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Objectives: To evaluate the effects of cardiac resynchronization therapy (CRTd) in patients with type 2 diabetes mellitus (T2DM) optimized via automatic vs. echocardiography-guided approach., Background: The suboptimal atrio-ventricular (AV) and inter-ventricular (VV) delays optimization reduces CRTd response. Therefore, we hypothesized that automatic CRTd optimization might improve clinical outcomes in T2DM patients., Methods: We designed a prospective, multicenter study to recruit, from October 2016 to June 2019, 191 consecutive failing heart patients with T2DM, and candidate to receive a CRTd. Study outcomes were CRTd responders rate, hospitalizations for heart failure (HF) worsening, cardiac deaths and all cause of deaths in T2DM patients treated with CRTd and randomly optimized via automatic (n 93) vs. echocardiography-guided (n 98) approach at 12 months of follow-up., Results: We had a significant difference in the rate of CRTd responders (68 (73.1%) vs. 58 (59.2%), p 0.038), and hospitalizations for HF worsening (12 (16.1%) vs. 22 (22.4%), p 0.030) in automatic vs. echocardiography-guided group of patients. At multivariate Cox regression analysis, the automatic guided approach (3.636 [1.271-10.399], CI 95%, p 0.016) and baseline highest values of atrium pressure (automatic SonR values, 2.863 [1.537-6.231], CI 95%, p 0.006) predicted rate of CRTd responders. In automatic group, we had significant difference in SonR values comparing the rate of CRTd responders vs. non responders (1.24 ± 0.72 g vs. 0.58 ± 0.46 g (follow-up), p 0.001), the rate of hospitalizations for HF worsening events (0.48 ± 0.29 g vs. 1.18 ± 0.43 g, p 0.001), and the rate of cardiac deaths ( 1.13 ± 0.72 g vs. 0.65 ± 0.69 g, p 0.047)., Conclusions: Automatic optimization increased CRTd responders rate, and reduced hospitalizations for HF worsening. Intriguingly, automatic CRTd and highest baseline values of SonR could be predictive of CRTd responders. Notably, there was a significant difference in SonR values for CRTd responders vs. non responders, and about hospitalizations for HF worsening and cardiac deaths. Clinical trial ClinicalTrials.gov Identifier NCT04547244.

Aims: The high rate of implantable cardioverter defibrillator (ICD) lead failures related to the Sprint Fidelis' and Riata's design have raised serious concerns about the reliability of ICD leads. The St. Jude Medical Durata family of leads replaced the preceding Riata line following increased rates of lead failure (1.17% per year). The aim of our study was to evaluate the long-term performance of the Durata lead., Methods: Eight hundred and eighteen Durata ICD leads were implanted in 11 Italian centers. The incidence of lead failure, defined as a sudden rise in long-term pacing or defibrillation impedance and/or a sudden change in R-wave amplitude and capture thresholds, was assessed. The incidences of lead dislodgment and lead perforation were also evaluated., Results: During a median follow-up of 1353 days (3.7 years; 25-75th interquartile range 806-1887 days) lead failure occurred in 16/818 leads (0.54%/year). The overall survival, free of lead failure, was 98.9% at 3 years, 98.2% at 4 years and 97.5% at 5 years. Lead dislodgment occurred in 12/818 leads with an incidence of 0.4%/year. No cases of cardiac perforation were reported. No major adverse events were reported except for two cases of inappropriate shocks as a consequence of failure or dislodgment., Conclusion: Our study suggests that the Durata lead does not engender a higher risk of failure. Overall survival, free from lead failure, was found to be higher than previously reported for the Riata lead.

Introduction: Clinical trials did not provide conclusive evidence concerning the benefit of prophylactic implantable cardioverter-defibrillators (ICDs) in patients with severe nonischemic cardiomyopathy (NICM). We aimed to compare incidence of appropriate sustained ventricular arrhythmia (SVA) and device therapy in ischemic cardiomyopathy (ICM) vs NICM ICD and/or cardiac resynchronization therapy (CRT-D) patients., Methods and Results: We analyzed remote-monitoring data from devices of the Home Monitoring Expert Alliance network. SVA recordings were adjudicated by three independent electrophysiologists. Our cohort included 1,946 patients who received either an ICD (55%) or a CRT-D (45%) for primary prevention of sudden cardiac death. Median (interquartile range) age was 70 (62-77) years, 81% were male, and 52% were in the ICM group. Patients were remotely monitored for a maximum follow-up of 5 years. The 5-year product-limit estimate of SVA incidence in patients with an ICD was 47.3% (95% confidence interval [CI], 41.0%-53.9%) in the ICM group and 44.7% (36.9%-53.3%) in the NICM group. In patients with a CRT-D, SVA incidence was 45.7% (37.3%-55.0%) in ICM patients and 49.2% (40.4%-58.7%) in NICM patients. The adjusted hazard ratio for SVA in the ICM vs NICM group was 0.96 (95% CI: 0.70-1.30, P = .77) in ICD patients and 0.85 (95% CI: 0.61-1.18, P = .34) in CRT-D patients. SVAs triggered appropriate device therapies with similar incidence in all groups., Conclusion: In a large cohort of remotely monitored ICD and CRT-D recipients, SVA incidence did not significantly differ in ICM and NICM patients., (© 2019 Wiley Periodicals, Inc.)

Objectives: To evaluate clinical outcomes in patients with diabetes, treated by cardiac resynchronization therapy with a defibrillator (CRT-d), and glucagon-like peptide 1 receptor agonists (GLP-1 RA) in addition to conventional hypoglycemic therapy vs. CRTd patients under conventional hypoglycemic drugs., Background: Patients with diabetes treated by CRTd experienced an amelioration of functional New York Association Heart class, reduction of hospital admissions, and mortality, in a percentage about 60%. However, about 40% of CRTd patients with diabetes experience a worse prognosis., Materials and Methods: We investigated the 12-months prognosis of CRTd patients with diabetes, previously treated with hypoglycemic drugs therapy (n 271) vs. a matched cohort of CRTd patients with diabetes treated with GLP-1 RA in addition to conventional hypoglycemic therapy (n 288)., Results: At follow up CRTd patients with diabetes treated by GLP-1 RA therapy vs. CRTd patients with diabetes that did not receive GLP-1 RA therapy, experienced a significant reduction of NYHA class (p value < 0.05), associated to higher values of 6 min walking test (p value < 0.05), and higher rate of CRTd responders (p value < 0.05). GLP-1 RA patients vs. controls at follow up end experienced lower AF events (p value < 0.05), lower VT events (p value < 0.05), lower rate of hospitalization for heart failure worsening (p value < 0.05), and higher rate of CRTd responders (p value < 0.05). To date, GLP-1 RA therapy may predict a reduction of AF events (HR 0.603, CI [0.411-0.884]), VT events (HR 0.964, CI [0.963-0.992]), and hospitalization for heart failure worsening (HR 0.119, CI [0.028-0.508]), and a higher CRT responders rate (HR 3.707, CI [1.226-14.570])., Conclusions: GLP-1 RA drugs in addition to conventional hypoglycemic therapy may significantly reduce systemic inflammation and circulating BNP levels in CRTd patients with diabetes, leading to a significant improvement of LVEF and of the 6 min walking test, and to a reduction of the arrhythmic burden. Consequently, GLP-1 RA drugs in addition to conventional hypoglycemic therapy may reduce hospital admissions for heart failure worsening, by increasing CRTd responders rate. Trial registration NCT03282136. Registered 9 December 2017 "retrospectively registered".

Background: CHA 2 DS 2 -VASc is a validated score for predicting stroke in patients with atrial fibrillation (AF)., Objective: The purpose of this study was to assess whether the CHA 2 DS 2 -VASc score can predict new-onset AF in a cohort of patients with a cardiac implantable electronic device (CIED) followed with remote monitoring., Methods: Using the database of the Home Monitoring Expert Alliance project, we selected 2410 patients with no documented AF who had received a CIED with diagnostics on atrial high rate episodes (AHREs). The primary endpoint was time to first day with cumulative AHRE burden ≥15 minutes, 5 hours, 24 hours, and ≥7 consecutive days., Results: During a median duration of 24.1(11.5-42.9) months, the incidence of AHRE increased with increasing CHA 2 DS 2 -VASc. At 6 years, occurrence of ≥15-minute AHRE was 80.2% (CHA 2 DS 2 -VASc ≤1) vs 93.7% (CHA 2 DS 2 -VASc ≥5), whereas ≥5-hour AHRE incidence was 68.4% (CHA 2 DS 2 -VASc ≤1) vs 92.5% (CHA 2 DS 2 -VASc ≥5). Occurrence of ≥24-hour and ≥7-day AHREs also increased with increasing CHA 2 DS 2 -VASc: 9.1% and 3.9% (CHA 2 DS 2 -VASc ≤1) vs 40.4% and 28.7% (CHA 2 DS 2 -VASc ≥5), respectively. Adjusted hazard ratio for unitary CHA 2 DS 2 -VASc increase ranged from 1.09 (confidence interval 1.04-1.14; P <.001) with AHRE burden ≥15 minutes to 1.26 (confidence interval 1.11-1.42; P <.001) with AHRE burden ≥7 days. At receiver operating curve analysis, CHA 2 DS 2 -VASc ≥2 was estimated to predict persistent forms of AHREs with 95.8% sensitivity but 11.7% specificity at 3 years. CHA 2 DS 2 -VASc ≥5 had 77.0% specificity but 34.6% sensitivity., Conclusion: In a CIED population with no previous diagnosis of clinical AF, AHRE incidence increased with increasing CHA 2 DS 2 -VASc score. The association was stronger with longer AHREs, but the accuracy of CHA 2 DS 2 -VASc as AHRE predictor was moderate., (Copyright © 2018. Published by Elsevier Inc.)

Aims: The Really ProMRI study evaluates magnetic resonance imaging (MRI) access for patients with cardiac implantable electronic devices (CIEDs) as well as the performance of magnetic resonance (MR)-conditional leads when undergoing MRI., Methods and Results: Patients either with an MR-conditional pacemaker or implantable defibrillator (ICD) system or with at least a component (device or one or more leads) from an MR-conditional system, were asked to fill in a questionnaire when they were referred to a MR scan. The rate of prescription, denial, or execution of MR examinations was evaluated in a 1-year follow-up visit. In total, 555 patients [median age (interquartile range) 72.2 (62.2-78.6); 72% male] were enrolled, 49% (270) with a pacemaker, 51% (285) with an ICD system. Five-hundred and ten patients completed the follow-up period. A total of 37 MRI referrals were reported in 35 patients, with a consequent event rate of 7.0/100 patient-years (CI, 4.9-9.7). Fourteen were denied, while 23 [66%; (CI, 48-81%)] were performed. The number of patients with MR referrals was not statistically different between pacemaker and ICD groups (21 vs. 14; P = 0.178). The rate of scans performed was higher in the pacemaker subjects (19/23 vs. 4/14, P = 0.003), while it was similar between patients with or without a complete MR-conditional system (19/30 vs. 4/7, P = 0.606)., Conclusion: In this study, we reported a 7.0/100 patient-year's event rate of MR prescriptions in CIED patients. Many examinations were denied, despite MR-conditional systems, especially in ICD patients. Regulatory and cultural changes are needed to allow wider access to MR imaging in CIED patients with MR-conditional systems.

Introduction: Ganglioneuroma (GN) is a benign, differentiated variety of neurogenic tumor. It is often asymptomatic and may be diagnosed by serendipity. Surgical removal is the treatment of choice. However, it has been suggested that postoperative complications and sequelae might outweigh the benefits of this approach. The purpose of the present study was to examine these issues in a large experience of neural tumors., Methods: Patients treated between 1992 and 2012 were retrospectively reviewed. Modern imaging, measurement of catecholamine metabolite excretion and metaiodobenzylguanidine were used for workup. Surgical treatment aimed at complete resection. Complications and sequelae were recorded. Literature was searched for regrowth or malignant transformation of GN., Results: Of 227 patients with neural tumors, 24 were GN patients (12 abdominal, 11 thoracic and 1 cervical with 8 dumbbell extensions). Six children were symptomatic (three with abdominal pain and mass, one with stridor or dysphonia, and one each with anisocoria and opsomyoclonus). However, 18 (75%) were asymptomatic and the diagnosis was incidental. Several tumors were large and involved more than one body space. There were no neurologic symptoms in eight cases with dumbbell extension. Complete resection was achieved in 20 children (83%) whereas gross residual was left in four. Postoperative complications were: Horner syndrome (3 patients), mild scoliosis (1 patient), adhesive bowel obstruction (1 patient) and acute urinary retention (1 patient). There was no evidence of either regrowth or malignant behavior in residual masses left in place after follow-up of 84 (1-194) months., Conclusions: There were a limited number of general minor complications in this series that did not include cases of regrowth or malignant transformation. However, these unfavorable events were occasionally reported in the literature. Since diagnosis of GN cannot be ascertained before removal of the mass, this should remain the aim of the treatment, although limiting the chances of complications to a minimum even if incomplete resection is the price to pay. Nonoperative attitudes should not be recommended in all cases, but they are certainly justified in some., (Georg Thieme Verlag KG Stuttgart · New York.)

Aims: Clinical trials have established that atrial fibrillation (AF) catheter ablation improves symptoms in appropriately selected patients. Confirmation of these results by long-term prospective observational studies is needed. This registry was created to describe the experience of 16 Italian centers with a large cohort of AF patients treated with catheter ablation guided by the NavX 3D mapping system., Methods: From November 2006 to May 2008, 545 consecutive patients (age 60.4 ± 9.8, 67 % male) with paroxysmal (44 %), persistent (43 %), and long-standing persistent (13 %) AF referred for catheter ablation guided by the NavX system, were included in this registry. For this paper, follow-up was censored at 24 months; however, patients are being followed in the ongoing registry., Results: Before the ablation, 80 % of patients failed to respond to at least one antiarrhythmic drug aimed at rhythm control. Pulmonary vein (PV) isolation guided by a circular mapping catheter was performed in 70 % of patients whereas non potential-guided PV encircling was performed in 30 % of patients. In 67 % of patients, additional left atrial (LA) substrate modification was performed. Image integration was performed in 9.2 % of patients. Considering a 3-month blanking period, after a single-ablation procedure, the patients had 1- and 2-year freedom from AF recurrence of 67.4 and 57.0 % (36.1 % off antiarrhythmic drugs), respectively. Cox regression analysis showed that AF recurrences during blanking (HR 2.1), and previous AF ablation (HR 3.3) were independent predictors of AF recurrences. Major procedure-related complications occurred in 53 patients (9.7 %). In 35 patients (6.7 %), a repeat procedure was performed at a median of 5 months after the initial procedure., Conclusions: This prospective, multicenter clinical experience provides significant insights into current ablation care of patients with AF. Despite favorable outcomes, real-world complication rates appear higher than previously recognized.