Role of extended external loop recorders for the diagnosis of unexplained syncope, pre-syncope, and sustained palpitations.

AIMS: To assess the diagnostic yield of new external loop recorders (ELRs) in patients with history of syncope, pre-syncope, and sustained palpitations. METHODS AND RESULTS: Since 2005, we have established a registry including patients who consecutively received ELR monitoring for unexplained syncope or pre-syncope/palpitations. The registry included 307 patients (61% females, age 58 ± 19 years, range 8-94 years) monitored by high-capacity memory ELR of two subsequent generations: SpiderFlash-A(®) (SFA(®), Sorin CRM), storing two-lead electrocardiogram (ECG) patient-activated recordings by loop-recording technique (191 patients, 54 patients with syncope, years 2005-09), and SpiderFlash-T(®) (SFT(®)), adding auto-trigger detection for pauses, bradycardia, and supraventricular/ventricular arrhythmias (116 patients, 38 patients with syncope, years 2009-12). All the patients previously underwent routine workup for syncope or palpitation, including one or more 24 h Holter, not conclusive for diagnosis. Mean monitoring duration was 24.1 ± 8.9 days. Among 215 patients with palpitations, a conclusive diagnosis was obtained in 184 patients (86% diagnostic yield for palpitation). Among 92 patients with syncope, a conclusive diagnosis was obtained in 16 patients (17% clinical diagnostic yield for syncope), with recording during syncope of significant arrhythmias in 9 patients, and sinus rhythm in 7 patients. Furthermore, asymptomatic arrhythmias were de novo detected in 12 patients (13%), mainly by auto-trigger detection, suggesting an arrhythmic origin of the syncope. CONCLUSIONS: The diagnostic yield of ELR in patients with syncope, pre-syncope, or palpitation of unknown origin after routine workup was similar to implantable loop recorder (ILR) within the same timeframe, therefore, ELR could be considered for patients candidate for long-term ECG monitoring, stepwise before ILR.

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.

The Interplay of PR Interval and AV Pacing Delays Used for Cardiac Resynchronization Therapy in Heart Failure Patients: Association with Clinical Response in a Retrospective Analysis of a Large Observational Study.

Background. Cardiac resynchronization therapy (CRT) is a treatment for heart failure (HF) patients with prolonged QRS and impaired left ventricular (LV) systolic function. We aim to evaluate how the baseline PR interval is associated with outcomes (all-cause death or HF hospitalizations) and LV reverse remodeling (>15% relative reduction in LV end-systolic volume). Methods. Among 2224 patients with CRT defibrillators, 1718 (77.2%) had a device programmed at out-of-the-box settings (sensed AV delay: 100 ms and paced AV delay: 130 ms). Results. In this cohort of 1718 patients (78.7% men, mean age 66 years, 71.6% in NYHA class III/IV, LVEF = 27 ± 6%), echocardiographic assessment at 6-month follow-up showed that LV reverse remodeling was not constant as a function of the PR interval; in detail, it occurred in 56.4% of all patients but was more frequent (76.6%) in patients with a PR interval of 160 ms. In a median follow-up of 20 months, the endpoint of death or HF hospitalizations occurred in 304/1718 (17.7%) patients; in the multivariable regression analysis it was significantly less frequent when the PR interval was between 150 and 170 ms (hazard ratio = 0.79, 95% confidence interval (CI): 0.63−0.99, p = 0.046). The same PR range was associated with higher probability of CRT response (odds ratio = 2.51, 95% CI: 1.41−4.47, p = 0.002). Conclusions. In a large population of CRT patients, with fixed AV pacing delays, specific PR intervals are associated with significant benefits in terms of LV reverse remodeling and lower morbidity. These observational data suggest the importance of optimizing pacing programming as a function of the PR interval to maximize CRT response and patient outcome.

The Impact of COVID-19 Pandemic and Lockdown Restrictions on Cardiac Implantable Device Recipients with Remote Monitoring.

From 2020, many countries have adopted several restrictions to limit the COVID-19 pandemic. The forced containment impacted on healthcare organizations and the everyday life of patients with heart disease. We prospectively analyzed data recorded from implantable defibrillators and/or cardiac resynchronization devices of Italian patients during the lockdown (LDP), post-lockdown period (PLDP) and a control period (CP) of the previous year. We analyzed device data of the period 9 March 2019-31 May 2020 of remotely monitored patients from 34 Italian centers. Patients were also categorized according to areas with high/low infection prevalence. Among 696 patients, we observed a significant drop in median activity in LDP as compared to CP that significantly increased in the PLDP, but well below CP (all p < 0.0001). The median day heart rate and heart rate variability showed a similar trend. This behavior was associated during LDP with a significant increase in the burden of atrial arrhythmias (p = 0.0150 versus CP) and of ventricular arrhythmias [6.6 vs. 1.5 per 100 patient-weeks in CP; p = 0.0026]; the latter decreased in PLDP [0.3 per 100 patient-weeks; p = 0.0035 vs. LDP]. No modifications were recorded in thoracic fluid levels. The high/low prevalence of COVID-19 infection had no significant impact. We found an increase in the arrhythmic burden in LDP coupled with a decrease in physical activity and heart rate variability, without significant modifications of transthoracic impedance, independent from COVID-19 infection prevalence. These findings suggest a negative impact of the COVID-19 pandemic, probably related to lockdown restrictions.

First-line therapy: insights from a real-world analysis of cryoablation in patients with atrial fibrillation.

AIMS: Pulmonary vein isolation (PVI) using cryoballoon ablation (CBA) is mainly reserved for patients with drug-refractory or drug-intolerant symptomatic atrial fibrillation. We evaluated a large cohort of patients treated in a real-world setting and examined the safety and efficacy profile of CBA when applied as a first-line treatment for atrial fibrillation. METHODS: In total, 249 patients (23% women; 56 ±â€Š13 years; mean left atrial diameter 41 ±â€Š7 mm; 73.5% paroxysmal atrial fibrillation; and 26.5% persistent atrial fibrillation) underwent an index PVI by CBA. Data were collected prospectively in the framework of the 1STOP ClinicalService project, involving 26 Italian cardiology centers. RESULTS: Median procedure and fluoroscopy times were 90.0 and 21.0 min, respectively. Acute procedural success was 99.8%. Acute/periprocedural complications were observed in seven patients (2.8%), including: four transient diaphragmatic paralyses, one pericardial effusion (not requiring any intervention), one transient ischemic attack, and one minor vascular complication. The Kaplan--Meier freedom from atrial fibrillation recurrence was 86.3% at 12 months and 76% at 24 months. Seventeen patients (6.8%) had a repeat catheter ablation procedure during the follow-up period. At last follow-up, 10% of patients were on an anticoagulation therapy, whereas 6.8% were on an antiarrhythmic drug. CONCLUSION: In our multicenter real-world experience, PVI by CBA in a first-line atrial fibrillation patient population was well tolerated, effective, and promising. CBA with a PVI strategy can be used to treat patients with paroxysmal and persistent atrial fibrillation with good acute procedural success, short procedure times, and acceptable safety. CLINICAL TRIAL REGISTRATION: clinicaltrials.gov (NCT01007474).

Sex effect on efficacy of pulmonary vein cryoablation in patients with atrial fibrillation: data from the multicenter real-world 1STOP project.

PURPOSE: Pulmonary vein isolation (PVI) using cryoablation (PVI-C) is a widespread therapy for treating symptomatic, recurrent atrial fibrillation (AF). The impacts of sex on efficacy and safety of PVI-C in a real-world clinical practice is lacking. In a multicenter prospective project, we evaluated whether clinical characteristics, procedure parameters, procedural complications, long-term AF recurrence rates, and/or AF-related symptoms differed according to sex in patients treated with PVI-C. METHODS: Data from the study population were collected in the framework of the 1STOP ClinicalService® project, involving 47 Italian cardiology centers. Multivariable statistical analyses were conducted to determine if any baseline clinical characteristics impacted the efficacy of PVI-C. RESULTS: From April 2012, 2125 patients (27% female, 59 ± 11 years, 73% paroxysmal AF, and mean left atrial diameter = 42 ± 8 mm) underwent PVI-C. According to baseline characteristics, women were more likely to be older, with higher clinical risk scores (e.g., CHA2DS2-VASc), and a higher number of tested antiarrhythmic drugs before the index PVI-C procedure. Male and female cohorts showed comparable procedure time (mean = 107.7 ± 46.8 min) and a similar incidence of periprocedural complications (4.5% overall), even after adjustment for baseline characteristics (P = 0.880). The multivariable analyses demonstrated that the strongest predictor of AF recurrences was sex (0.74; 95% CI 0.58-0.93; P = 0.011). After propensity score adjustment, the hazard ratio from a multivariable model, which included age and AF type (persistent) as covariates, was 0.76 (0.60-0.97) (P = 0.025). CONCLUSIONS: According to the 1STOP project, in a real-world setting, PVI-C was relatively safe regardless of the patient's sex; however, when considering efficacy of the procedure, female patients had a lower long-term efficacy in comparison to males. CLINICAL TRIAL REGISTRATION: NCT01007474.

Unusual presence of 'ghosts' following lead extraction for recurrent reactive pericarditis: a case report.

BACKGROUND: The presence of a persistent fibrous sheath in right-sided heart chambers after transvenous lead extraction has already been described in some studies as echocardiographic tubular mobile masses called 'ghosts'. Their presence has been associated with cardiac device-related infective endocarditis or local device infection, but to the best of our knowledge, this is the first case where 'ghosts' have been reported among non-infected patients. CASE SUMMARY: We present a case of a 73-year-old woman hospitalized due to worsening dyspnoea and a significant pericardial effusion, relapsed after pericardiocentesis with removal of about 1500 mL of non-haemorrhagic fluid. The patient's history revealed a previous dual-chamber pacemaker implantation due to symptomatic sick sinus syndrome. Transoesophageal echocardiography (TOE), essential to exclude endocarditis vegetations suggested an etiopathogenesis of mechanical irritation caused by the distal end of the passive fixation atrial lead on the right atrial appendage wall. Considering the echocardiographic report and the condition of reactive pericarditis with the early relapse of the significant pericardial effusion after pericardiocentesis, we opted for a lead removal procedure to eliminate the stimulus causing the irritation, with transoesophageal echocardiographic monitoring, thus the early detection of a 'ghost' was possible. DISCUSSION: This is the first clinical case describing the presence of fibrin 'ghosts' sometime after the implantation of a pacemaker, highlighting a non-exclusively infectious genesis, and emphasizing the importance of TOE for the early detection of this post-extraction complication and its monitoring.

Subcutaneous ICD implantation in a patient with hypertrophic cardiomyopathy after transvenous ICD failure: A case report.

We describe the case of a patient with hypertrophic cardiomyopathy who experienced the failure of a transvenous implantable cardioverter defibrillator (T-ICD) lead and the following inability of a second T-ICD to convert a ventricular fibrillation. A subcutaneous ICD (S-ICD) was finally implanted and was effective at defibrillation test.

Surgical ablation of arrhythmias.

The surgical approach was the earliest therapeutic ablation of hyperkinetic arrhythmias. Following the progressive improvements in electrophysiological mapping and operative techniques, new surgical approaches have been developed for the treatment of those arrhythmias related to ectopic phenomena or reentry mechanisms. These procedures have been proven to be highly effective but the associated morbidity and mortality were unacceptably high. More recent and advanced techniques of transcatheter ablation have revolutionized the treatment of these arrhythmias and now represent the treatment of choice in the majority of cases. However, the significant reduction in the operative risk and the improvement in patient outcome with respect to the past, thanks to a better patient selection and to advances in the surgical and myocardial protection techniques, make do that the surgical approach to some forms of arrhythmias is still valid, especially in those cases requiring associated surgery: atrial tachyarrhythmias in patients with congenital heart disease, post-ischemic ventricular tachycardias in patients who necessitate myocardial revascularization, and/or ventricular remodeling and chronic or paroxysmal atrial fibrillation in patients who require cardiac surgery. New techniques such as radiofrequency, microwaves and cryoablation guarantee the creation of linear and transmural lesions with minimum damage to the cardiac structures and appear very interesting as they are surgically simple and associated with shorter procedure times and less complications. The possibility of performing the ablative procedure completely on the epicardial surface may open the way for atrial fibrillation surgery on a totally beating heart and for procedures that are ever less invasive thus enabling treatment of patients without associated surgical indications.

Clinical Relevance Of Systematic CRT Device Optimization.

Cardiac Resynchronization Therapy (CRT) is known as a highly effective therapy in advanced heart failure patients with cardiac dyssynchrony. However, still one third of patients do not respond (or sub-optimally respond) to CRT. Among the many contributors for the high rate of non-responders, the lack of procedures dedicated to CRT device settings optimization (parameters to regulate AV synchrony and VV synchrony) is known as one of the most frequent. The most recent HF/CRT Guidelines do not recommend to carry-out optimization procedures in every CRT patient; they simply state those procedures "could be useful in selected patients", even though their role in improving response has not been proven. Echocardiography techniques still remain the gold-standard reference method to the purpose of CRT settings optimization. However, due to its severe limitations in the routine of CRT patients management (time and resource consuming, scarce reproducibility, inter and intra-operator dependency), echocardiography optimization is widely under-utilized in the real-world of CRT follow-up visits. As a consequence, device-based techniques have been developed to by-pass the need for repeated echo examinations to optimize CRT settings. In this report the available device-based optimization techniques onboard on CRT devices are shortly reviewed, with a specific focus on clinical outcomes observed in trials comparing these methods vs. clinical practice or echo-guided optimization methods. Particular emphasis is dedicated to hemodynamic methods and automaticity of optimization algorithms (making real the concept of "ambulatory CRT optimization"). In fact a hemodynamic-based approach combined with a concept of frequent re-optimization has been associated - although retrospectively - with a better clinical outcome on the long-term follow-up of CRT patients. Large randomized trials are ongoing to prospectively clarify the impact of automatic optimization procedures.

Left ventricular ejection fraction overcrossing 35% after one year of cardiac resynchronization therapy predicts long term survival and freedom from sudden cardiac death: single center observational experience.

BACKGROUND: Reverse remodeling and increased LVEF after CRT correlate with survival and heart failure hospitalizations, but their relationship with the risk of SCD is unclear. We aimed to evaluate whether exceeding a threshold value of 35% for left ventricular ejection fraction (LVEF) 1 year after cardiac resynchronization therapy (CRT) predicts survival and freedom from sudden cardiac death (SCD). METHODS: 330 patients who survived ≥ 6 months after CRT (males 80%, age 62 ± 11 years) were grouped according to 1-year LVEF ≤ 35% (Group 1, n=187, 57%) or >35% (Group 2, n=143, 43%). According to changes vs. baseline (reduction of left end-systolic volume [LVESV] ≥ 10% or increase of LVEF% > 10 units), patients were also classified as echocardiographic (Echo) non-responders (Group A, n=152, 46%) or responders (Group B, n=178, 54%). RESULTS: At baseline, LVESV volume was larger and LVEF was lower in Group 1 vs. Group 2 (p<0.001). After 1 year, echocardiographic improvement was greater in Group 2 vs. Group 1 (p<0.001 for changes in both LVESV and LVEF). Over a median follow-up of 49 months, 47 patients (14%) died, 36 in Group 1 vs. 11 in Group 2 (19% vs. 8%, p=0.004). A significantly higher rate of freedom from all-cause mortality (p=0.002), cardiovascular mortality (p<0.001) and SCD (p<0.001) was observed in Group 2. Multivariate analysis demonstrated that only 1-year LVEF >35% was associated with freedom from SCD/VF. CONCLUSIONS: LVEF >35% after 1 year of CRT characterizes a favorable long-term outcome, with a very low risk for SCD.

[Risk stratification for sudden cardiac death: should we juist consider ejection fraction?]. / La stratificazione del rischio di morte improvvisa: dobbiamo considerare solo la frazione di eiezione?

Sudden cardiac arrest is a leading cause of death in industrialized countries. There is solid clinical evidence for implantable cardioverter-defibrillators as the only effective means of preventing sudden cardiac arrest and reducing mortality in high-risk patients. The therapeutic strategy has definitively been validated, but we have not yet identified with the same effectiveness the patients who most likely will benefit from such therapy. Risk stratification of sudden death is therefore one of the major unresolved issues of modern cardiology. Current guidelines identify ejection fraction as the only instrumental parameter for risk stratification of sudden cardiac death. It is strongly consolidated from "old and new" clinical trials that ejection fraction reduction is the real powerful predictor of total mortality and sudden death regardless of its etiology; however it cannot be considered as an indisputable gold standard predictor of risk because it lacks of sensitivity and specificity in the prediction of sudden death. It is reasonable that many factors besides ejection fraction influence patient prognosis; there are different aspects suggesting that a reduction in ejection fraction is a risk factor only in combination with other risk factors. The implantable cardioverter-defibrillator therapy is expensive and associated with possible complications. We therefore need better methods for risk stratification of our patients in order to increase the real cost-effectiveness of current and future treatment options.

Patient selection for biventricular pacing.

INTRODUCTION: Biventricular pacing improves functional status in the majority of patients with drug-refractory heart failure, dilated cardiomyopathy, and interventricular conduction delay. The aim of this study was to analyze the baseline clinical and functional data of a cohort of patients implanted with a biventricular stimulation system in a single-center experience, to verify if the pathophysiologic characteristics of patients affect outcome, and to determine if preliminary identification of the right candidates for the new therapy is possible with noninvasive parameters. METHODS AND RESULTS: Since March 1999, 52 patients with advanced heart failure (idiopathic cardiomyopathy 50%, ischemic cardiomyopathy 35%, other etiology 15%) and left bundle branch block underwent cardiac resynchronization and were followed prospectively. Paired analysis over mean (+/- SD) follow-up of 348 +/- 154 days showed an overall significant decrease of QRS width (baseline 194 +/- 33.2 msec vs follow-up 159.6 +/- 20.1 msec), New York Heart Association (NYHA) functional class (baseline 3.2 +/- 0.5 vs follow-up 2.3 +/- 0.5), quality-of-life score (baseline 54 +/- 25 vs follow-up 25 +/- 16), and increase of maximal VO2 (baseline 12.6 +/- 2.5 mL/kg/min vs follow-up 15.0 +/- 3.3 mL/kg/min). There were 80% responders (documented, persistent decrease > or = 1 NYHA class) and 20% nonresponders (same NYHA class or decline of status; need for heart transplant; death due to progressive pump failure). No significant differences in baseline clinical and functional variables between the two subgroups were observed. In responders, there was a highly significant global improvement of all variables; in nonresponders, no parameters changed between baseline and follow-up. CONCLUSION: These data confirm the role of biventricular pacing in improving the functional status of the great majority of a selected patient population having advanced heart failure and left bundle branch block with wide QRS complex. Basal demographic, clinical, and functional characteristics are not helpful in preliminary selection of responders. Simple evaluation of NYHA class confirms favorable outcome (improvement of functional and hemodynamic status).