Biomedical subjects
Publications and source records attributed to J D Maloney.
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The goal of radiofrequency catheter ablation and the criterion for efficacy is the elimination of arrhythmogenic myocardium. The application of radiofrequency current in the heart clearly results in lower morbidity and mortality rates than thoracic and cardiac surgical procedures in general, and comparisons of therapy with radiofrequency catheter ablation and therapy with thoracic and cardiac surgical procedures in randomized clinical trials is unwarranted. Trials of radiofrequency catheter ablation versus medical or implantable cardioverter-defibrillator therapy may be indicated in certain conditions, such as ventricular tachycardia associated with coronary artery disease. Randomized trials are recommended for new and radical departures in technology that aim to accomplish the same goals as radiofrequency catheter ablation. Surveillance using registries and/or databases is necessary in the assessment of long-term safety and efficacy.
OBJECTIVES: This study assessed the useful role of intracardiac mapping and radiofrequency catheter ablation in eliminating drug-refractory monomorphic ventricular ectopic beats in severely symptomatic patients. BACKGROUND: Ventricular ectopic activity is commonly encountered in clinical practice. Usually, it is not associated with life-threatening consequences in the absence of significant structural heart disease. However, frequent ventricular ectopic beats can be extremely symptomatic and even incapacitating in some patients. Currently, reassurance and pharmacologic therapy are the mainstays of treatment. There has been little information on the use of catheter ablation in such patients. METHODS: Ten patients with frequent and severely symptomatic monomorphic ventricular ectopic beats were selected from three tertiary care centers. The mean frequency +/- SD of ventricular ectopic activity was 1,065 +/- 631 beats/h (range 280 to 2,094) as documented by baseline 24-h ambulatory electrocardiographic (ECG) monitoring. No other spontaneous arrhythmias were documented. These patients had previously been unable to tolerate or had been unsuccessfully treated with a mean of 5 +/- 3 antiarrhythmic drugs. The site of origin of ventricular ectopic activity was accurately mapped by using earliest endocardial activation time during ectopic activity or pace mapping, or both. RESULTS: During electrophysiologic study, no patient had inducible ventricular tachycardia. The ectopic focus was located in the right ventricular outflow tract in nine patients and in the left ventricular posteroseptal region in one patient. Frequent ventricular ectopic beats were successfully eliminated by catheter-delivered radiofrequency energy in all 10 patients. The mean number of radiofrequency applications was 2.6 +/- 1.3 (range 1 to 5). No complications were encountered. During a mean follow-up period of 10 +/- 4 months, no patient had a recurrence of symptomatic ectopic activity, and 24-h ambulatory ECG monitoring showed that the frequency of ventricular ectopic activity was 0 beat/h in seven patients, 1 beat/h in two patients and 2 beats/h in one patient. CONCLUSIONS: Radiofrequency catheter ablation can be successfully used to eliminate monomorphic ventricular ectopic activity. It may therefore be a reasonable alternative for the treatment of severely symptomatic, drug-resistant monomorphic ventricular ectopic activity in patients without significant structural heart disease.
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Management of multiple cardiac arrhythmias in some patients with both an implantable cardioverter defibrillator (ICD) and a pacemaker has demonstrated several advantages. In such circumstances, it is imperative that pacemaker function and its programmed parameters be preserved following a defibrillation shock. This article describes the effects encountered by a specific programmable polarity pacemaker (RelayR 294-03) when subjected to electrical defibrillation in a canine model. Three pacemakers were repeatedly tested in three separate dog experiments. Each pacemaker, with its leads implanted in the right atrium and the right ventricle, was subjected to a minimum total number of 24 high energy biphasic and monophasic shocks (600-700 V) delivered by a coexisting ICD system using three different defibrillating lead configurations. None of the pacemaker systems showed any failure in function; all pacemakers continued to function within preshock specification and conversion to unipolar pacing and/or backup mode was not observed in any of the tests. Intracardiac electrical potentials measured directly off the ICD and the pacemaker leads, during a defibrillation shock (mean 566.6 V; 23.7 J), showed that potentials measured in a bipolar configuration (tip-ring: mean 21.0 V in atrium, 12.0 V in ventricle) were significantly less than potentials measured in a unipolar configuration (tip-can: mean 387.9 V in atrium, 394.0 V in ventricle; ring-can: mean 405.6 V in atrium, 395.4 V in ventricle). Our compatibility tests demonstrate that use of this programmable-polarity pacemaker in concert with an ICD system appears to be safe. Testing similar to the present study should be conducted prior to complete clinical acceptance of combined ICD and pacemaker implantation.
The goal of radiofrequency catheter ablation and the criterion for efficacy is the elimination of arrhythmogenic myocardium. The application of radiofrequency current in the heart clearly results in lower morbidity and mortality rates than thoracic and cardiac surgical procedures in general, and comparisons of therapy with radiofrequency catheter ablation and therapy with thoracic and cardiac surgical procedures in randomized clinical trials are unwarranted. Trials of radiofrequency catheter ablation versus medical or implantable cardioverter defibrillator therapy may be indicated in certain conditions, such as ventricular tachycardia associated with coronary artery disease. Randomized trials are recommended for new and radical departures in technology that aim to accomplish the same goals as radiofrequency catheter ablation. Surveillance using registries and/or databases is necessary in the assessment of long-term safety and efficacy.
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.
The role of permanent cardiac pacing for the management of neurocardiogenic syncope is controversial; however, it does have a secondary role in appropriately selected individuals. Neurocardiogenic syncope includes vaso-vagal and enhanced antagonism of sympathetic-parasympathetic mechanisms. Differentiation of the so-called cardiac inhibitory, vasodepressor, and mixed forms of these disorders is frequently misleading when establishment of effective treatment strategies is attempted. Cardiac pacing can artificially restore near-normal heart rate and atrioventricular synchrony during a neurocardiogenic syncopal episode; however, cardiac pacing does not alter the peripheral vasodilatation, nor does it prevent the occurrence of the reflux response. Syncopal patients with carotid sinus hypersensitivity or vasovagal responses that include marked bradycardia and loss of atrioventricular synchrony can be supported by dual-chamber cardiac pacing in combination with other therapeutic interventions that diminish the severity of the reflex response. The conditions of patients with carotid sinus syndrome and carotid sinus hypersensitivity are frequently improved with cardiac pacing, and the conditions of elderly patients with vasovagal syncope are commonly improved with artificial pacing. The classic younger patient with malignant vasovagal syncope derives less benefit from artificial pacing; however, in carefully selected persons dual-chamber pacing combined with drug therapy and education decreases syncopal episodes and permits a return to normal activities.
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To analyze if patient selection bias could contribute to the improved prognosis reported for ventricular tachycardia (VT) and ventricular fibrillation (VF) when therapy is guided by electrophysiologic studies (EPS), we studied 90 consecutive patients admitted to a tertiary referral center with recent VT/VF who were candidates for EPS. Seventeen patients (19%) died during the initial hospital admission, and 30 (33%) died after discharge. Survival probability was 0.83 (95% confidence interval [CI], 0.74-0.90); 0.67 (95% CI, 0.56-0.75); and 0.53 (95% CI, 0.42-0.63) at 1 month, 1 year, and 3 years, respectively. Of the 56 patients (62%) who underwent EPS during their initial hospitalization, only 1 died during that admission. Patients in whom EPS could not be performed had characteristics associated with a poorer prognosis. NYHA functional class (p = 0.005), inability to perform baseline EPS (p = 0.003) and use of digoxin (p = 0.016) were independent predictors of death. Early in-hospital mortality in patients with VT/VF remains high. Thus, omission of these deaths in reports of EPS-guided therapy creates incomplete, biased cohorts. Furthermore, there may be a bias toward a healthier population among hospital survivors undergoing EPS. These findings may contribute to better outcomes in current series compared to historical controls.
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)
On May 4-5, 1993, a policy conference was held in San Diego, California, under the sponsorship of the North American Society of Pacing and Electrophysiology (NASPE) to identify the fundamental goals of antibradycardia pacemaker follow-up, evaluate the effectiveness with which it achieves those goals, and formulate specific recommendations as to how it can be made more effective. The conference addressed clinical, administrative, and educational objectives, focusing on existing and potential resources for follow-up testing and the appropriate frequency of their application. The training of physicians and associated professionals engaged in follow-up also was addressed, as were regulatory and reimbursement issues. This report summarizes the conclusions and recommendations arrived at during the conference and subsequently approved by the NASPE Board of Trustees.
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.
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)
OBJECTIVES: This study assessed the function of the left atrial appendage in the pericardioversion period to gain insights into mechanisms involved in thromboembolism after cardioversion of atrial fibrillation. BACKGROUND: Systemic embolization associated with electrical cardioversion of atrial fibrillation is thought to originate from the left atrium or left atrial appendage, or both. However, the mechanism involved is poorly understood. METHODS: We studied left atrial appendage function with transesophageal echocardiography in 20 patients with atrial fibrillation before and after successful electrical cardioversion. We measured left atrial appendage emptying and filling velocities by pulsed wave Doppler echocardiography, characterized Doppler emptying patterns, measured atrial appendage areas and assessed the presence or absence of spontaneous echo contrast or thrombus. RESULTS: Organized left atrial appendage function returned in 16 (80%) of 20 patients immediately after cardioversion. Atrial appendage emptying velocities before cardioversion were greater in patients without (0.39 +/- 0.02 m/s) than in those with (0.25 +/- 0.12 m/s) spontaneous echo contrast (p = 0.045). Furthermore, emptying velocities before cardioversion were significantly greater than late diastolic emptying velocities after cardioversion (0.31 +/- 0.15 vs. 0.14 +/- 0.12 m/s, p = 0.0001), as well as in both the group with (0.25 +/- 0.12 vs. 0.13 +/- 0.13 m/s, p = 0.001) and the group without (0.39 +/- 0.02 vs. 0.15 +/- 0.12 m/s, p = 0.01) spontaneous echo contrast. In addition, left atrial and atrial appendage spontaneous echo contrast developed in 4 of 20 patients and increased in intensity in 3 of 20 patients in the immediate postcardioversion period. CONCLUSIONS: Organized left atrial appendage function returns in most patients immediately after cardioversion of atrial fibrillation. However, its function is impaired compared with that before cardioversion. Furthermore, spontaneous echo contrast increased in 7 (35%) of 20 patients after cardioversion. These observations suggest that stunned left atrial appendage function after cardioversion may predispose the chamber to thrombus formation, which may play a role in the mechanism involved in the occurrence of embolization after cardioversion.
OBJECTIVE: To determine whether the atrial-based pacing modalities ("physiologic pacing") improve survival when compared with single-chamber ventricular pacing in patients with the sick sinus syndrome. DESIGN: Retrospective, nonrandomized study. SETTING: A tertiary care teaching hospital. PATIENTS: A total of 507 patients with a mean age of 66 years who received an initial pacemaker for the sick sinus syndrome between January 1980 and December 1989. Pacing modes were ventricular (22%), atrial (4%), and dual-chamber (74%). MEASUREMENTS: Total and cardiovascular mortality rates. Mean follow-up was 66 months. RESULTS: Independent predictors of total mortality by the Cox proportional hazards model were 1) New York Heart Association functional class (hazard ratio = 1.67/class; 95% Cl, 1.31 to 2.11); 2) age (hazard ratio = 1.62/12-year increment; Cl, 1.28 to 2.05); 3) peripheral vascular disease (hazard ratio = 2.21; Cl, 1.42 to 3.42); 4) bundle branch block (hazard ratio = 2.04; Cl, 1.33 to 3.13); 5) coronary artery disease (hazard ratio = 1.66; Cl, 1.15 to 2.39); and 6) valvular heart disease (hazard ratio = 1.71; Cl, 1.08 to 2.69). The same variables were independent predictors of cardiovascular mortality, with cerebrovascular disease reaching borderline statistical significance (hazard ratio = 1.69; Cl, 1.00 to 2.86). Using univariate analysis, single-chamber ventricular pacing had more than 40% increased risk for both total and cardiovascular death, but the difference was of borderline statistical significance (total mortality: P = 0.053; hazard ratio = 1.43; Cl, 0.99 to 2.07; cardiovascular mortality: P = 0.15; hazard ratio = 1.41; Cl = 0.87 to 2.29). CONCLUSIONS: Because the role of the ventricular pacing mode as a long-term predictor of total and cardiovascular mortality remains inconclusive, a large, randomized study is necessary to confirm whether physiologic pacing provides a substantial reduction in mortality when compared with ventricular pacing.
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