive of a structural defect, e.g. out-of-range impedance, nonphysiological electrical noise or ineffective therapy.

Results
From January 2013 to July 2021, 2403 patients were implanted and followed up (78% male, age 49±15years, ejection fraction 45±16%, body mass index 26±4Kg/m2). A 3501-model lead was used in 1697 patients and a 3401-model in 706 patients. During a median follow-up of 38 months [25th–75th percentile: 24-55], we detected 4 malfunctioning model-3501 leads and 2 model-3401 leads. After analysis of the returned leads by the manufacturer’s technical services, a single model-3501 lead failure was a fracture distal to the proximal ring electrode, as described in the manufacturer’s advisory letter. No deaths or permanent injuries occurred as a result of lead failures. The survival of 3501-model leads at 4 years was 99.5% (95% confidence interval, 99.0 to 99.9) compared with 99.9% (95% confidence interval, 99.6 to 100.0) of 3401-model leads (p=0.110). The cumulative occurrence rate of the 3501-model safety notification fracture was 0.1% (95% confidence interval, 0.0 to 0.3).

Conclusions
In this large multicenter analysis, the survival probability of model-3501 S-ICD leads was in line with that reported by the manufacturer, was not significantly lower than that of 3401-model leads (not affected by a safety notification), and still higher than that reported with transvenous leads. Although an enhanced electrode is now available, which addresses the potential for electrode body fracture, the present findings are reassuring and may have significant implications for the management of patients who have affected leads.
Association between right ventricular dysfunction and appropriate icd therapy
Authors: Chiba T , Kajiyama T , Yutaka Y , Ryuzaki S , Sugawara M , Kitagawa M , Ito R , Nakano M , Nakano M , Kondo Y , Kobayashi Y 
Published: May 2022

Abstract

Funding Acknowledgements
Type of funding sources: None.

Background
Right ventricular fractional area change (RVFAC) as right ventricular function is recently referred as an independent predictor of sudden cardiac death (SCD). The purpose of this study was to evaluate the association of RVFAC and appropriate ICD therapy in order to determine the cut-off value of RVFAC.

Methods
Consecutive patients who underwent initial ICD implantation for any diseases except for non-dilated phase hypertrophic cardiomyopathy and channelopathy were retrospectively enrolled from 2012 to 2018. Primary endpoint was an initial appropriate ICD therapy. Transthoracic echocardiographic parameters before ICD implantation were evaluated by one physician and one echocardiologist to be validated. Right ventricular dimensions and function were also measured to be analyzed.

Results
In total, 172 patients (60.3±13.6 years, 131 males) including 63 ischemic cardiomyopathy were enrolled. Ninety patients received an ICD as a secondary prophylaxis. Mean LVEF and RVFAC were 38.3±14.3% and 35.8±8.82%, respectively. There was little correlation between RVFAC and LVEF (correlation coefficient =0.274). Regarding appropriate ICD therapy events, the best cut-off value of RVFAC was 34.8%. The odds ratio of low RVFAC was 2.731 (95%CI: 1.456-5.121, P=0.00174). Secondary prophylactic cohort with low RVFAC showed highest incidence of appropriate ICD therapy as shown in the figure. In multivariate analysis, only low RVFAC is an independent predictor of appropriate ICD therapy (HR: 3.53, 95%CI:1.78- 6.99, P=0.0003).

Conclusion
Low RVFAC seemed independently associated with increased appropriate ICD therapy.
Accuracy of non-invasive anatomical lead localization in CRT patients: BSPM vs 12-lead ECG
Authors: Sedova K , Van Dam P , Blahova M , Necasova L , Sramko M , Kautzner J 
Published: May 2022

Abstract

Funding Acknowledgements
Type of funding sources: Public grant(s) – National budget only. Main funding source(s): Grant agency AZV, Ministry of Health of the Czech Republic

Background
Non-invasive, inverse ECG (iECG), estimating the cardiac activation from ECG signals, may be useful both to support CRT implant and optimization. However, most iECG strategies require a 32-250 electrode body surface potential mapping (BSPM), limiting their clinical utility.

Objective
This proof of concept study evaluates the accuracy of our novel PaceView iECG method to localize the LV/RV pacemaker lead to the cardiac anatomy using either a 96-electrode BSPM or the 12-lead ECG.

Methods
PaceView generates activation sequences in combination with the equivalent double layer source model to simulate the corresponding ECG signals. An initial activation sequence is iteratively optimized to match simulated and measured ECG signals. A BSPM with 96 electrodes and CT were recorded for every patient with implanted CRT. The CT was used to create patient-specific heart/torso model and to localize the ECG electrodes and CRT leads. From a BSPM, 9 signals were selected to obtain the 12-lead ECG. Both BSPM and 12-lead ECG were used to localize the RV/LV lead as the earliest ventricular activation site.

Results
In this study 14 consecutive patients with dilated cardiomyopathy were enrolled: mean age 58±9 years, 7 females. The localization error for the RV/LV lead was 10.4±5.4 (max 22) / 11.3±5.5 (max 20.4) mm using the 12 lead ECG and 11.7±6.1 (max 26.2) / 13.5±5.8 (max 24.5) mm for the BSPM. The time used for a 3D activation map computation was 0.9-1.8 s.

Conclusion
Our preliminary results show that the non-invasive lead localization error, using the 12-lead ECG, is small and comparable with a 96-lead BSPM. Therefore PaceView might be clinically beneficial, by actively localizing the LV/RV pacing sites during CRT implant, and optimize AV or VV delays at CRT follow-ups.
ELECTRa Registry Outcome Score (EROS): validation in a single center population
Authors: Segreti L , Fiorentini F , Giannotti Santoro M , Barletta V , Zucchelli G , Di Cori A , De Lucia R , Canu A , Viani S , Paperini L , Cellamaro T , Soldati E , Carluccio M , Branchitta G , Bongiorni MG 
Published: May 2022

Abstract

Funding Acknowledgements
Type of funding sources: None.

Introduction
The ELECTRa Registry Outcome Score (EROS) was developed to identify patients at increased transvenous lead extraction (TLE) risk

Purpose
Aim of the study is to explore the efficiency of EROS for stratifying patients undergoing TLE.

Methods
We performed a retrospective analysis of 1293 patients who underwent to TLE in our center. We performed extraction procedures with manual traction or mechanical dilatation. We calculated EROS, and we divided patients into 3 groups depending on the EROS class. For this purpose, we made statistical analysis and comparison between EROS 1+2 vs. EROS 3 groups. We used an X2 for among-group comparisons or Fisher’s exact test if the expected cell count was less than five.

Results
Our analysis included 1293 patients. EROS-1 counted 726 patients (56,1%), EROS-2 367 (28,4%) patients and EROS-3 200 (15,5%) patients. There was no statistical difference in peri-procedural death between EROS-1+2 and EROS-3 (0.18% vs 1.50%, p=0.134). Major complications (0.82% vs. 3.00%, p=0.014), minor complications (3.11% vs. 6.50%, p=0.019) and use of internal jugular approach (6.13% vs. 14.50%, p&lt;0.001) was significantly higher in EROS 3 patients.

Conclusion
EROS effectively separates patients at higher risk of complications. Use of internal jugular approach was significantly higher in EROS 3 patients.
Transvenous lead extraction: safety and efficacy of local anesthesia
Authors: Fiorentini F , Segreti L , Giannotti Santoro M , Viani S , Zucchelli G , Di Cori A , De Lucia R , Grifoni G , Paperini L , Soldati E , Barletta V , Canu A , Della Volpe S , Mazzocchetti L , Bongiorni MG 
Published: May 2022

Abstract

Funding Acknowledgements
Type of funding sources: None.

Introduction
Patients undergoing transvenous lead extraction (TLE) usually receive general anesthesia, although in our experience local anesthesia is a frequent alternative.

Purpose
We sought to verify safety and effectiveness of local anesthesia in patients undergoing tranvenous lead extraction (TLE).

Methods
A retrospective analysis of patients who underwent to TLE in our center was performed. 1293 patients were divided in three groups depending on EROS class and comparisons were made in each group depending on type of anesthesia. Lead extraction was performed by manual traction or mechanical dilatation and use of transjugular approach was evaluated on case-by-case.

Results
In the EROS 1 group (726 pts.) 559 (77%) receive local anesthesia, in the EROS 2 (367 pts.) 252 (69%) and in the EROS 3 (200 pts.) 73 (36%). There was no differences in total complications (EROS 1 3.76% vs 2.99%, p=0.814, EROS 2 4.76% vs 5.21%, p=0.851, EROS 3 5.48% vs 11.81%, p=0.210) and clinical success (EROS 1 98.75% vs 99.40%, p=0.689, EROS 2 98.41% vs 94.78%, p=0.077, EROS 3 80.82% vs 85.04%, p=0.439) between local and general anesthesia throughout the groups; use of internal jugular approach was significantly higher in EROS 2 patients undergoing general anesthesia (4.76% vs 11.30%, p=0.021), while in EROS 1 and 3 patients this difference was not statistically significant (EROS 1 5.01% vs 8.38%, p= 0.101, EROS 3 8,22% vs 18,11%, p=0.056).

Conclusion
These results suggest that local anesthesia in patients undergoing transvenous lead extraction does not affect procedural outcomes and safety. Complex procedures with the need for internal jugular approach may drive this choice with preference for general anesthesia.
Risk of pericardiac effusion after cardiac implantable electronic device implantation a nationwide study
Authors: Zhou Y , Haxha S , Torp-Pedersen C , Philbert B , Nielsen O W , Sajadieh A , Koeber L , Gislason G H , Bang C N 
Published: May 2022

Abstract

Funding Acknowledgements
Type of funding sources: None.

Background
Procedural pericardiac effusion (PE) is considered a major complication to implantation of cardiac implantable electronic devices (CIED), including permanent pacemakers (PM), cardiac resynchronization therapy devices with defibrillators (CRT-D) or without (CRT-P), and implantable cardioverter defibrillators (ICD), as it can cause life threatening cardiac tamponade. Very little is known about risk factors for procedural PE.

Aim
To identify the patient- and procedure related risk factors associated with clinically relevant procedural PE.

Methods & Results
This is a nationwide retrospective observational cohort study based on data on 51.599 patients from the Danish Pacemaker Register. Included were all Danish patients who received their first PM, CRT or ICD from 2000 – 2018. Procedural PE was defined related to the invasive procedure if it occurred within 1 months after the invasive procedure and no cancer was diagnosed before the procedure. Pre-specified risk factors, including sex, age, year, implantation center-type and device type were analyzed by multivariable logistic regression models to estimate the association with PE. A total of 78 (0.2%) patients were diagnosed with procedural PE, with a median age of 73 years and 43% were females. In adjusted logistic regression analysis age &gt; 70, heart failure [aOR 1.64 (1.01;2.67)], ischemic heart disease [aOR 1.84 (1.13;2.99)], direct oral anticoagulation [aOR 1.77 (1.13–2.77.)], amiodarone use [aOR 3.03 (1.75–5.22)], beta blocking agent [aOR 2.26 (1.23 –4.14)], university hospitals [aOR 2.59 (1.18 –5.67)] and PM implantation [aOR 3.38 (1.77;6.45)], were associated with PE.

Conclusion
Procedural PE is a rare complication after CIED implantation in Denmark. Importantly most of the risk factors for PE are modifiable. Optimizing the modifiable risk factors may reduce the risk of complication.
Predictors of all-cause mortality for patients undergoing transvenous lead extraction
Authors: Azari A , Kristjansdottir I , Gatti P , Gadler F 
Published: May 2022

Abstract

Funding Acknowledgements
Type of funding sources: None.

Background
Risk assessment of TLE patients may be challenging due to incomplete knowledge about possible risk factors for post-TLE outcomes. The aim of this study was to identify predictors of 30-day and 1-year mortality in a large retrospective series of patients undergoing TLE at a high-volume centre.

Methods
Medical journals of 893 consecutive patients undergoing TLE between January 1, 2010 and December 31, 2018 were analysed. Univariate logistic regression analysis was performed to identify risk factors.

Results
A total of 893 patients were identified. Local infection was the dominant TLE indication (40.5%), and pacemaker was the most common CIED (49.4%). Mean age was 65 + 16 years and 73.0% were males. The median follow up was 3.9 years (IQR, 2.0-6.4 years). Staphylococcus aureus was the most common microorganism found in blood cultures of the systemic infection group (39.9%). A total of 179 (69.4%) systemic infection patients had vegetations on echocardiography, where majority engaged the lead(s). The 30-day and 1 year mortality rates were 2.5% (86.4% had systemic infection) and 9.7% (64.4% had systemic infection), respectively. Per-procedural mortality occurred in 1 patient with systemic infection. Significant predictors of 30-day mortality were low haemoglobin, systemic infection as TLE-indication, clinical frailty scales (CFS) 5-7 and stage 5 chronic kidney disease (CKD). In case of 1-year mortality, age, CRT-P/D (vs ICD), reduced ejection fraction, anaemia, BMI &lt;25 kg/m2, CFS 4-7 and CKD stages 3-5 were identified as significant predictors. In the systemic infection subgroup, elevated white blood cell (WBC) count was associated with 30-day and 1 year mortality. Additionally CRP interval 200-300, low WBC count and WBC interval 8.8-15 correlated signigicantly with 1-year mortality within the systemic infection cohort. In the local infection subgroup, a significant correlation between CRP interval 100-150 and 1-year mortality was found.

Conclusions
Systemic infection as TLE-indication carries a high 30-days post-TLE all-cause mortality rate and is significantly correlated with short and long-term mortality, where elevated inflammatory parameters carried additional mortality risk in this subgroup. Anaemia, chronic kidney disease, CRT compared to ICD, reduced EF and patient-related features as high clinical frailty scale levels and BMI &lt;25 kg/m2 predicted worse prognosis in the entire TLE-cohort.
Conduction system pacing in the adult congenital population; feasibility and outcomes
Authors: Riad O , Hunnybun D , O’connor M , Shi R , Cantor E , Jarman J , Foran J , Markides V , Gatzoulis M , Wong T 
Published: May 2022

Abstract

Funding Acknowledgements
Type of funding sources: None.

Background
Left bundle pacing (LBP) is an evolving pacing method designed to capture the intrinsic conduction and minimise ventricular dys- synchrony. Anatomical complexity, scars of previous corrective surgeries and haemodynamic properties of adult congenital heart disease (ACHD) population could increase challenges of LBP. We describe our experience in LBP in ACHD patients and different patient groups.

Purpose
To compare the feasibility of LBP in ACHD patient population and non-ACHD patients.

Methods
We included all patients who had LBP at our institution in 2020 and 2021. Demographic data, imaging data, procedural parameters and follow up data were collected and analysed.

Results
A total of 36 patients were included and divided into two groups: ACHD (n=8, mean age, 54 years, 38% females) and non-ACHD (n=28, mean age, 74 years, 43% females). ACHD anatomy included simple lesions (4) as atrial and ventricular septal defects, partial anomalous pulmonary venous drainage, bicuspid aortic valve and Shone’s syndrome, moderate (3), as Tetralogy of Fallot with surgical repair, and complex (1), as transposition of great arteries with Mustard repair. Non-ACHD included patients with structurally normal heart, dilated cardiomyopathy, and those who underwent mitral and aortic valve interventions. Mean left ventricular ejection fraction in ACHD group was 59.5%, and 57.5% in non-ACHD. Late gadolinium enhancement in basal septal area was present in 5 patients in ACHD group. Acute success rate, defined as capture of left bundle branch, was 100% in ACHD group, and 88% in non-ACHD. No acute complications were recorded in both groups. Mean pre-procedural QRS duration was longer in ACHD group (170 ms, vs, 120, p=&lt;0.001). Mean reduction in QRS duration in ACHD group was 27 ms, vs, 15, p= 0.856. Mean procedural and fluoroscopy times were similar in both groups (ACHD, 75.5 minutes, vs, 70, p= 0.26, and ACHD, 9 minutes, vs 7.13, respectively, p= 0.46). Pacing parameters at implantation and after 2 months were satisfactory in both groups (Fig 1).

Conclusion
Left bundle pacing is feasible in ACHD population as compared to non-ACHD patients, with low incidence of complications. Procedural and fluoroscopic times were similar in both groups. Pacing parameters were satisfactory and stable over 2 month-follow up.