Automatic remote monitoring utilizing daily transmissions: transmission reliability and implantable cardioverter defibrillator battery longevity in the TRUST trial.

Aims: Benefits of automatic remote home monitoring (HM) among implantable cardioverter defibrillator (ICD) patients may require high transmission frequency. However, transmission reliability and effects on battery longevity remain uncertain. We hypothesized that HM would have high transmission success permitting punctual guideline based follow-up, and improve battery longevity. This was tested in the prospective randomized TRUST trial. Methods and results: Implantable cardioverter defibrillator patients were randomized post-implant 2:1 to HM (n = 908) (transmit daily) or to Conventional in-person monitoring [conventional management (CM), n = 431 (HM disabled)]. In both groups, five evaluations were scheduled every 3 months for 15 months. Home Monitoring technology performance was assessed by transmissions received vs. total possible, and number of scheduled HM checks failing because of missed transmissions. Battery longevity was compared in HM vs. CM at 15 months, and again in HM 3 years post-implant using continuously transmitted data. Transmission success per patient was 91% (median follow-up of 434 days). Overall, daily HM transmissions were received in 315 795 of a potential 363 450 days (87%). Only 55/3759 (1.46%) of unsuccessful scheduled evaluations in HM were attributed to transmission loss. Shock frequency and pacing percentage were similar in HM vs. CM. Fifteen month battery longevity was 12% greater in HM (93.2 ± 8.8% vs. 83.5 ± 6.0% CM, P < 0.001). In extended follow-up of HM patients, estimated battery longevity was 50.9 ± 9.1% (median 52%) at 36 months. Conclusion: Automatic remote HM demonstrated robust transmission reliability. Daily transmission load may be sustained without reducing battery longevity. Home Monitoring conserves battery longevity and tracks long term device performance. Clinical trial registration: ClinicalTrials.gov; NCT00336284.

Ablation Versus Amiodarone for Treatment of Persistent Atrial Fibrillation in Patients With Congestive Heart Failure and an Implanted Device: Results From the AATAC Multicenter Randomized Trial.

BACKGROUND: Whether catheter ablation (CA) is superior to amiodarone (AMIO) for the treatment of persistent atrial fibrillation (AF) in patients with heart failure is unknown. METHODS AND RESULTS: This was an open-label, randomized, parallel-group, multicenter study. Patients with persistent AF, dual-chamber implantable cardioverter defibrillator or cardiac resynchronization therapy defibrillator, New York Heart Association II to III, and left ventricular ejection fraction <40% within the past 6 months were randomly assigned (1:1 ratio) to undergo CA for AF (group 1, n=102) or receive AMIO (group 2, n=101). Recurrence of AF was the primary end point. All-cause mortality and unplanned hospitalization were the secondary end points. Patients were followed up for a minimum of 24 months. At the end of follow-up, 71 (70%; 95% confidence interval, 60%-78%) patients in group 1 were recurrence free after an average of 1.4±0.6 procedures in comparison with 34 (34%; 95% confidence interval, 25%-44%) in group 2 (log-rank P<0.001). The success rate of CA in the different centers after a single procedure ranged from 29% to 61%. After adjusting for covariates in the multivariable model, AMIO therapy was found to be significantly more likely to fail (hazard ratio, 2.5; 95% confidence interval, 1.5-4.3; P<0.001) than CA. Over the 2-year follow-up, the unplanned hospitalization rate was (32 [31%] in group 1 and 58 [57%] in group 2; P<0.001), showing 45% relative risk reduction (relative risk, 0.55; 95% confidence interval, 0.39-0.76). A significantly lower mortality was observed in CA (8 [8%] versus AMIO (18 [18%]; P=0.037). CONCLUSIONS: This multicenter randomized study shows that CA of AF is superior to AMIO in achieving freedom from AF at long-term follow-up and reducing unplanned hospitalization and mortality in patients with heart failure and persistent AF. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00729911.

Role of Automatic Wireless Remote Monitoring Immediately Following ICD Implant: The Lumos-T Reduces Routine Office Device Follow-Up Study (TRUST) Trial.

INTRODUCTION: The incidence of unscheduled encounters and problem occurrence between ICD implant and first in-person evaluation (IPE) recommended at 12 weeks is unknown. Automatic remote home monitoring (HM) may be useful in this potentially unstable period. METHODS AND RESULTS: ICD patients were randomized 2:1 to HM enabled post-implant (n = 908) or to conventional monitoring (CM; n = 431). Groups were compared between implant and prior to first scheduled IPE for IPE incidence, causes, and actionability (reprogramming, system revision, medication changes) and event detection time. HM and CM patients were similar (mean age 63 years, 72% male, LVEF 29%, primary prevention 73%, DDD 57%). In the post-implant interval assessed (HM 100 ± 21.3 days vs. CM 101 ± 20.8 days, P = 0.54), 85.4% (776/908) HM patients and 87.7% CM (378/431) patients had no cause for IPE (P = 0.31). When IPE occurred, actionability in HM (64/177 [36.2%]) was greater versus CM (15/62 [24.2%], P = 0.12). Actionable items were discovered sooner with HM (P = 0.025). Device reprogramming or lead revision was triggered following 53/177 (29.9%) IPEs in HM versus 9/62 (14.5%) in CM (P = 0.018). Arrhythmia detection was enhanced by HM: 276 atrial and ventricular episodes were detected in 135 follow-ups in contrast to CM (65 episodes at 17 IPEs). More silent arrhythmic episodes were discovered by HM (7.2% vs. 1.5% [P = 0.15]). Since 27/42 (64.3%) IPEs driven by HM alerts were actionable, event notification was a valuable method for problem detection. Importantly, HM did not increase incidence of non-actionable IPEs (P = 0.72). CONCLUSION: Activation of automatic remote monitoring should be encouraged soon post-ICD implant.

Periprocedural stroke and bleeding complications in patients undergoing catheter ablation of atrial fibrillation with different anticoagulation management: results from the Role of Coumadin in Preventing Thromboembolism in Atrial Fibrillation (AF) Patients Undergoing Catheter Ablation (COMPARE) randomized trial.

BACKGROUND: Periprocedural thromboembolic and hemorrhagic events are worrisome complications of catheter ablation for atrial fibrillation (AF). The periprocedural anticoagulation management could play a role in the incidence of these complications. Although ablation procedures performed without warfarin discontinuation seem to be associated with lower thromboembolic risk, no randomized study exists. METHODS AND RESULTS: This was a prospective, open-label, randomized, parallel-group, multicenter study assessing the role of continuous warfarin therapy in preventing periprocedural thromboembolic and hemorrhagic events after radiofrequency catheter ablation. Patients with CHADS2 score ≥1 were included. Patients were randomly assigned in a 1:1 ratio to the off-warfarin or on-warfarin arm. The incidence of thromboembolic events in the 48 hours after ablation was the primary end point of the study. The study enrolled 1584 patients: 790 assigned to discontinue warfarin (group 1) and 794 assigned to continuous warfarin (group 2). No statistical difference in baseline characteristics was observed. There were 39 thromboembolic events (3.7% strokes [n=29] and 1.3% transient ischemic attacks [n=10]) in group 1: two events (0.87%) in patients with paroxysmal AF, 4 (2.3%) in patients with persistent AF, and 33 (8.5%) in patients with long-standing persistent AF. Only 2 strokes (0.25%) in patients with long-standing persistent AF were observed in group 2 (P<0.001). Warfarin discontinuation emerged as a strong predictor of periprocedural thromboembolism (odds ratio, 13; 95% confidence interval, 3.1-55.6; P<0.001). CONCLUSION: This is the first randomized study showing that performing catheter ablation of AF without warfarin discontinuation reduces the occurrence of periprocedural stroke and minor bleeding complications compared with bridging with low-molecular-weight heparin. CLINICAL TRIAL REGISTRATION URL: http://www.clinicaltrials.gov. Unique identifier: NCT01006876.

Efficacy and safety of automatic remote monitoring for implantable cardioverter-defibrillator follow-up: the Lumos-T Safely Reduces Routine Office Device Follow-up (TRUST) trial.

BACKGROUND: Monitoring implantable cardiac device function and patient condition is important. The Lumos-T Safely Reduces Routine Office Device Follow-Up (TRUST) trial tested the hypothesis that remote home monitoring with automatic daily surveillance (HM) is safe and effective for implantable cardioverter-defibrillator follow-up for 1 year and enables rapid physician evaluation of significant events. METHODS AND RESULTS: In total, 1339 patients were randomized 2:1 to HM or conventional follow-up. Follow-up checks occurred at 3, 6, 9, 12, and 15 months after implantation. HM was used before office visits at 3 and 15 months in the HM group. At 6, 9, and 12 months, HM only was used but was followed by office visits if necessary. Conventional patients were evaluated with office visits only. Scheduled office visits and unscheduled evaluations, incidence of morbidity, and time elapsed from first event occurrence in each patient to physician evaluation were tracked for each group. HM and conventional patients were similar (age, 63.3+/-12.8 versus 64.0+/-12.1 years; gender, 72.0% versus 73.1% male; New York Heart Association class II, 55.9% versus 60.4%; pathology: left ventricular ejection fraction, 29.0+/-10.7% versus 28.5+/-9.8%; coronary artery disease, 64.8% versus 71.7%; primary prevention indication, 72.2% versus 73.8%; and dual-chamber implants, 57.8% versus 56.6%). HM reduced total in-hospital device evaluations by 45% without affecting morbidity. In the HM group, 85.8% of all 6-, 9-, and 12-month follow-ups were performed remotely only, indicating that HM provided sufficient assessment in the majority. Median time to evaluation was <2 days in the HM group compared with 36 days in the conventional group (P<0.001) for all arrhythmic events. CONCLUSIONS: HM is safe and allows more rapid detection of actionable events compared with conventional monitoring in patients with implantable electronic cardiac devices.

Periprocedural stroke and management of major bleeding complications in patients undergoing catheter ablation of atrial fibrillation: the impact of periprocedural therapeutic international normalized ratio.

BACKGROUND: Catheter ablation of atrial fibrillation is associated with the potential risk of periprocedural stroke, which can range between 1% and 5%. We developed a prospective database to evaluate the prevalence of stroke over time and to assess whether the periprocedural anticoagulation strategy and use of open irrigation ablation catheter have resulted in a reduction of this complication. METHODS AND RESULTS: We collected data from 9 centers performing the same ablation procedure with the same anticoagulation protocol. We divided the patients into 3 groups: ablation with an 8-mm catheter off warfarin (group 1), ablation with an open irrigated catheter off warfarin (group 2), and ablation with an open irrigated catheter on warfarin (group 3). Outcome data on stroke/transient ischemic attack and bleeding complications during and early after the procedures were collected. Of 6454 consecutive patients in the study, 2488 were in group 1, 1348 were in group 2, and 2618 were in group 3. Periprocedural stroke/transient ischemic attack occurred in 27 patients (1.1%) in group 1 and 12 patients (0.9%) in group 2. Despite a higher prevalence of nonparoxysmal atrial fibrillation and more patients with CHADS2 (congestive heart failure, hypertension, age >75 years, diabetes mellitus, and prior stroke or transient ischemic attack) score >2, no stroke/transient ischemic attack was reported in group 3. Complications among groups 1, 2, and 3, including major bleeding (10 [0.4%], 11 [0.8%], and 10 [0.4%], respectively; P>0.05) and pericardial effusion (11 [0.4%], 11 [0.8%], and 12 [0.5%]; P>0.05), were equally distributed. CONCLUSIONS: The combination of an open irrigation ablation catheter and periprocedural therapeutic anticoagulation with warfarin may reduce the risk of periprocedural stroke without increasing the risk of pericardial effusion or other bleeding complications.

Left atrial appendage: an underrecognized trigger site of atrial fibrillation.

BACKGROUND: Together with pulmonary veins, many extrapulmonary vein areas may be the source of initiation and maintenance of atrial fibrillation. The left atrial appendage (LAA) is an underestimated site of initiation of atrial fibrillation. Here, we report the prevalence of triggers from the LAA and the best strategy for successful ablation. METHODS AND RESULTS: Nine hundred eighty-seven consecutive patients (29% paroxysmal, 71% nonparoxysmal) undergoing redo catheter ablation for atrial fibrillation were enrolled. Two hundred sixty-six patients (27%) showed firing from the LAA and became the study population. In 86 of 987 patients (8.7%; 5 paroxysmal, 81 nonparoxysmal), the LAA was found to be the only source of arrhythmia with no pulmonary veins or other extrapulmonary vein site reconnection. Ablation was performed either with focal lesion (n=56; group 2) or to achieve LAA isolation by placement of the circular catheter at the ostium of the LAA guided by intracardiac echocardiography (167 patients; group 3). In the remaining patients, LAA firing was not ablated (n=43; group 1). At the 12+/-3-month follow-up, 32 patients (74%) in group 1 had recurrence compared with 38 (68%) in group 2 and 25 (15%) in group 3 (P<0.001). CONCLUSIONS: The LAA appears to be responsible for arrhythmias in 27% of patients presenting for repeat procedures. Isolation of the LAA could achieve freedom from atrial fibrillation in patients presenting for a repeat procedure when arrhythmias initiating from this structure are demonstrated.

Pulmonary-vein isolation for atrial fibrillation in patients with heart failure.

BACKGROUND: Pulmonary-vein isolation is increasingly being used to treat atrial fibrillation in patients with heart failure. METHODS: In this prospective, multicenter clinical trial, we randomly assigned patients with symptomatic, drug-resistant atrial fibrillation, an ejection fraction of 40% or less, and New York Heart Association class II or III heart failure to undergo either pulmonary-vein isolation or atrioventricular-node ablation with biventricular pacing. All patients completed the Minnesota Living with Heart Failure questionnaire (scores range from 0 to 105, with a higher score indicating a worse quality of life) and underwent echocardiography and a 6-minute walk test (the composite primary end point). Over a 6-month period, patients were monitored for both symptomatic and asymptomatic episodes of atrial fibrillation. RESULTS: In all, 41 patients underwent pulmonary-vein isolation, and 40 underwent atrioventricular-node ablation with biventricular pacing; none were lost to follow-up at 6 months. The composite primary end point favored the group that underwent pulmonary-vein isolation, with an improved questionnaire score at 6 months (60, vs. 82 in the group that underwent atrioventricular-node ablation with biventricular pacing; P<0.001), a longer 6-minute-walk distance (340 m vs. 297 m, P<0.001), and a higher ejection fraction (35% vs. 28%, P<0.001). In the group that underwent pulmonary-vein isolation, 88% of patients receiving antiarrhythmic drugs and 71% of those not receiving such drugs were free of atrial fibrillation at 6 months. In the group that underwent pulmonary-vein isolation, pulmonary-vein stenosis developed in two patients, pericardial effusion in one, and pulmonary edema in another; in the group that underwent atrioventricular-node ablation with biventricular pacing, lead dislodgment was found in one patient and pneumothorax in another. CONCLUSIONS: Pulmonary-vein isolation was superior to atrioventricular-node ablation with biventricular pacing in patients with heart failure who had drug-refractory atrial fibrillation. (ClinicalTrials.gov number, NCT00599976.)

Visually-guided balloon catheter ablation of atrial fibrillation: experimental feasibility and first-in-human multicenter clinical outcome.

BACKGROUND: Electric isolation of the pulmonary veins (PVs) can successfully treat patients with paroxysmal atrial fibrillation. However, it remains technically challenging to identify the left atrial-PV junction and sequentially position the ablation catheter in a point-by-point contiguous fashion to isolate the PVs. In this study, a novel endoscopic ablation system was used to directly visualize and ablate tissue at the left atrial-PV junction with laser energy. METHODS AND RESULTS: This study consisted of 2 phases: a short-term (n=9) and long-term (n=11) canine experimental validation phase and a multicenter clinical feasibility phase (n=30 paroxysmal atrial fibrillation patients). After transseptal puncture, the balloon-based endoscopic ablation system was advanced to each PV ostium, and arcs of laser energy (90 degrees to 360 degrees ) were projected onto the target left atrial-PV junction. Electric PV isolation was defined with a circular multielectrode catheter. In the short-term preclinical experimental phase, 15 of 17 targeted PVs (88%) were successfully isolated. Pathological examination revealed well-demarcated circumferential lesions with minimal endothelial disruption. In the long-term experiments, 9 of 10 targeted veins (90%) remained persistently isolated (at 4 to 8 weeks). In the clinical phase, 105 of 116 PVs (91%) were successfully isolated. After a single procedure, the 12-month drug-free rate of freedom from atrial fibrillation was 60% (18 of 30 patients). There were no significant PV stenoses, but adverse events included 1 episode of cardiac tamponade, 1 stroke without residual defect, and 1 asymptomatic phrenic nerve palsy. CONCLUSIONS: This study establishes the feasibility of a novel paradigm for AF ablation: direct visualization to guide catheter ablation of the left atrial-PV junction.

Left atrial appendage tip: an unusual site of successful ablation after failed endocardial and epicardial mapping and ablation.

Uncommon sites of ablation for arrhythmias can be the cause of failed ablations. This series includes 4 cases requiring ablation at the tip of the left atrial appendage after both endocardial and epicardial mapping and ablation failed.

Higher rate of recurrent atrial flutter and atrial fibrillation following atrial flutter ablation after cardiac surgery.

INTRODUCTION: Atrial flutter (AFL) is common after cardiac surgery. However, the types of post-cardiac surgery AFL, its response to catheter-based radiofrequency ablation, and its relationship to atrial fibrillation (AF) are unknown. METHODS AND RESULTS: We retrospectively studied all patients who underwent mapping and ablation for AFL after cardiac surgery from January 1990 to July 2004. One hundred randomly selected patients without prior cardiac surgery (PCS) who underwent mapping and ablation of AFL served as the control population. A total of 236 patients formed the study population (mean age 62 + 13 years, 22% female) and 100 patients formed the control population (mean age 60 + 13 years, 25% female). The majority of patients without PCS had cavo-tricuspid isthmus (CTI)-dependent AFL when compared to patients with PCS (93% vs 72%, respectively, P < 0.0001). In contrast, scar-related AFL was more common in patients with PCS as compared to patients without PCS (22% vs 3%, P < 0.0001). Predictors of scar related AFL in multivariable regression analysis included PCS and left-sided AFL. Acute success rates and complications were similar between the groups. When compared to patients with AFL ablation without PCS, those that had AFL after PCS had higher rates of recurrence of both AFL (1% vs 12%, P < 0.0001; mean time to recurrence 1.85 years) and AF (16% vs 28%, P = 0.02; mean time to recurrence 2.67 years). CONCLUSION: Despite ablation of AFL, patients with PCS have a higher rate of AFL and AF when compared to patients without PCS who underwent ablation of atrial flutter during long-term follow-up.

Long-term functional and neurocognitive recovery in patients who had an acute cerebrovascular event secondary to catheter ablation for atrial fibrillation.

INTRODUCTION: Cerebral thromboembolic event (CTE) is a possible complication of pulmonary vein antrum isolation (PVAI). The objective of this study was to report long-term functional and neurocognitive recovery in patients who had a CTE during or within 48 hours of catheter ablation. METHODS AND RESULTS: We screened 3,060 patients who underwent PVAI between January 2000 and June 2007. Out the 3,060 patients, 26 patients (0.8%) (61 +/- 8 years, 88% males) had a CTE during or within 48 hours of the procedure. We followed these 26 patients (study group) over time and assessed their functional and neurocognitive recovery status. No preferential vascular territory for the site of obstruction was found; right anterior circulation-5 patients (26%), left anterior circulation-5 patients (26%), posterior circulation-3 patients (16%), and 2 or more territories-6 patients (32%), (P-value = 0.8). The average international normalized ratio at the time of CTE was 1.33 +/- 0.4. Two patients died during the study period. At the end of 38.4 +/- 24 months follow-up, most surviving patients had complete neurocognitive and functional recovery irrespective of the severity of periprocedural stroke. CONCLUSIONS: Periprocedural stroke in the setting of catheter ablation for atrial fibrillation is relatively rare. When it occurs, complete functional and neurocognitive recovery over time is the likely outcome for most patients.

The impact of statins and renin-angiotensin-aldosterone system blockers on pulmonary vein antrum isolation outcomes in post-menopausal females.

AIMS: To assess whether treatment with statins or renin-angiotensin-aldosterone system (RAAS) inhibitors as potential procedural 'augmenting agents' improved atrial fibrillation (AF) catheter ablation recurrence rates in post-menopausal females (PMFS). METHODS AND RESULTS: Five hundred and eighteen consecutive female patients had undergone AF catheter ablation from January 2005 to May 2008. Post-menopausal females were selected and procedure outcomes were compared between cohorts of PMFS treated with statins or RAAS inhibitors to untreated PMFS. Out of 408 PMFS, 36 (8.8%) were treated with a combination of RAAS inhibitors and statins, thus were excluded leaving a total of 372 (91.2%) patients in the study. Out of 372 patients, 111 (29.8%) were on statins (Group 1), 59 (15.9%) on RAAS inhibitors (Group 2), and 202 (54.3%) without RAAS inhibitors or statins [(Group 3) control population]. Over a mean follow-up time of 24 +/- 8.3 (median 25) months, 78 (70.6%) in Group 1, 38 (65.4%) in Group 2, and 139 (68.8%) in Group 3 had procedural success. Statin or RAAS inhibitor use did not predict lower recurrence rates [hazard ratio (HR): 1.26, P = 0.282 and HR: 1.14, P = 0.728, respectively]. When compared with controls, no difference in the cumulative incidence of recurrence was found with statin or RAAS inhibitors use (P = 0.385 and P = 0.761, respectively). CONCLUSION: Treatment with statins or RAAS inhibitors did not improve catheter ablation success rates among PMFS. Thereby, from a clinical standpoint, PMFS should not be started on these treatments as a procedural 'augmenting agent' at this time.

The impact of myocardial viability on the clinical outcome of cardiac resynchronization therapy.

INTRODUCTION: Around 30% of patients do not respond to cardiac resynchronization therapy (CRT). Nonischemic cardiomyopathy has been identified as an independent predictor of response to CRT, probably due to the absence of compact scar. METHODS AND RESULTS: The relationship between cardiac scar, ischemia, and hibernation (both at the left-ventricular pacing site and as a total burden) and response to CRT was studied in patients with ischemic cardiomyopathy using the perfusion-viability positron emission tomography (PET) test. Sixty-six patients with ischemic cardiomyopathy and traditional criteria for CRT were included. All patients underwent PET scan prior to CRT. Using PET, the amount and location of scarred, ischemic, and hibernating myocardium were characterized. No revascularization was indicated. Responders were defined by an improvement of left-ventricular ejection fraction (LVEF) >or= 5% and/or New York Heart Association (NYHA) class >or= 1 degree. During a mean follow-up of 26.2 +/- 22.2 months, there was a significant improvement in NYHA class and reverse remodeling in patients with the LV lead inserted remotely from the scar. However, reverse remodeling of a similar degree was present also in patients with extensive scarring including the lateral wall. The presence of ischemia, hibernation, or nontransmural scar at the pacing-site did not significantly modify the outcome of CRT as compared with viable myocardium. There were only 38% of CRT-nonresponders. Neither the extent of scar, ischemia, hibernation, or viability predicted outcome or mortality. Twenty patients died during the follow-up, one patient underwent heart transplant. CONCLUSIONS: At follow-up, response to CRT is observed regardless of the presence of extensive scarring. Left ventricular (LV) pacing at sites with ischemia, hibernation, or nontransmural scar does not appear to modify the effect of CRT as compared to viable tissue.

Relationship between catheter forces, lesion characteristics, "popping," and char formation: experience with robotic navigation system.

INTRODUCTION: Popping, char and perforation are complications that can occur following catheter ablation. We measured the amount of grams (g) applied to the endocardium during ablation using a sensor incorporated in the long sheath of a robotic system. We evaluated the relationship between lesion formation, pressure, and the development of complications. METHODS: Using a robotic navigation system, lesions were placed in the left atrium (LA) at six settings, using a constant duration (40 seconds) and flow rate of either 17 cc/min or 30 cc/min with an open irrigated catheter (OIC). Evidence of complications was noted and lesion location recorded for later analysis at necropsy. RESULTS: Lesions using 30 Watts (W) were more likely to be transmural at higher (>40 g) than lower (<30 g) pressures (75% vs 25%, P < 0.001). Significantly higher number of lesions using >40 g of pressure demonstrated "popping" and crater formation as compared with lesions with 20-30 g of pressure (41% vs 15%, P = 0.008). A majority of lesions placed using higher power (45 W) with higher pressures (>40 g) were associated with char and crater formation (66.7%). No lesions using 10 g of pressure were transmural, regardless of the power. Lesions placed with a power setting less than 35 W were more likely to result in "relative" sparing of the endocardial surface than lesions at a power setting higher than 35 W (62% vs 33.3%, P = 0.02) regardless of the pressure. CONCLUSIONS: When using an OIC, lower power settings (

The magnitude of reverse remodelling irrespective of aetiology predicts outcome of heart failure patients treated with cardiac resynchronization therapy.

AIMS: We assessed the relationship between cardiac resynchronization therapy (CRT)-induced reverse remodelling and mortality during a long-term follow-up in a prospective observational study. METHODS AND RESULTS: We analyzed data from a prospective registry including 398 consecutive patients who underwent CRT between September 1998 and September 2007. Left ventricular ejection fraction (LVEF) was assessed before CRT and in the period between 3 and 6 months following implant. All-cause mortality, urgent transplantation and implantation of left ventricular assist device were all considered relevant events. A total of 398 (179 non-ischaemic and 219 ischaemic) patients were analysed. Overall, the increase of LVEF was statistically significant and was computed with 7.0 points (95% CI 5.8-8.3, P < 0.001). Non-ischaemic patients had a larger increase [9.2 points (95% CI 7.0-11.1), P < 0.001] of their LVEF from baseline, when compared with the ischaemic group. The median duration of follow-up was 4.4 years. The cumulative incidence of all events at the end of the 96 months period of follow-up was 55% and it was 34% (95% CI 29-40) at 5 years. At the multivariable analysis of the event-free survival, aetiology lost its predictive value (HR 0.92, P = 0.47), while a change in LVEF >or=6 points still significantly decreased the risk of event during the follow-up (HR 0.30, P = 0.001). CONCLUSION: Reverse remodelling measured by LVEF after 3 months is a good predictor of long-term outcome. Patients with an increase in LVEF >or=6 points have an excellent event-free survival approaching 66% at 5 years of follow-up.

Atrial fibrillation ablation in patients with therapeutic international normalized ratio: comparison of strategies of anticoagulation management in the periprocedural period.

BACKGROUND: The best approach to management of anticoagulation before and after atrial fibrillation ablation is not known. METHODS AND RESULTS: We compared outcomes in consecutive patients undergoing pulmonary vein antrum isolation for persistent atrial fibrillation. Early in our practice, warfarin was stopped 3 days before ablation, and a transesophageal echocardiogram was performed to rule out clot. Enoxaparin, initially 1 mg/kg twice daily (group 1) and then 0.5 mg/kg twice daily (group 2), was used to "bridge" patients after ablation. Subsequently, warfarin was continued to maintain the international normalized ratio between 2 and 3.5 (group 3). Minor bleeding was defined as hematoma that did not require intervention. Major bleeding was defined as either cardiac tamponade, hematoma that required intervention, or bleeding that required blood transfusion. Pulmonary vein ablation was performed in 355 patients (group 1=105, group 2=100, and group 3=150). More patients had spontaneous echocardiographic contrast in groups 1 and 2. One patient in group 1 had an ischemic stroke compared with 2 patients in group 2 and no patients in group 3. In group 1, 23 patients had minor bleeding, 9 had major bleeding, and 1 had pericardial effusion but no tamponade. In group 2, 19 patients had minor bleeding, and 2 patients developed symptomatic pericardial effusion with need for pericardiocentesis 1 week after discharge. In group 3, 8 patients developed minor bleeding, and 1 patient developed pericardial effusion with no tamponade. CONCLUSIONS: Continuation of warfarin throughout pulmonary vein ablation without administration of enoxaparin is safe and efficacious. This strategy can be an alternative to bridging with enoxaparin or heparin in the periprocedural period.

Anatomic location of pulmonary vein electrical disconnection with balloon-based catheter ablation.

INTRODUCTION: Balloon-based catheters are an emerging technology in catheter ablation for atrial fibrillation, which aim to achieve consistent and rapid ablation encirclement of pulmonary veins (PVs). Recent emphasis has been placed on achieving more proximal electrical isolation within the PV-left atrial (LA) junction. We sought to evaluate the precise anatomic level of PV electrical disconnection with current design balloon-based catheters. METHODS AND RESULTS: Thirteen patients with drug-refractory paroxysmal atrial fibrillation undergoing balloon catheter ablation with the endoscopic laser system (CardioFocus) or the high frequency-focused ultrasound system (ProRhythm) underwent electroanatomic mapping (EAM) of the left atrium. Intracardiac echocardiographic (ICE) imaging was used for visualization of the position of the balloon catheter during energy delivery. Detailed point analysis of the location of electrical disconnection was then documented on EAM and with ICE. Successful electrical isolation was achieved in all 52 PVs. Despite ICE imaging confirming balloon catheter position at the antrum of the PVs, the location of electrical disconnection was demonstrated to be at or near the tubular ostium of the PVs on EAM and on ICE in all patients. CONCLUSION: Current generation balloon-based catheter ablation achieves electrical isolation distal in the LA-PV junction. This may limit the results of such systems in treating nonparoxysmal forms of atrial fibrillation.

Low incidence of left atrial or left atrial appendage thrombus in patients with paroxysmal atrial fibrillation and normal EF who present for pulmonary vein antrum isolation procedure.

INTRODUCTION: The incidence of left atrial appendage (LAA) thrombus in patients with paroxysmal atrial fibrillation (PAF) who present for pulmonary vein antrum isolation procedure (PVAI) is unknown. METHODS AND RESULTS: All consecutive patients from January 2000 to June 2004 who underwent a PVAI received a computed tomography (CT) to evaluate LAA thrombus before the procedure and 3 months post-PVAI. All patients were followed prospectively. One thousand two hundred twenty-one patients received a PVAI during the study dates. All patients received a CT pre-PVAI at 3 months, and 601 (49%) received a transesophageal echocardiography (TEE) pre-PVAI. Per protocol, all patients who had CT scans that were positive for LAA thrombus received a TEE. There were 9 patients who had LAA thrombus on CT scan, but only 3 had LAA thrombus on TEE. Using TEE as the gold standard, only 3 patients had an LAA thrombus before PVAI; of these patients, 2 had chronic AF with average ejection fraction (EF) of 48% and 1 patient had PAF with EF 25%. No patients with PAF and normal EF had LAA thrombus. Patients with LAA thrombus pre-PVAI had lower EF than patients without LAA thrombus (40% vs. 53%, P = 0.007) but had similar LA size (5.0 vs. 4.5 cm, P = 0.77). No other differences in baseline characteristics were noted. CONCLUSIONS: In this registry of 1,221 patients, we did not observe LA thrombus in PAF patients with normal EF who present for PVAI. Prescreening CT alone is likely to be sufficient in paroxysmal AF patients with normal EF, and the use of TEE may not be needed.