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Submuscular versus subcutaneous pectoral implantation of cardioverter-defibrillators: effect on high voltage pathway impedance and defibrillation efficacy.

Implantable cardioverter-defibrillator (ICD) pulse generators are now routinely positioned in a pectoral location, either submuscularly (under the pectoralis muscles) or subcutaneously (over the pectoralis muscles). Furthermore, in current ICDs, the generator shield usually participates in the defibrillation energy pathway ("hot can"). Consequently, the precise generator location could affect defibrillation system efficacy. To assess this issue, we compared high voltage pathway impedance and defibrillation threshold (DFT) in 20 patients undergoing submuscular and 46 patients undergoing subcutaneous pectoral implantation of an Angeion Sentinel ICD and an AngeFlex dual-coil defibrillation lead. Measurements were performed at time of ICD implant, pre-hospital discharge, and 1, 3 and/or 6 months later. Following induction of ventricular fibrillation, 569 biphasic waveform shocks were delivered between the generator shield and either the distal defibrillation coil (RV/can configuration) or both proximal and distal coils (RV/SVC/can configuration). Impedance differences between submuscular and subcutaneous implants were approximately 3-4 Ohms (p value of 0.132 to < 0.001 depending on time of follow-up and lead configuration). A significant increase in impedance over time was noted independent of implant location and lead configuration. The DFT at implant or pre-discharge was assessed in 27 individuals, and was 9.9 +/- 3.8 J in 8 patients in the submuscular group, and 7.4 +/- 3.3 J in 19 patients in the subcutaneous group (p = 0.057). In conclusion, anatomic location of a "hot can" ICD generator (submuscular versus subcutaneous) influences impedance to defibrillation current, but the impact is of small magnitude and does not appear to result in clinically important differences in DFT.

Aged↗

Rise in chronic defibrillation energy requirements necessitating implantable defibrillator lead system revision.

The chronic defibrillation energy requirement (DER) is believed to remain clinically stable in patients with defibrillators. Six patients (two with an epicardial and four with a nonthoracotomy system) were identified with a rise in their chronic DER, which eliminated a 10-J safety margin, thus necessitating a defibrillator lead system revision. The mean increase in DER was 14.7 +/- 4 J and was discovered at a mean of 16.0 +/- 18 months (range 2-41) following implantation. Management included placement of a defibrillator with a biphasic waveform, placement of an additional defibrillation electrode, or both. At 2 months following revision of the defibrillation system, a 10-J DER safety margin was present in each patient. In some patients, there is a progressive increase in the chronic DER with elimination of a 10-J safety margin necessitating revision of the defibrillation system. Routine reevaluation of the chronic DER, therefore, is necessary to identify these patients.

Aged↗

Value of pre-hospital discharge defibrillation testing in recipients of implanted cardioverter defibrillators.

Opinions vary regarding the need to perform defibrillation testing prior to hospital discharge in recipients of state-of-the-art cardioverter defibrillators (ICDs). Our protocol is to perform predischarge ICD testing 1 day after implant. This report includes 682 consecutive implants. Adverse observations at testing were grouped into (1) risk of defibrillation failure, (2) surgical complications, (3) sensing/pacing issues or narrow defibrillation margin warranting closer follow-up, or (4) findings correctable by device reprogramming. Among the 682 patients, 63% had single-chamber and 37% dual-chamber or biventricular ICDs. In 48 patients (7%) there were 69 concerns and/or interventions, with overlaps among the four categories, including one failure to defibrillate (0.15%), and six other patients at risk. Surgical complications included 11 hematomas (1.6%), and six lead dysfunctions. Closer follow-up was indicated in 19 patients (2.7%), for high pacing thresholds in seven, sensing issues in seven, and <10 J defibrillation margin in five. Device reprogramming was needed in 31 patients (4.5%), for tachycardia detection and therapy settings in 12, and for pacing/sensing functions in 22 patients. In eight patients ventricular fibrillation could not be induced. There was no morbidity or mortality due to testing. The state-of-the-art ICDs delivering biphasic shocks are remarkably reliable. The routine pre-hospital discharge defibrillation testing of such ICDs may be optional and left to the physicians' discretion.

Defibrillators, Implantable↗

Implantation and follow-up of a third-generation cardioverter defibrillator: comparison of epicardial and nonthoracotomy defibrillation lead system.

OBJECTIVE: The intraoperative and follow-up results were compared in 67 patients with ventricular tachyarrhythmias who underwent implantation of the Ventritex Cadence defibrillator with either epicardial patch (EPI, 25 patients) or nonthoracotomy CPI Endotak (ENDO, 42 patients) defibrillation lead systems. RESULTS: There was no significant difference between groups in age, sex, structural heart disease, ejection fraction, arrhythmia history, or drug therapy. Successful implantation was accomplished in all patients using either lead system. In the ENDO group, 35 patients (83%) had a defibrillation threshold < or = 550 V and did not require a subcutaneous patch. Intraoperatively, the defibrillation threshold was 453 +/- 139 V (13 +/- 9 J) for EPI and 490 +/- 113 V (15 +/- 8 J) for ENDO (P = NS). There were no perioperative deaths in either group. At predischarge testing, the defibrillation threshold was 445 +/- 183 V (14 +/- 12 J) for EPI and 439 +/- 133 V (13 +/- 7 J) for ENDO (P = NS). During a mean follow-up of 16 +/- 8 months, there were no sudden deaths, and four patients died from congestive heart failure (3 EPI, 1 ENDO). During follow-up, 916 spontaneous arrhythmia episodes occurred in 16 of 25 EPI patients (64%) and 967 episodes occurred in 31 of 42 ENDO patients (74%) (P = NS). The number of episodes detected as ventricular fibrillation were 192 for EPI (21%) and 232 for ENDO (24%), with first shock success in 76% and 75%, respectively; all episodes were successfully terminated by the device. In the remaining episodes detected as ventricular tachycardia, antitachycardia pacing was attempted and was successful in 672 of 724 episodes (93%) with EPI and 666 of 735 episodes (91%) with ENDO lead systems (P = NS). Acceleration of ventricular tachycardia with antitachycardia pacing occurred in 21 episodes (3%) with EPI and in 37 episodes (5%) with ENDO leads (P = NS). CONCLUSIONS: A nonthoracotomy approach using the third generation cardioverter defibrillator Cadence V-100 is safe and effective and has clinical results that are not significantly different from epicardial defibrillation lead systems.

Adolescent↗

Interactions between CPR and defibrillation waveforms: effect on resumption of a perfusing rhythm after defibrillation.

BACKGROUND: Cardiopulmonary resuscitation (CPR) improves survival from cardiac arrest. The interactions between CPR and the new biphasic (BiP) defibrillation waveforms have not been defined. Our purpose was to compare the effect of CPR versus no CPR during BiP and damped sinusoidal (DS) shocks on the termination of ventricular fibrillation (VF) and the resumption of a perfusing rhythm. METHODS: We studied 20 pigs; VF was induced electrically and allowed to persist for 6 min. During VF episodes each pig received (in random order): (a) 6 min of full CPR (continuous ventilation and closed chest mechanical compression (Thumper, Michigan Instruments)) followed by DS defibrillation at 100 J; (b) no CPR, DS defibrillation; (c) 6 min of full CPR and BiP defibrillation at 100 J; and (d) no CPR, BiP defibrillation. RESULTS: BiP shocks with CPR terminated VF in 83% of attempts versus 45% without CPR (15/18 and 5/11 respectively, P<0.05). DS shocks with CPR were successful in terminating VF in 53% of attempts; DS shocks without CPR were successful in 44% (8/15 and 7/16, respectively, P=NS). No animal achieved a perfusing rhythm after shocks of either waveform if CPR did not precede the shocks during the 6-min VF period, whereas if CPR was administered during VF 46% (11/24) of the combined BiP/DS shocks restored a perfusing rhythm (P<0.01). CONCLUSION: In this experimental long duration VF model, CPR was essential for a perfusing rhythm after termination of VF by shocks with either waveform. CPR facilitated the termination of VF and resumption of a perfusing rhythm after biphasic waveform defibrillation but not after damped sinusoidal waveform defibrillation.

Animals↗

A comparison of transthoracic impedance using standard defibrillation paddles and self-adhesive defibrillation pads.

The success of defibrillation is related to transmyocardial current. This current is inversely proportional to transthoracic impedance (TTI). A similar TTI between different pads and paddles is important to deliver a consistent therapeutic dose to all subjects. Failure to do so may result in either insufficient or excessive transmyocardial current leading to a risk of failed defibrillation or tissue damage respectively. Several different types of defibrillation paddles and self-adhesive defibrillation pads are currently available for clinical use but the TTI achieved with each type has not been established. We measured TTI using two types of commonly used paddles and self-adhesive pads to establish whether any significant differences exist between the products. TTI in 40 adult males was measured using defibrillation paddles and self-adhesive defibrillation pads placed in the antero-apical position. Measurements were made using a 30 kHz low amplitude AC current and taken at end-expiration. Mean TTI (omega)+/-S.D. was 68.2+/-16.1 (Hewlett Packard paddles; A), 62.8+/-13.2 (Hewlett Packard pads; B), 64.6+/-14.3 (PhysioControl paddles; C) and 95.6+/-22.3 (PhysioControl pads; D). Significant differences existed between all groups (P < 0.05) except between B and C. Differences in TTI between A, B and C were small and probably of no clinical significance. TTI in group D is significantly larger. Although transmyocardial current is related to TTI, the relationship is complex and differences in TTI alone cannot predict the outcome from defibrillation.

Adult↗

Direct current application: easy induction of ventricular fibrillation for the determination of the defibrillation threshold in patients with implantable cardioverter defibrillators.

For the determination of the defibrillation threshold, the induction of ventricular fibrillation is mandatory. However, in severely damaged hearts it is sometimes difficult to induce ventricular fibrillation by rapid stimulation or alternating current. Only rapid nonclinical ventricular tachycardias may result, and their cardioversion threshold may be different from the defibrillation threshold. Therefore, it was the purpose of this study to test the potential of direct current (DC) application to rapidly induce ventricular fibrillation in patients with an implanted cardioverter defibrillator. The defibrillation threshold had to be determined in 13 patients (9 with coronary heart disease, 4 with dilative cardiomyopathy, ejection fraction 35%) during and 2 weeks after the implantation of a cardioverter defibrillator. DC was applied 37 times by a commercially available 9-V DC battery via a bipolar catheter for about 3 seconds. Ventricular fibrillation was induced 23 times (62%) and rapid nonclinical ventricular tachycardias were induced six times (16%). In one patient clinical ventricular tachycardia was observed. In seven instances (19%) sinus rhythm remained. In 12 of the 13 patients, ventricular fibrillation could be induced by DC. Thus, the induction of ventricular fibrillation by DC application may serve as an additional tool to induce ventricular fibrillation, determining the defibrillation threshold in implantable cardioverter defibrillator patients.

Cardiac Catheterization↗

A population-based method for the estimation of defibrillation energy requirements in humans. Assessment of time-dependent effects with a transvenous defibrillation system.

BACKGROUND: A weighted logistic regression analysis was developed to allow pooling of patient data for the study of the stability of defibrillation energy requirements with a new nonthoracotomy lead defibrillation system. METHODS AND RESULTS: One hundred twenty patients were prospectively studied with a single-model nonthoracotomy implantable cardioverter defibrillator (ICD) system at the time of implant and at 3 months. The pooled data of all shocks delivered to all patients were fitted to a logistic function to construct a defibrillation voltage/energy dose-response relationship. The crude logit curve was weighted in quartiles according to the average shock energy delivered per patient. Shocks at implant (n = 802; 6.6 +/- 2.5 shocks/patient) and follow-up (n = 292; 2.4 +/- 1.2 shocks/patient) were analyzed. The modeled voltage/energy required for 50% successful defibrillation (95% CI) in the pooled data was 367 V (273, 461) and 9.8 J (6.7, 12.9) at implant and 338 V (264, 412) and 10.5 J (8, 13.0) at follow-up. The conventional measure of lowest successful voltage/energy (95% CI) was 430 V (411, 449) and 12.1 J (11, 13.2) at implant and 415 V (391, 439) and 11.3 J (10, 12.6) at follow-up. There were no statistically significant differences between implant and follow-up energy requirements with either method. CONCLUSIONS: The nonthoracotomy lead system used in this study demonstrated stability of defibrillation energy requirements at implant and 3-month follow-up. A new technique for the estimation of the defibrillation energy dose-response relationship was derived by using a weighted logistic regression analysis.

Aged↗

[Defibrillation with an automatic external defibrillator outside the hospital: a life-saving, but restricted treatment?].

Application of the automatic external defibrillator can improve the chance of success during resuscitation of out-of-hospital cardiac arrest, because lay persons can defibrillate awaiting the arrival of the ambulance. Defibrillation is mentioned in the Dutch Individual Health Care Professionals Act as a precluded action. Defibrillation with an automatic external defibrillator should be excluded from the list of precluded actions, because application is almost 100% safe and because the subject is not within the scope of the law which is restricted to professional activities and non-emergency actions. Defibrillation with an automatic external defibrillator is acceptable.

Electric Countershock↗

Transthoracic impedance does not affect defibrillation, resuscitation or survival in patients with out-of-hospital cardiac arrest treated with a non-escalating biphasic waveform defibrillator.

OBJECTIVE: This is a study of the influence of transthoracic impedance (TTI) on defibrillation, resuscitation and survival in patients with out-of-hospital cardiac arrest (OHCA), treated with a non-escalating impedance-compensating 150 J biphasic waveform defibrillator. METHODS: Cardiac arrest data from two EMS systems were analyzed retrospectively. All witnessed arrests from patients who presented with a shockable rhythm and were treated initially by BLS personnel were included (n = 102). For each defibrillation and resuscitation outcome variable, we tested differences in mean TTI for successful versus unsuccessful outcome. The effect of call-to-shock time on overall outcome was also examined. RESULTS: Initial shocks defibrillated 90% [83-95%] (95% confidence interval) of patients. Cumulative success with two shocks was 98% [93-100%] and with three shocks was 99% [95-100%]. TTI averaged 90 +/- 23 Omega. First-shock success, cumulative success through two shocks and cumulative success through the first-shock series were unrelated to TTI, as were BLS ROSC, pre-hospital ROSC, hospital admission and discharge. In contrast and consistent with previous findings, call-to-shock time was highly predictive of survival. CONCLUSIONS: High impedance patients were defibrillated by the biphasic waveform used in this study at high rates with a fixed energy of 150 J and without energy escalation. Rapid defibrillation rather than differences in patient impedance accounts for resuscitation success.

Cardiography, Impedance↗

Safety and efficacy of implantable defibrillator therapy with programmed shock energy at twice the augmented step-down defibrillation threshold: results of the prospective, randomized, multicenter Low-Energy Endotak Trial.

Whether the safety and efficacy of implantable cardioverter defibrillator (ICD) therapy can be assured with lower output devices is an important question. The purpose of this study was to evaluate whether programming the device output at twice the augmented defibrillation threshold was as safe and effective as using the maximum energy. Patients indicated for ICD therapy, but without slow monomorphic ventricular tachycardia (MVT), who achieved an augmented defibrillation threshold (DFT plus) < or = 15 joules (J) with a single endocardial lead system and a biphasic defibrillator were included in the study. Prior to ICD implantation, patients were randomized into 2 groups. The shock energies in test group patient were set as follows: first shock at twice DFT plus, the second to fifth shocks at maximum output (34 J). In control group patients, all shocks were programmed at 34 J. The study population consisted of 166 consecutive patients (mean age 57.4 +/- 12.1 years, mean left ventricular ejection fraction 36.8 +/- 13.8%). Mean DFT plus was 9.6 +/- 3.2 J in test group patients and 10.1 +/- 3.5 J in control group patients (p = 0.36). During a mean follow-up of 24.2 +/- 9.6 months, 736 arrhythmia episodes were analyzed. The first shock efficacy was 98.3% in the test group patients versus 97.4% in the control group (p = 0.45). Total mortality was 6%, equally distributed in both study groups. The results of this study prove that the method of doubling the defibrillation energy at the DFT plus level provides an adequate safety margin in defibrillator therapy.

Adult↗

Increase in defibrillation threshold in non-thoracotomy implantable defibrillators using a biphasic waveform.

We have previously reported a chronic increase in defibrillation threshold in a non-thoracotomy implantable cardioverter-defibrillator (ICD) system using monophasic waveforms. To determine if this phenomenon is related to the lead system or the waveform used, we studied the chronic defibrillation threshold in consecutive patients receiving an ICD capable of delivering biphasic waveforms with the same lead system previously evaluated. Twenty-five patients received an ICD with biphasic shock waveform and have been followed for 4 to 15 months. All have undergone defibrillation threshold measurements using the identical testing protocol with biphasic waveforms at implant and at 2 months. Coronary artery disease was present in 15, idiopathic dilated cardiomyopathy in 9, and valvular heart disease in 1. The presenting arrhythmia was ventricular fibrillation in 11, ventricular tachycardia in 10, and syncope with inducible ventricular tachycardia in 4. The configuration of the shocking electrodes was randomized; the lead-only configuration was used in 14 patients (56%), and a subcutaneous patch was used in the remaining patients. Mean defibrillation threshold using a step-down technique was 9.8 +/- 1.0 J at implant, 13.2 +/- 1.6 J at 2 months, and 12.4 +/- 1.5 J at 6 months (p = 0.01 by analysis of variance). There was no change in clinical status, cardiac size, radiographic lead position, or impedance between implant and 2 months. These findings suggest the increase in defibrillation threshold in this ICD system is not related to the type of waveform used, but rather is a feature of non-thoracotomy as opposed to epicardial electrodes.

Adult↗

Effect of failed defibrillation shocks on electrogram amplitude in a nonintegrated transvenous defibrillation lead system.

Concern has been raised regarding the ability of a nonthoracotomy integrated lead system to redetect ventricular fibrillation following failed defibrillation shocks due to diminution in postshock intracardiac electrogram amplitude. Whether such a problem could occur with other lead systems is not known, leading to uncertainty regarding a potential ongoing risk of sudden cardiac death in some patients despite implantable cardioverter-defibrillator therapy. To investigate this problem, we measured the amplitude of 10 consecutive ventricular fibrillation endocardial electrograms immediately before and immediately after failed defibrillation shocks in 15 patients at the time of implantation of a nonintegrated, transvenous, pace/sense/defibrillation lead. Overall, mean electrogram amplitude decreased 21%, from 10.7 +/- 4.6 mV before to 8.5 +/- 4.9 mV immediately after failed defibrillation shocks. The change in electrogram amplitude postshock was directly related to shock energy (r = 0.85, p < 0.0005), but shock waveform had no differential effect. Electrogram amplitude could also increase after failed shocks, particularly following those of low energy. No failures to redetect ventricular fibrillation were found. Thus, intracardiac electrogram amplitude is reduced following failed defibrillation shocks in this nonintegrated lead system, but by an amount less than that previously reported for some integrated lead systems. Our findings reveal that failed low energy defibrillation shocks are likely to result in less diminution in postshock intracardiac electrogram amplitude than high energy shocks, and that the postshock amplitude may even increase after some failed shocks.

Aged↗

Feasibility of atrial sensing via a free-floating single-pass defibrillation lead for dual-chamber defibrillators.

BACKGROUND: Detection and misclassification of rapidly conducted atrial fibrillation (AF) and marked sinus tachycardia by implantable cardioverter defibrillators (ICD) can result in the delivery of inappropriate therapies. Continuous atrial sensing may improve the differentiation between supraventricular and ventricular tachycardia. The present approach is to implant a separate atrial pacing lead connected to a dual-chamber defibrillator. We hypothesized that a free-floating single-pass defibrillation lead reliably senses the atrial electrical activity. The aim of the study was to assess during implantation the efficacy of a custom-built free-floating single-pass defibrillation lead and to record sinus rhythm (SR), induced AF, and atrial flutter (Afl). METHODS: The free-floating single-pass defibrillation lead (Biotronik, Berlin, Germany) had an atrial bipole with 10 mm spacing and a distance between the atrial bipole and the electrode tip of 13.5, 15 or 17-cm. The lead was temporarily implanted in 15 patients during an ICD implantation. Fifteen seconds recordings were made during SR and after the induction of AF and Afl as well as during induced ventricular fibrillation. The amplitude and the time that the amplitude was less than 0.3 mV were assessed. RESULTS: The amplitude during SR (2.1 +/- 1.4 mV) was significantly higher compared with the amplitudes for Afl (1.3 +/- 0.5 mV; p < 0.02) and AF (0.7 +/- 0.5 mV; p < 0.001). Low amplitudes were not observed during SR and rarely during Afl (1.6 +/- 3.1%), but they were observed 19.9 +/- 15.9% of the time during AF (p < 0.05). The correlation coefficients between SR and AF amplitudes were r = 0.25, between SR and Afl amplitudes r = 0.31, and between AF and Afl amplitudes r = 0.41. During the ventricular fibrillation conversion test 9 patients were in continuous SR. The P-wave amplitude before the induction of ventricular fibrillation was 2.1 +/- 1.4 mV. The signal during ventricular fibrillation decreased to 1.1 +/- 0.7 mV and increased immediately after the termination of ventricular fibrillation to 1.6 +/- 0.8 mV. CONCLUSIONS: The recorded unfiltered signals indicate that SR as well as AF and Afl can immediately be detected after the implantation of the new free-floating single-pass defibrillation lead. High signal amplitude during SR did not predict high amplitude during AF or Afl. During induced ventricular fibrillation the P-wave amplitude decreased intermittently.

Aged↗

High defibrillation threshold at cardioverter defibrillator implantation under amiodarone treatment: favorable effects of D, L-sotalol.

A 57-year-old man with primary dilated cardiomyopathy and obesity received an implantable cardioverter defibrillator because of recurrent, poorly tolerated ventricular tachycardia despite continuous treatment with amiodarone. When the device was implanted, assessment of the ability to defibrillate induced ventricular fibrillation showed high energy requirements, with a lack of conventional safety margin between energies effective at defibrillation testing and maximal device output. Treatment with oral amiodarone was withdrawn and substituted with oral sotalol. A repeat defibrillation test, performed 54 days after amiodarone withdrawal and during D,L -sotalol treatment, showed a reduction in defibrillation energy requirements. In view of this experience, replacement of amiodarone treatment with an alternate class III agent (D,L -sotalol or other agents, if available) can be considered as a possible option in case of high defibrillation threshold at the time of the implantation in a patient receiving continuous amiodarone treatment.

Administration, Oral↗

Defibrillation thresholds and perioperative mortality associated with endocardial and epicardial defibrillation lead systems. The PCD investigators and participating institutions.

Defibrillation thresholds (DFT) and perioperative mortality were evaluated in 123 patients who had endocardial defibrillation leads implanted in conjunction with the Medtronic model 7216A/7217 (Medtronic, Inc.) cardioverter-defibrillator (ICD). Clinical variables, implant DFTs, and 30-day perioperative mortality were compared with 266 patients who had the ICD implanted with epicardial defibrillation leads. The two groups were comparable in age, gender, and incidence of coronary artery disease. New York Heart Association Class I and II were more frequent in patients with endocardial leads )87.7%) as compared to those with epicardial leads (78.8%; P < 0.001). Mean left ventricular ejection fraction was significantly higher in patients with the endocardial lead system (37% vs 33%; P < 0.05). A significant proportion of patients with epicardial lead systems underwent another cardiac surgical procedure at the time of ICD implantation (13.9%) as compared to none in those who had endocardial leads implanted (P < 0.001). All patients with endocardial leads had implantation of triple lead systems as compared to 53.4% with epicardial leads (P < 0.001). The man DFT at implant was lower in epicardial lead recipients (8.9 J) as compared to endocardial lead recipients (13.3 J; P < 0.001). Perioperative mortality had a significant trend to lower risk for endocardial lead systems (0.8%) as compared to epicardial systems (4.2%; P = 0.07). We conclude that this endocardial lead system has additional electrode and higher defibrillation energy requirements than the epicardial lead systems used with the Medtronic pacemaker ICD. However, the use of endocardial nonthoracotomy defibrillation leads is associated with a markedly reduced perioperative risk of ICD implantation.(ABSTRACT TRUNCATED AT 250 WORDS)

Defibrillators, Implantable↗

Derivation of a defibrillator implant criterion based on probability of successful defibrillation.

Common criteria for implant of a cardioverter defibrillator include verification of a 2:1 energy safety margin or a fixed safety margin of 10 joules. These criteria have been established empirically. We present a statistically model based on defibrillation efficacy curves which may be used to establish a criterion which would meet a predetermined target. As an example, an implant criterion is derived based on a goal of 1-year sudden cardiac death survival of at least 99% by selecting an expected first-shock efficacy to meet that target. Logistic regression was performed on data from over 1,500 defibrillator implants including successful epicardial and transvenous electrode system implants as well as data from unsuccessful implants. A random sample from these curves was used to generate a representative sample of 1,000 potential implant candidates. By assuming successful defibrillation using a series of shocks at specified energies, i.e., choosing an implant criterion, the probability of successful defibrillation of the patient by a single shock at a predetermined maximum output can be established. Independent data are used to validate the model's accuracy in predicting defibrillation efficacy within the derived example.

Clinical Protocols↗

Cerebral oxygenation during defibrillator threshold testing of implantable cardioverter defibrillators.

BACKGROUND: The induction of ventricular fibrillation (VF) during defibrillator threshold testing of implantable cardioverter defibrillators (ICD) provokes global cerebral hypoperfusion and impaired oxygen delivery. Limited data are available on the neurophysiological effects of defibrillator threshold testing. Near infrared spectroscopy (NIRS) can noninvasively measure changes in specific chromophores, which reflect cerebral oxygenation at the intravascular and mitochondrial levels. We performed a prospective trial using NIRS to analyze cerebral cortical oxygenation during defibrillator threshold testing. METHODS: Eleven patients (men = 9; age = 64 +/- 11 years: LVEF = 44 +/- 11%) underwent subpectoral ICD implantation and defibrillator threshold testing under general anesthesia. A NIRO 300 spectrometer was used to measure the absolute changes in the concentrations of oxyhemoglobin, de-oxyhemoglobin, and cytochrome c oxidase copper moiety during each procedure. The mean arterial blood pressure was monitored simultaneously. RESULTS: The mean number of defibrillator threshold tests was two (range 2-6). Twenty-six episodes of VF (duration 13.1 +/- 9.7 seconds; cycle length 230.2 +/- 20.8 ms) and two episodes of VT (duration 15 +/- 2.8 seconds; cycle length 320 +/- 11.3 ms) were induced. Each episode of VF and VT resulted in a decrease in the mean arterial blood pressure to 23.9 +/- 7.5 mmHg (p < or = 0.05) and oxyhemoglobin (-4.2 +/- 1.7 micromol/L; p < or = 0.05) and an increase in de-oxyhemoglobin (2.7 +/- 1.4 micromol/L). There was no change in the cytochrome c oxidase copper moiety redox status (0.09 +/- 0. 30 micromol/L). CONCLUSION: Our results suggest that impaired oxygen delivery during induced VF and VT does not affect oxygen availability at the cellular intra-mitochondrial level.

Brain↗