Clinical Implications of Brief Device-Detected Atrial Tachyarrhythmias in a Cardiac Rhythm Management Device Population: Results from the Registry of Atrial Tachycardia and Atrial Fibrillation Episodes.

BACKGROUND: The RATE Registry (Registry of Atrial Tachycardia and Atrial Fibrillation Episodes) is a prospective, outcomes-oriented registry designed to document the prevalence of atrial tachycardia and/or fibrillation (AT/AF) of any duration in patients with pacemakers and implantable cardioverter defibrillators (ICDs) and evaluate associations between rigorously adjudicated AT/AF and predefined clinical events, including stroke. The appropriate clinical response to brief episodes of AT/AF remains unclear. METHODS: Rigorously adjudicated electrogram (EGM) data were correlated with adjudicated clinical events with logistic regression and Cox models. Long episodes of AT/AF were defined as episodes in which the onset and/or offset of AT/AF was not present within a single EGM recording. Short episodes of AT/AF were defined as episodes in which both the onset and offset of AT/AF were present within a single EGM recording. RESULTS: We enrolled 5379 patients with pacemakers (N=3141) or ICDs (N=2238) at 225 US sites (median follow-up 22.9 months). There were 359 deaths. There were 478 hospitalizations among 342 patients for clinical events. We adjudicated 37 531 EGMs; 50% of patients had at least one episode of AT/AF. Patients with clinical events were more likely than those without to have long AT/AF (31.9% vs. 22.1% for pacemaker patients and 28.7% vs. 20.2% for ICD patients; P<0.05 for both groups). Only short episodes of AT/AF were documented in 9% of pacemaker patients and 16% of ICD patients. Patients with clinical events were no more likely than those without to have short AT/AF (5.1% vs. 7.9% for pacemaker patients and 11.5% vs. 10.4% for ICD patients; P=0.21 and 0.66, respectively). CONCLUSIONS: In the RATE Registry, rigorously adjudicated short episodes of AT/AF, as defined, were not associated with increased risk of clinical events compared with patients without documented AT/AF. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00837798.

New-Onset Atrial Fibrillation in the Critically Ill.

OBJECTIVE: To determine the association of new-onset atrial fibrillation with outcomes, including ICU length of stay and survival. DESIGN: Retrospective cohort of ICU admissions. We found atrial fibrillation using automated detection (≥ 90 s in 30 min) and classed as new-onset if there was no prior diagnosis of atrial fibrillation. We identified determinants of new-onset atrial fibrillation and, using propensity matching, characterized its impact on outcomes. SETTING: Tertiary care academic center. PATIENTS: A total of 8,356 consecutive adult admissions to either the medical or surgical/trauma/burn ICU with available continuous electrocardiogram data. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: From 74 patient-years of every 15-minute observations, we detected atrial fibrillation in 1,610 admissions (19%), with median burden less than 2%. Most atrial fibrillation was paroxysmal; less than 2% of admissions were always in atrial fibrillation. New-onset atrial fibrillation was subclinical or went undocumented in 626, or 8% of all ICU admissions. Advanced age, acute respiratory failure, and sepsis were the strongest predictors of new-onset atrial fibrillation. In propensity-adjusted regression analyses, clinical new-onset atrial fibrillation was associated with increased hospital mortality (odds ratio, 1.63; 95% CI, 1.01-2.63) and longer length of stay (2.25 d; CI, 0.58-3.92). New-onset atrial fibrillation was not associated with survival after hospital discharge (hazard ratio, 0.99; 95% CI, 0.76-1.28 and hazard ratio, 1.11; 95% CI, 0.67-1.83, respectively, for subclinical and clinical new-onset atrial fibrillation). CONCLUSIONS: Automated analysis of continuous electrocardiogram heart rate dynamics detects new-onset atrial fibrillation in many ICU patients. Though often transient and frequently unrecognized, new-onset atrial fibrillation is associated with poor hospital outcomes.

Hypertrophic Cardiomyopathy Registry: The rationale and design of an international, observational study of hypertrophic cardiomyopathy.

Hypertrophic cardiomyopathy (HCM) is the most common monogenic heart disease with a frequency as high as 1 in 200. In many cases, HCM is caused by mutations in genes encoding the different components of the sarcomere apparatus. Hypertrophic cardiomyopathy is characterized by unexplained left ventricular hypertrophy, myofibrillar disarray, and myocardial fibrosis. The phenotypic expression is quite variable. Although most patients with HCM are asymptomatic, serious consequences are experienced in a subset of affected individuals who present initially with sudden cardiac death or progress to refractory heart failure. The Hypertrophic Cardiomyopathy Registry study is a National Heart, Lung, and Blood Institute-sponsored 2,750-patient, 44-site, international registry and natural history study designed to address limitations in extant evidence to improve prognostication in HCM (NCT01915615). In addition to the collection of standard demographic, clinical, and echocardiographic variables, patients will undergo state-of-the-art cardiac magnetic resonance for assessment of left ventricular mass and volumes as well as replacement scarring and interstitial fibrosis. In addition, genetic and biomarker analyses will be performed. The Hypertrophic Cardiomyopathy Registry has the potential to change the paradigm of risk stratification in HCM, using novel markers to identify those at higher risk.

Catheter Ablation of Arrhythmia During Pregnancy.

Cardiac arrhythmia as a complication of pregnancy can be problematic to maternal health and fetal life and development. Catheter ablation of tachyarrhythmias during pregnancy has been successfully performed in selected patients with limited experience. Techniques to limit maternal and fetal radiation exposure, including intracardiac echo and electroanatomic mapping systems, are particularly important in this setting. Specific accommodations are necessary in the care of the gravid patient during catheter ablation.

Major complications and mortality within 30 days of an electrophysiological procedure at an academic medical center: implications for developing national standards.

BACKGROUND: Despite growing attention to performance and quality measures, national standards for reporting of outcomes after all electrophysiology (EP) procedures have not yet been developed. We sought to characterize the incidence and timing of adverse events up to 30 days after EP procedures at a tertiary academic medical center. METHODS AND RESULTS: We prospectively followed all patients undergoing EP procedures between January 2010 and September 2012. All were followed for 30 days postprocedure either in clinic or by telephone. Major complications were defined as events related to the procedure that led to prolongation of hospital stay or readmission, required additional procedural intervention, or resulted in death or significant injury. These were further categorized as intraprocedure, postprocedure, or postdischarge events. Seven EP physicians collectively adjudicated whether complications were directly related to the procedure. A total of 3,213 procedures were performed. Major complications occurred in 2.2% of patients; 49% of these events occurred after discharge. Death occurred in 0.6% of patients; 73% of these deaths were found to be secondary to worsening of the patient's underlying comorbid conditions and unrelated to the procedure. CONCLUSIONS: When considering national standards for reporting outcomes of all EP procedures, continued follow-up after discharge is important. In our cohort, half of major complications occurring within 30 days occurred after discharge. In addition, three-quarters of deaths within 30 days were not directly related to the procedure and caution should be used in using all-cause mortality as an outcome measure for EP procedures.

Acute decompensated heart failure: update on new and emerging evidence and directions for future research.

Acute decompensated heart failure (ADHF) is a complex clinical event associated with excess morbidity and mortality. Managing ADHF patients is challenging because of the lack of effective treatments that both reduce symptoms and improve clinical outcomes. Existing guideline recommendations are largely based on expert opinion, but several recently published trials have yielded important data to inform both current clinical practice and future research directions. New insight has been gained regarding volume management, including dosing strategies for intravenous loop diuretics and the role of ultrafiltration in patients with heart failure and renal dysfunction. Although the largest ADHF trial to date (ASCEND-HF, using nesiritide) was neutral, promising results with other investigational agents have been reported. If these findings are confirmed in phase III trials, novel compounds, such as relaxin, omecamtiv mecarbil, and ularitide, among others, may become therapeutic options. Translation of research findings into quality clinical care can not be overemphasized. Although many gaps in knowledge exist, ongoing studies will address issues around delivery of evidence-based care to achieve the goal of improving the health status and clinical outcomes of patients with ADHF.

Efficacy and safety of ventricular tachycardia ablation with mechanical circulatory support compared with substrate-based ablation techniques.

AIMS: Catheter ablation of ventricular tachycardia (VT) can be limited by haemodynamic instability. In these cases, substrate-based ablation is typically performed. An alternative is to perform activation and entrainment mapping during VT supported by a percutaneous left ventricular assist device (pVAD). We sought to compare the complication and success rates of pVAD-assisted VT ablation with scar-based techniques. METHODS AND RESULTS: Thirteen consecutive patients with haemodynamically unstable VT underwent pVAD-assisted ablation (pVAD group) and were retrospectively compared with 18-matched patients undergoing a substrate-based VT ablation (non-pVAD group). There was no significant difference in age or ejection fraction between the groups although pVAD patients tended to have more shocks in the preceding months. Procedure times were longer for the pVAD group. The number of monomorphic VTs induced was greater in the pVAD group (3.2 vs. 1.6, P= 0.04); however, after ablation, there was no difference in inducibility between the pVAD and non-pVAD group (10 of 13 vs. 12 of 18; 77 vs. 67%, P = 0.69). There was no difference in acute complications including stroke or death. At 9 ± 3 months, 1-year freedom from implantable cardioverter-defibrillator (ICD) shocks/therapies for sustained VT were similar (P= 0.96). In multivariable analysis, the absence of atrial fibrillation (hazard ratio=0.15, P= 0.04) was associated with a lower incidence of ICD shocks. CONCLUSIONS: In high-risk patients, pVAD-assisted VT ablation guided by activation and entrainment mapping is a feasible alternative to substrate mapping and allows outcomes comparable to substrate mapping.

Bundle-branch block morphology and other predictors of outcome after cardiac resynchronization therapy in Medicare patients.

BACKGROUND: Clinical trials of cardiac resynchronization therapy (CRT) have enrolled a select group of patients, with few patients in subgroups such as right bundle-branch block (RBBB). Analysis of population-based outcomes provides a method to identify real-world predictors of CRT outcomes. METHODS AND RESULTS: Medicare Implantable Cardioverter-Defibrillator Registry (2005 to 2006) data were merged with patient outcomes data. Cox proportional-hazards models assessed death and death/heart failure hospitalization outcomes in patients with CRT and an implantable cardioverter-defibrillator (CRT-D). The 14 946 registry patients with CRT-D (median follow-up, 40 months) had 1-year, 3-year, and overall mortality rates of 12%, 32%, and 37%, respectively. New York Heart Association class IV heart failure status (1-year hazard ratio [HR], 2.23; 3-year HR, 1.98; P<0.001) and age ≥ 80 years (1-year HR, 1.74; 3-year HR, 1.75; P<0.001) were associated with increased mortality both early and late after CRT-D. RBBB (1-year HR, 1.44; 3-year HR, 1.37; P<0.001) and ischemic cardiomyopathy (1-year HR, 1.39; 3-year HR, 1.44; P<0.001) were the next strongest adjusted predictors of both early and late mortality. RBBB and ischemic cardiomyopathy together had twice the adjusted hazard for death (HR, 1.99; P<0.001) as left BBB and nonischemic cardiomyopathy. QRS duration of at least 150 ms predicted more favorable outcomes in left BBB but had no impact in RBBB. A secondary analysis showed lower hazards for CRT-D compared with standard implantable cardioverter-defibrillators in left BBB compared with RBBB. CONCLUSIONS: In Medicare patients, RBBB, ischemic cardiomyopathy, New York Heart Association class IV status, and advanced age were powerful adjusted predictors of poor outcome after CRT-D. Real-world mortality rates 3 to 4 years after CRT-D appear higher than previously recognized.

Ablation of incessant left atrial tachycardia without fluoroscopy in a pregnant woman.

BACKGROUND: Management of symptomatic atrial arrhythmia in pregnancy remains a challenge. In this case report, a pregnant woman with incessant tachycardia underwent successful left atrial ablation. The entire procedure was performed without fluoroscopy. METHODS AND RESULTS: A 20-year-old woman, 27 weeks pregnant, was admitted with congestive cardiac failure and incessant atrial tachycardia. She had an elevated brain natriuretic peptide (BNP) and chest X-ray demonstrating heart failure. The 12-lead electrocardiogram (ECG) showed atrial tachycardia with a cycle length of 310 ms, inverted P waves in lead I and the inferior leads, and a ventricular rate of 84 bpm during 2:1 block. Echocardiogram showed a global reduction in left ventricular function with a left ventricular ejection fraction (LVEF) of 0.40. Electrical cardioversion failed. Rate control could not be achieved with beta-blockers and calcium antagonists. Amiodarone with repeat cardioversion was also unsuccessful. The patient then underwent catheter ablation. The entire procedure was performed using intracardiac echocardiography (ICE) and electroanatomical mapping with no fluoroscopy. Electrophysiology (EP) study and an activation map of the left atrium confirmed a focal left atrial tachycardia which was successfully ablated. Six weeks postablation, the left ventricular function had normalized and the patient delivered a healthy child at term, without complication. CONCLUSION: Ablation of left atrial tachycardia using ICE and electroanatomical guidance is feasible in pregnant women.

Treatment of a malpositioned transcutaneous ventricular pacing lead in the left ventricle via direct aortic puncture.

An 81-year-old woman with progressive cough was hospitalized 2 weeks following transcutaneous pacemaker implantation. Imaging revealed an absent brachiocephalic vein and aberrant course of a ventricular lead into the aorta with implantation into the left ventricle. We describe the unusual anatomic course, diagnosis, and surgical extraction of a malpositioned pacer lead.

Sonication of explanted cardiac rhythm management devices for the diagnosis of pocket infections and asymptomatic bacterial colonization.

BACKGROUND: Correct diagnosis of the causative organism is critical for the treatment of pacemaker and defibrillator pocket infections. No gold standard for this exists, although swab and tissue cultures are frequently used. The purpose of this study was to determine the value of ultrasonication of explanted generators in the diagnosis of pocket infections and asymptomatic bacterial colonization. METHODS: Samples were prospectively collected during pacemaker and defibrillator generator extractions for elective replacements, upgrades, or pocket infections. The devices were placed in an ultrasonicator for 5 minutes and the fluid sent for culture, along with swab and tissue cultures. RESULTS: Eighty-two patients with pacemakers (n = 46) or defibrillators (n = 36) underwent generator explantation, 66 of these for elective reasons and 16 for pocket infection. In patients with pocket infection, 15 (94%) received a definitive bacterial diagnosis using a combination of all three-culture modalities. Cultures were positive in 15 sonicated fluid, 13 tissue, and 11 swab samples, with Staphylococcus aureus and other skin flora commonly seen. In asymptomatic patients, 14 (21%) had positive cultures. Cultures were positive in 11 sonicated fluid, eight tissue, and two swab samples. Skin flora was commonly seen, but three of the sonicated fluid cultures grew gram-negative rods. No patients with asymptomatic colonization developed clinical infection during the follow-up period. CONCLUSIONS: Ultrasonication is an inexpensive and simple technique that improves the bacteriologic diagnosis of device pocket infections. It also identifies a significant proportion of patients with asymptomatic colonization, although this is not a marker of future pocket infection.

Predictors of Major Atrial Fibrillation Endpoints in the National Heart, Lung, and Blood Institute HCMR.

OBJECTIVES: This study sought to identify predictors of major clinically important atrial fibrillation endpoints in hypertrophic cardiomyopathy. BACKGROUND: Atrial fibrillation (AF) is a common morbidity associated with hypertrophic cardiomyopathy (HCM). The HCMR (Hypertrophic Cardiomyopathy Registry) trial is a prospective natural history study of 2,755 patients with HCM with comprehensive phenotyping. METHODS: All patients received yearly telephone follow-up. Major AF endpoints were defined as requiring electrical cardioversion, catheter ablation, hospitalization for >24 h, or clinical decisions to accept permanent AF. Penalized regression via elastic-net methodology identified the most important predictors of major AF endpoints from 46 variables. This was applied to 10 datasets, and the variables were ranked. Predictors that appeared in all 10 sets were then used in a Cox model for competing risks and analyzed as time to first event. RESULTS: Data from 2,631 (95.5%) patients were available for analysis after exclusions. A total of 127 major AF endpoints events occurred in 96 patients over 33.3 ± 12.4 months. In the final model, age, body mass index (BMI), left atrial (LA) volume index, LA contractile percent (active contraction), moderate or severe mitral regurgitation (MR), and history of arrhythmia the most important. BMI, LA volume index, and LA contractile percent were age-dependent. Obesity was a stronger risk factor in younger patients. Increased LA volume, reduced LA contractile percent, and moderate or severe MR put middle-aged and older adult patients at increased risk. CONCLUSIONS: The major predictors of major AF endpoints in HCM include older age, high BMI, moderate or severe MR, history of arrhythmia, increased LA volume, and reduced LA contractile percent. Prospective testing of a risk score based on these parameters may be warranted.

Image integration using intracardiac ultrasound and 3D reconstruction for scar mapping and ablation of ventricular tachycardia.

BACKGROUND: Ablation of ventricular tachycardia (VT) reduces implantable cardioverter defibrillator shocks. Intracardiac ultrasound (ICE) can visualize and quantify the function of all left ventricular wall segments. We thus hypothesized that ICE could identify scar tissue and provide a guide to facilitate substrate-guided VT ablation. METHODS: Eighteen patients underwent VT ablation with real time ICE mapping from the right atrium and ventricle with online 3D-image reconstruction of scar segments. The left ventricle was also scar mapped by traditional electroanatomic mapping (CARTO) for comparison. Images from these 2 scar mapping techniques were compared to each other as well as to a preprocedure transthoracic echocardiogram. RESULTS: The average age was 65 +/- 12 years and 12 (67%) were male (15 [83%] had ischemic cardiomyopathy). Two patients (12%) had recurrence of their clinical VT (1 remained on an antiarrhythmic medication, the other had a repeat ablation) over a follow-up of 127 +/- 33 days. No periprocedural or long-term adverse events occurred. A total of 248 wall segments were analyzed. All 3 modalities were concordant in scar identification in 193 (78%) segments. The ICE segments correlated with the electroanatomic map in 213 (86%) segments versus 198 (80%), which correlated with transthoracic echocardiography and electroanatomic mapping (P = 0.046). Specifically, the ICE wall motion scores were closer to the electroanatomic mapping in the basal segments and showed a higher accuracy in ischemic heart disease. CONCLUSION: These data demonstrate that real time ICE images provide accurate chamber geometries and scar boundaries of the left ventricle. These scar borders were more accurate than transthoracic echocardiography and illustrate the feasibility of ICE for substrate-based ablation for VT.

Real-time rotational ICE imaging of the relationship of the ablation catheter tip and the esophagus during atrial fibrillation ablation.

INTRODUCTION: Atrioesophageal fistula is a rare complication of atrial fibrillation (AF) ablation that should be avoided. We investigated whether rotational intracardiac echocardiography (ICE) can help to minimize ablation close to the esophagus. METHODS AND RESULTS: We studied 41 patients referred for catheter ablation of refractory AF. A rotational ICE catheter was inserted into the (LA) to determine the location of the esophagus. The esophagus was identified to be either adjacent to the pulmonary vein (PV) ostium or to a cuff 2 cm outside the ostium. Circumferential ablation was performed at the PV ostium, with the exact ablation location determined by ICE. The relationship of the catheter tip to the esophagus was imaged during energy delivery, allowing interruption when respiration moved the tip closer to the esophagus. Out of 41 patients, the esophagus was seen near left-sided PVs in 32 and near right-sided PVs in three patients. The median distance from LA endocardium to esophagus was 2.2 mm (range, 1.4-6 mm). In 21 of 35 patients with a closely related esophagus, ablation over the esophagus was avoided by ablating either lateral or medial to the esophagus. In 14 patients, the esophagus could not be avoided, and risk was minimized by limiting lesion size. Significant movement (>10 mm) of the esophagus during the procedure occurred in 3/41 cases. CONCLUSION: Rotational ICE can accurately determine the distance of ablation sites from the esophagus. Real-time imaging of the relationship of the ablation catheter tip to the esophagus may reduce the incidence of esophageal injury.

Distinct Subgroups in Hypertrophic Cardiomyopathy in the NHLBI HCM Registry.

BACKGROUND: The HCMR (Hypertrophic Cardiomyopathy Registry) is a National Heart, Lung, and Blood Institute-funded, prospective registry of 2,755 patients with hypertrophic cardiomyopathy (HCM) recruited from 44 sites in 6 countries. OBJECTIVES: The authors sought to improve risk prediction in HCM by incorporating cardiac magnetic resonance (CMR), genetic, and biomarker data. METHODS: Demographic and echocardiographic data were collected. Patients underwent CMR including cine imaging, late gadolinium enhancement imaging (LGE) (replacement fibrosis), and T1 mapping for measurement of extracellular volume as a measure of interstitial fibrosis. Blood was drawn for the biomarkers N-terminal pro-B-type natriuretic peptide (NT-proBNP) and high-sensitivity cardiac troponin T (cTnT), and genetic analysis. RESULTS: A total of 2,755 patients were studied. Mean age was 49 ± 11 years, 71% were male, and 17% non-white. Mean ESC (European Society of Cardiology) risk score was 2.48 ± 0.56. Eighteen percent had a resting left ventricular outflow tract (LVOT) gradient ≥30 mm Hg. Thirty-six percent had a sarcomere mutation identified, and 50% had any LGE. Sarcomere mutation-positive patients were more likely to have reverse septal curvature morphology, LGE, and no significant resting LVOT obstruction. Those that were sarcomere mutation negative were more likely to have isolated basal septal hypertrophy, less LGE, and more LVOT obstruction. Interstitial fibrosis was present in segments both with and without LGE. Serum NT-proBNP and cTnT levels correlated with increasing LGE and extracellular volume in a graded fashion. CONCLUSIONS: The HCMR population has characteristics of low-risk HCM. Ninety-three percent had no or only mild functional limitation. Baseline data separated patients broadly into 2 categories. One group was sarcomere mutation positive and more likely had reverse septal curvature morphology, more fibrosis, but less resting obstruction, whereas the other was sarcomere mutation negative and more likely had isolated basal septal hypertrophy with obstruction, but less fibrosis. Further follow-up will allow better understanding of these subgroups and development of an improved risk prediction model incorporating all these markers.

Device therapies in the post-myocardial infarction patient with left ventricular dysfunction.

The post-myocardial infarction (MI) patient with left ventricular dysfunction (LVD) is at risk for ventricular arrhythmias resulting in sudden cardiac death. In high-risk post-MI patients with a depressed left ventricular ejection fraction, prophylactic implantable cardioverter defibrillators (ICDs) may significantly improve survival. These benefits are in addition to those of optimal pharmacologic therapy, and ICD therapy should be considered the standard of care in these patients. Recent device trials have demonstrated the benefits of prophylactic ICD placement in patients who have been selected based on post-MI left ventricular systolic dysfunction alone. In addition, cardiac resynchronization therapy can improve the quality of life beyond that achievable with drug therapy alone and should be considered in patients with symptomatic heart failure with QRS prolongation. Further risk stratification studies of post-MI LVD patients will allow ICD therapy to be applied in a more cost-effective manner.