Ablation of CTI-dependent flutter using different ablation technologies: acute and long-term outcome from the LEONARDO study.

BACKGROUND: A novel ablation catheter has been released to map and ablate the cavo-tricuspid isthmus (CTI) in patients with atrial flutter (AFL), improving ablation efficiency. METHODS: We evaluated the acute and long-term outcome of CTI ablation aiming at bidirectional conduction block (BDB) in a prospective, multicenter cohort study enrolling 500 patients indicated for typical AFL ablation. Patients were grouped on the basis of the AFL ablation method (linear anatomical approach, Conv group n = 425, or maximum voltage guided, MVG group, n = 75) and ablation catheter (mini-electrodes technology, MiFi group, n = 254, or a standard 8-mm ablation catheter, BLZ group, n = 246). RESULTS: Complete BDB according to both validation criteria (sequential detailed activation mapping or mapping only the ablation site) was achieved in 443 patients (88.6%). The number of RF applications needed to achieve BDB was lower in the MiFi MVG group vs both the MiFi Conv group and the BLZ Conv group (3.2 ± 2 vs 5.2 ± 4 vs 9.3 ± 5, p < 0.0001 for all comparisons). Fluoroscopy time was similar among groups, whereas we observed a reduction in the procedure duration from the BLZ Conv group (61.9 ± 26min) to the MiFi MVG group (50.6 ± 17min, p = 0.048). During a mean follow-up of 548 ± 304 days, 32 (6.2%) patients suffered an AFL recurrence. No differences were found according to BDB achieved by both validation criteria. CONCLUSIONS: Ablation was highly effective in achieving acute CTI BDB and long-term arrhythmia freedom irrespective of the ablation strategy or the validation criteria for CTI chosen by the operator. The use of an ablation catheter equipped with mini-electrodes technology seems to improve ablation efficiency. CLINICAL TRIAL REGISTRATION: Atrial Flutter Ablation in a Real World Population. (LEONARDO). CLINICALTRIALS: gov Identifier: NCT02591875.

Association Between Device-Detected Sleep-Disordered Breathing and Implantable Defibrillator Therapy in Patients With Heart Failure.

BACKGROUND: Sleep-disordered breathing is highly prevalent in heart failure (HF) and has been suggested as a risk factor for malignant ventricular arrhythmias. The Respiratory Disturbance Index (RDI) computed by an implantable cardioverter-defibrillator (ICD) algorithm accurately identifies severe sleep apnea. OBJECTIVES: In the present analysis, the authors evaluated the association between ICD-detected sleep apnea and the incidence of appropriate ICD therapies in patients with HF. METHODS: We enrolled 411 HF patients who had received an ICD endowed with an algorithm that calculates the RDI each night. In this analysis, the weekly mean RDI value was considered. The endpoint was the first appropriate ICD shock. RESULTS: The median follow-up was 26 months (25th to 75th percentile: 16-35 months). During follow-up, 1 or more ICD shocks were documented in 58 (14%) patients. Patients with shocks were younger (age 66 ± 13 years vs 70 ± 10 years; P = 0.038), and had more frequently undergone implantation for secondary prevention (21% vs 10%; P = 0.026). The maximum RDI value calculated during the entire follow-up period did not differ between patients with and without shocks (55 ± 15 episodes/h vs 54 ± 14 episodes/h; P = 0.539). However, the ICD-detected RDI showed considerable variability during follow-up. The overall median of the weekly RDI was 33 episodes/h (25th to 75th percentile: 24-45 episodes/h). A time-dependent Cox regression model revealed that a continuously measured weekly mean RDI of ≥45 episodes/h was independently associated with shock occurrence (HR: 4.63; 95% CI: 2.54-8.43; P < 0.001), after correction for baseline confounders (age, secondary prevention). CONCLUSIONS: In HF patients, appropriate ICD shocks were more likely to be delivered during periods when patients exhibited more sleep-disordered breathing. (Arrhythmias Detection in a Real World Population [RHYTHM DETECT]; NCT02275637).

Decongestive treatment adjustments in heart failure patients remotely monitored with a multiparametric implantable defibrillators algorithm.

AIMS: HeartLogic algorithm combines data from multiple implantable defibrillators (ICD)-based sensors to predict impending heart failure (HF) decompensation. A treatment protocol to manage algorithm alerts is not yet known, although decongestive treatment adjustments are the most frequent alert-triggered actions reported in clinical practice. We describe the implementation of HeartLogic for remote monitoring of HF patients, and we evaluate the approach to diuretic dosing and timing of the intervention in patients with device alerts. METHODS: The algorithm was activated in 229 ICD patients at eight centers. The median follow-up was 17 months (25th-75th percentile: 11-24). Remote data reviews and patient phone contacts were undertaken at the time of HeartLogic alerts, to assess the patient's status and to prevent HF worsening. We analyzed alert-triggered augmented HF treatments, consisting of isolated increases in diuretics dosage. RESULTS: We reported 242 alerts (0.8 alerts/patient-year) in 123 patients, 137 (56%) alerts triggered clinical actions to treat HF. The HeartLogic index decreased after the 56 actions consisting of diuretics increase. Specifically, alerts resolved more quickly when the increases in dosing of diuretics were early rather than late: 28 days versus 62 days, p < .001. The need of hospitalization for further treatments to resolve the alert condition was associated with higher HeartLogic index values on the day of the diuretics increase (odds ratio: 1.11, 95% CI: 1.02-1.20, p = .013) and with late interventions (odds ratio: 5.11, 95% CI: 1.09-24.48, p = .041). No complications were reported after drug adjustments. CONCLUSIONS: Decongestive treatment adjustments triggered by alerts seem safe and effective. The early use of decongestive treatment and the use of high doses of diuretics seem to be associated with more favorable outcomes.

Combined Use of S-ICD and Absorbable Antibacterial Envelopes: A Proof-of-concept Study.

BACKGROUND: Absorbable antibacterial envelopes (AAEs) are currently recommended in patients undergoing a transvenous ICD implantation in cases at high risk of infection, who are now preferably implanted with a subcutaneous ICD (S-ICD). Nevertheless, experiences using a combined approach with S-ICD and AAE have not been reported. The aim of our study was to evaluate this strategy in patients at very high risk of infection. METHODS: Twenty-five patients were implanted with the S-ICD+AAE using our combined approach, restricted to patients who would fit our decisional flow algorithm identifying very high-risk patients. Patients were followed up 1 month after discharge and every 6 months thereafter. Complications were defined as device-related events requiring medical or surgical intervention for resolution and/or device reprogramming. RESULTS: Twenty-five patients (92% males, mean age 58.5±14.1 years) were implanted with the S-ICD device and the AAE using our combined approach. The most common high-infective risk factors were diabetes requiring insulin treatment (80%) and CKD requiring hemodialysis (48%), with 7 (28%) patients presenting with more than 2 risk factors. A single mild early post-operative hematoma was observed that was managed conservatively with a spontaneous resolution. Despite a very high-risk cohort, only a single late pocket infection was detected and solved conservatively with antibiotic therapy. CONCLUSIONS: The preliminary data of this proof-of-concept study show how a combined deployment of AAE and S-ICD in selected patients at very high risk of infection is a safe and feasible technique and may offer a reliable treatment option in specific and selected clinical settings.

A reproducible sensor pattern to suspect COVID19 pulmonary infection with LATITUDE. Case report and literature review.

A 78 year-old patient with postischaemic dilated cardiomyopathy and severely reduced ejection fraction was implanted with a Boston Scientific RESONATE X4 CRT-D and followed by LATITUDE remote monitoring platform. From the end of January to the end of March 2021 he was hospitalized for COVID19 pneumonia followed by two episodes of acute heart decompensation with bilateral pleural effusion. We remotely followed the patient and identified a typical Heart Logic sensor pattern linked to the COVID19 pneumonia, different from the one linked to the heart failure (HF). We eventually made a literature review on the topic.

Implantable Cardioverter Defibrillator Multisensor Monitoring during Home Confinement Caused by the COVID-19 Pandemic.

AIMS: The utilization of remote monitoring platforms was recommended amidst the COVID-19 pandemic. The HeartLogic index combines multiple implantable cardioverter defibrillator (ICD) sensors and has proved to be a predictor of impending heart failure (HF) decompensation. We examined how multiple ICD sensors behave in the periods of anticipated restrictions pertaining to physical activity. METHODS: The HeartLogic feature was active in 349 ICD and cardiac resynchronization therapy ICD patients at 20 Italian centers. The period from 1 January to 19 July 2020, was divided into three phases: pre-lockdown (weeks 1-11), lockdown (weeks 12-20), post-lockdown (weeks 21-29). RESULTS: Immediately after the implementation of stay-at-home orders (week 12), we observed a significant drop in median activity level whereas there was no difference in the other contributing parameters. The median composite HeartLogic index increased at the end of the Lockdown. The weekly rate of alerts was significantly higher during the lockdown (1.56 alerts/week/100 pts, 95%CI: 1.15-2.06; IRR = 1.71, p = 0.014) and post-lockdown (1.37 alerts/week/100 pts, 95%CI: 0.99-1.84; IRR = 1.50, p = 0.072) than that reported in pre-lockdown (0.91 alerts/week/100 pts, 95%CI: 0.64-1.27). However, the median duration of alert state and the maximum index value did not change among phases, as well as the proportion of alerts followed by clinical actions at the centers and the proportion of alerts fully managed remotely. CONCLUSIONS: During the lockdown, the system detected a significant drop in the median activity level and generated a higher rate of alerts suggestive of worsening of the HF status.

[Pulmonary embolism and SARS-CoV-2: analysis of patients hospitalized for pulmonary embolism and COVID-19 in a Northern Italian center]. / Embolia polmonare e SARS-CoV-2: analisi delle caratteristiche dei pazienti ricoverati presso un centro nel nord Italia per embolia polmonare associata a COVID-19.

BACKGROUND: Coronavirus disease 2019 (COVID-19) has shown high morbidity and mortality and the relationship between pulmonary embolism (PE) and COVID-19 is well established in the literature. METHODS: We describe the characteristics of a cohort of COVID-19 patients (EP-COV) hospitalized at our Centre with PE, investigating how COVID-19 may have influenced their outcomes, as compared to patients without COVID-19 hospitalized for PE in the same months of 2020 (EP-2020) and 2019 (EP-2019). RESULTS: EP-COV patients (n=25) were younger (60.5 ± 8.5 vs 71.4 ± 14.5 vs 70.9 ± 11.8 years, p=0.003), more frequently male (76% vs 48% vs 35%, p=0.016), with a lower history of neoplasia (12% vs 47% vs 40%, p=0.028) and more clinically severe (SOFA score 3.4 ± 1.4 vs 2.2 ± 1.4 vs 1 ± 1.1, p<0.001 and PaO2/FiO2 ratio 223.8 ± 75.5 vs 306.5 ± 49.3 vs 311.8 ± 107.5) than EP-2020 (n=17) and EP-2019 patients (n=20). D-dimer and C-reactive protein were higher in EP-COV (p=0.038 e p<0.001, respectively). The rate of concomitant deep vein thrombosis associated with PE did not differ significantly between the three groups. EP-COV patients developed PE more frequently during in-hospital stay than non-COVID-19 patients (p = 0.016). The mortality rate was higher in EP-COV than in EP-2020 and EP-2019 patients (36% vs 0% vs 5%, p=0.019). CONCLUSIONS: In our study, the risk factors for PE in COVID-19 patients seem to differ from the traditional risk factors for venous thromboembolism; EP-COV patients are clinically more severe and display a higher mortality rate than EP-2020 and EP-2019 patients.

Multiparametric Implantable Cardioverter-Defibrillator Algorithm for Heart Failure Risk Stratification and Management: An Analysis in Clinical Practice.

BACKGROUND: The HeartLogic algorithm combines multiple implantable cardioverter-defibrillator sensors to identify patients at risk of heart failure (HF) events. We sought to evaluate the risk stratification ability of this algorithm in clinical practice. We also analyzed the alert management strategies adopted in the study group and their association with the occurrence of HF events. METHODS: The HeartLogic feature was activated in 366 implantable cardioverter-defibrillator and cardiac resynchronization therapy implantable cardioverter-defibrillator patients at 22 centers. The median follow-up was 11 months [25th-75th percentile: 6-16]. The HeartLogic algorithm calculates a daily HF index and identifies periods IN alert state on the basis of a configurable threshold. RESULTS: The HeartLogic index crossed the threshold value 273 times (0.76 alerts/patient-year) in 150 patients. The time IN alert state was 11% of the total observation period. Patients experienced 36 HF hospitalizations, and 8 patients died of HF during the observation period. Thirty-five events were associated with the IN alert state (0.92 events/patient-year versus 0.03 events/patient-year in the OUT of alert state). The hazard ratio in the IN/OUT of alert state comparison was (hazard ratio, 24.53 [95% CI, 8.55-70.38], P<0.001), after adjustment for baseline clinical confounders. Alerts followed by clinical actions were associated with less HF events (hazard ratio, 0.37 [95% CI, 0.14-0.99], P=0.047). No differences in event rates were observed between in-office and remote alert management. CONCLUSIONS: This multiparametric algorithm identifies patients during periods of significantly increased risk of HF events. The rate of HF events seemed lower when clinical actions were undertaken in response to alerts. Extra in-office visits did not seem to be required to effectively manage HeartLogic alerts. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02275637.

Catheter Ablation of Atrial Fibrillation in Heart Failure: from Evidences to Guidelines.

PURPOSE OF REVIEW: Catheter ablation of atrial fibrillation in heart failure seems to be the way to improve the quality of life, life expectance, and prognosis. In this review, we outline the growing role of this therapy and which patients can benefit from it. RECENT FINDINGS: While previous studies comparing rate control and rhythm control had not demonstrated the superiority of rhythm control in the prognosis of patients with atrial fibrillation and heart failure, recent findings seem to demonstrate that catheter ablation of atrial fibrillation reduces mortality and hospitalization for heart failure and improves the quality of life, when compared to medical therapy alone. An early rhythm-control strategy in atrial fibrillation may reduce cardiovascular death, stroke, hospitalization for HF, or acute coronary syndrome. Catheter ablation in heart failure is an effective and safe solution to obtain a rhythm control and, therefore, to improve outcomes. A better selection of the patients could help to avoid futile procedures and to identify patients requiring a closer follow-up, to redo procedures, or the addition of antiarrhythmic drugs.

Does the Age Affect the Outcomes of Cardiac Resynchronization Therapy in Elderly Patients?

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: <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 >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 > 80 years, COPD and CKD are predictors of worse outcomes.

Minimal fluoroscopy approach for right-sided supraventricular tachycardia ablation with a novel ablation technology: Insights from the multicenter CHARISMA clinical registry.

BACKGROUND: No data exist on the ability of the novel Rhythmia 3-D mapping system to minimize fluoroscopy exposure during transcatheter ablation of arrhythmias. We report data on the feasibility and safety of a minimal fluoroscopic approach using this system in supraventricular tachycardia (SVT) procedures. METHODS: Consecutive patients were enrolled in the CHARISMA registry at 12 centers. All right-sided procedures performed with the Rhythmia mapping system were analyzed. The acquired electroanatomic information was used to reconstruct 3-D cardiac geometry; fluoroscopic confirmation was used whenever deemed necessary. RESULTS: Three hundred twenty-five patients (mean age = 56 ± 17 years, 57% male) were included: 152 atrioventricular nodal reentrant tachycardia, 116 atrial flutter, 41 and 16 right-sided accessory pathway and atrial tachycardia, respectively. Overall, 27 481 s of fluoroscopy were used (84.6 ± 224 s per procedure, equivalent effective dose = 1.1 ± 3.7 mSv per patient). One hundred ninety-two procedures (59.1%) were completed without the use of fluoroscopy (zero fluoroscopy, ZF). In multivariate analysis, the presence of a fellow in training (OR = 0.15, 95% CI: 0.05-0.46; p = .0008), radiofrequency application (0.99, 0.99-1.00; p = .0002), and mapping times (0.99, 0.99-1.00; p = .042) were all inversely associated with ZF approach. Acute procedural success was achieved in 97.8% of the cases (98.4 vs. 97% in the ZF vs. non-ZF group; p = .4503). During a mean of 290.7 ± 169.6 days follow-up, no major adverse events were reported, and recurrence of the primary arrhythmia was 2.5% (2.1 vs. 3% in the ZF vs. non-ZF group; p = .7206). CONCLUSIONS: The Rhythmia mapping system permits transcatheter ablation of right-sided SVT with minimal fluoroscopy exposure. Even more, in most cases, the system enables a ZF approach, without affecting safety and efficacy.

Catheter ablation of atrial fibrillation in heart failure: clinical, prognostic, and echocardiographic outcome.

PURPOSE: Catheter ablation (CA) for atrial fibrillation (AF) in heart failure (HF) patients is associated with a lower rate of cardiac events compared with medical therapy. This study deals with the clinical, echocardiographic, and prognostic outcomes in these patients. Prognostic scores, as MAGGIC (Meta-analysis Global Group in Chronic Heart Failure) score, may help to predict the outcomes. METHODS: From a single center, 47 patients with AF, HF, and left ventricular ejection fraction (LVEF) < 50% underwent CA. The primary endpoints were NYHA functional class, LVEF, and MAGGIC score. RESULTS: The median age of patients was 59 years; 49% had paroxysmal AF. At 12 months, a significant improvement of NYHA class (median before II [interquartile range (IQR) II-III] vs median after I [IQR I-II]) and of LVEF (median before 44% [IQR 37-47] vs median after 55% [IQR49-57]) was observed (p value < 0.001). The MAGGIC 1-year and 3-year probability of death was estimated before (mean score 13 [IQR 11-17]) and at 12-month (mean score 11 [IQR 8-13]), showing a significant decrease in the probability of death (p value <0.001). At 12-month, a lower LVEF was associated with more HF hospitalizations (p value 0.035). Coronary artery disease (CAD) (HR 5, p value 0.035) and MAGGIC score (HR 1.2, p value 0.030) were predictors of HF hospitalization. CONCLUSIONS: CA for AF in HF patients was associated with a significant improvement of NYHA functional class and LVEF and a higher life expectation. CAD history, LVEF < 40%, and MAGGIC score before ablation were predictors of HF hospitalization.

Advantages of the integration of ICE and 3D electroanatomical mapping and ultrasound-guided femoral venipuncture in catheter ablation of atrial fibrillation.

PURPOSE: To evaluate how the integration of intracardiac echocardiography (ICE) and ultrasound-guided femoral venipuncture (USGVC) may affect the safety of catheter ablation (CA) of atrial fibrillation (AF). METHODS: From a single center 374 patients with AF underwent 3D electroanatomic mapping-guided CA with or without the integration of ICE and USGVC. The primary endpoints were periprocedural complications, fluoroscopy time, and procedure time between the two groups. RESULTS: The median age of patients was 60 years. Sixteen patients had major complications (4.3%); 10 of these (2.7%) had major vascular complications. Thirty-seven patients had minor complications (9.9%) that did not require intervention. There were fewer major complications in the CA with the aid of ICE and USGVC than in the conventional approach (1% vs 7%, p = 0.004). The combined approach required less fluoroscopy time than the conventional procedure (median with ICE + USGVC 14 min (interquartile range (IQR) 8-21) vs median without ICE + USGVC 22 min (IQR 17-32)), p < 0.001, and less radiofrequency time (median with ICE + USGVC 1686 s (IQR 1367-1998) vs median time without ICE + USGVC: 1792 s (IQR 1390-2400)), p = 0.012. After adjustment for confounding factors, only the use of ICE + USGVC (hazard ratio: 0.139; p = 0.05) was a significantly protective factor against major complications. CONCLUSION: The use of ICE and USGVC in CA of AF is associated with significantly fewer major complications and lower fluoroscopy and radiofrequency time, so these aids increased the safety of the procedure.

[An unusual presentation of cardiac involvement during the COVID-19 pandemic]. / COVID-19 e coinvolgimento cardiaco: una presentazione inusuale.

Severe acute respiratory syndrome coronavirus 2 may affect the cardiovascular system and cause acute cardiac injury. Other authors described cases of myocarditis with reduced systolic function and/or a life-threatening presentation. We describe the clinical course of an unusual presentation with isolated reversible high degree atrioventricular block in a patient with COVID-19. In this case, a "wait and see approach" avoided an unnecessary permanent pacemaker implantation.

Prospective evaluation of the multisensor HeartLogic algorithm for heart failure monitoring.

BACKGROUND: The HeartLogic algorithm measures data from multiple implantable cardioverter-defibrillator-based sensors and combines them into a single index. The associated alert has proved to be a sensitive and timely predictor of impending heart failure (HF) decompensation. HYPOTHESIS: We describe a multicenter experience of remote HF management by means of HeartLogic and appraise the value of an alert-based follow-up strategy. METHODS: The alert was activated in 104 patients. All patients were followed up according to a standardized protocol that included remote data reviews and patient phone contacts every month and at the time of alerts. In-office examinations were performed every 6 months or when deemed necessary. RESULTS: During a median follow-up of 13 (10-16) months, the overall number of HF hospitalizations was 16 (rate 0.15 hospitalizations/patient-year) and 100 alerts were reported in 53 patients. Sixty alerts were judged clinically meaningful, and were associated with multiple HF-related conditions. In 48 of the 60 alerts, the clinician was not previously aware of the condition. Of these 48 alerts, 43 triggered clinical actions. The rate of alerts judged nonclinically meaningful was 0.37/patient-year, and the rate of hospitalizations not associated with an alert was 0.05/patient-year. Centers performed remote follow-up assessments of 1113 scheduled monthly transmissions (10.3/patient-year) and 100 alerts (0.93/patient-year). Monthly remote data review allowed to detect 11 (1%) HF events requiring clinical actions (vs 43% actionable alerts, P < .001). CONCLUSIONS: HeartLogic allowed relevant HF-related clinical conditions to be identified remotely and enabled effective clinical actions to be taken; the rates of unexplained alerts and undetected HF events were low. An alert-based management strategy seemed more efficient than a scheduled monthly remote follow-up scheme.

ICD-measured heart sounds and their correlation with echocardiographic indexes of systolic and diastolic function.

BACKGROUND: Novel implantable defibrillators (ICDs) allow first (S1) and third (S3) heart sounds to be measured by means of an embedded accelerometer. ICD-measured S1 and S3 have been shown to significantly correlate with hemodynamic changes in acute animal models. The HeartLogic algorithm (Boston Scientific) measures and combines multiple parameters, including S3 and S1, into a single index to predict impending heart failure decompensation. We evaluated the echocardiographic correlates of ICD-measured S1 and S3 in patients with ICD and cardiac resynchronization therapy ICD. METHODS: The HeartLogic feature was activated in 104 patients. During in-office visits, patients underwent echocardiographic evaluation, and parameters of systolic and diastolic function were correlated with S3 and S1 amplitude measured on the same day as the visit. RESULTS: S3 amplitude inversely correlated with deceleration time of the E-wave (r = -0.32; 95% CI -0.46 - -0.17; P < 0.001), and S1 amplitude significantly correlated with left ventricular ejection fraction (r = 0.17; 95% CI 0.03-0.30; P = 0.021). S3 > 0.9 mG detected a restrictive filling pattern with 85% (95% CI 72%-93%) sensitivity and 82% (95% CI 75%-88%) specificity, while S1 < 1.5 mG detected ejection fraction < 35% with 28% (95% CI 19%-40%) sensitivity and 88% (95% CI 80%-93%) specificity. CONCLUSION: ICD-measured heart sound parameters are significantly correlated with echocardiographic indexes of systolic and diastolic function. This confirms their utility for remote patient monitoring when used as single sensors and their potential relevance when considered in combination with other physiological ICD sensors that evaluate various aspects of heart failure physiology.

Subcutaneous implantable cardioverter defibrillator in patients with arrhythmogenic right ventricular cardiomyopathy: Results from an Italian multicenter registry.

BACKGROUND: Despite expanding indication of the subcutaneous implantable cardioverter defibrillator (S-ICD) in clinical practice, limited data exists on safety and efficacy of S-ICD in arrhythmogenic right ventricular cardiomyopathy (ARVC) patients. The aim of this multicenter study was to evaluate the safety and efficacy of S-ICD in ARVC patients. METHODS: The study population included 44 consecutive patients with definite ARVC diagnosis according to the 2010 ITF criteria (57% male, mean age 37 ±â€¯17 years [range 10-75 years]) who received an S-ICD. Eighteen (41%) patients were implanted for secondary prevention. RESULTS: At implant, all inducible patients (34/44) had conversion of ventricular fibrillation at 65 J. No early complications occurred. During a median follow-up of 12 months (7-19), 3 (6.8%) patients experienced complications requiring surgical revision. No local or systemic device-related infections were observed. Six patients (14%) received a total of 61 appropriate and successful shocks on ventricular arrhythmias. Six (14%) patients experienced 8 inappropriate shocks for oversensing of cardiac signal (4 cases) and non-cardiac signal (4 cases) with one patient requiring device explantation. No patients had the device explanted due to the need for antitachycardia pacing. CONCLUSIONS: The study shows that S-ICD provides safe and effective therapy for termination of both induced and spontaneous malignant ventricular tachyarrhythmias with high energy shocks in ARVC patients, but the risk of inappropriate shocks and complications needing surgical revision should be considered.

Preliminary experience with the multisensor HeartLogic algorithm for heart failure monitoring: a retrospective case series report.

AIMS: In the Multisensor Chronic Evaluation in Ambulatory Heart Failure Patients study, a novel algorithm for heart failure (HF) monitoring was implemented. The HeartLogic (Boston Scientific) index combines data from multiple implantable cardioverter defibrillator (ICD)-based sensors and has proved to be a sensitive and timely predictor of impending HF decompensation. The remote monitoring of HF patients by means of HeartLogic has never been described in clinical practice. We report post-implantation data collected from sensors, the combined index, and their association with clinical events during follow-up in a group of patients who received a HeartLogic-enabled device in clinical practice. METHODS AND RESULTS: Patients with ICD and cardiac resynchronization therapy ICD were remotely monitored. In December 2017, the HeartLogic feature was activated on the remote monitoring platform, and multiple ICD-based sensor data collected since device implantation were made available: HeartLogic index, heart rate, heart sounds, thoracic impedance, respiration, and activity. Their association with clinical events was retrospectively analysed. Data from 58 patients were analysed. During a mean follow-up of 5 ± 3 months, the HeartLogic index crossed the threshold value (set by default to 16) 24 times (over 24 person-years, 0.99 alerts/patient-year) in 16 patients. HeartLogic alerts preceded five HF hospitalizations and five unplanned in-office visits for HF. Symptoms or signs of HF were also reported at the time of five scheduled visits. The median early warning time and the time spent in alert were longer in the case of hospitalizations than in the case of minor events of clinical deterioration of HF. HeartLogic contributing sensors detected changes in heart sound amplitude (increased third sound and decreased first sound) in all cases of alerts. Patients with HeartLogic alerts during the observation period had higher New York Heart Association class (P = 0.025) and lower ejection fraction (P = 0.016) at the time of activation. CONCLUSIONS: Our retrospective analysis indicates that the HeartLogic algorithm might be useful to detect gradual worsening of HF and to stratify risk of HF decompensation.

Subcutaneous implantable cardioverter defibrillator implantation: An analysis of Italian clinical practice and its evolution.

BACKGROUND: The subcutaneous implantable cardioverter defibrillator (S-ICD) is a relatively novel alternative to the transvenous ICD for the treatment of life-threatening ventricular arrhythmias, and is currently used in the clinical practice of several centers. The aim of this analysis was to describe current Italian practice regarding S-ICD implantation and its evolution over the years. METHODS: We analyzed 607 consecutive patients (78% male, 48 ±â€¯16 years) who underwent S-ICD implantation in 39 Italian centers from 2013 to 2017. RESULTS: Structural cardiomyopathy was present in 78% of patients and 30% of patients received their device for secondary prevention. The proportion of patients with dilated cardiomyopathy and with left ventricular ejection fraction ≤35% increased from ≤2014 to 2017 (from 38% to 58%, from 33% to 53%, respectively; both p < 0.05). Almost all procedures (97%) were performed in electrophysiology laboratories. Over the last 4 years, the 2-incision implantation technique has been widely adopted, with sub- or inter-muscular positioning of the generator, under local anesthesia or deep sedation (≤2014 versus 2017: all p < 0.001). Defibrillation testing was performed in 81% of patients. Shock energy of ≤65 J was successful in 93.9% of patients and the overall cardioversion success rate at ≤80 J was 99.8%. CONCLUSIONS: Our analysis confirmed that the S-ICD continues to be preferentially used in specific patients (younger, less frequently with dilated cardiomyopathy and low ejection fraction.). Nonetheless, we noted a trend toward the wider use of S-ICD in patients with dilated cardiomyopathy and systolic dysfunction over the years. Novel approaches have been adopted while the acute efficacy of the system has remained stably high.

Sudden onset sensorineural hearing loss caused by meningeal carcinomatosis secondary to occult malignancy: report of two cases.

Meningeal carcinomatosis (MC) is an uncommon form of metastasis of solid tumors. In the absence of clinical meningeal or parenchymal involvements, the sensorineural hearing loss (SNHL) as the starting symptom of MC is very infrequent. We report the history of two patients affected by MC who presented first with progressive SNHL. In both cases the early magnetic resonance imaging (MRI) finding mimicked bilateral masses in the cerebellopontine angle (CPA). Only the histopathologic result and surgical biopsy in cases 1 and 2, respectively, identified masses secondary to occult malignancy. However the available investigations could not discover the primary site of metastatic carcinoma. Despite the poor prognosis, because of the rarity and severity of MC we consider important to make known our experience in order to consider metastatic tumors in the differential diagnosis for sudden SNHL.