Long-Term Follow-Up of Patients With Tetralogy of Fallot and Implantable Cardioverter Defibrillator: The DAI-T4F Nationwide Registry.

BACKGROUND: Tetralogy of Fallot (TOF) is the most common cyanotic congenital heart disease, and sudden cardiac death represents an important mode of death in these patients. Data evaluating the implantable cardioverter defibrillator (ICD) in this patient population remain scarce. METHODS: A Nationwide French Registry including all patients with tetralogy of Fallot with an ICD was initiated in 2010 by the French Institute of Health and Medical Research. The primary time to event end point was the time from ICD implantation to first appropriate ICD therapy. Secondary outcomes included ICD-related complications, heart transplantation, and death. Clinical events were centrally adjudicated by a blinded committee. RESULTS: A total of 165 patients (mean age, 42.2±13.3 years, 70.1% males) were included from 40 centers, including 104 (63.0%) in secondary prevention. During a median (interquartile range) follow-up of 6.8 (2.5-11.4) years, 78 (47.3%) patients received at least 1 appropriate ICD therapy. The annual incidence of the primary outcome was 10.5% (7.1% and 12.5% in primary and secondary prevention, respectively; P=0.03). Overall, 71 (43.0%) patients presented with at least 1 ICD complication, including inappropriate shocks in 42 (25.5%) patients and lead dysfunction in 36 (21.8%) patients. Among 61 (37.0%) patients in primary prevention, the annual rate of appropriate ICD therapies was 4.1%, 5.3%, 9.5%, and 13.3% in patients with, respectively, 0, 1, 2, or ≥3 guidelines-recommended risk factors. QRS fragmentation was the only independent predictor of appropriate ICD therapies (hazard ratio, 3.47 [95% CI, 1.19-10.11]), and its integration in a model with current criteria increased the 5-year time-dependent area under the curve from 0.68 to 0.81 (P=0.006). Patients with congestive heart failure or reduced left ventricular ejection fraction had a higher risk of nonarrhythmic death or heart transplantation (hazard ratio, 11.01 [95% CI, 2.96-40.95]). CONCLUSIONS: Patients with tetralogy of Fallot and an ICD experience high rates of appropriate therapies, including those implanted in primary prevention. The considerable long-term burden of ICD-related complications, however, underlines the need for careful candidate selection. A combination of easy-to-use criteria including QRS fragmentation might improve risk stratification. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03837574.

Cryoablation for persistent and longstanding persistent atrial fibrillation: results from a multicentre European registry.

AIMS: Although cryoballoon pulmonary vein isolation is a well-established treatment for paroxysmal atrial fibrillation (AF), it's role in persistent AF is unclear. We examined procedural success and long-term outcomes of cryoablation in persistent and longstanding persistent AF. METHODS AND RESULTS: International multicentre registry from three UK and eight European centres. Consecutive patients undergoing cryoablation for persistent AF included. Procedural data, complications, and follow-up were prospectively recorded. Patients were followed-up at 3, 6, and 12 months with an electrocardiogram with open access to arrhythmia nurses thereafter. Ambulatory monitoring was dictated by symptoms. Success was defined as freedom from AF or atrial tachycardia lasting >30 s off antiarrhythmic drugs (AADs). Six hundred and nine consecutive cryoablation procedures. Mean procedure and fluoroscopy times were 95 ± 65 and 13 ± 10 min. Single procedure success rates were 368/602 (61%) off AADs over a median of 2.4 (1.0-4.0) years. Arrhythmia-free survival off AADs was 64% and 57% for persistent and longstanding persistent AF at 24 months of follow-up (P = 0.02). Rate of repeat ablations was 20% in persistent and 32% in longstanding persistent AF (P = 0.006). Cox regression analyses showed a significant association between duration of AF and left atrial diameter and arrhythmia recurrence [hazard ratio (HR) 1.05, P-value 0.01 and HR 1.02, P-value 0.004]. CONCLUSION: Cryoablation for persistent AF is safe, fast and has good outcomes at long-term follow-up. Cryoablation is reasonable as a first line option for these patients. Short procedure times may help increase capacity of cardiac units to meet the rising demand for AF ablation. Randomised control trials are needed to compare outcomes with different techniques.

Results from a multicentre comparison of cryoballoon vs. radiofrequency ablation for paroxysmal atrial fibrillation: is cryoablation more reproducible?

AIM: Cryoballoon ablation (Cryoballoon) has emerged as a new alternative for the treatment of symptomatic drug-refractory atrial fibrillation (AF). Whether the results of Cryoballoon are more reproducible than those of radiofrequency (RF) ablation remains to be proved. METHODS AND RESULTS: A total of 860 consecutive patients undergoing a first ablation procedure for paroxysmal AF (467 treated with RF and 393 treated with Cryoballoon) were selected from a prospective multicentre survey of AF ablation (FrenchAF). Radiofrequency and Cryoballoon were compared regarding mid-term efficacy and safety. During a median follow-up of 14 months (interquartile range 8-23), patients treated with Cryoballoon displayed similar rates of freedom from atrial arrhythmia relapse in centres performing this technique (68-80% at 18 months). However, in centres performing RF, a greater heterogeneity in procedural results was observed (46-79% were free from atrial arrhythmia relapse at 18 months). On multivariate analysis, Cryoballoon (HR = 0.47, 95% CI 0.35-0.65, P < 0.001) and annual AF ablation caseload (HR = 0.87 per every 100 AF ablation procedures per year; 95% CI 0.80-0.96, P = 0.003) were independent predictors of procedural success. However, on sensitivity analysis, according to the ablation method, annual AF ablation caseload predicted only sinus rhythm maintenance in the subgroup of patients treated with RF. Analysis of interoperator results with Cryoballoon and RF confirmed lower reproducibility of RF, but suggested that besides caseload, other operator-related factors may play a role. CONCLUSION: Cryoballoon seems to be less operator-dependent and more reproducible than RF in the setting of paroxysmal AF ablation.

Selective Vulnerability of Cortical Border Zone to Microembolic Infarct.

BACKGROUND AND PURPOSE: Endovascular procedures, including atrial fibrillation transcatheter ablation, may cause microembolization of brain arteries. Microemboli often cause small sized and clinically silent cerebral ischemias (SCI). These lesions are clearly visible on early postoperative magnetic resonance diffusion-weighted images. We analyzed SCI distribution in a population of patients submitted to atrial fibrillation transcatheter ablation. METHODS: Seventy-eight of 927 consecutive patients submitted to atrial fibrillation transcatheter ablation were found positive for acute SCI on a postoperative magnetic resonance. SCI were identified and marked, and their coordinates were transformed from native space into the International Consortium for Brain Mapping/Montreal Neurological Institute space. We then computed the voxel-wise probability distribution map of the SCI using the activation likelihood estimation approach. RESULTS: SCI were more commonly found in the cortex. In supratentorial regions, SCI selectively involved cortical border zone between anterior, middle, and posterior cerebral arteries; in infratentorial regions, distal territory of posteroinferior cerebellar artery. Possible explanations include selective embolization, linked to the vascular anatomy of pial arteries supplying those territories, reduced clearance of emboli in a relatively hypoperfused zone, or a combination of both. This particular distribution of lesions has been reported in both animal models and in patients with microemboli of different sources. CONCLUSIONS: A selective vulnerability of cortical border zone to microemboli occurring during atrial fibrillation transcatheter ablation was observed. We hypothesize that such selectivity may apply to microemboli of different sources.

Pulmonary vein isolation with a new multipolar irrigated radiofrequency ablation catheter (nMARQ™): feasibility, acute and short-term efficacy, safety, and impact on postablation silent cerebral ischemia.

BACKGROUND: Simultaneous multipolar ablation catheters have been proposed to simplify pulmonary vein isolation (PVI) in paroxysmal atrial fibrillation (AF). Recently, a new multipolar irrigated radiofrequency (RF) ablation catheter (nMARQ™, Biosense Webster Inc., Diamond Bar, CA, USA) combining both 3-dimensional electroanatomic mapping and multipolar open-irrigated ablation capability has been developed. Aim of our study was to assess feasibility, acute and short-term success and safety of PVI by the use of this new technology with particular regard to the incidence of postablation silent cerebral ischemia (SCI). METHODS AND RESULTS: Twenty-five patients (76% males; age 57 ± 13 years) with paroxysmal AF underwent PVI using the nMARQ™ catheter. PVI, confirmed by Lasso catheter mapping, was achieved in 100 out of 102 pulmonary veins (98%) identified, and final PVI was obtained in 24 out of 25 (96%) patients. The overall concordance between Lasso and nMARQ™ signals in demonstrating PVI was 78%. No major procedural complications occurred and no patient suffered SCI, on the basis of cerebral magnetic resonance imaging performed before and after the procedure. Following a 6-month follow-up, 17/25 (68%) patients remained free from AF without antiarrhythmic drugs. CONCLUSIONS: In our preliminary experience, PVI with nMARQ™ catheter appears to be feasible and safe, without incidence of SCI. Long-term clinical efficacy has to be evaluated in further studies.

Evaluation of time course and predicting factors of progression of paroxysmal or persistent atrial fibrillation to permanent atrial fibrillation.

BACKGROUND: To evaluate time course and predictors of progression of paroxysmal or persistent atrial fibrillation (AF) to permanent AF. METHODS AND RESULTS: We included 460 patients referred for paroxysmal (n = 337) or persistent (n = 123) AF between 1994 and 2012. Mean follow-up was 13.2 ± 6.5 years. AF progression rate was 3.7% per year, 19.7% at 5 years, and 38.1% at 10 years. Lone AF was diagnosed in 217 patients (47%). Predictors of permanent AF were: age, persistent AF, left atrial (LA) size, left ventricular-fractional shortening (LV-FS), lack of antiarrhythmic (AA) drugs, VVI pacing (P < 0.001 for all), and valvular disease (P < 0.02). Independent predictors were age (P < 0.001), persistent AF (P < 0.001), LA diameter (P < 0.005), lack of AA drugs (P < 0.005), and VVI pacing (P < 0.01). When adjusted at means of covariates, persistent AF and age >75 years remained highly significant (P < 0.01). LA dimension >50 mm was highly significant at univariate model (P < 0.001) but to a lesser extent when adjusted (P < 0.05). In patients with paroxysmal AF-with age <75 years-on AA drugs, progression rate to permanent AF was 6.5% at 5 years and 23.7% at 10 years. Among four predictors (age, LA size, LV-FS, and VVI pacing), only age (P < 0.01) and LA size (P < 0.005) remained independently significant, but LA size was not significant when adjusted. CONCLUSIONS: Progression to permanent AF is a slow process. Aging, LA size, VVI pacing, lack of AA therapy, and a persistent form of AF independently increased the progression to permanent AF.

Monitoring in the management of atrial fibrillation.

We performed a survey on current practice of atrial fibrillation (AF) detection and monitoring and its relevance in patient management among the European Heart Rhythm Association Research Network. The focus of this questionnaire is on the use and relevance of remote AF detection in device patients and its clinical consequences like starting oral anticoagulation or improving device programming to avoid inappropriate shock therapy. Remote device data are already used by 76.8% of the centres in their implantable cardioverter defibrillator/cardiac resynchronization therapy device patients to detect AF and trigger relevant clinical decision making! The majority of these centres are also asking for the option of remote device programming.

Sex Differences in Outcomes of Tetralogy of Fallot Patients With Implantable Cardioverter-Defibrillators.

BACKGROUND: Women with congenital heart disease at high risk for sudden cardiac death have been poorly studied thus far. OBJECTIVES: The aim of this study was to assess sex-related differences in patients with tetralogy of Fallot (TOF) and implantable cardioverter-defibrillators (ICDs). METHODS: Data were analyzed from the DAI-T4F (French National Registry of Patients With Tetralogy of Fallot and Implantable Cardioverter Defibrillator) cohort study, which has prospectively enrolled all patients with TOF with ICDs in France since 2010. Clinical events were centrally adjudicated by a blinded committee. RESULTS: A total of 165 patients (mean age 42.2 ± 13.3 years) were enrolled from 40 centers, including 49 women (29.7%). Among the 9,692 patients with TOF recorded in the national database, the proportion of women with ICDs was estimated to be 1.1% (95% CI: 0.8%-1.5%) vs 2.2% (95% CI: 1.8%-2.6%) in men (P < 0.001). The clinical profiles of patients at implantation, including the number of risk factors for ventricular arrhythmias, were similar between women and men. During a median follow-up period of 6.8 years (IQR: 2.5-11.4 years), 78 patients (47.3%) received at least 1 appropriate ICD therapy, without significant difference in annual incidences between women (12.1%) and men (9.9%) (HR: 1.22; 95% CI: 0.76-1.97; P = 0.40). The risk for overall ICD-related complications was similar in women and men (HR: 1.33; 95% CI: 0.81-2.19; P = 0.30), with 24 women (49.0%) experiencing at least 1 complication. CONCLUSIONS: Our findings suggest that women with TOF at high risk for sudden cardiac death have similar benefit/risk balance from ICD therapy compared with men. Whether ICD therapy is equally offered to at-risk women vs men warrants further evaluation in TOF as well as in other congenital heart disease populations. (French National Registry of Patients With Tetralogy of Fallot and Implantable Cardioverter Defibrillator [DAI-T4F]; NCT03837574).

Radiofrequency catheter ablation of atrial fibrillation: a cause of silent thromboembolism? Magnetic resonance imaging assessment of cerebral thromboembolism in patients undergoing ablation of atrial fibrillation.

BACKGROUND: Radiofrequency left atrial catheter ablation has become a routine procedure for treatment of atrial fibrillation. The aim of this study was to assess with preprocedural and postprocedural cerebral magnetic resonance imaging the thromboembolic risk, either silent or clinically manifest, in the context of atrial fibrillation ablation. The secondary end point was the identification of clinical or procedural parameters that correlate with cerebral embolism. METHODS AND RESULTS: A total of 232 consecutive patients with paroxysmal or persistent atrial fibrillation who were candidates for radiofrequency left atrial catheter ablation were included in the study. Pulmonary vein isolation or pulmonary vein isolation plus linear lesions plus atrial defragmentation with the use of irrigated-tip ablation catheters was performed. All of the patients underwent preprocedural and postablation cerebral magnetic resonance imaging. A periprocedural symptomatic cerebrovascular accident occurred in 1 patient (0.4). Postprocedural cerebral magnetic resonance imaging was positive for new embolic lesions in 33 patients (14). No clinical parameters such as age, hypertension, diabetes mellitus, previous history of stroke, type of atrial fibrillation, and preablation antithrombotic treatment showed significant correlation with ischemic cerebral embolism. Procedural parameters such as activated clotting time value and, in particular, electric or pharmacological cardioversion to sinus rhythm correlated with an increased incidence of cerebral embolism. Cardioversion was also associated with an increased risk of 2.75 (95 confidence interval, 1.29 to 5.89; P=0.009). CONCLUSIONS: Radiofrequency left atrial catheter ablation carries a low risk of symptomatic cerebral ischemia but is associated with a substantial risk of silent cerebral ischemia detected on magnetic resonance imaging. Independent risk factors for cerebral thromboembolism are the level of activated clotting time and, in particular, the electric or pharmacological cardioversion to sinus rhythm during the procedure.

Incidence of silent cerebral thromboembolic lesions after atrial fibrillation ablation may change according to technology used: comparison of irrigated radiofrequency, multipolar nonirrigated catheter and cryoballoon.

INTRODUCTION: Silent cerebral ischemic lesions have recently emerged as the most frequent complications after pulmonary vein isolation (PVI). To reduce thromboembolic complications, new types of catheters and energy source have been introduced in clinical practice. The study purpose is to compare the incidence of new silent cerebral ischemic events in patients with paroxysmal atrial fibrillation (PAF) undergoing PVI with different ablation technologies. METHODS AND RESULTS: One hundred and eight patients (67% men; age 56 ± 9 years) with PAF were enrolled in a consecutive manner to undergo PVI performed with irrigated radiofrequency (RF) catheter (Group 1, 36 patients), multielectrode catheter (PVAC) associated with duty-cycled RF generator (Group 2, 36 patients) and cryoballoon (Group 3, 36 patients). The protocol included a cerebral magnetic resonance imaging before and after the procedure. After PVI, the following patients showed new silent cerebral ischemic lesions at postprocedural cerebral MRI: 3 patients in Group 1 (8.3%), 14 patients in Group 2 (38.9%), 2 patients in Group 3 (5.6%). PVAC related to higher incidence of silent cerebral ischemic events compared to irrigated RF (P = 0.002) and cryoballoon (P = 0.001), whereas no statistical differences were found between irrigated RF catheter and cryoballoon groups (8.3% vs 5.6%, P = 0.5). At the multivariate analysis, the only independent predictor of new ischemic asymptomatic cerebral lesions after PVI was ablation performed with PVAC (OR 1.48 95% CI 1.19-1.62, P < 0.001). CONCLUSION: The incidence of silent cerebral lesions after PVI is different depending on technologies used: PVAC increases the risk of 1.48 times compared to irrigated RF and cryoballoon ablation.

Remote monitoring for active cardiovascular implantable electronic devices: a European survey.

This survey sampled today's European practices in the use of remote monitoring (RM) for the follow-up of active cardiovascular implantable electronic devices. Eighty-five per cent of the responding centres are currently using RM. For the majority, RM is expected to increase importantly within 5 years, and it has already led to a new organization of care based on dedicated allied professionals and/or the creation of RM units. There are still major limitations for the development of RM, such as ethical and legal aspects, reimbursement issues, and the lack of specific national- and European-updated guidelines which need to be informed.

Validation of success following atrial fibrillation ablation: a European survey.

This survey sampled the follow-up (FU) strategies for atrial fibrillation ablation used by electrophysiology/ablation centres in Europe. Currently, FU relies on symptoms and short-term ECG recordings rather than monitoring by implantable devices. The responding centres show a lack of confidence in the long-term success after ablation, and confusion about definition of success which needs to be informed by updated European guidelines.

Performance and survival of transvenous defibrillation leads: need for a European data registry.

Although the use of implantable cardioverter defibrillator (ICD) therapy has increased over the last decades, the reporting of ICD lead performance is inadequate. So far, there is neither a European nor worldwide registry on ICD leads. The published long-term results from national or multicentre registries encompass relatively small patient cohorts. Nevertheless, the failure of ICD leads may have substantial clinical consequences, including failure to sense, failure to pace, failure to defibrillate, inappropriate shocks, and even death of the patient. The reported ICD lead survival varies significantly between studies: 91-99% at 2 years, 85-95% at 5 years, and 60-72% at 8 years. Thus, the true incidence of lead malfunction cannot be defined as outlined in the present review. One current initiative of the European Heart Rhythm Association is to initiate and develop a Europe-wide registry to monitor, over a prolonged follow-up period, the performance of ICDs and ICD leads.

Optimized post-operative surveillance of permanent pacemakers by home monitoring: the OEDIPE trial.

AIMS: The OEDIPE trial examined the safety and efficacy of an abbreviated hospitalization after implantation or replacement of dual-chamber pacemakers (PM) using a telecardiology-based ambulatory surveillance programme. METHODS AND RESULTS: Patients were randomly assigned to (i) an active group, discharged from the hospital 24 h after a first PM implant or 4-6 h after replacement, and followed for 4 weeks with Home-Monitoring (HM), or (ii) a control group followed for 4 weeks according to usual medical practices. The primary objective was to confirm that the proportion of patients who experienced one or more major adverse events (MAE) was not higher in the active than in the control group. The study included 379 patients. At least one treatment-related MAE was observed in 9.2% of patients (n = 17) assigned to the active group vs. 13.3% of patients (n = 26) in the control group (P = 0.21), a 4.1% absolute risk reduction (95% CI -2.2 to 10.4; P = 0.98). By study design, the mean hospitalization duration was 34% shorter in the active than in the control group (P < 0.001), and HM facilitated the early detection of technical issues and detectable clinical anomalies. CONCLUSION: Early discharge with HM after PM implantation or replacement was safe and facilitated the monitoring of patients in the month following the procedure.

Outcomes after cryoballoon or radiofrequency ablation for persistent atrial fibrillation: a multicentric propensity-score matched study.

PURPOSE: Recent data show no benefit of additional ablation beyond pulmonary vein isolation (PVI) in persistent atrial fibrillation (AF). Evidence suggests that radiofrequency energy (RF) and cryoballoon (CRYO) have comparable efficacy for PVI. We aimed to assess the outcomes after a single catheter ablation procedure, comparing PVI using CRYO vs. RF ablation for PVI plus additional ablation in a cohort of patients with persistent AF. METHODS: In this prospective multicenter propensity score-matched comparison, 59 consecutive patients undergoing CRYO ablation of persistent AF were matched to 59 patients treated with RF from November 2010 to June 2012. RESULTS: During a mean follow-up of 15.6 ± 11.5 months, 43.2 % of patients presented atrial arrhythmia relapse after a blanking period of 3 months, which was comparable between the two groups (40.7 % in CRYO vs. 45.8 % in RF, Log rank P = 0.14; HR = 0.67, 95 %CI 0.38-1.16, P = 0.15), despite the fact that 52.5 % of RF patients add additional complex fractionated atrial electrogram ablation, as well as left atrial linear ablation in over two-thirds (roof line in 67.8 % and mitral isthmus in 32.2 %). On multivariate Cox regression, only AF duration in years (HR = 1.10, 95 %CI 1.01-1.10, P = 0.04) was a predictor of relapse. Patients undergoing RF ablation presented a numerically, but non-significantly, lower complication rate (6.8 vs 10.2 %, P = 0.51). CONCLUSION: In our multicenter experience, freedom from atrial arrhythmias was comparable among matched patients treated with CRYO and RF, despite non-significant trends in favor of RF in terms of complications, at the cost of longer procedure times.

Position paper for management of elderly patients with pacemakers and implantable cardiac defibrillators Groupe de rythmologie et stimulation cardiaque de la Société française de cardiologie et Société française de gériatrie et gérontologie.

Despite the increasingly high rate of implantation of pacemakers (PM) and cardioverter-defibrillators (ICD) in elderly patients, data supporting their clinical and cost-effectiveness in this age stratum are ambiguous and contradictory. We reviewed the data regarding the applicability, safety, and effectiveness of the conventional pacing, ICD and cardiac resynchronization therapy (CRT) in elderly patients. Although peri-procedural risk may be slightly higher in the elderly, the procedure of implantation of PMs and ICDs is still relatively safe in this age group. In older patients with sinus node disease, a general consensus is that dual chamber pacing, along with the programming of an algorithm to minimise ventricular pacing is preferred. In very old patients presenting with intermittent or suspected AV block, VVI pacing may be appropriate. In terms of correcting potentially life-threatening arrhythmias, the effectiveness of ICD therapy is comparable in older and younger individuals. However, the assumption of persistent ICD benefit in the elderly population is questionable, as any advantage of the device on arrhythmic death may be attenuated by a higher total non-arrhythmic mortality. While septuagenarians and octogenarians have higher annual all-cause mortality rates, ICD therapy may remain effective in selected patients at high risk of arrhythmic death and with minimum comorbidities despite advanced age. ICD implantation among the elderly, as a group, may not be cost-effective, but the procedure may reach cost-effectiveness in those expected to live >5-7 years after implantation. The elderly patients usually experience a significant functional improvement after CRT, similar to that observed in middle-aged patients. Management of CRT non responders remains globally the same, while considering a less aggressive approach in terms of re interventions (revision of LV lead placement, addition of a RV or LV lead, LV endocardial pacing configuration). Overall, age, comorbidities and comprehensive geriatric assessment should be the decisive factor in making a decision on device implantation selection for survival and well-being benefit in elderly patients.

Position paper for management of elderly patients with pacemakers and implantable cardiac defibrillators: Groupe de Rythmologie et Stimulation Cardiaque de la Société Française de Cardiologie and Société Française de Gériatrie et Gérontologie.

Despite the increasingly high rate of implantation of pacemakers (PMs) and implantable cardioverter defibrillators (ICDs) in elderly patients, data supporting their clinical and cost-effectiveness in this age stratum are ambiguous and contradictory. We reviewed the data regarding the applicability, safety and effectiveness of conventional pacing, ICDs and cardiac resynchronization therapy (CRT) in elderly patients. Although periprocedural risk may be slightly higher in the elderly, the implantation procedure for PMs and ICDs is still relatively safe in this age group. In older patients with sinus node disease, the general consensus is that DDD pacing with the programming of an algorithm to minimize ventricular pacing is preferred. In very old patients presenting with intermittent or suspected atrioventricular block, VVI pacing may be appropriate. In terms of correcting potentially life-threatening arrhythmias, the effectiveness of ICD therapy is similar in older and younger individuals. However, the assumption of persistent ICD benefit in the elderly population is questionable, as any advantageous effect of the device on arrhythmic death may be attenuated by higher total non-arrhythmic mortality. While septuagenarians and octogenarians have higher annual all-cause mortality rates, ICD therapy may remain effective in selected patients at high risk of arrhythmic death and with minimum comorbidities despite advanced age. ICD implantation among the elderly, as a group, may not be cost-effective, but the procedure may reach cost-effectiveness in those expected to live more than 5-7years after implantation. Elderly patients usually experience significant functional improvement after CRT, similar to that observed in middle-aged patients. Management of CRT non-responders remains globally the same, while considering a less aggressive approach in terms of reinterventions (revision of left ventricular [LV] lead placement, addition of a right ventricular or LV lead, LV endocardial pacing configuration). Overall, physiological age, general status and comorbidities rather than chronological age per se should be the decisive factors in making a decision about device implantation selection for survival and well-being benefit in elderly patients.

Does periprocedural anticoagulation management of atrial fibrillation affect the prevalence of silent thromboembolic lesion detected by diffusion cerebral magnetic resonance imaging in patients undergoing radiofrequency atrial fibrillation ablation with open irrigated catheters? Results from a prospective multicenter study.

BACKGROUND: Silent cerebral ischemia (SCI) has been reported in 14% of cases after catheter ablation of atrial fibrillation (AF) with radiofrequency (RF) energy and discontinuation of warfarin before AF ablation procedures. OBJECTIVE: The purpose of this study was to determine whether periprocedural anticoagulation management affects the incidence of SCI after RF ablation using an open irrigated catheter. METHODS: Consecutive patients undergoing RF ablation for AF without warfarin discontinuation and receiving heparin bolus before transseptal catheterization (group I, n = 146) were compared with a group of patients who had protocol deviation in terms of maintaining the therapeutic preprocedural international normalized ratio (patients with subtherapeutic INR) and/or failure to receive pretransseptal heparin bolus infusion and/or ≥2 consecutive ACT measurements <300 seconds (noncompliant population, group II, n = 134) and with a group of patients undergoing RF ablation with warfarin discontinuation bridged with low molecular weight heparin (group III, n = 148). All patients underwent preablation and postablation (within 48 hours) diffusion magnetic resonance imaging. RESULTS: SCI was detected in 2% of patients (3/146) in group I, 7% (10/134) in group II, and 14% (21/148) in group III (P <.001). "Therapeutic INR" was strongly associated with a lower prevalence of postprocedural silent cerebral ischemia (SCI). Multivariable analysis demonstrated nonparoxysmal AF (odds ratio 3.8, 95% confidence interval 1.5-9.7, P = .005) and noncompliance to protocol (odds ratio 2.8, 95% confidence interval 1.5-5.1, P <.001] to be significant predictors of ischemic events. CONCLUSION: Strict adherence to an anticoagulation protocol significantly reduces the prevalence of SCI after catheter ablation of AF with RF energy.

Microembolism and catheter ablation I: a comparison of irrigated radiofrequency and multielectrode-phased radiofrequency catheter ablation of pulmonary vein ostia.

BACKGROUND: Cerebral diffusion-weighted MRI lesions have been observed after catheter ablation of atrial fibrillation. We hypothesized that conditions predisposing to microembolization could be identified using a porcine model of pulmonary vein ablation and an extracorporeal circulation loop. METHODS AND RESULTS: Ablations of the pulmonary veins were performed in 18 swine with echo monitoring. The femoral artery and vein were cannulated and an extracorporeal circulation loop with 2 ultrasonic bubble detectors and a 73-µm filter were placed in series. Microemboli and microbubbles were compared between ablation with an irrigated radiofrequency system (Biosense-Webster) and a phased radiofrequency multielectrode system (pulmonary vein ablation catheter [PVAC], Medtronic, Inc, Carlsbad, CA) in unipolar and 3 blended unipolar/bipolar modes. Animal pathology was examined. The size and number of microbubbles observed during ablation ranged from 30 to 180 µm and 0 to 3253 bubbles per ablation. Microbubble volumes with PVAC (29.1 nL) were greater than with irrigated radiofrequency (0.4 nL; P=0.045), and greatest with type II or III microbubbles on transesophageal echocardiography. Ablation with the PVAC showed fewest microbubbles in the unipolar mode (P=0.012 versus bipolar). The most occurred during bipolar energy delivery with overlap of proximal and distal electrodes (median microbubble volume, 1744 nL; interquartile range, 737-4082 nL; maximum, 19 516 nL). No cerebral MRI lesions were seen, but 2 animals had renal embolization. CONCLUSIONS: Left atrial ablation with irrigated radiofrequency and PVAC catheters in swine is associated with microbubble and microembolus production. Avoiding overlap of electrodes 1 and 10 on PVAC should reduce the microembolic burden associated with this procedure.

Microembolism and catheter ablation II: effects of cerebral microemboli injection in a canine model.

BACKGROUND: Asymptomatic cerebral lesions have been observed on diffusion weighted MRI (DWI) scans shortly after catheter ablation of atrial fibrillation, but the pathogenesis of these lesions is incompletely understood. METHODS AND RESULTS: Twelve dogs underwent selective catheterization of the internal carotid or vertebral arteries. Either a microbubbled mixture of air (1.0-4.0 mL), blood, contrast, and saline (n=5), or heat-dried pulverized blood (particle size <600 µm) mixed with saline and contrast (n=6) was injected. One sham control experiment was performed. MRI scans were performed preinjection, and at 1, 2, and 4 days postinjection. Neurological tests were performed daily. Gross pathology and histopathology were performed on the brains after being euthanized on day 4. Three animals died <24 hours after injection. Hyperintense lesions were observed on DWI (median maximum diameter 3.1 mm) in 2 of 4 animals after air embolism and in 3 of 5 animals after particulate embolism. No DWI lesions were detected in the remaining 5 animals (including the sham control). Lesions seen on DWI and confirmed on the fluid attenuating inversion recovery sequence correlated well with anatomic lesions on histopathology. CONCLUSIONS: Cerebral embolization of air microbubbles or microparticulate debris that approximate the embolic sources from catheter ablation can create hyperintense DWI punctate lesions in a canine model. The location and size of the DWI/fluid attenuating inversion recovery lesions correlate with pathological findings.