Comparison of three cardioverter defibrillator implantation techniques: initial results with transvenous pectoral implantation

A total of 121 patients underwent epicardial (n = 32), transvenous abdominal (n = 30), and transvenous pectoral (n = 59) ICD implants. Perioperative complications were defined as those occurring within 30 days after surgery. Hospital costs were calculated with $750 per day as a fixed charge. Duration of surgery was the time between the first skin incision and the last skin suture. Severe perioperative complications that were life-threatening or required surgical intervention occurred in the epicardial (6%) and transvenous (10%) abdominal groups, but not in the pectoral group. Perioperative mortality occurred only in the epicardial abdominal group, predominantly in patients with concomitant surgery (18%), and in 5% of patients without concomitant surgery. The duration of surgery was significantly shorter for transvenous pectoral implantation (58 +/- 15 min, P < 0.05) compared to transvenous abdominal implantation (115 +/- 38 min). Epicardial abdominal ICD implantation had the longest procedure time (154 +/- 31 min). The postimplant hospital length of stay was significantly shorter for pectoral implantation (5 +/- 3 days, P < 0.05) compared to transvenous (13 +/- 5) and epicardial (19 +/- 5) abdominal implantation. Total hospitalization costs significantly decreased in the pectoral implantation group ($4,068 +/- $2,099 for the pectoral group vs $14,887 +/- $4,415 and $9,975 +/- $3,657 for the epicardial and the transvenous abdominal group, respectively, P < 0.05). These initial results demonstrate the advantage of transvenous pectoral ICD implantation in terms of perioperative complications, procedure time, hospital length of stay, and hospitalization costs.     

Complications associated with pectoral cardioverter-defibrillator implantation: comparison of subcutaneous and submuscular approaches. Worldwide Jewel Investigators

OBJECTIVES: The aim of this study was to compare complications in a large cohort of patients undergoing pectoral cardioverter-defibrillator implantation with a subcutaneous or submuscular approach. BACKGROUND: Pectoral placement of implantable cardioverter-defibrillator (ICD) pulse generators is now routine because of downsizing of these devices. subcutaneous implantation has been advocated by some because it is a simple surgical procedure comparable to pacemaker insertion. Others have favored submuscular insertion to avoid wound complications. These surgical approaches have not been compared previously. METHODS: The subjects for this study were 1,000 consecutive patients receiving a Medtronic Jewel ICD at 93 centers worldwide. Cumulative follow-up for all patients was 633.7 patient-years, with 64.9% of patients followed up for > or = 6 months. The complications evaluated were erosion, pocket hematoma, seroma, wound infection, dehiscence, device migration, lead fracture and dislodgment. RESULTS: Subcutaneous implantation was performed in 604 patients and submuscular implantation in the remaining 396. The median procedural times were shorter for subcutaneous implantation (p = 0.014). In addition, the cumulative percentage of patients free from erosion was greater for subcutaneous implantations (p = 0.03, 100% vs. 99.1% at 6 months). However, lead dislodgment was more common with subcutaneous implantations (p = 0.019, 2.3% vs. 0.5% at 6 months) and occurred primarily during the first month postoperatively. Overall, there were no significant differences in cumulative freedom from complications between groups (4.1% vs. 2.5%, p = 0.1836). CONCLUSIONS: Subcutaneous pectoral implantation of this ICD can be performed safely and has a low complication rate. This approach requires a simple surgical procedure and, compared with the submuscular approach, is associated with shorter procedure times and comparable overall complication rates. However, early follow-up is important in view of the increased lead dislodgment rate.     

The concurrent implantation of a last-generation automatic defibrillator and a 2-chamber pacemaker

BACKGROUND: Potentially lethal interactions between concomitantly implanted pacemaker and automatic first-generation cardioverter-defibrillator have been reported. We therefore evaluated the reliability and safety of simultaneous implantation of dual-chamber pacemakers with a fourth generation cardioverter-defibrillator incorporating an improved arrhythmia detection system. METHODS: Concomitant implantation of an automatic cardioverter defibrillator and a dual-chamber pacemaker was performed in four patients for malignant tachyarrhythmias and symptomatic bradycardia. Two Jewel 7219C and two Micro Jewel 7223 (Medtronic Inc.) implantable cardioverter defibrillators were connected to an endocardial lead (Medtronic Mod. 6936). In 2 patients with a previously implanted cardioverter-defibrillator, the pacemaker was connected to bipolar atrial and ventricular leads. In the 2 patients who already had a dual-chamber pacemaker, the unipolar pacing leads implanted previously were used. At the time of implantation of the second device, interaction testing was performed evaluating ventricular fibrillation detection during high-output asynchronous pacing. Testing for malfunctions, reprogramming or variations of pacing thresholds of the pacemakers after electric shocks was also carried out. Moreover, intracavitary signals, stimulation thresholds and electrical therapies delivered were evaluated during follow-up. RESULTS: During interaction testing, induced ventricular fibrillation was detected, with no delay, in 4/4 cases (100%). After a mean follow-up of 6.3 +/- 5 months (range 2-13), 5 shocks for ventricular fibrillation, 10 shocks for fast ventricular tachycardia and 72 antitachycardia pacings were delivered. All these electrical therapies were considered appropriate. No symptomatic sustained tachyarrhythmia remained undetected. CONCLUSIONS: These data suggest that concomitant implantation of a fourth-generation automatic cardioverter-defibrillator and a dual-chamber pacemaker using either unipolar or bipolar leads can be performed safely. Extreme caution and rigorous interactions testing is nevertheless advised when considering this device combination.     

Additional lead improves defibrillation efficacy with an abdominal 'hot can' electrode system

BACKGROUND: Although the left prepectoral site is preferred for "hot can" placement, this site is unavailable in some patients. We evaluated the influence of electrode location on defibrillation thresholds with alternative hot can and transvenous lead configurations. METHODS AND RESULTS: Three interrelated studies were performed. In group 1, the importance of hot can location was investigated by pairing a right ventricular lead to five different hot can placement sites in seven pigs. The defibrillation energies for right pectoral, left pectoral, left subaxillary, and right and left abdominal hot can sites were 20.3+/-2.7,* 15.9+/-3.8, 14.9+/-2.5, 32.0+/-3.4,* and 30.0+/-3.4 J,* respectively (*P<.005 versus left pectoral and left subaxillary sites). In group 2, the value of a three-electrode configuration with an abdominal hot can placement was investigated by adding a subclavian vein lead to the pectoral or abdominal hot can configurations in seven pigs. The defibrillation energies for left pectoral and abdominal sites were 18.6+/-4.2 and 29.0+/-5.8 J (P=.0001), respectively. The addition of a right or left subclavian vein lead with an abdominal hot can reduced the threshold to 19.3+/-4.2* or 18.8+/-3.2,* respectively (*P=.0001 versus abdominal site). In group 3, the contribution of the abdominal hot can electrode to the three-electrode configuration was tested by a comparison with two purely transvenous two-electrode configurations in six pigs. The defibrillation energy (19.9+/-3.2 J) for the abdominal hot can with a subclavian vein lead was lower than the transvenous lead configurations with a subclavian vein (29.0+/-2.5 J, P=.0001) or a superior vena cava lead (30.7+/-3.7 J, P=.0001). The right ventricular lead was the sole cathode during the first phase of the biphasic shock in all experiments. CONCLUSIONS: Defibrillation energy depends on the hot can placement site. The addition of a subclavian vein lead with an abdominal hot can improves defibrillation efficacy to the level of the pectoral placement and is better than a purely transvenous lead configuration.     

Intracardiac QRS electrogram width--an arrhythmia detection feature for implantable cardioverter defibrillators: exercise induced variation as a base for device programming

Delivery of inappropriate therapy of implantable cardioverter defibrillators (ICD) due to inaccurate arrhythmia detection represents a major clinical problem. Different arrhythmia detection criteria such as the "stability" of the cycle length or the suddenness of "onset" of tachycardia have been implemented in ICD software to prevent inappropriate therapy. The new Medtronic model 7223Cx ICD offers an additional detection parameter (QRS width), which reflects changes in the duration of ventricular depolarization as a tool to distinguish supraventricular from ventricular tachycardias. Although this criterion can be programmed based on ECG parameters derived from resting ECGs, this may not be sufficient since QRS width is subject to considerable changes due to transient myocardial ischemia, changes in autonomic tone, or frequency dependent effects of antiarrhythmic drugs. The present study aimed to determine frequency dependent changes in QRS width in individual patients at rest and during symptom-limited exercise testing in 16 patients with documented ventricular tachycardia (N = 13) or ventricular fibrillation (N = 3). The optimal EGM slew threshold and the individual variation of QRS width were determined. Measurements obtained at the end of the implantation procedure were compared to those performed at hospital discharge. The majority of patients showed a wider variation in QRS duration as measured from 30 consecutive cycles during exercise as compared to rest. For example, the QRS range (i.e., the difference between the maximal and the minimal QRS width measured) averaged 7 +/- 3 ms at rest and increased to 11 +/- 3 ms during exercise (P = 0.004) with an increase of > or = 4 ms observed in 11 (69%) of 16 patients. In 13 (81%) of 16 patients a reprogramming of at least one QRS width parameter from its value at the time of implantation was necessary. Thus, the QRS width measured from the intracardiac EGM shows significant intraindividual variations in different physiological conditions. For optimal programming of the QRS width parameter, measurements obtained during exercise are important.     

Effect of the addition of an abdominal hot can cardioverter/defibrillator pulse generator on the defibrillation energy requirements in a single-lead endocardial defibrillation system

AIMS: The effects of a cardioverter/defibrillator system with an electrically active generator can, applied without recourse to thoracotomy, have not been investigated in the abdominal position in humans. The purpose of this acute clinical study was to evaluate the defibrillation efficacy of an abdominally positioned hot can electrode in connection with a single lead endocardial defibrillation system. PATIENTS AND METHODS: Thirty consecutive patients undergoing implantation of a cardioverter/defibrillator or pulse generator replacement were enrolled in this study Each patient received an integrated, tripolar single-lead system. This was tested using an asymmetrical biphasic defibrillation waveform with constant energy delivery. Defibrillation energy, peak voltage, peak current and impedance were compared between two electrode configurations: (A) in this configuration the distal right ventricular coil was negative and the proximal coil positive; (B) in this configuration the distal right ventricular coil was negative and the proximal coil and the abdominal hot can (65 ccm), as common anode, were positive. Defibrillation threshold testing started at 15 J with stepwise energy reduction (10 J, 8 J, 5 J and 3 J) until defibrillation was ineffective. RESULTS: Compared to the single-lead configuration, the abdominal hot can configuration revealed at 17.5% reduction in defibrillation energy requirements (8.6 J +/- 4.3 J vs 10.43 J +/- 3.9 J; P = 0.041), a 15.7% reduction in peak voltage (308.6 V +/- 63 V vs 365.3 V +/- 68 V; P = 0.003), and a 21.6% reduction in impedance (41.1 omega +/- 6.3 omega vs 52.4 omega +/- 6.6 omega; P < 0.001). Peak current showed a significant increase during hot can testing of 8.2% (7.2 A +/- 1.8 A vs 7.8 A +/- 2.2 A; P = 0.16). CONCLUSION: An abdominally placed hot can pulse generator lowered defibrillation energy requirements in patients with an endocardial defibrillation lead system.     

Compatibility of a nonthoracotomy lead system with a biphasic implantable cardioverter-defibrillator. Cadence-Endotak 60-Series IDE investigators

This prospective multicenter study was conducted under the Food and Drug Administration Investigational Device Exemption to evaluate the safety and efficacy of the combination of the Cadence implantable defibrillator (Ventritex, Inc.) and 60-series Endotak C leads (Cardiac Pacemakers, Inc.). Implantation was attempted in 148 patients with hemodynamically compromising ventricular tachycardia or fibrillation (VF), or with pace-terminable ventricular tachycardia. The system was successfully implanted in 97% of patients, with 96% of implants in a transvenous-lead-alone configuration. At implantation, the defibrillation threshold was 455 +/- 94 V (14 +/- 6 J) for lead-alone patients and 532 +/- 40 V (19 +/- 3 J) for those requiring a subcutaneous patch. VF conversion efficacy was reconfirmed in patients who underwent a 3-month chronic induction study. The system successfully detected all 763 induced arrhythmias and terminated 99.5% of them; after system modification, successful conversion was demonstrated in the 2 patients who initially had induced episodes requiring external defibrillation (1 lead revision; 1 reprogramming). All spontaneous episodes were terminated with an implantable-cardioverter defibrillator. Postshock VF redetection times were significantly shorter than initial detection times (4.5 +/- 1.8 seconds detection, 2.1 +/- 0.7 seconds redetection; p<0.0001). During an 8-month mean follow-up (range 1 to 31 months), 2 unwitnessed deaths were classified as sudden cardiac deaths, and 11 patients experienced a total of 12 complications, none of which was associated with the Cadence-Endotak combination.     

Comparison of metoprolol and sotalol in preventing ventricular tachyarrhythmias after the implantation of a cardioverter/defibrillator

The purpose of this prospective study was to evaluate, on an intention-to-treat basis, the efficacy of d,l-sotalol and metoprolol with regards to the recurrence of arrhythmic events after implantable cardioverter defibrillator (ICD) implantation. After ICD implantation, 70 patients were randomly assigned to treatment with either metoprolol (mean dosage 104+/-37 mg/day in 35 patients) or d,l-sotalol (mean dosage 242+/-109 mg/day in 35 patients). During follow up ventricular tachycardia (VT), fast VT, and ventricular fibrillation (VF) episodes were calculated. Metoprolol treatment led to a marked reduction in the recurrence of arrhythmic events. Actuarial rates for absence of VT recurrence at 1 and 2 years were significantly higher in the metoprolol group compared with the d,l-sotalol group (83% and 80% vs 57% and 51%, respectively, p=0.016). The actuarial rates for absence of fast VT or VF were 80% in the metoprolol group compared with 46% in the d,l-sotalol group (p=0.002). During a follow up of 26+/-16 months, there were 3 deaths in the metoprolol group compared with 6 deaths in the d,l-sotalol group. Actuarial rates of overall survival were not significantly different in the 2 groups (91% vs 83%, p=0.287). In this prospective, randomized, controlled study the recurrence rate of ventricular tachyarrhythmias in patients treated with metoprolol was lower than in patients treated by d,l-sotolol.     

Clinical significance of sleep apnea disorders after implantation of a cardioverter-defibrillator in patients with cardiac disease and sustained ventricular tachyarrhythmia

The purpose of our study was to determine the prevalence of sleep related breathing disorders (SRBD) in patients with an implantable cardioverter-defibrillator (ICD) and to evaluate prospectively the possible influence of SRBD on arrhythmia recurrence and circadian arrhythmia variation as well as on cardiac mortality during long-term follow-up. Forty consecutive ICD recipients with cardiac disease and a documented history of spontaneous, life-threatening, ventricular tachyarrhythmias underwent full-night polysomnography and were followed for 2 years. In 16 of 40 patients (40%), SRBD were diagnosed (Apnea/Hypopnea Index (AHI) > 10); in 9 of these 16 patients (56%) central sleep apneas (CSA) occurred (in 8 of these 9 patients in combination with Cheyne-Stokes respiration). Seven of the 16 patients with SRBD (44%) revealed obstructive sleep apneas (OSA). AHI was 32 +/- 15 (12-60) in patients with CSA and 32 +/- 27 (11-86) in patients with OSA. Patients with and without SRBD were comparable concerning left ventricular ejection fraction, NYHA classification, cardiac disease, ICD indication, and concomitant medication. ICD registered ventricular tachyarrhythmias occurred in 10 of 24 patients (42%) without SRBD, in 4 of 9 patients (44%) with CSA, and in 3 of 7 patients (44%) with OSA. The numbers and circadian variation of episodes registered during follow-up in patients without SRBD, with OSA or CSA were comparable (14 +/- 25, median 4 vs 15 +/- 15, median 7 vs 4 +/- 5, median 2.5). The 2-year cardiac mortality was highest in patients with CSA (4/9 (44%) vs. 0/7 patients (0%) with OSA vs 3/24 patients (12.5%) without SRBD. Thus, the prevalence of SRBD in patients with chronic heart failure and a history of malignant ventricular tachyarrhythmias is high (40%) and the occurrence of CSA seems to be predictive for cardiac mortality in these patients. An influence of moderate SRBD on arrhythmia recurrence and circadian variation of spontaneous sustained tachyarrhythmic events could not be demonstrated.     

Heart rate variability index in congestive heart failure: relation to clinical variables and prognosis

AIM: To evaluate the clinical and prognostic value of the heart rate variability index in patients with congestive heart failure. METHODS: Sixty-four patients with chronic congestive heart failure and sinus rhythm underwent clinical assessment, 24-h ambulatory electrocardiography and echocardiography. Patients were followed for 6 to 30 months. Cardiac death or heart transplantation constituted the primary end-point of the study. RESULTS: The heart rate variability index was related to left ventricular ejection fraction (r=0.29, P=0.02) and New York Heart Association class (P=0.01). Patients with a restrictive left ventricular filling pattern had a lower heart rate variability index compared to patients with a non-restrictive pattern (26+/-11 vs 33+/-9 units, P=0.01). Patients who died (n=11) or underwent heart transplantation (n=4) had a lower heart rate variability index compared to survivors (21+/-10 vs 33+/-9 units, P<0.0001). In multivariate survival analysis, a reduced heart rate variability index was related to survival independent of parameters of left ventricular function. CONCLUSION: The heart rate variability index provides independent information on clinical status and prognosis in patients with chronic congestive heart failure.     

Comparison of immunodot and western blot assays for diagnosing Lyme borreliosis

Device-based testing of single-lead pectoral defibrillators (defibrillation efficacy testing without an external defibrillation system after complete implantation of the device) resulted in an adequate defibrillation threshold (< or = 20 J) in 45 of 50 study patients (90%). Mean surgical implantation time (skin to skin) was 62 +/- 29 minutes without perioperative mortality and without implantable cardioverter defibrillator infection during follow-up. Thus, device-based testing appears to be a simple and safe method to test defibrillation efficacy of single-lead pectoral defibrillators.     

Implantable cardioverter defibrillator utilization among device recipients presenting exclusively with syncope or near-syncope

INTRODUCTION: Implantable cardioverter defibrillators (ICDs) are occasionally used in presumed high-risk patients with electrocardiographically undocumented syncope, although the incidence of ventricular tachyarrhythmias in this population is not well defined. METHODS AND RESULTS: We studied 33 consecutive patients receiving an ICD (67% nonthoracotomy and 70% tiered therapy) after electrophysiologic testing for unmonitored "syncope" (n = 29) or "near-syncope" (n = 4). Atherosclerotic heart disease was present in 24 (73%); mean left ventricular ejection fraction (LVEF) was 0.39 +/- 0.15; and sustained monomorphic ventricular tachycardia (SMVT) was inducible in 18 (55%). Over a median follow-up of 17 months (range 4 to 61), 12 patients (36%) received > or = 1 appropriate ICD discharge triggered by SMVT (cycle length 230 to 375 msec) in 10 and ventricular flutter or fibrillation in 2--without concomitant antiarrhythmic medication in 8 of 12 cases. Inducible SMVT and LVEF < or = 0.35 were statistically significant, independent predictors of an appropriate ICD discharge (P < 0.02 and P < 0.03, respectively). Estimated 1-year cumulative survival free of appropriate discharge was 34% versus 87%, respectively, in patients with versus without inducible SMVT (P < 0.02), and 18% versus 56%, respectively, in patients with LVEF < or = 0.35 versus LVEF > 0.35 (P < 0.03). CONCLUSION: In this highly select, multicenter population of ICD recipients with electrocardiographically undocumented syncope, a substantial incidence of appropriate device discharges was observed, particularly in patients with inducible SMVT and LVEF < or = 0.35. These findings support the notion that, in patients with LV dysfunction and inducible SMVT, ventricular tachyarrhythmias are likely to account for episodes of syncope or near-syncope.     

Preferential selection of specific rotavirus gene segments in coinfection and multiple passages with reassortant viruses and their parental strain

INTRODUCTION: The size of current implantable cardioverter defibrillators (ICD) is still large in comparison to pacemakers and thus not convenient for pectoral implantation. One way to reduce ICD size is to defibrillate with smaller capacitors. A trade-off exists, however, since smaller capacitors may generate a lower maximum energy output. METHODS AND RESULTS: In a prospective randomized cross-over study, the step-down defibrillation threshold (DFT) of an experimental 90-microF biphasic waveform was compared to a standard 125-microF biphasic waveform. The 90-microF capacitor delivered the same energy faster and with a higher peak voltage but provided only a maximum energy output of 20 instead of 34 J. DFTs were determined intraoperatively in 30 patients randomized to receive either an endocardial (n = 15) or an endocardial-subcutaneous array (n = 15) defibrillation lead system. Independent of the lead system used, energy requirements did not differ at DFT for the experimental and the standard waveforms (10.3 +/- 4.1 and 9.5 +/- 4.9 J, respectively), but peak voltages were higher for the experimental waveform than for the standard waveform (411 +/- 80 and 325 +/- 81 V, respectively). For the experimental waveform the DFT w as 10 J or less using an endocardial lead-alone system in 10 (67%) of 15 patients and in 12 (80%) of 15 patients using an endocardial-subcutaneous array lead system. CONCLUSIONS: A shorter duration waveform delivered by smaller capacitors does not increase defibrillation energy requirements and might reduce device size. However, the smaller capacitance reduces the maximum energy output. If a 10-J safety margin between DFT and maximum energy output of the ICD is required, only a subgroup of patients will benefit from 90-microF ICDs with DFTs feasible using current defibrillation lead systems.     

Low-energy endocardial defibrillation using dual, triple, and quadruple electrode systems

The feasibility of achieving both universal application of nonthoracotomy leads and low (< or = 15 J) defibrillation energy requirements by optimizing lead system configuration for use with low-output (<30 J) biphasic shock pulse generators was examined. Sixteen patients (mean age 62 +/- 8 years and mean left ventricular ejection fraction of 38 +/- 15%) were included in the study. All patients had either experienced syncope with induced ventricular tachycardia (n = 4) or had documented sustained ventricular tachycardia (n = 7) or ventricular fibrillation (n = 5). Defibrillation threshold testing was performed in 2 stages on different days in these patients. In the first stage, 2 defibrillation catheter electrodes were positioned in the right ventricle and superior vena cava with an axillary cutaneous patch. Fifteen-joule, 10- and 5-J biphasic shocks were delivered across 3 different electrode configurations-right ventricle to superior vena cava, right ventricle to axillary patch, right ventricle to a combination of superior vena cava and axillary patch. In the second stage, an 80-ml can electrode was added subcutaneously in a pectoral location to the previous leads. Configurations compared were the right ventricle to pectoral can, and right ventricle to an "array"-combining superior vena cava, can, and axillary patch leads. The defibrillation threshold was determined using a step-down method. In stage 1, mean defibrillation threshold for the right ventricle to axillary patch (12.7 +/- 5.9 J) and right ventricle to superior vena cava plus axillary patch (9.8 +/- 5.2 J) configurations was lower than the right ventricle to superior vena cava configuration (14.2 +/- 6.4 J, p <0.05). In stage 2, the defibrillation was higher for the right ventricle to pectoral can (9.2 +/- 5.1 J) configuration compared with the right ventricle to the array (5.6 +/- 3.6 J, p < or =0.05). The right ventricle to array had the lowest defibrillation threshold, whereas the right ventricle to pectoral can was the best dual electrode system. Low-energy endocardial defibrillation (< or =10 J) was feasible in 72% of tested patients with > 1 electrode configuration at 10 J, whereas only 53% of successful patients could be reverted at >1 electrode configuration at 5 J (p <0.05). Reduction in maximum pulse generator output to < or =25 J using these electrode configurations with bidirectional shocks is feasible and maintains an adequate safety margin.     

Familial hypertrophic cardiomyopathy. Cardiac ultrasonic abnormalities in genetically affected subjects without echocardiographic evidence of left ventricular hypertrophy

AIMS: It is not known whether the apparent normality of echocardiographic examination results, in subjects bearing a mutation for hypertrophic cardiomyopathy but without ultrasonic left ventricular hypertrophy, is due to incomplete phenotypic expression, or inaccurate echocardiographic criteria. The aim of this study was to search for echocardiographic abnormalities in these patients. METHODS AND RESULTS: Echocardiography was performed in 100 subjects from two families with a mutation in the beta-MHC (720) or My-BPC (714) genes. We compared genetically affected subjects with an apparently normal left ventricle (thickness < 13 mm) (20 patients), and nonaffected first-degree relatives (61 normal subjects). (1) Patients had a thicker left ventricular wall (9.7 +/- 1.4 vs 8.9 +/- 1.4 mm, P = 0.03), a greater indexed mass (107 +/- 18 vs 97 +/- 17 g. m-2, P = 0.03), a larger left atrium (27 +/- 9 vs 23 +/- 10 mm3, P = 0.09) and lower wall stress (78 +/- 11 vs 89 +/- 15 10(3) dynes. cm-2, P = 0.002); these differences were highly significant after adjustment for height, age and systolic blood pressure either for wall thickness (P = 0.000003), mass (P = 0.005) or atrial volume (P = 0.001), and the ventricular systolic dimension appeared smaller (P = 0.01); (2) results remained significant (P < 0.01) when a lower cut-off value (< or = 11 mm) or only adults (> or = 18 years) were considered; (3) a subanalysis of Family 714 (13 patients, 25 normals matched for sex, age and height) showed the same trends. CONCLUSION: In familial hypertrophic cardiomyopathy, genetically affected subjects with an apparently normal heart by echocardiography show slight ultrasonic structural and functional left ventricular modifications, suggesting that the phenotype of the disease is a continuous spectrum from normal structure to typical hypertrophy.     

Effects on cardiac performance of atrioventricular node catheter ablation using radiofrequency current for drug-refractory atrial arrhythmias

Patients with atrial fibrillation or atrial flutter (AF) are candidates for radiofrequency (RF) catheter ablation of the atrioventricular (AV) node with the aim being to control heart rate. As patients with AF can have markedly impaired ventricular function, information concerning the hemodynamic effects of AV node ablation using RF current would be valuable. Fourteen consecutive patients (mean age 65 +/- 3 years) with drug-resistant AF underwent AV node catheter ablation with RF current and had permanent pacemaker implantation. The mean left ventricular ejection fraction (EF) by two-dimensional echocardiography immediately before ablation was 42 +/- 3% (range 14%-54%) and their mean exercise time was 4.4 +/- 0.4 minutes. Complete AV block was achieved in all 14 patients with 6 +/- 2 RF applications (range 1-18). There was no evidence of any acute cardiodepressant effect associated with delivery of RF current, and EF 3 days after ablation was 44 +/- 4%. By 6 weeks after ablation, the left ventricular EF was significantly improved compared to baseline (47 +/- 4% postablation vs 42 +/- 3% preablation; P < 0.05), and this modest increase in EF was accompanied by an improvement in exercise time (5.4 +/- 0.4 min). In conclusion, delivery of RF current for AV node catheter ablation in patients with AF and reduced ventricular function is not associated with any acute cardiodepressant effect. On the contrary, improved control of rapid heart rate following successful AV node ablation is associated with a modest and progressive improvement in cardiac performance.     

Can amiodarone pulmonary toxicity be predicted in patients undergoing implantable cardioverter defibrillator implantation?

Implantable cardioverter defibrillator (ICD) implantation is rapidly becoming accepted as primary therapy for malignant ventricular arrhythmias. Many patients undergoing ICD implantation are on concomitant antiarrhythmic drugs to decrease shock frequency, slow tachycardia rate, and suppress supraventricular arrhythmias. Amiodarone is a potent antiarrhythmic agent that is also frequently used in the treatment of patients with refractory ventricular arrhythmias. Ten to forty percent of patients undergoing ICD implantation will also be taking amiodarone. It has been reported to cause pulmonary toxicity in about 5% of patients per year. Acute amiodarone toxicity presenting as adult respiratory distress syndrome has been reported much less frequently. Although perioperative morbidity due to amiodarone has been described, the risk, predictability, and consequences of acute pulmonary toxicity from amiodarone in patients undergoing ICD implantation have not been previously described. We reviewed the records of 99 consecutive patients undergoing ICD implantation at our institution from October 1987 to April 1992. Thirty-nine patients were taking 480 +/- 230 mg of amiodarone (median 400 mg, lower 20th percentile 400 mg, upper 80th percentile 800 mg) for 291 +/- 554 days prior to ICD implantation. Ten patients taking amiodarone developed acute pulmonary toxicity clinically manifesting as diffuse pulmonary infiltrates on chest radiography and adult respiratory distress syndrome with hypoxia (arterial pO2 < 60 mmHg) without evidence of pneumonia or elevated pulmonary capillary wedge pressure (PCW < or = 15 mmHg). Of the 60 patients not taking amiodarone none developed adult respiratory distress syndrome.(ABSTRACT TRUNCATED AT 250 WORDS)     

Modern electrodes with and without steroid: effects on stimulation current of cardiac pacemakers

The aim of the investigation was to test whether new leads without steroid, a meshwire tip leads (Ionyx 4180, CPI; n = 10) and a carbon tip lead (Facet ITP 13, Vitatron; n = 10), have electrical characteristics similar to a new steroid-eluting tip lead (CapSure SP 4023, Medtronic; n = 10) and their impact on the pacemaker's pacing current. Pacing thresholds, impedance, and R-wave amplitudes measured at implantation were similar for the three leads. One, 4 and 12 weeks after implantation both nonsteroid leads had significantly higher pacing thresholds at 0.1 and 0.3 ms pulse duration in comparison to the steroid lead (after 12 weeks at 0.3 ms steroid: 0.9 +/- 0.2 V, carbon: 2.1 +/- 0.5 V; meshwire: 1.5 +/- 0.5 V). This result was restricted to the carbon lead after 52 weeks. At 0.5 ms pulse duration higher pacing thresholds were obtained for the carbon lead (after 12 weeks at 0.5 ms; steroid: 0.8 V, carbon: 1.7 +/- 0.6 V; meshwire: 1.1 +/- 0.4 V). Impedance of the steroid lead was 531 +/- 61 ohms, 535 +/- 54 ohms, and 511 +/- 50 ohms, respectively, after 4, 12, and 52 weeks, whereas the carbon lead had significantly higher values with 652 +/- 84 ohms, 669 +/- 93 ohms, and 657 +/- 107 ohms, respectively. The impedance of the meshwired lead (4 weeks: 585 +/- 92 ohms; 12 weeks: 592 +/- 89 ohms; 52 weeks: 550 +/- 130 ohms) did not differ from the steroid lead.(ABSTRACT TRUNCATED AT 250 WORDS)     

Proinsulin: recent observations and controversies

INTRODUCTION: Defibrillation thresholds (DFTs) usually are determined with the patient in the supine position. However, patients may be in the upright position when a shock is delivered during follow-up, which may explain some first shock failures observed clinically. This study investigated whether body posture affects defibrillation energy requirements of nonthoracotomy implantable cardioverter defibrillators with biphasic shocks. METHODS AND RESULTS: Using a step up-down protocol, DFTs were compared intraindividually in 52 patients ("active-can" sytems in 41 patients, two-lead systems in 11 patients) for the supine and upright positions as achieved by a tilt table. The mean DFT was 7.3 +/- 4.2 J in the supine versus 9.2 +/- 4.8 J in the upright position (P = 0.002). Repeated comparison in reversed order 3 months after implantation in 22 patients revealed thresholds of 6.2 +/- 2.5 J (supine) versus 8.4 +/- 3.7 J (upright; P < 0.03) 1 week and 4.4 +/- 2.4 J (supine) versus 6.2 +/- 4.1 J (upright; P < 0.04) 3 months after implantation. DFTs decreased significantly for both body positions from 1 week to 3 months after implantation (P < 0.04). CONCLUSION: (1) DFTs for biphasic shocks delivered by nonthoracotomy defibrillators are higher in the upright compared to the supine body position. (2) Differences remain significant 3 months after implantation. For both body positions, DFT decreases significantly from 1 week to 3 months after implantation. These findings have important implications for programming first shock energy to lower than maximal values or for development of devices with lower maximal stored energy.     

Potential benefit from implantable cardioverter-defibrillator therapy in patients with and without heart failure

BACKGROUND: Whether patients with heart failure derive a benefit from therapy with implantable cardioverter-defibrillators (ICDs) has been questioned. The purpose of this study was to investigate whether New York Heart Association (NYHA) functional class had an impact on the potential benefit from ICD therapy as assessed from data stored in the memory of ICDs. METHODS AND RESULTS: Between 1989 and 1996, 603 patients (77% men; 59% with coronary artery disease and 16% with dilated cardiomyopathy; age, 57+/-13 years; ejection fraction, 44+/-18%) were treated with an ICD with extended memory function (storage of electrograms and/or RR intervals from treated episodes) in combination with endocardial lead systems. The stages of heart failure (NYHA functional class I through III) at implantation were correlated with overall mortality and the recurrence of fast ventricular tachyarrhythmias (>240 bpm) during follow-up. The potential benefit of the device was estimated as the difference between overall mortality and the hypothetical death rate had the device not been implanted. The latter was based on the recurrence of fast and, without termination by the devices, presumably fatal ventricular tachyarrhythmias. In the overall group, a significant difference between hypothetical death rate and overall mortality was observed (13.9%, 23.5%, and 26.6% at 1, 3, and 5 years, respectively) that suggested a benefit from ICD implantation. In patients in NYHA class I, the estimated benefit, which increased over time, was 15.2%, 29.2%, and 35.6% after 1, 3, and 5 years, respectively. In patients in NYHA class II or III, the estimated benefit increased until the third year (21.8% and 21.9%, respectively) and then remained constant until the fifth year (22.9% and 23.8%, respectively). Even those patients in NYHA class III with a history of decompensated heart failure benefited from ICD implantation. CONCLUSIONS: Analysis of stored ECG data suggests that in patients with a history of ventricular tachycardia or ventricular fibrillation, ICD therapy may lead to a prolongation of life in NYHA classes I through III. The initial benefit is greatest in patients in NYHA class II and class III, but the estimated benefit might persist longest for patients in NYHA class I.