bluuebunny/crossref_metadata_2025_split huggingface dataset:
Relationship between episodes of unsustained VTs detected early after an ICD implant and subsequent monomorphic VTs causing appropriate therapy
Authors: Jimenez-Candil J , Perez J , Sanchez M , Hernandez J , Morinigo J.L , Sanchez P.L 
Published: November 2020

Abstract

Introduction
Non-sustained ventricular tachycardias (NSVT) are observed frequently among ICD patients with left ventricular dysfunction (LVD).

Purpose
To analyze the relationship between episodes of NSVTs and monomorphic VTs (MVTs) that subsequently cause appropriate therapies.

Methods
416 ICD patients with LVD (LVEF &lt;45%) followed for 41±27 months. ICD programming (detection and therapies) was standardized. NSVT was defined as any VT of ≥5 beats which did not met the detection criteria occurring within the first 6 months after ICD implant. We analyzed 2201 NSVTs (10+7 beats), which occurred in 250 of the 416 patients (Median=2; IQR=0–7). The mean cycle length (CL) of NSVT was 323±32 ms (adjusted per multiple episodes/patient, generalized estimating equation method (GEEM)).

Results
During the follow-up, 1441 MVT occurred in 183 patients. After showing a significant correlation between burden of NSVT and the occurrence of appropriate therapies due to MVT (C coefficient=0.68; p&lt;0.001), we observed that subjects with &gt;5 NSVT presented an excess of adjusted risk: HR=1.97 (95% CI=1.45–2.72); p&lt;0.001. However, the adjusted mean CL of NSVTs was similar in patients with (322±34) vs. without MVT (324±26 ms); p=0.3.
Among patients who presented NSVTs and MVTs (n=145 subjects), we analyzed the relationship between the adjusted mean CL of the NSVTs (n=1288 episodes) and the CL of the first appropriate therapy due to MVT occurring subsequently. We found a significant and positive correlation between the two (r=0.88; p&lt;0.001); the strongest correlation was observed in subjects with &gt;5 NSVTs (r=0.97, n=52)). The robustness of such correlation was similar in individuals with ischemic (r=0.86; n=91) versus non-ischemic cardiomyopathy (r=0.90; n=54), and in primary (r=0.86; n=75) versus secondary prevention (r=0.90; n=70). The agreement between the CL of first MVT and the adjusted mean CL of NSVT episodes (GEEM) was determined according to the Bland-Altman Method. The difference between the two values was 2±8.3 ms, with only 7.6% (11/145) of patients in whom the difference between the two CL was outside the concordance limits. The agreement was greater, again, in individuals with &gt;5 NSVTs. As shown in the Figure, in more than 95% of patients both values were within the interval of agreement (0.32±4 ms).

Conclusions
1-The burden of NSVTs occurring early after an ICD implant, but not their CL, is associated with a higher incidence of appropriate therapies due to MVT at follow-up.
2-The CL of the NSVTs and that of the first and subsequent MVTs is virtually the same in patients with higher NSVT burden. Therefore, it could be the same tachycardia, but with different duration.
Figure 1

Funding Acknowledgement
Type of funding source: None
Defibrillation threshold modeling to refine implant recommendations for an extravascular ICD system
Authors: Wilkinson J , Blauer J , Abeyratne A , Dhume R , Edmonson J , Haqqani H , Kotschet E , O'Donnell D , Schu C , Severseike L , Swenson D , Takayama J , Crozier I 
Published: November 2020

Abstract

Background
The extravascular ICD (EV ICD) is a novel defibrillator that couples a substernal lead to a device under the left axilla. The electrode locations for best defibrillation performance are unknown. In this study we use data from a 21 patient pilot study to address this question.

Objective
To create computational torso models to study the effect of device and lead position on defibrillation threshold (DFT).

Methods
Finite element models were developed from CT and intraoperative imaging of the 21 patients enrolled in the EV ICD Pilot Study. Between 150 and 200 combinations of electrode locations were created for each patient, including the actual implant locations as determined from post-implant CT. The shock amplitudes from DFT testing and multiple vector impedance measurements from a large subset of patients and their as-implanted models were used to calibrate global model parameters. In total, 3330 implant models were automatically meshed, simulated and analyzed to compute predicted DFT values. For each patient an acceptable implant zone was calculated in which it is predicted that they would pass implant DFT testing. The zones for all patients were aligned and combined using common anatomical landmarks so that a common zone for acceptable DFT performance could be calculated for the cohort.

Results
Two patients were omitted due to incomplete CT data and 16 models were used during the calibration phase. Final analysis was performed using 19 patient models. The model results recommend positioning the lead slightly left of the sternal midline with the most proximal electrode 10 mm above the xiphisternal junction. Similarly, the device should be positioned so that its upper margin is at the height of the leftmost projection of the heart as seen in the AP view, and its posterior margin aligned with the posterior margin of the ventricles. The figure illustrates these positions. The model predicts that using these locations will result in acceptable DFT performance for all 19 patients - including one who failed testing at implant.

Conclusion
Modeling showed that DFT is dependent on both lead and device location. Furthermore, the predicted DFT and impedance values are consistent with clinical measurements. Specific lead and device locations were determined that are both clinically identifiable and provide acceptable DFTs in all patients.
Implant positioning

Funding Acknowledgement
Type of funding source: Private company. Main funding source(s): Medtronic PLC
Automated screening tool for Subcutaneous Implantable Defibrillator in Brugada syndrome has a high eligibility rate which is predicted by simple electrocardiographic parameters
Authors: Marelli S , Kukavica D , Mazzanti A , Chargeishvili T , Trancuccio A , Monteforte N , Bloise R , Marino M , Napolitano C , Priori S.G 
Published: November 2020

Abstract

Background
Manual electrocardiographic (ECG) screening tools for the use of subcutaneous cardiac defibrillator (S-ICD) have been associated with high ineligibility rates in Brugada syndrome patients (BrS). Although recent works identified ECG parameters for S-ICD eligibility in general population, automated screening tool (AST) for S-ICD eligibility have not even been assessed in large series of patients with BrS.

Purpose
This study evaluates the AST-derived eligibility rates for an S-ICD in patients with BrS, and ECG parameters associated with S-ICD eligibility.

Methods
Screening for S-ICD eligibility was performed using AST in 194 consecutive patients with BrS. Eligibility was defined when at least one of the three vectors was acceptable both in supine and standing position. Twelve-lead ECGs were registered during the screening. ECG parameters associated with AST eligibility were identified using multivariable logistical regression.

Results
Our study population consisted of 194 patients, with male preponderance (n=165/194; 85%); and were 43±12 years old at the time of screening. Majority of patients presented a spontaneous type 1 pattern during screening (n=128/194; 66%), with an average pattern height of 3±3 mm.
Remarkably, 93% of patients passed the screening with AST. No differences in eligibility rates in terms of gender (93% males vs. 93% females eligible; p=1) and age (48±9 years non-eligible vs. 42±12 eligible; p=0.07) existed. Notably, our eligibility rate was 2.5 times higher than rates reported in literature when using manual screening tools (p=0.023). Independent 12-lead ECG parameters (Table) associated with AST eligibility were duration of S wave &lt;80 ms in aVF and R/T ratio ≥3 in lead II (Figure), which have a high positive predictive value (97% and 99%, respectively) for screening eligibility.

Conclusions
Most BrS patients (93%) are eligible for S-ICD when AST is used. S wave &lt;80 ms in aVF, and R/T ratio ≥3 in lead II have a high positive predictive value for S-ICD eligibility.

Funding Acknowledgement
Type of funding source: Public grant(s) – National budget only. Main funding source(s): The Italian Ministry of Research and University Dipartimenti di Eccellenza 2018–2022 grant to the Molecular Medicine Department (University of Pavia)
Comparison of de novo and upgrade to resynchronization therapy: a propensity-score matched analysis
Authors: Brandao M , Goncalves Almeida J , Monteiro J , Montenegro Sa F , Fonseca P , Rosas F , Santos E , Ribeiro J , Oliveira M , Goncalves H , Primo J , Braga P 
Published: November 2020

Abstract

Background
Upgrade to resynchronization therapy (CRT) from conventional pacemaker (P) or defibrillator (D) is common practice in Europe. However, guidelines (GL) are discordant: Pacing GL give a class I recommendation, while Heart Failure (HF) GL provide a class IIb indication. Previous studies suggested worse outcomes in upgraded patients (pts).

Aim
To compare response rate and clinical outcomes in a cohort of pts receiving de novo or upgrade to CRT.

Methods
Single-center retrospective study of consecutive pts submitted to CRT implantation (2007–2017). Major adverse cardiac events (MACE) included HF hospitalization (HHF) or all-cause mortality. Clinical response was defined as New York Heart Association class improvement without MACE in the first year of follow-up (FU). Left ventricle end-systolic volume reduction of &gt;15% denoted echocardiographic (echo) response. Survival analysis with Kaplan-Meier method and Log-rank test was performed. Propensity-score matching (PSM) analysis was made to adjust for possible confounder variables.

Results
230 CRT recipients (70.9% male, mean age 67±11 years, 71.5% non-ischemic cardiomyopathy, 39.6% CRT-P) were included, of whom 46 (20%) underwent an upgrade. Upgraded pts were older (69.8 vs 65.9 years, p=0.015), with higher rates of permanent atrial fibrillation (37.0% vs 12.7%, p=0.001), moderate to severe valve disease (45.7% vs 22.3%, p=0.002), chronic kidney disease (37.0% vs 17.2%, p=0.005) and treatment with mineralocorticoid receptor antagonists (79.1% vs 52.0%, p=0.002). They were more likely to receive CRT-P (65.2% vs 33.2%, p&lt;0.001) and CRT-D were more often implanted for secondary prevention (60.0% vs 17.9%, p=0.001). No differences emerged in procedural complications, clinical (74.4% vs 71.4%, p=0.712) or echo (66.7% vs 69.7%, p=0.822) response rates.
During a median FU of 3±4 years, all-cause mortality was similar among groups (Log Rank test, p=0.522, unadjusted hazard ratio [HR] 1.25, confidence interval [CI] 95% 0.62–2.49, p=0.534). There was a statistical tendency for higher MACE rate in the upgrade group (Log Rank test, p=0.064, HR 1.66, CI 95% 0.95–2,91, p=0.076). No differences were found in lead dislodgement (10.9% vs 7.1%, p=0.368) or endocarditis (2.2% vs 4.3%, p=0.692) rates.
PSM analysis identified 88 matched pairs (46 upgrade/42 de novo pts). In this cohort, all-cause mortality (Log Rank test, p=0.77, HR 0.89, CI 95% 0.39–2.03, p=0.78) and MACE (Log Rank test, p=0.36, HR 1.38, CI 95% 0.68–2.81, p=0.37) were comparable between groups [graph no. 1].

Conclusion
Upgrade to CRT was similar to de novo implantation in terms of complications and clinical and echo response, in this cohort. The risk for MACE and mortality was also comparable.
Graph 1

Funding Acknowledgement
Type of funding source: None
10-year outcomes of triple-site versus standard cardiac resynchronization therapy randomized trial (TRUST CRT)
Authors: Mazurek M , Jedrzejczyk-Patej E , Kowalski O , Sredniawa B , Sokal A , Pruszkowska-Skrzep P , Pluta S , Kukulski T , Szulik M , Stabryla-Deska J , Kalarus Z , Lenarczyk R 
Published: November 2020

Abstract

Background
Triple-Site versus Standard Cardiac Resynchronization Therapy Randomized Trial (TRUST CRT) was initiated in 2009 to verify the hypothesis whether triple-site (single right, double left) cardiac resynchronization therapy (CRT) may be superior to conventional, biventricular resynchronization in patients with advanced heart failure.

Objectives
To report 6-month outcomes and 10-year survival in TRUST CRT.

Methods
100 consecutive patients with moderate to severe heart failure, ejection fraction of 35% or less, electrical and mechanical dyssynchrony, were randomly assigned in a 1:1 fashion to triple-site CRT defibrillator (TRIV) or to conventional CRT-D. The primary objective evaluated response-rate, defined as the 6-month's combined end point of alive status, freedom from hospitalization for heart failure or heart transplantation, relative≥10% increase in ejection fraction, ≥10% in peak oxygen consumption, and ≥10% in 6-minute walking distance. The secondary objective was to assess the occurrence of major adverse cardiovascular events (hospitalization for exacerbated heart failure requiring modification of pharmacotherapy, heart transplant or death) at month 6 and during remote observation.

Results
At month 6, the response-rate was higher in triple-site than conventional CRT-D group (51.1 vs. 26.5%, P=0.014). There were 2 deaths or heart failure events in the triple-site group (4%) as compared with 8 in the group assigned to conventional CRT-D (16%). A triple-site resynchronization resulted in 12% absolute risk reduction for secondary end point (hazard ratio 0.25; 95 percent confidence interval, 0.05 to 1.17, P=0.056, in comparison with the conventional CRT-D group). After 10 years of observation (median follow up of 7.1 years; range: 1.2–10.4) 57 patients (58.2%) died: 24 (53.3%) in the triple-site group, 31 (60.8%) in the conventional group (P=0.46) and 2 patients with and ICD (failed CRT implantation) [Figure].

Conclusions
In patients with advanced heart failure, triple-site resynchronization combined with an ICD did not result in better survival than conventional resynchronization therapy in a median observation of 7.1 years.
Figure 1

Funding Acknowledgement
Type of funding source: None
Adequate contacts after remote monitoring alerts were associated with improved outcomes in chronic heart failure: results from the OptiLink HF study
Authors: Wintrich J , Pavlicek V.P , Brachmann J.B , Bosch R.B , Butter C.B , Oswald H.O , Rybak K.R , Mahfoud F.M , Boehm M.B , Ukena C.U 
Published: November 2020

Abstract

Aims
To investigate the effects of adequate reactions to telemedicine alerts triggered by fluid index threshold crossings (FTC) on clinical outcomes in the OptiLink HF trial.

Methods
We separated adequate from inadequate reactions to FTC transmissions in patients with remote impedance-based monitoring (RM) of fluid status in the OptiLink HF trial. Adequate contacts had to meet the following criteria: i) initial telephone contact within 2 working days after FTC transmission, ii) follow-up contacts according to study protocol, and iii) medical intervention initiated after FTC due to true fluid overload. We compared time to cardiovascular (CV) death or heart failure (HF) hospitalization and all CV- and HF-hospitalizations at follow-up between RM patients contacted adequately or inadequately and patients with usual care (UC).

Results
In the RM group, transmission of at least one FTC alert occurred in 356 patients (70.5%; n=505). While 113 patients (31.7%; n=356) have been contacted adequately after every FTC, in 243 patients (68.3%; n=356) at least one FTC was not responded by an adequate contact. Adequate responses to RM significantly reduced risk of the primary endpoint (hazard ratio (HR), 0.68; 95% confidence interval (CI) 0.48–0.95; p=0.025, figure 1), and led to a significantly lower number of CV (52.1±7.5 vs. 99.9±19.8; p=0.007) and HF hospitalizations per 100 patient years when compared with UC (26.1±4.4 vs. 67±15.2; p=0.007).

Conclusion
RM with adequate reactions to FTC alerts significantly reduced total number of both CV and HF hospitalizations and improved clinical outcomes in patients with advanced HF and implantable cardioverter defibrillator (ICD).

Funding Acknowledgement
Type of funding source: None
Incidence and causes of in-hospital mortality in cardiac device-related infections
Authors: Doring M , Ebert M , Lucas J , Hindricks G , Richter S 
Published: November 2020

Abstract

Introduction
Cardiac device-related infections (CDRI) are associated with increased in-hospital mortality despite effective treatment by transvenous lead extraction (TLE) and antibiotic therapy. Data on mortality and causes of death are scarce and predictors of mortality are not well defined.

Purpose
To analyse the incidence and causes of mortality in CDRI and identify predictors of mortality in a large single centre experience.

Methods
All patients undergoing TLE for CDRI in our department between May 2012 and January 2020 were included in a prospective registry. Patient characteristics, procedural and follow-up data were collected and analysed. A Kaplan-Meier analysis was used to analyse the influence of different infection types on mortality. Univariate and multivariate cox regression analysis was applied to identify risk factors for mortality.

Results
Among 561 consecutive patients (72±12 years; 77% male) treated for CDRI (51.2% systemic and 48.8% localized infection), 61 patients (10.9%) died during the index hospitalization. The most frequent cause of death was severe systemic infection or sepsis in 38 patients (6.8%), followed by end-stage heart failure (9; 1.6%), respiratory insufficiency (3; 0.5%), ventricular arrhythmias (3; 0.5%), asystole (2; 0.4%), pulmonary embolism (2; 0.4%), acute enteric ischemia (2; 0.4%), mechanical ileus (1; 0.2%), and unwitnessed sudden death (1; 0.2%). Patients who died had significantly more often systemic infections (p&lt;0.001), positive blood cultures (p&lt;0.001), severe renal dysfunction (GFR &lt;30ml/min; p&lt;0.001), heart failure with reduced ejection fraction (HFrEF; p=0.001), and diabetes (p=0.004). Kaplan-Meier survival analysis showed a significantly higher mortality in patients with systemic CDRI as compared to localized infection (log-rank p&lt;0.001). Several factors were predictors of mortality in univariate analysis: systemic infection (HR 4.64, 95% CI 2.18–9.84; p&lt;0.001), GFR &lt;30 ml/min (HR 4.27, 95% CI 2.57–7.09; p&lt;0.001), vegetation in TOE (HR 3.68, 95% CI 1.78–7.43; p&lt;0.001), positive blood cultures (HR 2.52, 95% CI 1.46–4.37; p=0.001), diabetes (HR 1.89, 95% CI 1.12–3.18; p=0.018), HFrEF (HR 1.83, 95% CI 1.09–3.05; p=0.021), tricuspid regurgitation (HR 1.79, 95% CI 1.21–2.65, p=0.004), and days from hospital admission to explant (HR 1.04, 95% CI 1.02–1.06; p&lt;0.001). Multivariate analysis revealed severe renal dysfunction (HR 2.71, 95% CI 1.47–5.00; p=0.001) and days from hospital admission to TLE (HR 1.029, 95% CI 1.004–1.055, p=0.021) as independent predictors of in-hospital mortality.

Conclusion
In-hospital mortality in CDRI is particularly high in patients with severe systemic infection and sepsis despite state-of the-art treatment. Delayed TLE is associated with an increased in-hospital mortality. Therefore, TLE should be performed early in the course of CDRI, particularly in patients with severe systemic infection.

Funding Acknowledgement
Type of funding source: None
Trends of sex differences in outcomes of cardiac electronic device implantations in the United States
Authors: Mohamed M , Volgman A.S , Contractor T , Sharma P.S , Kwok C.S , Martin G.P , Barker D , Patwala A , Mamas M.A 
Published: November 2020

Abstract

Background
There is limited evidence on the differences in procedural outcomes between sexes after de novo cardiac implantable electronic device implantation (CIED). Furthermore, it is unclear whether any sex-based disparities have changed over the years.

Purpose
To compare procedural outcomes of de novo CIED implantation between sexes and study the trends of these outcomes over a 11-year period in a nationally representative sample.

Methods
Using the National Inpatient Sample, all hospitalisations between 2004 and 2014 for de novo CIED implantation were included, stratified by sex. Multivariable logistic regression was performed to 1) examine the association between sex and in-hospital complications of CIED implantation, expressed as odds ratios (OR) with 95% confidence intervals (CI), and 2) analyse trends of in-hospital outcomes by assessing the interaction term between time (years) and sex as covariates.

Results
Out of 2,815,613 hospitalisations for de novo CIED implantation, 41.9% were performed on women. Women were associated with increased adjusted odds of major adverse cardiovascular events (composite of mortality, thoracic and cardiac complications; OR 1.17 95% CI 1.16, 1.19), procedure-related bleeding (OR 1.13 95% CI 1.12, 1.15), and local complications (thoracic: OR 1.42 95% CI 1.40, 1.44, cardiac: OR 1.44 95% CI 1.38, 1.50). (p&lt;0.001 for all) Notably, there was no difference in odds of all-cause mortality between sexes (OR women: 0.96 95% CI 0.94, 1.00). The odds of adverse complications in the overall CIED cohort were persistently raised in women throughout the study period, whereas similar odds of all-cause mortality across the sexes were observed throughout the study period (see Figure).

Conclusion
In a national cohort of CIED implantations we demonstrate that women are at a persistently higher risk of procedure-related adverse events other than mortality compared to men. This trend is concerning and warrants further work on procedural techniques to neutralise these sex disparities.
Trends of odds of complications in women

Funding Acknowledgement
Type of funding source: Private company. Main funding source(s): This work constitutes part of a PhD for MOM that is supported by Medtronic Ltd. Medtronic Ltd. was not involved in the conceptualization, design, conduct, analysis, or interpretation of the current study.