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Lead dwell time10 years is a recognized predictor for transvenous lead extraction (TLE) failure and complications. Data on the efficacy and safety of TLE using the bidirectional rotational mechanical sheaths in patients with very old leads are lacking. In this multicenter study, we reported the outcomes of transvenous rotational mechanical lead extraction in patients with leads implanted for ≥10 years.A total of 441 leads (median: 159 months [135-197]; range: 120-487) in 189 consecutive patients were removed with the Evolution RL sheaths (Cook Medical, Bloomingtom, IN, USA) and mechanical ancillary tools supporting the procedures.The main indication for TLE was infection in 74% of cases. Complete procedural success rate, clinical success rate, per lead were 94.8% and 98.2%, respectively. Failure of lead extraction was seen in 1.8% of leads. The additional use of a snare via the femoral approach was required in 9% of patients. Lead dwell time was the only predictor of incomplete led removal (odds ratio: 1.009; 95% confidence interval [CI]: 1.003-1.014; p = .002). Four major complication (2%) were encountered. During a mean time follow-up of 31 ± 27 months, 21 patients (11%) died. No procedure-related mortality occurred. Predictors of mortality included severe left ventricular systolic dysfunction (hazard ratio [HR]: 8.06; 95% CI: 2.99-21.73; p = .001), TLE for infection (HR: 8.0; 95% CI: 1.04-62.5; p = .045), diabetes (HR: 3.7; 95% CI: 1.48-9.5; p = .005), and previous systemic infection (HR: 3.1; 95% CI: 1.17-8.24; p = .022). Incomplete lead removal or failure lead extraction did not impact on survival during follow-up.Our findings demonstrated that the use of bidirectional rotational TLE mechanical sheaths combined with different mechanical tools and femoral approach allows reasonable success and safety in patients with very old leads at experienced specialized centers.

Atrial fibrillation (AF) is an uncommon arrhythmia in young adults without structural heart disease, and cryoballoon pulmonary vein isolation (CB-PVI) is an important therapeutic strategy for rhythm control in patients with drug-refractory AF. The aim of this analysis was to evaluate efficacy and safety of CB-PVI in a large cohort of young patients in comparison with middle-aged adults in a real-world setting.From 2012 to 2020, a total of 3033 patients with AF underwent CB-PVI and were followed prospectively in the framework of the 1STOP Clinical Service project, involving 34 Italian centers. Out of 3033 total 1STOP project subjects, a subgroup of 1318 patients were defined which included a YOUNG group (age ≤ 45 years; n = 368) and a MIDDLE-AGED group (age 60-65 years; n = 950).The acute success rate of PVI did not differ between the two cohorts (99.9 ± 1.3% vs. 99.8 ± 3.2%, p = 0.415). There was no difference in procedural characteristics, and periprocedural complication rates were similar among the two cohort (1.9% vs. 2.3%, p = 0.646). The 12-month freedom from AF recurrence was 88.9% (95% confidence interval [CI]: 84.7-92.0) in the YOUNG cohort and 85.6% (95% CI: 82.9-88.0) in the MIDDLE-AGED group. At 36-month follow-up, freedom from AF recurrence was 72.4% (65.5%-78.2%) and 71.8% (67.7%-75.6%), respectively with no significant difference among groups (p = 0.550).CB-PVI had similar efficacy and safety in YOUNG and MIDDLE-AGED patients. Younger age did not affect acute procedural results, complication rate, or AF recurrence after a single procedure.

The 2020 severe acute respiratory syndrome coronavirus 2 outbreak entailed reduced availability of traditional (in-office) cardiology consultations. Remote monitoring is an alternative way of caring that may potentially mitigate the negative effects of the epidemic to the care of cardiovascular diseases. We evaluated the outcome of implantable cardioverter defibrillator (ICD) carriers followed up remotely in 2020 (epidemic period) versus 2019 (control).We included all patients with an ICD who remained remotely monitored from the beginning to the end of each year. The combined end point included: new-onset atrial fibrillation; sustained ventricular tachycardia170 bpm without ICD intervention; appropriate ICD intervention (either shock or antitachycardia pacing); any-cause death. Multiple events in the same patients were counted separately if occurring ≥48 h apart.In 2020, 52 end points occurred in 37 of 366 (10%) ICD carriers [0.14/patient (95% confidence interval [CI] = 0.11-0.19)] versus 43 end points in 32 of 325 (10%) ICD carriers in 2019 [0.13/patient (95% CI = 0.10-0.18) P = 0.75]. There was no difference between the distribution of any individual end point in 2020 versus 2019 although a nonsignificant mortality increase was observed (from 2.8% to 4.6%, P = 0.19). The lowest weekly event rate occurred during the national lock down in spring 2020 but a similar trend occurred also in 2019 suggesting that the effect may not be linked to social distancing measures.We did not observe an increase in a combined end point including arrhythmic events and mortality in ICD carriers who were remotely monitored in 2020, compared to 2019, despite the negative impact of the coronavirus disease 2019 outbreak on the healthcare system.

Purpose The aim of the present study was to evaluate the outcome of patients underwent subcutaneous implantable cardioverter defibrillator (S-ICD) implantation with the intermuscular (IM) two-incision technique during 3-year follow-up. Methods the study population consisted of 105 consecutive patients (79 male; median 50 [13–77] years) underwent S-ICD implantation with the IM two-incision technique. The composite primary end point of the study consisted of device-related complications and inappropriate shocks (IAS). Secondary end points included the individual components of the primary end point, death from any cause, appropriate therapy, major adverse cardiac events, hospitalization for heart failure, and heart transplantation. Results According to the PRAETORIAN score, the risk of conversion failure was classified as low in 99 patients (94.3%), intermediate in 6 (5.7%).Ventricular fibrillation was successfully converted at ≤65 J in 97.4% of patients. During a median follow-up of 39 (16–53) months, 10 patients (9.5%) experienced device-related complications, and 9 (8.5%) patients reported IAS. Lead-associated complications were the most common (5 patients, 4.7%), including 2 cases of lead failure (1.9%). Pocket complications were reported in 2 patients (1.9%). Extra-cardiac oversensing (3.8%) represented the leading cause of IAS. No T-wave oversensing episodes were recorded. Twelve patients (11.4%) experienced appropriate shocks. Eight patients (7.6%) died during follow-up. IAS or device-related complications did not impact on mortality. Conclusions The overall device-related complications and IAS rates over 3 years of follow-up were 9.5% and 8.5%, respectively. According to our findings, the IM two-incision technique allows for optimal positioning of the device achieving a low PRAETORIAN score with a high conversion rate. IM two-incision technique allows low incidence of pocket complications, shifting the type of complications towards lead-related complications, which represent the most common complications. The IM two-incision technique would not seem to impact the occurrence of IAS. Management of complications are safe without impact on the outcome.

BACKGROUND Recent studies have shown that Evolution RL bidirectional rotational mechanical sheath (Cook Medical,USA) is an effective and safe technique for transvenous lead extraction (TLE). We reported our experience with the bidirectional rotational mechanical tools using a multidisciplinary approach highlighting the value of a joint cardiac surgeon and electrophysiologist collaboration. METHODS The study population comprised 84 patients (77%male;mean age 65±18 years) undergoing TLE.After multidisciplinary evaluation, a combined procedure was considered. RESULTS The main indication for TLE was infection in 54 cases (64%).Overall,152 leads were extracted with a mean implant duration of 94±63 months (range 12-421).Complete procedural success rate, clinical success rate, and lead removal with clinical success rate were 91.6 % (77/84),97.6% (82/84), and 98.6%(150/152), respectively.Eighteen combined procedure were performed in 12 patients (14%), such as "hybrid approach" (n = 2) or TLE concomitant to:1) transcatheter aspiration procedure for large vegetation (n = 8); 2) left ventricular assistance device implantation as bridge to cardiac transplantation (n = 1); 3) permanent pacing with epicardial leads (n = 6); 4) tricuspid valve replacement (n = 1).One major complication (1.2%) and 11 (13%) minor complications were encountered.No injury to the superior vena cava occurred and no procedure-related deaths were reported. During a mean time follow-up of 21±18 months, 17 patients (20%) died.They were more often diabetics (P = 0.02), and they underwent TLE more often for infection (P = 0.004). CONCLUSIONS Our results support the finding that excellent outcomes can be achieved in performing TLE of chronically implanted leads by using the Evolution RL bidirectional rotational mechanical sheath and a multidisciplinary team approach involving both electrophysiologist and cardiac surgeon as first line operators. This article is protected by copyright. All rights reserved.

Background The aim of the present study was to evaluate the outcome of patients underwent subcutaneous implantable cardioverter defibrillator (S-ICD) implantation with the intermuscular (IM) two-incision technique during 3-year follow-up. Methods the study population consisted of 105 consecutive patients (79 male; median 50 [13-77] years) underwent S-ICD implantation with the IM two-incision technique. Results according to the PRAETORIAN score, the risk of conversion failure was classified as low in 99 patients (94.3%), intermediate in 6 (5.7%). Ventricular fibrillation was successfully converted at ≤65 J in 97.4% of patients. During a median follow-up of 39 (16-53) months, 10 patients (9.5%) experienced device-related complications and 9 (8.5%) patients reported shocks (IAS). Lead-associated complications were the most common (3.8%), including 2 cases of lead failure (1.9%). Pocket complications were reported in 2 patients (1.9%). Extra-cardiac oversensing (3.8%) represented the leading cause of IAS. No T-wave oversensing episodes were recorded. Twelve patients (11.4%) experienced appropriate shocks. Eight patients (7.6%) died during follow-up. IAS or device-related complications did not impact on mortality (HR 0.5;95%CI 0-4.3;P=0.5; HR 0.7;95%CI 0.1-6.0;P=0.8, respectively). Conclusions according to our findings, the IM two-incision technique allows for optimal positioning of the device achieving a low PRAETORIAN score with a high conversion rate. IM two-incision technique allows low incidence of pocket complications, shifting the type of complications towards lead-related complications, which represent the most common complications. The IM two- incision technique would not seem to impact the occurrence of IAS. Management of complications are safe without impact on the outcome.

When approaching infected lead removal in cardiac device-related infective endocarditis (CDRIE), a surgical consideration for large (>20 mm) vegetations is recommended. We report our experience with the removal of large CDRIE vegetations using the AngioVac system, as an alternative to conventional surgery. We retrospectively reviewed all infected lead extractions performed with a prior debulking using the AngioVac system, between October 2016 and April 2022 at our institution. A total of 13 patients presented a mean of 2(1) infected leads after a mean of 5.7(5.7) years from implantation (seven implantable cardioverter-defibrillators, four cardiac resynchronization therapy-defibrillators, and two pacemakers). The AngioVac system was used as a venous–venous bypass in six cases (46.2%), venous–venous ECMO-like circuit (with an oxygenator) in five (38.5%), and venous–arterial ECMO-like circuit in two cases (15.4%). Successful (>70%) aspiration of the vegetations was achieved in 12 patients (92.3%) and an intraoperative complication (cardiac perforation) only occurred in 1 case (7.7%). Subsequent lead extraction was successful in all cases, either manually (38.5%) or using mechanical tools (61.5%). The AngioVac system is a promising effective and safe option for large vegetation debulking in CDRIE. Planning the extracorporeal circuit design may represent the optimal strategy to enhance the tolerability of the procedure and minimize adverse events.

AngioVac system (AngioDynamics) has already proved to be a useful tool in the treatment of thrombotic and endocarditic formations concerning the venous district. Herein, the AngioVac aspiration system combined with the bidirectional rotational Evolution mechanical sheath lead extraction was used for an effective and safety cardiac-device-related-infective-endocarditis removal in a grown-up congenital heart disease patient through a totally peripheral approach.

Aims This report describes the findings of the 2018 Italian Catheter Ablation Registry of the Italian Association of Arrhythmology and Cardiac Pacing (AIAC). Methods The Italian Catheter Ablation Registry systematically collects data on the ablation procedures performed in Italy. Data collection was retrospective. A standardized questionnaire was completed by participating centres. Results We collected data on 15 714 catheter ablation procedures performed in Italy during 2018 in 94 electrophysiology centres. In most centres (75/94, 80%), a single electrophysiology laboratory was available, and a hybrid electrophysiology laboratory was available in 15% (14/94) of centres. In most (93%) centres, at least two electrophysiologists were involved in the catheter ablation procedures. In only 13 out of 94 (14%) electrophysiology laboratories, an anaesthesiologist assists every electrophysiology procedure; in most cases (74/94, 79%), an on-demand anaesthesiology service was available. On-site cardiothoracic surgery was reported in 43 out of 94 (46%) centres.Nonfluoroscopic navigation systems were available in most centres (88/94, 93%). Intracardiac echocardiography was used in 59 out of 94 (63%) electrophysiology laboratories. Atrial fibrillation (31%) was the most frequently treated ablation target, followed by atrioventricular nodal re-entrant tachycardia (20%) and cavo-tricuspid isthmus (15%). In 61.7% of all procedures, a 3D mapping system was used. In about one-third of procedures, a near-zero approach was performed. Conclusion In most Italian electrophysiology centres, a single electrophysiology laboratory was available and at least two electrophysiologists were involved in the ablation procedures. An increasing number of procedures were performed by means of a nonfluoroscopic mapping system with a near-zero approach.

Background Subcutaneous implantable cardioverter defibrillator (S-ICD) is a suitable alternative for transvenous ICD (TV-ICD) patients who have undergone transvenous lead extraction (TLE). Limited data are available on the outcome of S-ICD patients implanted after TLE. We assessed the safety, efficacy, and outcome of S-ICD implantation after TLE of TV-ICD. Methods The study population consisted of 36 consecutive patients with a median age of 52 (44–66) years who underwent S-ICD implantation after TLE of TV-ICD. Results Indications for TLE were infection (63.9%) and lead malfunction (36.1%). During a median follow-up of 31 months, 3 patients (8.3%) experienced appropriate therapy and 7 patients (19.4%) experienced complications including inappropriate therapy (n = 4; 11.1%), isolated pocket erosion (n = 2; 5.5%), and ineffective therapy (n = 1; 2.8%). No lead/hardware dysfunction was reported. Premature device explantation occurred in 4 patients (11%). Eight patients (22.2%) died during follow-up, six of them (75%) because of refractory heart failure (HF). There were no S-ICD-related deaths. Predictors of mortality included NYHA class ≥ 2 (HR 5.05; 95% CI 1.00–26.38; p = 0.04), hypertension (HR 22.72; 95% CI 1.05–26.31; p = 0.02), diabetes (HR 10.64; 95% CI 2.05–55.60; p = 0.001) and ischemic heart disease (HR 5.92; 95% CI 1.17–30.30; p = 0.01). Conclusion Our study provides evidences on the use of S-ICD as an alternative after TV-ICD explantation for both infection and lead failure. Mortality of S-ICD patients who underwent TV-ICD explantation does not appear to be correlated with the presence of a prior infection, S-ICD therapy (appropriate or inappropriate), or S-ICD complications but rather to worsening of HF or other comorbidities.

BACKGROUND Axillary vein access (AVA) using fluoroscopic landmarks is an effective and safe approach for cardiac implantable electronic devices (CIEDs) implantation. However, it may result in a higher radiation exposure. Ultrasound-guided axillary access (USAA) is an effective alternative technique to conventional subclavian access for CIEDs implantation. Studies comparing USAA and AVA using fluoroscopic landmarks are lacking. The purpose of this study was to compare the safety, efficacy, and radiation exposure data of the USAA approach with the AVA using fluoroscopic landmarks. METHODS The study population included 95 consecutive patients (61% male, median age 78 years [71-85 years]) referred for CIEDs implantation using AVA with fluoroscopic landmark (n = 46) or USAA (n = 49). Baseline characteristics and radiation exposure data (Air-Kerma [mGy], DAP [Gy-cm2 ], fluoroscopy time [seconds], and X-rays emission time [seconds]) were compared according to the technique used for the AVA. RESULTS Axillary vein was successfully accessed in 45 of 49 (92%) patients using ultrasound and in 42 of 46 (91%) patients using fluoroscopic landmarks (P = 1.00). Air-Kerma, DAP, fluoroscopy time, and X-rays emission time were shorter for USAA group compared with AVA using fluoroscopic landmarks (11 mGy [8-20] vs 37 mGy [24-81], P

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 multicenter study that included patients with paroxysmal/persistent atrial fibrillation (AF) who 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 into 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 min after PVI, whereas the incidence of late PVR was evaluated at repeat procedure. Results: Overall, 490 patients were divided into groups 1 (258) and 2 (232). There was no significant difference in the procedural time, fluoroscopy time, and rate of the 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 a 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 a lower range of AI is highly effective and is not associated with a higher rate of acute and late PVR. No predictors of PV reconnection were found.

Subclinical atrial fibrillation (SCAF) may represent a cause of embolic stroke of undetermined source (ESUS) and its detection has important implications for secondary prevention with anticoagulation. Indications to implantable cardiac monitors (ICM) include SCAF detection. The aims of this study were to (1) evaluate the frequency of ICM-detected SCAF; (2) determine predictors of SCAF; and (3) identify patients who would benefit most from ICM implantation.Between February 2017 and November 2020, all consecutive patients referred for ICM implantation after a diagnosis of ESUS and without previous history of atrial fibrillation or atrial flutter were included in this study. SCAF was diagnosed if the ICM electrogram demonstrated an episode of irregularly irregular rhythm without distinct P waves lasting 2 min.We enrolled 109 patients (age 66, SD = 13 years; 36% females). During a median follow-up of 19.2 (IQR 11.0-27.5) months, SCAF episodes were detected in 36 (33%) patients. Only abnormal P wave terminal force in lead V1, left atrial end-systolic indexed volume 34 ml/mA multiparametric evaluation has the best accuracy to predict SCAF in ESUS patients and may help identifying those who would benefit most from ICM.

From 2020, many countries have adopted several restrictions to limit the COVID-19 pandemic. The forced containment impacted on healthcare organizations and the everyday life of patients with heart disease. We prospectively analyzed data recorded from implantable defibrillators and/or cardiac resynchronization devices of Italian patients during the lockdown (LDP), post-lockdown period (PLDP) and a control period (CP) of the previous year. We analyzed device data of the period 9 March 2019–31 May 2020 of remotely monitored patients from 34 Italian centers. Patients were also categorized according to areas with high/low infection prevalence. Among 696 patients, we observed a significant drop in median activity in LDP as compared to CP that significantly increased in the PLDP, but well below CP (all p < 0.0001). The median day heart rate and heart rate variability showed a similar trend. This behavior was associated during LDP with a significant increase in the burden of atrial arrhythmias (p = 0.0150 versus CP) and of ventricular arrhythmias [6.6 vs. 1.5 per 100 patient-weeks in CP; p = 0.0026]; the latter decreased in PLDP [0.3 per 100 patient-weeks; p = 0.0035 vs. LDP]. No modifications were recorded in thoracic fluid levels. The high/low prevalence of COVID-19 infection had no significant impact. We found an increase in the arrhythmic burden in LDP coupled with a decrease in physical activity and heart rate variability, without significant modifications of transthoracic impedance, independent from COVID-19 infection prevalence. These findings suggest a negative impact of the COVID-19 pandemic, probably related to lockdown restrictions.

Background: When an implantable-cardioverter defibrillator (ICD) lead becomes non-functional, a recommendation currently exists for either lead abandonment or removal. Lead abandonment and subcutaneous ICD (S-ICD) implantation may represent an additional option for patients who do not require pacing. The aim of this study was to investigate the outcomes of a strategy of lead abandonment and S-ICD implantation in the setting of lead malfunction.Methods: We analyzed all consecutive patients who underwent S-ICD implantation after abandonment of malfunctioning leads and compared their outcomes with those of patients who underwent extraction and subsequent reimplantation of a single-chamber transvenous ICD (T-ICD).Results: Forty-three patients underwent S-ICD implantation after abandonment of malfunctioning leads, while 62 patients underwent extraction and subsequent reimplantation of a new T-ICD. The two groups were comparable. In the extraction group, no major complications occurred during extraction, while the procedure failed and an S-ICD was implanted in 4 patients. During a median follow-up of 21 months, 3 major complications or deaths occurred in the S-ICD group and 11 in the T-ICD group (HR 1.07; 95% CI 0.29–3.94; P = 0.912). Minor complications were 4 in the S-ICD group and 5 in the T-ICD group (HR 2.13; 95% CI 0.49–9.24; P = 0.238).Conclusions: In the event of ICD lead malfunction, extraction avoids the potential long-term risks of abandoned leads. Nonetheless the strategy of lead abandonment and S-ICD implantation was feasible and safe, with no significant increase in adverse outcomes, and may represent an option in selected clinical settings. Further studies are needed to fully understand the potential risks of lead abandonment.Clinical Trial Registration: URL: ClinicalTrials.gov Identifier: NCT02275637

A 52‐year‐old male with no history of familiar sudden death arrived at our Emergency Department after syncope with loss of consciousness occurred during high fever. The thoracic high‐resolution computed tomography demonstrated bilateral multiple ground‐glass opacities. The nose‐pharyngeal swab resulted positive for SARS‐CoV‐2. The 12‐lead ECG presented a “coved‐type” aspect in leads V1 and V2 at the fourth intercostal space and a first degree atrio‐ventricular block. As soon as the temperature went down, the 12‐lead ECG resumed a normal aspect, maintaining a long PR interval.

BACKGROUND Multipoint pacing (MPP) may improve clinical outcomes in patients with cardiac resynchronization therapy defibrillators (CRT-D), but its impact on battery longevity in a real-world population has not been investigated in large trials. OBJECTIVE Compare projected battery longevity in CRT-D patients with and without MPP during long-term follow-up. METHODS The Italian registry on multipoint left ventricular pacing (IRON-MPP) is a prospective, multicenter registry of patients implanted with MPP-capable CRT-D devices. Projected battery longevity during follow-up was compared for patients with MPP (MPP ON) vs single-site (MPP OFF) left ventricular pacing at CRT-D implantation. A sub-analysis excluded crossover patients with MPP activation or deactivation occurring after implantation. A second sub-analysis excluded patients with a right or left ventricular pacing amplitude >2.5 V. RESULTS Out of 237 CRT-D patients (71 ± 9 years, 81% male) followed for 1.9 ± 0.8 years, 102 (43%) had MPP ON at implantation. Programmed atrial and ventricular outputs and percentage of pacing were similar between groups. MPP was associated with a 0.44 years reduction in projected battery longevity (P = .03) during long-term follow-up. Results were similar for the first and second sub-analyses, with a 0.57 years (P

Background: More and more heart failure (HF) patients aged ≥ 75 years undergo cardiac resynchronization therapy (CRT) device implantation, however the data regarding the outcomes and their predictors are scant. We investigated the mid- to long-term outcomes and their predictors in CRT patients aged ≥ 75 years. Methods: Patients in the Cardiac Resynchronization Therapy Modular (CRT MORE) Registry were divided into three age-groups: &lt, 65 (group A), 65–74 (group B) and ≥75 years (group C). Mortality, hospitalization, and composite event rate were evaluated at 1 year and during long-term follow-up. Results: Patients (n = 934) were distributed as follows: group A 242, group B 347, group C 345. On 12-month follow-up examination, 63% of patients ≥ 75 years displayed a positive clinical response. Mortality was significantly higher in patients ≥ 75 years than in the other two groups, although the rate of hospitalizations for HF worsening was similar to that of patients aged 65–74 (7 vs. 9.5%, respectively, p = 0.15). Independent predictors of death and of negative clinical response were age &gt, 80 years, chronic obstructive pulmonary disease (COPD) and chronic kidney disease (CKD). Over long-term follow-up (1020 days (IQR 680-1362)) mortality was higher in patients ≥ 75 years than in the other two groups. Hospitalization and composite event rates were similar in patients ≥ 75 years and those aged 65–74 (9 vs. 11.8%, p = 0.26, and 26.7 vs. 20.5%, p = 0.06). Conclusion: Positive clinical response and hospitalization rates do not differ between CRT recipients ≥ 75 years and those aged 65–74. However, age &gt, 80 years, COPD and CKD are predictors of worse outcomes.

Several epidemiological studies found an association between acute exposure to fine particulate matter of less than 2.5 &mu, m and 10 &mu, m in aerodynamic diameter (PM2.5 and PM10) and cardiovascular diseases, ventricular fibrillation incidence and mortality. The effects of pollution on atrial fibrillation (AF) beyond the first several hours of exposure remain controversial. A total of 145 patients with implantable cardioverter-defibrillators (ICDs), cardiac resynchronization therapy defibrillators (ICD-CRT), or pacemakers were enrolled in this multicentric prospective study. Daily levels of PM2.5 and PM10 were collected from monitoring stations within 20 km of the patient&rsquo, s residence. A Firth Logistic Regression model was used to evaluate the association between AF and daily exposure to PM2.5 and PM10. Exposure levels to PM2.5 and PM10 were moderate, being above the World Health Organization (WHO) PM2.5 and PM10 thresholds of 25 &mu, g/m3 and 50 &mu, g/m3, respectively, on 26% and 18% of the follow-up days. An association was found between daily levels of PM2.5 and PM10 and AF (95% confidence intervals (CIs) of 1.34&ndash, 2.40 and 1.44&ndash, 4.28, respectively) for an increase of 50 &micro, g/m3 above the WHO threshold. Daily exposure to moderate PM2.5 and PM10 levels is associated with AF in patients who are not prone to AF.

Funding Acknowledgements NONE Background operative anesthetic requirements and peri-operative discomfort are barriers to wide adoption of the subcutaneous implantable cardioverter defibrillator (S-ICD) system expecially when the intermuscular technique is used due to the greater amount of tissue dissection. The procedure is most commonly performed under general anesthesia (GA). There is growing interest in transitioning away from the routine use of GA and towards several alternative anesthesia modalities implifying the anesthetic management of the S-ICD implant procedure without the involvement of an anesthesiologist. Purpose we assessed the feasibility of ultrasound-guided serratus anterior plane block (US-SAPB) in patients undergoing S-ICD implantation with the intermuscular two-incision technique. Methods: the study population included 38 consecutive patients (84% male; median, 53 [46-62] years) who received S-ICD implantation using the intermuscular two-incision technique. All procedures were performed under US-SAPB and sedoanalagesia without the involvement of an anesthesiologist. Results the average procedure time was 67 ± 14 minutes.No patient experienced significant hemodynamic changes or oxygen desaturation during the period of US- SAPB procedure and sedation; there was no need for pharmacological interventions. The whole procedute was well tollerated without discomfort and complications in the absence of needing GA except in one (2.6%) patient who required GA with laryngeal mask airway. Patients remained always able to respond appropriately to neurological monitoring during S-ICD implantation procedure. There were no procedure-related complications. Conclusion US-SAPB and the intermuscular two-incision technique may be a safe and feasible promising combination for S-ICD implantation overcoming potential barrier to wieder S-ICD adoption in the clinical practice.

Background Ablation index (AI) is a new lesion quality marker that has been demonstrated to allow a high single-procedure arrhythmia-free survival in single-center studies. This prospective, multi-center study was designed to evaluate the reproducibility of pulmonary vein (PV) isolation guided by the AI. Methods A total of 490 consecutive patients with paroxysmal (80.4%) and persistent AF underwent first time PV isolation and were divided in four study groups according to operator's preference in choosing the ablation catheter (a contact force (ST) or contact force surround flow (STSF) catheter) and the AI setting (330-450 or 380-500 at anterior wall or posterior wall, respectively). Results At 12 months a high rate of freedom from AF recurrences was observed in patients with both paroxysmal and persistent AF (91% vs 83.3%; P = .039). There was no difference in the rate of AF recurrence among the four study groups (4.5% in group ST330-450, 12.2% in group ST 380-500, 14.9% in group STSF330-450, 9.4% in group STSF380-500; P = .083). Recurrence was also similar between patients treated with a ST (8%) or STSF catheter (12.1%; P = .2), and within patients targeting an AI settings of 330 to 450 (10.9%) or 380 to 500 (10.3%; P = .64). In patients with paroxysmal AF, there was no difference (P = .12) in the 1-year freedom from AF recurrence among 14 operators that performed ≥10 ablation procedure. Conclusions An ablation protocol respecting strict criteria for contiguity and quality lesion resulted in high rate of 1-year freedom from AF recurrence, irrespective of the ablation catheters, AI settings, and operator.

Myotonic dystrophy type 1 (DM1) is a multisystemic disorder characterized by progressive cardiac conduction impairment, arrhythmias, and sudden death. Mexiletine is a sodium channel blocker drug used by patients with DM1 for treatment of myotonia, even though definitive proof of its safety over long-term follow-up is lacking.The purpose of this study was to assess the impact of mexiletine for treatment of neurological symptoms on the composite endpoint of significant electrocardiogram modification (new onset or worsening of atrioventricular [AV] or intraventricular conduction delay) and bradyarrhythmic complications requiring pacemaker (PM) implantation (advanced AV block, symptomatic sinus pause3 seconds).This retrospective longitudinal study included a series of consecutive patients with genetically confirmed DM1 evaluated at our neurology and cardiology clinics from January 1, 2011, to January 1, 2020, who received mexiletine 200 mg twice daily. Patients with a PM, implantable cardioverter-defibrillator, or severe conduction abnormality (PQ interval ≥230 ms, complete bundle branch block, or atrial fibrillation) at enrollment were excluded.The study comprised 18 mexiletine-treated patients and 68 mexiletine-free controls. Over median follow-up of 53 months, the endpoint was reached by 4 (22%) mexiletine-treated patients and 23 (33%) non-mexiletine-treated patients (log-rank P = .45). In 3 non-mexiletine-treated patients, bradyarrhythmic complications requiring PM implantation were observed. At univariable analysis, only the presence of mild conduction delay (first-degree AV block with PQ interval230 ms or left anterior fascicular block) at baseline predicted the endpoint (hazard ratio 2.22; 95% confidence interval 1.04-4.76).Mexiletine 200 mg twice daily is safe in patients with DM1 and no severe conduction abnormality.

INTRODUCTION Early evidence suggests that multipoint left ventricular pacing (MPP) may improve response to cardiac resynchronization therapy (CRT). It is unknown whether this benefit is sustained and cost-effective. We used real-world data to evaluate long-term impact of MPP-ON clinical status, heart failure hospitalizations (HFH) and costs. METHODS The Italian registry on multipoint left ventricular pacing is a prospective, multicenter registry of patients implanted with MPP-enabled CRT devices. For this analysis, clinical and echocardiographic data were collected through 24 months and compared between patients with (MPP-ON) or without (MPP-OFF) early MPP activation at implant. The total cost of each HFH was estimated with national Italian reimbursement rates. RESULTS The study included 190 MPP-OFF and 128 MPP-ON patients with similar baseline characteristics. At 1 and 2 years, the MPP-ON group had lower rates of HFH vs MPP-OFF (1-year hazard ratio [HR]: 0.14, P = .0014; 2-year HR: 0.38, P = .009). The finding persisted in a subgroup of patients with consistent MPP activation through follow-up (1-year HR: 0.19; P = .0061; 2-year HR: 0.39, P = .022). Total HFH per-patient costs were lower in the MPP-ON vs the MPP-OFF group at 1 year (€101 ± 50 vs €698 ± 195, P

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 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.

Cardiomyopathies and channelopathies are heterogeneous disorders that increase the risk of sudden cardiac death (SCD). Implantable cardioverter-defibrillator (ICD) therapy is safe and effective for preventing SCD in patients at risk for malignant ventricular arrhythmias. Because of the poor positive predictive value of current risk stratification tools, the majority of patients implanted with an ICD will never receive a life-saving therapy but will be exposed to the risk of complications such as device infection, lead failure and inappropriate therapy. Subcutaneous ICD (S-ICD) now constitutes a valuable alternative to conventional transvenous ICD in patients with cardiomyopathies and channelopathies as it provides protection from SCD while avoiding the risks of intravascular lead infection or failure. This may be particularly advantageous for young patients with a very long life expectancy. On the other hand, S-ICD cannot deliver antitachycardia pacing or antibradycardia pacing. The purpose of this article is to review the available evidence and the future perspectives of S-ICD therapy in patients with cardiomyopathies or channelopathies.

Background Professional guidelines are based on the best available evidence. However, patients treated in clinical practice may differ from those included in reference trials. Objective The aim of this study was to evaluate the effects of cardiac resynchronization therapy (CRT) in a large population of patients implanted with a CRT device stratified in accordance with the 2016 European heart failure (HF) guidelines. Methods We collected data on 930 consecutive patients from the Cardiac Resynchronization Therapy MOdular REgistry. The primary end point was a composite of death and HF hospitalization. Results Five hundred sixty-three (60.5%) patients met class I indications, 145 (15.6%) class IIa, 108 (11.6%) class IIb, and 114 (12.3%) class III. After a median follow-up of 1001 days, 120 (14.7%) patients who had an indication to CRT had died and 71 (8.7%) had been hospitalized for HF. The time to the end point was longer in patients with a class I indication (hazard ratio 0.55; 95% confidence interval 0.39–0.76; P = .0001). After 12 months, left ventricular (LV) end-systolic volume had decreased by ≥15% in 61.5% (320/520) of patients whereas in 57.5% (389/676) of patients the absolute LV ejection fraction improvement was ≥5%. Adherence to class I was also associated with an absolute LV ejection fraction increase of >5% (P = .0142) and an LV end-systolic volume decrease of ≥15% (P = .0055). Conclusion In our population, ∼60% of patients underwent implantation according to the 2016 European HF guidelines class I indication. Adherence to class I was associated with a lower death and HF hospitalization rates and better LV reverse remodeling.

AIMS Pocket hematoma is a common complication of cardiac implantable electronic device (CIED) procedures. the aim of the study was to research the clinical factors associated with pocket hematoma formation after CIED implantation or replacement and to identify the best perioperative antithrombotic management. METHODS We retrospectively analyzed 500 consecutive patients who underwent to CIED implantation or replacement at our center from November 2014. RESULTS Among our population, 206 patients (41.2%) were on anticoagulant therapy at the time of the intervention: 68 (13.6%) on ongoing Warfarin; 111 (22.2%) on low-molecular-weight heparin (LMWH); and 27 (5.4%) on ongoing direct oral anticoagulants. Antiplatelet therapy was present in 262 (52.4%) patients: in particular, 50 (10%) were on dual antiplatelet therapy, 64 (12.8%) were on single antiplatelet therapy and anticoagulant therapy, whereas 12 (2.4%) were on anticoagulant with dual antiplatelet therapy.Incidence of pocket hematoma after CIEDs implantation was of 4.6%. Considering the different perioperative anticoagulant strategies, patients on LMWH presented the higher hematoma rate [11/100 patients (11.0%), P

We report a case of a 63‐year‐old man referred for lead extraction with the bidirectional rotational Evolution® RL mechanical sheath because of systemic infection. As it was judged a “high‐risk” procedure, we opted for a “hybrid,” minimally invasive approach consisting in a minithoracotomic access. This technique is a feasible approach, and it might be a potential safer alternative in the most challenging transvenous lead extraction procedures.

Aims Despite optimal oral anticoagulation with vitamin K antagonist, left atrial (LA) thrombus could be detected in the left appendage (LAA) in >2% of patients with atrial fibrillation (AF) and CHA 2 DS 2 -VASc score≥1 but few data are available for patients treated with non-vitamin K antagonist oral anticoagulants (NOACs). We evaluated the occurrence and predictors of LA thrombi by means of transesophageal echocardiography (TOE) in consecutive patients with non-valvular AF who received for at least 3weeks Apixaban, Dabigatran, or Rivaroxaban. Methods This study included 414 consecutive patients (male 252, 60.6%, mean age 67.3years) referred to our Centers for catheter ablation of AF (n=220, 53.1%) or scheduled electrical cardioversion (n=194, 46.9%). Patients were on Dabigatran (n=160), Rivaroxaban (n=150) or Apixaban (n=104). TOE was performed in all cases within 12h prior to ablation or cardioversion. Results Preprocedural TOE revealed LA thrombus in 15/414 patients (3.6%), all located in the LAA (Apixaban 3/104 2.9%, Dabigatran 5/160 3.1%, and Rivaroxaban 7/150 4.7%, p=0.69). Of these, 14 patients had persistent AF. Patients with LAA thrombus had a mean CHA 2 DS 2 -VASc score of 3 (3–4). Higher CHA 2 DS 2 -VASc score (p=0.02), but not the type of NOAC, significantly predicted the presence of LA thrombus. Conclusion The incidence of LAA thrombus in a cohort of patients anticoagulated with NOACs is low but not negligible, in any case similar among the 3 drugs. Preprocedural TOE should be considered in patients with a CHA 2 DS 2 -VASc score>3.

Permanent His bundle pacing (HBP) has rapidly been adapted into clinical practice in recent years as a physiologic pacing. The 3830 (Medtronic Inc, MN, USA) pacing lead commonly used for HBP is lumenless, and there are limited reports available on extraction of this lead. No data exists on transvenous lead extraction (TLE) of very old HBP lead. Concerns remain about injury to the conduction system during extraction and the lack of lumen for placing a locking stylet for TLE when powered sheaths are required. We reported a unique case of TLE of very old HBP lead (14 years and 3 months) and other two leads, such as passive atrial and passive right ventricular apex backup.

Background The effectiveness of implantable cardioverter-defibrillator (ICD) in the elderly is uncertain, given their competing risk of nonarrhythmic death. Guidelines state that an ICD should be implanted if the expectation of survival is at least 1 year. However, survival is not easy to predict in elderly patients with severe cardiac disease. Aim To assess 12-month survival after ICD implantation in patients aged ≥75 years, to identify predictors of 12-month mortality, and to evaluate the incidence of ICD therapy during follow-up. Methods We retrospectively analyzed all clinical, instrumental, and survival data of patients ≥75 years old who received an ICD in our center from 2000 to 2013. Results We included 127 patients (mean age 78 years). ICD was implanted for primary prevention in 61%. The 12-month survival rate was 87.4%. At both univariate and multivariate analyses, left ventricular ejection fraction (EF) ≤ 25%, and moderate to severe impaired renal function (IRF) independently predicted 12-month mortality that was as high as 45.5% in patients with both risk factors. During a median follow-up of 38 months, 30 patients (23.6%) received ≥1 appropriate ICD interventions, but only 3.1% of shocks occurred during the first year, and none in the subgroup of patients with EF ≤ 25% and IRF. Conclusion Twelve-month survival in elderly patients after ICD implantation is good and the indication for ICD should not be based on age alone. However, the subgroup with EF ≤ 25% and IRF showed a high 12-month nonarrhythmic mortality and did not benefit from ICD implantation.

Background The traditional technique for subcutaneous implantable cardioverter defibrillator (S-ICD) implantation, which involves three incisions and a subcutaneous pocket, is associated with possible complications, including inappropriate interventions. The aim of this prospective multicenter study was to evaluate the efficacy and safety of an alternative intermuscular two-incision technique for S-ICD implantation. Methods The study population included 36 consecutive patients (75% male, mean age 44 ± 12 years [range 20–69]) who underwent S-ICD implantation using the intermuscular two-incision technique. This technique avoids the superior parasternal incision for the lead placement and consists of creating an intermuscular pocket between the anterior surface of the serratus anterior and the posterior surface of the latissimus dorsi muscles instead of a subcutaneous pocket. Results All patients were successfully implanted in the absence of any procedure-related complications with a successful 65-J standard polarity defibrillation threshold testing, except in one, who received a second successful shock after pocket revision. During a mean follow-up of 10 months (range 3–30), no complications requiring surgical revision were observed. At device interrogation, stable sensing without interferences was observed in all patients. Two patients (5.5%) experienced appropriate and successful shock on ventricular fibrillation and in four patients (11%), a total of seven nonsustained self-terminated ventricular tachycardias were correctly detected. No inappropriate interventions were observed. Conclusions Our experience suggests that the two-incision intermuscular technique is a safe and efficacious alternative to the current technique for S-ICD implantation that may help reducing complications including inappropriate interventions and offer a better cosmetic outcome, especially in thin individuals.

Operative anaesthetic requirements and perioperative discomfort are barriers to wide adoption of the subcutaneous implantable cardioverter defibrillator (S-ICD) system, especially when the intermuscular technique is used because of the greater amount of tissue dissection. The procedure is most commonly performed under general anaesthesia (GA). There is growing interest in transitioning away from the routine use of GA and towards several alternative anaesthesia modalities for the S-ICD implant procedure without the involvement of an anaesthesiologist. We assessed the feasibility of ultrasound-guided serratus anterior plane block (US-SAPB) in patients undergoing S-ICD implantation with the intermuscular two-incision technique. The study population included 38 consecutive patients (84% male; median, 53 [46–62] years) who received S-ICD implantation using the intermuscular two-incision technique. All procedures were performed under US-SAPB and conscious sedation without the involvement of an anaesthesiologist. The average procedure time was 67 ± 14 min. No patient experienced significant haemodynamic changes or oxygen desaturation during the period of the US-SAPB procedure and sedation; there was no need for pharmacological interventions. The entire procedure was well tolerated without discomfort or complications and with no need for GA, except in one (2.6%) patient who received GA with a laryngeal mask airway. Patients always remained able to respond appropriately to neurological monitoring during the S-ICD implantation procedure. There were no procedure-related complications. US-SAPB and the intermuscular two-incision technique may be a promising safe and feasible combination for S-ICD implantation, overcoming the potential barrier to wider S-ICD adoption in clinical practice.

Background The benefit of cardiac resynchronization therapy (CRT) in patients (pts) with chronic kidney disease (CKD) remains controversial despite frequent use. Pts with impaired renal function have systematically been excluded from randomized clinical trials and therefore specific recommendations for the use of CRT in these pts are still lacking. Purpose Study objectives were to assess long-term outcomes and clinical/echocardiographic response in a large population of patients with moderate-to-severe impaired renal function implanted with a CRT device in accordance with the current standard of care. Methods We prospectively analyzed clinical, instrumental data and survival of pts with CKD who received a CRT device in the CRT-MORE registry from 2011 to 2014. Adverse events for the analysis of clinical outcome comprised death from any cause and nonfatal HF events requiring hospitalization after CRT implantation. LV reverse remodeling and Clinical Response (CR) were also evaluated at 12-month follow-up. Patients were stratified according to current definition of CKD stage: low-moderate CKD with a GFR = 45–59 mL/min (stage 3A); moderate CKD with a GFR = 30–44 mL/min (stage 3B) and severe CKD with a GFR = 15–29 mL/min (stage 4). Results Of the 922 consecutive patients enrolled in the registry, 416 (45%) pts had a moderate-to-severe impaired renal function (43% Stage 3A, 43% Stage 3B and 14% Stage 4). The mean follow-up was 935±506 days. By the end of the study, 85 pts had died and 47 pts had been hospitalized for HF. The combined end-point of death or HF hospitalization was reached by 121 (29%) pts. After 12 months the absolute LVEF improvement was greater than 10% in 37% of pts and 58% of pts displayed a positive clinical response. The percentage of pts who died was higher in the group of pts with severe CKD (32.8% vs 18.4%; p=0.012, compared to the group of pts with moderate CKD). On the contrary the percentage of pts who had at least one HF hospitalization was lower in the group with more severe CKD (2% vs 13%; p=0.011). According to CKD stage both LV remodeling (LVEF improvement ranging from 43.7% - 3A - to 30.8% - 4) and CR (positive response ranging from 63.9% - 3A - to 50% - 4) were higher in low-moderate stage and decreased with CKD severity. At multivariate Cox regression analysis adjusted for baseline confounders, CKD class at implantation [HR=1.5; 95% CI: 1.06–2.14; p=0.0219], chronic obstructive pulmonary disease [HR=1.89; 1.18–3.01; p=0.0077], persistent/permanent AF [HR=1.86; 1.15–3.01; p=0.0115] and male gender [HR=1.92; 1.07–3.46; p=0.0301] remained associated with death. Conclusions Among CKD patients in the CRT-MORE registry, severity of renal dysfunction at the time of CRT implantation was associated with worse prognosis, lower clinical response and LV reverse remodeling. Acknowledgement/Funding None

BACKGROUND: Atrial fibrillation (AF) ablation outcome is still operator dependent. Ablation Index (AI) is a new lesion quality marker that has been demonstrated to allow acute durable pulmonary vein (PV) isolation followed by a high single-procedure arrhythmia-free survival. This prospective, multicenter study was designed to evaluate the reproducibility of acute PV isolation guided by the AI. METHODS: A total of 490 consecutive patients with paroxysmal (80.4%) and persistent AF underwent first time PV encircling and were divided in four study groups according to operator preference in choosing the ablation catheter (a contact force [ST] or contact force surround flow [STSF] catheter) and the AI setting (330 at posterior and 450 at anterior wall or 380 at posterior and 500 at anterior wall). Radiofrequency was delivered targeting interlesion distance ≤6 mm. RESULTS: The rate of first-pass PV isolation (ST330 90 ± 16%, ST380 87 ± 19%, STSF330 90 ± 17%, STSF380 91 ± 15%, P = .585) was similar among the four study groups, whereas procedure (ST330 129 ± 44 minutes, ST380 144 ± 44 minutes, STSF330 120 ± 72 minutes, STSF380 125 ± 73 minutes, P < .001) and fluoroscopy time (ST330 542 ± 285 seconds, ST380 540 ± 416 seconds, STSF330 257 ± 356 seconds, STSF380 379 ± 454 seconds, P

Objectives The aim of the study was to confirm the value of the VALID‐cardiac resynchronization therapy (CRT) risk score in predicting outcome and to assess its association with clinical response (CR) in an unselected real‐world CRT population. Methods and Results The present analysis comprised all consecutive CRT patients (pts) enrolled in the CRT‐MORE registry from 2011 to 2013. Pts were stratified into five groups (quintiles 1‐5) according to the VALID‐CRT risk predictor index applied to the CRT‐MORE population. In the analysis of clinical outcome, adverse events comprised death from any cause and non‐fatal heart failure (HF) events requiring hospitalization. CR at 12‐month follow‐up was also assessed. We enrolled 905 pts. During a median follow‐up of 1005 [627‐1361] days, 134 patients died, and 79 had at least one HF hospitalization. At 12 months, 69% of pts displayed an improvement in their CR. The mean VALID‐CRT risk score derived from the CRT‐MOdular Registry (MORE) population was 0.317, ranging from −0.419 in Q1 to 2.59 in Q5. The risk‐stratification algorithm was able to predict total mortality after CRT (survival ranging from 93%‐Q1 to 77%‐Q5; hazards ratio [HR] = 1.42, 95% confidence interval [CI]: 1.25‐1.61, P

Pulmonary vein isolation (PVI) is the most widely adopted strategy for paroxysmal atrial fibrillation (PAF) ablation. Limited evidence on acute results and late outcomes of cryoballoon (CB)-PVI in patients with structural heart disease (SHD) exist. The aim of this analysis was to compare acute procedural results and the 1-year recurrence rate of a single CB-PVI procedure in a PAF population with and without SHD.From April 2012 to May 2017, a total of 2,031 patients with AF underwent CB-PVI and were followed prospectively in the framework of the One Shot TO Pulmonary vein isolation (1STOP) ClinicalService project, involving 36 Italian cardiology centres. We identified patients with SHD according to criteria proposed by current ESC guidelines: left ventricular (LV) systolic or diastolic dysfunction, long-standing hypertension with LV hypertrophy, and/or other structural heart disease. Data on procedural outcomes and long-term freedom from AF recurrence were evaluated.Our population consisted of 1,452 patients, of whom 282 (19.4%) were classified as having SHD. Compared to non-SHD patients, the SHD cohort was older (mean ± standard deviation, 62.9 ± 9.0 vs 58.2 ± 11.4 years; p 0.001), was more frequently male (79.1% vs 69.8%; p 0.002), had a higher thrombo-embolic risk (CHACB-PVI was extensively applied to treat patients with PAF. Unlike previous PVI experiences, the acute success and recurrence rate after a single procedure was not related to the presence of SHD or to the degree of cardiac remodelling. Further studies are required to define whether CB-PVI has a useful role in patients with a significantly reduced ejection fraction as those patients were under-represented in the current population.