[Prevention, diagnosis and treatment of cardiac implantable electronic device infections. Position paper of the Italian Association of Arrhythmology and Cardiac Pacing (AIAC)]. / Prevenzione, diagnosi e trattamento delle infezioni dei dispositivi cardiaci elettronici impiantabili. Position paper dell'Associazione Italiana di Aritmologia e Cardiostimolazione (AIAC).

The number of cardiac implantable electronic device (CIED) implantations has increased over recent years as a result of population growth, increasing life expectancy, adoption of guidelines, and better access to healthcare. Device-related infection is, however, one of the most serious complications of CIED therapy associated with significant morbidity, mortality, and financial healthcare burden. Although many preventive strategies such as administration of intravenous antibiotic therapy before implantation are well recognized, uncertainties still exist about other regimens. Uncertainties have remained about the role of various preventive, diagnostic, and treatment measures such as skin antiseptics, pocket antibiotic solutions, anti-bacterial envelopes, prolonged antibiotics post-implantation, and others. The key aspect to successful treatment of definite CIED infections is complete removal of all parts of the system and transvenous hardware, including the device and all leads. Thus, transvenous lead extraction has been increasing. Expert consensus statements on how to prevent, diagnose, and treat CIED infections and on lead extraction have been published by the European Heart Rhythm Association in 2020 and 2018, respectively. The aim of this AIAC position paper is to describe the current knowledge on the risks for device-related infections and to assist healthcare professionals in their clinical decision making regarding its prevention, diagnosis, and management by providing the latest update of the most effective strategies.

Rationale and study design of the Italian Registry in the setting of Atrial Fibrillation Ablation with Rivaroxaban - IRIS.

BACKGROUND: Catheter ablation (CA) of atrial fibrillation (AF) is used routinely to establish rhythm control. There is mounting evidence that CA procedures should be performed during continuous oral anticoagulation and direct oral anticoagulants (DOACs) are considered the first anticoagulation strategy. Few real-life data are now available and even less in the Italian panorama. METHODS: IRIS is an Italian multicenter, non-interventional, prospective study which will be enrolled consecutive AF patients eligible for CA and treated with Rivaroxaban; patients in treatment with Rivaroxaban proceeded directly to CA while Rivaroxaban-naive patients were scheduled for CA after 4 weeks of uninterrupted anticoagulation unless the exclusion of atrial thrombi. Rivaroxaban was uninterrupted or shortly uninterrupted (<24 hours) prior CA, in line with routinely practice of each operator. Patients will be followed on continuous anticoagulation for 1 month after the ablation. The primary efficacy outcome is the cumulative incidence of all-cause death and systemic embolism while the primary safety outcome is the incidence of major bleeding events. The secondary outcomes are represented by non-major bleeding events. All events must be occurred within the first 30 days after the procedure. RESULTS: Two hundred fifty patients are expected to be enrolled and the study is estimated to be completed by the end of 2022. Up to now 56 patients have been enrolled. CONCLUSIONS: This study is the first large Italian prospective study on the management of Rivaroxaban in patients undergoing CA of AF. It aims to depict a comprehensive view of anticoagulation strategy prior CA in several Italian electrophysiology labs.

Feasibility and safety of catheter ablation of electrical storm in ischemic dilated cardiomyopathy.

AIMS: Electrical storm is an emergency in 'implantation of a cardioverter defibrillator' carriers with ischemic dilated cardiomyopathy (DCM) and negatively impacts long-term prognosis. We evaluated the feasibility, safety, and effectiveness of radiofrequency catheter ablation (RFCA) in controlling electrical storm and its impact on survival and ventricular tachycardia/fibrillation recurrence. METHODS: We enrolled 27 consecutive patients (25 men, age 73.1 ±â€Š6.5 years) with ischemic DCM and an indication to RFCA for drug-refractory electrical storm. The immediate outcome was defined as failure or success, depending on whether the patient's clinical ventricular tachycardia could still be induced after RFCA; electrical storm resolution was defined as no sustained ventricular tachycardia/ventricular fibrillation in the next 7 days. RESULTS: Of the 27 patients, 1 died before RFCA; in the remaining 26 patients, a total of 33 RFCAs were performed. In all 26 patients, RFCA was successful, although in 6/26 patients (23.1%), repeated procedures were needed, including epicardial ablation in 3/26 (11.5%). In 23/26 patients (88.5%), electrical storm resolution was achieved. At a follow-up of 16.7 ±â€Š8.1 months, 5/26 patients (19.2%) had died (3 nonsudden cardiac deaths, 2 noncardiac deaths) and 10/26 patients (38.5%) had ventricular tachycardia recurrence; none had electrical storm recurrence. A worse long-term outcome was associated with lower glomerular filtration rate, wider baseline QRS, and presence of atrial fibrillation before electrical storm onset. CONCLUSION: In patients with ischemic DCM, RFCA is well tolerated, feasible and effective in the acute management of drug-refractory electrical storm. It is associated with a high rate of absence of sustained ventricular tachycardia episodes over the subsequent 7 days. After successful ablation, long-term outcome was mainly predicted by baseline clinical variables.

Improved implant and postoperative lead performance in CRT-D patients implanted with a quadripolar left ventricular lead. A 6-month follow-up analysis from a multicenter prospective comparative study.

PURPOSE: Small single-center comparative studies suggest improved outcomes in cardiac resynchronization therapy (CRT) patients implanted with a quadripolar left ventricular (LV) lead in comparison with non-quadripolar (bipolar) leads. This study represents the first large multicenter prospective registry comparing implant and 6-month postoperative lead performance following CRT-defibrillator (CRT-D) implantation with quadripolar vs. bipolar leads. METHODS: During a 39-month period, 418 consecutive patients having CRT-D implantation attempts with either a quadripolar (n = 230) or bipolar LV lead (n = 188) were enrolled in the registry. The primary outcome of the study was LV lead failure defined as any abnormality, excluding infection, resulting in surgical lead revision or CRT termination. Additionally, operative and follow-up data were analyzed for significant difference between groups. RESULTS: Baseline characteristics of both groups were similar. In 72.9 % of quadripolar leads versus 65.0 % of bipolar leads, the LV lead successfully engaged the predefined ideal target side branch (p = 0.47). Implant duration and fluoroscopy times were significantly shorter when a quadripolar lead was used (p = 0.007 and p = 0.001, respectively). The primary end point occurred in six patients (2.7 %) in the quadripolar group and in 14 patients (8.0 %) in the bipolar group (p = 0.02). Clinically significant phrenic nerve stimulation (PNS) occurred in 4.6 vs. 14.2 % of quadripolar vs. bipolar patients, respectively (p = 0.002); all PNS were resolved noninvasively through programming in the quadripolar group vs. 84 % in bipolar group (p = 0.75). The use of a bipolar lead was associated with a higher risk of surgical LV lead revision (6.3 vs. 2.3 %; p = 0.057) and a higher incidence of dislodgment (5.7 vs. 2.7 %; p = 0.16). CONCLUSIONS: This multicenter study demonstrates that the use of a quadripolar LV lead results in significantly lower rates of lead-related problems and reduced procedural and fluoroscopic times for biventricular system implantation. This has important implications for LV pacing lead choice.

Catheter ablation of atrial fibrillation guided by a 3D electroanatomical mapping system: a 2-year follow-up study from the Italian Registry On NavX Atrial Fibrillation ablation procedures (IRON-AF).

AIMS: Clinical trials have established that atrial fibrillation (AF) catheter ablation improves symptoms in appropriately selected patients. Confirmation of these results by long-term prospective observational studies is needed. This registry was created to describe the experience of 16 Italian centers with a large cohort of AF patients treated with catheter ablation guided by the NavX 3D mapping system. METHODS: From November 2006 to May 2008, 545 consecutive patients (age 60.4 ± 9.8, 67 % male) with paroxysmal (44 %), persistent (43 %), and long-standing persistent (13 %) AF referred for catheter ablation guided by the NavX system, were included in this registry. For this paper, follow-up was censored at 24 months; however, patients are being followed in the ongoing registry. RESULTS: Before the ablation, 80 % of patients failed to respond to at least one antiarrhythmic drug aimed at rhythm control. Pulmonary vein (PV) isolation guided by a circular mapping catheter was performed in 70 % of patients whereas non potential-guided PV encircling was performed in 30 % of patients. In 67 % of patients, additional left atrial (LA) substrate modification was performed. Image integration was performed in 9.2 % of patients. Considering a 3-month blanking period, after a single-ablation procedure, the patients had 1- and 2-year freedom from AF recurrence of 67.4 and 57.0 % (36.1 % off antiarrhythmic drugs), respectively. Cox regression analysis showed that AF recurrences during blanking (HR 2.1), and previous AF ablation (HR 3.3) were independent predictors of AF recurrences. Major procedure-related complications occurred in 53 patients (9.7 %). In 35 patients (6.7 %), a repeat procedure was performed at a median of 5 months after the initial procedure. CONCLUSIONS: This prospective, multicenter clinical experience provides significant insights into current ablation care of patients with AF. Despite favorable outcomes, real-world complication rates appear higher than previously recognized.

Influence of myocardial viability on responsiveness to cardiac resynchronization in ischemic dilated cardiomyopathy: a prospective observational cohort study.

OBJECTIVE: To understand whether patients with post-ischemic dilated cardiomyopathy and myocardial viability (MV) could benefit from cardiac resynchronization therapy (CRT) in terms of clinical, echocardiographic and neuro- hormonal parameters compared to patients without MV. METHODS: One hundred and four consecutive patients were enrolled in a prospective observational cohort study. Using dobutamine stress echocardiography, 2 groups were identified: group A of 51 patients with MV and group B of 53 patients without MV. All patients were implanted with biventricular pacing devices combined with an internal cardioverter-defibrillator. Clinical, echocardiographic and neuro-hormonal parameters were evaluated at baseline and at six month follow-up. Analysis of variance for repeated measures on each variable suggestive of remodeling was performed. We considered responder every patient with: decrease of > 15% in left ventricular volumes and/or improvement in left ventricular ejection fraction of > 5% in addition to NYHA class improvement. RESULTS: All the variables improved in both groups (time effect). Comparing the two groups (group effect), the following variables were significantly better in group A: N-terminal pro-B-type natriuretic peptide (p=0.02), NYHA class (p=0.003), reverse remodeling (RR) (p=0.007), dP/dt (p=0.005), left ventricular ejection fraction (p=0.009), 3rd sound (p=0.01), and left ventricular end-systolic volume after the first week (p=0.035). RR occurred at the first week after CRT only in Group A and was maintained for all the time of this study. The maximum difference of the decrease of left ventricular volumes between the two groups occurred after the first week (p<0.001). CONCLUSION: Patients with MV responded better than patients without MV with a significant improvement after the first week from CRT.

Real-time integration of intracardiac echocardiography and 3D electroanatomical mapping to guide catheter ablation of isthmus-dependent atrial flutter in a patient with complete situs inversus and interruption of the inferior vena cava with azygos continuation.

Atrial tachycardias are relatively common in patients with congenital heart disease. However, complex anomalies involving the heart and the great vessels might compromise the results of the ablation procedure. This report describes a clinical application of the new Cartosound™ module as an adjunctive technology to understand the mechanism of the arrhythmia and to guide successfully the ablation in a complex anatomy. Isthmus-dependent atrial flutter was diagnosed in a patient with complete situs inversus and interruption of the inferior vena cava with azygos continuation. Under these unusual circumstances, Cartosound facilitates interventional navigation within the right atrium and its adjacent structures and minimizes radiation exposure.

Combined use of cryoballoon and focal open-irrigation radiofrequency ablation for treatment of persistent atrial fibrillation: results from a pilot study.

BACKGROUND: Pulmonary vein isolation (PVI) achieved using a cryoballoon has been shown to be safe and effective. This treatment modality has limited effectiveness for treatment of persistent atrial fibrillation (AF). OBJECTIVE: The purpose of this study was to evaluate a combined approach using a cryoballoon for treatment of PVI and focal radiofrequency (RF) left atrial substrate ablation for treatment of persistent AF. METHODS: Twenty-two consecutive patients with persistent AF were included in the study. PVI initially was performed with a cryoballoon. Left atrial complex fractionated atrial electrograms (CFAEs) then were ablated using an RF catheter. Finally, linear ablations using the RF catheter were performed. RESULTS: Eighty-three PVs, including five with left common ostia, were targeted and isolated (100%). Seventy-seven (94%) of 82 PVs targeted with the cryoballoon were isolated, and 5 (6%) required use of RF energy to complete isolation. A mean of 9.7 +/- 2.6 cryoablation applications per patient was needed to achieve PVI. Median time required for cryoablation per vein was 600 seconds, and mean number of balloon applications per vein was 2.5 +/- 1.0. In 19 (86%) patients in whom AF persisted after PVI, CFAE areas were ablated using the RF catheter. Two cases of transient phrenic nerve paralysis occurred. After a single procedure and mean follow-up of 6.0 +/- 2.9 months, 86.4% of patients were AF-free without antiarrhythmic drugs. CONCLUSION: A combined approach of cryoablation and RF ablation for treatment of persistent AF is feasible and is associated with a favorable short-term outcome.

Right ventricular substrate mapping using the Ensite Navx system: Accuracy of high-density voltage map obtained by automatic point acquisition during geometry reconstruction.

BACKGROUND: Contact point-to-point electroanatomic mapping (Pt-Map) is a validated tool to evaluate right ventricular (RV) substrate. When using the EnSite NavX system (St. Jude Medical, St Paul, Minnesota), geometry reconstruction by dragging the mapping catheter (Geo-Map) allows for quicker acquisition of a large number of points and better definition of anatomy, but it is not validated for substrate mapping. OBJECTIVE: This study evaluates the feasibility and accuracy of Geo-Map. METHODS: Thirteen patients (mean age 38 +/- 12 years) with RV arrhythmias and an apparently normal heart underwent cardiac magnetic resonance imaging (MRI), Pt-Map, and Geo-Map. The 2 maps were compared in terms of mapping procedural time, radiation time, and total number of points acquired. We finally compared the number and characteristics of low-potential areas on each patient's Pt-Map, Geo-Map, and cardiac MRI. RESULTS: Geo-Map required significantly shorter mapping and radiation times in comparison to Pt-Map (12.4 +/- 4.6 vs. 31.9 +/- 10.1 and 5.8 +/- 2.1 vs. 12.1 +/- 3.9, P <.001). Furthermore, Geo-Map was based on a significantly higher density of points in comparison to Pt-Map (802 +/- 205 vs. 194 +/- 38, P <.001). Taking into consideration the total number of RV regions analyzed, the Pt-Map and Geo-Map disagreed in 2 of 65 (3%) regions (P = NS), which only Geo-Map identified as low-potential areas and indeed corresponded to wall motion abnormalities on MRI. CONCLUSION: Voltage maps obtained through RV geometry acquisition have accuracy comparable to that of conventional point-by-point mapping in detecting low-voltage areas, have a good correlation with MRI wall motion abnormalities, and allow a significant reduction in procedural time and x-ray exposure.

Catheter ablation of atrial fibrillation in patients with diabetes mellitus type 2: results from a randomized study comparing pulmonary vein isolation versus antiarrhythmic drug therapy.

INTRODUCTION: Atrial fibrillation (AF) and diabetes mellitus type 2 (DM2) often coexist; however, a small number of patients with DM2 undergoing catheter ablation (CA) of AF have been included in previous studies. The aim of this study was to evaluate safety and efficacy of ablation therapy in DM2 patients with drug refractory AF. METHODS AND RESULTS: From January 2005 to September 2006, 70 patients with a diagnosis of DM2 and paroxysmal (n = 29) or persistent (n = 41) AF were randomized to receive either pulmonary vein isolation or a new antiarrhythmic drug treatment (ADT) with a 1-year follow-up. The primary endpoint was the time to first AF recurrence. By Kaplan-Meier analysis, at the end of follow-up, 42.9% of patients in the ADT group and 80% of patients who received a single ablation procedure and were without medications were free of AF (P = 0.001). In the ablation group, a significant improvement in quality-of-life (QoL) scores as compared with ADT group was observed. Six patients in the ADT group (17.1%) developed significant adverse drug effects. Hospitalization rate during follow-up was higher in the ADT group (P = 0.01). The only complication attributable to ablation was one significant access-site hematoma. CONCLUSION: In patients with DM2, CA of AF provides significant clinical benefits over the ADT and appears to be a reasonable approach regarding feasibility, effectiveness, and low procedural risk.

Initial experience with the Mesh catheter for pulmonary vein isolation in patients with paroxysmal atrial fibrillation.

BACKGROUND: A novel catheter design (HD Mesh ablator, Bard) combining high-density circumferential mapping and direct radiofrequency (RF) energy delivery has been developed to map and isolate the pulmonary veins (PVs). OBJECTIVE: The purpose of this study was to assess the feasibility of the Mesh catheter for PV isolation in patients with paroxysmal atrial fibrillation (AF). METHODS: Twenty consecutive patients (mean age 56.4 +/- 12.2 years; 16 men) with paroxysmal drug-refractory AF were referred for ablation. The procedure was performed in a stepwise manner: PV isolation was initially attempted with the Mesh ablator, and if that was not successful, a conventional ablation approach was then used. RESULTS: A total of 73 PVs including seven veins with left common ostium were targeted. Successful deployment of the Mesh was achieved in all but four veins (94.5%). Using the Mesh catheter for ablation, PV isolation was achieved in 46 (63%) of the 73 PVs. The mean (RF) ablation time required to achieve complete isolation was 12.4 +/- 6.1 minutes per PV. The Mesh-only approach allowed isolation of all veins in eight (40%) patients. In combination with conventional ablation, successful PV isolation was achieved in 71 (97%) of 73 PVs. No complications attributable to the Mesh ablator occurred in this series. CONCLUSIONS: PV isolation using the Mesh catheter is feasible and may simplify the current PV isolation procedures. With the current catheter design, PV isolation could be achieved in 63% of PVs. A larger Mesh diameter with an over-the-wire design may help improve the acute success rate.

Diagnostic value of endomyocardial biopsy guided by electroanatomic voltage mapping in arrhythmogenic right ventricular cardiomyopathy/dysplasia.

UNLABELLED: Voltage Mapping-Guided Biopsy in ARVC/D. INTRODUCTION: To improve the endomyocardial biopsy (EMB) diagnostic sensitivity for arrhythmogenic right ventricular cardiomyopathy/dysplasia (ARVC/D), we hypothesized a biopsy sampling focused on selected right ventricle (RV) low-voltage areas identified by electroanatomic voltage mapping. METHODS AND RESULTS: The study population (22 patients, 10 men; mean age 34 +/- 10 years) included 11 patients with overt ARVC/D (group A) and 11 patients with suspected ARVC/D (group B), according to both arrhythmic profile and standardized noninvasive diagnostic criteria. In all 22 patients, an RV bipolar voltage mapping was performed with CARTO system sampling multiple endocardial sites (262 +/- 61), during sinus rhythm, with a 0.5-1.5 mV color range setting of voltage display. All 11 (100%) group A patients and 8 of the 11 (73%) group B patients (P = nonsignificant [NS]) presented RV low-voltage areas (<0.5 mV). In 8 group A patients and in all 8 group B patients with a pathological RV voltage map, an EMB focused on the low-voltage areas was performed. In 6 (75%) group A patients and in 7 (87%) group B patients (P = NS), voltage mapping-guided EMB was diagnostic for ARVC/D. In the remaining 3 patients, only nonspecific histological findings were observed. CONCLUSIONS: The results of our study (1) confirm the high diagnostic sensitivity of RV voltage mapping in patients with overt ARVC/D, (2) document a high prevalence of RV low-voltage areas even in patients with suspected ARVC/D, and (3) demonstrate that in patients with clinical evidence or suspicion for ARVC/D, presenting RV low-voltage areas, EMB guided by voltage mapping may provide ARVC/D diagnosis confirmation.

Safety of single transseptal puncture for ablation of atrial fibrillation: retrospective study from a large cohort of patients.

INTRODUCTION: Transseptal puncture (TSP) is the conventional approach to assess the left atrial chamber. This technique has been widely used in interventional cardiology and, in the last years, this approach is mostly applied to electrophysiologic procedures. For atrial fibrillation (AF) ablation, two or more transseptal sheaths are often positioned in the left atrium in the majority of centers, therefore requiring two or more transseptal punctures. Theoretically, double puncture could bear additional risks or could increase the risk of persistence of septal defects. We reported the results of a retrospective analysis of a single transseptal puncture as a simplified approach for positioning multiple catheters in the left atrium during AF ablation. METHODS: Between November 2003 and November 2005, 1,150 consecutive patients (mean age 54 +/- 8 years, 75% men) were considered for AF ablation and underwent single transseptal puncture for positioning multiple catheters in the left atrium. RESULTS: In only 6 of 1,150 (0.5%) cases a second transseptal puncture was required to position the ablation catheter in the left atrium. Neither acute complications related to transseptal catheterization such as atrial or aortic perforations, pericardial tamponade, thrombotic formation, or air embolism, nor complications due to the attempts of crossing the septum with the ablation catheter were reported. In all cases, each mapping catheter was properly maneuvered at different sites in the left atrium and at the pulmonary veins. In no patient was a residual septal atrial defect after the transseptal maneuvers detected during a mean follow up of 14 +/- 2 months. CONCLUSIONS: This retrospective study on a large cohort of patients shows that single transseptal puncture for positioning two or more catheters in the left atrium for AF ablation is a highly successful and safe maneuver with a very low morbidity in the majority of patients. This may avoid potential complications related to a second transseptal puncture.

Endomyocardial biopsy guided by electroanatomic voltage mapping in arrhythmogenic right ventricular cardiomyopathy: a case report.

A positive endomyocardial biopsy (EMB) is a major diagnostic criterion for arrhythmogenic right ventricular cardiomyopathy (ARVC). Nevertheless, its sensitivity is low due to the focal nature of the disease. Moreover, myocardial samples are usually taken from the uncommonly involved interventricular septum to minimize the risk of perforation. In this report, we describe a novel bioptical approach for ARVC diagnosis guided by the identification of right ventricle (RV) affected regions by means of electroanatomical voltage mapping.

Pulmonary vein vestibule ablation for the control of atrial fibrillation in patients with impaired left ventricular function.

INTRODUCTION: Congestive heart failure (CHF) and atrial fibrillation (AF) are frequently linked, and when associated produce additive deleterious effects. In this prospective study, the effects of catheter ablation for AF in patients with impaired left ventricular (LV) function are presented. METHODS: Baseline data and clinical outcome have been prospectively collected in 105 consecutive patients who underwent pulmonary vein ablation for the control of AF. We evaluated 40 patients affected by LV dysfunction with ejection fraction (EF)<40% and compared them to the remaining 65 patients with normal ventricular function in terms of changes in LV function, maintenance of sinus rhythm, and quality of life during follow-up. RESULTS: After a mean follow-up of 14+/-2 months, 87% of patients with impaired LV function and 92% of patients with normal ventricular function were in sinus rhythm, with or without antiarrhythmic therapy (P=NS). A significant improvement in LVEF and fractional shortening was documented in patients with CHF (33+/-2% vs 47+/-3%, and 19+/-4% vs 30+/-3%, P<0.01 for both comparisons). Evaluation of exercise capacity and quality of life documented better improvements in patients with CHF compared to patients without CHF. CONCLUSIONS: Catheter ablation in patients with LV dysfunction is feasible, not associated with higher procedural complications, and provides a significant improvement in LV performance, symptoms, and quality of life during follow-up.