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Background: The precise reasons for failure to cannulate the coronary sinus during biventricular device implantation are unknown. Visualization of the coronary sinus ostium during electrophysiology procedures may enhance understanding of how unusual anatomy can affect successful cannulation of the coronary sinus. Objectives: The aim of this study was to describe the morphology of valves at the coronary sinus ostium (CSO) visualized directly with an illuminated fiberoptic endoscope during implantation of biventricular devices. Methods: The coronary sinus anatomy of one hundred consecutive patients undergoing implantation of biventricular devices was investigated using a fiberoptic endocardial visualization catheter (EVC). Results: The CSO was clearly visualized in 98 patients using the EVC. A Thebesian valve was seen in 54% of these. Almost all Thebesian valves were positioned at the inferior (61%) or posterior (33%) aspect of the CSO. Only six patients had Thebesian valves that covered more than 70% of the CSO, but all were successfully implanted with a transvenous left ventricular pacing lead after cannulating the coronary sinus under direct visualization. Conclusions: Over half of patients undergoing biventricular device implantation have identifiable Thebesian valves. Even valves covering the majority of the ostial area may be traversed using direct visualization and modern catheterization techniques. [ABSTRACT FROM AUTHOR]

A prospective study evaluating the functionality and ease of use of the Medtronic CareLink Network, 'CareLink,' was conducted at ten investigational sites. This internet-based remote monitoring service allows clinicians to remotely manage their patients' implantable cardioverter defibrillators (ICDs) and chronic diseases. The network is comprised of a patient monitor, a secure server, and clinician and patient websites. Under clinician direction, patients interrogated their ICDs at home, and transmitted data to secure servers via a standard telephone line. Comprehensive device data and a 10-second presenting rhythm electrogram were captured by the monitor and available for access and review on the clinician website. The information could also be printed using a standard desktop computer with internet access. During this study, patients were asked to transmit device data twice, at least 7 days apart, as scheduled by the clinic. Monitor functionality was assessed, and ease of using the system components was evaluated via questionnaires completed by patients and clinicians following each data transmission and review. Fifty-nine patients (64 +/- 14 years, range 22-85 years) completed 119 transmissions with only 14 calls to the study support center. Clinician review of data transmissions revealed several clinically significant findings, including silent AF discovery, assessment of antiarrhythmic drug efficacy in a previously diagnosed AF patient, previously unobserved atrial undersensing, and ventricular tachycardia. ICD patients found the monitor easy to use. Clinicians were pleased with the performance of the network and the quality of the web-accessed data, and found it comparable to an in-office device interrogation. CareLink is a practical tool for routine device management and may allow timely identification of clinically important issues. [ABSTRACT FROM AUTHOR]

Background: Little is known about the very long term durability of atrial fibrillation (AF) ablation., Objective: The purpose of this study was to evaluate very long term AF ablation outcomes., Methods: We followed 5200 patients undergoing 7145 ablation procedures. We evaluated outcomes after single and multiple ablation procedures for paroxysmal (PAF; 33.6%), persistent (PeAF; 56.4%), and long-standing (LsAF; 9.9%) AF. We compared 3 ablation eras by initial ablation catheter: early (101 patients) using solid big tip (SBT) catheters (October 2003 to December 2005), intermediate (2143 patients) using open irrigated tip (OIT) catheters (December 2005 to August 2016), and contemporary (2956 patients) using contact force (CF) catheters (March 2014 to December 2021)., Results: AF freedom at 5, 10, and 15 years was as follows: initial ablation: PAF 67.8%, 56.3%, 47.6%; PeAF 46.6%, 35.6%, 26.5%; and LsAF 30.4%, 18.0%, 3.4%; final ablation: PAF 80.3%, 72.6%, 62.5%; PeAF 60.1%, 50.2%, 42.5%; and LsAF 43.4%, 32.0%, 20.6%. For PAF and PeAF, CF ablation procedures were better than OIT ablation procedures (P < .0001) and both were better than SBT ablation procedures (P < .001). LsAF had no outcome improvement over the eras. The 8-year success rate after final ablation for CF, OIT, and SBT catheter eras was as follows: PAF 79.1%, 71.8%, 60.0%; PeAF 55.9%, 50.7%, 38.0%; and LsAF 42.7%, 36.2%, 31.8%. Highest AF recurrence was in the first 2 years, with a 2- to 15-year recurrence of 2%/yr. Success predictors after initial and final ablation procedures were younger age, smaller left atrium, shorter AF duration, male sex, less persistent AF, lower CHA 2 DS 2 -VASc score, fewer drugs failed, and more recent catheter era., Conclusion: After year 2, there is 2%/yr recurrence rate for all AF types. Ablation success is best in the CF catheter era, intermediate in the OIT era, and worst in the SBT era. Over the ablation eras, outcomes improved for PAF and PeAF but not for LsAF. We should follow patients indefinitely after ablation. We need an understanding of how to better ablate more persistent AF., (Copyright © 2023 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)

The mobile cardiac acoustic monitoring system is a promising tool to enable detection and assist the diagnosis of left ventricular systolic dysfunction (LVSD). The objective of the study was to evaluate the diagnostic value of electromechanical activation time (EMAT), an important cardiac acoustic biomarker, in quantifying LVSD among left bundle branch pacing (LBBP) and right ventricular apical pacing (RVAP) patients using a mobile acoustic cardiography monitoring system. In this prospective single-center observational study, pacemaker-dependent patients were consecutively enrolled. EMAT, the time from the start of the pacing QRS wave to first heart sound (S1) peak; left ventricular systolic time (LVST), the time from S1 peak to S2 peak; and ECG were recorded simultaneously by the mobile cardiac acoustic monitoring system. LVEF was measured by echocardiography. A logistic regression model was applied to evaluate the association between EMAT and reduced EF (LVEF < 50%). A total of 105 pacemaker-dependent patients participated. The RVAP group (n = 58) displayed a significantly higher EMAT than the LBBP group (n = 47) (150.95 ± 19.46 vs. 108.23 ± 12.26 ms, p < 0.001). Pearson correlation analysis revealed a statistically significant negative correlation between EMAT and LVEF (p < 0.001). Survival analysis showed the sensitivity and specificity of detecting LVEF to be < 50% when EMAT ≥ 151 ms were 96.00% and 96.97% in the RVAP group. In LBBP patients, the sensitivity and specificity of using EMAT ≥ 110 ms as the cutoff value for the detection of LVEF < 50% were 75.00% and 100.00%. There was no significant difference in LVST with or without LVSD in the RVAP group (p = 0.823) and LBBP group (p = 0.086). Compared to LVST, EMAT was more helpful to identify LVSD in pacemaker-dependent patients. The cutoff point of EMAT for diagnosing LVEF < 50% differed regarding the pacing type. Therefore, the mobile cardiac acoustic monitoring system can be used to identify the progress of LVSD in pacemaker patients.

Objectives: This first-in-human feasibility study was undertaken to translate the novel low-voltage MultiPulse Therapy (MPT) (Cardialen, Inc., Minneapolis, Minnesota), which was previously been shown to be effective in preclinical studies in terminating atrial fibrillation (AF), into clinical use., Background: Current treatment options for AF, the most common arrhythmia in clinical practice, have limited success. Previous attempts at treating AF by using implantable devices have been limited by the painful nature of high-voltage shocks., Methods: Forty-two patients undergoing AF ablation were recruited at 6 investigational centers worldwide. Before ablation, electrode catheters were placed in the coronary sinus, right and/or left atrium, for recording and stimulation. After the induction of AF, MPT, which consists of up to a 3-stage sequence of far- and near-field stimulation pulses of varied amplitude, duration, and interpulse timing, was delivered via temporary intracardiac leads. MPT parameters and delivery methods were iteratively optimized., Results: In the 14 patients from the efficacy phase, MPT terminated 37 of 52 (71%) of AF episodes, with the lowest median energy of 0.36 J (interquartile range [IQR]: 0.14 to 1.21 J) and voltage of 42.5 V (IQR: 25 to 75 V). Overall, 38% of AF terminations occurred within 2 seconds of MPT delivery (p < 0.0001). Shorter time between AF induction and MPT predicted success of MPT in terminating AF (p < 0.001)., Conclusions: MPT effectively terminated AF at voltages and energies known to be well tolerated or painless in some patients. Our results support further studies of the concept of implanted devices for early AF conversion to reduce AF burden, symptoms, and progression., Competing Interests: Funding Support and Author Disclosures This study was supported by Cardialen Inc., Minneapolis, Minnesota; Medtronic Plc., Dublin, Ireland; and the National Heart, Lung, and Blood Institute of the National Institutes of Health under award number 1 R43 HL107055-01. Dr. Ng was supported by the National Institute of Health Research (NIHR) (Clinical Lectureship 1716) and British Heart Foundation (RG/16/3/32175). Drs. Ng, Qureshi, and Peters were supported the Imperial College Centre for Cardiac Engineering and the NIHR Imperial Biomedical Research Centre. Drs. Ng, Mead, Peters and Efimov have or had consulting agreements with Cardialen. Mr. Shelton and Drs. Bourn and Sharma are current or former employees of Cardialen. Drs. Efimov and Peters are shareholders of Cardialen. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2021 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: The clinical effectiveness of ablating non-paroxysmal atrial fibrillation (non-PAF) relies on proper patient selection. We developed and validated a scoring system to predict non-PAF ablation outcomes., Methods: Data on 416 non-PAF ablations were analysed using binary logistic regression at a London centre. Identified preprocedural variables, which independently predicted freedom from atrial tachyarrhythmia. Twenty-one possible predictive variables and a model with c-statistic 0.751-explained outcome variation in London at mean follow-up 12±3 months. An additive point score (range 0-9) was developed-the FLAME score: female=1; long-lasting persistent atrial fibrillation=1; left atrial diameter in mm: 40 to <45 = 1, 45 to <50 = 2, 50 to <55=3, ≥55 =4; mitral regurgitation (MR) mild to moderate=1; extreme comorbidity=2. Extreme comorbidities include severe MR, moderate mitral stenosis, mitral replacement, hypertrophic cardiomyopathy or congenital heart disease., Results: The FLAME score was applied to data (882 non-PAF ablations) at a Californian centre, and predicted the outcome of both single (p<0.0001) and multiple (p<0.0001) procedures. For first ablation (follow-up 2.1 years (median, IQR 1.0-4.1)), FLAME score: 0-1 predicts 62% success, 2-4 44% and ≥5 29% (P trend <0.0001). After the final ablation (mean procedures: 1.4±0.6, follow-up 1.8 years (median, IQR 0.8-3.6)), FLAME score: 0-1 predicts 81% success, 2-4 65% and ≥5 44% (P trend <0.0001)., Conclusions: FLAME score is easily calculated, derived in London, and predicted single and multiple procedural outcomes for non-PAF ablations in California. In patients with a high score, even multiple procedures are usually ineffective., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Little is known about the long-term outcomes and predictors of success of high-power, short-duration (HPSD) contact force (CF) atrial fibrillation (AF) ablations., Objective: The purpose of this study was to determine long-term freedom from AF and predictors of freedom from AF for 50-W, 5- to 15-second CF ablation., Methods: We examined 4-year outcomes and predictors of freedom from AF after AF ablation for 1250 consecutive patients undergoing HPSD CF ablations., Results: Patient demographics were age 66.6 ± 10.5 years, female 30.9%, left atrial (LA) size 4.26 ± 0.66 cm, paroxysmal AF 35.7%, persistent AF 56.6%, and longstanding AF 7.7%. Initial ablation times were procedure 114.2 ± 45.9 minutes, fluoroscopy 15.5 ± 11.5 minutes, and total radiofrequency 20.6 ± 7.7 minutes. TactiCath was used in 47.7%, SmartTouch in 52.3%, and posterior wall isolation (PWI) was performed in 34%. Four-year freedom from AF after multiple ablations were paroxysmal AF 87.0%, persistent AF 71.9%, and longstanding AF 64.9%. Single procedure success was 74.9% for TactiCath, 64.7% for SmartTouch (P <.001), and 73.0% for no PWI vs 58.9% for PWI (P <.0001). PWI did not change outcomes for paroxysmal AF but had worse outcomes for nonparoxysmal AF. Multivariate analysis showed 6 independent predictors of worse outcome after initial ablation: older age (P = .014), female gender (P <.0001), persistent AF (P = .0001), larger LA size (P <.001), PWI (P = .049), and use of SmartTouch vs TactiCath catheter (P = .007). Redo ablations were performed in 13.8%, and the outcome was better when more veins had reconnected after the initial ablation and when AF was paroxysmal., Conclusion: Analysis revealed 6 independent predictors of outcome for HPSD CF. At redo ablations, the outcome was better if more veins had reconnected and could be re-isolated., (Copyright © 2020 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)

Background: Heart failure is a major health concern and often requires echocardiography to confirm the diagnosis. We introduce a new method that uses a wearable heart sound and electrocardiogram (ECG) device that can be used in the outpatient setting., Objective: The purpose of this study was to determine the value of synchronized analysis of heart sounds and ECG in identifying patients with depressed left ventricular ejection fraction (dLVEF) <50%., Methods: One hundred eighty-nine patients (76 with dLVEF; 113 with normal ejection fraction) were enrolled. All were admitted to the hospital because of dyspnea or chest discomfort. N-Terminal pro-B-type natriuretic peptide (NT-proBNP) was measured in all patients. LVEF was determined by echocardiography. Heart sound and ECG signals were simultaneously recorded using the wearable synchronized phonocardiogram and ECG device. Heart sound and ECG signals were automatically analyzed using wavelet analysis and utilized to determine electromechanical activation time (EMAT), EMAT/RR, S1-S2 time, and S1-S2/RR., Results: EMAT in the dLVEF group was significantly higher than that in the control group (159.82 ± 83 ms vs 91.58 ± 28 ms). Pearson correlation test showed a negative correlation between EMAT and LVEF (r = -0.449; P <.001). Receiver operating characteristic curve analysis demonstrated that the sensitivity and specificity of EMAT ≥104 ms for the diagnosis of EF <50% were 92.1% and 92%, respectively. Patients with intermediate NT-proBNP values were identified as dLVEF by EMAT ≥104 ms, with sensitivity of 93.5% and specificity of 92.8%., Conclusion: The heart sound and ECG signal index EMAT contributes to the diagnosis of EF <50% and is especially helpful in patients with an inconclusive NT-proBNP value., (Copyright © 2020 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)

Purpose: To compare findings in patients undergoing atrial fibrillation(AF) and/or atrial flutter(AFl) ablation after failed cut and sew (CS) vs. non-cut and sew (NCS) surgical maze., Methods: We compared 10 patients with prior CS to 25 with prior NCS maze undergoing catheter ablation after failed maze., Results: Patient demographics: Age 68.3 ± 8.7 CS vs. 68.2 ± 9.2 NCS(P = 0.977), male 70% CS vs. 72% NCS(P = 1.000), LA size 5.11 ± 0.60 cm CS vs. 4.54 ± 0.92 cm NCS(P = 0.096), sternotomy 100% CS vs. 64% of NCS(P = 0.036). Concomitant heart surgery in 100% CS and 68% NCS(P = 0.073). NCS used radiofrequency 84%, cryoablation 8%, microwave 4%, and ultrasound 4%. All maze operations targeted pulmonary vein (PV) isolation. The maze also targeted the mitral isthmus 100% CS vs. 36% NCS(P = 0.001) and the tricuspid isthmus 90% CS vs. 40% NCS (P = 0.018). Maze failure arrhythmia mechanism was AF 0% CS and 56% NCS (P = 0.0006). Nine CS pts failed for AFl and 1 for RA tachycardia. For NCS pts, 11 failed for AFl. CS isolated 94% of PVs and NCS isolated only 26% of PVs (P < 0.0005). At EPS, clinical and induced arrhythmias were ablated and non-isolated PVs were isolated. After final ablation, arrhythmia-free rates were 60% for CS and 52% for NCS (P = 0.723) after 2.99 ± 2.35 years., Conclusions: After failed surgical maze, CS isolated nearly all PVs and NCS never isolated all PVs and the clinical rhythm was more frequently AF for NCS and AFl for CS. CS remains the surgical gold standard for durable PV isolation.

Background: Many centers use radiofrequency (RF) energy at 25-35 W for 30-60 seconds. There is a safety concern about using higher power, especially on the posterior wall., Objective: The purpose of this study was to examine complication rates for atrial fibrillation (AF) ablations performed with high-power, short-duration RF energy., Methods: We examined the complication rates of 4 experienced centers performing AF ablations at RF powers from 45-50 W for 2-15 seconds per lesion. In total, 13,974 ablations were performed in 10,284 patients. On the posterior wall, 11,436 ablations used 45-50 W for 2-10 seconds, and 2538 ablations used power reduced to 35 W for 20 seconds. Esophageal temperature monitoring was used in 13,858 (99.2%)., Results: Demographics were age 64 ± 11 years, male 68%, left atrial size 4.4 ± 0.7 cm, paroxysmal AF 37%, persistent AF 42%, longstanding AF 20%, antiarrhythmic drugs failed 1.4 ± 0.7, hypertension 54%, diabetes 15%, previous cerebrovascular accident/transient ischemic attack 7%, and CHA 2 DS 2 -VASc score 2.1 ± 1.4. Procedural time was 116 ± 41 minutes. Complications were death in 2 (0.014%; 1 due to stroke and 1 due to atrioesophageal fistula), pericardial tamponade in 33 (0.24%; 26 tapped, 7 surgical), strokes <48 hours in 6 (0.043%), strokes 48 hours-30 days in 6 (0.043%), pulmonary vein stenosis requiring intervention in 2 (0.014%), phrenic nerve paralysis in 2 (0.014%; both resolved), steam pops 2 (0.014%) without complications, and catheter char 0 (0.00%). There was 1 atrioesophageal fistula in 11,436 ablations using power 45-50 W on the posterior wall and 3 in 2538 ablated with 35 W on the posterior wall (P = .021), although 2 of the 3 had no esophageal monitoring during a fluoroless procedure., Conclusion: AF ablations can be performed at 45-50 W for short durations with very low complication rates. High-power, short-duration ablations have the potential to shorten procedural and total RF times and create more localized and durable lesions., (Copyright © 2018 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: There is an association between obesity and atrial fibrillation (AF). The impact of obesity on AF ablation procedures is unclear., Objective: The purpose of this study was to evaluate the influence of body mass index (BMI) on patient characteristics, long-term ablation outcomes, and procedural complications., Methods: We evaluated 2715 patients undergoing 3742 AF ablation procedures. BMI was ≥30 kg/m 2 in 1058 (39%) and ≥40 kg/m 2 in 129 (4.8%). Patients were grouped by BMI ranges (<25, 25-<30, 30-<35, 35-<40, and ≥40 kg/m 2 )., Results: As BMI increased from <25 to ≥40 kg/m 2 , age decreased from 65.3 ± 11.2 to 61.2 ± 9.2 years (P < .001), left atrial size increased from 3.91 ± 0.68 to 4.72 ± 0.62 cm (P < .005), and CHADS 2 scores increased from 1.24 ± 1.10 to 1.62 ± 1.09 (P < .001). As BMI increased, paroxysmal AF decreased from 48.0% to 16.3% (P < .0001) and there was an increase in dilated cardiomyopathy (from 7.6% to 12.4%; P < .0001), hypertension (from 41.0% to 72.9%; P < .0001), diabetes (from 4.3% to 23.3%; P < .0001), and sleep apnea (from 7.0% to 46.9%; P < .0001). For the entire cohort, for BMI ≥35 kg/m 2 the 5-year ablation freedom from AF decreased from 67%-72% to 57% (P = .036). For paroxysmal AF, when BMI was ≥40 kg/m 2 ablation success decreased from 79%-82% to 60% (P = .064), and for persistent AF, when BMI was ≥35 kg/m 2 ablation success decreased from 64%-70% to 52%-57% (P = .021). For long-standing AF, there was no impact of BMI on outcomes (P = .624). In multivariate analysis, BMI ≥35 kg/m 2 predicted worse outcomes (P = .036). Higher BMI did not impact major complication rates (P = .336). However, when BMI was ≥40 kg/m 2 , minor (from 2.1% to 4.4%; P = .035) and total (from 3.5% to 6.7%; P = .023) complications increased., Conclusion: In patients undergoing AF ablation, increasing BMI is associated with more patient comorbidities and more persistent and long-standing AF. BMI ≥35 kg/m 2 adversely impacts ablation outcomes, and BMI ≥40 kg/m 2 increases minor complications., (Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.)

Purpose: The purpose of this study was to evaluate ultra high density-activation sequence mapping (UHD-ASM) for ablating atypical atrial flutters., Methods: For 23 patients with 31 atypical atrial flutters (AAF), we created UHD-ASM., Results: Demographics age = 65.3 ± 8.5 years, male = 78%, left atrial size = 4.66 ± 0.64 cm, redo ablation 20/23(87%). AAF were left atrial in 30 (97%). For each AAF, 1273 ± 697 points were used for UHD-ASM. Time to create and interpret the UHD-ASM was 20 ± 11 min. For every AAF, the entire circuit was identified. Thirty (97%) were macroreentry. AAF cycle length was 267 ± 49 ms, and the circuit length was 138 ± 38 mm (range 35-187). Macroreentry atrial flutters took varied pathways, but each had an area of slow conduction (ASC) averaging 16 ± 6 mm (range 6-29) in length. Entrainment was not utilized. We targeted the ASC and ablation terminated AAF directly in 19/31 (61.3%) and altered AAF activation in 7/31 (22.6%), all of which terminated directly with additional mapping/ablation. AAF degenerated to atrial fibrillation in 2/31 (6.5%) with RF and could not be reinduced after ASC ablation. Median time from initial ablation to AAF termination was 64 s. Thus, 28/31 (90.3%) terminated with RF energy and/or could not be reinduced after ASC ablation. At 1 year of follow-up, 77% were free of atrial tachycardia or atrial flutter and 61% were free of all atrial arrhythmias., Conclusions: Using rapidly acquired UHD-ASM, the entire AAF circuit as well as the target ASC could be identified. Most AAF were left atrial macroreentry. Ablation of the ASC or microreentry focuses directly terminated or eliminated AAF in 90.3% without the need for entrainment mapping.

Background: Leadless cardiac pacemakers have emerged as a safe and effective alternative to conventional transvenous single-chamber ventricular pacemakers. Herein, we report a multicenter experience on the feasibility and safety of acute retrieval (<6 weeks) and chronic retrieval (>6 weeks) of the leadless cardiac pacemaker in humans., Methods and Results: This study included patients enrolled in 3 multicenter trials, who received a leadless cardiac pacemaker implant and who subsequently underwent a device removal attempt. The overall leadless pacemaker retrieval success rate was 94%: for patients whose leadless cardiac pacemaker had been implanted for <6 weeks (acute retrieval cohort), complete retrieval was achieved in 100% (n=5/5); for those implanted for ≥ 6 weeks (chronic retrieval cohort), retrieval was achieved in 91% (n=10/11) of patients. The mean duration of time from implant to retrieval attempt was 346 days (range, 88-1188 days) in the chronic retrieval cohort, and nearly two thirds (n=7; 63%) had been implanted for >6 months before the retrieval attempt. There were no procedure-related adverse events at 30 days post retrieval procedure., Conclusions: This multicenter experience demonstrated the feasibility and safety of retrieving a chronically implanted single-chamber (right ventricle) active fixation leadless pacemaker., Clinical Trial Registration: URL: https://www.clinicaltrials.gov. Unique identifiers: NCT02051972, NCT02030418, and NCT01700244., (© 2016 American Heart Association, Inc.)

Background: Patients with a variety of clinical presentations undergo atrial fibrillation (AF) ablation. Long-term ablation success rates can vary considerably., Objective: The purpose of this study was to develop a clinical scoring system to predict long-term freedom from AF after ablation., Methods: We retrospectively derived the scoring system on a development cohort (DC) of 1125 patients undergoing AF ablation and tested it prospectively in a test cohort (TC) of 937 patients undergoing AF ablation., Results: The demographics of the DC patients were as follows: age 62.3 ± 10.3 years, male sex 801 (71.2%), left atrial size 4.30 ± 0.69 cm, paroxysmal AF 348 (30.9%), number of drugs failed 1.3 ± 1.1, hypertension 525 (46.7%), diabetes 100 (8.9%), prior stroke/transient ischemic attack 78 (6.9%), prior cardioversion 528 (46.9%), and CHADS2 score 0.87 ± 0.97. Multivariate analysis showed 6 independent variables predicting freedom from AF after final ablation: coronary artery disease (P = .021), atrial diameter (P = .0003), age (P = .004), persistent or long-standing AF (P < .0001), number of antiarrhythmic drugs failed (P < .0001), and female sex (P = .0001). We created a scoring system (CAAP-AF) using these 6 variables, with scores ranging from 0 to 13 points. The 2-year AF-free rates by CAAP-AF scores were as follows: 0 = 100%, 1 = 95.7%, 2 = 96.3%, 3 = 83.1%, 4 = 85.5%, 5 = 79.9%, 6 = 76.1%, 7 = 63.4%, 8 = 51.1%, 9 = 53.6%, and ≥10 = 29.1%. Ablation success decreased as CAAP-AF scores increased (P < .0001). The CAAP-AF score also predicted freedom from AF in the TC. The 2-year Kaplan-Meier AF-free rates by CAAP-AF scores were as follows: 0 = 100%, 1 = 87.0%, 2 = 89.0%, 3 = 91.6%, 4 = 90.5%, 5 = 84.4%, 6 = 70.1%, 7 = 71.0%, 8 = 60.7%, 9 = 68.9%, and ≥10 = 51.3%. As CAAP-AF scores increased, 2-year freedom from AF in the TC decreased (P < .0001)., Conclusion: An easily determined clinical scoring system was derived retrospectively and applied prospectively. The CAAP-AF score predicted freedom from AF after ablation in both a DC and a TC of patients undergoing AF ablation. The CAAP-AF score provides a realistic AF ablation outcome expectation for individual patients., (Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved.)

Aims: Atrial fibrillation ablation requires peri-procedural oral anticoagulation (OAC) to prevent thromboembolic events. There are several options for OAC. We evaluate peri-procedural AF ablation complications using a variety of peri-procedural OACs., Methods and Results: We examined peri-procedural OAC and groin, bleeding, and thromboembolic complications for 2334 consecutive AF ablations using open irrigated-tip radiofrequency (RF) catheters. Pre-ablation OAC was warfarin in 1113 (47.7%), dabigatran 426 (18.3%), rivaroxaban 187 (8.0%), aspirin 472 (20.2%), and none 136 (5.8%). Oral anticoagulation was always interrupted and intraprocedural anticoagulation was unfractionated heparin (activated clotting time, ACT = 237 ± 26 s). Pre- and post-OAC drugs were the same for 1591 (68.2%) and were different for 743 (31.8%). Following ablation, 693 (29.7%) were treated with dabigatran and 291 (12.5%) were treated with rivaroxaban. There were no problems changing from one OAC pre-ablation to another post-ablation. Complications included 12 (0.51%) pericardial tamponades [no differences for dabigatran (P = 0.457) or rivaroxaban (P = 0.163) compared with warfarin], 12 (0.51%) groin complications [no differences for rivaroxaban (P = 0.709) and fewer for dabigatran (P = 0.041) compared with warfarin]. Only 5 of 2334 (0.21%) required blood transfusions. There were two strokes (0.086%) and no transient ischaemic attacks (TIAs) in the first 48 h post-ablation. Three additional strokes (0.13%), and two TIAs (0.086%) occurred from 48 h to 30 days. Only one stroke had a residual deficit. Compared with warfarin, the neurologic event rate was not different for dabigatran (P = 0.684) or rivaroxaban (P = 0.612)., Conclusion: Using interrupted OAC, low target intraprocedural ACT, and irrigated-tip RF, the rate of peri-procedural groin, haemorrhagic, and thromboembolic complications was extremely low. There were only minimal differences between OACs. Low-risk patients may remain on aspirin/no OAC pre-ablation. There are no problems changing from one OAC pre-ablation to another post-ablation., (© The Author 2014. Published by Oxford University Press on behalf of the European Society of Cardiology.)

Background: Atrial fibrillation (AF) ablation procedures generally use intraprocedural activated clotting time (ACT) of >300-350 seconds to prevent thromboembolic events., Objective: To evaluate bleeding and thromboembolic procedural complications in patients with symptomatic AF undergoing ablation procedures with low intraprocedural ACT., Methods: We examined a subset of 372 of 2334 (15.9%) AF ablation procedures using open-irrigated tip radiofrequency catheters at 50 W, interrupted oral anticoagulation, and a target ACT of 225 seconds, with average ACT ≤210 seconds., Results: There were 372 ablation procedures in 339 patients with average ACT ≤210 seconds. Patient demographic characteristics were as follows: age 60.9 ± 9.4 years, men 269 (79.3%), left atrial (LA) size 4.27 ± 0.65 cm, prior stroke/transient ischemic attack 24 (7.1%), CHADS2 score 0.94 ± 0.98, and CHA2DS2-VASc score 1.53 ± 1.35. AF type was categorized as paroxysmal in 107 (31.6%), persistent in 200 (59.0%), and long-standing persistent in 32 (9.4%). Procedural and LA times were 119 ± 26 and 82 ± 24 minutes. Patients underwent preprocedure transesophageal echocardiography. The heparin bolus (8738 ± 2823 units, 93.4 mg/kg) was given after LA access, and the maintenance infusion was 1000 units/hour via a single transseptal sheath with subsequent adjustments based on ACT values. The average ACT was 202 ± 7.5 seconds per procedure, with 116 patients with average ACT <200 seconds and 16 patients with all ACTs <200 seconds. Complications occurred in 7 of 372 (1.9%) ablation procedures, including 2 pericardial tamponades (0.54%), 1 groin pseudoaneurysm (0.27%), and 1 pulmonary embolus, several weeks postablation. There were no other bleeding events and no strokes/transient ischemic attacks or systemic thromboemboli., Conclusion: Using open-irrigated tip radiofrequency catheters at 50 W and preablation transesophageal echocardiography as well as infusing maintenance heparin through a single transseptal sheath, AF ablation can be performed safely despite ACT averaging ≤210 seconds. While we are not advocating target ACTs this low, our data suggest that long ACTs may not be absolutely necessary for preventing thromboembolic events. Lower target ACTs may potentially reduce bleeding complications., (Copyright © 2014 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)

Aims: Atrial fibrillation (AF) is associated with a high incidence of strokes/thromboembolism. The CHADS2 score assigns points for several clinical variables to identify stroke risk. The CHA2DS2-VASC score uses the same variables but also incorporates age 65 to 74, female gender, and vascular disease in an effort to provide a more refined risk of stroke/thromboembolism. We aimed to examine oral anticoagulation (OAC) recommendations for a cohort of patients undergoing AF ablation depending upon whether thrombo-embolic risk was determined by the CHADS2 or CHA2DS2-VASC score., Methods and Results: For 1411 patients we compared OAC recommendations for each of these risk stratification schemes to one of the three OAC strategies: (i) NO-OAC, (ii) CONSIDER-OAC, and (iii) DEFINITE-OAC. Compared with the CHADS2 score, the CHA2DS2-VASC score reduced NO-OAC from 40.3 to 21.8% and CONSIDER-OAC from 36.6 to 27.9% while increasing DEFINITE-OAC from 23.0 to 50.2% of patients. Age 65 to 74 and female gender accounted for 95.2% and vascular disease for only 4.8% of recommendations for more aggressive OAC using CHA2DS2-VASC. Most vascular disease occurred in patients with higher CHADS2 scores already recommended for DEFINITE-OAC (P < 0.0001). Reclassifying 30 females of age <65 with a CHA2DS2-VASC score of 1 to the NO-OAC group had minimal effect on the overall recommendations., Conclusion: Compared with the CHADS2 score, in our AF ablation population, the CHA2DS2-VASC score markedly increases the number of AF patients for whom OAC is recommended. It will be important to determine by randomized trials if this major paradigm shift to greater use of OAC using the CHA2DS2-VASC scoring improves patient outcomes.

Purpose: This study was conducted to examine the outcomes in patients with prior stroke/transient ischemic attack (CVA/TIA) after atrial fibrillation (AF) ablation and the feasibility of discontinuing oral anticoagulation (OAC)., Methods: This study examined long-term outcomes following AF ablations in 108 patients with a history of prior thromboembolic CVA/TIA. Because of risks of OAC, we frequently discontinue OAC in these patients after successful ablation. These patients understand the risks/benefits of discontinuing OAC and remain on OAC for a longer time following successful AF ablation, compared to our patients without prior CVA/TIA., Results: Patient age was 66.2 ± 9.0 years with an average CHADS2 score = 3.0 ± 0.9 and CHA2DS2-VASc score = 4.1 ± 1.4. Following 1.24 ablations, 71 (65.7%) patients were AF free 2.8 ± 1.6 (median 2.3) years after their last ablation. OAC was discontinued in 55/71 (77.5%) patients an average of 7.3 months following the final ablation. These 55 patients had 2.2 ± 1.3 (median 1.8) years of follow-up off of OAC. Kaplan-Meier analysis suggests little AF recurrence >1 year following initial or final ablations, suggesting that 1 year post successful ablation may be the appropriate time to consider discontinuing OAC. Thirty-seven patients had AF postablation, and 32/37 (86.5%) remained on OAC. One patient with a mechanical valve had a stroke despite OAC. Bleeding occurred in 8.3% of patients on OAC and 0% of patients off OAC (P = 0.027)., Conclusions: Patients with prior CVA/TIAs, who undergo successful AF ablation, have a low incidence of subsequent thromboembolic events. Most patients who appear AF free postablation may be able to discontinue OAC after successful ablation with a low thromboembolic risk and with a reduced bleeding risk.

Purpose: Atrial fibrillation (AF) ablation uses expensive technology and equipment. Physicians have considerable latitude over equipment choice. Average Medicare reimbursement is $10,338 for uncomplicated AF ablations. The purpose of this study is to evaluate the cost of special equipment chosen by physicians to perform AF ablation., Methods: We obtained the list price cost of special capital equipment and of disposable equipment (intracardiac ultrasound probes, transseptal needles/sheaths, and ablation/recording catheters) commonly used for radiofrequency (RF) AF ablation. We also evaluated the equipment cost of using robotic magnetic navigation and cryoablation. Then we evaluated costs for several physician equipment choice scenarios., Results: Using open irrigated-tip catheters, the lowest estimated cost-per-case for manual RF ablation of AF was $6,637, and the highest estimated cost of manual RF ablation was $12,603. Assuming 200 AF ablations/year and a 6-year magnet life, the cost-per-case of using magnetic navigation ablation ranged from $12,261-$15,464. The cost-per-case using cryoballoons alone ranged from $12,847-$15,320, and if focal cryoablation or RF touch-up is needed, cryoablation cost increased to $15,942-$22,284., Conclusions: Physicians have many choices in AF ablation equipment. Equipment costs in our arbitrary scenarios range from $6,637 to $22,284 per case. More important than the specific cost of each scenario is the concept that these are physician-driven costs, and as such, physicians will need to determine if more expensive technologies increase procedural efficacy and/or patient safety enough to justify the greater procedural equipment costs.

Patients appearing free of atrial fibrillation (AF) based on limited electrocardiographic monitoring/clinical history late after ablation may still have a large silent AF burden and thus have failed ablations and may be at risk of thromboembolism. We evaluated long-term monitoring (LTM; 7 days or 1 year) in 203 patients off antiarrhythmic drugs who were clinically free of AF >1 year after ablation. A 7-day monitor was done in 186 and 17 had pacemakers in whom the most recent year was analyzed. Arrhythmia recurrence was >30 seconds of AF, flutter, or tachycardia. LTM was done 3.1 ± 1.3 years (range 1.1 to 7.3) after the last ablation. AF recurred in only 8 of 186 (4.3%) on 7-day monitoring. One had persistent AF. For the other 7, AF burden was 0.0075% to 3.34% with 3 of 7 having an AF burden ≤0.037%. AF recurred in 4 of 17 patients (23.5%) with pacemakers. The 4 patients with pacemakers and AF had a 1-year AF burden of 0.0037% to 0.16%. Given the longer duration of monitoring, pacemakers detected more AF than 7-day monitors (p <0.011). AF duration before ablation was the only predictor of AF recurrence on LTM (p = 0.01). In patients with symptomatic AF who appeared free of AF on clinical grounds an average of 3 years after ablation, AF burden on LTM was low. In conclusion, monitoring by implanted devices detects more AF than 7-day monitors, most patients exceeding the failure definition of >30 seconds have a small AF burden, and when using LTM for follow-up the definition of "ablation failure" may be better described by an AF burden >0.5% rather than a single 30-second arrhythmia recurrence., (Copyright © 2012 Elsevier Inc. All rights reserved.)

Purpose: The purpose of this study was to evaluate how atrial fibrillation (AF) ablation has evolved over time with regards to patient characteristics, procedural variables, complications, and outcomes., Methods: We evaluated trends over time from 2003 to 2010 in clinical characteristics, procedural variables, complications, and Kaplan-Meier AF-free rates after the initial and final AF ablation in 1,125 patients undergoing 1,504 ablations., Results: Evaluating trends from 2003 to 2010, we found that patients undergoing AF ablation became older (P < 0.0001), had higher CHADS(2) scores (P < 0.0001), and more coronary artery disease (P = 0.021), persistent AF (P < 0.0001), hypertension (P < 0.0001), and previous strokes/transient ischemic attacks (P = 0.005). Procedure times decreased from 256 ± 49 to 122 ± 28 min (P < 0.0005), fluoroscopy times decreased from 134 ± 29 to 56 ± 19 min (P < 0.0005), and major (P = 0.023), minor (P = 0.023), and total complications (P = 0.001) decreased over time. The learning curve to minimize complications was 6 years. For paroxysmal AF, initial ablation AF-free rates improved over time (P = 0.015) but improvement plateaued in recent years. For persistent AF, initial ablation AF-free rates trended toward improvement over time (P = 0.062) but also plateaued in recent years. For long-standing persistent AF (P = 0.995), there was no outcome improvement after initial ablation over time. There was no trend for improved final outcomes (including repeat ablations) over time for paroxysmal, persistent, or long-standing AF (P = 0.150 to P = 0.978)., Conclusions: Despite decreased procedural and fluoroscopy times and reduced complication rates, post-ablation freedom from AF has not improved commensurately in recent years. A better understanding of AF initiation and maintenance may be required to devise personalized approaches to AF ablation and further improve outcomes.

Aims: Atrial fibrillation (AF) ablation is generally performed after patients fail antiarrhythmic drug (AAD) therapy. Some patients have drug contraindications or choose to avoid a lifetime of drug therapy. Little is known about the impact of previous drug therapy on ablation outcomes. We evaluated AAD use before AF ablation and its impact on ablation outcomes., Methods and Results: We evaluated freedom from AF after ablation and patients' clinical characteristics by number of AADs failed in 1125 patients undergoing 1504 ablations. We also evaluated reasons why some patients did not receive prior drug therapy. Cox multivariate analysis examined factors predicting ablation failure. Patients failing more drugs before ablation were older (P = 0.001), had a longer duration of AF (P = 0.0001), were more likely female (P = 0.037), had more repeat ablations (P = 0.045), and less paroxysmal AF (P = 0.003). For patients with either paroxysmal or persistent AF, the number of drugs failed predicted AF recurrence (P = 0.0001). Other factors predicting AF recurrence following final ablation included age (P = 0.004), left atrial size (P = 0.002), female gender (P = 0.0001), and persistent AF (P = 0.0001). The reason for not receiving prior drug therapy was medical in 21.5% and patient choice in 78.5%. Number of drugs failed did not influence ablation outcome for patients with long-standing persistent AF (P = 0.352)., Conclusions: For paroxysmal and persistent AF patients undergoing ablation, those failing fewer AADs have different clinical characteristics than those who fail more drugs. Our study also suggests that the more drugs failed pre-ablation, the lower the freedom from AF post-procedure, possibly due to AF progression during drug trials.

Introduction: Atrial fibrillation (AF) ablation requires postprocedural anticoagulation to prevent thromboembolic events because of the ablation procedure itself or due to recurrent AF postprocedure. Dabigatran is a new anticoagulant and may be useful after AF ablation to prevent thromboembolic events., Methods and Results: We evaluated 123 consecutive patients who were started on dabigatran after AF ablation. Patients were given enoxaparin 0.5 mg/kg at the end of the procedure, which was repeated 12 hours later and then discontinued. Dabigatran was started 22 hours postablation with drug dose based on renal function. Primary outcomes were thromboembolic events, bleeding complications, and side effects over a 30-day follow-up period. The preablation anticoagulant was warfarin in 56 (45.5%) patients, dabigatran in 34 (27.6%), and aspirin in 26 (21.1%). Seven (5.7%) patients were on no anticoagulant before ablation. The patients on dabigatran before ablation with normal renal function had the drug stopped 36 hours preablation. There were no preprocedural or intraprocedural thromboembolic episodes or bleeding. Three patients received dabigatran 75 mg bid and the rest 150 mg bid. There were no postablation strokes, transient ischemic attacks, or systemic thromboemboli in any patient. Three patients discontinued dabigatran and were changed to warfarin, 2 because of gastrointestinal side effects and 1 because of a diffuse rash., Conclusions: Dabigatran is safe and well tolerated after AF ablation. It did not cause bleeding complications and there were no thromboembolic events. Dabigatran appears to be an alternative to warfarin after AF ablation., (© 2011 Wiley Periodicals, Inc.)

Background: Atrial fibrillation (AF) ablation requires transseptal puncture to gain entry to the left atrium (LA). On rare occasions, LA entry cannot be achieved or cardiac perforation results in pericardial tamponade., Objective: This study sought to compare a new radiofrequency (RF) transseptal needle with the standard needle., Methods: We evaluated 1,550 AF ablations in 1,167 patients. We compared 975 transseptal punctures done using a standard needle to 575 done using a new electrode-tipped needle attached to an RF perforation generator., Results: The rate of failure to cross the atrial septum was lower for the RF needle (1 of 575 [0.17%] vs. 12 of 975 [1.23%], P = .039) and there were fewer pericardial tamponades with the RF needle (0 of 575 [0.00%] vs. 9 of 975 [0.92%], P = .031). Multivariate analysis showed the RF needle use was the only variable associated with a lower incidence of tamponade (P = .04). Becasuse the RF needle was used later in our series, we examined our 975 standard needle punctures over time for evidence of improved operator experience that might explain the superior RF results. For the standard needle, there was no trend for improved septal crossing rates (P = .794) or fewer tamponades (P = .456) with more operator experience. Instrumentation time was shorter for the RF needle (27.1 ± 10.9 vs. 36.4 ± 17.7 minutes, P < .0001)., Conclusion: Our data suggest that the RF needle is superior to the standard transseptal needle. It results in shorter instrumentation times, a greater efficacy in transseptal crossing, and fewer episodes of pericardial tamponade., (Copyright © 2011 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)

Current ablation consensus documents define persistent atrial fibrillation (AF) as AF lasting >1 week to 1 year or AF requiring cardioversion or pharmacologic conversion in <1 week. These 2 persistent AF subgroups may have different clinical characteristics and ablation outcomes. We compared 179 patients whose persistent AF was always terminated in <1 week by cardioversion/drugs to 244 whose AF actually lasted >1 week to 1 year. Patients with AF termination in <1 week by cardioversion/drugs had smaller left atrial (LA) size (4.1 ± 0.6 vs 4.5 ± 0.7 cm, p <0.0001), a longer AF history (7.5 ± 7.5 vs 6.0 ± 7.2 years, p = 0.035), more failed drugs (1.6 ± 1.0 vs 1.3 ± 1.0, p = 0.004), lower body mass index (28.5 ± 5.5 vs 30.3 ± 5.5, p = 0.0008), and fewer cardiomyopathies (3.9% vs 11.1%, p = 0.01). Cox multivariate analysis showed that LA size (p = 0.02), female gender (p = 0.001), and coronary artery disease (p = 0.03) predict ablation failure. There was a linear relation between duration of longest AF episode and LA size (p = 0.0001). Longest AF episode duration was the only factor predicting LA size (p = 0.001). Kaplan-Meier analysis showed more patients with AF termination in <1 week by cardioversion/drugs were free of AF after ablation (p = 0.042) than those whose AF actually lasted >1 week to 1 year. Once AF lasted >1 week, duration up to 1 year did not affect ablation success. In conclusion, patients whose persistent AF is always terminated by drugs/cardioversion in <1 week have different clinical characteristics and better ablation outcomes than patients whose AF persists beyond 1 week. This suggests that maintaining sinus rhythm before ablation is beneficial and that the definition of AF2 may need revision., (Copyright © 2011 Elsevier Inc. All rights reserved.)

Background: Ablation is more successful for patients with paroxysmal atrial fibrillation (AF1) than for those with persistent (AF2) or longstanding persistent AF (AF3). Many patients fail initial ablation and undergo repeat ablations. Little is known about repeat ablation procedure times, complications, and outcomes., Methods: We evaluated Kaplan-Meier freedom from AF by AF type and sex for initial and repeat ablations and for final status of 843 patients undergoing 1122 ablations. We examined complications, procedure times and reasons why patients do not undergo repeat ablations. Cox multivariate analysis evaluated factors predicting ablation failure., Results: Initial ablations were more successful in AF1 than AF2 or AF3 (P < .0001) patients. For each AF type, repeat ablations were more successful than initial ablations (P = .01 to <.001). Procedure times (139.1 ± 49.1 vs 135.3 ± 45.6 minutes, P = .248) and major complications (1.66% vs 2.87%, P = .216) were similar. Women had different clinical characteristics than men, similar initial and repeat ablation success rates but lower overall success because of fewer repeat ablations (57.8% vs 68.2%, P = .047) due to patient choice (P = .028). Patients with either successful initial ablations or undergoing repeat ablations had late AF recurrence rates of 0% to 1.5% a year. Age (P = .012), larger left atria (P = .002), female sex (P = .001), AF2 (P < .0001), AF3 (P = .003), and coronary disease (P = .003) predicted failure., Conclusions: Repeat ablations are more successful than initial ablations, have similar procedure times and complication rates, help determine final success rates, and may explain sex difference in success rates. For the best outcomes, patients should assume that a repeat ablation may be required to eliminate AF., (Copyright © 2011 Mosby, Inc. All rights reserved.)

Background: Point-by-point use of open irrigated tip catheters (OITCs) at 50 W increases atrial fibrillation (AF) ablation cure rates but also increases complications. We determined if constantly moving the OITC (perpetual motion) when using 50 W increases ablation cure rates without increasing complications., Methods: We evaluated procedural data, complications, and individual procedure cure rates (IPCRs) for AF ablation using closed tip catheters (CTC) versus OITC at 40, 45, and 50 W in 1,122 ablations. We used "perpetual motion" to move the OITC at 50 W every 3-10 seconds., Results: The OITC showed higher IPCR than CTC at 45 W (P = 0.012) and 50 W (P < 0.0005). For the OITC, IPCR increased from 44.6% to 60.7% as power increased from 40 to 50 W (P = 0.008). The OITC appeared superior to the CTC for all types of AF. For paroxysmal AF, increasing OITC power from 40 to 50 W provided no increase in IPCR (70.6% vs 71.2%, P = 0.827). For persistent AF, increasing power from 40 to 50 W increased IPCR from 34.5% to 59.5% (P = 0.001). Complications were similar for the CTC and the OITC at any power. The OITC at 50 W had shorter procedure, left atrial, and fluoroscopy times (P < 0.0005)., Conclusions: Increasing OITC power from 40 to 50 W increases IPCR with no increase in complications as long as the 50 W setting is done using "perpetual motion." The OITC 50 W power setting results in shorter procedure and fluoroscopy times and should be considered for AF ablations., (©2010, The Authors. Journal compilation ©2010 Wiley Periodicals, Inc.)

Guidelines largely based on closed-tip catheters recommend activated clotting times (ACTs) >300 to 350 seconds during atrial fibrillation (AF) ablation to prevent thrombus and char formation. Open irrigated tip catheters (OITC) may decrease complications and permit lower ACTs. This study evaluated factors contributing to vascular and hemorrhagic complications during AF ablation with emphasis on catheter type, anticoagulation level, procedural and clinical variables, and gender. In 1,122 AF ablations we examined catheter used, ACT level, gender, and complications. Target ACTs initially were >300 seconds and were decreased to 225 seconds for the OITC. Average ACT ranges were created: <250, 250 to 299, 300 to 350, and >350 seconds. Average ACT was <250 seconds in 557 ablations (complication rate 1.62%). Cochran-Armitage analysis showed that complications increased linearly as ACT increased and peaked at 5.55% for ablations with ACTs >350 seconds (p = 0.038). Women were older (66 ± 10 vs 60 ± 10 years, p <0.001) and had more paroxysmal AF (43% vs 28%, p = 0.007) and more hypertension (50% vs 40%, p = 0.013). Women received less heparin but were over-represented in higher ACT ranges (p <0.0001) consistent with a pharmacokinetic gender difference. There was no difference in vascular or hemorrhagic complications between men and women (2.3% vs 2.9%, p = 0.668). Multivariate logistic regression showed that only use of the OITC was associated with lower complication rates (p = 0.024). In conclusion, AF ablation with the OITC is safe with a target ACT of 225 seconds., (Copyright © 2011 Elsevier Inc. All rights reserved.)

Background: Cardiac resynchronization therapy (CRT) reduces morbidity and mortality in appropriately selected patients with heart failure. Optimal left ventricular (LV) lead placement is useful in enhancing response from CRT. Three significant obstacles to LV lead placement are patient-specific variations in coronary venous anatomy, phrenic nerve stimulation, and a significant rate of LV lead dislodgement or microdislodgement., Objective: The primary objective of this study was to determine the safety and effectiveness of the Medtronic StarFix active fixation LV lead. Secondary objectives evaluated implant success, lead placement and procedure time, lead handling and lobe deployment, additional electrical performance, and all adverse events reported in the study., Methods: There were 441 patients enrolled in this multicenter study. Standard cardiac resynchronization therapy (CRT) inclusion criteria were used. Patients were followed up for a mean of 23 months. Implant data, success with CRT, LV lead performance, clinical outcomes, and experience with LV lead revisions were prospectively evaluated., Results: The mean LV stimulation threshold at implant was 1.3 +/- 1 volts and was stable over time. Sensing was also excellent. In 96.3% of the implantations in this study, the physician was able to place the lead in a nonanterior position. Extracardiac (phrenic nerve) stimulation required invasive intervention in 11 subjects (2.5%). Only 3 dislodgements (0.7%) were observed. Two occurred in the first 5 implants and were attributed to inadequate engagement of the venous subbranch., Conclusion: The Medtronic 4195 is safe and highly efficacious. It affords the physician more choices in lead placement location and has a remarkably low dislodgement rate., (Copyright 2010 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)

Background: Indications for implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators have greatly expanded in the last 5 years, encompassing a wider variety of patients with a multitude of comorbidities. To meet the needs of these patients, the managing clinicians need to streamline their follow-up care. New ICD/cardiac resynchronization therapy defibrillators provide enhanced device status and disease progression remote monitoring capabilities that support more comprehensive and efficient follow-ups. In addition, this monitoring between follow-ups is likely to impact health care utilization., Methods and Results: The Clinical evaluation Of remote NotificatioN to rEduCe Time to clinical decision (CONNECT) study will randomize approximately 2,000 patients implanted with an ICD with or without CRT capabilities from 150 sites in the United States to remote monitoring versus standard in-office care. This study will evaluate the time from clinical event to clinical decision in response to the event, as well as the associated impact on health care utilization and quality of life. Patients monitored remotely will be provided a home monitor for transmitting device diagnostics to the clinician's office. These devices will use wireless telemetry, allowing the automatic transmission of diagnostics to the office without the need for patient intervention. Patients receiving in-office care will be followed in the office at a fixed schedule and without remote monitoring. All patients will be followed for 15 months postimplant., Conclusion: The CONNECT study is evaluating the impact of remote monitoring and early notification using wireless telemetry on the time to clinical decisions, the allocation of health care utilization, and quality of life. Results from this study are expected mid-2009.

Remote monitoring for atrial fibrillation (AF) provides invaluable tools for diagnosis and management. Recent advances in monitoring technology have improved the ability to care for patients with AF. Wireless remote monitoring of implanted devices is revolutionizing the way health care professionals care for this subgroup of patients. Early identification and treatment of paroxysmal AF episodes has the potential to reduce the progression to persistent or permanent AF. Prompt initiation of anticoagulant therapy can reduce the rate of strokes. More thorough and real-time remote monitoring can help evaluate to improve the efficacy of rate control, antiarrhythmic drug therapy, and catheter or surgical ablation procedures. In addition to improvements in clinical care, early detection and treatment of AF could reduce health care costs associated with AF.

Background: Despite improvements in cardiac resynchronization therapy (CRT) implantation techniques, a significant minority of CRT attempts are unsuccessful. Inability to cannulate the coronary sinus (CS) because of difficult anatomy is a major reason for unsuccessful CRT implantation. Direct visualization of intracardiac structures during the implant may facilitate access into the CS. The present study describes CRT implantation with the aid of an endocardial visualization catheter (EVC)., Methods: Fifty-eight consecutive patients (mean age 72 +/- 12 years; ejection fraction 26.2% +/- 7.0%; New York Heart Association [NYHA] class 2.9) underwent CRT implantation using a steerable fiberoptic EVC (Acumen Medical, Inc., Sunnyvale, CA)., Results: The EVC was able to visualize the CS ostium in all cases. The CS was successfully cannulated in 57 (98.3%) of 58 patients. The time from vascular access to CS visualization was 6 +/- 5 minutes, and the total time to CS access was 8 +/- 6 minutes. Successful left ventricle (LV) lead implantation was accomplished in 55 (94.8%) of 58 patients. Three patients who had a previous history of failed LV lead implantation were successfully implanted using the EVC., Conclusion: Fiberoptic imaging of intracardiac structures during CRT implantation may be performed rapidly in a wide range of patients with an EVC. The ability to visualize right atrial anatomy may aid CS access and LV lead implantation.

The purpose of this study is to assess the potential utility and practicality of microwave (MW) ablation in the creation of linear lesion for the treatment of atrial flutter. In the search for a more versatile form of energy for ablation of complex arrhythmias, MW, with its more direct form of heating, has been considered a potential alternative to radiofrequency. MW ablation is expected to offer an advantage in creating deeper or more uniform linear lesions but data on its usefulness remain lacking. Microwave ablation was applied to the inferior vena cava and tricuspid annulus isthmus in eight canines weighing 67.2 +/- 4.8 lbs. We applied stationary ablations across the isthmus using 60-75 W power of 2,450-MHz MW energy delivered through a deflectable catheter with a 12- or 18-mm antenna, achieving 70.1 degrees +/- 9.0 degrees C antenna's temperature. Ablations were made between the coronary sinus os and the low lateral right atrium. Bidirectional block at the isthmus was accomplished in seven canines with an average of 2.7 +/- 1.3 ablations while in one canine, only unidirectional block was achieved after five ablations. Gross pathological examination identified 16 transmural ovaloid and linear lesions measuring 9.4 +/- 3.4 mm long, 4.9 +/- 2.0 mm wide, and 2.1 +/- 0.6 mm deep. In one canine the lesion extended to the surface of the tricuspid valve leaflet and in two other to the opposing anterior right ventricular wall. There were no coronary vascular or other structural damage. Histopathological examination showed hemolyzed blood on the surface, subendocardial hemorrhage and necrosis, and degeneration and fragmentation of the atrial myocardium. We concluded that single application ablation could achieve complete isthmus block using MW energy delivered through appropriately sized antenna. Such ablation may be useful for producing linear lesions for the treatment of atrial flutter.

Microwave has been considered a potentially more effective and more versatile form of energy than radiofrequency. Its feasibility has been tested using various prototype systems and catheter designs. This study assessed the safety and efficacy of a clinically-suitable prototype microwave power supply and catheter system with a lateral-firing antenna design for atrioventricular (AV) junction ablation in canines and to correlate with tissue histopathology. The system consisted of a deflectable catheter with a 6-mm antenna and a thermocouple; and a 2.45-GHz frequency generator with power, time, and temperature controls. AV junction ablations were performed using 75 W energy for up to 60 seconds. Effective heating was confirmed by a rise in catheter temperature to 69.3 +/- 8.8 degrees C. Complete AV nodal block was accomplished in all canines after an average of 4.1 +/- 2.8 applications at 66.8 +/- 7.7 degrees C, and persisted after 28 days in all chronic animals. Lesions were consistent with thermal necrosis, were hemispherical to semi linear in shape and have distinct borders. Acute lesions were 3.4 +/- 1.5 mm wide, 4.8 +/- 2.1 long, and 2.0 +/- 0.9 deep. Chronic lesions showed typical healing and were smaller in size. Ablations did not cause any transvalvular, vascular or other cardiac structural damage, and no coagulum formation was noted on the antenna or catheter tip. Microwave AV junction ablation using this clinical prototype system specifically designed for it was safe and effective. Lesion's depth was limited to 5 mm with 60-second heating while its shape corresponded to the antenna's length. Microwave energy may provide greater versatility for producing discrete or linear ablation.

This study was designed to test a microwave (MW) ablation system using approximately 2,450 MHz of energy and a deflectable catheter with forward-firing tip antenna, an early clinical prototype system. In vitro three-dimensional thermal mapping of single and double helix antenna designs was performed. Quantitative measurements of antenna radiation were recorded on tissue phantoms equipped with temperature sensors distributed radially and outwardly. In vivo testing consisted of closed-chest AV junction ablation in three dogs. Thermal mapping showed hemispherical heat distribution from the tip antenna. For the double helix design, this distribution was measured at 8.4-mm diameter with a maximum temperature of 61.62 degrees C. As expected, the single helix design produced less heating with a measured diameter of 6.4 mm and maximum temperature of 55.90 degrees C. The in vivo study produced lesions of geometry and size concordant with these heating patterns. MW ablation produced bundle branch block in one dog and complete AV nodal block in the remaining two, without transvalvular or other structural damage. The histopathology of the lesions was typical of a thermal burn showing hemorrhage and coagulative necrosis with clearly demarcated borders. We conclude that, using this early clinical prototype system with a deflectable catheter and a forward-firing tip antenna design, MW heating can produce a moderate-size lesion and is safe and effective for cardiac ablation.

A new generic code, patterned after and compatible with the NASPE/BPEG Generic Pacemaker Code (NBG Code) was adopted by the NASPE Board of Trustees on January 23, 1993. It was developed by the NASPE Mode Code Committee, including members of the North American Society of Pacing and Electrophysiology (NASPE) and the British Pacing and Electrophysiology Group (BPEG). It is abbreviated as the NBD (for NASPE/BPEG Defibrillator) Code. It is intended for describing the capabilities and operation of implanted cardioverter defibrillators (ICDs) in conversation, record keeping, and device labeling, and incorporates four positions designating: (1) shock location; (2) antitachycardia pacing location; (3) means of tachycardia detection; and (4) antibradycardia pacing location. An additional Short Form, intended only for use in conversation, was defined as a concise means of distinguishing devices capable of shock alone, shock plus antibradycardia pacing, and shock plus antitachycardia and antibradycardia pacing.

Twenty-one patients with heart failure (New York Heart Association [NYHA] class II to IV) received a 24-hour infusion of enoximone followed by a 12-hour washout period. Patients were randomly assigned to one of four treatment groups. Groups I to III received an 0.5 mg/kg bolus, followed by a maintenance infusion of 2.5, 5.0, or 10.0 micrograms/kg/min. Group IV patients received a maintenance infusion of 5.0 micrograms/kg/min without a loading dose. Serial assessment of hemodynamics, plasma levels of enoximone and enoximone sulfoxide, and ventricular ectopy were performed. Enoximone produced a clinically significant increase in cardiac index, and a decrease in mean pulmonary artery wedge pressure and systemic vascular resistance in all groups. Enoximone mildly increased heart rate, and had a minimal effect on mean arterial pressure. There was no statistically significant change in ventricular ectopy during the infusion. Significant hemodynamic improvement was noted at even the lowest infusion rate, and did not increase in linear fashion at higher infusion rates. In patients who did not receive an initial loading bolus of 0.5 mg/kg, the increase in cardiac index was delayed by approximately 1 hour. Plasma concentrations of both enoximone and its major metabolite continued to rise throughout the 24-hour infusion in group III (10.0 micrograms/kg/min), rather than reaching steady state as predicted by the terminal exponential half-lives of these compounds. This is suggestive of nonlinear pharmacokinetics and indicates a potential for excessive accumulation of enoximone and its metabolite during prolonged infusion. These findings may have important implications in guiding the intravenous administration of enoximone.(ABSTRACT TRUNCATED AT 250 WORDS)

Enoximone is a phosphodiesterase inhibitor, which has been studied extensively for use in the management of patients with moderate-to-severe heart failure. The authors have studied the absorption and disposition kinetics of enoximone and its primary metabolite, enoximone sulfoxide, after both single oral doses of enoximone and at steady-state after short-term chronic oral therapy. A total of ten patients (two female, eight male) with moderate-to-severe heart failure (NYHA class II-IV) were enrolled into the study after giving written informed consent. The plasma levels of enoximone sulfoxide were greater than those of enoximone at all sampling times. The peak enoximone sulfoxide plasma concentrations ranged from 3.5 to 17.3 times the peak enoximone plasma levels for individual patients. The average steady-state plasma concentrations for enoximone were 115 +/- 40 ng/mL and 190 +/- 78 ng/mL for 50 mg every 8 hours and 100 mg every 8 hours dosage regimens, respectively. The absorption and disposition kinetics of enoximone were found to be significantly variable between patients. The authors also evaluated the relationship between dose administered and steady-state plasma levels as well as the relationship between the observed and predicted steady-state plasma levels. The authors found a linear relationship between the dose that was administered and the accrued plasma levels, as well as a good correlation between the predicted and observed steady-state levels. Although these data confirm previous reports that the sulfide metabolite of enoximone accumulates extensively in the plasma during oral therapy, reaching levels much higher than those of enoximone, these data do not support previous suggestions that the disposition of enoximone is nonlinear.

Patients with atrioventricular (AV) node reentrant tachycardia characteristically have short and constant retrograde His-atrium conduction times (H2A2 intervals) during the introduction of ventricular extrastimuli. It has therefore been suggested that the tachycardia circuit involves retrograde conduction up an accessory pathway located in perinodal tissue. If the mechanism of surgical cure of AV node reentrant tachycardia is interruption of this accessory pathway, postoperative changes in retrograde conduction would be expected. Thirteen patients with drug-refractory AV node reentrant tachycardia underwent surgery. Preoperatively, H2A2 intervals were short and constant. During AV node reentrant tachycardia, earliest atrial activation was seen near the His bundle and was 0 to 25 ms before ventricular activation in all patients except one. Surgery consisted of dissection of right atrial septal and anterior inputs to the AV node and central fibrous body. Postoperatively, the H2A2 interval remained short and constant compared with preoperative values although it was slightly prolonged (74 +/- 18 versus 61 +/- 21 ms, p less than 0.005). Twelve of the 13 patients are free of tachycardia after 28 +/- 13 months and no patient has had evidence of AV node block. Thus, surgical cure of AV node reentrant tachycardia is highly successful; however, there is no reason to postulate an accessory pathway or use of perinodal tissue as part of the tachycardia circuit and the mechanism of surgical success remains obscure.

Twenty-one patients with heart failure (NYHA class II-IV) received a 24-hour infusion of enoximone, followed by a 12-hour washout period. Patients were randomly assigned to one of four treatment groups. Groups I-III received a 0.5 mg/kg bolus, followed by a maintenance infusion of 2.5, 5.0 or 10.0 micrograms/kg/minute. Group IV patients received a maintenance infusion of 5.0 micrograms/kg/minute without the bolus. Serial assessments of haemodynamics, plasma levels of enoximone and enoximone sulphoxide, and ventricular ectopy were performed. Enoximone produced a significant increase in cardiac index (28.1-46.7%) and a decrease in mean pulmonary artery wedge pressure (6.4-35.7%) and systemic vascular resistance (34.7-78.9%). Enoximone had minimal effect on heart rate and blood pressure. In patients who did not receive an initial bolus of 0.5 mg/kg, haemodynamic changes were delayed by approximately 1 hour. Significant haemodynamic improvement was noted at even the lowest infusion rate and did not increase in linear fashion at higher infusion rates. During infusion of enoximone at 10.0 micrograms/kg/minute, both enoximone and its sulphoxide accumulated non-linearly and did not achieve a steady state. No significant adverse effects were noted in these patients. Enoximone infusion at rates greater than 5.0 micrograms/kg/minute may confer minimal additional haemodynamic benefit, while resulting in significant accumulation of enoximone and enoximone sulphoxide. Ventricular ectopy did not increase significantly in most patients.

The currently available automatic implantable cardioverter-defibrillator has proven highly successful for termination of ventricular tachycardia and fibrillation. Newer devices, however, permit lower energy shocks to be delivered initially and longer episodes of arrhythmia to occur before shocks are delivered. These changes may result in longer durations of arrhythmia before successful termination. Little is known about the effects of the duration of ventricular fibrillation on the efficacy of defibrillating shocks. In this study, we examined the efficacy of defibrillating shocks in 22 patients undergoing automatic implantable cardioverter-defibrillator implantation or generator change. Defibrillating shocks ranging from 300 to 600 V (5.9-24.2 J) were delivered in matched pairs after 5 and 15 seconds of ventricular fibrillation. For the 300-V shocks (5.9 J), defibrillation was accomplished in 82% of patients when the shocks were given after 5 seconds of ventricular fibrillation and in only 45% of patients when the shocks were delivered after 15 seconds (p less than 0.01). At higher energies, there was no difference in the efficacy of defibrillation shocks delivered after 5 compared with 15 seconds of ventricular fibrillation. The postshock aortic, systolic, and diastolic blood pressures were significantly lower when the shocks were given after 15 seconds of ventricular fibrillation than after only 5 seconds. We conclude that the duration of ventricular fibrillation affects defibrillation efficacy especially at energies that are relatively low compared with maximal device outputs and that longer episodes of ventricular fibrillation cause more postshock hemodynamic depression. These observations have implications for defibrillation threshold testing at the time of device implantation and for the design and programming of future automatic implantable antitachycardia devices.

A 48-year-old actively homosexual man who had undergone liver transplantation for cirrhosis secondary to hepatitis B infection six years previously presented with a syndrome of diffuse pain, cholestasis, and low-grade fever. The development of thrombocytopenia and persistent hypoprothrombinemia precluded liver biopsy. Subsequently, a skin eruption and VDRL result of 1:128 indicated that most of the findings could be explained by a diagnosis of secondary syphilis with luetic hepatitis and periostitis. This impression was confirmed by a complete response to penicillin therapy. The relation of thrombocytopenia to lues in this case remains uncertain.

Although lanthanum ions (La+++) block calcium influx in cardiac cells, they may paradoxically accentuate the sodium-free contracture. We have therefore studied the effects of La+++ on the zero sodium response in chick embryonic myocardial cell aggregates. Zero sodium alone causes: (a) A maintained contracture; (b) Asynchronous localized contractions that are selectively inhibited by caffeine or ryanodine, and presumably reflect release of calcium from the sarcoplasmic reticulum; (c) A nonspecific conductance increase that is ascribable to calcium-activated ion channels. Addition of La+++ potentiates the sodium-free contracture, and causes similar potentiation of the localized contractions and the conductance increase. All three phenomena occur 5-10-fold faster in 1 mM La+++ than in sodium-free fluid alone. In contrast, when La+++ is combined with caffeine or ryanodine, the zero sodium response is suppressed. We conclude that the paradoxical effect of La+++ on the contracture is not due to calcium influx, but to enhancement, or disinhibition of intracellular calcium release. Relaxation of normal myocardium may involve control of spontaneous calcium release by lanthanum- and sodium-sensitive calcium transport across the surface membrane.

The automatic implantable cardioverter-defibrillator was implanted in 270 patients because of life-threatening arrhythmias over a 7 year period. There was a history of sustained ventricular tachycardia or fibrillation, or both, in 96% of these patients, 80% had one or more prior cardiac arrests and 78% had coronary artery disease as their underlying diagnosis. The average ejection fraction was 34%, and 96% of these patients had had an average of 3.4 antiarrhythmic drug failures per patient before defibrillator implantation. There were four perioperative deaths and eight patients had generator infection or generator erosion, or both, during the perioperative period or during long-term follow-up. Concomitant antiarrhythmic drug therapy was given to 69% of patients. Shocks from the device were given to 58% of patients. and 20% received "problematic" shocks. The device was removed from 16 patients during long-term follow-up for a variety of reasons. There were 7 sudden cardiac deaths and 30 nonsudden cardiac deaths, 18 of which were secondary to congestive heart failure. The actuarial incidence of sudden death, total cardiac death and total mortality from all causes was 1%, 7% and 8%, respectively, at 1 year, and 4%, 24% and 26% at 5 years. The automatic implantable cardioverter-defibrillator nearly eliminates sudden death over a long-term follow-up period in a high risk group of patients. It has an acceptable rate of complications or problems, or both, and most late deaths in these patients are nonsudden and of cardiovascular origin.

Cardiac automaticity is partly due to a diastolic sodium current. Possible mediators of this include tetrodotoxin-sensitive "fast" channels, cesium-sensitive time-dependent pacemaker current channels, calcium-gated nonspecific channels, and electrogenic sodium-calcium exchange. We have studied the effects of abrupt sodium removal on membrane current and conductance in voltage-clamped chick embryonic myocardial cell aggregates, in the presence of various sodium flux inhibitors. Total replacement of sodium by lithium, Tris, or tetraethylammonium ions in aggregates clamped in the pacemaker range caused a brief outward current followed by a sustained net inward current. The outward current reached a peak value of 1.1 +/- 0.5 microA/cm2 at a mean latency of 5.4 +/- 1.2 sec. (n = 6; V = -70.5 +/- 8.9 mV; Tris). Conductance often decreased during the outward current. The inward current developed exponentially (t = 19 +/- 5 sec) and reached a steady state value of -1.6 +/- 0.4 microA/cm2. This current was reversed by depolarization (mean reversal potential = -13 +/- 13 mV), and was accompanied by increased conductance and spontaneous mechanical activity. Neither of the sodium-removal currents was affected by 20 microM tetrodotoxin. Cesium (up to 20 mM) had no effect on the late inward current or the mechanical activity, but decreased the early outward current by 80 +/- 12%. Manganese (25 mM), which blocks sodium-calcium exchange, abolished the late inward current and the mechanical activity. Manganese also reduced the early outward current by 27 +/- 10%. Manganese and cesium together blocked all the effects of sodium removal. We conclude that removal of extracellular sodium interrupts a cesium-sensitive "background" current, that may be related to the time-dependent pacemaker current, If. Sodium removal also causes gradual activation of a nonspecific conductance, which can ultimately depolarize the cells, and which may be gated by cytoplasmic calcium.

The automatic implantable cardioverter-defibrillator currently utilizes an electrode system that requires a major operation for implantation. Effective defibrillation using an implantable cardioverter-defibrillator catheter positioned transvenously would eliminate the morbidity associated with such surgery. Fifteen patients undergoing defibrillator implantation were studied to compare the efficacy of the catheter with that of the superior vena cava spring (6.7 cm2, anode)-left ventricular patch (13.5 cm2, cathode) electrode system using truncated exponential waveforms with 60% tilt. The catheter is 11F in diameter and tripolar. A distal platinum-iridium tip used for pacing was separated by 4 mm from a middle 4.3 cm2 platinum electrode; these were positioned at the right ventricular apex. The proximal 8.5 cm2 platinum electrode was situated at the superior vena cava-right atrial junction. Defibrillation was performed using the middle (cathode) and proximal (anode) electrodes. Ventricular fibrillation was induced by alternating current six times, and defibrillation shocks of 1, 5, 10, 15, 20 or 25 J were given in random order, first using the catheter and then the spring-patch system. Rescue shocks of higher energy were given if there was failure. Although very low energy levels appeared to be slightly more efficacious when using the spring-patch system, there was no statistically significant difference between the electrode systems for any of the energies tested. Permanent implantation of the catheter would have been suitable in 45% of the patients, as compared with 54% of patients with the spring-patch system (p = NS).(ABSTRACT TRUNCATED AT 250 WORDS)