Efficacy and safety of novel left ventricular pacing leads: 1-year analysis of the NAVIGATOR trial.

OBJECTIVES: Assess safety and performance of novel quadripolar preshaped left ventricular (LV) leads: NAVIGO 4LV 2D ('S shaped') and NAVIGO 4LV ARC ('U shaped'). METHODS: Patients indicated for cardiac resynchronisation therapy were enrolled in a multicentre, prospective, controlled study (NAVIGATOR, NCT03279484). Patients were implanted with either a NAVIGO 4LV 2D or ARC lead, and assessed at 10 weeks, 6, 12 and 24 months post-implant. Co-primary safety and performance endpoints were assessed at 10 weeks. Safety endpoint was the patients' rate free from lead-related complications. Performance endpoint was the rate of patients with successful lead performance, defined as LV pacing threshold ≤2.5 V at 0.5 ms on at least one pacing vector, and the absence of phrenic nerve stimulation at the final programmed configuration. Lead-related complications and electrical parameters were monitored throughout study. RESULTS: A NAVIGO 4LV lead was successfully implanted in 211 out of 217 patients (97.2%). The safety endpoint was met, with 100% and 96.1% of patients free from complications for NAVIGO 4LV 2D and ARC, respectively. The performance endpoint was met with 98.1% and 98.9% of patients with a successful lead performance for NAVIGO 4LV 2D and ARC, respectively. Over 12 months, the global complication-free rate for both leads was 97.1% (95% CI: 93.71% to 98.70%), with a mean pacing capture threshold of 1.23 V±0.73 V and a mean impedance of 951 Ω±300.1 Ω. CONCLUSION: A high implantation success rate and low complication rate was reported for the novel NAVIGO 4LV 2D and ARC leads, along with successful performance up to 12 months.

Very-early detection of atrial fibrillation after ablation evaluated by a wearable ECG-patch predicts late blanking period recurrence: Preliminary data from a prospective registry.

Introduction: Atrial fibrillation (AF) ablation represents a safe and effective procedure to restore sinus rhythm. The idea that post-procedural AF episodes - during the blanking period - are not considered treatment failure has been increasingly challenged. The E-Patch, a single-use adhesive electrode, facilitates extended continuous ECG monitoring for 120 h. This pilot study aims to assess the effectiveness of this ambulatory monitoring device and investigate whether very-early AF recurrence correlates with delayed blanking period ablation outcomes. Methods: We conducted a single-center, prospective, longitudinal study, including consecutive post-ablation patients monitored with the E-patch. The ability of the device to continuously record was analyzed, as well as the occurrence of AF episodes during external 7-day loop-recorder in the 2nd-month post-ablation. Results: We included 40 patients, median age 62 years (IQR 56-70). E-Patch monitoring was obtained for a median of 118 h (IQR 112-120), with no discomfort nor interpretation artefacts. Very-early AF recurrence was detected in 11 (27.5 %) patients, with a median AF burden of 7 % (IQR 6 %-33 %). Late-blanking period AF was detected in 13 (33 %) of the external 7-day loop recordings. Of the 11 patients that had very-early AF recurrence, 10 (91 %) had late-blanking AF. Very-early AF detection showed 77 % (95 % CI 64 %-90 %) sensitivity and 96 % (95 % CI 90-100 %) specificity in predicting late-blanking AF, with a non-parametric ROC curve AUC of 0.903 (95 % 0.797--1.0). Conclusion: The E-Patch was able to detect very-early AF during an extended period. Very-early AF detection emerges as a predictor of AF recurrence during the late blanking period post-ablation.

Permanent pacemaker implantation after alcoholic septal ablation induced complete heart block: Long-term impact.

INTRODUCTION AND OBJECTIVES: Patients with hypertrophic obstructive cardiomyopathy (HOCM) that remain symptomatic despite optimized medical therapy often undergo alcohol septal ablation (ASA). One of the most frequent complications is complete heart block (CHB), requiring a permanent pacemaker (PPM) in variable rates of up to 20% of patients. The long-term impact of PPM implantation in these patients remains unclear. This study aimed to evaluate the long-term clinical outcomes in patients who implant PPM after ASA. METHODS: Patients who underwent ASA at a tertiary center were consecutively and prospectively enrolled. Patients with previous PPM or implantable cardio-defibrillator were excluded from this analysis. Patients with and without PPM implantation after ASA were compared based on their baseline characteristics, procedure data and three-year primary endpoint of composite of all-cause mortality and hospitalization and secondary endpoint of composite of all-cause mortality and cardiac cause hospitalization. RESULTS: Between 2009 and 2019, 109 patients underwent ASA, 97 of whom were included in this analysis (68% female, mean age 65.2 years old). 16 patients (16.5%) required PPM implantation for CHB. In these patients, no vascular access, pacemaker pocket or pulmonary parenchyma complications were noted. The baseline characteristics of comorbidities, symptoms, echocardiographic and electrocardiographic findings were identical in the two groups, with higher mean age (70.6±10.0 years vs. 64.1±11.9 years) and lower beta-blocker therapy rate (56% vs. 84%) in the PPM group. Procedure-related data showed higher creatine kinase (CK) peaks in the PPM group (1692 U/L vs. 1243 U/L), with no significant difference in the alcohol dose. At three years after ASA procedure, there were no differences in the primary and secondary endpoints between the two groups. CONCLUSIONS: Permanent pacemaker after ASA induced CHB do not affect long term prognosis in hypertrophic obstructive cardiomyopathy patients.

Clinical outcome of a single procedure cryoballoon ablation for the treatment of atrial fibrillation: A real-world multicenter experience in Portugal.

BACKGROUND: Cryoballoon ablation (CBA) for pulmonary vein isolation (PVI) has been growing as an alternative technique, not only in patients with paroxysmal atrial fibrillation (PAF) but also in persistent atrial fibrillation (AF). Cryoballoon ablation has demonstrated encouraging acute and mid-term results. However, data on long-term follow-up of CB-based PVI are scarce. OBJECTIVE: We sought to examine efficacy, safety, and long-term outcomes of CBA in PAF and persistent AF in four Portuguese centers. METHODS: All patients that were treated with the cryoballoon catheter according to routine practices with a second-generation 28-mm CB in four centers were included. This was a retrospective, non-randomized analysis. Patients were followed-up for >12 months and freedom from atrial arrhythmias (AA) was evaluated at the end of follow-up. RESULTS: Four hundred and six patients (57.7±12.4 years, 66% men) participated. AF was paroxysmal in 326 patients (80.2%) and persistent in 80 (19.7%). The mean procedure time duration was 107.7±50.9 min, and the fluoroscopy time was 19.5±9.7 min. Procedural/periprocedural complications occurred in 30 cases (7.3%), being transient phrenic nerve palsy the most frequent incident (2 out of 3 complications). Anatomic variations of the PV were present in 16.1% of cases. At a mean follow-up of 22.0±15.0 months, 310 patients (76.3%) remained in stable sinus rhythm, with at least one AF episode recurrence documented in 98 cases (24.1%). The recurrence rate was 20.5% in the PAF group and 37.8% in the persistent AF group. CONCLUSION: In this multicenter experience, a single CBA procedure resulted in 75.9% freedom from AF at a 22-month follow-up. This technique was demonstrated to be a safe and effective option in experienced centers for the treatment of PAF and PersAF.

The atrial fibrillation burden during the blanking period is predictive of time to recurrence after catheter ablation.

Objective: This study aimed to assess whether atrial fibrillation (AF) occurrence or its corresponding daily mean burden (in minutes/day) during the mid to late blanking period after pulmonary vein isolation (PVI), predicts AF recurrence. Methods: Analysis of consecutive first PVI ablation patients undergoing prolonged electrocardiogram (ECG) monitoring during the second and third months after PVI. The clinical variables, total AF burden, and their relationship with time to recurrence were studied. Results: 477 patients with a mean age of 56.9 (SD = 12.3) years (63.7 % male; 71.7 % paroxysmal AF), from which 317 (66.5 %) had an external event recorder between 30 and 90 days after ablation. Median follow-up of 16.0 (P 25:12.0: P 75:33.0) months, 177 (37 %) patients had an AF recurrence, with 106 (22.2 %) having the first episode after 12 months of follow-up. In the group of patients with an event recorder, 80 (25.2 %) had AF documented during the blanking period. Multivariable analysis showed that AF during the blanking period was associated with a 4-fold higher risk of recurrence (HR: 3.98; 95 %CI: 2.95-5.37), and, compared to patients in sinus rhythm, those with an AF burden ≥ 23 min/day had an approximately 7-fold higher risk of recurrence (HR estimate: 6.79; 95 %CI: 4.56-10.10). Conclusions: The probability of experiencing AF recurrence can be predicted by atrial tachyarrhythmia episodes during the second and third months after PVI. Atrial arrhythmias burden > 23 min/day has a high predictive ability for recurrence.

EHRA expert consensus statement and practical guide on optimal implantation technique for conventional pacemakers and implantable cardioverter-defibrillators: endorsed by the Heart Rhythm Society (HRS), the Asia Pacific Heart Rhythm Society (APHRS), and the Latin-American Heart Rhythm Society (LAHRS).

With the global increase in device implantations, there is a growing need to train physicians to implant pacemakers and implantable cardioverter-defibrillators. Although there are international recommendations for device indications and programming, there is no consensus to date regarding implantation technique. This document is founded on a systematic literature search and review, and on consensus from an international task force. It aims to fill the gap by setting standards for device implantation.

Quality indicators for the care and outcomes of adults with atrial fibrillation.

AIMS: To develop quality indicators (QIs) that may be used to evaluate the quality of care and outcomes for adults with atrial fibrillation (AF). METHODS AND RESULTS: We followed the ESC methodology for QI development. This methodology involved (i) the identification of the domains of AF care for the diagnosis and management of AF (by a group of experts including members of the ESC Clinical Practice Guidelines Task Force for AF); (ii) the construction of candidate QIs (including a systematic review of the literature); and (iii) the selection of the final set of QIs (using a modified Delphi method). Six domains of care for the diagnosis and management of AF were identified: (i) Patient assessment (baseline and follow-up), (ii) Anticoagulation therapy, (iii) Rate control strategy, (iv) Rhythm control strategy, (v) Risk factor management, and (vi) Outcomes measures, including patient-reported outcome measures (PROMs). In total, 17 main and 17 secondary QIs, which covered all six domains of care for the diagnosis and management of AF, were selected. The outcome domain included measures on the consequences and treatment of AF, as well as PROMs. CONCLUSION: This document defines six domains of AF care (patient assessment, anticoagulation, rate control, rhythm control, risk factor management, and outcomes), and provides 17 main and 17 secondary QIs for the diagnosis and management of AF. It is anticipated that implementation of these QIs will improve the quality of AF care.

Long-term follow-up of adult patients with congenital heart disease and an implantable cardioverter defibrillator.

OBJECTIVE: Sudden cardiac death is common in the adult congenital heart disease (ACHD) population. Knowledge and experience about the use of implantable cardioverter defibrillators (ICD) in ACHD patients is very limited. We aimed to characterize a cohort of patients with ACHD and ICDs. DESIGN: Thirty consecutive ACHD patients submitted to an ICD implantation in a single tertiary center were evaluated. Data on baseline clinical features, heart defect, indication for ICD, type of device, appropriate therapies, ICD-related complication, and mortality during follow-up were collected. RESULTS: Of the 30 patients, 56.7% received appropriate therapies due to ventricular tachycardia (VT) or ventricular fibrillation (VF). The rate of inappropriate therapies and device-related complications was 33.3%. Secondary prevention and primary prevention patients with class I indications for ICD had more appropriate therapies than complication, but this relationship was reversed for patients with class II indications. Remote monitoring played an important role in diagnosing new atrial arrhythmias before scheduled visits in 46.2% of patients, leading to a change in medication. VT/VF episodes were associated with a composite of death, cardiac transplantation, and hospital admission (OR 13.0; 95% CI: 2.1-81.5). CONCLUSION: ICDs are not only useful in preventing SCD, but also have a major role in diagnosing atrial tachyarrhythmias ahead of scheduled visits. Although improvements in ICD technology might reduce complications and inappropriate therapies, adequate selection of candidates for primary prevention still remains difficult because of the lack of clear indications.

Left atrial appendage volume as a new predictor of atrial fibrillation recurrence after catheter ablation.

PURPOSE: Recurrence of atrial fibrillation (AF) after catheter ablation is common, being clinically relevant to identify predictors of recurrence. The left atrial appendage (LAA) role as an AF trigger is scarcely explored. Our aim was to identify if LAA volume is an independent predictor of AF recurrence after catheter ablation. METHODS: We analysed 52 patients (aged 54 ± 10 years, 58% male) with paroxysmal and persistent AF who underwent a first AF catheter ablation and had performed contrast-enhanced cardiac computed tomography (CT) prior to the procedure. RESULTS: The mean left atrial and LAA volumes measured by cardiac CT were 98.9 ± 31.8 and 9.3 ± 3.5 mL, respectively. All patients received successful pulmonary vein isolation and were followed up for 24 months. AF recurrence occurred in 17 patients (33%). LAA volume was significantly greater in patients with AF recurrence than in those without recurrence (11.3 ± 2.9 vs. 8.2 ± 3.4 mL; p = 0.002). Multivariable analysis using Cox regression revealed that LAA volume (hazard ratio 1.32; 95% confidence interval 1.12-1.55; p = 0.001) and persistent AF (hazard ratio 4.22; 95% confidence interval 1.48-12.07; p = 0.007) were independent predictors for AF recurrence. An LAA volume greater than 8.825 mL predicted AF recurrence with 94% sensitivity and 66% specificity. The Kaplan-Meier analysis showed a lower rate free from AF recurrence in the group with an LAA volume >8.825 mL (p < 0.001). CONCLUSIONS: Larger LAA volume was associated with AF recurrence after catheter ablation in patients with paroxysmal and persistent AF.

The arterial baroreflex effectiveness index in risk stratification of chronic heart failure patients who are candidates for cardiac resynchronization therapy.

INTRODUCTION: Baroreflex function is an independent marker of prognosis in heart failure (HF). However, little is known about its relation to response to cardiac resynchronization therapy (CRT). The aim of this study is to assess arterial baroreflex function in HF patients who are candidates for CRT. METHODS: The study population consisted of 25 patients with indication for CRT, aged 65±10 years, NYHA functional class ≥III in 52%, QRS width 159±15 ms, left ventricular ejection fraction (LVEF) 29±5%, left ventricular end-systolic volume (LVESV) 150±48 ml, B-type natriuretic peptide (BNP) 357±270 pg/ml, and peak oxygen consumption (peak VO2) 18.4±5.0 ml/kg/min. An orthostatic tilt test was performed to assess the baroreflex effectiveness index (BEI) by the sequence method. This group was compared with 15 age-matched healthy individuals. RESULTS: HF patients showed a significantly depressed BEI during tilt (31±12% vs. 49±18%, p=0.001). A lower BEI was associated with higher BNP (p=0.038), lower peak VO2 (p=0.048), and higher LVESV (p=0.031). By applying a cut-off value of 25% for BEI, two clusters of patients were identified: lower risk cluster (BEI >25%) QRS 153 ms, LVESV 129 ml, BNP 146 pg/ml, peak VO2 19.0 ml/kg/min; and higher risk cluster (IEB ≤25%) QRS 167 ms, LVESV 189 ml, BNP 590 pg/ml, peak VO2 16.2 ml/kg/min. CONCLUSIONS: Candidates for CRT show depressed arterial baroreflex function. Lower BEI was observed in high-risk HF patients. Baroreflex function correlated closely with other clinical HF parameters. Therefore, BEI may improve risk stratification in HF patients undergoing CRT.

Time to left ventricular reverse remodeling after cardiac resynchronization therapy: Better late than never.

INTRODUCTION: Left ventricular reverse remodeling (LVRR), defined as reduction of end-diastolic and end-systolic dimensions and improvement of ejection fraction, is associated with the prognostic implications of cardiac resynchronization therapy (CRT). The time course of LVRR remains poorly characterized. Nevertheless, it has been suggested that it occurs ≤6 months after CRT. OBJECTIVE: To characterize the long-term echocardiographic and clinical evolution of patients with LVRR occurring >6 months after CRT and to identify predictors of a delayed LVRR response. METHODS: A total of 127 consecutive patients after successful CRT implantation were divided into three groups according to LVRR response: Group A, 19 patients (15%) with LVRR after >6 months (late LVRR); Group B, 58 patients (46%) with LVRR before 6 months (early LVRR); and Group C, 50 patients (39%) without LVRR during follow-up (no LVRR). RESULTS: The late LVRR group was older, more often had ischemic etiology and fewer patients were in NYHA class ≤II. Overall, group A presented LVRR between group B and C. This was also the case with the percentage of clinical response (68.4% vs. 94.8% vs. 38.3%, respectively, p<0.001), and hospital readmissions due to decompensated heart failure (31.6% vs. 12.1% vs. 57.1%, respectively, p<0.001). Ischemic etiology (OR 0.044; p=0.013) and NYHA functional class

Short QT syndrome presenting as syncope: how short is too short?

We report the case of a 52-year-old man who presented to our emergency department (ED) after three episodes of syncope in the seven hours before admission. During his stay in the ED he had recurrent ventricular tachycardia (VT) requiring external electrical cardioversion. A 12-lead electrocardiogram (ECG) showed a short QT (SQT) interval (270 ms, QTc 327 ms), with frequent R-on-T extrasystoles triggering sustained polymorphic VT. After exclusion of other precipitating causes, the patient was diagnosed as having SQT syndrome (SQTS) according to the Gollob criteria. To our knowledge, this is the first known documentation of an SQT-caused arrhythmic episode on a 12-lead ECG, as well as the first reported case of SQTS in Portugal. The patient received an implantable cardioverter-defibrillator and was discharged. At a follow-up assessment 14 months later he was symptom-free, interrogation of the device showed no arrhythmic events, and the ECG showed a QT interval of 320 ms (QTc 347 ms).

[Tilt training increases vasoconstrictor reserve in patients with neurocardiogenic syncope]. / O treino de ortostatismo (tilt training) aumenta a reserva vasoconstritora em doentes com síncope reflexa neurocardiogénica.

UNLABELLED: Neurocardiogenic syncope (NCS) is a common clinical entity resulting from an excessive reflex autonomic response, particularly during orthostatism. Treatment options are controversial and of limited effectiveness. Tilt training (TT) is a promising option to treat these patients. However, its mechanism of action and clinical impact remain unclear. OBJECTIVE: To characterize hemodynamic and autonomic responses during a TT program in patients with NCS refractory to conventional measures. METHODS: We studied 28 patients (50% male, mean age 41±14 years) without structural heart disease, with NCS documented by tilt testing. The TT program included 9 tilt sessions (3 times a week, 30 min) (60° - 6 sessions, 70° - 3 sessions), under ECG and blood pressure monitoring combined with home orthostatic self-training and 10° head-up during sleep. Systolic volume, cardiac output, total peripheral resistance, baroreflex sensitivity and heart-rate variability were computed. Patients were reassessed at 1 month and every 6 months for a maximum of 36 months (24±12 months). RESULTS: Over the course of the TT program there was a significant increase in total peripheral resistance (1485±225 vs. 1591±187 dyn·s·cm(-5), p<0.05), with a decrease in standard deviation (206±60 vs. 150±42, p<0.05). During follow-up, syncope recurred in five patients (19%), with a significant reduction in the number of episodes (4.0±3.2/patient in the 12 months before TT vs. 1.4±0.8/patient post-TT, p<0.05). CONCLUSION: In refractory NCS, TT may be an effective therapeutic option, with long-term benefits. These results appear to be due to an increase in vasoconstrictor reserve combined with a reduction in its variance.