for the REPLACE Registry InvestigatorsBackground-Prospective studies defining the risk associated with pacemaker or implantable cardioverter-defibrillator replacement surgeries do not exist. These procedures are generally considered low risk despite results from recent retrospective series reporting higher rates. Methods and Results-We prospectively assessed predefined procedure-related complication rates associated with elective pacemaker or implantable cardioverter-defibrillator generator replacements over 6 months of follow-up. Two groups were studied: those without (cohort 1) and those with (cohort 2) a planned transvenous lead addition for replacement or upgrade to a device capable of additional therapies. Complications were adjudicated by an independent events committee. Seventy-two US academic and private practice centers participated. Major complications occurred in 4.0% (95% confidence interval, 2.9 to 5.4) of 1031 cohort 1 patients and 15.3% (95% confidence interval, 12.7 to 18.1) of 713 cohort 2 patients. In both cohorts, major complications were higher with implantable cardioverter-defibrillator compared with pacemaker generator replacements. Complications were highest in patients who had an upgrade to or a revised cardiac resynchronization therapy device (18.7%; 95% confidence interval, 15.1 to 22.6). No periprocedural deaths occurred in either cohort, although 8 later procedure-related deaths occurred in cohort 2. The 6-month infection rates were 1.4% (95% confidence interval, 0.7 to 2.3) and 1.1% (95% confidence interval, 0.5 to 2.2) for cohorts 1 and 2, respectively. Conclusions-Pacemaker and implantable cardioverter-defibrillator generator replacements are associated with a notable complication risk, particularly those with lead additions. These data support careful decision making before device replacement, when managing device advisories, and when considering upgrades to more complex systems. Clinical Trial Registration-URL: http://www.clinicaltrials.gov. Unique identifier: NCT00395447.
We test cPDS on the problem of predicting hospitalizations due to heart diseases within a calendar year based on information in the patients Electronic Health Records prior to that year. cPDS converges faster than centralized methods at the cost of some communication between agents. It also converges faster and with less communication overhead compared to an alternative distributed algorithm. In both cases, it achieves similar prediction accuracy measured by the Area Under the Receiver Operating Characteristic Curve (AUC) of the classifier. We extract important features discovered by the algorithm that are predictive of future hospitalizations, thus providing a way to interpret the classification results and inform prevention efforts.
Because decreases in the ratio of myocardial insoluble to soluble collagen parallel LV dilatation in rats, reductions in myocardial collagen cross-linking may be an important mechanism contributing to LV dilatation in heart disease.
Background-It is common practice to empirically limit the radiofrequency (RF) power when ablating the posterior left atrium during atrial fibrillation ablation to avoid thermal injury to the esophagus. The objective of this study was to determine whether RF energy delivery limited by luminal esophageal temperature (LET) monitoring is associated with a reduction in esophageal injury compared with a strategy of RF power limitation alone. Methods and Results-Eighty-one consecutive patients who underwent atrial fibrillation ablation followed by esophageal endoscopy were included in this observational study. All patients underwent extraostial electric pulmonary vein isolation by using an electroanatomic mapping system and irrigated RF ablation. All RF applications on the posterior left atrium were limited to 35 W. A commercially available, single-thermocouple esophageal probe was used to monitor LET in a subset of patients (nϭ67). In these cases, applications were promptly interrupted when LET was Ն38.5°C; further applications were performed at reduced power to obtain a LET Ͻ38.5°C. Esophageal endoscopy was performed 1 to 3 days after the procedure. Ablation-related esophageal ulcerations were identified in 9 of 81 (11%) patients. All patients were asymptomatic. Of these 81 patients, LET monitoring during ablation occurred in 67 (83%) of patients. Esophageal injury was observed more frequently (36% versus 6%, PϽ0.006) in the group without LET monitoring. Conclusions-These data suggest that LET monitoring may be associated with a reduction in esophageal injury compared with power limitation alone. (Circ Arrhythmia Electrophysiol. 2008;1:162-168.)
Background-The present study examines the safety and feasibility of using a remote magnetic navigation system to perform endocardial and epicardial substrate-based mapping and radiofrequency ablation in patients with scar-related ventricular tachycardia (VT). Methods and Results-Using the magnetic navigation system, we performed 27 procedures on 24 consecutive patients with a history of VT related to myocardial infarction, dilated cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, hypertrophic cardiomyopathy, or sarcoidosis. Electroanatomic mapping of the left ventricular, right ventricular, and ventricular epicardial surfaces was constructed in 24, 10, and 12 patients, respectively. Completechamber VT activation maps were created in 4 patients. A total of 77 VTs were inducible, of which 21 were targeted during VT with the remotely navigated radiofrequency ablation catheter alone. With a combination of entrainment and activation mapping, 17 of 21 VTs (81%) were successfully terminated in a mean of 8.4Ϯ8.2 seconds; for the remainder, irrigated radiofrequency ablation was necessary. The mean fluoroscopy times for endocardial and epicardial mapping were 27Ϯ23 seconds (range, 0 to 105 seconds) and 18Ϯ18 seconds (range, 0 to 49 seconds), respectively. In concert with a manually navigated irrigated ablation catheter, 75 of 77 VTs (97%) were ultimately ablated. Four patients underwent a second procedure for recurrent VT, 3 with the magnetic navigation system. After 1.2 procedures per patient, VT did not recur during a mean follow-up of 7Ϯ3 months (range, 2 to 12 months). Conclusions-The present study demonstrates the safety and feasibility of remote catheter navigation to perform substrate mapping of scar-related VT in a wide range of disease states with a minimal amount of fluoroscopy exposure.
In this multicenter prospective study with 6 months of follow-up, infections associated with CIED replacements were surprisingly infrequent, possibly due to the use of preoperative antibiotics. Patients with infections were more likely to have had a postoperative hematoma, and sites with higher infection rates had sicker patients and lower overall procedural volume.
BACKGROUND
Pulmonary vein isolation (PVI) is recognized as a potentially
curative treatment for atrial fibrillation (AF). Ablation of complex
fractionated atrial electrograms (CFAEs) in addition to PVI has been
advocated as a means to improve procedural outcomes, but the benefit remains
unclear.
OBJECTIVE
To synthesize the available data testing the incremental benefit of
adding CFAE ablation to PVI.
METHODS
We performed a meta-analysis of controlled studies comparing the
effect of PVI with CFAE ablation versus PVI alone in patients with
paroxysmal and nonparoxysmal AF.
RESULTS
Of the 481 reports identified, 8 studies met our inclusion criteria.
There was a statistically significant increase in freedom from atrial
tachyarrhythmia (AT) with the addition of CFAE ablation (RR 1.15,
p=0.03). In the 5 reports of nonparoxsymal AF (3 randomized
controlled trials, one controlled clinical trial, and one trial using
matched historical controls), addition of CFAE ablation resulted in a
statistically significant increase in freedom from AT (n=112/181
[62%] for PVI+CFAE versus n=84/179
[47%] for PVI alone; RR 1.32, p=0.02). In
trials of paroxysmal AF (3 randomized controlled trials and one trial using
matched historical controls), addition of CFAE ablation did not result in a
statistically significant increase in freedom from AT (n=131/166
[79%] for PVI+CFAE versus n=122/164
[74%] for PVI alone; RR 1.04, p=0.52).
CONCLUSIONS
In these studies of patients with nonparoxysmal AF, addition of CFAE
ablation to PVI results in greater improvement in freedom from AF. No
additional benefit of this combined approach was observed in patients with
paroxysmal AF.
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