Cardiac lead extraction with a novel locking stylet.

Extraction of chronically implanted pacing and defibrillator leads is facilitated by using specialized locking stylets placed in the lead to allow application of traction and to stabilize the lead during sheath dissection of fibrotic tissue. We report the initial multicenter series of cases using a novel lead locking device (LLD). In 57 consecutive patients presenting at 6 institutions for lead extraction, 99 leads were treated using the LLD. After removing the pulse generator, leads were severed, the inner coil dilated and an LLD was successfully inserted and locked in the inner lumen of 95/99 (96 %) leads. With traction applied to the LLD, a variety of sheaths were advanced over the lead body to separate it from adhesions. In 97/99 (98 %) leads, all or most of the lead was removed via the implant vein; 2 leads were removed via the femoral vein. No major complications were observed. The LLD deploys safely and reliably, and provides stable support for advancement of dissecting sheaths.

Intravascular extraction of problematic or infected permanent pacemaker leads: 1994-1996. U.S. Extraction Database, MED Institute.

Of the 400,000-500,000 permanent pacemaker leads implanted worldwide each year, around 10% may eventually fail or become infected, becoming potential candidates for removal. Intravascular techniques for removing problematic or infected leads evolved over a 5-year period (1989-1993). This article analyzes results from January 1994 through April 1996, a period during which techniques were fairly stable. Extraction of 3,540 leads from 2,338 patients was attempted at 226 centers. Indications were: infection (27%), nonfunctional or incompatible leads (25%), Accufix or Encore leads (46%), or other causes (2%). Patients were 64+/-17 years of age (range 5-96); 59% were men, 41% women. Leads were implanted 47+/-41 months (maximum 26 years), in the atrium (53%), ventricle (46%), or SVC (1%). Extraction was attempted via the implant vein using locking stylets and dilator sheaths, and/or transfemorally using snares, retrieval baskets, and sheaths. Complete removal was achieved for 93% of leads, partial for 5%, and 2% were not removed. Risk of incomplete or failed extraction increased with implant duration (P<0.0001), less experienced physicians (P<0.0001), ventricular leads (P<0.005), noninfected patients (P<0.0005), and younger patients (P<0.0001). Major complications were reported for 1.4% of patients (<1% at centers with >300 cases), minor for 1.7%. Risk of complications increased with number of leads removed (P<0.005) and with less experienced physicians (P<0.005); risk of major complications was higher for women (P<0.01). Given physician experience, appropriate precautions, and appropriate patient selection, contemporary lead removal techniques allow success with low complication rates.

Initial experience with larger laser sheaths for the removal of transvenous pacemaker and implantable defibrillator leads.

BACKGROUND: In a previous randomized trial, the 12F laser sheath removed pacing leads via the implant vein more successfully than traditional mechanical tools alone. Two larger sizes of laser sheath, the 14F and 16F models, were developed to extract defibrillator leads and large-diameter pacing leads implanted for the chronic. These devices use pulsed ultraviolet laser light to core though fibrotic tissue grown over the lead body to free the lead from the vasculature. A mandatory prospective registry studied the safety and effectiveness profiles of the larger laser sheaths vis-à-vis the 12F laser sheath. METHODS AND RESULTS: In this study, 863 patients underwent extraction of 1285 leads at 52 sites. Patients treated with the 14F device tended to have older leads than the 12F population; the 16F population, which comprised mostly defibrillator patients, were younger, had younger leads, and were more often male than the 12F population. Clinical success (extracting the entire lead or the lead body minus the distal electrode) was observed in 91% to 92% of cases for all device sizes. The overall complication rate was 3.6%, with 0.8% perioperative mortality. Incidence of complications was independent of laser sheath size. CONCLUSIONS: The 14F and 16F laser sheaths offer an extraction option for larger long-term transvenous pacemaker and defibrillator leads that is as safe and effective as the 12F laser sheath.

Pacemaker lead extraction with the laser sheath: results of the pacing lead extraction with the excimer sheath (PLEXES) trial.

OBJECTIVES: The purpose of this study was to evaluate the safety and effectiveness of pacemaker lead extraction with the excimer sheath in comparison to nonlaser lead extraction. BACKGROUND: Fibrotic attachments that develop between chronically implanted pacemaker leads and to the venous, valvular and cardiac structures are the major obstacles to safe and consistent lead extraction. Locking stylets and telescoping sheaths produce a technically demanding but effective technique of mechanically disrupting the fibrosis. However, ultraviolet excimer laser light dissolves instead of tearing the tissue attachments. METHODS: A randomized trial of lead extraction was conducted in 301 patients with 465 chronically implanted pacemaker leads. The laser group patients had the leads removed with identical tools as the nonlaser group with the exception that the inner telescoping sheath was replaced with the 12-F excimer laser sheath. Success for both groups was defined as complete lead removal with the randomized therapy without complications. RESULTS: Complete lead removal rate was 94% in the laser group and 64% in the nonlaser group (p = 0.001). Failed nonlaser extraction was completed with the laser tools 88% of the time. The mean time to achieve a successful lead extraction was significantly reduced for patients randomized to the laser tools, 10.1 +/- 11.5 min compared with 12.9 +/- 19.2 min for patients randomized to nonlaser techniques (p < 0.04). Potentially life-threatening complications occurred in none of the nonlaser and three of the laser patients, including one death (p = NS). CONCLUSIONS: Laser-assisted pacemaker lead extraction has significant clinical advantages over extraction without laser tools and is associated with significant risks.

Five-years experience with intravascular lead extraction. U.S. Lead Extraction Database.

From December 1988 to April 1994, the extraction of 2,195 intravascular pacing leads from 1,299 patients was attempted at 193 centers. Indications were: infection (54%, including 10% septicemia), pacemaker reoperation with removal of nonfunctional or incompatible leads (40%), and other causes (6%). Extraction was attempted via the implant vein using locking stylets and dilator sheaths, via the femoral vein using snares, retrieval baskets, and sheaths, or via both approaches. Leads had been implanted for 0.2 months to 24 years (mean 56 months). At the conclusion of the intravascular procedure, 86.8% of the leads were completely removed, 7.5% were partially removed, and 5.7% were not removed. For physicians performing their first case, 12% of leads were not removed; for physicians who had performed more than 10 cases, only 2% of leads were not removed. Of the 189 leads where extraction attempts had previously failed, 75.1% were completely removed, 14.8% were partially removed, and 10.1% were not removed. Scar tissue increased in severity with implant duration, was a complicating factor, and was the main cause of failure to remove leads. Use of the femoral approach increased with implant duration (5% of leads implanted 12 months or less, 11% of leads 13 months to 3 years, 20% of leads 4-7 years, and 31% of leads 8-24 years), primarily because of increasingly abundant scarring and prior lead damage. Fatal and near fatal complications occurred in 2.5%, including 8 (0.6%) deaths (3 hemopericardium/tamponade, 1 hemothorax, 3 pulmonary embolus, 1 stroke).(ABSTRACT TRUNCATED AT 250 WORDS)

Intravascular lead extraction using locking stylets, sheaths, and other techniques.

UNLABELLED: Septicemia necessitates extraction of chronic pacemaker leads. Using locking stylets and sheaths to extract leads via the implantation vein (subclavian, cephalic, or jugular) and maneuvering devices, sheaths, and retrieval baskets via the femoral approach, extraction of 228 leads implanted 5 days to 240 months (mean 55 months) was attempted in 136 patients (mean 62 years) at 34 institutions. In addition to septicemia (9%) and infection (39%), total 48%, indications included prophylaxis/replacement (40%), and other (12%). Seventy-seven leads were atrial, 151 ventricular; 147 were unipolar, 81 bipolar; 96 had silicone insulation, 127 polyurethane, 1 poly/silicone, and 2 undetermined. Fixation included tines or fins (160), screw (40), flange (12), and other (16). One hundred and ninety-four leads were completely extracted, 19 partly extracted, and 15 not extracted. Procedural complications were: torn atrium requiring open heart repair (1), hemothorax requiring a chest tube and blood transfusions (1), subacute hemothorax requiring drainage 18 days after discharge (1), thrombosis treated by drugs (1), and myocardial avulsion without sequela (1). Important observations included the significant training required due to the large number of possible clinical variables, and the need to be prepared for life-threatening cardiovascular complications. With training, procedures done at higher volume and lower volume institutions met with similar success. CONCLUSION: Intravascular lead extraction is a viable technique whose benefits outweigh the risks, given the proper intensive training and open heart surgical backup, and may obviate the need for open heart surgery for lead extraction.

Fatigue of the His-Purkinje system during routine electrophysiologic studies.

In this report we describe fatigue of the His-Purkinje system during retrograde stimulation of the His bundle by ventricular programmed stimulation. The patient underwent electrophysiologic evaluation for syncope. Antegrade conduction and supraventricular studies were normal with the exception of baseline left bundle branch block. During programmed ventricular stimulation, the patient developed intra-Hisian and infra-Hisian block with symptomatic 3:1 atrioventricular heart block requiring insertion of a permanent pacemaker. This case demonstrates the need for careful study of both antegrade and retrograde conduction properties of the His bundle and atrioventricular node when performing standard His bundle studies in evaluation of syncope.

Differential electrophysiologic properties of decremental retrograde pathways in long RP' tachycardia.

Long RP' supraventricular tachycardias (SVT) often demonstrate both slow and decremental conduction properties in the retrograde pathway of the reentrant circuit. The electrophysiologic properties of these pathways are poorly understood. We studied 10 patients with long RP' SVT (RP'/RR, 0.52 to 0.71); five had the unusual form of atrioventricular nodal reentry (fast-slow) and five patients had accessory AV pathways with slow, decremental retrograde conduction properties. During SVT, the effects of intravenous adenosine (37.5 to 150 micrograms/kg), which increases potassium current (iK) in supraventricular tissue and hyperpolarizes membrane potential toward Ek (-90 mV), and the response to slow-inward channel blockade with verapamil (0.10 to 0.20 mg/kg iv) were evaluated. Adenosine and verapamil has similar effects in the presence of fast-slow AV nodal reentry since both agents terminated SVT by producing block in the retrograde slow AV nodal pathway. In contrast, adenosine and verapamil had differential effects on retrograde conduction in decremental accessory pathways. Adenosine terminated all episodes of SVT in the retrograde decremental pathway, whereas verapamil had a direct effect on this tissue in only two of five patients. Decremental retrograde accessory pathways can therefore demonstrate at least two types of electrophysiologic responses. Pathways that respond only to adenosine-induced hyperpolarizing K+ current likely comprise depressed fast-Na+ channel tissue, i.e., partially depolarized (greater than -60 to -70 mV) atrial tissue. In contrast, decremental accessory pathways that respond to both modulation of the slow-inward calcium current and K+ conductance have pharmacologic properties similar to those of the AV node and may represent more completely depolarized atrial fibers with resting membrane potentials of -60 mV or less.

Right ventricular blood temperature profiles for rate responsive pacing.

To establish the efficacy of a temperature-based pacemaker control algorithm, right ventricular temperature and heart rate were measured for 12-70 hours in eight patients (51 +/- 17 years) and in one normal volunteer (28 years) during a variety of activities including exercise, rest, sleeping, eating, drinking, and bathing. A diurnal variation in heart rate and temperature was observed. Drinking caused transient temperature changes (less than one minute); during eating, increases of 0.07-0.36 degrees C over 3-12 minutes were observed. An increase of 0.24 degrees C over 8.5 minutes was observed in one patient during bathing. An abrupt drop in temperature was typically observed at the onset of exercise, followed by a steady temperature rise. During treadmill exercise, after a drop (0.13-0.48 degrees C, Bruce n = 4; 0.16-0.34 degrees C, Naughton, n = 3) during the first 1-2 minutes, temperature rose steadily through the end of peak exercise (0.45-1.01 degrees C, Bruce; 0.28-0.47 degrees C, Naughton). A temperature dip was also observed when a patient was told exercise would start but the treadmill failed to turn on. The dip is probably secondary to changes in blood flow from the peripheral circulation to the central system at the onset of exercise. Repeated exercise separated by short rests caused progressive blunting of the initial dip. Right ventricular temperature changes in a predictable manner with daily activity, allowing a temperature algorithm to detect rest and exercise.

Prevalence of ischemia by quantitative thallium-201 scintigraphy in patients with ventricular tachycardia or fibrillation inducible by programmed stimulation.

The prevalence of exercise-induced ischemia was determined by thallium-201 (TI-201) scintigraphic criteria in patients with ventricular tachycardia (VT) or ventricular fibrillation (VF) inducible by programmed electrical stimulation. Thirty-eight patients (age 57 +/- 19 years), of whom 87% had angiographic coronary artery disease, underwent quantitative TI-201 exercise scintigraphy within 14 days of invasive electrophysiologic testing. The mean rest ejection fraction was 38 +/- 9%. Eighty percent of patients had 1 or more regions with akinetic or dyskinetic wall motion. Thallium-201 scan segments were scored as normal or containing redistribution defects or mild or severe persistent defects. Only 4 patients (10%) had only redistribution defects and 9 (24%) had both redistribution defects and persistent defects; 32 of 38 patients (84%) had 1 or more persistent defects, of which 26 had at least 1 severe, persistent defect (more than 50% reduction in TI-201 activity). Patients with and without exercise-induced VT had a similar prevalence of redistribution. Redistribution defect prevalence was similar in patients with polymorphic VT (3 of 13) and monomorphic VT (10 of 25) during programmed electrical stimulation (difference not significant). Thus, patients with VT or VF induced by programmed ventricular stimulation have extensive TI-201 scintigraphic abnormalities on exercise scintigrams, predominantly those suggesting scar, with associated severe regional wall motion abnormalities at rest. The scintigraphic prevalence of exercise-induced ischemia is low and TI-201 redistribution and exercise ST depression are observed with equal frequency in patients with and those without VT induced during exercise.

Adenosine: a clinical experience and comparison with verapamil for the termination of supraventricular tachycardias.

The efficacy and side-effects of adenosine for treatment of supraventricular arrhythmias were compared to verapamil therapy in patients presenting to the emergency room. Clinical variables and the time interval from the initiation of treatment to the termination of the supraventricular tachycardia, as well as the time from the initial effective dose of medication to the termination of supraventricular tachycardia were compared for adenosine and verapamil. Adenosine was given to a total of 44 patients, 16 patients in the electrophysiology laboratory, and 28 patients in the emergency room for evaluation and termination of their tachycardia. In the electrophysiology laboratory, 7 patients had AV node reentry, 5 had Wolff-Parkinson-White syndrome, 2 of whom had atrial flutter and fibrillation but no bypass tract reentry, 1 had concealed bypass tract reentry, 1 had Lown-Ganong-Levine syndrome, 1 had intraatrial reentry, and 1 had an automatic atrial tachycardia. Twenty-five patients received adenosine in the emergency room and 3 patients in the hospital for 31 episodes of supraventricular arrhythmias. In the emergency room, 11 patients had supraventricular tachycardia due to AV node reentry, 3 had Wolff-Parkinson-White syndrome, 6 had atrial flutter or intra-atrial re-entry, 2 had ventricular tachycardia, and 3 had sinus tachycardia. In the hospital, 2 patients had atrial flutter and one had sinus tachycardia. The group of 14 patients with supraventricular tachycardia due to Wolff-Parkinson-White syndrome or AV node reentry presenting in the emergency room were compared in a retrospective manner to the patients treated with standard verapamil therapy with respect to time from initiation of therapy to termination of supraventricular tachycardia and time from effective dose of medication to the termination of supraventricular tachycardia, as well as side-effects. There was no significant difference between the two groups with respect to clinical variables. Adenosine converted 18 of 18 episodes of supraventricular tachycardia in 14 patients 24.6 +/- 9.6 seconds from the administration of the effective dose (0.104 +/- 0.024 mg/kg) and a mean of 4.4 +/- 2.0 minutes from the initiation of therapy. Verapamil converted 29 of 32 episodes of supraventricular tachycardia in 20 patients, 10.9 +/- 7 minutes from the administration of the effective dose, and a mean of 16.8 +/- 20 minutes from the initiation of therapy using a mean of 8.4 +/- 3.4 mg of IV verapamil.(ABSTRACT TRUNCATED AT 400 WORDS)

Adverse reactions to antiarrhythmic drugs during therapy for ventricular arrhythmias.

We analyzed the incidence of adverse reactions to antiarrhythmic drugs in 123 consecutive patients with a history of sustained ventricular tachycardia or ventricular fibrillation. Blood levels were measured serially and were maintained within the usual therapeutic range. Minor reactions were defined as those that required dosage reduction and major reactions as those that required drug discontinuation or permanent pacing for bradycardia. A total of 237 individual, oral drug trials were evaluated in the 123 patients. Adverse reactions were noted in 79 trials (33%). Fifty-nine (48%) of the 123 patients had one or more adverse reaction. Major reactions were noted in 36 patients (29%). Adverse effects occurred during 49% of trials with mexiletine hydrochloride, 44% of trials with amiodarone, 24% of trials with procainamide hydrochloride, and 18% of trials with quinidine sulfate or gluconate. In conclusion, clinically significant adverse reactions are common during drug therapy for ventricular arrhythmias. These observations indicate that with the drugs used in this study, an acceptable risk-benefit ratio will be possible only in patients at a significant risk for a symptomatic arrhythmia. Antiarrhythmic drug therapy in patients at low risk for serious arrhythmia should be discouraged.

Syncope as a symptom. A practical approach to etiologic diagnosis.

Etiologic diagnosis of syncope is best approached within the framework of three categories: cardiovascular, noncardiovascular, and unexplained. A meticulous history and physical examination plus screening laboratory studies will pinpoint a cause in nearly half of cases. In patients who have recurrent syncope, a history suggestive of dysrhythmia, or structural heart disease, further testing may include a variety of procedures such as 24-hour electrocardiographic monitoring, two-dimensional echocardiography, exercise stress testing, and electrophysiologic testing.

Sustained ventricular tachyarrhythmias within 2 months of acute myocardial infarction: results of medical and surgical therapy in patients resuscitated from the initial episode.

Sustained ventricular tachycardia or fibrillation that develops during the early recovery period after acute myocardial infarction is a common clinical problem whose management remains controversial. Fifty-three patients who survived an initial episode of sustained ventricular tachycardia or fibrillation occurring between 3 and 60 days (mean +/- SD 21 +/- 16) after myocardial infarction were evaluated. Most of these patients had had a large (peak creatine kinase = 1,729 +/- 882 IU) complicated infarction. Forty-two (79%) of the 53 patients had had repetitive sustained ventricular arrhythmias and the condition of 19 of these could not be stabilized with drug therapy. Twenty-eight patients received medical therapy only. Twenty-four survived and were discharged from the hospital. Twenty-five patients underwent infarctectomy or aneurysmectomy either on an emergency basis (16 patients) or electively because of coexistent heart failure or angina (9 patients). Intraoperative mapping was attempted in these patients but was completely successful in only 13 (52%). Operative mortality was 16% with all deaths occurring in patients who were in shock before surgery. Five of 21 surgically treated survivors required long-term antiarrhythmic therapy. Twenty-one of 24 patients medically treated remain alive and well after 15 +/- 10 months of follow-up. Nineteen of 21 surgically treated patients remain alive and well after 17.9 +/- 11 months. One of these patients required reoperation for severe mitral regurgitation. These results confirm the poor medical prognosis of sustained ventricular tachyarrhythmias that present during the first 2 months after myocardial infarction but demonstrate that an acceptable rate of survival can be achieved with a combined medical and surgical approach to therapy.

Effects of coronary grafting technique upon reperfusion cardiac rhythm, ventricular function, and other variables.

The effects of different techniques of aortocoronary bypass grafting on reperfusion cardiac rhythm and ventricular function have not been systematically evaluated for possible advantages or disadvantages. The placement of proximal anastomoses before cardiopulmonary bypass and sequential coronary grafting with reperfusion via both the grafts and the native circulation were prospectively compared to traditional grafting and reperfusion via native arteries. More than 40 biochemical, thermal, temporal, hemodynamic, and other variables, including arrhythmias and myocardial failure, were measured intraoperatively and postoperatively. Spontaneous resumption of a cardiac rhythm occurred more frequently with traditional grafting technique in association with a larger cardioplegia volume and a higher serum potassium. However, the disadvantage of the traditional technique was a higher incidence of cardiac failure postoperatively and greater use of isoproterenol after discontinuation of bypass. While cardiac rhythm resumed spontaneously more often with the traditional technique, the increased incidence of cardiac failure postoperatively has serious implications. Thus, placement of proximal anastomoses before cardiopulmonary bypass seems warranted.

Diagnostic and therapeutic use of adenosine in patients with supraventricular tachyarrhythmias.

Adenosine has been shown to affect both sinus node automaticity and atrioventricular (AV) nodal conduction. The effects of increasing doses of intravenous adenosine were assessed in 46 patients with supraventricular tachyarrhythmias. Adenosine reliably terminated episodes of supraventricular tachycardia in all 16 patients with AV reciprocating tachycardia, in 13 of 13 patients with AV nodal reentrant tachycardia and in 1 of 2 patients with junctional tachycardia with long RP intervals. Adenosine produced transient high grade AV block without any effect on atrial activity in six patients with intraatrial reentrant tachycardia, four patients with atrial flutter, three patients with atrial fibrillation and in single patients with either sinus node reentry or an automatic atrial tachycardia. The dose of adenosine required to terminate episodes of supraventricular tachycardia was variable (range 2 to 23 mg). Side effects were minor and of short duration. These results demonstrate that adenosine is useful for the acute therapy of supraventricular tachycardia whenever reentry through the AV node is involved. When arrhythmia termination is not affected, atrial activity may be more readily analyzed during adenosine-induced transient AV block.

Low-energy defibrillation: safe and effective.

During cardiopulmonary bypass, 150 cardiac surgical patients were prospectively evaluated for the number, energy, current, and success rates of direct current (DC) shocks required to terminate reperfusion ventricular fibrillation (1 degree) or ventricular fibrillation occurring subsequent to a nonfibrillatory reperfusion rhythm (2 degrees). Thirty-one percent of 1-J shocks and 58% of 2.5-J shocks defibrillated. Above 2.5 J, the defibrillation success rate reached a plateau of 50-60%. Myocardial resistance decreased significantly after the first shock but remained stable during subsequent shocks. Lower defibrillating currents and myocardial resistances than had been previously reported were observed. The feasibility of low-energy defibrillation during cardiopulmonary bypass was therefore documented.

Acute electrophysiologic effects of bethanidine sulfate in patients with ventricular tachycardia or fibrillation.

Ten patients with a history of ventricular tachycardia or ventricular fibrillation underwent electrophysiologic study with programmed stimulation before and 90 minutes after oral administration of bethanidine sulfate, 20 mg/kg. Mean plasma bethanidine concentration was 2.62 +/- 2.2 (+/- SD) micrograms/ml at the start of repeat testing. This dose of bethanidine produced no effect on sinus node function, atrioventricular conduction, or atrial or ventricular refractoriness. Ventricular tachycardia or fibrillation, inducible in all patients during the control study, could still be initiated by ventricular stimulation in 9 of 10 patients after bethanidine. Bethanidine suppressed the ability to initiate an arrhythmia in one patient with ventricular fibrillation during control stimulation. Orthostatic hypotension was seen in all patients despite pretreatment with the tricyclic antidepressant, protriptyline, 15 mg every 8 hours. The results suggest that bethanidine has few electrophysiologic effects and is of limited efficacy during electrophysiologic testing in patients with life-threatening ventricular arrhythmias.

Determinants of reperfusion cardiac electrical activity after cold cardioplegic arrest during coronary bypass surgery.

In a prospective study of 99 patients with coronary artery disease, reperfusion of the heart after a period of ischemia (protected by contemporary techniques of myocardial preservation) resulted in spontaneous resumption of cardiac electrical activity in 53%, spontaneous defibrillation in 10%, reperfusion ventricular fibrillation (VF) in 32% and indeterminate rhythm in 5%. In hearts spontaneously developing rhythms excluding VF (as opposed to hearts requiring direct-current shock), factors significantly associated were a higher plasma potassium concentration (5.2 vs 4.8 mEq/liter), shorter reperfusion time (1 vs 4 minutes), higher plasma magnesium concentration (1.36 vs 1.25 mg/dl) and a lower myocardial temperature (27 vs 32 degrees C). The duration of ischemia, arterial blood gas levels, plasma catecholamine levels, plasma ionized calcium levels, volume of cardioplegia and mean arterial pressure did not relate to occurrence of spontaneous episodes. However, VF developed in 39 of 52 patients (75%) with spontaneous resumption of electrical activity. This event was associated with lower myocardial temperature. Thus, direct-current shocks were ultimately required in 77 of the 99 patients (78%). Although certain thermal, biochemical and hemodynamic variables facilitate spontaneous resumption of cardiac rhythm, the development of VF may negate the potential benefit of this event in the prevention of myocardial damage from direct-current defibrillation.