Biomedical subjects
Publications and source records attributed to Kenneth A Ellenbogen.
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Because the number of implantable cardiac devices has dramatically increased, device alerts and advisories have become a part of routine clinical practice. When a physician is faced with the management of a patient with an implanted device that has been the subject of a recall or advisory, the major concern facing the clinician is how to manage the patient and whether the device needs to be replaced. A rational approach to evaluating patients with a device or lead that is the subject of a US Food and Drug Administration advisory requires evaluating the competing risks of elective device or lead replacement versus keeping the recalled device or lead in place. It is important to keep in mind that the risks of replacing devices are not insignificant and may outweigh the risks of death from device malfunction. Ultimately, this decision should be based on the estimated device (lead) malfunction rate, device (lead) dependency, and an individual center's procedural risk for complications from generator (lead) removal, and should also factor in patient preferences.
BACKGROUND: Implantable cardioverter-defibrillator (ICD) lead failures often present as inappropriate shock therapy. An algorithm that can reliably discriminate between ventricular tachyarrhythmias and noise due to lead failure may prevent patient discomfort and anxiety and avoid device-induced proarrhythmia by preventing inappropriate ICD shocks. OBJECTIVES: The goal of this analysis was to test an ICD tachycardia detection algorithm that differentiates noise due to lead failure from ventricular tachyarrhythmias. METHODS: We tested an algorithm that uses a measure of the ventricular intracardiac electrogram baseline to discriminate the sinus rhythm isoelectric line from the right ventricular coil-can (i.e., far-field) electrogram during oversensing of noise caused by a lead failure. The baseline measure was defined as the product of the sum (mV) and standard deviation (mV) of the voltage samples for a 188-ms window centered on each sensed electrogram. If the minimum baseline measure of the last 12 beats was <0.35 mV-mV, then the detected rhythm was considered noise due to a lead failure. The first ICD-detected episode of lead failure and inappropriate detection from 24 ICD patients with a pace/sense lead failure and all ventricular arrhythmias from 56 ICD patients without a lead failure were selected. The stored data were analyzed to determine the sensitivity and specificity of the algorithm to detect lead failures. RESULTS: The minimum baseline measure for the 24 lead failure episodes (0.28 +/- 0.34 mV-mV) was smaller than the 135 ventricular tachycardia (40.8 +/- 43.0 mV-mV, P <.0001) and 55 ventricular fibrillation episodes (19.1 +/- 22.8 mV-mV, P <.05). A minimum baseline <0.35 mV-mV threshold had a sensitivity of 83% (20/24) with a 100% (190/190) specificity. CONCLUSION: A baseline measure of the far-field electrogram had a high sensitivity and specificity to detect lead failure noise compared with ventricular tachycardia or fibrillation.
BACKGROUND: Successful radiofrequency (RF) ablation of typical, isthmus-dependent atrial flutter requires establishment and confirmation of bidirectional conduction block across the cavotricuspid isthmus. Low atrial pacing usually is performed from the bipoles of the 20-pole Halo catheter, septal and lateral to the cavotricuspid isthmus ablation line. However, occasionally this is difficult because of high pacing thresholds and/or saturation of the atrial electrograms recorded near the pacing catheter. OBJECTIVES: The purpose of this study was to assess if right ventricular (RV) pacing and resulting retrograde atrial activation can be used to assess conduction block from the septum to the lateral wall in a clockwise direction. METHODS: Thirty-five consecutive male patients (mean age 64 +/- 10 years; mean ejection fraction 42 +/- 13%; mean left atrial dimension 44 +/- 6 mm) with typical isthmus-dependent atrial flutter were studied. The following electrophysiology catheters were used: 20-pole catheter along the tricuspid annulus, quadripolar catheters at the His and/or RV apex, and 8-mm ablation catheter. Following RF ablation of the cavotricuspid isthmus, bidirectional conduction block was confirmed in all 35 patients by pacing at a cycle length of 600 ms from bipoles septal and lateral to the cavotricuspid isthmus ablation line. Conduction times from pacing artifact to adjacent bipolar atrial electrograms and reversal of atrial activation pattern were analyzed. RV pacing was performed and retrograde atrial activation pattern assessed. If retrograde AV nodal conduction was absent, isoproterenol was infused intravenously at 2 microg/min, and RV pacing was repeated. The conduction time between the double potentials across the cavotricuspid isthmus ablation line was measured. RESULTS: Mean conduction times across the isthmus during septal (S), lateral (L), and RV pacing were 145 +/- 21 ms, 144 +/- 24 ms, and 129 +/- 20 ms, respectively. Retrograde AV nodal conduction was present in 34 of 35 patients (isoproterenol 8 patients). Evidence of conduction block by a clear change in activation pattern across the isthmus was seen during RV pacing in 33 of 35 patients with bidirectional conduction block. CONCLUSION: RV pacing is a simple and easy maneuver that can be performed to assess isthmus conduction in most patients.
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AIMS: To detect and characterize the acoustic energy generated by microbubble (MB) formation in an isolated tissue preparation. MB formation during radiofrequency (RF) ablation indicates excessive tissue heating and may precede explosive 'pops'. Currently, MB formation can only be detected with echocardiography. We hypothesized that MB formation can be detected with high-sensitivity phonocardiography. METHODS AND RESULTS: In a saline bath, RF lesions were created in sections of porcine left ventricle, using a 4 mm tip irrigated catheter. MB formation was visualized with an echocardiography probe. In 20 preparations, RF energy was begun at 25 W and increased by 5 W every 20 s until a pop occurred. A high-sensitivity computerized phonocardiography transducer with frequency bandwidth of 2 kHz and system noise -90 dB (SonoMedica, Inc., Vienna, VA, USA) was coupled to the external glass wall of the bath. In 15 of 20 (75%) preparations, a characteristic acoustic signature corresponding to MB formation was noted before the pop. These signals were within the 600-2000 Hz range and had an intensity range of 10-40 dB. The earliest MB and acoustic signals occurred 51.3+/-51.5 s before the pop. The acoustic signals continued intermittently up to 10.3+/-12.9 s before the pop. CONCLUSION: The acoustic energy created by MB formation can be detected in an isolated tissue preparation, using a computer-based phonocardiography system. Characteristic acoustic signatures are present before pops and correspond to MB formation. Acoustic monitoring for MB formation may allow for the titration of cooled RF ablation without echocardiography.
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PURPOSE OF REVIEW: Heart failure is a major public health problem. Many heart failure patients have electrical and mechanical ventricular dyssynchrony, which are risk factors for death in heart failure patients. RECENT FINDINGS: Cardiac resynchronization therapy, by stimulating both ventricles, is a strategy to improve ventricular dyssynchrony. SUMMARY: This paper describes the historic development of this therapy; reviews the results of completed clinical cardiac resynchronization therapy studies, and discusses ongoing and future studies.
BACKGROUND: Microbubble formation during pulmonary vein (PV) radiofrequency (RF) ablation of atrial fibrillation (AF) occurs relatively frequently. Prior studies have shown that microbubble formation may be associated with an increased risk of complications. However, the incidence, time course, and temperature characteristics of microbubble formation during AF ablation with an 8-mm catheter have not been prospectively described in humans. METHODS: We studied 46 (30 men, age 56+/-10 years) patients with AF who underwent RF ablation of PVs between January 2005 and December 2005 using an 8F, 8-mm Biosensetrade mark ablation catheter (Biosense-Webster, Diamond Bar, CA, USA). All patients underwent continuous intracardiac echocardiography (ICE). Microbubble patterns were classified as either type 1 (intermittent, scattered microbubble formation) or type 2 (explosive shower of dense microbubbles). Formation of any microbubbles was detected by ICE and the time, PV location, and electrode temperature were recorded. RESULT: A total of 1,479 (32+/-13, range 12-73) RF lesions were delivered to 167 veins. Twenty (2%) lesions were classified as type 2. Since the number of lesions resulting in type 2 bubbles was very small, only type 1 lesions were included in the final analysis. Thirty-nine (85%) patients had at least one lesion associated with bubble formation during ablation (mean: 7+/-7 lesions, range 1-28 lesions). Twenty-three percent (327) of the RF lesions resulted in bubble formation. RF generator power setting during lesions resulting in bubble formation was lower than lesions which did not result in bubble formation (47.9+/-7.4 W vs 49.7+/-7.1 W, P<0.001). Logistic regression analysis revealed a significant negative correlation (P<0.001) between RF generator power settings and a positive correlation between the generator temperature settings and formation of bubbles (both P<0.02). However, the maximum temperature attained was not different between lesions resulting in bubble formation (n=327) and those which did not result in bubble formation (n=1,139). Fifty-three (16%) of the lesions associated with bubble formation occurred within 2-10 seconds after RF was begun. Bubble formation was significantly more frequent in left superior PVs compared to the other PVs (left superior PV 27.3% left inferior PV 18.6%, right superior PV 20.5%, and right inferior PV 18.8%, P=0.005, left superior PV vs other PVs, P<0.001) even after adjustment for the other factors including generator power settings and the temperature setting. CONCLUSION: Bubble formation is common during RF ablation of PV with 8-mm tip catheter and can occur as early as 2 seconds after starting RF. RF generator power is negatively correlated with bubble formation while generator temperature settings are positively correlated with formation of bubbles. Microbubble formation is also more frequent with ablation of the left superior PV probably due to better catheter contact in that area.
Atrial fibrillation (AF) and congestive heart failure (CHF) affect millions of patients in the United States. Several studies suggest that AF and in particular the irregular ventricular response might be contributing to the left ventricular dysfunction. Studies that compared pharmacologic rate control to atrioventricular junction (AVJ) ablation followed by right ventricular pacing which restores a regular ventricular response, failed to show an improvement when compared to pharmacological rare control. These results might be explained by the fact that while AVJ ablation restored a regular ventricular response, it subjected patients to the detrimental effects of RV apical pacing. The AVERT-AF trial (Atrio-VEntricular Junction Ablation Followed by Resynchronization Therapy in patients with CHF and AF) is a prospective, randomized, double-blinded, multicenter trial that will be testing the hypothesis that AVJ ablation followed by biventricular pacing significantly improves exercise capacity and functional status compared to pharmacologic rate control in patients with chronic AF and depressed ejection fraction, regardless of rate or QRS duration. A total of 180 patients will be enrolled to test the primary endpoint, which is exercise duration. Patients_enrollment will begin in summer 2006 and is expected to be completed in 2008. The results of this trial should help define the best treatment option for this common arrhythmia in patients with left ventricular dysfunction.
BACKGROUND: The sequence of atrial and ventricular electrograms following termination of ventricular pacing during supraventricular tachycardia has been shown to reliably differentiate atrial tachycardia from atrioventricular nodal reentrant tachycardia (AVNRT) and atrioventricular reentrant tachycardia (AVRT). However in patients with long HV intervals, this may be misleading due to a pseudo "A-A-V" response. The aim of the present study is to see if inclusion of the timing of the His-bundle in the electrogram response (ER) following ventricular pacing would reliably identify the mechanism of tachycardia in patients with long HV intervals. METHODS: Eight patients (7 men) with AVNRT and underlying bundle branch block and long HV (>55 msec) intervals underwent ventricular pacing at 10-40 msec shorter than the tachycardia cycle length during SVT. The ER was classified as "A-A-H" or "A-H" depending on the number of atrial electrograms (A) prior to His deflection following VEP. RESULTS: The ER following ventricular pacing was classified as A-H in all 8 patients. However, using conventional classification the response was A-A-V in 5 of 8 patients due to delayed ventricular activation secondary to long HV intervals and would erroneously suggest atrial tachycardia. The ER was A-V in only 1 of 8 patients. In the remaining 2 patients the A and V electrograms were simultaneous. CONCLUSIONS: Incorporating the His-bundle in the ER following ventricular pacing would eliminate the pseudo "A-A-V" response in patients with AVNRT and long HV intervals. Labeling the response to ventricular pacing as "A-H" or "A-A-H" is simple and more accurate.
OBJECTIVES: While defibrillation energy requirements (DERs) have been extensively studied in patients receiving conventional defibrillators, the DERs of patients receiving cardiac resynchronization therapy with defibrillation capability (CRT-D) devices have not been well described. The purpose of this analysis was to characterize DERs (defined as true threshold or the presence of appropriate safety margins) in patients undergoing implant of a CRT-D and to determine whether DERs in this population were similar to those reported for patients undergoing implantation of conventional defibrillators. METHODS: Data were analyzed retrospectively from the VENTAK CHF/CONTAK CD biventricular pacing study. An appropriate safety margin of at least 10 J was verified with at least two successful conversions with 21 J or less. Multivariate logistic regression was performed to determine baseline predictors of failed DER testing. RESULTS: Of 501 patients enrolled, 444 (89%) had successful DER test outcomes. Of the remaining 57 patients, 34 converted with energies > or = 21J, and 23 had their testing terminated prematurely or were not tested, primarily due to patient condition. Larger left ventricular internal dimension in diastole (P = 0.003) and prolonged procedure time (P = 0.01) were significant predictors of higher energy requirements. Few significant complications arose from DER testing. CONCLUSIONS: DER testing can be accomplished safely and successfully in the majority of CRT-D patients. However, safety margins cannot be ascertained in a significant number of these patients. Left ventricular inner diameter in diastole (LVIDd) and prolonged procedure time may predict higher DERs, and could be used to anticipate the need for a high-energy device or inclusion of a subcutaneous array.
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Previous trials of cardiac resynchronization therapy (CRT) have suggested that this therapy can significantly improve functional class and exercise capacity during short-term follow-up. The impact of this therapy on morbidity and mortality has only recently been reported. The Cardiac Resynchronization-Heart Failure (CARE-HF) study has definitively shown that CRT significantly reduces mortality (36%, p < 0.002) in patients with NYHA functional class III and IV heart failure and ventricular dyssynchrony. This study also shows that CRT reverses ventricular remodeling and improves myocardial performance progressively for at least 18 months. In heart failure patients, the CARE-HF and Comparison of Medical Therapy, Pacing, and Defibrillation in Heart Failure (COMPANION) (the earlier major morbidity/mortality trial) studies together show the unequivocal benefit for CRT therapy and CRT therapy with back-up defibrillation to significantly reduce mortality and hospitalization compared with optimal medical therapy. Both studies suggest the benefit of adding the implantable cardiac defibrillator to CRT devices, as over one-third of deaths in the CRT-pacemaker arm of both the COMPANION and CARE-HF studies were sudden.
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