Mortality trials with implantable defibrillators

The continuing disappointing results from recent major studies with antiarrhythmic drugs combined with the continuing excellent outcomes with implantable cardioverter-defibrillators is making it exceedingly difficult, ethically, to conduct future randomized trials comparing the 2 treatment options. On the other hand, the high quality of stored Holter electrograms and the therapy history retrievable from current implantable cardioverter-defibrillators creates opportunities for needed trials on drug efficacy without this ethical dilemma.     

The current status of implantable automatic defibrillators

The implantable cardioverter defibrillator has become an important therapy for patients with sustained or life threatening ventricular arrhythmias. Although the concept for the implantable cardioverter defibrillator originated in the late 1960s, the first device was implanted in humans in 1980. Since then, the technology has improved rapidly the design, function and reliability of the devices have been greatly modified. There are currently five companies dealing with defibrillators in Spain incorporating multiple options in defibrillation, pacing and sensing capabilities. New devices with atrioventricular pacing and atrial defibrillation possibilities will soon become available. The purpose of this article is to review the principal functions of implantable cardioverter defibrillators currently available.     

Catheter ablation and implantable atrial defibrillators in supraventricular cardiac arrhythmias

This study was designed to evaluate drug use and drug costs of treatment of 1112 AIDS patients at the Infectious Diseases Unit at F. Houphou?t Boigny Hospital in Marseilles, France, between January 1, 1990 and December 31, 1994. All drug expenditures directly or indirectly related to AIDS treatment were recorded for both inpatients and outpatients. There were 1952 hospital stays. For each stay baseline characteristics including age, sex risk factors, costs, and duration of hospitalization were noted. Patients were mainly young male drug addicts around thirty years of age. Reason for admission was also noted. The overall number of admissions per year has decreased since 1991 probably due to development of outpatient care. The number of stays per patient per year has decreased since 1993 because of the use of more appropriate therapeutic and prophylactic protocols. The number of drugs used was high increasing from 750 in 1990 to 868 in 1994. Cost of treatment doubled between 1990 and 1994 due to the introduction of many expensive new drugs. Closer analysis showed that the greatest increase in expenditure involved 'antibiotic/antiviral', 'psychiatry/neurology' and 'specialized therapy'. Although not frequently prescribed, costly drugs such as immunoglobulins, hematopoietic growth factors, and parenteral nutrition solutions accounted for a high proportion of total costs. Since AZT, ddI and ddC were used mainly for outpatient treatment, their cost was low in inpatients. Cytomegalovirus-related retinitis, tuberculosis, and multiple infections were cost-intensive complications. The increasing number of cytomegalovirus infections underlines the need for cost evaluation and surveillance of this complication. This study demonstrates that cost of treating AIDS patients is rising due to the use of more and costlier drugs. This finding underlines the need to evaluate and compare new therapeutic modalities in terms of cost effectiveness.     

Predictors of psychosocial adjustment in patients with implantable cardioverter defibrillators

Predictors of psychological distress/adjustment were examined in 25 patients following placement of ICDs. Patients completed a demographic questionnaire and a standardized questionnaire of psychological symptoms (i.e., Symptom Checklist-90 Revised; SCL-90-R). The number of discharges categorized by the patient as inappropriate and appropriate were also ascertained. The number of ICD discharges categorized as inappropriate and diminished levels of physical activity (r = 0.53 and 0.63, P < 0.01, respectively) did significantly relate to overall psychological distress. In addition, after controlling for age and prior psychiatric and physical health status through a stepwise multiple regression analysis, the occurrence of ICD discharges categorized as inappropriate and diminished physical activity continued to significantly predict overall psychological distress (R2 = 0.41, P < 0.01). However, the number of ICD discharges categorized as appropriate did not significantly predict overall psychological distress. The results of this investigation suggest that further refinement of the ICD could reduce the risk of exposure to potential psychological distress, and an analysis of prior and anticipated patient physical activity levels should be a factor when calibrating minimum ICD discharge threshold levels.     

Predischarge arrhythmia induction testing of implantable defibrillators may be unnecessary in selected cases

Complete postoperative evaluation of implantable cardioverter-defibrillators (ICDs) before discharge, including arrhythmia induction, has been the standard since their introduction. Whereas the original ICDs provided little telemetered information and used separate pace-sense and defibrillation leads, modern, third-generation devices provide pace-sense function information in addition to other data and are used in conjunction with integrated transvenous endocardial leads that combine pace-sense and defibrillation function. Changes in lead position, which can potentially result in either an inability to detect fibrillation or to terminate it, should be mirrored by changes in resting pace-sense function. Thus, for newer ICDs implanted with integrated endocardial lead systems, it is possible that in at least some cases predischarge arrhythmia inductions can be avoided. Two hundred patients receiving third-generation ICDs in conjunction with integrated transvenous leads were evaluated before discharge. Defibrillation detection or termination problems were seen in 8. Declines in resting R-wave amplitude and pacing impedance were significantly associated with such complications (-7 +/- 5 vs -0.3 +/- 2.3 mV [p <0.0001] and -158 +/- 138 vs -93 +/- 76 omega [p <0.05], for those with vs without complications, respectively), as were gross right ventricular lead migrations on chest x-ray. No patient with a defibrillation complication had an R-wave change of <3 mV. However, 13% of patients without complications had R-wave changes of >3 mV. It is concluded that a pace-sense evaluation of ICDs may be a satisfactory screen to determine those who need to go on to complete testing with arrhythmia induction in selected cases.     

Cryotherapy of liver metastases. Initial results

PATIENTS AND METHOD: Between 1 Jan 1996 and 1 Apr 1998 29 patients underwent cryosurgical therapy for liver metastasis at the Department of Surgery at the University of Mainz. RESULTS: No complications occurred following cryosurgery alone (n = 12). Within the group of patients with a combined procedure (n = 11) 1 patient had temporary liver failure and 1 patient died of sepsis. Following freezing of the cutting zone (n = 6) 1 patient showed a bile fistula and 1 ascites. In 15 cases of 28 dismissed patients with remaining destroyed tumor tissue the follow-up showed no tumor recurrence (median follow-up 11 months). On the other hand 9 patients had a tumor recurrence within the liver, 3 patients at extrahepatic regions and 7 patients developed a tumor recurrence within the freezing zone.     

Hereditary deafness in Turkey. Initial results

The authors describe a study in progress to identify Turkish families with hereditary hearing loss and isolate possible responsible disease genes. Due to extreme genetic heterogeneity and limited audiological differentiation of hereditary hearing loss, it is necessary to identify large or small families from genetic isolates to locate loci responsible for hearing loss on a chromosome. To accomplish this goal, the medical records of 3800 children were examined at the ENT Clinic of Ege University between 1975 and 1994. All were suspected of having various hearing impairments. Additionally, students from two schools for the hearing impaired in Izmir and Eskisehir, Turkey were examined. To date, 16 families with syndromal deafness and 55 families with non-syndromal hereditary hearing loss involving two or more affected individuals have been identified and categorized according to the mode of inheritance. The majority (66%) of the non-syndromal families showed an autosomal recessive pattern, 29% an autosomal dominant inheritance and 5% an X-linked mode of inheritance. In the study presented there has been a predominance of affected males versus females and the consanguinity rate was 22%.     

Electron-beam CT-angiography in abdominal aortic aneurysms. Initial results

PURPOSE: To evaluate the suitability of ultrafast electron-beam tomography (EBT) for the investigation of abdominal aortic aneurysms using CTA. METHODS: Thirty-one patients with suspected abdominal aortic aneurysm were investigated with EBT using an Evolution XP scanner (Siemens, Erlangen) with the newest software version 12.34 with continuous volume scanning of 140 images in 17 s. Collimation was 3 mm, table increment 4 mm with overlapping image reconstruction every 2 mm, exposure time 200 ms (124 mAs), resulting in a scan-range of 28 cm. A quantity of 80 ml contrast material was administered (flow 4 ml/s). Visualization of the abdominal aorta and its branches was performed with MIPs and shaded surface display. Evaluation of image quality was based on a four-step classification scale (1 = good, 4 = insufficient) for the demonstration of the abdominal aorta and the visceral, renal and iliac arteries. RESULTS: All EBT examinations demonstrated high and homogeneous density values along the whole vessel course with a mean density value of 258.7 +/- 47.3 HU for the abdominal aorta and the iliac arteries. Quality evaluation for the vessel demonstration showed mean values between 1.22 and 1.57 for the abdominal aorta and the visceral, renal and iliac arteries. CONCLUSIONS: EBT with 140 slices and slice reconstruction every 2 mm offers a high z-axis resolution resulting in high-quality CT angiographies of the whole abdominal aorta and its branches.     

Prospective evaluation of new and old criteria to discriminate between supraventricular and ventricular tachycardia in implantable defibrillators

This study was designed to evaluate the ability to distinguish between supraventricular tachycardias (SVTs) and ventricular tachycardias (VTs) based on onset, stability, and width criteria in an implantable defibrillator. Inappropriate detection of atrial fibrillation and sinus tachycardia is a common problem in patients with implantable defibrillators. The onset, stability, and width criteria were studied in 17 patients who underwent implantation of a Medtronic 7218C implantable defibrillator by inducing sinus tachycardia and atrial fibrillation. Additional data on the width criteria was obtained by pacing at separate sites in both the left and right ventricle. Patients were studied at different times for up to 6 months to determine any changes in the criteria. The onset and stability criteria caused inappropriate detections in 36% and 12% of the episodes, respectively. The addition of the width criteria decreased the inappropriate detection using the onset and stability criteria to 5% and 2%, respectively. Pacing from the RV apex, RV outflow tract, and LV apex was appropriately detected as wide in 76%, 41%, and 94%, respectively. The width criteria changed over time in individual patients, but was stable by 6 months in all but one patient. No single criterion is satisfactory for distinguishing between SVT and VT in this patient population, but the combination of criteria seems to provide better discrimination. The width criteria can change dramatically over time and needs to be monitored carefully. Newer algorithms will need to be developed to allow better detection of supraventricular tachycardias.     

Problems in managing patients with long QT syndrome and implantable cardioverter defibrillators: a report of two cases

Implantable cardioverter-defibrillators (ICDs) have been a successful adjunct to the management of arrhythmias in patients with Long QT syndrome (LQTS). In two patients, interactions between LQTS and the ICD were diagnosed and corrected. Oversensing of T waves was confirmed in the first, while in the second, the arrhythmia disappeared when T wave abnormalities improved after cessation of H2 blocker therapy. In patients with LQTS and an ICD, T wave oversensing should be considered. Interventions that may have an adverse effect on repolarization should be avoided.     

Radiofrequency catheter ablation of atrioventricular junctional ("AV nodal") reentrant tachycardia in patients with implantable cardioverter defibrillators

Catheter ablation of tachycardias has been undertaken successfully in patients with ICDs without damage to the ICD or lead. Ablation of the slow AV nodal pathway, however, is technically challenging because the lead of the ICD lies close to the ablation site. We report successful ablation of AV junctional reentrant tachycardia (AVJRT) in three patients with ICDs. In all cases, the ablation site was within a few millimeters of the ICD lead. The ablation was successful in all cases and did not cause damage to the ICD or lead. The patients have remained free of recurrence of AVJRT during a mean follow-up of 12 months.     

Cockett syndrome. Initial results with percutaneous treatment in 6 patients

Intimal hypertrophy with venous spur formation caused by compression of the left common iliac vein by the right common iliac artery is advanced as the etiology of the higher incidence of deep venous thrombosis involving the left leg. In most cases of left iliofemoral thrombosis no underlying compression syndrome is detected or treated because the left common iliac vein has to be cleared from thrombi before compression can be identified. A series of 6 consecutive retrospectively analyzed patients with acute left iliofemoral thrombosis is presented. In these patients a left iliac vein compression syndrome was detected after percutaneous intraluminal thrombolysis with Actilyse (rt-PA). This compression was successfully relieved by insertion of a wall stent. Percutaneous treatment of Cockett's syndrome seems an attractive alternative for conservative and/or surgical management.     

Initial experience with a laser sheath to extract chronic transvenous implantable cardioverter-defibrillator leads

This is the first study of the use of a laser sheath to remove chronic transvenous implantable cardioverter-defibrillator leads. A 16Fr laser sheath was used to extract 14 leads from 11 patients, 6 of whom had undergone failed previous extraction attempts using conventional tools.     

Initial results of intraluminal ultrasound in gynecologic diagnosis

The derivatization of poly(p-(chloromethyl)styrene-co-divinylbenzene) (Merrifield resin) with N-(tert-butoxycarbonyl)-2-aminoethanethiol is presented as a convenient route for the generation of thiol terminated peptides using a solid phase methodology. Maximum resin substitution reached 92% (773 mumol/g) after 24 h. However, at 30 min, yields exceeded 400 mumol/g, above which the resin is suitable for solid phase peptide synthesis. Thiol terminated peptides are well-suited for subsequent chemical conjugation reactions or for the formation of organic monolayers on metal substrates.     

Initial results with the unreamed AO tibial nail

It is generally accepted that intramedullary nailing in combination with reaming should be avoided in treating open fractures. However, the use of an unreamed, solid nail combined with interlocking also allows stabilization of open and complex fractures. 20 tibia fractures (65% open, 45% complex fractures) have been treated by the AO unreamed tibial nail (UTN), 12 (5 of them open fractures) by direct nailing and 8 after initial stabilization by an external fixator. In our series no intraoperative complications, no soft-tissue healing problems and no infections occurred. Thus, treatment of both open and comminuted fractures by UTN appears to be safe and generally needs no secondary stabilization.     

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.     

Favorable results of implantable cardioverter-defibrillator implantation in patients older than 70 years

BACKGROUND: The clinical results of implantable cardioverter-defibrillator (ICD) implantation in the elderly have received limited documentation. As the longevity of the U.S. population has increased, so has the need for ICD implantation in the elderly. We evaluated the efficacy and outcome of ICD implantation in elderly patients (>70 years) compared with younger patients. METHODS: The case records of all consecutive patients who underwent ICD implantation at our institution between 1986 and 1994 were reviewed. Of a total of 238 patients, 78 patients were 70 years of age or older and 160 patients were younger than 70 years of age. RESULTS: The mean age of the younger group was 58 years and that of the elderly group was 74 years. There were no statistical differences in the presence of coronary artery disease, left ventricular systolic function, the inducibility of arrhythmias, or the history of sudden cardiac death. The hospital morbidity rate was similar in both groups (6.9% in the younger group and 7.7% in the elderly group; p = not significant). The operative mortality rate was 1.9% for the younger group and 1.3% for the elderly group (p = not significant). At a mean follow-up of 33 +/- 26 months, Kaplan-Meier survival curves demonstrated similar survival rates, with 93%, 82%, and 65% of the patients alive at 1, 3, and 6 years, respectively. CONCLUSIONS: Implantable cardioverter-defibrillator implantation was equally effective in the treatment of patients older than 70 years as in younger patients. No differences in theoretic survival or morbidity were observed.