The pendulum swings: reappraising prepaid health care systems.
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Biomedical subjects
Publications and source records attributed to S Saksena.
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Laser ablation was performed intraoperatively in a patient with coronary artery disease and Wolff-Parkinson-White syndrome. Histopathological evaluation of the laser ablation site revealed a transverse laser incision in the left atrial septum and mitral valve annulus. There was hemorrhage in the atrioventricular (AV) groove with interruption of a posterolateral AV connection. The laser lesion was confined largely to the atrial aspect of the AV annulus. We conclude that laser catheter ablation of accessory pathways is feasible in humans.
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.
Implantable cardioverter defibrillator (ICD) therapy has become the mainstay of therapy for patients with a history of sudden cardiac death or life-threatening ventricular arrhythmias. The current generation of ICDs used for secondary prevention combines features for tachycardia reversion with demand ventricular pacing, antitachycardia pacing, programmable shock therapy, and tachycardia events memory. Although demand pacing and defibrillation is indicated for primary prevention usage of ICDs, the application of antitachycardia pacing modes is more controversial. High energy cardioversion and defibrillation shocks remaining the mainstay of sudden death prevention will be redefined as more effective defibrillation shock modes and lead systems are developed. Fourth-generation ICD systems accomplished a significant reduction of device size and almost universal success using an endocardial lead configuration and pectoral implant. A variety of new directions of ICD therapy in clinical practice such as primary prevention applications and the adjunctive role of antiarrhythmic drug therapy are currently being examined in clinical trials. The concepts underlying initiation of tachyarrhythmias are being studied to develop new approaches to tachycardia prevention. These include rate support, subthreshold stimulation, and multiple site pacing. The current developments of ICD therapy promise continued growth of this technology.
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The clinical efficacy and safety of a second-generation braided endocardial pacing, cardioversion and defibrillation lead system was evaluated in 25 patients with ventricular tachycardia (VT) or ventricular fibrillation (VF). The lead system consisted of two 8Fr active fixation endocardial leads each with pacing and defibrillation electrodes and a thoracic patch electrode. Monophasic and biphasic shocks were delivered using a triple-electrode configuration with a right ventricular common cathode and right atrial and thoracic patch anodes. VT and VF were electrically induced. Rapid VT (rate > or = 180 beats/min) and VF were initially terminated by 20 J (550 V) shocks and slow VT (rate < 180 beats/min) by 10 J (400 V) shocks. One hundred fourteen episodes (rapid VT/VF 73, slow VT 41) were treated with 128 shocks (monophasic 80, biphasic 48). Mean ventricular pacing threshold was 0.7 +/- 0.5 ms before and 0.9 +/- 0.5 ms after endocardial shock delivery (p > 0.2). Mean ventricular electrogram amplitude in sinus rhythm was 11.9 +/- 5.7 mV before and 11.4 +/- 5.1 mV after shock delivery (p > 0.2). Simultaneous monophasic endocardial shocks terminated 53% of VF episodes at < or = 20 J. Simultaneous biphasic shocks terminated 94% of all VF episodes at < or = 20 J (p < 0.03). Efficacy of > or = 10 J shocks for rapid VT/VF was greater for biphasic (92%) versus monophasic (74%) shocks (p < 0.05) at lower average shock energy (15 +/- 7 J vs 19 +/- 7 J, respectively, p < 0.05).(ABSTRACT TRUNCATED AT 250 WORDS)
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A prospective randomized double-blind study was conducted to evaluate the efficacy of propranolol in patients with portal hypertension undergoing long-term endoscopic sclerotherapy (EST) for recurrent variceal bleeding. Consecutive patients with portal hypertension (Child's class A or B) due to cirrhosis (n = 72), non-cirrhotic portal fibrosis (n = 29) and extrahepatic portal venous obstruction (n = 13) attending the liver clinic of a tertiary care center were included in the study. All patients had had at least one documented episode of variceal bleed in the previous 4 weeks. Fifty-eight patients received propranolol and 56 received placebo in addition to weekly EST. Rebleeding occurred in 12 (21%) patients in the placebo group and 10 (17%) patients in the propranolol group during a mean follow-up period of 24.4 +/- 10.4 months in the former and 23.8 +/- 9.2 months in the latter group (P > 0.1). The number of episodes of rebleeding (14 in the placebo and 12 in the propranolol group) were also similar (P > 0.1). The median bleeding-free period was more than 40 months in both treatment groups (P > 0.1). The mean transfusion requirements and the number of hospital admissions for rebleeding were also similar in the two treatment groups (P > 0.1). Complete obliteration of varices was achieved in 44 (78.9%) patients in the placebo group and 43 (75.5%) patients in the propranolol group (P > 0.1). Recurrence of new varices was seen in two patients in the placebo and in three of those in the propranolol group. Seven patients in the placebo group and five in the propranolol group died (P > 0.1). Complications related to EST were similar in the two treatment groups but additional adverse effects were observed in the propranolol group. The cumulative incidence of rebleeding in the placebo group was 12.7 and in the propranolol group it was 11.2 per 100 patient years of follow-up. It is concluded that the addition of propranolol in patients with portal hypertension and fair hepatic function on long-term EST does not confer any additional benefit.
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The beneficial effects of implanted cardioverter defibrillator (ICD) therapy in patients with malignant ventricular tachyarrhythmias and variable degrees of left ventricular (LV) dysfunction are debated. ICD use and patient survival were examined in 128 patients with malignant ventricular arrhythmias and moderate or severe LV dysfunction. Group I included 64 patients with moderate LV dysfunction (LV ejection fraction of > 30%) and group II, 64 patients with severe LV dysfunction (LV ejection fraction of < or = 30%). Follow-up period ranged from 1 to 78 months. The two groups were similar in age, incidence of coronary artery disease and presenting arrhythmia. The mean LV ejection fraction in group I was 44% +/- 8% and group II was 22% +/- 5% (P < 0.0001). At 4 years of follow-up, 66% of patients from group I and 62% from group II (P = NS) had ICD activation for presumed ventricular tachyarrhythmia. Survival was calculated using actuarial analysis. Arrhythmic or sudden death mortality at 4 years of follow-up was 4% in group I and 7% in group II (P = NS). Cardiac mortality was for group I, 7% (P < 0.05), 12% (P < 0.01), 15% (P < 0.01), and 15% (P < 0.01) for follow-up years 1, 2, 3, and 4, respectively. For group II, cardiac mortality was 27%, 36%, 41%, and 41% for follow-up years for 1, 2, 3, and 4, respectively. The majority of cardiac deaths in both groups was observed in the first 2 years of follow-up.(ABSTRACT TRUNCATED AT 250 WORDS)
Defibrillation thresholds (DFT) and perioperative mortality were evaluated in 123 patients who had endocardial defibrillation leads implanted in conjunction with the Medtronic model 7216A/7217 (Medtronic, Inc.) cardioverter-defibrillator (ICD). Clinical variables, implant DFTs, and 30-day perioperative mortality were compared with 266 patients who had the ICD implanted with epicardial defibrillation leads. The two groups were comparable in age, gender, and incidence of coronary artery disease. New York Heart Association Class I and II were more frequent in patients with endocardial leads )87.7%) as compared to those with epicardial leads (78.8%; P < 0.001). Mean left ventricular ejection fraction was significantly higher in patients with the endocardial lead system (37% vs 33%; P < 0.05). A significant proportion of patients with epicardial lead systems underwent another cardiac surgical procedure at the time of ICD implantation (13.9%) as compared to none in those who had endocardial leads implanted (P < 0.001). All patients with endocardial leads had implantation of triple lead systems as compared to 53.4% with epicardial leads (P < 0.001). The man DFT at implant was lower in epicardial lead recipients (8.9 J) as compared to endocardial lead recipients (13.3 J; P < 0.001). Perioperative mortality had a significant trend to lower risk for endocardial lead systems (0.8%) as compared to epicardial systems (4.2%; P = 0.07). We conclude that this endocardial lead system has additional electrode and higher defibrillation energy requirements than the epicardial lead systems used with the Medtronic pacemaker ICD. However, the use of endocardial nonthoracotomy defibrillation leads is associated with a markedly reduced perioperative risk of ICD implantation.(ABSTRACT TRUNCATED AT 250 WORDS)
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BACKGROUND: A significant proportion of patients receiving endocardial defibrillation lead systems must accept either high defibrillation thresholds (DFTs) with lower safety margins or lead implantation by thoracotomy. We examined the feasibility of achieving universal application of endocardial leads and lower defibrillation energy requirements by optimizing the lead system location in conjunction with biphasic shocks. METHODS AND RESULTS: Two defibrillation catheter electrodes were positioned in the right ventricle and superior vena cava. Thoracic patch electrodes were placed at three sites (apical, pectoral, and axillary). Fifteen-joule, 10-J, and 5-J bidirectional simultaneous biphasic shocks were delivered across three different triple electrode configurations (right ventricle, superior vena cava, and patch) after inducing ventricular fibrillation (VF), and DFT was determined. All patients in whom VF was reproducibly inducible (14 patients) could be reproducibly defibrillated at 15 J at one or more patch electrode locations. Fifteen-joule shocks were effective at three thoracic electrode locations in 12 patients and at two electrode locations in 6 patients. The lowest mean single-shock DFT was 8.1 +/- 3.8 J. In 4 patients, ventricular flutter was reproducibly induced and reverted at 15 J in all patients. Mean DFT for the axillary location was 8.3 +/- 3.5 J and was significantly lower than apical (12.8 +/- 5.6 J, P = .008) and pectoral (11.6 +/- 4.1 J, P < .04) patch locations. The probability of success was significantly higher at 10 J with axillary location (78% of patients, P < .03 compared with both other sites) and at 15 J (P < .05 compared with the apical location). Low-energy endocardial defibrillation (< or = 10 J) was feasible in 10 of 14 tested patients at more than 1 thoracic electrode location at 10 J, whereas only 1 of 7 successful patients could be reverted at more than 1 electrode location at 5 J (P < .02). CONCLUSIONS: The use of axillary or pectoral patch lead location can allow endocardial defibrillation with biphasic shocks at energies < or = 15 J in this lead configuration. Virtually universal application of endocardial defibrillation lead systems can be predicted from these data. Reduction in maximum pulse generator output to < or = 25 J using these two thoracic electrode locations with bidirectional shocks can be feasible and maintain an adequate safety margin and permit thoracic pulse generator implantation. Lowering endocardial defibrillation energy < 10 J requires increasing specificity of thoracic electrode location.
Bidirectional shocks using 2 current pathways have been used in endocardial lead systems for implantable cardioverter-defibrillators, but the optimal shock waveform for endocardial defibrillation is unknown. The clinical efficacy and electrical characteristics of bidirectional monophasic and biphasic shocks for endocardial cardioversion-defibrillation of fast monomorphic or polymorphic ventricular tachycardia (VT), or ventricular fibrillation (VF) were evaluated. Thirty-three patients (mean age 60 +/- 12 years, and mean left ventricular ejection fraction 34 +/- 13%) were studied. Defibrillation catheter electrodes were located in the right ventricular apex and superior vena cava/right atrial junction. A triple-electrode configuration including the 2 catheter electrodes and a left thoracic patch was used to deliver bidirectional shocks from the right ventricular cathode to an atrial anode (pathway 1) and the thoracic patch (pathway 2). The shock waveforms examined were sequential and simultaneous monophasic, and simultaneous biphasic. The efficacy of 580 V (20 J) shocks for fast monomorphic VT were comparable for the 3 waveforms (73% for sequential monophasic, 73% for simultaneous monophasic, and 100% for simultaneous biphasic). However, for polymorphic VT and VF, 580 V sequential monophasic shocks had a significantly lower efficacy (25%) than did simultaneous monophasic (75%; p = 0.01) or biphasic (89%; p less than 0.001) shocks. Single-shock defibrillation thresholds with simultaneous biphasic shocks were significantly lower (9 +/- 5 J) than were those with simultaneous monophasic shocks (15 +/- 4 J; p less than 0.02).(ABSTRACT TRUNCATED AT 250 WORDS)