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PubMedDate not supplied

Y2K: effects on pacemaker and implantable defibrillator programmers.

All permanent pacemakers and implantable defibrillators (PPM/ICDs) will continue to function as programmed without regard to the date in the year 2000 (Y2K). All manufacturers contacted reassured us that some of these devices incorporate a day/year clock in the circuitry; however, these are not involved in sensing or delivering programmed therapy. Some manufacturers' device programmers will roll over to the year 2000 without any problems at all, whereas others may have difficulty with date and time stamping on printed reports. We tested 14 different types of PPM/ICD programmers for Y2K compliance using 8 tests. Five of the 14 models passed each test and were labeled at our institution with a green "Y2K" sticker to identify them as Y2K compatible and needing no special attention after December 31, 1999. The most common test failed was the ability to roll the date forward from December 31, 1999, with the programmer power off. Organizations should consider testing and replacing noncompliant device programmers or placing a red sticker with "Y2K" crossed out on noncompliant pieces. The red sticker alerts the advanced practice nurse or physician to the need to confirm the appropriate date and time in the programmer after startup in the year 2000 and before interrogating or programming any PPM/ICD, to avoid inappropriate date and time stamping on printed reports from that programmer.

Attitude of Health Personnel↗

PubMed1994

Risk and benefit of additional aortocoronary bypass grafting in patients undergoing cardioverter-defibrillator implantation.

It is unclear whether additional aortocoronary bypass grafting should be performed in patients who need an automatic implantable cardioverter defibrillator (ICD) in one- or two-step procedures. Therefore we studied the follow-up of 139 patients who underwent epicardial implantation of the cardioverter defibrillator (CD). All patients had coronary artery disease and recurrent ventricular tachycardia or fibrillation. Eighty-nine patients had implantation of the CD without additional surgical approaches (group G1), and 50 patients had concomitant aortocoronary bypass grafting (group G2). Perioperative mortality (within 30 days after CD implant) was 1 (1%) of 89 patients in G1 and 6 (12%) of 50 patients in G2 (p < 0.01). During the mean follow-up of 26 +/- 20 months, sudden death occurred in four (4%) of 89 patients in G1 and two (4%) of 50 patients in G2. Twenty-three (17%) patients died of cardiac failure (18 [20%] patients in G1 and 5 [10%] patients in G2). ICD discharges occurred in 69 (78%) of 89 patients in G1 and in 36 (72%) of 50 patients in G2. The mean incidence of ICD discharges was 23 +/- 69 shocks per patient in G1 and 18 +/- 25 shocks per patient in G2 (p = NS). We conclude that concomitant aortocoronary bypass grafting during CD implantation leads to a higher perioperative mortality. Avoidance of myocardial ischemia does not significantly influence sudden death mortality nor markedly reduce the number of ICD discharges.

Adult↗

PubMed1999

Prevention of implantable-defibrillator shocks by treatment with sotalol. d,l-Sotalol Implantable Cardioverter-Defibrillator Study Group.

BACKGROUND: Patients with implantable cardioverter-defibrillators often receive adjunctive antiarrhythmic therapy to prevent frequent shocks. We tested the efficacy and safety of sotalol, a beta-blocker with class III antiarrhythmic effects, for this purpose. METHODS: In a multicenter trial, patients were stratified according to left ventricular ejection fraction (< or =0.30 or >0.30), randomly assigned to double-blind treatment with 160 to 320 mg of sotalol per day (151 patients) or matching placebo (151 patients), and followed for 12 months. Kaplan-Meier analyses of the time to an event were performed. Three end points were used: the delivery of a first shock for any reason or death from any cause, the first appropriate shock for a ventricular arrhythmia or death from any cause, and the first inappropriate shock for a supraventricular arrhythmia or death from any cause. RESULTS: Compliance with double-blind treatment was similar in the two groups. There were seven deaths in the placebo group and four in the sotalol group. As compared with placebo, treatment with sotalol was associated with a lower risk of death from any cause or the delivery of a first shock for any reason (reduction in risk, 48 percent; P<0.001 by the log-rank test), death from any cause or the delivery of a first appropriate shock (reduction in risk, 44 percent; P=0.007), or death from any cause or the delivery of a first inappropriate shock (reduction in risk, 64 percent; P=0.004). Sotalol also reduced the mean (+/-SD) frequency of shocks due to any cause (1.43+/-3.53 shocks per year, as compared with 3.89+/-10.65 in the placebo group; P=0.008). In the sotalol group, the reduction in the risk of death from any cause or the delivery of a first shock for any reason did not differ significantly between patients with ejection fractions of more than 0.30 and those with ejection fractions of 0.30 or less. CONCLUSIONS: Oral sotalol was safe and efficacious in reducing the risk of death or the delivery of a first defibrillator shock whether or not ventricular function was depressed.

Adrenergic beta-Antagonists↗

PubMed2001

Use of implantable pacemakers and implantable defibrillators in hypertrophic cardiomyopathy.

Recent data have emerged to help guide the use of implantable pacemakers and implantable defibrillators in patients who have hypertrophic cardiomyopathy (HCM). Controlled studies of the use of dual chamber pacemakers to treat outflow tract obstruction in HCM have shown little benefit, and have raised the possibility that earlier favorable reports were demonstrating an element of placebo effect. In particular, there is no recent support for earlier claims of regression of ventricular hypertrophy from chronic dual chamber pacing. Several reports have added to our understanding of the risk factors for sudden death in HCM. A normal blood pressure response to exercise appears to identify a subset of patients at low risk for sudden death. In a recent study of a large number of HCM patients, the risk of sudden death was found to be directly proportional to the extent of left ventricular hypertrophy. There is accumulating evidence that the implantable defibrillator is highly effective in terminating malignant ventricular arrhythmias in HCM patients, and HCM patients thought to be at significant risk for sudden death should be offered defibrillator implantation.

Arrhythmias, Cardiac↗

PubMed1999

Patient discomfort following pectoral defibrillator implantation using conscious sedation.

BACKGROUND: The miniaturization of implantable cardioverter defibrillators (ICDs) has made pectoral implantation possible. However, postoperative pain following the procedure has not been systematically studied. The aim of the current study was to prospectively assess patient discomfort and identify factors influencing pain perception during follow-up. METHODS: Pain related to device implantation was quantified in 21 consecutive patients (age, 61 +/- 11 years; 17 men and 21 women; 16 of 21 had coronary artery disease; left ventricular ejection fraction, 32% +/- 15%) undergoing pectoral ICD implantation with conscious sedation (fentanyl 118 +/- 72 micrograms midazolam 14 +/- 9 mg). Patients completed the Visual Analogue Scale (VAS, 0-100) and the McGill Pain Questionnaire 24 hours and 1 month postoperatively. Regression analysis was used to define clinical and procedure related variables affecting patient discomfort and frequency of postoperative analgesic use. RESULTS: The mean VAS score was 34 +/- 20 24 hours postoperatively. A single (4.8%) patient described postoperative pain as severe. Pain was reported to be moderate by 10 (47.6%) patients and mild by 10 (47.6%) patients. Intraoperative fentanyl requirement was a predictor of postoperative pain (R = 0.51, P = 0.036), and procedural duration was a strong predictor of postoperative analgesic use (R = 0.75, P < 0.001). Pain at 1 month decreased to a VAS score of 19 +/- 18 (P = 0.002 vs 24 hours) and was rated to be severe, moderate, and mild by 1, 3, and 17 patients, respectively. Late pain was related to a VAS score at 24 hours (R = 0.67, P = 0.004). CONCLUSIONS: (1) Pectoral ICD implantation using conscious sedation is well tolerated. (2) Postoperative discomfort correlates with longer procedural times and larger intraoperative narcotic requirements.

Adult↗

PubMed1999

Outcome of patients with nonischemic dilated cardiomyopathy and unexplained syncope treated with an implantable defibrillator.

OBJECTIVES: The purpose of this study was to determine the outcome of patients with nonischemic dilated cardiomyopathy, unexplained syncope and a negative electrophysiology test who are treated with an implantable defibrillator. BACKGROUND: Patients with nonischemic cardiomyopathy and unexplained syncope may be at high risk for sudden cardiac death, and they are sometimes treated with an implantable defibrillator. METHODS: This study prospectively determined the outcome of 14 consecutive patients who had a nonischemic cardiomyopathy, unexplained syncope and a negative electrophysiology test and who underwent defibrillator implantation (Syncope Group). Nineteen consecutive patients with a nonischemic cardiomyopathy and a cardiac arrest who were treated with a defibrillator (Arrest Group) served as a control group. RESULTS: Seven of 14 patients (50%) in the Syncope Group received appropriate shocks for ventricular arrhythmias during a mean follow-up of 24+/-13 months, compared with 8 of 19 patients (42%) in the Arrest Group during a mean follow-up of 45+/-40 months (p = 0.1). The mean duration from device implantation until the first appropriate shock was 32+/-7 months (95% confidence interval [CI], 18 to 45 months) in the Syncope Group compared to 72+/-12 months (95% CI, 48 to 96 months) in the Arrest Group (p = 0.1). Among patients who received appropriate shocks, the mean time from defibrillator implantation to the first appropriate shock was 10+/-14 months in the Syncope Group, compared with 48+/-47 months in the Arrest Group (p = 0.06). Recurrent syncope was always associated with ventricular tachyarrhythmias. CONCLUSIONS: The high incidence of appropriate defibrillator shocks and the association of recurrent syncope with ventricular arrhythmias support the treatment of patients with nonischemic cardiomyopathy, unexplained syncope and a negative electrophysiology test with an implantable defibrillator.

Cardiomyopathy, Dilated↗

PubMedDate not supplied

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↗

PubMed1999

[The clinical practice guidelines of the Sociedad Española de Cardiología on the automatic implantable defibrillator].

Since the first implantation in man in 1980 implantable cardioverter defibrillator technology has greatly improved and the number of devices implanted has increased considerably every year. Non thoracotomy lead systems and biphasic shocks are now the approach of choice, offering an almost 100% success rate. This document reviews the recommendations for qualification of personnel and for the centres implanting and carrying out follow-ups on defibrillators. The current indications for the implantation of implantable cardioverter defibrillator are also addressed.

Arrhythmias, Cardiac↗

PubMed1997

Atrial diagnostics in a tiered therapy implantable defibrillator.

Dual chamber sensing has been proposed in implantable defibrillators as an additional diagnostic modality for enhanced differentiation of ventricular and supraventricular tachycardias. A patient with different rates of wide QRS complex tachycardias is described in whom a tiered therapy implantable defibrillator with atrial sensing capability was implanted. Atrial diagnostic data in this patient enabled definitive diagnosis of his ventricular tachycardias and guided management decisions of his arrhythmia.

Defibrillators, Implantable↗

PubMed2003

Clinical significance of device-related complications in clinical trials and implications for future trials: insights from the Antiarrhytmics Versus Implantable Defibrillators (AVID) trial.

BACKGROUND: Implantation of transvenous implantable cardioverter-defibrillators (ICDs) utilizing a non-thoracotomy approach has become routine therapy for survivors of life-threatening tachyarrhythmias. In the Antiarrhythmics versus Implantable Defibrillator (AVID) Trial, we sought to identify and prospectively characterize the frequency of lead and ICD-related complications. Between June 1, 1993, and April 7, 1997, 539 patients received non-thoracotomy ICDs. A total of 62 first complications occurred. The subclavian route of insertion resulted in more complications than the cephalic vein route, 46 of 339 (14%) versus 6 of 135 (4%), p =.005 as did the abdominal versus pectoral generator site; 31 of 238 (13%) versus 17 of 291 (6%), p <.02. Most dislodgements and system infections tended to occur in the 3 months following implantation, whereas lead fractures continued to occur throughout follow-up. Failure to use peri-operative antibiotics was a predictor of system infection (p =.001). These data suggest that cephalic vein access and pectoral generator site may result in fewer complications. Although implantation techniques and generator technology continue to evolve, the continued occurrence of lead fractures and the need for premature system revision supports the practice of close routine ICD system surveillance.

Aged↗

PubMed2006

Psychological reaction to potential malfunctioning of implantable defibrillators.

BACKGROUND: Psychological problems following implantable cardioverter defibrillators (ICD) implantation are diverse and include increased levels of anxiety. Anxiety may even rise further when possible malfunctioning of an ICD is announced, with a higher risk of serious ventricular arrhythmias and death as a consequence. Following the public statement of Medtronic, all patients in the Netherlands with the specific Medtronic ICD were contacted for extra device evaluation. The aim of this exploratory study was to determine whether the proportion of ICD patients with high levels of anxiety would increase after this extra device evaluation. METHODS: Patients were recruited from an ongoing prospective study on psychological effects of ICD implantation. Thirty-three patients completed the State subscale of the State-Trait Anxiety Inventory (STAI) before and after extra device evaluation. The STAI can identify patients with high levels of anxiety. RESULTS: A high level of anxiety was experienced by two patients (6.1%) at baseline and eight patients (24.2%) at follow-up (P=0.031). Hence, ICD patients were significantly more likely to experience high levels of anxiety following the public statement of potential malfunctioning of their device. CONCLUSION: A public statement regarding device safety may increase levels of anxiety among ICD patients. Given the potential triggering effect of high levels of anxiety on arrhythmias, psychological support may be considered for some of the ICD patients after such public statement.

Anxiety↗

PubMed1983

The automatic implantable defibrillator: local ventricular bipolar sensing to detect ventricular tachycardia and fibrillation.

The first-generation automatic implantable defibrillator implanted in man sensed arrhythmias by monitoring a transcardiac electrocardiographic signal. This sensing system reliably detected ventricular fibrillation and sinusoidal ventricular tachycardia but failed to sense all nonsinusoidal ventricular tachycardias. To solve this problem, a new ventricular tachycardia detection scheme was developed using a local ventricular bipolar electrogram and electronic circuits using rate averaging and automatic gain control to permit sensing of electrograms down to 0.1 mV. This detection scheme was tested during electrophysiologic studies in 11 patients with ventricular tachycardia and fibrillation. All 22 episodes of induced ventricular tachycardia with a rate above the selected cutoff were detected after an average of 5.1 +/- 1.8 seconds. No episodes below the rate cutoff were detected. The bipolar circuits also reliably detected ventricular fibrillation. Arrhythmia detection and signal quality in 9 patients receiving automatic defibrillators using the new bipolar rate detection circuit were compared with the findings in 5 patients previously receiving units that sensed arrhythmias using the transcardiac electrocardiographic signal. Compared with the transcardiac monitoring units the newer bipolar units had shorter and more uniform sense times (5.5 +/- 1.4 versus 12.2 +/- 7.1 seconds). It is concluded that malignant ventricular tachyarrhythmias can be sensed accurately using bipolar rate detection and that this system has numerous advantages over the previously used transcardiac electrocardiographic signal.

Aged↗

PubMed2005

A comparison of the AVID and DAVID trials of implantable defibrillators.

We compared 2 studies of implantable cardiac defibrillators (ICDs) to determine the effects of device mode on outcomes. The Antiarrhythmics Versus Implantable Defibrillators (AVID) trial (1993 to 1997) demonstrated improved survival with the ICD compared with antiarrhythmic drug therapy. The Dual-chamber And VVI Implantable Defibrillator (DAVID) trial (2000 to 2002) showed that VVI pacing at 40 beats/min in patients with ICDs reduced the combined end point of death and hospitalization for congestive heart failure compared with DDDR pacing at 70 beats/min. Patients in the AVID trial (631 of 1,016) and the DAVID trial (221 of 506) meeting common inclusion and all exclusion criteria were studied. The major end points were the time to death, and the composite end point of time to death or hospitalization for congestive heart failure. Patients in the AVID and DAVID trials were similar, but more AVID patients had coronary artery disease (p = 0.04), history of myocardial infarction (p = 0.005), and previous ventricular arrhythmias (p = 0.03). DAVID patients underwent more previous revascularization procedures (coronary artery bypass surgery, p = 0.03; percutaneous coronary intervention, p = 0.001), and were more often taking beta-blocking drugs at hospital discharge (p <0.001). The backup VVI ICD groups in both studies had similar outcomes (p = 0.4), even when corrected for the previous demographic differences. The time-to- composite end point was similar in AVID patients treated with antiarrhythmic drugs and DAVID patients treated with DDDR ICDs (p = 0.6). Despite improved pharmacologic therapy and revascularization, outcomes have not improved with backup VVI pacing ICDs. If DDDR ICDs had been used in the AVID trial, benefit from ICDs for patients with serious ventricular arrhythmias could have been missed.

Adrenergic beta-Antagonists↗

PubMed1995

Infections after cardioverter-defibrillator implantation: observations in 335 patients over 10 years.

OBJECTIVE: To determine the incidence of infection after implantation of a cardioverter-defibrillator and the management of this complication. SUBJECTS: 335 consecutive patients who had a cardioverter-defibrillator implanted between January 1984 and December 1993. MAIN OUTCOME MEASURES: Incidence of infection within the first month after implantation (early infection) and after the first month (late infection). RESULTS: Infections associated with cardioverter-defibrillator devices occurred in 13 patients (3.9%) during a mean follow up of 22 (11) months. All patients had general signs of inflammation, fever (> 37.5 degrees C), and leucocytosis (> 10,000/ml) with or without purulent drainage. Five patients (38%) had infections during the first implantation, whereas eight patients (62%) had infections after replacement of the pulse generator. Early infection was observed in four patients (31%) and late infection in nine (69%). Incidence of infection was higher in patients who underwent epicardial cardioverter-defibrillator implantation (12/207 patients, 5.8%) than in those who received nonthoracotomy lead systems (1/125 patients, 0.8%) (P < 0.05). Infections were caused by staphyloccocus in 10 patients, pseudomonas in two patients, and streptococcus in one patient. The whole device had to be removed in all patients. During a mean follow up of 39 (29) months seven patients died: six of congestive heart failure and one of myocardial reinfarction. CONCLUSIONS: Infection, one of the most serious complications after cardioverter-defibrillator implantation, is associated with increased morbidity and mortality. When infection occurs the system must be removed to avoid a fatal outcome.

Adolescent↗

PubMed1997

Clinical implications of the "Multicenter Automatic Defibrillator Implantation Trial" (MADIT)

Efficacious therapy for chronic coronary patients, known to be at high risk of sudden arrhythmic death, has been a long-lasting challenge for cardiologists. The "Multicenter Automatic Defibrillator Implantation Trial" (MADIT) has demonstrated in a prospective, randomized trial that such patients achieve 54% better survival (p < or = 0.009) when treated with implantable defibrillators (ICDs) compared to conventional pharmaceutical therapy-primarily amiodarone. The identification of these patients is well-defined, and patients with previous myocardial infarction fitting the appropriate risk profile as defined by MADIT (ejection.fraction < or = 0.35), non-sustained ventricular tachycardia should seriously be considered for prophylactic ICD implantation.

Aged↗

PubMed1997

What can we expect from prophylactic implantable defibrillators?

Death due to ventricular tachyarrhythmia (VT) remains an important public health problem; patients with prior myocardial infarction (MI) constitute the largest identifiable population for prophylactic interventions. Targeting of progressively higher-risk subgroups of post-MI survivors carries inevitable tradeoffs with respect to the global impact of interventions on overall mortality. Therapy with aspirin, beta blockers, and angiotensin-converting enzyme (ACE) inhibitors comprise the benchmark against which all additional interventions, including implantable defibrillators, must be measured. Initial enthusiasm for empiric amiodarone therapy has been tempered by the limited benefit demonstrated in recent randomized trials. Trials of other class III antiarrhythmic drugs, including both d,l-sotalol and d-sotalol, have also failed to demonstrate survival benefit. The Multicenter Automatic Defibrillator Implantation Trial (MADIT) demonstrated significantly improved survival associated with defibrillators in a small subgroup of post-MI survivors with a high short-term risk of death. The ultimate number and optimal criteria for selection of patients who may benefit from prophylactic defibrillator therapy after MI will undergo continued evolution as new data from current and ongoing trials become available.

Amiodarone↗

PubMed1999

Local anaesthesia versus general anaesthesia for cardioverter-defibrillator implantation.

AIMS: Cardioverter-defibrillators are conventionally implanted under general anaesthesia. However, implantation under conscious sedation is being increasingly used. It has been shown that cardioverter-defibrillators can be implanted in a more pacemaker-like approach: under local anaesthesia for the surgical procedure, and with mild sedation for defibrillation threshold testing only. The aim of the present study was to compare local and general anaesthesia in defibrillation threshold testing and implantation of cardioverter-defibrillators. METHODS AND RESULTS: Forty patients were assigned to two groups: in the first 20 consecutive patients the cardioverter-defibrillator was implanted under general anaesthesia (GA), and in the subsequent 20 patients under local anaesthesia (LA). There was no significant difference between the two groups in regard of age, body weight, underlying disease, left ventricular ejection fraction, and NYHA classification. The defibrillation threshold was 13.7 +/- 5.5 J under local anaesthesia versus 10.7 +/- 4.7 J under general anaesthesia (n.s.). For defibrillation threshold testing 7.9 +/- 3.6 shocks had to be applied in patients under general anaesthesia versus 6.2 +/- 1.3 shocks under local anaesthesia (n.s.). Mean heart rate, arterial oxygen saturation and mean arterial blood pressure remained stable throughout defibrillation threshold testing, irrespective of the type of anaesthesia used. The duration of the surgical procedure was 62 +/- 16 min under GA and 60 +/- 14 min under LA (n.s.), however, the entire implantation procedure was significantly longer in patients under general anaesthesia than in those under local anaesthesia (124 +/- 24 min and 97 +/- 22 min, respectively, p < 0.005). There were no complications in either group and the procedure was well tolerated. With the use of local anaesthesia the cost of anaesthesia were reduced by 72%. CONCLUSION: Local anaesthesia in combination with mild sedation is as safe and well tolerated as general anaesthesia in cardioverter-defibrillator implantation. Lidocaine used for local anaesthesia does not adversely affect the defibrillation threshold. Device implantation in a pacemaker-like approach results in a significant reduction in total procedure time and costs, and facilitates scheduling of the procedure.

Anesthesia, General↗

PubMed2002

[Placement of an implantable defibrillator via the endocavitary route in a patient presenting with a univentricular heart and a Glenn anastomosis].

We report the observation of a female 45 year old patient presenting with a post-surgery complex congenital cardiopathy, associated with serious ventricular rhythm disorders necessitating the placement of an implantable defibrillator. The palliative surgery performed (cavo-pulmonary Glenn anastomosis) does not allow the usual access to the right ventricle via the superior vena cava. The different possibilities for defibrillator implantation are discussed. These include associating a surgical approach to introduce the bipolar probe with subcutaneous tunnelling to connect the probe to the box.

Arrhythmias, Cardiac↗