Automatic management of atrial and ventricular stimulation in a contemporary unselected population of pacemaker recipients: the ESSENTIAL Registry.

AIMS: We investigated the applicability of the Ventricular Capture Control (VCC) and Atrial Capture Control (ACC) algorithms for automatic management of cardiac stimulation featured by Biotronik pacemakers in a broad, unselected population of pacemaker recipients. METHODS AND RESULTS: Ventricular Capture Control and Atrial Capture Control were programmed to work at a maximum adapted output voltage as 4.8 V in consecutive recipients of Biotronik pacemakers. Ambulatory threshold measurements were made 1 and 12 months after pacemaker implant/replacement in all possible pacing/sensing configurations, and were compared with manual measurements. Among 542 patients aged 80 (73-85) years, 382 had a pacemaker implant and 160 a pacemaker replacement. Ventricular Capture Control could work at long term in 97% of patients irrespectively of pacing indication, lead type, and lead service life, performance being superior with discordant pacing/sensing configurations. Atrial Capture Control could work in 93% of patients at 4.8 V maximum adapted voltage and at any pulse width, regardless of pacing indication, lead type, and service life. At 12-month follow-up, a ventricular threshold increase ≥1.5 V had occurred in 4.4% of patients uneventfully owing to VCC functioning. Projected pacemaker longevity at 1 month was strongly correlated with the 12-month estimate, and exceeded 13 years in >60% of patients. CONCLUSION: These algorithms for automatic management of pacing output ensure patient safety in the event of a huge increase of pacing threshold, while enabling maximization of battery longevity. Their applicability is quite broad in an unselected pacemaker population irrespectively of lead choice and service of life.

Different image integration modalities to guide AF ablation: impact on procedural and fluoroscopy times.

BACKGROUND: Different image integration modalities are available for atrial fibrillation (AF) ablation, but their impact on procedural and fluoroscopy times has not been evaluated yet. METHODS: Sixty patients (mean age 52.2 ± 12.0 years, 48.3% men, 75% paroxysmal AF) undergoing pulmonary vein (PV) encircling with PV disconnection for symptomatic drug-refractory AF were randomized to ablation with CARTO electroanatomical mapping (Biosense Webster, Diamond Bar, CA, USA) integrated with: (1) preprocedural magnetic resonance imaging (MRI; Group 1); (2) intracardiac echocardiography (ICE; Group 2); (3) preprocedural MRI and ICE (Group 3). RESULTS: PV disconnection was achieved in all patients. Total procedural time (Group 1: 124.7 ± 47.0; Group 2: 112.5 ± 30.4; Group 3: 108.6 ± 34.7 minutes) and total ablation time were similar between groups (P = ns). MRI integration alone required a higher fluoroscopy time (23.8 ± 6.9 in Group 1 vs 11.0 ± 2.3 and 13.9 ± 4.2 minutes in Groups 2 and 3, respectively; P < 0.005) and a longer time spent in the left atrium (109.0 ± 43.5 in Group 1 vs 78.2 ± 29.7 and 74.8 ± 34.3 minutes in Groups 2 and 3, respectively; P = 0.03) in comparison to ICE integration. Addition of MRI to ICE integration showed a tendency for a higher fluoroscopy time in comparison to ICE integration alone (P = 0.06). At a mean follow-up of 9.1 ± 2.2 months, there were no significant differences in AF recurrences among the groups (P = ns). CONCLUSION: ICE image integration significantly reduces the fluoroscopy time and the time spent in the left atrium in comparison to MRI integration alone. Addition of MRI to ICE integration does not reduce total procedural time and seems to lead to higher fluoroscopy time in comparison to ICE integration alone.

Noncontact mapping of left ventricle during CRT implant.

INTRODUCTION: Not all candidates for cardiac resynchronization therapy (CRT) are responders at follow-up. Echocardiographic parameters of dyssynchrony do not predict the response. Analysis of electrical properties of left ventricle (LV) by noncontact mapping (NCM) could be useful to better identify candidates for CRT. METHODS AND RESULTS: We studied nine consecutive patients undergoing CRT. An NCM was positioned in the LV via atrial transeptal puncture. LV activation was recorded during sinus rhythm (SR), pacing from RV, from different LV epicardial locations, and in biventricular (BIV) pacing. The corresponding invasive pressure was determined. Heparin, administered during NCM, was reversed and CRT implant was completed. An offline analysis of the data was performed in order to measure transeptal and total LV activation time, to evaluate the site of earliest and latest LV activation, and the pattern of activation. No complications occurred. Mean time of total NCM procedures was 24 + or - 7 minutes. During SR, RV, LV, and BIV pacing, respectively, a "U"-shaped LV activation pattern was found in three, seven, four, and and two patients; mean LV activation time was 58.1 + or - 7.0, 81.7 + or - 15.8, 71.1 + or - 12.4, and 65.6 + or - 7.7 ms; and mean systolic LV peak pressure was 114 + or - 21, 97 + or - 18, 103 + or - 17 and 110 + or - 15 mmHg, respectively. LV activation was influenced by a slow conduction area at the pacing site and by the duration of transeptal time. CONCLUSION: An NCM during CRT is safe and feasible. It provides an additional information on electrical activation in SR and in various modality of pacing. Further studies with larger populations are needed in order to correlate electrical to clinical outcomes.

Change in the use of remote monitoring of cardiac implantable electronic devices in Italian clinical practice over a 5-year period: results of two surveys promoted by the AIAC (Italian Association of Arrhythmology and Cardiac Pacing).

AIMS: The aim of this study was to evaluate the use of remote monitoring in Italian clinical practice and its trend over the last 5 years. METHODS: In 2012 and 2017, two surveys were conducted. Both were open to all Italian implanting centres and consisted of 25 questions on the characteristics of the centre, their actual use of remote monitoring, applied organizational models and administrative and legal aspects. RESULTS: The questionnaires were completed by 132 and 108 centres in 2012 and 2017, respectively (30.6 and 24.7% of all Italian implanting centres). In 2017, significantly fewer centres followed up fewer than 200 patients by remote monitoring than in 2012, while more followed up more than 500 patients (all P < 0.005). In most of the centres (77.6%) that responded to both surveys, the number of patients remotely monitored significantly increased from 2012 to 2017.In both surveys, remote monitoring was usually managed by physicians and nurses. Over the period, primary review of transmissions by physicians declined, while it was increasingly performed by nurses; the involvement of technicians rose, while that of manufacturers' technical personnel decreased. The percentage of centres in which transmissions were submitted to the physician only in critical cases rose (from 28.3 to 64.3%; P < 0.001). In 86.7% of centres, the lack of a reimbursement system was deemed the main barrier to implementing remote monitoring. CONCLUSION: In the last 5 years, the number of patients followed up by remote monitoring has increased markedly. In most Italian centres, remote monitoring has increasingly been managed through a primary nursing model. The lack of a specific reimbursement system is perceived as the main barrier to implementing remote monitoring .

Radiofrequency ablation of atrial fibrillation: is the persistence of all intraprocedural targets necessary for long-term maintenance of sinus rhythm?

BACKGROUND: Several approaches have been developed for radiofrequency catheter ablation of atrial fibrillation, but the correct intraprocedural end point is still under debate, and few data exist about the destiny of ablation lesions over time. The aim of the present study was to evaluate the long-term maintenance of intraprocedural end points of ablation procedures. METHODS AND RESULTS: Inclusion criteria were (1) a previous ablation procedure of pulmonary vein (PV) encircling performed for drug-refractory persistent atrial fibrillation; (2) a "complete" intraprocedural end point, which consisted of voltage abatement inside the lesions, PV disconnection, and exit-block pacing from inside the lesions, attained in all PVs; and (3) stable sinus rhythm documented during a minimum follow-up of 2.5 years after the procedure. Twenty volunteers were selected (12 males, mean age 59+/-7 years) and underwent a repeat electrophysiological study. After a follow-up of 36.4+/-4.7 months, complete voltage abatement was maintained around 32 PVs (40.0%), PV disconnection persisted in 12 (37.5%) of the previously isolated PVs, and exit block was present in 39 PVs (48.7%). Ten patients who underwent a redo ablation procedure because of recurrences of atrial fibrillation were used as the control group. Differences in intraprocedural end-point maintenance between the 2 groups were not statistically significant. CONCLUSIONS: Common intraprocedural end points such as voltage abatement, PV disconnection, and exit block persist only in a limited number of patients, even when the outcome is favorable during follow-up. Further investigation will be required to determine whether such data will have implications for ablation strategies.

Comparison of myocardial deformation and velocity dyssynchrony for identification of responders to cardiac resynchronization therapy.

AIMS: It is unclear whether myocardial velocity or deformation indices of dyssynchrony are better at predicting response to cardiac resynchronization therapy (CRT). Therefore, two indices of left ventricular (LV) dyssynchrony based on myocardial velocity and deformation were compared to predict success of CRT. METHODS AND RESULTS: Sixty patients with dilated cardiomyopathy, New York Heart Association class III-IV, LV ejection fraction (EF) < or =35%, QRS >120 ms underwent CRT. The standard deviation of the averaged time-to-peak longitudinal negative strain (Tepsilon-SD) and positive systolic velocity (Tv-SD) of 12 LV segments were calculated before and after 6 months of CRT. Responders were defined at month 6 by > or =20% EF increase and/or > or =15% end-systolic volume (ESV) decrease with respect to baseline. On univariable analysis, baseline Tepsilon-SD and Tv-SD were both significantly associated with CRT response; however, the area under the receiver operating characteristic curve was better for Tepsilon-SD. On bivariable analysis, only Tepsilon-SD retained an independent prognostic value for CRT response. Results of the analysis did not change when the logistic models were adjusted for aetiology. CONCLUSION: Baseline dyssynchrony of longitudinal myocardial peak deformation (Tepsilon-SD) appears to be better than dyssynchrony of longitudinal myocardial peak systolic velocities (Tv-SD) for the identification of CRT responders.

Contact versus noncontact mapping for ablation of ventricular tachycardia in patients with previous myocardial infarction.

INTRODUCTION: The aim of this study was to compare contact versus noncontact mapping for radiofrequency (RF) ablation of any sustained post-myocardial infarction (MI) ventricular tachycardia (VT). METHODS: Forty patients with tolerated VT post-MI were randomized to RF ablation with contact (group 1) or noncontact (group 2) mapping systems. In both groups ablation of tolerated VT was guided by VT activation map confirmed by concealed entrainment. When untolerated VTs were induced, ablation was performed in group 1 according to pace mapping starting from the scar border zone and in group 2 according to the VT activation map confirmed by pace mapping. RESULTS: No differences were seen between the groups in terms of acute success rate of clinical VT ablation (95% vs 100%, respectively; P = ns) and in the noninducibility of any VT at the end of the procedure (55% vs 85%, respectively; P = 0.08). Moreover, untolerated VTs were eliminated in 30% of group 1 versus 83.3% of group 2 patients (P < 0.05). The mean total procedural and fluoroscopy times were 236.4 +/- 42.7 and 29.0 +/- 7.8 minutes in group 1 and 144.5 +/- 50.8 and 23.4 +/- 5.8 minutes in group 2 (P < 0.001 and < 0.05, respectively). At a mean follow-up of 15.2 +/- 6.7 months no differences were seen in VT recurrences between groups, but noninducibility at the end of the procedure was predictive of freedom from recurrences (P < 0.001). CONCLUSION: Both systems are useful for ablation of tolerated VT. Noncontact mapping is more effective for ablation of untolerated VT and allows the reduction of procedural and fluoroscopy times. Noninducibility at the end of the procedure seems predictive of freedom from recurrences during follow-up.

Paroxysmal atrial fibrillation ablation with the multipolar mapping and ablation catheter (Mesh-Bard).

Pulmonary veins (PVs) ablation is a valid treatment option for atrial fibrillation. The standard approach for PVs isolation usually requires two catheters or an electroanatomical reconstruction of the left atrium. We describe our initial experience with a single device for mapping and ablating in a patient referred to our center for the relapsing of atrial fibrillation 3 years after a previous ablation procedure. The newly available catheter MESH was safe and effective to quickly isolate two reconnected PVs.

Neurohormones and inflammatory mediators in patients with heart failure undergoing cardiac resynchronization therapy: time courses and prediction of response.

Despite interest in neurohormonal activation as a determinant of prognosis in chronic heart failure (CHF) and as a target for pharmacological treatments, data are lacking on the time-related effects of electrical cardiac resynchronization therapy (CRT) on a broad spectrum of neurohormones and cytokines. The aim of this study was to assess time-courses and extents of changes within the neurohormonal profile of CHF patients treated with CRT. We performed a prospective follow-up study in 32 patients with NYHA class III-IV CHF to investigate the effects of CRT on a broad panel of neurohormones proposed for characterization of CHF patients. Levels of atrial and brain natriuretic peptides (ANP, BNP), epinephrine, norepinephrine, aldosterone, plasma renin activity, IL-6, TNF, soluble receptors sTNFR1 and 2, and chromogranin A were assessed before implantation and after 3 months of CRT; when feasible, measurements were also performed at 1 week, 1 month and 12 months (clinical evaluation, echocardiography and ECG were also performed at each time-point). The results showed that at 3 months improvement in NYHA class and echographically assessed left ventricular (LV) reverse structural remodeling were accompanied by significant reductions versus baseline in ANP and BNP, but not in other neurohormones. Moreover a baseline ANP concentration < or = 150 pg/ml was a good predictor of response to CRT in terms of NYHA class reduction and reverse LV remodeling. In conclusion 3 months of CRT significantly reduce natriuretic peptides concentrations, while values of other neurohormones and inflammatory cytokines are relatively unvaried. A baseline ANP concentration < or = 150 pg/ml might be a clinically useful predictor of medium-term response to CRT.

Single lead catheter of implantable cardioverter-defibrillator with floating atrial sensing dipole implanted via persistent left superior vena cava.

Persistent left superior vena cava (LSVC) is a congenital anomaly with 0.3%-1% prevalence in the general population. It is usually asymptomatic but in case of transvenous lead positioning, i.e., for pacemaker or implantable cardioverter defibrillator (ICD), may be a cause for significant complications or unsuccessful implantation. Single lead ICD with atrial sensing dipole (ICD DX) is a safe and functional technology in patients without congenital abnormalities. We provide a review of the literature and a case report of successful implantation of an ICD DX in a patient with LSVC and its efficacy in treating ventricular arrhythmias.

Remote monitoring of implantable devices: Should we continue to ignore it?

The number of patients with implantable cardioverter defibrillators (ICDs) is increasing. In addition to improve survival, ICD can collect data related to device function and physiological parameters. Remote monitoring (RM) of these data allows early detection of technical or clinical problems and a prompt intervention (reprogramming device or therapy adjustment) before the patient require hospitalization. RM is not a substitute for emergency service and its consultation is now limited during working hours. Thus, a consent form is required to inform patients about benefits and limitations. The available studies indicate that remote monitoring is more effective than traditional calendar face to face based encounters. RM is safe, highly reliable, cost efficient, allows quick reply to failures, and reduces the number of scheduled visits and the incidence of inappropriate shocks with a positive impact on survival. It follows that RM has the credentials to be the standard of care for ICD management; however, unfortunately, there is a delay in physician acceptance and implementation. The recent observations from randomized IN-TIME study that showed a clear survival benefit with RM in heart failure patients have encouraged us to review both the negative and positive aspects of RM collected in a little more than a decade.

Cardiac resynchronization therapy guided by multimodality cardiac imaging.

AIMS: Up to 30-45% of implanted patients are non-responders to CRT. We evaluated the role of a 'CRT team' using cardiac magnetic resonance (CMR) and longitudinal myocardial strain to identify the target area defined as the most delayed and viable region for LV pacing. METHODS AND RESULTS: A total of 100 heart failure patients candidates for CRT divided into two groups were enrolled. Group 1 consisted of 50 consecutive patients scheduled for CRT and prospectively included. Group 2 (control) consisted of 50 patients with a CRT device implanted according to standard clinical practice and matched for age, sex, and LVEF with group 1. Patients were evaluated at baseline and at 6-month follow-up. In group 1, patients underwent two-dimensional speckle-tracking assessment of longitudinal myocardial strain and CMR imaging to identify the target area for LV lead pacing. A positive response to CRT was defined as a reduction of ≥15% of the LV end-systolic volume at 6-month follow-up. A total of 39 (78%) patients of group 1 were classified as responders to CRT whilst in group 2, only 28 (56%) were responders (P = 0.019). The 'CRT team' identified as target for LV pacing the lateral area in 30 (60%) patients, and the anterolateral or posterolateral areas in 12 (24%) patients. In 8 (16%) patients, the target was far from the lateral area, in the anterior or posterior areas. The patients with concordant position exhibited the highest positive response (93.1%) to CRT. CONCLUSIONS: Multimodality cardiac imaging as a guide for CRT implantation is useful to increase response rate.

Cardiac device therapy in patients with left ventricular dysfunction and heart failure: 'real-world' data on long-term outcomes (mortality, hospitalizations, days alive and out of hospital).

BACKGROUND: The impact on long-term outcomes of implantable cardioverter defibrillators (ICDs) and biventricular defibrillators for cardiac resynchronization (CRT-D) devices in 'real world' patients with heart failure (HF) needs to be assessed in terms of clinical effectiveness. METHODS AND RESULTS: A registry including consecutive HF patients who underwent a first implant of an ICD (891 patients) or a CRT-D device (709 patients) in 2006-2010 was followed (median 1487 days and 1516 days, respectively), collecting administrative data on survival, all-cause hospitalizations, cardiovascular or HF hospitalizations, and days alive and out of hospital (DAOH). Survival free from death/cardiac transplant was 61.9% and 63.8% at 5 years for ICD and CRT-D patients, respectively. Associated comorbidities (Charlson Comorbidity Index) had a significant impact on death/cardiac transplant, as well as on hospitalizations. The median values of DAOH% were 97.4% for ICD and 97.7% for CRT-D patients, but data were highly skewed, with the lower quartile of DAOH% values including values ranging between 0% and 52.8% for ICD and between 0% and 56.1% for CRT-D patients. Charlson Comorbidity Index was a very strong predictor of DAOH%. CONCLUSIONS: Patients who were implanted in 'real world' clinical practice with an ICD or a CRT-D device have, on average, a relatively favourable outcome, with a survival of around 62-64% at 5 years, but with an important burden of hospitalizations. Comorbidities, as evaluated by means of the Charlson Comorbidity Index, have a significant impact on outcomes in terms of mortality/heart transplant, hospitalizations and days spent alive and out of hospital.

Impact of remote monitoring on the management of arrhythmias in patients with implantable cardioverter-defibrillator.

BACKGROUND: In the last decade, there has been an exponential increase in cardioverter-defibrillator (ICD) implants. Remote monitoring systems, allow daily follow-ups of patients with ICD. OBJECTIVE: To evaluate the impact of remote monitoring on the management of cardiovascular events associated with supraventricular and ventricular arrhythmias during long-term follow-up. METHODS: A total of 207 patients undergoing ICD implantation/replacement were enrolled: 79 patients received remote monitoring systems and were followed up every 12 months, and 128 patients were followed up conventionally every 6 months. All patients were followed up and monitored for the occurrence of supraventricular and ventricular arrhythmia-related cardiovascular events (ICD shocks and/or hospitalizations). RESULTS: During a median follow-up of 842 days (interquartile range 476-1288 days), 32 (15.5%) patients experienced supraventricular arrhythmia-related events and 51 (24.6%) patients experienced ventricular arrhythmia-related events. Remote monitoring had a significant role in the reduction of supraventricular arrhythmia-related events, but it had no effect on ventricular arrhythmia-related events. In multivariable analysis, remote monitoring remained as an independent protective factor, reducing the risk of supraventricular arrhythmia-related events of 67% [hazard ratio, 0.33; 95% confidence interval (CI), 0.13-0.82; P = 0.017]. CONCLUSION: Remote monitoring systems improved outcomes in patients with supraventricular arrhythmias by reducing the risk of cardiovascular events, but no benefits were observed in patients with ventricular arrhythmias.

Cardiac resynchronization therapy: implant rates, temporal trends and relationships with heart failure epidemiology.

BACKGROUND: Consensus guidelines define indications for cardiac resynchronization therapy (CRT), but the variability in implant rates in 'real world' clinical practice, as well as the relationship with the epidemiology of heart failure are not defined. METHODS AND RESULTS: In Emilia-Romagna, an Italian region with around 4.4 million inhabitants, a registry was instituted to collect data on implanted devices for CRT, with (CRT-D) or without defibrillation (CRT-P) capabilities. Data from all consecutive patients resident in this region who underwent a first implant of a CRT device in years 2006-2010 were collected and standardized (considering each of the nine provinces of the region). The number of CRT implants increased progressively, with a 71% increase in 2010 compared to 2006. Between 84 and 90% of implants were with CRT-D devices. The variability in standardized implant rates among the provinces was substantial and the ratio between the provinces with the highest and the lowest implant rates was always greater than 2. Considering prevalent cases of heart failure in the period 2006-2010, the proportion of patients implanted with CRT per year ranged between 0.23 and 0.30%. CONCLUSIONS: The application in 'real world' clinical practice of CRT in heart failure is quite heterogeneous, with substantial variability even among areas belonging to the same region, with the need to make the access to this treatment more equitable. Despite the increased use of CRT, its overall rate of adoption is low, if a population of prevalent heart failure patients is selected on the basis of administrative data on hospitalizations.

Radiofrequency ablation of paroxysmal atrial fibrillation by mesh catheter.

INTRODUCTION: Pulmonary veins isolation usually requires a multielectrode catheter for mapping in addition to the ablation catheter. We describe our experience with a new multipolar catheter designed for simultaneous mapping and ablation (MESH, Bard). METHODS AND RESULTS: We tested the catheter in 15 patients (mean age 61.1 +/- 7.9; eight men) scheduled for paroxysmal atrial fibrillation ablation. The catheter was positioned in front of the pulmonary vein ostia. A pulmonary vein potential was demonstrated in 63.5% of the veins, which were disconnected with a mean of 1.6 radiofrequency applications with a mean time of 351 +/- 125.8 s (range 180-650) for each vein. Mean procedural time was 93 +/- 17.1 min (range 65-120), and fluoroscopy time was 13.7 +/- 4.0 (range 5-15) min. No complications occurred during and after or procedures. CONCLUSION: Pulmonary veins disconnection with MESH ablator catheter is feasible with short procedural and X-ray exposure time. Further studies are needed to compare this new device to standard multipolar mapping catheters in order to evaluate its ability to correctly identify pulmonary vein potentials and to compare its safety and efficacy.

Radiofrequency atrial fibrillation ablation based on pathophysiology: a diversified protocol with long-term follow-up.

BACKGROUND: The optimal approach and long-term results of radiofrequency catheter ablation of atrial fibrillation (AF) are still unknown. We report our experience with respect to an ablation protocol diversified on a patient's AF pathophysiology with long-term follow-up. METHODS: Seventy-two patients with paroxysmal/persistent drug-resistant AF were selected. Patients with apparently normal hearts (group 1, n = 20) underwent electrophysiological disconnection of pulmonary veins (PVs) presenting a clear PV potential, whereas those with even initial cardiopathy (group 2, n = 52), underwent PV encircling. RESULTS: Sinus rhythm was maintained at 6 months in 85% of group 1 and 71% of group 2 patients. After 42 months of follow-up, including 15.2% re-do procedures, 85% of group 1 and 77% of group 2 patients were in sinus rhythm, including patients with anti-arrhythmic drugs (AADs). The long-term success rate without AADs was 75% and 46% for each group, respectively. Age and the 6-month success of the procedure were predictive of sinus rhythm maintenance during follow-up. CONCLUSIONS: An ablation protocol diversified on AF pathophysiology assured, at 3 years of follow-up, sinus rhythm maintenance in 85% of patients with a normal heart and in 77% of those with even initial cardiopathy. The 6-month result of the ablation procedure remained stable over time.