Safety and diagnostic yield of noninvasive ventricular stimulation performed via tiered therapy implantable defibrillators.

Extensive electrophysiological testing is critical for the effective utilization of sophisticated tachycardia detection and termination algorithms available in tiered therapy ICDs. To evaluate the safety and diagnostic yield of electrophysiological testing via noninvasive ventricular stimulation, we performed 294 electrophysiological studies in 154 patients (age 65 +/- 10; left ventricular ejection fraction 0.36 +/- 0.15) with tiered therapy ICDs. Stimulation was performed under methohexital anesthesia. A total of 918 sustained ventricular tachyarrhythmias were induced (3.1 +/- 2.5 per procedure): monomorphic VT, 550; ventricular flutter, 74; and VF, 246. The results of invasive and noninvasive programmed stimulation were compared for 79 patients who had both studies under similar treatment. Overall concordance was 83%, and did not differ significantly between patients who had the noninvasive stimulation via epicardial or endocardial pacing leads. VF could be induced in 206 of 257 studies (82%), and it was less likely to be induced in patients on amiodarone (74% vs 85%; P = 0.02), or beta blockers (55% vs 83%; P = 0.017). No patient presented a serious complication. Minor complications occurred during 39 studies: transient laryngospasm in 1, unintended delivery of an ICD shock to a conscious patient in 4; induction of sustained atrial fibrillation in 8; need for external rescue defibrillation shocks in 13; and delivery of inappropriate shocks for supraventricular rhythms in 14 studies. Noninvasive ventricular stimulation performed under methohexital anesthesia is safe. Its diagnostic yield compares favorably with that of conventional electrophysiological studies. VF can be induced in a majority of patients. There is good correlation between invasive and noninvasive programmed stimulation for induction of VT. Noninvasive ventricular stimulation may emerge as standard procedure for the initial programming and follow-up of ICDs.

Nonthoracotomy- versus thoracotomy-implantable defibrillators. Intention-to-treat comparison of clinical outcomes.

BACKGROUND: Nonthoracotomy-implantable cardioverter/defibrillator (ICD) systems may represent a significant advance in the treatment of patients with life-threatening ventricular arrhythmias, but their merits relative to those of the well-established thoracotomy systems remain largely unknown. The objective of this study was to compare the short- and long-term clinical outcomes after attempted ICD implantation via a nonthoracotomy versus thoracotomy approach in similar groups of patients. METHODS AND RESULTS: Between September 1990 and December 1992, 212 consecutive patients underwent attempted ICD system implantation without concomitant cardiac surgery at a single institution. Approach selection was not randomized but rather was based primarily on hardware availability. Primary comparisons of short- and long-term outcome were performed according to the "intention-to-treat" principle. Implantation was attempted via a nonthoracotomy approach in 120 patients (57%) and via a thoracotomy approach in 92 patients (43%). Prior cardiac surgery was more prevalent in the nonthoracotomy patients; otherwise, groups did not differ significantly in terms of prognostically relevant clinical characteristics. Nonthoracotomy implantation was successful in 101 patients (84%). After crossover to thoracotomy implantation (14 patients), the eventual success rate for ICD system implantation was 96% in the nonthoracotomy group. Thoracotomy implantation was successful in 89 patients (97%). Operative mortality was 3.3% in the nonthoracotomy and 4.3% in the thoracotomy groups (P = .73). Nonthoracotomy group patients were less likely to experience postoperative congestive heart failure (6% versus 16%; P = .02) or supraventricular arrhythmia (6% versus 18%; P = .004) and had significantly shorter postoperative intensive care and total hospitalization. Total hospital costs were significantly lower in the nonthoracotomy group ($32,205 versus $37,265; P = .001). After a follow-up of 16 +/- 9 months, there were 17 deaths in the nonthoracotomy group (none sudden) and 12 deaths in the thoracotomy group (1 sudden). One- and 2-year Kaplan-Meier survival probabilities were .87 (95% CI, .78 to .91) and .80 (95% CI, .68 to .88) in the nonthoracotomy group and .90 (95% CI, .82 to .95) and .87 (95% CI, .77 to .93) in the thoracotomy group (P = .56; log-rank test). CONCLUSIONS: Nonthoracotomy ICD implantation is associated with reduced surgical morbidity, postoperative hospital care requirement, and hospital costs and has similar efficacy in preventing sudden death relative to the thoracotomy approach. From these nonrandomized data, it appears that a nonthoracotomy approach should be considered preferable in most patients requiring ICD therapy.

Single-chamber ventricular pacing is not associated with worsening heart failure in sick sinus syndrome.

Ventricular pacing (with loss of normal atrioventricular synchrony) has been considered to have a role in the development or progression of congestive heart failure (CHF) in patients with sick sinus syndrome (SSS). No rigorous study has tested this hypothesis. Five hundred seven consecutive patients with SSS who received an initial pacemaker from January 1980 to December 1989 were studied. Atrial or dual-chamber pacemakers were implanted in 395 patients and ventricular pacemakers in 112. After a mean follow-up of 65 +/- 37 months, 97 patients (19%) developed new CHF or increased their New York Heart Association functional class. By univariate analysis, preimplant predictors for these events were left ventricular dysfunction (p < 0.001), valvular heart disease (p = 0.004), peripheral vascular disease (p = 0.005), diabetes (p = 0.02), coronary artery disease (p = 0.02), high New York Heart Association functional class (p = 0.03) and complex ventricular arrhythmia (p = 0.03). By multivariate analysis (logistic regression), the only predictors for CHF were valvular heart disease (p = 0.002; odds ratio [OR] 2.51), peripheral vascular disease (p = 0.003; OR 1.7) and complex ventricular arrhythmia (p = 0.027; OR 2.74). When the analysis was restricted to patients who had preimplant assessment of left ventricular function, independent predictors for CHF were left ventricular dysfunction (p < 0.001; OR 1.66), and complex ventricular arrhythmia (p < 0.001; OR 1.75). In conclusion, progressive or new-onset CHF is a consequence of the underlying cardiovascular disease. In the present population of patients with SSS, ventricular pacing mode was not associated with an increased incidence of CHF.

Durability of bipolar coaxial endocardial pacemaker leads compared with unipolar leads.

BACKGROUND: The coaxial design allows for thinner bipolar endocardial pacemaker leads, but recent reports have suggested a higher incidence of failure for this sophisticated configuration. OBJECTIVE: To compare the long-term survival of bipolar coaxial and unipolar leads. METHODS: Retrospective follow-up. RESULTS: Between January 1, 1980 and June 30, 1991, 1142 bipolar coaxial leads and 1181 unipolar leads were implanted at the Cleveland Clinic. The mean follow-up was 33 +/- 32 months (range 1 to 138 months). Ten bipolar coaxial leads failed (0.88%), as did 9 unipolar leads (0.76%). At 5 years the cumulative survival was 98.6% for both types of leads; however, at 10 years the survival of bipolar coaxial leads was only 92.4% compared with 98.6% of unipolar leads (P = .03; relative risk 2.7, 95% confidence interval = 1.1 to 6.9). CONCLUSIONS: The sophisticated design of bipolar coaxial leads could be the cause of their increased vulnerability. The benefit-to-risk ratio of this design should be prospectively reevaluated.

Long-term performance of endocardial pacing leads.

To assess the performance of endocardial pacemaker leads and to identify factors associated with structural lead failure, medical records of 2,611 endocardial pacing leads (in 1,518 patients) implanted between 1980 and 1991, having at least 1 month of follow-up, were reviewed. Leads without structural failure had normal function at the last follow-up date, or were discontinued for reasons other than structural failure (patient death, infection, dislodgment, lead-pacemaker incompatibility, operative complication, or abandonment by telemetry not related to failure). Leads with suspected structural failures were invasively or noninvasively disconnected because of clinical malfunction (loss of capture or sensing, oversensing, elevated thresholds, or skeletal muscular stimulation). Leads with verified structural failures met the criteria for suspected lead failure and also had a visible defect seen in the operating room or on chest roentgenograms, a change in the impedance interpreted by the physician as lead disruption, or a manufacturer's return product report that confirmed structural failure. Variables analyzed included patients' age and gender, paced chamber, venous access, insulation materials, fixation mechanism, coaxial design, polarity, and different lead models. The cumulative lead survival at 5 and 10 years were 97.4% and 92.9%, respectively, for suspected failures; and 98.7% and 97.3%, respectively, for verified failures. Leads in older patients (> or = 65 years old), and leads in atrial position had fewer verified failures (P = 0.014 and P = 0.007, respectively). Unipolar leads also tended to perform better according to the verified definition (P = 0.07).(ABSTRACT TRUNCATED AT 250 WORDS)

Chronic atrial fibrillation and stroke in paced patients with sick sinus syndrome. Relevance of clinical characteristics and pacing modalities.

BACKGROUND: The goal of the report was to study the long-term incidence and the independent predictors for chronic atrial fibrillation and stroke in 507 paced patients with sick sinus syndrome, adjusting for differences in baseline clinical variables with multivariate analysis. METHODS AND RESULTS: From 1980 to 1989, we implanted 376 dual-chamber, 19 atrial, and 112 ventricular pacemakers to treat patients with sick sinus syndrome. After a maximum follow-up of 134 months (mean: 59 +/- 38 months for chronic atrial fibrillation, 65 +/- 37 months for stroke), actuarial incidence of chronic atrial fibrillation was 7% at 1 year, 16% at 5 years, and 28% at 10 years. Independent predictors for this event, from Cox's proportional hazards model, were history of paroxysmal atrial fibrillation (P < .001; hazard ratio [HR] = 16.84), use of antiarrhythmic drugs before pacemaker implant (P < .001; HR = 2.25), ventricular pacing mode (P = .003; HR = 1.98), age (P = .005; HR = 1.03), and valvular heart disease (P = .008; HR = 2.05). For patients with preimplant history of paroxysmal atrial fibrillation, independent predictors were prolonged episodes of paroxysmal atrial fibrillation (P < .001; HR = 2.56), long history of paroxysmal atrial fibrillation (P = .004; HR = 2.05), ventricular pacing mode (P = .025; HR = 1.69), use of antiarrhythmic drugs before pacemaker implant (P = .024; HR = 1.71), and age (P = .04; HR = 1.02). Actuarial incidence of stroke was 3% at 1 year, 5% at 5 years, and 13% at 10 years. Independent predictors for stroke were history of cerebrovascular disease (P < .001; HR = 5.22), ventricular pacing mode (P = .008; HR = 2.61), and history of paroxysmal atrial fibrillation (P = .037; HR = 2.81). CONCLUSIONS: Development of chronic atrial fibrillation and stroke in paced patients with sick sinus syndrome are strongly determined by clinical variables and secondarily by the pacing modality. Ventricular pacing mode predicts chronic atrial fibrillation in patients with preimplant paroxysmal atrial fibrillation but not in those without it.

Initial experience with the maze procedure for atrial fibrillation.

From January 1991 until May 1992, a total of 14 patients (mean age 48 years) underwent the maze procedure for refractory atrial fibrillation (mean duration, 7 years; mean number of antiarrhythmic medications, six). Three patients had had embolic events, one patient had had a cardiac arrest from flecainide, one had pulmonary fibrosis from amiodarone, and six of ten who were employed were temporarily disabled. Two patients underwent successful mitral valve repair in which the maze procedure was added as a secondary goal of the operation. Postoperative fluid retention was a problem in five patients (36%). Six patients (43%) were temporarily treated with an antiarrhythmic medication. Two patients (14%) with preoperative sick sinus syndrome required pacemakers. One patient was discharged from the hospital but died suddenly less than 1 month after the operation (7% operative mortality) of hyperkalemia caused by acute renal failure. All patients beyond 3 postoperative months (100% "cure") are receiving no antiarrhythmic medications, have sinus rhythm, or have p-wave tracking with ventricular pacing. Atrial contraction has been documented by cinegraphic magnetic resonance imaging studies and by Doppler echocardiography performed when sinus rhythm had resumed. The maze procedure is an extensive operation but is indicated for selected patients who have the severe sequelae of atrial fibrillation.

Is absolute hypovolemia a risk factor for vasovagal response to head-up tilt?

To test the hypothesis that hypovolemia is associated with an increased incidence of vasovagal syncope during head-up tilt (HUT) 45 patients with history of syncope or presyncope were studied. Blood volume (radio-iodinated serum albumin) was determined, then subjects underwent a graded HUT (from 15 degrees-60 degrees HUT) with cuff blood pressure and ECG monitoring. All patients were kept on their own medications during evaluation. Thirty patients (12 male, 18 female, mean age 50 +/- 19 [SD] years) had hypovolemia, defined as blood volume < 90% of lab normal for corresponding sex, while 15 patients (7 male, 8 female, mean age 52 +/- 21 years) were normovolemic with blood volume ranging from 91%-110% of sex-matched normal subjects. The normovolemic patients served as controls. During HUT, a vasovagal response was elicited in 5 of the 30 hypovolemics and in 4 of the 15 normovolemic (16.7% and 26.7%, respectively, P = NS). In those who developed vasovagal response, the changes of heart rate and blood pressure during HUT were not significantly different between hypovolemics and normovolemics, neither at the endpoint (vasovagal response) nor immediately before the development of the vasovagal response. In patients with nonvasovagal events, four types of hemodynamic responses to tilt were observed: normal blood pressure response associated with normal heart rate increase, normal blood pressure response in association with accentuated increase in heart rate, orthostatic hypotension with normal acceleration of heart rate, and orthostatic hypotension with accelerated increase in heart rate.(ABSTRACT TRUNCATED AT 250 WORDS)

Long-term performance of epimyocardial pacing leads in adults: comparison with endocardial leads.

The long-term performance of epimyocardial pacing leads in children is well established, but few studies have analyzed the performance in adults. This issue has clinical relevance in view of the increased use of epimyocardial leads with implantable cardioverter defibrillator and antitachycardia pacing systems. We analyzed 93 epimyocardial pacing "systems" (121 leads: 65 unipolar, 28 bipolar) in adult patients (age 57 +/- 16 years), implanted since January 1980. Two different models were studied: Medtronic 4951 "Stab-on" (n = 35) and Medtronic 6917/6917A "Screw-in" (n = 58). A control group was created by randomly matching each epimyocardial system with two endocardial leads, according to age and year of implant. Epimyocardial and endocardial leads were followed-up for 44 +/- 35 and 43 +/- 35 months, respectively (P = NS). Freedom from failure for epimyocardial leads was 0.91 (95% Confidence Interval [95% CI] = 0.82 to 0.96) at 5 years, and 0.91 (95% CI = 0.69 to 0.98) at 10 years. No difference was found between the two analyzed models. Freedom from failure for endocardial leads was 0.97 (95% CI = 0.93 to 0.99) and 0.90 (95% CI = 0.61 to 0.97) at 5 and 10 years, respectively. Epimyocardial leads had a significantly poorer short-term survival than endocardial leads, secondarily to earlier "technique related" failures (P = 0.03; relative risk 3.0; Wilcoxon test). However, overall long-term performance was similar to endocardial leads. Epimyocardial pacing leads, meticulously implanted and tested, have a long-term performance similar to endocardial pacing leads.

The Maze procedure: surgical therapy for refractory atrial fibrillation.

Although atrial fibrillation is well tolerated by most patients, in some patients the consequences may be severe. The Maze procedure is a new open-heart operation that creates a carefully designed maze of incisions in the atrial myocardium; this maze then acts as an electrical conduit to channel atrial impulses from the sinoatrial node to the atrioventricular node. The Maze procedure has been shown to restore sinus rhythm and atrial systole (thus reducing the risk of thromboembolism), improve hemodynamics, alleviate palpitations, and eliminate the need for antiarrhythmic and anticoagulant drugs. We describe our first patient to undergo this operation.

Pacing lead survival: performance of different models.

UNLABELLED: Recent reports have shown poor survival of some leads currently in use. Long-term survival analysis of 2,444 leads (1,059 atrial and 1,385 ventricular) implanted in this institution since January 1980, and having at least 1 month of follow-up was performed. The survival of 123 different models was compared with the average survival of all the leads implanted in the corresponding chamber. Failure was defined as inactivation of the lead (electrical abandonment, explant, or cap) due to insulator and/or conductor fracture. RESULTS: The mean follow-up was 33 +/- 32 months. The cumulative survival for different atrial lead models was consistent with the average performance in the atrium. No atrial lead showed better or worse survival compared to the others. In the ventricular group, the Medtronic 4012 lead showed statistically significant poorer survival (P = 0.01) compared with the average survival of the ventricular leads. The Cardiac Pacemakers, Inc. (CPI) 4010 lead showed a nonsignificant (P = 0.12) worse performance than the average for ventricular leads. CONCLUSIONS: (1) The Medtronic 4012 had a significantly poorer performance than the rest of the leads. A trend in similar direction was found for the CPI 4010, also in the ventricular group; (2) Atrial lead models showed a stable survival; and (3) Frequent follow-up is required for some leads, especially in pacemaker dependent patients.

Incidence and predictors of loss of pacing in the atrium in patients with sick sinus syndrome.

Atrial and dual-chamber pacemakers may be associated with reduced morbidity in patients with the sick sinus syndrome (SSS). In some patients, however, subsequent development of chronic atrial fibrillation or atrial lead failure make long-term pacing in the atrium not feasible. We analyzed the incidence and predictors of loss of atrial pacing in 395 consecutive patients with SSS (376 with dual-chamber pacemakers and 19 with single-chamber atrial pacemakers). None of them was in established atrial fibrillation at time of implant. Patients were followed-up for 55 +/- 35 months. Actuarial survival of effective atrial pacing was 92.5% at 1 year, 85% at 5 years, and 76.5% at 10 years. Overall, 60 patients lost atrial pacing. The most frequent cause was the development of chronic atrial fibrillation (53 patients). By multivariate analysis (Cox proportional-hazards model), independent predictors of loss of pacing in the atrium were preimplant episodes of paroxysmal atrial fibrillation (PAF) lasting more than 1 hour (P < 0.001; hazard ratio (HR) = 4.3); prior history of PAF for more than 5 years (P < 0.001; HR = 2.67; and endocardial P wave < 2 mV (P = 0.014; HR = 1.96). In a subgroup of patients (n = 187) who had echocardiograms, a left atrium > 50 mm was also an independent predictor of loss of atrial pacing (P = 0.028; HR = 2.28).(ABSTRACT TRUNCATED AT 250 WORDS)

Long-term multicenter experience with a second-generation implantable pacemaker-defibrillator in patients with malignant ventricular tachyarrhythmias. The Guardian Multicenter Investigators Group.

A second-generation implantable pacemaker-cardioverter-defibrillator was evaluated in 200 patients with sustained ventricular tachycardia, ventricular fibrillation or prior cardiac arrest. The device permits demand ventricular pacing for bradyarrhythmias and for long QT interval or tachycardia suppression, uses programmable (3 to 30 J) energy shocks for conversion of ventricular tachycardia and ventricular fibrillation and is used with conventional pacing and defibrillation leads. Ventricular tachycardia/fibrillation recognition is based on the ventricular electrogram rate and requires reconfirmation before shock delivery. Two hundred patients (mean age 62 years, mean left ventricular ejection fraction 36%) were enrolled and followed up for 0 to 23 months (mean 12). Epicardial lead system implantation was performed with use of an anterolateral thoracotomy (38%), median sternotomy (26%) and subxiphoid (20%) or subcostal (16%) approach. Perioperative mortality rate was 5.5% (all nonarrhythmic deaths). Implant defibrillation threshold ranged from 3 to 30 J (mean 15), with initial programmed shock energy ranging from 3 to 30 J (mean 22). Ventricular tachycardia/fibrillation sensing threshold ranged from 0.7 to 1.8 mV (median 1) and the tachycardia detection interval from 288 to 416 ms (median 320). Reprogramming of implant variables was necessary for reliable electrographic sensing (54 patients), programmed shock therapy (61 patients) and tachycardia detection rate (63 patients). Device activation for potential shock delivery occurred in 111 patients (55.5%) with actual shock delivery after ventricular tachycardia/fibrillation reconfirmation in 66 patients (33%). During follow-up study, there was a 1% arrhythmia mortality rate, 6.5% cardiac mortality rate and 10.5% total mortality rate. This study demonstrates that the programmable implantable pacemaker-cardioverter-defibrillator is effective in preventing arrhythmic death, yet reduces patient exposure to repeated shock therapy. Reprogramming is usually necessary during follow-up for optimal function.

Flecainide therapy in patients treated for supraventricular tachycardia with near normal left ventricular function.

Concerns about the safety and efficacy of class IC antiarrhythmic agents have arisen as a result of the recent CAST data. We reviewed records of 175 consecutive patients treated with flecainide between July 1, 1988 and July 5, 1989. One hundred ten patients with normal or mildly impaired left ventricular function and symptomatic supraventricular arrhythmias were identified. Follow-up data were obtained on 102 patients for a mean of 14 months. The average duration of flecainide therapy was 13 months. Tachyarrhythmias treated included atrial fibrillation/flutter, atrioventricular reentry, and atrioventricular nodal reentry. Flecainide provided effective antiarrhythmic therapy in 62% of the patients and was discontinued in 38% of the patients. Left atrial size did not predict treatment failure. Two patients developed proarrhythmic events (nonsustained ventricular tachycardia). There were no deaths during the follow-up period. In conclusion, flecainide provides safe and effective therapy for supraventricular tachyarrhythmias in patients with normal or mildly impaired left ventricular function.

Analysis of deaths in patients with an implantable cardioverter defibrillator.

The cause of death and clinical characteristics of 26 patients that died after implantable cardioverter defibrillator placement were reviewed and compared to the 145 patients still living after a mean follow-up of 17 months. Operative mortality was 4% (7/171) and resulted from postoperative ventricular arrhythmias (four patients), heart failure (two patients), and respiratory failure (one patient). Operative mortality was significantly higher (1.7% vs 9.6%, P less than 0.05) following concomitant surgical procedures. Total late mortality was 11% (18/171). Thirteen deaths (75%) occurred in-hospital from progressive deterioration of left ventricular function (nine patients), arrhythmia (two patients), and noncardiac causes (two patients). Outpatient mortality was 3.5% (6/171) and resulted from presumed sudden cardiac death in five of six patients; two of the five had devices that were inactive, one had high defibrillation thresholds, and two had suspected bradyarrhythmic deaths. One postoperative death and one late in-hospital death were also considered sudden cardiac deaths for a total of seven patients with defibrillation system failures. By multivariant analysis, preoperative clinical characteristics associated with a worse prognosis following defibrillator implantation were identified: presentation as ventricular tachycardia (P less than 0.02), induction of sustained monomorphic ventricular tachycardia (P less than 0.05), poor left ventricular performance (P less than 0.01), poor functional status (P less than 0.001), and the use of diuretics (P less than 0.01). Frequent device discharges (P less than 0.001) and concomitant antitachycardia pacing systems (P less than 0.001) were markers for greater arrhythmia recurrence and were potent predictors of a worse prognosis and particularly sudden death.

DDIR versus VVIR pacing in patients with paroxysmal atrial tachyarrhythmias.

Patients with sinus node dysfunction (SND) in particular those with tachycardia-bradycardia syndrome and patients undergoing atrioventricular nodal ablation procedures for refractory paroxysmal atrial tachyarrhythmias (PAT), are candidates for single chamber (VVIR mode) or dual chamber rate responsive (DDIR mode) systems. To evaluate the benefits and disadvantages of each pacing mode we retrospectively analyzed 33 patients with a history of frequent PAT who received a VVIR (22 patients); or a DDDR pacemaker (11 patients) programmed to the DDIR mode. The mean follow-up time was 25 and 18 months, respectively. Preimplant left atrial diameter was significantly smaller in the DDIR group. Chronic atrial fibrillation developed in 54% of the VVIR patients and 27% of the DDIR group, but this difference was not significant. Complications of patients with VVIR pacemakers included new mitral and tricuspid insufficiency, stroke, pacemaker intolerance and aggravated congestive heart failure. Patients with DDIR pacemakers had a lower incidence of symptoms and complications. However, this group received more antiarrhythmic medication, required a closer follow-up, and their pacemakers needed frequent reprogramming. Our findings suggest that VVIR is a poor choice for patients with SND, congestive heart failure, and PAT, and that DDIR may be an acceptable alternative.

Early clinical experience with a minute ventilation sensor DDDR pacemaker.

UNLABELLED: The new DDDR pacemaker META DDDR utilizes a minute ventilation sensor based on transthoracic impedance measurements. The sensor determines the metabolic indicated interval, the atrioventricular (AV) delay and the postventricular atrial refractory period (PVARP). The baseline PVARP must be carefully selected to define nonphysiological tachycardias. If a P wave falls within the PVARP the pacemaker will automatically switch to the VVIR mode. This behavior prevents tracking of paroxysmal atrial tachyarrhythmias (PAT). Twenty-eight patients with sinus node dysfunction (n = 20), AV junction ablation (n = 5), complete or intermittent AV block (n = 3); who received a META DDDR pacemaker were studied. The mean age was 65 +/- 13 years. RESULTS: mode switching (reversion) to VVIR was observed in 57% of the patients. Forty-two percent had episodes of mode switching to VVIR during a stress test, four related to PAT, and seven to sinus tachycardia. Fifty percent had episodes of mode switching to VVIR during a 24-hour Holter, four related to PAT, three to retrograde P wave sensing, and two to sinus tachycardia. At the last follow-up, 20 of the 26 patients initially programmed to the DDDR mode remained in the DDDR mode, while five were reprogrammed to the DDD and one to the VVIR mode. Mode switching has a high sensitivity but a low specificity for PAT. It appears to be a useful approach to prevent rapid tracking of atrial tachyarrhythmias. Careful PVARP programming is critical to appropriate reversion behavior, but further modifications of the algorithm are needed to improve its performance.

Implantable cardioverter defibrillator implanted by nonthoracotomy approach: initial clinical experience with the redesigned transvenous lead system.

Standard implantation procedure for the implantable cardioverter defibrillator (ICD) has traditionally required a thoracotomy approach. A newly revised nonthoracotomy defibrillator lead system that uses a single transvenous tripolar endocardial lead alone or in combination with a subcutaneous/submuscular patch lead was introduced into clinical trials in September, 1990. Fourteen patients requiring a cardioverter defibrillator for recurrent sustained ventricular tachycardia (eight patients) or aborted sudden cardiac death (six patients) were evaluated for implantation of this lead system. Primary successful lead system implantation was obtained in nine patients. The remaining five patients had unacceptably high defibrillation thresholds (DFTs) for implantation. One of the nine initially successful implants demonstrated unacceptable DFTs and cross-talk inhibition from a permanent pacemaker necessitating removal of the nonthoracotomy lead system and replacement with a conventional lead system via thoracotomy. All remaining primary implanted patients experienced successful conversion of induced ventricular fibrillation prior to hospital discharge. Continued follow-up and greater experience to confirm the durability and efficacy of the nonthoracotomy AICD lead system are needed.

Retrospective analysis of patients undergoing one- or two-stage strategies for myocardial revascularization and implantable cardioverter defibrillator implantation.

Internal defibrillation leads were placed at time of coronary revascularization in 79 patients. In 34, an implantable cardioverter defibrillator (ICD) was placed simultaneously (group I). A two-stage strategy (selective implantation of the ICD in patients with postoperative spontaneous or inducible ventricular tachycardia [VT]) was followed in 45 patients (group II). Group I patients had failed more antiarrhythmic drug trials (2.9 +/- 1.6 vs 1.5 +/- 1.6; P = 0.02), including amiodarone (62% vs 20%; P less than 0.001). There were four operative deaths in each group. Postoperatively, VT was present in 27 group II patients (60%), 25 of whom received an ICD (two refused device implantation). Patients with postoperative VT had a lower left ventricular ejection fraction than those without VT (33 +/- 9 vs 47 +/- 16; P = 0.01). Actuarial survival at 1, 2, and 3 years was 88 +/- 6, 88 +/- 7, and 88 +/- 10 in group I; and 83 +/- 6, 76 +/- 7, and 76 +/- 11 in group II (NS). No patient without an ICD (based on the postoperative electrophysiological study [EPS]) died suddenly. Five patients (6%) had ICD system infection. Sudden death was largely prevented by either strategy, but relatively high rates of operative mortality and ICD system infection were observed. Prospective studies should identify patients more likely to benefit from one or another strategy.