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Biomedical subjects

H Calkins

Publications and source records attributed to H Calkins.

At least 19 recordsLinked to original sources
PubMed2001

Fludrocortisone acetate to treat neurally mediated hypotension in chronic fatigue syndrome: a randomized controlled trial.

CONTEXT: Patients with chronic fatigue syndrome (CFS) are more likely than healthy persons to develop neurally mediated hypotension (NMH) in response to prolonged orthostatic stress. OBJECTIVE: To examine the efficacy of fludrocortisone acetate as monotherapy for adults with both CFS and NMH. DESIGN: Randomized, double-blind, placebo-controlled trial conducted between March 1996 and February 1999. SETTING: Two tertiary referral centers in the United States. PATIENTS: One hundred individuals aged 18 to 50 years who satisfied Centers for Disease Control and Prevention criteria for CFS and had NMH provoked during a 2-stage tilt-table test. Eighty-three subjects had adequate outcome data to assess efficacy. INTERVENTION: Subjects were randomly assigned to receive fludrocortisone acetate, titrated to 0.1 mg/d (n = 50) or matching placebo (n = 50) for 9 weeks, followed by 2 weeks of observation after discontinuation of therapy. MAIN OUTCOME MEASURE: Proportion of subjects in each group with at least a 15-point improvement on a 100-point global wellness scale. RESULTS: Baseline demographic and illness characteristics between the groups were similar; CFS had been present for at least 3 years in 71%. Using an intention-to-treat analysis, 7 subjects (14%) treated with fludrocortisone experienced at least a 15-point improvement in their wellness scores compared with 5 (10%) among placebo recipients (P =.76). No differences were observed in several other symptom scores or in the proportion with normal follow-up tilt test results at the end of the treatment period. CONCLUSIONS: In our study of adults with CFS, fludrocortisone as monotherapy for NMH was no more efficacious than placebo for amelioration of symptoms. Failure to identify symptomatic improvement with fludrocortisone does not disprove the hypothesis that NMH could be contributing to some of the symptoms of CFS. Further studies are needed to determine whether other medications or combination therapy are more effective in treating orthostatic intolerance in patients with CFS.

Adult↗
PubMed2001

Laser ablation of the pulmonary veins by using a fiberoptic balloon catheter: implications for treatment of paroxysmal atrial fibrillation.

BACKGROUND AND OBJECTIVE: Focal sources of paroxysmal atrial fibrillation may be treatable by electrical isolation of the pulmonary veins from the left atrium. A new fiberoptic balloon catheter was tested as an alternative to radiofrequency catheter ablation for creation of circumferential thermal lesions at the pulmonary vein orifice. STUDY DESIGN/MATERIALS AND METHODS: In vitro and in vivo experiments were conducted in canine hearts to demonstrate efficacy and optimize ablation dosimetry. Continuous-wave, 1.06-microm, Nd:YAG laser radiation was delivered radially through diffusing optical fiber tips enclosed in a balloon catheter. During in vivo studies, the catheter was placed at the pulmonary vein orifice through a left atrial appendage sheath under X-ray fluoroscopic guidance during an open-chest procedure. Additionally, circumferential lesions in the left atrial appendage were correlated with epicardial electrograms demonstrating elimination of electrical activity. RESULTS: The pulmonary veins were successfully ablated by using laser powers of 30--50 W and irradiation times of 60--90 seconds. Transmural, continuous, and circumferential lesions were produced in the pulmonary veins in a single application without evidence of tissue vaporization or endothelial disruption. CONCLUSION: Laser ablation by using a fiberoptic balloon catheter may represent a promising alternative to radiofrequency catheter ablation for electrical isolation of the pulmonary veins from the left atrium during treatment of paroxysmal atrial fibrillation. Further development and testing of the fiberoptic catheter is warranted for possible clinical studies.

Animals↗
PubMed2001

Catheter ablation for cardiac arrhythmias.

The safety and efficacy of catheter ablation for treatment of most types of cardiac arrhythmias are well established. These arrhythmias and arrhythmia substrates include AVNRT, accessory pathways, focal atrial tachycardia, atrial flutter, idiopathic ventricular tachycardia, and bundle-branch re-entry. Catheter ablation is considered as an alternative to pharmacologic therapy in the treatment of these cardiac arrhythmias.

Arrhythmias, Cardiac↗
PubMed2001

Prospective randomized comparison of the safety and effectiveness of placement of endocardial pacemaker and defibrillator leads using the extrathoracic subclavian vein guided by contrast venography versus the cephalic approach.

The purpose of this prospective randomized study was to compare the safety and efficacy of the cephalic approach versus a contrast-guided extrathoracic approach for placement of endocardial leads. Despite an increased incidence of lead fracture, the intrathoracic subclavian approach remains the dominant approach for placement of pacemaker and implantable defibrillator leads. Although this complication can be prevented by lead placement in the cephalic vein or by lead placement in the extrathoracic subclavian or axillary vein, these approaches have not gained acceptance. A total of 200 patients were randomized to undergo placement of pacemaker or implantable defibrillator leads via the contrast-guided extrathoracic subclavian vein approach or the cephalic approach. Lead placement was accomplished in 99 of the 100 patients randomized to the extrathoracic subclavian vein approach as compared to 64 of 100 patients using the cephalic approach. In addition to a higher initial success rate, the extrathoracic subclavian vein medial approach was determined to be preferable as evidenced by a shorter procedure time and less blood loss. There was no difference in the incidence of complications. In conclusion, these results demonstrate that lead placement in the extrathoracic subclavian vein guided by contrast venography is effective and safe. It was also associated with no increased risk of complications as compared with the cephalic approach. These findings suggest that the contrast-guided approach to the extrathoracic portion of the subclavian vein should be considered as an alternative to the cephalic approach.

Aged↗
PubMed2000

Visualization and temporal/spatial characterization of cardiac radiofrequency ablation lesions using magnetic resonance imaging.

BACKGROUND: The purpose of this study was to describe a system and method for creating, visualizing, and monitoring cardiac radiofrequency ablation (RFA) therapy during magnetic resonance imaging (MRI). METHODS AND RESULTS: RFA was performed in the right ventricular apex of 6 healthy mongrel dogs with a custom 7F nonmagnetic ablation catheter (4-mm electrode) in a newly developed real-time interactive cardiac MRI system. Catheters were positioned to intracardiac targets by use of an MRI fluoroscopy sequence, and ablated tissue was imaged with T2-weighted fast spin-echo and contrast-enhanced T1-weighted gradient-echo sequences. Lesion size by MRI was determined and compared with measurements at gross and histopathological examination. Ablated areas of myocardium appeared as hyperintense regions directly adjacent to the catheter tip and could be detected 2 minutes after RF delivery. Lesions reached maximum size approximately 5 minutes after ablation, whereas lesion signal intensity increased linearly with time but then reached a plateau at 12.2+/-2.1 minutes. Lesion size by MR correlated well with actual postmortem lesion size and histological necrosis area (55.4+/-7.2 versus 49.7+/-5.9 mm(2), r=0.958, P<0.05). CONCLUSIONS: RFA can be performed in vivo in a new real-time interactive cardiac MRI system. The spatial and temporal extent of cardiac lesions can be visualized and monitored by T2- and T1-weighted imaging, and MRI lesion size agrees well with actual postmortem lesion size. MRI-guided RFA may be a useful approach to help facilitate anatomic lesion placement and to provide insight into the biophysical effects of new ablation techniques and technologies.

Animals↗
PubMed2000

Resuscitation after prolonged ventricular fibrillation with use of monophasic and biphasic waveform pulses for external defibrillation.

BACKGROUND: Survival after prolonged ventricular fibrillation (VF) appears severely limited by 2 major factors: (1) low defibrillation success rates and (2) persistent post-countershock myocardial dysfunction. Biphasic (BP) waveforms may prove capable of favorably modifying these limitations. However, they have not been rigorously tested against monophasic (MP) waveforms in clinical models of external defibrillation, particularly where rescue from prolonged VF is the general rule. METHODS AND RESULTS: We randomized 26 dogs to external countershocks with either MP or BP waveforms. Hemodynamics were assessed after shocks applied during sinus rhythm, after brief VF (>10 seconds), and after resuscitation from prolonged VF (>10 minutes). Short-term differences in percent change in left ventricular +dP/dt(max) (MP -16+/-28%, BP +9.1+/-24%; P=0.03) and left ventricular -dP/dt(max) (MP -37+/-26%, BP -18+/-20%; P=0.05) were present after rescue from brief VF, with BP animals exhibiting less countershock-induced dysfunction. After prolonged VF, the BP group had lower mean defibrillation thresholds (107+/-57 versus 172+/-88 J for MP, P=0.04) and significantly shorter resuscitation times (397+/-73.7 versus 488+/-74.3 seconds for MP, P=0.03). CONCLUSIONS: External defibrillation is more efficacious with BP countershocks than with MP countershocks. The lower defibrillation thresholds and shorter resuscitation times associated with BP waveform defibrillation may improve survival after prolonged VF arrest.

Animals↗
PubMed2000

Temporal repolarization lability in hypertrophic cardiomyopathy caused by beta-myosin heavy-chain gene mutations.

BACKGROUND: Certain genetic mutations associated with hypertrophic cardiomyopathy (HCM) carry an increased risk of sudden death. QT variability identifies patients at a high risk for sudden death from ventricular arrhythmias. We tested whether patients with HCM caused by beta-myosin heavy-chain (beta-MHC) gene mutations exhibit labile ventricular repolarization using beat-to-beat QT variability analysis. METHODS AND RESULTS: We measured the QT variability index and heart rate-QT interval coherence from Holter monitor recordings in 36 patients with HCM caused by known beta-MHC gene mutations and in 26 age- and sex-matched controls. There were 7 distinct beta-MHC gene mutations in these 36 patients; 9 patients had HCM caused by the malignant Arg(403)Gln mutation and 8 patients had HCM caused by the more benign Leu(908)Val mutation. The QT variability index was higher in HCM patients than in controls (-1.24+/-0.17 versus -1. 58+/-0.38, P<0.01), and the greatest abnormality was detected in patients with the Arg(403)Gln mutation (-0.99+/-0.49 versus -1. 46+/-0.43 in controls, P<0.05). In keeping with this finding, coherence was lower for the entire HCM group than for controls (P<0. 001). Coherence was also significantly lower in patients with the Arg(403)Gln mutation compared with controls (P<0.05). CONCLUSIONS: These findings suggest that (1) patients with HCM caused by beta-MHC gene mutations exhibit labile repolarization quantified by QT variability analysis and, hence, may be more at risk for sudden death from ventricular arrhythmias, and (2) indices of QT variability may be particularly abnormal in patients with beta-MHC gene mutations that are associated with a poor prognosis.

Adult↗
PubMed2000

Cost-effectiveness of catheter ablation in patients with ventricular tachycardia.

BACKGROUND: This study evaluated the cost-effectiveness of catheter ablation therapy versus amiodarone for treating ventricular tachycardia (VT) in patients with structural heart disease. The analysis used a societal perspective for a hypothetical cohort of VT patients with implantable cardioverter-defibrillators, who were experiencing frequent shocks. METHODS AND RESULTS: We calculated incremental cost-effectiveness of ablation relative to amiodarone over 5 years after treatment initiation. Event probabilities were from the Chilli randomized clinical trial (Chilli Cooled Ablation System, Cardiac Pathways Corporation, Sunnyvale, Calif), the literature, and a consensus panel. Costs were from 1998 national Medicare reimbursement schedules. Quality-of-life weights (utilities) were estimated using an established preference measurement technique. In a hypothetical cohort of 10 000 patients, 5-year costs were higher for patients undergoing ablation compared with amiodarone therapy ($21 795 versus $19 075). Ablation also produced a greater increase in quality of life (2.78 versus 2.65 quality-adjusted life-years [QALYs]). This yielded a cost-effectiveness ratio of $20 923 per QALY gained for ablation compared with amiodarone. Results were relatively insensitive to assumptions about ablation success and durability. In less severe patients with good ejection fractions who suffer their first VT episode, the incremental cost-effectiveness ratio was $6028 per QALY gained. These cost-effectiveness ratios are within the range generally thought to warrant technology adoption. CONCLUSIONS: This study demonstrates that, from a societal perspective, catheter ablation appears to be a cost-effective alternative to amiodarone for treating VT patients.

Catheter Ablation↗
PubMed2000

Linear lesions in myocardium created by Nd:YAG laser using diffusing optical fibers: in vitro and in vivo results.

BACKGROUND AND OBJECTIVE: Linear lesions may be necessary for successful catheter ablation of cardiac arrhythmias such as atrial fibrillation. This study uses laser energy delivered through diffusing optical fibers as an alternative to radiofrequency energy for the creation of linear lesions in cardiac tissue in a single application. STUDY DESIGN/MATERIALS AND METHODS: Samples of canine myocardium were placed in a heated, circulating saline bath and irradiated with a 1.06-microm, continuous-wave Nd:YAG laser during in vitro studies. Laser ablation was then performed in vivo on the epicardial surface of the right ventricle during an open-chest procedure by using similar ablation parameters. Laser energy was delivered to the tissue by being diffused radially through flexible optical fiber tips oriented parallel to the tissue surface. Histology and temperature measurements verified transmurality, continuity, and linearity of the lesions. RESULTS: Peak tissue temperatures measured in vitro remained low (51 +/- 1 degrees C at the endocardial surface, 61 +/- 6 degrees C in the mid-myocardium, and 55 +/- 6 degrees C at the epicardial surface) with no evidence of tissue charring or vaporization. Lesion dimensions produced in vitro and in vivo were similar (depth, 6 mm; width, 8-10 mm; length, 16-22 mm), demonstrating that tissue perfusion in vivo did not significantly alter the heating. CONCLUSION: Long linear lesions, necessary for duplication of the surgical maze procedure during catheter ablation of atrial fibrillation, may be created by using laser radiation delivered through flexible diffusing optical fiber tips. Further development of steerable catheters for endocardial atrial ablation and studies correlating thermal damage zones with electrophysiologic indicators of irreversible conduction block are warranted.

Animals↗
PubMed2000

Catheter ablation of ventricular tachycardia in patients with structural heart disease using cooled radiofrequency energy: results of a prospective multicenter study. Cooled RF Multi Center Investigators Group.

OBJECTIVES: The purpose of this multicenter study was to evaluate the safety and efficacy of a radiofrequency (RF) catheter ablation system with internal saline irrigation. BACKGROUND: Catheter ablation of ventricular tachycardia (VT) associated with structural heart disease is more difficult than ablation of idiopathic VT. The larger size of responsible reentrant circuits contributes to the difficulty in achieving an adequate ablation lesion with conventional techniques. Recently, cooling of the ablation electrode by saline irrigation has been shown to increase RF lesion size. METHODS: The patient population included 146 patients who participated in the Cooled RF Ablation System clinical trial and underwent an attempt at ablation of VT occurring in the presence of structural heart disease. The duration of follow-up was 243 +/- 153 days. RESULTS: Catheter ablation was acutely successful, as defined by elimination of all mappable VTs, in 106 patients (75%). In 59 patients (41%), no VT of any type was inducible after ablation. Twelve patients (8%) experienced a major complication. After catheter ablation, 66 patients (46%) developed one or more episodes of a sustained ventricular arrhythmia. CONCLUSIONS: The results of this study demonstrate that catheter ablation of all mappable forms of sustained VT can be performed with high initial success and a moderate incidence of major complications (8%).

Adult↗
PubMed2000

Prospective comparison of lesions created using a multipolar microcatheter ablation system with those created using a pullback approach with standard radiofrequency ablation in the canine atrium.

The aim of this study was to compare the lesions created using a multipolar microcatheter (MICRO) ablation system in the right canine atrium to a pullback approach with a standard radiofrequency (STND RF) ablation and to determine the value of electrogram amplitude and pacing threshold in predicting transmurality of lesions. Ten dogs underwent right atrial ablation using a MICRO (6 dogs) or STND RF (4 dogs) ablation system in each animal. Attempts were made to create linear RF lesions at four predetermined atrial sites. RF energy was delivered for 60 seconds using closed-loop, temperature control to achieve a target temperature of 60 degrees C for STND RF and 50 degrees C for MICRO. Unipolar atrial electrogram amplitude and atrial pacing threshold were obtained before and after ablation. Pathological analysis was determined at 4 weeks after ablation. Lesions created with MICRO were narrower, more likely to be continuous, and more likely to be anchored to an anatomic structure than those lesions which were created using a STND RF. No difference was observed in overall lesion length or in the proportion of lesions that were transmural over at least 50% of their length. Of lesions created using MICRO, a significant relation was observed between transmurality of lesion and unipolar electrogram amplitude as well as pacing threshold. Further studies are needed to determine if this type of ablation technique and parameters during ablation may facilitate a successful catheter-based MAZE procedure.

Animals↗
PubMed2000

Analysis of the pattern of initiation of sustained ventricular arrhythmias in patients with implantable defibrillators.

INTRODUCTION: The purpose of this study was to analyze the pattern of initiation of sustained ventricular arrhythmias in patients with varying types of underlying structural heart disease. METHODS AND RESULTS: The study group consisted of 90 patients with an implantable cardioverter defibrillator. Cardiovascular diagnoses included coronary artery disease in 64 patients (71%). The patients were divided into four groups based on the type and severity of structural heart disease. Two hundred sixty episodes of sustained ventricular arrhythmias were analyzed. The mean coupling interval of the initiating beat of all ventricular arrhythmias was 523 +/- 171 msec. The coupling interval of the initiating beat was longer in patients with impaired ventricular function, particularly those with nonischemic dilated cardiomyopathy. The prematurity index was similar regardless of the type of underlying structural heart disease. However, the prematurity index was shorter in patients with polymorphic ventricular tachycardia (VT) compared to those with monomorphic VT. A pause was observed more commonly before the onset of polymorphic VT/ventricular fibrillation than sustained monomorphic VT. Two hundred twenty-two (85%) of the arrhythmia episodes were initiated by a late-coupled premature beat, 33 (13%) were initiated by an early-coupled premature beat, and 5 episodes (2%) were initiated with a short-long-short sequence. The pattern of initiation of the ventricular arrhythmias was similar in all patient groups and for both monomorphic and polymorphic tachycardias. CONCLUSION: These findings demonstrate that sustained ventricular arrhythmias typically are initiated by late-coupled ventricular premature depolarizations, regardless of the type or severity of underlying structural heart disease or resultant arrhythmia.

Adult↗
PubMed1999

Comparison of a novel rectilinear biphasic waveform with a damped sine wave monophasic waveform for transthoracic ventricular defibrillation. ZOLL Investigators.

OBJECTIVES: We compared the efficacy of a novel rectilinear biphasic waveform, consisting of a constant current first phase, with a damped sine wave monophasic waveform during transthoracic defibrillation. BACKGROUND: Multiple studies have shown that for endocardial defibrillation, biphasic waveforms have a greater efficacy than monophasic waveforms. More recently, a 130-J truncated exponential biphasic waveform was shown to have equivalent efficacy to a 200-J damped sine wave monophasic waveform for transthoracic ventricular defibrillation. However, the optimal type of biphasic waveform is unknown. METHODS: In this prospective, randomized, multicenter trial, 184 patients who underwent ventricular defibrillation were randomized to receive a 200-J damped sine wave monophasic or 120-J rectilinear biphasic shock. RESULTS: First-shock efficacy of the biphasic waveform was significantly greater than that of the monophasic waveform (99% vs. 93%, p = 0.05) and was achieved with nearly 60% less delivered current (14 +/- 1 vs. 33 +/- 7 A, p < 0.0001). Although the efficacy of the biphasic and monophasic waveforms was comparable in patients with an impedance < 70 ohms (100% [biphasic] vs. 95% [monophasic], p = NS), the biphasic waveform was significantly more effective in patients with an impedance > or = 70 ohms (99% [biphasic] vs. 86% [monophasic], p = 0.02). CONCLUSIONS: This study demonstrates a superior efficacy of rectilinear biphasic shocks as compared with monophasic shocks for transthoracic ventricular defibrillation, particularly in patients with a high transthoracic impedance. More important, biphasic shocks defibrillated with nearly 60% less current. The combination of increased efficacy and decreased current requirements suggests that biphasic shocks as compared with monophasic shocks are advantageous for transthoracic ventricular defibrillation.

Aged↗
PubMed1999

Pharmacologic approaches to therapy for vasovagal syncope.

Vasovagal syncope is a common disorder of autonomic cardiovascular regulation. Many pharmacologic agents have been proposed as effective in the management of this condition based on nonrandomized clinical trials. Notably, only 3 agents--atenolol, midodrine, and paroxetine--have demonstrated efficacy in the treatment of vasovagal syncope in at least 1 prospective, randomized, placebo-controlled clinical trial. Other therapies commonly used in treating syncope include increased salt and fluid intake and fludrocortisone. In this review, we provide a summary of currently available data that support or question the use of various pharmacologic agents for treatment of vasovagal syncope.

Atenolol↗