Complications of replacing implantable devices in response to advisories: a single center experience.

BACKGROUND: Advisories for implanted devices present a challenging management problem since no specific guidelines exist for device replacement under these circumstances. Since the rate and severity of complications is an important factor in the decision-making, we sought to review our experience with replacement of devices under advisory. METHODS: Medical records of patients with devices under advisory were reviewed. A total of 237 patients (age 68+/-13 years, men 71%, implantable cardioverter-defibrillator (ICD) 87%) underwent device replacement in response to advisories (Medtronic Inc. 43% and Guidant Inc. 57%) at our institution between February 2005 and June 2006. RESULTS: The mean time from original device implantation to replacement was 31+/-16 months (3-73 months). During a mean follow-up of 198+/-103 days, there was a 5.5% overall rate of complications related to the procedure. Major complications requiring re-operation affected 2.1% of patients. There were no deaths associated with device replacement. Device failure prior to replacement was documented in 1.7% of patients, with syncope occurring in one patient. A history of diabetes mellitus (23%), peripheral vascular disease (4%), obstructive lung disease (7%), end-stage renal disease (2%), or use of anticoagulation (44%) did not predict the occurrence of complications after advisory device replacement. CONCLUSION: This single center experience shows a lower major complication rate from replacement of devices under advisory than previously reported. Experience from this center and others may be useful in guiding future management of patients in the setting of device advisories.

Atrioventricular nodal reentrant tachycardia associated with idiopathic ventricular tachycardia: clinical and electrophysiologic characteristics.

BACKGROUND: Case reports have described the coexistence of ventricular tachycardia (VT) and supraventricular tachycardia in the same patient. This study examines the frequency of dual atrioventricular nodal (AVN) physiology, AVN echo beats, and atrioventricular nodal reentrant tachycardia (AVNRT) in patients with VT. METHODS: Programmed atrial and ventricular stimulation was performed in 132 consecutive patients referred for electrophysiologic study of symptomatic VT. Of the 132, 99 patients had structural heart disease, and 33 patients had idiopathic ventricular tachycardia (IVT). RESULTS: Among the 33 patients with IVT, 23 had dual AVN physiology. Compared with patients with structural heart disease undergoing VT ablation, dual AVN pathways (70% vs 27%, P < .0001), dual AVN pathways with echo beats (24% vs 8%, P = 0.03), and AVNRT (21% vs 1%, P = .0002) were more common in patients with IVT. CONCLUSION: Dual AVN physiology and AVNRT appear to be associated with IVT. This finding suggests that patients with IVT should undergo a complete electrophysiologic evaluation, and the diagnosis of coexistent AVNRT should be considered in this population.

Simultaneous atrial and ventricular anti-tachycardia pacing as a novel method of rhythm discrimination.

OBJECTIVE: To evaluate a new discrimination algorithm for supraventricular (SVT) and ventricular (VT) tachycardias, based on the response to simultaneous (A+V) atrial (A) and ventricular (V) anti-tachycardia pacing (ATP). METHODS: Patients undergoing electrophysiological testing or dual-chamber implantable cardioverter-defibrillator (ICD) implantation were enrolled (N = 32) and underwent A+V ATP through a Marquis ICD with investigational software. If persisting after ATP, the rhythm was classified as VT if the first electrical event was sensed on the V channel and as an SVT otherwise. RESULTS: Arrhythmia sequences (N = 275; 53 VT; 222 SVT) were analyzed in 26 patients (age = 51 +/- 17 years, 13 men, LVEF = 0.49 +/- 0.14). In response to A+V ATP, 55% of SVT versus 41% of VT episodes were terminated (P = NS). Termination of VT but not of SVT was more likely with faster (50% at ATP/arrhythmia cycle length (CL) = 0.81 vs 8% at ATP/arrhythmia CL = 0.88, P = 0.02) but not with longer ATP bursts (P = NS). Of the 115 arrhythmias that persisted after A+V ATP, the algorithm correctly classified 24 of 24 VT (GEE-adjusted sensitivity = 100%) and 85 of 91 SVT (GEE-adjusted specificity = 93%). Proarrhythmia was noted after two A+V ATP, in the form of atrial fibrillation induction and VT acceleration. CONCLUSIONS: We describe a new algorithm that can discriminate between SVT and VT with a high sensitivity and specificity. This form of ATP can terminate 55% of SVT sequences. The performance of this new algorithm merits further testing in a large population of dual-chamber ICD patients.

Renal insufficiency predicts the time to first appropriate defibrillator shock.

BACKGROUND: Indications for implantable cardioverter defibrillator (ICD) implantation are expanding, but many primary and secondary ICD trials have excluded patients with advanced renal insufficiency. We investigated the effect of renal function on the incidence and time to first appropriate ICD shock. METHOD: We analyzed data from all new ICD implantations at a tertiary care center from July 2001 to December 2002. RESULTS: During a mean follow-up time of 445 +/- 285 days, 29 (13%) of 230 patients (age 63 +/- 14 years, 79% men, 77% white, 75% coronary artery disease, left ventricular ejection fraction 0.28 +/- 0.14) received 41 appropriate shocks. Patients were divided into tertiles according to their serum creatinine level. The 1-year incidence of appropriate ICD shock was 3.8%, 10.8%, and 22.7% in the first, second, and third tertiles, respectively (P = .003). Using the same cut off values of serum creatinine, the 1-year incidence of appropriate ICD therapy (shock and antitachycardia pacing) was 8.8%, 20.8%, and 26.3% (P = .02). After correcting for age, sex, race, left ventricular ejection fraction, indication for ICD implantation, and use of beta-blockers in a Cox regression model, serum creatinine was still an independent predictor of the time to first appropriate ICD shock (hazard ratio 6.0 for the third compared with the first tertile, P = .001). CONCLUSION: Renal insufficiency is a strong predictor of appropriate ICD shocks. Defibrillator therapy should therefore not be withheld based on the presence of this comorbidity. The mechanisms underlying the relationship between renal function and ventricular arrhythmias deserve further investigation.

Biventricular pacing reduces ventricular arrhythmic burden and defibrillator therapies in patients with heart failure.

BACKGROUND: Cardiac resynchronization therapy (CRT) has recently emerged as a new modality for the treatment of patients with advanced heart failure (HF). HYPOTHESIS: Cardiac resynchronization therapy reduces atrial and ventricular arrhythmia burdens. METHODS: We analyzed the clinical data of patients who underwent an upgrade from a dual-chamber to a biventricular implantable cardioverter-defibrillator (ICD) at a tertiary care center. RESULTS: Nineteen patients (age 67 +/- 10 years, 18 men, left ventricular [LV] ejection fraction 0.24 +/- 0.07) underwent an upgrade to CRT-ICD. The LV lead was placed in a lateral position in 11, posterolateral in 4, and anterolateral in 3 patients. Baseline New York Heart Association class of HF improved in 11 (58%) patients who were considered "responders." After adjusting for the duration of follow-up before and after the upgrade, the number of patients receiving any ICD therapy decreased significantly from 13 to 4 (p = 0.004) and the total number of therapies decreased from 72 to 17 (p = 0.067). Also, the number of detections of sustained ventricular arrhythmias decreased from 40 to 11 episodes (p = 0.05), but the decrease in the number of detected supraventricular arrhythmias and mode switch episodes was not significant. The reduction in the ventricular arrhythmia load was independent of whether or not the patient responded to CRT. CONCLUSION: Our data suggest that CRT reduces ventricular but not atrial arrhythmia burden in patients with HF irrespective of their clinical response. This suggests that the reduction in arrhythmia is primarily an electrical phenomenon. Further studies are needed to confirm these findings and to uncover their underlying mechanisms.

Relation of advanced heart failure symptoms to risk of inappropriate defibrillator shocks.

Inappropriate implantable cardioverter-defibrillator (ICD) shocks continue to be a major source of distress to patients and a drain on the health care system. Expanding indications for ICD implantation include a large portion of patients with heart failure. This study investigated the relation between inappropriate ICD shocks and the severity of heart failure symptoms. Predictors of the time to first inappropriate ICD therapy were investigated in 230 consecutive patients implanted in 2001 and 2002. Thirty-two patients received 42 inappropriate shocks during a median follow-up of 501 days. Inappropriate shocks were due to atrial fibrillation (AF) or tachycardia (n = 31), other supraventricular tachycardias (n= 6), sinus tachycardia (n = 3), and noise or double counting (n = 2). The time to first inappropriate ICD shock was earliest in patients with advanced classes of heart failure (1- and 2-year shock-free survival of 79% and 70% for patients in New York Heart Association [NYHA] class III or IV vs 92% and 88% for patients in NYHA class I or II, respectively, p = 0.02). After correcting for age, gender, the presence of coronary artery disease, the presence of AF, the use of beta blockers, and indication for ICD implantation in a Cox regression model, advanced heart failure (NYHA class III or IV) remained an independent predictor of first inappropriate ICD shocks (hazard ratio 2.7, p = 0.01). Other predictors of the time to first inappropriate ICD shock included the presence of AF as the baseline rhythm at the time of the ICD implantation and the absence of coronary disease. In conclusion, inappropriate ICD shocks are predominantly due to AF. Advanced heart failure is an independent predictor of the time to first inappropriate ICD shocks. The effect of ICD programming and antiarrhythmic drug therapy on the incidence of inappropriate shocks deserves further investigation.

Indications for internal cardioverter defibrillator implantation predict time to first shock and the modulating effect of beta-blockers.

BACKGROUND: Patients receive implantable cardioverter defibrillator (ICD) for varying indications. Whether these indications influence the time to first ICD shock is suspected but not confirmed. The modulating effect of beta-blockers on shock-free survival is not fully elucidated. METHOD: A retrospective analysis of 230 consecutive patients (age 63 +/- 14 years, 79% men, 75% ischemic, 70% beta-blockers) implanted with an ICD was performed. Patients were divided into 4 groups depending on the ICD indication: groups A (secondary prevention of sudden death), B (left ventricular ejection fraction < or = 35% and positive electrophysiology study [EPS]), C (left ventricular ejection fraction < or = 35% and negative EPS or no EPS performed), and D (patients who did not meet inclusion criteria for groups A, B, or C). Time to shock was analyzed by the Kaplan-Meier method. RESULTS: During a mean follow-up of 489 +/- 280 days, 57 (24.7%) patients received 82 shocks (49% appropriate). The 1-year shock-free survival for patients in groups A, B, C, and D were 57%, 77%, 79%, and 91%, respectively (P = .03), for total shocks and 75%, 92%, 92%, and 100%, respectively (P = .007), for appropriate shocks. For patients in group A, the use of beta-blockers increased the 1-year shock-free survival from 48% to 61% for total shocks and from 65% to 79% for appropriate shocks. CONCLUSION: Time to first shock is determined by the indication for ICD implantation and is not predicted by the results of EPS. Patients with secondary indications for ICD implantation are at highest risk of shocks and may deserve consideration for prophylactic antiarrhythmic drugs. beta-Blockers increase the time to first ICD shock in patients implanted for secondary prevention of sudden death.

Utilization of implantable cardioverter-defibrillators in survivors of cardiac arrest in the United States from 1996 to 2001.

OBJECTIVES: We analyzed the incidence of implantable cardioverter-defibrillator (ICD) therapy in survivors of cardiac arrest (CA) in the U.S. from 1996 through 2001. BACKGROUND: Cardiac arrest is a class I indication for ICD therapy. The current patterns of ICD utilization in survivors of CA have not been fully examined. METHODS: We searched a representative sample of all hospital discharges for patients admitted with the primary diagnosis of CA who survived to hospital discharge. Patients with a concomitant diagnosis of acute myocardial infarction or previous ICD in situ were excluded. RESULTS: From 1996 to 2001, 113,262 patients were admitted for CA. Of those, 63,745 (56.3%) did not survive to hospital discharge. Of the remaining 49,517 patients, 30.7% received an ICD before discharge, with a gradual increase in implantation rates from 1996 (23.6%) to 2001 (46.3%). Using logistic regression for the years 2000 and 2001, patients who were discharged without an ICD were older (odds ratio [OR] 0.93 for every 10-year increase in age, p < 0.001), more likely to be African American (OR 0.19, p < 0.001), and more likely to be admitted to a smaller hospital (OR 2.24 for each additional 100 beds, p < 0.001). These predictors were independent of other co-morbid illnesses. CONCLUSIONS: Although they are increasing, the rates of ICD therapy after CA remain very low. There are gross discrepancies by race. At a time when newer indications for ICD implantation are emerging, efforts should be focused on identifying the causes of this underutilization and discrepancies in survivors of CA.

Selected patients listed for cardiac transplantation may benefit from defibrillator implantation regardless of an established indication.

BACKGROUND: End-stage heart failure (HF) patients are at high risk of sudden cardiac death. This study evaluates the role of implantable cardiac defibrillators (ICDs) in HF patients awaiting cardiac transplantation. METHODS: We identified 194 consecutive patients (age 51 +/- 12 years) with New York Heart Association Class 3 or 4 HF (ejection fraction 22 +/- 9%) listed for cardiac transplantation, 35 of whom underwent ICD implantation. Of the implanted patients, 16 (Group A) had an established indication for ICD implantation (cardiac arrest, n = 10; sustained ventricular tachycardia [VT], n = 3; and positive electrophysiology study, n = 3). Nineteen patients (Group B) underwent ICD implantation for non-established indications (syncope with non-ischemic cardiomyopathy, n = 4; non-sustained VT, n = 15). There were no procedural complications from ICD implantation. RESULTS: During follow-up of 9.2 +/- 10.1 months, there were 3 deaths in the ICD groups (A and B), and 40 in the control group (8.6% vs 25.2%, p = 0.032). Five patients in Group A and 6 in Group B (31%) received appropriate ICD therapy. The number of therapies per patient and the time to the first shock were similar between Groups A and B. Four of 6 Group B patients on outpatient inotropic therapy (67%) received appropriate ICD therapy. CONCLUSIONS: Selected end-stage heart failure patients awaiting heart transplantation, including those without established ICD indications, are at high risk for malignant arrhythmias and may benefit from ICD implantation. Patients with ICD seem to have improved survival compared to those without ICD. Randomized prospective studies are needed to confirm these findings.

Variable electrocardiographic characteristics of isthmus-dependent atrial flutter.

OBJECTIVES: The purpose of this study was to characterize variations in flutter-wave (F-wave) morphology among patients with clockwise isthmus-dependent (CWID) and counterclockwise isthmus-dependent (CCWID) right atrial flutter (AFL) and to attempt to correlate F-wave morphology with echocardiographic data and clinical patient characteristics. BACKGROUND: Variations in F-wave morphology on surface electrocardiogram (ECG) during CCWID and CWID flutter have been reported but never systematically characterized. METHODS: Over a four-year period, 139 patients with AFL on ECG underwent electrophysiologic study and echocardiography at our institution. Electrocardiographic data, intracardiac recordings, echocardiographic data, and patient characteristics were reviewed retrospectively. RESULTS: Of 156 AFLs evaluated, 130 were CCWID, 26 were CWID. Three types of CCWID flutter were observed: type 1 had purely negative F-waves inferiorly, types 2 and 3 had F-waves inferiorly with small (type 2) or broad (type 3) positive terminal deflections; CCWID flutter types 2 and 3 were associated with higher incidence of left atrial (LA) enlargement, heart disease, and atrial fibrillation (Afib) than type 1. Two types of CWID flutter were observed: type 1 had notched positive F-waves with a distinct isoelectric segment inferiorly. Type 2 had broader F-waves inferiorly with positive and negative components and a short isoelectric segment. CONCLUSIONS: Variable ECG patterns for CCWID and CWID AFL exist. A positive component of the F-wave in the inferior leads during CCWID flutter is associated with an increased likelihood of heart disease, Afib, and LA enlargement.