Electrical storm treatment by percutaneous stellate ganglion block: the STAR study.

BACKGROUND AND AIMS: An electrical storm (ES) is a clinical emergency with a paucity of established treatment options. Despite initial encouraging reports about the safety and effectiveness of percutaneous stellate ganglion block (PSGB), many questions remained unsettled and evidence from a prospective multicentre study was still lacking. For these purposes, the STAR study was designed. METHODS: This is a multicentre observational study enrolling patients suffering from an ES refractory to standard treatment from 1 July 2017 to 30 June 2023. The primary outcome was the reduction of treated arrhythmic events by at least 50% comparing the 12 h following PSGB with the 12 h before the procedure. STAR operators were specifically trained to both the anterior anatomical and the lateral ultrasound-guided approach. RESULTS: A total of 131 patients from 19 centres were enrolled and underwent 184 PSGBs. Patients were mainly male (83.2%) with a median age of 68 (63.8-69.2) years and a depressed left ventricular ejection fraction (25.0 ± 12.3%). The primary outcome was reached in 92% of patients, and the median reduction of arrhythmic episodes between 12 h before and after PSGB was 100% (interquartile range -100% to -92.3%). Arrhythmic episodes requiring treatment were significantly reduced comparing 12 h before the first PSGB with 12 h after the last procedure [six (3-15.8) vs. 0 (0-1), P < .0001] and comparing 1 h before with 1 h after each procedure [2 (0-6) vs. 0 (0-0), P < .001]. One major complication occurred (0.5%). CONCLUSIONS: The findings of this large, prospective, multicentre study provide evidence in favour of the effectiveness and safety of PSGB for the treatment of refractory ES.

Ivabradine as a treatment option for junctional ectopic tachycardia in an adult female.

A Junctional ectopic tachycardia diagnosis was performed using two electrophysiological maneuvers in an adult female with a narrow-complex supraventricular tachycardia with a bystander AV-node slow pathway conduction, who previously underwent catheter ablation attempts for an atrio-ventricular nodal re-entrant tachycardia misdiagnosis. The first maneuver was atrial entrainment with an atrial-His-His-atrial response. The second was based on the response to a premature atrial complex delivered at different phases of the tachycardia cycle confirming that anterograde slow pathway conduction and retrograde fast pathway were not involved. Considering that verapamil, diltiazem, bisoprolol + flecainide, and nadolol were ineffective, we tried ivabradine with no sustained arrhythmias during 18-months.

Anatomical-based percutaneous left stellate ganglion block in patients with drug-refractory electrical storm and structural heart disease: a single-centre case series.

AIMS: The adoption of percutaneous stellate ganglion blockade for the treatment of drug-refractory electrical storm (ES) has been increasingly reported; however, the time of onset of the anti-arrhythmic effects, the safety of a purely anatomical approach in conscious patients and the additional benefit of repeated procedures remain unclear. METHODS AND RESULTS: This study included consecutive patients undergoing percutaneous left stellate ganglion blockade (PLSGB) in our centre for drug-refractory ES. Lidocaine, bupivacaine, or a combination of both were injected in the vicinity of the left stellate ganglion. Overall, 18 PLSGBs were performed in 11 patients (age 69 ± 13 years; 63.6% men, left ventricular ejection fraction 31.6 ± 16%). Seven patients received only one PLSGB; three underwent two procedures and one required three PLSGB and two continuous infusions to control ventricular arrhythmias (VAs). All PLSGBs were performed with an anatomical approach; lidocaine, alone, or in combination was used in 77.7% of the procedures. The median burden of VAs 1 h after each block was zero compared with five in the hour before (P < 0.001); 83% of the patients were free from VAs; the efficacy at 24 h increased with repeated blocks. The anti-arrhythmic efficacy of PLSGB was not related to anisocoria. No procedure-related complications were reported. CONCLUSION: Anatomical-based PLSGB is a safe and rapidly effective treatment for refractory ES; repeated blocks provide additional benefits. Percutaneous left stellate ganglion blockade should be considered for stabilizing patients to allow further ES management.

Long-term outcome of catheter ablation for atrial fibrillation in patients with severe left atrial enlargement and reduced left ventricular ejection fraction.

AIMS: Data regarding the efficacy of catheter ablation in heart failure patients with severely dilated left atrium and reduced left ventricular ejection fraction (LVEF) are scanty. We sought to assess the efficacy of catheter ablation in patients with reduced LVEF and severe left atrial (LA) enlargement, and to compare it to those patients with preserved left ventricular function and equally dilated left atrium. METHODS AND RESULTS: Three patient groups with paroxysmal or persistent atrial fibrillation (AF) undergoing a first pulmonary vein isolation (PVI) were considered: Group 1 included patients with normal or mildly abnormal LA volume (≤41 mL/m2) and normal LVEF; Group 2 included patients with severe LA enlargement (>48 mL/m2) and normal LVEF; and Group 3 included patients with severe LA enlargement and reduced LVEF. Time to event analysis was used to investigate AF recurrences. The study cohort includes 439 patients; Group 3 had a higher prevalence of cardiovascular risk factors. LA enlargement was associated with a two-fold in risk of AF recurrence, on the contrary only a smaller non-significant increase of 30% was shown with the further addition of LVEF reduction. CONCLUSIONS: The long-term outcome of patients with severe LA dilatation and reduced LVEF is comparable to those with severe LA enlargement but preserved LVEF. Long-term efficacy of PVI is certainly affected by the enlargement of the left atrium, but less so by the addition of a reduced LVEF. CA remains the best strategy for rhythm control both in paroxysmal and persistent AF in this subgroup of patients.

Tumor necrosis factor-α predicts response to cardiac resynchronization therapy in patients with chronic heart failure.

BACKGROUND: Pro-inflammatory cytokines contribute to the pathophysiology of heart failure (HF) and are up-regulated in affected patients. We investigated whether pro-inflammatory cytokines might predict the response to cardiac resynchronization therapy (CRT). METHODS AND RESULTS: Plasma levels of tumor necrosis factor-α (TNF-α) and interleukin-6 were assessed in 91 patients before CRT. Response to CRT was defined as a decrease ≥15% in left ventricular end-systolic volume (LVESV) at 6 months. Baseline TNF-α did correlate with LVESV reduction (P=0.001) after CRT. The subject group was divided according to tertiles of TNF-α. From the lower to the upper tertile LVESV (-31±28%, -17±17%, -9±22%) and LV end-diastolic volume (-23±25%, -14±16%, -4±18%) were progressively less reduced after CRT (P<0.001). The proportion of responders to CRT was 70%, 42% and 33%, according to the lower, intermediate and upper tertile of TNF-α distribution (P=0.01). Serious cardiac events (cardiac death, HF hospitalization or urgent heart transplantation) occurred in 63% of patients in the upper tertile vs. 32% and 17% in the intermediate and lower tertiles, respectively, during a median follow-up of 47 months (P<0.001). CONCLUSIONS: Circulating TNF-α predicts the degree of LV reverse remodeling after CRT and may contribute to the early identification of those patients at higher risk of events after device implantation.

A pediatric telecardiology system that facilitates integration between hospital-based services and community-based primary care.

INTRODUCTION: Telecardiology has emerged as a vital field within telemedicine, fostering collaboration between hospital and community medicine. This pilot study introduces an innovative pediatric telecardiology system, comprising a telecardiology system seamlessly integrated with a hospital telemedicine platform. A smooth flow of ECG execution, transmission, and reporting between Primary Care Pediatrician clinics and the hospital was tested as the primary objective. User experience surveys were also considered. METHODS: The study involved three Primary Care Pediatrician clinics, and the enrollment of children took place consecutively from January to July 2023. We integrated a digital electrocardiographic signal acquisition unit and online information transmission-capable tablets, that were provided to the pediatricians, with a telemedicine multitenant platform that facilitated the transmission of the patient's ECG data from the community to the Hospital Pediatric Cardiologist. RESULTS: A total of 158 children (80 M/78F, 8.9 ± 2.8 yrs) underwent ECG recording (78.5 % medical certificates, 21.5 % presence of symptoms) The transmission and reporting of ECGs were successfully completed in all cases, without technical issues. Normal findings on the ECG were demonstrated in 94.9 % of children. 70.8 % of respondents completed all parts of the survey. Respondents had a high level of education (90 %) and demonstrated excellent or good competence in using digital technologies (89 %). 51 % of respondents were not familiar with the term "Telemedicine" and 81 % of the cases had no previous telemedicine experience. 90 % of users were very satisfied or satisfied with the service. Connection problems (2.8 %) and concerns about the service's reliability compared to standard care (3.7 %) were mentioned as possible limitations of the telecardiology. CONCLUSIONS: Our pediatric telecardiology system offers a valuable diagnostic tool to enhance patient management in the community.

Efficacy of early use of Percutaneous Stellate Ganglion Block for electrical storms.

BACKGROUND: Electrical Storm (ES) is a life-threatening condition requiring a rapid management. Percutaneous Stellate Ganglion Block (PSGB) proved to be safe and effective on top of standard therapy, but no data are available about its early use. METHODS: We considered all patients enrolled from 1st July 2017 to 30th April 2024 in the STAR registry (STellate ganglion block for Arrhythmic stoRm), a multicentre, international, observational, prospective registry. We aimed to assess the effectiveness of the first PSGB only. Patients were divided into two groups depending on whether they received PSGB before (Early-PSGB, often due to AAD contraindication) or after (Delayed-PSGB) intravenous antiarrhythmic drugs (AADs other than beta-blockers). RESULTS: We considered 180 PSGB (26 Early-PSGB and 154 AAD-first). In the early-PSGB group we observed a statistically significant reduction of treated arrhythmic events in the hour after PSGB compared to the hour before: 0 (0-0) vs 4.5 (1-10), p<0.001 and the extent of the reduction was similar in the Early-PSGB and delayed-PSGB group [-4.5 (-7 to -2) vs. -2.5 (-3.5 to -1.5), p=ns]. The percentage of patients free from arrhythmias was similar in the two groups up to 12 hours after PSGB (81%vs 84%, p=0.6 after one hour; 77% vs 79%, p=0.8 at three hours and 65% vs 69%, p= 0.7 after 12 hours). CONCLUSIONS: PSGB proved to be effective also when used early in the treatment of ES. Due to its rapidity of action, our results may suggest its early use to reduce the number of defibrillations and possibly to reduce the likelihood of a refractory ES.

Sacubitril/valsartan effects on arrhythmias and left ventricular remodelling in heart failure: An observational study.

AIMS: Conflicting results have been reported in the literature on the potential antiarrhythmic effect of sacubitril/valsartan in heart failure patients with reduced ejection fraction (HFrEF). The objectives of this study were: 1- to evaluate the long term effects of sacubitril/valsartan on arrhythmic burden in HFrEF patients; 2- to evaluate the correlation between the reduction of premature ventricular complexes during f-up and reverse remodelling. METHODS: We identified 255 consecutive HFrEF patients treated with sacubitril/valsartan between March 2017 and May 2020 and followed by the Heart Failure and Cardiac Transplant Unit of IRCCS San Matteo Hospital in Pavia (Italy). Within this subgroup, 153 patients underwent 24 h-Holter-ECG or implantable cardioverter defibrillators (ICD) interrogation at baseline, at 12 months (t1) and at 24 months (t2) and transthoracic echocardiography at baseline and after 12 months after the beginning of sacubitril/valsartan. Cardiac-related hospitalizations were analyzed in the 12 months preceding and during 24 months following the drug starting date. RESULTS: Global burden of 24-h premature ventricular complexes (PVC) was significantly reduced at 12 months (t1) and at 24 months (t2) as compared to the same period before treatment (1043 [304-3360] vs 768 [82-2784] at t1 vs 114 [9-333] at t2, P = 0.000). In the subgroup of patients implanted with biventricular ICD (n = 30), the percentage of biventricular pacing increased significantly (96% [94-99] vs 98% [96-99] at t1 vs 98%[97-100] at t2; P = 0.027). The burden of non-sustained ventricular tachycardia and sustained ventricular tachycardia did not change from baseline to t1 and t2, but a reduction of patients with at least one ICD appropriate shock was reported. The correlations between reduction in 24 h PVC and reduction in LV-ESVi or improvement in LVEF were not statistically significant (respectively R = 0.144, P = 0.197 and R = -0.190, P = 0.074). Heart failure related hospitalizations decreased during follow up (11.1% in the year before treatment vs 4.6% at t1 and 4.6% at t2; P = 0.040). CONCLUSION: Sacubitril/valsartan reduced the number of premature ventricular complexes and increased the percentage of biventricular pacing in a cohort of HFrEF patients already on optimal medical therapy. PVC reduction did not correlate with reverse left ventricular remodelling. Whether sacubitril/valsartan has any direct antiarrhythmic effects is an issue to be better explored in future studies.

Genetic variants of the renin-angiotensin-aldosterone system and reverse remodeling after cardiac resynchronization therapy.

BACKGROUND: Reverse remodeling (RR) after cardiac resynchronization therapy (CRT) is associated with favorable clinical outcomes in heart failure (HF). The renin-angiotensin-aldosterone system (RAAS) is involved in the remodeling process. METHODS AND RESULTS: We assessed the association between RR and 8 common RAAS gene variants, which were determined by TaqMan assays, in 156 outpatients with chronic HF. RR was defined as a >15% decrease in left ventricular end systolic volume (LVESV) at 9 (interquartile range 7-12) months after CRT. We matched 76 patients who did not show RR (RR-) to 80 RR+ control subjects by age, sex, HF etiology, New York Heart Association (NYHA) functional class and left ventricular ejection fraction (LVEF). The frequency of the minor allele of the NR3C2 gene (rs5522 C/T), encoding the mineralocorticoid receptor, was higher in RR- than in RR (24/126 vs 10/150; P value after false discovery rate correction: <.0193). Conversely, LVESV decreased significantly less after CRT in carriers of the NR3C2 minor C allele (P = .02). After adjustment for age, sex, NYHA functional class, previous myocardial infarction, atrial fibrillation, and LVEF, RR- remained independently associated with NR3C2 C allele carriage (odds ratio 3.093, 95% confidence interval 1.253-7.632). CONCLUSIONS: The association of RR- after CRT with a common polymorphism in the mineralocorticoid receptor gene involved in aldosterone signaling suggests a possible role for variants in RAAS genes in progressive LV function decline, despite apparently effective CRT.

Chronic vagus nerve stimulation: a new and promising therapeutic approach for chronic heart failure.

AIMS: In chronic heart failure (CHF), reduced vagal activity correlates with increased mortality and acute decompensation. Experimentally, chronic vagus nerve stimulation (VNS) improved left ventricular (LV) function and survival; clinically, it is used for the treatment of drug-refractory epilepsy. We assessed safety and tolerability of chronic VNS in symptomatic CHF patients, using a novel implantable nerve stimulation system. The secondary goal was to obtain preliminary data on clinical efficacy. METHODS AND RESULTS: This multi-centre, open-label phase II, two-staged study (8-patient feasibility phase plus 24-patient safety and tolerability phase) enrolled 32 New York Heart Association (NYHA) class II-IV patients [age 56 ± 11 years, LV ejection fraction (LVEF) 23 ± 8%]. Right cervical VNS with CardioFit (BioControl Medical) implantable system started 2-4 weeks after implant, slowly raising intensity; patients were followed 3 and 6 months thereafter with optional 1-year follow-up. Overall, 26 serious adverse events (SAEs) occurred in 13 of 32 patients (40.6%), including three deaths and two clearly device-related AEs (post-operative pulmonary oedema, need of surgical revision). Expected non-serious device-related AEs (cough, dysphonia, and stimulation-related pain) occurred early but were reduced and disappeared after stimulation intensity adjustment. There were significant improvements (P < 0.001) in NYHA class quality of life, 6-minute walk test (from 411 ± 76 to 471 ± 111 m), LVEF (from 22 ± 7 to 29 ± 8%), and LV systolic volumes (P = 0.02). These improvements were maintained at 1 year. CONCLUSIONS: This open-label study shows that chronic VNS in CHF patients with severe systolic dysfunction may be safe and tolerable and may improve quality of life and LV function. A controlled clinical trial appears warranted.

Multisystem Inflammatory Syndrome in Children Unmasking Brugada Type 1 Pattern.

We describe the case of a 14-year-old boy hospitalized for multisystem inflammatory syndrome in children who developed atrial fibrillation during the acute phase and a transient Brugada type 1 pattern in the subacute phase. Eight months later, a provocative test with ajmaline confirmed the suspicion of Brugada syndrome. (Level of Difficulty: Intermediate.).

Delayed ICD lead cardiac perforation: comparison of small versus standard-diameter leads implanted in a single center.

BACKGROUND: An increased risk of delayed cardiac perforation (DCP) with active-fixation small-diameter ICD leads has recently been reported, especially with regard to the St. Jude Riata lead (St. Jude Medical, Sylmar, CA, USA). Few data on the risk of DCP in small versus standard-diameter leads implanted in a single high-volume center are available. Moreover, no data on the performances of St. Jude's new small-diameter Durata lead are as yet available. The aim of this study was to assess the incidence of DCP in small versus standard-diameter leads implanted in our center. METHODS: Between January 2003 and October 2009, 437 small-diameter leads (190 Medtronic Sprint Fidelis [Medtronic Inc., Minneapolis, MN, USA], 196 Riata, 51 Durata) and 421 standard-diameter (>8 Fr) leads were implanted. RESULTS: After a median follow-up of 421 days seven of 858 (0.8%) patients experienced DCP. The incidence of DCP was higher in patients with small-diameter leads than in those with standard-diameter leads (1.6% vs 0%, P = 0.01). No cases of DCP occurred among 371 passive-fixation leads versus 1.4% of events among active-fixation leads (P = 0.02). The incidence of DCP was 2.5% in Riata, 1% in Sprint Fidelis, 0% in Durata, and 0% in standard-diameter leads (P < 0.01 for Riata vs standard-diameter leads). CONCLUSIONS: Small-diameter active-fixation ICD leads are at increased risk of DCP, a finding mostly due to the higher incidence of events in the Riata family. By contrast, passive-fixation small-diameter leads and standard-diameter leads appear to be safe enough regarding the risk of DCP. Our preliminary data suggest that the new Durata lead is not associated with an increased risk of DCP.

Subcutaneous versus transvenous implantable defibrillator: An updated meta-analysis.

BACKGROUND: Implantable cardioverter-defibrillator (ICD) placement is a well-established therapy for prevention of sudden cardiac death. The subcutaneous implantable cardioverter-defibrillator (S-ICD) was specifically designed to overcome some of the complications related to the transvenous implantable cardioverter-defibrillator (TV-ICD), such as lead complications and systemic infections. Evidence on the comparison of S-ICD vs TV-ICD are limited. OBJECTIVE: The purpose of this study was to conduct an updated meta-analysis comparing S-ICD vs TV-ICD. METHODS: Electronic databases were searched for studies directly comparing clinical outcomes and complications between S-ICD and TV-ICD. The primary outcome was the composite of clinically relevant complications (lead, pocket, major procedural complications; device-related infections) and inappropriate shocks. Secondary outcomes included death and the individual components of the primary outcome. RESULTS: Thirteen studies comprising 9073 patients were included in the analysis. Mean left ventricular ejection fraction was 40% ± 10%; 30% of patients were female; and 73% had an ICD implanted for primary prevention. There was no statistically significant difference in the risk of the primary outcome between S-ICD and TV-ICD (odds ratio [OR] 0.80; 95% confidence interval [CI] 0.53-1.19). Patients with S-ICD had lower risk of lead complications (OR 0.14; 95% CI 0.06-0.29; P <.00001) and major procedural complications (OR 0.18; 95% CI 0.06-0.57; P = .003) but higher risk of pocket complications (OR 2.18; 95% CI 1.30-3.66; P = .003) compared to those with TV-ICD. No significant differences were found for the other outcomes. CONCLUSION: In patients with an indication for ICD without the need for pacing, TV-ICD and S-ICD are overall comparable in terms of the composite of clinically relevant device-related complications and inappropriate shock.

Incidence of Ventricular Arrhythmias and 1-Year Predictors of Mortality in Patients Treated With Implantable Cardioverter-Defibrillator Undergoing Generator Replacement.

Background When implantable cardioverter defibrillator (ICD) battery is depleted most patients undergo generator replacement (GR) even in the absence of persistent ICD indication. The aim of this study was to assess the incidence of ventricular arrhythmias and the overall prognosis of patients with and without persistent ICD indication undergoing GR. Predictors of 1-year mortality were also analyzed. Methods and Results Patients with structural heart disease implanted with primary prevention ICD undergoing GR were included. Patients were stratified based on the presence/absence of persistent ICD indication (left ventricular ejection fraction ≤35% at the time of GR and/or history of appropriate ICD therapies during the first generator's life). The study included 371 patients (82% male, 40% with ischemic heart disease). One third of patients (n=121) no longer met ICD indication at the time of GR. During a median follow-up of 34 months after GR patients without persistent ICD indication showed a significantly lower incidence of appropriate ICD shocks (1.9% versus 16.2%, P<0.001) and ICD therapies. 1-year mortality was also significantly lower in patients without persistent ICD indication (1% versus 8.3%, P=0.009). At multivariable analysis permanent atrial fibrillation, chronic advanced renal impairment, age >80, and persistent ICD indication were found to be significant predictors of 1-year mortality. Conclusions Patients without persistent ICD indication at the time of GR show a low incidence of appropriate ICD therapies after GR. Persistent ICD indication, atrial fibrillation, advanced chronic renal disease, and age >80 are significant predictors of 1-year mortality. Our findings enlighten the need of performing a comprehensive clinical reevaluation of ICD patients at the time of GR.

Direct oral Xa inhibitors versus warfarin in patients with cancer and atrial fibrillation: a meta-analysis.

AIMS: Patients with cancer are at higher risk of atrial fibrillation, thromboembolic complications and bleeding events compared with the general population. The aim of the present meta-analysis was to compare the efficacy and safety of direct oral Xa inhibitor anticoagulants versus warfarin in patients with cancer and atrial fibrillation. METHODS: We searched electronic databases for randomized controlled trials comparing direct oral Xa inhibitor anticoagulants and warfarin in cancer patients. The primary efficacy outcome was stroke or systemic embolism. The primary safety outcome was major bleeding. A subgroup analysis was performed to explore the outcome differences between patients with active cancer or history of cancer. RESULTS: Three trials with a total of 3029 cancer patients were included in the analysis. There was no statistically significant difference in the risk of stroke or systemic embolism [risk ratio (RR) 0.76; 95% confidence interval (CI) 0.52-1.10] between the two therapeutic strategies. Direct oral Xa inhibitors significantly reduced the incidence of major bleeding compared with warfarin (RR 0.79; 95% CI 0.63-0.99; P = 0.04; number needed to treat = 113). These results were consistent both in patients with active cancer and in those with history of cancer. CONCLUSION: In patients with cancer and atrial fibrillation, direct oral Xa inhibitors have a similar efficacy and may be safer compared with warfarin. These results are consistent both in patients with active cancer and history of cancer.

Meta-Analysis Comparing Cryoballoon Versus Radiofrequency as First Ablation Procedure for Atrial Fibrillation.

Pulmonary vein isolation is the cornerstone of atrial fibrillation (AF) ablation. Radiofrequency (RF) represents a standard of care for pulmonary vein isolation, whereas cryoballoon (CB) ablation has emerged as a valid alternative. The aim of our meta-analysis was to explore the efficacy and safety of CB compared with RF as first ablation procedure for AF. We searched the literature for studies that investigated this issue. The primary efficacy outcome was AF recurrence. The safety outcomes were: pericardial effusion, cardiac tamponade, phrenic nerve palsy, vascular complications, and major bleedings. Fourteen randomized controlled studies and 34 observational studies were included in the analysis. A total of 7,951 patients underwent CB ablation, whereas 9,641 received RF ablation. Mean follow-up was 14 ± 7 months. Overall, CB reduced the incidence of AF recurrence compared with RF ablation (relative risk [RR] 0.86; 95% confidence interval [CI] 0.78 to 0.94; p = 0.001), and this result was consistent across different study design and AF type. CB had a significantly higher rate of phrenic nerve palsy, whereas it was related to a lower incidence of pericardial effusion, cardiac tamponade (RR 0.58; 95% CI 0.38 to 0.88; p = 0.011) and vascular complications (RR 0.61; 95% CI 0.48 to 0.77; p <0.001) compared with RF. There was no significant difference in major bleedings between the 2 strategies. CB ablation had a shorter procedural time compared with RF (mean difference -20.76 minutes; p <0.001). In conclusion, considered its efficacy/safety profile and short procedural time, CB ablation represents the preferable option for first AF ablation procedure.

Incidence of appropriate anti-tachycardia therapies after elective generator replacement in patient with heart failure initially implanted with a defibrillator for primary prevention: Results of a meta-analysis.

BACKGROUND: Implantable cardioverter-defibrillator (ICD) is an effective therapy to reduce mortality in heart failure. When the ICD generator approaches the end of life, most of the patients undergo an elective generator replacement (GR) even if they no longer meet implantation criteria. Whether arrhythmic risk should be re-assessed at the time of GR is still an open question. The aim of our study was to assess, via a meta-analysis, the occurrence of appropriate ICD therapies after GR in patients stratified based on the presence/absence of ICD indication at the time of GR. METHODS: Via a systematic literature search for primary prevention studies (January 2000-Sectember 2018), 2976 studies were analyzed. 6 studies were lastly included. Patients were categorized into two groups: "with ICD indication" in case of LVEF≤35% at the time of GR and/or appropriate therapies during the first ICD life; "without ICD indication" in case of a LVEF>35% and no previous ICD therapies. Incidences of appropriate ICD therapies were computed as number of events per 100 person-year. RESULT: We included 478 pts. (65%) with and 255 patients (35%) without persistent ICD indication. The incidence of appropriate therapies was 12.3/100-person-year in patients with vs. 3.4 in patients without persistent ICD indication (2.98 fold higher risk of ICD therapies). CONCLUSION: Patients who no longer meet ICD implantation criteria at the time of GR present a significantly lower risk of appropriate ICD therapies after GR. The results of this study underline the importance of an arrhythmic risk re-stratification at the time of GR.

Long term vagal stimulation in patients with advanced heart failure: first experience in man.

BACKGROUND: Experimentally, vagal stimulation (VS) is protective in chronic heart failure (HF). In man, VS is used in refractory epilepsy but has never been used in cardiovascular diseases. Increased sympathetic and reduced vagal activity predict increased mortality in HF. AIMS: This pilot study assessed feasibility and safety and tested possible efficacy of chronic VS in HF patients. METHODS: We studied 8 patients (mean age 54 years). CardioFit (BioControl Medical), a VS implantable system delivering pulses synchronous with heart beats through a multiple contact bipolar cuff electrode, was used. VS was started 2-4 weeks after implant, slowly raising intensity; patients were followed 1, 3 and 6 months thereafter. RESULTS: All procedures were successful: as sole surgical side effect, one patient had transient hoarseness. VS was well tolerated, with only mild side effects (cough and sensation of electrical stimulation). There was a significant improvement in NYHA class, Minnesota quality of life (from 52+/-14 to 31+/-18, p < 0.001), left ventricular end-systolic volume (from 208+/-71 to 190+/-83 ml, p = 0.03), and a favourable trend toward reduction in end-diastolic volume. CONCLUSIONS: This novel approach to the treatment of patients with HF is feasible, and appears safe and tolerable. The preliminary efficacy results appear promising. These findings suggest the opportunity to proceed with a larger multicentre study.

Contact force technology integrated with 3D navigation system for atrial fibrillation ablation: improving results?

INTRODUCTION: Pulmonary veins isolation (PVI) by radiofrequency (RF) ablation is currently an established treatment for symptomatic, drug-resistant paroxysmal atrial fibrillation. Although the effectiveness of the therapy has been clearly demonstrated, success rate after a single procedure is still sub-optimal. The main reason for recurrences after PVI is electrical pulmonary vein-atrium reconnection. In order to increase the likelihood of permanent PVI, the creation of a transmural, durable lesion is mandatory. The main determinants of lesion size and transmurality are power, stability, duration and contact-force during RF application. In recent times, catheters with contact-force sensors have been developed and released for clinical use. Areas covered: The present review summarizes rational and clinical evidences for efficacy and safety of contact force (CF) technology integrated into 3D navigation systems for AF ablation. Expert commentary Although CF technology has a strong rational, clinical data on the superior safety and efficacy of CF technology over traditional non-CF catheters are still conflicting. The reason for that is very likely to rely on the lack of definite data on how to optimize CF parameters and how to integrate CF data with power, duration of RF applications and information on catheter stability.

Submammary device implantation. Good long-term performance and better patients' satisfaction. A single-center experience.

INTRODUCTION: Device related distress negatively affects the quality of life of cardiac device recipients mostly of women. A submammary approach has been proposed to reduce the physical impact of the implantation. Our aim was to assess the safety of this approach and to evaluate the patients' acceptance of the device. METHODS: We enrolled 42 patients who underwent a submammary device. The primary endpoint was the need for implant revision that was assessed in the study group compared with the overall control group of 72 standard cardiac device recipients (29 females and 43 males)and with the female group (29 females of controls). In the female population (42 women of the submammary group and 29 of controls) patients' acceptance was calculated with the Florida Patient Acceptance Survey (FPAS). RESULTS: The rate of implant revision was similar in the two groups and the revision-free survival was comparable with a median follow-up of about six years (Log rank test p=0.949). Similar results were found when considering only the female population. Patients' acceptance was greater in the submammary group [total FPAS 85 (95%CI 83-86) vs 74.5 (95%CI 70.2-77.3) p<0,001] and a strongly significant superiority of the submammary group was found regarding body image concerns [10 (95%CI 10-10) vs 8 (95%CI 8-8) p<0.001) and device related distress [23 (95%CI 22-23) vs 1 (95%CI 1-1) p<0.001]. CONCLUSIONS: Submammary device implantation is safe and more accepted than standard approach. Our results should encourage cardiologists to suggest this approach to their patients for a better acceptance of the therapy.