Contemporary Advances in Cardiac Remote Monitoring: A Comprehensive, Updated Mini-Review.

Over the past decade, remote monitoring (RM) has become an increasingly popular way to improve healthcare and health outcomes. Modern cardiac implantable electronic devices (CIEDs) are capable of recording an increasing amount of data related to CIED function, arrhythmias, physiological status and hemodynamic parameters, providing in-depth and updated information on patient cardiovascular function. The extensive use of RM for patients with CIED allows for early diagnosis and rapid assessment of relevant issues, both clinical and technical, as well as replacing outpatient follow-up improving overall management without compromise safety. This approach is recommended by current guidelines for all eligible patients affected by different chronic cardiac conditions including either brady- and tachy-arrhythmias and heart failure. Beyond to clinical advantages, RM has demonstrated cost-effectiveness and is associated with elevated levels of patient satisfaction. Future perspectives include improving security, interoperability and diagnostic power as well as to engage patients with digital health technology. This review aims to update existing data concerning clinical outcomes in patients managed with RM in the wide spectrum of cardiac arrhythmias and Hear Failure (HF), disclosing also about safety, effectiveness, patient satisfaction and cost-saving.

Conduction system disease management in patients candidate and/or treated for the aortic valve disease: an Italian Survey promoted by Italian Association of Arrhythmology and Cardiac Pacing (AIAC).

BACKGROUND: Conduction system disorders represent a frequent complication in patients undergoing surgical (surgical aortic valve replacement, SAVR) or percutaneous (transcatheter aortic valve implantation, TAVI) aortic valve replacement. The purpose of this survey was to evaluate experienced operators approach in this clinical condition. METHODS: This survey was independently conducted by the Italian Association of Arrhythmology and Cardiac Pacing (AIAC) and it consisted of 24 questions regarding the respondents' profile, the characteristics of participating centres, and conduction disease management in different scenarios. RESULTS: Fifty-five physicians from 55 Italian arrhythmia centres took part in the survey. Prophylactic pacemaker implantation is rare. In case of persistent complete atrioventricular block (AVB), 49% and 73% respondents wait less than one week before implanting a definitive pacemaker after SAVR and TAVI, respectively. In case of second degree AVB, the respondents wait some days more for definitive implantation. Respondents consider bundle branch blocks, in particular pre-existing left bundle branch block (LBBB), the worst prognostic factors for pacemaker implantation after TAVI. The implanted valve type is considered a relevant element to evaluate. In patients with new-onset LBBB and severe/moderate left ventricular systolic dysfunction, respondents would implant a biventricular pacemaker in 100/55% of cases, respectively. CONCLUSIONS: Waiting time before a definitive pacemaker implantation after aortic valve replacement has reduced compared to the past, and it is anticipated in TAVI vs. SAVR. Bundle branch blocks are considered the worse prognostic factor for pacemaker implantation after TAVI. The type of pacemaker implanted in new-onset LBBB patients without severe left ventricular systolic dysfunction is heterogeneous.

A global analysis of implants and replacements of pacemakers and cardioverter-defibrillators before, during, and after the COVID-19 pandemic in Italy.

At the beginning of the COVID-19 emergency, non-urgent surgical procedures had to be deferred, but also emergencies were reduced. To assess the global trend of pacemaker (PM) and implantable cardiac-defibrillator (ICD) procedures performed in Italy before, during, and after the first COVID-19 emergency, all the Italian hospital discharge records related to PM/ICD procedures performed between 2012 and 2021, sent to the National Institute of Health, were reviewed. Compared to 2019, in 2020, there was a reduction of first PM implants (52,216 to 43,962, -16%; p < 0.01), but not replacements (16,591 to 17,331, + 4%; p = 0.16). In particular, in April 2020, there was a drop of first implants (- 53,4% vs the average value of April 2018 and April 2019; p < 0.01), while the reduction of replacements was less evident (-32.6%; p = NS). In 2021, PM procedures increased to values similar to the pre-pandemic period. A reduction of ICD procedures was observed in 2020 (22,355, -7% toward 2019), mainly in April 2020 (- 46% vs April 2018/April 2019; p = 0.03). In 2021, the rate of ICD procedures increased (+ 14% toward 2020). A non-significant reduction of "urgent" procedures (complete atrioventricular block for PM and ventricular fibrillation for ICD), even in April 2020, was observed. In 2020, there was a reduction of first PM implants and ICDs, offset by increased activity in 2021. No decrease in PM replacements was observed, and the drop in "urgent" PM and ICD procedures was not statistically significant.

[The Pacemaker and Implantable Cardioverter-Defibrillator Registry of the Italian Association of Arrhythmology and Cardiac Pacing - Report 2022]. / Registro Italiano Pacemaker e Defibrillatori Associazione Italiana di Aritmologia e Cardiostimolazione Report 2022.

BACKGROUND: The Pacemaker (PM) and Implantable Cardioverter-Defibrillator (ICD) Registry of the Italian Association of Arrhythmology and Cardiac Pacing (AIAC) collects information about demographics, clinical characteristics, main indications for PM/ICD therapy and device types from the voluntary Italian collaborating centers. METHODS: For the year 2022 main data about national PM and ICD implantation activity were obtained on the basis of European Cards and subsequently analyzed to create a standard report. RESULTS: PM Registry: data about 17 800 PM implantations were collected (14 191 first implants and 3609 replacements). The number of collaborating centers was 152. Median age of treated patients was 81 years (75 quartile I; 86 quartile III). Main ECG indications included atrioventricular conduction disorders in 46.0% of first PM implants, sick sinus syndrome in 17.7%, atrial fibrillation plus bradycardia in 7.7%, other unspecified ECG and electrophysiological abnormalities in 43.0%. For first PM implants, pacing in DDDR mode was reported in 42.2%, followed by DDD mode (20.6%), VVIR mode (25.1%), VVI mode (11.1%) and finally VDD-VDDR (5.1%). Median value of longevity of explanted PMs was 8.3 years. ICD Registry: data about 5210 ICD implantations were obtained (3656 first implants and 1554 replacements). The number of collaborating centers was 301. Median age of treated patients was 72 years (63 quartile I; 79 quartile III). Primary prevention indication was reported in 72.4% of first implants, secondary prevention in 27.6% (cardiac arrest in 4.6% of records). A single-chamber ICD was used in 30.3% of first implants, dual-chamber ICD in 30.0% and biventricular ICD in 39.7%. Median value of longevity of explanted ICDs was 7.0 years. CONCLUSIONS: In the calendar year 2022, the Italian PM Registry showed stable electrocardiographic and symptom indications, with an important prevalence of dual-chamber pacing. The ICD Registry documented a large use of prophylactic and biventricular ICDs, reflecting a favorable adherence in clinical practice to trials and guidelines. The ICD longevity and the number of recalls demonstrated a favorable trend.

REducing INFectiOns thRough Cardiac device Envelope: insight from real world data. The REINFORCE project.

AIMS: Infections resulting from cardiac implantable electronic device (CIED) implantation are severely impacting on patients' and on health care systems. The use of TYRXTM absorbable antibiotic-eluting envelope has proven to decrease major CIED infections within 12 months of CIED surgery. The aim is to evaluate the impact of the envelope use on infection-related clinical events in a real-world contemporary patient population. METHODS AND RESULTS: Data on patients undergoing CIED surgery were collected prospectively by participating centers of the One Hospital ClinicalService project. Patients were divided into two groups according to whether TYRXTM absorbable antibiotic-eluting envelope was used or not. Out of 1819 patients, 872 (47.9%) were implanted with an absorbable antibiotic-eluting envelope and included in the Envelope group and 947 (52.1%) patients who did not receive an envelope were included in the Control group. Compared to control, patients in the Envelope group had higher thrombo-embolic or hemorrhagic risk, higher BMI, lower LVEF and more comorbidities. During a mean follow-up of 1.4 years, the incidence of infection-related events was significantly higher in the control compared to the Envelope group (2.4% vs. 0.8%, P = 0.007). The five-year cumulative incidence of infection-related events was 8.1% in the control and 2.1% in the Envelope group (HR: 0.34, 95%CI: 0.14-0.80, P = 0.010). CONCLUSION: In our analysis, the use of an absorbable antibiotic-eluting envelope in the general CIED population was associated with a lower risk of systemic and pocket infection.

Prognostic significance of remotely monitored nocturnal heart rate in heart failure patients with reduced ejection fraction.

BACKGROUND: Elevated resting heart rate is a risk factor for cardiovascular events. OBJECTIVE: The purpose of this study was to investigate the clinical significance of nocturnal heart rate (nHR) and 24-hour mean heart rate (24h-HR) obtained by continuous remote monitoring (RM) of implantable devices. METHODS: We analyzed daily-sampled trends of nHR, 24h-HR, and physical activity in patients on ß-blocker therapy for chronic heart failure and with implantable cardioverter-defibrillators or cardiac resynchronization therapy defibrillators (CRT-Ds). Patients were grouped by average nHR and 24h-HR quartile during follow-up to estimate the respective incidence of nonarrhythmic death and device-treated ventricular tachycardia/fibrillation (VT/VF). RESULTS: The study cohort included 1330 patients (median age 69 years [interquartile range 61-77 years]; 41% [n = 550] with CRT-D; median follow-up 25 months [interquartile range 13-42 months]). Compared with patients in the lowest nHR quartile (≤57 beats/min) group, patients in the highest quartile group (>65 beats/min) had an increased risk of nonarrhythmic death (adjusted hazard ratio [AHR] 2.25; 95% confidence interval [CI] 1.13-4.50; P = .021) and VT/VF (AHR 1.98; 95% CI 1.40-2.79; P < .001) and were characterized by the lowest level of physical activity (P ≤ .0004 vs every other nHR quartiles). The highest 24h-HR quartile group (>75 beats/min) showed an increased risk of VT/VF (AHR 2.13; 95% CI 1.52-2.99; P < .001) and a weaker though significant association with nonarrhythmic mortality (AHR 1.80; 95% CI 1.00-3.22; P = .05) as compared with the lowest 24h-HR quartile group (≤65 beats/min). CONCLUSION: In remotely monitored patients with implantable cardioverter-defibrillator/CRT-D on ß-blocker therapy for heart failure, elevated heart rates (nHR >65 beats/min and 24h-HR >75 beats/min) were associated with increased mortality and VT/VF risk. nHR showed a stronger association than 24h-HR with worst prognosis and lowest physical activity.

HeartInsight: from SELENE HF to implementation in clinical practice.

There is strong evidence that remote monitoring in cardiac implantable electronic devices can detect device malfunctions earlier than conventional monitoring and that it can be useful for detecting cardiac arrhythmias, while little data are available for an improved management of heart failure (HF). HeartInsight is a new remote monitoring algorithm developed and validated in the SELENE HF study that combines information from a diverse set of sensors integrated into one alert to detect worsening HF with promising accuracy. However, the shift from detecting technical issues or arrhythmia episodes to early predicting clinical events underscores the need to understand how to properly integrate these tools into the clinical workflow by defining an organizational model and shared guidelines for the management of HF alerts. Here, we critically discuss issues that will be raised by the implementation of this 'enhanced' remote monitoring approach to HF care in daily clinical practice.

[2020 Catheter Ablation Registry of the Italian Association of Arrhythmology and Cardiac Pacing]. / Registro Italiano Ablazioni 2020. Associazione Italiana di Aritmologia e Cardiostimolazione.

BACKGROUND: This report describes the findings of the 2020 Italian Catheter Ablation Registry of the Italian Association of Arrhythmology and Cardiac Pacing (AIAC). METHODS: Data collection was retrospective. A standardized questionnaire was completed by each of the participating centers. RESULTS: A total of 10 378 ablation procedures were performed by 66 institutions. Most centers (70%) have an electrophysiology laboratory, and 23% a hybrid cardiac surgery laboratory. All centers have a 3D mapping system. The median number of electrophysiologists and nurses involved in the electrophysiology laboratory was 3.5 and 3, respectively. An electrophysiology technician was involved in 35% of all centers. In 88.2% of cases, catheter ablation was performed for supraventricular arrhythmias; the most frequently treated arrhythmia was atrial fibrillation (39.4%), followed by atrioventricular nodal reentrant tachycardia (18.6%), and common atrial flutter (10.6%). In 72.9% of patients, catheter ablation was performed using a 3D mapping system, with a "near-zero" fluoroscopic approach in 37.7% of all patients. CONCLUSIONS: The 2020 Italian Catheter Ablation Registry confirmed that the electrophysiology activity was markedly affected by the COVID-19 pandemic; atrial fibrillation is the most frequently treated arrhythmia with an increasing number of procedures performed with a 3D mapping system and a "near-zero" approach.

[The Pacemaker and Implantable Cardioverter-Defibrillator Registry of the Italian Association of Arrhythmology and Cardiac Pacing - Report 2021]. / Registro Italiano Pacemaker e Defibrillatori Associazione Italiana di Aritmologia e Cardiostimolazione Report 2021.

BACKGROUND: The Pacemaker (PM) and Implantable Cardioverter-Defibrillator (ICD) Registry of the Italian Association of Arrhythmology and Cardiac Pacing (AIAC) collects information about demographics, clinical characteristics, main indications for PM/ICD therapy and device types from the voluntary Italian collaborating centers. METHODS: For the year 2021 main data about national PM and ICD implantation activity were obtained on the basis of European Cards and subsequently analyzed to create a standard report. RESULTS: PM Registry: data about 18 631 PM implantations were collected (15879 first implants and 2752 replacements). The number of collaborating centers was 121. Median age of treated patients was 82 years (76 quartile I; 87 quartile III). Main ECG indications included atrioventricular conduction disorders in 26.8% of first PM implants, sick sinus syndrome in 12.2%, atrial fibrillation plus bradycardia in 9.6%, other unspecified ECG and electrophysiological abnormalities in 43.0%. For first PM implants, pacing in DDDR mode was reported in 46.5%, followed by DDD mode (20.6%), VVIR mode (15.0%), VVI mode (9.0%) and finally VDD-VDDR (5.8%). Median value of longevity of explanted PMs was 8.9 years. ICD Registry: data about 6878 ICD implantations were obtained (4708 first implants and 2170 replacements). The number of collaborating centers was 345. Median age of treated patients was 72 years (70 quartile I; 75 quartile III). Primary prevention indication was reported in 86.3% of first implants, secondary prevention in 13.7% (cardiac arrest in 4.4% of records). A single-chamber ICD was used in 32.1% of first implants, dual-chamber ICD in 30.3% and biventricular ICD in 37.6%. Median value of longevity of explanted ICDs was 6.9 years. CONCLUSIONS: In the calendar year 2021, the Italian PM Registry showed stable electrocardiographic and symptom indications, with an important prevalence of dual-chamber pacing. The ICD Registry documented a large use of prophylactic and biventricular ICDs, reflecting a favorable adherence in the clinical practice to trials and guidelines. The ICD longevity and the number of recalls demonstrated a favorable trend. In order to increase and optimize the cooperation of Italian PM and ICD implanting centers, the online data entry (https://www.aiac.it/riprid) should be adopted at large scale.

Temporal association between drops in thoracic impedance and malignant ventricular arrhythmia: A longitudinal analysis of remote monitoring trends.

INTRODUCTION: Thoracic impedance (TI) drops measured by implantable cardioverter-defibrillators (ICDs) have been reported to correlate with ventricular tachycardia/fibrillation (VT/VF). The aim of our study was to assess the temporal association of decreasing TI trends with VT/VF episodes through a longitudinal analysis of daily remote monitoring data from ICDs and cardiac resynchronization therapy defibrillators (CRT-Ds). METHODS AND RESULTS: Retrospective data from 2384 patients were randomized 1:1 into a derivation or validation cohort. The TI decrease rate was defined as the percentage of rolling weeks with a continuously decreasing TI trend. The derivation cohort was used to determine a TI decrease rate threshold for a ≥99% specificity of arrhythmia prediction. The associated risk of VT/VF episodes was estimated in the validation cohort by dividing the available follow-up into 60-day assessment intervals. Analyses were performed separately for 1354 ICD and 1030 CRT-D patients. During a median follow-up of 2.0 years, 727 patients (30.4%) experienced 3298 confirmed VT/VF episodes. In the ICD group, a TI decrease rate of >60% was associated with a higher risk of VT/VF episode in a 60-day assessment interval (stratified hazard ratio, 1.42; 95% confidence interval (CI), 1.05-1.92; p = .023). The TI decrease preceded (40.8%) or followed (59.2%) the VT/VF episodes. In the CRT-D group, no association between TI decrease and VT/VF episodes was observed (p = .84). CONCLUSION: In our longitudinal analysis, TI decrease was associated with VT/VF episodes only in ICD patients. Preventive interventions may be difficult since episodes can occur before or after TI decrease.

Five waves of COVID-19 pandemic in Italy: results of a national survey evaluating the impact on activities related to arrhythmias, pacing, and electrophysiology promoted by AIAC (Italian Association of Arrhythmology and Cardiac Pacing).

BACKGROUND: The subsequent waves of the COVID-19 pandemic in Italy had a major impact on cardiac care. METHODS: A survey to evaluate the dynamic changes in arrhythmia care during the first five waves of COVID-19 in Italy (first: March-May 2020; second: October 2020-January 2021; third: February-May 2021; fourth: June-October 2021; fifth: November 2021-February 2022) was launched. RESULTS: A total of 127 physicians from arrhythmia centers (34% of Italian centers) took part in the survey. As compared to 2019, a reduction in 40% of elective pacemaker (PM), defibrillators (ICD), and cardiac resynchronization devices (CRT) implantations, with a 70% reduction for ablations, was reported during the first wave, with a progressive and gradual return to pre-pandemic volumes, generally during the third-fourth waves, slower for ablations. For emergency procedures (PM, ICD, CRT, and ablations), recovery from the initial 10% decline occurred in most cases during the second wave, with some variability. However, acute care for atrial fibrillation, electrical cardioversions, and evaluations for syncope showed a prolonged reduction of activity. The number of patients with devices which started remote monitoring increased by 40% during the first wave, but then the adoption of remote monitoring declined. CONCLUSIONS: The dramatic and profound derangement in arrhythmia management that characterized the first wave of the COVID-19 pandemic was followed by a progressive return to the volume of activities of the pre-pandemic periods, even if with different temporal dynamics and some heterogeneity. Remote monitoring was largely implemented during the first wave, but full implementation is needed.

Ventricular Arrhythmias and Implantable Cardioverter-Defibrillator Therapy in Women: A Propensity Score-Matched Analysis.

BACKGROUND: Causes of sex differences in incidence of sustained ventricular arrhythmias (SVAs) are poorly understood. OBJECTIVES: This study aims to investigate sex-specific risk of SVAs and device therapies by balancing sex groups in relation to several baseline characteristics with the propensity score (PS). METHODS: We used a large remote monitoring dataset from implantable cardioverter-defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds). Study endpoints were time to the first appropriate SVA, time to the first device therapy for SVA, and time to the first ICD shock. Results were compared between females and a PS-matched male subgroup. RESULTS: In a cohort of 2,532 patients with an ICD or CRT-D (median age, 70 years), 488 patients (19.3%) were women. After selecting 488 men PS-matched for 19 variables relative to baseline demographics, implant indications, principal comorbidities, and concomitant therapy, yet the SVA rate at the 2.1-year median follow-up was significantly lower in women than in man (adjusted HR: 0.65; 95% CI: 0.51-0.81; P < 0.001). Women also showed a reduced risk of any device therapy (HR: 0.59; 95% CI: 0.45-0.76; P < 0.001) and shocks (HR: 0.66; 95% CI: 0.47-0.94; P = 0.021). Differences in sex-specific SVA risk profile were not confirmed in CRT-D patients (HR: 0.78; 95% CI: 0.55-1.09; P = 0.14) nor in those with an ejection fraction <30% (HR: 0.80; 95% CI: 0.52-1.23; P = 0.31). CONCLUSIONS: After matching demographics, indications, principal comorbidities, and concomitant therapy, women still exhibited a lower SVA risk profile than men, except in the subgroups of CRT-D or/and ejection fraction <30%.

The value of wearable cardioverter defibrillator in adult patients with recent myocardial infarction: Economic and clinical implications from a health technology assessment perspective.

AIMS: Sudden cardiac death (SCD) causes high mortality and substantial societal burdens for healthcare systems (HSs). The risk of SCD is significantly increased in patients with reduced left ventricular ejection fraction after myocardial infarction (MI). Current guidelines recommend re-evaluation of cardioverter-defibrillator implantation 40 days post-MI, earliest. Medical therapy alone does not provide sufficient protection against SCD, especially in the first month post-MI, and needs time. Consequently, there is a gap in care of high-risk patients upon hospital discharge. The wearable cardioverter defibrillator (WCD) is a proven safe, effective therapy, which temporarily protects from SCD. Little information on WCD cost-effectiveness exists. We conducted this research to demonstrate the medical need of the device in the post-MI setting defining WCD cost-effectiveness. METHODS & RESULTS: Based on a randomized clinical trials (RCTs) and Italian and international data, we developed a Markov-model comparing costs, patient survival, and quality-of-life, and calculated the Incremental Cost-Effectiveness Ratio (ICER) of a WCD vs. current standard of care in post-MI patients. The rather conservative base case analysis - based on the RCT intention-to-treat results - produced an ICER of €47,709 per Quality Adjusted Life Year (QALY) gained, which is far lower than the accepted threshold of €60,000 in the Italian National HS. The ICER per Life Year (LY) gained was €38,276. CONCLUSION: WCD utilization in post-MI patients is clinically beneficial and cost-effective. While improving guideline directed patient care, the WCD can also contribute to a more efficient use of resources in the Italian HS, and potentially other HSs as well.

[The Pacemaker and Implantable Cardioverter-Defibrillator Registry of the Italian Association of Arrhythmology and Cardiac Pacing - Report 2020]. / Registro Italiano Pacemaker e Defibrillatori ­ Associazione Italiana di Aritmologia e Cardiostimolazione ­ Report 2020.

BACKGROUND: The Pacemaker (PM) and Implantable Cardioverter-Defibrillator (ICD) Registry of the Italian Association of Arrhythmology and Cardiac Pacing (AIAC) collects information about demographics, clinical characteristics, main indications for PM/ICD therapy and device types from the Italian collaborating centers. METHODS: For the year 2020, the main data about national PM and ICD implantation activity were obtained on the basis of European Cards and subsequently analyzed to create a standard report. RESULTS: PM Registry: data about 22 080 PM implantations were collected (18 027 first implants and 3803 replacements). The number of collaborating centers was 142. Median age of treated patients was 82 years (75 quartile I; 87 quartile III). ECG indications included atrioventricular conduction disorders in 31.0% of first PM implants, sick sinus syndrome in 13.8%, atrial fibrillation plus bradycardia in 9.9%, other unspecified ECG and electrophysiological abnormalities in 36.6%. Use of single-chamber PMs was reported in 29.0% of first implants, of dual-chamber PMs in 68.2%, of PM with cardiac resynchronization therapy (CRT) in 2.7%. ICD Registry: data about 11 931 ICD implantations were obtained (8266 first implants and 3665 replacements). The number of collaborating centers was 330. Median age of treated patients was 72 years [63 quartile I; 79 quartile III]. Primary prevention indication was reported in 85.0% of first implants, secondary prevention in 15.0% (cardiac arrest in 4.2%). A single-chamber ICD was used in 30.2% of first implants, dual-chamber ICD in 31.2% and biventricular ICD in 38.6%. CONCLUSIONS: In the calendar year 2020, the Italian PM Registry showed stable ECG and symptom indications, with an important prevalence of dual-chamber pacing. The ICD Registry documented a large use of prophylactic and biventricular ICDs, reflecting a favorable adherence in clinical practice to trials and guidelines. The ICD longevity and the number of recalls demonstrated a favorable trend. In order to increase and optimize the cooperation of Italian PM and ICD implanting centers, the online data entry (https://www.aiac.it/riprid) should be adopted at large scale.

One-year mortality after implantable defibrillator implantation: do risk stratification models help improving clinical practice?

PURPOSE: The purpose of this study was to assess the available mortality risk stratification models for implantable cardioverter defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) patients. METHODS: We conducted a review of mortality risk stratification models and tested their ability to improve prediction of 1-year survival after implant in a database of patients who received a remotely controlled ICD/CRT-D device during routine care and included in the independent Home Monitoring Expert Alliance registry. RESULTS: We identified ten predicting models published in peer-reviewed journals between 2000 and 2021 (Parkash, PACE, MADIT, aCCI, CHA2DS2-VASc quartiles, CIDS, FADES, Sjoblom, AAACC, and MADIT-ICD non-arrhythmic mortality score) that could be tested in our database as based on common demographic, clinical, echocardiographic, electrocardiographic, and laboratory variables. Our cohort included 1,911 patients with left ventricular dysfunction (median age 71, 18.3% female) from sites not using any risk stratification score for systematic patient screening. Patients received an ICD (53.8%) or CRT-D (46.2%) between 2011 and 2017, after standard physician evaluation. There were 56 deaths within 1-year post-implant, with an all-cause mortality rate of 2.9% (95% confidence interval [CI], 2.3-3.8%). Four predicting models (Parkash, MADIT, AAACC, and MADIT-ICD non-arrhythmic mortality score) were significantly associated with increased risk of 1-year mortality with hazard ratios ranging from 3.75 (CI, 1.31-10.7) to 6.53 (CI 1.52-28.0, p ≤ 0.014 for all four). Positive predictive values of 1-year mortality were below 25% for all models. CONCLUSION: In our analysis, the models we tested conferred modest incremental predicting power to ordinary screening methods.

Combining home monitoring temporal trends from implanted defibrillators and baseline patient risk profile to predict heart failure hospitalizations: results from the SELENE HF study.

AIMS: We developed and validated an algorithm for prediction of heart failure (HF) hospitalizations using remote monitoring (RM) data transmitted by implanted defibrillators. METHODS AND RESULTS: The SELENE HF study enrolled 918 patients (median age 69 years, 81% men, median ejection fraction 30%) with cardiac resynchronization therapy (44%), dual-chamber (38%), or single-chamber defibrillators with atrial diagnostics (18%). To develop a predictive algorithm, temporal trends of diurnal and nocturnal heart rates, ventricular extrasystoles, atrial tachyarrhythmia burden, heart rate variability, physical activity, and thoracic impedance obtained by daily automatic RM were combined with a baseline risk-stratifier (Seattle HF Model) into one index. The primary endpoint was the first post-implant adjudicated HF hospitalization. After a median follow-up of 22.5 months since enrolment, patients were randomly allocated to the algorithm derivation group (n = 457; 31 endpoints) or algorithm validation group (n = 461; 29 endpoints). In the derivation group, the index showed a C-statistics of 0.89 [95% confidence interval (CI): 0.83-0.95] with 2.73 odds ratio (CI 1.98-3.78) for first HF hospitalization per unitary increase of index value (P < 0.001). In the validation group, sensitivity of predicting primary endpoint was 65.5% (CI 45.7-82.1%), median alerting time 42 days (interquartile range 21-89), and false (or unexplained) alert rate 0.69 (CI 0.64-0.74) [or 0.63 (CI 0.58-0.68)] per patient-year. Without the baseline risk-stratifier, the sensitivity remained 65.5% and the false/unexplained alert rates increased by ≈10% to 0.76/0.71 per patient-year. CONCLUSION: With the developed algorithm, two-thirds of first post-implant HF hospitalizations could be predicted timely with only 0.7 false alerts per patient-year.

The Practice of Deep Sedation in Electrophysiology and Cardiac Pacing Laboratories: Results of an Italian Survey Promoted by the AIAC (Italian Association of Arrhythmology and Cardiac Pacing).

The aim of this survey, which was open to all Italian cardiologists involved in arrhythmia, was to assess common practice regarding sedation and analgesia in interventional electrophysiology procedures in Italy. The survey consisted of 28 questions regarding the approach to sedation used for elective direct-current cardioversion (DCC), subcutaneous implantable cardioverter-defibrillator (S-ICD) implantation, atrial fibrillation (AF) ablation, ventricular tachycardia (VT) ablation, and transvenous lead extraction procedures. A total of 105 cardiologists from 92 Italian centres took part in the survey. The rate of centres where DCC, S-ICD implantation, AF ablation, VT ablation and lead extraction procedures were performed without anaesthesiologic assistance was 60.9%, 23.6%, 51.2%, 37.3%, and 66.7%, respectively. When these procedures were performed without anaesthesiologic assistance, the drugs (in addition to local anaesthetics) commonly administered were benzodiazepines (from 64.3% to 79.6%), opioids (from 74.4% to 88.1%), and general anaesthetics (from 7.1% to 30.4%). Twenty-three (21.9%) of the 105 cardiologists declared that they routinely administered propofol, without the supervision of an anaesthesiologist, in at least one of the above-mentioned procedures. In current Italian clinical practice, there is a lack of uniformity in the sedation/analgesia approach used in interventional electrophysiology procedures.

[2019 Catheter Ablation Registry of the Italian Association of Arrhythmology and Cardiac Pacing]. / Registro Italiano Ablazioni 2019. Associazione Italiana di Aritmologia e Cardiostimolazione.

BACKGROUND: This report describes the findings of the 2019 Italian Catheter Ablation Registry of the Italian Association of Arrhythmology and Cardiac Pacing (AIAC). METHODS: Data collection was retrospective. A standardized questionnaire was completed by each of the participating centers. RESULTS: A total of 15 201 ablation procedures were performed by 91 institutions. Most (78%) of the centers has one electrophysiology laboratory, and 17% of them has a hybrid cardiac surgery laboratory. Almost all (98%) centers have a 3D mapping system. The median number of electrophysiologists and nurses involved in the electrophysiology laboratory was 3 and an electrophysiology technician was involved in 30% of all centers. In 88.4% of cases, ablations were performed for supraventricular arrhythmias, and among these the most frequently treated arrhythmia was atrial fibrillation (32.9%), followed by atrioventricular nodal reentrant tachycardia (23.9%), and common atrial flutter (11.7%). In 10 256 (67.4%) patients catheter ablation was performed by means of a 3D mapping system, with a "near-zero" fluoroscopic approach in 4626 (30.4%) of all patients. CONCLUSIONS: The 2019 Italian Catheter Ablation Registry confirmed that atrial fibrillation is the most commonly treated arrhythmia in the ablation centers with an increasing number of procedures performed with a 3D mapping system and a "near-zero" approach.

Impact of COVID-19 Pandemic on Remote Monitoring of Cardiac Implantable Electronic Devices in Italy: Results of a Survey Promoted by AIAC (Italian Association of Arrhythmology and Cardiac Pacing).

The COVID-19 pandemic has had a profound impact on the organisation of health care in Italy, with an acceleration in the development of telemedicine. To assess the impact of the COVID-19 pandemic on the spread of remote monitoring (RM) of cardiac implantable electronic devices (CIEDs) in Italy, a survey addressed to cardiologists operating in all Italian CIED-implanting centres was launched. A total of 127 cardiologists from 116 Italian arrhythmia centres took part in the survey, 41.0% of all 283 CIED-implanting centres operating in Italy in 2019. All participating centres declared to use RM of CIEDs. COVID-19 pandemic resulted in an increase in the use of RM in 83 (71.6%) participating centres. In a temporal perspective, an increase in the median number of patients per centre followed up by RM was found from 2012 to 2017, followed by an exponential increase from 2017 to 2020. In 36 participating centres (31.0%) a telehealth visits service was activated as a replacement for in-person outpatient visits (in patients with or without CIED) during the COVID-19 pandemic. COVID-19 pandemic has caused an acceleration in the use of RM of CIEDs and in the use of telemedicine in the clinical practice of cardiology.

Cardiac resynchronization therapy defibrillators in patients with permanent atrial fibrillation.

AIMS: There are conflicting data on the benefit of cardiac resynchronization therapy (CRT) in heart failure (HF) patients with permanent atrial fibrillation (AF). We aimed to compare patient outcomes according to the presence or absence of permanent AF at device implantation. METHODS AND RESULTS: We retrospectively analysed remote monitoring data from 1141 CRT defibrillators. Propensity score with inverse-probability weighting method was used to balance AF and sinus rhythm (SR) groups. Analysis endpoints included total mortality, appropriate defibrillation shocks, and CRT percentage. There were 229 patients (20.1%) in the AF group and 912 patients (79.9%) in the SR group. Compared with SR patients, AF patients were older (median age, 77 vs. 72 years, P < 0.001), more frequently male (82.5% vs. 75.5%, P = 0.02), and had higher heart rate (75.7 vs. 71.0 b.p.m., P < 0.001). Of the 229 AF patients, 162 (70.7%) received suboptimal CRT (<98%) and 67 (29.3%) had adequate CRT (≥98%). During a median follow-up of 24 months, total mortality did not differ between AF and SR groups (propensity-score-weighted hazard ratio, HR 1.32 [95% confidence interval, 0.82-2.15], P = 0.25). The risk of appropriate shocks was significantly higher in the AF group with <98% CRT than in the SR group (weighted-HR, 1.99 [1.21-3.26], P = 0.006) and was similar in the AF group with ≥98% CRT versus the SR group (1.29 [0.66-2.53], P = 0.45). During follow-up, sinus rhythm was recovered in 23 patients in the AF group (10%) after a median time of 106 (42-256) days. The rate of sinus rhythm recovery in the AF group was 4.5 (95% CI, 2.8-6.7) per 100 patient-years; the rate of permanent AF occurrence in the SR group was 2.5 (95% CI, 1.9-3.3) per 100 patient-years. CONCLUSIONS: Although mortality was similar across patient groups, patients with permanent AF and suboptimal CRT had twofold higher risk of appropriate shocks than SR patients or AF patients with CRT ≥ 98%.