James A. Roth

Influence of left ventricular function on outcome of patients treated with implantable defibrillators.

Background The outcomes of patients treated with implantable defibrillators were compared between patients with left ventricular ejection fraction ≥30% and <30%. Methods and Results Of 68 consecutive patients treated with implantable defibrillators, 40 patients (group 1) had left ventricular ejection fraction ≥30%, and 28 patients (group 2) had left ventricular ejection fraction <30%. Sudden death, surgical mortality, nonsudden arrhythmia-related death (death within 24 hours after an arrhythmic event despite initial termination of the arrhythmia by the implantable defibrillator), total arrhythmia-related death (including sudden death, surgical death, and nonsudden arrhythmia-related death), and total cardiac death were compared between the two groups. Surgical mortality was 4.4% (09% in group 1, 11% in group 2). During the follow-up of 31±27 months, actuarial survival rates free of events were 97%, 97%, and 97% in group 1 and 96%, 91%, and 82% in group 2 at 12, 24, and 36 months, respectively, for sudden death (p = NS); 97%, 97%, and 97% in group 1 and 85%, 81%, and 72% in group 2 at 12, 24, and 36 months, respectively, for sudden death and surgical mortality (p < 0.05); 97%, 97%, and 97% in group 1 and 82%, 78%, and 709% in group 2 at 12, 24, and 36 months, respectively, for total arrhythmia-related death (p < 0.05); and 95%, 95%, and 95% in group 1 and 82%, 69%, and 57% in group 2 at 12, 24, and 36 months, respectively, for total cardiac death (p < 0.05). Four (57%) of seven nonsudden cardiac deaths during the initial 36-month follow-up period were causally related to arrhythmia (three surgical deaths and one arrhythmia-related nonsudden death). Conclusions The outcome of patients treated with implantable defibrillators is strongly influenced by the degree of left ventricular dysfunction. In group 1 patients, surgical mortality, sudden death, and total cardiac death are rare. In group 2, sudden death rate may not be markedly different from that of group 1 patients. However, the risk of therapy (surgical mortality) is high. Many nonsudden cardiac deaths are causally related to arrhythmia (surgical mortality or nonsudden arrhythmia-related death). Therefore, the survival rate free of total arrhythmia-related death is significantly lower in group 2 (70% versus 97% in group 1 at 3 years). Further studies are needed to determine the roles of defibrillator therapy and other therapies in various clinical settings.

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.

Comparison of clinical characteristics and frequency of implantable defibrillator use between randomized patients in the antiarrhythmics vs implantable defibrillators (avid) trial and nonrandomized registry patients

In the Antiarrhythmics Vs Implantable Defibrillators (AVID) trial, all patients who meet the study entry criteria are followed in a registry. During the period between June 1993 and June 1995, of 1,117 patients who were enrolled in the registry and met the study entry criteria, 476 were randomized to receive either implantable cardioverter-defibrillators (ICDs) or drug therapy (amiodarone or sotalol), and 641 patients were not randomized for a variety of reasons including: patient refusal (42%); physician refusal (43%); concerns about ability to maintain follow-up over several years (10%), and others (6%). There were no significant differences between the 476 randomized and 641 nonrandomized patients with regard to clinical characteristics, left ventricular function, history of congestive heart failure, medical history, and previous cardiac procedures performed before the index event, except that randomized patients were slightly older (65 vs 62 years) and had a slightly higher prevalence of coronary artery disease and previous myocardial infarction. The index event and location of the index event were not significantly different between the 2 groups. Although 14% of registry patients received neither ICD nor antiarrhythmic drug therapy, ICDs were no more frequently used in the registry patient than antiarrhythmic drugs (45% for ICD vs 42% for drugs). Thus, randomized AVID patients have very similar clinical characteristics, cardiac history, and presenting arrhythmias as to nonrandomized eligible patients. Therefore, the results of the AVID trial may be generalized for all patients with AVID-eligible arrhythmias.

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)

Long-Term outcomes and modes of death of patients treated with nonthoracotomy implantable defibrillators

Long-term outcomes of all patients who underwent nonthoracotomy implantable cardioverter-defibrillator (ICD) implantation at our institution from April 1991 to October 1994 were studied using the intention-to-treat analysis. Of 94 consecutive patients, 81 underwent nonthoracotomy ICD implantation and 13 underwent thoracotomy (for concomitant surgery in 11 and unavailability of nonthoracotomy leads in 2). Six of 81 patients had a high defibrillation threshold, 4 subsequently underwent thoracotomy, and 2 were treated with amiodarone. Surgical mortality was 0%. The duration of follow-up was 20 +/- 13 months, and was > 12 months in 74% of 67 living patients. Actuarial survival rates at 1 and 2 years were, respectively, 98% and 94% for sudden death and 91% and 83% for total mortality. Deaths during long-term follow-up were mostly due to nonsudden cardiac or noncardiac deaths. Two-year mortality rates were 12% and 25% in patients with ejection fraction > or = 30% and < 30%, respectively. Thus, instances of sudden death and surgical mortality are very few in patients with nonthoracotomy ICDs. Deaths during long-term follow-up are mostly due to nonsudden cardiac and noncardiac deaths. Therefore, ICD therapy may have greater impact on survival in patients with lower risks of nonsudden cardiac and cardiac death (e.g., younger patients with minimal heart disease) than in patients with severe cardiac or noncardiac disease. Prospective studies are needed to address this question.

Long-term stability of defibrillation thresholds with intrapericardial defibrillator patches.

From March 1982 to May 1, 1992, 105 consecutive patients underwent initial implant of cardioverter defibrillators (ICD) at our institution. Twenty‐nine patients (23 male and 6 female, average ejection fraction 32.24%) with ICD systems implanted via thoracotomy and either intra‐ or extrapericardial patches, had one or more revisions including 56 generator changes or staged implant procedures, three patch revisions, one patch lead fracture without revision, and one sensing lead revision. The time between pulse generator revisions averaged 19.5 months. Initial defibrillation threshold mean was 12.8 joules (n = 25); at first revision, 14.46 joules (n = 29), (P = NS); by fifth revision, 15.0 joules (n = 2), (P = NS). One patch was noted to be crinkled at 70 months; one patch had migrated by 39 months, and two patch leads had fractured at the costal margin by 69 and 90 months. One patient with marginal defibrillation thresholds had an additional patch placed at revision to an upgraded ICD unit. Once acceptable defibrillation threshold (DFT) is obtained, the long‐term intrapericardial DFT remains stable unless a specific problem occurs. As a small, nonstatistically significant increase in DFT may occur, caution must be exercised in patients with marginal DFTs.

Influence of left ventricular function on survival and mode of death after implantable defibrillator therapy (Cleveland Clinic Foundation and Montefiore Medical Center experience)

To determine the influence of left ventricular (LV) function on survival and mode of death in patients with an implantable cardioverter-defibrillator (ICD), sudden death, surgical mortality, total arrhythmia-related death, total cardiac death and total death were retrospectively evaluated in 377 consecutive patients. The outcomes were also compared between patients with an LV ejection fraction > or = 30% (214 patients, group 1) and < 30% (148 patients, group 2). Surgical mortality was 3.9% (1.8% in group 1, 7% in group 2). During the follow-up of 25 +/- 20 months, actuarial survival rates of all patients at 3 years were 96% for sudden deaths, 81% for total cardiac deaths and 74% for total mortality. When the 2 groups were compared, survival rates of groups 1 and 2 at 3 years, respectively, were 99 and 90% for sudden death (p < 0.05), 97 and 84% for sudden death and surgical mortality (p < 0.01), 94 and 80% for the total arrhythmia-related death (p < 0.001), 88 and 68% for total cardiac death (p < 0.0001), and 81 and 62% for total mortality (p < 0.002). In group 2, 73% of total cardiac deaths within 1 year were causally related to the arrhythmia. Thus, in patients with an ICD, sudden death rates were very low. However, total cardiac death and total death rates were relatively higher. The outcomes of patients with an ICD were strongly influenced by the degree of LV dysfunction.(ABSTRACT TRUNCATED AT 250 WORDS)

Initial Experience with Transvenous Implantable Cardioverter Defibrillator Lead Systems: Operative Morbidity and Mortality

Introduction of non‐thoracotomy lead systems™ (Medtronic, Inc.) for the implantable cardioverter defibrillator (ICD) has expanded the indications for use of this mode of therapy. Patients previously considered “too ill” to undergo a thoracotomy as well as patients who are at a high risk for developing sudden death but without previous cardiac arrest, are now considered candidates. The initial experience with the non‐thoracotomy lead system at our institution was analyzed for morbidity and mortality. Thirty‐four patients underwent attempted intravascular lead implantation, with 30 having initial successful implantation (88.2%). There were 23 males; average ejection fraction (EF) was 38.6%. Three patients developed pulmonary edema and low output immediately after the procedure. Three patients developed electromechanical dissociation during defibrillation threshold testing. A prolonged testing time for the non‐thoracotomy lead system was noted when compared to the thoracotomy system (57.39 vs 32.30 min; P < 0.0000). There were more intraoperative morbidities with the non‐thoracotomy leads than with the thoracotomy system. There were no perioperative deaths. The potential consequences of prolonged anesthesia time and extensive defibrillation threshold testing should be considered when choosing the route of ICD implant, the type of anesthesia, and the intraoperative testing protocol for each patient.

Oxypurinol Nephrolithiasis in Regional Enteritis Secondary to Allopurinol Therapy

A patient with regional enteritis and recurrent uric acid nephrolithiasis was treated with allopurinol. While on 600 mg of allopurinol daily, she began to pass many small, soft, yellow stones. Analysis of the stones by liquid chromatographic and gas chromatograph/mass spectrometric techniques revealed that their major constituent was oxypurinol, a metabolite of allopurinol. Metabolic studies of the patient indicated that increasing doses of allopurinol were associated with increases in xanthine and oxypurinol excretion, while uric acid excretion was not reduced. This case illustrates a complication of high-dose allopurinol therapy in the treatment of uric acid nephrolithiasis.

Comparison and frequency of ventricular arrhythmias after defibrillator implantation by thoracotomy versus nonthoracotomy approaches

Postoperative exacerbation of ventricular arrhythmias has been reported in some patients treated with thoracotomy implantable cardioverter-defibrillators (ICDs). This phenomenon, which may be related to epicardial patch electrodes, may be less frequent after nonthoracotomy ICD implantation. In this nonrandomized study, postoperative arrhythmias in thoracotomy approaches (n = 52) were compared with those in nonthoracotomy approaches (n = 59). Preoperatively, all patients were clinically stable receiving an antiarrhythmic regimen chosen by serial drug testing. Nine of 52 patients in the thoracotomy group developed sustained ventricular tachycardia postoperatively while receiving the same antiarrhythmic regimen chosen preoperatively, and 1 patient eventually died. Two additional patients developed frequent and prolonged episodes of nonsustained ventricular tachycardia requiring changes in the antiarrhythmic regimen. In the nonthoracotomy group, only 3 of 59 patients developed sustained ventricular tachycardia and 1 developed frequent nonsustained ventricular tachycardia. Thus, only 4 of 59 patients in the nonthoracotomy group developed clinically significant ventricular arrhythmia during the postoperative period compared with 11 of 52 patients in the thoracotomy group (p < 0.05). Surgical mortality was 6% in the thoracotomy group, and 0% in the nonthoracotomy group. In the remaining clinically stable patients, a marked (sevenfold) increase in asymptomatic ventricular arrhythmias was noted in 15 of 39 patients in the thoracotomy group, and in 3 of 55 patients in the nonthoracotomy group (p < 0.05). Thus, postoperative exacerbation of ventricular arrhythmia, sometimes noted with thoracotomy approaches, is very rare with nonthoracotomy approaches.