bluuebunny/crossref_metadata_2025 huggingface dataset:
Prediction of Left Atrial Appendage occluder size based on 3D printed models
Authors: Hudec M , Chovancik J , Jiravsky O , Hecko J , Miklik R , Sknouril L
Published: May 2021

Funding Acknowledgements

Type of funding sources: None.

Background

occlusion of the left atrial appendage (LAA) is an established method in the prevention of thromboembolic complications in patients with atrial fibrillation and high bleeding risk. There is a huge anatomical variability of LAA and choosing the right type and size of the occluder may be challenging and result in a time-consuming procedure with repeated repositioning of the selected device, or a need to use another device. These aspects may lead to a prolonged or more aggressive manipulation resulting in periprocedural complications and a suboptimal result. The current technology of 3D printing allows us to obtain a real model of the LAA and to simulate the course of implantation.

Purpose

in a post-hoc analysis to compare occluder sizes predicted as optimal by simulation on a 3D-printed LAA model to actually implanted LAA occluders, and analyse potential benefits of such simulations.

Methods

We analysed 32 consecutive patients after a TEE-guided implantation of the Amulet occluder in whom a CT cardiac scan had been performed prior to the procedure. Based on the CT, an LAA 3D model was printed out post-hoc for each patient. Two experienced operators blinded to the procedural results simulated the implantation ex-vivo and agreed on the most appropriate size of the occluder to fit in the LAA. If the simulation-based size matched the size of the primary operator`s choice and this occluder was actually implanted („intention-to-implant and implanted"), the match was considered positive; otherwise it was negative. The number of positive and negative matches and corresponding procedural characteristics were analysed.

Results

The positive match was found in 9 (28.1%) cases. Out of 23 (71.9%) negative matches, there were 11 (47.8%) implantations using a bigger-than-simulated and 12 (52.2%) smaller-than-simulated occluder; in 2 (8.7%) cases the actually implanted occluder matched the simulated size but was a 2nd -choice occluder. In positive-match cases compared to negative-match cases, there was a statistically significant less need for an occluder reposition (median 0.0 vs 1.0, p = 0,02), and a trend to a shorter procedural time (average 66.7+ 13.3 min vs 85.2 + 32.8 min, p = 0.112) and less contrast agent consumption (average 188.9 + 67.9ml vs 220.9 + 112.4ml, p = 0.43).

Conclusion

 The preliminary results of our study suggest that a CT-based 3D modelling of the LAA shape and simulating the LAA occlusion procedure ex-vivo have a potential to become useful tools to reduce procedural time and complications. Our results might serve as a rational for a prospective study. Abstract Figure. Occluder in the 3D model
Left atrial appendage closure in the presence of thrombus: incidence, technique and outcomes
Authors: Fontenla Cerezuela A , Gomez-Blazquez I , Corros C , Rodriguez D , Borrego-Bernabe L , Marco Del Castillo A , Ramos-Jimenez J , Solis J , Sarnago F , Lopez-Gil M , Bueno H , Salguero R , Arribas F
Published: May 2021

Funding Acknowledgements

Type of funding sources: None.

Background

Patients with left atrial appendage (LAA) thrombus are excluded for LAA occlusion (LAAO) in clinical trials. However, some of them may require this therapy due to repeated thromboembolisms despite accurate anticoagulation. 

Aim

The aim of the study is to describe the prevalence of LAA thrombosis in patients submitted for LAAO in a high-volume center of LAAO procedures, explaining the employed technique and results in this scenario.

Methods

Single-center retrospective analysis including all consecutive patients referred for LAAO.

Results

LAA thrombus was detected by TEE in 8/76 patients referred for LAAO (10.5%). Five of them underwent LAAO despite the presence of thrombus due to clinical conditions. All the procedures were successfully performed with  Amulet devices (Table). The following preventive measures were putting in place during the implants: avoidance of contrast injection into the LAA during the procedure (non-touch technique), TEE measure for device size election; and TEE device deployment guidance with special care to the the sheath orientation and depth enabling a slow and single implant of the device partially released in the LAA before complete implantation at the entrance of the LAA (Figure. A&B: Large LAA thrombus partially occupying the landing zone. C: Thrombus sealed by LAAO device. D&E: Non-touch technique: echo-guided progressive deployment of the LAAO device without thrombus shifting). No cerebral protection devices were used. TEE performed one month after the procedure ruled out the presence of residual thrombi or leaks in all cases. There were no events after a median follow-up of 17.1 months (range: 32.3-1.1)

Conclusion

LAAO in patient with LAA thrombus can be effectively and safely performed, in high-volume centers  and with an accurate technique, under accurate TEE guidance. Abstract Figure. LAA thrombus and occlusion technique
Comparison of conventionally performed and electroanatomic mapping system guided catheter ablation for AV nodal reentrant tachycardia - prospective single-centre study
Authors: Dorottya D , Janosi K , Vilmanyi G , Simor T , Kupo P
Published: May 2021

Funding Acknowledgements

Type of funding sources: None.

Introduction

Radiofrequency (RF) catheter ablation in atrioventricular nodal reentry tachycardia (AVNRT) is highly effective. Three-dimensional electroanatomic mapping system (EAMS)-guided procedures are becoming more widespread.

Purpose

  We aimed to compare EAMS-guided procedures to conventionally, only-fluoroscopy approach for slow pathway ablation.

Methods

 152 patients undergoing electrophysiological study and slow pathway ablation due to documented AV nodal reentrant tachycardia were included in our prospective single-centre study.  In 102 patients the procedure was performed conventionally (Group 1) and 50 patients underwent an electroanatomic mapping system (EAMS) -guided approach (Group 2).

Results

In Group 2, 80% of the procedures were performed without the use of radiation. The procedure time (median (interquartile range): 65 (50-84) min vs. 75 (60-96.3) min, p =0.005) was significantly shorter in Group 1, with longer fluoroscopy time (4.2 (2.4-7.9) min vs. 0 (0-0) min, p < 0.001). There was no difference either in the number of RF applications (mean ± standard deviation 10.8 ± 8.5 vs. 10.2 ± 7.7, p = 0.66) or in the ablation time (297 ± 237 s vs. 294 ± 196 s, p = 0.74). All patients were treated successfully. One recurrence occurred in each groups during the follow-up.

Conclusions

In our series, EAMS-guided approach for slow pathway ablation was associated with reduced fluoroscopy and longer procedure time compared to conventional, only-fluoroscopy approach. No difference was found in ablation time, success rate or recurrence.
Atrioventricular block as a predictor of major adverse cardiac events in acute coronary syndrome patients
Authors: Santos H , Santos M , Almeida I , Miranda H , Sa C , Almeida S , Chin J , Sousa C , Almeida L
Published: May 2021

Funding Acknowledgements

Type of funding sources: None.

OnBehalf

Portuguese Registry of Acute Coronary Syndromes

Background

Atrioventricular block (AVB) can be a consequence of ischemia in acute coronary syndrome (ACS). Then, its expected, that AVB occurrence is associated with higher rates of major adverse cardiac events (MACE).

Objective

Evaluate if sustained AVB was a predictor of MACE in ACS hospitalized patients.

Methods

Multicenter retrospective study, based on the Portuguese Registry of ACS between 1/10/2010-3/05/2020. Patients were divided into two groups: A – patients without AVB, and B – patients that presented AVB. Were excluded patients without a previous cardiovascular history or clinical data regarding AVB occurrence. MACE was defined as re-infarction, congestive heart failure, cardiogenic shock, a mechanical complication of myocardial infarction, completed atrioventricular block, sustained ventricular tachycardia, cardiac arrest, stroke, major hemorrhage, transfusion and hospitalization death. Univariate logistic regression was performed to assess if AVB in ACS patients was a predictor of MACE.

Results

A total of 32157 patients was analyze and 23774 had information regarding AVB. From the group of patients that presented AVB, 214 (0.9%) had re-infarction, 3847 (16.2%) had congestive heart failure, 1018 (4.3%) had cardiogenic shock, 1069 (4.5%) had atrial fibrillation, 152 (0.6%) had a mechanical complication of myocardial infarction, 354 (1.5%) had sustained ventricular tachycardia, 706 (3.0%) had cardiac arrest, 152 (0.6%) had stroke, 364 (1.5%) had major hemorrhage, 353 (1.5%) had blood transfusion and 928 (3.0%) died. AVB did not predict re-infarction (p = 0.145), congestive heart failure (p = 0.334), atrial fibrillation (p = 0.171), mechanical complication of myocardial infarction (p = 0.465) and cardiac arrest (p = 0.142). Logistic regression revealed that AVB in ACS patients was a predictor of cardiogenic shock (odds ratio (OR) 2.350, p = 0.012, confidence interval (CI) 1.207-4.572), sustained ventricular tachycardia (OR 2.269, p = 0.013, CI 1.187-4.340), stroke (OR 2.231, p < 0.001, CI 1.779-5.852), major hemorrhage (OR 3.863, p < 0.001, CI 2.667-5.558), blood transfusion (OR 4.291, p < 0.001, CI 3.002-6.137) and hospitalization death (OR 2.699, p < 0.001, CI 1.725-4.222).

Conclusions

AVB in ACS patients predict MACE, namely cardiogenic shock, sustained ventricular tachycardia, stroke, major hemorrhage, blood transfusion and hospitalization death.
Permanent pacemaker implantation in unexplained syncope patients with electrophysiology study-proven atrioventricular node disease
Authors: Doundoulakis I , Gatzoulis KA , Arsenos P , Dilaveris P , Tsiachris D , Antoniou CK , Sideris S , Kordalis A , Soulaidopoulos S , Laina A , Tsioufis K
Published: May 2021

Funding Acknowledgements

Type of funding sources: None.

Background/Introduction: Syncope, whose cause is unknown after an initial assessment, has an uncertain prognosis. It is critical to identify patients at highest risk who may require a pacemaker and to identify the cause of recurrent syncope to prescribe proper therapy

Purpose

Aim of this study was to evaluate the effect of permanent pacing on the incidence of syncope in patients with unexplained syncope and electrophysiology study-proven atrioventricular node disease.

Methods

This was an observational study based on a prospective registry of 236 consecutive patients (60.20 ± 18.66 years, 63.1% male, 60.04 ± 9.50 bpm) presenting with recurrent unexplained syncope attacks admitted to our hospital for invasive electrophysiology study (EPS). Τhe implantation of a permanent antibradycardia pacemaker (ABP) was offered to all patients according to the results of the EPS. 135 patients received the ABP, while 101 denied.

Results

The mean of reported syncope episodes was 1.97 ± 1.10 (or presyncope 2.17 ± 1.50) before they were referred for a combined EP guided diagnostic and therapeutic approach. Over a mean follow-up of approximately 4 years (49.19 ±  29.58 months), the primary outcome event (syncope) occurred in 31 of 236 patients (13.1%), 6 of 135 (4.4%) in the ABP group as compared to 25 of 101 (24.8%) in the no pacemaker group (p < 0.001).

Conclusion

Among patients with a history of unexplained syncope, a set of positivity criteria for the presence of EPS defined atrioventricular node disease, identifies a subset of patients who will benefit from permanent pacing.
Depression and anxiety at time of implantable cardioverter defibrillator implantation and the biological link with cardiovascular disease
Authors: Van Der Lingen ACJ , Rijnierse MT , Hooghiemstra AM , Elshout S , Van Halm VP , Batelaan NM , Van Rossum AC , Pedersen SS , Leeuwis AE , Allaart CP
Published: May 2021

Funding Acknowledgements

Type of funding sources: None.

Background

Psychological distress, such as symptoms of anxiety and depression, are frequently present in patients receiving an implantable cardioverter defibrillator (ICD) and they are associated with adverse outcomes. Multiple pathophysiological mechanisms may explain the link between psychological distress and cardiovascular disease, such as autonomic dysfunction, neuro-endocrine alterations and chronic inflammation.

Purpose

The present study aims to examine the prevalence of psychological distress at time of ICD implantation and evaluates the complex interplay between psychological distress, autonomic function, neuro-endocrine alterations and inflammatory status in ICD patients.

Methods

We conducted a prospective study that included ICD patients receiving an ICD for primary and secondary prevention of sudden cardiac death. Prior to implantation, patients underwent extensive psychological evaluation, including validated questionnaires for depression, anxiety and personality traits. Cardiac status was evaluated by left ventricular ejection fraction (LVEF) assessment, New York Heart Association (NYHA) functional class evaluation, 6-minute walk test (6MWT), and 24-hour Holter monitoring for heart rate variability (HRV). Thyroid function, catecholamine levels and inflammatory status were also evaluated.

Results

Of 178 patients included (age 64 ± 12, 79% male, LVEF 35 ± 13%), 35% had symptoms of depression and 32% had symptoms of anxiety. Symptoms of depression and anxiety increased significantly with higher NYHA functional class (P < 0.001). Depressive symptoms were associated with a reduced 6MWT (411 ± 128 m versus 488 ± 89 m, P < 0.001), lower LVEF (29 ± 9% versus 36 ± 13%, P = 0.03), higher heart rate (74 ± 13 bpm versus 70 ± 13 bpm, P = 0.02), higher thyroid stimulating hormone levels (1.8 [1.3-2.8] mU/L versus 1.5 [1.0-2.2] mU/L, P = 0.04) and multiple HRV parameters, indicating reduced HRV. Anxiety symptoms were only associated with a reduced 6MWT (433 ± 112 m versus 477 ± 102, P = 0.02). Symptoms of depression or anxiety were not correlated with c-reactive protein, NT-proBNP or catecholamine levels.

Conclusion

A substantial part of ICD patients has symptoms of depression and anxiety at time of ICD implantation. Depression was correlated with a higher NYHA class, reduced exercise capacity,  reduced LV-function and alterations in autonomic function, suggesting a biological link between depression and cardiac status. Whether depression and anxiety leads to an increase in ventricular arrhythmias will be determined during further follow-up. Abstract Figure. NYHA class and psychological distress
Small left ventricular size predicts implantable cardioverter defibrillator therapy in long-term observation of patients with left ventricular assist device for non-ischemic cardiomyopathy
Authors: Nakao M , Watanabe M , Koizumi T , Kadosaka T , Koya T , Hagiwara H , Kamada R , Tenma T , Anzai T
Published: May 2021

Funding Acknowledgements

Type of funding sources: None.

Background

 The number of patients who received left ventricular assisted device (LVAD) implantation because of end-stage heart failure has been increasing. In those patients, ventricular arrhythmias (VAs) occur commonly, and electrical storm (ES) and shock therapies by implantable cardioverter-defibrillator (ICD) are considered to increase mortality. Although it is important to identify patients with higher risk of VA events, there have been limited data reporting the risk of VAs in LVAD patients during long-term follow up, especially in non-ischemic cardiomyopathy (NICM).

Purpose

 We sought to clarify the predictors of ICD therapies in LVAD patients diagnosed as NICM during long-term follow up.

Methods

We retrospectively analyzed non-ischemic heart failure patients whom a continuous flow LVAD was implanted as a bridge to transplantation therapy from July 2011 to February 2019. ICD programming was generally set as follows; one zone setting (VF zone with maximum shocks) for primary prevention or two zone setting (VF with maximum shocks and VT with ATPs and shocks) for secondary prevention. ICD settings were generally unchanged after LVAD implantation. Clinical and echocardiographic data were collected before and 3 months after LVAD implantation. Device interrogation was performed every 4 - 6 months at out-patient clinic. Patients were followed until May 2019.

Results

A total of 25 patients were included in the study. The mean age was 49 years, 88% were men. They majority of patients (52%) were diagnosed as idiopathic dilated cardiomyopathy. During the median follow up duration of 889 days (IQR 546 – 2070), 27 appropriate shock events occurred in 7 patients and 154 appropriate ATP-only events in 10 patients. The group with appropriate ICD event (11 patients, 44%) had significantly smaller LVDd (65.2 ± 4.0 vs. 79.4 ± 3.5 mm; p = 0.01) and higher LVEF (26.2 ± 1.6 vs. 20.5 ± 1.4 %; p = 0.02) before LVAD implantation. When patients were divided into 2 groups based on the median value (70.0 mm) of LVDd before LVAD implantation (pre LVDd), patients with smaller pre LVDd (≤ 70mm) had significantly higher rate of appropriate ICD treatment than those with larger pre LVDd (> 70 mm) (Log-rank p < 0.01). In univariate cox regression analysis, pre LVDd was negatively associated with appropriate ICD therapy (hazard ratio 0.94, 95% confidence interval 0.88 - 0.99; p = 0.02).

Conclusion

Smaller LVDd before LVAD implantation might be a possible predictor of appropriate ICD treatment in patients with NICM. Abstract Figure.
Malignant arrythmic storm, stellate ganglion and diabetes mellitus
Authors: Jiravsky O , Spacek R , Chovancik J , Stepanova R , Hudec M , Svobodnik A , Sknouril L , Fiala M
Published: May 2021

Funding Acknowledgements

Type of funding sources: None.

Introduction

Malignant arrhythmic storm (MAS) increases mortality more than three-fold according to current data. In the acute setting, besides resolving reversible causes, antiarrhythmics are the mainstay of treatment. The role of suppressing the local sympathetic nervous system activity, using stellate ganglion block (SGB) for example, is still being investigated. 

Purpose

To show short-term efficacy of SGB in suppressing the ventricular arrhythmia recurrence in MAS. To identify subgroups of patients with better clinical response after SGB.

Methods

All consecutive patients with MAS, with standard treatment failure and ventricular arrhythmia recurrence, treated with ultrasound guided SGB, instilating 7ml of 0,5% Bupivacain.

58 MAS treated with SGB durin 2017 – 2020. There were 49 men (84,5%), average age 68,7 +/- 11,4, with average left ventricular EF 28,9 +/- 8,43%. There were 17 diabetics (29,3%). 

Results

When we compare the numbers of defibrillations for sustained ventricular tachycardia 48 hours before and 48 hours after SGB, being the primary therapeutic endpoint in MAS, we see a 96,7% reduction (p < 0,001). When we evaluate ventricular arrhythmias treated with both antitachycardia pacing and shocks, then we see 90% reduction (p < 0,001). The effect of SGB in ventricular arrhythmia suppression was statistically significant during the entire follow-up of 8 days.

When we analyzed the cohort, looking for groups showing better response after SGB in terms of ventricular arrhythmia reduction, the only group showing statistical significance in this regard are patients with diabetes mellitus. 

Conclusions

In our cohort, stellate ganglion block is exceptionally effective in the treatment algorithm of malignant arrhythmic storm. SGB shows significantly higher efficacy in the subgroup of patients with diabetes mellitus. Abstract Figure. VA before and after BSG
Efficacy of Kids Save Lives program on students knowledge on the subject of automatic external defibrillators
Authors: Parisis C , Bouletis A , Chatzidimitriou K , Palla D , Makri P , Ntaliani M , Aggelosopoulou M , Economou K , Triantafyllou TH
Published: May 2021

Funding Acknowledgements

Type of funding sources: None.

Background

Sudden cardiac death is one of the main issues worldwide, with more than 700.000 deaths annually. It is strongly believed that the implementation of "Kids Save Lives" project in schools can change this situation. The World Health Organization endorsed the ‘Kids Save Lives’ project in 2015 in order to reduce mortality. On the other hand the use of automatic external defibrillators (AED) is associated with higher survival rate after a cardiac arrest.

Purpose

Τo evaluate the level and the improvement of theoretical knowledge of secondary school students on the subject of AEDs  before and after the "Kids Save Lives" respectively.

Material – Method: Data collection took place on the academic periods of 2017-2018 and 2018-2019 and was performed in secondary schools. A total of 5562 students participated on the "Kids save Lives" program according to the European Resuscitation Council (ERC) and World Health Organization (WHO) statement. A 12 point questionnaire was answered by the students before and after the "kids saves lives" program. Among other questions, there was one which investigate the knowledge of students in the usage of AEDs and another one asked students to refer a place, where somebody can find an AED.

Results

The training improves significantly the theoretical knowledge regarding the usage of AEDs, with the percentage of correct answers being 49 % and 85,9%, before and after the  course respectively (p < 0.001).  Moreover, only 19,8% of the students knew a place, where somebody can find an AED before  the course and 77,2% after the course (p < 0,001)

Conclusions

The overall results strongly depict the benefits of "Kids Save Lives" program by improving the theoretical knowledge on the subject of AEDs. Further research is needed to identify the times a student must follow the program to maximize its effectiveness and more action must take place in order to make students familiar with AEDs.
Noninvasive programmed ventricular stimulation for prediction of future events in patients with cardioverter-defibrillator implanted for primary prevention of sudden cardiac death
Authors: Futyma P , Santangeli P , Zarebski L , Wrzos A , Sander J , Futyma M , Kulakowski P
Published: May 2021

Funding Acknowledgements

Type of funding sources: None.

OnBehalf

The NIPS-ICD Investigators

Background

Implantable cardioverter-defibrillator (ICD) offers an opportunity to examine vulnerability to ventricular tachycardia (VT) or ventricular fibrillation (VF) by performing non-invasive programmed ventricular stimulation (NIPS). Whether NIPS can predict mortality in patients with primary prevention ICD, has not yet been examined.

Purpose

To examine a long-term predictive value of NIPS for identification of patients at increased risk of death during follow up.

Methods

The study group consisted of consecutive 41 patients with ICD implanted for primary prevention of sudden cardiac death, included in the prospective NIPS-ICD study (ClinicalTrials ID: NCT02373306) (34 males, age 64 ± 11 years). The patients underwent NIPS using the protocol up to three premature extrastimuli at 600, 500 and 400ms drive cycle lengths. The end-point of NIPS was induction of sustained VT or VF or completion of the protocol.

Results

At baseline NIPS, VT/VF was induced in 8 (20%) patients. After 5 year follow up mortality rate was significantly higher in patients who had VT/VF induced at NIPS vs no VT/VF at NIPS (38% vs 12%, p = 0.04). The difference in mortality was most remarkable at 3 (38% vs 3%, p = 0.001) and 4 years (38% vs 6%, p = 0.007). The NIPS-induced VT/VF had a sensitivity of 37.5%, specificity of 88%, positive predictive value of 43% and negative predictive value of 85% for occurrence of death during follow up. An occurrence of secondary composite endpoint consisting of VT/VF recurrence or death was also most frequent in NIPS-inducible group (75% vs 24%, p = 0.037). In a multivariate Cox-Proportional Hazard model induction of VT/VF at NIPS along with age≥65, and treatment with amiodarone was an independent predictor of the composite endpoint during follow-up

Conclusions

Inducibility of VF/VF during NIPS in patients with primary prevention ICD is associated with higher mortality and higher incidence of composite endpoint consisting of  death or VT/VF during a long term observation. Abstract Figure. Kaplan-Meier survival curves
Cardiovascular magnetic resonance determinants of ventricular arrhythmic events after myocardial infarction
Authors: Jauregui B , Soto-Iglesias D , Penela D , Acosta J , Fernandez-Armenta J , Linhart M , Ordonez A , Chauca A , Carreno JM , Scherer C , Mont L , Bosch X , Ortiz-Perez JT , Berruezo A
Published: May 2021

Funding Acknowledgements

Type of funding sources: None.

Background

 Late gadolinium enhancement cardiac magnetic resonance (LGE-CMR) permits to identify the arrhythmogenic substrate in chronic post-myocardial infarction (MI) patients. It is unknown why a minority of chronic post-MI patients develop sustained ventricular tachycardias (VT) over follow-up, regardless of their left ventricular ejection fraction (LVEF).

Objectives

 To noninvasively characterize scar differences and potential predictors of VT occurrence in chronic post-MI patients.

Methods

 A case-control study was designed through retrospective LGE-CMR data analysis of chronic post-MI patients i) consecutively referred for VT substrate ablation after a first VT episode (n = 66), and ii) from a control group (n = 84) with no arrhythmia evidence. The myocardium was characterized differentiating core, border zone (BZ) and BZ channels (BZC) using the ADAS 3D post-processing imaging platform. Clinical and scar characteristics, including a novel parameter, the BZC mass, were compared between both groups.

Results

 150 post-MI patients were included for analysis. Four multivariate Cox proportional hazards regression models were created for total scar mass (model 1), BZ mass (model 2), core mass (model 3), and BZC mass (model 4, see table). All of them were adjusted by age, sex, and LVEF. In the corresponding models, only total scar mass, BZ mass, core mass, and BZC mass were independent variables associated with the development of VT. BZC mass showed the best performance: a cut-off of 5.15 g identified the cases with 92.4% sensitivity and 86.9% specificity  [AUC 0.93 (0.89–0.97); p < 0.001], with a significant increase in the AUC compared to the other scar parameters (p < 0.001 for all pairwise comparisons using the De Long’s test). By using BZC mass as a risk stratification parameter together with LVEF, the net reclassification improvement (NRI) was 33.3% for the cases, and 39.3% for the controls. The net proportion of patients reclassified correctly was 36.7%

Conclusions

 The mass of BZC, automatically obtained with a commercially available CMR post-processing software, is the strongest independent variable associated with the occurrence of clinical SMVT in post-MI patients after covariate adjustment for age, sex, and LVEF. The measurement of BZC mass could permit a more accurate arrhythmia risk stratification than LVEF in chronic post-MI patients (NRI 36.7%). Scar characteristics analyzed from LGE-CMR imaging should be taken into consideration to better stratify ventricular arrhythmia risk in chronic post-MI patients. Abstract Figure. ROC curves for predicting VT occurrence
Leadless pacemaker implantation after transcatheter aortic valve implantation, should we go simple?
Authors: Gonzalez L , Martinez-Sande JL , Garcia-Seara J , Rodriguez-Manero M , Fernandez-Lopez XA , Gonzalez Juanatey JR
Published: May 2021

Funding Acknowledgements

Type of funding sources: None.

Introduction

Transcatheter aortic valve implantation (TAVI) is a valvular replacement that has been developed as an alternative in patients with high and intermediate risk. One of the more frequent complications are new on-set conduction abnormalities.

Purpose

The purpose of the study was to evaluate the performance of leadless pacemakers (LPM) after TAVI and compare it with conventional pacemaker implantations (VVI- PM).

Methods

This was a prospective observational study that included all consecutive patients in which a TAVI and a PM was implanted during the same hospitalization (January 1 2015 to December 31 2020). Clinical, echocardiographic, ECG at implant characteristics, and related complications were described.

Results

 From a total of 126 patients (21.3%) with PM implantation: 2 required cardiac resynchronization system, 73 DDD-PM, 29 VVI-PM, 22 LPM. Clinical and echocardiographic characteristics are described in table 1. Main follow-up was of 12 months and 22 patients (79.7%) developed AF. Electrical parameters were stable in conventional and LPM. Total mortality was of 33 patients (26.2%), there was one case of infectious endocarditis in a DDD-PM, and there were no complications in LPM patients.

Conclusions. New on-set of conductions abnormalities are one of the main related complications in TAVI patients. In our study, patients with LPM had a safe performance with low complications rate. Table 1 DDD-PM (73) VVI-PM(29) LPM(22) p Age 84.2 83,1 79,4 0.1753 Men 35 (47.9%) 19 (65,5%) 12 (54,5%) 0.108746 Hypertension 67 (91.8%) 23 (79,3%) 10 (45,4%) 0.077846 Diabetes Mellitus 19 (26%) 12 (41,4%) 7 (31,8%) 0.128362 COPD 13 (17.8%) 7 (24.1%) 4 (18.2%) 0.073172 Renal insufficiency 15 (20.5%) 9 (31%) 10 (45,4%) 0.260054 AF 13 (17.8%) 27 (93.1%) 21 (95.4%) < 0.00001 Ischemic cardiomiopathy 24 (32.9%) 16 (55.2%) 7 (31.8%) 0.063504 LVEF 57.5 56 59 0.298312 Sinus Rhythm at implant 72 (98.6%) 2 (6.9%) 1 (4.5%) < 0.00001 RBBB Pre-TAVI 22 (30.1%) 3 (10.3%) 7 (31.8%) 0.06561 AF at follow-up 11 (15.1%) 28 (96.6%) 22 (100%) < 0.00001 Mortality 14 (19.2%) 14 (48.3%) 5 (22.7%) 0.002973 Complications 4 (5.5%) 1 (3.4%) 0 0.668225 Clinical, electrical and echocardiographic characteristics.
Leadless or conventional transvenous ventricular permanent pacemakers: a nationwide matched control study
Authors: Bodin AB , Clementy NC , Bisson ABI , Pierre BP , Herbert JH , Babuty DB , Fauchier LF
Published: May 2021

Funding Acknowledgements

Type of funding sources: None.

Introduction / Background

Leadless ventricular permanent pacemakers (leadless VVI, LPM) were designed to reduce lead-related complications of conventional VVI pacemakers (CPM).

Purpose

The aim of our study was to assess and compare real-life clinical outcomes within the first 30 days and during a mid-term follow-up with the two techniques at a nationwide level.

Methods

This French longitudinal cohort study was based on the national hospitalization database covering hospital care from for the entire population. All adults (age ≥18 years) hospitalized in French hospitals From January 1, 2017 to September 1, 2020, who underwent a first LPM or CPM implantation were included.

Results

Of 42,315 patients included in the cohort, 40,828 patients (96%) had a CPM and 1,487 had a LPM. Using propensity score, 1,344 patients with CPM were adequately matched in a 1:1 fashion with LPM patients.

Clinical outcomes at day 30

In the unmatched population, within the 30 days after implantation, patients with LPM had a lower rate of all-cause mortality (OR: 0.635, 95%CI: 0.527-0.765, p <0.0001) and from a cardiovascular cause (OR: 0.568, 95%CI: 0.405-0.797, p = 0.001). They also had lower rates of major bleeding and need for transfusion. There was no significant difference between groups regarding tamponade, pneumothorax or hemothorax.

In the matched population, LPM implantation was still significantly associated with a lower rate of all-cause death (OR: 0.583, 95%CI: 0.456-0.744, p < 0.0001), cardiovascular death (OR: 0.413, 95%CI: 0.271-0.629, p < 0.0001) or transfusion (OR: 0.481, 95%CI: 0.296-0.780, p < 0.0001). However, tamponade, pneumothorax or hemothorax and major bleeding were not significantly different between the two groups.

Clinical outcomes during mid-term follow-up

In the unmatched patients, mean follow-up was 8.6 ± 10.5 months. Annual incidence of all-cause death was high in both groups, and significantly higher in the LPM group than in CPM group (31%/year vs. 20%/year, p < 0.0001) with a HR of 1.519 (95%CI: 1.296-1.780). Cardiovascular death was not significantly different between groups. Infective endocarditis was higher in the LPM group than in the CPM group with a HR of 2.108 (95%CI: 1.119-3.973). In the matched patients, mean follow-up was 6.2 ± 8.7 months. All-cause death, cardiovascular death and infective endocarditis were not significantly different between groups.

Conclusion

Patients treated with leadless VVI pacemakers had better clinical outcomes in the first month compared to the patients treated with conventional VVI pacing. During a mid-term follow-up, risk of all-cause death, cardiovascular death and endocarditis in patients treated with leadless VVI pacemaker was not statistically different after propensity score matching.
Five year outcomes of the subcutaneous implantable cardioverter-defibrillator EFFORTLESS (evaluation of factors impacting clinical outcome and cost effectiveness of the S-ICD) registry
Authors: Lambiase P , Theuns DAMJ , Murgatroyd FD , Barr CS , Eckardt L , Neuzil P , Scholten MF , Hood MA , Kuschyk J , Brisben A , Carter N , Knops RE , Boersma LVA
Published: May 2021

Funding Acknowledgements

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

OnBehalf

EFFORTLESS Registry

Introduction

Patients (pts) implanted with transvenous (TV) implantable cardioverter-defibrillator (ICD) experience complications (Cx) associated with TV leads and inappropriate shocks (IAS) for atrial fibrillation (AF) or other supraventricular tachycardias (SVT). The EFFORTLESS S-ICD Registry is a 5-year (yr) follow-up (f/u) study of pts implanted with the subcutaneous ICD (S-ICD).

Purpose

To report on the 5-yr outcomes of pts with a wide range of S-ICD indications implanted with early generation devices.

Methods

Pts were enrolled at 43 centers February 2011-December 2014. Kaplan-Meier Cx, appropriate shock (AS), and IAS rates are reported.

Results

994 pts (495 retrospective) were enrolled in the EFFORTLESS study and 984 pts (28% female, 48 ± 17 yrs, BMI 27 ± 6 kg/m2, ejection fraction 43 ± 18%) underwent S-ICD implantation. Mean study f/u was 4.4 ± 1.6 yrs. The pt cohort had diverse etiologies: 31% ischemic heart disease, 19% non-ischemic cardiomyopathy, 11% hypertrophic cardiomyopathy, 17% channelopathies, and 20% of pts miscellaneous. Total system- and procedure-related Cx (table) were 9.4% at 5 yrs. AS and IAS rates at 5 yrs were 15.9% and 16.9%, respectively and the IAS rates for AF/SVT and t wave oversensing were 3.1% and 5.8%, respectively. More pts experienced Cx and IAS in the first yr than in yrs 2-5 altogether (8.7 vs 8.2%), the most common as a result of discomfort/erosion (38%), IAS (26%), system infection (9%), and premature battery depletion (9%). Of these late Cx, 74% were experienced by retrospective pts. Spontaneous conversion efficacy for the first shock and final shocks was 89.7% and 97.7%. Of the 91 (9.2%) deaths reported, none were associated with the S-ICD system or procedure. Cause of death was cardiac for 40 pts, non-cardiac for 40 pts, other for 4 pts, and unknown for 7 pts. Only 20 (2.0%) pts had their S-ICD replaced for a TV device for pacing: 4 bradycardia, 7 anti-tachycardia, and 9 for biventricular pacing.

Conclusions

The EFFORTLESS registry provides 5-year follow-up for a diverse, large, multinational S-ICD registry. Complications primarily occurred in the first year but remained low through 5 years. Inappropriate shock rates were typically observed in older generation devices prior to introduction of the SMART Pass filter. Replacement for TV-ICD due to the need for pacing was rare. Outcome 30 day 1 yr 2 yr 3 yr 4 yr 5yr Annual Complications (Kaplan-Meier) 2.0 5.3 6.8 7.6 8.6 9.4 1.9 IAS, overall (Kaplan-Meier) 1.7 8.7 11.6 13.1 14.6 16.9 3.4 IAS, t wave oversensing 3.4 5.8 1.2
Predictors of success and complications in laser lead extraction
Authors: Madej T , Matschke K , Knaut M
Published: May 2021

Funding Acknowledgements

Type of funding sources: None.

Background

Extraction of cardiac implantable electronic device (CIED) leads using excimer laser is in use since > 20 years, but the predictors of success, all-cause complications and mortality are not yet sufficiently statistically evaluated. 

Method

All consecutive laser extractions performed at our institution between September 2011 and March 2020 with lead age > 12 months were included and retrospectively analysed.

Results

792 leads (mean age 75 months) were extracted during 335 procedures. The indication for extraction was pocket infection in 59%, CIED endocarditis in 25%, lead dysfunction or upgrade in 14% and others in 2%.

94.6% of leads were extracted complete, 4.2% partial (< 4 cm rest) and the extraction failed in 1.3% of the leads (retention of ≥ 4 cm rest).

Multivariable analysis identified lead age > 7.5 years (odds ratio [OR] 6.5; p = 0.0281), broken leads (OR 28.0; p = 0.0009) and implantable cardioverter-defibrillator (ICD) leads (OR 6.5; p = 0.0010) as independent predictors of failed extraction. CIED-endocarditis was independently associated with complete extraction (OR 3.3; p = 0.0218).

Complete procedural success or clinical success was achieved in 330 of 335 procedures (98.6%). The lead extraction failed in five cases (1.5%). Major procedure-associated adverse events (injuries of the great vessels or heart) occurred in four cases (1.2%). Two patients died perioperatively (0.6%). Minor complications occurred in 13 cases (3.9%).

Major adverse events (MAE) causally not related to the procedure occurred in 18 (5.4%) of the patients. The most frequent MAE was postoperative aggravation of the sepsis (10 patients; 3.0%).  Independent predictors of major adverse events were CIED-endocarditis (OR 6.0; p = 0.0175), preoperative C-reactive-protein (CRP) > 35 mg/l (OR 3.8; p = 0.0412) and body mass index (BMI) ≥ 25 kg/m2 (OR 5.0; p = 0.0489).

Ten patients (3%) died during the hospital stay.  CIED-endocarditis with preoperative CRP > 35 mg/l was independently associated with hospital mortality in multivariable analysis (OR 10.7; p = 0.0020). The Kaplan-Meyer analysis of 30-day mortality showed a significantly worse survival of patients with endocarditis (Log-Rank p = 0.0102).

Conclusion

Leads > 7.5 years, broken leads and ICD leads are independent predictors of failed extraction. CIED endocarditis, CRP > 35 and BMI ≥ 25 are associated with MAE. CIED endocarditis is related to higher short-term mortality despite successful lead extraction. Abstract Figure. Predictors of major adverse events
Rate of device-related infections using an antibacterial envelope in patients undergoing cardiac resynchronisation therapy re-operations
Authors: Frausing M , Nielsen JC , Johansen JB , Joergensen OD , Gerdes C , Olsen T , Kronborg MB
Published: May 2021

Funding Acknowledgements

Type of funding sources: Private grant(s) and/or Sponsorship. Main funding source(s): Karen Elise Jensen Foundation

Background

Cardiac resynchronisation therapy (CRT) re-operations are associated with a particularly high risk of device-related infection (DRI). An antibacterial envelope has been shown to reduce the occurrence of DRIs in a broad population of moderate-to-high risk patients.

Purpose

To investigate the efficacy of an antibacterial envelope in a very high-risk patient population undergoing CRT re-operation.

Methods

In this Danish two-centre, observational cohort study, we included consecutive patients who underwent a CRT pacemaker- or defibrillator re-operation procedure between January 2008 and November 2019. We obtained data from the Danish Pacemaker and ICD Register and through systematic medical chart review. Follow-up was restricted to two years.

Results

A total of 1943 patients were included in the study; 736 (38%) patients received an antibacterial envelope. Envelope patients had more independent risk factors for infection than non-envelope patients. Sixty-seven (3.4%) patients met the primary end point of DRI requiring device system extraction; 50 in the non-envelope group and 17 in the envelope group (4.1% vs. 2.3%, adjusted hazard ratio [HR] 0.52, 95% confidence interval [CI] 0.30-0.90, p = 0.021). This difference persisted in propensity score analysis (HR 0.51 95% CI 0.29-0.90, p = 0.019).

Conclusion

Use of an antibacterial envelope was associated with a clinically and statistically significant reduction in DRIs in patients undergoing CRT re-operations. Our results were comparable to those recently reported from a large randomized controlled trial, which suggests a proportional effect of the envelope even in very high risk patients.
Non-invasive and invasive autonomic tests to facilitate cardioneuroablation and complex indications for transcutaneous lead extraction and discontinuation of permanent pacing
Authors: Wileczek A , Reichert A , Kluk M , Sledz S , Sledz A , Kosior J , Polewczyk A , Kutarski A , Jagielski D , Buchta-Nitecka A , Karbarz D , Stec S
Published: May 2021

Funding Acknowledgements

Type of funding sources: None.

OnBehalf

Rare-A-Care registry

Background

 Extracardiac vagal nerve stimulation (ECANS) and cardioneuroablation (CNA) are promising methods to cure vagally mediated bradycardia and validate indications for permanent pacing for sinus node dysfunction (SND), atrioventricular blocks (AVB), tachycardia-bradycardia syndrome (TBS) and cardio-inhibitory or mixed reflex syncope (VVS). There are limited information on clinical utility of those procedures in validation of indication for continuation of permanent pacing (PM) and transcutaneous lead extraction (TLE).

Methods

 Data were collected from prospective multicentre registry of CNA facilitated by interdisciplinary consultations, state-of-art autonomic tests, atropine/propranolol tests, electrophysiologic study as well as ECANS. Share-decision making were used by EP-HEART-TEAM to developed patient-oriented therapy.

Results

 Between June 2018-Jan 2021 the first 102 consecutive patients underwent interdisciplinary approach before invasive EPS and/or invasive ECANS, to consider biatrial, binodal CNA, if possible to cure functional bradycardia. Eleven (10%) patients had implanted permanent PM"s due to SND/AVB/TBS/CI-VVS and were considered for TLE. In 2 out of 11 cases CNA was not performed due to: 1) structural advanced 2nd and 3rd degree AVB with indication for TLE and permanent HBP (no.1), 2) incidental severely symptomatic persistent 3rd degree AVB more than 15 year ago without any further bradycardia episodes (only TLE, no.2). In further 9 of 11 cases with PM CNA was performed, however TLE was not attempted in 2 patients [(SND + PVC ablation + indication for beta-blocker therapy due to IHD in older male. TLE had not yet been attempted to confirm long-term success therapy by patient and/or physician (no.3); two periprocedural successful CNA resulted in disappearance of CI reflex however  despite pacing syncopal events persist due to mixed etiology (no.4)]. In further 7/11 cases TLE-s were performed. Three cases had TLE prior to CNA [VVS-CI + advanced functional AVB - prior 3 pacemaker reimplantations and further "rescue" CNA, (no.5); CI-VVS + pacemaker infection (no.6); TLE of PM + TBS no.7]. Finally, in 4 cases TLE was recommended after CNA [CI-VVS (no.8, no.9 and no.10); mixed etiology: TBS + VVS-CI + intermittent, recurrent pericardial efffusion due to lead perforation, PM syndrome, (no. 11)]. 

Conclusions

 Interdisciplinary and comprehensive autonomic approach with ECANS and CNA enable EP-HEART-TEAM to offer patient-oriented therapy with a complex clinical scenarios before final decision about TLE and discontinuation of permanent pacing therapy.
Value of electrocardiographic screening for the early diagnosis of arrhythmic and malignant heart disease in pediatric age
Authors: Leoni L , Elhyka A , Ferretto S , Fumanelli J , Cerutti A , Di Salvo G
Published: May 2021

Funding Acknowledgements

Type of funding sources: None.

Background

The 12-lead electrocardiogram (ECG) is an instrument that can identify cardiac conduction system abnormalities that predispose to sudden cardiac death (SCD) in completely asymptomatic subjects.

The rate of sudden cardiac death in pediatric age is estimated to be around 1-1.5 cases per 100.000 individuals, and 10-15% of events occur during physical activity.

We evaluated the importance of the electrocardiogram performed in pediatric age in the early detection of asymptomatic electrocardiographic alterations, suggestive for the presence of electrical or structural heart disease potentially at risk for sudden death.

Materials and Methods

We analyzed 623 patients between 0 and 16 years of age who were sent to the second level pediatric arrhythmology clinic in Padua Hospital between October 2013 and March 2020. The patients were redirected at our clinic after a first finding of electrocardiographic alterations, following ECG performed before the beginning of sport activity, suspected of life-threatening pathologies. The following parameters were evaluated of all patients: clinical suspect of sending the pediatric arrhythmology clinic and electrocardiogram. Then, depending on the type of pathology suspected, the following diagnostic tests were carried out to confirm the clinical suspicion, and if confirmed, to carry out an adequate risk stratification: Holter ECG, ergometric

Results

Among the evaluated population (623 patients), 393 patients (63%) were sent to the pediatric arrhythmology clinic by sports medicine, 179 (29%) were sent by clinical o family pediatrician, and 51 patients (8%) were sent after ECG performed at hospital facilities for familiarity. The majority, 280 patients (45%), were sent for suspected WPW; 124 patients (20%) were sent for BEV and suspected ARVD; 85 patients (14%) for suspected long QT, 31 patients (5%) for suspected Brugada Pattern; 7 patients (1%) suspected CPVT; 8 patients (1%) for electrocardiographic changes with suspected HCM; 1 patient (0.01%) suspected shortened QT, and 88 patients (14%) for other arrhythmic disorders not at risk of sudden death. The diagnosis of WPW was confirmed in 280 patients, LQTS in 45 patients, SQTS in 1 patient, S. di Brugada in 8 patients, CPVT in 5 patients, HCM in 8 patients and ARVD in 6 patients.

Conclusions

Our study shows that the electrocardiographic screening already in pediatric age allows the diagnosis and subsequent early treatment of life-threatening arrhythmic heart diseases.