Background Patients with cardiomyopathies and channelopathies are usually younger and have a pred... more Background Patients with cardiomyopathies and channelopathies are usually younger and have a predominantly arrhythmia-related prognosis; they have nearly normal life expectancy thanks to the protection against sudden cardiac death provided by the implantable cardioverter defibrillator (ICD). The subcutaneous ICD (S-ICD) is an effective alternative to the transvenous ICD, and has evolved over the years. Objective To evaluate the rate of inappropriate shocks (IS), appropriate therapies and device-related complications in patients with cardiomyopathies and channelopathies who underwent modern S-ICD implantation. Methods We enrolled consecutive patients with cardiomyopathies and channelopathies who had undergone implantation of a modern S-ICD from January 2016 to December 2020, and who were followed-up until December 2022. Results A total of 1338 S-ICD implantations were performed within the observation period. Of these patients, 628 had cardiomyopathies or channelopathies. The rate of ...
Pulmonary vein isolation is becoming the treatment of choice for symptomatic atrial fibrillation ... more Pulmonary vein isolation is becoming the treatment of choice for symptomatic atrial fibrillation (AF) that is refractory to drugs [1–3]. However, thromboembolic complications are an important limitation of this approach [4], occurring in up to 2.8% of the patients. Alternative energy sources such as cryoablation and ultrasound have the potential to improve the safety of the procedure by preventing disruption of the endothelial surface during energy delivery [5,6].
Aims Subcutaneous implantable cardioverter–defibrillator (S-ICD) therapy is expanding rapidly. Ho... more Aims Subcutaneous implantable cardioverter–defibrillator (S-ICD) therapy is expanding rapidly. However, there are few data on the S-ICD extraction procedure and subsequent patient management. The aim of this analysis was to describe the procedure, management, and outcome of S-ICD extractions in clinical practice. Methods and results We enrolled consecutive patients who required complete S-ICD extraction at 66 Italian centres. From 2013 to 2022, 2718 patients undergoing de novo implantation of an S-ICD were enrolled. Of these, 71 required complete S-ICD system extraction (17 owing to infection). The S-ICD system was successfully extracted in all patients, and no complications were reported; the median procedure duration was 40 (25th–75th percentile: 20–55) min. Simple manual traction was sufficient to remove the lead in 59 (84%) patients, in whom lead-dwelling time was shorter [20 (9–32) months vs. 30 (22–41) months; P = 0.032]. Hospitalization time was short in the case of both non-...
This article is an open access article distributed under the terms and conditions of the Creative... more This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY
Background limited data on real-world safety and efficacy of leadless pacemakers (LPMs) in patien... more Background limited data on real-world safety and efficacy of leadless pacemakers (LPMs) in patients who underwent transvenous lead extraction (TLE) are currently available. The present study aims to assess long-term safety and efficacy of LPMs implantation following TLE, compared with LPM de novo implant patients. Methods consecutive patients who underwent LPM implantation in 12 centers joining the International LEAdless PacemakEr (i-LEAPER) registry were enrolled end retrospectively considered. Patients receiving LPM following TLE (n=184) were compared with patients with de novo implant (n=995). The primary endpoint was LPM-related complications rate at implant and during follow-up (FU). Additionally, differences in electrical performance were assessed between the two groups. Results 1179 patients were enrolled in this study and followed for a median of 33 months. LPM related major complications and all-cause mortality did not differ among the two groups (1.6% TLE group vs. 2.2% de...
Background One of the current limitations of the S–ICD is the relatively large size of the genera... more Background One of the current limitations of the S–ICD is the relatively large size of the generator compared to the TV (transvenous) ICD. There is little evidence whether the size of the current S–ICD generator is associated with an elevated risk of device–related complications in patients with a low body mass index (BMI). Purpose Aim of this study was to compare the device–related complications and long–term outcomes in a large real world cohort of S–ICD recipients in patients with a BMI <18 kg/m2 compared to patients with a BMI >18 kg/m2. Methods All consecutive patients meeting current guideline indications for ICD implantation and undergoing implantation of a S–ICD device (Boston Scientific, Marlborough, Massachusetts, USA) at 21 European institutions enrolled in the extended ELISIR registry were used for the current analysis. Patients were classified into two cohorts, depending on the BMI at the time of device implantations: BMI < 18 kg/m2 versus > 18 kg/m2. Result...
Journal of Interventional Cardiac Electrophysiology
Purpose Ablation Index (AI) is a radiofrequency lesion quality marker. The AI value that allows e... more Purpose Ablation Index (AI) is a radiofrequency lesion quality marker. The AI value that allows effective and safe pulmonary vein isolation (PVI) is still debated. We evaluated the incidence of acute and late PV reconnection (PVR) with different AI settings and its predictors. Methods The Ablation Index Registry is a multicentre study that included patients with paroxysmal/persistent atrial fibrillation (AF) underwent first time ablation. Each operator performed the ablation using his preferred ablation catheter (ThermoCool® SmartTouch or Surround Flow) and AI setting (380 posterior-500 anterior and 330 posterior-450 anterior). We divided the study population in two groups according to the AI setting used: Group 1 (330-450) and Group 2 (380-500). Incidence of acute PVR was validated within 30 minutes after PVI, whereas the incidence of late PVR was evaluated at repeat procedure. Results Overall, 490 patients were divided in Group 1 (258) and 2 (232). There was no significant difference in the procedural time, fluoroscopy time, and rate of first-pass PVI between the two study groups. Acute PVR was observed in 5.6% PVs. The rate of acute PVR was slightly higher in Group 2 (64/943, 6.8%, PVs) than in Group 1 (48/1045, 4.6% PVs, p=0.04). Thirty patients (6%) underwent repeat procedure and late PVR was observed in 57/116 (49%) PVs (number of reconnected PV per patient of 1.9±1.6). A similar rate of late PVR was found in the two study groups. No predictors of acute and late PVR were found. Conclusion Ablation with lower range of AI is highly effective and is not associated with higher rate of acute and late PVR. No predictors of PV reconnection were found.
Purpose In patients affected by heart failure an association exists between sleep apnea (SA) meas... more Purpose In patients affected by heart failure an association exists between sleep apnea (SA) measured by polysomnography and adverse outcome. Impedance-based implantable cardioverter defibrillator (ICD) algorithms have been designed to compute the Respiratory Disturbance Index (RDI) to identify severe SA. The purpose of the DASAP-HF study was to evaluate the accuracy of RDI for the prediction of severe SA, and investigate the prognostic value of device-detected RDI values. Methods Patients with left ventricular ejection fraction ≤35% implanted with an ICD were enrolled and followed for 24 months. One month after implantation, patients underwent a polysomnographic study (PS) for assessing the apnea-hypopnea index (AHI). The average RDI value was calculated over a 1-week period preceding the sleep study and compared with the assessment of severe SA at PS (AHI ≥30 episodes/h). The endpoint was all-cause death after 24 months. Results 224 out of 265 enrolled patients had usable RDI valu...
Background Patients with cardiomyopathies and channelopathies are usually younger and have a pred... more Background Patients with cardiomyopathies and channelopathies are usually younger and have a predominantly arrhythmia-related prognosis; they have nearly normal life expectancy thanks to the protection against sudden cardiac death provided by the implantable cardioverter defibrillator (ICD). The subcutaneous ICD (S-ICD) is an effective alternative to the transvenous ICD, and has evolved over the years. Objective To evaluate the rate of inappropriate shocks (IS), appropriate therapies and device-related complications in patients with cardiomyopathies and channelopathies who underwent modern S-ICD implantation. Methods We enrolled consecutive patients with cardiomyopathies and channelopathies who had undergone implantation of a modern S-ICD from January 2016 to December 2020, and who were followed-up until December 2022. Results A total of 1338 S-ICD implantations were performed within the observation period. Of these patients, 628 had cardiomyopathies or channelopathies. The rate of ...
Pulmonary vein isolation is becoming the treatment of choice for symptomatic atrial fibrillation ... more Pulmonary vein isolation is becoming the treatment of choice for symptomatic atrial fibrillation (AF) that is refractory to drugs [1–3]. However, thromboembolic complications are an important limitation of this approach [4], occurring in up to 2.8% of the patients. Alternative energy sources such as cryoablation and ultrasound have the potential to improve the safety of the procedure by preventing disruption of the endothelial surface during energy delivery [5,6].
Aims Subcutaneous implantable cardioverter–defibrillator (S-ICD) therapy is expanding rapidly. Ho... more Aims Subcutaneous implantable cardioverter–defibrillator (S-ICD) therapy is expanding rapidly. However, there are few data on the S-ICD extraction procedure and subsequent patient management. The aim of this analysis was to describe the procedure, management, and outcome of S-ICD extractions in clinical practice. Methods and results We enrolled consecutive patients who required complete S-ICD extraction at 66 Italian centres. From 2013 to 2022, 2718 patients undergoing de novo implantation of an S-ICD were enrolled. Of these, 71 required complete S-ICD system extraction (17 owing to infection). The S-ICD system was successfully extracted in all patients, and no complications were reported; the median procedure duration was 40 (25th–75th percentile: 20–55) min. Simple manual traction was sufficient to remove the lead in 59 (84%) patients, in whom lead-dwelling time was shorter [20 (9–32) months vs. 30 (22–41) months; P = 0.032]. Hospitalization time was short in the case of both non-...
This article is an open access article distributed under the terms and conditions of the Creative... more This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY
Background limited data on real-world safety and efficacy of leadless pacemakers (LPMs) in patien... more Background limited data on real-world safety and efficacy of leadless pacemakers (LPMs) in patients who underwent transvenous lead extraction (TLE) are currently available. The present study aims to assess long-term safety and efficacy of LPMs implantation following TLE, compared with LPM de novo implant patients. Methods consecutive patients who underwent LPM implantation in 12 centers joining the International LEAdless PacemakEr (i-LEAPER) registry were enrolled end retrospectively considered. Patients receiving LPM following TLE (n=184) were compared with patients with de novo implant (n=995). The primary endpoint was LPM-related complications rate at implant and during follow-up (FU). Additionally, differences in electrical performance were assessed between the two groups. Results 1179 patients were enrolled in this study and followed for a median of 33 months. LPM related major complications and all-cause mortality did not differ among the two groups (1.6% TLE group vs. 2.2% de...
Background One of the current limitations of the S–ICD is the relatively large size of the genera... more Background One of the current limitations of the S–ICD is the relatively large size of the generator compared to the TV (transvenous) ICD. There is little evidence whether the size of the current S–ICD generator is associated with an elevated risk of device–related complications in patients with a low body mass index (BMI). Purpose Aim of this study was to compare the device–related complications and long–term outcomes in a large real world cohort of S–ICD recipients in patients with a BMI <18 kg/m2 compared to patients with a BMI >18 kg/m2. Methods All consecutive patients meeting current guideline indications for ICD implantation and undergoing implantation of a S–ICD device (Boston Scientific, Marlborough, Massachusetts, USA) at 21 European institutions enrolled in the extended ELISIR registry were used for the current analysis. Patients were classified into two cohorts, depending on the BMI at the time of device implantations: BMI < 18 kg/m2 versus > 18 kg/m2. Result...
Journal of Interventional Cardiac Electrophysiology
Purpose Ablation Index (AI) is a radiofrequency lesion quality marker. The AI value that allows e... more Purpose Ablation Index (AI) is a radiofrequency lesion quality marker. The AI value that allows effective and safe pulmonary vein isolation (PVI) is still debated. We evaluated the incidence of acute and late PV reconnection (PVR) with different AI settings and its predictors. Methods The Ablation Index Registry is a multicentre study that included patients with paroxysmal/persistent atrial fibrillation (AF) underwent first time ablation. Each operator performed the ablation using his preferred ablation catheter (ThermoCool® SmartTouch or Surround Flow) and AI setting (380 posterior-500 anterior and 330 posterior-450 anterior). We divided the study population in two groups according to the AI setting used: Group 1 (330-450) and Group 2 (380-500). Incidence of acute PVR was validated within 30 minutes after PVI, whereas the incidence of late PVR was evaluated at repeat procedure. Results Overall, 490 patients were divided in Group 1 (258) and 2 (232). There was no significant difference in the procedural time, fluoroscopy time, and rate of first-pass PVI between the two study groups. Acute PVR was observed in 5.6% PVs. The rate of acute PVR was slightly higher in Group 2 (64/943, 6.8%, PVs) than in Group 1 (48/1045, 4.6% PVs, p=0.04). Thirty patients (6%) underwent repeat procedure and late PVR was observed in 57/116 (49%) PVs (number of reconnected PV per patient of 1.9±1.6). A similar rate of late PVR was found in the two study groups. No predictors of acute and late PVR were found. Conclusion Ablation with lower range of AI is highly effective and is not associated with higher rate of acute and late PVR. No predictors of PV reconnection were found.
Purpose In patients affected by heart failure an association exists between sleep apnea (SA) meas... more Purpose In patients affected by heart failure an association exists between sleep apnea (SA) measured by polysomnography and adverse outcome. Impedance-based implantable cardioverter defibrillator (ICD) algorithms have been designed to compute the Respiratory Disturbance Index (RDI) to identify severe SA. The purpose of the DASAP-HF study was to evaluate the accuracy of RDI for the prediction of severe SA, and investigate the prognostic value of device-detected RDI values. Methods Patients with left ventricular ejection fraction ≤35% implanted with an ICD were enrolled and followed for 24 months. One month after implantation, patients underwent a polysomnographic study (PS) for assessing the apnea-hypopnea index (AHI). The average RDI value was calculated over a 1-week period preceding the sleep study and compared with the assessment of severe SA at PS (AHI ≥30 episodes/h). The endpoint was all-cause death after 24 months. Results 224 out of 265 enrolled patients had usable RDI valu...
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