bluuebunny/crossref_metadata_2025_split huggingface dataset:
Safety of omitting defibrillation efficacy testing with subcutaneous defibrillators: a propensity matched case-control study
Authors: Bianchi V , Bisignani G , Russo V , Migliore F , Tola G , Viani S , Rossi P , Biffi M , Palmisano P , Checchi L , Licciardello G , Francia P , Leidi C , Ospizio R , D"onofrio A 
Published: May 2021

Abstract

Funding Acknowledgements
Type of funding sources: None.

Background
Defibrillation efficacy testing (DT) is recommended at implantation of subcutaneous implantable cardioverter–defibrillators (S-ICD). However, prior works found that adherence to this recommendation is declining in clinical practice.

Purpose
To compare survival from all-cause death and first ineffective shock (primary endpoint) and the composite of all-cause death, ineffective shock, inappropriate shock and device-related complication (secondary endpoint) between patients who underwent DT and those with omitted DT.

Methods
We analyzed 1652 consecutive patients who underwent S-ICD implantation in 60 Italian centers from 2013 to 2019.

Results
DT was not performed in 325 (20%) patients (no-DT patients). As compared with the DT group, these patients were older (51 ± 16 vs. 48 ± 15 years; p &lt; 0.01) and had lower ejection fraction (37 ± 16% vs. 46 ± 16%; p &lt; 0.01). The 325 no-DT patients were propensity matched with 325 patients of the DT group. During a median follow up of 19 months, 27 (4.2%) patients died for any-cause. During follow-up, 34 (5.2%) patients received appropriate shocks to treat discrete episodes of VT/VF. The first shock was effective in 30 out of 34 patients (88%), whereas a second shock was required to terminate VT/VF in 3 patients and a third shock in the last one. The primary endpoint occurred in 31 (4.8%) patients, and the risk was not significantly increased in the no-DT cohort (HR = 1.26, 95%CI:0.62-2.55, p = 0.522). Inappropriate shocks were reported in 36 (5.5%) patients and device-related complications in 25 (3.8%) patients during follow-up. Survival from the composite secondary endpoint was comparable between groups (HR = 0.86, 95%CI:0.57-1.32, p = 0.500).

Conclusions
Our data confirmed that DT is frequently omitted in current clinical practice, especially in older patients with worse systolic function. A strategy that omits DT did not appear to compromise the effectiveness of the S-ICD and no additional risk seems associated with DT omission at a mid-term follow-up. These data suggest that routine DT at S-ICD implant might not be necessary. Randomized trials are needed to confirm this finding.
New onset depression and anxiety in patients with an implantable cardioverter defibrillator during 24 months of follow-up
Authors: Pedersen SS , Nielsen JC , Wehberg S , Jorgensen OD , Riahi S , Haarbo J , Philbert BT , Johansen JB 
Published: May 2021

Abstract

Funding Acknowledgements
Type of funding sources: Foundation. Main funding source(s): Danish Heart Foundation

OnBehalf
DEFIB-WOMEN study group

Background
Patients adjust well to living with an implantable cardioverter defibrillator (ICD), but 20% develop anxiety and depression that may compromise their quality of life (QoL) and increase risk of ventricular tachyarrhythmias and mortality.

Purpose
We examined the incidence and correlates of new onset anxiety and depression during 24 months of follow-up in ICD patients without depression and anxiety.

Methods
Patients with a first-time ICD (n = 1040) enrolled in the national, multi-centre prospective observational DEFIB-WOMEN study completed questionnaires on anxiety, depression and physical QoL at baseline, 3-, 6-, 12-, and 24 months. Information on demographic and clinical data was obtained from the Danish Pacemaker and ICD Register.

Results
During 24 months of follow-up, 46-57 (4%-5%) patients developed new onset anxiety and 42-47 (4%-5%) new onset depression. The incidence of new onset comorbid anxiety and depression was higher with 69-80 (7%-8%). Age [HR:0.54; 95%CI:0.36-0.80], marital status [HR:1.66; 95%CI:1.01-2.73], secondary prevention indication [HR:1.43; 95%CI:1.00-2.04], Type D personality [HR:2.50; 95%CI:1.62-3.86], and lower self-reported physical functioning [HR:1.48; 95%CI:1.00-2.17] were associated with new onset anxiety during follow-up. Age [HR:0.57; 95%CI:0.37-0.89], higher self-reported physical functioning [HR:0.46; 95%CI:0.25-0.85], smoking [HR:2.13; 95%CI:1.33-3.40], Type D personality [HR:2.53; 95%CI: 1.57-4.05], and lower self-reported physical functioning [HR:1.64; 95%CI:1.08-2.48] were associated with new onset depression.

Conclusion
Between 4%-8% of patients with a first-time ICD with no anxiety or depression at baseline are at risk of new onset anxiety, depression, or comorbid anxiety and depression up to 24 months post implant, suggesting that safeguarding their QoL and prognosis warrants that we screen patients not only at baseline.
Endocardial pacing is not haemodynamically superior to trans-coronary sinus epicardial pacing in cardiac resynchronization therapy: the Endo-Epi CRT study
Authors: Okafor O , Zegard A , Stegemann B , Arif S , De Bono J , Marshall H , Leyva F 
Published: May 2021

Abstract

Funding Acknowledgements
Type of funding sources: Private grant(s) and/or Sponsorship. Main funding source(s): Medtronic

Background
Cardiac resynchronization therapy (CRT) conventionally involves trans-coronary sinus, epicardial left ventricular (LV) pacing. Some studies have suggested that endocardial LV pacing may be superior to epicardial LV pacing.

Objectives
To compare the acute haemodynamic effects of CRT when delivered from endocardial (Endo-CRT) and epicardial LV stimulation sites (Epi-CRT).

Methods and results
Sixteen CRT recipients (aged 70.4 ± 10.1 years [mean ± SD], 62.5% male, QRS: 156.5 ± 16.1 ms, LBBB in 13 [81.3%]) in sinus rhythm underwent intra-procedural measurements of the rate of rise of LV pressure (dP/dtmax) during Endo- and Epi-CRT (RADI pressure wire). Epi-CRT was delivered in basal, mid and apical positions. The Endo-CRT pacing site was chosen using iterative, biplane fluoroscopic views, to target the same position as the Epi-CRT site on the endocardium (see Figure A). Compared to AAI pacing (10 beats per minute above intrinsic rate), both Endo-CRT and Epi-CRT led to an increase in LV dP/dtmax (6.52 ± 8.90% and 6.15 ± 7.97% respectively, both p &lt; 0.001). There were no significant differences in the change in LV dP/dtmax (ΔLV dP/dtmax) between Endo-CRT and Epi-CRT at basal (p = 0.54), mid (p = 0.78) or apical LV stimulation sites (p = 0.12) [Figure B].

Conclusions
Endo-CRT is not haemodynamically superior to Epi-CRT. Abstract Figure.
Better outcome at lower costs after implementing a CRT-care pathway: a comprehensive evaluation of real-world data
Authors: Van Stipdonk AMW , Schretlen S , Dohmen W , Knackstedt C , Brunner-Larocca HP , Vernooy K 
Published: May 2021

Abstract

Funding Acknowledgements
Type of funding sources: Private grant(s) and/or Sponsorship. Main funding source(s): Medtronic plc.

Background
Cardiac resynchronization therapy (CRT) requires intensive, complex and multi-disciplinary care to maximize clinical benefit in heart failure patients. In current practice, this is often incomplete due to limitations in time, resources and coordination of care.

Purpose
We evaluated the effect of the introduction of a novel multidisciplinary, standardized CRT care pathway (CRT-CPW) compared with usual care, on clinical outcome and costs.

Methods
The CRT care pathway (CRT-CPW) design, based on an expert consensus of experienced European CRT specialists; focussed on structuring patient selection, implantation and follow-up heart failure treatment and device management. To facilitate and guarantee quality, checklists fitted to each moment in the care pathway were designed, to aid contributors. The CRT-CPW was implemented in the Maastricht University Medical Centre in 2014. Data from patients receiving usual care (2012-2014, 222 patients) and patients receiving care under the CRT-CPW (2015-2018, 241 patients) were compared. Data was extracted from the hospital information system. The primary outcome was the composite of all-cause mortality and heart failure (HF) hospitalization. Hospital-related costs of cardiovascular care after CRT implantation was analysed to address cost-effectiveness.

Results
Patient demographics were comparable in both groups, except that the CRT-CPW group showed more AF and previous myocardial infarction at baseline. The combined endpoint of death from any cause and admission for HF occurred in 127 patients (57.2%) in the usual care group and 64 patients (26.6%) in the CRT- CPW group (adjusted HR 0.68 (95% CI, 0.49 to 0.93), p = 0.015) (Figure 1A). Total costs for cardiology related hospitalizations reduced significantly in the CRT care pathway group (€ 19.177 ± 9.692 vs 20.613 ± 7.066, p&lt; 0.001, Table 4). Bootstrap analyses revealed that 90.7% of samples would show improved outcomes as well as reduction in costs in the CRT-CPW treatment group (Figure 1B).

Conclusion
The introduction of a novel CRT-CPW resulted in improved clinical outcome and reduced costs. Abstract Figure 1 Clinical outcome and costs
Futility risk model for predicting outcome after cardiac resynchronization therapy defibrillator implantation: data from a nationwide analysis
Authors: Maille B , Bodin A , Bisson A , Herbert J , Franceschi F , Koutbi-Franceschi L , Hourdain J , Martinez E , Zabern M , Deharo J-C , Fauchier L 
Published: May 2021

Abstract

Funding Acknowledgements
Type of funding sources: None.
Objective. Risk-benefit assessment for cardiac resynchronization therapy defibrillator (CRT-D) over a CRT pacemaker (CRT-P) is still a matter of debate. We aimed to identify patients with a bad outcome within one year after CRT-D implantation, and to develop a Futile CRT-D score.
Methods. Based on the administrative hospital-discharge database, all consecutive patients treated with CRT-D implantation in France between 2010 and 2019 were included. A prediction model was derived and validated for one-year all-cause death after CRT-D implantation (considered as futility) by using split-sample validation.
Results. 28,503 patients were included in the analysis (mean age 68 ± 10 years); 2,139 (7.5%) deaths were recorded in the first year. In the derivation cohort (n = 14,252), the final logistic regression model included as main predictors of futility older age, diabetes, mitral regurgitation, history of hospital stay with heart failure, history of pulmonary oedema, atrial fibrillation, renal, pulmonary, liver, or thyroid disease, denutrition and anemia. Based on Futile CRT-D score, 17% of these patients were categorized at high risk (Futile CRT-D score ≥13) and predicted futility at 17%.
Conclusion. The futility CRT-D score, established from a large nationwide cohort of patients treated with CRT-D may provide a relevant tool for optimizing healthcare decision. Death at one year in patients with CRTD OR (95%CI)pPointsAge (quartile)1.353 (1.266-1.446)&lt;0.00012Diabetes mellitus1.413 (1.225-1.629)&lt;0.00012Heart failure with congestion1.908 (1.501-2.423)&lt;0.00013History of pulmonary edema1.445 (1.194-1.749)&lt;0.00012Mitral regurgitation1.259 (1.074-1.475)0.0042Atrial fibrillation1.601 (1.395-1.838)&lt;0.00012Left BBB0.803 (0.698-0.924)0.002-1Dyslipidemia0.809 (0.696-0.940)0.006-1Denutrition1.709 (1.360-2.147)&lt;0.00012Chronic kidney disease1.574 (1.321-1.875)&lt;0.00012Lung disease1.230 (1.052-1.437)0.0092Sleep apnea syndrome0.740 (0.596-0.919)0.007-1Liver disease1.747 (1.384-2.206)&lt;0.00012Anaemia1.325 (1.105-1.589)0.0022BBB = bundle branch block.; * age quartile: 1 point when age &gt;61, 2 points when age &gt;69, 3 points when age &gt;75.Abstract Figure. AUC and incidences of all-causes death
Duration of the preejection phase is less preload dependent and therefore a better marker of acute response to cardiac resynchronization therapy than maximum pressure rise
Authors: Villegas-Martinez M , Odland HH , Sletten OJ , Khan F , Wajdan A , Elle OJ , Fosse E , Krogh MR , Remme EW 
Published: May 2021

Abstract

Funding Acknowledgements
Type of funding sources: Public grant(s) – EU funding. Main funding source(s): EU’s Horizon 2020 research and innovation program under the Marie Sklodowska-Curie
Background
There is no consensus on which haemodynamic marker should be used to quantify acute response to cardiac resynchronization therapy (CRT) during implantation of the device. CRT has been shown to acutely reduce left ventricular (LV) end systolic as well as end-diastolic volume (EDV), precluding the use of preload dependent markers such as LV maximum pressure rise (dP/dtmax).
Purpose
As resynchronization will abolish the uncoordinated regional early systolic contractions of the LV, it will shorten the time to maximal pressure rise and aortic valve opening. For this reason, the purpose of this study was to investigate if duration from the time-point of ventricular pacing to dP/dtmax is less preload dependent and a better marker of acute response to CRT than dP/dtmax by comparing how the 2 markers reflected LV function during different CRT configurations.
Methods
LV pressure by micromanometer and volume by sonomicrometry were measured in 6 anaesthetized canines with left bundle branch block. Transient caval constrictions were performed to vary preload. Preload dependency of the 2 markers was compared by normalizing their values and calculating their relations to EDV. In 4 of the animals, biventricular pacing was performed at 3 different pacing sites with variations in atrioventricular delays that provided a range of response to CRT. To correct for acute
changes in preload by CRT, stroke volume (SV) at identical EDV found from transient caval constrictions, were assessed and used as reference to grade improved LV function. Linear regression analysis was used to assess the correlation of both the duration of the preejection phase and dP/dtmax with SV.
Results
The duration of the preejection phase varied less with changes in preload compared to dP/dtmax: the slopes of their relation to EDV were -0.6 ± 0.7 %/ml and 4.8 ± 2.1 %/ml (p = 0.004), respectively. Turning CRT on, acutely reduced EDV from 74 ± 16 to 69 ± 17 ml (p &lt; 0.001) at the best pacing configuration. For the different pacing sites and settings, there was a consistent relation in all animals where the preejection phase shortened as SV increased (average r2 = 0.75) (Figure A). dP/dtmax showed no clear relation to SV (average r2 = 0.22) and included cases with both negative and positive slopes (Figure B).
Conclusions
The duration of the preejection phase correlated with changes in LV function induced by CRT while dP/dtmax performed poorly as preload was changed. Hence, the novel timing parameter was less preload dependent and may be a better marker for assessing acute response to CRT. Abstract Figure.
A method for accurately and dynamically optimising pacemaker atrio-ventricular delay timing using implantable physiological biomarkers
Authors: Miyazawa AA , Keene D , Johal M , Arnold AD , Peters NS , Kanagaratnam P , Linton NWF , Lim PB , Lefroy DC , Ng FS , Qureshi NA , Koa-Wing M , Whinnett ZI , Francis DP , Shun-Shin MJ 
Published: May 2021

Abstract

Funding Acknowledgements
Type of funding sources: Other. Main funding source(s): BRAVO trial: BHF SP/10/002/28189, FS/10/038, FS/11/92/29122, FS/13/44/30291) National Institute for Health Research Imperial Biomedical Research Centre. HOPE-HF trial: British Heart Foundation (CS/15/3/31405, FS/13/44/30291, FS/15/53/31615, FS/14/27/30752, FS/10/038).

Introduction
The optimal atrioventricular (AV) delay for implantable cardiac devices can be derived by echocardiography or beat-by-beat blood pressure measurements. However, both of these approaches are labour intensive and neither could be incorporated into an implantable cardiac device for frequent repeated optimisations. Laser Doppler perfusion monitoring (LDPM) measures blood flow through tissue. LDPM has been miniaturised ready to be incorporated into future implantable cardiac devices.

Purpose
We studied if LDPM is a clinically reliable alternative method to blood-pressure measurements to determine optimal AV delay.

Methods
Data from 58 patients undergoing 94 clinical AVD optimisations using LDPM and simultaneous non-invasive beat-by-beat blood pressure was obtained. The optimal AV delay for each method and for each optimisation was determined using a curve of haemodynamic response to switching from AAI (reference state) to DDD (test state) at a series of AV delays (40, 80, 120, 160, 200, 240 ms). We then compared the derived optimal AV delays between the two measurement approaches. We also assessed the impact of the paced heart-rate on agreement between laser Doppler and Blood-Pressure derived optimal AV delays.

Results
The AV delay derived using LDPM was not clinically significant different from that derived by blood pressure changes. The median difference was -9ms (IQR -26 to 7, p = 0.05). Variability between the two methods was low (median absolute deviation 17ms). Optimisations performed at higher heart-rates resulted in a non-significant smaller difference between the LDPM and blood-pressure derived AV delays (median absolute deviation 12 vs 22 ms, p = 0.11).

Conclusions
Optimal AVDs derived from non-invasive blood-pressure or laser Doppler perfusion methods are clinically equivalent. The addition of laser Doppler to future implantable cardiac devices may enable devices to dynamically and reliably optimise AV delays. Abstract Figure 1
A multiparametric ICD algorithm for heart failure risk stratification and management: an analysis in clinical practice
Authors: Calo" L , Bianchi V , Ferraioli D , Santini L , Dello Russo A , Carriere C , Santobuono VE , Andreoli C , La Greca C , Arena G , Talarico A , Pisano" E , De Ruvo E , Campari M , D"onofrio A 
Published: May 2021

Abstract

Funding Acknowledgements
Type of funding sources: None.

Introduction
The HeartLogic algorithm combines multiple implantable cardioverter defibrillator (ICD) sensors to identify patients at risk of heart failure (HF) events.

Purpose
We sought to evaluate the risk stratification ability of this algorithm in clinical practice. We also analyzed the alert management strategies adopted in the study group and their association with the occurrence of HF events.

Methods
The HeartLogic feature was activated in 366 ICD and cardiac resynchronization therapy ICD patients at 22 centers. The HeartLogic algorithm automatically calculates a daily HF index and identifies periods IN or OUT of an alert state on the basis of a configurable threshold (in this analysis set to 16).

Results
The HeartLogic index crossed the threshold value 273 times (0.76 alerts/patient-year) in 150 patients over a median follow-up of 11 months [25-75 percentile: 6-16]. Overall, the time IN the alert state was 11% of the total observation period. Patients experienced 36 HF hospitalizations and 8 patients died of HF (rate: 0.12 events/patient-year) during the observation period. Thirty-five events were associated with the IN alert state (0.92 events/patient-year versus 0.03 events/patient-year in the OUT of alert state). The hazard ratio in the IN/OUT of alert state comparison was (HR: 24.53, 95% CI: 8.55-70.38, p &lt; 0.001), after adjustment for baseline clinical confounders. Alerts followed by clinical actions were associated with a lower rate of HF events (HR: 0.37, 95% CI: 0.14-0.99, p = 0.047). No differences in event rates were observed between in-office and remote alert management. By contrast, verification of HF symptoms during post-alert examination was associated with a higher risk of HF events (HR: 5.23, 95% CI: 1.98-13.83, p &lt; 0.001).

Conclusions
This multiparametric ICD algorithm identifies patients during periods of significantly increased risk of HF events. The rate of HF events seemed lower when clinical actions were undertaken in response to alerts. Extra in-office visits did not seem to be required in order to effectively manage HeartLogic alerts, while post-alert verification of symptoms seemed useful in order to better stratify patients at risk of HF events.
Venoplasty to gain venous access during cardiac device implantation is feasible and safe
Authors: Lankveld T , Stipdonk AMW , Brans RJB , Luermans JGLM , De Haan MW , Vernooy K 
Published: May 2021

Abstract

Funding Acknowledgements
Type of funding sources: None.

Background
Venous obstruction is relatively common after cardiac implantable electronic device (CIED) implantation. After CIED implantation 15% of the patients present with a severe or total occlusion. This poses a problem during lead revisions or upgrades often leading to implantation failure or complex extraction or lead tunneling procedures. Percutaneous balloon venoplasty might be a suitable option but is rarely performed.

Purpose
To identify the feasibility and safety of venoplasty during cardiac device implantation procedures.

Methods
We retrospectively included consecutive cardiac device implantations in which venoplasty was performed during the same procedure from December 2018 until December 2020. The venoplasty was done either planned or ad hoc, by an interventional radiologist.

Results
We included 17 patients, 14 (82%) were male, aged 73 ± 11 years. Fifteen (88%) patients required an upgrade or lead revision and two were de novo implantations. The subclavian vein was the site of occlusion in 13 (76%) patients. In 16 (94%) patients venoplasty was successful and all intended leads could be implanted subsequently. In the patient with the unsuccessful recanalization both an antegrade and retrograde approach via the vena femoralis was attempted. No venoplasty related complications occurred.
The figure shows a succesful upgrade from a single chamber ICD (panel A) to a CRT-D (panel D) after venoplasty for a total occulsion of the vena subclavia (panel B and C).

Conclusions
Percutaneous balloon venoplasty is a safe and feasible method for patients in whom venous access is an issue during CIED implantation. This method can be performed ad hoc and prevents contralateral lead implantation with tunneling or lead extraction. Abstract Figure. Venoplasty during upgrade.