Publications by authors named "Angelo Auricchio"

275 Publications

Clinical and economic impact of HeartLogic™ compared with standard care in heart failure patients.

ESC Heart Fail 2021 Feb 22. Epub 2021 Feb 22.

Cardiovascular Center Aalst, Department of Cardiology, Onze Lieve Vrouw Hospital, Moorselbaan 164, Aalst, 9300, Belgium.

Aims: The implantable cardiac defibrillator/cardiac resynchronization therapy with defibrillator-based HeartLogic™ algorithm has recently been developed for early detection of impending decompensation in heart failure (HF) patients; but whether this novel algorithm can reduce HF hospitalizations has not been evaluated. We investigated if activation of the HeartLogic algorithm reduces the number of hospital admissions for decompensated HF in a 1 year post-activation period as compared with a 1 year pre-activation period.

Methods And Results: Heart failure patients with an implantable cardiac defibrillator/cardiac resynchronization therapy with defibrillator with the ability to activate HeartLogic and willingness to have remote device monitoring were included in this multicentre non-blinded single-arm trial with historical comparison. After a HeartLogic alert, the presence of HF symptoms and signs was evaluated. If there were two or more symptoms and signs apart from the HeartLogic alert, lifestyle advices were given and/or medication was adjusted. After activation of the algorithm, patients were followed for 1 year. HF events occurring in the 1 year prior to activation and in the 1 year after activation were compared. Of the 74 eligible patients (67.2 ± 10.3 years, 84% male), 68 patients completed the 1 year follow-up period. The total number of HF hospitalizations reduced from 27 in the pre-activation period to 7 in the post-activation period (P = 0.003). The number of patients hospitalized for HF declined from 21 to 7 (P = 0.005), and the hospitalization length of stay diminished from average 16 to 7 days (P = 0.079). Subgroup analysis showed similar results (P = 0.888) for patients receiving cardiac resynchronization therapy during the pre-activation period or not receiving cardiac resynchronization therapy, meaning that the effect of hospitalizations cannot solely be attributed to reverse remodelling. Subanalysis of a single-centre Belgian subpopulation showed important reductions in overall health economic costs (P = 0.025).

Conclusion: Activation of the HeartLogic algorithm enables remote monitoring of HF patients, coincides with a significant reduction in hospitalizations for decompensated HF, and results in health economic benefits.
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http://dx.doi.org/10.1002/ehf2.13252DOI Listing
February 2021

Risk stratification of patients undergoing transvenous lead extraction with the ELECTRa Registry Outcome Score (EROS): an ESC EHRA EORP European lead extraction ConTRolled ELECTRa registry analysis.

Europace 2021 Feb 22. Epub 2021 Feb 22.

School of Biomedical Engineering and Imaging Sciences, King's College London, St Thomas' Hospital, London SE1 7EH, UK.

Aims: Transvenous lead extraction is associated with a significant risk of complications and identifying patients at highest risk pre-procedurally will enable interventions to be planned accordingly. We developed the ELECTRa Registry Outcome Score (EROS) and applied it to the ELECTRa registry to determine if it could appropriately risk-stratify patients.

Methods And Results: EROS was devised to risk-stratify patients into low risk (EROS 1), intermediate risk (EROS 2), and high risk (EROS 3). This was applied to the ESC EORP European Lead Extraction ConTRolled ELECTRa registry; 57.5% EROS 1, 31.8% EROS 2, and 10.7% EROS 3. Patients with EROS 3 or 2 were significantly more likely to require powered sheaths and a femoral approach to complete procedures. Patients with EROS 3 were more likely to suffer procedure-related major complications including deaths (5.1 vs. 1.3%; P < 0.0001), both intra-procedural (3.5 vs. 0.8%; P = 0.0001) and post-procedural (1.6 vs. 0.5%; P = 0.0192). They were more likely to suffer post-procedural deaths (0.8 vs. 0.2%; P 0.0449), cardiac avulsion or tear (3.8 vs. 0.5%; P < 0.0001), and cardiovascular lesions requiring pericardiocentesis, chest tube, or surgical repair (4.6 vs. 1.0%; P < 0.0001). EROS 3 was associated with procedure-related major complications including deaths [odds ratio (OR) 3.333, 95% confidence interval (CI) 1.879-5.914; P < 0.0001] and all-cause in-hospital major complications including deaths (OR 2.339, 95% CI 1.439-3.803; P = 0.0006).

Conclusion: EROS successfully identified patients who were at increased risk of significant procedural complications that require urgent surgical intervention.
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http://dx.doi.org/10.1093/europace/euab037DOI Listing
February 2021

False positive ECG for STEMI after ROSC, is it a matter of timing?

Resuscitation 2021 Feb 18. Epub 2021 Feb 18.

Division of Cardiology, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.

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http://dx.doi.org/10.1016/j.resuscitation.2021.01.046DOI Listing
February 2021

A Primary Prevention Clinical Risk Score Model for Patients With Brugada Syndrome (BRUGADA-RISK).

JACC Clin Electrophysiol 2021 Feb 28;7(2):210-222. Epub 2020 Oct 28.

The Barts Heart Centre, Barts Health NHS Trust, London, United Kingdom. Electronic address:

Objectives: The goal of this study was to develop a risk score model for patients with Brugada syndrome (BrS).

Background: Risk stratification in BrS is a significant challenge due to the low event rates and conflicting evidence.

Methods: A multicenter international cohort of patients with BrS and no previous cardiac arrest was used to evaluate the role of 16 proposed clinical or electrocardiogram (ECG) markers in predicting ventricular arrhythmias (VAs)/sudden cardiac death (SCD) during follow-up. Predictive markers were incorporated into a risk score model, and this model was validated by using out-of-sample cross-validation.

Results: A total of 1,110 patients with BrS from 16 centers in 8 countries were included (mean age 51.8 ± 13.6 years; 71.8% male). Median follow-up was 5.33 years; 114 patients had VA/SCD (10.3%) with an annual event rate of 1.5%. Of the 16 proposed risk factors, probable arrhythmia-related syncope (hazard ratio [HR]: 3.71; p < 0.001), spontaneous type 1 ECG (HR: 3.80; p < 0.001), early repolarization (HR: 3.42; p < 0.001), and a type 1 Brugada ECG pattern in peripheral leads (HR: 2.33; p < 0.001) were associated with a higher risk of VA/SCD. A risk score model incorporating these factors revealed a sensitivity of 71.2% (95% confidence interval: 61.5% to 84.6%) and a specificity of 80.2% (95% confidence interval: 75.7% to 82.3%) in predicting VA/SCD at 5 years. Calibration plots showed a mean prediction error of 1.2%. The model was effectively validated by using out-of-sample cross-validation according to country.

Conclusions: This multicenter study identified 4 risk factors for VA/SCD in a primary prevention BrS population. A risk score model was generated to quantify risk of VA/SCD in BrS and inform implantable cardioverter-defibrillator prescription.
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http://dx.doi.org/10.1016/j.jacep.2020.08.032DOI Listing
February 2021

Modified Design of Stimulation Of the Left Ventricular Endocardium for Cardiac Resynchronization Therapy in Non-responders, Previously Untreatable and High-Risk Upgrade Patients (SOLVE-CRT) Trial.

Am Heart J 2021 Feb 14. Epub 2021 Feb 14.

Namsa, Contract Research Organization, Minneapolis, United States.

The WiSE system is a novel, leadless endocardial system that can provide cardiac resynchronization therapy in patients who cannot be treated with a conventional epicardial left ventricular lead. Safety and efficacy was being evaluated in the pivotal, randomized, double-blind SOLVE-CRT Trial (Stimulation of the Left Ventricular Endocardium for Cardiac Resynchronization Therapy.) The trial was initiated in 2018; however, patient enrollment was significantly impacted by the COVID-19 pandemic necessitating a change in design. This paper describes the revised trial and the scientific rationale for the specific changes in the protocol.
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http://dx.doi.org/10.1016/j.ahj.2021.02.008DOI Listing
February 2021

Worldwide Survey of COVID-19 Associated Arrhythmias.

Circ Arrhythm Electrophysiol 2021 Feb 7. Epub 2021 Feb 7.

Department of Medicine, Division of Cardiology, Columbia University Vagelos College of Physicians and Surgeons, New York, NY.

- COVID-19 has led to over 1 million deaths worldwide and has been associated with cardiac complications including cardiac arrhythmias. The incidence and pathophysiology of these manifestations remain elusive. In this worldwide survey of patients hospitalized with COVID-19 who developed cardiac arrhythmias, we describe clinical characteristics associated with various arrhythmias, as well as global differences in modulations of routine electrophysiology practice during the pandemic. - We conducted a retrospective analysis of patients hospitalized with COVID-19 infection worldwide with and without incident cardiac arrhythmias. Patients with documented atrial fibrillation (AF), atrial flutter (AFL), supraventricular tachycardia (SVT), non-sustained or sustained ventricular tachycardia (VT), ventricular fibrillation (VF), atrioventricular block (AVB), or marked sinus bradycardia (HR<40bpm) were classified as having arrhythmia. De-identified data was provided by each institution and analyzed. - Data was collected for 4,526 patients across 4 continents and 12 countries, 827 of whom had an arrhythmia. Cardiac comorbidities were common in patients with arrhythmia: 69% had hypertension, 42% diabetes mellitus, 30% had heart failure and 24% coronary artery disease. Most had no prior history of arrhythmia. Of those who did develop an arrhythmia, the majority (81.8%) developed atrial arrhythmias, 20.7% developed ventricular arrhythmias, and 22.6% had bradyarrhythmia. Regional differences suggested a lower incidence of AF in Asia compared to other continents (34% vs. 63%). Most patients in in North America and Europe received hydroxychloroquine, though the frequency of hydroxychloroquine therapy was constant across arrhythmia types. Forty-three percent of patients who developed arrhythmia were mechanically ventilated and 51% survived to hospital discharge. Many institutions reported drastic decreases in electrophysiology procedures performed. - Cardiac arrhythmias are common and associated with high morbidity and mortality among patients hospitalized with COVID-19 infection. There were significant regional variations in the types of arrhythmias and treatment approaches.
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http://dx.doi.org/10.1161/CIRCEP.120.009458DOI Listing
February 2021

Optimized Implementation of cardiac resynchronization therapy - a call for action for referral and optimization of care.

Europace 2021 Feb 5. Epub 2021 Feb 5.

Leeds Institute of Cardiovascular and Metabolic Medicine, University of Leeds, Leeds, UK.

Cardiac resynchronization therapy (CRT) is one of the most effective therapies for heart failure with reduced ejection fraction and leads to improved quality of life, reductions in heartfailure hospitalization rates and reduces all-cause mortality. Nevertheless, up to two-thirds ofeligible patients are not referred for CRT. Furthermore, post implantation follow-up is oftenfragmented and suboptimal, hampering the potential maximal treatment effect. This jointposition statement from three ESC Associations, HFA, EHRA and EACVI focuses onoptimized implementation of CRT. We offer theoretical and practical strategies to achievemore comprehensive CRT referral and post-procedural care by focusing on four actionabledomains; (I) overcoming CRT under-utilization, (II) better understanding of pre-implantcharacteristics, (III) abandoning the term 'non-response' and replacing this by the concept ofdisease modification, and (IV) implementing a dedicated post-implant CRT care pathway.
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http://dx.doi.org/10.1093/europace/euab035DOI Listing
February 2021

Association of Timing of Electrocardiogram Acquisition After Return of Spontaneous Circulation With Coronary Angiography Findings in Patients With Out-of-Hospital Cardiac Arrest.

JAMA Netw Open 2021 Jan 4;4(1):e2032875. Epub 2021 Jan 4.

Division of Cardiology, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.

Importance: Electrocardiography (ECG) is an important tool to triage patients with out-of-hospital cardiac arrest (OHCA) after return of spontaneous circulation (ROSC). An immediate coronary angiography after ROSC is recommended only in patients with an ECG that is diagnostic of ST-segment elevation myocardial infarction (STEMI). To date, the benefit of this approach has not been demonstrated in patients with a post-ROSC ECG that is not diagnostic of STEMI.

Objective: To assess whether the time from ROSC to ECG acquisition is associated with the diagnostic accuracy of ECG for STEMI.

Design, Setting, And Participants: This retrospective, multicenter cohort study (the Post-ROSC Electrocardiogram After Cardiac Arrest study) analyzed consecutive patients older than 18 years who were resuscitated from OHCA between January 1, 2015, and December 31, 2018, and were admitted to 1 of the 3 participating centers in Europe (Pavia, Italy; Lugano, Switzerland; and Vienna, Austria).

Exposure: Only patients who underwent coronary angiography during hospitalization and who acquired a post-ROSC ECG before the angiography were enrolled. Patients with a nonmedical cause of OHCAs were excluded.

Main Outcomes And Measures: The primary end point was false-positive ECG findings, defined as the percentage of patients with post-ROSC ECG findings that met STEMI criteria but who did not show obstructive coronary artery disease on angiography that was worthy of percutaneous coronary angioplasty.

Results: Of 586 consecutive patients who were admitted to the 3 participating centers, 370 were included in the analysis (287 men [77.6%]; median age, 62 years [interquartile range, 53-70 years]); 121 (32.7%) were enrolled in the participating center in Pavia, Italy; 38 (10.3%) in Lugano, Switzerland; and 211 (57.0%) in Vienna, Austria. The percentage of false-positive ECG findings in the first tertile of ROSC to ECG time (≤7 minutes) was significantly higher than that in the second (8-33 minutes) and third (>33 minutes) tertiles: 18.5% in the first tertile vs 7.2% in the second (odds ratio [OR], 0.34; 95% CI, 0.13-0.87; P = .02) and 5.8% in the third (OR, 0.27; 95% CI, 0.15-0.47; P < .001). These differences remained significant when adjusting for sex (≤7 minutes: reference; 8-33 minutes: OR, 0.32; 95% CI, 0.12-0.85; P = .02; >33 minutes: OR, 0.26; 95% CI, 0.14-0.47; P < .001), age (≤7 minutes: reference; 8-33 minutes: OR, 0.34; 95% CI, 0.13-0.89; P = .03; >33 minutes: OR, 0.27; 95% CI, 0.15-0.46; P < .001), number of segments with ST-elevation (≤7 minutes: reference; 8-33 minutes: OR, 0.35; 95% CI, 0.15-0.81; P = .01; >33 minutes: OR, 0.28; 95% CI, 0.15-0.52; P < .001), QRS duration (≤7 minutes: reference; 8-33 minutes: OR, 0.35; 95% CI, 0.14-0.87; P = .02; >33 minutes: OR, 0.27; 95% CI, 0.15-0.48; P < .001), heart rate (≤7 minutes: reference; 8-33 minutes: OR, 0.35; 95% CI, 0.13-0.93; P = .04; >33 minutes: OR, 0.29; 95% CI, 0.15-0.55; P < .001), epinephrine administered (≤7 minutes: reference; 8-33 minutes: OR, 0.35; 95% CI, 0.13-0.98; P = .045; >33 minutes: OR, 0.27; 95% CI, 0.16-0.48; P < .001), shockable initial rhythm (≤7 minutes: reference; 8-33 minutes: OR, 0.35; 95% CI, 0.13-0.96; P = .04; >33 minutes: OR, 0.26; 95% CI, 0.15-0.46; P < .001), and 3 or more shocks administered (≤7 minutes: reference; 8-33 minutes: OR, 0.36; 95% CI, 0.13-1.00; P = .05; >33 minutes: OR, 0.27; 95% CI, 0.16-0.48; P < .001) in bivariable analyses.

Conclusions And Relevance: This study suggests that early ECG acquisition after ROSC in patients with OHCA is associated with a higher percentage of false-positive ECG findings for STEMI. It may be reasonable to delay post-ROSC ECG by at least 8 minutes after ROSC or repeat the acquisition if the first ECG is diagnostic of STEMI and is acquired early after ROSC.
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http://dx.doi.org/10.1001/jamanetworkopen.2020.32875DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7801935PMC
January 2021

Short P-Wave Duration is a Marker of Higher Rate of Atrial Fibrillation Recurrences after Pulmonary Vein Isolation: New Insights into the Pathophysiological Mechanisms Through Computer Simulations.

J Am Heart Assoc 2021 Jan 7;10(2):e018572. Epub 2021 Jan 7.

Division of Cardiology Cardiocentro Ticino Lugano Switzerland.

Background Short ECG P-wave duration has recently been demonstrated to be associated with higher risk of atrial fibrillation (AF). The aim of this study was to assess the rate of AF recurrence after pulmonary vein isolation in patients with a short P wave, and to mechanistically elucidate the observation by computer modeling. Methods and Results A total of 282 consecutive patients undergoing a first single-pulmonary vein isolation procedure for paroxysmal or persistent AF were included. Computational models studied the effect of adenosine and sodium conductance on action potential duration and P-wave duration (PWD). About 16% of the patients had a PWD of 110 ms or shorter (median PWD 126 ms, interquartile range, 115 ms-138 ms; range, 71 ms-180 ms). At Cox regression, PWD was significantly associated with AF recurrence (=0.012). Patients with a PWD <110 ms (hazard ratio [HR], 2.20; 95% CI, 1.24-3.88; =0.007) and patients with a PWD ≥140 (HR, 1.87, 95% CI, 1.06-3.30; =0.031) had a nearly 2-fold increase in risk with respect to the other group. In the computational model, adenosine yielded a significant reduction of action potential duration 90 (52%) and PWD (7%). An increased sodium conductance (up to 200%) was robustly accompanied by an increase in conduction velocity (26%), a reduction in action potential duration 90 (28%), and PWD (22%). Conclusions One out of 5 patients referred for pulmonary vein isolation has a short PWD which was associated with a higher rate of AF after the index procedure. Computer simulations suggest that shortening of atrial action potential duration leading to a faster atrial conduction may be the cause of this clinical observation.
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http://dx.doi.org/10.1161/JAHA.120.018572DOI Listing
January 2021

Left Atrial Appendage Electrical Isolation Reduces Atrial Fibrillation Recurrences: A Simulation Study.

Circ Arrhythm Electrophysiol 2021 Jan 24;14(1):e009230. Epub 2020 Dec 24.

Center for Computational Medicine in Cardiology, Institute of Computational Science, Università della Svizzera italiana, Lugano, Switzerland (A.G., S.P., G.C., R.K., A.A.).

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http://dx.doi.org/10.1161/CIRCEP.120.009230DOI Listing
January 2021

Electrocardiographic predictors of successful resynchronization of left bundle branch block by His bundle pacing.

J Cardiovasc Electrophysiol 2021 Feb 4;32(2):428-438. Epub 2021 Jan 4.

National Heart and Lung Institute, Imperial College London, Hammersmith Hospital, London, UK.

Background: His bundle pacing (HBP) is an alternative to biventricular pacing (BVP) for delivering cardiac resynchronization therapy (CRT) in patients with heart failure and left bundle branch block (LBBB). It is not known whether ventricular activation times and patterns achieved by HBP are equivalent to intact conduction systems and not all patients with LBBB are resynchronized by HBP.

Objective: To compare activation times and patterns of His-CRT with BVP-CRT, LBBB and intact conduction systems.

Methods: In patients with LBBB, noninvasive epicardial mapping (ECG imaging) was performed during BVP and temporary HBP. Intrinsic activation was mapped in all subjects. Left ventricular activation times (LVAT) were measured and epicardial propagation mapping (EPM) was performed, to visualize epicardial wavefronts. Normal activation pattern and a normal LVAT range were determined from normal subjects.

Results: Forty-five patients were included, 24 with LBBB and LV impairment, and 21 with normal 12-lead ECG and LV function. In 87.5% of patients with LBBB, His-CRT successfully shortened LVAT by ≥10 ms. In 33.3%, His-CRT resulted in complete ventricular resynchronization, with activation times and patterns indistinguishable from normal subjects. EPM identified propagation discontinuity artifacts in 83% of patients with LBBB. This was the best predictor of whether successful resynchronization was achieved by HBP (logarithmic odds ratio, 2.19; 95% confidence interval, 0.07-4.31; p = .04).

Conclusion: Noninvasive electrocardiographic mapping appears to identify patients whose LBBB can be resynchronized by HBP. In contrast to BVP, His-CRT may deliver the maximum potential ventricular resynchronization, returning activation times, and patterns to those seen in normal hearts.
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http://dx.doi.org/10.1111/jce.14845DOI Listing
February 2021

Challenges in activation of remote monitoring in patients with cardiac rhythm devices during the coronavirus (COVID-19) pandemic.

Int J Cardiol 2021 04 2;328:247-249. Epub 2020 Dec 2.

Division of Cardiology, Cardiocentro Ticino, Lugano, Switzerland.

Background: Remote monitoring (RM) technology embedded in cardiac rhythm devices permits continuous monitoring of device function, and recording of selected cardiac physiological parameters and cardiac arrhythmias and may be of utmost utility during Coronavirus (COVID-19) pandemic, when in-person office visit for regular follow-up were postponed. However, patients not alredy followed-up via RM represent a challenging group of patients to be managed during the lockdown.

Methods: We reviewed patient files scheduled for an outpatient visit between January 1, 2020 and May 11th, 2020 to assess the proportion of patients in whom RM activation was possible without office visit, and compared them to those scheduled for visit before the lockdown.

Results: During COVID-19 pandemic, RM activation was feasible in a minority of patients (7.8% of patients) expected at outpatient clinic for a follow-up visit and device check-up. This was possible in a good proportion of complex implantable devices such as cardiac resynchronization therapy and implantable cardioverter defibrillator but only in a minority of patients with a pacemaker the RM function could be activated during the period of restricted access to hospital.

Conclusions: Our experience strongly suggest to consider the systematic activation of RM function at the time of implantation or - by default programming - in all cardiac rhythm management devices.
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http://dx.doi.org/10.1016/j.ijcard.2020.11.063DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7709476PMC
April 2021

Reconstruction of three-dimensional biventricular activation based on the 12-lead electrocardiogram via patient-specific modelling.

Europace 2020 Nov 26. Epub 2020 Nov 26.

Center for Computational Medicine in Cardiology, Institute of Computational Science, Università della Svizzera italiana, Via Giuseppe Buffi 13, CH-6904 Lugano, Switzerland.

Aims: Non-invasive imaging of electrical activation requires high-density body surface potential mapping. The nine electrodes of the 12-lead electrocardiogram (ECG) are insufficient for a reliable reconstruction with standard inverse methods. Patient-specific modelling may offer an alternative route to physiologically constraint the reconstruction. The aim of the study was to assess the feasibility of reconstructing the fully 3D electrical activation map of the ventricles from the 12-lead ECG and cardiovascular magnetic resonance (CMR).

Methods And Results: Ventricular activation was estimated by iteratively optimizing the parameters (conduction velocity and sites of earliest activation) of a patient-specific model to fit the simulated to the recorded ECG. Chest and cardiac anatomy of 11 patients (QRS duration 126-180 ms, documented scar in two) were segmented from CMR images. Scar presence was assessed by magnetic resonance (MR) contrast enhancement. Activation sequences were modelled with a physiologically based propagation model and ECGs with lead field theory. Validation was performed by comparing reconstructed activation maps with those acquired by invasive electroanatomical mapping of coronary sinus/veins (CS) and right ventricular (RV) and left ventricular (LV) endocardium. The QRS complex was correctly reproduced by the model (Pearson's correlation r = 0.923). Reconstructions accurately located the earliest and latest activated LV regions (median barycentre distance 8.2 mm, IQR 8.8 mm). Correlation of simulated with recorded activation time was very good at LV endocardium (r = 0.83) and good at CS (r = 0.68) and RV endocardium (r = 0.58).

Conclusion: Non-invasive assessment of biventricular 3D activation using the 12-lead ECG and MR imaging is feasible. Potential applications include patient-specific modelling and pre-/per-procedural evaluation of ventricular activation.
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http://dx.doi.org/10.1093/europace/euaa330DOI Listing
November 2020

Impact of contact force sensing technology on outcome of catheter ablation of idiopathic pre-mature ventricular contractions originating from the outflow tracts.

Europace 2020 Nov 18. Epub 2020 Nov 18.

Department of Cardiology, University Hospital Basel, University of Basel, Basel, Switzerland.

Aims: Catheter ablation of frequent idiopathic pre-mature ventricular contractions (PVC) is increasingly performed. While potential benefits of contact force (CF)-sensing technology for atrial fibrillation ablation have been assessed in several studies, the impact of CF-sensing on ventricular arrhythmia ablation remains unknown. This study aimed to compare outcomes of idiopathic outflow tract PVC ablation when using standard ablation catheters as opposed to CF-sensing catheters.

Methods And Results: In a retrospective multi-centre study, unselected patients undergoing catheter ablation of idiopathic outflow tract PVCs between 2013 and 2016 were enrolled. All procedures were performed using irrigated-tip ablation catheters and a 3D electro-anatomical mapping system. Sustained ablation success was defined as a  ≥80% reduction of pre-procedural PVC burden determined by 24 h Holter ECG during follow-up. Overall, 218 patients were enrolled (median age 52 years, 51% males). Baseline and procedural data were similar in the standard ablation (24%) and the CF-sensing group (76%). Overall, the median PVC burden decreased from 21% (IQR 10-30%) before ablation to 0.2% (IQR 0-3.0%) after a median follow-up of 2.3 months (IQR 1.4-3.9 months). The rates of both acute (91% vs. 91%, P = 0.94) and sustained success (79% vs. 74%, P = 0.44) were similar in the standard ablation and the CF-sensing groups. No differences were observed in subgroups according to arrhythmia origin from the RVOT (65%) or LVOT (35%). Complications were rare (1.8%) and evenly distributed between the two groups.

Conclusion: The use of CF-sensing technology is not associated with increased success rate nor decreased complication rate in idiopathic outflow tract PVC ablation.
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http://dx.doi.org/10.1093/europace/euaa315DOI Listing
November 2020

Optimized implementation of cardiac resynchronization therapy: a call for action for referral and optimization of care: A joint position statement from the Heart Failure Association (HFA), European Heart Rhythm Association (EHRA), and European Association of Cardiovascular Imaging (EACVI) of the European Society of Cardiology.

Eur J Heart Fail 2020 12;22(12):2349-2369

Cardiologie, CHU Rennes - LTSI Inserm UMR 1099, Université Rennes-1, Rennes, France.

Cardiac resynchronization therapy (CRT) is one of the most effective therapies for heart failure with reduced ejection fraction and leads to improved quality of life, reductions in heart failure hospitalization rates and all-cause mortality. Nevertheless, up to two-thirds of eligible patients are not referred for CRT. Furthermore, post-implantation follow-up is often fragmented and suboptimal, hampering the potential maximal treatment effect. This joint position statement from three European Society of Cardiology Associations, Heart Failure Association (HFA), European Heart Rhythm Association (EHRA) and European Association of Cardiovascular Imaging (EACVI), focuses on optimized implementation of CRT. We offer theoretical and practical strategies to achieve more comprehensive CRT referral and post-procedural care by focusing on four actionable domains: (i) overcoming CRT under-utilization, (ii) better understanding of pre-implant characteristics, (iii) abandoning the term 'non-response' and replacing this by the concept of disease modification, and (iv) implementing a dedicated post-implant CRT care pathway.
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http://dx.doi.org/10.1002/ejhf.2046DOI Listing
December 2020

Ventricular arrhythmia risk is associated with myocardial scar but not with response to cardiac resynchronization therapy.

Europace 2020 09;22(9):1391-1400

CIBERCV, Instituto de Salud Carlos III, Av. Monforte de Lemos, 3-5. Pabellón 11, Planta 0 28029, Madrid, Spain.

Aims: Sudden cardiac death (SCD) risk estimation in patients referred for cardiac resynchronization therapy (CRT) remains a challenge. By CRT-mediated improvement of left ventricular ejection fraction (LVEF), many patients loose indication for primary prevention implantable cardioverter-defibrillator (ICD). Increasing evidence shows the importance of myocardial scar for risk prediction. The aim of this study was to investigate the prognostic impact of myocardial scar depending on the echocardiographic response in patients undergoing CRT.

Methods And Results: Patients with indication for CRT were prospectively enrolled. Decision about ICD or pacemaker implantation was based on clinical criteria. All patients underwent delayed-enhancement cardiac magnetic resonance imaging. Median follow-up duration was 45 (24-75) months. Primary outcome was a composite of sustained ventricular arrhythmia, appropriate ICD therapy, or SCD. A total of 218 patients with LVEF 25.5 ± 6.6% were analysed [158 (73%) male, 64.9 ± 10.7 years]. Myocardial scar was observed in 73 patients with ischaemic cardiomyopathy (ICM) (95% of ICM patients); in 62 with non-ischaemic cardiomyopathy (45% of these patients); and in all but 1 of 36 (17%) patients who reached the primary outcome. Myocardial scar was the only significant predictor of primary outcome [odds ratio 27.7 (3.8-202.7)], independent of echocardiographic CRT response. A total of 55 (25%) patients died from any cause or received heart transplant. For overall survival, only a combination of the absence of myocardial scar with CRT response was associated with favourable outcome.

Conclusion: Malignant arrhythmic events and SCD depend on the presence of myocardial scar but not on CRT response. All-cause mortality improved only with the combined absence of myocardial scar and CRT response.
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http://dx.doi.org/10.1093/europace/euaa142DOI Listing
September 2020

Spatio-temporal prediction model of out-of-hospital cardiac arrest: Designation of medical priorities and estimation of human resources requirement.

PLoS One 2020 31;15(8):e0238067. Epub 2020 Aug 31.

Data Science Lab, Institute of Computational Science, Università della Svizzera italiana, Lugano, Switzerland.

Aims: To determine the out-of-hospital cardiac arrest (OHCA) rates and occurrences at municipality level through a novel statistical model accounting for temporal and spatial heterogeneity, space-time interactions and demographic features. We also aimed to predict OHCAs rates and number at municipality level for the upcoming years estimating the related resources requirement.

Methods: All the consecutive OHCAs of presumed cardiac origin occurred from 2005 until 2018 in Canton Ticino region were included. We implemented an Integrated Nested Laplace Approximation statistical method for estimation and prediction of municipality OHCA rates, number of events and related uncertainties, using age and sex municipality compositions. Comparisons between predicted and real OHCA maps validated our model, whilst comparisons between estimated OHCA rates in different yeas and municipalities identified significantly different OHCA rates over space and time. Longer-time predicted OHCA maps provided Bayesian predictions of OHCA coverages in varying stressful conditions.

Results: 2344 OHCAs were analyzed. OHCA incidence either progressively reduced or continuously increased over time in 6.8% of municipalities despite an overall stable spatio-temporal distribution of OHCAs. The predicted number of OHCAs accounts for 89% (2017) and 90% (2018) of the yearly variability of observed OHCAs with prediction error ≤1OHCA for each year in most municipalities. An increase in OHCAs number with a decline in the Automatic External Defibrillator availability per OHCA at region was estimated.

Conclusions: Our method enables prediction of OHCA risk at municipality level with high accuracy, providing a novel approach to estimate resource allocation and anticipate gaps in demand in upcoming years.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0238067PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7458314PMC
October 2020

High-density mapping in patients undergoing ablation of atrial fibrillation with the fourth-generation cryoballoon and the new spiral mapping catheter.

Europace 2020 11;22(11):1653-1658

Division of Cardiology, Cardiocentro Ticino, Lugano, Switzerland.

Aims: To assess the value of high-density mapping (HDM) in revealing undetected incomplete pulmonary vein isolation (PVI) after the fourth-generation cryoballoon (CB4G) ablation compared to the previous cryoballoon's versions.

Methods And Results: Consecutive patients with paroxysmal or early-persistent atrial fibrillation (AF) undergoing CB ablation as the index procedure, assisted by HDM, were retrospectively included in this study. A total of 68 patients (52 males; mean age: 60 ± 12 years, 58 paroxysmal AF) were included, and a total of 272 veins were mapped. Fourth-generation cryoballoon with the new spiral mapping catheter (SMC) was used in 35 patients (51%). Time to PVI was determined in 102/132 (77%) and in 112/140 (80%) veins during second-generation cryoballoon/third-generation cryoballoon (CB2G/CB3G) and CB4G ablation, respectively (P = 0.66). There was a statistically significant difference in terms of discrepancy rate between the SMC and the mini-basket catheter in PV detection after CB4G and CB2G/CB3G ablation(1.4% vs. 7.6%; P = 0.01). A total of 57 patients (84%) remained free of symptomatic AF during a mean follow-up of 9.8 ± 4.6 months.

Conclusion: High-density mapping after cryoballoon ablation using CB4G and the new SMC identifies incomplete PVI, not detected by the new SMC, in a significantly lower proportion of veins compared to HDM performed after the other generation CB ablation.
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http://dx.doi.org/10.1093/europace/euaa160DOI Listing
November 2020

The effect of centre volume and procedure location on major complications and mortality from transvenous lead extraction: an ESC EHRA EORP European Lead Extraction ConTRolled ELECTRa registry subanalysis.

Europace 2020 11;22(11):1718-1728

Department of Biomedical Engineering and Imaging Sciences, King's College London, London, UK.

Aims: Transvenous lead extraction (TLE) should ideally be undertaken by experienced operators in a setting that allows urgent surgical intervention. In this analysis of the ELECTRa registry, we sought to determine whether there was a significant difference in procedure complications and mortality depending on centre volume and extraction location.

Methods And Results: Analysis of the ESC EORP European Lead Extraction ConTRolled ELECTRa registry was conducted. Low-volume (LoV) centres were defined as <30 procedures/year, and high-volume (HiV) centres as ≥30 procedures/year. Three thousand, two hundred, and forty-nine patients underwent TLE by a primary operator cardiologist; 17.1% in LoV centres and 82.9% in HiV centres. Procedures performed by primary operator cardiologists in LoV centres were less likely to be successful (93.5% vs. 97.1%; P < 0.0001) and more likely to be complicated by procedure-related deaths (1.1% vs. 0.4%; P = 0.0417). Transvenous lead extraction undertaken by primary operator cardiologists in LoV centres were associated with increased procedure-related major complications including death (odds ratio 1.858, 95% confidence interval 1.007-3.427; P = 0.0475). Transvenous lead extraction locations varied; 52.0% operating room, 9.5% hybrid theatre and 38.5% catheterization laboratory. Rates of procedure-related major complications, including death occurring in a high-risk environment (combining operating room and hybrid theatre), were similar to those undertaken in the catheterization laboratory (1.7% vs. 1.6%; P = 0.9297).

Conclusion: Primary operator cardiologists in LoV centres are more likely to have extractions complicated by procedure-related deaths. There was no significant difference in procedure complications between different extraction settings. These findings support the need for TLE to be performed in experienced centres with appropriate personnel present.
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http://dx.doi.org/10.1093/europace/euaa131DOI Listing
November 2020

Response to "Electrocardiographic sexual differences in patients with atrial fibrillation".

Int J Cardiol 2020 06;308:50-51

Center for Computational Modeling in Cardiology, Switzerland; Cardiocentro Ticino, Switzerland. Electronic address:

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http://dx.doi.org/10.1016/j.ijcard.2020.03.016DOI Listing
June 2020

Leadless left ventricular endocardial pacing in nonresponders to conventional cardiac resynchronization therapy.

Pacing Clin Electrophysiol 2020 09 9;43(9):966-973. Epub 2020 May 9.

School of Biomedical Engineering and Imaging Sciences, King's College London, London, UK.

Background: Endocardial pacing may be beneficial in patients who fail to improve following conventional epicardial cardiac resynchronization therapy (CRT). The potential to pace anywhere inside the left ventricle thus avoiding myocardial scar and targeting the latest activating segments may be particularly important. The WiSE-CRT system (EBR systems, Sunnyvale, CA) reliably produces wireless, endocardial left ventricular (LV) pacing. The purpose of this analysis was to determine whether this system improved symptoms or led to LV remodeling in patients who were nonresponders to conventional CRT.

Method: An international, multicenter registry of patients who were nonresponders to conventional CRT and underwent implantation with the WiSE-CRT system was collected.

Results: Twenty-two patients were included; 20 patients underwent successful implantation with confirmation of endocardial biventricular pacing and in 2 patients, there was a failure of electrode capture. Eighteen patients proceeded to 6-month follow-up; endocardial pacing resulted in a significant reduction in QRS duration compared with intrinsic QRS duration (26.6 ± 24.4 ms; P = .002) and improvement in left ventricular ejection fraction (LVEF) (4.7 ± 7.9%; P = .021). The mean reduction in left ventricular end-diastolic volume was 8.3 ± 42.3 cm (P = .458) and left ventricular end-systolic volume (LVESV) was 13.1 ± 44.3 cm (P = .271), which were statistically nonsignificant. Overall, 55.6% of patients had improvement in their clinical composite score and 66.7% had a reduction in LVESV ≥15% and/or absolute improvement in LVEF ≥5%.

Conclusion: Nonresponders to conventional CRT have few remaining treatment options. We have shown in this high-risk patient group that the WiSE-CRT system results in improvement in their clinical composite scores and leads to LV remodeling.
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http://dx.doi.org/10.1111/pace.13926DOI Listing
September 2020

Epicardial Fibrosis Explains Increased Endo-Epicardial Dissociation and Epicardial Breakthroughs in Human Atrial Fibrillation.

Front Physiol 2020 21;11:68. Epub 2020 Feb 21.

Department of Physiology, Maastricht University, Maastricht, Netherlands.

Background: Atrial fibrillation (AF) is accompanied by progressive epicardial fibrosis, dissociation of electrical activity between the epicardial layer and the endocardial bundle network, and transmural conduction (breakthroughs). However, causal relationships between these phenomena have not been demonstrated yet. Our goal was to test the hypothesis that epicardial fibrosis suffices to increase endo-epicardial dissociation (EED) and breakthroughs (BT) during AF.

Methods: We simulated the effect of fibrosis in the epicardial layer on EED and BT in a detailed, high-resolution, three-dimensional model of the human atria with realistic electrophysiology. The model results were compared with simultaneous endo-epicardial mapping in human atria. The model geometry, specifically built for this study, was based on MR images and histo-anatomical studies. Clinical data were obtained in four patients with longstanding persistent AF (persAF) and three patients without a history of AF.

Results: The AF cycle length (AFCL), conduction velocity (CV), and EED were comparable in the mapping studies and the simulations. EED increased from 24.1 ± 3.4 to 56.58 ± 6.2% ( < 0.05), and number of BTs per cycle from 0.89 ± 0.55 to 6.74 ± 2.11% ( < 0.05), in different degrees of fibrosis in the epicardial layer. In both mapping data and simulations, EED correlated with prevalence of BTs. Fibrosis also increased the number of fibrillation waves per cycle in the model.

Conclusion: A realistic 3D computer model of AF in which epicardial fibrosis was increased, in the absence of other pathological changes, showed increases in EED and epicardial BT comparable to those in longstanding persAF. Thus, epicardial fibrosis can explain both phenomena.
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http://dx.doi.org/10.3389/fphys.2020.00068DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7047215PMC
February 2020

A Bayesian spatiotemporal statistical analysis of out-of-hospital cardiac arrests.

Biom J 2020 07 3;62(4):1105-1119. Epub 2020 Feb 3.

Fondazione Ticino Cuore, Breganzona, Switzerland.

We propose a Bayesian spatiotemporal statistical model for predicting out-of-hospital cardiac arrests (OHCAs). Risk maps for Ticino, adjusted for demographic covariates, are built for explaining and forecasting the spatial distribution of OHCAs and their temporal dynamics. The occurrence intensity of the OHCA event in each area of interest, and the cardiac risk-based clustering of municipalities are efficiently estimated, through a statistical model that decomposes OHCA intensity into overall intensity, demographic fixed effects, spatially structured and unstructured random effects, time polynomial dependence, and spatiotemporal random effect. In the studied geography, time evolution and dependence on demographic features are robust over different categories of OHCAs, but with variability in their spatial and spatiotemporal structure. Two main OHCA incidence-based clusters of municipalities are identified.
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http://dx.doi.org/10.1002/bimj.201900166DOI Listing
July 2020

An Utstein-based model score to predict survival to hospital admission: The UB-ROSC score.

Int J Cardiol 2020 06 15;308:84-89. Epub 2020 Jan 15.

Cardiocentro Ticino, Lugano, Switzerland.

Aims: To develop and validate a multi-parametric practical score to predict the probability of survival to hospital admission of an out-of-hospital cardiac arrest (OHCA) victim by using Utstein Style-based variables.

Methods: All consecutive OHCA cases occurring from 2015 to 2017 in two regions, Pavia Province (Italy) and Canton Ticino (Switzerland) were included. We used random effect logistic regression to model survival to hospital admission after an OHCA. We computed the model area under the ROC curve (AUC ROC) for discrimination and we performed both internal and external validation by considering all OHCAs occurring in the aforementioned regions in 2018. The Utstein-Based ROSC (UB-ROSC) score was derived by using the coefficients estimated in the regression model. The score value was obtained adding the pertinent score components calculated for each variable. The score was then plotted against the probability of survival to hospital admission.

Results: 1962 OHCAs were included (62% male, mean age 73 ± 16 years). Age, aetiology, location, witnessed OHCA, bystander CPR, EMS arrival time and shockable rhythm were independently associated with survival to hospital admission. The model showed excellent discrimination (AUC 0.83, 95%CI 0.81-0.85) for predicting survival to hospital admission, also at internal cross-validation (AUC 0.82, 95%CI 0.80-0.84). The model maintained good discrimination after external validation by using the 2018 OHCA cohort (AUC 0.77, 95%CI 0.74-0.80).

Conclusions: UB-ROSC score is a novel score that predicts the probability of survival to hospital admission of an OHCA victim. UB-ROSC shall help in setting realistic expectations about sustained ROSC achievement during resuscitation manoeuvres.
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http://dx.doi.org/10.1016/j.ijcard.2020.01.032DOI Listing
June 2020

Sex-related electrocardiographic differences in patients with different types of atrial fibrillation: Results from the SWISS-AF study.

Int J Cardiol 2020 05 3;307:63-70. Epub 2020 Jan 3.

Center for Computational Modeling in Cardiology, Switzerland; Cardiocentro Ticino, Switzerland. Electronic address:

Background: Sex-related electrocardiographic differences are a well-known phenomenon, but not their expression in patients with atrial fibrillation (AF). In this study we aim to assess the presence of significant sex-related differences in ECG features, with particular attention to P-wave parameters, of a large cohort of patients affected by different types of AF.

Methods: A 5-min resting 16-lead ECG was evaluated for 1119 AF patients in sinus rhythm. The durations of the main ECG waves and intervals were measured for both atrial and ventricular activity. Moreover, the beat-to-beat P-wave variability was computed for lead II and for the first principal component (PC1) computed across the 16 leads. The percentage of variance explained by PC1 was computed.

Results: Males compared to females showed significantly longer RR interval (1.02 ± 0.16 s vs 0.97 ± 0.15 s, p < .001), PQ interval (191 ± 34 ms vs 183 ± 35 ms, p = .008), QRS duration (105 ± 17 ms vs 98 ± 13 ms, p = .021), significantly lower percentage of variance explained by PC1 and P-wave variability. Males with paroxysmal AF compared to females with paroxysmal AF had significantly longer RR interval (1.01 ± 0.17 s vs 0.96 ± 0.14 s, p < .001), shorter QTc (388 ± 27 ms vs 402 ± 27 ms, p < .001), lower P-wave variability in PC1. Males with persistent AF compared to females with persistent AF had significantly shorter QTc interval (396 ± 30 ms vs 407 ± 26 ms, p = .019), longer PQ interval (194 ± 35 ms vs 182 ± 30 ms, p = .037), higher V1 terminal force (2.1 ± 1.2 mV*ms vs 1.8 ± 1 mV*ms, p = .007), lower percentage of variance explained by PC1.

Conclusions: AF patients present with several sex-related ECG differences. Consequently, sex should be taken into account when developing ECG algorithms identifying patients at risk for AF progression.
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http://dx.doi.org/10.1016/j.ijcard.2019.12.053DOI Listing
May 2020

The influence of scar on the spatio-temporal relationship between electrical and mechanical activation in heart failure patients.

Europace 2020 05;22(5):777-786

Center for Computational Medicine in Cardiology, Università della Svizzera italiana, Via G. Buffi 13, CH-6900 Lugano, Switzerland.

Aims: The aim of this study was to determine the relationship between electrical and mechanical activation in heart failure (HF) patients and whether electromechanical coupling is affected by scar.

Methods And Results: Seventy HF patients referred for cardiac resynchronization therapy or biological therapy underwent endocardial anatomo-electromechanical mapping (AEMM) and delayed-enhancement magnetic resonance (CMR) scans. Area strain and activation times were derived from AEMM data, allowing to correlate mechanical and electrical activation in time and space with unprecedented accuracy. Special attention was paid to the effect of presence of CMR-evidenced scar. Patients were divided into a scar (n = 43) and a non-scar group (n-27). Correlation between time of electrical and mechanical activation was stronger in the non-scar compared to the scar group [R = 0.84 (0.72-0.89) vs. 0.74 (0.52-0.88), respectively; P = 0.01]. The overlap between latest electrical and mechanical activation areas was larger in the absence than in presence of scar [72% (54-81) vs. 56% (36-73), respectively; P = 0.02], with smaller distance between the centroids of the two regions [10.7 (4.9-17.4) vs. 20.3 (6.9-29.4) % of left ventricular radius, P = 0.02].

Conclusion: Scar decreases the association between electrical and mechanical activation, even when scar is remote from late activated regions.
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http://dx.doi.org/10.1093/europace/euz346DOI Listing
May 2020

Evaluation, Management, and Outcomes of Patients Poorly Responsive to Cardiac Resynchronization Device Therapy.

J Am Coll Cardiol 2019 11;74(21):2588-2603

Cardiocentro Ticino, Lugano, Switzerland.

Background: "Nonresponse" to cardiac resynchronization therapy (CRT) is recognized, but definition(s) applied in practice, treatment(s), and their consequences are little known.

Objectives: The authors sought to assess nonresponse in the prospective, international, ADVANCE CRT registry (Advance Cardiac Resynchronization Therapy Registry).

Methods: Each subject's response was assessed at 6 months post-implantation using site-specific definitions and compared with the independently derived clinical composite score (CCS). Treatment(s) and hospitalization(s) were tracked during the following 6 months.

Results: Of 1,524 subjects enrolled in 69 centers (68 ± 12 years of age, 32% female, ischemic disease 39%), 74.3% received CRT-defibrillator devices, using mainly quadripolar LV leads (75%) deployed laterally (78%). Indications for CRT were wider than past trials. Among 1,327 evaluable subjects, site-defined nonresponse was 20.0% (greater age, comorbidities, ischemic cardiomyopathy, non-left bundle branch block, and lower %CRT pacing vs. responders). Site definitions used mainly clinical criteria (echocardiography infrequently), and underestimated nonresponders by 35% compared with CCS (58% sensitivity vs. CCS). Overall, more site-defined nonresponders received treatment (55.9% vs. 38.3% of responders; p < 0.001) using medication changes and heart failure education, but device programming less frequently. Intensification of in-clinic/remote evaluations and involvement of heart failure specialists remained minimal. Remarkably, 44% of site-defined nonresponders received no additional treatment. Frequency and duration of hospitalizations, and death, among site-defined nonresponders was significantly higher than responders.

Conclusions: A high incidence of CRT nonresponders persists despite good patient selection and LV lead position, but site identification methods have modest sensitivity. Following diagnosis, nonresponders are often passively managed, without specialty care, with poor outcome. ADVANCE CRT exposes a vulnerable group of heart failure patients. (Advance Cardiac Resynchronization Therapy Registry [ADVANCE CRT]; NCT01805154).
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http://dx.doi.org/10.1016/j.jacc.2019.09.043DOI Listing
November 2019

Biomarkers to predict the response to cardiac resynchronization therapy.

Europace 2019 Nov;21(11):1609-1620

Cardiovascular Research Centre, OLV Hospital Aalst, Moorselbaan 164, B, Aalst, Belgium.

Cardiac resynchronization therapy (CRT) is an established non-pharmacological treatment for selected heart failure patients with wide QRS duration. However, there is a persistent number of non-responders throughout. The prediction of the CRT response is paramount to adequately select the correct patients for CRT. One of the expanding fields of research is the development of biomarkers that predict the response to CRT. A review of the available literature on biomarkers in CRT patients has been performed to formulate a critical appraisal of the available data. The main conclusion of our review is that biomarker research in this patient population is very fragmented and broad. This results in the use of non-uniform endpoints to define the CRT response, which precludes an in-depth comparison of the available data. To improve research development in this field, a uniform definition of the CRT response and relevant endpoints is necessary to better predict the CRT response.
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http://dx.doi.org/10.1093/europace/euz168DOI Listing
November 2019

Transvenous lead extraction procedures in women based on ESC-EHRA EORP European Lead Extraction ConTRolled ELECTRa registry: is female sex a predictor of complications?

Europace 2019 12;21(12):1890-1899

Direttore UO Cardiologia 2 SSN, Azienda Ospedaliero-Universitaria, Pisa, Italy.

Aims: Female sex is considered an independent risk factor of transvenous leads extraction (TLE) procedure. The aim of the study was to evaluate the effectiveness of TLE in women compared with men.

Methods And Results: A post hoc analysis of risk factors and effectiveness of TLE in women and men included in the ESC-EHRA EORP ELECTRa registry was conducted. The rate of major complications was 1.96% in women vs. 0.71% in men; P = 0.0025. The number of leads was higher in men (mean 1.89 vs. 1.71; P < 0.0001) with higher number of abandoned leads in women (46.04% vs. 34.82%; P < 0.0001). Risk factors of TLE differed between the sexes, of which the major were: signs and symptoms of venous occlusion [odds ratio (OR) 3.730, confidence interval (CI) 1.401-9.934; P = 0.0084], cumulative leads dwell time (OR 1.044, CI 1.024-1.065; P < 0.001), number of generator replacements (OR 1.029, CI 1.005-1.054; P = 0.0184) in females and the number of leads (OR 6.053, CI 2.422-15.129; P = 0.0001), use of powered sheaths (OR 2.742, CI 1.404-5.355; P = 0.0031), and white blood cell count (OR 1.138, CI 1.069-1.212; P < 0.001) in males. Individual radiological and clinical success of TLE was 96.29% and 98.14% in women compared with 98.03% and 99.21% in men (P = 0.0046 and 0.0098).

Conclusion: The efficacy of TLE was lower in females than males, with a higher rate of periprocedural major complications. The reasons for this difference are probably related to disparities in risk factors in women, including more pronounced leads adherence to the walls of the veins and myocardium. Lead management may be key to the effectiveness of TLE in females.
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http://dx.doi.org/10.1093/europace/euz277DOI Listing
December 2019

Acute fluctuating neurological deficits after pulmonary vein isolation: unmasking a rare complication due to spontaneous spinal subdural bleeding: a case report.

Eur Heart J Case Rep 2019 Sep 5;3(3):ytz109. Epub 2019 Jul 5.

Department of Cardiology, Fondazione Cardiocentro Ticino, Via Tesserete 48, CH-6900 Lugano, Switzerland.

Background: Pulmonary vein isolation (PVI) is becoming the therapy of choice for symptomatic paroxysmal drug-refractory atrial fibrillation (AF). The most frequently reported complications are vascular complications (1.4%). Bleeding complications of the central nervous system have rarely been described. We report a case of spontaneous spinal bleed after PVI.

Case Summary: A 68-year-old woman with a 2-year history of highly symptomatic paroxysmal AF (EHRA 3) was referred for a PVI redo procedure. A high-density mapping showed pulmonary vein reconnection of all pulmonary veins successfully isolated by radiofrequency ablation. During the entire procedure, the patient had sinus rhythm with an ACT around 300 s. No intraprocedural and peri-procedural complications occurred. Four hours after haemostasis, the anticoagulation clotting time (ACT) was 110 s and rivaroxaban (20 mg) was reinitiated. In the following hours, the patient developed fluctuating neurological lower limb symptoms. A lumbar magnetic resonance imaging showed a subdural spinal haematic collection with an associated epidural component from L3 to S2 exerting compression over the dural sheath. A conservative treatment approach was adopted with progressive recovery of sensorial and motor deficits. After 5 months, the patient still presented residual lower limb motor deficits necessitating the support of a walking stick.

Discussion: We describe the first case of a spontaneous spinal bleeding following PVI. Given the gradual diffusion of PVI to treat AF in more clinically complex patients with a larger range of comorbidities, particular consideration should be given to seek predisposing bleeding factors in order to assess the risk for neurological complications.
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http://dx.doi.org/10.1093/ehjcr/ytz109DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6764566PMC
September 2019