Quadruple pads approach for external cardioversion of atrial fibrillation.

This study examined the alternative of transthoracic quadruple pads shock delivery of two simultaneous 360-J shocks to convert refractory AF in patients failing standard external cardioversion. Forty-six patients (mean age 58 +/- 11 years, 23 men) with chronic AF (duration 14 +/- 17 months, range 1-60 months) were included. The left atrial diameter was 47 +/- 7 mm. The left ventricular ejection fraction was 59 +/- 11%. Antiarrhythmic drugs had failed to convert 44 (96%) of these patients. All patients underwent conventional external transthoracic cardioversion with pads applied in the antero-apical position using energy settings of 200 and 360 J, consecutively. In all patients who failed conventional cardioversion, quadruple pads were applied. Quadruple pads consisted of four pads, two in the antero-posterior position and two in a second apex-posterior position. Standard cardioversion to sinus rhythm was successful in 19 (41%) patients after use of a single 200-J shock and an additional 8 (17%) after a single 360-J shock. The total success rate was 58% after conventional cardioversion. The quadruple pads were successful in 14 (74%) of the remaining 19 patients. Four of the five patients who failed the quadruple pads approach subsequently also failed internal cardioversion. Thus, the cardioversion success rate was increased from 48% using the conventional approach to 89% using the quadruple pads approach. Quadruple pads external cardioversion is highly effective in converting chronic AF refractory to standard shock protocols to sinus rhythm. Moreover, the failure of the quadruple pads approach seems to predict poor response to internal cardioversion.

Reducing mortality from sudden cardiac death in the community: lessons from epidemiology and clinical applications research.

The reduction of mortality from sudden cardiac death (SCD) in the community remains a challenge. Clinical-epidemiologic studies have identified a range of factors that are associated with an increased risk of SCD. While of potential etiologic and prognostic importance, these factors have limited sensitivity and a low positive predictive value for SCD. On the other hand, clinical trials have suggested that a variety of interventions, including risk factor reduction, nutritional interventions, drug therapies, cardiac procedures, and new technologies, have the potential to reduce mortality from SCD. In this review, we examine what is known about the epidemiology and clinical application of interventions to reduce mortality from SCD; and, we consider the impact of both prevention and clinical interventions on mortality from SCD from a community perspective. There is mounting evidence that supports both public health and clinical efforts to prevent the occurrence of SCD. There also is evidence suggesting that new technologies, such as automated external defibrillators, have the potential to reduce case-fatality from SCD. Further progress will depend on improved methods to identify persons-at-risk, reduction of risk factors, and application of techniques -- both simple and advanced -- to improve survival in victims of SCD.

High-dose bolus lidocaine for chemical cardioversion of atrial fibrillation: a prospective, randomized, double-blind crossover trial.

BACKGROUND: Most drugs used for chemical cardioversion of atrial fibrillation have significant proarrhythmia risk and require close monitoring after administration. Lidocaine has few of the proarrhythmic concerns of most antiarrhythmic drugs and, at high bolus doses, prolongs the atrial refractory period well enough to be effective in converting atrial fibrillation to sinus rhythm. This finding has been previously demonstrated in a dog model. We sought to confirm the animal findings in human beings with lidocaine doses of 1.5 to 2.5 mg/kg. METHODS: Twenty patients with atrial fibrillation scheduled for elective cardioversion were enrolled in this study. In a randomized, double-blind, crossover study design, each patient received intravenous bolus lidocaine or saline. Patients were observed for 10 minutes after the initial bolus to assess efficacy. The second test drug was then delivered if the first was unsuccessful at cardioversion. RESULTS: All 20 patients received both lidocaine and saline placebo therapy in a crossover manner. None of the 20 patients converted to sinus rhythm with either therapy. The 95% confidence interval for effectiveness of lidocaine in this population was 0% to 14%. CONCLUSION: In this population of patients referred for elective cardioversion of atrial fibrillation, high-dose bolus lidocaine was ineffective in converting patients to sinus rhythm. Although this study was not sufficiently powered to rule out a low efficacy of lidocaine (<15%) or a higher efficacy in certain subgroups of atrial fibrillation, routine use of lidocaine for this indication is not warranted.

Efficacy of implantable cardioverter-defibrillators for the prevention of sudden death in patients with hypertrophic cardiomyopathy.

BACKGROUND: Hypertrophic cardiomyopathy is a genetic disease associated with a risk of ventricular tachyarrhythmias and sudden death, especially in young patients. METHODS: We conducted a retrospective multicenter study of the efficacy of implantable cardioverter-defibrillators in preventing sudden death in 128 patients with hypertrophic cardiomyopathy who were judged to be at high risk for sudden death. RESULTS: At the time of the implantation of the defibrillator, the patients were 8 to 82 years old (mean [+/-SD], 40+/-16), and 69 patients (54 percent) were less than 41 years old. The average follow-up period was 3.1 years. Defibrillators were activated appropriately in 29 patients (23 percent), by providing defibrillation shocks or antitachycardia pacing, with the restoration of sinus rhythm; the average age at the time of the intervention was 41 years. The rate of appropriate defibrillator discharge was 7 percent per year. A total of 32 patients (25 percent) had episodes of inappropriate discharges. In the group of 43 patients who received defibrillators for secondary prevention (after cardiac arrest or sustained ventricular tachycardia), the devices were activated appropriately in 19 patients (11 percent per year). Of 85 patients who had prophylactic implants because of risk factors (i.e., for primary prevention), 10 had appropriate interventions (5 percent per year). The interval between implantation and the first appropriate discharge was highly variable but was substantially prolonged (four to nine years) in six patients. In all 21 patients with stored electrographic data and appropriate interventions, the interventions were triggered by ventricular tachycardia or fibrillation. CONCLUSIONS: Ventricular tachycardia or fibrillation appears to be the principal mechanism of sudden death in patients with hypertrophic cardiomyopathy. In high-risk patients with hypertrophic cardiomyopathy, implantable defibrillators are highly effective in terminating such arrhythmias, indicating that these devices have a role in the primary and secondary prevention of sudden death.

Implantable defibrillators and antiarrhythmic drugs in patients at risk for lethal arrhythmias.

The high mortality rate and frequency of ventricular arrhythmias in patients with congestive heart failure has prompted numerous clinical trials aimed at reducing mortality by addressing arrhythmic death. Recently completed trials have suggested that for patients who have survived cardiac arrest, the preferred treatment may be an implantable cardioverter defibrillator (ICD). From the standpoint of primary prevention, implantable defibrillators and amiodarone have received the most attention. It remains unclear, however, to which patients these studies apply, and if and how the results might be generalized. No available studies confirm an additional benefit of pharmacologic or device-based antiarrhythmic therapy beyond that offered by optimal treatment with beta blockers, angiotensin-converting enzyme inhibitors, and lipid-lowering drugs in the majority of patients with cardiomyopathy. Clinical trials are ongoing to address these issues.

Comparison of naive sixth-grade children with trained professionals in the use of an automated external defibrillator.

BACKGROUND: Survival after out-of-hospital cardiac arrest (OHCA) is strongly influenced by time to defibrillation. Wider availability of automated external defibrillators (AEDs) may decrease response times but only with increased lay use. Consequently, this study endeavored to improve our understanding of AED use in naive users by measuring times to shock and appropriateness of pad location. We chose sixth-grade students to simulate an extreme circumstance of unfamiliarity with the problem of OHCA and defibrillation. The children's AED use was then compared with that of professionals. METHODS AND RESULTS: With the use of a mock cardiac arrest scenario, AED use by 15 children was compared with that of 22 emergency medical technicians (EMTs) or paramedics. The primary end point was time from entry onto the cardiac arrest scene to delivery of the shock into simulated ventricular fibrillation. The secondary end point was appropriateness of pad placement. All subject performances were videotaped to assess safety of use and compliance with AED prompts to remain clear of the mannequin during shock delivery. Mean time to defibrillation was 90+/-14 seconds (range, 69 to 111 seconds) for the children and 67+/-10 seconds (range, 50 to 87 seconds) for the EMTs/paramedics (P<0.0001). Electrode pad placement was appropriate for all subjects. All remained clear of the "patient" during shock delivery. CONCLUSIONS: During mock cardiac arrest, the speed of AED use by untrained children is only modestly slower than that of professionals. The difference between the groups is surprisingly small, considering the naïveté of the children as untutored first-time users. These findings suggest that widespread use of AEDs will require only modest training.

Analysis of defibrillation efficacy from myocardial voltage gradients with finite element modeling.

Increasing defibrillation efficacy by lowering the defibrillation threshold (DFT) is an important goal in positioning implantable cardioverter-defibrillator electrodes. Clinically, the DFT is difficult to estimate noninvasively. It has been suggested that the DFT relates to the myocardial voltage gradient distribution, but this relation has not been quantitatively demonstrated. We analyzed the relation between the experimentally measured DFT's and the simulated myocardial voltage gradients provided by finite element modeling. We performed a series of experiments in 11 pigs to measure the DFT's, and created and solved three-dimensional subject-specific finite element models to assess the correlation between the computed myocardial voltage gradient histograms and the DFT's. Our data show a statistically significant correlation between the DFT and the left ventricular voltage gradient distribution, with the septal region being more significant (correlation coefficient of 0.74) than other myocardial regions. The correlation between the DFT and the right ventricular and the atrial voltage gradient, on the other hand, is not significant.

MCG simulations of myocardial infarctions with a realistic heart-torso model.

Data from simulations of the anterior myocardial infarction (AMI) and inferior myocardial infarction (IMI) are presented. One infarct located in the anterior section of the left ventricle and a second one in the inferior wall of the left ventricle were modeled. A high-resolution finite element model of a heart and torso was used in this study. Differences in the normal and infarcted fields were computed. Our data suggest that the infarcted region contribution to the total magnetic field can be accounted for by an equivalent current dipole. It might also be possible to detect an infarct from these difference fields constructed for different cases of myocardial infarction. More simulations are needed to determine the relations between infarct sizes and locations and magnetic fields. These relations might then be used to detect various cases of myocardial infarction.

MCG simulations with a realistic heart-torso model.

Magnetocardiograms (MCG's) simulated with a high-resolution heart-torso model of an adult subject were compared with measured MCG's acquired from the same individual. An exact match of the measured and simulated MCG's was not found due to the uncertainties in tissue conductivities and cardiac source positions. However, general features of the measured MCG's were reasonably represented by the simulated data for most, but not all of the channels. This suggests that the model accounts for the most important mechanisms underlying the genesis of MCG's and may be useful for cardiac magnetic field modeling under normal and diseased states. MCG's were simulated with a realistic finite-element heart-torso model constructed from segmented magnetic resonance images with 19 different tissue types identified. A finite-element model was developed from the segmented images. The model consists of 2.51 million brick-shaped elements and 2.58 million nodes, and has a voxel resolution of 1.56 x 1.56 x 3 mm. Current distributions inside the torso and the magnetic fields and MCG's at the gradiometer coil locations were computed. MCG's were measured with a Philips twin Dewar first-order gradiometer SQUID-system consisting of 31 channels in one tank and 19 channels in the other.

Treatment of out-of-hospital cardiac arrest with a low-energy impedance-compensating biphasic waveform automatic external defibrillator. The LIFE Investigators.

Few victims of sudden cardiac arrest survive. A new generation of automatic external defibrillators (AEDs), smaller, lighter, easier to use, and less costly, makes the goal of widespread AED deployment and early defibrillation feasible. A low-energy impedance-compensating biphasic waveform allows AED device characteristics more suitable to the goal of early defibrillation than high-energy waveforms. This study observed the performance of such a biphasic waveform in the out-of-hospital setting on 100 consecutive victims of sudden cardiac arrest treated by a wide range of first-responders. AEDs incorporating 150-J impedance-compensating biphasic waveforms were placed into service of 34 EMS systems. Data were obtained from the AED PC data card-recording system. The first endpoint was to determine the effectiveness of this waveform in terminating ventricular fibrillation (VF). The second endpoint was to determine whether or not the use of such an AED culminated in an organized rhythm at the time of patient transfer to an advanced life support (ALS) team or emergency department (ED). The third endpoint was to assess the efficiency of the human-factors design of the AED by measuring user time intervals. The 34 sites provided data from 286 consecutive AED uses, 100 from SCA victims with VF as their initial rhythm upon attachment of the AED. All 286 patients were correctly identified by the AED as requiring a shock (100% sensitivity for the 100 VF patients) or not (100% specificity to the 186 patients not presenting in VF). Times from emergency call to first shock delivery averaged 9.1 +/- 7.3 minutes. A single 150-J biphasic shock defibrillated the initial VF episode in 86% of patients. For all 450 episodes of VF in these 100 patients, an average of 86% +/- 24% of VF episodes were terminated with a single biphasic shock. Of the 449 VF episodes that received up to three shocks, 97% +/- 11% were terminated with three shocks or fewer. The average number of shocks per VF episode was 1.3 +/- 0.7. The average time from AED power-on and pads attached to first defibrillation was 25 +/- 23 sec. At the time of patient transfer, an organized rhythm was present in 65% of the VF patients; asystole was the result in 25%, and VF was in progress in 10%. It is concluded that low-energy impedance-compensating biphasic waveforms terminate long-duration VF at high rates in out-of-hospital cardiac arrest and provide defibrillation rates exceeding those previously achieved with high-energy shocks. Use of this waveform allows AED device characteristics consistent with widespread AED deployment and early defibrillation.

Biphasic transthoracic defibrillation causes fewer ECG ST-segment changes after shock.

STUDY OBJECTIVE: Electrocardiographic abnormalities are common after transthoracic defibrillation. ECG ST-segment changes are especially problematic after defibrillation and may indicate ischemic or shock-induced cardiac dysfunction after resuscitation. Biphasic defibrillation waveforms, compared with monophasic waveforms, diminish shock-induced cardiac dysfunction in laboratory preparations. This effect has not been validated in human subjects. We therefore evaluated in a prospective, blinded fashion the effect of biphasic and monophasic transthoracic defibrillation on the ECG ST segment in 30 consecutive patients during surgery for the implantation of a cardioverter-defibrillator. METHODS: In each patient two low-energy truncated biphasic transthoracic defibrillation shocks (115 and 130 J) were compared with a standard clinical 200 J monophasic damped-sine wave shock. The biphasic shocks and the damped-sine wave shock have been demonstrated to have equal defibrillation efficacy of 97%. Fifteen-second ECG signals recorded across transthoracic defibrillation electrodes were digitized before ventricular fibrillation induction and immediately after each defibrillation attempt. The ST segments 80 msec after the J point were analyzed in a blinded fashion by two reviewers. The ST-segment deflection, QRS-interval duration, QT interval, and heart rate after each therapy were compared with baseline values. RESULTS: ECG ST-segment elevation was significantly greater with the 200-J damped-sine waveform than with either biphasic waveform. The ECG ST-segment levels were -.55 +/- .36 at baseline, -.76 +/- .36 mm after internal shock, -.02-.36 mm after 115-J biphasic shock, .21 +/- .38 mm after 130-J biphasic shock, and 2.09 +/- .37 mm after 200-J damped-sine wave shock (P<.0001). QRS-interval duration, QT interval, and heart rate did not change significantly with any waveform. CONCLUSION: Transthoracic defibrillation with biphasic waveforms results in less postshock ECG evidence of myocardial dysfunction (injury or ischemia) than standard monophasic damped sine waveforms without compromise of defibrillation efficacy.

Prospective evaluation of the effect of biphasic waveform defibrillation on ventricular pacing thresholds.

INTRODUCTION: Significant increases in ventricular pacing threshold have been observed following monophasic waveform ventricular defibrillation shocks. High-output pacing is recommended to ensure consistent capture, particularly in pacemaker-dependent patients who are likely to be defibrillated. Whether biphasic waveform defibrillation compounds this problem is not known. The purpose of this prospective study was to examine serial changes in ventricular pacing thresholds following single, multiple, low- and high-energy biphasic defibrillation shocks from an implanted defibrillator. METHODS AND RESULTS: Bipolar pacing thresholds before and after defibrillation, and the adequacy of pacing capture at three times preshock threshold in the immediate aftermath of ventricular defibrillation, were prospectively evaluated in 67 consecutively tested recipients of a biphasic implanted cardioverter defibrillator. Overall, serial pacing thresholds following successful defibrillation were completely unchanged after 141 of 177 (80%) ventricular fibrillation inductions. In no case did the threshold pulse width increment > 0.06 msec from its baseline value after shock, nor did pacing at a pulse width of three times preshock threshold from dedicated bipolar pacing electrodes fail to result in successful ventricular capture. Changes in threshold were not related to when measured from the time of shock, defibrillation energy, number of shocks, electrode system, chronicity of leads, shock orientation, or to clinical factors. CONCLUSIONS: No clinically important changes in pacing threshold were observed after biphasic waveform defibrillation. Bradycardia pacing at conventional pacemaker outputs of three times baseline pulse width threshold from bipolar electrodes dedicated exclusively to pacing or sensing (but not defibrillation) consistently allowed for an adequate safety margin following defibrillation.

Unipolar pectoral defibrillation systems.

Over the past 15 years, the implantation of automatic defibrillations has evolved from an obscure, impractical, and often morbid procedure to nearly a routine therapy. Initial large abdominally implanted generators with multiple epicardial leads have given way to much smaller, pectorally implanted systems utilizing only a single lead. These systems are better accepted by physicians and patients and rival recent-generation pacemakers in their implantation simplicity. Outcomes with single lead defibrillator implantation have been excellent. They are 99% effective at eliminating sudden death in large cohorts of patients, with overall survival of 94.4% at 18 months. Previously significant perioperative complications and mortality associated with epicardial systems have been virtually eliminated. Transvenous single lead systems now provide defibrillation efficacy at a level that makes epicardial leads unnecessary in most patients. Although inappropriate shocks are not a morbid complication, they still occur in approximately 15%-30% of patients. This is an area for improvement in defibrillator therapy, which, though invisible in total mortality statistics, is significant in terms of patient comfort and acceptance. Incremental improvements in pulse generator design and defibrillator lead technology are being made. Perhaps the most interesting new development will be the dual chamber device, incorporating and atrial electrode for sensing, pacing, and perhaps, atrial defibrillation. Such improvements will continue to make device therapy of all arrhythmias more versatile and improve patient comfort both in terms of device size and inappropriate shocks. It is unlikely, however, that further technological advances can further diminish the already small complication rate or improve the already excellent efficacy of current single lead systems. Defibrillator technology has already reached a maturity where technological improvements are less significant than efforts to better define the patient population who will benefit from the therapy.

A multicenter, randomized trial comparing an active can implantable defibrillator with a passive can system. Jewel Active Can Investigators.

Replacing one defibrillation electrode lead by the defibrillator can may simplify implantation of the ICD. In this multicenter study, 304 patients were randomized to receive either the biphasic active can (AC) (model 7219C system, Medtronic, Inc.) or the passive can (PC) (model 7219D system). The AC and PC systems were compared with respect to their ability to meet the implant defibrillation criterion and to defibrillate VF, and to DFTs, implant time, patient adverse events, and survival rates. A higher percentage fulfilled the implant defibrillation criterion on the first configuration with the AC (86.3% vs 75.9% for PC; P = 0.023), and the first shock success for terminating induced VF was 94% for AC compared to 89% for PC (P = 0.026). DFTs were significantly lower (10.9 vs 12.7 J; P = 0.031), and implant time was significantly shorter for the AC patients (99.2 vs 112.0 min; P = 0.002). The two groups showed no significant differences in 3-month adverse event rates, 3-month survival, and hospital stay.

Malignant sustained ventricular tachyarrhythmias in women: characteristics and outcome of treatment with an implantable cardioverter defibrillator.

Clinical rhythm, heart disease, ejection fraction, defibrillation threshold, recurrent arrhythmias, and mortality were compared in 268 consecutive recipients (213 men and 55 women) of their first implantable cardioverter defibrillator for life-threatening ventricular tachycardia or fibrillation. Women were younger than men, less likely to have structural heart disease, and more likely to have clinical ventricular fibrillation, a higher ejection fraction, and a lower defibrillation threshold. Complications of defibrillator placement were similar in both sexes. Unadjusted survival tended to be higher in women than in men (97% vs 90%, respectively, at 2 years, P = 0.08), largely due to fewer deaths from noncardiac causes or cardiac causes other than arrhythmia (P = 0.04). Women also tended to be at lower, albeit still substantial, risk for recurrent arrhythmias during follow-up (37% vs 52% in men at 2 years, P = 0.11). After adjustment for baseline differences, overall survival, arrhythmia death-free survival, nonarrhythmia death-free survival, and frequency of recurrent arrhythmias were not found to be gender related. Despite their apparent "lower risk" status on initial presentation, women remained at substantial risk for recurrent arrhythmias. This underscores the need to avoid being unduly biased by the "appearance" of health in managing women with malignant arrhythmias. That survival and other clinical endpoints were all ultimately independent of gender emphasizes the importance of other clinical variables in assessing risk from ventricular tachyarrhythmias.

Low-energy impedance-compensating biphasic waveforms terminate ventricular fibrillation at high rates in victims of out-of-hospital cardiac arrest. LIFE Investigators.

INTRODUCTION: New automatic external defibrillators (AEDs), which are smaller, lighter, easier to use, and less costly make the goal of widespread AED deployment and early defibrillation for out-of-hospital cardiac arrest feasible. The objective of this study was to observe the performance of a low-energy impedance-compensating biphasic waveform in the out-of-hospital setting on 100 consecutive victims of sudden cardiac arrest. METHODS AND RESULTS: AEDs incorporating a 150-J impedance-compensating biphasic waveform were used by 12 EMS systems. Data were obtained from the AED PC card reporting system. Defibrillation was defined as conversion to an organized rhythm or to asystole. Endpoints included: defibrillation efficacy for ventricular fibrillation (VF); restoration of an organized rhythm at the time of patient transfer to an advanced life support (ALS) team or to the emergency department (ED); and time from AED power-on to first defibrillation. The AED correctly identified 44 of 100 patients presenting in VF as requiring a shock (100% sensitivity) and 56 of 100 patients not in VF as not requiring a shock (100% specificity). The time from 911 call to first shock delivery averaged 8.1 +/- 3.0 minutes. A single 150-J biphasic shock defibrillated the initial VF episode in 39 of 44 (89%) patients. The average time from power-on to first defibrillation was 25 +/- 17 seconds. At patient transfer to ALS or ED care, an organized rhythm was present in 34 of 44 (77%) patients presenting with VF. Asystole was present in 7 (16%) and VF in 3 (7%). CONCLUSIONS: Low-energy impedance-compensating biphasic waveforms terminate long-duration VF at high rates in out-of-hospital cardiac arrest. Use of this waveform allows AED device characteristics consistent with widespread AED deployment and early defibrillation.

Experience with unipolar pectoral defibrillation.

With simple, single lead unipolar pectoral defibrillators, ICD technology has reached a level of ease and safety comparable to pacemaker implantation. It will be difficult to further decrease the morbidity associated with ICD implantation; just as it will be difficult to improve upon current device treatment of sudden cardiac death. Even as further incremental improvements in devices and leads will undoubtedly occur, at this point in ICD evolution, it is investigating the expanded use of this therapy as a prevention tool that is likely to have the largest overall impact on cardiac arrest survival.

Multicenter comparison of truncated biphasic shocks and standard damped sine wave monophasic shocks for transthoracic ventricular defibrillation. Transthoracic Investigators.

BACKGROUND: The most important factor for improving out-of-hospital ventricular fibrillation survival rates is early defibrillation. This can be achieved if small, lightweight, inexpensive automatic external defibrillators are widely disseminated. Because automatic external defibrillator size and cost are directly affected by defibrillation waveform shape and because of the favorable experience with truncated biphasic waveforms in implantable cardioverter-defibrillators, we compared the efficacy of a truncated biphasic waveform with that of a standard damped sine monophasic waveform for transthoracic defibrillation. METHODS AND RESULTS: The principal goal of this multicenter, prospective, randomized, blinded study was to compare the first-shock transthoracic defibrillation efficacy of a 130-J truncated biphasic waveform with that of a standard 200-J monophasic damped sine wave pulse using anterior thoracic pads in the course of implantable cardioverter-defibrillator testing. Pad-pad ECGs were also examined after transthoracic defibrillation. After the elimination of data for 24 patients who did not meet all protocol criteria, the results from 294 patients were analyzed. The 130-J truncated biphasic pulse and the 200-J damped sine wave monophasic pulse resulted in first-shock efficacy rates of 86% and 86%, respectively (P = .97). ST-segment levels measured 10 seconds after the shock in 151 patients in sinus rhythm were -0.26 +/- 1.58 and -1.86 +/- 1.93 mm for the 130- and 200-J shocks, respectively (P < .0001). CONCLUSIONS: We found that 130-J biphasic truncated transthoracic shocks defibrillate as well as the 200-J monophasic damped sine wave shocks that are traditionally used in standard transthoracic defibrillators and result in fewer ECG abnormalities after the shock.

Multicenter experience with a pectoral unipolar implantable cardioverter-defibrillator. Active Can Investigators.

OBJECTIVES: The purpose of this study was to prospectively examine in a multicenter study the methods of use, efficacy and complications of a unipolar cardioverter-defibrillator in patients at risk for sudden cardiac death. BACKGROUND: Implantation of cardioverter-defibrillators in the pectoral region offers a significant opportunity to improve the management of patients with life-threatening arrhythmias. Unipolar, single-lead, pectoral implantable cardioverter-defibrillators might decrease related mortality, morbidity and costs in the care of such patients. METHODS: From November 3, 1993 to May 8, 1995, a unipolar defibrillator (Medtronic model 7219C) was selected for use in 473 patients from 74 centers (386 [82%] men, 87 [18%] women; mean [+/- SD] age 59 +/- 13 years, range 16 to 88). The clinical indication for use was ventricular fibrillation in 157 patients, sustained ventricular tachycardia in 236, both ventricular tachycardia and ventricular fibrillation in 53 and syncope or inducible ventricular tachycardia/ventricular fibrillation in 27. Coronary artery disease was present in 323 patients (68%). The mean left ventricular ejection fraction was 0.36 +/- 0.15 (range 0.10 to 0.85). The distribution of New York Heart Association congestive heart failure was class I = 34%; class II = 45%; class III = 17%; and class IV = 2%. RESULTS: The unipolar cardioverter-defibrillator was inserted successfully in 464 (98%) of 473 candidates. Effective defibrillation occurred with the first shock polarity tested in 88% of patients, after a polarity switch in 8% and after lead or generator repositioning in 2%. The stored energy defibrillation threshold was obtained at implantation in 339 patients (72%) and was 11.5 +/- 6.1 J, with 72% of patients having a defibrillation threshold < or = 12 J. The mean "skin-to-skin" implantation time was 96 +/- 45 min (range 25 to 335 min). Complications occurred in 29 patients (6%). Device therapy for 2,160 spontaneous ventricular tachycardia or fibrillation episodes occurred in 128 patients (27%) over a 2,732 device-month experience (range 0 to 17.2) and was effective in 98.7% of episodes. There were 14 deaths (10 nonsudden cardiac, 3 sudden cardiac, 1 noncardiac). Cumulative survival, on an intention-to-treat basis from all causes of death at 17.2 months, was 94.4%. CONCLUSIONS: Unipolar pectoral implantable cardioverter-defibrillators can be inserted with a high likelihood of success in a relatively brief procedure. Defibrillation thresholds are low, morbidity is modest, and survival rates are good with this new type of implantable cardioverter-defibrillator.