Publications by authors named "Claudio Tondo"

230 Publications

Prevalence and outcome of silent hypoxemia in COVID-19.

Minerva Anestesiol 2021 03;87(3):325-333

Department of Anesthesiology, Intensive Care and Emergency Medicine, Medical University of Göttingen, Göttingen, Germany.

Background: In the early stages of COVID-19 pneumonia, hypoxemia has been described in absence of dyspnea ("silent" or "happy" hypoxemia). Our aim was to report its prevalence and outcome in a series of hypoxemic patients upon Emergency Department admission.

Methods: In this retrospective observational cohort study we enrolled a study population consisting of 213 COVID-19 patients with PaO2/FiO2 ratio <300 mmHg at hospital admission. Two groups (silent and dyspneic hypoxemia) were defined. Symptoms, blood gas analysis, chest X-ray (CXR) severity, need for intensive care and outcome were recorded.

Results: Silent hypoxemic patients (68-31.9%) compared to the dyspneic hypoxemic patients (145-68.1%) showed greater frequency of extra respiratory symptoms (myalgia, diarrhea and nausea) and lower plasmatic LDH. PaO2/FiO2 ratio was 225±68 mmHg and 192±78 mmHg in silent and dyspneic hypoxemia respectively (P=0.002). Eighteen percent of the patients with PaO2/FiO2 from 50 to 150 mmHg presented silent hypoxemia. Silent and dyspneic hypoxemic patients had similar PaCO2 (34.2±6.8 mmHg vs. 33.5±5.7 mmHg, P=0.47) but different respiratory rates (24.6±5.9 bpm vs. 28.6±11.3 bpm respectively, P=0.002). Even when CXR was severely abnormal, 25% of the population was silent hypoxemic. Twenty-six point five percent and 38.6% of silent and dyspneic patients were admitted to the ICU respectively (P=0.082). Mortality rate was 17.6% and 29.7% (log-rank P=0.083) in silent and dyspneic patients.

Conclusions: Silent hypoxemia is remarkably present in COVID-19. The presence of dyspnea is associated with a more severe clinical condition.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.23736/S0375-9393.21.15245-9DOI Listing
March 2021

[Typical atrial flutter catheter ablation complicated by right coronary artery spasm and occlusion. Case report and review of the literature].

G Ital Cardiol (Rome) 2021 Mar;22(3):244-249

Cardioangiologisches Centrum Bethanien, Agaplesion Markus-Krankenhaus, Francoforte sul Meno, Germania.

Right coronary artery lesion is an uncommon and serious complication of typical atrial flutter ablation. We report a case of right coronary artery occlusion during atrial flutter ablation managed with percutaneous coronary intervention, combined with a review of the literature, in order to obtain pathogenetic and epidemiological information about this complication.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1714/3557.35345DOI Listing
March 2021

Sudden Cardiac Death in Athletes: From the Basics to the Practical Work-Up.

Medicina (Kaunas) 2021 Feb 14;57(2). Epub 2021 Feb 14.

Heart Rhythm Center, Department of Clinical Electrophysiology and Cardiac Pacing at Monzino Cardiology Center, IRCCS, 20138 Milan, Italy.

Sudden cardiac death in athletes is a relatively rare event, but due to the increasing number of individuals practicing high-performance sports, in absolute terms, it has become an important issue to be addressed. Since etiologies are many and the occurrence is rare, tracing the ideal preparticipation screening program is challenging. So far, as screening tools, a comprehensive clinical evaluation and a simple 12-lead electrocardiogram (ECG) seem to be the most cost-effective strategy. Recent technological advances came to significantly help as second-line investigation tools, especially the cardiac magnetic resonance, which allows for a more detailed ventricular evaluation, cardiac tissue characterization, and eliminates the poor acoustic window problem. This article aims to review all aspects related to sudden cardiac death in athletes, beginning with definitions and epidemiology, passing through etiology and clinical characteristics, then finishing with a discussion about the best ambulatory investigational approach.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.3390/medicina57020168DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7918885PMC
February 2021

Ablation Index-guided high-power (50 W) short-duration for left atrial anterior and roofline ablation: Feasibility, procedural data, and lesion analysis (AI High-Power Linear Ablation).

J Cardiovasc Electrophysiol 2021 Apr 8;32(4):984-993. Epub 2021 Mar 8.

Cardioangiologisches Centrum Bethanien (CCB), Kardiologie, Medizinische Klinik III, Agaplesion Markus Krankenhaus, Akademisches Lehrkrankenhaus der Goethe-Universität Frankfurt am Main, Frankfurt am Main, Germany.

Objectives: To evaluate the feasibility, procedural data, and lesion characteristics of the anterior line (AL) and roofline (RL) ablation by using ablation index (AI)-guided high power (50 W) among patients with recurrent atrial fibrillation (AF) or atrial tachycardia (AT) after pulmonary vein isolation (PVI).

Methods: Data from 35 consecutive patients with macro-reentrant left atrial tachycardia or substrate at the left atrium anterior wall or roof after previous PVI were collected. Ablation power was set to 50 W, targeting AI 500 for AL and 400 for RL. The first-pass conduction block (FPB) was evaluated. The AL was arbitrarily divided into three (caudal, middle, and cranial) segments to analyze the location of conduction gaps in non-FPB patients.

Results: A total of 32 AL and 17 RL were deployed and FPB was achieved in 24 (75%) and 14 (82%) of them, respectively. In the non-FPB group, the most frequent gap location along the AL was the middle third. The final block of AL was achieved in 97%, and the block of RL was achieved in 100%. The radiofrequency (RF) ablation time was short (2.9 ± 0.8 min for AL and 46.2 ± 15.6 s for RL). For AL, the female gender was significantly more frequent in FPB than in non-FPB patients (p = .028); patients with non-FPB were associated with significantly longer RF time as compared to patients with FPB (204 ± 47 s vs. 161 ± 41 s; p = .02). No procedural complications occurred.

Conclusion: AI-guided high-power (50 W) ablation appears to be a feasible, effective, and fast technique for AL and RL ablation.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1111/jce.14973DOI Listing
April 2021

State of the art paper: Cardiovascular CT for planning ventricular tachycardia ablation procedures.

J Cardiovasc Comput Tomogr 2021 Feb 1. Epub 2021 Feb 1.

Centro Cardiologico Monzino, IRCCS, Milan, Italy; Department of Clinical Sciences and Community Health, Cardiovascular Section, University of Milan, Milan, Italy. Electronic address:

In the last 20 years coronary computed tomography angiography (CCTA) gained a pivotal role in the evaluation of patients with suspected coronary artery disease (CAD) as finally recognized by the ESC guidelines on stable CAD. Technological advances have progressively improved the temporal resolution of CT scanners, contemporary reducing acquisition time, radiation dose and contrast volume needed for the whole heart volume acquisition, further expanding the role of cardiac CT beyond coronary anatomy evaluation. Aim of the present review is to discuss use and benefit of cardiac CT for the planning and preparation of VT ablation.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.jcct.2021.01.002DOI Listing
February 2021

Cryoballoon atrial fibrillation ablation: Single-center safety and efficacy data using a novel cryoballoon technology compared to a historical balloon platform.

J Cardiovasc Electrophysiol 2021 Mar 10;32(3):588-594. Epub 2021 Feb 10.

Heart Rhythm Center at Centro Cardiologico Monzino IRCCS, Milan, Italy.

Introduction: Catheter ablation is superior to drugs regarding atrial fibrillation (AF) recurrence, symptoms improvement, and mortality reduction in heart failure. POLARx™ is a novel cryoballoon, with technical improvements seeking to improve outcomes. So far, its clinical evidence is restricted to a case report.

Methods: To compare the POLARx™ cryoballoon procedural safety and efficacy to the already established Arctic Front Advance PRO™ (AFAP) in a single-center cohort study, consecutive patients undergoing AF cryoablation with the POLARx™ were enrolled. Data were prospectively gathered. POLARx™ patients were compared with a historical cohort of patients submitted to AF cryoablation with the AFAP.

Results: Seventy patients were analyzed, 20 in POLARx™, and 50 in the AFAP group. They all underwent first-time pulmonary vein isolation, 77% were male, 94% had paroxysmal AF, median age was 62.5 years, median CHA DS -VASc 1, left-atrium size 34 ml/m², and 65% were receiving anticoagulation. The primary end-point, all pulmonary veins isolation, was 100% in both groups. The complication rate was similar (0% POLARx™ vs. 5.7% AFAP, p = .39). The median total procedural time was longer in the POLARx™ group (90 min vs. 60 min, p < .001), but the overall time-to-isolation (TTI; 44.8 s vs. 39 s, p = .253) and ablation time (15 min vs. 13.7 min, p = .122) was similar between POLARx™ and AFAP groups, respectively. Despite equal TTI, the POLARx™ had a lower minimal temperature reached (-57°C vs -47°C, p < .001).

Conclusion: The novel POLARx™ cryoballoon had similar efficacy and safety compared with the AFAP. It was also associated with longer procedural times, similar TTI, and lower minimum temperature reached.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1111/jce.14930DOI Listing
March 2021

Left posterior wall: The real key factor in the treatment of persistent atrial fibrillation.

Authors:
Claudio Tondo

J Cardiovasc Electrophysiol 2021 Mar 2;32(3):605-607. Epub 2021 Feb 2.

Department of Clinical Electrophysiology and Cardiac Pacing, Heart Rhythm Center, Monzino Cardiology Center, IRCCS, University of Milan, Milan, Italy.

View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1111/jce.14902DOI Listing
March 2021

Safety, effectiveness, and quality of life following pulmonary vein isolation with a multi-electrode radiofrequency balloon catheter in paroxysmal atrial fibrillation: 1-year outcomes from SHINE.

Europace 2020 Jan 15. Epub 2020 Jan 15.

Department of Cardiology, Na Homolce Hospital, Roentgenova 37, 150 00 Praha 5, Czechia.

Aims: To evaluate the safety and effectiveness of a compliant multi-electrode radiofrequency balloon catheter (RFB) used with a multi-electrode diagnostic catheter for pulmonary vein isolation (PVI).

Methods And Results: This prospective, multicentre, single-arm study was conducted at six European sites and enrolled patients with symptomatic paroxysmal atrial fibrillation. The primary effectiveness endpoint was entrance block in treated pulmonary veins (PVs) after adenosine/isoproterenol challenge. The primary safety endpoint was the occurrence of primary adverse events (PAEs) within 7 days. Cerebral magnetic resonance imaging and neurological assessments were performed pre- and post-ablation in a subset of patients. Atrial arrhythmia recurrence was assessed over 12 months via transtelephonic and Holter monitoring. Quality of life was assessed by the Atrial Fibrillation Effect on Quality of Life (AFEQT) questionnaire. Of 85 patients undergoing ablation per study protocol, PV entrance block was achieved in all (one PV required touch-up with a focal catheter). Acute reconnection of ≥1 PVs after adenosine/isoproterenol challenge was observed in 9.3% (30/324) of PVs ablated. Post-ablation, silent cerebral lesions were detected in 9.7% (3/31) of patients assessed, all of which was resolved at 1-month follow-up. One patient experienced a PAE (retroperitoneal bleed). Freedom from documented symptomatic and all arrhythmia was 72.2% and 65.8% at 12 months. Four patients (4.7%) underwent repeat ablation. Significant improvements in all AFEQT subscale scores were seen at 6 and 12 months.

Conclusion: PVI with the novel RFB demonstrated favourable safety and effectiveness, with low repeat ablation rate and clinically meaningful improvement in quality of life.

Clinicaltrials.gov Registration Number: NCT03437733.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1093/europace/euaa382DOI Listing
January 2020

Cryoablation for pulmonary veins isolation in obese patients with atrial fibrillation compared to nonobese patients.

Pacing Clin Electrophysiol 2021 Feb 12;44(2):306-317. Epub 2021 Jan 12.

Department of Cardiology, Ospedale San Luca, Istituto Auxologico, Milano, Italy.

Background: Pulmonary veins isolation (PVI) by cryoballoon (CB) ablation is marginally represented in clinical studies in obese patients. The aim of this analysis was to evaluate the safety and efficacy of CB-PVI in a large cohort of overweight and obese patients from the 1STOP project.

Methods: From 2012 to 2018, 2048 patients with atrial fibrillation (AF) (70% male, 59 ± 11 years; 75% paroxysmal AF) underwent index CB-PVI. The patient data were separated into three cohorts for statistical evaluation, including: normal weight (body mass index [BMI] < 25 kg/m ), overweight (BMI = 25-30 kg/m ), and obese patients (BMI > 30 kg/m ).

Results: Out of 2048 patients, 693 (34%) patients had a BMI < 25 and were deemed as normal. There were 944 (46%) patients categorized as overweight (BMI = 25-30) and 411 (20%) as obese (BMI > 30). Overweight or obese patients were more often in persistent AF, had more frequently hypertension and diabetes, had higher CHA DS -VASc score, and had a number of failed antiarrhythmic drug (AAD). Periprocedural complication rates were similar among the three cohorts. The 12-month freedom from AF recurrence was 76.4% in the normal BMI group as compared to 79.2% in the overweight and 73.5% in the obese group (p = .35). However, 48% of overweight patients were on AAD treatment during the follow-up. By multivariate analysis, BMI was not a predictor for AF recurrence following the index CB-PVI.

Conclusion: CB-PVI in obese patients is a safe procedure. Increased BMI (either moderate or severe) does not seem to be associated with a worse outcome or to a different rate of AAD discontinuation at 12 months.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1111/pace.14149DOI Listing
February 2021

QT Interval Monitoring and Drugs Management During COVID-19 Pandemic.

Curr Clin Pharmacol 2020 Dec 24. Epub 2020 Dec 24.

Department of Cardiology, ASST-Fatebenefratelli Sacco, Luigi Sacco University Hospital, Milan (IT). Italy.

While facing potentially high morbidity from COVID-19 without known effective therapies, the off-label use of several non-specific drugs has been advocated, including re-purposed anti-virals (e.g. remdesivir or the lopinavir/ritonavir combination), biologic agents (e.g. tocilizumab), and antimalarial drugs such as chloroquine and hydroxychloroquine, in association with or without azithromycin. Data regarding the effectiveness of these drugs in treating COVID-19 has been shown in some trials and clinical settings, but further randomised controlled trials are still being carried out. One of the main concerns regarding their widespread use however, are their possible effects on the QT interval and their arrhythmogenic potential. Some of this drugs have been in fact associated to QT prolongation and Torsades de Point, a potentially lethal ventricular arrhythmia. Aim of this review is to highlight the magnitude of this problem, to quickly refresh clinically impacting cornerstones of QT interval and TdP pathophysiology, to summarize the available evidence regarding the QT and arrhythmia impact of drugs used in different clinical settings in COVID-19 patients, and to help the physician dealing with the knowledge needed in the everyday clinical duties in case of doubts regarding QT-induced arrhythmias in this time of emergency.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.2174/1574884715666201224155042DOI Listing
December 2020

Multimodality Approach for Endovascular Left Atrial Appendage Closure: Head-To-Head Comparison among 2D and 3D Echocardiography, Angiography, and Computer Tomography.

Diagnostics (Basel) 2020 Dec 17;10(12). Epub 2020 Dec 17.

Department of Cardiovascular Imaging, Centro Cardiologico Monzino IRCCS, 20138 Milan, Italy.

Background: Percutaneous left atrial appendage closure (LAAC) requires accurate pre- and intraprocedural measurements, and multimodality imaging is an essential tool for guiding the procedure. Two-dimensional (2D TOE) and three-dimensional (3D TOE) transoesophageal echocardiography, cardiac computed tomography (CCT), and conventional cardiac angiography (CCA) are commonly used to evaluate left atrial appendage (LAA) size. However, standardized approaches in measurement methods by different imaging modalities are lacking. The aims of the study were to evaluate the LAA dimension and morphology in patients undergoing LAAC and to compare data obtained by different imaging modalities: 2D and 3D TOE, CCT, and CCA.

Methods: A total of 200 patients (mean age 70 ± 8 years, 128 males) were examined by different imaging techniques (161 2D TOE, 103 3D TOE, 98 CCT, and 200 CCA). Patients underwent preoperative CCT and intraoperative 2D and 3D TOE and CCA.

Results: A significant correlation was found among all measurements obtained by different modalities. In particular, 3D TOE and CCT measurements were highly correlated with an excellent agreement for the landing zone (LZ) dimensions (LZ diameter: r = 0.87; LAA depth: r = 0.91, < 0.001).

Conclusions: Head-to-head comparison among imaging techniques (2D and 3D TOE, CCT, and CCA) showed a good correlation among LZ diameter measurements obtained by different imaging modalities, which is a parameter of paramount importance for the choice of the LAAC device size. LZ diameters and area by 3D TOE had the best correlation with CCT.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.3390/diagnostics10121103DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7766723PMC
December 2020

Prior myocarditis and ventricular arrhythmias: The importance of scar pattern.

Heart Rhythm 2021 Apr 24;18(4):589-596. Epub 2020 Dec 24.

Centro Cardiologico Monzino, IRCCS, Milano, Italy; Department of Biomedical, Surgical and Dental Sciences, University of Milan, Milano, Italy.

Background: Multiple studies have addressed the importance of anteroseptal scar in patients with nonischemic cardiomyopathy. However, this pattern has never been fully evaluated in patients with prior myocarditis.

Objective: The purpose of this study was to evaluate whether anteroseptal scar is associated with worse outcome in patients with prior myocarditis and how it affects the efficacy of catheter ablation (CA).

Methods: This was a retrospective study of consecutive patients with prior myocarditis and arrhythmic presentation. Cardiac magnetic resonance and electroanatomic voltage mapping were used to identify the scar pattern. Patients were referred for either CA or escalated antiarrhythmic drug (AAD) therapy. The main outcome was ventricular arrhythmia (VA)-free survival according to the presence of anteroseptal scar.

Results: A total of 144 consecutive patients with prior myocarditis were included. Mean age was 42.1 ± 14.9 years, and 58% were men. Ejection fraction was normal in 73% of patients. Anteroseptal scar was present in 44% of cases. Sixty-one patients (42%) underwent CA. Overall, at 2-year follow-up, VA-free survival was 77% in the CA group. After CA, the mean number of AADs taken by each patient decreased from 1.8 to 0.9 per day (p<0.001). The presence of anteroseptal scar was found to be an independent predictor of VA relapse both in patients treated with CA (hazard ratio [HR] 3.6; 95% confidence interval [CI] 1.1-11.4; P = .03) and in the overall population (HR 2.0; 95% CI 1.2-3.5; P = .02) .

Conclusion: In patients with prior myocarditis and VA, the presence of anteroseptal scar negatively predicts outcomes irrespective of treatment strategy.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.hrthm.2020.12.016DOI Listing
April 2021

Clinical impact of defibrillation testing in a real-world S-ICD population: Data from the ELISIR registry.

J Cardiovasc Electrophysiol 2021 Feb 18;32(2):468-476. Epub 2020 Dec 18.

Department of Cardiology, Luigi Sacco Hospital, Milan, Italy.

Background: Current guidelines recommend defibrillation testing (DT) performance in patients with a subcutaneous implantable cardioverter defibrillator (S-ICD), theoretically to reduce the amount of ineffective shocks. DT, however, has been proven unnecessary in transvenous ICD and real-world data show a growing trend in avoidance of DT after S-ICD implantation.

Methods: All patients undergoing S-ICD implant at nine associated Italian centers joining in the ELISIR registry (ClinicalTrials.gov Identifier: NCT04373876) were enrolled and classified upon DT performance. Long-term follow-up events were recorded and compared to report the long-term efficacy and safety of S-ICD implantations without DT in a real-world setting.

Results: A total of 420 patients (54.0 ± 15.5 years, 80.0% male) were enrolled in the study. A DT was performed in 254 (60.5%) patients (DT+ group), while in 166 (39.5%) was avoided (DT- group). Over a median follow-up of 19 (11-31) months, a very low rate (0.7%) of ineffective shocks was observed, and no significant differences in the primary combined arrhythmic outcome were observed between the two groups (p = .656). At regression analysis, the only clinical predictor associated with the primary combined outcome was S-ICD placement for primary prevention (odds ratio: 0.42; p = .013); DT performance instead was not associated with a reduction in primary outcome (p = .375).

Conclusion: Implanting an S-ICD without DT does not appear to impact the safety of defibrillation therapy and overall patients' survival.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1111/jce.14833DOI Listing
February 2021

Characteristics of Patients With Arrhythmogenic Left Ventricular Cardiomyopathy: Combining Genetic and Histopathologic Findings.

Circ Arrhythm Electrophysiol 2020 12 15;13(12):e009005. Epub 2020 Dec 15.

Heart Rhythm Center (M.C., A.G., R.S., V.C., M.B., G.V., C.T.), Centro Cardiologico Monzino IRCCS, Milano.

Background: Arrhythmogenic left ventricular cardiomyopathy (ALVC) is an under-characterized phenotype of arrhythmogenic cardiomyopathy involving the LV ab initio. ALVC was not included in the 2010 International Task Force Criteria for arrhythmogenic right ventricular cardiomyopathy diagnosis and data regarding this phenotype are scarce.

Methods: Clinical characteristics were reported from all consecutive patients diagnosed with ALVC, defined as a LV isolated late gadolinium enhancement and fibro-fatty replacement at cardiac magnetic resonance plus genetic variants associated with arrhythmogenic right ventricular cardiomyopathy and of an endomyocardial biopsy showing fibro-fatty replacement complying with the 2010 International Task Force Criteria in the LV.

Results: Twenty-five patients ALVC (53 [48-59] years, 60% male) were enrolled. T wave inversion in infero-lateral and left precordial leads were the most common ECG abnormalities. Overall arrhythmic burden at study inclusion was 56%. Cardiac magnetic resonance showed LV late gadolinium enhancement in the LV lateral and posterior basal segments in all patients. In 72% of the patients an invasive evaluation was performed, in which electroanatomical voltage mapping and electroanatomical voltage mapping-guided endomyocardial biopsy showed low endocardial voltages and fibro-fatty replacement in areas of late gadolinium enhancement presence. Genetic variants in desmosomal genes (desmoplakin and desmoglein-2) were identified in 12/25 of the cohort presenting pathogenic/likely pathogenic variants. A definite/borderline 2010 International Task Force Criteria arrhythmogenic right ventricular cardiomyopathy diagnosis was reached only in 11/25 patients.

Conclusions: ALVC presents with a preferential involvement of the lateral and postero-lateral basal LV and is associated mostly with variants in desmoplakin and desmoglein-2 genes. An amendment to the current International Task Force Criteria is reasonable to better diagnose patients with ALVC.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1161/CIRCEP.120.009005DOI Listing
December 2020

Prospective use of ablation index for the ablation of right ventricle outflow tract premature ventricular contractions: a proof of concept study.

Europace 2021 Jan;23(1):91-98

Heart Rhythm Center, Centro Cardiologico Monzino, IRCCS, Milan, IT, Italy.

Aims: Radiofrequency catheter ablation (RFCA) represents an effective option for idiopathic premature ventricular contractions (PVCs) treatment. Ablation Index (AI) is a novel ablation marker incorporating RF power, contact force, and time of delivery into a single weighted formula. Data regarding AI-guided PVCs RFCA are currently lacking. Aim of the study was to compare AI-guided and standard RFCA outcomes in patients with PVCs originating from the right ventricle outflow tract (RVOT).

Methods And Results: Consecutive patients undergoing AI-guided RFCA of RVOT idiopathic PVCs were prospectively enrolled. Radiofrequency catheter ablation was performed following per-protocol target cut-offs of AI, depending on targeted area (RVOT free wall AI cut-off: 590; RVOT septum AI cut-off: 610). A multi-centre cohort of propensity-matched (age, sex, ejection fraction, and PVC site) patients undergoing standard PVCs RFCA was used as a comparator. Sixty AI-guided patients (44.2 ± 18.0 years old, 58% male, left ventricular ejection fraction 56.2 ± 3.8%) were enrolled; 34 (57%) were ablated in RVOT septum and 26 (43%) patients in the RVOT free wall area. Propensity match with 60 non-AI-guided patients was performed. Acute outcomes and complications resulted comparable. At 6 months, arrhythmic recurrence was more common in non-AI-guided patients whether in general (28% vs. 7% P = 0.003) or by ablated area (RVOT free wall: 27% vs. 4%, P = 0.06; RVOT septum 29% vs. 9% P = 0.05). Ablation Index guidance was associated with improved survival from arrhythmic recurrence [overall odds ratio 6.61 (1.95-22.35), P = 0.001; RVOT septum 5.99 (1.21-29.65), P = 0.028; RVOT free wall 11.86 (1.12-124.78), P = 0.039].

Conclusion: Ablation Index-guidance in idiopathic PVCs ablation was associated with better arrhythmic outcomes at 6 months of follow-up.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1093/europace/euaa228DOI Listing
January 2021

Redefining the Prognostic Value of High-Sensitivity Troponin in COVID-19 Patients: The Importance of Concomitant Coronary Artery Disease.

J Clin Med 2020 Oct 12;9(10). Epub 2020 Oct 12.

Department of Cardiology, ASST-Fatebenefratelli Sacco, Luigi Sacco University Hospital, 20157 Milan, Italy.

Background: Although studies assessing cardiovascular comorbidities and myocardial injury in Coronavirus disease 2019 (COVID-19) patients have been published, no reports focused on clinical outcomes of myocardial injury in patients with and without chronic coronary syndromes (CCS) are currently available.

Methods: In this study, consecutive COVID-19 patients admitted to four different institutions were screened for enrolment. Patients were divided into two groups (CCS vs. no-CCS). Association with in-hospital mortality and related predictors represented the main study outcome; myocardial injury and its predictors were deemed secondary outcomes.

Results: A total of 674 COVID-19 patients were enrolled, 112 (16.6%) with an established history of CCS. Myocardial injury occurred in 43.8% patients with CCS vs. 14.4% patients without CCS, as confirmed by high-sensitivity cardiac troponin (hs-cTn) elevation on admission or during hospitalization. The mortality rate in the CCS cohort was nearly three-fold higher. After adjusting for disease severity, myocardial injury resulted significantly associated with in-hospital mortality in the no-CCS group but not in CCS patients.

Conclusions: Patients with CCS and COVID-19 showed high mortality rate. Myocardial injury may be a bystander in CCS patients and COVID-19, while in patients without known history of CCS, myocardial injury has a significant role in predicting poor outcomes.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.3390/jcm9103263DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7601151PMC
October 2020

Combined epicardial and endocardial ablation for atrial fibrillation: Best practices and guide to hybrid convergent procedures.

Heart Rhythm 2021 Feb 9;18(2):303-312. Epub 2020 Oct 9.

Clinical Cardiovascular Research Center, University of Rochester School of Medicine & Dentistry, Rochester, New York; Department of Cardiology, Hackensack Meridian School of Medicine, Nutley, New Jersey. Electronic address:

The absence of strategies to consistently and effectively address nonparoxysmal atrial fibrillation by nonpharmacological interventions has represented a long-standing treatment gap. A combined epicardial/endocardial ablation strategy, the hybrid Convergent procedure, was developed in response to this clinical need. A subxiphoid incision is used to access the pericardial space facilitating an epicardial ablation directed at isolation of the posterior wall of the left atrium. This is followed by an endocardial ablation to complete isolation of the pulmonary veins and for additional ablation as needed. Experience gained with the hybrid Convergent procedure during the last decade has led to the development and adoption of strategies to optimize the technique and mitigate risks. Additionally, a surgical and electrophysiology "team" approach including comprehensive training is believed critical to successfully develop the hybrid Convergent program. A recently completed randomized clinical trial indicated that this ablation strategy is superior to an endocardial-only approach for patients with persistent atrial fibrillation. In this review, we propose and describe best practice guidelines for hybrid Convergent ablation on the basis of a combination of published data, author consensus, and expert opinion. A summary of clinical outcomes, emerging evidence, and future perspectives is also given.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.hrthm.2020.10.004DOI Listing
February 2021

Predictive role of early recurrence of atrial fibrillation after cryoballoon ablation.

Europace 2020 12;22(12):1798-1804

Heart Rhythm Centre, Centro Cardiologico Monzino IRCCS Milan, Italy.

Aims: The aims of this study were to determine the rate and the predictors of early recurrences of atrial fibrillation (ERAF) after cryoballoon (CB) ablation and to evaluate whether ERAF correlate with the long-term outcome.

Methods And Results: Three thousand, six hundred, and eighty-one consecutive patients (59.9 ± 10.5 years, female 26.5%, and 74.3% paroxysmal AF) were included in the analysis. Atrial fibrillation recurrence, lasting at least 30 s, was collected during and after the 3-month blanking period. Three-hundred and sixteen patients (8.6%) (Group A) had ERAF during the blanking period, and 3365 patients (Group B) had no ERAF. Persistent AF and number of tested anti-arrhythmic drugs ≥2 resulted as significant predictors of ERAF. After a mean follow-up of 16.8 ± 16.4 months, 923/3681 (25%) patients had at least one AF recurrence. The observed freedom from AF recurrence, at 24-month follow-up from procedure, was 25.7% and 64.8% in Groups A and B, respectively (P < 0.001). ERAF, persistent AF, and number of tested anti-arrhythmic drugs ≥2 resulted as significant predictors of AF. In a propensity score matching, the logistic model showed that ERAF 1 month after ablation are the best predictor of long-term AF recurrence (P = 0.042).

Conclusion: In patients undergoing CB ablation for AF, ERAF are rare and are a strong predictor of AF recurrence in the follow-up, above all when occur >30 days after the ablation.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1093/europace/euaa239DOI Listing
December 2020

Differentiating hereditary arrhythmogenic right ventricular cardiomyopathy from cardiac sarcoidosis fulfilling 2010 ARVC Task Force Criteria.

Heart Rhythm 2021 Feb 22;18(2):231-238. Epub 2020 Sep 22.

University Heart Center, University Hospital Zurich, Switzerland. Electronic address:

Background: The clinical presentation of cardiac sarcoidosis (CS) may resemble that of arrhythmogenic right ventricular cardiomyopathy (ARVC).

Objective: The purpose of this study was to identify clinical variables to better discriminate between patients with genetically determined ARVC and those with CS fulfilling definite 2010 ARVC Task Force Criteria (TFC).

Methods: In this multicenter study, 10 patients with CS fulfilling definite 2010 ARVC TFC were age and gender matched with 10 genetically proven ARVC patients. A cardiac F-fluorodeoxyglucose positron emission tomographic (F-FDG PET) scan was required for patients to be included in the study.

Results: The 2010 ARVC TFC did not reliably differentiate between the 2 diseases. CS patients presented with longer PR intervals, advanced atrioventricular block (AVB), and longer QRS duration (P <.001 and P = .009, respectively), whereas T-wave inversions (TWIs) in the peripheral leads were more common in ARVC patients (P = .009). CS patients presented with more extensive left ventricular involvement and lower left ventricular ejection fraction (LVEF), whereas ARVC patients had a larger right ventricular outflow tract (RVOT) (P = .044). PET scan positivity was only present in CS patients (90% vs 0%).

Conclusion: The 2010 ARVC TFC do not reliably differentiate between CS patients fulfilling 2010 ARVC TFC and those with hereditary ARVC. Prolonged PR interval, advanced AVB, longer QRS duration, right ventricular apical involvement, reduced LVEF, and positive F-FDG PET scan should raise the suspicion of CS, whereas larger RVOT dimensions, subtricuspid involvement and peripheral TWI favor a diagnosis of hereditary ARVC.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.hrthm.2020.09.015DOI Listing
February 2021

Arrhythmic safety of hydroxychloroquine in COVID-19 patients from different clinical settings.

Europace 2020 12;22(12):1855-1863

Department of Cardiology, ASST-Fatebenefratelli Sacco, Luigi Sacco Hospital, University of Milan, Milan, Italy.

Aims: The aim of the study was to describe ECG modifications and arrhythmic events in COVID-19 patients undergoing hydroxychloroquine (HCQ) therapy in different clinical settings.

Methods And Results: COVID-19 patients at seven institutions receiving HCQ therapy from whom a baseline and at least one ECG at 48+ h were available were enrolled in the study. QT/QTc prolongation, QT-associated and QT-independent arrhythmic events, arrhythmic mortality, and overall mortality during HCQ therapy were assessed. A total of 649 COVID-19 patients (61.9 ± 18.7 years, 46.1% males) were enrolled. HCQ therapy was administrated as a home therapy regimen in 126 (19.4%) patients, and as an in-hospital-treatment to 495 (76.3%) hospitalized and 28 (4.3%) intensive care unit (ICU) patients. At 36-72 and at 96+ h after the first HCQ dose, 358 and 404 ECGs were obtained, respectively. A significant QT/QTc interval prolongation was observed (P < 0.001), but the magnitude of the increase was modest [+13 (9-16) ms]. Baseline QT/QTc length and presence of fever (P = 0.001) at admission represented the most important determinants of QT/QTc prolongation. No arrhythmic-related deaths were reported. The overall major ventricular arrhythmia rate was low (1.1%), with all events found not to be related to QT or HCQ therapy at a centralized event evaluation. No differences in QT/QTc prolongation and QT-related arrhythmias were observed across different clinical settings, with non-QT-related arrhythmias being more common in the intensive care setting.

Conclusion: HCQ administration is safe for a short-term treatment for patients with COVID-19 infection regardless of the clinical setting of delivery, causing only modest QTc prolongation and no directly attributable arrhythmic deaths.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1093/europace/euaa216DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7543547PMC
December 2020

High-density mapping validation of antral pulmonary vein isolation and posterior wall isolation created with a new cryoballoon ablation system: The first reported case.

J Cardiovasc Electrophysiol 2020 12 15;31(12):3318-3321. Epub 2020 Sep 15.

Heart Rhythm Center, Centro Cardiologico Monzino IRCCS, Milan, Italy.

Cryoballoon ablation is a recognized and widespread method for pulmonary vein isolation. For many years the impossibility of using it to create additional lines was considered a drawback of this approach. However, recently, the technique was adapted to allow the creation of rooflines, and potentially also inferior lines. In this article, we present the first reported case of a patient submitted to pulmonary vein isolation plus posterior wall isolation using the novel Boston POLAR X™ cryoballoon exclusively. To confirm the quality of the lesions, the patient underwent pre and postablation high-density mapping.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1111/jce.14741DOI Listing
December 2020

Atrial fibrillation ablation in real life: is there room for improvements?

Authors:
Claudio Tondo

J Cardiovasc Med (Hagerstown) 2020 10;21(10):749-750

Centro Cardiologico Monzino, IRCCS, Cardiac Arrhythmia Research Centre, Milan, Italy.

View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.2459/JCM.0000000000001038DOI Listing
October 2020

Cardiac arrhythmia catheter ablation procedures guided by x-ray imaging: N-acetylcysteine protection against radiation-induced cellular damage (CARAPACE study): study design.

J Interv Card Electrophysiol 2020 Aug 24. Epub 2020 Aug 24.

Heart Rhythm Center, Centro Cardiologico Monzino IRCCS, Milan, Italy.

Purpose: Catheter ablation (CA) procedures are characterized by exposure to ionizing radiations (IR). IR can cause DNA damage and may lead to carcinogenesis if not efficiently repaired. The primary endpoint of this study is to investigate whether intravenous administration of N-acetylcysteine prior to CA procedure may prevent systemic oxidative stress and genomic DNA damage induced by exposure to IR.

Methods: The "Cardiac Arrhythmia catheter ablation procedures guided by x-Ray imaging: N-Acetylcysteine Protection Against radiation induced Cellular damagE" (CARAPACE) study is a prospective, randomized, single-blinded, parallel-arm monocenter study enrolling 550 consecutive patients undergoing CA at the Arrhythmology Unit of Centro Cardiologico Monzino (CCM). Inclusion criteria are age ≥ 18, indication for CA procedure guided by IR imaging, and written informed consent. IR levels will be measured via fluoroscopy time, effective dose, and dose area product. Glutathione and glutathione disulfide concentrations will be measured, and urinary levels of 8-iso-prostaglandin-F and 8-hydroxy-2-deoxyguanosine will be quantified. The enrolled patients will be randomized 1:1 to the N-acetylcysteine group or to the control group.

Results: We expect that pre-operative administration of N-acetylcysteine will prevent IR-induced systemic oxidative stress. The study will provide data on oxidative DNA damage assessed by urinary 8-hydroxy-2-deoxyguanosine levels and direct evidence of genomic DNA damage in blood cells by comet assay.

Conclusion: Catheter ablation procedures can lead to IR exposure and subsequent DNA damage. N-acetylcysteine administration prior to the procedure may prevent them and therefore lead to less possible complications.

Trial Registration: www.clinicaltrials.gov (NCT04154982).
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1007/s10840-020-00853-4DOI Listing
August 2020

Diagnostic Yield of Electroanatomic Voltage Mapping in Guiding Endomyocardial Biopsies.

Circulation 2020 Sep 14;142(13):1249-1260. Epub 2020 Aug 14.

Department of Clinical Electrophysiology and Pacing(M.C., V.C., A.G., G.V., F.T., R.S., C.T.), Centro Cardiologico Monzino IRCCS, Milano, Italy.

Background: Electroanatomic voltage mapping (EVM) is a promising modality for guiding endomyocardial biopsies (EMBs). However, few data support its feasibility and safety. We now report the largest cohort of patients undergoing EVM-guided EMBs to show its diagnostic yield and to compare it with a cardiac magnetic resonance (CMR)-guided approach.

Methods: We included 162 consecutive patients undergoing EMB at our institution from 2010 to 2019. EMB was performed in pathological areas identified at EVM and CMR. CMR and EVM sensitivity and specificity regarding the identification of pathological substrates of myocardium were evaluated according to EMB results.

Results: Preoperative CMR showed late gadolinium enhancement in 70% of the patients, whereas EVM identified areas of low voltage in 61%. Right (73%), left (19%), or both ventricles (8%) underwent sampling. EVM proved to have sensitivity similar to CMR (74% versus 77%), with specificity being 70% and 47%, respectively. In 12 patients with EMB-proven cardiomyopathy, EVM identified pathological areas that had been undetected at CMR evaluation. Sensitivity of pooled EVM and CMR was as high as 95%. EMB analysis allowed us to reach a new diagnosis, different from the suspected clinical diagnosis, in 39% of patients. The complications rate was low, mostly related to vascular access, with no patients requiring urgent management.

Conclusions: EVM proved to be a promising tool for targeted EMB because of its sensitivity and specificity for identification of myocardial pathological substrates. EVM was demonstrated to have accuracy similar to CMR. EVM and CMR together conferred a positive predictive value of 89% on EMB.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1161/CIRCULATIONAHA.120.046900DOI Listing
September 2020

Cryoballoon or radiofrequency ablation? Alternating technique for repeat procedures in patients with atrial fibrillation.

Pacing Clin Electrophysiol 2020 07 27;43(7):687-697. Epub 2020 Jun 27.

Cardiac Arrhythmia Research Centre, Centro Cardiologico Monzino IRCCS Milan, Milan, Italy.

Background: Which technique is better for repeat ablation in patients with atrial fibrillation (AF) remains unclear. The aim of the study was to compare long-term efficacy of repeat ablation using the alternative technique for the first redo ablation procedure: (a) cryoballoon (CB) re-ablation after a failed index pulmonary vein isolation (PVI) with radiofrequency (RF) ablation, RF-then-CB group or (b) RF repeat ablation following a failed CB ablation, CB-then-RF group.

Methods: Within the 1STOP Italian Project, consecutive patients undergoing repeat ablation with a different technique from the index procedure were included.

Results: We studied 474 patients, 349 in RF-then-CB and 125 in CB-then-RF group. Less women (21% vs 30%; P = .041), more persistent AF (33% vs 22%; P = .015), longer duration of AF (60 vs 31 months; P < .001), and more hypertension (50% vs 36%; P = .007) were observed in the RF-then-CB cohort as compared with the CB-then-RF group. The number of reconnected PVs was 3.7 ± 0.7 and 1.4 + 1.3 in RF-then-CB and CB-then-RF group, respectively (P < .001). During the follow-up, significantly less AF recurrence occurred in the CB-then-RF group (22% vs 8%, HR = 0.46; 95% CI: 0.24-0.92; P = .025). Cohort designation was the only independent predictor of AF recurrence.

Conclusion: Alternation of energy source for repeat ablation was safe and effective, regardless the energy used first. However, patients initially treated with CB PVI undergoing repeat ablation with RF current had less AF recurrence at long-term follow-up as compared with those originally treated by RF ablation receiving a CB repeat ablation.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1111/pace.13975DOI Listing
July 2020

Highlights from Heart Rhythm 2019: Cardiac Ablation, Pacing, and Monitoring.

Authors:
Claudio Tondo

J Innov Card Rhythm Manag 2019 Aug 15;10(8):3796-3799. Epub 2019 Aug 15.

Heart Rhythm Center, Monzino Cardiac Center, Department of Clinical Sciences and Community Health, University of Milan, Milan, Italy.

View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.19102/icrm.2019.100806DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7252691PMC
August 2019

Clinical and Molecular Data Define a Diagnosis of Arrhythmogenic Cardiomyopathy in a Carrier of a Brugada-Syndrome-Associated Mutation.

Genes (Basel) 2020 05 20;11(5). Epub 2020 May 20.

Cardiac Arrhythmia Research Centre, Centro Cardiologico Monzino IRCCS, 20141 Milan, Italy.

Plakophilin-2 () is the most frequently mutated desmosomal gene in arrhythmogenic cardiomyopathy (ACM), a disease characterized by structural and electrical alterations predominantly affecting the right ventricular myocardium. Notably, ACM cases without overt structural alterations are frequently reported, mainly in the early phases of the disease. Recently, the p.S183N mutation was found in a patient affected by Brugada syndrome (BS), an inherited arrhythmic channelopathy most commonly caused by sodium channel gene mutations. We here describe a case of a patient carrier of the same BS-related p.S183N mutation but with a clear diagnosis of ACM. Specifically, we report how clinical and molecular investigations can be integrated for diagnostic purposes, distinguishing between ACM and BS, which are increasingly recognized as syndromes with clinical and genetic overlaps. This observation is fundamentally relevant in redefining the role of genetics in the approach to the arrhythmic patient, progressing beyond the concept of "one mutation, one disease", and raising concerns about the most appropriate approach to patients affected by structural/electrical cardiomyopathy. The merging of genetics, electroanatomical mapping, and tissue and cell characterization summarized in our patient seems to be the most complete diagnostic algorithm, favoring a reliable diagnosis.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.3390/genes11050571DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7288341PMC
May 2020

Cardiac and arrhythmic complications in patients with COVID-19.

J Cardiovasc Electrophysiol 2020 05 13;31(5):1003-1008. Epub 2020 Apr 13.

Heart Rhythm Center, Centro Cardiologico Monzino IRCCS, Milan, Italy.

In December 2019, the world started to face a new pandemic situation, the severe acute respiratory syndrome-coronavirus 2 (SARS-CoV-2). Although coronavirus disease (COVID-19) clinical manifestations are mainly respiratory, major cardiac complications are being reported. Cardiac manifestations etiology seems to be multifactorial, comprising direct viral myocardial damage, hypoxia, hypotension, enhanced inflammatory status, ACE2-receptors downregulation, drug toxicity, endogenous catecholamine adrenergic status, among others. Studies evaluating patients with COVID-19 presenting cardiac injury markers show that it is associated with poorer outcomes, and arrhythmic events are not uncommon. Besides, drugs currently used to treat the COVID-19 are known to prolong the QT interval and can have a proarrhythmic propensity. This review focus on COVID-19 cardiac and arrhythmic manifestations and, in parallel, makes an appraisal of other virus epidemics as SARS-CoV, Middle East respiratory syndrome coronavirus, and H1N1 influenza.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1111/jce.14479DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7262150PMC
May 2020

Use of a multi-electrode radiofrequency balloon catheter to achieve pulmonary vein isolation in patients with paroxysmal atrial fibrillation: 12-Month outcomes of the RADIANCE study.

J Cardiovasc Electrophysiol 2020 06 23;31(6):1259-1269. Epub 2020 Apr 23.

Department of Cardiology, Barts Heart Centre, St Bartholomew's Hospital, Barts Health NHS Trust, London, United Kingdom.

Background: The RADIANCE first-in-man study evaluated acute (3-month) safety and design concept in terms of utility of a new multi-electrode radiofrequency (RF) balloon catheter (HELIOSTAR, Biosense Webster) to achieve pulmonary vein isolation (PVI). After study conclusion, a subset of patients was followed up to 12 months.

Methods: Patients with drug refractory paroxysmal atrial fibrillation were enrolled. Neurological assessment, cardiac and cerebral magnetic resonance imagings were performed pre and post procedure. Ablation was delivered at 15 Watts to each PV for 60 seconds (electrodes adjacent to the posterior wall limited to 20 seconds). Adenosine or isoproterenol was administered to confirm PVI. Esophageal endoscopy was performed 48 hours post procedure. Patients were clinically followed up for 12 months.

Results: Thirty-nine patients underwent catheter ablation from four centers. Mean age was 60.7 ± 10.0 years with 23 (57.5%) being male. Confirmation of PVI was performed in all PVs treated (152/152). Confirmation of isolation after one delivery was performed solely on 137 of 152 PVs of which 79.6% (109/137) achieved isolation with a single delivery of RF energy. Acute PV reconnection was seen in 4.6% (7/150) of PVs. Freedom from documented atrial arrhythmia at 12 months in those followed up was 86.4% (32/37). A total of 75.7% (28/37) of patients were free from atrial arrhythmia and off antiarrhythmic medications.

Conclusion: The HELIOSTAR RF balloon catheter allows for rapid and safe PVI with majority of PVs only requiring one application.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1111/jce.14476DOI Listing
June 2020

Left atrial appendage occlusion with the Amplatzer™ Amulet™ device: full results of the prospective global observational study.

Eur Heart J 2020 08;41(30):2894-2901

Heart Rhythm Centre at Monzino Cardiac Center, IRCCS, Department of Clinical Sciences and Community Health, University of Milan, Via Francesco Sforza 35, Milan 20122, Italy.

Aims: To evaluate the safety and efficacy of left atrial appendage occlusion (LAAO) with the Amplatzer™ Amulet™ occluder.

Methods And Results: Patients with atrial fibrillation eligible for LAAO were recruited to a prospective global study. Implant procedures were undertaken with echocardiographic guidance. Transoesophageal echocardiography (TOE) was undertaken 1-3 months post-LAAO. Implant and follow-up TOEs were evaluated by a CoreLab. The primary endpoint was a composite of ischaemic stroke and cardiovascular death at 2 years. Serious adverse events were adjudicated by an independent clinical events committee. A total of 1088 patients were enrolled, aged 75.2 ± 8.5 years; 64.5% were male. CHA2DS2-VASc and HAS-BLED scores were 4.2 ± 1.6 and 3.3 ± 1.1, respectively. A total of 71.7% had prior major bleeding, and 82.8% had contraindications to oral anticoagulants. Implant success was 99.1%. Major adverse events (≤7 days post-procedure) occurred in 4.0%, including death (0.3%), stroke (0.4%), major vascular (1.3%), and device embolization (0.2%). A total of 80.2% of patients were discharged on antiplatelet therapy alone. Peridevice flow was <3 mm in 98.4% at follow-up TOE. Device-related thrombus (DRT) was seen in 1.6% of cases. Cardiovascular death or ischaemic stroke occurred in 8.7% of patients at 2 years. The ischaemic stroke rate was 2.2%/year-a 67% reduction compared to the CHA2DS2-VASc predicted rate. Major bleeding (Bleeding Academic Research Consortium type ≥ 3) occurred at rates of 10.1%/year (year 1) and 4.0%/year (year 2).

Conclusion: Following LAAO with the Amplatzer Amulet device, the ischaemic stroke rate was reduced by 67% compared to the predicted risk. Closure was complete in 98.4% of cases and DRT seen in only 1.6%.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1093/eurheartj/ehaa169DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7421773PMC
August 2020