Rate and nature of complications with leadless transcatheter pacemakers compared with transvenous pacemakers: results from an Italian multicentre large population analysis.

AIMS: The safety and efficacy of leadless intracardiac-permanent pacemaker (L-PM) have been demonstrated in multiple clinical trials, but data on comparisons with conventional transvenous-permanent pacemaker (T-PM) collected in a consecutive, prospective fashion are limited. The aim of this analysis was to compare the rate and the nature of device-related complications between patients undergoing L-PM vs. T-PM implantation. METHODS AND RESULTS: Prospective, multicentre, observational project enrolling consecutive patients who underwent L-PM or T-PM implantation. The rate and nature of device-related complications were analysed and compared between the two groups. Individual 1:1 propensity matching of baseline characteristics was performed. A total of 2669 (n = 665 L-PM) patients were included and followed for a median of 39 months, L-PM patients were on average older and had more co-morbidities. The risk of device-related complications at 12 months was significantly lower in the L-PM group (0.5% vs. 1.9%, P = 0.009). Propensity matching yielded 442 matched pairs. In the matched cohort, L-PM patients trended toward having a lower risk of overall device-related complications (P = 0.129), had a similar risk of early complications (≤30 days) (P = 1.000), and had a significantly lower risk of late complications (>30 days) (P = 0.031). All complications observed in L-PM group were early. Most (75.0%) of complications observed in T-PM group were lead- or pocket-related. CONCLUSION: In this analysis, the risk of device-related complications associated with L-PM implantation tended to be lower than that of T-PM. Specifically, the risk of early complications was similar in two types of PMs, while the risk of late complications was significantly lower for L-PM than T-PM.

Long-term follow-up of patients with a quadripolar active fixation left ventricular lead: An Italian multicenter experience.

INTRODUCTION: Left ventricular (LV) lead optimal positioning is one of the most important determinants of cardiac resynchronization therapy (CRT) success. LV quadripolar active fixation (QAF) leads have been designed to ensure stable LV pacing in the target area and reduce the likelihood of phrenic nerve stimulation (PNS). The aim of this analysis is to compare performances, safety, and clinical outcomes of QAF with those of quadripolar passive fixation leads (QPL) and bipolar active fixation (BAF) leads in a real-world cohort of CRT patients. METHODS AND RESULTS: This retrospective analysis compared the procedure and follow-up data of 117 QAF included in the One Hospital ClinicalService project from nine Italian hospitals with two historical cohorts of 261 BAF and 124 QPL. QAF enabled basal pacing more frequently than QPL (24.1% vs. 6.5%, p < .001) but not differently from BAF (p = .981). At implant, mean QAF LV myocardial threshold (LVMT) was 1.21 ± 0.8 V at 0.4 ms, not different from that of BAF (p = .346) and QPL (p = .333). At a median follow-up of 22 months, LVMT was 1.37 ± 0.90 V (p = .036 vs. implant). Acute LV lead dislodgment occurrence was low in all cohorts: 1 (0.9%) in QAF, 4 in BAF (1.5%), and none (0.0%) in QPL. During follow-up, total LV-related complication rate was lower in QAF (0.5/100 patient-years) than in BAF (4.2/100 patient-years, p = .014) and QPL (3.6/100 patient-years, p = .055). QAF, BAF, and QPL annual rate of heart failure hospitalization were respectively 6.1/100 patient-years, 2.5/100 patient-years (p = .081), and 3.6/100 patient-years (p = .346). CRT responders' rate in QAF was 69.9%, with no difference in comparison to BAF (p = .998) and QPL (p = .509). During follow-up, mean left ventricular ejection fraction (LVEF) of QAF increased from 31.8 ± 10.1% to 40.3 ± 10.7% (p < .001). The average degree of echocardiographic response (ΔLVEF) did not differ between QAF and other cohorts; however, LVEF CRT responder's distribution of QAF differs from those of BAF (p = .003) and QPL (p = .022), due to a higher percentage of super-responders. CONCLUSIONS: QAF with short interelectrode spacing resulted in non-inferior clinical outcomes and CRT responders' rate in comparison to BAF and QPL, while reducing complication rate during follow-up and increasing the possibilities of electronic repositioning to manage PNS or to optimize resynchronization therapy.

Determinants of worse prognosis in patients with cardiac resynchronization therapy defibrillators. Are ventricular arrhythmias an adjunctive risk factor?

AIMS: Cardiac resynchronization therapy (CRT) is indicated in patients with systolic heart failure (HF), severe left ventricle (LV) dysfunction and interventricular dyssynchrony.In prospective observational research, we aimed to evaluate whether CRT-induced LV reverse remodelling and occurrence of ventricular arrhythmias (VT/VF) independently contribute to prognosis in patients with CRT defibrillators (CRT-D). METHODS: In 95 Italian cardiological centres, after a screening period of 6 months, patients were categorized according to VT/VF occurrence and CRT response, defined as LV end-systolic volume relative reduction >15% or LV ejection fraction absolute increase >5%. The main endpoint was death or HF hospitalizations. RESULTS: Among 1308 CRT-D patients (80% male, mean age 66 years), at 6 months, follow-up 71% were identified as CRT responders and 12% experienced appropriate VT/VF detections. The main endpoint was significantly and independently associated with previous myocardial infarction, New York Heart Association Class, VT/VF occurrence and with CRT response. CRT nonresponder patients who suffered VT/VF in the screening period had a risk of death or HF hospitalizations [HR = 7.82, 95% confidence interval (CI) = 3.95-15.48] significantly (P < 0.001) higher than CRT responders without VT/VF occurrence. This risk is mitigated without VT/VF occurrence (HR = 3.47, 95% CI = 2.03-5.91, P < 0.001) or in case of CRT response (HR = 3.11, 95% CI = 1.44-6.72, P = 0.004). CONCLUSION: Our data show that both CRT response and occurrence of VT/VF independently contribute to the risk of death or HF-related hospitalizations in CRT-D patients. Early VT/VF occurrence may be identified as a marker of disease severity than can be mitigated by CRT response both in terms of all-cause mortality and long-term VT/VF onset. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT00147290 and NCT00617175.

Oral procainamide as pharmacological treatment of recurrent and refractory ventricular tachyarrhythmias: A single-center experience.

BACKGROUND: Antiarrhythmic therapy for recurrent ventricular arrhythmias in patients who have undergone catheter ablation, and in whom amiodarone and/or beta-blockers were ineffective or contraindicated, is a controversial issue. OBJECTIVE: The present study sought to evaluate the efficacy and tolerability of oral procainamide in patients with recurrent ventricular arrhythmias when the standard therapy strategy had failed. METHODS: All patients treated with procainamide for recurrent ventricular tachycardia (VT) or ventricular fibrillation (VF) in our institution between January 2010 and May 2019 were enrolled. The primary endpoint was the total number of implantable cardioverter-defibrillator (ICD) interventions after the beginning of procainamide therapy. Secondary endpoints were the total number of VTs and VFs recorded on the ICDs' controls and discontinuation of therapy. The events occurring during procainamide treatment were compared with a matched-duration period before the initiation of therapy with procainamide. Patients therefore served as self-controls. RESULTS: A total of 34 consecutive patients (32 male, 94.1%; mean age 74.4 ± 9.7 years) were included in the retrospective analysis. The mean time of procainamide treatment was 12.9 ± 13.7 months (median 9 [2-20] months). The mean dose of procainamide was 1207 ± 487 mg/day. Procainamide therapy significantly decreased ICD interventions (median 5 [0-22.5] vs 15.5 [3-32.25], P < .05). Procainamide also decreased the total number of VT/VF episodes (median 5.5 [0.75-30] vs 19 [7.5-30], P < .05). Only 3 patients (8.8%) presented severe side effects (dyspnea or hypotension), requiring discontinuation of therapy. CONCLUSION: Oral procainamide was associated with a significant decrease in ICD therapies and ventricular arrhythmias, showing an acceptable profile of tolerability.

Prevention of long-lasting atrial fibrillation through antitachycardia pacing in DDDR pacemakers.

OBJECTIVE: The MINERVA trial showed that in pacemaker patients with atrial fibrillation (AF) history, DDDRP pacing combining three algorithms - (a) atrial antitachycardia pacing with Reactive ATP enabled, (b) atrial preventive pacing and (c) managed ventricular pacing (MVP)-may effectively delay progression to persistent/permanent AF compared with standard DDDR pacing. We performed a comparative non-randomised evaluation to evaluate if Reactive ATP can be the main driver of persistent/permanent AF reduction independently on preventive pacing. METHODS: Thirty-one centres included consecutive dual-chamber pacemaker patients with AF history. Reactive ATP was programmed in all patients while preventive atrial pacing was not enabled. These patients were compared with the three groups of MINERVA randomised trial (Control DDDR, MVP, and DDDRP). The main endpoint was the incidence of AF longer than 7 consecutive days. RESULTS: A total of 146 patients (73 years old, 54% male) were included and followed for a median observation period of 31 months. The 2-year incidence of AF > 7 days was 12% in the Reactive ATP group, very similar to that found in the DDDRP arm of the MINERVA trial (13.8%, P = .732) and significantly lower than AF incidence found in the MINERVA Control DDDR arm (25.8%, P = .012) and in the MINERVA MVP arm (25.9%, P = .025). CONCLUSIONS: In a real-world population of dual-chamber pacemaker patients with AF history, the use of Reactive ATP is associated with a low incidence of persistent AF, highlighting that the positive results of the MINERVA trial were related to the effectiveness of Reactive ATP rather than to preventive pacing.

Unpredictable Fall of Severe Emergent Cardiovascular Diseases Hospital Admissions During the COVID-19 Pandemic: Experience of a Single Large Center in Northern Italy.

Background Northern Italy is one of the epicenters of severe acute respiratory syndrome coronavirus 2 (SARS-CoV 2) pandemic in Europe. The impact of the pandemic and the consequent lockdown on medical emergencies other than those SARS-CoV 2 pandemic related is largely unknown. The aim of this study was to analyze the epidemiologic impact of coronavirus disease 2019 pandemic on hospital admission for severe emergent cardiovascular diseases (SECDs) in a single Northern Italy large tertiary referral center. Methods and Results We quantified SECDs admissions to the Cardiology Division of Udine University Hospital between March 1, 2020 and March 31, 2020 and compared them with those of the same time frame during 2019. Compared with March 2019, we observed a significant reduction in all SECDs admissions: -30% for ST-segment-elevation acute coronary syndromes, -66% for non-ST-segment-elevation acute coronary syndromes and -50% for severe bradyarrhythmia. Conclusions A significant decrease in all SECDs admissions has been observed during the SARS-CoV 2. pandemic and was unlikely caused by a reduction in the incidence of cardiovascular diseases. Fear of contagion may have contributed to the unpredictable drop of SECDs. Social education about early recognition of symptoms of life-threatening cardiac conditions requiring appropriate care in a timely fashion may help to reduce this counterproductive phenomenon.

Favorable Trend of Implantable Cardioverter-Defibrillator Service Life in a Large Single-Nation Population: Insights From 10-Year Analysis of the Italian Implantable Cardioverter-Defibrillator Registry.

Background Implantable cardioverter-defibrillators (ICDs) are widely employed for the prevention of sudden cardiac death. Despite technological improvements, patients often need to undergo generator replacement, which entails the risk of periprocedural complications. Our aim was to estimate the service life of ICDs over a 10-year interval and to assess the main causes of replacement on the basis of data from the National ICD Registry of the Italian Society of Arrhythmology and Cardiac Pacing (AIAC). Methods and Results The registry includes data from over 400 hospitals in Italy. We included all patients who underwent device replacement from calendar years 2007 to 2016. The median service life of the ICDs and its trend over the years was estimated across the 3 types of devices (single-chamber, dual-chamber, cardiac resynchronization therapy defibrillator) and the indication to implantation. The causes of replacement were also analyzed. We included 29 158 records from 27 676 patients (80.9% men; mean age at device replacement 65.8±12.0 years). The median service life was 57.3 months (interquartile range 27.8 months). Over the years, service life showed an increasing trend. The majority of patients underwent elective replacement because of battery end of life, and over the years there was a significant reduction of replacement for recalls, erosion/infections, and cardiac resynchronization therapy upgrading. Conclusions Our data from a large single-nation population showed that the trend of ICD service life, independently from ICD type, indication, and settings, significantly improved over time. Moreover, there was a striking reduction of interventions for upgrading and infection/erosion. This favorable trend has important clinical, organizational, and financial implications.

Multicenter experience with the Evolution RL mechanical sheath for lead extraction using a stepwise approach: Safety, effectiveness, and outcome.

BACKGROUND: In addition to the Evolution RL sheath, tools by Cook Medical (Bloomington, IN, USA), supporting lead extraction (LE), are available. Data on their use are not reported in detail in previous studies. Moreover, data regarding outcome are lacking. The aim was to evaluate the safety and effectiveness of the Evolution sheath (Evolution RL and Evolution Shortie, Cook Medical) by using a stepwise approach with the available extraction tools and the outcome. METHODS: A total of 393 leads in 198 consecutive patients were removed with the Evolution RL sheath and ancillary tools using a stepwise approach. RESULTS: The main indication for LE was infection in 125 (63.1%) cases. The mean implant duration was 95.4 ± 59.7 months. According to our stepwise approach, the Evolution Shortie RL sheath was used in all cases and complete LE was achieved in 24 (12.2%) cases. The Evolution RL was used in 174 (87.8%) cases and the SteadySheath Evolution tissue stabilization sheath (Cook Medical) in 87 (44%) because of tenacious fibrosis anchored targeted leads. Compression coil (OneTie, Cook Medical) was used in 141 (71%) cases. Complete procedural success rate, clinical success rate, and lead removal with clinical success rate were 97%, 99%, and 99.5%, respectively. One major complication (0.5%) and 10 (5%) minor complications were encountered. During a mean time follow-up of 12 ± 9 months, 14 (7%) patients died. Predictors of mortality included impaired renal function (HR 5.7; 95% CI 1.9-17.6; P = 0.002), extraction because of infection (hazard ratio [HR] 4.0; 95% confidence interval [CI] 1-18.1; P = 0.045), and diabetes (HR 3.2; 95% CI 1.1-9.8; P = 0.036). CONCLUSIONS: Lead extraction using the Evolution RL bidirectional rotational mechanical sheath and ancillary tools in a systematic stepwise approach was effective and safe.

Multicentre experience with the second-generation subcutaneous implantable cardioverter defibrillator and the intermuscular two-incision implantation technique.

INTRODUCTION: The recently developed second-generation subcutaneous implantable cardioverter defibrillator (S-ICD) and the intermuscular two-incision implantation technique demonstrate potential favorable features that reduce inappropriate shocks and complications. However, data concerning large patient populations are lacking. The aim of this multicentre prospective study was to evaluate the safety and outcome of second-generation S-ICD using the intermuscular two-incision technique in a large population study. METHODS AND RESULTS: The study population included 101 consecutive patients (75% male; mean age, 45 ± 13 years) who received second-generation S-ICD (EMBLEM; Boston Scientific, Marlborough, MA) implantation using the intermuscular two-incision technique as an alternative to the standard implantation technique. Twenty nine (29%) patients were implanted for secondary prevention. Twenty four (24%) patients had a previously implanted transvenous ICD. All patients were implanted without any procedure-related complications. Defibrillation testing was performed in 80 (79%) patients, and ventricular tachycardia was successfully converted at less than or equal to 65 J in 98.75% (79/80) of patients without pulse generator adjustments. During a median follow-up of 21 ± 10 months, no complications requiring surgical revision or local or systemic device-related infections were observed. Ten patients (9.9%) received appropriate and successful shocks for ventricular arrhythmias. Three (2.9%) patients experienced inappropriate shocks due to oversensing the cardiac signal (n = 1), noncardiac signal (n = 1), and a combination of both cardiac and noncardiac signals (n = 1), with one patient requiring device explantation. No patients required device explantation due to antitachycardia pacing indications. CONCLUSIONS: According to our multicentre study, second-generation S-ICD implanted with the intermuscular two-incision technique is an available safe combination and appears to be associated with a low risk of complications, such as inappropriate shocks.

Prognostic role of non-sustained ventricular tachycardia detected with remote interrogation in a pacemaker population.

BACKGROUND: Non-sustained ventricular tachycardia (NSVT) can occur asymptomatically and can be incidentally detected in the internal records of pacemakers (PM). The clinical value of NSVT in the population of PM patients is still uncertain.Our aim was to assess the prevalence of NSVT detected by remote PM control, to describe the clinical and demographic characteristics of patients with NSVT, and to assess the prognostic significance of NSVT in terms of both overall and cardiovascular mortality. METHODS: Consecutive patients followed with PM remote interrogations from September 2010 to December 2015 were included. The transmissions pertaining to the first 12 months of remote control were analysed and the patients were divided by those presenting NSVT and those without NSVT. The two groups were compared in terms of total mortality and cardiovascular mortality based on the administrative data provided by the regional administration of the Italian National Health System. RESULTS: The prevalence of NSVT in 408 patients (62% males, mean age 75.6; SD 10.6 years old) was 21% in a year. During a mean follow-up duration of 44 months, NSVT did not emerge as independently associated with overall mortality, but was associated with cardiovascular mortality in a competing risk regression model with older age, male gender, diabetes, chronic renal insufficiency, ischemic cardiomyopathy and chronic obstructive pulmonary disease. CONCLUSIONS: We show that NSVT episodes recorded by remote control in a PM population are independently associated with cardiovascular mortality with possible implications for risk stratification and therapeutic options.

[The Pacemaker and Implantable Cardioverter-Defibrillator Registry of the Italian Association of Arrhythmology and Cardiac Pacing - Annual report 2016]. / Registro Italiano Pacemaker e Defibrillatori - Bollettino Periodico 2016. Associazione Italiana di Aritmologia e Cardiostimolazione.

BACKGROUND: The pacemaker (PM) and implantable cardioverter-defibrillator (ICD) registry of the Italian Association of Arrhythmology and Cardiac Pacing (AIAC) monitors the main epidemiological data in real-world practice. The survey for the 2016 activity collects information about demographics, clinical characteristics, main indications for PM/ICD therapy and device types from the Italian collaborating centers. METHODS: The registry collects prospectively national PM and ICD implantation activity on the basis of European cards. RESULTS: PM Registry: data about 23 496 PM implantations were collected (19 003 first implant and 4493 replacements). The number of collaborating centers was 204. Median age of treated patients was 81 years (75 quartile I; 86 quartile III). ECG indications included atrioventricular conduction disorders in 39.8% of first PM implants, sick sinus syndrome in 22.1%, atrial fibrillation plus bradycardia in 14.1%, other in 24.0%. Among atrioventricular conduction defects, third-degree atrioventricular block was the most common type (22.18% of first implants). Use of single-chamber PMs was reported in 26.9% of first implants, of dual-chamber PMs in 65.0%, of PMs with cardiac resynchronization therapy (CRT) in 1.5%, and of single lead atrial-synchronized ventricular stimulation (VDD/R PMs) in 6.6%. ICD Registry: data about 20 350 ICD implantations were collected (14 763 first implants and 5587 replacements). The number of collaborating centers was 430. Median age of treated patients was 72 years (63 quartile I; 78 quartile III]. Primary prevention indication was reported in 79.0% of first implants, secondary prevention in 21.0% (cardiac arrest in 7.9%). A single-chamber ICD was used in 32.2% of first implants, dual-chamber in 31.1% and biventricular in 36.7%. CONCLUSIONS: The PM and ICD Registry appears fundamental for monitoring PM and ICD utilization on a large national scale with rigorous examination of demographics and clinical indications. The PM Registry showed stable electrocardiographic and symptom indications, with an important prevalence of dual-chamber pacing. The use of CRT-PM regards a very limited number of patients. The ICD Registry documented a large use of prophylactic and biventricular ICD, reflecting a favorable adherence to trials and guidelines in clinical practice.

Safety and efficacy of the new bidirectional rotational Evolution® mechanical lead extraction sheath: results from a multicentre Italian registry.

Aims: The aim of this prospective multicentre study is to evaluate safety and efficacy of the new bidirectional rotational mechanical lead extraction (LE) sheath (Evolution RL, Cook Medical, USA) in chronically implanted leads (>1-year-old leads). Methods and results: Between September 2013 and June 2016, a total of 238 leads in 124 consecutive patients were removed by using the new Evolution RL rotational mechanical sheath. Indications for LE were cardiac device infection in 63 (50.8%) cases, lead malfunction in 41 (33.1%), upgrade in 1 (0.8%) case and for other reasons in the remaining 19 cases (15.3%). Ninety-one leads (38.2%) were implantable cardioverter defibrillator leads (81 dual coil vs. 10 single coil), 38 (16%) right ventricular leads, 86 (36.1%) right atrial leads, and 23 (9.7%) coronary sinus leads. The mean implant duration was 92.2 ± 52.9 months (range 12-336). 91.6% of the leads (218/238) were extracted completely with the Evolution RL alone, with the complete success rate rising to 98.7% (235/238 leads) with combined use of a snare. Overall clinical success rate was 100%. No Evolution sheath-related complications were noted. There were no deaths or major complications. Five minor complications (4%) were encountered. In cases of companion leads no wrapping or lead damage were observed. Conclusion: On the basis of our prospective multicentre study, the new hand-powered bidirectional rotational mechanical LE sheath is an effective and safe tool for the extraction of chronically implanted leads without major complications and lead wrapping or lead damage.

Prediction of mortality in patients with implantable defibrillator using CHADS2 score: data from a prospective observational investigation.

BACKGROUND: CHADS2 (congestive heart failure, hypertension, age ≥75 years, diabetes mellitus, previous stroke/TIA) score has been validated as a risk stratification score to predict stroke in patients with atrial fibrillation (AF). The objective of this analysis was to assess whether patient risk factors, in particular CHADS2 score, identified patients at risk of mortality. METHODS: 821 patients with an implantable cardioverter defibrillator were prospectively followed-up in 11 cardiology centers. Patients were grouped in 3 groups according to pre-specified risk classes: low (CHADS2 = 0), moderate (CHADS2 = 1, 2), and high (CHADS2 = 3-6). Information on clinical status and events, were collected during scheduled and unscheduled follow-up visits. Deaths were retrieved from medical records, or through the Regional Office of Vital Statistics. RESULTS: Over a mean follow-up of 44±26 months, 135 deaths occurred in the overall population: 6 (7.7%) in the low-risk population, 69 (13.8%) in moderate-risk patients and 60 (24.6%) in high-risk patients. Kaplan-Meier estimated of patient survival were significantly different in 3 patients groups (93.0%, 90.1%, 78.5% in low, moderate and high risk patients respectively, at 4 years P<0.001). A sub-analysis on patients without history of AF showed similar results. Multivariate regression analysis adjusted for baseline characteristics confirmed the high risk status (HR 1.88, 95% CI 1.27-2.80; P = 0.002) as an independent predictor of mortality adjusted for the baseline characteristics. CONCLUSIONS: In our multicenter research, the long-term mortality was higher in patients with high CHADS2 score than in those with lower risk score regardless the presence of history of AF. CHADS2 score could be considered a toll to predict all causes mortality.

Remote control improves quality of life in elderly pacemaker patients versus standard ambulatory-based follow-up.

BACKGROUND: Health-related quality of life (HRQoL) improves shortly after pacemaker (PM) implantation. No studies have investigated the HRQoL trend for elderly patients with a remote device monitoring follow-up system. METHODS: Using EuroQol-5D Questionnaire and the PM-specific Assessment of Quality of Life and Related Events Questionnaire, HRQoL was measured at baseline and then repeatedly during the 6 months following PM implantation in a cohort of 42 consecutive patients. Twenty-five patients were followed-up with standard outpatient visits, while 17 used a remote monitoring system. RESULTS: Aquarel scores were significantly higher in patients with remote device monitoring system regarding chest discomfort and arrhythmia subscales the first month after PM implant and remained stable until 6 months. Remote monitoring affected the rate of HRQoL improvement in the first 3 months after pacemaker implantation more than ambulatory follow-up. CONCLUSIONS: Remote device monitoring has a significant impact on HRQoL in pacemaker patients, increasing its levels up to 6 months after implant.

[The Pacemaker and Implantable Cardioverter-Defibrillator Registry of the Italian Association of Arrhythmology and Cardiac Pacing - Annual report 2015]. / Registro Italiano Pacemaker e Defibrillatori - Bollettino Periodico 2015. Associazione Italiana di Aritmologia e Cardiostimolazione.

BACKGROUND: The pacemaker (PM) and implantable cardioverter-defibrillator (ICD) Registry of the Italian Association of Arrhythmology and Cardiac Pacing (AIAC) monitors the main epidemiological data in real-world practice. The survey for the 2015 activity collects information about demographics, clinical characteristics, main indications for PM/ICD therapy and device types from the Italian collaborating centers. METHODS: The Registry collects prospectively national PM and ICD implantation activity on the basis of European cards. RESULTS: PM Registry: data about 24 285 PM implantations were collected (19 194 first implant and 5091 replacements). The number of collaborating centers was 218. Median age of treated patients was 81 years (75 quartile I; 86 quartile III). ECG indications included atrioventricular conduction disorders in 42.8% of first PM implants, sick sinus syndrome in 22.9%, atrial fibrillation plus bradycardia in 15.1%, other in 19.2%. Among atrioventricular conduction defects, third-degree atrioventricular block was the most common type (23.8% of first implants). Use of single-chamber PMs was reported in 26.9% of first implants, of dual-chamber PMs in 63.4%, of PMs with cardiac resynchronization therapy (CRT) in 1.8%, and of single lead atrial-synchronized ventricular stimulation (VDD/R PMs) in 7.9%. ICD Registry: data about 15 363 ICD implantations were collected (11 453 first implants and 3910 replacements). The number of collaborating centers was 434. Median age of treated patients was 71 years (63 quartile I; 78 quartile III]. Primary prevention indication was reported in 77.3% of first implants, secondary prevention in 22.7% (cardiac arrest in 8.0%). A single-chamber ICD was used in 29.3% of first implants, dual-chamber in 34.6% and biventricular in 36.1%. CONCLUSIONS: The PM and ICD Registry appears fundamental for monitoring PM and ICD utilization on a large national scale with rigorous examination of demographics and clinical indications. The PM Registry showed stable electrocardiographic and symptom indications, with an important prevalence of dual-chamber pacing. The use of CRT-PM regards a very limited number of patients. The ICD Registry documented a large use of prophylactic and biventricular ICD, reflecting a favorable adherence to trials and guidelines in clinical practice.

Can we predict new AF occurrence in single-chamber ICD patients? Insights from an observational investigation.

BACKGROUND: Atrial tachyarrhythmias (AT/AF) have been associated with an increased risk of mortality, morbidity and ischemic stroke. Up to now, single chamber ICD diagnostics was not able to detect AT/AF, therefore the incidence of new onset AT/AF in patients with single chamber ICD is not known. OBJECTIVE: To evaluate incidence and predictors of AT/AF occurrence in patients with dual-chamber ICD with no pacing indications and no history of AT/AF that strictly mimic single chamber ICD recipient. METHODS & RESULTS: Consecutive dual-chamber ICD patients were prospectively followed by 47 Italian cardiologic centers in an observational research. Clinical and device data were reviewed by expert cardiologists to assess AT/AF occurrence. Multivariate regression analysis evaluated the risk of new-onset AT/AF and its association with patients' baseline characteristics and with CHADS2 score. 428 (13.4% female, 64years old) patients were followed for a median observation period of 31months. AT/AF episodes occurred in 160 (37.4%) patients when considering at least 5min duration, in 95 (22.2%) for AT/AF ≥6h, in 47 (11.0%) for AT/AF ≥1day, in 29 (6.8%) for AT/AF ≥7days. Patients with CHADS2≥2, who comprised 36% of the whole population, showed higher incidence of AT/AF ≥6h compared with patients with CHADS2<2 (Hazard Ratio=1.69, 95% Confidence Interval=1.13-2.53, p=0.011). CONCLUSIONS: Our observations in a population of dual-chamber ICD patients with no pacing indications and no history of AT/AF, who strictly mimic single-chamber ICD recipients, highlight that AT/AF episodes occurred in the 37.5% of the population and CHADS2 score is predictive of new-onset AT/AF.

Device pacing diagnostics overestimate effective cardiac resynchronization therapy pacing results of the hOLter for Efficacy analysis of CRT (OLÉ CRT) study.

BACKGROUND: A high percentage of biventricular (BiV) or left ventricular (LV) pacing in cardiac resynchronization therapy (CRT) devices has been associated with superior clinical outcomes. However, the percent ventricular (%V) pacing reported by CRT devices simply indicates the number of paces the device has delivered and not the proportion of pacing that has captured the LV effectively. OBJECTIVE: The purpose of this study was to determine whether a beat-by-beat evaluation of effective pacing would provide a more accurate evaluation of CRT delivery. METHODS: An automatic electrogram (EGM)-based algorithm that classifies each LV pace as effective or ineffective based on detection of QS/QS-r morphology on the unipolar LV EGM during pacing was developed and validated. LV EGMs that were recorded by 24-hour Holter from 57 CRT patients were postprocessed. The percent effective CRT (%e-CRT) pacing was calculated by dividing the time spent in e-CRT pacing by the total time of the recording. RESULTS: In this CRT cohort, the average %V pacing (94.8% ± 8%) significantly overestimated the %e-CRT pacing (87.5% ± 23%; P <.001). A significant minority of subjects (18%) had a discrepancy of at least 3 percentage points between %V pacing and %e-CRT pacing (mean 39% ± 41%). CONCLUSION: Current device pacing diagnostics overestimate the amount of CRT pacing actually delivered. The new algorithm quantifies ineffective CRT pacing, which enables clinicians to identify patients with this issue and to address the reasons behind suboptimal CRT delivery.

Intermuscular Two-Incision Technique for Subcutaneous Implantable Cardioverter Defibrillator Implantation: Results from a Multicenter Registry.

BACKGROUND: The traditional technique for subcutaneous implantable cardioverter defibrillator (S-ICD) implantation, which involves three incisions and a subcutaneous pocket, is associated with possible complications, including inappropriate interventions. The aim of this prospective multicenter study was to evaluate the efficacy and safety of an alternative intermuscular two-incision technique for S-ICD implantation. METHODS: The study population included 36 consecutive patients (75% male, mean age 44 ± 12 years [range 20-69]) who underwent S-ICD implantation using the intermuscular two-incision technique. This technique avoids the superior parasternal incision for the lead placement and consists of creating an intermuscular pocket between the anterior surface of the serratus anterior and the posterior surface of the latissimus dorsi muscles instead of a subcutaneous pocket. RESULTS: All patients were successfully implanted in the absence of any procedure-related complications with a successful 65-J standard polarity defibrillation threshold testing, except in one, who received a second successful shock after pocket revision. During a mean follow-up of 10 months (range 3-30), no complications requiring surgical revision were observed. At device interrogation, stable sensing without interferences was observed in all patients. Two patients (5.5%) experienced appropriate and successful shock on ventricular fibrillation and in four patients (11%), a total of seven nonsustained self-terminated ventricular tachycardias were correctly detected. No inappropriate interventions were observed. CONCLUSIONS: Our experience suggests that the two-incision intermuscular technique is a safe and efficacious alternative to the current technique for S-ICD implantation that may help reducing complications including inappropriate interventions and offer a better cosmetic outcome, especially in thin individuals.

What We Can Learn from "Super-responders".

This review discusses the state of the art of knowledge to help decision making in patients who are candidates for cardiac resynchronization therapy (CRT) and to analyze the long-term total and cardiac mortality, sudden death, and CRT with a defibrillator intervention rate, as well as the evolution of echocardiographic parameters in patients with a left ventricular (LV) ejection fraction of greater than 50% after CRT implantation. Owing to normalization of LV function in super-responders, the need for a persistent defibrillator backup is also considered.

Multipoint Pacing versus conventional ICD in Patients with a Narrow QRS complex (MPP Narrow QRS trial): study protocol for a pilot randomized controlled trial.

BACKGROUND: Despite an intensive search for predictors of the response to cardiac resynchronization therapy (CRT), the QRS duration remains the simplest and most robust predictor of a positive response. QRS duration of ≥ 130 ms is considered to be a prerequisite for CRT; however, some studies have shown that CRT may also be effective in heart failure (HF) patients with a narrow QRS (<130 ms). Since CRT can now be performed by pacing the left ventricle from multiple vectors via a single quadripolar lead, it is possible that multipoint pacing (MPP) might be effective in HF patients with a narrow QRS. This article reports the design of the MPP Narrow QRS trial, a prospective, randomized, multicenter, controlled feasibility study to investigate the efficacy of MPP using two LV pacing vectors in patients with a narrow QRS complex (100-130 ms). METHODS: Fifty patients with a standard ICD indication will be enrolled and randomized (1:1) to either an MPP group or a Standard ICD group. All patients will undergo a low-dose dobutamine stress echo test and only those with contractile reserve will be included in the study and randomized. The primary endpoint will be the percentage of patients in each group that have reverse remodeling at 12 months, defined as a reduction in left ventricular end-systolic volume (LVESV) of >15% from the baseline. DISCUSSION: This feasibility study will determine whether MPP improves reverse remodeling, as compared with standard ICD, in HF patients who have a narrow QRS complex (100-130 ms). TRIAL REGISTRATION: ClinicalTrials.gov, NCT02402816 . Registered on 25 March 2015.