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PubMed2006

Implantable cardiac arrhythmia devices--Part II: implantable cardioverter defibrillators and implantable loop recorders.

Implantable cardiac devices have become firmly entrenched as important therapeutic tools for a variety of cardiac conditions. The second part of this two-part review discusses the contemporary use and follow-up of implantable cardioverter defibrillators (ICD) and the implantable loop recorder. The ICD has become the standard therapy for protecting patients against sudden cardiac death. Two recent trials, the Multicenter Automatic Defibrillator Trial II (MADIT II) and the Sudden Cardiac Death Heart Failure Trial (SCD-HEFT), demonstrated that the ICD is associated with a significant survival benefit for patients with reduced ejection fraction (< 0.30-0.35), particularly if heart failure symptoms are present. The ICD has an important role in the management of other conditions associated with a high risk for sudden death, such as hypertrophic cardiomyopathy, long QT syndrome, and Brugada syndrome. The implantable loop recorder has become an important diagnostic tool for the patient with unexplained syncope.

Arrhythmias, Cardiac↗
PubMed2005

[Postmarketing surveillance in patients with cardiac pace-makers or automatic implantable defibrillators].

This article includes an overview of the actual French control and regulation system of the safety alerts involving pacemakers and implantable cardioverter-defibrillator and an evaluation of the general information and trends about the characteristics of the reported incidents obtained in the last years in that field. The national security agencies have the mission to collect the data on safety and efficacy of medical devices but manufacturers, physicians and patients also have a role to play. The technical appreciation of the necessity of a notification is not easy in some cases but the lack of notification of a severe incident may lead to heavy penal consequences. If doubtful cases, one should keep in mind the spirit of these safety systems: a collective insurance against the risks related to the use of medical devices. In the 10 last years, the annual advisory rate was increased. The pacemakers were recalled more frequently than implantable cardioverter-defibrillators in absolute value but less frequently in relative value (advisories per 100 person-years). This increase may be related to the growing number of device implants and expanding indications for device therapy, to the increasing sophistication of the devices and to the modifications in the regulation aspects of these problems with a closer attention of users and physicians to the several types of malfunctions.

Consumer Product Safety↗
PubMed2005

[Indications for automatic implantable defibrillators in patients with the Brugada syndrome].

Brugada syndrome is a primary electrical cardiac disease characterized by an ST segment elevation in V1-V2 leads on surface ECG and an increased risk of polymorphic ventricular tachyarrhythmia (ventricular tachycardia and/or ventricular fibrillation). The objective of the treatment is to prevent sudden death and it therefore includes in some cases the implantation of an automatic implantable cardiac defibrillator (AICD). In secondary prevention (i.e. after a first episode of resuscitated ventricular fibrillation), the implantation of AICD is mandatory (indication of class 1 level A). In primary prevention (i.e. in patients without documented ventricular fibrillation), the guidelines are not definitively established. We may consider two different clinical situations. First, the patient complains from syncope and this justifies the implantation of an AICD. Second, the patient is asymptomatic and the physician has to discuss the implantation of an AICD. Two parameters should be analysed: the pattern of ECG and the result of right programmed ventricular stimulation. An evident ST segment elevation (>2 mm) is associated with a high risk of sudden death. Likewise, the inducibility of a ventricular tachycardia or fibrillation is considered at the present time as a factor linked to sudden death and justifies the implantation of an AICD. On the other hand, a normal resting ECG only associated with a provoked ST segment elevation by class I antiarrhythmic drug (flecainide) defines a group of patients with a low risk of sudden death, and these patients do not require the implantation of an AICD.

Death, Sudden, Cardiac↗
PubMed2004

Subanalyses of secondary prevention implantable cardioverter-defibrillator trials: antiarrhythmics versus implantable defibrillators (AVID), Canadian Implantable Defibrillator Study (CIDS), and Cardiac Arrest Study Hamburg (CASH).

PURPOSE OF REVIEW: Controlled trials for secondary prevention of sudden death--Antiarrhythmics Versus Implantable Defibrillators (AVID), Canadian Implantable Defibrillator Study (CIDS), and Cardiac Arrest Study Hamburg (CASH)--have been published and subanalyses of them provide useful clinical information on the outcome during the follow-up of this population. RECENT FINDINGS: Results from a meta-analysis showed a significant risk reduction (RR) of 25 to 27% of total mortality (P < 0.001) and 50 to 52% of arrhythmic death (P < 0.001). Compared with amiodarone, patients treated with an implantable cardioverter-defibrillator (ICD) in AVID had a maximal benefit in survival when the ejection fraction (EF) was between 20 and 34%. In CIDS, the group of higher risk (older than 70 years, EF less than 3.5%, and New York Heart Association class III-IV) presented a 50% RR of mortality. It has been demonstrated that the imbalance in beta-blocker use cannot explain the better survival in the ICD patients. After 3 years the recurrence of arrhythmia was 64% in the ICD group of the AVID trial. Patients enrolled after an episode of ventricular tachycardia were more likely to have appropriate therapy during follow-up. Older age, lower blood pressure, history of atrial fibrillation, diabetes, congestive heart failure, and prior pacemaker were parameters used for high-risk stratification. Conversely, inducibility of ventricular tachyarrhythmias on electrophysiology did not predict death. SUMMARY: Patients with ICD after ventricular tachyarrhythmias have a 28% RR in total mortality. Individuals with EF between 20 to 34% received the highest benefit with ICD therapy.

Anti-Arrhythmia Agents↗
PubMed2001

[Prophylactic value of automatic implantable defibrillators: a case report of a patient with asymptomatic Brugada syndrome].

The authors report the case of an asymptomatic 32 year old man with no family history of sudden death but with ECG changes suggesting Brugada's syndrome. He underwent implantation of an automatic defibrillator after inducible syncope ventricular fibrillation had been demonstrated during electrophysiological investigation. The later occurrence of three episodes of ventricular fibrillation treated by the defibrillator confirmed a posteriori the logic of this therapeutic approach.

Adult↗
PubMed1995

Implantable defibrillation and thromboembolic events.

In ICD patients thromboembolic events (TEEs) are described as possible complications at implant or during the follow-up. We report four cases of TEEs (two peripheral and two cerebral; 6.5% of patients) that occurred in our series during a mean follow-up of 19.4 months. The patients had chronic postinfarction LV aneurysm (3) and idiopathic dilated cardiomyopathy (1). None had previous embolisms nor evidence of left atrial or LV clots at standard preoperative transthoracic echocardiography. No paroxysms of atrial fibrillation were documented prior or after ICD implant. We discuss the possible causes of embolization and the suitability of anticoagulant therapy in ICD patients.

Aged↗
PubMed2004

[Implantable defibrillator and ventricular resynchronisation].

Ventricular resynchronisation by pacing, introduced at the end of the 1990s, has revolutionised the management of advanced chronic cardiac failure. Its value in the reduction of haemodynamic mortality has been demonstrated in the latest studies. However, despite these decisive advances, patients with cardiac failure continue to have a high incidence of sudden death which, classically, according to its stage of progression, represents 28 to 68% of deaths in this condition. The implantable automatic defibrillator (IAD) has been shown to be effective in preventing sudden death, mainly in patients with severe left ventricular dysfunction. Based on these data, and in a context of rapid technological progress, devices capable of both defibrillating and resylchronising the heart have been introduced. The problems experienced at the beginning of their utilisation, mainly related to "double-counting" of left and right ventricular electrical activation have been resolved and the method is now technically feasible. A complication rate >10%, mainly due to the implantation of the left heart catheter, continues to bear witness to the difficulties of this technique and to the severity of the condition of patients referred for the treatment. The COMPANION trial has shown a greater reduction in mortality of patients treated by resynchronisation associated with IAD compared with resynchronisation alone or medical therapy in > or = Stage III cardiac failure. The SCD-HeFT trial has recently demonstrated that the primary prevention of global mortality by the IAD is effective in cardiac failure irrespective of the underlying cardiac pathology, especially in functional Stage II. These results should lead to significant increase in the indications for implantation of devices capable of both resynchronisation and defibrillation. However, the obvious problems of cost associated with the difficulty of the technique mean that a systematic attitude cannot be recommended. A case-by-case discussion has its place but the causal cardiac disease, ischaemic or not, does not seem to be a determining factor.

Cardiac Pacing, Artificial↗
PubMed1997

Does the initial presentation of patients with implantable defibrillator influence the outcome?

The influence of the clinical presentation on the long-term outcome in 213 consecutive patients with ICDs, ECG storage capability, and nonthoracotomy leads, was analyzed. Sixty-six patients presented with cardiac arrest (CA), 81 patients with hemodynamically stable VT, and 66 patients with syncope (SY). Patient characteristics were: mean age CA 62, VT 61, SY 61 years; mean ejection fraction CA 31%, VT 29%, SY 30%; coronary artery disease CA 71%, VT 71%, SY 64% (all P > 0.05 Fisher's exact test); female gender CA 40%, VT 14%, SY 19% (CA vs VT and SY, P < 0.005); inducibility by programmed stimulation CA 50%, VT 84%, SY 61% (VT vs CA and SY, P < 0.001, CA vs SY, P > 0.05). During a mean follow-up of 14.5 months, 29 patients died: CA 12%, VT 14%, SY 9% (P > 0.05). Comparing Kaplan-Meier curves, no difference in the time course of overall mortality was found (log-rank P > 0.05). In the CA, VT, and SY groups, 543, 1,630, and 189 ICD therapies (including antitachycardia pacing, low energy cardioversion, and defibrillation) were observed, respectively. Actuarial analysis showed a shorter interval between implantation and first ICD therapy for VT versus CA and SY (log-rank P < 0.005). Patients presenting with VT experienced earlier and more frequent ICD therapies than patients with CA or SY independent of age, ejection fraction, and heart disease. No difference in overall mortality and time course of fatal events was observed among the three groups.

Actuarial Analysis↗
PubMed2001

Survey of cardiac pacing and implanted defibrillator practice patterns in the United States in 1997.

A survey of implanters of permanent cardiac pacemakers and ICDs in the United States during 1997 was conducted to identify present and changing patterns in indications for pacing, implantation techniques, pacing-mode selection, follow-up, and opinions regarding pacing and ICD related issues. This report is an update from 1993 of surveys performed every 4 years for the International Cardiac Pacing and Electrophysiology Society (ICPES). Questionnaires were sent to implanting physicians who were members of the North American Society of Pacing and Electrophysiology (NASPE), and who might, therefore, be expected to be more conversant than others with the state of the art. Four major manufacturers also provided estimates of the numbers of pacemakers and ICDs implanted in the United States from 1994 through 1997. In 1997, approximately 182,000 new rhythm management devices, including 153,000 primary pacing systems and 29,000 ICDs, were implanted, an increase of 24% for pacemakers and 90% for ICDs since 1994. In 1997, pacemaker implantations were performed by about 8,600 physicians working in 3,300 hospitals and 1,000 independent "surgi-centers." From 1994 to 1997, sales in the United States of dual chamber pacemakers rose from 58% to 69% of the total, and adaptive rate systems from 74% to 90%. ICD sales increased by about 29% per year from 18,700 to 35,000 units. This study disclosed significant differences among implanter subcategories and between present and earlier practices, and it provided useful insights into trends in pacemaker and defibrillator practice. Future surveys would be facilitated if a standardized implant registry like that used in Europe were established in the United States.

Cardiac Pacing, Artificial↗
PubMed2003

Use of the AutoCapture Pacing System with implantable defibrillator leads.

INTRODUCTION: Previous studies using various bipolar pacemaker leads have shown that the AutoCapture (AC) Pacing System is able to verify ventricular capture and regulate pacing output, increasing patient safety with respect to unexpected threshold changes and potentially prolonging device longevity. An increasing number of patients with implantable cardioverter defibrillators (ICDs) require ventricular pacing that contributes to a shortening of longevity of these systems. This prospective study tested the compatibility of the AC system with bipolar ICD leads. METHODS: The AC algorithm was evaluated prior to ICD testing in 30 ICD recipients. A single coil, active fixation, true bipolar ventricular lead was implanted in 21 patients, and a dual coil, passive fixation, integrated bipolar ventricular lead was implanted in 9 patients. A ventricular evoked response sensitivity test and an AC threshold test were performed using a pacemaker with the ventricular AC algorithm. RESULTS: AC was recommended in 22/30 (73.3%) of implants, including 20/21 (95.2%) with the single coil and 2/9 (22.2%) with the dual coil lead. Mean polarization was lower (1.23 +/- 0.95 mV vs 3.70 +/- 2.33 mV, P = 0.013) while the mean evoked response was higher (18.04 +/- 8.29 mV vs 10.13 +/- 4.22 mV, P = 0.002) with the single coil leads. CONCLUSION: Automatic threshold tracking using the AC is compatible with ICD leads. Leads with lower polarization and greater evoked response are more likely to result in recommendation of AC use. Use of this system offers the potential for increasing ICD generator longevity and improving patient safety in response to late unexpected threshold increases.

Aged↗
PubMed2001

The right ventricular outflow tract as an unusual location for an implantable defibrillator electrode in a patient with arrhythmogenic right ventricular dysplasia.

A 41-year-old woman with arrhythmogenic right ventricular dysplasia (ARVD) underwent the implantation of an implantable cardioverter-defibrillator (ICD), in which the defibrillator electrode was unusually located in the right ventricular (RV) outflow tract. Although fractionated electrograms were demonstrated in the RV apex, which is the usual site for ICD electrodes, normal electrograms were recorded in the RV outflow tract during an electrophysiologic study. An electrode with a screw-in tip was used to fix the implant in the RV outflow tract and obtain successful defibrillation. If normal electrograms are recorded in the RV outflow tract, the site may prove to be an alternative location for an ICD electrode even for ARVD patients.

Adult↗
PubMed2001

Left superior vena cava persistence in patients undergoing pacemaker or cardioverter-defibrillator implantation: a 10-year experience.

OBJECTIVE: The persistence of a left superior vena cava (LSVC) has been observed in 0.3% of the general population as established by autopsy. In the adult population, it is an important anatomic finding if a left superior approach to the heart is considered. The aim of the study was to evaluate the prevalence of a LSVC in patients undergoing pacemaker (PM) and cardioverter-defibrillator (CD) implantation. DESIGN: We observed the prevalence of LSVC during a 10-year period; each patient undergoing PM or transvenous CD implantation received a left cephalic/left subclavian venous approach to the heart. With this technique, LSVC persistence is easily diagnosed during lead placement. RESULTS: A total of 1,139 patients consecutively underwent PM implantation during 10 years: 4 patients had persistent LSCV (0.34%). Among 115 patients undergoing CD implantation, 2 patients with LSVC (1.7%) were observed. Overall LSVC persistence was found in 6 of 1,254 patients (0.47%). Two patients, one of whom had no right superior vena cava (RSVC), received a left-sided PM, whereas two other patients received right-sided devices. Both CD patients received a left-sided active-can device: the first patient with a right-sided lead tunneled to the left pectoral pocket, as a result of poor catheter handling through the LSVC and coronary sinus, and the second patient with a screw-in lead from LSVC. Long-term follow-up of these patients (average +/- SD, 41 +/- 26 months) revealed absence of lead dislodgment and appropriate device function regardless of lead implantation site. CONCLUSIONS: Persistence of LSVC in adults undergoing PM/CD implantation is similar to that of the general population (0.47% in our study). The left-sided implant can be achieved by stylet shaping and by use of active fixation leads in most patients, with a reliable outcome at short term in addition to appropriate device performance at follow-up. Assessment of the RSVC is advisable when planning a right-sided implantation, since a minority of patients lacks this vessel.

Defibrillators, Implantable↗
PubMed2005

Preimplantation B-type natriuretic peptide concentration is an independent predictor of future appropriate implantable defibrillator therapies.

OBJECTIVE: To assess prospectively whether preimplantation B-type natriuretic peptide (BNP) and C reactive protein (CRP) concentrations predict future appropriate therapies from an implantable cardioverter-defibrillator (ICD). DESIGN AND SETTING: Prospective cohort study conducted in a tertiary cardiac care centre. METHODS: 345 consecutive patients undergoing first time ICD implantation were prospectively studied. Serum BNP and CRP concentrations were obtained the day before ICD implantation. Patients were followed up with device interrogation to assess for appropriate shocks or antitachycardia pacing. Inappropriate therapies were excluded. Mean (SD) follow up was 13 (5) months. RESULTS: Patients had ischaemic (71%), primary dilated (17%), and valvar or other cardiomyopathies (12%). About half (52%) had ICDs implanted for primary prevention. Sixty three (18%) received appropriate ICD therapies. Serum creatinine, beta blocker, statin, and angiotensin converting enzyme inhibitor usage did not differ between therapy and no therapy groups. By univariate comparison, ejection fraction (p = 0.048), not taking amiodarone (p = 0.033), and BNP concentration (p = 0.0003) were risk factors for ICD therapy. However, by Cox regression multivariate analysis, only BNP above the 50th centile was a significant predictor (hazard ratio 2.19, 95% confidence interval 1.07 to 4.71, p = 0.040). Median BNP was 573 ng/l versus 243 ng/l in therapy and no therapy patients, respectively (p = 0.0003). More patients with BNP above the 50th centile (27% v 10%, p = 0.006) received ICD therapies. CONCLUSIONS: A single preimplantation BNP concentration determination is independently predictive of ICD therapies in patients with cardiomyopathies undergoing first time ICD implantation. CRP was not independently predictive of ICD therapies when compared with BNP.

Biomarkers↗
PubMed1995

Randomized study of implantable defibrillator as first-choice therapy versus conventional strategy in postinfarct sudden death survivors.

BACKGROUND: In retrospective studies of sudden cardiac death survivors, the implantable cardioverter-defibrillator (ICD) compares favorably with medical and surgical therapy. Thus, use of the conventional strategy of starting treatment with antiarrhythmic drugs (AD), at least in certain patient categories, may be questionable. The goal of this study was to analyze the effectiveness of ICD implantation as first-choice therapy versus the conventional therapeutic strategy of starting with AD. METHODS AND RESULTS: Sixty consecutive survivors of cardiac arrest caused by old myocardial infarction were randomly assigned early ICD implantation (n = 29) or conventional therapy (n = 31). Baseline characteristics were similar in the two groups. Therapy in each patient was always guided by ECG monitoring, exercise testing, and programmed electrical stimulation (PES). Primary end points (main outcome events, including death, recurrent cardiac arrest, and cardiac transplantation), number of invasive procedures and antiarrhythmic therapy changes, and duration of hospitalization were compared. Median follow-up was 24 months (mean, 27 months). In the early ICD group, 4 patients (14%) died, all of cardiac causes. In the conventional group, 20 patients failed AD and subsequently underwent map-guided ventricular tachycardia (VT) surgery (6 patients) or ICD implantation (14 patients). Of the 6 VT surgery patients, 1 died, 1 had cardiac transplantation, and 1 had an ICD implantation because of persistent inducibility despite the addition of AD. Of the 11 patients who remained on AD as sole therapy, 2 died in the hospital before they could be retested by PES, leaving 9, judged adequately protected by AD alone. Of those, 5 died, and 1 survived recurrent cardiac arrest followed by ICD implantation. In total, 16 conventionally treated patients ended up with late ICD implantation, 3 of whom died. Thus, total mortality in the conventional group was 11 patients (35%): 4 died suddenly, 5 died of heart failure, and 2 died of noncardiac causes. Comparison of the main outcome events in both strategies showed a significant difference in favor of early ICD implantation (hazard ratio, 0.27; 95% CI, 0.09 to 0.85; P = .02). In addition, the early ICD group underwent fewer invasive procedures (median, 1 versus 3; P < .0001), had less therapy changes (P < .0001), and spent fewer days in hospital (median, 34 versus 49; P = .02). CONCLUSIONS: These data suggest that ICD implantation as first choice is preferable to the conventional approach in survivors of cardiac arrest caused by old myocardial infarction. Conventionally treated patients are likely to end up with an ICD, and those who remain on AD as sole therapy have a high risk of death regardless of efficacy assessment, including PES.

Anti-Arrhythmia Agents↗
PubMed2003

Cardiac resynchronization therapy with or without an implantable defibrillator: only indicated when everything else has failed?

Cardiac resynchronization therapy (CRT) is potentially an important new treatment for patients with heart failure due to left ventricular systolic dysfunction and cardiac dyssynchrony. There is growing evidence that CRT can improve symptoms although it is possible that similar benefits could be obtained by skillful manipulation of pharmacological therapy. There is also preliminary but inconclusive evidence to suggest that CRT alone or in synergy with an implantable cardiac defibrillator (ICD) may reduce morbidity and mortality. However, fashion is in danger of overtaking facts and it is important to ensure that benefits are not only statistically proven but clinically meaningful and cost-effective. Optimal timing of intervention and patient selection will be essential to ensure that treatment is deployed efficiently. If CRT with or without ICD becomes part of mainstream therapy for heart failure this will have far-reaching consequences for heart failure management. Implantation is a skilled and often time-consuming procedure. Long-term management of both CRT and ICD is likely to provide challenges in terms of lead technology, pacing thresholds and device management. Heart failure physicians will have to learn new skills and collaborate more closely with electrophysiologists. Such developments, in addition to the need for complex pharmacological interventions will accelerate the move away from general practice and towards specialist care for this most common of malignant diseases. If CRT does reduce mortality, it will graduate from an adjunctive therapy which could be used to an essential one that should be used as part of routine therapy for appropriate patients. Currently, CRT is a symptomatic therapy for patients with severe heart failure resistant to intensive pharmacological therapy delivered by a heart failure specialist.

Arrhythmias, Cardiac↗
PubMed1999

Cardiac pacemakers and implantable defibrillators in terminal care.

The use of cardiac pacemakers and arrhythmia control devices is increasingly common. The presence of a previously placed pacemaker or implantable cardioverter-defibrillator (ICD) in a terminally ill patient may result in medical and ethical issues for the patient, family, and healthcare provider. Two cases are presented to illustrate the complex issues that may arise in the terminally ill with a pacemaker or an ICD. Based on these cases and a review of published data, it is likely that the disabling of a previously placed pacemaker will neither hasten nor prolong the natural history of the underlying illness in most instances. There are uncommon but potentially severe adverse effects of disabling the pacemaker; therefore, pacemakers should generally be left intact in terminally ill patients. It is more difficult to generalize as to whether deactivation of an ICD is appropriate; in this case death may be hastened and the decision concerning an ICD will depend on the specific clinical scenario. Patient and family education regarding palliative care treatment goals and the function of pacemakers and other implanted arrhythmia control devices can help to alleviate anxiety surrounding the impact of this technology at the end of life.

Aged↗