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Over a 5-year period, 110 cardioverter-defibrillators (109 epicardial, 1 transvenous) were implanted consecutively in selected patients with ventricular tachyarrhythmias. The perioperative course of this patient population was examined to determine the associated morbidity and mortality of the procedure. Patients were predominantly male, with coronary artery disease and a decreased left ventricular ejection fraction. Most underwent median sternotomy for implantable cardioverter defibrillator implantation. The incidence of perioperative mortality was found to be 2.7%. New-onset atrial fibrillation or flutter occurred in 17.3% of the patients during the postoperative period and aggravation of ventricular tachyarrhythmias in 19.1%. The ICD system became infected in 2.7% of the patients and the mediastinal incision site infected in 2.4%. Pneumonia developed in 4.5%. Other complications included significant blood loss, ICD pocket hematomas, and lead dislodgement. There is an appreciable incidence of morbidity and mortality associated with ICD implantation.
Nocardia spp. are common environmental organisms that, to our knowledge, have never been implicated as causing an implantable defibrillator or pacemaker infection. We describe a 70-year-old male with a recent implantable cardiac defibrillator revision and subsequent device infection and bacteremia caused by a Nocardia nova complex isolate.
Implantable cardioverter defibrillator detection of ventricular fibrillation is inherently a complicated process. Nevertheless, there is a clinical imperative that ventricular fibrillation be detected with 100% sensitivity. Incumbent with the need for such a high sensitivity is a trade-off that results in diminished ventricular fibrillation detection specificity, which in turn results in unnecessary delivery of high-energy shocks. In this review we look in generic terms at the different lead and detection systems available and the effect of these systems on both undersensing and oversensing of ventricular fibrillation. In addition, several clinical and programming issues that affect sensitivity and specificity of ventricular fibrillation detection are reviewed.
Implantable cardioverter defibrillators (ICDs) detect and defibrillate ventricular fibrillation (VF) and ventricular tachycardia (VT). Other therapies which use less energy are also available to terminate VT. Previous studies have shown that ICD rate schemes often misdiagnose VT as VF. In this study, an improved VF classification scheme was designed and tested, which employs the classic rate criteria plus paired signal concordance (PSC); PSC uniquely detects VF where VT and VF rates overlap (220-340 ms). Two signals from a bipolar pair (1 cm) recorded in a unipolar sense exhibit similar signal shape for concordant rhythms, such as sinus rhythm and VT, and disconcordance for VF. Once the rate criterion is met, PSC is measured by the peak normalized cross-correlation coefficient calculated over the depolarization. Variability, measured by a modified range, determined the contextual diagnosis over a passage. Sinus rhythm (20), VT (12), VF (22), atrial fibrillation (10), sinus rhythm with ventricular premature depolarizations (7), and polymorphic VT (4) passages were recorded from 38 patients. Rate-PSC was tested with unfiltered, digitized signals (1-500 Hz, 1,000 samples per second) and with filtered, downsampled signals (1-50 Hz, 100 samples per second). Sensitivity values, or percentage of correct VF detection, and specificity values, or detection of all other rhythms, were generated and compared with simulations of three commercial ICDs programmed to similar settings as rate-PSC and to nominal settings. The sensitivity values for rate-PSC with unfiltered and with filtered signals and for ICDs with 220 ms and with nominal settings were 100%, 100%, 48-80%, and 100%, respectively; the corresponding specificity values were 95%, 83%, 93%, and 7-13%, respectively. It was concluded that the rate-PSC scheme was able to reliably separate VF from other rhythms, even rhythms that have a variable morphology or variable rate. With the confidence of accurate VF detection, use of low-energy therapies for non-VF rhythms will increase device longevity and enhance patient comfort.
Implantable cardioverter defibrillators (ICDs) have evolved from the treatment of last resort to the gold standard therapy for patients at high risk for ventricular tachyarrhythmias. High-risk patients include those who have survived life-threatening arrhythmias, and individuals with cardiac diseases who are at risk for such arrhythmias, but are symptomless. Use of an ICD will affect the patient's quality of life. Some drugs can substantially affect defibrillator function and efficacy, and possible drug-device interactions should be considered. Patients with ICDs may encounter cell phones, antitheft detectors, and many other sources of potential electromagnetic Interference. In addition to treating ventricular tachyarrhythmias, new defibrillators provide full featured dual chamber pacing, and could treat atrial arrhythmias, and congestive heart failure by means of biventricular pacing.
Implantable cardioverter defibrillators (ICDs) are available with independently programmable duration and tilt of the shock pulse waveform. Manufacturers do not, however, commonly advise how these parameters can be programmed for optimal clinical benefit. From theoretical considerations, the author recommends programming both parameters based on the measured lead system resistance R into which the shock is delivered. Assuming that the defibrillation pulse decline below the defibrillation threshold rheobase is undesirable because of the possibility of refibrillation. Mathematical relationships expressing optimal pulse duration and tilt as functions of the output time constant can be derived that are valid for monophasic pulses and the first phase of biphasic pulses. Two ICD manufacturers provide for programmable tilt (Medtronic GEM III, atrial channel) or both tilt T and pulse duration PD. (St. Jude Medical newest devices). Considering its output capacitance, it is recommended that the Medtronic Gem III should be programmed for T = 50% when R < 75 omega and 65% when R < 38 omega. The author considers programming tilt to 30% or 40% useless in clinical conditions. By the same reasoning, he recommends that the newer St. Jude Medical ICDs should be programmed to T = 50% if R < 75 omega and 60% if R < 41 omega, and PD = 5.5, 5.0, 4.5, 4.0, 3.5, and 3.0 ms for R < 75, 73, 62, 51, 40, and 32 omega, respectively. PD = 6 ms was considered clinically unrealistic. Programmable shock pulse duration and tilt are useful in optimizing defibrillation, but it is suggested that this can best be accomplished by programming these parameters with the guidance of theory as described in this discussion.
Implantable cardioverter defibrillators (ICDs) have become an important therapeutic modality for patients who have had a cardiac arrest or are at risk for life-threatening ventricular arrhythmias. Clinical trials have confirmed the role of the ICD for patients with sustained ventricular arrhythmias and have expanded the indications to include patients with coronary artery disease, left ventricular dysfunction, nonsustained ventricular tachycardia, and inducible ventricular tachycardia. Numerous technologic advances in ICDs have resulted in decreased size, greater ease of placement, and increased functionality. Important advancements have been made in the effectiveness of arrhythmia classification and electrogram storage. Dual-chamber ICDs have become increasingly sophisticated with rate-adaptive sensors. Biventricular pacing is being combined with ICD function in patients with heart failure, systolic dysfunction, and QRS widening. Future advances in devices will likely lead to improved arrhythmia classification, more advanced automated features, and additional features including more sophisticated sensors and biventricular pacing systems.
Today, we are facing an exponential increase in implantation of cardioverter defibrillators (ICD). The intraoperative and follow-up results are reported in 105 patients (pts) with ventricular tachyarrythmias who underwent ICD implantation in the catheterization laboratory. Fifty-seven pts (54%) hat their first ICD implant (G 1), whereas 46 pts (44%) underwent pulse generator replacement or electrode revision (2 pts, 2%) (G 2). In all pts, ICD implant or pulse generator replacement was performed under general anesthesia from the beginning. In 57/58 pts (98%) in G 1, ICD implantation was possible with a mean defibrillation threshold (DFT) of 13 +/- 8 joules. One patient hat a DFT of > 25 joules and ICD implantation was not achieved. This patient underwent epicardial lead implantation 1 day later. One patient in G 1 had a vessel rupture (v. subclavia) intraoperatively. During a mean follow-up of 5 +/- 2 (< 1-13) months, three pts (3%) died from congestive heart failure, 2, 4 and 6 months after device implantation. An infection occurred in 1 patient in G 2, 3 months after generator replacement. Our data show that in the majority of patients ICD implantation in the cath-lab is possible, safe, and the complication rate is low. Therefore, ICD implantation in the cath-lab can generally be recommended.
BACKGROUND: The Multicenter Unsustained Tachycardia Trial (MUSTT) was designed to evaluate an antiarrhythmic treatment strategy, including drugs and implantable defibrillators (ICDs), guided by electrophysiological (EP) testing. We performed several statistical analyses to assess the contribution of defibrillators to the observed treatment benefit. METHODS AND RESULTS: First, the effects of defibrillators were indirectly examined by comparing the randomized treatment arms (EP-guided therapy versus no antiarrhythmic therapy) within subgroups that varied according to ICD usage. Use of ICDs increased during the trial; hence, the randomized treatments were compared according to date of enrollment. There were also site-specific differences in ICD use; hence, the randomized arms were compared within groups of sites defined by level of ICD use. There was a distinct "dose response" in relation to ICD use. Where ICD use was high, EP-guided therapy produced significant reductions in arrhythmic death or cardiac arrest (P<0.004). Where ICD use was low, there was no benefit of EP-guided therapy. Finally, outcomes of EP-guided therapy patients who received an ICD were directly compared with outcomes of other patients using the Cox proportional hazards model with receipt of an ICD as a time-dependent covariate. Adjusted for other prognostic factors, patients who received an ICD had risk reductions of >70% in arrhythmic death or cardiac arrest and >50% in total mortality (P<0.001 for both end points). CONCLUSIONS: The benefit of EP-guided antiarrhythmic therapy observed in MUSTT was due to improved outcomes among patients who received an ICD but not among patients who received antiarrhythmic drugs.
Internal defibrillating leads were implanted in 6 dogs through a left thoracotomy and in 6 pigs through a subxiphoid approach. The effects of digoxin (0.04 mg per kilogram of body weight), procainamide (15 mg per kilogram), and propranolol (0.2 mg per kilogram) on the defibrillation threshold was determined 30 to 60 minutes following intravenous administration. Resultant blood levels were equal to or greater than therapeutic levels. Individually these drugs resulted in no appreciable change in the defibrillation threshold from baseline. Pathological study of the myocardium obtained from 6 dogs that underwent more than two hundred shocks each did not demonstrate any abnormality. The 6 pigs were reliably defibrillated, this indicating that thoracotomy is not required for successful implantation. The automatic implantable defibrillator is not the definitive treatment for recurrent ventricular arrhythmias, but is a practical regimen of therapy for a select group of high-risk, out-of-hospital patients. These observations advance our knowledge of the use of this device and give more assurance for future implantation in this select group of patients.
OBJECTIVES: The aim of this study was to compare complications in a large cohort of patients undergoing pectoral cardioverter-defibrillator implantation with a subcutaneous or submuscular approach. BACKGROUND: Pectoral placement of implantable cardioverter-defibrillator (ICD) pulse generators is now routine because of downsizing of these devices. subcutaneous implantation has been advocated by some because it is a simple surgical procedure comparable to pacemaker insertion. Others have favored submuscular insertion to avoid wound complications. These surgical approaches have not been compared previously. METHODS: The subjects for this study were 1,000 consecutive patients receiving a Medtronic Jewel ICD at 93 centers worldwide. Cumulative follow-up for all patients was 633.7 patient-years, with 64.9% of patients followed up for > or = 6 months. The complications evaluated were erosion, pocket hematoma, seroma, wound infection, dehiscence, device migration, lead fracture and dislodgment. RESULTS: Subcutaneous implantation was performed in 604 patients and submuscular implantation in the remaining 396. The median procedural times were shorter for subcutaneous implantation (p = 0.014). In addition, the cumulative percentage of patients free from erosion was greater for subcutaneous implantations (p = 0.03, 100% vs. 99.1% at 6 months). However, lead dislodgment was more common with subcutaneous implantations (p = 0.019, 2.3% vs. 0.5% at 6 months) and occurred primarily during the first month postoperatively. Overall, there were no significant differences in cumulative freedom from complications between groups (4.1% vs. 2.5%, p = 0.1836). CONCLUSIONS: Subcutaneous pectoral implantation of this ICD can be performed safely and has a low complication rate. This approach requires a simple surgical procedure and, compared with the submuscular approach, is associated with shorter procedure times and comparable overall complication rates. However, early follow-up is important in view of the increased lead dislodgment rate.
UNLABELLED: The pectoral approach to implantation of cardioverter/defibrillators has the aim to further simplify the implantation of transvenous defibrillation systems. The PCD 7219 D/C is a device of the fourth generation which makes the pectoral implantation feasible due to a weight of 132 g, a size of 89 x 64 x 18 mm, a volume of 83 cm3 and a surface of 108 cm2. The use of the "active-can"-system (PCD 7219 C) requires the implantation of only one right ventricular lead. The PCD 7219 D/C was implanted in 75 patients with ventricular tachyarrhythmias, the follow-up period was 12 +/- 4 (1-24) months. Subpectoral implantation was feasible in 59 patients (79%), in 55 with a left pectoral, in 4 with a right pectoral approach due to previous left-sided operation or thrombosis of the left subclavian vein. Male sex (p < 0.005), body weight (p < 0.005) and body surface (p < 0.05) were predictors of pectoral implantation. In the 45 patients (60%) with a unipolar defibrillation system ("active can") the defibrillation threshold was significantly lower compared to those with a dual lead system (9.9 +/- 6.5, 2.5-24 Joule vs. 19 +/- 4.5, 6-24 Joule p < 0.0001). In one patient with pectoral and in one patient with abdominal implantation a dislodgement of the right ventricular lead was diagnosed and an operative revision was indicated. CONCLUSION: The down-sized implantable cardioverter/defibrillator PCD 7219 D/C makes the pectoral implantation feasible in the majority of patients. The use of the "active-can"-system requires the implantation of only one right ventricular lead with significantly lower defibrillation thresholds.
A highly reliable ventricular fibrillation detector and a satisfactory electrode system for delivering defibrillating pulses to the heart play a central role in the development of an automatic implantable defibrillator suitable for clinical use. Among the four implanted electrode designs tested, the combination of an electrode placed in the superior vena cava with a conformal electrode on the apex of the heart provided satisfactory defibrillation thresholds with ease of implantation. A new sensing method is also described for which an electrogram derived from the defibrillating electrodes is used as input. A form of a density function is developed for a filtered version of the input, ventricular fibrillation being characterized by a density curve lacking a large peak occurring at a level corresponding to the baseline of the filtered signal. These ideas are being incorporated into the design of a prototype implantable defibrillator delivering pulses of 24 joules.
Implantable cardioverter defibrillators have been shown to provide similar survival benefits for patients who have left ventricular dysfunction due to ischemic heart disease and for subsets of patients who have nonischemic cardiomyopathy. Findings in this study extend these observations by showing that patients who have ischemic or nonischemic heart disease and receive implantable cardioverter defibrillators not only have comparable mortality rates but also similar tachyarrhythmia frequencies during follow-up; further, mortality and tachyarrhythmia outcomes are independent of initial arrhythmia indication.
Coronary revascularization has been suggested as sole therapy for secondary prevention of sudden cardiac arrest associated with ischemia. The use of implantable defibrillators (ICD) in combination with coronary revascularization for this patient population is unclear. Among 412 consecutive patients receiving an ICD, 23 (6%) were identified as sudden cardiac arrest survivors who were noninducible with programmed stimulation and had unstable angina or ischemia on a functional study; they underwent successful coronary revascularization. During a follow-up of 34 +/- 18 months, 10 (43%) of the 23 patients received ICD shocks (8 +/- 8 per patient, range 1 to 22 shocks), and nine of the 10 patients had syncope/presyncope associated with at least one ICD discharge. Patients with ICD discharges were compared with those without ICD discharges, and no clinical characteristics were statistically different between the two groups. In conclusion, revascularization alone may be inadequate therapy for survivors of sudden cardiac arrest associated with ischemia who are noninducible with programmed stimulation, and clinical variables cannot predict which patients are likely to have recurrent malignant ventricular arrhythmias.
Twenty-seven consecutive patients with refractory ventricular arrhythmias were investigated for implantation of an nonthoracotomy cardioverter-defibrillator lead system. Supply with a nonthoracotomy lead system could be achieved in 25 of 27 patients (92.5%), while implantation proved impossible in two patients due to elevated defibrillation thresholds. After implantation of an endocardial defibrillation electrode no differences were found compared to the implantation of an endocardial defibrillation electrode with a subcutaneous chest wall defibrillation patch with regard to the defibrillation thresholds obtained for monophasic defibrillation waveform. Supply with an endocardial defibrillation lead system was successful in 18 of 25 patients (72%). Ten consecutive patients with implantation of an endocardial defibrillation lead system alone were compared for defibrillation efficacy following monophasic and biphasic defibrillation waveforms. Defibrillation with biphasic waveforms led to a decrease in the necessary defibrillation energy from 19 J (4.6 J) to 10 J (4.0 J). There was occurrence of refractory ventricular fibrillation that could not be controlled by endocardial and transthoracic defibrillation in two patients during the intraoperative testing of defibrillation thresholds. In both cases these arrhythmias could be terminated by the described method of endocardial/extrathoracic defibrillation (200 J). Further perioperative complications were not observed. Over a mean follow-up of 6.8 (1-17) months all patients demonstrated regular functioning of the cardioverter-defibrillator. Dislocation of defibrillation electrodes did not occur. Implantation of a cardioverter-defibrillator can be performed without thoracotomy in the majority of cases. The use of defibrillator systems with biphasic waveform widens the scope for implantation of nonthoracotomy defibrillating lead systems.
BACKGROUND: Intraoperative testing and defibrillation threshold determination may jeopardise patients, scheduled for implantation of a cardioverter-defibrillator (ICD). The purpose of this study was the assessment of the influence of consecutive defibrillation attempts on left ventricular systolic and diastolic function by means of transoesophageal echocardiography (TEE). METHODS: Eighteen patients with malignant ventricular arrhythmias that were resistant to antiarrhythmic drugs were monitored with TEE before, during and after implantation of a cardioverter-defibrillator. Left ventricular fractional area contraction as a measure of ejection fraction was assessed before and after each defibrillation attempt. Transmitral and right upper pulmonary venous flow parameters were evaluated before and after the whole implantation procedure. RESULTS: Adequate data were available in 14 patients during 4 consecutive attempts. No major alterations were observed in heart rate or fractional area contraction, measured at 30 s and 3 min after defibrillation. Overall, the ratio of early-to-late transmitral filling decreased significantly after the implantation procedure (from 0.91 +/- 0.12 to 0.82 +/- 0.14; P < 0.05). Systolic pulmonary venous flow velocity decreased from 0.49 +/- 0.11 to 0.41 +/- 0.10 m/s (P = 0.04); this decrease was observed in both groups. A significant increase of the atrial contraction wave (from 0.25 +/- 0.06 to 0.34 +/- 0.07 m/s; P < 0.03) was seen. Subdividing patients related to their precperative ejection fraction, a significant decrease of the early-to-late transmitral filling of the LV was revealed in patients with ejection fraction less than 35% (group 1). Also, a significantly lower systolic fraction of the pulmonary venous flow after ICD implantation in conjunction with a significantly longer diastolic flow time was shown in this patient group in comparison with patients with a preoperative ejection fraction of more than 35% (group 2). CONCLUSION: Defibrillation threshold testing of the ICD system changes LV inflow characteristics and impedes diastolic function of the left ventricle and may thus precipitate heart failure by this mechanism. No deleterious effects of threshold testing were observed with respect to fractional area contraction nor any deterioration of LV function was found in a clinically significant amount due to consecutive defibrillation attempts.