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PubMed1999

Coronary artery bypass grafting and defibrillator implantation in patients with ventricular tachyarrhythmias and ischemic heart disease.

In patients with sustained ventricular tachyarrhythmias and myocardial ischemia due to multivessel coronary artery disease, it remains unclear whether revascularization is enough to control the arrhythmias or whether additional implantation of a defibrillator is indicated. We therefore reviewed our clinical strategy of performing both bypass surgery and implantation of a defibrillator in patients with syncopal ventricular tachycardia or fibrillation and significant multivessel coronary artery disease. We retrospectively reviewed the outcome of 18 patients with malignant ventricular tachyarrhythmias, significant multivessel coronary artery disease, and signs of myocardial ischemia who underwent both bypass surgery and defibrillator implantation. Data on these patients were compared to data from 232 other defibrillator patients with respect to baseline clinical variables, cardiac events, and mortality during follow-up. Except for underlying pathology, no other important differences in baseline characteristics were noted between the study patients and the other defibrillator patients. The cumulative occurrence of shocks during follow-up was comparable in both groups (66% vs 67%). The cumulative survival from all-cause mortality was 94% in the study patients and 78% in the others (P = NS). Pre- and postoperative electrophysiological testing was not useful to predict arrhythmia recurrences. In this population of patients with ventricular tachyarrhythmias and ischemia due to multivessel coronary artery disease, bypass surgery alone would not have prevented recurrences of arrhythmias. An excellent survival and a high incidence of shocks after both bypass surgery and defibrillator implantation were observed.

Aged↗
PubMed1985

The implanted defibrillator: relation of defibrillating lead configuration and clinical variables to defibrillation threshold.

Forty-two defibrillating lead systems for the automatic implantable defibrillator were implanted and tested in 41 patients. Two basic lead configurations were used: 1) spring-patch, consisting of a transvenous superior vena cava spring electrode as the anode and an apical or left lateral ventricular patch electrode (either small [13.9 cm2] or large [27.9 cm2]) as the cathode; and 2) patch-patch, consisting of an anterior right ventricular patch as the anode and a posterior left ventricular patch as the cathode. Of the 42 lead systems, 10 were spring-patch and 32 were patch-patch combinations. The defibrillation threshold for the patch-patch combinations (9.8 +/- 6.5 J, mean +/- standard deviation) was significantly (p less than 0.01) lower than that for the spring-patch combinations (19.1 +/- 10.3 J). Subgroup analysis revealed the lowest defibrillation thresholds for patch-patch combinations with at least one large patch. Total surface area of defibrillating leads was strongly negatively correlated with the defibrillation threshold (p less than 0.005). Analysis of the relation of clinical variables to defibrillation threshold revealed that only amiodarone therapy was independently associated with a significantly (p less than 0.05) higher defibrillation threshold. Thus, surface area of the defibrillating leads is a critical determinant of the defibrillation threshold for the implanted defibrillator. Patch-patch lead systems with at least one large patch may provide an increased safety margin for defibrillation. Conversely, amiodarone therapy is associated with higher defibrillation thresholds and may decrease the margin of safety.

Adolescent↗
PubMed1988

Transvenous and subcutaneous electrode system for an implantable defibrillator, improved on large pigs.

The currently required surgical procedure for implantable defibrillator implantation is a limiting factor and several groups are therefore investigating transvenous approaches. Our electrode system consists of a nondistal right ventricular catheter electrode and two or three subcutaneously (SC) placed electrodes. An optimal location for these SC electrodes is important to obtain the lowest possible defibrillation threshold (DFT) by allowing a more homogeneous current distribution within the thorax. An empirical approach consists of placing randomly the SC electrodes to find out the lowest possible DFT. A mathematical approach is to calculate the SC electrode locations for an optimal electric field distribution by using magnetic resonance images of thorax cross-sections and a specially designed computer program. Our recent experimental results are based on a series of 15 pigs weighing between 60 and 102 Kg. DFT ranged between 10 and 26 joules. We conclude that an electrode system with a right ventricular electrode and two or three subcutaneous electrodes can be optimized to reach a DFT for pigs with human-near body weights which is compatible with the energy capabilities of our implantable device.

Animals↗
PubMed1998

Enhanced detection criteria in implantable defibrillators.

INTRODUCTION: Enhanced detection criteria in third-generation implantable defibrillators have been implemented to avoid inappropriate therapy of fast supraventricular arrhythmias. We prospectively analyzed the use of these criteria in patients with an implantable defibrillator with electrogram storing capability. METHODS AND RESULTS: In 82 consecutive patients with a Guidant-CPI implantable defibrillator, sudden onset > 9% and stability < 40 msec were systematically programmed in zone 1 of therapy together with a sustained rate duration security mechanism. All detected tachycardia episodes were analyzed. The study population consisted of 59 patients who had at least one episode of tachycardia detected in zone 1 during follow-up. The tachycardia rate in zone 1 never exceeded 210 beats/min. Twenty patients had no episodes during follow-up, and three patients had episodes detected exclusively in zone 2 of therapy. Supraventricular arrhythmias were detected frequently in the ventricular tachycardia zone (193 of 690 tachycardia episodes in 23 of 59 patients). Use of sudden onset was very effective in detecting sinus tachycardias (65 of 67 episodes), and stability was very useful in detecting atrial fibrillation (31 of 32 episodes). However, sensitivity in detecting ventricular tachycardia was only 90% (451 of 497 episodes). Application of the sustained rate duration criterion allowed appropriate treatment of all ventricular tachycardia episodes, increasing sensitivity to 100%; however, specificity in appropriate nontreatment of supraventricular decreased from 96% to 83%. Subsequent analysis of different algorithms applied to our data showed that sudden onset > 9% and stability < 40 msec was the algorithm with the best specificity and sensitivity. CONCLUSION: Programming sudden onset and stability detection criteria with a sustained rate duration safety net for triggering tachycardia therapy results in appropriate device management in most patients with supraventricular and slow (< 210 beats/min) ventricular tachycardias.

Algorithms↗
PubMed2003

High defibrillation thresholds in transvenous biphasic implantable defibrillators: clinical predictors and prognostic implications.

The aim of this study was to identify clinical characteristics that distinguish patients with high DFTs and assess the prognostic implication. DFTs testing is a lengthy, potentially painful, and a hazardous process. Little information is available concerning the identification of patients with high DFT who undergo ICD surgery with transvenous leads and biphasic energy. This study analyzed 968 patients from two separate clinical studies who received a Medtronic cardioverter defibrillator from January 1995 through November 1999 and who had DFT testing measured by a binary search protocol. Compared to 865 patients with low defibrillation thresholds (< 18 J), the 103 patients with high thresholds (> or = 18 J) had a lower LVEF (34 +/- 16.7 vs 38.3 +/- 16.2%, P = 0.01), a worse NYHA functional class (23% Class I, 43% Class II, 29% Class III, 5% Class IV vs. 27% Class I, 55% Class II, 17% Class III, 1% Class IV, P < 0.0001), had bypass surgery less often (10.7 vs 27.5%, P < 0.0001), used amiodarone within the past 6 weeks (42.7 vs 27.2%, P = 0.002), and had a history of ventricular fibrillation more often (44.7 vs 33.1%, P = 0.02). Information concerning the number of shocks delivered was available in 345 (35%) patients; 23 were in the high DFT group and 322 were in the low DFT group. Twelve (52%) of the 23 patients in the high DFT arm received 3.6 +/- 2.7 shocks (median 2.5) and 106 (33%) of the 322 patients with low DFT received 4.9 +/- 9.5 shocks (median 2). After 6 months the mortality rate of patients with high thresholds was 11.7 vs 7.8% in patients with low thresholds (P = 0.118). Using a multivariate logistic regression model the significant predictors of death were older age, higher NYHA class, lower LVEF, amiodarone use, had a presenting arrhythmia of ventricular fibrillation and CHF but not initial high defibrillation thresholds. The study found that (1) 11% of patients have high DFTs, (2) clinical characteristics that identify high defibrillation thresholds are NYHA Class III, IV, low ejection fraction, no previous history of bypass surgery, prior amiodarone use preoperatively, and presenting with ventricular fibrillation, and (3) while high DFTs were associated with a more ill patient population, there was no difference in survival in a 6-month follow-up. Patients with a predicted low DFTs may be eligible for abbreviated ICD testing while high risk patients require formal testing.

Case-Control Studies↗
PubMed2004

Cardioverter defibrillator implantation in a child with isolated noncompaction of the ventricular myocardium and ventricular fibrillation.

Isolated noncompaction of the ventricular myocardium is a rare unclassified cardiomyopathy and is thought to be due to arrest of myocardial morphogenesis. In fetal life, it is characterized by an excessively prominent trabecular meshwork and deep intratrabecular recesses, and occurs in the left ventricle in the absence of structural heart disease. Echocardiography provides evidence for the diagnosis. The noncompacted ventricular myocardium may be accompanied by depressed ventricular function, systemic embolism, Wolff-Parkinson-White syndrome, left bundle branch block, and ventricular arrhythmia. Although onset of symptoms is frequently delayed until adulthood, symptomatic children have a poor prognosis. In this report, we describe a case of 6-year-old girl who had a history of recurrent syncope. Transthoracic echocardiographic examination showed a localized prominent trabeculation and deep intratrabecular recesses at the inferoapical region of the left ventricle. She had several episodes of ventricular fibrillation which was refractory to pharmacological treatment. An implantable cardioverter defibrillator (ICD) was successfully operated three times during follow-up.

Cardiomyopathies↗
PubMed1993

Does ventricular fibrillation cause myocardial stunning during defibrillator implantation?

Induction of ventricular fibrillation (VF) is an important part of the process of inserting implantable cardioverter defibrillators (ICDs), allowing the measurement of defibrillation thresholds. However, animal studies have revealed that repeated cycles of VF and defibrillation result in depressed left ventricular (LV) function and reduced cardiac output. Short intervals of VF do not affect myocardial contractility but longer periods produce heart failure. Induced VF was used in a canine model to study profound myocardial stunning leading to heart failure, as well as the therapeutic potential of the phosphodiesterase inhibitor, amrinone (combined with epinephrine and norepinephrine). Amrinone was found to significantly (p < 0.05) increase contractility when added to a stable preparation supported by epinephrine and norepinephrine infusion; amrinone or catecholamines alone had no effect. In the clinical setting, the following factors may affect LV contractility during ICD surgery: catecholamines released as a result of hypotension; negative VF; ischemia; antiarrhythmic drugs; anesthetics; and bradycardia after device testing. Patients (n = 125) have tolerated ICD insertion well. Early data reveals no significant changes in ejection fraction. Though rare, death due to myocardial stunning and LV power failure can occur during ICD insertion. It may be possible to use arterial pressure monitoring to predict this event in vulnerable patients.

Animals↗
PubMed1997

Value of radiography in diagnosing complications of cardioverter defibrillators implanted without thoracotomy in 437 patients.

OBJECTIVE: This study evaluated the usefulness of radiography in assessing the frequency and cause of complications of nonthoracotomy-implanted cardioverter defibrillators. MATERIALS AND METHODS: Between May 1992 and December 1995, 437 consecutive patients at our institution underwent cardioverter defibrillator placement. Routine follow-up included external device testing at 6 weeks after placement and every 3 months thereafter. Chest radiographs were obtained immediately after placement, annually, and at the time of any suspected complication. Retrospective review of radiographs and medical charts was done for all patients with clinical complications. RESULTS: Forty-five complications (10%) were clinically diagnosed: lead or patch fracture in fifteen (33%) patients, electric lead dysfunction in eight (18%), infection in eight (18%), lead retraction in six (13%), patch fold in two (5%), hematoma in two (5%), and other complications in four (9%) patients. Eighteen complications (40%) were radiographically evident. Lead retraction, hematoma, patch fold, patch migration, and the twiddler syndrome were radiographically confirmed in 100% of cases. The average time for these complications to be detected was 68 days; 92% were detected within 23 days. Conversely, only four (27%) lead fractures, one (13%) electric lead dysfunction, and one (13%) infection were radiographically confirmed. These latter complications were discovered an average of 579 days after cardioverter defibrillator placement. CONCLUSION: Radiography plays a secondary role in the diagnosis of cardioverter defibrillator complications and is particularly limited beyond 1 month after placement. Radiographs may be helpful in the first month after placement because early complications are the most radiographically apparent.

Aged↗
PubMed1996

Surgical aspects of a randomized trial of defibrillator implantation during coronary artery bypass surgery. The CABG Patch Trial.

BACKGROUND: Whether prophylactic insertion of an implantable cardioverter defibrillator (ICD) improves the survival of high-risk patients undergoing coronary artery bypass graft surgery (CABG) is being assessed in the CABG Patch Trial. This report describes the surgical aspects of the study. METHODS AND RESULTS: As of February 28, 1995, 847 patients (1.6% of 54102 screened) were enrolled and eligible for randomization to CABG or CABG plus ICD. Intraoperatively, 56 were eliminated by postenrollment exclusions, 67 were judged too unstable for randomization, and 724 were randomized (80% of the goal of 900). The average preoperative ejection fraction was 0.27 +/- 0.06 (n = 724); left ventricular (LV) end-diastolic pressure averaged 22 +/- 12 mm Hg (n = 548) Cardiopulmonary bypass (CPB) time averaged 108 minutes in control subjects, 126 minutes in the ICD group. After CPB, mechanical support was employed in 23% of patients and inotropic support in 73%; shock occurred in 8% and deep sternal wound infection in 1.3%. The surgical mortality was 6%; median length of stay was 8 days. Compared with randomized patients, patients whom surgeons judged too unstable to randomize were distinguished by statistically significant increases in mechanical support after CPB (51% versus 23%, P < .05) and postoperative shock (19% versus 8%, P < .05). Also, surgical mortality was greater (9% versus 6%) but was not statistically significant. CONCLUSIONS: The initial phases of the CABG Patch Trial have been conducted with acceptable surgical mortality, morbidity, and length of stay. Surgical exclusion of some patients from randomization has been corroborated by data indicating hemodynamic instability. This trial will provide information about the risks and outcome of CABG surgery in patients with impaired LV function.

Aged↗
PubMed1994

[Automatic implantable defibrillators: long-term results].

The automatic implantable defibrillator is an essential component of the preventive management of sudden death of patients with malignant ventricular arrhythmias. Though its efficacy in this indication is not contested, the data concerning its influence on global cardiac mortality is more controversial. The elements of this controversy are reviewed. Several prognostic factors are implicated, the principal of which being the patient's haemodynamic status as assessed by objective evaluation of left ventricular function. Prospective randomised studies comparing medical therapy with the automatic implantable defibrillator are under way and should provide a better understanding of its indications in the future.

Arrhythmias, Cardiac↗
PubMed2001

[Implantable defibrillator. Update].

The implantable cardioverter-defibrillator is a device able to detect and efficiently treat life-threatening ventricular arrhythmias. Its decisive accomplishment in reducing sudden cardiac death and total cardiac mortality, opposed to the insufficient reliability of the traditional therapies explains its present ascendancy. In this review, the working principles and the implant techniques are developed, as well as the complications and the usual problems which could be encountered in implanted patients. Finally, the current indications are discussed in the light of recent clinical trials.

Arrhythmias, Cardiac↗
PubMed2003

The Dual Chamber and VVI Implantable Defibrillator (DAVID) Trial: rationale, design, results, clinical implications and lessons for future trials.

T he Dual Chamber and VVI Implantable Defibrillator (DAVID) trial randomized 506 patients and tested the hypothesis that the dual-chamber pacing mode would produce improved hemodynamics and would in turn reduce congestive heart failure, heart failure hospitalizations, heart failure deaths, atrial fibrillation, strokes, ventricular arrhythmias, and total mortality compared to backup ventricular pacing in patients indicated for implantable defibrillator therapy. Patients had either primary prevention indications (47%) or secondary prevention indications (53%) for implantable defibrillator therapy but had no indications for bradycardia pacemaker support. All the patients had moderate to severe left ventricular dysfunction with a left ventricular ejection fraction of 40% or less (mean = 27%) and were consistently treated with angiotensin converting enzyme inhibitors or angiotensin II receptor blockers (86%) and beta adrenergic blocking agents (85%). The primary combined endpoint of hospitalization for congestive heart failure or death was paradoxically increased and statistically significant ( p = 0.03) at one year in the patients paced in the dual chamber mode (22.6%) compared to patients randomized to ventricular backup pacing (13.3%). Both heart failure hospitalization and mortality contributed outcome. Another perspective would consider this a randomized controlled study of presence or absence of pacemaker therapy in patients with left ventricular dysfunction and indications for implantable defibrillator therapy. Ventricular backup pacing produced less than 3% ventricular and no atrial pacing, while dual chamber pacing produced approximately 60% atrial and ventricular paced heart beats. The poor outcome in the dual chamber paced group correlated with the percentage of right ventricular pacing and suggests that right ventricular pacing caused ventricular dyssynchrony. The poor outcome associated with right ventricular pacing compared to intrinsic activation in the control group of the DAVID trial is reminiscent of the poor outcome associated with prolonged intraventricular conduction activation in the control groups compared to biventricular pacing in the intervention groups of the cardiac resynchronization trials. The direct conclusion from these results are that patients with indications for implantable defibrillators and no indication for pacing should not be paced in the dual chamber pacing mode. It is not appropriate to conclude that only single chamber implantable defibrillators should be implanted. There are other potential advantages to having an implanted atrial lead including improved secondary outcomes. However the DAVID trial results suggest that the dual chamber paced mode was not associated with improved quality of life or decreased frequency of hospitalization, inappropriate shocks from the defibrillator or atrial fibrillation. The more important question is what is the optimal pacing mode in these patients? The AAIR mode is under investigation in the DAVID II study in an attempt to identify a pacing mode that preserves atrio-ventricular synchrony, normal atrio-ventricular timing, prevents bradycardia and also prevents right ventricular stimulation. Caution should be taken to not directly apply these results to patients with either an indication for pacemaker therapy or to patients with an indication for cardiac resynchronization therapy since patients from neither population were included. However, considering the large magnitude of the deleterious effects associated with dual chamber pacing in the DAVID trial future studies should explore the possibility that left ventricular stimulation may be the only pacing mode capable of preventing bradycardia without increasing death and congestive heart failure.

Anti-Arrhythmia Agents↗
PubMed1991

Lateral thoracotomy for the automatic implantable defibrillator.

In 51 patients who required automatic implantable cardioverter defibrillator implantation without additional cardiac procedures, the lead system was implanted using a lateral thoracotomy approach, with complete muscle sparing in the last 24 patients. Exposure was excellent and allowed repositioning of leads for optimal defibrillation thresholds in 18 patients. Five of 19 patients who had previously undergone intrapericardial procedures required intrapericardial dissection for lead placement to provide satisfactory defibrillation thresholds. There were no intraoperative deaths or infarctions. The 30-day mortality rate of 3.9% was comparable with those in other series, and the use of muscle-sparing techniques and supplemental epidural anesthesia prevented pulmonary complications or the need for prolonged ventilatory support. We favor a muscle-sparing lateral thoracotomy incision for automatic implantable cardioverter defibrillator insertion, particularly in patients with a history of previous intrapericardial procedures.

Adult↗
PubMed1997

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↗