Implantation technique and optimal subcutaneous defibrillator chest position: a PRAETORIAN score-based study.

AIMS: The traditional technique for subcutaneous implantable cardioverter-defibrillator (S-ICD) implantation involves three incisions and a subcutaneous pocket. Recently, a two-incision and intermuscular (IM) technique has been adopted. The PRAETORIAN score is a chest radiograph-based tool that predicts S-ICD conversion testing. We assessed whether the S-ICD implantation technique affects optimal position of the defibrillation system according to the PRAETORIAN score. METHODS AND RESULTS: We analysed consecutive patients undergoing S-ICD implantation. The χ2 test and regression analysis were used to determine the association between the PRAETORIAN score and implantation technique. Two hundred and thirteen patients were enrolled. The S-ICD generator was positioned in an IM pocket in 174 patients (81.7%) and the two-incision approach was adopted in 199 (93.4%). According to the PRAETORIAN score, the risk of conversion failure was classified as low in 198 patients (93.0%), intermediate in 13 (6.1%), and high in 2 (0.9%). Patients undergoing the two-incision and IM technique were more likely to have a low (<90) PRAETORIAN score than those undergoing the three-incision and subcutaneous technique (two-incision: 94.0% vs. three-incision: 78.6%; P = 0.004 and IM: 96.0% vs. subcutaneous: 79.5%; P = 0.001). Intermuscular plus two-incision technique was associated with a low-risk PRAETORIAN score (hazard ratio 3.76; 95% confidence interval 1.01-14.02; P = 0.04). Shock impedance was lower in PRAETORIAN low-risk patients than in intermediate-/high-risk categories (66 vs. 96 Ohm; P = 0.001). The PRAETORIAN score did not predict shock failure at 65 J. CONCLUSION: In this cohort of S-ICD recipients, combining the two-incision technique and IM generator implantation yielded the lowest PRAETORIAN score values, indicating optimal defibrillation system position. CLINICAL TRIAL REGISTRATION: http://clinicaltrials.gov/ Identifier: NCT02275637.

Are implantable cardiac monitors reliable tools for cardiac arrhythmias detection? An intra-patient comparison with permanent pacemakers.

INTRODUCTION: Implantable cardiac monitor (ICM) is an established tool for the management of unexplained syncope and atrial fibrillation (AF) even if its accuracy of arrhythmia detection may be suboptimal. The aim of this study was to perform an intra-patient comparison of the diagnostic capability of ICM with a dual-chamber PM as a gold standard. METHODS: We included 19 patients with a previously implanted ICM (BioMonitor 2 Biotronik, Berlin, Germany), who received a dual-chamber PM for standard indications. ICM-detected arrhythmic events in a 6-month follow-up were compared with those detected by the PM and classified by visual inspection of intracardiac electrograms. RESULTS: During follow up, ICMs generated 15 false asystole and 39 false bradycardia detections in 5 patients (26.3%) due to recurrent premature ventricular contractions. A total of 34 true high ventricular rate (HVR) episodes were detected by the PM. Of them, 30 (88%) events were also recorded by the ICM, which further detected 14 false HVR snapshots, leading to a sensitivity and positive predictive value of 88% and 68%, respectively. In addition, PM identified 234 true AF episodes. Of them, 225 (96%) events were also detected by the ICM, while 8 (42%) ICMs stored 50 AF episodes classified as false positives. The ICM sensitivity for AF was 96% with a positive predictive value of 82%. CONCLUSION: Our intra-patient comparison with permanent PM confirmed that ICM is an effective tool for cardiac arrhythmias detection. ICM algorithms for AF and HVR detection were highly sensitive with an acceptable rate of false positive episodes.

Pacemaker pocket infection: Innovative conservative treatment in elderly patients with no signs of systemic infection.

BACKGROUND: The gold standard to treat cardiovascular implantable electronic devices (CIEDs) infections is the complete system removal. The aim of this retrospective analysis is to assess the feasibility and safety of an alternative conservative surgical system revision approach, to be applied in elderly patients who refused the extraction procedure, in case of no signs of systemic infection. METHODS: Between May 2009 and January 2019, we performed system revision of 25 patients (15 men and 10 women, median age 81 [IQ: 75-85] years) with negative blood culture, no signs of vegetation, who experienced CIED infections. RESULTS: In all patients the following surgical procedure was applied: the pocket was opened, the wound's necrotic tissue was dissected en bloc; fibrotic tissue was excised. The pocket was washed with hydrogen peroxide and saline solution. The pocket was then closed without implanting the device and left with a continuous infusion of antibiotics and normal saline for 4 days. Subsequently the new generator was implanted, possibly in a different pocket than the previous one. All patients underwent a median follow up of 24 [IQ: 14-34] months. In 24 patients out of the 25 observed the procedure was safe and effective, except for one patient who needed the extraction. CONCLUSIONS: The two-stage surgical revision technique is feasible and safe. It may be considered for elderly patients who refused extraction and presented no signs of systemic infection or in some categories of patients. In case of failure of the procedure, subsequent treatment with complete extraction of the system would not be precluded.

Sensing performance, safety, and patient acceptability of long-dipole cardiac monitor: An innovative axillary insertion.

BACKGROUND: The recommended location for implantable cardiac monitor (ICM) insertion is the left pectoral region. We tested whether an innovative left axillary implantation approach could be applicable for a new ICM, characterized by a long sensing dipole. METHODS: We considered a series of 55 patients consecutively implanted with a long-dipole ICM (BioMonitor 2); the first 30 subjects underwent prepectoral location insertion, while the subsequent 25 received the ICM in the axillary region. Sensing performances collected at 1-month follow-up were compared between the two groups. During the visit, each patient was also asked to fill in a brief questionnaire to assess patient acceptability of the device. RESULTS: All patients had a successful insertion of ICM. Mean R-wave amplitude was 0.87 ± 0.44 mV in the prepectoral group and 1.00 ± 0.45 mV in the axillary one, without any significant difference. The percentage of patients with visible P wave was also comparable between the two approaches (65.5% vs 68.2%, P = 0.84). None of the patients reported device-related issues or discomfort, and ICM was generally well accepted and tolerated by all the involved patients. CONCLUSION: Axillary insertion may represent a valid alternative to the standard one for long-dipole ICM technology providing not only patient acceptability but also high-quality sensing performances.

Effectiveness and safety of implantable loop recorder and clinical utility of remote monitoring in patients with unexplained, recurrent, traumatic syncope.

BACKGROUND: Implantable loop recorder (ILR) is still underutilized in clinical practice, especially in the setting of elderly patients with recurrent, traumatic, unexplained syncope. Data on the actual risk of traumatic syncopal recurrence during ILR monitoring in this specific patient setting are lacking. RESEARCH DESIGN AND METHODS: Prospective, multicentre registry enrolling consecutive patients undergoing ILR insertion for unexplained, recurrent, traumatic syncope. In a proportion of enrolled patients, remote monitoring (RM) was used for device follow-up. The risk of traumatic and non-traumatic syncopal recurrences during ILR observation were prospectively assessed. RESULTS: A total of 483 consecutive patients (68±14 years, 59% male) were enrolled. During a median follow-up of 18 months, a final diagnosis was reached in 270 patients (55.9%). The risk of syncopal and traumatic syncopal recurrence was of 26.5 and 9.3%, respectively. RM significantly reduced the time to diagnosis (19.7±10.3 vs. 22.1±10.8 months; p=0.015) and was associated with a significant reduction in the risk of syncope recurrence of 48% (p<0.001), and of traumatic syncope recurrence of 49% (p=0.018). CONCLUSIONS: ILR monitoring is effective and safe in patients with unexplained, recurrent, traumatic syncope. RM reduces the time to diagnosis and significantly reduces the risk of traumatic and non-traumatic syncopal relapses.

Insertable cardiac monitor with a long sensing vector: Impact of obesity on sensing quality and safety.

Background: Fat layers in obese patients can impair R-wave detection and diagnostic performance of a subcutaneous insertable cardiac monitor (ICM). We compared safety and ICM sensing quality between obese patients [body mass index (BMI) ≥ 30 kg/m2] and normal-weight controls (BMI <30 kg/m2) in terms of R-wave amplitude and time in noise mode (noise burden) detected by a long-sensing-vector ICM. Materials and methods: Patients from two multicentre, non-randomized clinical registries are included in the present analysis on January 31, 2022 (data freeze), if the follow-up period was at least 90 days after ICM insertion, including daily remote monitoring. The R-wave amplitudes and daily noise burden averaged intraindividually for days 61-90 and days 1-90, respectively, were compared between obese patients (n = 104) and unmatched (n = 268) and a nearest-neighbour propensity score (PS) matched (n = 69) normal-weight controls. Results: The average R-wave amplitude was significantly lower in obese (median 0.46 mV) than in normal-weight unmatched (0.70 mV, P < 0.0001) or PS-matched (0.60 mV, P = 0.003) patients. The median noise burden was 1.0% in obese patients, which was not significantly higher than in unmatched (0.7%; P = 0.056) or PS-matched (0.8%; P = 0.133) controls. The rate of adverse device effects during the first 90 days did not differ significantly between groups. Conclusion: Although increased BMI was associated with reduced signal amplitude, also in obese patients the median R-wave amplitude was >0.3 mV, a value which is generally accepted as the minimum level for adequate R-wave detection. The noise burden and adverse event rates did not differ significantly between obese and normal-weight patients.Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT04075084 and NCT04198220.

[ANMCO Position paper: Ionizing radiation exposure and radioprotection in the cath-lab]. / Position paper ANMCO: Radioesposizione e radioprotezione nei laboratori di cardiologia interventistica.

In the last decades, because of the improvements in the percutaneous treatment of coronary heart disease, valvular heart disease, congenital heart defects, and the increasing number of cardiac resynchronization therapy and cardioverter-defibrillator implantations, the interventional cardiologists' radio-exposure has importantly risen, causing concerns for ionizing radiation-associated diseases such as cancer and neurodegenerative disorders. Consequently, the radiation exposure issue importantly affects operators' safety. However, our knowledge of this field is poor and most operators are unaware to be at risk, especially because of the absence of effective preventive measures. The aim of this ANMCO position paper is to improve the awareness of operators and identify new ways of reducing operator ionizing radiation dose and minimizing the risk.

The Telecardiology Revolution: From Emergency Management to Daily Clinical Practice.

AIMS: Telecardiology is one of the most widespread applications of telemedicine. We aimed to report the design and development of a telecardiology system in the sanitary district of Cosenza, one of the largest in Italy, with a complex orography, and healthcare reorganization needs, for the management of the emergency network and daily clinical practice. METHODS: Our telecardiology network connects 8 hospitals, 9 first aid centers, 20 local 118-EMS stations, 1 helicopter station, 8 hospital emergency departments, 59 hospital departments, and 3 catheterization laboratories. All data are centralized on a dedicated server, accessible from any location for real-time assessment. The quality, source, and timing of the electrocardiograms transmitted were evaluated. RESULTS: From October 2015 to December 2019, a total of 389,970 ECGs were transmitted. The quality of ECGs was optimal in 52%, acceptable in 42%, and poor in 6% of the cases. The number of poor-quality ECGs was only 3% in the last 2 years. Out of the total, 145,097 (37.2%) were transmitted from the emergency departments and 5318 (1.4%) from the 118-EMS. Of interest, a sizable part of the ECG was related to routine clinical practice, comprising 110,556 (28.3%) from the cardiology department and 79,256 (20.3%) from other noncardiovascular departments. Finally, the average reporting time was significantly decreased compared to reporting times without a telecardiology system (5-10 vs. 45-90 min). CONCLUSION: Our telecardiology system provides efficient cardiology assistance for all types, settings, and phases of cardiovascular diseases.

The "Defibrillation Testing, Why Not?" survey. Testing of subcutaneous and transvenous defibrillators in the Italian clinical practice.

BACKGROUND: Defibrillation testing (DT) can be omitted in patients undergoing transvenous implantable cardioverter-defibrillator (T-ICD) implantation, but it is still recommended for patients at risk for a high defibrillation threshold and for ICD generator changes. Moreover, DT is still recommended on implantation of subcutaneous ICD (S-ICD). The aim of the present survey was to analyze the current practice of DT during T-ICD and S-ICD implantations. METHODS: In March 2021, an ad hoc questionnaire on the current performance of DT and the standard practice adopted during testing was completed at 72 Italian centers implanting S-ICD and T-ICD. RESULTS: 48 (67%) operators reported never performing DT during de-novo T-ICD implantations, while no operators perform it systematically. The remaining respondents perform it for patients at risk for a high defibrillation threshold. DT is never performed at T-ICD generator change. At the time of de-novo S-ICD implantation, DT is never performed by 9 (13%) operators and performed systematically by 48 (66%). The remaining operators frequently omit DT in patients with more severe systolic dysfunction. DT is not performed at S-ICD generator change by 92% of operators. DT is conducted by delivering a first shock energy of 65 J by 60% of operators, while the remaining 40% test lower energy values. CONCLUSIONS: In current clinical practice, most operators omit DT at T-ICD implantation, even when still recommended in the guidelines. DT is also frequently omitted at S-ICD implantation, and a wide variability exists among operators in the procedures followed during DT.

Management of older patients with unexplained, recurrent, traumatic syncope and bifascicular block: Implantable loop recorder versus empiric pacemaker implantation-Results of a propensity-matched analysis.

BACKGROUND: In patients with unexplained syncope and bifascicular block (BFB), syncope may be caused by intermittent atrioventricular (AV) block. When a correlation between syncope and bradyarrhythmia is not documented in these patients, 2 alternative management strategies can be adopted: (1) empiric pacemaker (PM) implantation or (2) long-term continuous electrocardiographic monitoring by implantable loop recorder (ILR). OBJECTIVE: The purpose of this study was to compare the risk of syncope recurrence associated with empiric PM implantation or ILR monitoring. METHODS: A prospective, multicenter, observational study enrolled consecutive patients with unexplained, recurrent, traumatic syncope and BFB who underwent ILR monitoring or empiric PM implantation. The risk and causes of syncope recurrence were assessed and compared between the 2 groups. Individual 1:1 propensity matching of baseline characteristics was performed. RESULTS: A total of 309 consecutive patients (age 77.2 ± 12.2 years; 60.8% male) were enrolled. Propensity matching yielded 89 matched pairs. After median follow-up of 33 months, empiric PM implantation was associated with a significantly lower risk of syncope recurrence than ILR monitoring (19.1 vs 46.1%; P <.001). A total of 35 patients (39.3%) who underwent ILR monitoring developed bradyarrhythmias (68.6% paroxysmal AV block) requiring PM implantation during follow-up. Excluding bradyarrhythmic syncope, the most frequent causes of syncope recurrence in both study groups were reflex syncope and orthostatic hypotension. CONCLUSION: In patients with unexplained, recurrent, traumatic syncope and BFB, empiric PM implantation significantly reduced the risk of syncope recurrence in comparison with ILR monitoring. A high rate of patients who underwent ILR monitoring developed bradyarrhythmias requiring PM implantation.

The need for a subsequent transvenous system in patients implanted with subcutaneous implantable cardioverter-defibrillator.

BACKGROUND: The absence of pacing capabilities may reduce the appeal of subcutaneous implantable cardioverter-defibrillator (S-ICD) devices for patients at risk for conduction disorders or with antitachycardia pacing (ATP)/cardiac resynchronization (CRT) requirements. Reports of rates of S-ICD to transvenous implantable cardioverter-defibrillator (TV-ICD) system switch in real-world scenarios are limited. OBJECTIVE: The purpose of this study was to investigate the need for a subsequent transvenous (TV) device in patients implanted with an S-ICD and its predictors. METHODS: All patients implanted with an S-ICD were enrolled from the multicenter, real-world iSUSI (International SUbcutaneouS Implantable cardioverter defibrillator) Registry. The need for a TV device and its clinical reason, and appropriate and inappropriate device therapies were assessed. Logistic regression with Firth penalization was used to assess the association between baseline and procedural characteristics and the overall need for a subsequent TV device. RESULTS: A total of 1509 patients were enrolled (age 50.8 ± 15.8 years; 76.9% male; 32.0% ischemic; left ventricular ejection fraction 38% [30%-60%]). Over 26.5 [13.4-42.9] months, 155 (10.3%) and 144 (9.3%) patients experienced appropriate and inappropriate device therapies, respectively. Forty-one patients (2.7%) required a TV device (13 bradycardia; 10 need for CRT; 10 inappropriate shocks). Body mass index (BMI) >30 kg/m2 and chronic kidney disease (CKD) were associated with need for a TV device (odds ratio [OR] 2.57 [1.37-4.81], P = .003; and OR 2.67 [1.29-5.54], P = .008, respectively). CONCLUSION: A low rate (2.7%) of conversion from S-ICD to a TV device was observed at follow-up, with need for antibradycardia pacing, ATP, or CRT being the main reasons. BMI >30 kg/m2 and CKD predicted all-cause need for a TV device.

Age-related differences and associated mid-term outcomes of subcutaneous implantable cardioverter-defibrillators: A propensity-matched analysis from a multicenter European registry.

BACKGROUND: A few limited case series have shown that the subcutaneous implantable cardioverter-defibrillator (S-ICD) system is safe for teenagers and young adults, but a large-scale analysis currently is lacking. OBJECTIVES: The purpose of this study was to compare mid-term device-associated outcomes in a large real-world cohort of S-ICD patients, stratified by age at implantation. METHODS: Two propensity-matched cohorts of teenagers + young adults (≤30 years old) and adults (>30 years old) were retrieved from the ELISIR Registry. The primary outcome was the comparison of inappropriate shock rate. Complications, freedom from sustained ventricular arrhythmias, and overall and cardiovascular mortality were deemed secondary outcomes. RESULTS: Teenagers + young adults represented 11.0% of the entire cohort. Two propensity-matched groups of 161 patients each were used for the analysis. Median follow-up was 23.1 (13.2-40.5) months. In total, 15.2% patients experienced inappropriate shocks, and 9.3% device-related complications were observed, with no age-related differences in inappropriate shocks (16.1% vs 14.3%; P = .642) and complication rates (9.9% vs 8.7%; P = .701). At univariate analysis, young age was not associated with increased rates of inappropriate shocks (hazard ratio [HR] 1.204 [0.675-2.148]: P = .529). At multivariate analysis, use of the SMART Pass algorithm was associated with a strong reduction in inappropriate shocks (adjusted HR 0.292 [0.161-0.525]; P <.001), whereas arrhythmogenic right ventricular cardiomyopathy (ARVC) was associated with higher rates of inappropriate shocks (adjusted HR 2.380 [1.205-4.697]; P = .012). CONCLUSION: In a large multicenter registry of propensity-matched patients, use of the S-ICD in teenagers/young adults was safe and effective. The rates of inappropriate shocks and complications between cohorts were not significantly different. The only predictor of increased inappropriate shocks was a diagnosis of ARVC.

COVID-19 and STEMI: The role of telecardiology in the management of STEMI diagnosis during COVID 19 pandemic.

BACKGROUND: Telecardiology has the advantage of reducing patient's access time to the hemodynamics units. Data from literature show a reduction in ST-elevation myocardial infarction (STEMI) during COVID-19 pandemic. However, there is a low number of studies on the impact of telecardiology during the pandemic. METHODS: Our telecardiology system is composed of a Hub-and-Spoke network of hospitals and ambulances that ensures a rapid exchange of information allowing STEMI patients to be treated in the shortest time possible. We compared data from electrocardiograms (ECGs) transmissions and STEMI diagnosis collected between February and April 2020 with the data from the same period of 2019. RESULTS: Despite a significant reduction of ECGs transmissions from the telecardiology network was observed, the number of diagnosed STEMI during 2020 was stable and did not show any significant difference compared to 2019. The total number of STEMI diagnosis in the months under examination during 2019 were 47 out of 7463 ECGs (0.63%), while in 2020 were 48 out of 5797 ECGs (0.83%). CONCLUSIONS: The efficiency of our telecardiology system along with the low spread of the infection in our region contributed to maintaining the number of STEMI diagnosis and patient's care in line with the past even during the pandemic.

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.

Subcutaneous implantable cardioverter-defibrillator and defibrillation testing: A propensity-matched pilot study.

BACKGROUND: To date, only a few comparisons between subcutaneous implantable cardioverter-defibrillator (S-ICD) patients undergoing and those not undergoing defibrillation testing (DT) at implantation (DT+ vs DT-) have been reported. OBJECTIVE: The purpose of this study was to compare long-term clinical outcomes of 2 propensity-matched cohorts of DT+ and DT- patients. METHODS: Among consecutive S-ICD patients implanted across 17 centers from January 2015 to October 2020, DT- patients were 1:1 propensity-matched for baseline characteristics with DT+ patients. The primary outcome was a composite of ineffective shocks and cardiovascular mortality. Appropriate and inappropriate shock rates were deemed secondary outcomes. RESULTS: Among 1290 patients, a total of 566 propensity-matched patients (283 DT+; 283 DT-) served as study population. Over median follow-up of 25.3 months, no significant differences in primary outcome event rates were found (10 DT+ vs 14 DT-; P = .404) as well as for ineffective shocks (5 DT- vs 3 DT+; P = .725). At multivariable Cox regression analysis, DT performance was associated with a reduction of neither the primary combined outcome nor ineffective shocks at follow-up. A high PRAETORIAN score was positively associated with both the primary outcome (hazard ratio 3.976; confidence interval 1.339-11.802; P = .013) and ineffective shocks alone at follow-up (hazard ratio 19.030; confidence interval 4.752-76.203; P = .003). CONCLUSION: In 2 cohorts of strictly propensity-matched patients, DT performance was not associated with significant differences in cardiovascular mortality and ineffective shocks. The PRAETORIAN score is capable of correctly identifying a large percentage of patients at risk for ineffective shock conversion in both cohorts.

Implantable loop recorder in clinical practice.

The implantable loop recorder (ILR), also known as insertable cardiac monitor (ICM) is a subcutaneous device used for diagnosing heart rhythm disorders. These devices have been strongly improved and miniaturized during the last years showing several reliable features along with the availability of remote monitoring which improves the diagnostic timing and the follow-up strategy with a potential reduction of costs for health care. The recent advent of injectable ILRs makes the procedure even easier and more tolerated by patients. ILR allows the investigation of unexplained recurrent syncope with uncertain diagnosis, revealing a possible relationship with cardiac arrhythmias. In addition, it has recently been equipped with sophisticated algorithms able to detect atrial fibrillation episodes. This new opportunity may provide to the physicians systematic heart rhythm screening with possible effects on patient antiarrhythmic and anticoagulant therapy management. The use of such devices will surely increase, since they may be helpful to diagnose a wide range of disorders and pathologies. Indeed, further studies should be performed in order to identify all the potentialities of these tools.