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PubMed1997

Modification of patient driving behavior after implantation of a cardioverter defibrillator.

Driving habits among recipients of ICDs have not been well characterized previously, yet such information may have implications for development of national policy. This study was undertaken to characterize driving behavior after defibrillator implantation in our patient population. From 1988-1993, 82 ICDs were implanted at the University of Florida. All patients received defibrillator teaching preoperatively and postoperatively with particular emphasis placed on driving restrictions. A standardized questionnaire was developed to ascertain driving behavior, compliance with restrictions, and occurrence of motor vehicle accidents following implantation. The patients were divided into two groups according to whether or not they had received a shock from their device since implantation. Group I patients did, and Group II patients did not. Fifty-two out of 82 (63%, Group I) patients had at least one shock. The remaining 30 patients had received no shocks. Mean age and gender were no different between the two groups. Mean time since implantation was 6 +/- 1.3 years in Group I, compared to 4 +/- 1.5 years in Group II (P = 0.001). Forty-seven out of 52 (90%) and 26 out of 30 (87%) in Groups I and II, respectively, resumed driving after defibrillator implantation. There was no difference in the amount of time that passed prior to resumption of driving. Group I patients drove more, 20.5 +/- 27 miles/day compared to patients in Group II, 8.3 +/- 9.7 miles/day (P = 0.02). No patient experienced device discharge during driving; likewise, no patient was involved in a motor vehicle accident secondary to their device firing. Sixty-seven out of 82 (82%) patients complied with the instructions they thought they heard; seven patients in Group I and eight patients in Group II deliberately did not follow our advice. The majority of patients do comply with physician instructions, although the instructions they remember are not always the instructions given. If a national policy is created to prohibit driving after ICD implantation, effective enforcement may be difficult.

Accidents, Traffic↗
PubMed1997

Pacing induced ventricular fibrillation in internal cardioverter defibrillator patients: a new form of proarrhythmia.

Current model internal cardioverter defibrillators (ICDs) have cardioversion, defibrillation, pacemaker, and telemetry function. Telemetry documents arrhythmia and facilitates therapeutic adjustments. We report two cases of pacing induced VF terminated by the defibrillator, with the device responsible for both initiation and correction of the arrhythmia.

Arrhythmia, Sinus↗
PubMed1997

Management of patients with life-threatening ventricular tachyarrhythmias in the defibrillator era: the need to differentiate.

Patients with a history of sustained ventricular tachyarrhythmias form an extremely inhomogeneous group with respect to presenting arrhythmia, underlying cardiac disease, and therefore, risk of dying suddenly. For subgroups such as ventricular tachycardia in the absence of underlying cardiac disease, radiofrequency catheter ablation offers cure. In others, implantation of a cardioverter defibrillator already appears to have gained the therapy of first choice, leaving only a secondary role to antiarrhythmic drugs. It must be emphasized however, that these new therapeutic strategies have their pros and cons like the older, seemingly out-fashioned approaches of noninvasively or invasively guided antiarrhythmic drug therapy or empiric amiodarone treatment. Until the advent of controlled randomized trials comparing the implantable cardioverter defibrillator (ICD) with the best other, usually medical form of treatment, physicians must continue to base their individual therapeutic decisions on circumstantial published and personal experience. In doing so, the recent achievements of catheter ablation and defibrillator implantation have definitely improved patient care, but have not made antiarrhythmic drugs jobless. With all the alternatives at hand, it remains a challenging task to weigh the benefits and risks of the various approaches against each other in an attempt to tailor the antiarrhythmic intervention to the very individual need of the patient.

Amiodarone↗
PubMed1998

Pneumothorax: an unusual cause of ICD defibrillation failure.

We describe two patients with defibrillation failure of implantable cardioverter defibrillators (ICDs) resulting from large left pneumothoraxes following subclavian vein puncture during the implantation. Following pneumothorax drainage, low defibrillation thresholds (DFTs) were attained without further manipulations. The absence of other signs and symptoms of pneumothorax and the presence of satisfactory pacing function during the procedure, resulted in a significant delay in diagnosis. Pneumothorax should be included in the differential diagnosis when unexpected high DFTs are found during ICD implantation or predischarge testing. This complication is avoidable by a different surgical approach, cephalic vein cutdown.

Aged↗
PubMed1998

Multiple inappropriate shocks precipitated by interrogation of an implantable cardioverter defibrillator.

A 57-year-old man suffered multiple inappropriate shocks from an implantable cardioverter defibrillator that could not be inactivated because the magnet switch feature was deactivated. Attempts to interrogate the defibrillator caused shocks to be delivered. Emergent explantation was performed and a loose sensing lead was discovered. Sensing and defibrillation leads functioned normally, and testing of the explanted generator demonstrated no abnormalities. A new generator was put in place and the patient has been without shocks for 6 months. This case illustrates the need for robust methods of attenuating electromagnetic interference and the importance of multiple methods of device inactivation.

Defibrillators, Implantable↗
PubMed1998

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.

Aged↗
PubMed1998

Myocardial lactate extraction during repeated fibrillation/defibrillation episodes in defibrillator implantation testing.

Intraoperative testing with several fibrillation/defibrillation episodes (FDEs) is routinely performed during defibrillator implantation. Testing is considered safe even in patients with severe cardiac impairment, provided the recovery timespans and number of FDEs are adapted to the individual patient. Myocardial lactate extraction (MLE) was examined in two testing protocols. In 30 patients with coronary artery disease defibrillator implantations were performed under intravenous anesthesia. A percutaneous catheter was positioned into the coronary sinus (CS) underfluoroscopy. Two groups were randomly formed: group A (n = 20, mean number of FDEs: 4.2/patient) with 2 minutes waiting time between FDEs, and group B (n = 10, mean number of FDEs 4.1/patients) with 10 minutes between FDEs. Defibrillation pulses were released 15 seconds after T wave shock induced fibrillation. To estimate MLE, arterial and CS blood samples were collected before and after each FDE. After the last FDE, samples were obtained after 5, 10, and up to 20 minutes. In group A, MLE fell from a baseline value of 29.6% +/- 3.6% before the FDEs to 7.8% +/- 5.4% immediately after the episodes. MLE recovered to 27.2% +/- 6.5% within 1 minute and overshot to 35.6% +/- 5.8% within 5 minutes. In group B, MLE decreased from 37.6% +/- 7.5% to 15.1% +/- 8.1% immediately after each FDE and rose to its original value (33.6 +/- 7.8) within the 5-minute recovery period. MLE decreased immediately after each FDE, and recovered within 1 minute even in poor left ventricular function. For full MLE recovery a 2-minute wait between episodes is sufficient, if the total number of FDEs does not exceed four.

Aged↗
PubMed1999

Transvenous atrial cardioversion threshold in patients with implantable cardioverter defibrillator: influence of active pectoral can.

Recent studies have shown that transvenous atrial cardioversion is feasible with lead configurations primarily designed for implantable cardioverter defibrillators (ICD). The purpose of this study was to examine the influence of an active pectoral ICD can on the atrial cardioversion threshold (ADFT). Forty consecutive patients received a transvenous single lead system (Endotak DSP 0125, CPI, St. Paul, MN, USA) in combination with a left subpectoral ICD (Ventak Mini, CPI) for treatment of malignant ventricular tachyarrhythmias. Patients were randomized into two groups: 21 received a Hot Can 1743 and 19 patients a Cold Can 1741. Step-down testing of the ventricular defibrillation threshold (VDFT) was performed intraoperatively and evaluation of the ADFT for induced atrial fibrillation (AF) at predischarge. After testing, each patient received a 2-J shock and was asked to quantify discomfort on a numerical scale ranging from 0 to 10. Both groups were comparable with regard to all clinical parameters studied. The mean VDFT in patients with a Hot Can device was significantly lower than in patients with a Cold Can (7.5 +/- 2.3 J vs 9.8 +/- 3.8 J; P < 0.03). The mean ADFT in the Hot Can group tended to be lower than in the group with Cold Cans (3.4 +/- 1.4 J vs 4.5 +/- 2.4 J; P = 0.07), and the proportion of patients in whom atrial cardioversion was accomplished at low energies (< or = 3 J) was higher in patients with active compared with patients with inactive pulse generators (57% vs 26%; P < 0.04). The mean discomfort reported after delivery of a 2-J shock was comparable in both groups (Hot Can 5.2 +/- 1.9; Cold Can: 5.3 +/- 2.1; P = NS). We conclude that the inclusion of an active left subpectoral can in the defibrillation vector of a ventricular ICD seems to reduce the energy requirements for atrial cardioversion without increasing the discomfort caused by low energy shocks.

Atrial Fibrillation↗
PubMed1999

A randomized controlled clinical trial comparing ventricular fibrillation detection time between two transvenous defibrillator models. The Acute Ventak AV investigator group.

The Ventak AV is an implantable cardioverter defibrillator with dual chamber pacing capability. Features include detection and treatment of ventricular arrhythmias, detection of atrial arrhythmias, as well as dual chamber pacing. The objective of the investigation was to verify the efficacy of the Ventak AV in detecting ventricular fibrillation in the presence of dual chamber pacing. Thirty-three patients, who were to receive an implantable defibrillator were randomized (1:1) in a paired comparison study to the Ventak AV (study device) and the Ventak Mini (control) during defibrillation threshold testing. In order to create a "worst case scenario" for sensing of ventricular fibrillation, pacing was performed at high lower rate limit values (Ventak AV DDD pacing at 150/min, Ventak Mini at VVI 100/min). Ventricularfibrillation was induced and the randomized device was allowed to detect and treat the arrhythmia. This test was repeated for each patient using the alternate device in a randomized order, such that all patients were tested with both devices. The mean ventricular fibrillation detection time for the Ventak AV was 2.0+/-0.11 seconds and for the control device the detection time was 1.8+/-0.11 seconds (P = 0.26). Appropriate tachyarrhythmia therapy decision was documented in all episodes for both devices. The study patient population demonstrated equivalent ventricular fibrillation detection time between the Ventak AV and the Ventak Mini. The Ventak AV demonstrated effectiveness in detecting ventricular fibrillation in the presence of high rate dual chamber pacing.

Adult↗
PubMed1999

Twiddler's syndrome with transvenous defibrillators in the pectoral region.

Advances in technology have enabled the implantation of defibrillators in the pectoral region. Complications encountered with pacemakers may also be observed with defibrillators. We describe two cases of twiddler's syndrome in patients with defibrillators implanted subcutaneously in the left pectoral region.

Aged↗
PubMed2000

Temporal and geographical trends in indications for implantation of cardiac defibrillators in Europe 1993-1998. Medtronic ICD System Investigators.

Despite the demonstrated efficacy of implantable cardioverter defibrillators (ICDs) in reducing sudden and total mortality in selected populations, their implantation rates vary greatly between countries. The aim of our study was to analyze temporal and geographical trends in ICD implantations in countries with similar health related expenditure in Western Europe. A total of 2,257 patients from ten European evaluation studies of Medtronic defibrillators and defibrillation electrodes, conducted between 1993 and 1998, representing 12 countries, was included in this analysis. Rates of implantation and clinical characteristics were compared between countries and years of implantation. Rates of implantation differed greatly between Western European countries and did not correlate with indices of health related expenditure (i.e., number of patients per physician and number of patients per hospital bed). However, there was a strong and statistically significant negative correlation between the use of amiodarone and the rates of implantation (r = -0.66, P = 0.02). Temporal trends showed a significant increase in the age of the patients receiving an ICD between 1993 and 1998 (57 +/- 14 vs 61 +/- 12 years, mean +/- SD, P < 0.001). There was also a temporal trend towards an increased incidence of coronary artery disease and a significant decrease in the incidence of cardiomyopathy. There was a temporal increase in implantations in patients with a history of ventricular tachycardia. Despite a general scientific agreement that ICDs are a first line treatment for patients at high risk of sudden cardiac death, their acceptance remains low in several developed countries. This low acceptance may not be entirely related to budget constraint but may also be related to their perceived efficacy by physicians and health authorities.

Amiodarone↗
PubMed2000

Reduction in defibrillation threshold using an auxiliary shock delivered in the middle cardiac vein.

Defibrillation in the middle cardiac vein (MCV) has been shown to reduce ventricular defibrillation thresholds (DFTs). Low amplitude auxiliary shock (AS) from an electrode sutured to the left ventricle at thoracotomy have also been shown to reduce DFT if delivered immediately prior to a biphasic shock (between the ventricular RV and superior vena caval (SVC) electrodes). This study investigates the impact on DFT of an AS shock from a transvenously placed MCV lead system. A standard defibrillation electrode was positioned in the RV in eight anesthetized pigs (35-43 kg). A 50 x 1.8-mm electrode was inserted in the MCV through an 8 Fr angioplasty guide catheter. A 150-V (leading edge) monophasic AS was delivered (95 microF capacitor) from the MCV-->Can with three different pulse widths (3, 5, 7 ms). A primary biphasic shock (PS) (95 microF capacitor, phase 1: 44% tilt, 1.6-ms extension and phase 2: 2.5-ms fixed duration) was delivered from the RV-->Can +/- AS. The four configurations were randomized and DFTs (PS + AS) assessed using a modified binary search. Ventricular fibrillation (VF) was induced with 60 Hz AC followed 10 seconds later by the test shock. The DFTs were compared using repeated measures analysis of variance (ANOVA). All configurations incorporating AS produced significant (P < 0.05) reduction in the DFT compared to no AS (13.8 +/- 7.4 J). There was no difference in the efficacy of differing pulse widths (P > 0.05); 3 ms (11.0 +/- 5.4 J), 5 ms (11.5 +/- 6.0), and 7 ms (10.6 +/- 5.3 J). In conclusion, delivering an AS from a transvenous lead system deployed in the MCV reduces the DFT by 23% compared to a conventional RV-->Can shock alone.

Analysis of Variance↗
PubMed2004

Evaluation of safety and efficacy of pacemaker and defibrillator implantation by axillary incision in pediatric patients.

We successfully implanted 11 pacemakers, 6 defibrillators, and 1 biventricular pacemaker in 18 pediatric patients (15 female; 4 to 15 years, average age: 9) using the retropectoral transvenous approach with a hidden axillary incision. The average follow-up period was 24 months (range 49 months). Eight patients had congenital structural heart conditions (d-transposition of great arteries S/P Mustard operation, d-transposition of great arteries S/P arterial switch operation, truncus arteriosus, right ventricular diverticula, ventricular septal defect, hypertrophic cardiomyopathy). Four patients had acquired heart conditions (dilated cardiomyopathy, myocarditis). Excellent sensing and pacing thresholds were achieved in all attempted implantations. There was no pneumothorax. There was one lead dislodgement. One lead fracture distant from the subclavian vein occurred 4 months after implantation. Implantation of pacemakers and defibrillators via axillary incisions can be safe and effective in pediatric patients. This approach avoids skin erosion when implanting large devices such as defibrillators or biventricular devices in small patients with limited muscle mass while achieving superior aesthetic results. The axillary or extrathoracic venous entry site avoids subclavian crush syndrome.

Adolescent↗
PubMed2004

Implantation of submammary implantable cardioverter defibrillators.

Implantable cardioverter defibrillators (ICDs) are routinely placed in the left pectoral area using a transvenous approach. This approach may result in poor cosmetic outcome and cause psychological problems, especially in younger patients. To avoid this, several alternative implantation techniques have been developed. For cosmetic reasons, we used a submammary technique to implant ICDs into three young women. Apart from defibrillation threshold testing, the procedures were performed under local anesthesia. Threshold testing was done under general anesthesia. Appropriate defibrillation thresholds were obtained in all three cases, and all the patients tolerated the procedure well. There were no complications in a mean of 22 months of follow-up, and the cosmetic results were very good.

Adult↗
PubMed2006

Quality of death: implantable cardioverter defibrillators and proactive care.

OBJECTIVES: The purpose of this paper is to discuss quality of death (QOD) among patients with congestive heart failure (CHF) and implantable cardioverter defibrillators. We outline recommendations that enhance QOD from the device patient and specialty cardiology perspectives. BACKGROUND: Contemporary treatment of CHF patients routinely includes both pharmacologic therapy and the use of cardiac devices. The implantable cardioverter defibrillator prevents premature death in heart failure patients, though not death itself. CONCLUSIONS: Active discussion and consideration of patient's QOD is indicated in implantable cardioverter defibrillator patients to prevent unnecessary treatment and to increase control over perceived quality of life by patients and family.

Death↗
PubMed2006

Effects of angiotensin converting enzyme inhibitor and angiotensin II receptor blocker on ventricular defibrillation threshold.

BACKGROUND: Angiotensin converting enzyme (ACE) inhibitors and Angiotensin II (AII) receptor blockers have previously been shown to be beneficial in treating patients with not only hypertension but also with cardiovascular diseases. Therefore, such drugs may potentially be used in patients with an implantable cardioverter defibrillator (ICD) who show cardiac dysfunctions. OBJECTIVE: This study aimed to determine effects of short-term administration of the ACE inhibitor (CV-3317) and the AII receptor blocker (CV-11974, an active form of candesartan) on internal defibrillation threshold (DFT) in anesthetized canine hearts. METHODS: DFTs were evaluated using a "hot can" defibrillation lead system in: (a) seven dogs following three intravenous administrations of 20 cc saline; (b) 11 dogs that received intravenous CV-3317 doses of 1 mg/kg, 10 mg/kg, and 50 mg/kg; and in (c) 10 dogs that were intravenously given 0.1 mg/kg, 1 mg/kg, and 10 mg/kg CV-11974. DFTs were determined using a "down-up down-up" protocol. RESULTS: Mean DFT delivered energies at baseline and following three consecutive intravenous saline injections were 16.4 +/- 9.3 J, 15.3 +/- 7.5 J, 15.9 +/- 7.1 J, and 15.5 +/- 5.6 J, respectively. Those at baseline and following 1 mg/kg, 10 mg/kg, and 50 mg/kg intravenous CV-3317 were 12.9 +/- 6.4 J, 12.2 +/- 6.4 J, 11.0 +/- 6.6 J, and 11.9 +/- 6.6 J, respectively. Similarly, those at baseline and after 0.1 mg/kg, 1 mg/kg, and 10 mg/kg CV-11974 were 13 +/- 6.6 J, 12.5 +/- 6 J, 12.9 +/- 5.8 J, and 13.2 +/- 6.6 J, respectively. There were no significant differences between DFT at baseline and the others in each treatment group. CONCLUSIONS: Since an ACE inhibitor and an AII receptor blocker did not alter DFT, such drugs may be useful in ICD patients without a decrease in safety margins.

Analysis of Variance↗
PubMed2006

Seasonal variations of ventricular arrhythmia clusters in defibrillator recipients.

BACKGROUND: Clustering ventricular arrhythmias are the consequence of acute ventricular electrical instability and represent a challenge in the management of the growing number of patients with an implantable cardioverter-defibrillator (ICD). Triggering factors can rarely be identified. OBJECTIVES: Several studies have revealed seasonal variations in the frequency of cardiovascular events and life-threatening arrhythmias, and we sought to establish whether seasonal factors may exacerbate ventricular electrical instability leading to arrhythmia clusters and electrical storm. METHODS: Two hundred and fourteen consecutive defibrillator recipients were followed-up during 3.3 +/- 2.2 years. Arrhythmia cluster was defined as the occurrence of three or more arrhythmic events triggering appropriate defibrillator therapies within 2 weeks. Time intervals between two clusters were calculated for each month and each season, and were compared using Kruskal-Wallis test and Wilcoxon-Mann-Whitney test with Bonferroni adjustment. RESULTS: During a follow-up of 698 patient years, 98 arrhythmia clusters were observed in 51 patients; clustering ventricular arrhythmias were associated with temporal variables; they occurred more frequently in the winter and spring months than during the summer and fall. Accordingly, the time intervals between two clusters were significantly shorter during winter and spring (median and 95% CI): winter 16 (5-19), spring 11.5 (7-25), summer 34.5 (15-55), fall 50.5 (19-65), P = 0.0041. CONCLUSION: There are important seasonal variations in the incidence of arrhythmia clusters in ICD recipients. Whether these variations are related to environmental factors, change in physical activity, or psychological factors requires further study.

Defibrillators, Implantable↗