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PubMed1999

Arrhythmia recurrence in patients with a healed myocardial infarction who received an implantable defibrillator: analysis according to the clinical presentation.

OBJECTIVES: The purpose of this study was to analyze the type of arrhythmia recurrence, based on stored electrograms, in patients with a healed myocardial infarction (MI) who received an implantable defibrillator. BACKGROUND: Previous studies suggest that patients presenting with cardiac arrest (CA) tend to recur as ventricular fibrillation (VF), whereas those suffering sustained monomorphic ventricular tachycardia (SMVT) tend to recur as SMVT. However, these data have not been confirmed in a homogeneous population of patients with MI. METHODS: A total of 88 patients was divided into three groups according to their clinical presentation: SMVT (n = 57), CA (n = 16) or syncope (n = 15). RESULTS: There were no significant differences in clinical characteristics among groups. In the electrophysiologic study SMVT was induced in 93%, 94% and 80% of patients, respectively (p = NS). During the follow-up period, 52% of patients presented a total of 671 episodes of ventricular arrhythmia treated by the defibrillator. All recurrences were as SMVT except for one VF. There were 610 episodes of SMVT treated with antitachycardia pacing, with an effectiveness of 96%. A total of 61 episodes was treated initially with cardioversion. No differences in the probability of recurrence were observed among groups, although the statistical power was low (50%). CONCLUSIONS: In patients with an old infarction and malignant ventricular arrhythmias, the majority of recurrences are due to SMVT independently of the clinical presentation (SMVT, CA or syncope) or the induced arrhythmia at the electrophysiologic study. The programming of an antitachycardia zone seems to be appropriate also for patients who present with CA or syncope.

Aged↗

PubMed1997

Long-term follow-up of cardioverter-defibrillator implanted under conscious sedation in prepectoral subfascial position.

BACKGROUND: Implantable cardioverter-defibrillators (ICDs) with intravenous electrode systems and downsized generators can be implanted by use of operative techniques similar to those employed for the insertion of permanent pacemakers. However, the safety, efficacy, and long-term follow-up of simplified implantation procedures remain to be evaluated. This report is a prospective long-term evaluation of nonselected patients receiving ICDs in the prepectoral subfascial position under conscious sedation. METHODS AND RESULTS: Clinical characteristics of the 231 consecutive patients included a mean age of 63 years, a male-to-female ratio of 6.4, a left ventricular ejection fraction of 0.34, a mild-to-moderate heart failure in 91%, coronary artery disease in 84%, and a history of aborted sudden cardiac death or refractory ventricular tachyarrhythmias. Insertion of transvenous leads and prepectoral subfascial ICD implantation were performed in electrophysiology laboratories under local anesthesia and conscious sedation with intravenous midazolam and propofol. Successful implantation in all patients (operation time, 80 +/- 32 minutes, mean +/- SD) irrespective of body size and skin thickness was free of major complications, including need for emergency intubation. After surgery, 1 pocket hematoma, 1 seroma, and 1 pneumothorax required treatment. There was no operative or first-month mortality. During long-term follow-up averaging 453 +/- 296 days, six leads required repositioning, but pocket erosions or infections did not occur. First-year total survival was 97%. CONCLUSIONS: Implantation under conscious sedation of ICDs in the prepectoral subfascial position is a safe and effective procedure with low operative and postoperative morbidity and favorable long-term outcome.

Adolescent↗

PubMed1984

The potential role of the implantable defibrillator in malignant ventricular arrhythmias.

A malignant arrhythmia is one which threatens life and is difficult to predict, prevent or treat. Any arrhythmia which falls into this category is an indication for the implantable defibrillator. The simplicity of this statement is of course deceiving. Transthoracic defibrillation, which for 20 years has been the therapeutic standard, has provided us with the greatest insight and understanding of cardiac arrhythmias. In the long run, the same information will be acquired with the implanted defibrillator. However, technical, medical and economic factors are more complex and will not be resolved in the near future.

Arrhythmias, Cardiac↗

PubMed2005

Long-term incidence of malignant ventricular arrhythmia and shock therapy in patients with primary defibrillator implantation does not differ from event rates in patients treated for survived cardiac arrest.

INTRODUCTION: Recent trials have demonstrated benefit of prophylactic defibrillator (ICD) implantation compared to conventional treatment in high-risk patients. However, many patients have rare or no sustained arrhythmias following implantation. Our study addresses the question, whether patients with prophylactic defibrillator implantation have a lower risk for life-threatening ventricular tachycardia (VT) or ventricular fibrillation (VF) compared to sudden cardiac death (SCD) survivors. METHODS AND RESULTS: Over 7 years we enrolled 245 patients. Occurrence of spontaneous sustained VT/VF resulting in adequate ICD treatment was the endpoint. Incidence, type, and treatment of sustained arrhythmia in 43 previously asymptomatic ICD recipients (group B) were compared to data of 202 survivors of imminent SCD (group A). All patients had severely impaired left ventricular ejection fraction (<45%). Group B patients had long runs (>6 cycles, <30 s) of VT during Holter monitoring and inducible sustained arrhythmia. Incidence of rapid VT and VF (cycle length <240 ms/heart rate >250 bpm) after 4 years (35% in both groups, P = ns) and adequate defibrillator therapies (57% vs 55%, P = ns) were similar in both groups after univariate and multivariate analysis. Cumulative mortality tended to be lower in group B compared to group A, but the difference was not statistically significant. CONCLUSION: During long-term follow-up, incidence of sustained rapid ventricular arrhythmia in prophylactically treated patients is as high as that of SCD survivors. Benefit from defibrillator implantation for primary prevention (group B) appears to be comparable to that for survived cardiac arrest (group A).

Adult↗

PubMed2006

An ill wind-iatrogenic air embolus around pacing leads during defibrillator implant with coexisting pulmonary fibrosis.

We present a case of air embolism during biventricular defibrillator implantation in a 58-year-old man with pulmonary fibrosis. To prevent air entry after the dilator was removed, the subclavian venous sheath was covered before the lead was introduced. Air embolism occurred during inspiration around the lead body in the appropriate sized sheath but without a hemostatic valve. Extraordinary swings in intrathoracic pressure due to noncompliant lungs may have contributed to this unusual complication.

Defibrillators, Implantable↗

PubMed1998

A testing system for implantable cardioverter defibrillators.

Implantable cardioverter defibrillator (ICD) testing during the implantation process is important in order to avoid repeated induction of arrhythmias, which extends the implantation procedure and poses a risk to the patient. Hence, an in vitro testing system has been designed to assist optimal device programming and avoid repetitive inductions. The system includes a high-speed computer with A/D and D/A subsystems. Software has been designed to eliminate repeated arrhythmia induction by real-time capture and storage of the electrogram. Subsequently, the electrogram can be replayed into ICD software simulators at a variety of settings to determine candidate programming parameters. To validate the simulation system, signals were fed directly to an ICD via an attenuator. Output event markers were captured simultaneously with the signal into a digital file to assess the device performance. Four ventricular tachycardia (VT), three supraventricular tachycardia, (SVT), three atrial flutter (AFL), three atrial fibrillation (AF), and ten ventricular fibrillation (VF) passages were used to verify the system. Test settings were 110-160 beats/min for detection rate and 5 seconds for shock delay. The simulator and ICD detected the episodes for all passages at the 110 beats/min setting. For the setting of 160 beats/min, two VTs, two SVTs, three AFLs, and nine VFs were detected by the device, but no Afb triggered a shock. The simulator detection criteria were met by two VTs, two SVTs, three AFLs, ten VFs, and one AF. The mean detection time was 6,869-7,330 ms (110-160 beats/min) for the simulator and 7,840-8,170 ms for device. Comparison of results showed general agreement between simulator and device. Results demonstrated that device behavior at a variety of settings can be elucidated by the simulator for selection of optimal performance. The automated system can also function as a test bed for evaluation of new algorithms during device development and design.

Algorithms↗

PubMed2006

Is there a role for antiarrhythmic drugs in patients with implantable defibrillators?

With remarkable advancement in technology and clinical research, implantable cardioverter defibrillators (ICDs) have replaced antiarrhythmic drugs as the preferred modality for both primary and secondary prevention of arrhythmic deaths. However, concomitant use of antiarrhythmics in patients with ICDs remains common, often for prevention or reduction of appropriate and inappropriate shocks caused by ventricular and supraventricular arrhythmias, respectively. The role of empiric antiarrhythmic therapy in this patient population remains less clearly defined, with conflicting information from various small randomized trials. Use of antiarrhythmic drugs in the ICD patient population not only can cause potentially serious side effects but can also interact or interfere with the ICD device function. In addition, the effect on survival in patients with ICDs is not well characterized. Given the many potential side effects, drug-device interactions, unclear survival effect, and lack of convincing clinical data supporting its use, empiric antiarrhythmic therapy in the ICD patient population cannot be recommended at this time.

Anti-Arrhythmia Agents↗

PubMed1998

A decade of clinical trial developments in postmyocardial infarction, congestive heart failure, and sustained ventricular tachyarrhythmia patients: from CAST to AVID and beyond. Cardiac Arrhythmic Suppression Trial. Antiarrhythmic Versus Implantable Defibrillators.

Multiple trials using antiarrhythmic drugs, pharmacologic therapy, and implantable cardioverter defibrillators have been performed in an attempt to improve survival in patients: (1) postmyocardial infarction; (2) with congestive heart failure, with and without nonsustained ventricular tachycardia; and (3) with sustained ventricular tachycardia and those who have survived an out-of-hospital cardiac arrest. This article reviews some of the key findings and limitations of completed and ongoing trials. We also make recommendations for the current treatment of such patients based on the results of these trials.

Adrenergic beta-Antagonists↗

PubMed1988

Implantable defibrillation: eight years clinical experience.

Implantation of the first automatic defibrillator occurred in February 1980. Incorporation of cardioversion capability in 1982 resulted in the AICD automatic implantable cardioverter defibrillator. Between April 1, 1982 and April 15, 1988, 3610 patients in 236 U.S. and 84 international centers received AICD pulse generators. Patient population consisted of 2904 males and 683 females with recurrent ventricular tachycardia and/or fibrillation, mean age 59 yrs. (range 9-96 yrs.). Primary diagnoses reported for the patient group were: coronary artery disease (63.5%), nonischemic cardiomyopathy (12.9%), other (6.4%) and unspecified (17.2%). Mean reported LV ejection fraction was 32.8%. Follow-up averaged 12.2 mo. (range 0-72 mo.). Of 385 deaths, 94 (24%) were sudden. Cumulative percentage survival (+/- S.E.) from sudden cardiac death (SCD) was 98.0 +/- 0.3%, 96.5 +/- 0.5%, 95.2 +/- 0.7%, 93.7 +/- 1.0%, 93.7 +/- 1.0% and 89.7 +/- 4.0% at 12, 24, 36, 48, 60 and 72 months, respectively. Operative mortality (less than or equal to 30 days) was 2.5%. Reported side effects/complications were similar to those of pacemakers. To date, 33% of the patients received spontaneous device countershocks. AICD pulse generator survival from electrical and mechanical failures was 92.8 +/- 0.5%, 88.4 +/- 0.7%, 86.7 +/- 0.8% and 86.4 +/- 0.9% at 12, 18, 24 and 30 mos. Data analysis demonstrates that the AICD has had a significant impact on patient survival from SCD.

Death, Sudden↗

PubMed1995

Arrhythmias after cardioverter-defibrillator implantation: comparison of epicardial and transvenous systems.

Surgery for implantable cardioverter-defibrillators can cause postoperative exacerbation of ventricular and atrial arrhythmias. It is not known whether the techniques of electrode implantation (epicardial vs transvenous) influence the incidence of arrhythmia exacerbation. We reviewed the postoperative course of 229 consecutive patients who received either epicardial (n = 119) or transvenous (n = 110) implantations from 1984 to 1994. Exacerbation of ventricular tachycardia (VT) was defined as an increase in the number of sustained VTs during the postoperative versus the preoperative 2 weeks. Of the entire cohort, 18 patients (8%) developed exacerbation of VT after operation, which was more frequent in patients with epicardial than with transvenous implantations (12% vs 4%, p < 0.03, odds ratio 3.5, 95% confidence interval 1.0 to 13.2). New-onset atrial fibrillation occurred in 15% of patients with epicardial versus 1% of those with transvenous implantations (p = 0.00005, odds ratio 19.4, 95% confidence interval 2.7 to 86.7). These differences persisted after excluding patients with concurrent cardiac surgery. Preoperative occurrence of arrhythmias was the strongest independent predictor for postoperative occurrence (p < 0.01 for VT, p < 0.0001 for atrial fibrillation). Epicardial implantation (p = 0.03) and a history of myocardial infarction (p = 0.04) were independent predictors for postoperative VT exacerbation, whereas epicardial implantation (p < 0.05) and concurrent coronary bypass surgery (p = 0.0001) were independent predictors for postoperative new atrial fibrillation. Perioperative discontinuation of antiarrhythmic drugs did not influence postoperative VT exacerbation. Epicardial implantation was associated with longer length of hospital stay than transvenous implantation (p = 0.0005), independent of age, left ventricular ejection fraction, and concurrent cardiac surgery.

Aged↗

PubMed2002

[The amiodarone-beta blockers combination could represent an alternative treatment in patients at risk for sudden death in which a benefit from implantable defibrillators has not been clearly demonstrated].

The combination of amiodarone and beta-blockers appears superior to amiodarone alone in the prevention of sudden death. At present this combination can be proposed to patients at risk of sudden death in whom a beneficial effect of the implantable defibrillator has not been clearly demonstrated. Therefore, the patients who can be treated with this combination appear the following ones: patients with sustained ventricular tachycardia (VT) causing severe hemodynamic compromise and ejection fraction > 35%; patients with hemodynamically well-tolerated sustained VT; patients with ischemic heart disease, syncope of unknown cause and induction of VT or ventricular fibrillation (VF) during electrophysiologic study; patients with sustained VT or VF and age > 80 years; patients with left ventricular dysfunction, without history of sustained VT or VF, but with "symptomatic ventricular arrhythmias".

Adrenergic beta-Antagonists↗

PubMed1998

Quality of life at baseline: is assessment after randomization valid? The AVID Investigators. The Antiarrhythmics Versus Implantable Defibrillators.

OBJECTIVES: The purpose of this report is to examine whether differences existed between patients who completed a baseline quality of life (QoL) form before being informed about their randomized assignments versus those who completed it after knowing their randomization assignments. METHODS: In the pilot phase of the Antiarrhythmics Versus Implantable Defibrillators (AVID) study (n = 200), 113 patients completed a baseline QoL battery prior to randomization (drug versus defibrillator), 49 additional patients completed this battery after randomization, and 38 patients did not complete this battery. Baseline demographic, clinical and QoL data were compared for these groups. RESULTS: Although the two groups with QoL data were not significantly different regarding various clinical and demographic characteristics, they did have significantly different QoL profiles. Patients with QoL collected before randomization had better overall QoL scores and mental health scores. CONCLUSIONS: These data suggest that patients with worse QoL may be less willing to complete a baseline QoL form in a timely manner or that knowledge of the randomization assignment may have an effect on QoL.

Aged↗

PubMed1994

Comparison and frequency of ventricular arrhythmias after defibrillator implantation by thoracotomy versus nonthoracotomy approaches.

Postoperative exacerbation of ventricular arrhythmias has been reported in some patients treated with thoracotomy implantable cardioverter-defibrillators (ICDs). This phenomenon, which may be related to epicardial patch electrodes, may be less frequent after nonthoracotomy ICD implantation. In this nonrandomized study, postoperative arrhythmias in thoracotomy approaches (n = 52) were compared with those in nonthoracotomy approaches (n = 59). Preoperatively, all patients were clinically stable receiving an antiarrhythmic regimen chosen by serial drug testing. Nine of 52 patients in the thoracotomy group developed sustained ventricular tachycardia postoperatively while receiving the same antiarrhythmic regimen chosen preoperatively, and 1 patient eventually died. Two additional patients developed frequent and prolonged episodes of nonsustained ventricular tachycardia requiring changes in the antiarrhythmic regimen. In the nonthoracotomy group, only 3 of 59 patients developed sustained ventricular tachycardia and 1 developed frequent nonsustained ventricular tachycardia. Thus, only 4 of 59 patients in the nonthoracotomy group developed clinically significant ventricular arrhythmia during the postoperative period compared with 11 of 52 patients in the thoracotomy group (p < 0.05). Surgical mortality was 6% in the thoracotomy group, and 0% in the nonthoracotomy group. In the remaining clinically stable patients, a marked (sevenfold) increase in asymptomatic ventricular arrhythmias was noted in 15 of 39 patients in the thoracotomy group, and in 3 of 55 patients in the nonthoracotomy group (p < 0.05). Thus, postoperative exacerbation of ventricular arrhythmia, sometimes noted with thoracotomy approaches, is very rare with nonthoracotomy approaches.

Aged↗

PubMed2000

Implantable defibrillator therapy in Naxos disease.

Naxos disease is a unique form of right ventricular cardiomyopathy with a high prevalence of malignant ventricular arrhythmias, including sudden cardiac death. As a hereditary systemic disease confined to a small island, it has been closely studied over the last 15 years. The implantation of an automatic defibrillator provides an alternative form of antiarrhythmic management to improve life expectancy in these high risk cardiac patients. We present the first two Naxos disease patients with malignant ventricular arrhythmias who had defibrillator implantation.

Arrhythmogenic Right Ventricular Dysplasia↗

PubMed2004

Comparison of perception of health status by physicians, nurses, and patients in the Dual-chamber And VVI Implantable Defibrillator (DAVID) trial.

Previous studies have shown a poor correlation between health and quality-of-life assessments by patients, physicians, and nurses. Some have argued that patients are treated impersonally in clinical trials. Because one would expect that patient care would be compromised if this were the case, we used the Dual-chamber And VVI Implantable Defibrillator (DAVID) clinical trial setting to see if these assertions truly reflect the assessments of quality of life by health care professionals. Physicians, nurses, and patients in the DAVID trial had concordant assessments of the patients' perception of health status. The findings dispel assertions that patient concerns are not reliably assessed.

Clinical Trials as Topic↗

PubMed1998

Prospective evaluation of shoulder-related problems in patients with pectoral cardioverter-defibrillator implantation.

BACKGROUND: The pectoral approach to implantation of cardioverter defibrillators (ICDs) has become a standard in defibrillator therapy because of reduced generator size, weight, and volume. But the size of these devices is still comparable to the size of the early conventional antibradycardia pacemakers that were associated with a number of significant pocket- and shoulder-related problems after implantation in the pectoral region. In a prospective, single-center study of 50 patients with subpectoral implantation of a fourth-generation ICD, the ipsilateral shoulder joint was evaluated regarding active shoulder motility, shoulder-related pain, shoulder function, shoulder elevation, insertion tendinitis, and morphologic alterations of the shoulder. METHODS AND RESULTS: The shoulder was evaluated before implantation and at 3, 6, and 12 months after implantation. Shoulder motility was documented by evaluating active abduction, forward flexion, and external rotation. Shoulder-related pain and function were documented by the "Basic Shoulder Evaluation Form," insertion tendinitis was diagnosed by standardized palpation and the impingement test, and morphologic alterations were documented by ultrasound and radiograph of the shoulder. Three months after implantation, 20 (40%) patients had a reduced active abduction, 30 (60%) patients had an impaired active forward flexion, and eight (16%) patients had a reduced external rotation. Thirty-one (62%) patients reported shoulder-related pain or impaired shoulder function according to the "Basic Shoulder Evaluation Form." Twenty-four (48%) patients showed a shoulder elevation and 21 (42%) patients demonstrated clinical signs of insertion tendinitis. After 12 months the number of patients with reduced active abduction, forward flexion, and external rotation dropped to four (8%). Shoulder-related pain and reduced function were documented in seven (13%) patients, four (8%) patients still had shoulder elevation, and five (10%) patients still had signs of insertion tendinitis. None of the postoperatively performed ultrasounds or radiographs showed any pathologic shoulder alterations. No predictors for the occurrence of shoulder-associated problems could be found. CONCLUSIONS: (1) Decreased active shoulder motility, shoulder-related pain, reduced function, shoulder elevation, and insertion tendinitis of the ipsilateral shoulder joint are diagnosed in many patients 3 months after subpectoral ICD implantation. (2) After 12 months the number of patients with impaired shoulder motility, function, shoulder-related pain, shoulder elevation, and insertion tendinitis decreased significantly. (3) Ultrasound and radiographs of the ipsilateral shoulder showed no evidence of pathologic morphologic alterations after subpectoral ICD implantation. (4) No shoulder-associated problems required an operative revision of the subpectoral generator pocket.

Defibrillators, Implantable↗

PubMed2005

Cost advantage of dual-chamber versus single-chamber cardioverter-defibrillator implantation.

OBJECTIVES: The purpose of this study was to determine the least expensive strategy for device selection in patients receiving implantable cardioverter-defibrillators (ICDs). BACKGROUND: Device cost for a single-chamber ICD is less than an atrioventricular (dual-chamber) ICD (AV-ICD); however, some patients without clinical need for AV-ICD at implantation might require a later upgrade, potentially offsetting the initial cost advantage of the single-chamber device. METHODS: Decision analysis was used to estimate expected resource utilization costs of three alternative implantation strategies: 1) single-chamber device in all, with later upgrade to AV-ICD if needed; 2) initial implantation of an AV-ICD in all; and 3) targeted device selection on the basis of results of electrophysiologic testing (presence or absence of induced bradyarrhythmias or atrial arrhythmias). Clinical base estimates were obtained from retrospective review of all patients receiving ICDs between June 1997 and July 2001 at a single university hospital. Economic inputs were collected from national and single-center sources. RESULTS: In patients without other indications for electrophysiologic study (EPS), the expected per-person cost was least with the strategy of universal initial AV-ICD implantation (36,232 dollars) compared with initial single-chamber ICD/upgrade as needed (39,230 dollars) or EPS-guided selection (41,130 dollars). Sensitivity analyses demonstrated that universal AV-ICD implantation remained least expensive with upgrade rates as low as 10%. At a 5% upgrade rate, AV-ICD remained cheapest if the device cost-differential narrowed to 1,568 dollars. For patients undergoing EPS for risk assessment, EP-guided selection was least expensive. CONCLUSIONS: The strategy of universal AV-ICD implantation, which provides the benefits of dual-chamber capability while obviating any potential need for future upgrade, is the least costly strategy for most patient populations receiving ICDs.

Atrial Fibrillation↗

PubMedDate not supplied

Automatic implantable defibrillator for the patient with recurrent refractory malignant ventricular arrhythmias: case report.

Clinically, the first line of treatment for patients experiencing potentially lethal arrhythmias includes antiarrhythmic medications and/or treatment of underlying causes such as ischemia or congestive heart failure. However, if the treatment is not successful in controlling the arrhythmia, the automatic implantable defibrillator is a viable alternative for the prevention of sudden death in these patients. The case report presents one example of how the automatic implantable defibrillator can supplement conventional medical therapy when success in suppressing recurrent arrhythmias cannot be obtained. This concept has been demonstrated in this 59-year-old woman who underwent several medication trials in an attempt to control her life-threatening arrhythmias.

Electric Countershock↗