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Background High adherence to remote monitoring (RM) in pacemaker (PM) patients improves outcomes; however, adherence remains suboptimal. Bluetooth low-energy (BLE) technology in newer-generation PMs enables communication directly with patient-owned smart devices using an app without a bedside console. Objective To evaluate the success rate of scheduled RM transmissions using the app compared to other RM methods. Methods The BlueSync Field Evaluation was a prospective, international cohort evaluation, measuring the success rate of scheduled RM transmissions using a BLE PM or cardiac resynchronization therapy PM coupled with the MyCareLink Heart app. App transmission success was compared to 3 historical “control” groups from the Medtronic de-identified CareLink database: (1) PM patients with manual communication using a wand with a bedside console (PM manual transmission), (2) PM patients with wireless automatic communication with the bedside console (PM wireless); (3) defibrillator patients with similar automatic communication (defibrillator wireless). Results Among 245 patients enrolled (age 64.8±15.6 years, 58.4% men), 953 transmissions were scheduled through 12 months, of which 902 (94.6%) were successfully completed. In comparison, transmission success rates were 56.3% for PM manual transmission patients, 77.0% for PM wireless patients, and 87.1% for defibrillator wireless patients. Transmission success with the app was superior across matched cohorts based on age, sex, and device type (single vs dual vs triple chamber). Conclusion The success rate of scheduled RM transmissions was higher among patients using the smart device app compared to patients using traditional RM using bedside consoles. This novel technology may improve patient engagement and adherence to RM., Graphical abstract

Transvenous pacing is nowadays the cornerstone of interventional management of bradyarrhythmias. It is still associated, however, with significant complications, mostly related to indwelling transvenous leads or device pocket. In order to reduce these complications, leadless pacemakers have been recently introduced into clinical practice, but no guidelines are yet available to indicate who are those patients that might benefit the most and whether leadless pacing should be preferred in the old or young population. This survey aims to describe the use of leadless pacemaker devices in a real-world setting.Eleven arrhythmia centers in the Lombardy region (out of a total of 17 participating centers) responded to the proposed questionnaire regarding patient characteristics and indications to leadless pacing.Out of a total of 411 patients undergoing leadless pacing during 4.2 ± 0.98 years, the median age was 77 years, with 0.18% of patients having less than 18 years, 29.9% 18-65 years, 34.3% 65-80 years and 35.6%80 years. The most common indication was slow atrial fibrillation (49% of patients), followed by atrioventricular block and sinoatrial dysfunction. Two centers reported in-hospital complications.Leadless pacemakers proved to be a safe pacing strategy actually destined mostly to elderly patients.

As the main title ‘COVID-19 revolution: a new challenge for the internist’ states, the global coronavirus infection disease 2019 (COVID-19) pandemic represented a new challenge for the internists. This paper is part of a series of articles written during the difficult period of the ongoing global pandemic and published all together in this fourth issue of the Italian Journal of Medicine, with the aim of sharing the direct experiences of those who were the first to face this severe emergency, expressing each point of view in the management of COVID-19 in relation to other diseases. Each article is therefore the result of many efforts and a joint collaboration between many colleagues from the Departments of Internal Medicine or Emergency Medicine of several Italian hospitals, engaged in the front line during the pandemic. These preliminary studies therefore cover diagnostic tools available to health care personnel, epidemiological reflections, possible new therapeutic approaches, discharge and reintegration procedures to daily life, the involvement of the disease not only in the lung, aspects related to various comorbidities, such as: coagulopathies, vasculitis, vitamin D deficiency, gender differences, etc.. The goal is to offer a perspective, as broad as possible, of everything that has been done to initially face the pandemic in its first phase and provide the tools for an increasingly better approach, in the hope of not arriving unprepared to a possible second wave. This paper in particular deals with hypovitaminosis D and COVID-19.

COVID-19 is a respiratory disease due to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Patients with SARS-CoV-2 infection can experience a range of clinical manifestations, from no symptoms to critical illness. The management and healthcare setting of this disease change according to the degree of its severity. In the mild form, patients need only symptomatic therapy, like antipyretic drugs, while in the more severe form, patients need to be hospitalized, multiparametric monitoring, prevention of complications, anti-inflammatory and antiviral drugs.

Wernicke’s encephalopathy (WE) is an acute neurological disorder resulting from thiamine deficiency, commonly found in alcohol use disorder (AUD) patients. Liver transplantation (LT) could represent a risk factor for the onset of WE in AUD patients, due to the onset of chronic depletion of thiamine in this population and the high metabolic demand of surgery and the postoperative period. However, few data are available about the risk of the onset of WE in AUD patients after LT. Here we report three cases of AUD patients who developed WE with confusion and delirium after LT. Prompt parenteral administration of thiamine led to a rapid improvement of the clinical condition and a complete remission of neurological symptoms after 3–4 days. In addition, a search of the available English literature was conducted in order to perform a review of the possible association between the onset of WE and LT in AUD patients. A prophylactic treatment regimen based on the administration of thiamine could be suggested in AUD patients before and after LT. Further studies are needed to determine the optimal regimen of thiamine in the prevention of WE in this setting.

Background: In recent years, direct-acting oral anticoagulants (DOACs) have entered clinical practice for stroke prevention in non-valvular atrial fibrillation or prevention and treatment of venous thromboembolism. However, remaining uncertainty regarding DOAC use in some clinical scenarios commonly encountered in the real world has not been fully explored in clinical trials. Methods: We report on use of a Delphi consensus process on DOAC use in non-valvular atrial fibrillation patients. The consensus process dealt with 9 main topics: (i) DOACs vs vitamin K antagonists in atrial fibrillation (AF) patients; (ii) therapeutic options for patients with stable total time in range treated with vitamin K antagonists; (iii) therapeutic options for patients aged > 85 years; (iv) therapeutic management of hyperfiltering patients; (v) pharmacologic interactions; (vi) therapeutic options in the long-term treatment (prevention) of patients with AF and acute coronary syndrome after the triple therapy; (vii) low doses of DOACs in AF patients; (viii) ischemic stroke in patients inappropriately treated with low doses of DOACs; (ix) management of patients taking DOACs with left atrial appendage thrombosis. Results: A total of 101 physicians (cardiologists, internists, geriatricians, and hematologists) from Italy expressed their level of agreement on each statement by using a 5-point Likert scale (1 = strongly disagree; 2 = disagree; 3 = somewhat agree; 4 = agree; 5 = strongly agree). Votes 1-2 were considered to be disagreement; votes 3-5 were considered to be agreement. Agreement among the respondents of ≥ 66% for each statement was considered consensus. A brief discussion of the results for each topic is also reported. Conclusions: In clinical practice, there is still uncertainty on DOAC use, especially in elderly, fragile, comorbid, and hyperfiltering patients. Résumé: Contexte: Depuis quelques années, les cliniciens prescrivent des anticoagulants oraux directs (AOD) pour prévenir les accidents vasculaires cérébraux (AVC) chez les patients présentant une fibrillation auriculaire (FA) non valvulaire ou pour prévenir et traiter les thromboembolies veineuses. Cependant, les doutes que suscite encore l’emploi des AOD dans certains contextes courants de la pratique clinique n’ont pas encore été bien explorés dans le cadre des études cliniques. Méthodologie: Nous avons utilisé la méthode de Delphes, une démarche visant à dégager un consensus, afin d’évaluer le recours aux AOD chez des patients présentant une FA non valvulaire. L’étude comprenait 9 thèmes principaux : i) utilisation des AOD et des antagonistes de la vitamine K chez les patients présentant une FA; ii) options thérapeutiques pour les patients traités par un antagoniste de la vitamine K dont l’état se maintient depuis un certain temps dans une plage de valeurs normales; iii) options thérapeutiques pour les patients âgés de plus de 85 ans; iv) prise en charge thérapeutique des patients souffrant d’hyperfiltration; v) interactions pharmacologiques; vi) options thérapeutiques pour le traitement prolongé (préventif) des patients présentant une FA et un syndrome coronarien aigu après une trithérapie; vii) utilisation des AOD à faible dose chez les patients présentant une FA; viii) AVC ischémique chez les patients traités de façon inappropriée par un AOD à faible dose; ix) prise en charge des patients prenant un AOD qui présentent une thrombose de l’appendice auriculaire gauche. Résultats: Au total, 101 médecins (cardiologues, internistes, gériatres et hématologues) italiens ont exprimé leur degré d’accord avec chacun des énoncés proposés sur une échelle de Likert à 5 points (1 = tout à fait en désaccord; 2 = en désaccord; 3 = moyennement d’accord; 4 = d’accord; 5 = tout à fait d’accord). Une note de 1 ou 2 a été considérée comme un désaccord et une note de 3, 4 ou 5, comme un accord. On considérait qu’il y avait un consensus si 66 % ou plus des répondants étaient d’accord avec l’énoncé. Nous présentons également brièvement les résultats obtenus pour chacun des thèmes. Conclusions: Dans la pratique clinique, l’emploi des AOD soulève encore des doutes, en particulier chez les patients âgés, fragiles ou présentant des affections concomitantes ou une hyperfiltration.

Safety of Catheter Ablation for Atrial Fibrillation Introduction Despite catheter ablation (CA) becoming an accepted treatment option for symptomatic, drug-resistant atrial fibrillation (AF), safety of this procedure continues to be cause for concern. Aim of the present multicenter registry was to assess the incidence of early CA complications and detect their predictors in a contemporary, unselected AF population Methods and Results From January 1, 2011 to December 31, 2011, data from 2,323 consecutive patients who underwent CA (median age 60 [52–67]; 72.3% male) for AF in 29 Italian centers were collected. All major complications occurring to the patient from admission to 30th postprocedural day were recorded. No procedure-related death was observed. Major complications occurred in 94 patients (4.0%): 50 patients (2.2%) suffered vascular access complications; 12 patients (0.5%) developed cardiac tamponade; 14 patients (0.6%) presented with pericarditis; 5 patients (0.2%) had transient ischemic attack; 4 patients had stroke; 3 patients (0.1%) had phrenic nerve paralysis; 3 patients (0.1%) had hemothorax. Other isolated but serious adverse events were documented in 3 patients (0.1%). Female gender (OR 2.643; 95% CI 1.686–4.143; P < 0.0001) and longer procedural duration (OR 2.195; 95% CI 1.388–3.473; P < 0.001) independently predicted a higher risk of complications. Conclusion Major complications occurred in 4.0% of the CA procedures for AF, with vascular access complications being the most frequent events.

In recent years, significant progress has been made in furthering our knowledge of chronic liver disease (CLD) and evaluating the therapeutic approaches. These have been updated in the form of recommendations by international scientific societies. Through a retrospective analysis, this study aimed to verify whether these recommendations have been applied in real practice. The study design included data gathered from all patients consecutively hospitalized for decompensated liver cirrhosis during one year. A pre-made master form was used to record data on the patients’ past knowledge of the etiology and management of their liver disease. As expected, hepatitis C virus (HCV) was the most frequent cause of CLD, while 41 cases were cryptogenic. In 69 of 263 patients with HCV infection, viral genotyping had been performed, although only 39 of these cases had been treated. Only 3 of 44 patients suffering from hepatitis B virus (HBV)-related liver cirrhosis had been treated in the past, while 11 patients were still being treated. Among the remaining patients, 15 were not aware that they had CLD and 15 had never been considered for antiviral treatment. In 81 cases, the disease had progressed to hepatocellular carcinoma, but only 19 patients had discovered the tumor following regular ultrasound screening. Thirty-seven patients were receiving specific treatment consistent with the stage of their disease. The management of HBV- and HCV-related CLD in Sicily is far from optimal, and although the natural history and management practices of these diseases are well known, this knowledge is a long way from being applied in our daily practice.

Perisinusal atrial tachycardia may represent a challenging situation due to unsustained burst characterizing the arrhythmia, sensitivity to bumping, and potential complications including sinus node ablation. This case describes the use of a noncontact mapping system to map and ablates this arrhythmia. Benefit of this technology is described. (PACE 2013; 36:e11–e14)

Background Pulmonary vein isolation (PVI) is one of the common endpoints of all atrial fibrillation (AF) ablation procedures and is most often validated using a preshaped circular catheter. However, three-dimensional (3D) electroanatomical systems used for anatomy reconstruction and to guide coalescent delivery of ablation lesions avoid the use of multiple transeptal punctures and multiple catheters in the left atrium. Objective To assess correspondence in PVI validation between a 3D electroanatomical system and a Lasso catheter. Methods Twenty-five patients affected by nonpermanent AF were enrolled after giving informed consent. After ablation of all four pulmonary vein (PV) ostia, encircled areas were extensively mapped (15 ± 5 points acquired for each PV ostium) to assess the absence of any electrical activity conducted from the left atrium to the PV. At the end of the procedure, the physician performing the ablation procedure judged the complete versus incomplete PVI according to Carto/ablation catheter mapping during coronary sinus pacing. Thereafter, a second operator blinded to the result of the ablation procedure positioned a preshaped Lasso catheter in each PV ostium and annotated complete/incomplete PVI during pacing from the coronary sinus. Results PVI as assessed with CARTO was 100% concordant with Lasso evaluation of PVI. Fluoroscopic times were 2.5 ± 0.9 minutes to complete circumferential PV ablation and 5.5 ± 1.9 minutes to properly position the Lasso catheter. No acute complications were reported in this series of patients. Conclusions PVI assessment using a 3D electroanatomical system is as accurate as Lasso evaluation, with excellent concordance.

course parallel to the mitral valve that separated the atrium into postero-superior and anterior-inferior halves (Figure 4). 3D ultrasound revealed a large opening in the infero-posterior side with a regular flow without hemodynamically significant stenosis (Figure 5). The cine-MRI confirmed the presence of a small leftright jet flow owing to the traction of the inter-atrial septum by the intra-atrial membrane. Due to the huge communication and the absence of symptoms, currently we didn’t consider invasive diagnostic tests or surgery intervention for correction of the defects. We decided to put the patient on therapy with low-dose of acetylsalicylic acid and follow him periodically.

Objectives We compared ablation strategy with antiarrhythmic drug therapy (ADT) in patients with paroxysmal atrial fibrillation (PAF). Background Atrial fibrillation (AF) ablation strategy is superior to ADT in patients with an initial history of PAF, but its role in patients with a long history of AF as compared with ADT remains a challenge. Methods One hundred ninety-eight patients (age, 56 ± 10 years) with PAF of 6 ± 5 years’ duration (mean AF episodes 3.4/month) who had failed ADT were randomized to AF ablation by circumferential pulmonary vein ablation (CPVA) or to the maximum tolerable doses of another ADT, which included flecainide, sotalol, and amiodarone. Crossover to CPVA was allowed after 3 months of ADT. Results By Kaplan-Meier analysis, 86% of patients in the CPVA group and 22% of those in the ADT group who did not require a second ADT were free from recurrent atrial tachyarrhythmias (AT) (p Conclusions Circumferential pulmonary vein ablation is more successful than ADT for prevention of PAF with few complications. Atrial fibrillation ablation warrants consideration in selected patients in whom ADT had already failed and maintenance of sinus rhythm is desired. (A Controlled Randomized Trial of CPVA Versus Antiarrhythmic Drug Therapy in for Paroxysmal AF: APAF/01; http://clinicaltrials.gov/ct/show ; NCT00340314 )

We conducted a randomized, controlled trial of circumferential pulmonary-vein ablation for the treatment of chronic atrial fibrillation.A total of 146 patients with a mean (+/-SD) age of 57+/-9 years who had chronic atrial fibrillation were randomly assigned to receive amiodarone and undergo two cardioversions during the first three months alone (the control group) or in combination with circumferential pulmonary-vein ablation. Cardiac rhythm was assessed with daily telephonic transmissions for one year. The left atrial diameter and the severity of symptoms were assessed at 12 months.Among the 77 patients assigned to undergo circumferential pulmonary-vein ablation, ablation was repeated because of recurrent atrial fibrillation in 26 percent of patients and atypical atrial flutter in 6 percent. An intention-to-treat analysis showed that 74 percent of patients in the ablation group and 58 percent of those in the control group were free of recurrent atrial fibrillation or flutter without antiarrhythmic-drug therapy at one year (P=0.05). Among the 69 patients in the control group, 53 (77 percent) crossed over to undergo circumferential pulmonary-vein ablation for recurrent atrial fibrillation by one year and only 3 (4 percent) were in sinus rhythm without antiarrhythmic-drug therapy or ablation. There were significant decreases in the left atrial diameter (12+/-11 percent, P0.001) and the symptom severity score (59+/-21 percent, P0.001) among patients who remained in sinus rhythm after circumferential pulmonary-vein ablation. Except for atypical atrial flutter, there were no complications attributable to circumferential pulmonary-vein ablation.Sinus rhythm can be maintained long term in the majority of patients with chronic atrial fibrillation by means of circumferential pulmonary-vein ablation independently of the effects of antiarrhythmic-drug therapy, cardioversion, or both. The maintenance of sinus rhythm is associated with a significant decrease in both the severity of symptoms and the left atrial diameter.

Objectives Few data have been published on transcatheter ablation of atrial fibrillation (AF) in patients with mitral valve prostheses. Thus, we sought to report our experience. Background Ablation is an effective treatment for AF. Patients with prosthetic mitral valves represent a special group because of an increased risk from the ablation procedure due to the possibility of damage to the prosthetic valve. Methods Between July 2001 and July 2003, 26 patients with mitral valve prostheses (MVP) underwent circumferential pulmonary vein ablation for AF. A matched group of 52 ablated patients without MVP acted as control subjects. After a blanking period of three months, a follow-up of 12 months was considered for MVP patients and controls. Holter recordings were performed in all subjects at 3, 6, and 12 months. Results Radiation exposure was higher in the MVP group, with fluoroscopy times of 35.3 ± 21 min versus 20.9 ± 15 min in controls. At the end of follow-up, 73% of MVP patients were in sinus rhythm, compared with 75% of controls. Atrial tachycardia occurred in six (23%) MVP patients, requiring repeat ablation in three, and one (2%) control subject, which settled without treatment. One transient ischemic attack and one femoral pseudoaneurysm occurred in the MVP group. No complications occurred in the control group. Conclusions Ablation of AF in patients with MVP is feasible, with outcomes similar to those of standard patients. Complications were higher among MVP patients with a greater radiation exposure and a higher incidence of post-ablation atrial tachycardia.

BACKGROUND Ventricular fibrillation can be the presenting arrhythmia in children with asymptomatic Wolff-Parkinson-White syndrome. Deaths due to this arrhythmia are potentially preventable. METHODS We performed a randomized study in which prophylactic radiofrequency catheter ablation of accessory pathways was compared with no ablation in asymptomatic children (age range, 5 to 12 years) with the Wolff-Parkinson-White syndrome who were at high risk for arrhythmias. The primary end point was the occurrence of arrhythmic events during follow-up. RESULTS Of the 165 eligible children, 60 were determined to be at high risk for arrhythmias. After randomization, but before any ablation had been performed, the parents withdrew 13 children from the study. Of the remaining children, 20 underwent prophylactic ablation and 27 had no treatment. The characteristics of the two groups were similar. There were three ablation-related complications, one of which led to hospitalization. During follow-up, 1 child in the ablation group (5 percent) and 12 in the control group (44 percent) had arrhythmic events. Two children in the control group had ventricular fibrillation, and one died suddenly. The cumulative rate of arrhythmic events was lower among children at high risk who underwent ablation than among those at high risk who did not. The reduction in risk associated with ablation remained significant after adjustment in a Cox regression analysis. In both the ablation and the control groups, the independent predictors of arrhythmic events were the absence of prophylactic ablation and the presence of multiple accessory pathways. CONCLUSIONS In asymptomatic, high-risk children with the Wolff-Parkinson-White syndrome, prophylactic catheter ablation performed by an experienced operator reduces the risk of life-threatening arrhythmias.

background Young age and inducibility of atrioventricular reciprocating tachycardia or atrial fibrillation during invasive electrophysiological testing identify asymptomatic patients with a Wolff–Parkinson–White pattern on the electrocardiogram as being at high risk for arrhythmic events. We tested the hypothesis that prophylactic catheter ablation of accessory pathways would provide meaningful and durable benefits as compared with no treatment in such patients. methods From 1997 to 2002, among 224 eligible asymptomatic patients with the Wolff–Parkinson–White syndrome, patients at high risk for arrhythmias were randomly assigned to radio-frequency catheter ablation of accessory pathways (37 patients) or no treatment (35 patients). The end point was the occurrence of arrhythmic events over a five-year follow-up period. results Patients assigned to ablation had base-line characteristics that were similar to those of the controls. Two patients in the ablation group (5 percent) and 21 in the control group (60 percent) had arrhythmic events. One control patient had ventricular fibrillation as the presenting arrhythmia. The five-year Kaplan–Meier estimates of the incidence of arrhythmic events were 7 percent among patients who underwent ablation and 77 percent among the controls (P

OBJECTIVES This study was designed to investigate the potential of circumferential pulmonary vein (PV) ablation for atrial fibrillation (AF) to maintain sinus rhythm (SR) over time, thus reducing mortality and morbidity while enhancing quality of life (QoL). BACKGROUND Circumferential PV ablation is safe and effective, but the long-term outcomes and its impact on QoL have not been assessed or compared with those for medical therapy. METHODS We examined the clinical course of 1,171 consecutive patients with symptomatic AF who were referred to us between January 1998 and March 2001. The 589 ablated patients were compared with the 582 who received antiarrhythmic medications for SR control. The QoL of 109 ablated and 102 medically treated patients was measured with the SF-36 survey. RESULTS Median follow-up was 900 days (range 161 to 1,508 days). Kaplan-Meier analysis showed observed survival for ablated patients was longer than among patients treated medically (p < 0.001), and not different from that expected for healthy persons of the same gender and calendar year of birth (p = 0.55). Cox proportional-hazards model revealed in the ablation group hazard ratios of 0.46 (95% confidence interval [CI], 0.31 to 0.68; p < 0.001) for all-cause mortality, of 0.45 (95% CI, 0.31 to 0.64; p < 0.001) for morbidities mainly due to heart failure and ischemic cerebrovascular events, and of 0.30 (95% CI, 0.24 to 0.37; p < 0.001) for AF recurrence. Ablated patients' QoL, different from patients treated medically, reached normative levels at six months and remained unchanged at one year. CONCLUSIONS Pulmonary vein ablation improves mortality, morbidity, and QoL as compared with medical therapy. Our findings pave the way for randomized trials to prospect a wider application of ablation therapy for AF.

Biventricular pacing (BVP) improves hemodynamics and symptoms in patients with heart failure with bundle branch block. Patients with a left ventricular ejection fraction0.35 and ventricular tachyarrhythmias are at risk of sudden cardiac death, and they benefit most from implantable cardioverter defibrillators (ICDs). No study has evaluated the efficacy of the BVP-ICD combination in patients with heart failure with no history of syncope or sustained ventricular tachycardia (VT) or ventricular fibrillation (VF). Our prospective, observational study was performed on 135 consecutive patients with heart failure (aged, 64 +/- 11 years; 76% male; New York Heart Association functional class, 3.1 +/- 0.8; ejection fraction 0.28 +/- 0.06; ischemic heart failure, 43%; QRS interval duration, 153 +/- 11 msec) treated at our cardiac pacing unit between January 1999 and April 2001. In the first year (control phase), BVP alone was implanted. After that, BVP with ICD backup was used (prophylactic phase). Follow-up data were obtained by outpatient visits with electrocardiographic and echocardiographic examinations done at 3-month intervals. For patients who died, we examined hospital records, death certificates, and autopsy reports. Follow-up time averaged 840 days. The first 47 patients received BVP alone. During follow-up study, 19% of these patients died suddenly, and 11% died of worsening heart failure. None of the patients who died suddenly had hemodynamic deterioration or BVP malfunction before the event. The BVP-ICD group comprised 88 patients (18% with VT/VF inducibility on electrophysiologic testing). During follow-up study, 32% of these patients (18% with positive electrophysiologic testing) had VT/VF episodes successfully treated by ICD; 5% received inappropriate discharges on atrial fibrillation; and 6% died of heart failure with 1 sudden cardiac death. Cox proportional hazards model in the BVP-ICD group compared with BVP alone revealed hazard ratios for all-cause mortality and sudden cardiac death of 0.76 (95% confidence interval [CI], 0.58 to 0.96; p = 0.01) and 0.08 (95% CI, 0.05 to 0.42; p0.01), respectively, adjusting for baseline characteristics and follow-up duration. Mortality in patients with heart failure remains high after BVP implantation, mainly because of sudden cardiac death. Although there are limitations with an observational study, our experience suggests that ICD backup grants increased security in BVP patients without conventional class I ICD indications.

Despite catheter ablation (CA) becoming an accepted treatment option for symptomatic, drug-resistant atrial fibrillation (AF), safety of this procedure continues to be cause for concern. Aim of the present multicenter registry was to assess the incidence of early CA complications and detect their predictors in a contemporary, unselected AF populationFrom January 1, 2011 to December 31, 2011, data from 2,323 consecutive patients who underwent CA (median age 60 [52-67]; 72.3% male) for AF in 29 Italian centers were collected. All major complications occurring to the patient from admission to 30th postprocedural day were recorded. No procedure-related death was observed. Major complications occurred in 94 patients (4.0%): 50 patients (2.2%) suffered vascular access complications; 12 patients (0.5%) developed cardiac tamponade; 14 patients (0.6%) presented with pericarditis; 5 patients (0.2%) had transient ischemic attack; 4 patients had stroke; 3 patients (0.1%) had phrenic nerve paralysis; 3 patients (0.1%) had hemothorax. Other isolated but serious adverse events were documented in 3 patients (0.1%). Female gender (OR 2.643; 95% CI 1.686-4.143; P0.0001) and longer procedural duration (OR 2.195; 95% CI 1.388-3.473; P0.001) independently predicted a higher risk of complications.Major complications occurred in 4.0% of the CA procedures for AF, with vascular access complications being the most frequent events.

Background— Information on comparative outcome between radiofrequency catheter ablation (RFA) and antiarrhythmic drugs (AADs) >1 year after randomization is important for clinical decision-making. Methods and Results— A total of 198 patients (age, 56±10 years) with paroxysmal atrial fibrillation were randomly assigned to RFA (99 patients) or to AADs (99 patients). We evaluated efficacy of RFA or AADs in a comparable 48-month follow-up period according to intention-to-treat analysis. Cardiac rhythm was assessed with daily transtelephonic transmissions. Quality of life was also analyzed. At 4 years, among the 99 patients first assigned to RFA, the procedure was repeated because of recurrent atrial fibrillation/atrial tachycardia in 27 patients (27.3%). Among the 99 patients randomly assigned to AADs, 87 (87.9%) crossed over to undergo RFA and 4 years after random assignment only 12 (12.1%) were in sinus rhythm with AAD alone without ablation. Despite the high level of crossovers, at 4 years the intention-to-treat analysis showed that 72.7% of patients in the ablation arm and 56.5% of those initially randomly assigned to AADs were free of recurrent atrial fibrillation/atrial tachycardia ( P =0.017). During the follow-up, 19.2% of AAD patients progressed to persistent atrial fibrillation before switching to RFA. RFA significantly improved quality of life ( P Conclusions— With follow-up extended to 4 years after randomly assigned, ablation remains superior to antiarrhythmic drug in these patients with paroxysmal atrial fibrillation. Clinical Trial Registration— URL: http://www.clinicaltrials.gov . Unique identifier: NCT00340314.

Perisinusal atrial tachycardia may represent a challenging situation due to unsustained burst characterizing the arrhythmia, sensitivity to bumping, and potential complications including sinus node ablation. This case describes the use of a noncontact mapping system to map and ablates this arrhythmia. Benefit of this technology is described.

Catheter ablation techniques for atrial fibrillation are evolving with targets for radiofrequency ablation of atrial fibrillation increasingly being selected based on anatomic considerations. Such anatomic ablation techniques require precise catheter localization and stable contact during ablation. Even experienced electrophysiologists occasionally encounter difficulties in maintaining stable catheter contact, especially in some regions of complex anatomy where catheter stability is crucial. Limitations of manually deflected conventional ablation catheters in performing complex catheter maneuvers may also contribute to these challenges. The CARTO RMT version 8 has been recently released to guide left atrial mapping and ablation in conjunction with the Stereotaxis system for remote control of the ablation catheter. We aim to describe how this system works and why it is needed in the field of catheter ablation.

Background: patients with long-lasting permanent atrial fibrillation (AF) are often destined to remain in AF life-long. In this cohort outcomes of ablation techniques are disappointing, with 20 –74% success rate and 30 –50% repeat procedure. The adjunctive clinical benefit of targeting multiple right and left atrial (LA) sites beyond the pulmonary vein (PV)-LA junction with the aim of achieving acute AF termination has not been prospectively evaluated in a randomized study. Methods and results: 60 patients with permanent atrial fibrillation of more than 1 year duration, with early recurrence after electrical cardioversion and medical therapy with one or more antiarrhythmic agents were enrolled (mean age 59±10, mean AF duration 60 months, mean LA dimension 44±7 mm, left ventricular EF >40% in all) and randomized to standard circumferential PV ablation (CPVA, control group, N=30) or an extended CPVA schema targeting also inferior LA, atrial septum, LA appendage, coronary sinus and right atrium (test group, N=30). In the test group the procedural endpoint was sinus rhythm (SR) restoration by radiofrequency energy; at each step average cycle length was measured and ablation was stopped if patient gained SR. In the control group the standard CPVA technique was applied. All patient transmitted daily transtelephonic ECG strips whereas at 3, 6 and 12 months an echocardiogram and a 48 hour Holter was obtained. Antiarrhythmic drug therapy was continued for 3 months after ablation in both group (blanking period in which patients were allowed to undergo electrical cardioversion). AF terminated in 5% and 55% of control and test subjects; mean procedure duration was 66 and 88 minutes in the 2 groups; No significant complications occurred in both groups. After a mean follow-up of 4 months, 67% of control patients were sinus as compared with 83% in the test group (p Conclusion: Preliminary data show that a modified CPVA ablation strategy in patients with permanent AF is associated with acute AF termination in 55% of patients and achieves medium term restoration and maintenance of sinus rhythm in 83% of patients.

Left Atrium Remodeling in Repeat AF Ablation. Introduction: There is limited information describing late changes in the electroanatomic characteristics of the left atrium (LA) associated with recurrence after an anatomical circumferential pulmonary vein ablation (CPVA) for atrial fibrillation (AF). Methods and Results: Forty-seven patients (57 ± 8 years) undergoing a repeat ablation after CPVA were included. Using an electroanatomic mapping system, we measured the bipolar voltage by averaging points in the pulmonary vein (PV)-LA junction and four other LA sites. Conduction velocity and AF cycle length (AFCL) were also measured and the results are compared with the first procedure. After an initial decrease observed at the end of the first procedure, voltage and conduction velocity returned to intermediate values in all LA sites, with lower voltage at the LIPV antrum (P = 0.004), and lower conduction velocity across the LIPV and RSPV (P < 0.001). Conduction gaps were more prevalent at the septal aspect of the right PV encircling lines (85%), between the left atrial appendage (LAA) and the LSPV (70%) and lines at the posterior wall (71%). There was a nonsignificant increase in AFCL, with a more widespread distribution of organized electrograms (32.4% vs 46.6%). Conclusion: Recurrence after CPVA is associated with a reverse process of voltage and conduction velocity increase across ablated areas, especially the PV-LA junction, and is related to the presence of conduction gaps, which are distributed mostly at the septal aspect of the lines encircling the right PVs and at the LAA-LSPV area. Organization of atrial electrograms seen during AF ablation is maintained at a repeat procedure.

We compared ablation strategy with antiarrhythmic drug therapy (ADT) in patients with paroxysmal atrial fibrillation (PAF).Atrial fibrillation (AF) ablation strategy is superior to ADT in patients with an initial history of PAF, but its role in patients with a long history of AF as compared with ADT remains a challenge.One hundred ninety-eight patients (age, 56 +/- 10 years) with PAF of 6 +/- 5 years' duration (mean AF episodes 3.4/month) who had failed ADT were randomized to AF ablation by circumferential pulmonary vein ablation (CPVA) or to the maximum tolerable doses of another ADT, which included flecainide, sotalol, and amiodarone. Crossover to CPVA was allowed after 3 months of ADT.By Kaplan-Meier analysis, 86% of patients in the CPVA group and 22% of those in the ADT group who did not require a second ADT were free from recurrent atrial tachyarrhythmias (AT) (p0.001); a repeat ablation was performed in 9% of patients in the CPVA group for recurrent AF (6%) or atrial tachycardia (3%). At 1 year, 93% and 35% of the CPVA and ADT groups, respectively, were AT-free. Ejection fraction, hypertension, and age independently predicted AF recurrences in the ADT group. Circumferential pulmonary vein ablation was associated with fewer cardiovascular hospitalizations (p0.01). One transient ischemic attack and 1 pericardial effusion occurred in the CPVA group; side effects of ADT were observed in 23 patients.Circumferential pulmonary vein ablation is more successful than ADT for prevention of PAF with few complications. Atrial fibrillation ablation warrants consideration in selected patients in whom ADT had already failed and maintenance of sinus rhythm is desired. (A Controlled Randomized Trial of CPVA Versus Antiarrhythmic Drug Therapy in for Paroxysmal AF: APAF/01; http://clinicaltrials.gov/ct/show; NCT00340314).

BACKGROUND Circumferential pulmonary vein ablation (CPVA) is an effective treatment for atrial fibrillation (AF). Accurate left atrial (LA) mapping is essential for creating lesions at the LA‐ pulmonary vein (PV) junction, avoiding PV stenosis. OBJECTIVES The purpose of this study was to establish whether endocardial impedance varies within the LA and PVs and whether it is a useful tool for mapping and ablation. METHODS Pilot Phase: Three-dimensional LA maps were created using CARTO. Impedance (Z) was measured using a radiofrequency generator at multiple points in the LA, PV ostia (PVO), and deep PVs in 79 patients undergoing their first AF ablation (group 1) and 29 patients undergoing repeat CPVA (group 2). Prospective Phase: In an additional 20 patients, using pilot phase data, one operator defined catheter tip location as either LA or PVO based on CARTO and fluoroscopy. A second operator blinded to CARTO simultaneously did the same based on impedance at 15 4 points per patient. RESULTS Group 1: ZLA was 99.4 9.0 .Z PVO was higher (109.2 8.5 ), rising further as the catheter advanced into deep PV (137 18). ZPVO differed from ZLA by 9 4 . Group 2 had a lower ZLA and ZPVO compared with group 1 (P .05). Impedance monitoring differentiated between LA and PVO, with 91% specificity and sensitivity, 96% positive predictive value, and 81% negative predictive value. At 3-month follow-up, no patients had evidence of PV stenosis on magnetic resonance imaging. CONCLUSION Impedance mapping reliably identifies the LA‐PV transitional zone, facilitating AF ablation, and its use is associated with a low incidence of PV stenosis.

Radiofrequency catheter ablation is currently used widely and successfully to treat a variety of arrhythmias, and ablation for atrial fibrillation represents the frontier of arrhythmia research. Development in many areas will offer to the electrophysiologic community a more rational and effective background upon which select patients for ablation and identify the optimal ablative strategy. Among mechanisms recognized for having a role in atrial fibrillation stay pulmonary vein focal triggers, rotor at the pulmonary vein-left atrial junction, a critical mass to sustain fibrillatory conduction and vagal ganglia. The latter represents the frontier of research as with new technologies based on magnetic resonance imaging they could be easily and specifically identified and targeted for ablation. It is fundamental that both CARTO and NavX systems are currently investigating integration with magnetic resonance imaging to reconstruct the left atrium. Furthermore a learning curve effect can be abated with the use of new systems for the remote control of the catheter such as stereotaxis. In the last decade, we empirically devised a technique that is both safe and effective for curing atrial fibrillation. Briefly, using a three-dimensional mapping system, either CARTO or NavX system, we reconstruct the left atrium and the pulmonary ostia; thereafter circumferential ablation lines are normally created starting at the lateral mitral annulus and withdrawing posterior then anterior to the left-sided pulmonary veins, passing between the left superior pulmonary vein and the left atrial appendage before completing the circumferential line on the posterior wall of the left atrium. The right pulmonary veins are isolated in a similar fashion, and then a posterior line connecting the two circumferential lines on the roof is performed to reduce the risk of macroreentrant atrial tachycardias. The endpoint for circumferential ablation is a70-90% reduction in voltage within the isolated regions. In this article we sought to describe critical methodological aspects of our techniques along with future implementation with new technologies and to summarize our published clinical experience on the most prestigious journals.

Background Thoracic surgeons have limited experience of inflammatory pseudotumors of the lung owing to their rare occurrence in routine clinical practice. Methods We retrospectively investigated the clinicopathologic features of 18 patients with inflammatory pseudotumor of the lung observed between 1992 and 2002. Results There were 13 men and 5 women. Median age was 57 years. Eight patients (44%) were symptomatic. Computed tomographic scan showed a solitary nodule (≤3 cm) in 12 patients, bilateral nodules in 1, and a mass in 5. Two patients had undergone prior incomplete resections. Lobectomy was performed in 5 patients, bilobectomy in 1, segmentectomy in 1, and wedge resection in 11. Complete resection was achieved in 13 patients (72%). There was no operative mortality. Follow-up was complete in all patients (range, 13 to 134 months; median, 63 months). Overall 3-year and 5-year survival rates were 82% and 74%, respectively. Thirteen patients are currently alive with no evidence of disease, 1 is alive with disease, 1 died of unrelated causes, and 3 had a relapse and died. Completeness of resection and lesion size less than or equal to 3 cm were associated with a better survival ( p p = 0.007, respectively). Multivariate Cox analysis confirmed the association between completeness of resection and better survival, which is independent of other clinicopathologic variables ( p = 0.02). Conclusions This series shows that a significant number of patients with inflammatory pseudotumor of the lung have a poor prognosis and confirms the need for radical resection in the treatment of this unusual entity.

Patients on hemodialysis (HD) who undergo surgery represent a high risk group requiring careful perioperative management to avoid electrolyte imbalance and hemodynamic instability. The aim of the study was to analyze the postoperative outcome in terms of complications and survival of a group of patients on HD who had undergone pulmonary resection for non-small cell lung cancer (NSCLC). Six patients on HD underwent seven pulmonary resections at our institution from 1998 to 2003. The underlying kidney disease was nephrosclerosis in two patients and glomerulonephritis in four. The mean levels of blood urea nitrogen and serum creatinine were 107 +/- 11.5 mg/dl and 7.9 +/- 0.64 mg/dl, respectively. The mean preoperative PO2 and FEV1 were 77.6 +/- 2.4 mmHg and 2.4 +/- 0.16 liters, respectively. The histologic diagnosis was squamous cell carcinoma in four cases and adenocarcinoma in three. One patient underwent two lung resections in 4 years for two primary lung cancers. Five patients underwent lobectomy, one underwent a wedge resection, and in one case pneumonectomy was performed after neoadjuvant chemotherapy. There was no operative mortality. Postoperatively, atrial fibrillation occurred in two patients associated with sputum retention in both, and two other patients had hyperkalemia (complication rate 57%). One patient died of cardiac complications 27 months after surgery. The remaining five patients are currently alive with no evidence of disease. Patients on HD who undergo lung resection have a high rate of postoperative complications. Although the underlying disease influences long-term survival, radical lung resection in NSCLC patients is recommended in selected cases. Careful metabolic, hematologic, and pharmaceutical management is mandatory during the perioperative period. RI ciriaco, paola/H-5716-2012

Background— Circumferential pulmonary vein ablation (CPVA) is effective in curing atrial fibrillation (AF), but new-onset left atrial tachycardia (AT) is a potential complication. We evaluated whether a modified CPVA approach including additional ablation lines on posterior wall and the mitral isthmus would reduce the incidence of AT after PV ablation. Methods and Results— A total of 560 patients (291 men, 52%; age, 56.5±7.3 years) entered the study; 280 were randomized to CPVA alone (group 1) and 280 to modified CPVA (group 2). The primary end point was freedom from AT after the procedure. In group 1, 28 patients (10%) experienced new-onset AT, and 41 (14.3%) experienced recurrent AF. In group 2, 11 patients (3.9%) experienced AT, and 36 (12.9%) had recurrent AF. Group 1 was more likely to experience AT than group 2 ( P =0.005). Freedom from AF after ablation was similar in both groups ( P =0.57). Among those in group 1, gap-related macroreentrant AT was documented in 23 of the 28 patients (82%), and focal AT was found in 5 (18%). In group 2, gap-related macroreentrant AT was found in 8 of the 11 patients (73%), and focal AT was seen in 3 (27%). Two patients in group 1 and 1 patient in group 2 had both AT and AF. The strongest predictor of AT was the presence of gaps ( P Conclusions— Modified CPVA is as effective as CPVA in preventing AF but is associated with a lower risk of developing incessant AT.

Few data have been published on transcatheter ablation of atrial fibrillation (AF) in patients with mitral valve prostheses. Thus, we sought to report our experience.Ablation is an effective treatment for AF. Patients with prosthetic mitral valves represent a special group because of an increased risk from the ablation procedure due to the possibility of damage to the prosthetic valve.Between July 2001 and July 2003, 26 patients with mitral valve prostheses (MVP) underwent circumferential pulmonary vein ablation for AF. A matched group of 52 ablated patients without MVP acted as control subjects. After a blanking period of three months, a follow-up of 12 months was considered for MVP patients and controls. Holter recordings were performed in all subjects at 3, 6, and 12 months.Radiation exposure was higher in the MVP group, with fluoroscopy times of 35.3 +/- 21 min versus 20.9 +/- 15 min in controls. At the end of follow-up, 73% of MVP patients were in sinus rhythm, compared with 75% of controls. Atrial tachycardia occurred in six (23%) MVP patients, requiring repeat ablation in three, and one (2%) control subject, which settled without treatment. One transient ischemic attack and one femoral pseudoaneurysm occurred in the MVP group. No complications occurred in the control group.Ablation of AF in patients with MVP is feasible, with outcomes similar to those of standard patients. Complications were higher among MVP patients with a greater radiation exposure and a higher incidence of post-ablation atrial tachycardia.

Heart failure (HF) may complicate ischemic heart disease in both its acute and chronic manifestations, representing a prevalent health problem throughout the world. Development of therapies to improve heart function, relieve symptoms, reduce hospitalizations and improve survival is a high priority in cardiovascular medicine. The available pharmacological strategies, including angiotensin-converting enzyme inhibitors, angiotensin receptor antagonists, beta-blockers, and aldosterone receptor antagonists have recently been complemented by new electrical therapy, including implantable cardioverter-defibrillators for "MADIT II" patients and cardiac resynchronization for the 30% of HF patients with concomitant intraventricular conduction delay. The wide variety of available HF medications provides ample evidence that we have not yet succeeded in this effort. Safe and effective inotropic electrical therapy could be a useful addition to our therapeutic armamentarium in an attempt to correct Ca2+ fluxes abnormalities during the cardiac action potential. Cardiac contractility modulation (CCM) by means of non-excitatory electrical currents delivered during the action potential plateau has been shown to acutely enhance systolic function in humans with HF. Herewith, we report on our preliminary experience with CCM therapy for patients with HF, providing fundamental notions to characterize the rationale of this novel form of therapy. Briefly, CCM therapy appears to be safe and feasible. Proarrhythmic effects of this novel therapy seem unlikely. Preliminary data indicate that CCM gradually and significantly improves systolic performance, symptoms and functional status. The technique would appear to be attractive as an additive treatment for severe HF. Controlled randomized studies are needed to validate this novel concept.

Purpose: To report the use of endovascular stenting for treatment of patients with symptomatic obstruction of brachiocephalic surgical reconstructions. Methods: Twenty-two patients (17 men; mean age 65+/-6 years) with 24 symptomatic obstructions of brachiocephalic Dacron bypass grafts (2 aorto-innominate, 9 subclavian-carotid, and 11 carotid-subclavian) were treated with balloon-expandable stents delivered via a percutaneous brachial access or surgical exposure of the common carotid artery. A distal protection device was utilized in the 9 patients with subclavian-carotid bypass grafts. All patients were followed by clinical and Doppler examinations. Results: Procedural success was 100%; 1 (4.5%) patient developed transient intraprocedural aphasia owing to intolerance to the distal protection balloon occlusion. All 22 patients reported complete relief of their presenting symptoms. Over a 29-month follow-up, 3 (13.6%) restenoses were found, but none was due to stent compression. Conclusions: Stenting for obstructed brachiocephalic reconstructions appears to be a safe, effective, and durable therapeutic strategy. Purpose: To report the use of endovascular stenting for treatment of patients with symptomatic obstruction of brachiocephalic surgical reconstructions. Methods: Twenty-two patients (17 men; mean age 65±6 years) with 24 symptomatic obstructions of brachiocephalic Dacron bypass grafts (2 aorto-innominate, 9 subclavian-carotid, and 11 carotid-subclavian) were treated with balloon-expandable stents delivered via a percutaneous brachial access or surgical exposure of the common carotid artery. A distal protection device was utilized in the 9 patients with subclavian-carotid bypass grafts. All patients were followed by clinical and Doppler examinations. Results: Procedural success was 100%; 1 (4.5%) patient developed transient intraprocedural aphasia owing to intolerance to the distal protection balloon occlusion. All 22 patients reported complete relief of their presenting symptoms. Over a 29-month follow-up, 3 (13.6%) restenoses were found, but none was due to stent compression. Conclusions: Stenting for obstructed brachiocephalic reconstructions appears to be a safe, effective, and durable therapeutic strategy.

Background— There are no data to evaluate the relationship between autonomic nerve function modification and recurrent atrial fibrillation (AF) after circumferential pulmonary vein ablation (CPVA). This study assesses the incremental benefit of vagal denervation by radiofrequency in preventing recurrent AF in a large series of patients undergoing CPVA for paroxysmal AF. Methods and Results— Data were collected on 297 patients undergoing CPVA for paroxysmal AF. Abolition of all evoked vagal reflexes around all pulmonary vein ostia was defined as complete vagal denervation (CVD) and was obtained in 34.3% of patients. Follow-up ended at 12 months. Heart rate variability attenuation, consistent with vagal withdrawal, was detectable for up to 3 months after CPVA, particularly in patients with reflexes and CVD, who were less likely to have recurrent AF than those without reflexes ( P =0.0002, log-rank test). Only the percentage area of left atrial isolation and CVD were predictors of AF recurrence after CPVA ( P P =0.025, respectively). Conclusions— This study suggests that adjunctive CVD during CPVA significantly reduces recurrence of AF at 12 months.

This study was designed to investigate the potential of circumferential pulmonary vein (PV) ablation for atrial fibrillation (AF) to maintain sinus rhythm (SR) over time, thus reducing mortality and morbidity while enhancing quality of life (QoL).Circumferential PV ablation is safe and effective, but the long-term outcomes and its impact on QoL have not been assessed or compared with those for medical therapy.We examined the clinical course of 1,171 consecutive patients with symptomatic AF who were referred to us between January 1998 and March 2001. The 589 ablated patients were compared with the 582 who received antiarrhythmic medications for SR control. The QoL of 109 ablated and 102 medically treated patients was measured with the SF-36 survey.Median follow-up was 900 days (range 161 to 1,508 days). Kaplan-Meier analysis showed observed survival for ablated patients was longer than among patients treated medically (p0.001), and not different from that expected for healthy persons of the same gender and calendar year of birth (p = 0.55). Cox proportional-hazards model revealed in the ablation group hazard ratios of 0.46 (95% confidence interval [CI], 0.31 to 0.68; p0.001) for all-cause mortality, of 0.45 (95% CI, 0.31 to 0.64; p0.001) for morbidities mainly due to heart failure and ischemic cerebrovascular events, and of 0.30 (95% CI, 0.24 to 0.37; p0.001) for AF recurrence. Ablated patients' QoL, different from patients treated medically, reached normative levels at six months and remained unchanged at one year.Pulmonary vein ablation improves mortality, morbidity, and QoL as compared with medical therapy. Our findings pave the way for randomized trials to prospect a wider application of ablation therapy for AF.

We assessed the feasibility of cardiac contractility modulation (CCM) by electric currents applied during the refractory period in patients with heart failure (HF). Extracellular electric currents modulating action potential and calcium transients have been shown to potentiate myocardial contractility in vitro and in animal models of chronic HF. CCM signals were biphasic square-wave pulses with adjustable amplitude, duration, and time delay from sensing of local electric activity. Signals were applied to the left ventricle through an epicardial vein (in 12 patients) or to the right ventricular (RV) aspect of the septum endocardially (in 6 patients). Simultaneous left ventricular (LV) and aortic pressure measurements were performed using a Millar catheter (Millar Instruments, Houston, Texas). Hemodynamics during RV temporary dual-chamber pacing was regarded as the control condition. Both LV and RV CCM stimulation increased dP/dt(max) to a similar degree (9.1 +/- 4.5% and 7.1 +/- 0.8%, respectively; p0.01 vs controls), with associated aortic pulse pressure changes of 10.3 +/- 7.2% and 10.8 +/- 1.1% (p0.01 vs controls). Regional systolic wall motion assessed quantitatively by color kinesis echocardiography was markedly enhanced near the CCM electrode, and the area of increased contractility involved 4.6 +/- 1.2 segments per patient. In 6 patients with HF with left bundle branch block, CCM signals delivered during biventricular pacing (BVP) produced an additional 16.1 +/- 3.7% increase in dP/dt(max) and a 17.0 +/- 7.5% increase in pulse pressure compared with BVP alone (p0.01). CCM stimulation in patients with HF enhanced regional and global measures of LV systolic function, regardless of the varied delivery chamber or whether modulation was performed during RV pacing or BVP.

Antiarrhythmic drugs are commonly used for prevention of recurrent atrial fibrillation (AF) despite inconsistent efficacy and frequent adverse effects. Catheter ablation has been proposed as an alternative treatment for paroxysmal AF.To determine the efficacy of catheter ablation compared with antiarrhythmic drug therapy (ADT) in treating symptomatic paroxysmal AF.A prospective, multicenter, randomized (2:1), unblinded, Bayesian-designed study conducted at 19 hospitals of 167 patients who did not respond to at least 1 antiarrhythmic drug and who experienced at least 3 AF episodes within 6 months before randomization. Enrollment occurred between October 25, 2004, and October 11, 2007, with the last follow-up on January 19, 2009.Catheter ablation (n = 106) or ADT (n = 61), with assessment for effectiveness in a comparable 9-month follow-up period.Time to protocol-defined treatment failure. The proportion of patients who experienced major treatment-related adverse events within 30 days of catheter ablation or ADT was also reported.At the end of the 9-month effectiveness evaluation period, 66% of patients in the catheter ablation group remained free from protocol-defined treatment failure compared with 16% of patients treated with ADT. The hazard ratio of catheter ablation to ADT was 0.30 (95% confidence interval, 0.19-0.47; P.001). Major 30-day treatment-related adverse events occurred in 5 of 57 patients (8.8%) treated with ADT and 5 of 103 patients (4.9%) treated with catheter ablation. Mean quality of life scores improved significantly in patients treated by catheter ablation compared with ADT at 3 months; improvement was maintained during the course of the study.Among patients with paroxysmal AF who had not responded to at least 1 antiarrhythmic drug, the use of catheter ablation compared with ADT resulted in a longer time to treatment failure during the 9-month follow-up period.clinicaltrials.gov Identifier: NCT00116428.