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Background Pulmonary vein isolation by cryoablation (PVI-C) is a standard therapy for the treatment of patients with symptomatic atrial fibrillation (AF). AF symptoms are highly subjective; however, they are important outcomes for the patient. The aim is to describe the use and impact of a web-based App to collect AF-related symptoms in a population of patients who underwent PVI-C in seven Italian centers. Methods A patient App to collect AF-related symptoms and general health status was proposed to all patients who underwent an index PVI-C. Patients were divided into two groups according to the utilization of the App or the non-usage. Results Out of 865 patients, 353 (41%) subjects composed the App group, and 512 (59%) composed the No-App group. Baseline characteristics were comparable between the two cohorts except for age, sex, type of AF, and body mass index. During a mean follow-up of 7.9±13.8 months, AF recurrence was found in 57/865 (7%) subjects with an annual rate of 7.36% (95% CI:5.67-9.55%) in the No-App versus 10.99% (95% CI:9.67-12.48%) in the App group, p=0.007. In total, 14,458 diaries were sent by the 353 subjects in the App group and 77.1% reported a good health status and no symptoms. In only 518 diaries (3.6%), the patients reported a bad health status, and bad health status was an independent parameter of AF recurrence during follow-up. Conclusions The use of a web App to record AF-related symptoms was feasible and effective. Additionally, a bad health status reporting in the App was associated with AF recurrence during follow-up.

It has been observed that the fourth-generation cryoballoon (CB4) ablation catheter increased the rate of acute real-time recordings of pulmonary vein isolation (PVI) during the ablation for the treatment of atrial fibrillation (AF). The aim of this analysis was to compare the long-term outcome results between patients treated with the CB4 and second-generation cryoballoon (CB2).In total, 492 patients suffering from AF, underwent PVI ablation with either the CB2 or CB4 catheter within this examination of the 1STOP real-world Italian project and were included in the analysis. Specifically, 246 consecutive patients treated by CB4 were compared to 246 propensity-matched control patients who underwent PVI using CB2.When comparing the patient cohorts treated with CB2 versus CB4, acute success rate (99.6 ± 4.7% vs. 99.7 ± 3.6%, p = .949) and peri-procedural complications (3.7% vs.1.2%, p = .080) were similar in both groups, respectively. However, procedure time (100 vs.75 min, p .001) and fluoroscopy duration (21 vs.17 min, p .001) were all significantly lower in the CB4 treated patient cohort. At the 12-month follow-up, the freedom from AF recurrence after a 90-day blanking period was significant higher in the CB4 as compared with the CB2 group (93.3% vs.81.3%, p .001).In summary, usage of the CB4 ablation catheter increased the rate of acute PVI recording capability and resulted in a higher rate of long-term PVI success, as demonstrated by the reduced rate of AF recurrence in comparison to the CB2 cohort at the 12-month follow-up period.

Cardiac amyloidosis (CA) manifests as infiltrative cardiomyopathy with a hypertrophic pattern, usually presenting with heart failure with preserved ejection fraction (HFpEF). In addition, degenerative valvular heart disease, particularly severe aortic stenosis, is commonly seen in patients with CA. However, amyloid fibril deposition may also infiltrate the conduction system and promote the development of electrical disorders, including ventricular tachyarrhythmias (VT), atrio-ventricular block, or acute electromechanical dissociation (EMD). These manifestations can increase the risk of sudden cardiac death (SCD). This review summarizes the pathophysiological mechanisms and risk factors for sudden cardiac death in cardiac amyloidosis and focuses on the major current concerns regarding medical and device management in this challenging scenario. Heart involvement is the major determinant of survival in patient with amyloidosis and a “sudden death” occurs in approximately two-thirds of patients with cardiac amyloidosis. Moreover, the AL amyloid fibrils are shown to be highly cytotoxic to the ventricular myocardial, explaining why ventricular arrhythmias appear more frequently in AL over ATTR. Proposed mechanisms driving electrophysiological manifestations of CA involve intramural coronaries, microvascular ischemia, or patchy myocardium infiltration of amyloid fibrils, causing the development of anatomical re-entrant circuits responsible for ventricular arrhythmia. The prevalence of non-sustained ventricular tachycardia (NSVT) in AL amyloidosis ranges from 5 to 27% with routine monitoring and 100% during the stem cell transplant period. The guidelines don't provide specific indications regarding insertion of implantabile cardioverter defibrillator (ICD) and they don't clarify whether some patients subtypes can benefit from them. Amyloid infiltration into the conduction system enhances the genesis of rhythm disturbances, including fatal ventricular arrhythmias and SCD. Current pharmacological anti-arrhythmic therapies are poorly tolerated in CA, and there are no robust recommendations on the management of ventricular arrhythmias in this subset of patients. Furthermore, the benefit of ICD implantation is highly variable according to the different clinical stages of the disease. Therefore, further studies are needed to create a standardized diagnostic algorithm and appropriate treatment strategy for this special population.

The absence of pacing capabilities may reduce the appeal of subcutaneous implantable cardioverter-defibrillator (S-ICD) devices for patients at risk for conduction disorders or with antitachycardia pacing (ATP)/cardiac resynchronization (CRT) requirements. Reports of rates of S-ICD to transvenous implantable cardioverter-defibrillator (TV-ICD) system switch in real-world scenarios are limited.The purpose of this study was to investigate the need for a subsequent transvenous (TV) device in patients implanted with an S-ICD and its predictors.All patients implanted with an S-ICD were enrolled from the multicenter, real-world iSUSI (International SUbcutaneouS Implantable cardioverter defibrillator) Registry. The need for a TV device and its clinical reason, and appropriate and inappropriate device therapies were assessed. Logistic regression with Firth penalization was used to assess the association between baseline and procedural characteristics and the overall need for a subsequent TV device.A total of 1509 patients were enrolled (age 50.8 ± 15.8 years; 76.9% male; 32.0% ischemic; left ventricular ejection fraction 38% [30%-60%]). Over 26.5 [13.4-42.9] months, 155 (10.3%) and 144 (9.3%) patients experienced appropriate and inappropriate device therapies, respectively. Forty-one patients (2.7%) required a TV device (13 bradycardia; 10 need for CRT; 10 inappropriate shocks). Body mass index (BMI)30 kg/mA low rate (2.7%) of conversion from S-ICD to a TV device was observed at follow-up, with need for antibradycardia pacing, ATP, or CRT being the main reasons. BMI30 kg/m

Introduction Use of non-vitamin K oral anticoagulants (NOACs) has rapidly increased worldwide. We aimed to systematically assess the available evidence regarding the safety and efficacy of NOACs in patients undergoing cardiac implantable electronic device (CIED) surgery. Methods We performed a systematic literature search. Eligible randomised controlled trials and cohort studies were included. The primary outcome measures were clinically significant device-pocket haematoma and thromboembolic events. Results A total of 12 studies were included, equating to 2120 patients. The separate pooling of rate of events showed a low incidence of clinically significant device-pocket haematoma, although numerically higher in patients on continued (1.5%; CI95%0.8–3.0) versus interrupted NOAC (0.9%; CI95%0.5–1.7). The rate of any device-pocket haematoma was numerically higher in the continued versus interrupted NOAC group (5.4%; CI95%3.8–7.7 versus 2.4%; CI95%1.8–3.3). The incidence of thromboembolic events (0.4%; CI95%0.2–0.8) was low and comparable. From a meta-analysis of 3 studies (equating to 773 subjects) allowing for a comparison of continued versus interrupted NOAC, we found no significant difference between the 2 strategies in terms of clinically significant pocket haematoma (RR1.14; CI95%0.43–3.06, p = 0.79), thromboembolic complications (RR1.03; CI95%0.06–16.37, p = 0.98), and any pocket haematoma (RR1.19; CI95%0.65–2.20, p = 0.57). Conclusion Use of NOACs at the time of CIEDs surgery appears to be safe, and either strategy of peri-procedure continuation or interruption might be reasonable. However, continuation of NOAC seems to be associated with a numerically higher rate of bleeding complications. Certainty of the evidence is low, and further studies are required to confirm these findings.

Multiple left ventricular pacing strategies have been suggested for improving response to cardiac resynchronization therapy (CRT). However, these programming strategies may sometimes entail accepting configurations with high pacing threshold and accelerated battery drain. We assessed the feasibility of predefined pacing programming protocols, and we evaluated their impact on device longevity and their cost-impact. We estimated battery longevity in 167 CRT-D patients based on measured pacing parameters according to multiple alternative programming strategies: single-site pacing associated with lowest threshold, non-apical location, longest interventricular delay, and pacing from two electrodes. To determine the economic impact of each programming strategy, we applied the results of a model-based cost analysis using a 15-year time horizon. Selecting the electrode with the lowest threshold resulted in a median device longevity of 11.5 years. Non-apical pacing and interventricular delay maximization were feasible in most patients and were obtained at the price of a few months of battery life. Device longevity of > 10 years was preserved in 87% of cases of non-apical pacing and in 77% on pacing at the longest interventricular delay. The mean reduction in battery life when the second electrode was activated was 1.5 years. Single-site pacing strategies increased the therapy cost by 4–6%, and multi-site pacing by 12–13%, in comparison with the lowest-cost scenario. Modern CRT-D systems ensure effective pacing and allow multiple optimization strategies for maximizing service life or for enhancing effectiveness. Single- or multi-site pacing strategies can be implemented without compromising device service life and at an acceptable increase in therapy cost.

Background Twelve-lead ECG represents the most common diagnostic tool in clinical cardiology and allows an immediate screening of left ventricular hypertrophy (LVH), but current criteria might have poor clinical usefulness in everyday clinical practice due to lack of sensitivity. Methods The current study aims to review and compare the clinical performance of known ECG criteria of LVH in a real-life setting; 2134 patients had ECG and echocardiographic exams performed during the same hospitalization. All traces were retrospectively analysed, and the amplitudes of the waves were manually measured. Transthoracic echocardiography was considered as the gold standard to assess LVH. Results LVH had a prevalence of 58%. Considering the diagnostic performance of ECG criteria for LVH, the Cornell voltage carried the best area under the receiver operating characteristic curve (0.678), while RaVF (R wave in aVF lead) had the poorer result (0.440). The R5/R6 criterion had the best sensitivity (60%), but with the worst specificity (37.4%). The 'Q or S aVR' had the best specificity (99.9%) but lacks sensitivity (0.80%). The Peguero Lo Presti criterion had a sensitivity of 42.3% and a specificity of 75.8%. The Cornell voltage and the Cornell product had similar area under the receiver operating characteristic curve values which were found to be significantly greater compared with other criteria. Conclusion Current ECG criteria of LVH have low sensitivity despite an acceptable specificity. Among these, Cornell voltage and Cornell product criteria were equally found to have a more accurate diagnostic performance compared with other criteria. To overcome the intrinsic limitations of the current ECG LVH criteria, a new paradigm in the analysis of electrocardiographic data might be necessary.

A few limited case series have shown that the subcutaneous implantable cardioverter-defibrillator (S-ICD) system is safe for teenagers and young adults, but a large-scale analysis currently is lacking.The purpose of this study was to compare mid-term device-associated outcomes in a large real-world cohort of S-ICD patients, stratified by age at implantation.Two propensity-matched cohorts of teenagers + young adults (≤30 years old) and adults (30 years old) were retrieved from the ELISIR Registry. The primary outcome was the comparison of inappropriate shock rate. Complications, freedom from sustained ventricular arrhythmias, and overall and cardiovascular mortality were deemed secondary outcomes.Teenagers + young adults represented 11.0% of the entire cohort. Two propensity-matched groups of 161 patients each were used for the analysis. Median follow-up was 23.1 (13.2-40.5) months. In total, 15.2% patients experienced inappropriate shocks, and 9.3% device-related complications were observed, with no age-related differences in inappropriate shocks (16.1% vs 14.3%; P = .642) and complication rates (9.9% vs 8.7%; P = .701). At univariate analysis, young age was not associated with increased rates of inappropriate shocks (hazard ratio [HR] 1.204 [0.675-2.148]: P = .529). At multivariate analysis, use of the SMART Pass algorithm was associated with a strong reduction in inappropriate shocks (adjusted HR 0.292 [0.161-0.525]; P.001), whereas arrhythmogenic right ventricular cardiomyopathy (ARVC) was associated with higher rates of inappropriate shocks (adjusted HR 2.380 [1.205-4.697]; P = .012).In a large multicenter registry of propensity-matched patients, use of the S-ICD in teenagers/young adults was safe and effective. The rates of inappropriate shocks and complications between cohorts were not significantly different. The only predictor of increased inappropriate shocks was a diagnosis of ARVC.

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 To date, only a few comparisons between subcutaneous implantable cardioverter-defibrillator (S-ICD) patients undergoing and those not undergoing defibrillation testing (DT) at implantation (DT+ vs DT–) have been reported. Objective The purpose of this study was to compare long-term clinical outcomes of 2 propensity-matched cohorts of DT+ and DT– patients. Methods Among consecutive S-ICD patients implanted across 17 centers from January 2015 to October 2020, DT– patients were 1:1 propensity-matched for baseline characteristics with DT+ patients. The primary outcome was a composite of ineffective shocks and cardiovascular mortality. Appropriate and inappropriate shock rates were deemed secondary outcomes. Results Among 1290 patients, a total of 566 propensity-matched patients (283 DT+; 283 DT–) served as study population. Over median follow-up of 25.3 months, no significant differences in primary outcome event rates were found (10 DT+ vs 14 DT–; P = .404) as well as for ineffective shocks (5 DT– vs 3 DT+; P = .725). At multivariable Cox regression analysis, DT performance was associated with a reduction of neither the primary combined outcome nor ineffective shocks at follow-up. A high PRAETORIAN score was positively associated with both the primary outcome (hazard ratio 3.976; confidence interval 1.339–11.802; P = .013) and ineffective shocks alone at follow-up (hazard ratio 19.030; confidence interval 4.752–76.203; P = .003). Conclusion In 2 cohorts of strictly propensity-matched patients, DT performance was not associated with significant differences in cardiovascular mortality and ineffective shocks. The PRAETORIAN score is capable of correctly identifying a large percentage of patients at risk for ineffective shock conversion in both cohorts.

Recently, the Food and Drug Administration issued a recall for the subcutaneous implantable cardioverter-defibrillator (S-ICD) because of the possibility of lead ruptures and accelerated battery depletion.The aim of this study was to evaluate device-related complications over time in a large real-world multicenter S-ICD cohort.Patients implanted with an S-ICD from January 2015 to June 2020 were enrolled from a 19-institution European registry (Experience from the Long-term Italian S-ICD registry [ELISIR]; ClinicalTrials.gov identifier NCT0473876). Device-related complication rates over follow-up were collected. Last follow-up of patients was performed after the Boston Scientific recall issue.A total of 1254 patients (median age 52.0 [interquartile range 41.0-62.2] years; 973 (77.6%) men; 387 (30.9%) ischemic) was enrolled. Over a follow-up of 23.2 (12.8-37.8) months, complications were observed in 117 patients (9.3%) for a total of 127 device-related complications (23.6% managed conservatively and 76.4% required reintervention). Twenty-seven patients (2.2%) had unanticipated generator replacement after 3.6 (3.3-3.9) years, while 4 (0.3%) had lead rupture. Body mass index (hazard ratio [HR] 1.063 [95% confidence interval 1.028-1.100]; P.001), chronic kidney disease (HR 1.960 [1.191-3.225]; P = .008), and oral anticoagulation (HR 1.437 [1.010-2.045]; P = .043) were associated with an increase in overall complications, whereas older age (HR 0.980 [0.967-0.994]; P = .007) and procedure performed in high-volume centers (HR 0.463 [0.300-0.715]; P = .001) were protective factors.The overall complication rate over 23.2 months of follow-up in a multicenter S-ICD cohort was 9.3%. Early unanticipated device battery depletions occurred in 2.2% of patients, while lead fracture was observed in 0.3%, which is in line with the expected rates reported by Boston Scientific.

Introduction The subcutaneous ICD (S-ICD) is a valid alternative to transvenous systems (TV-ICD) for the treatment of life-threatening arrhythmias, and the extravascular position of the lead allows a significant reduction of the risk of infection. Current guidelines recommend defibrillation threshold testing (DFT) at the time of S-ICD implantation (class I). Although randomised trials have proven the safety of TV-ICD implantation with no DFT, it is unclear whether such an approach could be adopted for S-ICD as well. The PRAETORIAN score, based on post-implantation chest X-ray, can accurately predict a high defibrillation threshold after S-ICD implantation. The aim of this retrospective multicentre study was to evaluate the efficacy and safety of S-ICD implantation with no DFT. Methods We enrolled 203 consecutive patients undergoing S-ICD implantation in six different centres between October 2012 and January 2019. It was left at discretion of the operator whether performing or not DFT at the time of the procedure. Baseline device settings were collected, and the PRAETORIAN score was retrospectively calculated whenever chest X-ray was available. Both remote or in-clinic device interrogation reports were systemically analysed, and all the shocks and arrhythmia episodes identified. All the patients provided consent form and ethical approval was obtained. Results The population (mean age 57.6 ± 14.2) was divided in two groups, based on whether DFT was performed at the time of the S-ICD implantation: 72 patients (35.4%) underwent DFT (DFT+ group), while 131 patients (64.5%) did not (DFT- group). In the DFT- group, mean LVEF was lower (32 ± 8% vs 42 ± 17%, p Conclusions This study suggests that implantation of S-ICD with no DFT might be reasonable. These results should be confirmed in prospective randomised trials.

Funding Acknowledgements No funding Introduction Multiple left ventricular pacing strategies have been suggested for improving response to cardiac resynchronization therapy (CRT). However, these programming strategies can be obtained by accepting configurations with high pacing threshold and accelerated battery drain. We assessed the feasibility of predefined pacing programming protocols and we evaluated their impact on device longevity and their cost-impact. Methods We estimated battery longevity in 167 CRT-D (RESONATE, Boston Scientific) patients based on measured pacing parameters and according to multiple programming strategies: single-site pacing associated with lowest threshold, non-apical location, longest interventricular delay, pacing from two electrodes. To determine the economic impact of each programming strategy, we applied the results of a published model-based cost analysis to a 15-year time-horizon. Results Selecting the electrode with the lowest threshold resulted in a median device longevity of 11.5 years. Non-apical pacing and interventricular delay maximization were feasible in most patients (99% non-apical pacing, 65% RV-to-LV interval >80ms), and were obtained at the price of a few months of battery life. Device longevity of >10 years was preserved in 87% of cases of non-apical pacing and in 77% on pacing at the longest interventricular delay. The mean reduction in battery life when the second electrode was activated was 1.5 years. Single-site pacing strategies increased the therapy cost by 4-6%, and multi-site pacing by 12-13%, in comparison with the best-case scenario. Conclusions Modern CRT-D systems ensure effective pacing and allow multiple optimization strategies for maximizing service life or for enhancing effectiveness. Single- or multi-site pacing strategies can be implemented without compromising device service life and at an acceptable increase in therapy cost. Abstract Figure. Image1

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

Atrial fibrillation (AF), is the most common sustained arrhythmia and is associated with a substantial increase in morbidity and mortality. Several studies have demonstrated sex-related differences in various aspects, including age at diagnosis, clinical manifestations, management and prognosis. These dissimilarities may dictate different approaches to management and could translate to differences in outcomes. However, similarly to other cardiovascular therapies, there may be a tendency to treat females more conservatively and less aggressively than male patients. The use of oral anticoagulants, for example, is lower in female patients with AF. Electrical cardioversion is less often used. Likewise, despite higher rates of adverse reactions to antiarrhythmic drugs in women, they are less likely to undergo catheter ablations, a well-established therapeutic approach to symptomatic patients with recurrences of AF. In this article, we review sex related dissimilarities in patients with AF. In addition, we discuss various treatment options, and specifically refer to differences in access of treatment, success rates, and potential treatment-related complications. ispartof: EUROPACE vol:21 issue:5 pages:690-697 ispartof: location:England status: published

Pulmonary vein isolation (PVI) using cryoablation (PVI-C) is a widespread therapy for treating symptomatic, recurrent atrial fibrillation (AF). The impacts of sex on efficacy and safety of PVI-C in a real-world clinical practice is lacking. In a multicenter prospective project, we evaluated whether clinical characteristics, procedure parameters, procedural complications, long-term AF recurrence rates, and/or AF-related symptoms differed according to sex in patients treated with PVI-C. Data from the study population were collected in the framework of the 1STOP ClinicalService® project, involving 47 Italian cardiology centers. Multivariable statistical analyses were conducted to determine if any baseline clinical characteristics impacted the efficacy of PVI-C. From April 2012, 2125 patients (27% female, 59 ± 11 years, 73% paroxysmal AF, and mean left atrial diameter = 42 ± 8 mm) underwent PVI-C. According to baseline characteristics, women were more likely to be older, with higher clinical risk scores (e.g., CHA2DS2-VASc), and a higher number of tested antiarrhythmic drugs before the index PVI-C procedure. Male and female cohorts showed comparable procedure time (mean = 107.7 ± 46.8 min) and a similar incidence of periprocedural complications (4.5% overall), even after adjustment for baseline characteristics (P = 0.880). The multivariable analyses demonstrated that the strongest predictor of AF recurrences was sex (0.74; 95% CI 0.58–0.93; P = 0.011). After propensity score adjustment, the hazard ratio from a multivariable model, which included age and AF type (persistent) as covariates, was 0.76 (0.60–0.97) (P = 0.025). According to the 1STOP project, in a real-world setting, PVI-C was relatively safe regardless of the patient’s sex; however, when considering efficacy of the procedure, female patients had a lower long-term efficacy in comparison to males. NCT01007474

Aims This registry was created to describe the experience of 76 Italian centres with a large cohort of recipients of multipoint pacing (MPP) capable cardiac resynchronization therapy (CRT) devices. Methods and results A total of 507 patients in whom these devices had been successfully implanted were enrolled between August 2013 and May 2015. We analysed: (i) current clinical practices for the management of such patients, and (ii) the impact of MPP on heart failure clinical composite response and on the absolute change in ejection fraction (EF) at 6 months. Multipoint pacing was programmed to ‘ON’ in 46% of patients before discharge. Methods of optimizing MPP programming were most commonly based on either the greatest narrowing of the QRS complex (38%) or the electrical delays between the electrodes (34%). Clinical and echocardiographic follow-up data were evaluated in 232 patients. These patients were divided into two groups according to whether MPP was programmed to ‘ON’ ( n = 94) or ‘OFF’ ( n = 138) at the time of discharge. At 6 months, EF was significantly higher in the MPP group than in the biventricular-pacing group (39.1 ± 9.6 vs. 34.7 ± 7.6%; P < 0.001). Even after adjustments, early MPP activation remained an independent predictor of absolute increase in LVEF of ≥5% (odds ratio 2.5; P = 0.001). At 6 months, an improvement in clinical composite score was recorded in a greater proportion of patients with MPP-ON than in controls (56 vs. 38%; P = 0.009). On comparing optimal MPP and conventional vectors, QRS was also seen to have decreased significantly ( P < 0.001). Conclusion This study provides information that is essential in order to deal with the expected increase in the number of patients receiving MPP devices in the coming years. The results revealed different practices among centres, and establishing the optimal programming that can maximize the benefit of MPP remains a challenging issue. Compared with conventional CRT, MPP improved clinical status and resulted in an additional increase in EF. Clinical Trial Registration . Unique identifier: [NCT02606071][1]. [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT02606071&atom=%2Feuropace%2Fearly%2F2016%2F05%2F16%2Feuropace.euw094.atom

Introduction Catheter ablation has been evaluated as treatment for fascicular ventricular tachycardia (FVT) in several single-centre cohort studies, with variable results regarding efficacy and outcomes. Methods A systematic search was performed on PubMed, EMBASE and Cochrane database (from inception to November 2017) that included studies on FVT catheter ablation. Results Thirty-eight observational non-controlled case series comprising 953 patients with FVT undergoing catheter ablation were identified. Three studies were prospective and only 5 were multi-centre. Eight-hundred and eighty-four patients (94.2%) had left posterior FVT, 25 (3.4%) left anterior FVT and 30 (2.4%) other forms. In 331 patients (41%), ablation was performed in sinus rhythm (SR). The mean follow-up period was 41.4 ± 10.7 months. Relapse of FVT occurred in 100 patients (10.7%). Among the 79 patients (8.3%) requiring a further procedure after the index ablation, 19 (2%) had further FVT relapses. Studies in which ablation was performed in FVT had similar success rate after multiple procedures compared to ablation in SR only (95.1%, CI95% 92.2–97%, I2 = 0% versus 94.8%, CI95% 87.6–97.9%, I2 = 0%, respectively). Success rate was numerically lower in paediatric-only series compared to non-paediatric cases (90.0%, CI95% 82.1–94.6%, I2 = 0% versus 94.3%, CI95% 92.2–95.9%, I2 = 0%, respectively). Conclusion Data derived from observational non-controlled case series, with low-methodological quality, suggest that catheter ablation is a safe and effective treatment for FVT, with a 93.5% success rate after multiple procedures. Ablation during FVT represents the first-line and most commonly used approach; however, a strategy of mapping and ablation during SR displayed comparable procedural results to actively mapping patients in FVT and should therefore be considered in selected cases where FVT is not inducible.

Background Many patients requiring cardiac implantable electronic device (CIED) implantation are on long-term oral anticoagulant therapy. While continuation of warfarin has been shown to be safe and reduce bleeding complications compared to interruption of warfarin therapy and heparin bridging, it is not known which novel oral anticoagulants (NOAC) regimen (interrupted vs uninterrupted) is better in this setting. Methods One-hundred and one patients were randomized to receive CIED implantation with either interrupted or uninterrupted/continuous NOAC therapy before surgery. No heparin was used in either treatment arm. The primary end-point was the presence of a clinically significant pocket hematoma after CIED implantation. The secondary end-point was a composite of other major bleeding events, device-related infection, thrombotic events, and device-related admission length postdevice implantation. Results Both treatment groups were equally balanced for baseline variables and concomitant medications. One clinically significant pocket hematoma occurred in the uninterrupted NOAC group and none in the interrupted group (P = 0.320). There was no difference in other bleeding complications. No thrombotic events were observed in either of the two groups. Conclusions Despite the paucity of bleeding events, data from this pilot study suggest that uninterrupted NOAC therapy for CIED implantation appears to be as safe as NOAC interruption and does not increase bleeding complications.

Aim: To evaluate Attain Performa (Medtronic, Dublin, Ireland) quadripolar lead performance in clinical practice and, secondarily, to compare its long term clinical outcomes vs bipolar leads for left ventricular (LV) pacing. Methods and results: We retrospectively analyzed clinical, procedural and follow-up data of 215 patients implanted with a quadripolar lead. One hundred and twenty one patients implanted with bipolar lead were selected to compare long-term clinical outcomes. The quadripolar lead was implanted in the target vein in 196 patients (91%) without acute dislodgements. In 50% of patients the chosen final pacing configuration at implant would not have been available with bipolar leads. A dedicated quadripolar pacing vector was chosen more frequently when the LV tip location was apical than otherwise (65.6% vs 42.7%, p = 0.003). After a median follow-up of 14 months, the LV pacing threshold was less than 2.5 V at 0.4 ms in 98 patients (90%) with a safety margin between phrenic nerve and LV pacing threshold >3 V in 97 patients (89%). We observed a slight trend toward a lower risk of heart failure worsening and a lower incidence of ventricular arrhythmias and pulmonary congestion in patients implanted with quadripolar leads compared with the control group. Conclusion: Quadripolar leads improve the management of phrenic nerve stimulation at no trade-off with pacing threshold and lead stability. Quadripolar leads seems to be associated with a lower incidence of VT/VF and pulmonary congestion, when compared with bipolar leads, but further investigations are necessary to confirm that this positive effect is associated with better LV reverse remodeling. Keywords: Short-spaced quadripolar lead, Cardiac resynchronization therapy, Phrenic nerve stimulation, Heart failure, Re-implantation

AIMS: Cryoballoon ablation (CRAB) as a modality for pulmonary vein isolation (PVI) is increasingly being accepted. We aim to study the long-term durability of CRAB in atrial fibrillation. METHODS: The first 51 consecutive patients with documented paroxysmal atrial fibrillation(PAF) who underwent CRAB at our institute were considered. Forty patients formed the study group. Successful PVI was achieved in all the patients. Patients were evaluated with Holter ECG recordings at 1, 3, 6 and 12 months and subsequent follow-up was biannual and based on the clinical status and physician discretion whether symptoms occurred. For the study purpose, a baseline ECG, a 24-h Holter and clinical evaluation were performed in all patients at final follow-up. RESULTS: A large 28-mm cryoballoon (CB) was used in 38 patients (95%), and the small 23-mm CB in the remaining two individuals (2%). The freedom from atrial fibrillation off-antiarrhythmic drug treatment (AAD) after a single procedure at a mean follow-up of 36.6 ± 4 months was 57.5% (23/40). Transient right phrenic nerve palsy was the most common complication. CONCLUSION: Single balloon size CRAB provides a durable atrial fibrillation-free-AAD-free survival in drug-resistant PAF patients over long-term follow-up with a success rate of 57.5% with a single procedure.

AIMS: Implementation of remote home monitoring systems (HM) in clinical practice has become undoubtedly an added value for all patients with implantable cardiac devices. The aim of this study was to investigate the impact of HM in a population of children with Brugada syndrome (BS) who received an implantable cardioverter defibrillator (ICD). METHODS AND RESULTS: Eleven children (age between 6 months and 18 years) implanted with an ICD were followed either by means of HM and with conventional in-hospital visits in our centre. Alerts and/or device-related clinical events were recorded, analysed, and subsequent clinical decisions were made if needed. During an average observation time of 26 months a total of 16 relevant alerts (13 pre-emptive alerts) were recorded in seven patients of our population. One patient experienced appropriate therapies for life-threatening ventricular arrhythmias. Three patients experienced inappropriate therapies due to supraventricular tachycardia and lead dislodgement. By means of HM two patients were discovered to have lead problems because of dislodgement or lead fracture. Mean anticipation of treatment based on the alerts was 76 ± 59 days. CONCLUSION: Remote monitoring systems substantially improve the proper management of children with BS. AIMS: Implementation of remote home monitoring systems (HM) in clinical practice has become undoubtedly an added value for all patients with implantable cardiac devices. The aim of this study was to investigate the impact of HM in a population of children with Brugada syndrome (BS) who received an implantable cardioverter defibrillator (ICD). METHODS AND RESULTS: Eleven children (age between 6 months and 18 years) implanted with an ICD were followed either by means of HM and with conventional in-hospital visits in our centre. Alerts and/or device-related clinical events were recorded, analysed, and subsequent clinical decisions were made if needed. During an average observation time of 26 months a total of 16 relevant alerts (13 pre-emptive alerts) were recorded in seven patients of our population. One patient experienced appropriate therapies for life-threatening ventricular arrhythmias. Three patients experienced inappropriate therapies due to supraventricular tachycardia and lead dislodgement. By means of HM two patients were discovered to have lead problems because of dislodgement or lead fracture. Mean anticipation of treatment based on the alerts was 76 ± 59 days. CONCLUSION: Remote monitoring systems substantially improve the proper management of children with BS.

Background A proband of Brugada syndrome (BrS) is the first patient diagnosed in a family. There are no data regarding this specific, high-risk population. Objectives This study sought to investigate the Brugada probands diagnosed from 1986 through the next 28 years. Methods We included 447 probands belonging to families with a diagnostic type 1 electrocardiogram Brugada pattern. The database was divided into 2 periods: the first period identified patients who were part of the initial cohort that became the consensus document on BrS in 2002 (early group); the second period reflected patients first diagnosed from 2003 to January 2014 (latter group). Results There were 165 probands in the early group and 282 in the latter group. Aborted sudden death as the first manifestation of the disease occurred in 12.1% of the early group versus 4.6% of the latter group (p = 0.005). Inducibility during programmed electrical stimulation was achieved in 34.4% and 19.2% of patients, respectively (p Conclusions Since being first described, the presentation of BrS has changed. There has been a decrease in aborted sudden cardiac death as the first manifestation of the disease among patients who were more recently diagnosed. These variations in initial presentation have important clinical consequences. In this setting, the value of inducibility to stratify individuals with BrS has changed.

Weight-stable obese subjects have an increased risk of arrhythmias and sudden death, even in the absence of cardiac dysfunction, and the risk of sudden cardiac death (SCD) with increasing weight is seen in both genders. The mechanism of unexplained deaths in obese patients is still unclear and may be related to ventricular repolarization abnormalities. The aim of this study is to determine the effect of severe obesity on spatial and transmural ventricular repolarization and to clarify the influence of bariatric surgery with a consequent substantial weight loss on arrhythmogenic substrate in the morbidly obese population.For the study, we enrolled 100 severely obese patients; 50 age-matched non-obese healthy subjects were also recruited as controls. All subjects underwent conventional 12-lead electrocardiography for analysis of spatial and transmural ventricular repolarization assessed by corrected QT dispersion (QTc-d), corrected JT dispersion (JTc-d) and transmural dispersion of repolarization, (TDR). All subjects underwent bariatric surgery and were resubmitted to electrocardiographic, biochemical and anthropometric examination 12 months postoperatively.Severely obese patients had greater values in QTc-d, JTc-d and TDR than the normal-weight controls. Bariatric surgery reduced significantly the QTc-d value, JTc-d value and TDR value. There was a significant correlation between decrease of heterogeneity of repolarization indexes (QTd, JTd and TDR) and bariatric surgery-induced weight loss.In severely obese patients, surgically-induced weight loss is associated with significant decrease in the heterogeneity of ventricular repolarization. The reduction of spatial (QTc-d, JTc-d) and transmural dispersion of repolarization (TDR) may be of clinical significance, by reducing the risk of potentially fatal arrhythmias in morbidly obese subjects.

A proband of Brugada syndrome (BrS) is the first patient diagnosed in a family. There are no data regarding this specific, high-risk population.This study sought to investigate the Brugada probands diagnosed from 1986 through the next 28 years.We included 447 probands belonging to families with a diagnostic type 1 electrocardiogram Brugada pattern. The database was divided into 2 periods: the first period identified patients who were part of the initial cohort that became the consensus document on BrS in 2002 (early group); the second period reflected patients first diagnosed from 2003 to January 2014 (latter group).There were 165 probands in the early group and 282 in the latter group. Aborted sudden death as the first manifestation of the disease occurred in 12.1% of the early group versus 4.6% of the latter group (p = 0.005). Inducibility during programmed electrical stimulation was achieved in 34.4% and 19.2% of patients, respectively (p 0.001). A spontaneous type 1 electrocardiogram pattern at diagnosis was present in 50.3% early versus 26.2% latter patients (p = 0.0002). Early group patients had a higher probability of a recurrent arrhythmia during follow-up (19%) than those of the latter group (5%) (p = 0.007). The clinical suspicion and use of a sodium-channel blocker to unmask BrS has allowed earlier diagnoses in many patients.Since being first described, the presentation of BrS has changed. There has been a decrease in aborted sudden cardiac death as the first manifestation of the disease among patients who were more recently diagnosed. These variations in initial presentation have important clinical consequences. In this setting, the value of inducibility to stratify individuals with BrS has changed.

In 1990 the American Heart Association (AHA) established a standard 0.05 to 150Hz bandwidth for the routine recording of 12-lead electrocardiograms (ECGs). However, subsequent studies have indicated a very high prevalence of deviations from the recommended cutoffs.This prospective observational study investigates the impact of 40Hz compared to 150Hz high-frequency cutoffs on ECG quality and clinical interpretation in a single-center surgical outpatient population.1582 consecutive adult patients underwent two standard 12-lead ECG tracings using different high-frequency cutoffs (40Hz and 150Hz). Two blinded cardiologists randomly reviewed and interpreted the recordings according to pre-defined parameters (PR and ST segment, Q and T wave abnormalities). An arbitrary score, ranging from 1 to 3, was established to evaluate the perceived quality of the recordings and the non-interpretable ECGs were noted. The tracings were then matched to compare interpretations between 40 and 150Hz filters.A 40Hz high-frequency cutoff resulted in an increased rate of optimal quality ECGs compared to the 150Hz cutoff (93.4% vs 54.6%; p0.001) and a lower rate of non-interpretable traces (0.25% vs 4.80%; p0.001). Analyzing the morphologic parameters, no significant differences between the filter settings were found, except for a higher incidence of the J-point elevation in the 40Hz high-frequency cutoff (p=0.007) and a higher incidence of left ventricular hypertrophy in the 150Hz high-frequency cutoff (7.4% vs 5.4%, p0.001). The latter was noted only in ECGs with borderline QRS amplitudes (between 3.3 and 3.7mV; p0.001).Despite current recommendations, the large deviation from standard high-frequency cutoff in clinical practice does not seem to significantly affect ECG clinical interpretation and a 40Hz high-frequency cutoff of the band-pass filtering may be acceptable in a low risk population, allowing for a better quality of tracings.

A 71-year-old woman with severe nonischemic dilated cardiomyopathy and low ejection fraction with severe mitral regurgitation and tricuspid regurgitation and pulmonary hypertension underwent multiple valve repairs and cardiac resynchronization therapy implantation with epicardial shock leads. (PACE 2013; 36:e56–e58)

Item does not contain fulltext BACKGROUND: Since their implementation in clinical practice, remote home monitoring systems (HM) have undoubtedly become an added value in patients with implantable devices for cardiac rhythm management. The aim of this study was to investigate the impact of HM on clinical management and outcome in patients with channelopathies and other arrhythmogenic diseases who received an implantable cardioverter defibrillator (ICD). METHODS: Fifty-four patients (age 6 months--74 years) were followed by means of HM in our ICD clinic. Alerts and/or device-related clinical events were analysed in all patients and subsequent clinical decisions were made if indicated. RESULTS: During an average observation time of 27 months, 46 alerts were received from 32 different patients. Five patients (9%) received appropriate therapies for life-threatening arrhythmias and four patients (8%) inappropriate therapies because ofT wave oversensing or supraventricular tachycardias. Three patients had alerts due to electrical noise (two on the atrial, one on the ventricular channel). Overall, 18 alerts (39%) required a modification of the pharmacological therapy or the programming of the device. Mean anticipation of clinical visits based on the alerts was 92.6 +/- 56 days (median 97, interquartile range 50-150). CONCLUSION: HM substantially improves the clinical management of patients with cardiac arrhythmogenic disease by early recognition of device-related inappropriate therapies and subsequent anticipation of treatment adaptation.

Atrial fibrillation (AF) can be the first manifestation of latent Brugada syndrome (BS). The aim of our study was to assess the prevalence of AF as the first clinical diagnosis in patients with BS and their demographic and clinical characteristics and diagnosis management in a large cohort of patients. The patient group consisted of 611 patients with BS. The data from those with a diagnosis of AF previous to the identification of BS were analyzed (n = 35). Eleven cases were unmasked after the initiation of a class I antiarrhythmic drug and one during the establishment of general anesthesia. In the remaining population, BS was diagnosed using an ajmaline test performed mainly because of younger age in patients with lone AF (n = 13), previous syncope or sudden cardiac death (n = 3), or a clinical history of sudden cardiac death in the family (n = 5). The mean patient age was 49 +/- 15 years, 21 were male patients, 14 had a family history of sudden death, 15 had had previous syncope, and 4 had survived cardiac arrest. Concomitant electrical disorder was found in 13 patients. Remarkably, 21 patients had normal findings on the baseline electrocardiogram. In conclusion, AF could be one of the first clinical manifestations of latent BS in a considerable number of patients. This identification is crucial because the treatment of these patients is subject to relevant changes. The ajmaline test plays an essential role, mainly in young patients with a family history of sudden death, despite having normal findings on a baseline electrocardiogram. (C) 2013 Elsevier Inc. All rights reserved. (Am J Cardiol 2013;111:362-367)

An electrophysiological study in a patient with a previous corridor operation was performed because of syncope. The atrial electrograms showed the persistence of the sinus rhythm in the right atrial corridor despite an organized atrial fibrillation in the left atrium. The first case described of a long term follow-up in a corridor operation, one of the first described surgical approach for the treatment of atrial fibrillation, that gave the beginning to the non-pharmacological approach of this arrhythmia. (C) 2013 Elsevier Inc. All rights reserved.

We present the case of a 50-year-old patient with several episodes of syncope and documented simultaneous wide and narrow QRS complex tachycardia. We then review this tacharrhythmia, focusing on electrophysiological findings and pathophysiology, diagnosis and treatment., Journal Article, info:eu-repo/semantics/published

Although the assessment of diastolic dysfunction (DD) is an integral part of routine cardiologic examinations, little is known about associated electrocardiographic (ECG) changes. Our aim was to investigate a potential role of ECG indices for the recognition of patients with DD., Journal Article, info:eu-repo/semantics/published

Item does not contain fulltext AIMS: Transseptal puncture (TP) appears to be safe in experienced hands; however, it can be associated with life-threatening complications. The aim of our study was to demonstrate the added value of routine use of transoesophageal echocardiography (TEE) for the correct positioning of the transseptal system in the fossa ovalis, thus potentially preventing complications during fluoroscopy-guided TP performed by inexperienced operators. METHODS AND RESULTS: Two hundred and five patients undergoing pulmonary vein isolation procedure (PVI) for drug-resistant paroxysmal or persistent atrial fibrillation were prospectively included. When the operator (initially blinded to TEE) assumed that the transseptal system was in a correct position according to fluoroscopical landmarks, the latter was then checked with TEE unblinding the physician. If necessary, further refinement of the catheter position was performed. Refinement >10 mm, or in case of catheter pointing directly at the aortic root or posterior wall were considered as major repositioning. Thirty-four patients required major repositioning. Regression analysis revealed age (P: 0.0001, Wald: 12.9, 95% confidence interval: 1.04-1.16), left atrial diameter (P: 0.01, Wald: 6.6, 95% confidence interval: 1.04-1.34), previous PVI (P: 0.01, Wald: 6.3, 95% confidence interval: 1.31-8.76), and atrial septal thickness (P: 0.03, Wald: 4.5, 95% confidence interval: 1.05-3.4) as independent predictors of major revision with TEE. CONCLUSION: Routine 2D TEE in addition to traditional fluoroscopic TP appears to be very useful to guide the TP assembly in a correct puncture position and thus, to avoid TP-related complications. However, further randomized prospective comparative studies are necessary to support these suggestions. 01 mei 2012

Item does not contain fulltext AIMS: Cryoballoon ablation has proven very effective in achieving pulmonary vein isolation (PVI). The novel Achieve inner lumen mapping catheter designed to be used in conjunction with the cryoballoon, serves as both a guidewire and a mapping catheter. To our knowledge, this is the first study comparing the latter to verification of electrical isolation with the 'traditional' circular mapping catheter. METHODS AND RESULTS: We assigned 40 consecutive patients matched for age and left atrial diameter suffering of paroxysmal atrial fibrillation to cryoballoon PVI using either the circular mapping catheter or the Achieve as a mapping catheter. Duration of procedure as well as fluoroscopy times were significantly lower in the Achieve group than in the circular mapping catheter group (111 +/- 14 min vs. 126 +/- 13 min, P < 0.005 and 22 +/- 5 min vs. 29 +/- 4 min, P < 0.0001, respectively). There were no significant differences between both groups in terms of mean degree of occlusion, mean minimal temperatures, and PVI. Pulmonary vein isolation could be documented by real-time recordings in 55% of veins in the Achieve group with mean time to isolation of 65 +/- 23 s. CONCLUSION: Cryoballoon ablation in conjunction with the novel Achieve is feasible, safe, and affords PVI in nearly all veins in similar proportions to the approach with the traditional guidewire. Furthermore, if compared to the procedure with the circular mapping catheter, cryoballoon ablation with the Achieve is significantly faster and associated to shorter fluoroscopy times.

Rao, Jayakeerthi Y Sarkozy, Andrea Asmundis, Carlo DE Namdar, Mehdi Ricciardi, Danilo Bayrak, Fatih Dalili, Mohammad Chierchia, Gian-Battista Brugada, Pedro J Cardiovasc Electrophysiol. 2012 Dec;23(12):1395-1397. doi: 10.1111/j.1540-8167.2012.02304.x. Epub 2012 Apr 17.

Left ventricular hypertrophy is 1 of the most frequent cardiac manifestations associated with an unfavorable prognosis. However, many different causes of left ventricular hypertrophy exist. The aim of the present study was to assess the diagnostic value of common electrocardiographic (ECG) parameters to differentiate Fabry disease (FD), amyloidosis, and nonobstructive hypertrophic cardiomyopathy (HC) from hypertensive heart disease (HHD) and aortic stenosis (AS). In 94 patients with newly diagnosed FD (n = 17), HHD (n = 20), amyloidosis (n = 17), AS (n = 20), and HC (n = 20), common ECG parameters were analyzed and tested for their diagnostic value. A stepwise approach including the Sokolow-Lyon index, corrected QT duration, and PQ interval minus P-wave duration in lead II to overcome P-wave abnormalities was applied. A corrected QT duration < 440 ms in combination with a PQ interval minus P-wave duration in lead II < 40 ms was 100% sensitive and 99% specific for the diagnosis of FD, whereas a corrected QT duration > 440 ms and a Sokolow-Lyon index