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Biomedical subjects

Kenneth A Ellenbogen

Publications and source records attributed to Kenneth A Ellenbogen.

At least 55 records · Page 3Linked to original sources
PubMed2005

Trial to evaluate the management of paroxysmal supraventricular tachycardia during an electrophysiology study with tecadenoson.

BACKGROUND: Tecadenoson is a potent selective A1-adenosine receptor agonist with a dose-dependent negative dromotropic effect on the AV node. Tecadenoson terminates induced paroxysmal supraventricular tachycardia (PSVT) without the clinically significant side effects caused by stimulation of other adenosine receptors. This trial was designed to determine a safe and effective tecadenoson bolus for termination of electrophysiologically induced PSVT. METHODS AND RESULTS: Patients with a history of symptomatic PSVT and inducible PSVT at the time of a clinically indicated electrophysiology study were randomized into a multicenter, double-blind, placebo-controlled trial. Five 2-dose tecadenoson bolus regimens were evaluated versus placebo (75/150, 150/300, 300/600, 450/900, 900 microg/900 microg). The second bolus was administered only if PSVT persisted for 1 minute after the first bolus. Each tecadenoson regimen resulted in a significant therapeutic conversion rate compared with placebo (range, 50.0% to 90.3%, analysis of all patients dosed; n=181; P<0.0005). Conversion by the first bolus was dose related (range: placebo, 3.3% to 86.7% for 900 microg/900 microg). Time to conversion was dose dependent, with a median time of <1 minute for the 3 highest dose regimens. Postconversion arrhythmias were transient, requiring no additional treatment in 4 regimens (including placebo). Transient second- and third-degree heart block occurred at higher doses (300/600, 450/900, 900 microg/900 microg) and was supported with backup pacing when needed. No effect on blood pressure was observed. Ten patients with a history of asthma or chronic obstructive pulmonary disease tolerated tecadenoson without bronchospasm. CONCLUSIONS: We identified an optimal tecadenoson regimen (300 microg/600 microg) that effectively and rapidly converted 90% (28 of 31) of PSVT patients to normal sinus rhythm with no significant adverse effects.

Adenosine↗
PubMed2005

Implantable cardioverter defibrillators and cardiac resynchronization therapy in patients with left ventricular dysfunction: randomized trial evidence through 2004.

Although many studies have shown that implantable cardioverter defibrillator (ICD) therapy improves the survival of patients with significant left ventricular dysfunction, the magnitude of effectiveness of ICD therapy in clinically defined subgroups remains uncertain. Similarly, although studies have shown an improvement in patients' hemodynamics and quality of life with cardiac resynchronization therapy (CRT), there is a continuing uncertainty about the effect of CRT on patients' survival and the magnitude of improvement in quality of life with this therapy. On August 24, 2004, an ad hoc group of experts representing clinical cardiovascular medicine, biostatistics, economics, and health policy were joined by representatives of the Food and Drug Administration, Centers for Medicare and Medicaid Services (Baltimore, Md), Agency for Healthcare Research and Quality (Rockville, Md), and the device industry for a 1-day round table to review the available clinical trial evidence on the effect of ICD therapy in the primary prevention of sudden cardiac death and the effect of CRT in patients with congestive heart failure. The meeting was organized by the Duke Clinical Research Institute, Durham, NC, and funded in part by the Agency for Healthcare Research and Quality. This document summarizes the evidence reviewed at that meeting and the discussions of that evidence.

Death, Sudden, Cardiac↗
PubMed2005

Unusual variant of atrioventricular nodal reentrant tachycardia.

Electrophysiologic study in a patient with supraventricular tachycardia revealed an unusual activation pattern in the coronary sinus (CS) electrodes. Pacing maneuvers confirmed the tachycardia was a slow-slow AV nodal reentrant tachycardia with double potentials in the distal CS electrodes due to an earlier left atrial signal (50 ms) and later CS musculature activation. The left-sided AV nodal inputs were successfully ablated from within the CS.

Cardiac Pacing, Artificial↗
PubMed2005

Temporal patterns of ventricular tachyarrhythmia recurrences follow a Weibull distribution.

UNLABELLED: Temporal patterns of ventricular tachyarrhythmias. INTRODUCTION: The objective of this study was to test whether the temporal patterns of ventricular tachyarrhythmia recurrences in patients with implantable cardioverter-defibrillator (ICD) follow a random or a clustered distribution. METHODS: Data analysis was conducted using the Medtronic (Minneapolis, MN) Gem DR database of 521 ICD patients. Patients with >or=3 sustained ventricular tachyarrhythmia detections that resulted in shock or antitachycardia pacing therapies were studied. The times between consecutively treated ICD detections for each patient were compared to an exponential model of random recurrences and a Weibull model for clustered recurrences. RESULTS: Seventy-one patients had >or=3VT episodes during follow-up of 131+/-86 days. A total of 2347 VT episodes were recorded (33+/-65 episodes/patient, median 10 episodes/patient). Patient age was 66+/-13 years, 78% male, 83% coronary artery disease, ejection fraction 31+/-11%, and 63% were taking antiarrhythmic drugs. By the Kolmogorov-Smirnov goodness-of-fit test, 38 of 71 patients (53.5%) showed that the pattern of detections differed from an exponential model (P<0.01 for each patient and the proportion of patients was similar to chance at P=0.65). In contrast, only 11 out of 71 patients (15.5%) showed that the pattern differed from the Weibull model (P<0.01 for each patient). The proportion of patients fitting the Weibull model was significantly greater than chance and was greater that the proportion fitting the exponential model (both P<0.001). The time interval between consecutive detections was less than 1 hour for 78% of all 2347 detections. The proportion of all 521 patients with >or=2, >or=3, >or= 4, >or=6, >or=8, and >or=10 ICD detections in a 24-hour period was 10.5%, 9.5%, 8.1%, 7.0%, 6.3%, and 5.2%, respectively. CONCLUSION: In most patients with >or=3 ICD detections, the recurrence pattern of treated ventricular tachyarrhythmia detections are clustered and can be described by a Weibull distribution. The proportion of patients with multiple detections in a 24-hour period declines in a linear fashion as the number of events in 24 hours increases from 2 to 10 events.

Aged↗
PubMed2005

Serial changes in right ventricular apical pacing lead impedance predict changes in left ventricular ejection fraction and functional class in heart failure patients.

Pacing impedance has been proposed to monitor the clinical status of patients with congestive heart failure (CHF). This study examined whether changes in right ventricular (RV) pacing impedance correlate with changes in left ventricular ejection fraction (LVEF) and New York Heart Association (NYHA) functional class during long-term follow-up in pacemaker recipients with CHF. The study included 67 patients, 70 +/- 12 years of age, in NYHA class II or III, and with a mean LVEF = 29 +/- 8% at implant. LVEF, NYHA class, and bipolar pacing impedance at the RV outflow tract (RVOT) and apex (RVA) were measured at implant and at 3, 6, 9, and 12 months of follow-up. At implant, impedance was similar in RVOT (548 +/- 115 Omega) and RVA (571 +/- 174 Omega). Between implant and 3 months, mean impedance decreased (P < 0.0001) at both the RVOT (472 +/- 62 Omega) and RVA (488 +/- 86 Omega), LVEF increased (43 +/- 14%, P < 0.0001), and the NYHA class decreased from 2.4 +/- 0.5 to 2.1 +/- 0.6 (P = 0.0001). Changes in RVA impedance correlated with changes in LVEF (r = 0.45, P = 0.002). A 50 Omega decrease in RVA impedance corresponded to a 3% decrease in LVEF. RVA impedance decreased significantly as NYHA class increased from I to IV (P = 0.04). There was no correlation between impedance measured at the RVOT and LVEF or NYHA class. A decrease in bipolar pacing impedance at the RVA was associated with worsening LVEF and the NYHA class. The use of pacing impedance to monitor the clinical status in CHF is dependent on the RV pacing site.

Aged↗
PubMed2005

Automatic identification of clinical lead dysfunctions.

Implantable cardioverter defibrillators (ICD) lead dysfunctions can cause inappropriate shocks. Current ICDs store lead diagnostics and detected episodes. This stored information with intracardiac electrograms (EGM) and sensed RR interval patterns may characterize the ICD lead performance. The aim of this analysis was to determine the sensitivity and positive predictive value (PPV) of an automatic lead dysfunction identification algorithm. This algorithm uses RR and EGM data to distinguish noncardiac oversensing (OS), for example, due to conductor fracture, and cardiac OS, for example, T-wave OS, from detected episodes. The algorithm also uses lead diagnostics: sensing integrity counter trends (e.g., RR intervals <140 ms), nonsustained tachyarrhythmias episodes with a mean RR <200 ms and impedance trends to identify lead fractures. The PPV was determined using the stored memory from 1,756 ICD patients enrolled in a 13-center long-term lead study with an average follow-up of 18.3 patient-months. Sensitivity was determined in 35 patients who presented with OS or lead fracture-related adverse events confirmed by stored ICD diagnostics. The algorithm sensitivity was 97.1% (34/35). There were 43 additional patients identified by the algorithm without an adverse event. Stored ICD diagnostics confirmed lead dysfunctions in 32 of 43 patients corresponding with an 85.7% PPV (66/77). ICD memory diagnostics and episodes with intracardiac EGM may be used to identify ICD lead dysfunctions with high sensitivity and PPV. This algorithm may be implemented in postprocessing ICD environments (e.g., remote server, programmer) to rapidly identify lead dysfunction prior its clinical manifestation.

Algorithms↗
PubMed2005

Multicenter, prospective, randomized safety and efficacy study of a new atrial-based managed ventricular pacing mode (MVP) in dual chamber ICDs.

BACKGROUND: Ventricular desynchronization caused by right ventricular pacing may impair ventricular function and increase risk of heart failure (CHF), atrial fibrillation (AF), and death. Conventional DDD/R mode often results in high cumulative percentage ventricular pacing (Cum%VP). We hypothesized that a new managed ventricular pacing mode (MVP) would safely provide AAI/R pacing with ventricular monitoring and DDD/R during AV block (AVB) and reduce Cum%VP compared to DDD/R. METHODS: MVP RAMware was downloaded in 181 patients with Marquis DR ICDs. Patients were initially randomized to either MVP or DDD/R for 1 month, then crossed over to the opposite mode for 1 month. ICD diagnostics were analyzed for cumulative percentage atrial pacing (Cum%AP), Cum%VP, and duration of DDD/R pacing for spontaneous AVB. RESULTS: Baseline characteristics included age 66 +/- 12 years, EF 36 +/- 14%, and NYHA Class II-III 36%. Baseline PR interval was 190 +/- 53 msec and programmed AV intervals (DDD/R) were 216 +/- 50 (paced)/189 +/- 53 (sensed) msec. Mean Cum%VP was significantly lower in MVP versus DDD/R (4.1 +/- 16.3 vs 73.8 +/- 32.5, P < 0.0001). The median absolute and relative reductions in Cum%VP during MVP were 85.0 and 99.9, respectively. Mean Cum%AP was not different between MVP versus DDD/R (48.7 +/- 38.5 vs 47.3 +/- 38.4, P = 0.83). During MVP overall time spent in AAI/R was 89.6% (intrinsic conduction), DDD/R 6.7% (intermittent AVB), and DDI/R 3.7% (AF). No adverse events were attributed to MVP. CONCLUSIONS: MVP safely achieves functional atrial pacing by limiting ventricular pacing to periods of intermittent AVB and AF in ICD patients, significantly reducing Cum%VP compared to DDD/R. MVP is a universal pacing mode that adapts to AVB and AF, providing both atrial pacing and ventricular pacing support when needed.

Adult↗
PubMed2004

Clinical assessment and management of patients with implanted cardioverter-defibrillators presenting to nonelectrophysiologists.

All physicians increasingly will encounter patients who have implanted cardioverter-defibrillators (ICDs) for protection from ventricular arrhythmias. This advisory provides a concise summary relevant to the assessment and management of patients with ICDs, including those who present to primary care or emergency department physicians with symptoms suggesting arrhythmia or ICD malfunction and those who require cardiac or surgical procedures.

Anti-Arrhythmia Agents↗
PubMed2004

An algorithm to predict implantable cardioverter-defibrillator lead failure.

OBJECTIVES: The goal of this analysis was to test an algorithm that identifies implantable cardioverter-defibrillator (ICD) lead problems before clinical failure and/or inappropriate therapy. BACKGROUND: The ICD lead failures typically present as inappropriate shock therapy. Identifying lead failures before their clinical presentation may prevent patient discomfort, improve device longevity, and avoid device-induced proarrhythmia. METHODS: We tested an algorithm that uses two measures of oversensing and one measure of abnormal impedance to detect a lead failure. The oversensing measures consisted of a counter for RR intervals <140 ms and nonsustained ventricular tachycardia episodes with mean RR interval <200 ms. The impedance measure tracked lead impedances every day and each week. Abnormal impedance was defined as a decrease in impedances or an outlier value compared with baseline. Lead failures were identified when both oversensing measures were met or abnormal impedance and one oversensing measure occurred. The stored data from 696 patients with an ICD were analyzed to determine the sensitivity and specificity of the algorithm to detect lead failures. RESULTS: Twenty-nine patients demonstrated clinical lead failures with an average of 6 +/- 9 inappropriate shocks per patient. The two oversensing measures used in the algorithm predicted 72% (21 of 29) of the lead failures. Fulfilling at least two of the three impedance and oversensing measures, the sensitivity of our algorithm was 83% (24 of 29) with a 100% (667 of 667) specificity. CONCLUSION: Oversensing combined with abnormal impedance trends may be used to identify ICD lead failures with high sensitivity and very high specificity.

Algorithms↗
PubMed2004

Highlights of Heart Rhythm 2004, the Annual Scientific Sessions of the Heart Rhythm Society: May 19 to 22, 2004, in San Francisco, California.

Heart Rhythm 2004, the 25th Annual Scientific Sessions of the Heart Rhythm Society (formerly the North American Society of Pacing and Electrophysiology), met in San Francisco in May 2004. The meeting is the world's premier forum for the presentation of research and the exchange of state-of-the-art information in cardiac electrophysiology and pacing. Major new research findings were presented on the value of implantable cardioverter-defibrillator therapy, noninvasive methods for risk stratification, treatment of vasovagal syncope, radiofrequency ablation for atrial fibrillation, resynchronization therapy for heart failure, and new insights from basic science into the mechanisms of cardiac arrhythmias.

Arrhythmias, Cardiac↗