Switching to a 100% remote follow-up of implantable cardiac electronic devices: Organizational model and results of a single center experience.

INTRODUCTION: During the SARS-CoV-2 COVID-19 pandemic, the global health system needed to review important processes involved in daily routines such as outpatient activities within the hospital, including follow-up visits of implantable cardiac electronic devices (CIEDs) carried out in office. The aim of this study is to describe our 3.5 years of real-world experience of a full remote CIED follow-up, evaluate the success rate of remote transmissions, and verify the adopted organizational model. METHODS: From April 2020 to November 2023, all patients with an activated and well-functioning remote monitoring (RM) system and automatic algorithms, like autocapture and autosensing, underwent exclusive RM follow-up. Unscheduled in-office visits were only prompted by remote yellow or red alerts. Patients were divided into two groups, based on available technology: Manual Transmission System (MTS) and Automatic Transmission System (ATS). The ATS group, in addition to ensuring a daily transmission of any yellow or red alerts, was checked at least every 15 days to ensure a valid connection. An automatic transmission was scheduled once a year, irrespective of alerts occurred. The MTS group provided a manual transmission every 6 months. RESULTS: One thousand nine hundred thirty-seven consecutive patients were included in the study. By the end of November 2023, a total of 1409 patients (1192 in the ATS and 217 in the MTS group) were still actively followed by our remote clinic (384 expired, 137 dismissed, 7 transferred). The overall success rate of transmissions with the adopted organizational model was 96.6% in the ATS group (connection index) and 87% in the MTS group. Conventional in-hospital follow-up visits decreased by 44%. Total clinic working time, resulting from the sum of the time spent during in-hospital and remote follow-up, after an initial increase, was progressively reduced to the actual -25%. Mortality rate for any cause was 7.5% per year in remote follow-up patients and 8.3% (p=NS) in in-office patients. In the ATS group, no device malfunctions were notified to our remote clinic, before we had already realized it through appropriate alerts. CONCLUSIONS: The available technology makes moving to a 100% remote clinic possible, without overwhelming clinic workflow, safely. Adopting an appropriate organizational model, it is possible to maintain high transmission success rates. The automatic transmissions allow a more frequent control of patients with CIED.

Clinical Features and Mortality Rate of Infective Endocarditis in Intensive Care Unit: A Large-Scale Study and Literature Review.

BACKGROUND: Large-scale multicentric studies reported that, despite advances in diagnosis, antibiotics, and surgical treatment, infective endocarditis (IE) in-hospital mortality remains high. Most data have been obtained from patients treated in infective disease wards, internal medicine, cardiology, or cardiac surgery departments and are therefore heterogeneous. The few studies focused on complicated IE patients leading to intensive care unit (ICU) admission have reported different methodologies and results. The aim of our study was to describe the epidemiological, clinical, and microbial features of critically ill patients admitted to the ICU with a definite IE diagnosis. METHODS: We conducted a prospective case-series population study from January 1, 1998, to December 31, 2020. Patients were divided into 2 groups: 'Ward' (group 1) and 'ICU' patients (group 2), and a 1-year follow-up was performed. RESULTS: After performing a univariate and multivariate logistic regression analysis, we found that the independent predictors of ICU admission were vegetation diameter >10 mm, abnormal PaO2/FiO2 ratio, and acute heart failure. Five independent mortality risk factors were identified: SOFA score >14, not performing surgery, age >70 years, acute heart failure, and embolic complications. CONCLUSIONS: Infective endocarditis in-hospital mortality remains high. ICU admission and mortality can be predicted by independent risk factors.

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.

Antiplatelet and Anti-Coagulation Therapy for Left-Sided Catheter Ablations: What Is beyond Atrial Fibrillation?

Aim: International guidelines on the use of anti-thrombotic therapies in left-sided ablations other than atrial fibrillation (AF) are lacking. The data regarding antiplatelet or anticoagulation strategies after catheter ablation (CA) procedures mainly derive from AF, whereas for the other arrhythmic substrates, the anti-thrombotic approach remains unclear. This survey aims to explore the current practices regarding antithrombotic management before, during, and after left-sided endocardial ablation, not including atrial fibrillation (AF), in patients without other indications for anti-thrombotic therapy. Material and Methods: Electrophysiologists were asked to answer a questionnaire containing questions on antiplatelet (APT) and anticoagulation therapy for the following left-sided procedures: accessory pathway (AP), atrial (AT), and ventricular tachycardia (VT) with and without structural heart disease (SHD). Results: We obtained 41 answers from 41 centers in 15 countries. For AP, before ablation, only four respondents (9.7%) used antiplatelets and two (4.9%) used anticoagulants. At discharge, APT therapy was prescribed by 22 respondents (53.7%), and oral anticoagulant therapy (OAC) only by one (2.4%). In patients with atrial tachycardia (AT), before ablation, APT prophylaxis was prescribed by only four respondents (9.7%) and OAC by eleven (26.8%). At discharge, APT was recommended by 12 respondents (29.3%) and OAC by 24 (58.5%). For VT without SHD, before CA, only six respondents (14.6%) suggested APT and three (7.3%) suggested OAC prophylaxis. At discharge, APT was recommended by fifteen respondents (36.6%) and OAC by five (12.2%). Regarding VT in SHD, before the procedure, eight respondents (19.5%) prescribed APT and five (12.2%) prescribed OAC prophylaxis. At discharge, the administration of anti-thrombotic therapy depended on the LV ejection fraction for eleven respondents (26.8%), on the procedure time for ten (24.4%), and on the radiofrequency time for four (9.8%), with a cut-off value from 1 to 30 min. Conclusions: Our survey indicates that the management of anti-thrombotic therapy surrounding left-sided endocardial ablation of patients without other indications for anti-thrombotic therapy is highly variable. Further studies are necessary to evaluate the safest approach to these procedures.

Ventricular tachycardia ablation guided or aided by scar characterization with cardiac magnetic resonance: rationale and design of VOYAGE study.

BACKGROUND: Radiofrequency ablation has been shown to be a safe and effective treatment for scar-related ventricular arrhythmias (VA). Recent preliminary studies have shown that real time integration of late gadolinium enhancement cardiac magnetic resonance (LGE-CMR) images with electroanatomical map (EAM) data may lead to increased procedure efficacy, efficiency, and safety. METHODS: VOYAGE is a prospective, randomized, multicenter controlled open label study designed to compare in terms of efficacy, efficiency, and safety a CMR aided/guided workflow to standard EAM-guided ventricular tachycardia (VT) ablation. Patients with an ICD or with ICD implantation expected within 1 month, with scar related VT, suitable for CMR and multidetector computed tomography (MDCT) will be randomized to a CMR-guided or CMR-aided approach, whereas subjects unsuitable for imaging or with image quality deemed not sufficient for postprocessing will be allocated to standard of care ablation. Primary endpoint is defined as VT recurrences (sustained or requiring appropriate ICD intervention) during 12 months follow-up, excluding the first month of blanking period. Secondary endpoints will include procedural efficiency, safety, impact on quality of life and comparison between CMR-guided and CMR-aided approaches. Patients will be evaluated at 1, 6 and 12 months. DISCUSSION: The clinical impact of real time CMR-guided/aided ablation approaches has not been thoroughly assessed yet. This study aims at defining whether such workflow results in more effective, efficient, and safer procedures. If proven to be of benefit, results from this study could be applied in large scale interventional practice. Trial registrationClinicalTrials.gov, NCT04694079, registered on January 1, 2021.

Premature ventricular complex site of origin and ablation outcomes in patients with diabetes mellitus.

BACKGROUND: Premature ventricular complexes (PVCs) are frequent in patients with diabetes mellitus (DM). Still, the PVCs characteristics as well as the outcomes after catheter ablation in this population remain unknown. Aim of the study was to describe principal features of PVCs ablated in a wide DM-patients cohort and report postablation clinical outcomes in the follow-up of patients with DM and left ventricular dysfunction. METHODS: From April 2012 to April 2020 data of 544 patients (315 [58%] men, 55±16 y), consecutive patients submitted for PVC ablation, were prospectively collected. Patients with left ventricle (LV) systolic disfunction (LVEF<50%) were included in a prospective protocol and followed at 6 and 12 months, and annually thereafter. Baseline characteristic as well ablation outcomes were analyzed based on the presence of DM. RESULTS: Sixty (11%) patients had DM. Patients with DM more frequently had a PVC's site of origin (SOO) in the LV (45 [75%] vs. 229 [48%], P<0.001). The most frequent PVC's SOO in DM patients was the LV outflow tract (OT) (35 [58%] patients: 12 aortic cusps; 12 LV summit; 11 in the myocardium immediately inferior to the valvular plane). Fifty-five (92%) patients with DM had an acute successful ablation, without differences compared with patients without DM (55 [92%] vs. 437 [90%], P=0.9). Twenty-tree (38%) DM-patients had LV dysfunction at the ablation time. In these patients, mean PVC burden decreased from 26±11% at baseline to 4±5% (P<0.001); LVEF increased from 36±8% to 42±11% (P<0.01) and NYHA class improved from 2.2±0.6 to 1.8+0.5 (P<0.01), after a mean follow-up of 37±14 months. CONCLUSIONS: Patients with DM frequently have PVC with a LV-SOO, being the LVOT the most frequent SOO in this population. Among DM patients with LV dysfunction, ablation persistently and significantly reduce the PVC burden improving functional status. Patients with DM have lower benefit in terms of LV function recovery after ablation compared with non-diabetic patients.

Incidence and clinical relevance of left atrial appendage membranes: a new congenital heart disease?

AIMS: Left atrial appendage (LAA) membranes are rare congenital anomalies. Those involving the appendage orifice may obstruct its emptying flows, thus promoting blood stasis and clot formation. However, the epidemiology of LAA membranes has never been studied and a correlation with appendage thrombosis has never been proved. Very few case reports described LAA membranes, therefore, their frequency and clinical significance are not known. Moreover, their presence and degree are of crucial importance in planning LAA percutaneous closure, a procedure whose indication is evolving, and whether their presence can represent technical issues during the device implantation is not known. This study aimed to evaluate the incidence and the clinical significance of LAA membranes. METHODS AND RESULTS: A population of 6030 consecutive transoesophageal echo (TOE) studies has been retrospectively reviewed in order to find those patients in whom an LAA membrane has been found. A literature research has been performed to review previous described cases. Among 6030 TOE cases, an LAA membrane has been described in 6 (prevalence of 1/1000). In one case, the membrane was associated to a severe LAA hypoplasia and in another case to an LAA thrombus (these represent the first cases ever described). All patients had an atrial fibrillation (AF) history and two were in AF during the TOE exam. CONCLUSION: LAA membranes are rare congenital abnormalities occasionally discovered during a TOE exam, frequently in patients affected by AF. In half of the cases, they obstruct the LAA flow, thus theoretically pre-disposing to clot formation. They may be rarely associated to an appendage hypoplasia. During a TOE exam, cardiac imagers should always rule out their presence.

Imaging Techniques for the Study of Fibrosis in Atrial Fibrillation Ablation: From Molecular Mechanisms to Therapeutical Perspectives.

Atrial fibrillation (AF) is the most prevalent form of cardiac arrhythmia. It is often related to diverse pathological conditions affecting the atria and leading to remodeling processes including collagen accumulation, fatty infiltration, and amyloid deposition. All these events generate atrial fibrosis, which contribute to beget AF. In this scenario, cardiac imaging appears as a promising noninvasive tool for monitoring the presence and degree of LA fibrosis and remodeling. The aim of this review is to comprehensively examine the bench mechanisms of atrial fibrosis moving, then to describe the principal imaging techniques that characterize it, such as cardiac magnetic resonance (CMR) and multidetector cardiac computed tomography (MDCT), in order to tailor atrial fibrillation ablation to each individual.

Stepwise approach for visualization and reconstruction of pulmonary valve with intracardiac echocardiography.

Ventricular tachycardia and premature ventricular complexes (PVCs) arising from right ventricular outflow tract (RVOT) are the most common type of ventricular arrhythmias (VAs) in patients without structural heart disease. Radiofrequency ablation is now the gold standard of treatment in this setting due to high efficacy rates and optimal safety profile. During the last few years, the pulmonary valve (PV) and the pulmonary artery (PA) have attracted much attention as reliable sites of origin of RVOT-type arrhythmias. In the mean while intracardiac echocardiogram (ICE) has undoubtedly improved our understanding of the cardiac anatomy. Aim of this paper is to provide an illustrated step-by-step guide on how to use ICE with the CARTOSOUND module to visualize and reconstruct 3D shell of the RV, the PV, as well of other contiguous anatomical structures (i.e., the aortic valve and coronary arteries) to perform aware and safe ablation in this region.

Body mass index is related to unsuccessful puncture attempts and failure to axillary vein cannulation during ultrasound-guided cardiac electronic device implantation.

PURPOSE: Ultrasound (US)-guided axillary vein cannulation is effective and safe during cardiac implantable electronic devices (CIEDs). It is a reasonable alternative to other techniques in order to shorten procedural time and decrease perioperative complications. However, in this context, the short-axis (out-of-plane) visualization to guide the vein puncture is the most used technique. The aim of our study is to describe a single-center experience with the US long-axis (in-plane) technique defining predictors of unsuccessful puncture attempts and failure to axillary vein cannulation in a cohort of patients undergoing CIEDs procedures. METHODS: From November 2017 to June 2019, consecutive patients undergoing CIEDs procedures were enrolled in the study. US-guided long axis (in-plane) view to guide axillary vein cannulation was used in all subjects. Unsuccessful puncture attempts (UAs) and complete failures to cannulate the vein were collected for each procedure. All patients were evaluated on a daily basis until hospital discharge and at 1-month follow up visit. RESULTS: Among 119 subjects (M: F = 75:44), mean age was 79 ± 9 years, mean BMI 25.7 ± 4.3 kg/m2, and mean BSA 1.74 ± 0.4 m2. We placed 95 pacemakers (32 single-, 61 dual-, and 2 triple-chamber) and 20 ICDs (7 single, 6 dual, 7 triple chambers). An upgrade from dual-chamber to triple-chamber device was carried out with the addition of a new lead in 3 patients. During a system revision, one new electrode was implanted. The overall leads inserted were 204. There were 33 initial unsuccessful attempts in 22/119 patients. US-guided axillary access was finally successful in 94.9% of patients (113/119). In the other cases (6/119), cephalic vein was isolated or blinded subclavian puncture was performed. Interestingly, at univariate analysis, an increasing BMI and BSA, male sex, and anticoagulant therapy were predictors of unsuccessful attempts or failure to cannulate the vein with US. Among those subjects, the multivariate logistic regression showed significant correlations only between BMI and unsuccessful attempts: odds ratio (OR) = 1.16, p = 0.009 [95% CI = 1.04-1.31], and BMI with failure to cannulate the vein: OR = 1.21, p = 0.03 [95%CI = 1.01-1.45]. The receiver operating characteristic (ROC) curves individuated the best BMI value cutoff point at 27 kg/m2 (area under the curve [AUC]: 68.6%) having a sensitivity of 63.6% and a specificity of 66.5% for unsuccessful puncture attempts; a BMI value of 28 kg/m2 (AUC 74.9%) had a sensitivity of 66.7% and a specificity of 66.7% for failure to cannulate the vein with the US-guided approach. CONCLUSIONS: Axillary vein long-axis (in-plane) US-guided cannulation during CIEDs implantation is characterized by a high success rate (94.9%). An elevated BMI is significantly related to unsuccessful puncture attempts or failure to cannulation. The higher is the BMI, the more are the chances to have difficult vein puncture or cannulation failure and to switch from US-guided approach to another technique.

Premature ventricular complex site of origin and ablation outcomes in patients with prior myocardial infarction.

BACKGROUND: Frequent premature ventricular complexes (PVCs) are common after a myocardial infarction (MI), but data on PVC ablation in this population are limited. OBJECTIVE: The purpose of this study was to analyze data on PVC ablation in post-MI patients. METHODS: Three hundred thirty-two patients with frequent PVCs and left ventricular (LV) dysfunction were prospectively studied. Data from 67 patients (20%; age 63 ± 10 years; 65 men [93%]) with previous MI were compared with the remaining 265 patients. RESULTS: PVCs in post-MI patients originate predominantly from the LV (92% LV vs 6% right ventricle [RV]; P <.001). The most frequent sites of origin (SOO) were MI scar in 23 patients (34%) and left ventricular outflow tract (LVOT) in 22 patients (33%). A papillary muscle origin was more frequent in post-MI patients (16% vs 4%; P = .001), whereas an RV outflow tract origin was less frequent (1% vs 33%; P <.001) compared to patients without MI. In post-MI patients, PVC burden decreased from 29% ± 12% at baseline to 4.6% ± 7% (P <.001); left ventricular ejection fraction (LVEF) improved from 33.6% ± 8% to 42% ± 10% (P <.001); and New York Heart Association functional class improved from 2.1 ± 0.7 to 1.4 ± 0.5 points (P <.001) at 12 months. Compared with the remaining 265 patients, there were no differences in acute ablation success (85% vs 85%; P = .45), complication rate (6% vs 6%; P = .41), or absolute improvement in LVEF (8.8 ± 10 vs 9.9 ± 11 absolute points; P = .38). CONCLUSION: PVC ablation significantly improves cardiac function and functional status in post-MI patients. PVCs predominantly originate from MI scar and LVOT. A papillary muscle SOO was found to be strongly associated with previous MI.

[Clinical pathway for electrical storm treatment in a healthcare network modeling. A proposal from ANMCO Tuscany]. / Percorso clinico-assistenziale in rete per il trattamento del paziente con "storm" aritmico. La proposta dell'ANMCO Toscana.

Electrical storm (ES) is defined as three or more episodes of sustained ventricular tachycardia (VT) or fibrillation (VF) within 24 h, or an incessant VT/VF lasting more than 12 h. It usually occurs in implantable cardioverter-defibrillator (ICD) recipients, and three or more device interventions are typically used for the diagnosis. ES incidence is particularly high in case of ICD implanted in secondary prevention (10-30%), with recurrences occurring in up to 80% of patients. A comprehensive evaluation of triggers, predictive factors of high-risk patients and an appropriate management of the acute/subacute and chronic phases are pivotal to reduce mortality and recurrences. Medical therapy with antiarrhythmic and anesthetic drugs, with appropriate device reprogramming and neuroaxial modulation if needed, are used to cool down the ES, which should ultimately be treated with ablation therapy or, less often, with an alternative treatment, such as denervation or stereotactic radiosurgery. An optimization of the clinical pathway in a network modeling is crucial to achieve the best treatment, eventually addressing patients to centers with VT ablation programs, and identifying the most challenging procedures and the most critical patients that should be treated only in high-volume tertiary centers. In this paper, we present a proposal of healthcare network modeling for ES treatment in a regional setting.

Optimal Antithrombotic Treatment of Patients with Atrial Fibrillation Early after an Acute Coronary Syndrome-Triple Therapy, Dual Antithrombotic Therapy with an Anticoagulant Or, Rather, Temporary Dual Antiplatelet Therapy?

The combination of atrial fibrillation (AF) and acute coronary syndrome (ACS) is a complex situation in which a three-dimensional risk-cardioembolic, coronary, and hemorrhagic-has to be carefully managed. Triple antithrombotic therapy (TAT) is burdened with a high risk of serious bleeding, while dual antithrombotic therapy with an anticoagulant (DAT) likely provides only suboptimal coronary protection early after stent implantation. Moreover, TAT precludes the advantages provided by the use of the latest and more potent P2Y12 inhibitors in ACS patients. Here, we aimed to simulate and compare the expected coronary, cardioembolic, and hemorrhagic outcomes offered by DAT, TAT, or modern dual antiplatelet therapy (DAPT) with aspirin plus one of the latest P2Y12 inhibitors in AF patients early after an ACS. The comparison of numbers needed to treat to prevent major adverse events with the various antithrombotic regimens suggests that AF-ACS patients at high ischemic and hemorrhagic risk and at moderately low embolic risk (CHA2DS2VASc score 2-4) might safely withhold anticoagulation after revascularization for one month taking advantage of a modern DAPT, with a favorable risk-to-benefit ratio. In conclusion, this strategy, not sufficiently addressed in recent European and North American guidelines or consensus documents, adds to the spectrum of treatment options in these difficult patients; it might be the best choice in a substantial number of patients; and should be prospectively tested in a randomized controlled trial.