Late retesting of system performance in ICD patients without spontaneous shocks.

UNLABELLED: One hundred five implantable cardioverter defibrillator (ICD) patients (71 +/- 9 years of age, 83% men) without spontaneous ICD discharges for > or = 12 months were tested to assess high voltage (HV) circuit integrity and the system's ability to recognize and terminate ventricular fibrillation (VF). Indications for ICD implantation were sustained ventricular tachycardia (VT) (35%), cardiac arrest (27%), and inducible VT (38%). Eighty-two percent of the patients had coronary artery disease (CAD), and the mean left ventricular ejection fraction (LVEF) was 36% +/- 13%. RESULTS: One hundred patients had inducible VF and five did not. Testing led to ICD reprogramming in 50 (49%) patients. Two (1.9%) patients required ICD replacement: (1) a 45-year-old patient with a Ventritex 110 ICD implanted for 13 months interfaced with a CPI 0062 lead implanted for 46 months could not be defibrillated internally (impedance nonmeasurable); (2) an 82-year-old patient with a 23-month-old Medtronic 7219 ICD interfaced with 6936 and 6933 leads whose defibrillation threshold (DFT) had doubled since implantation (24 J from 12 J). Lead fractures were found in both cases (proximal coil of the 0062, and subcutaneously in the 6933). Based on DFT determinations, the first shock output was programmed lower in 37 patients and higher in 10 patients. Shock pulse width was changed in one patient and the ventricular refractory period in another. No programming changes were made in 54 (51%) patients. CONCLUSIONS: (1) Late testing of HV circuit integrity in ICD patients without an ICD shock in > or = 12 months identifies previously unsuspected HV lead fractures; (2) chronic DFT testing resulted in HV output reprogramming in one-half of the patients.

Predischarge arrhythmia induction testing of implantable defibrillators may be unnecessary in selected cases.

Complete postoperative evaluation of implantable cardioverter-defibrillators (ICDs) before discharge, including arrhythmia induction, has been the standard since their introduction. Whereas the original ICDs provided little telemetered information and used separate pace-sense and defibrillation leads, modern, third-generation devices provide pace-sense function information in addition to other data and are used in conjunction with integrated transvenous endocardial leads that combine pace-sense and defibrillation function. Changes in lead position, which can potentially result in either an inability to detect fibrillation or to terminate it, should be mirrored by changes in resting pace-sense function. Thus, for newer ICDs implanted with integrated endocardial lead systems, it is possible that in at least some cases predischarge arrhythmia inductions can be avoided. Two hundred patients receiving third-generation ICDs in conjunction with integrated transvenous leads were evaluated before discharge. Defibrillation detection or termination problems were seen in 8. Declines in resting R-wave amplitude and pacing impedance were significantly associated with such complications (-7 +/- 5 vs -0.3 +/- 2.3 mV [p <0.0001] and -158 +/- 138 vs -93 +/- 76 omega [p <0.05], for those with vs without complications, respectively), as were gross right ventricular lead migrations on chest x-ray. No patient with a defibrillation complication had an R-wave change of <3 mV. However, 13% of patients without complications had R-wave changes of >3 mV. It is concluded that a pace-sense evaluation of ICDs may be a satisfactory screen to determine those who need to go on to complete testing with arrhythmia induction in selected cases.

The implantable cardioverter defibrillator: modern implantation techniques and their impact on outcomes.

The implantable cardioverter defibrillator has revolutionized the management of lethal ventricular arrhythmias in susceptible patients. In its second decade of existence, the implantable cardioverter defibrillator has undergone significant technologic enhancements which have resulted in ease of implantation, lower mortality rates, and shorter hospital stays. The newer pectoral size devices have been successfully implanted in a variety of patients, using models from several device manufacturers. Improvements in lead technology have paralleled those of the device itself. These include the unique concept of "unipolar" defibrillation as well as the trend toward dual chamber lead systems. Results of these newer technologies are favorable: comparably low defibrillation thresholds have been reported with the newer lead configurations, with lower operative mortality. However, morbidity attached to earlier lead systems remains as high as 16%. It is anticipated that the results will further improve as shorter transvenous leads and better connector material become routinely available. Finally, the clinical outcomes in the early postoperative phase indicate fewer proarrhythmic effects leading to shorter hospital stays in patient equipped with the latest types of pectoral implants. Continued progress at the level of the patient-device interface is expected to result in every better patient acceptance and proliferation of implantable cardioverter defibrillator therapy.

Initial clinical experience with a dual lead endocardial defibrillation system with atrial pace/sense capability. United States and Canada Enguard Investigations.

Ninety-three patients underwent implants of the Telectronics Model 4211 ICD attached to the Enguard PFX endocardial defibrillation lead system. Eighty-one males and 12 females ranging in age from 25-85 years (mean = 64). Coronary disease was the substrate in the majority (88%); mean left ventricular ejection fraction was 30%. VT was present in 66%, VF in 22%, and both in 7%. Three lead configurations were used in the study: ventriculo-atrial (U1, 86%); bidirectional (B2, 12%); and ventricular to patch (U2, 2%). Mean RV pacing thresholds were 0.46 V pre- and 0.54 V posttesting, with no significant differences between the two. Mean R wave voltage was 11.05 mV pre- and 11.72 mV posttesting, also not significantly different. A subgroup of 13 patients had mean atrial pacing thresholds of 0.59 V at 0.5 msec pulse width, with mean P waves of 4.01 mV. Mean defibrillation threshold for the entire group was 10.6 J using biphasic waveforms. Defibrillation thresholds by configuration were: 399 V (U1); 475 V (U2); and 350 V (B2). All patients but one had thresholds < 550 V in at least one configuration. The 4211/Enguard system was implanted without (86%) or with (14%) a subcutaneous patch electrode. Early postoperative findings related to the ICD system include: one device circuit failure, one early lead dislodgement, and one pacing exist block.(ABSTRACT TRUNCATED AT 250 WORDS)

Cost and length of hospital stay: comparisons between nonthoracotomy and epicardial techniques in patients receiving implantable cardioverter defibrillators.

Twenty-five patients with implantable cardioverter defibrillators (ICDs) implanted intrathoracically (group I) were compared with 25 patients who underwent implant using the nonthoracotomy approach (group II). All systems were implanted by the same medical team, in the same high volume implanting center. Indications for implantation were comparable in both groups. Patient characteristics were not statistically different with the exception of age (66-group I vs 71-group II; P < 0.05). Although left ventricular ejection fractions appeared to differ (32% vs 37%, respectively), this difference was not statistically significant (P = 0.06). ICD models used in group I were: Ventritex Cadence (16), Telectronics Guardian 4211 (2), Medtronic PCD (7); in group II they were: Ventritex Cadence (15), Guardian 4211 (2), and CPI 1600 (1). Total length of hospital stay was 16 +/- 6 days for group I versus 12 +/- 5 for group II (P < 0.05). Number of postoperative days in an intensive care unit was 3.2 +/- 2.8 for group I versus 0.5 +/- 0.6 for group II (P < 0.0001). Postoperative length of stay was 8.2 +/- 3.1 for group I versus 5.7 +/- 4.4 for group II (P < 0.001). Mean total hospital charges for the entire length of stay were $72,918 +/- $26,770 in group I versus $55,031 +/- $42,870 in group II, representing a mean reduction of 21% in global costs for group II patients. These data confirm that nonthoracotomy ICD implantation in an experienced center is associated with significantly shorter hospital stays, a virtual elimination of the need for postoperative intensive care, and globally lower total hospital costs. In addition, the presence of a statistically older population in group II does not negate these beneficial effects.

Exacerbation of ventricular arrhythmias during the postoperative period after implantation of an automatic defibrillator.

The postoperative course of 68 consecutive patients treated with an implantable defibrillator during the period from 1982 through 1990 was studied. In 46 patients (group 1), no concomitant surgery was performed during the implantation. In 22 patients (group 2), concomitant surgery (coronary artery bypass [n = 12], valve replacement [n = 3] or arrhythmia surgery [n = 7]) was performed. All patients in group 1 were clinically stable before surgery, receiving an antiarrhythmic regimen chosen by serial drug testings. The same regimen was continued postoperatively. Eight of the 46 patients in group 1 whose condition had been stable in the hospital for 19 +/- 25 days preoperatively developed multiple episodes of sustained ventricular tachycardia 4 +/- 9 days after implantation while receiving the same antiarrhythmic regimen. Although the exacerbation was transient in some patients, six required different antiarrhythmic therapy and one eventually died. Two additional patients had frequent and prolonged episodes of nonsustained ventricular tachycardia that could trigger the defibrillator, requiring changes in the antiarrhythmic regimen. Another patient had progressive cardiac failure and died on day 5. A marked (sevenfold) increase in asymptomatic ventricular arrhythmias was noted in 42% of the remaining 35 patients. In group 2 (combined surgery), one patient developed refractory ventricular tachycardia 3 days postoperatively and died on that day. Three patients developed frequent nonsustained ventricular tachycardia postoperatively, requiring changes in the antiarrhythmic regimen. The overall surgical mortality rate was 4.4% (4.3% in group 1 and 4.5% in group 2) and was due to refractory ventricular tachycardia in two patients and cardiac failure in one.(ABSTRACT TRUNCATED AT 250 WORDS)

Retrograde (ventriculoatrial) conduction in congenital complete heart block.

Retrograde ventriculoatrial (VA) conduction is documented at the time of dual chamber pacemaker implantation in a 36-year-old patient with congenital complete atrioventricular (AV) block. Programmed ventricular stimulation with stimuli of increasing prematurity demonstrated a lack of decremental conduction via a unidirectional retrograde pathway. Because retrograde VA conduction has been associated with pacemaker mediated endless loop tachycardia, the status of retrograde conduction should be assessed in all patients undergoing dual chamber pacemaker implantation, including those with congenital complete AV block who have previously been considered to have no conductive tissue between atria and ventricles.

Benefits of implantable defibrillators are overestimated by sudden death rates and better represented by the total arrhythmic death rate.

Benefits of the implantable defibrillator on survival were studied in 56 consecutive patients (concomitant coronary bypass or arrythmia surgery in 15) during an 8 year period between 1982 and 1990. During a follow-up period of 29 +/- 25 months, six patients had a sudden death and eight patients had a nonsudden cardiac death. Nonsudden cardiac deaths included three surgical deaths (death within 30 days after the surgery; two in patients without and one in a patient with concomitant cardiac surgery), one arrhythmia-related nonsudden death (death within 24 h after an arrhythmic event despite initial termination of the arrhythmia by the implantable defibrillators) and four nonarrhythmic cardiac deaths. The actuarial survival rate free of events at 1, 2 and 3 years was 96%, 96% and 92%, respectively, for sudden death, 91%, 91% and 87% for sudden death and surgical mortality and 89%, 89% and 85% for total arrhythmic death (sudden death, surgical mortality and arrhythmia-related nonsudden death). Thus, in patients treated with an implantable defibrillator, 1) the rate of sudden death is low (8% at 3 years); 2) 50% of nonsudden cardiac deaths are causally related to arrhythmia (surgical mortality or arrhythmia-related nonsudden death); 3) the total arrhythmic death rate is substantially higher than the sudden death rate; and 4) benefits of an implantable defibrillator are overestimated by reported sudden death and nonsudden cardiac death rates. The benefits may be better represented by the total arrhythmic death and nonarrhythmic cardiac death rates.