Preliminary experience with a hybrid nonthoracotomy defibrillating system that includes a biphasic device: comparison with a standard monophasic device using the same lead system.

OBJECTIVES: This study analyzed the advantage of combining a biphasic device with a transvenous system and compared the results with those obtained with a standard monophasic device. BACKGROUND: Available lead systems use monophasic pulses and may require lengthy intraoperative testing to achieve adequate defibrillation threshold in a conspicuous number of patients. The option of biphasic waveform may provide further benefits. However, clinical experience with a permanent implant is lacking. METHODS: Fifty-five patients underwent testing and received a permanent implant using the Endotak lead system associated with a CPI monophasic device. The remaining 36 patients received a permanent implant with the Endotak lead system connected to a biphasic device. In both groups a subcutaneous patch was combined when needed to obtain acceptable defibrillation thresholds. RESULTS: Biphasic pulses resulted in lower mean (+/- SD) defibrillation thresholds (monophasic 15 +/- 4.7 J vs. biphasic 12 +/- 5 J, p = 0.03) and a better implantation rate (100% biphasic vs. 89% monophasic, p = 0.07). Biphasic pulses allowed implantation with less ventricular fibrillation induction (7.4 +/- 3.2 vs. 3.5 +/- 1.8, p < 0.01) and a mean shorter procedure time (168 +/- 39 vs. 111 +/- 30 min, p < 0.01). With the biphasic waveform a greater proportion of patients met the implantation criteria with the lead system alone (83% vs. 45%, p < 0.01). When needed, the left prepectoral location of the patch electrode was always sufficient in left subscapular position was required in 15 patients in the monophasic group. Implantation of the biphasic device was associated with a shorter mean hospital stay (3.8 +/- 0.8 vs. 5.4 +/- 2.2 days, p < 0.01). CONCLUSIONS: Incorporation of a biphasic device in a transvenous implantable cardioverter-defibrillator uniformly increases the efficacy of the system and the ease of implantation.

Efficacy of the implantable cardioverter-defibrillator in the elderly.

OBJECTIVES: We sought to assess the effect of advanced age on the outcome of patients with an implantable cardioverter-defibrillator (ICD). BACKGROUND: ICDs are effective in preventing sudden cardiac death in susceptible patients, but their beneficial effect on survival is attenuated by the high rate of nonsudden cardiac death in those treated. Although advanced age is an important variable in determining cardiovascular mortality, its impact on the outcome of patients with an ICD has been inadequately studied. METHODS: We performed multivariate analysis of a data base consisting of 769 consecutive patients with an ICD. Seventy-four patients > or = 75 years old at ICD implantation (Group 1) were compared with the remaining 695 patients (Group 2). RESULTS: The two groups were similar in clinical presentation, left ventricular function and gender distribution. The mean follow-up time was 29 and 42 months, respectively, for patients in Group 1 and Group 2. Actuarial survival at 4 years was 57% in Group 1 versus 78% in Group 2 (p = 0.0001). This difference was primarily due to a higher rate of nonsudden cardiac death in Group 1. On multivariate analysis, age > or = 75 years, New York Heart Association functional class III, left ventricular ejection fraction < 30% and appropriate shocks during follow-up were independently associated with increased mortality (odds ratio 3.56, 1.8, 1.6 and 1.39, respectively). CONCLUSIONS: Among patients with similar functional class and ejection fraction, the mortality risk is increased threefold in those > or = 75 years old at the time of ICD implantation. Extrapolation of results from younger patients is likely to overestimate ICD benefit in the elderly.

Feasibility of concomitant implantation of permanent transvenous pacemaker and defibrillator systems.

In 17 patients (14 men and 3 women aged 69 +/- 10 years), a transvenous pacemaker was implanted before (8 patients), following (7 patients), or simultaneously (2 patients) with the insertion of a transvenous defibrillator. Indications included malignant ventricular arrhythmias and symptomatic bradycardia in all patients. All patients had structural heart disease. All pacemakers were non-programmable bipolar, either single chamber (n = 7) or dual chamber (n = 10). Eleven pacemakers were rate responsive. The Transvene system was implanted in 7 patients (Pacer-Cardioverter-Defibrillator in 6 patients and the Cadence defibrillator in 1). The Endotak lead system was implanted in 10 patients (Ventak in 7 patients and the Cadence in 3). The mean defibrillation threshold was 16 +/- 5 J. Repositioning of the pacemaker leads eliminated undersensing of ventricular fibrillation by the defibrillator, which occurred during asynchronous pacing in 2 patients. During a mean follow-up of 11 +/- 6 months, 2 patients died because of pump failure and 7 patients received defibrillator therapy for ventricular arrhythmias. No significant complications were noted. Successful concomitant implantation of transvenous pacemakers and defibrillators was thus accomplished in 17 patients, which suggests that insertion of a second transvenous device can be safely accomplished.

Reemployment following implantation of the automatic cardioverter defibrillator.

One hundred one patients who received an implantable automatic cardioverter defibrillator (ACD) were evaluated to determine the reemployment rate and factors associated with return to work. Forty-seven were employed before ACD implantation. Their mean (+/- standard deviation) age was 53 +/- 11 years, 83% were men, 75% had coronary artery disease, 76% presented with cardiac arrest and 28% had concomitant cardiac surgery. The mean ejection fraction of these patients was 0.41 +/- 0.15. At follow-up, 29 patients (62%) had resumed work at 11 +/- 9 weeks after implantation. Those who returned to work were better educated (15 vs 11 years, p less than 0.001) and less likely to have a history of prior myocardial infarction (p less than 0.05). There were no significant differences between patients who returned to work and those who did not in terms of age, sex, race, functional class, ejection fraction, extent of coronary artery disease, reason for ACD, or concomitant surgery. Multivariate analysis revealed that level of education was the single best predictor of reemployment status. The only other factors found to add significant predictive power in a stepwise analysis were extent of coronary artery disease and marital status. The model using these 3 variables had a sensitivity of 83% and a specificity of 72%. It was concluded that (1) most patients employed before ACD implantation are able to return to work after the procedure, and (2) nonmedical factors play an important role in the resumption of work-related activities. These findings have important quality-of-life and cost-effectiveness implications for ACD implantees.

Comparison of outcome of implantable cardioverter defibrillator implantation in patients with severe versus moderately severe left ventricular dysfunction secondary to atherosclerotic coronary artery disease.

This study was undertaken to assess the feasibility and clinical outcome of implantable cardioverter-defibrillators (ICDs) among patients with coronary artery disease and left ventricular ejection fraction (LVEF) of <20%. The morbidity, mortality, and the long-term survival of 117 patients with LVEF of <20% (group 1) were compared with 321 patients with LVEF of 20% to 40% (group 2). Mortality in the first 30 days after ICD implantation was 0% for group 1 and 0.6% in group 2. Actuarial survival (all cause) at the end of 2, 4, and 5 years were 83%, 70%, and 62%, respectively, in group 1 and 90%, 80%, and 71% in group 2 (p = 0.05). Fifty-five patients (47%) in group 1 and 126 patients (39%) in group 2 received appropriate shocks during follow up. Among the patients in group 1, the overall survival at 2 years after an appropriate shock from an ICD was 92% for patients <60 years of age, 77% for patients ages 60 to 69, and 53% for patients >70 years old. Although the overall survival of patients in group 1 was slightly lower compared with those in group 2, in a multivariate analysis, the EF was not an independent predictor of poor survival. The ICD can be implanted with acceptable operative morbidity and mortality in selected patients with LVEF of <20%.

Implantable cardioverter-defibrillator therapy for prevention of sudden cardiac death.

Patients with known symptomatic VT or VF are at high risk for sudden cardiac death. Various therapeutic choices can be used to reduce the incidence of arrhythmic sudden cardiac death. These include beta-blockers, class I and III antiarrhythmic agents, VT focal ablations, and ICD therapy. The overall incidence of sudden cardiac death in ICD recipients is less than 2% per year, a rate of survival not achieved with any of the available antiarrhythmic agents. VT surgical therapy can produce comparable survival results, but the minimal operative mortality is higher than that with ICD therapy. In patients with noninducible VT/VF or inducible polymorphic VT, and in those refractory to or intolerant of antiarrhythmic agents and poor left ventricular function, ICD therapy may be the only realistic option.

Survival in patients with depressed left ventricular function treated by implantable cardioverter defibrillator.

Mortality in patients with cardiovascular disease is generally due to pump failure or lethal ventricular arrhythmias. In patients with ventricular tachycardia (VT) or ventricular fibrillation (VF) and poor left ventricular (LV) function the death rate is particularly high. The overall incidence of premature arrhythmic death rate in patients with poor LV function is not totally clear. Since implantable cardioverter defibrillator (ICD) could prevent arrhythmic death in any population, we proceeded to analyze mortalities in patients with poor LV function who received ICD. Among a total of 200 consecutive patients receiving ICD at our institution, 68 (34%) had LV ejection fraction (LVEF) of less than 30%. Thirty-one of these (45%) experienced appropriate ICD discharges and 17/31 (55%) had multiple shocks. Survival curves in this population revealed a 5 year projected overall survival of 11% whereas an actual survival was 60%. Even those who ultimately died from nonsudden causes, life was prolonged by ICD in a significant number of cases. Based upon these findings it is concluded that ICD has a major impact on survival in patients with poor LV function suggesting that many of these patients die prematurely from arrhythmia causes.

A follow-up study of patients with implantable cardioverter defibrillators.

This study involves 381 patients who received an implantable cardioverter defibrillator (ICD) for management of serious ventricular dysrhythmias and were followed for up to 9 years. The device was effective in preventing sudden cardiac death (SCD), with survival rates of 97% at 3 years and 94% at 5 years. Complication rates were low. Two hundred and twenty-five patients received at least one shock; 2.3 shocks per patient year were received. Shocks were categorized as appropriate, indeterminate, or inappropriate. Definitions of these categories and their occurrence are discussed and the characteristics and experiences of these patients are described.

Effects of initial polarity on defibrillation threshold with biphasic pulses.

BACKGROUND: Previous studies have shown that the polarity of epicardial patches significantly affects the defibrillation efficacy of monophasic shocks. However, whether this improvement can be extended to different pulsing methods and lead systems, such as biphasic shocks using endocardial defibrillating electrodes, is unknown. METHODS: Twenty consecutive patients undergoing testing and permanent implant using an Endotak lead system with a biphasic device were included in the study. In each patient the defibrillation threshold was determined delivering biphasic pulses with the distal coil as the cathode and the proximal coil as the anode during the positive phase and with the polarity reversed. The initial electrode polarity tested was chosen randomly. The defibrillation threshold was defined as the lowest pulse amplitude that effectively terminated ventricular fibrillation induced with 60-Hz alternating current. For each biphasic pulse peak voltage, pulse duration, resistance, and stored energy were recorded. RESULTS: Of the 20 patients, 12 (60%) had lower defibrillation threshold when the proximal coil was negative, whereas only 2 patients had a lower defibrillation threshold when the distal coil was negative. In four patients a subcutaneous patch would have been required if only the biphasic pulse with the distal coil as negative had been tested. The mean stored defibrillation threshold energy was lower with the configuration using the proximal coil as cathode (16.3 +/- 8.8 J vs 21.5 +/- 11 J; P < 0.01). CONCLUSION: Change in the initial polarity of biphasic shocks may influence defibrillation efficacy and should, therefore, be assessed in each patient to achieve a more satisfactory safety margin and minimize the use of more invasive lead configurations.

Role of implantable cardioverter defibrillator therapy in the management of high-risk patients.

Cardiovascular mortality from ventricular tachycardia (VT) and ventricular fibrillation (VF) continues to be a major health problem. Several therapeutic approaches are now available to treat patients with known VT/VF. Among the various therapeutic options are antiarrhythmic drugs, catheter or surgical ablation of VT focus, and implantable cardioverter defibrillator (ICD). The overall 2-year cardiovascular mortality is significantly reduced by ICD therapy. The ICD is particularly useful in patients with 1) no inducible but clinical VT/VF, 2) drug refractory VT/VF, and 3) VT/VF in association with left ventricular ejection fraction of less than or equal to 30%. Significant improvements in ICD therapy have already been made; these improvements include tiered antitachycardia therapy, antibradycardia pacing, lower defibrillation threshold, and longer life of generator. Further improvements are expected, including nonthoracotomy approach to defibrillation, pectoral implant, and dual chamber sensing. It is likely that with all of the advances in ICD therapy its acceptance as a therapeutic option will increase.

Psychological support and psychiatric management of patients with automatic implantable cardioverter defibrillators.

There are well over 6,000 automatic implantable cardioverter defibrillators (AICD) that have been implanted in the United States since 1980. The device clearly reduces arrhythmic mortality in high risk patients. Many AICD patients have other cardiac diseases, most commonly, coronary artery disease with associated prior myocardial infarctions. These patients have special psychosocial stresses that may make them vulnerable to depression and other psychological disturbances. Psychological support together with psychiatric treatment, if needed, should be provided to these patients. Use of psychotropic medications should be closely monitored, especially in this population, as many of these drugs can exacerbate ventricular tachyarrhythmias. Special precautions should also be taken when administering electroconvulsive therapy in these patients.

Defibrillation efficacy of commercially available biphasic impulses in humans. Importance of negative-phase peak voltage.

BACKGROUND: Recent studies have shown that specifically shaped biphasic waveforms can lower energy requirements for ventricular defibrillation. We prospectively compared the defibrillation efficacy of three different biphasic wave shapes incorporated in three commercially available implantable defibrillators. The results led to the development of a second protocol in which the importance of negative-phase peak voltage and duration was investigated. METHODS AND RESULTS: Defibrillation threshold (DFT) testing using different biphasic waveforms was performed randomly on 42 patients undergoing implantation of a cardioverter-defibrillator for ventricular arrhythmias. In 23 patients (group 1), 3 waveforms were tested: a CPI waveform with 60% positive-phase (P1) tilt and 50% negative-phase (P2) tilt, a Medtronic waveform with 65% fixed tilt in both P1 and P2, and a Ventritex waveform with 60% P1 tilt and a P2 leading edge voltage equal to half of the P1 trailing edge voltage. In 19 patients (group 2), 3 biphasic waveforms with equal P1 tilt at 65% but shorter P2 duration or smaller P2 peak voltage were tested. The Endotak C 60 series lead system (CPI) was used in 11 patients in group 1 and 10 patients in group 2. A Transvene lead system (Medtronics) was used in the remaining patients. Stored energy required for defibrillation was significantly lower with the CPI waveform compared with the Ventritex waveform. In group 2, energy requirements were significantly increased for the waveform with a smaller P2 peak voltage, whereas a short P2 duration did not influence defibrillation success. CONCLUSIONS: Our results suggest that specifically shaped biphasic waveforms delivered from commercially available devices can affect energy requirements for defibrillation. More importantly, the amplitude of the P2 peak voltage may be a more critical determinant than the P2 duration for defibrillation success of biphasic waveforms in humans.

Ventricular fibrillation sensing and detection by implantable defibrillators: is one better than the others? A prospective, comparative study.

INTRODUCTION: We prospectively compared the performance of the sensing and detection systems of three leading defibrillator manufacturers: Medtronic, Guidant, and Ventritex. METHODS AND RESULTS: Ventricular fibrillation signal was digitally recorded during defibrillator implantation and subsequently played back sequentially to a Medtronic Micro Jewel II 7223Cx, a Guidant MINI II 1762, and a Ventritex Cadet V-115C. The devices were programmed for single-zone detection, at nominal settings. Rate cutoff was set at 320 msec (185/min for the MINI). We analyzed 253 episodes from 47 patients. Median undersensing was 0%, 2.1%, and 5.3% for the Jewel, MINI, and Cadet, respectively (P < 0.001 for each paired comparison). Detection time was 4.1 +/- 1.6 seconds, 3.4 +/- 1.6 seconds, and 4.3 +/- 2.2 seconds for the Jewel, MINI, and Cadet, respectively (P < 0.001 between MINI-Jewel and MINI-Cadet; P < 0.01 between Jewel-Cadet). Delayed detection (detection time longer than the mean of all observations + 2 SD) occurred in 3 (1.2%), 7 (2.8%), and 18 (7.1%) episodes for the Jewel, MINI, and Cadet, respectively. Performance for all devices was worse when the short-separation integrated bipolar lead was used and when the episode followed a failed high-energy shock. CONCLUSION: Statistically significant differences were seen in sensing and detection performance among the devices and device/lead combinations during ventricular fibrillation. These differences are related to specific features of the respective devices and should be taken into account during clinical practice, as well as in future device development.

Ventricular fibrillation and polymorphic ventricular tachycardia with critical coronary artery stenosis: does bypass surgery suffice?

INTRODUCTION: Previous studies have suggested that coronary artery bypass surgery is sufficient to prevent recurrence of sudden death in patients with critical coronary artery stenosis presenting with ventricular fibrillation or polymorphic ventricular tachycardia. We present our experience in patients with one or more episodes of sudden death associated with documented ventricular fibrillation or polymorphic ventricular tachycardia and severe operable coronary artery disease who underwent defibrillator implant at the time of bypass surgery. METHODS AND RESULTS: Fifty-eight consecutive patients (age 63 +/- 8 years) were included in this study. Eighteen of the 58 patients had no evidence of previous myocardial infarction. The mean ejection fraction was 37 +/- 13%. All patients underwent electrophysiologic study before and after revascularization. At the time of first defibrillator discharge, each patient was reevaluated to exclude the presence of ischemia. The benefits of defibrillator implant were estimated comparing the projected survival based upon defibrillator discharge preceded by syncope or presyncope with survival curves generated including total death and sudden plus cardiac death. After a mean follow-up of 4.6 +/- 2 years, 22 patients received appropriate shocks preceded by syncope or presyncope, and an additional 19 patients received asymptomatic shocks. At 4 years, survival free of total death was 71.2%, and the projected survival was 58.8% (P < 0.05). Multivariate analysis showed that ejection fraction lower than 30% and induction of arrhythmia with one or two extrastimuli (S2, S3) were independent predictors for defibrillator discharge. None of the remaining variables including age, gender, number of bypasses, history of myocardial infarction, and type of arrhythmias induced were predictive for death and occurrence of shocks. CONCLUSIONS: In patients with ventricular fibrillation and polymorphic ventricular tachycardia, bypass surgery does not protect from recurrence of life-threatening arrhythmias, and, as in our population, defibrillator implant may have significant impact on survival.

Does reception of appropriate shocks from the implantable cardioverter defibrillator affect survival?

The implantable cardioverter defibrillator has become an important therapeutic modality for treatment of life-threatening ventricular tachyarrhythmias. Recent reports have suggested that patients who receive appropriate shocks from this device have an inordinately high overall mortality, and questioned the extent of benefit these patients derive from the implant. This report analyzed the survival among 184 patients who received the implantable cardioverter defibrillator to assess survival differences between patients who received appropriate shocks versus those who did not. At a mean follow-up of 24 +/- 18.7 months, 68 patients received an appropriate shock from their device while 116 did not receive an appropriate shock. Overall survival of the entire population was quite similar to those published by others. There was no significant difference between overall survival of patients who received an appropriate shock versus those who did not. However, there was a statistically significant difference in sudden death mortality. The group of patients that received appropriate shocks included all five sudden deaths. This observation suggested that sudden death in this population was likely due to ventricular tachyarrhythmias rather than strictly bradycardia or asystole. The "benefit" of the device to the entire population was also assessed by estimating survival after receipt of the first appropriate shock. Using this approach, an estimated 10% of patients died without receiving an appropriate shock. In other words, ultimately, 90% of patients were expected to benefit from the device. This survival curve, which initiated only after receipt of the first appropriate shock was fairly similar to those estimated from conventional methods. Therefore, survival after receipt of an appropriate shock was comparable to overall survival and there was no significant difference between survival of patients who received appropriate shocks and those who did not.

Implantable cardioverter defibrillator for prevention of sudden cardiac death in patients with ventricular tachycardia and ventricular fibrillation: ICD therapy in sudden cardiac death.

Among the various therapy options for survivors of ventricular tachycardia-ventricular fibrillation (VT-VF), the implantable cardioverter defibrillator (ICD) seems most promising. It reliably terminates VT-VF and thus significantly impacts sudden cardiac death (SCD) survival. It is more effective than any of the known antiarrhythmic drugs in prevention of SCD, particularly among survivors of cardiac arrest. Compared to VT surgery, the ICD therapy can be offered to a larger pool of patients and can be placed at a lower surgical risk. With proper patient selection, ICD therapy is of major benefits to its recipients since it markedly reduces the chances of VT-VF related mortality; the main cause of premature death in this population. The ICD therapy is cost effective when compared to other medical interventions and could be more so if the implant is carried out early in the course of VT-VF management.

Sudden death in patients with implantable cardioverter-defibrillators.

UNLABELLED: Of the 733 patients with implantable cardioverter-defibrillators (ICDs) from 1982 to 1995 in our center, 20 died suddenly while the ICD was activated. This number included 16 men and four women with a mean age of 60 +/- 8 years and ejection fractions of 24.2% +/- 8.6%. ICDs were implanted for drug refractory ventricular tachycardia (VT) in 13 patients and for resucitated cardiac arrest in seven patients. The clinical VT was associated with syncope in 7 of 13 patients. VT was induced in 18 patients and was hemodynamically unstable in 12 patients. Shock therapies associated with syncope were delivered in 7 of 15 patients during the follow-up. This subgroup of patients survived a median of only 18 months after ICD implant. Ventricular fibrillation-defibrillation was found to surround death in nine patients. CONCLUSIONS: (1) Sudden death victims of the ICD population are characterized by poor left ventricular function and hemodynamically unstable ventricular tachyarrhythmias. (2) Ventricular tachyarrhythmias are the major cause of sudden death in ICD patients.

Molecular cloning and expression of a cDNA encoding human electron transfer flavoprotein-ubiquinone oxidoreductase.

Electron-transfer flavoprotein-ubiquinone oxidoreductase (ETF-QO) in the inner mitochondrial membrane accepts electrons from electron-transfer flavoprotein which is located in the mitochondrial matrix and reduces ubiquinone in the mitochondrial membrane. The two redox centers in the protein, FAD and a [4Fe4S]+2,+1 cluster, are present in a 64-kDa monomer. We cloned several cDNA sequences encoding the majority of porcine ETF-QO and used these as probes to clone a full-length human ETF-QO cDNA. The deduced human ETF-QO sequence predicts a protein containing 617 amino acids (67 kDa), two domains associated with the binding of the AMP moiety of the FAD prosthetic group, two membrane helices and a motif containing four cysteine residues that is frequently associated with the liganding of ferredoxin-like iron-sulfur clusters. A cleavable 33-amino-acid sequence is also predicted at the amino terminus of the 67-kDa protein which targets the protein to mitochondria. In vitro transcription and translation yielded a 67-kDa immunoprecipitable product as predicted from the open reading frame of the cDNA. The human cDNA was expressed in Saccharomyces cerevisiae, which does not normally synthesize the protein. The ETF-QO is synthesized as a 67-kDa precursor which is targeted to mitochondria and processed in a single step to a 64-kDa mature form located in the mitochondrial membrane. The detergent-solubilized protein transfers electrons from ETF to the ubiquinone homolog, Q1, indicating that both the FAD and iron-sulfur cluster are properly inserted into the heterologously expressed protein.

Experience with two different nonthoracotomy systems for implantable defibrillator in 170 patients.

Implantation of a nonthoracotomy system (Medtronic PCD or CPI Endotak) was attempted in 170 patients with ventricular tachycardia (VT) or ventricular fibrillation (VF) not requiring concomitant cardiac surgery. A nonthoracotomy system could be successfully implanted in 95 of the 115 patients with the PCD system and 49 of 55 patients receiving the Endotak lead system. In 26 patients with failed nonthoracotomy system because of defibrillation threshold (DFT) > 25 joules (J), an epicardial system was implanted at the same setting. Patients receiving the two lead systems were comparable with regard to age, sex, and ejection fraction. However, since the PCD system offers tiered therapy multiprogrammable options, all attempts were made to implant this lead system in patients with VT that could be pace terminated. Mean DFT (15 +/- 4.7 vs 17 +/- 4.6 J; P = 0.03) and implant time (2.5 +/- 0.6 vs 3.3 +/- 0.7 hours; P = 0.02) were less with the Endotak lead system. There was no perioperative mortality. During a mean follow-up of 20 +/- 4 months, there were eight instances of lead dislodgment in patients receiving the PCD system. There were four nonsudden cardiac deaths and one sudden death in the Endotak group and three nonsudden deaths in the PCD group. Sudden cardiac death and total survival using the intention-to-treat analysis during this follow-up period were 99% and 95%, respectively. In conclusion, successful implantation, perioperative mortality, and survival rate are comparable with both lead systems; however, incorporating two defibrillating electrodes in one lead minimizes lead dislodgment and reduces implant time.

When is it safe not to replace an implantable cardioverter defibrillator generator?

In most reports on patients receiving implantable cardioverter defibrillators, shocks were received mainly during the first 2 to 3 years. Thus, the question had been raised as to the need for device replacement after 3 or 4 years if no shocks had been received. In order to answer this question, shock experience in 184 patients receiving the implantable cardioverter defibrillator was analyzed. Patients were followed for a mean of 24 +/- 18.7 months. A patient's shock was judged to be appropriate if there was electrocardiographic documentation of sustained ventricular tachyarrhythmia at the time of shock or if it was preceded by sudden onset of presyncopal or syncopal symptoms. The majority of patients had coronary artery disease. In approximately two-thirds of patients, left ventricular ejection fraction was below 40%. One hundred fourteen patients had inducible sustained monomorphic ventricular tachycardia. On follow-up, there were 29 deaths, five of which were sudden. Sixty-eight patients received an appropriate shock during follow-up (37%). Over 90% of these 68 received their first shock within the 2 years after implant. The actuarial risk of receiving an appropriate shock by the fifth year after implant was 69%. Conversely, 31% of patients who survived 5 years had not received an appropriate shock. Hazard analysis indicates that there is a high incidence of first appropriate shock during the year following implant. Subsequently, the incidence dropped to a relatively steady rate with a rise in this rate during the fifth year. This analysis suggested a bimodal distribution of appropriate shocks.(ABSTRACT TRUNCATED AT 250 WORDS)